chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient appeared nervous but remained calm, seated in the chair while I prepared the vaccine next to her. She sat still during the administration without flinching or moaning. I withdrew the needle, activated the safety mechanism, and discarded the vaccine into the sharps - all within seconds. As I reached for the bandaid a few seconds later, patient immediately stood up straight. I gently grabbed her and immediately sat her back down in the chair and told her no and to wait as I wasn't done. Within moments she fell forward bent over the waist, and patient's head made first impact with the floor. The mother and I picked patient back up and seated her back into the chair. Patient was difficult to keep seated, so the mother sat on the floor and put patient in lap (mother's back was against wall). I took three blood pressure readings with a child size wrist cuff, each SBP remained in the 140s. Pulse remained around 80-100 bpm. Patient did not endorse pain in her arm, but potentially felt pain on her forehead. She remained in mother's lap for the recovery period, with some crying and moaning. We provided ice for patient's forehead. Patient was able to walk out with support from mother. They remainded under observation with pharmacist, myself, and mother for ~ 30minutes. Mother was instructed to wait at least 30 min and to stay longer if needed.
hives and itching; hives and itching; This spontaneous report was received from a physician via company representative regarding a 9-year-old male child patient. Information on patient's medical history, concurrent conditions and concomitant therapies were not reported. On 02-MAY-2019 the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) via unknown route for prophylaxis (also reported as for prevention of HPV: Human papilloma virus), strength, dose, frequency, lot # and expiration date were not reported.On 03-MAY-2019, the mother of the patient called the physician's office to report that her child (patient) had developed hives and itching (urticaria and pruritus) on 02-MAY-2019. It was not specified if events had occurred at injection site or elsewhere on the body. Patient had not recovered from the events urticaria and pruritis. Causality assessment was not reported. There was no involvement of product quality issue (PQC).   This is one of the two reports received from the same source.
Pregnancy; headache; This spontaneous prospective pregnancy case was reported by a nurse and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnancy) and HEADACHE (headache) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0391C202A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 19-Dec-2020 and the estimated date of delivery was 20-Sep-2021. On 08-Jan-2021, the patient experienced HEADACHE (headache). On 12-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  second week of the pregnancy.  On 12-Jan-2021, EXPOSURE DURING PREGNANCY (Pregnancy) had resolved. At the time of the report, HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Jan-2021, Pregnancy test: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.  Company Comment: This is a case of product exposure during pregnancy with Headache in this 31-year-old female patient. Based on the current available information and temporal association between the use of the product and the start date of the Headache, a causal relationship cannot be excluded. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.   Most recent FOLLOW-UP information incorporated above includes: On 02-Feb-2021: Follow up received on 02-Feb-2021 and event headache was included.; Sender's Comments: This is a case of product exposure during pregnancy with Headache in this 31-year-old female patient. Based on the current available information and temporal association between the use of the product and the start date of the Headache, a causal relationship cannot be excluded. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Both hands went numb while sleeping.  Right leg and foot had tingling pain, like I had small slivers all over.  My right leg is the site of my shingles when I had it 12/21 and 1/17.
received / 1st dose of Shingrix / 22nd October, 2020 /  received the COVID vaccine / second dose was delayed; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 22nd October 2020, batch number-33TL7 expiration date-30th September 2022).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional information was provided as follows:  The age at vaccination was not applicable for this report. The patient received 1st dose of Shingrix at primary reporter's facility. Till the time of reporting, patient did not received 2nd dose of Shingrix, which led to incomplete course of vaccination. The patient received the Covid vaccine and so the 2nd dose of shingrix was delayed. No further details were provided at the time of call. The reporter consented to follow up.
ER visit 10/14/2019 via ambulance with respiratory distress, followed by diarrhea, hospitalized one day in ICU, and one day on the other floor.  Discharged on 10/16/19 around 4:00 P.M.  Returned to the  ER  via ambulance on 10/16/19 around 8:00 P.M. with  seizures, was later  intubated for three weeks, remained in the hospital for five weeks,  followed by a week and 1/2 of rehabilitation in a different hospital.  Has required PT, OT, Speech, Special Education, seizure meds, MRI and numerous of other medical issues.
Information has been received from a lawyer and a consumer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medications were not provided. The patient's healthcare providers recommended and/or prescribed ZOSTAVAX (lot# and route not provided) to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 18-DEC-2014, a healthcare provider administered the ZOSTAVAX vaccine to the patient. The patient was inoculated with the ZOSTAVAX vaccine to obtain permanent prevention and protection against shingles and zoster-related injuries. On or about 18-NOV-2015, the patient was treated by a healthcare provider for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. Additional information has been requested.
Suspected clinical vaccination failure (vaccination failure); Suspected COVID-19 infection; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 20220606884(0.0) (Janssen), 20220542436 (Janssen).  A male patient received BNT162b2 (BNT162B2), in Nov2021 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine janssen (COVID-19 VACCINE JANSSEN), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for immunisation, covid-19 immunisation. The patient's family history included: "Asthma flares" (ongoing), notes: Patient's concurrent conditions included: asthma flares (everyone in immediate family has asthma). The patient's concomitant medications were not reported. The following information was reported: SUSPECTED COVID-19 (medically significant) with onset 20Apr2022, outcome "recovered" (2022), described as "Suspected COVID-19 infection"; DRUG INEFFECTIVE (medically significant) with onset 20Apr2022, outcome "recovered" (2022), described as "Suspected clinical vaccination failure (vaccination failure)". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: (20Apr2022) Unknown Results, notes: Around 20Apr2022, the patient experienced covid-19. Therapeutic measures were not taken as a result of drug ineffective, suspected covid-19.  Clinical course: The patient recovered at home and was not treated. The casual relationship between Drug: Janssen covid-19 vaccine and events was Possible.  Company Remarks: covid-19 vaccine ad26.cov2.s-suspected clinical vaccination failure. The events has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the events (s) than the drug. Specifically: special situations. Therefore, this event is considered not related.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
PRODUCT STORAGE ERROR; VACCINE ADMINISTERED AFTER STORAGE OUTSIDE OF THE RECOMMENDED STORAGE CONDITIONS; This spontaneous report received from a health care professional concerned a 40 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822809, and expiry: 04-AUG-2022) dose was not reported, administered on 25-FEB-2022 for prophylactic vaccination. Age at time of vaccination 40 years old. No concomitant medications were reported. On 25-FEB-2022, the patient experienced vaccine administered after storage outside of the recommended storage conditions. On an unspecified date, the patient experienced product storage error. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccine administered after storage outside of the recommended storage conditions and product storage error was not reported. This report was non-serious. This case, from the same reporter is linked to 20220558451, 20220558340, 20220558439, 20220558455, 20220558511, 20220558638, 20220558852, 20220558823, 20220558343, 20220558345, 20220558349, 20220558378, 20220558383 and 20220558598.
pt was feverish on 23may94,6:30pm;pt taken to ER BC was done;pt vomited, would not eat or drink; ER MD felt it was a virus, gave pt motrin;mon said pt has hives all over body;
Persistent itchy skin bubling on arms, mainly near left forearm near elbow. Persistent peeling skin on hands and fingers - mainly right hand. Never had this before.
Started day of shot given. They did not tell me to get in a different arm than the first. Lump at first not painful at injection site. Sunday apon waking arm all the way up and all around even shoulder Is painful, red, swollen and inches. Ice and ibuprofen not helping. I went to local imediant care, they told me it was pretty bad case of "Covid Arm"
On April 23, about 26 days after the second shot I experience general discomfort.  I took my blood pressure and it was elevated and my heart beat was irregular.  I called my doctor, but due to  a busy schedule he could not see me until May 6.   At the time of my Doctor visit I felt OK and my heart beat was normal.  He suggested a follow up with a Zio patch monitor.  Because of busy schedules and other delays I could not get the monitor until until August 30. I wore the monitor for two weeks.
Patient states he awake on 12-11-22 with a swollen left ankle, midsternum pain and generalized weakness, limited range of motion in bilateral arms. Reports that today his only symptom is pain to the right shoulder.
Soreness in arm; headache; fatigue; This is a spontaneous report from a contactable consumer (patient). A 67-year-old non-pregnant female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and Expiry date not reported, age at vaccination: 67-year-old), via an unspecified route of administration, in Arm Right on 08Feb2021 12:00 PM as dose 1, single for COVID-19 immunisation. Medical history included COVID-19 (COVID-19 positive prior vaccination). Concomitant medications included Irbesartan and amlodipine taken for an unspecified indication, start and stop date were not reported. On 08Feb2021at 12:15 AM, the patient experienced soreness in arm, headache and fatigue. The patient did not receive any corrective treatment. The patient did not receive any other vaccine in four weeks. The patient was not tested COVID positive post vaccination. The outcome of the events was not resolved.  Follow-up attempts completed. No further information expected.
The day after receiving the second Moderna vaccine, recipient experiences severe side effects including: arm rash, fever 102.4, joint pain (described as "every" joint in her body), vomiting. Symptoms lessened the next day. Third and forth days after vaccine, recipient just feels very tired. She did not experience significant side effects after her first vaccine.
Information has been received from a physician concerning a 25 year old female who on 03-JUL-2007 was vaccinated intramuscularly with her first dose of GARDASIL (lot# not reported). Concomitant therapy included DEPO-PROVERA. On 20-SEP-2007 the patient was vaccinated intramuscularly with her second dose of GARDASIL (lot# not reported). On 25-SEP-2007 the patient experienced joint aches and right hip numbness and pain. She was seen by a rheumatologist and was diagnosed with erythema nodosum from GARDASIL. She was advised to not get the third dose in the series and was seen in the office on 26-MAR-2008 and she reported no problems. Subsequently, the patient recovered from joint aches and right hip numbness and pain. No further information is available.
This spontaneous report as received from a medical assistant refers to a 15 year old patient of unknown gender. On 04-JAN-2016, the patient was vaccinated with an improperly stored dose of the GARDASIL 9 (dose, anatomical location and route of administration were not provided, lot # L016429 with expiration date 09-AUG-2017). The vaccine underwent temperature excursion of either +1 or -1 degree Celsius for 255.5 total cumulative hours, which was detected by a data logger. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Patient become unresponsive and faint approximately 5-10 minutes after receiving dose 2 of the covid vaccine. After consuming some water patient vomited and remained unresponsive. Pharmacist went to get epi-pen to administer but upon returning with it the patient was responsive again and reported no difficulty breathing. Epi-pen was not administered.
I received the vaccine at 8:30 am on 1/14/22. By 8:00 pm that evening, I felt really bad - severe pain in my arm, fever, body aches. On 1/15/22, I could barely lift my left arm as it hurt so bad. I noticed that the left armpit was starting to swell and I ran a 102.3 F. fever all day and had body aches, headache, and fatigue. 1/16/22, fever was down to 100 degrees and body aches started to improve. Armpit was still swollen at this time. On 1/17/22 still felt fatigued and noticed that the swelling in the armpit appeared to be worse than the previous day. 1/18/22 - swelling in armpit is significantly worse and left ear has been hurting as well. Called primary care physician to get checked. Have appointment on 1/19/2022.
COMPLETED PHYSICAL THERAPY TO IMPROVE BALANCE; This spontaneous case was reported by a consumer and describes the occurrence of BALANCE DISORDER (COMPLETED PHYSICAL THERAPY TO IMPROVE BALANCE) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Plaque psoriasis.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) Solution for injection in pre-filled pen, Citrate free. On an unknown date, the patient experienced BALANCE DISORDER (COMPLETED PHYSICAL THERAPY TO IMPROVE BALANCE). At the time of the report, BALANCE DISORDER (COMPLETED PHYSICAL THERAPY TO IMPROVE BALANCE) outcome was unknown.            It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No concomitant medications were reported.  On an unknown date patient received booster dose.  The reporter's causality for the event of completed physical therapy to improve balance with HUMIRA was no reasonable possibility.  No treatment information was reported.
On 9/26/2006, patient felt dizzy. She described her head as "swimming".  She complained of headache.  She stated that her right arm hurt and was stiff.  On 9/27/06 patient dizziness had improved, but arm pain persisted.
patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The reporter was an internal medicine manager.  Concomitant medication of the patient was not reported.  The reporter reported that because their facility had not been able to download the digital data logger, they had been put on hold by the agency at the moment and cannot administer the Moderna COVID-19 vaccine to patients until an assessment by the agency was made. There had been no power outages that would have impacted the Moderna vaccine. However, the reporter reiterated that because the facility was unable to download the digital data logger, this issue was treated as a temperature excursion. The reporter was unable to download the data logger for the months of December 2021, January 2022 and February 2022. The reporter was filling out a temperature excursion assessment with the agency.   The reporter mentioned that the patient had been administered dose while the temperature excursion assessment was ongoing. The reporter also reported that, no adverse reactions were reported by the patient.  No treatment information was provided by the reporter.
Patient was given pfizer covid 19 omicron vaccine for ages 6 months - 4 years instead of pfizer covid 19 oricron vaccine for ages 5year - 11years.
This spontaneous report as received from a other health professional refers to approximately 19 year old female patient. Patient's medical history and concurrent condition was not reported. On 08-MAY-2014 the patient was vaccinated with LIQUID PEDVAXHIB (dose and frequency unknown) in the left deltoid. On an unknown date approximately in 2014 there were out of range temp logs and the vaccines that have been administered to patients. The outcome of the event was unknown. This is one of the several patients reports received from the same source. Additional information has been requested.
Pt had a erythematous rash bilaterally on pt's thighs 2 hour to MMR, DPT, Polio, Hib vaccine on Monday. 2 days later left leg 5 cm concentrate erythema, Non-painful rash on right thigh 3 cm erythematous rash non-painful rash. Pt was sent home and told to give Motrin for fever. Pt is to return to clinic if fever exceeds 101.
Initial report received from a healthcare professional on 12 August 2013. A female patient, whose age, medical history and concomitant medication were not reported, had received an intramuscular dose of ADACEL (Lot number: U4612AA, expiry date: 20 September 2015, anatomical site of vaccination was not reported) on an unspecified date. The patient was pregnant. The patient's last menstrual period date was 06 December 2012 and the estimated date of delivery was 12 September 2013. The patient's health during pregnancy and risk factors (e.g.: alcohol, tobacco or recreational drugs) were reported as "NA". Treatment for infertility was not reported. At the time of this report, the patient did not experience any adverse event. List of documents held by the sender: None.
Ill; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "Ill".  Additional information: The reporter asked if a person got the 1st dose of the Pfizer vaccine and gets ill, how long should a patient wait before getting the 2nd dose.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.