chrisvoncsefalvay/vaers-outcomes huggingface dataset:
administered 2 vials of diluent; administered 2 vials of diluent.; administered 2 vials of diluent.; This case was reported by a other health professional via call center representative and described the occurrence of overdose in a 59-year-old male patient who received Herpes zoster (Shingrix) (batch number 2LC3P, expiry date 15th November 2022) for prophylaxis.   On 25th June 2021, the patient received the 2nd dose of Shingrix. On 25th June 2021, unknown after receiving Shingrix, the patient experienced overdose, inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the overdose, inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The office manager reported that,  patient was supposed to receive his 2nd shot of Shingrix but instead they admiistered 2 vials of diluent, which led to overdose, inappropriate preparation of medication and inappropriate dose of vaccine administered. No more details reported. The reporter consented to follow up.
Headache, Sedation, Arthralgia, Fever, NauseaVomiting,  Chills, pain at the injection site
Patient stated they experienced left arm tingling following receiving the vaccine.  Client was evaluated by onsite Fire Rescue.  Client was released to go home at 12:33 pm .  Per Fire Rescue no additional evaluation needed.
Fever, chills, dry sore throat, headache, body and joint pain, nausea starting 5 hours after vaccination and lasting at least 12 hours
3 people died.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: DEATH (death, medically significant), outcome "fatal", described as "3 people died.". The patient date of death was unknown. The reported cause of death was "3 people died.". It was not reported if an autopsy was performed.  Clinical Information: A 77-years-old caller stated that she was not interested in getting the vaccine because many of her friends died because of the side effects. Caller reported that, 14 people she knows have side effects and 3 people died. She is seeking information on if the vaccine is fully FDA approved or under EUA, when did this approval take place, how did it get approved since it has not been years.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200071657 Same reporter/drug/AE, different patient; Reported Cause(s) of Death: 3 people died.
This spontaneous report as received from a consumer via Clinic refers to a currently 77 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 16-JUN-2017, the patient was vaccinated with improperly stored dose of PNEUMOVAX 23 1 dose unit (lot # M036728, Expiry date was not reported) for prophylaxis. There were no previous temperature excursions recorded. It was unknown if data logger was involved. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1801USA000346: US-009507513-1801USA000349: US-009507513-1801USA000342: US-009507513-1801USA000344: US-009507513-1801USA000347: US-009507513-1801USA000345: US-009507513-1801USA000339: US-009507513-1801USA000340: US-009507513-1801USA000341: US-009507513-1801USA000343: US-009507513-1801USA000348: US-009507513-1801USA000338: US-009507513-1801USA000363: US-009507513-1801USA000361: US-009507513-1801USA000367: US-009507513-1801USA000359: US-009507513-1801USA000355: US-009507513-1801USA000371: US-009507513-1801USA000356: US-009507513-1801USA000357: US-009507513-1801USA000358: US-009507513-1801USA000369: US-009507513-1801USA000370: US-009507513-1801USA000368: US-009507513-1801USA000373: US-009507513-1801USA000374: US-009507513-1801USA000375: US-009507513-1801USA000376: US-009507513-1801USA000377: US-009507513-1801USA000378: US-009507513-1801USA000379: US-009507513-1801USA000380: US-009507513-1801USA000381: US-009507513-1801USA000382: US-009507513-1801USA000383: US-009507513-1801USA000384: US-009507513-1801USA000352: US-009507513-1801USA000354: US-009507513-1801USA000360: US-009507513-1801USA000364: US-009507513-1801USA000366: US-009507513-1801USA000372: US-009507513-1801USA000385: US-009507513-1801USA000387: US-009507513-1801USA000386: US-009507513-1801USA000388: US-009507513-1801USA000350: US-009507513-1801USA000351: US-009507513-1801USA000353: US-009507513-1801USA000362: US-009507513-1801USA000365.
She lost consciousness one minute after the vaccine administration. Mother wanted us to call emergency + shortly after she regained her consciousness. Patient reported to have cold sweats and wanted to lie down.
Information has been received from a physician concerning a 10-year-old female with a sulfa allergy who on an unspecified date, was vaccinated with a first dose of VARIVAX. On an unspecified date, the patient was exposed to chickenpox and was given a second dose of VARIVAX (lot# 658302/1032U). Post vaccination, the child had febrile episodes, up to 103 F at times and was hospitalized twice. During the first hospitalization, all sorts of extensive tests were performed including auto immune and neurological testing. All tests were normal. The patient was diagnosed with a fever and was discharged after several days. The second hospitalization was on 01-Dec-2007 where another extensive evaluation was performed, all tests were normal and the patient was diagnosed with fever again. It was suspected that the patient has Pediatric Autoimmune Neuropsychiatric Disorders Associated with Strep (PANDAS) because the patient had developed tic and tremors. The outcome was not reported. Not product quality complaint was involved. The physician considered the adverse events to be disabling. This is one of several reports from the same reporter. A lot check has been initiated. Additional information has been requested.
Narrative:  COVID infection following COVID vaccine series 07/27, Pfizer, dose #1 08/17, Pfizer, dose #2 12/16 pt cc: fever, sore throat exposure: unknown 12/20 SARS-COV-2 Variant Sequencing: pending 12/20COVID swab, result: detected 12/28 COVID swab, result: detected
Bruise and red itchy rash at injection site. Rash is 2in in diameter
Pt received MMR on 06/29/2000. Pt started itching on 06/30/2000. Pt seen in ER due to rash over entire body that developed 07/01/2000
Narrative: Patient was not previously COVID-19 positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. On 2/3/21, notes state patient was inpatient at hospital after having multiple surgeries/partial amputation of left foot after receiving an infection. Patient not receiving care from our hospital so unclear if passing on 2/28/21 was related to infection/complications from surgery. Comorbidities include advanced age, CKD, prostate cancer, DM2, CAD, HTN, HLD.
SLEPT A LOT; EYES HURT; DIARRHEA; JOINTS ACHED; FATIGUE; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 03-APR-2021 08:15 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 04-APR-2021, the subject experienced slept a lot. On 04-APR-2021, the subject experienced eyes hurt. On 04-APR-2021, the subject experienced diarrhea. On 04-APR-2021, the subject experienced joints ached. On 04-APR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fatigue, slept a lot, eyes hurt, diarrhea and joints ached was not reported. This report was non-serious.
pt recv 1 dose of varicella vax 3/30/98 & 18 days later pt devel  ``rash over entire body' rash was described atypical chickenpox, red papules w/some vesicles.
Mild chest tightness & mild SOB, tingling in hands, & generalized itch. Symptoms improved with BENADRYL 25 mg 2 tabs PO at 9 am & CLARITIN 10 mg at 9:40 on 10/17/11.
A report was received from a health professional on 10/23/02, concerning a male vaccinee of unknown age who was inadvertently administered the Fluvirin vaccine subcutaneously on 10/23/02. The vaccinee did not experienced any adverse event. There was insufficient information to determine the reporter's causality assessment. Cross reference with PJP200200611.
several hr p/vax pt began having scratchy throat & cough, joint pains lasted 2 days;cough productive of yellow sputum;no inc temp;+chest x-ray RLL pneumonia-started on med unable to complete med d/t upset stomach;
Pt began having itching and tingling sensation and rash and redness to b/l hands on Sunday 01/24/2021.  She present to the ER at hospital on Monday 01/25/2021. Pt had blood testing and was prescribed on discharge benadryl and prednisone.
severe pain @ the site of the inj & throughout the entire shoulder & arm area (2 days); no swelling or fever); advil taken
Patient presented to the ED with shortness of breath. He was hospitalized for Covid bilateral pneumonia and treated with Remdesivir.
Subject in pneumococcal vaccine trial, with severe COPD, was hospitalized with cancer of the tongue and nodes in neck. Vaccination took place on 9/25/2007. According to the physician, the relationship to treatment is 'None'. We would be happy to forward the Study's SAE Report Form upon request.  12/31/08 Reviewed study SAE. FINAL DX: cancer of tongue & nodes in neck Records reveal patient experienced pain with swallowing.  Scheduled to have surgery & begin chemo.
lump at meating of top of shoulder and left arm the next day and also vomiting the next day
This spontaneous report as received from a medical assistant refers to a 15 month old patient with moderate bilateral hearing loss an no drug allergies. On an unknown dates, the patient had received the ROTATEQ series (orally, 2 ml dose, lot # J008383, expiration date 28-NOV-2014, lot # J010970, expiration date 20-MAR-2015 and K001196, expiration date 22-OCT-2015). Concomitant therapies included sodium fluoride. On an unknown date, the patient had tested positive for Rotavirus. It was reported that the child experienced diarrhoea, nausea and vomiting on 14-FEB-2015 and was seen in the physician's office on 16-FEB-2015. Medical assistant stated that a stool sample was collected and did test positive for Rotavirus (date unspecified). It was also reported that stool tests for giardia, parasites and ovum were also performed (results were not reported). The child was treated with oral fluids. The outcomes of the events were unknown. The patient sought medical attention and was seen in the physician's office. The relatedness between the events and ROTATEQ was not reported. This is one of several reports from the same reporter. Additional information has been requested.
On Tuesday 02/23/2021 about 0700, client discovered area around injection site to be red, swollen, and tender to touch.  Per client it is the size of 2 quarters together.  Client seen by PMD today (02/24/01), told rash is related to COVID vaccine.  Per client her PMD prescribed a topical cream and told to take an antihistamine as needed.  Client report rash reaction is better today, not swollen, hot or tender to touch.
He got his vaccine, he had no problems, not even pain, said it was  perfect.  Then on 3/26/21 he had chest pain he could not move or breath.  He went to the hospital, after he was able to move and breath.  He had x-rays, EKG's, blood tests and MRI's.  He saw many doctors and the last was cardiologist.  He was seen from 3/28/21 to recently by specialists.  He saw the cardiologist last week, and at that time he said that he had pericarditis and that the sac around his heart was inflamed.  The medications that he had been given were working but it was still working and he has a 5% chance of the problem coming back.  The pain is beginning to get stronger again and is going to call Dr. and see what else can be done, especially when he breaths in  he has pain and when he bends down it's painful as well, and he has a headache and other problems as well.  He was put on Colchicine for this.
One shot of AstraZeneca and one of Moderna (Interchangeability); Patient received a first shot of AstraZeneca. Then, patient went and got a first shot of the Moderna vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (One shot of AstraZeneca and one of Moderna (Interchangeability)) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received a first shot of AstraZeneca. Then, patient went to the US, and got a first shot of the Moderna vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Astrazeneca (First shot). Past adverse reactions to the above products included No adverse event with Astrazeneca.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (One shot of AstraZeneca and one of Moderna (Interchangeability)) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received a first shot of AstraZeneca. Then, patient went and got a first shot of the Moderna vaccine). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (One shot of AstraZeneca and one of Moderna (Interchangeability)) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received a first shot of AstraZeneca in India. Then, patient went and got a first shot of the Moderna vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
Vaccine was administered 1/16/21 on 1/17/21 arm soreness, tenderness, feverish & chills 1/19/21 injection site inflamed/redness down to elbow. Patient went to doctor for examination. Pt was given antibiotics. The area was wiped with alcohol prior to vaccination
Very bead headaches and migraines. I have no history of headaches before vaccine. It started within couple hours of vaccine and continue to get since on daily basis. I am college student and it is interfering with my ability to study. This is definitely a reaction of the vaccine. I take Tylenol or advil when needed which I never had to do before vaccine. It's ruining my life
Joint pains, fatigue and Myalgia symptoms for 3 weeks. Prescribed Tylenol 500 mg. Patient was directed to take twice a day if needed.
I felt off/not myself for about 30 hours after the second dose. A migraine for 48 hrs.  a red welt on my arm at the injection site, I found it 1/13 it was small and got bigger overnight.  I took Benadryl on  1/17 and it got smaller.  the morning of 1/18 it was back just as big  as before the benadryl.  It is about 5 inches accross and 3 inches up and down
doses administered after excursion; No adverse event; Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable 131 patients received doses of the vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable 131 patients received doses of the vaccine), PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion) and NO ADVERSE EVENT (No adverse event) in an 83-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 14-Oct-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable 131 patients received doses of the vaccine). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable 131 patients received doses of the vaccine), PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable 131 patients received doses of the vaccine) and PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion).    No Concomitant medications were provided. Reporter reported that a temperature excursion that occurred several days ago in the Freezer. Multiple patients received vaccine from vaccine that underwent a temperature excursion in the Freezer. Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable 131 patients received doses of the vaccine in question. Patient did not report any adverse event. No treatment medications were provided.
Fever all day that ranges from 102 Deg. F. - 101.9 Deg F.; body ache; fatigue; slight cough; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever all day that ranges from 102 Deg. F. - 101.9 Deg F.), PAIN (body ache), FATIGUE (fatigue) and COUGH (slight cough) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced PYREXIA (Fever all day that ranges from 102 Deg. F. - 101.9 Deg F.), PAIN (body ache), FATIGUE (fatigue) and COUGH (slight cough). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PYREXIA (Fever all day that ranges from 102 Deg. F. - 101.9 Deg F.), PAIN (body ache), FATIGUE (fatigue) and COUGH (slight cough) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication include, Multivitamins.
Local erythema and significant swelling (entire upper arm) within 24 hours of MCV vaccination.
Morning after the shot: woke up with little bit of raised hard bump around injection site. Very painful.   10/11am about notice bigger, raised area. Now red and hot. Around 4cm long and 3.5cm wide.   10pm same size, slightly itchy. Still red, painful, and hot. Still headache.   2/10 7:30am Injection site still painful (slightly less so maybe), red, and raised.   6:40 Has widened. 4.75cm long, 5cm wide. More itchy less painful. Still hard, raised and red. Maybe less hard.   2/11 less painful, less red, less raised, same size. Very itchy. VERY tired and weak feeling.  Fading more in evening. Less itchy. Less sore. Can sleep in it.   2/12 not raised at all. Still red and slightly itchy.   2/13 tiny bit red. No other symptoms.
Pt. started coughing Tuesday, June 22, 2021, in the afternoon and it worsened through the rest of day. She also was beginning to be drowsy. Wednesday, June 23, 2021, coughing continued, she became drowsier, she felt warm to the touch (forehead, face, arms, back) and was not acting like herself. Thursday, June 24, 2021, 9am she was at the clinic. The doctor ordered an x-ray and blood work. After results arrived, we were advised to go to the emergency room. There the doctor ordered CT scan. The results showed an abscess and fluid in her left lung and pneumonia. Her lung was drained, was not able to get all of it out. They discussed surgery but needed to send pt. to ER. The discussion for surgery was a daily thing but never happened. They tried multiple procedures, CT scans, etc. On Tuesday, June 29, 2021 there was a meeting called with her doctor to discuss palliative care. The risk of surgery and all the complications following were high risk. Pt. did not understand that she needed to leave the IV and drainage tube in as well as leaving the oxygen on. Based on the complications and pts. quality of life after surgery and the fact that the fluid and pneumonia spread quickly throughout her body - the doctors were leaning towards end-of-life comfort. It all happened so fast! The evening of the 29th, pt. was transported home to end her life on hospice. On Wednesday, June 30, 2021 pt. passed away in the afternoon. Pt. was rarely ever sick. Once in a great while she would get a runny nose or little cough. Everyone around her would catch a virus and she simply would not. We had a member of our family test positive for COVID-19 in November 2020, and pt. never showed any symptoms of being ill.  This was all before she received the COVID-19 Vaccine. About a week or two after she received the second vaccine, on May 27,2021. she had increased behaviors with eating and daily ADLs. But the behaviors were her ?normal? behaviors that would occasionally come and go. Nothing was ever persistent.  Then on Tuesday June 22, 2021 when sick like symptoms started to appear it was less then four weeks after the second vaccine.
Temp 103, dizzy.  Both arms hurt (IM right arm).  Completely better in 72 hours - probably a virus, no problems since.