chrisvoncsefalvay/vaers-outcomes huggingface dataset:
rash five days; This case was reported by a other health professional via sales rep and described the occurrence of rash in a patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received the 1st dose of Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, 5 days after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Bexsero and Bexsero Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 02-JUN-2022 Reporter's Comments:  The reporter reported that the patient received first dose of Bexsero and five days post vaccination the patient experienced rash. The reporter consented to follow up.
Within 15 minutes of receiving the flu vaccine student complained of headaches. Presented no other signs and symptoms of adverse reactions.
pain and pressure in his center chest developed shortly after receiving vaccine at approximately 5pm; patient presented to the ED at approximately 0330 early the next morning; ECG, labs, Xray, bedside ultrasound all negative; GI cocktail provided some improvement in sx; discharged to home; recurrence of sx later in the day 4/26, resulted in second visit to ED; all labs and abd CT negative;
Patient received expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) 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) (unknown route) 1 dosage form. On 07-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine). On 10-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medicines were reported No treatment medicines were reported
Patient states right arm  has been sore since immunization given. Patient states soreness is located in injection site area.
Two weeks after her second Covid dose, patient is  on a permanent menstrual cycle, with 3-4 days break in between.  She has had all her labs and everything checks out fine. She was seen by a GYN and she suggested birth control to stop the bleeding, but even  that does not stop it. For the record, her period started at 12, and for the past 2 years , she has been on a regular cycle.
Fever (101 PO) 72 hours after vaccine (responded to acetaminophen) and rash: red macular lesions (5-15 mm) with central vesicle over trunk. Some pruritis ->treated with antihist.
I noticed immediately after the shots he was tired and fell asleep and slept all afternoon (very unlike him).  Around 5 pm he woke up and vomited all over. I noticed he was burning up with a fever.  I took him to Urgent Care but the doctor wouldn't discuss the possibility of it being a vaccine related issue.  He continued to act lethargic, rapid pulse, pale in color, fast heartbeat the rest of the evening. I took his temperature at midnight and his fever was 105.  I rushed him to the hospital and he was treated for a high fever and released the next day.  He is still dealing with a fever, lethargic behavior, fussiness and now diarrhea.
Quadracel vaccine was given to a 3 year old patient, no AE; Quadracel vaccine was given to a 3 year old patient because the child was behind on her vaccinations, no AE; Quadracel vaccine was given to a 3 year old patient which had temperature excursion at 1.65 C due hurricane, No AE; Initial information received on 05-Aug-2020 regarding an unsolicited valid non-serious case received from a pediatrician. This case involves a 36-months-old female patient who experienced received a 0.5 mL dose of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] (lot C5763AA and expiry date: 26-Aug-2022) via an intramuscular route in the right for prophylactic vaccination on 29-Jul-2020.  The patient's medical history, past medical treatment, past vaccination and family history were not provided.  Concomitant medications included VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) and HEPATITIS A VACCINE (HEPATITIS A VACCINE) for prophylactic vaccination.  It was an actual medication error case due to inappropriate age at vaccine administration and product storage error temperature too low.   It was also a case of off label use.  Description: Facility experienced a temperature excursion due to the Hurricane. Lowest temperature: 1.65 Celsius, Duration of status: 50 minutes for Quadracel vaccine which was given to a 3 years old patient. Quadracel is to be used in children between the ages of 4 and 6 which was know by nurse still she was persistent on wanting to give it (Quadracel) to the child because the child was behind on her vaccinations.  At the time of this report, 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.
Patient briefly passed out was dizzy, sweating and unsure of where she was. This occurred about 5 minutes after receiving a flu shot. All was called and patient's HR & BP was checked (rt was normal). EMS stated that patient was fine and had not had a true reaction.
Pt began complaining of tingling and swelling of left face, neck and throat about 15 minutes of vaccine. VS: 156/ 89, HR 84,  O2 sats 99% on RA. Paramedics called after IM Benadryl 50 mg given. She was transported by ambulance to the ER. Pt also c/o migraine and of not eating all day.
red mark in the right arm; This is a spontaneous report from a contactable consumer (self-reported). A 57-years-old female patient received First dose of BNT162B2 (Pfizer-biontech covid-19 vaccine, Formulation: solution for injection, Lot number EL3246) via unspecified route of administration in Arm Right on 22Jan2021 in afternoon as single dose for covid-19 immunisation. Medical history included thyroid cancer from 2011. concomitant medication was not reported. Patient reported 3 days before she got her first COVID-19 Vaccine dose, she got a Shingles vaccine on 19Jan2021. Patient had blood work done recently because she has to go every once in a while to an endocrinologist. Patient reported that, her doctor was against her getting her Shingles shot. She said she had asked her doctor to get the Shingles shot because she had seen a Shingles vaccine commercial that said people over 50 years old should get the Shingles vaccine. She said her doctor told her she didn't need the Shingles vaccine. She said she decided to get the Shingles vaccine on her own because she had worked for a lady who had Shingles. On 22Jan2021, patient noticed that the red mark in the right arm, from the first dose, is still there. She asked if it will ever go away. She stated it has been 3 weeks and if it stays another 20 days she will be concerned. On 11Feb2021, patient got second COVID-19 Vaccine shot on left arm and showed the red mark on her right arm to the staff after the vaccine facility. She said none of the staff could tell her anything about the red mark on her right arm at the first COVID-19 Vaccine. The outcome of the event was not recovered.
sore achy arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore achy arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Food allergy, Sulfonamide allergy, Latex allergy and Dust allergy. Concomitant products included RIVAROXABAN (XARELTO) for an unknown indication.    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 PAIN IN EXTREMITY (sore achy arm). At the time of the report, PAIN IN EXTREMITY (sore achy arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Description of Event or Problem:Patient has been taking a blood thinner Xarelto to prevent blood clots.  No treatment information was reported.
After shot administered, began to feel a ball in my throat that stayed for hours after my vaccination.  I suffered from dry throat and mouth for the next 2 weeks.  I was producing very little saliva.
Tightness in throat and chest. Approx 8 hours after vaccine malaise, muscle aches, fever, headache
rashes, rashes got bad, new rashes on the forehead ,face and wrist; muscle soreness on the injection site; she still has the itchiness; This spontaneous case was reported by a patient and describes the occurrence of PRURITUS (she still has the itchiness), RASH (rashes, rashes got bad, new rashes on the forehead ,face and wrist) and VACCINATION SITE PAIN (muscle soreness on the injection site) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 052B22A, 068H21A and 066H21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (She had the worst symptoms for 2 weeks and symptoms lingered for about 2 months) on 31-Dec-2021.   On 12-Feb-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Aug-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. In 2022, the patient experienced PRURITUS (she still has the itchiness). On 23-Aug-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (muscle soreness on the injection site). On 30-Aug-2022, the patient experienced RASH (rashes, rashes got bad, new rashes on the forehead ,face and wrist). The patient was treated with PREDNISONE for Allergic reaction, at a dose of 20 milligram once a day and IBUPROFEN for Allergic reaction, at a dose of 1-2 pills. On 26-Aug-2022, VACCINATION SITE PAIN (muscle soreness on the injection site) had resolved. At the time of the report, PRURITUS (she still has the itchiness) and RASH (rashes, rashes got bad, new rashes on the forehead ,face and wrist) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Dec-2021, SARS-CoV-2 test: (Positive) Positive.         Patient height reported as 5. No other vaccines was given within 1 month prior to Moderna COVID-19 vaccine. No concomitant medications was reported. Patient did not experienced a similar event in the past. Patient had new rashes appeared on her forehead, face and wrist on 1-Sep-2022. It was reported that patient will see a specialist for the rashes. Patient had gone to emergency room on 31-Aug-2022. Patient was given steroid for her allergic reaction.
presented with entire upper arm (shoulder to below elbow) pruritis and edema, erythema, induration, warmth 11/14.  no airway or respiratory symptoms; no systemic rash.  will continue Zyrtec and add Benadryl 25 mg q6h prn & hydrocortisone 1% cream at margins bid prn
This case was reported by a consumer (the subject's grandmother) and described the occurrence of low grade fever in a 5-month-old female subject who was vaccinated with HAVRIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. On 29 November 2011 "before noon" the subject received a dose of HAVRIX (details unknown) and experienced wrong vaccine administered. The subject was supposed to receive ENGERIX B and received HAVRIX by mistake. On 29 November 2011 at 14:00 the same day after vaccination with HAVRIX the subject experienced low grade fever. A healthcare provider was consulted regarding the events. At the time of reporting the fever was unresolved. The consumer also reported events for the subject's fraternal twin who also had low grade fever and wrong vaccine administered (see case ID A0956137A for details).
blood pressure skyrocketed; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPERTENSION (blood pressure skyrocketed) in a 41-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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, 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 experienced HYPERTENSION (blood pressure skyrocketed) (seriousness criterion hospitalization). At the time of the report, HYPERTENSION (blood pressure skyrocketed) had resolved. The patient was quadriplegic for the past fifteen years. She was fine after receiving the first vaccine. The patient received the second vaccine, then a few weeks after her blood pressure skyrocketed. She was hospitalized with her blood pressure spiking. As reported, she had been stable without issues for over one year. No treatment information was provided. Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded  This case was linked  INC.-MOD-2021-142140 (E2B Linked Report).; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded , INC.-MOD-2021-142140:crosslinked; brother in law
Information has been received from a consumer concerning her 85 year old mother with osteoporosis who on 21-SEP-2007 was vaccinated with ZOSTAVAX. Concomitant therapy included alendronate sodium, tablet (MSD). The consumer stated that in December 2007, her mother experienced a blister on her lip and ulceration on lip and roof of mouth after receiving ZOSTAVAX. The physician felt blister was a cold sore. In January 2008, the patient recovered. Additional information is not expected.
Severe headache, severe muscle achiness, that lasted more than 24 hours and prohibited working. mild fever/chills;
swelling; redness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (swelling) and VACCINATION SITE ERYTHEMA (redness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced VACCINATION SITE SWELLING (swelling) and VACCINATION SITE ERYTHEMA (redness). At the time of the report, VACCINATION SITE SWELLING (swelling) and VACCINATION SITE ERYTHEMA (redness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. Treatment products include Couple of pain killers and other medications for health issues.
First day right after the vaccine  the left arm was extremely sore, the next day I felt like I had the flu.  body aches , headache, knees aching , abdominal pain, could not eat, lots of chill, breaking out in sweats .
11/09/2021, I woke up around midnight, and when I opened my eyes, the room was tilting. I was nauseas. I was really dizzy and vomiting for a few hours. When I turned my head, I was dizzy, it seemed like everything was tilting for a few hours until I was finally able to go to sleep. The next morning, 11/09/2021 I went to the urgent care and the doctor said I was probably experiencing vertigo. The doctor prescribed - Meclizine 25 mg, 1 tablet 3 times a day as needed. After the initial attack, I did not have anything like that, but I would have periods of slight nausea or dizziness maybe 2 or 3 day afterwards.
Client received the 1st COVID vaccine (unknown lot and expiration) on 04/22/2020 and is requesting to receive 1st dose of Janssen. EMT took vitals (blood pressure: 150/82, heart rate: 66, respirations: 16, and oxygen saturation 97%)  for baseline information and a possible medical consult. Per patient underlying conditions are hypertension and diabetes, allergic to penicillin and currently taking losartan and metformin. Per patient no adverse reactions noted after vaccine administration. Per CDC Guidance, patient is approved to receive primary dose of Janssen. Patient received and completed 15 minutes of observation, no adverse reactions noted. PHN provided education regarding ER precautions, follow up with MD, and educated on the use of V-Safe. VAERS completed.
Pt developed about 50 vesicles over period of 24 hours c/o itching.
hurt to raise her arm the day after the shot.; This is a spontaneous report from a contactable consumer via Pfizer sales representative. A 70-years-old female patient received bnt162b2 (Solution injection; Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced hurt to raise her arm the day after the shot on an unspecified date. The outcome of the event was unknown.  Information about lot/ batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Uncontrollable blood pressure. I had to double up on bp medication and just received a new prescription to try to regain control. I had headaches for the first two weeks as they have now subsided. My toes burn on the underneath of both feet. I am making an appointment to have them looked at. It burns! I had difficulty swallowing and my acid reflux flares up almost every day and I had it under control for the past five years.
extreme pain; barely able to walk; anemia; Elevated Sed Rate after receiving 2nd dose of Pfizer COVID Vaccine; This is a spontaneous report received from a contactable consumer or other non hcp. A female patient of an unspecified age received  2nd dose of bnt162b2 (COMIRNATY,Batch/Lot Number: EW0191), via an unspecified route of administration on 10Jun2021 as Dose 2,single for covid-19 immunization.The patient medical history and concomitant medications were not reported.The patient experienced extreme pain,barely able to walk,anemia,elevated sed rate after receiving 2nd dose of pfizer covid vaccine on an unspecified date.Caller also wants to know if .3ml is the same dose everyone gets or if there are different doses? Caller thinks that she definitely has received an overdose.The patient previously received her 1st dose of Pfizer covid vaccine on 11May2021,EW0183 lot number.The outcome of the event was unknown.The patient was suggested to take anti-inflammatories by the physician.  Follow up (17Sep2021): This is a follow-up spontaneous report from a contactable consumer.The treatment suggestion for extreme pain was updated.When writing down information being provided to the caller, the caller stated that what she is experiencing is not involving her hands so far. Follow-Up (24Sep2021): Follow-up attempts are completed. No further information is expected.
SORE ARM; NAUSEA; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1808609, and expiry: UNKNOWN) dose was not reported, administered on 21-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced sore arm, and nausea. The action taken with covid-19 vaccine was not applicable. The patient recovered from nausea, and had not recovered from sore arm. This report was non-serious.
FEVER, CHILLS, MYALGIA, HEADACHE, NAUSEA Narrative:
pt recvd vax; T 105.5 R in eve;apap given & sponge bath given by mom; brought T down to 102 R; mom said PT fine p/ that;
Headache after the first dose; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache after the first dose) in a 43-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) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headache after the first dose). At the time of the report, HEADACHE (Headache after the first dose) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications was not provided by the reporter. Treatment information was not provided.    This case was linked to MOD-2021-063828 (Patient Link).
Child was given injection and moved while being injected. Child was immediately given second injection . Needle scrapped arm when child had moved and caused bleeding.  Child was given gauze to stop bleeding and band aid. Arm was cleaned and new band aid was applied. Ice pack was provided to ice arm.
pt diagnosed positive for COVID in nursing home,11 days prior to hosp admission; admitted to hosp with hypothermia, left sided pneumonia and renal insufficiency; family states she's requiring more O2 and is less interactive; hx of Alzheimer's, DM; COVID test is positive; treated with steroids and antibiotics; DNR/DNI; sent to ICU where she shortly passed away
5 Hours after Administration of shot - Severe uncontrollable Chills, Extreme Muscle Aches, Fever, Rapid heartrate (in excess of 130-150 for over 2 hours).  The following Day - Extreme Fatigue
Hive like rash on upper extremity where injection was received, severe soreness and tenderness.
Patient had breakthrough COVID-19 infection requiring hospitalization, presenting with 4 day history of cough and diarrhea.
I recieved the 1st Ja/nssen vaccine on friday 11/5/2021. I started with  a rash on sunday 11/7/21. Then started with throat tingling, and tongue tingling on 11/08/21. I am in employee health now on 11/8/21 @ 1612 waiting to see a doctor.
Injection site swollen, red, painful and warm to touch starting witching 12  hours of injection and still remarkable after 48 hours from injection time.
Initial report received on 07-NOVEMBER-2013 from a pharmacist. A 12-year-old female patient whose medical history and concomitant medications were not reported, received a dose of ADACEL via intramuscular route (site of administration not reported) on 17-SEPTEMBER 2007. On 18-SEPTEMBER 2007, after vaccination the patient experienced redness, swelling and tenderness at the injection site. Corrective treatment was not reported. At the time of this report the outcome of the event was resolved. List of documents held by sender: none.