chrisvoncsefalvay/vaers-outcomes huggingface dataset:
injection site warm to touch; headache; severe itching; pain in arm radiating to elbow; pain in arm radiating to elbow; "5 pink spots that merged into one giant spot with red on the inside"; "5 pink spots that merged into one giant spot with red on the inside"; This case was reported by a consumer via call center representative and described the occurrence of injection site warmth in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th November 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 15th November 2019, 2 days after receiving Shingrix, the patient experienced injection site warmth, headache, pruritus, pain in arm, pain in elbow, red rash and skin discoloration. On an unknown date, the outcome of the injection site warmth, headache, pruritus, pain in arm, pain in elbow, red rash and skin discoloration were not recovered/not resolved.   It was unknown if the reporter considered the injection site warmth, headache, pruritus, pain in arm, pain in elbow, red rash and skin discoloration to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient received vaccine in unknown arm. The patient was advised to follow up with her physician and told her to go to the emergency room. The patient wanted to know how the virus is extracted to create the vaccine. The patient did not want to provide any demographic information. No other information was obtained. The reporter did not consented to follow up. The outcome of the events were reported as not recovered/resolved in the database however in source document, it was mentioned as recovering/resolving.
Severe chills of entire body with intense shaking post injection of 1st SHINGRIX vaccine. The episode lasted 30-45 minutes. I had the injection at approximately 3:35pm on 01/02/2019 and the chills began approximately 3:15am the following morning.
A non-serious, spontaneous report of hives, swelling of the throat and diarrhea has been received from a certified medical assistant (patient's parent) concerning a 15-year-old male, subsequent to FLUMIST. Medical history and concomitant mediations were not reported. On 05-Sep-2009, the patient received FLUMIST. On 05-Sep-2009, within 25-30 minutes after receiving FLUMIST, the patient was covered head to toe with hives, experienced swelling of the throat, and diarrhea. The events resolved.
Patient is at day 43 after the first vaccine; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient is at day 43 after the first vaccine) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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(s). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient is at day 43 after the first vaccine). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient is at day 43 after the first vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   On day 43 of receiving 1st dose Nurse practitioner asked if it is ok to give the patient his second dose today, or do they need to restart the vaccine series. No concomitant medications were mentioned. No treatment details were reported.
DIZZINESS; ELEVATED BLOOD PRESSURE; ANXIETY; This spontaneous report received from a patient concerned a 51 year old female. The patient's height, and weight were not reported. The patient's past medical history included: migraines, and concurrent conditions included: heavy metals allergy, and highly sensitive to chemicals. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: UNKNOWN) dose was not reported, administered on 06-AUG-2021 for prophylactic vaccination. Concomitant medications included acetylsalicylic acid, ascorbic acid, ergocalciferol, and zinc. On 06-AUG-2021, the patient experienced dizziness. On 06-AUG-2021, the patient experienced elevated blood pressure. On 06-AUG-2021, the patient experienced anxiety. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from elevated blood pressure, had not recovered from dizziness, and the outcome of anxiety was not reported. This report was non-serious.
The patient's chart had stated patient is due for a flu vaccine and covid booster. The patient said he had received his covid booster but not the flu vaccine and so medical assistant administered the flu vaccine. However, she queried the immunization registry after the patient left to find the patient's covid booster and that's when the chart updated and showed the patient already received the flu vaccine for this flu season on 10/4/2022. Per CDC guidelines: "If a larger dose (volume) of influenza vaccine is inadvertently administered, count the dose as valid. Revaccination with additional vaccine is not needed." Patient was called about an hour after he left to notify him of the error but did not answer.  message was sent to the patient to notify him of the error. Patient has yet to respond or call back.
This spontaneous report was received from a pharmacist and refers to a 62 year old female patient. The patient's concomitant medications and pertinent medical history were not provided. The patient had a drug reaction or allergy to codeine. She had no illnesses at the time of vaccination. On 06-NOV-2017, the patient was vaccinated with her first dose of ZOSTAVAX, lot # N015627 with expiration date on 04-JUL-2018, subcutaneously for shingles prevention (dose and vaccination site were not reported). The ZOSTAVAX was reconstituted with sterile diluent (dose, lot # and expiration date were not reported). On 06-NOV-2017, reported as "later that evening", the patient developed itching at the ZOSTAVAX injection site. On 08-NOV-2017, the patient developed a raised bump that was 2 inches in diameter (reported also "2 inches long red bump"), that was painful to the touch and slightly itchy. The patient stated that the bump was warm to touch. The patient did not seek medical attention. No laboratory diagnostics were performed and no treatment was given for the events. The outcome of "raised bump that was 2 inches in diameter, that was painful to touch and slightly itchy" was reported as not recovered/not resolved (reported also as unknown). The outcome of "red bump" and "bump was warm to touch" was unknown. The relatedness between the events and ZOSTAVAX was not assessed by the reporter.
Approximately 5 min after receiving dose, I felt dizzy/lightheaded  and asked the nurse to check my BP. BP was markedly elevated at 188/96. Waves of dizziness every 5-10  minutes for an hour, and became milder through the day. BP remained elevated 140s-150s SBP until next day when back to normal at 115-125 SBP.
Parent reports 24 hours after vaccination area erythematous, indurated, warm, unable to ambulate on 11/16. Did not call physician. Called physician on 11/17 at 8 PM, leg swollen involving knee and 18 X 14 cm indurated, warm, erythematous. Negative cellulitis.
1. Arm hurt so much I could not sleep.  It got better as the week progressed, but on Friday it began to itch. 2.  When I woke up on Tuesday, after receiving the shot on Monday, I had diarrhea which reminded me of having covid. 3.  I was weak or exhausted until today (Friday) after receiving the shot on Monday.  I am scheduled to receive my second shot and I will do it, but I am apprehensive about it.
pt recv vax 23APR96 approx 10AM, advised warm compresses @ home that day;mom reported rxn on 25APR96;pt seen 315PM;25APR95 in office dx secondary to DTP hot, pink area 6" x 4", sore to touch, soft, not severely tender;advise warm compress;
PT. STATED ON 7/3/2016 HER LEGS GAVE OUT AND COULD NOT WALK 7/8- PT COMPLAINED OF SWOLLEN FACE, THROAT, AND NECK.  PT WAS TREATED AND RELEASED FROM THE ER ON BOTH DATES.  7-8-26 PT RECEIVED RX'S OF ALBUTEROL MDI, TESSALON, AND AZITHROMYCIN. PT MD STATED SHE WAS ALLERGIC TO SHINGLES VACCINE.
Low grade fever 100. To 101. Lasting 18 hours. Muscle and joint pain. Nausea
shortness of breath/difficulty breathing; bronchitis cough; chronic bronchitis; pelvic pain; neck hurts to move; sore throat; Difficulty breathing; Really bad headache; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (shortness of breath/difficulty breathing), COUGH (bronchitis cough), BRONCHITIS CHRONIC (chronic bronchitis), PELVIC PAIN (pelvic pain) and NECK PAIN (neck hurts to move) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included ALBUTEROL SULFATE, BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT), BUSPIRONE, CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000), PANTOPRAZOLE, LAMOTRIGINE, LORATADINE (CLARITIN [LORATADINE]) and ACETYLSALICYLIC ACID, CAFFEINE, PARACETAMOL (EXCEDRIN MIGRAINE) for an unknown indication.    On 08-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-May-2021, the patient experienced HEADACHE (Really bad headache). On 09-May-2021, the patient experienced DYSPNOEA (shortness of breath/difficulty breathing), COUGH (bronchitis cough), BRONCHITIS CHRONIC (chronic bronchitis), PELVIC PAIN (pelvic pain), NECK PAIN (neck hurts to move), OROPHARYNGEAL PAIN (sore throat) and DYSPNOEA (Difficulty breathing). At the time of the report, DYSPNOEA (shortness of breath/difficulty breathing), COUGH (bronchitis cough), BRONCHITIS CHRONIC (chronic bronchitis), PELVIC PAIN (pelvic pain), NECK PAIN (neck hurts to move), OROPHARYNGEAL PAIN (sore throat), DYSPNOEA (Difficulty breathing) and HEADACHE (Really bad headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication was reported.
Client reports when he received his first dose of Pfizer within one hour he was nauseated and it lasted 30 minutes and it resolved on its own.  Provided client with water and a snack.  Client was approved for Second dose and client did not have any reaction for second dose.
Foggy; Mild Thirst; Mild Body Aches; Tired; Mild Chills; Low grade Fever; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Foggy), THIRST (Mild Thirst), MYALGIA (Mild Body Aches), PYREXIA (Low grade Fever) and FATIGUE (Tired) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Apr-2021, the patient experienced PYREXIA (Low grade Fever). On 15-Apr-2021, the patient experienced FEELING ABNORMAL (Foggy), THIRST (Mild Thirst), MYALGIA (Mild Body Aches), FATIGUE (Tired) and CHILLS (Mild Chills). On 18-Apr-2021, FEELING ABNORMAL (Foggy), THIRST (Mild Thirst), MYALGIA (Mild Body Aches), PYREXIA (Low grade Fever), FATIGUE (Tired) and CHILLS (Mild Chills) had resolved.            No concomitant and treatment medications were reported.   This case was linked to MOD21-079122, MOD21-079074 (E2B Linked Report).; Sender's Comments:  MOD21-079122:Crosslinked MOD21-079074:Crosslinked
No additional AE or PQC; the patient received a dose of ENGERIX-B instead of RECOMBIVAX HB.; This spontaneous report has been received from a health care professional (HCP) (also reported as a pharmacist) concerning a male patient of unknown age.  The patient's concurrent conditions, medical history, concomitant therapies and drug/allergy history were not reported.  On 05-SEP-2023, the patient was vaccinated with the first dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) of their three-dose series (dose, anatomical location, route of administration, lot#, expiration date were not reported) for prophylaxis. On 05-OCT-2023, the patient was vaccinated with hepatitis b vaccine rhbsag (yeast) (ENGERIX B) (dose, anatomical location, route of administration, lot#, expiration date, and indication were not reported) as the second dose instead of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) (Interchange of vaccine products).  No additional adverse event was reported.
Eight days after the second dose of my vaccine I went to work and I felt extremely weak and tiredness. I was having chills and feeling feverish with right lower quadrant area. I had pain in the perirectal area. Without examination the doctor diagnosed Vaginosis. I missed four days of work and I was given antibiotics. I could hardly function and I was in a lot of pain. My symptoms resolved in seven days after the antibiotics. After the course of medication was over my symptoms returned. I went to my PCP and there was inflammation and I started to have loose stools which continued for six weeks. A vaginal culture was negative. When I went to my own doctor she identified right lower quadrant pain but the CT scan was negative. I was given a colonoscopy and everything was negative. I went back to the ER 04/29/2021 and they found some Pancreatitis and Terminal Ileitis. I had to go back to the ER 05/02/2021 because I was dehydrated and my blood pressure and heart rate were elevated. I have only been able to work intermittently since this whole thing started and I have been unable to work for 9 days in a row on more than one occasion. I have lost 16 lbs since this started and I have had little appetite. I am still flushed almost every day for 1-5 hours at a time. My stomach is still very sensitive.  ER (name provided). GI Dr. (name provided). I have changed to Silver Centrum and Probiotic and reduced some of my Vitamins and I have added Diflucan.
Pt was inadvertently given Hep A before the appropriate age of 12 mos. Pt was scheduled for Hep B #3.
daughter had pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 42-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 42 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 Immunization. The following information was reported: PAIN (non-serious) with onset Sep2022, outcome "unknown", described as "daughter had pain".  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Systemic: Exhaustion-Mild, Systemic: Nausea-Severe, Systemic: Rise in BP, Dizziness, Kidney Pain-Medium
Complaints of tingly in left leg, warm feeling all over body. This happened one hour after vaccination. Tingly resolved, but leg is still sore.
77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.; product storage error; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.), PRODUCT STORAGE ERROR (product storage error) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.), PRODUCT STORAGE ERROR (product storage error) and NO ADVERSE EVENT (no adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.), PRODUCT STORAGE ERROR (product storage error) and NO ADVERSE EVENT (no adverse event) outcome was unknown.      The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) was unknown.   For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.) and PRODUCT STORAGE ERROR (product storage error).    No concomitant medications were reported. It was reported that the doses were administered before it was known if the vaccine was ok to use after the excursion. No treatment medications were reported.  This case contains information for the 69th of 77  patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-696122 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-696122:Master case
Flu like symptoms with fever of 101° for over a week. Now continue to have joint pain and EXTREME Hot Flashes that feel like I am in menopause again!
Few hours after  vaccine.  hives  / rash on body occurred treated with  Benadryl
Vomiting, speech, unsteady, hospitalization. 11/23/2009 MR, DC summary for 11/16-11/17/2009 and PCP records for 11/13/2009. DC DX change in mental staus ?etiology  Patient with c/o's change in mental status, headache and vomiting. Tx: Dilantin
This case was reported by a nurse via call center representative and described the occurrence of rheumatoid arthritis aggravated in a adult patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included rheumatoid arthritis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, unknown after receiving SHINGRIX, the patient experienced rheumatoid arthritis aggravated (serious criteria GSK medically significant), fever, pain, muscle soreness, injection site swelling, influenza like illness, difficulty sleeping, injection site erythema and injection site warmth. The patient was treated with TYLENOL and BENADRYL. On an unknown date, the outcome of the rheumatoid arthritis aggravated, fever, pain, muscle soreness, injection site swelling, influenza like illness, difficulty sleeping, injection site erythema and injection site warmth were unknown. It was unknown if the reporter considered the rheumatoid arthritis aggravated, fever, pain, muscle soreness, injection site swelling, influenza like illness, difficulty sleeping, injection site erythema and injection site warmth to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The patient complained of generalized, all over feverish achy feeling, muscle soreness, swollen at site and flu like symptoms with injection site reactions. The reporter reported upon programme called back that, the patient reported that she thought it might have worsened her rheumatoid arthritis, and could not sleep. The reporter reported no reports of adverse experience prior to this lot. Shortage was mentioned. The nurse gave the 4th patient TYLENOL and BENADRYL to alleviate symptoms. No additional details were provided. The nurse stated that, due to workload she was unable to provide requested data but can supply at a later time. This case was 1 of the 4 cases, reported by the same reporter.
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). A 6 year-old male patient received bnt162b2 (BNT162B2), administered in leg right, administration date 04Dec2021 16:00 (Lot number: FK5127) at the age of 6 years as dose 2, single for Covid-19 immunisation. Relevant medical history included: "constipation" (unspecified if ongoing); "sensory processing disorder" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "ADHD" (unspecified if ongoing). Concomitant medication(s) included: FLU taken for immunisation, administration date 24Nov2021. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: FK5127, Location of injection: Leg Right, Vaccine Administration Time: 03:45 PM), administration date: 13Nov2021, when the patient was 6 years old, for Covid-19 Immunization, reaction(s): "vaccine location=Right leg". The following information was reported: PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (non-serious) with onset 04Dec2021 16:00, outcome "unknown", described as "vaccine location=Right leg"; OROPHARYNGEAL PAIN (non-serious) with onset 04Dec2021 21:00, outcome "recovered" (Dec2021), described as "sore throat"; CHILLS (non-serious) with onset 04Dec2021 21:00, outcome "recovered" (Dec2021), described as "chills"; MYALGIA (non-serious) with onset 04Dec2021 21:00, outcome "recovered" (Dec2021), described as "muscle aches"; PYREXIA (non-serious) with onset 04Dec2021 21:00, outcome "recovered" (Dec2021), described as "low grade fever"; VOMITING (non-serious) with onset 04Dec2021 21:00, outcome "recovered" (Dec2021), described as "vomiting". Therapeutic measures were taken as a result of oropharyngeal pain, chills, myalgia, pyrexia, vomiting. Additional information: Location of injection for vaccine received within 4 weeks PRIOR: dose 1 Flu vaccine in Right leg. Facility where the most recent COVID-19 vaccine was administered: Doctor's office/urgent care. Treatment received for the adverse event was Zofran. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Follow-up attempts are completed. No further information is expected.
Redness of upper arm towards mid forearm after Typhoid shot. Redness, tender to the touch, and pain caused on shoulder. Elbow and wrist inflammation all under arm towards forearm.
Received injection 10:30am within one hour nausea, aching, burning cough. 7:00 returned to clinic with symptoms. Conferred with Dr, Motrin 400mg 6-8 hours as needed and Compazine 10mg every 6 hours as needed. Freq small amount of fluids.
ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE RESPIRATORY FAILURE, UNSPECIFIED ACUITY
Pt. reported swelling & erythema. Pt was seen in the ER- no hospitalization.  Tx'ed with Keflex & Bactroban and instructed to elevate extremity. Follow up on 11/26/03: "Rt arm affected-completed resolved."
I am female. A week in a half after I received my 1st dose of Pfizer, I broke out in a rash on my right lower back near my bra strap. It was itchy and then painful. It spread to underneath my right armpit. I was diagnosed with shingles the day after I received my second shot. I am currently taking anti viral and Tylenol for the pain.