chrisvoncsefalvay/vaers-outcomes huggingface dataset:
7 years old was administered Flublok, no AE; Initial information received on 08-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case is linked to case 2019SA281991 (same reporter).  This case involves a seven years old patient (gender not reported) who received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot number and Exp. Date not reported) via unknown route in unknown administration site on an unknown date.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error case due to inappropriate age at vaccine administration.  At the time of reporting, no adverse reactions were reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.  Information on the batch number was requested.  List of documents held by sender: none.
1 week after receiving the vaccine the same arm that received the shot had aches between elbow and neck.  A red spot appeared on the arm slightly below the injection site about 3 to 4 inches in diameter that was tender, warm and swollen.  Discomfort and redness lasted about 2 days.  Took ibuprofen to ease the discomfort.
About 5 weeks after getting the vaccine, both of my lower legs (knee and below) started to hurt and they feel like they are swollen.  Sometimes it hurts just to stand up.
Information has been received regarding a case in litigation from a lawyer, a male patient of unknown age, and his spouse. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant. The patient was prescribed the ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On an unknown date in 2015, the male patient was administered the ZOSTAVAX by a pharmacist in a pharmacy (lot number, dosage and route of administration not provided). On an unknown date later in 2015, the patient was treated by a healthcare provider at a hospital for the following injury resulting from his ZOSTAVAX use: shingles. The patient claims damages including: injury to themselves, loss of consortium, and economic losses. The outcome of the shingles is unknown. Additional information has been requested.
Positive pregnancy on 4/7/08, 5 6/7 week gestation.
5/2/07 Local - Red 1/4 area Midday - 24 hrs later, local area became swollen. Systemic - stiff neck and achy joints, wrists ankles, knees, jaw - hot - cold flashes through head 5/2, s5/4 stiff neck and hot flashes continue, face flushed slightly
08/09/2009 Mild, other. Redness. 3 inch diameter, tender to touch.
A lot of pain in the arm (left) where the injection was placed; Could not lift arm; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (A lot of pain in the arm (left) where the injection was placed) and VACCINATION SITE MOVEMENT IMPAIRMENT (Could not lift arm) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced INJECTION SITE PAIN (A lot of pain in the arm (left) where the injection was placed) and VACCINATION SITE MOVEMENT IMPAIRMENT (Could not lift arm). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, INJECTION SITE PAIN (A lot of pain in the arm (left) where the injection was placed) and VACCINATION SITE MOVEMENT IMPAIRMENT (Could not lift arm) outcome was unknown.        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.   Concomitant medication was not provided.  Treatment includes warm and cold compress alternately, aspirin cream on the area.   Reporter did not allow further contact
The patient was administered a volume of 0.25mL instead of the appropriate volume of 0.5mL. The error was recognized the following day and outreach was made to Moderna and CDC for clinical recommendations for the next step. Upon response from the clinical team 9 days later the patient was informed of the error and was given the direction to return to the pharmacy at as soon as possible to receive a complete dose of 0.5mL. No adverse events had been reported. Patient received full dose on 9-16-22
Patient seen at ED with redness and swelling at vaccination site. Ultrasound done at ED showing cellulitis. Patient was prescribed Clindamycin for cellulitis and lactobacillus to prevent diarrhea.
I felt itching right after taking the vaccine. I stayed for 30 min and it was not getting worse. The next day, when I waked up, my left arm is swelling and itching. Redness appears as an allergy symptom. The itching, swelling,  redness did not go off until today, which has been a week after the vaccine. The symptom is only limited to the left arm, near the injection site.
The evening of shot started having pain that didn't go away and it became very bad in joints and muscles of upper arm which went down to his elbows on his left arm. Have hard time putting on shirts because of the pains
Around 6:30pm on 7/28/21 pt complained  of tingling/warmth/ redness down legs.  Mom gave does of bendaryl. Patient is better today. No longer has symptoms.
After the 2nd vaccine, I had a typical achy arm and I felt tired and run down. Less than 24 hours, I was feeling back to normal. Around 8/6/2021 I started to come down with flu like symptoms- pressure in my sinus near my eyes, fatigue, upset stomach, sneezing, runny nose and pressure in my ears. I did go see the doctor and I got tested for COVID and it was negative. The doctor did recommend OTC medications but I decided to just increase my vitamins. Those flu like symptoms resolved within 24 hours. Recently, around 8/16/2021, I have been noticing a pain in my right leg. It starts mid calf and going toward my foot and to my ankle. I can feel the pain in my bone right below the ankle. When I use my foot to walk or step, that is when I feel the pain. It feel uncomfortable. On a scale of 1-10 the pain right now is around a 2. I have not seen a doctor about this pain.
pt recv vax 21AUG96 & 5NOV97 pt devel chickenpox that consisted of less than 10 lesions;
Headache, Fever, inj site pain/soreness/tenderness; body aches, chills, fever, headache Narrative: Day 1 -inj site pain 3-4 hours after shot and body aches; Day 2-inj site tenders, warm to touch, redness, sore, chills, fever, headache; Day 3 - inj site sore chills and fever; Day 4 - inj site soreness
Hives on both legs, 25mg Benadryl every 4 hours.
Initial information received on 03-Oct-2018 regarding an unsolicited valid non-serious case received from other health professional (physician assistant). This case involves a 10 years old male patient who was vaccinated with a dose of suspect IPOL, lot N1J451M, expiry date: 05-Oct-2019 via unknown route in the right deltoid on 02-Oct-2018, which was improperly stored. The patient's past vaccination(s) included Polio Vaccine with 3 Oral and 2 inactivated. The patient's past medical history, medical treatment(s) and family history were not provided. It was an actual medication error due to incorrect product storage. It was reported that temperature excursion occurred and reached a low temp of 32.7 F for total time of 3 hours and 58 minutes. It was reported that no known reported symptoms. 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.
Nurse that administered the COVID vaccine on 12/06/2022 and 01/09/2023 was informed by patient that his physician requested him to be revaccinated with all vaccine due to being a Bone Marrow Transplant (BMT) patient.
Shortness of Breath, Low Oxygen Saturation, Coughing Interstitial Lung Disease Flare
mild SOB, rash at upper chest area, mild tongue swelling (as stated by pt)
heart palpitations; chest tightness/chest was a little tight; fever/felt feverish with a temperature of100.4; feeling exhausted and has fatigue; This is a spontaneous report received from a contactable consumer(patient). A 59-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCIN), dose 1 via an unspecified route of administration, administered in arm left on 08Aug2021 13:30 (Lot Number: FA7485; Expiration Date: 31Oct2021) at the age of 59-year-old as single dose for covid-19 immunisation. Patient had COVID virus 18Feb2021 to 01Mar2021. The fever had gone away before he got the vaccine. Patient had benign heart murmur from 1974 (from 12 years old). His dad had open heart bypass when he was 62 years old and his dad died of a heart attack. The patient's concomitant medications were not reported.  No other drugs were received prior Vaccinations (within 4 weeks). Patient mentioned that he had the side effects that people in general have. He experienced fever, chest tightness, feeling exhausted and has fatigue on 10Aug2021. Patient also had heart palpitations which he described as "unbelievable" on 10Aug2021. These events did not result in emergency room or physician office. Clinical course: patient stated he didn't have any side effects for the first 24 hours. His injection site never hurt. The next day (10Aug2021) he felt feverish with a temperature of 100.4, so he took paracetamol (TYLENOL); he felt like he had COVID again on 10Aug2021; his chest was a little tight; he was exhausted and  fatigued; then he started to experience heart palpitations like skipping beats. During the day they were very pronounced but they seemed to go away at night. During the day he could feel the palpitations. The fever was only that day. He took paracetamol once and the fever didn't come back. Patient stated a little palpitation not a big deal to him; but the palpitations he got after the vaccine were unbelievable although not so bad when laying down. He was scheduled to get the second dose of the vaccine this past Sunday. He isn't going to get it until he see a cardiologist. He had not seen a doctor or had any tests yet. He has an appointment 22Sep2021 with a cardiologist. And he was planning to get an antibody serum test tomorrow or the next day.  His symptoms have subsided now and gone away. Outcome of fever was recovered on 10Aug2021, of other events was recovered on 15Aug2021.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Patient jerked away upon administration resulting in the left arm being scratched by the needle. Patient then held arm still for proper administration. Small area, very shallow scratch, whole area (scratch and injections site) covered with adhesive bandage. Whole dose administered at once.
10 mins. after pt. received the flu shot she complained of chest pain.  The nurse gave her NTG. & then the pt. c/o of difficulty breathing so the nurse started the pt's O2. After approximately 2 mins. the pt became unconscious and fell to the floor.  The nurse called 911, administered 0.3 ml of adrenalin & performed CPR.  The pt. responded within 30 seconds. The EMT's arrived, took over care of the pt. & transported her to the ED.  She was in the hospital overnight in the telemetry unit & discharged the following day. The hospital discharge summary received on 12/11/03 states syncope.
After one week, was in hosp. for 2 wks with pneumonia. The discharge summary received on 1/28/04 states fever, chills, weakness and hyponatremia.
Fatigue, joint pain in knees, headache, very sore arm. Overall stiffness in body and tiredness throughout the day, but severe joint pain in knees is the worst part. It had gone away for 2 weeks after having it for 2-3 weeks straight after the second shot, but it has come back as of 5 days ago. This is pain I've never had before in my life.
Sore throat, cough, congestion, fatigue. symptoms resolving.starting 1/5/22
Improper administration- Injected too high- hit bone and has had shoulder discomfort for 2 weeks. Patient will be seeing provider.
Red itchy eyes, throat dry, coughing more. BP elevated from normal range 149/93 Pulse 113; earlier BP checked was much lower during dental visit, dizziness/lightheaded. During PHA screening, BP 122/77.
Narrative:  Patient has a hx of migraines since 04/2020. After receiving the JJ/Janssen Covid vaccine(exp 5/25/21) on 3/6/2021, patient has been experiencing an increase in number and intensity of his migraines/headaches. use to experience headaches 1-2 times a month, now it has been coming 6-8 times per month. Was able to control migraines with EXCEDRIN MIGRAINE. excedrin d/c'd and patient started on Imitrex.
Patient called/talked with me in the morning around 10AM. She stated that she got the vaccine the previous day and around 4:30 in the evening she has aching all over body and she couldn't walk. However, She's feeling better at the time we're talking. I advice her that since she's feeling better, she can take some Tylenol to help with the aching, rest and drink plenty of fluid.  I advice her to get medical help if she's feeling worse.
Latent edema, urticaria and erythema in injection seem one week prior that was new
Pt experienced chills/flushing, chills/shaking, dizziness. BP 141/91, HR 102, T 98.4.  10 min later BP 120/80. Pt has hx of panic attacks/anxiety. Pt was very nervous prior to getting this vaccine. Pt has had similar rxn before. Pt was stable & released from vaccination site 1hr after vaccination
Muscle aches; Chills; Pain at site; Redness; itching at insertion site; This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th January 2020, the patient received the 2nd dose of Shingrix. In January 2020, less than a week after receiving Shingrix, the patient experienced muscle pain, chills, injection site pain, injection site erythema and injection site itching. On an unknown date, the outcome of the muscle pain, chills and injection site pain were recovered/resolved and the outcome of the injection site erythema and injection site itching were not recovered/not resolved.   It was unknown if the reporter considered the muscle pain, chills, injection site pain, injection site erythema and injection site itching to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The reporter stated that the patient had muscle pain, chills and injection site pain after vaccination. The patient also had redness and itching at insertion site. The reporter asked what is the pathology that causes side effects with the second shot. The reporter did not consent to follow up. This case is 1 out of 3 cases reported by the same reporter.
Moderna COVID-19 Vaccine EUA  A very itchy rash has developed around the injection site in the upper left arm about 5 days after the injection and continues .  It is about 1" tall and 2" wide, pinkish in color.
Rash under the site of the injection. Rash still present Fever and chills during second and third day after the second dose. Took tylenol while these symptoms lasted.
Tiredness/fatigue; Soreness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Tiredness/fatigue) and VACCINATION SITE PAIN (Soreness at the injection site) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced FATIGUE (Tiredness/fatigue) and VACCINATION SITE PAIN (Soreness at the injection site). At the time of the report, FATIGUE (Tiredness/fatigue) and VACCINATION SITE PAIN (Soreness at the injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided. Treatment information was not provided.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
redness; itching; fever; shivering; headache; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced injection site erythema, injection site itching, fever, shivering and headache. On an unknown date, the outcome of the injection site erythema and injection site itching were unknown and the outcome of the fever, shivering and headache were recovered/resolved.   It was unknown if the reporter considered the injection site erythema, injection site itching, fever, shivering and headache to be related to Shingrix.  Additional information was provided as follows: The patient received 1st dose of Shingrix two and half month ago from the time of report. The patient experienced fever, shivering and headache which lasted for 24 hours. The patient also experienced mild redness and itching at the injection site. This is one of 3 cases reported.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site itching in a 67-year-old female patient who received SHINGRIX. Concomitant products included Atorvastatin, Metformin and Pneumococcal vaccine. On 2nd March 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 2nd March 2018, less than a day after receiving SHINGRIX, the patient experienced injection site itching. On 3rd March 2018, the patient experienced injection site erythema, injection site tenderness and injection site warmth. The patient was treated with BACTRIM, ZYRTEC, BENADRYL and Ice Pack (NOS). On an unknown date, the outcome of the injection site itching, injection site erythema, injection site tenderness and injection site warmth were unknown. The reporter considered the injection site itching, injection site erythema, injection site tenderness and injection site warmth to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGIRX vaccine on left deltoid and Pneumococcal vaccine on right arm. Later the same night on 2nd March 2018, the patient had a slight itching at the site of the injection. The next day the area at the injection site became red and tender with increased warmth and since then the area has expanded in size. The patient had no fever, no other rash, no shortness of breath. All of these symptoms were described as a local reaction at the injection site. On 5th March 2018 she was ordered an antibiotic BACTRIM DS twice daily for 10 days and recommended ice, ZYTREC, and BENADRYL. It was unknown what brand name or manufacturer for the pneumococcal vaccine documented in the patient's chart as had been administered on the same day as the SHINGRIX. No further details were provided during the call. The reporter was transferred to the GSK Medical Information team regarding the inquiry of whether or not this consumer should have the second dose in the series after having had the described reaction at the injection site. The reporter granted permission to be contacted and prefers to be contacted via telephone or email.
Dry skin reaction all over the body. Itching and peeling of the skin. This symptom lasted for a week.
Rapid heart beats; Arm ache; Low potassium; Fever; Chills; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (Rapid heart beats), PAIN IN EXTREMITY (Arm ache), BLOOD POTASSIUM DECREASED (Low potassium), PYREXIA (Fever) and CHILLS (Chills) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure high. Concomitant products included BUSPIRONE for Allergy NOS, OMEPRAZOLE for Stomach discomfort.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, the patient experienced HEART RATE INCREASED (Rapid heart beats), PAIN IN EXTREMITY (Arm ache), BLOOD POTASSIUM DECREASED (Low potassium), PYREXIA (Fever), CHILLS (Chills) and NAUSEA (Nausea). On 08-Mar-2021, PAIN IN EXTREMITY (Arm ache) had resolved. At the time of the report, HEART RATE INCREASED (Rapid heart beats), BLOOD POTASSIUM DECREASED (Low potassium), PYREXIA (Fever), CHILLS (Chills) and NAUSEA (Nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Mar-2021, Electrocardiogram: low potassium level Potassium level was little low.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.   Reporter did not allow further contact
Patient c/o mild dizziness with nausea and one episode of vomiting following FluMist vaccination.  Dizziness and nausea occurred about 15 minutes post vaccination.  Vomiting episode was approximately 50 minutes post vaccination.  Patient denied SOB, blackout, tight throat, chest pain, itching, rash, or any other symptoms.  Symptoms of dizziness and nausea resolved within the hour with bed rest, but a mild 2/10 dull, throbbing headache remained which is consistent with his typical headaches patient experiences.  Physician states symptoms consistent with vasovagal phenomenon following vaccination with FluMist.