chrisvoncsefalvay/vaers-outcomes huggingface dataset:
developed burning, hot and redness on her face; hot and redness on her face; redness on her face; Chills; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (developed burning, hot and redness on her face), FEELING HOT (hot and redness on her face), ERYTHEMA (redness on her face) and CHILLS (Chills) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced BURNING SENSATION (developed burning, hot and redness on her face), FEELING HOT (hot and redness on her face), ERYTHEMA (redness on her face) and CHILLS (Chills). At the time of the report, BURNING SENSATION (developed burning, hot and redness on her face), FEELING HOT (hot and redness on her face) and ERYTHEMA (redness on her face) had resolved and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  The patient received treatment with diphenhydramine (Benadryl).
no additional AEs reported; GARDASIL 9 were administered to multiple unknown patients following temperature excursion; This non-valid, spontaneous report was received from an office manager and referred to multiple patients of unknown age and gender. The patients' concurrent conditions, concomitant therapies and medical history was not provided.  On an unknown date, multiple patients were vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe, injection, 1 dose, lot # and expiration dates: 1775811, 07-DEC-2023; 1775827, 27-JUN-2024; W009829, 19-OCT-2024; U032681, 26-OCT-2023; and 1780876, 09-NOV-2023 (administration sites, and routes of administration were not provided) administered for prophylaxis.On unknown dates, the doses of vaccines experienced the temperature excursions of 8.55 Celsius degrees for 8 minutes and 9.29 Celsius degrees for 12 minutes (product storage error). There were no previous excursions reported. No additional adverse event (AE) details were reported (no adverse event).  This report is non-valid due to lack of patients' identifiers.  Follow-up information was received from an office manager on 10-MAY-2023:  The patient identifiers was updated such as date of birth, address and gender.  On 21-NOB-2022, the patient was vaccinated with one dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe, injection, 1 dose, lot # and expiration dates: 1775811, 07-DEC-2023; 1775827, 27-JUN-2024; W009829, 19-OCT-2024; U032681, 26-OCT-2023; and 1780876, 09-NOV-2023 (administration sites, and routes of administration were not provided) administered for prophylaxis.  Temperature excursion total time was 25 minutes. There was 3 temperature excursions: on 09-SEP-2022 for 8 minutes, on 16-SEP-2022 for 5 minutes and on 03-JAN-2023 for 12 minutes. Excursions were not noted until after the first fact due to employee error of cleaning data logger more than once a day.  The vaccines was purhased with public and privet founds and were given in private doctor's office/ hospital.The medication error occurred in the point of storage in clinical practice.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2304USA002221:
Patient reports redness around injection site 3inx3in in size, swollen to approximately 1/4 inch thickness, itches and pain.
Vagal response - dizzy, nauseated. Gave vaccine lying down due to previous fainting with vaccines.
Mom called 6/26/13 stating patient had swelling, tenderness, redness of muscle where he received his meningitis vaccine. Mom states it began day after it was given and lasted till 6/24/13 when it finally resolved. Mom states patient told her that his muscle also felt like it was twitching but usually mom could not see anything. Mom states Ibuprofen was given and symptoms resolved. Patient had no fever.
Patient had severe pain in his right shoulder that required numerous doctor visits. patient is still having pain a year later.
12 year old that received  Dtap instead of Tdap/ No AE; 12 year old that received  Dtap instead of Tdap/ no AE; Initial information received on 17-Sep-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 12 years old patient who received 0.5 ml dose of vaccines DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (lot C5254AB and expiry date: 18-Sep-2019) instead of DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE on 22-Jul-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant vaccination included MENINGOCOCCAL VACCINE A/C/Y/W CONJ (DIP TOX) (MENACTRA) for Immunisation.   It was an actual medication error due to wrong vaccine administered and Inappropriate age at vaccine administration.  At the time of reporting no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Numbness of left arm from injection sight down to hand. No feeling still. Left side chest pain
A report was received from a female vaccinee in the USA on 2/11/05. No details were provided regarding the vaccinee's medical history or concomitant medications. The vaccinee has stated she has no allergies to eggs. In December 2001, the vaccinee received an influenza vaccination. Within 10 days after vaccination, the vaccinee experienced many symptoms including dizziness, ringing of the ears and total imbalance. The vaccinee was referred to a neurologist who diagnosed her symptoms as a severe reaction to the flu vaccination. The vaccinee underwent physical therapy and it was explained that the symptoms might never completely disappear. The symptoms reoccur when the vaccinee is tired. Follow up information will be sought. A follow up report was received from a female vaccinee in the US on 2/23/05. On an unspecified date in December 2001, the vaccinee received Fluvirin (batch # E10801LA). The vaccinee was treated for what was thought to be an inner ear infection because of extreme dizziness, nausea, ringing of the ears and other symptoms. The vaccinee was seen by a neurologist who diagnosed a severe reaction to the flu shot. The vaccinee was extremely limited in her every day activities. The vaccinee's symptoms have not diminished and often re-occur when she is extremely fatigued. Further information is expected.
Information has been received from a registered nurse referring to a patient of unknown age and gender. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions reported. On 26-AUG-2015, the patient was vaccinated with ZOSTAVAX (1 ml, Lot #L016284, expiration date: 07-AUG-2016), which were improperly stored for 13 days. The outcome was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Excessive redness and swelling at injection site, severe itching over entire body. Ice applied to site, loratadine 10 mg given.
Leak from luerlock and unable to estimate if more than half a dose given; full dose immediately administered after in opposite arm
Painful for the shot; bright red, Some Redness; left arm swollen, left arm was swollen above shoulder almost down to elbow; groggy; felt like she had been drugged, terrible reaction to third shot.; Caller reports she is not immunocompromised, Patient states "I got my booster shot"; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Painful for the shot), VACCINATION SITE ERYTHEMA (bright red, Some Redness), VACCINATION SITE SWELLING (left arm swollen, left arm was swollen above shoulder almost down to elbow), SOMNOLENCE (groggy) and FEELING ABNORMAL (felt like she had been drugged, terrible reaction to third shot.) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039D21A, 042L20A and 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LEVOTHYROXINE, VITAMIN B NOS (B-COMPLEX [VITAMIN B NOS]) and CALCIUM for an unknown indication.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Oct-2021, the patient experienced SOMNOLENCE (groggy), FEELING ABNORMAL (felt like she had been drugged, terrible reaction to third shot.) and OFF LABEL USE (Caller reports she is not immunocompromised, Patient states "I got my booster shot"). On 13-Oct-2021, the patient experienced VACCINATION SITE PAIN (Painful for the shot), VACCINATION SITE ERYTHEMA (bright red, Some Redness) and VACCINATION SITE SWELLING (left arm swollen, left arm was swollen above shoulder almost down to elbow). The patient was treated with NAPROXEN SODIUM (ALEVE) at a dose of 1 dosage form. On 12-Oct-2021, OFF LABEL USE (Caller reports she is not immunocompromised, Patient states "I got my booster shot") had resolved. At the time of the report, VACCINATION SITE PAIN (Painful for the shot) and VACCINATION SITE SWELLING (left arm swollen, left arm was swollen above shoulder almost down to elbow) was resolving and VACCINATION SITE ERYTHEMA (bright red, Some Redness), SOMNOLENCE (groggy) and FEELING ABNORMAL (felt like she had been drugged, terrible reaction to third shot.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant include : B - shot 1/month, crill oil , organic collagen.  Treatment include : Treatment Aleve in morning and night for a knee that was acting up for about three weeks (that started before shot).   This case was linked to MOD-2021-354658, MOD-2021-354665 (Patient Link).
Prior to initiating the Engerix-B immunization series, and after the 1st and 2nd injection of Engerix-B, the vaccinee tested negative for Hep-B surface antigen (HBsAg). On 1/8/02, the vaccinee received his 3rd injection of Engerix-B. On 1/15/02, 7 days post vax, the vaccinee tested positive for HBsAg. Tests for HBsAg on 1/16/2002 and 2/7/02 were also positive. Liver function tests were "within normal limits", and he was not exhibiting signs of Hep-B infection. Two donors for the vaccinee's previous blood transfusions were re-tested for the Hep-B virus; both were negative for HBsAg. The reporter considered the positive HBsAg tests to be possibly related to Engerix-B administration.
Pain in arm: 7/30-7/31 Pain in shoulder radiating up the neck 7/31 morning, subsided with one dose of Tylenol, returned 8/2  Tight chest 7/31-8/1 Lightheadedness, nausea, mild headache 7/31 morning
Patient passed out approximately 15 minutes after the injection and urinated her pants. No further care or actions needed at this time.
This spontaneous report as received from a nurse practitioner refers to a patient of unknown age and gender. The patient was administered dose 1 of GARDASIL on 17-OCT-2013, dose 2 on 14-nOV-2013 and dose 3 on 04-FEb-2014. Lot numbers, route and dose were not reported. No adverse effects were reported. Additional information has been requested.
Flulike symptoms (chills, muscle aches, joint aches, hot and cold spells) beginning 4/21 around 10 pm resolved by 4/23 AM Arm soreness at injection site beginning 4/21 evening and resolved 4/23 am.
Within nine hours of receiving the shot I began to suffer chills and a fever of 101.6, with a high of 101.8.  The fever lasted 12 hours.  I also had fatigue, headache, metallic taste in month and dizziness.  I felt awful.  I began to feel better after about 2 1/2 days.  I still have an occasional headache (not severe or constant), but it seems more allergy related (stuffy nose and drainage).  I would not take the vaccine again because I  thought my response was too strong.  I thought I would provide this information given the pause of the vaccine, so you could gather additional information/feedback.
Received vaccine to left arm at 3:15-3:30pm on 7/25/21. By 11:30 pm, onset of arm pain at injection site and left 4th and 5th fingers tingling and numbness. Arm pain resolved in 48 hours. I continue to have numbness and tingling to left 4th finger.
Pt received yellow fever vaccine. She became having a reaction that night. Fever 102.7. Body aches, she thought throat was swelling used inhaler. Went to her physician 7-8-13.
Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037B21A - 025B21A and 026A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Mar-2021, the patient 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 received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication information was reported. No Treatment medications were provided   This case was linked to MOD-2021-326632.
Patient was given Hepatitis A vaccine and did not need one was due for a MENACTRA. Age of patient at time of event: 11 years.
This spontaneous report was received from a Registered Nurse referring to a patient of unknown age and gender. Information about the patient's medical history and concurrent conditions was not provided. On 21-MAR-2016, the patient was vaccinated with an improperly stored (Temperature: 32F - Time frame: 5 minutes) dose of VAQTA (lot # L023232 and expiration date: 25-FEB-2016, administration route was not provided). No concomitant therapies were reported. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Immediately after nausea, body aches, 10 mins- itchy in my throat inside and out, red rash on my throat- external, throat tightened. 2 days arm soreness, next few days I felt like I had COVID-19.
A 6 foot adult appearing male, received the Moderna vaccine. The afternoon of his vaccination we recognized the patient was 15 years old.  We immediately called the mother. The child had been completely asymptomatic four hours after receiving the vaccine. The following morning the patient continued to have no symptoms, as we communicated with the Mother.
Lot # may have been FJ5682. My card is confusing. The night of my shot my blood pressure was very high, higher than normal. This continued on 4/14 until the PM -- so 24 hours. I also started developing a cold sore which manifested approx. 4/16-17. I was prescribed valacyclovir on 4/20/22 by my dermatologist.  All of these events may not have been related, but the timing was suspicious. No other adverse effects.
7/28/21 significant past medical history of HTN, DM2, and squamous cell carcinoma of chest wall; presents w/a chief complaint of SOB, fever, lightheadedness, and cough
Breakthrough case admission after three vaccines Pfizer 5/17/21 Lot# Ew0176;  Pfizer 6/19/21 LOt# Ew0167;  Pfizer 2/14/22 LOt# FJ6369
No adverse event. Wrong vaccine given to newborn. Instead of Hep B, the baby received TdaP (adacel)
Redness around injection site - left thigh - acutely occurred within 1-2 minutes, several cm wide.
~15-30 minutes after receiving fluzone in left deltoid mtoher stated that pt. tongue began to swell.  Two hours after symptoms began his mother called the health department and stated that his tongue was swelling and wanted to know what to do.  Health department staff informed mother to immediately call 911, but had caregiver take him to local ER. According to mother, he received benadryl and steriods and sent home from ER.  He was home resting, without any difficulty, within 3 hours of treatment.
On 12/25/21 I started feeling lightheaded and when I was walking to the bathroom I passed out and when I got to the bathroom I passed out again. So then I had to lay down for about an hour I got clammy and then I felt better, it happened again in March of 2022 I was out and went out to eat and felt lightheaded and felt dizzy and told my friend I was dizzy but my friends stated I passed out 3 times but I don't remember and my friend stated I hit my head on the table and had to have a MRI done in March.
got soreness in the arm; This is a spontaneous report from a contactable consumer (patient):  A male patient of unspecified gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) on 20Jan2021 at single dose via an unspecified route of administration for COVID-19 immunization. Relevant medical history and concomitant medications were not reported. On an unspecified date after vaccination patient got soreness in the arm. He asked if Tylenol or aspirin could relax the pain. At the time of the reporting event outcome was unknown.  Information on the lot/ batch number has been requested.
Patient received FLUMIST on 9/26/14. The following day he had a stomach ache, congestion, stuffy nose and he broke out in a rash.
I have a history of a cyst on the right side of my upper back. A week after my vaccination I started to feel the cyst on my back when I would stretch. It was not painful but just annoying. Not too long after I noticed swelling on the right side of my neck where a lymph node was. I went to my physician and they did notate that my cyst had grown and it had become slightly red. I was prescribed, a medication to help reduce the swelling of the cyst , which was Doxycycline.  I also met with my general surgeon and he recommended that we reduce the size of the cyst before removal and gave me a topical cream. My primary care agreed with treatment options and believe that the lymph node swelling has to do with the cyst. Right now I have stopped feeling my cyst which may mean it has reduced in size a bit. Lymph node swelling is still present however it is the size of about a pea. No notable symptoms other than swelling and if I move my head from side to side.
sore arm; tiredness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and FATIGUE (tiredness) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced FATIGUE (tiredness). On 28-Apr-2021, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) and FATIGUE (tiredness) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Apr-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications reported.  No treatment information was provided.
Vaccine was administered high on right arm. She began experiencing arm/shoulder pain which has grown progressively worse and is limiting movement ability. We will proceed with medical care through occupational health and in conjunction with her primary care physician.
On 8-5-11 at 3:08 p.m. mom reported pt had developed a 3 inch long red, raised area on the (R) leg that was warm to touch. She also had a fever of 102. Was seen on 8-6-11 at 4:30 pm and the area of redness was 9cm x 4cm. Was started on Amoxicillin 250mg TID x 7 days.
Pt. states after receiving the 2nd dose 06/21/2021 that evening feeling fatigued. Next morning 06/22/2021 really feeling fatigued and nauseous. Dr. conversation, stating doctor did not believe the existence of symptoms. Still feeling exhausted, muscle pain, fatigued, nauseous, stabbing pain in the right temple, left side abdomen pain, whelps on neck left side, hives present on back, wheezing at times.  Chest pains on/off.