chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a nurse via field representative refers to a female patient of unknown age. A couple of weeks ago, on an unknown date in 2014, the patient was vaccinated with GARDASIL (dosage information unknown). No concomitant medication was reported. The patient fainted after administration of GARDASIL. The patient sought medical attention (in office). The patient was given fluids and monitored in the office and recovered from the event with in 1 hour. The causality of the event was unknown. A product quality complaint (PQC) was not involved. Additional information has been requested.
Patient came to ED with cough, dyspnea, nausea, and vomiting.  Patient was admitted to the hospital with Covid and treated with remdesivir.
Missed his/her 2nd dose, more than 42 days; I broke out in hives after the 1st dose; I was fatigued after the 1st dose; Chills after the 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed his/her 2nd dose, more than 42 days), URTICARIA (I broke out in hives after the 1st dose), FATIGUE (I was fatigued after the 1st dose) and CHILLS (Chills after the 1st dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021, the patient experienced FATIGUE (I was fatigued after the 1st dose) and CHILLS (Chills after the 1st dose). On 01-May-2021, the patient experienced URTICARIA (I broke out in hives after the 1st dose). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed his/her 2nd dose, more than 42 days). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed his/her 2nd dose, more than 42 days), URTICARIA (I broke out in hives after the 1st dose), FATIGUE (I was fatigued after the 1st dose) and CHILLS (Chills after the 1st dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication not reported.  Treatment medication not provided.
Genital rash; rash severity increases at night to the point that he cannot sleep; When pressed on the bump, it turns yellow; rash on legs/Hand rash/rash become very bumpy if patient itches; Itching; This spontaneous case was reported by a pharmacist and describes the occurrence of PRURITUS (Itching), GENITAL RASH (Genital rash), INSOMNIA (rash severity increases at night to the point that he cannot sleep), VACCINATION SITE DISCOLOURATION (When pressed on the bump, it turns yellow) and RASH (rash on legs/Hand rash/rash become very bumpy if patient itches) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, the patient experienced PRURITUS (Itching). On 25-Mar-2021, the patient experienced RASH (rash on legs/Hand rash/rash become very bumpy if patient itches). On an unknown date, the patient experienced GENITAL RASH (Genital rash), INSOMNIA (rash severity increases at night to the point that he cannot sleep) and VACCINATION SITE DISCOLOURATION (When pressed on the bump, it turns yellow). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 50 mg once a day; PREDNISONE at a dose of 50 mg once a day and CETIRIZINE HYDROCHLORIDE (CETRIZINE) at a dose of 20 mg once a day. At the time of the report, PRURITUS (Itching), GENITAL RASH (Genital rash), INSOMNIA (rash severity increases at night to the point that he cannot sleep), VACCINATION SITE DISCOLOURATION (When pressed on the bump, it turns yellow) and RASH (rash on legs/Hand rash/rash become very bumpy if patient itches) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 02-Apr-2021: This follow up was received on 02 April 2021, which reported that the rash developed did not subside and so the patient wants to know if it is okay to receive second dose which was due by 10 days. On 23-Jun-2021: Received second dose of vaccination which didn't seem like aggravating the issue-Updated treatment medications.
Tonic clonic seizure at 10Am on 9/24/16 without incontinence. Seen in ER, Normal PE and electrolytes.
Developed neck right arm pain immediately after head/neck trauma in Mar 2003; received AVA#4 one month later with continued neck pain, intermittent right arm pain which became chronic; found to have C5-6 disc herniation Sep 2003, resulting in ACDF Jan 2004; received AVA#5 May 2004 during slow post-op recovery process; had continued intermittent neck/right arm pain & found to have C6-7 disc herniation Jun 2006 resulting in 2nd ACDF Sep 2006; had poor post-op recovery with only 20% improvement; diagnosed with reflex sympathetic dystrophy or complex regional pain syndrome June 2007; poor response to multiple courses PT & pain management modalities; remains symptomatic with limited use right arm, minimal neck ROM. Symptoms: Weakness, Paresthesia.  5/6/09 Received medical summary & medical records. FINAL DX: reflex sympathetic dystrophy or complex regional pain syndrome; GERD; post traumatic stress syndrome; depressive disorder; memory/concentration loss Records reveal patient experienced head/neck injury 3/03 after hitting head & having severe headache, neck muscle spasms & pain in right arm immediately after.  5/03 dx w/muscle strain/sprain & c-spine degenerative changes.  9/03 MRI revealed spurring C5-6, calcification of anterior longitudinal ligament, herniated pulposus C5-6.  Saw private neurosurgeon w/herniated disc, degenerative spondylitis & intermittent left radicular complaints.  Conservative tx ineffective & had C5-6 cervical disc fusion done 1/04.  Slow recovery.  8/04 MVA w/excerbation of neck pain.  1/06 MRI revealed C6-7 disc protrusion w/neck & arm pain.  6/06 developed sudden excruciating chest/right arm pain & MRI revealed C6-7 herniation.  9/06 had 2nd neck surgery complicated by hoarseness & dysphagia.  Very limited improvement by 5/07.  6/07 referred for pain management, dx w/RSD & tx w/multiple modalities.  Eval & tx for depression & PTSD 1/08 related to chronic pain.  10/08 dx w/hypothyroidism.  MRI/MRA brain 3/08 abnormal w/mesial temporal sclerosis.  Pt w/currently difficulty w/ADLs & unable to drive.
cardiovascular symptoms; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 60-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot number: unknown) via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Previously patient took first dose of bnt162b2 (batch/lot number: unknown) via unspecified route on an unknown date for covid-19 immunization. On an unspecified date, the patient experienced cardiovascular symptoms after my 2nd dose of his COVID vaccine. The outcome of event was unknown.    Follow-up (07Oct2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
No additional AE; Consumer reporting her daughter was given an expired vaccine. No additional AE. No PQC.; This spontaneous report was received from the patient's mother and refers to a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 24-MAY-2021, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II)(recombinant human albumin) subcutaneous injection, 0.5 milliliter, lot #S014429, expiration date: 09-MAY-2021, administered for prophylaxis (strength, route and site of administration were not provided) (expired vaccine used). The mother of the patient thought that it was pediatricians office fault that gave to daughter an expired vaccine. She stated that she received a call from the pediatrician and they said the site has wrong records; there has been cases where the lab has the wrong expiration date. The mother requested another immunization but the pediatrician refused. She wanted to make sure her daughter was covered but the pediatrician said he cannot give her another shot. The pediatrician said it is impossible to give her shot that was expired and it was a problem at lab and the site that did not have records. Mother stated she never checked records at all and always trusts the pediatrician but recently had a problem with a nurse and that was why she checked the records. The mother finally moved the patient to another pediatrician's office and they would perform a blood test and find out if her daughter is covered with vaccine and if not they will give another shot. Caller stated the pediatrician that gave the expired vaccine did not offer this at all and was in denial and acted like he could not make mistakes. She just wanted this to be documented so this did not happen again to another child. No additional adverse event was reported.  During follow-up process the contact with pediatrician office was performed. The nurse reported no adverse event occurred and the vaccine administered to the patient was not expired (conflicting information). The office used a system which recorded the vaccine that was administered to the patient and that she could fax in the report from the system if needed. The patients electronic medical record was not updated correctly and that is why the consumer believed the vaccine was expired.
headache; little fever; This is a spontaneous report from a contactable consumer (patient).   A 68-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number: EN6200, expiration date was not reported) via an unspecified route of administration, on 27Feb2021 16:00 (at the age of 68-years-old), at dose 1, single for covid-19 immunization. Medical history included allergy to arthropod sting. The patient's concomitant medications were not reported. The patient had a normal very mild reaction to the vaccination and stated that it was like a headache/ little headache and a little fever on the first day after the first dose of vaccination (28Feb2021). The patient had the second dose vaccination on 20Mar2021 15:30 (lot number: EN6205) for covid-19 immunization. The outcome of the events was unknown.     Follow-up (30Mar2021): No follow-up attempts are possible. No further information is expected.
2MAY91 pt recvd Engerix-B; w/in 15 min of the inject pt devel swelling & a rash; pt is reported to have recovered;
Patient reports that while waiting the required 15 minutes post vaccination he became "dizzy" and felt like he would pass out. The patient requested assistance and was brought back to medical observation 1. The patient was laid in a semi-fowlers position and vitals were obtained by medical staff. After a few minutes the patient reported he felt "back to normal" and requested to leave. All vitals were within normal limits upon departure.   1432 HR- 104     Resp- 18    BP- 141/60    SpO2- 95%  1444 HR- 100    Resp- 16    BP- 138/58     SpO2- 95%
Case previously recorded as MA2009-6273. Initial case report received from a health care professional on 25 NOV 2009. Twenty children younger than 04 years of age received FLUVIRIN influenza A intramuscular inadvertent administration on an unknown date. No adverse event reported. Medical history: No reported. Agency reference no. NA09-008851.
Pt had first Moderna covid vaccine on 7/29/2021 with no initial reaction. Since 8/5/2021 with the beginning of symptoms., pt has noticed a erythematous rash around possible vaccine site of left deltoid region. Not pruritic. Little more than 2 cm in height and width. It can feel warm at times.   Never had a reaction to any vaccine prior  COVID ARM
Pfizer BioNTech COVID 19 vaccine EUA-  Chills, nausea, muscle aches, headache. Motrin 400 mg taken Q4-6 hours
This spontaneous report as received from a Medical Assistant refers to 9 weeks old infant, gender not reported. On 05-DEC-2014, the patient was vaccinated with ROTATEQ, Lot # K010642, orally. It was reported that the administered vaccine was subjected to temperature excursion during storage. No adverse event reported. This is one of the several reports from the same reporter. Additional information has been requested.
No adverse event; Patient received an expired vaccine; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received an expired vaccine) and NO ADVERSE EVENT (No adverse event) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 057M21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 19-Aug-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 19-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received an expired vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received an expired vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient received an expired vaccine).    No concomitant medications were reported. Reporter stated that she still had vaccine that have been expired and she wanted to know how to dispose of it.  She stated that it was their 1st booster and the vaccine had expired a few days ago and a patient receiving it did not make a difference. That the patient was still getting the benefit from the vaccine.  No treatment medications were reported.
administered an extra dose; Patient got an extra dose of Engerix-B and Havrix; This case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 74-year-old male patient who received HBV (Engerix B) (batch number 7XY23, expiry date 29th April 2023) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis, HAV (Havrix) (batch number J95H7, expiry date 22nd May 2022) for prophylaxis, hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis, HAV (Havrix) for prophylaxis and hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Engerix B (completed the primary series in 2018) and Havrix (completed the primary series in 2018).   On 10th March 2022, the patient received the 4th dose of Engerix B, Engerix B Pre-Filled Syringe Device, the 4th dose of Havrix and Havrix Pre-Filled Syringe Device. On an unknown date, the patient received the 3rd dose of Havrix and Havrix Pre-Filled Syringe Device. On 10th March 2022, unknown after receiving Engerix B, Engerix B Pre-Filled Syringe Device, Havrix and Havrix Pre-Filled Syringe Device and not applicable after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced extra dose administered. On an unknown date, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered and extra dose administered 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 details were provided as follows: The case was reported by Registered Nurse. The reporter stated that, she administered an extra dose of Engerix-B and Havrix to a patient, which led to extra dose administered. The reporter consented to follow up via email. Note: 3rd dose of Havrix was also considered as suspect as only 2 doses are considered in the primary schedule (a single dose and a booster dose). This case is linked with US2022045525, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022045525:Same reporter
Pt was (assumed) to have been given 0.1mL Anthrax vaccine intradermally, inadvertently (instead of PPD skin test). Pt has local reaction to left arm resembling Anthrax reaction (localized inflammation, swelling, mild pain, warmth). Will follow-up to see if reaction subsides. Unknown which vaccine was given.
Vaccine was administered on 1/12/21 at Memory Care. On 1/15/21 at 12:30 he developed slurred speech at his facility and slumped to his left side. Out of concern for stroke he was sent by ambulance to Hospital. There he was found to have no evidence of stroke on MRI or CT angiogram. He was admitted to the hospital due to fever and  elevated inflammatory markers (ferritin, CRP) and transaminases. He was found to have a positive SARS-CoV-2 PCR and IgG. His symptoms resolved the following morning and may have represented a TIA. He had many markers consistent with COVID-19 and his CT pulmonary angiogram did show ground glass opacities but no pulmonary embolism. It was difficult to assess if this was a reinfection with COVID-19, persistent PCR positivity from November, or an adverse event to the vaccine.
I'm feeling a little tired; red in her face; around her eye is swollen; around her eye is swollen and red; swelling; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient. Other Case identifier(s): US-PFIZER INC-202101294991 (Pfizer).  A 65 year-old female patient (unknown if pregnant) received bnt162b2 (BNT162B2), administration date 23Sep2021 (Batch/Lot number: unknown) at the age of 65 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "allergies to shellfish" (unspecified if ongoing); "Allergies: mold" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization. The following information was reported: FATIGUE (non-serious) with onset Sep2021, outcome "unknown", described as "I'm feeling a little tired"; ERYTHEMA (non-serious) with onset Sep2021, outcome "unknown", described as "red in her face"; EYE SWELLING (non-serious) with onset Sep2021, outcome "unknown", described as "around her eye is swollen"; OCULAR HYPERAEMIA (non-serious) with onset Sep2021, outcome "unknown", described as "around her eye is swollen and red"; SWELLING (non-serious) with onset Sep2021, outcome "unknown", described as "swelling".  Additional information:She received her second Covid 19 vaccine on 22Sep2021 so it's been almost a week or a week and a day and at the time she received the Covid 19 vaccine she didn't had any problems. But now her eyes, around her eyes were swollen and red and the swelling was really bad and she was red in her face. She was asking if this was a side effect. She reports she was born with allergies to shellfish and mold. She was not sure if she was allergic to eggs because she does not eat a lot of eggs. Her face was red and her eyes were very swollen and around her eyes it was red in each eye.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow-up (27Oct2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Noted approx. 1 1/2x 1 inch red warm area to right thigh area, child alert playful, no distress noted.
Seven days after receiving the first vaccine, my arm was hot to the touch when I woke up.  Throughout the day the area around the injection site became red, very hot and firm to the touch, slightly swollen, and itchy.  The symptoms were the most acute 9 days after the initial injection and subsided by day day 11.  In total, the symptoms lasted 4 days, with some very faint redness on the 4th day.
Pro Air Inhaler Advair 500 Inhaler Dizziness difficulty catching my breathg fatigue
Lower back pain that then was only localized to the right flank. Worse when breathing.  Ibuprofen helped with symptoms a bit. I visited the ED and on US a gallstone was detected, not obstructing ducts but the decision was made to have it removed.
Feels like she's going to pass out after 1st dose; Dizziness with walking after 1st dose/Really bad dizziness after 1st dose; Trouble breathing after 1st dose; Vertigo after the 1st dose; she can't work because of the dizziness; Arm sore after the 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of PRESYNCOPE (Feels like she's going to pass out after 1st dose), DIZZINESS (Dizziness with walking after 1st dose/Really bad dizziness after 1st dose), DYSPNOEA (Trouble breathing after 1st dose), VERTIGO (Vertigo after the 1st dose) and IMPAIRED WORK ABILITY (she can't work because of the dizziness) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037b21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Heart attack, Vertigo and Pacemaker insertion (cardiac). Concurrent medical conditions included Diabetes.    On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRESYNCOPE (Feels like she's going to pass out after 1st dose), DIZZINESS (Dizziness with walking after 1st dose/Really bad dizziness after 1st dose), DYSPNOEA (Trouble breathing after 1st dose), VERTIGO (Vertigo after the 1st dose), IMPAIRED WORK ABILITY (she can't work because of the dizziness) and PAIN IN EXTREMITY (Arm sore after the 1st dose). At the time of the report, PRESYNCOPE (Feels like she's going to pass out after 1st dose), DIZZINESS (Dizziness with walking after 1st dose/Really bad dizziness after 1st dose), DYSPNOEA (Trouble breathing after 1st dose), VERTIGO (Vertigo after the 1st dose), IMPAIRED WORK ABILITY (she can't work because of the dizziness) and PAIN IN EXTREMITY (Arm sore after the 1st dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient was prescribed a medicine for vertigo but patient did not know if she wanted to take it. The patient was taking a medication for ear infection (not specified). The patient was due for her second dose on 20-May-2021 and was thinking about not getting it.   Most recent FOLLOW-UP information incorporated above includes: On 16-Jul-2021: Follow-up received updated reporter contact details.
I am breastfeeding my 4 month old baby. Two days after I received the vaccine, he had blood and mucous in his stool for 2 days. No other causes identified and no changes.
This case was reported by a pharmacist and described an adult subject of unspecified gender who did not respond to the hepatitis B vaccine recombinant Engerix B, immunization series. The pharmacist reported that two individuals are non responders to the Engerix B series, however, subject identifiers were not provided. On an unspecified date before 9/12/2005, the subject received a dose of Engerix B (dose number not provided). At an unspecified time following the administration of Engerix B, on an unspecified date on or before Sept 12 2005, a hepatitis B surface antibody titer was negative.