chrisvoncsefalvay/vaers-outcomes huggingface dataset:
(This RN was not direct observer of initial incident. Initial events as reported by initial responding RNs). Pt had just received Pfizer vaccination and was seated in observation area. Was observed to be "not looking well" and approached by staff. Pt began to hyperventilate, exhibit repetitive jerking motions to upper body/"pseudo seizure-like activity", and reported feeling nauseated. Began to slide out of chair, x2 RNs assisted pt to floor. Pt then placed in wheelchair and taken to Triage tent A. Pt remained alert and oriented throughout duration of event.   VS @0915- BP 128/77  HR 131  Sats 100% on RA.  0.3mg IM epinephrine given at 0919. VS @ 0920 HR 108 0938 O2 sats 87% on RA, applied 0.5L O2 via nonrebreather mask. Sats back up to 100% @ 0939. Pt remains alert, intermittently exhibits periods of jerking actions and hyperventilation between periods of calm. With staff assist, called husband  who was en route. VS @ 0940-  HR 101, Sats 100% on 0.5L via nonrebreather. 50mg IM Benadryl given at 0940. VS @ 0950 HR 109  sats 100% on RA. Husband, to bedside.  Pt remains alert. 1007  EMS arrives for transport to Emergency Department
Immediately after administering the flu shot into the deltoid muscle the patient began bleeding excessively and a 3/4" size hard blue lump developed at the injection site.  The bleeding stopped after applying a cotton ball. The patient was contacted 2 hours after the vaccination and they reported that the hard lump was still there, yet there was no pain.
Myalgia, Fever, UrticariaPruritus,  Anorexia, SOA, rhinorrhea, chills, Narrative: Self treated with benadryl and motrin
Approximately 5 minutes after vaccines were given, child collapsed to the floor.  She took a hard blow to the back of her head.  Regained consciousness quickly.  She was transported to the ER (ambulance) after complaining of neck pain.  No treatment given - Released.
Low body temperature; Fatigue; Anxiety; Brain fog; High BP/Pressure in head and high blood pressure; Severe chills; Strange redness across her shoulders; Arm hurt after shot; Pressure in head; Very loose stools; Nausea; This is a spontaneous report from a contactable consumer reporting for herself.  A 59-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 05Apr2021 13:30 (Batch/Lot Number: EP7533) as single dose for covid-19 immunisation  (Age at vaccination: 59 years) .  Medical history included liver disorder , hypersensitivity, hepatitis C  from , osteopetrosis , arthropod sting allergy , drug hypersensitivity  , gluten sensitivity  (She is borderline celiac, and she will get really bad gastro problems for 2 or 3 days after digesting gluten) , penicillin hypersensitivity  (She has itching, rash, nausea) , peanuts allergy (Keeps an EPI pen for this). Concomitant medications  included d-ribose, polypeptide (TRANSFER FACTOR [D-RIBOSE;POLYPEPTIDE]) taken for hepatitis C from 2003 to 03Apr2021; ascorbic acid (VITAMIN C ACID) taken for an unspecified indication from an unspecified start date to 03Apr2021; vitamin D3 (VITAMIN D3) taken for osteopetrosis from an unspecified start date to Apr2021; probiotics (PROBIOTICS) taken for an unspecified indication, start and stop date were not reported.   The patient experienced high bp/pressure in head and high blood pressure  on 05Apr2021 with outcome of unknown , fatigue  on an unspecified date with outcome of unknown , severe chills  on 05Apr2021 with outcome of unknown , low body temperature on an unspecified date with outcome of unknown , strange redness across her shoulders  on 05Apr2021 with outcome of recovered , arm hurt after shot  on 05Apr2021 with outcome of unknown , pressure in head  on 05Apr2021 with outcome of unknown , very loose stools on 05Apr2021 with outcome of unknown , nausea  on 05Apr2021 with outcome of unknown , brain fog  on 06Apr2021 with outcome of not recovered , anxiety on an unspecified date with outcome of unknown. Hypertension was considered an Important Medical Event. The remaining events were non serious.  The patient underwent lab tests and procedures which included blood pressure increased: 179/98, 170/97   on   unknown date  , blood pressure measurement: 152/87 on 06Apr2021   , body temperature decreased: low  No follow-up attempts are needed. No further information is expected.
She received inactivated influenza vaccine at medical center on Sept 29, 2014; injection into her left upper deltoid (vaccine has not yet been recorded in immunization history). She stated the site was high; she immediately experienced a sharp pain at the injection site, which has never resolved. She has been treating with self-directed range of motion, she already takes NSAIDs routinely for her DJD of her knee, and has been using heat and ice. MRI was done which demonstrated a small fluid collection most consistent with subdeltoid/subacromial bursitis. She received steroid injection which was helpful for several months, but symptoms returned in April 2015 and have continued intermittently.
In preparing to give the vaccine, the vaccinator saw the syringe had a bubble in it. She cleared the bubble which reduced the volume in the syringe. The dose dropped from 0.5 ml to 0.3-0.4 ml.  he vaccinator gave the dose anyways and then expressed concerns to her overseeing physician, . Dr.  contacted me, - Pharmacy Director, after hours to discuss. Pulled medical team to discuss situation and how to handle possible reduction in dose.   Plan of Action - Dr. reported the situation to the patient. We will keep them on the same dosing schedule. Will recommend checking quantitative antibody levels 10-14 days after second dose to evaluate immune response. This should have been discussed with the patient by Dr.  and his team.
Information has been received from a registered nurse practitioner concerning a 12 year old female who on an unspecified date was vaccinated with the first dose of GARDASIL (lot # not provided).  After getting first dose of GARDASIL, the patient developed rash on her whole body.  The patient sought medical attention.   At the time of reporting, the patient had recovered.  Additional information has been requested.
A non-serious spontaneous report of FLUMIST administered to 19 month old was received from a physician concerning a 19-month-old female. Neither the patient's past medical history nor the concomitant medications were reported. There was no adverse event associated with this mediation error; therefore, treatment and reporter causality assessments are not applicable, and the event was considered resolved. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 yeas to 59 months of age. Additional information was received on 01-Mar-2011: Reporter confirmed that there was no late occurrence of adverse events.
I started out on my upper body with red, no itching, hive looking areas that were just red areas. Then it progressed to a rash look (a raised area). On my upper body it started as red, no rash. Then a month later on my legs it started as a rash. I've taken a dose of steroid and it didn't help. The middle of April is when the leg rashes started, the raised rash areas. But for my upper body rash it went from my arms down, the red areas. When I went to the doctor they said she knew it was a drug allergy due to the pattern. She sent me to the dermatologist who put me on Metoprolol and she saw me again in May and I was still high on blood pressure so she added valsartan. And had me come back every week to monitor. By June 8th I was on a 3rd blood pressure medication, Norvasc. And got me set up with a dermatologist who did biopsy because the upper body and lower looked different. The results showed it was a drug allergy. Since then I've been back to the cardiologist and the 3 medications have controlled it. I still have the rash spreading and been on steroids for 4 times to clear this up. All it does is calm it down and doesn't go away. I'm no longer taking it because it didn't help. Now I'm on a antibiotic 2x day to hopefully clear this up. I had a high blood pressure episode and had to go the ER. In Sep. around the 15th I had COVID that started with a horrible headache and went to the hospital to get tested and it was positive. I also had weakness and was wiped out. These symptoms were very severe like 8/9 on a scale of 1-10. These symptoms lasted probably 5-6 days. And then it got a little better. My doctors are afraid for me to get another vaccine due to the severe symptoms I've had.
This spontaneous report as received from a doctor of pharmacy refers to a patient of unknown age and gender. Pertinent medical history and drug reactions/allergies were not reported. On 29-OCT-2013, the patient was vaccinated with ZOSTAVAX (lot # J006155 and expiry date 30-AUG-2014) (dose and route were not reported). No concomitant medication was reported. The call was reported originally on 04-NOV-2013 in which the reporter requested the stability for an improperly stored ZOSTAVAX. At the time of the call it was reported that the ZOSTAVAX was exposed to 15F for an unspecified amount of hours but reported that no doses of ZOSTAVAX were administered. The reporter called back again on 05-NOV-2013, and stated that he thought that the ZOSTAVAX might had been stored improperly since May 2013 and that the temperature of the ZOSTAVAX had ranged between 15F and 20F for an unspecified amount of hours. At that time the reporter was unsure if the ZOSTAVAX was administered but stated that he thought the ZOSTAVAX would have been administered. On further investigation, the pharmacist reported that ZOSTAVAX had been improperly stored since about 10-OCT-2013 reaching a highest of 20F for a total time of 600 hours. It was reported that the patient had no adverse effect. Further investigation stated that the pharmacist had determined that this case might involve approximately 5 different Lots of ZOSTAVAX (details unspecified) stored improperly at temperatures up to 21F. He stated the time frame for the excursions would be as of the day each of the ZOSTAVAX Lots was received at his facility through the date of patient administration, which he believed might had been months, dating back to on an unknown date in May 2013. These involved approximately 40 patients. He had no specific breakdown of time frame as his record didn't indicate when he received each Lot but he was calling further for the data. He also could not identify, at this time, which Lot # was administered on which date. Pharmacist would call back after he had compiled all of the necessary information and would like revaccination recommendations for any excursion that could not be supported. Pharmacist stated there had been no adverse effects noted by any of the patients. The pharmacist faxed a spreadsheet which included the 38 patients names, the date of administration as well as the lot and expiration dates of the ZOSTAVAX which was unsupported an administrated. This is one of several reports from the same source. Additional information has been requested.
Began feeling very tired and slightly confused.  Left work one hour, one home I had a slight fever of 99 so I took Tylenol  and tried to sleep.  Woke with a headache and cold not get warm all night.
Nurse accidentally gave my child the wrong vaccine. He was supposed to receive Polio and was given MMR without consent
Received flu shot left upper arm on 10-24-12 about 1500. Developed itching et hives left temporal area, left outer et inner ear, left upper chest - lasted approx 4 days.
hot flushes Numbness  Tingling Throat and chest tightness dizziness felt hot all over lip cyanosis
scheduled for his second dose today but after he woke-up he is not feeling well; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A male patient received bnt162b2 (BNT162B2), administration date 05Mar2021 (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: MALAISE (non-serious) with onset 26Mar2021, outcome "unknown", described as " scheduled for his second dose today but after he woke-up he is not feeling well".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Can't lift it up parallel without shooting pain; Shoulder just hurts/can't lift it up parallel without shooting pain/ My left shoulder is still in pain; This spontaneous case was reported by a consumer and describes the occurrence of HYPOKINESIA (Can't lift it up parallel without shooting pain) and ARTHRALGIA (Shoulder just hurts/can't lift it up parallel without shooting pain/ My left shoulder is still in pain) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017E21A and 051C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HYPOKINESIA (Can't lift it up parallel without shooting pain) and ARTHRALGIA (Shoulder just hurts/can't lift it up parallel without shooting pain/ My left shoulder is still in pain). At the time of the report, HYPOKINESIA (Can't lift it up parallel without shooting pain) and ARTHRALGIA (Shoulder just hurts/can't lift it up parallel without shooting pain/ My left shoulder is still in pain) had not resolved.      No concomitant medication was provided by reporter. No treatment information was provided by reporter.   This case was linked to MOD-2021-318973 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 16-Sep-2021: Follow up received: Outcome of the event updated.
NO ADVERSE EVENT WAS NOTED. ADMINISTERED EXPIRED VACCINE. VACCINE EXPIRED ON 4/1/2022 AND WAS ADMINISTERED ON 04/19/2022.
Patient presented fever and fussiness (7 hours after vaccine administered). Vomiting 15 times > (24 hours after loss of consciousness for seconds and stiffness. Repeated similar episodes 4 hours after. 12/22/06 Received medical records from hospital which reveal patient admitted 10/24/06-10/27/06 with fever & vomiting since receiving flu vax.  On day after vax had brief tonic-clonic episode with eyes rolling back, cyanosis & limpness afterward.  Fever 101 & had 2nd seizure.  Afebrile in hospital & no further seizures. Final DX: Febrile seizure s/p immunization w/flu vax; 2 brief febrile seizures.
Starting 1-2 days after initial shot, I have had tingling and some numbness running down the outside side of the same arm as injection site but mostly in that hand especially in my last two fingers; Starting 1-2 days after initial shot, I have had tingling and some numbness running down the outside side of the same arm as injection site but mostly in that hand especially in my last two fingers; There is also still some minor pain at the injection site; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration in the right arm on 24Mar2021 at 15:00 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Medical history included vitiligo. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medications. On 26Mar2021, Starting 1-2 days after initial shot, the patient experienced tingling and some numbness, it was running down the outside side of the injection site arm but mostly in that hand especially in last two fingers of same arm and also there was a still some minor pain at the injection site. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events tingling and some numbness running outside side of the injection site arm but mostly in that hand especially in last two fingers and minor pain at the injection site were not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
covid-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (covid-19) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L21A) for COVID-19 vaccination.     Concurrent medical conditions included Hyperlipidemia, Hypertension and Allergy NOS. Concomitant products included ATORVASTATIN for an unknown indication.    On 18-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (covid-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 09-May-2022 to 13-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (covid-19) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2022, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medication was not provided by the reporter.  Company Comment: This spontaneous case concerns a 69-year-old male patient with no relevant medical history reported, who experienced the unexpected non-serious AESI event of COVID-19 unspecified days after receiving fourth dose of mRNA-1273 vaccine. It was reported that patient started with Paxlovid On 09-May-2022.  and Covid symptoms returned and tested positive on antigen test 8 days after starting with Paxlovid. The current pandemic situation of COVID-19 may remain as confounder to the event Covid-19. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 69-year-old male patient with no relevant medical history reported, who experienced the unexpected non-serious AESI event of COVID-19 unspecified days after receiving fourth dose of mRNA-1273 vaccine. It was reported that patient started with Paxlovid On 09-May-2022.  and Covid symptoms returned and tested positive on antigen test 8 days after starting with Paxlovid. The current pandemic situation of COVID-19 may remain as confounder to the event Covid-19. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Body aches, chills, possible fever (temperature not actually taken) On night of administration lasting through second day, or day after vaccination administration
Vaginal spotting for 3 days after vaccine and 7 days late for period.
Pt hx of exposure to chickenpox through siblings 14Dec97. 17Dec97 pt recv vax 1st dose of varicella virus vax live SC. 27Dec97 pt exp break out of chickenpox. More than 50 lesions.mostly waist up. Slight fever 2 days.
Narrative: Daughter called to report on 4/24/21 that patient was experiencing "paralysis" in the legs (still had the ability to move feet but was unable to stand) for several hours after receiving 2nd COVID vaccine. Daughter reports that patient suffered similar side effect from the first vaccine but it only last for ~2 hours. Of note, patient was admitted to the hospital on 4/25/21, per discharge summary it states that after 2nd vaccine patient experienced a fall and was found to have severe spinal stenosis upon admission that required surgery.
Was very sick; Back ache; Felt like flu; Sore throat; Felt like had covid; Fever; very sore all over/ very sore all over; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Was very sick), BACK PAIN (Back ache), INFLUENZA LIKE ILLNESS (Felt like flu), OROPHARYNGEAL PAIN (Sore throat) and COVID-19 (Felt like had covid) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 13-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Aug-2021, the patient experienced ILLNESS (Was very sick), BACK PAIN (Back ache), INFLUENZA LIKE ILLNESS (Felt like flu), OROPHARYNGEAL PAIN (Sore throat), COVID-19 (Felt like had covid), PYREXIA (Fever) and MYALGIA (very sore all over/ very sore all over). At the time of the report, ILLNESS (Was very sick), BACK PAIN (Back ache), INFLUENZA LIKE ILLNESS (Felt like flu), OROPHARYNGEAL PAIN (Sore throat), COVID-19 (Felt like had covid), PYREXIA (Fever) and MYALGIA (very sore all over/ very sore all over) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No concomitant medications were reported.  No treatment medications were reported.
Patient reports developing swelling of L index finger/"trigger finger," about a week after receiving 1st Pfizer vaccine. Finger continues to be swollen/bent. Reports this has happened in the past to a finger on his right hand. Denies any other s/s or concerns. Did not seek medical care.
This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (pregnant) in a female patient of an unknown age 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) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (pregnant). At the time of the report, EXPOSURE DURING PREGNANCY (pregnant) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication was reported. No treatment medication was reported.
COVID-19; COVID-19; He had too much scarring to his lungs; Fell and broke his neck; Fell and broke his neck; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 76-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Had Cardio/renal issues" (unspecified if ongoing); "Had Cardio/renal issues" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (death), COVID-19 (death), outcome "fatal" and all described as "COVID-19"; PULMONARY FIBROSIS (death, medically significant), outcome "fatal", described as "He had too much scarring to his lungs"; FALL (medically significant), CERVICAL VERTEBRAL FRACTURE (medically significant), outcome "unknown" and all described as "Fell and broke his neck". The patient date of death was 28Jul2022. Reported cause of death: "COVID-19", "He had too much scarring to his lungs". It was not reported if an autopsy was performed. Clinical course: He had complications from COVID. He was totally vaccinated but had Cardio/renal issues so he was high risk. He had too much scarring to his lungs. He died. He did get over the first bought with COVID, but fell and broke his neck and got COVID again and died 28Jul2022. He had all but the last two boosters.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Reported Cause(s) of Death: He had too much scarring to his lungs; COVID-19; COVID-19