chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Extremely sore arm at the site of injection.; This is a spontaneous report from a contactable consumer or other non hcp (patient herself). A 46-years-old non pregnant female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot number: EL3247, Expiry date: Unknown) via an unspecified route of administration, administered in Arm Left on 18Feb2021 at 10:15 AM (at a age of 46-year-old)  as dose 2, single for COVID-19 immunisation. The patient previously took bnt162b2 (BNT162B2, Lot number: EL3247, Expiry: Unknown) via an unspecified route of administration, administered in Left arm on 28Jan2021 as dose 1 single, for COVID-19 immunisation. patient medical history and concomitant medications were not reported. The patient had no known allergies. Patient was not positive for COVID-19 prior to vaccination and not tested post vaccination. Patient did not receive any other vaccines within 4 weeks and other medications 2 weeks prior to the COVID vaccine. On 19Feb2021 at 07:00 AM the patient experienced extremely sore arm at the site of injection. The patient did not receive any treatment for adverse events. The outcome of the event was not recovered.   Follow-up (13May2021): Follow-up attempts completed. No further information expected.
Bilateral facial paralysis - symptoms started on the right on April 21, 2021.  Patient was seen by PCP on April 22, 2021 and started on Valtrex and steroids for the treatment of Bell's Palsy.  On April 24, 2021 the left side developed paralysis as well.  Patient was seen in the ED.  Labs,  MRI and CT of the head were performed.  Lumbar puncture was attempted but unsuccessful.  Patient was discharged home and had lumbar puncture as outpatient on April 29, 2021 as well as additional blood work.  Tests showed no malignancy or infectious etiology.  He was started on another round of steroids on May 7, 2021.  Started physical therapy the following week.  Still has minimal facial mobility at the time of this submission.
A report was received from a consumer on 10/20/2003 concerning a male vaccinee of unknown age who experienced tiredness, and felt achy 1 day after receiving expired Fluvirin on 10/19/2003. On 10/19/2003 the vaccinee believes he received expired Fluvirin.  On 10/20/2003 the vaccinee felt tired and achy. No follow up.  Permission not granted to contact physician. Update 1, 12 December 2003 A follow up report was received from a consumer indicating that the vaccine he received had not expired.  The reporter stated that "Everything is OK'. Follow up pending.
Soreness at site of injection and headache on the first day; sore throat, headache, and body aches on the second day following vaccination
Since I was vaccinated at the pharmacy with COVID vaccine I have more abundant menstruation from 4 days now it is 15 to 16 days with clots, it does not seem to end. I have never had problems with my female health.
-I waited 30 minutes at Pharmacy after vaccine - all seemed fine -When I got home, I felt tingling in my lips and the skin below my mouth began to swell (angioedema-a reaction I usually get when I have an allergic reaction to anything). -No problems breathing, must itchy throat -Taking Bendedryl around clock - have NOT had to use Epi-pen, but feel like I have really bad allergies
Information has been received from a nurse practitioner concerning an approximately 18 years old female patient with drug hypersensitivity to Ibuprofen and no medical history, who on an unspecified date was vaccinated with the second dose of GARDASIL (Lot # unspecified). There was no concomitant medication. The nurse reported that three days after received the second dose of GARDASIL, the patient experienced bilateral arm rash. The nurse mentioned that the rash resolved after one week. Lab diagnostics were not performed. No medication was prescribed. The patient sought medical attention by the visit to the physician's office. Follow-up information has been received from a registered nurse concerning a 18 year old student female who on an unspecified date was vaccinated with a second dose of GARDASIL. The nurse reported that the patient possibly experienced a rash on bilateral dorsal forearms that developed 3 days after vaccination. Reporter also stated that vaccine was given by another provider, no vaccine was administered by her clinic. Additional information is not expected.
Expired dose administered; 1st dose on 28Jun2022, 2nd on 13Dec2022; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 47-year-old female patient who received HAV (Havrix adult) (batch number 7YA99, expiry date 30th September 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Havrix adult  (received 1st dose on 28th June 2022).   On 13th December 2022, the patient received the 2nd dose of Havrix adult 1 ml and Havrix Pre-Filled Syringe Device. On 13th December 2022, unknown after receiving Havrix adult and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used and drug dose administration interval too short. On an unknown date, the outcome of the expired vaccine used and drug dose administration interval too short were unknown.     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: 13-Dec-2022 Reporter's comment: The reporter did not consent to follow-up. Additional supportive information: The patient received 2nd dose of Havrix in left deltoid as expired one earlier than the recommended interval, which led to expired vaccine used and shortening of vaccine schedule.
Changes in my period.  I'm very regular.  My period arrives promptly every single month.  I'm not pregnant as i tested already.  I also have more frequent headaches, pain in my knees and muscle aches.
Information has been received from a consumer concerning her daughter who on an unspecified date was vaccinated with a dose of MMR II (therapy route and lot # not provided). On an unspecified date, the patient had a reaction to the MMR II. At the time of reporting, the patient's status was not provided. No further information is available.
fatigue; shortness of breath; This case was reported by a other health professional via sales rep and described the occurrence of fatigue in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fatigue and shortness of breath. On an unknown date, the outcome of the fatigue and shortness of breath were recovered/resolved.   It was unknown if the reporter considered the fatigue and shortness of breath to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient experienced fatigue and shortness of breath for 1 weeks. No other information was reported.
Information has been received from a nurse practitioner concerning a 19 year old female who on 05-AUG-2008 was vaccinated with the first dose of GARDASIL vaccine (yeast) (therapy route and lot number not reported). Concomitant therapy included oral hormonal contraceptives (unspecified). On 05-AUG-2008 the patient experienced a lump, redness and swelling at the injection site after she received her first dose of GARDASIL vaccine (yeast). The patient's symptoms began immediately after she received the dose. The patient sought unspecified medical attention. The swelling and redness subsided but the lump has persisted and as of 05-SEP-2008 has become larger. Additional information has been requested.
Severe blinding headaches; dime sized rash on leg, & back; upset stomach; loose stool; This is a spontaneous report from a contactable consumer (patient). A 65-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number: EL3247, expiration date: not reported) via an unspecified route of administration, in right arm, on 02Feb2021 12:30 (at the age of 65-years-old), at dose 1, single as for covid-19 immunization from hospital. Medical history included known allergies to strawberries (hives). Concomitant medications included estradiol; montelukast; amlodipine; spironolactone. Prior to vaccination the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the covid-19 vaccine. The patient has not been tested with covid-19 after the vaccination.  The patient had her second dose of vaccination on 25Feb2021. The patient experienced severe blinding headaches, dime sized rash on leg, & back, upset stomach and loose stool on 02Feb2021 16:00. No treatment was administered for the events. The outcome of the events was not recovered.    No follow-up attempts are possible. No further information is expected.
chills, shakes, body aches, 100.8-103.9 fever, fatigue
2 hours after receiving vaccination was very lightheaded and slightly disoriented. Had slight issue with gait. Went to bed early to sleep off thinking it was anxiety. Woke up the following day feeling normal. Starting at 10A shortness of breath began by noon I had a severe headache, shortness of breath, chest pain, shooting pain in my lower arms, thighs and calves, bad back pain, chest tightness, abdominal pain, low grade fever and heart palpitations.  Was admitted to the ER at 6PM on 8/25. Was treated with electrolytes, breathing treatment x-rays and blood work. Chest X-ray was clear, blood work was in normal ranges except for lymph auto level being low (12%). It was determined that inflammation was causing the shortness of breath and a course of prednisone was prescribed but was advised to be taken only if not improving in a few days.  I avoided taking the prednisone due to its effect on the vaccine. I instead used 6 puffs of Proair HFA into a spacer in substitution for a home nebulizer four times a day and continue to at this time (9/3/2021). Over the course of 2 more days many of the side effects subsided. However, I still fight with shortness of breath, random shooting pains throughout my body, head pressure, occasional abdominal pain/cramps and occasional heart palpitations. I returned to the doctor today, 9/3 for a check up on the ongoing issues and was given a script for an x-ray and blood work. This time the X-Ray has revealed an opacity in the lower right lobe of my lung. I was given a Z-Pak script while awaiting blood work results and have to return for a 6 week X-Ray appointment.
Information has been received via a company representative, from an office manager (certified medical assistant) who was reporting on behalf of a physician, referring to a 15 year six months old male patient. There was no pertinent medical history or any drug allergies. On 02-JUN-2016 the patient received the third dose of GARDASIL 9 (lot# M005714, intramuscular). The patient's two previous dosed were of GARDASIL (vaccination dates, lot number and route unknown). There was no concomitant therapy. The patient immediately after the administration of the GARDASIL 9 stated the his throat felt "Funny", no other description was provided. The representative confirmed it was not an anaphylactic reaction. The patient was monitored for 10 minutes in the provider's office and the reaction resolved on an unknown date in June 2016. No lab diagnostics study was preformed. The patient recovered. The causality was not provided. Additional information has been requested.
Headache, Myalgia, CONGESTION MUSCLE SPASM, SWELLING, WARMTH AND ITCHING AT INJECTION SITE Narrative:
Patient began having adverse events about 3 hours after injection. She started having a very sore arm making it difficult to move her arm laterally. The pain also migrated up to her neck and she noticed inflammation/swelling in her left hand and fingers. A friend also noticed that she had muscle was spasms in her deltoid region of her left arm. Since that time the inflammation has gone away in her hand and fingers and she no longer has pain in her neck or muscle spasms. The muscle pain has decreased by about 50% since the initial occurrence, but it is still affecting her abilities to perform and work. For treatment she has been using Ibuprofen 400-600mg three times daily. She has notified her doctor and is waiting on a call back with some direction on what to do. She will also keep me updated.
This spontaneous report as received from a physician refers to a patient of unknown age and gender. The patient was vaccinated with first dose of GARDASIL intramuscularly in 2008. The second dose of the same vaccine was received in June 2012 and the third dose is schedules on 11-OCT-2012. No other co-suspects were reported. No concomitant medications were reported. No known adverse effects. At the time of reporting the patient status was unknown. Additional information has been requested.
The child arrived to school two days after receiving the flu shot two days prior. Patient c/o pain to his upper left arm. There was a 2cm bruise at the injection site, below the injection site there was a 10x10cm area of redness and swelling which was hot to the touch. There was about a 2cm space between the bruise and the redness. Patient states his mom took him to the doctor yesterday and was given medication to take. Unknown what medication.
Left shoulder joint pain and limited mobility for 4 months. Treatment consisted of 400-800 mg Ibuprofen every 6-8 hours (dose was dependent on pain level that day). Also: the vaccine was given very high on the arm, close to the shoulder joint.
101.8 F FEVER, FATIGUE, SHORTNESS OF BREATH, JOINT PAINS.
Fever of 103.2, sever weakness,  severe headache,  severe body pain all over, nose bleeds,  hallucinations.  (Received my covid vaccine at my local pharmacy. )
Vomiting incident after the High Dose flu vaccine. Severe nausea, headache, excessive perspiration 24 hours after flu shot. Dizzy, tired. Patient states "feeling better this afternoon" (10/9/14 4:29 PM). 10/10/14 - triage RN advised to go to ER for evaluation.
A few hours after receiving my vaccine, I noticed that my eyes were becoming light sensitive and my vision became blurry. During the night I experienced about an hour of muscle spasms, and a couple hours of nausea. When I woke up my fever was 102 + and I had a headache and fatigue. The light sensitivity and blurry vision remained until the late afternoon/evening of May 14, so approx. 24-26 hours.
Case was hospitalized for Covid 8 months after completing primary series of Pfizer Covid vaccine. Hospitalized at: Hospital. Discharging physician: MD.  * Acute hypoxemic respiratory failure due to COVID-19  Assessment & Plan Diagnosed at MC 11/10 and started on dexamethasone for at that time. Presented to Hospital 11/13 with worsening weakness, confusion. Had difficulty tolerating PO dexamethasone 2/2 GI upset. Continued on dexamethasone on admission in addition to supportive therapies. With worsening weakness, confusion, elected to transition to comfort care 11/19.  - Discharged with hospice to the Facility  Severe sepsis with acute organ dysfunction  Assessment & Plan 4:31 PM 11/30/2021 Source of Infection: Viral Sepsis (including COVID-19) SIRS Criteria: Temp >38 C or < 36 C, HR > 90 and RR > 20 Acute Organ Dysfunction: Acute Respiratory Failure, Acute Metabolic Encephalopathy and Lactic Acidosis (Lactate > 2.0) Shock: Not Present Based on the above findings, the patient has evidence of: Severe sepsis (Sepsis + Acute organ dysfunction) Less than 30ml/kg bolus was ordered given p/w COVID PNA and no evidence of shock physiology. In addition, lactate normalized with 1L IVF in the ER. - Physiology has long since resolved.   Weakness Assessment & Plan Due to cvoid-19 pneumonia. Now on comfort care.   Acute metabolic encephalopathy Assessment & Plan Suspect initially driven by COVID and steroid use. Since then, ongoing hypoactive delirium. Mostly lays in bed sleepy. Suspect close to her new baseline. Now on comfort care
None- Situation discovered when a parent brought their child in for the second COVID 19 vaccine on 8/20/21. Parents provided incorrect patient information for child at each vaccination appointment. Parents stated child was 12 years old, when child was really 11 years old.  Because the doses were administered to someone under the approved use-age from the Pfizer EAU, VARES report entered.
Low Grade Fever, Body aches, chills, headache, tingling in face and lips
This case was reported by a consumer via call center representative and described the occurrence of injection site bleeding in a female patient who received FLULAVAL QUADRIVALENT. On an unknown date, the patient received FLULAVAL QUADRIVALENT. On an unknown date, less that a year after receiving FLULAVAL QUADRIVALENT, the patient experienced injection site bleeding, injection site swelling, difficulty breathing and hives. On an unknown date, the outcome of the injection site bleeding, injection site swelling, difficulty breathing and hives were unknown. It was unknown if the reporter considered the injection site bleeding, injection site swelling, difficulty breathing and hives to be related to FLULAVAL QUADRIVALENT. Additional details were provided as follows: This case was reported the patient's mother. The age at vaccination was not reported. The patient experienced hives up and down shoulder after receiving vaccination. The patient would require an emergency room visit for the reported events. The reporter declined to answer questions for safety report.
G45.9 TRANSIENT CEREBRAL ISCHEMIA 4/24/2023 NUMBNESS AND TINGLING OF SKIN
fatigue, hot skin, weakness, light headed, dizzy, brain fog for 5 days
Mother called EMS and they arrived at the home. Infant was lethargic.  Mother stated prior to calling baby was shaking all over and staring into space and lasted about 4 minutes.  No recent trauma.  Told EMS pt had immunizations this morning and last had dose of Tylenol at 1300.  Patient's lungs were clear, 100% SPO2 on RA, 99.4 tympanic temp.  Patient transported to EC, arriving at about 1900.  Vital signs on arrival were HR 150, RR 32, SPO2 97%, temp 100.9.  Patient given 80 mg Acetaminophen at 1915.  Patient had observed seizure activity 5 - 10 min, respirations dropped to less than 10/min. Began respirations by bag valve mask, pt began crying and O2 sats improved.  Placed on NC 2L.  Labs drawn at 2000 and pt sent to CT at 2100.  LP done to draw CSF at 2110. Meds given include Ativan 0.6 mg IV x1 at 2022, Vancomycin 120 mg IV x1, and Rocephin 300 mg IV x1 at 2130.  Patient transferred to Hospital via ambulance.
Nurse reported the patient had a urine pregnancy test done on 3/10/2020 after the third GARDASIL 9 dose was administered which was positive; the patient was administered the fist dose ofGARDASIL 9 on 1/14/2016 and was administered the second dose ofGARDASIL 9 on 3/14/2016 and was administered the third dose ofGARDASIL 9 on 3/10/2020/had a urine pregnancy test done on 3/10/2020 which was p; the patient was administered the first dose of GARDASIL 9 on 1/14/2016 and was administered the second dose of GARDASIL 9 on 3/14/2016 and was administered the third dose of GARDASIL 9 on 3/10/2020; This initial spontaneous prospective pregnancy report as received from a registered nurse refers to a currently 15-year-old female patient. She did not have a pertinent medical history. She had an allergy to pollen. Concomitant therapies included polyethylene glycol 3350 (MIRALAX) and loratadine (CLARITIN). This report concerned 1 patient and 1 combination product.  On 14-JAN-2016, the patient was vaccinated with a first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, intramuscularly, lot number K011325, expiration date 08-APR-2017. On 14-MAR-2016, she was vaccinated with a second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, intramuscularly, lot number K011325, expiration date 08-APR-2017, and on 10-MAR-2020, she was vaccinated with a third dose of  of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, intramuscularly, lot number 1637641, expiration date 16-FEB-2022 (exact doses and anatomical location of administration were not reported) as prophylaxis (reported as finish the series). On 10-MAR-2020, after the third dose of vaccine, the patient had an urine pregnancy test done, which was positive. Her last menstrual period (LMP) was on 17-FEB-2020 and the estimated date of delivery (EDD) was on 23-NOV-2020. The patient was provided counseling and a referral to obstetrics (OB) (also reported that the patient did not sought a medical attention). The pregnancy outcome was pending. The fetal outcome was unknown. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp., devicelotnumber: 1637641; expirationdate: 16-FEB-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
The 3rd day around 01/19/2021 I noticed that my arm was itching. After my shower I noticed it was red, but through the day it increased in redness and the next day 01/20/2021 it was a larger area. The second day it was about the size of a lemon . The next day 01/21/2021 the redness and swelling was on a major portion of my arm. I didn't seek medical treatment but my son in law is a physician and so I called him and told him about my symptoms and he said that it was not unusual and he said it would go away. It took about a week after to go away on 01/25/2021. I did not use any medication.
Shortness of breath  Rash on face Fever Chills Headache Nauseous  Dizzy Fatigue
Per parent report: round, red erythematous rash, appearing indurated, about 7-8 cm in diameter appearing 24-48 hrs post injection.  Resolved once seen in our office on 06/03/2019.
expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine used) in a 77-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 11-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine used). On 11-Nov-2021, EXPIRED PRODUCT ADMINISTERED (expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were provided. No treatment information were given.
A few Moments after receiving the vaccine, I was sitting down reading a book when I became hot head to toe and my heart began beating fast, hard without variance. My watch alerted me that my heart rate was 168.  I walked over to the pharmacist at this time. I lid down and they check my Blood pressure which was 116/63.  After the excitement in my heart subsided I had nausea extreme nausea with dry heaves.
Patient felt warm, off balance, disoriented, and was sweating profusely after his vaccination. This reaction started less than 5 minutes after administration of the Pfizer vaccine. EMS took the patient's blood pressure. The first reading was 80/50 mmHg and the second reading was 104/66 mmHg. After having water and sitting for 30 minutes the patient felt fine.
Ran fever after HEP A - 104 degrees.  Onset fever Friday -> Sunday (48 hours) No other sxs.
Redness at injection site, pain in arm used for injection, abdominal pain, and fatigue. Recommended benadryl and ibuprofen.