chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I vaccinated twice in early April however I was tested positive with the Covid-19 virus last Sunday; I vaccinated twice in early April however I was tested positive with the Covid-19 virus last Sunday; This is a spontaneous report from Pfizer sponsored program a contactable consumer or other non health care professional (Patient). A patient of unspecified age and gender received BNT162B2 (BNT162B2 Formulation: Solution for injection Batch/Lot number: not reported Expiration date: Unknown) via an unspecified route of administration on Apr2021 as dose 1, single and BNT162B2 (BNT162B2 Formulation: Solution for injection Batch/Lot number: not reported Expiration date: Unknown) via an unspecified route of administration on Apr2021 as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient stated that he/she got vaccinated twice in early April however patient was tested positive with the COVID-19 virus last Sunday on 26Sep2021. Patient further mentions, they were told not wear mask in public if vaccinated but this is false. Thank you and stay safe all. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 26Sep2021. Outcome of events was unknown.  The lot number for, the vaccine, BNT162B2, was not provided and will be requested during follow up.
Information has been received from a physician concerning a female who on an unspecified date was vaccinated with a dose of GARDASIL vaccine.  Subsequently the patient passed out at the office.  At the time of this report, the outcome was unknown.  Additional information has been requested.
pt recvd vax; approx 6 hrs later had n w/ emesis; t 100; general achiness; still cont approx 24 hrs later;
Sudden death (probable SIDS - coroners report pending) 2 1/2 days post immunization, child was fine between the vax and unexpected death. I doubt this is related to the vaccines, but wanting to be thorough.
Dyspnea and fatigue with elevated troponin followed by hospital admission and subsequent PEA/Bradycardic arrest.   Subdural hematoma found.  EF 25%.   Likely underlying undiagnosed MM.
35 y/o male SM referred to hospital from ED for f/u evaluation of chest pain S/P primary SPV and AVA #2 1/31/2008.  Symptoms:  Dyspnea, Diaphoresis, Nausea w/o vomiting, Paresthesia, Muscle Pain, Chest Pain, sub-sternal.  2/20/2008 MR received dated 2/7/08 to 6/2008 with DX:  Atypical Chest Pain s/p Smallpox vaccine. Pt presented to ER with 3 day hx of intermittant squeezing chest pain and pressure. Cardiac w/u and enzymes (-) so d/c for outpt f/u. Still having some CP 2/15/08. Tx with Motrin with gradual reduct of sx.  Returned 4/10/08 with c/o 1 wk hx of CP, cough, nausea and SOB when reclining. Also fatigue and swelling of hands and feet. Dx:  Atypical chest Pain. CP determined to be non-cardiac. Assess:  Anxiety.  Joint Pain localized in shoulder.
Atrial fibrillation; Cardiomyopathy; Mixed hyperlipidemia; This is a spontaneous report from a contactable consumer. This consumer reported the same events for himself and two other patients. This is the first of three cases.   An 82-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose on 04Mar2021 and first dose on 27Jan2021 (batch/lot numbers not reported); both via unspecified routes of administration as a single dose for COVID-19 immunisation. Medical history included type 2 diabetes. Concomitant medications were not specified and reported that they were too many to list, also he has quite a list of prescription. The patient stated since he has gotten both COVID shots and it was found out after going to the doctor and to a cardiologist that he was the third person that has been diagnosed with atrial fibrillation from taking the COVID shots and since he was the third person that they had recently after both shots, he thought he should call the toll number and report side effects after taking the vaccine. Consumer confirmed the date for diagnosis of atrial fibrillation as 08Mar2021 and stated primary care doctor, he went for his quarterly visit and she gave him an EKG and it showed this the fibrillation and he was immediately sent to a cardiologist who confirmed it after a second EKG and echocardiogram had both of those. Consumer stated it said atrial fibrillation, cardiomyopathy and mixed hyperlipidemia whatever that was, he has a print out of the diagnosis from the cardiologist in his hand. Consumer stated date of test was yesterday, 08Mar2021. Consumer stated he was given a new medicine Eliquis 5 mg twice a day as treatment. Consumer stated he just wanted to report this, since the doctor yesterday told him that he was the third patient that had both shots and came back with this. The outcome of the events was unknown.  Information about batch/lot number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021274387 Same reporter and drug, similar event, different patient;US-PFIZER INC-2021316269 Same reporter and drug, similar event, different patient
Bad rash all over her body. Went to her Dermatologist which he did a biopsy to try and find out what it was.
Case number PHEH2016US027823, is an initial spontaneous report received from a nurse on 24 Oct 2016. This report refers to a 50 years old female patient. Past medical history and concomitant medications were not reported. She was vaccinated with influenza vaccine (manufacturer unknown, batch number and expiry: not reported) and MMR vaccine on an unknown date. After vaccination, on an unknown date, she experienced cellulitis at injection site. The outcome, seriousness and causality of the events were not reported. The seriousness of the event vaccination site cellulitis was upgraded (medically significant) based on the information available in the source document.
Four and a half months after I had my vaccine I had a runny nose and a headache. I had body aches and a fever. I also lost my sense of smell and taste. I had a cough that wouldn't quit it was there all the time. I ended up with a form of Pneumonia. I tested positive for Covid-19 on 06/03/2021. I was prescribed two rounds of antibiotics and two rounds of steroids. My blood sugar which had been under control was out of control. I am back on Metformin now.  It has been ten weeks and I finally feel better. I was treated in the Post-Covid-19 clinic.
Patient admitted as inpatient on 3/21/22 due to closed displaced subtrochanteric fracutre of left femur pathologic secondary to osteoporosis. Patient was tested for COVID-19 and was positive on admission,3/21/22.
She has been having a spinal migraine on and off; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (She has been having a spinal migraine on and off) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MIGRAINE (She has been having a spinal migraine on and off). At the time of the report, MIGRAINE (She has been having a spinal migraine on and off) outcome was unknown.            Relevant concomitant medications were not reported.  The treatment information was  not provided.  Action taken with the drug in response to events was not applicable.   Reporter did not allow further contact
Erythema to right upper arm in an area 6-7 mm wide by 6-7 mm high.  Area warm to touch & slightly swollen. Erythemic area approx. 1 inch below injection site.  No itching noted.  No pain noted.
Client came out, sat in chair in clinic, Client stated she was fine. Staff, noted that she was unsteady in chair and went to get her water before leaving Client fell to her left, hit back of her head (heard by staff loud noise). Staff called to NP. Staff took Client's mask off and 2 staff members assisted her into a chair, very unsteady. Was given a cool pack and water. Client stated that she did eat prior getting a vaccine. NP stated she was pale in color. Gave her a drink of water. Staff assisted her in getting into the clinic and was shaky. Staff offered her a w/c, but Client declined. Client was unsteady and two RNs assisted her to lay on a clinic table. She ate half of a Kind bar and drink some water. Education provided to clinic room staff re: call  at soon as symptoms appear to call medical staff (RN or NP) to assess client. Client stated "I am fine," multiple times. Has an anxiety history. Her fiancee was contacted and came to pick her up. Directions to eat and drink. Had N/V and headache and agreed to seek medical attention if continues/worsens. TC yesterday, 8/23, at 1454 and left a msg to return call via Staff. Client returned staff's call and stated that she is feeling a little better and ate a grilled cheese. Continued to feel off balance every time she stands. Staff directed to seek further physician evaluation and verbalized that she will. Today, 08/24, at 0802, writer followed up with Client again. Client reports that she was advised to go to the ED per her PCP and multiple tests/scans were conducted while at the hospital and everything came back negative. Client informed writer that she feels better this morning.
This spontaneous report as received from a physician via company representative refers to a male patient of unknown age. On unknown date the patient was vaccinated with GARDASIL first dose (strength, dose unit, route, lot number and expiry date unknown). On an unknown date after first dose of with GARDASIL patient felt weird. The outcome of felt weird was unknown. This case # 1402USA005566 has been linked to case # 1402USA005386 via same reporter link. Additional information has been requested.
Pt stated that twice since administration she experienced episodes where Left hand became numb and cold and then turned red and blue. Upon presentation to health center one week after administratioin,  Left hand was warm, no edema present.  Radial pulse strong, good capillary refill. No swelling or erythema at sites of injections.  Menactra 0.5cc was given in Left deltoid and Varicella vaccine in subcutaneous tissue of left upper arm.
A company representative reported that 3 unidentified children received Prevnar vaccine and subsequently developed "duskiness" in the face and around the mouth". No additional information was available as of the date of this report. The reporter indicated that 3 children experienced this event; however, they are not presently identifiable. Additional reports will be generated when identifying information is provided.
Full body rash in the warm areas, under bra line, center of back, waistline, inside forearms. Slightly raised, itchy, doesn?t not hurt. No symptoms after shot except sore all over. Rash didn?t appear until the evening after the date of the shot.
Swelling; Redness; Pain; This case was reported by a other health professional via call center representative and described the occurrence of swelling in a 61-year-old female patient who received Herpes zoster (Shingrix) (batch number CE45H, expiry date 1st October 2022) for prophylaxis.   On 24th November 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 25th November 2021, 1 days after receiving Shingrix, the patient experienced swelling, erythema and pain. On an unknown date, the outcome of the swelling, erythema and pain were not recovered/not resolved.   It was unknown if the reporter considered the swelling, erythema and pain to be related to Shingrix.  Additional details were reported as follows: The pharmacy Intern called on behalf of a patient to inquire if the patient should receive the 2nd dose of the Shingrix vaccine if they are experiencing side effects.  The patient experienced pain,redness and swelling 1 day after receiving the vaccine and was still ongoing.
Pt was fine after administration. Several hrs later experienced swelling and redness at injection site - then swollen arm and armpit/axilla. Experienced angioedema and swollen tongue. Was treated at hospital.
sore arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In July 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 2 months after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient received first dose of Shingrix about 8 weeks ago and she experienced arm pain that had not resolved. The patient had been seen by her physician due to the pain. Emergency room visit required. The outcome of the event was reported as recovering/resolving in source document but as per narrative the outcome of the event was taken as not recovered/not resolved.
About 5 minutes later after administration, pt complained dizzy/sweating. Pt 's face turned pale and shows syncope symptom. Pt was still alert but he looks like almost fainting. Mom requested 911 and pt was transferred to hospital with paramedic.  we provided Pfizer Lot number to mom and advise to contact us if she need any other information from us.
Pain in back and bottom of head, Tachycardia, dizziness, syncope, sweating, weakness, elevated blood pressure, palpitations.
Left deltoid area red (approximately 30 mm redness), swollen, and warm to touch.  Denies pain or fever.
For 3 months patient having ongoing Left arm pain with neuropathy numbness tingling and also weakness. She additionally has had no menstrual cycles since whereas had them regularly prior to shot.
Chest pain, shortness of breath, Pericarditis, Nausea, loss of appetite, loss of 30 pounds in 2 1/2 months, dizziness, fatigue, nerve issues, sleep issues. Still occurring. Continuous.
None- vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 011J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information provided by the reporter. No treatment information provided   This case was linked to MOD-2021-395985 (Patient Link).
Information has been received from a physician concerning a 4 month old patient who on 06-DEC-2007 was vaccinated with a dose of Rotateq.  The patient did not experience any known symptoms.  No product quality complaint was involved.  No other information was provided.  Additional information has been requested.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE ACUTE STROKE DUE TO EMBOLISM OF UNSPECIFIED ARTERY
I got extremely dizzy at 4:00am on Sunday after getting the shot about noon on Friday (so roughly 40 hours later.) The vertigo was so severe that I had to lay on my back and try no to move my head any direction. Getting up even to go to the bathroom resulted in nausea because of the intense dizziness. The dizziness/vertigo lasted until about 9:00am Monday morning (so nearly 30 hours.) I actually still have some residual dizziness when I move my head a certain way, but it goes away quickly and doesn't cause nausea. (I was worried I'd have a similar reaction to the second shot, but I only had some fatigue and a sore arm with the second shot.)
Dizziness; Nausea; sore arm; This is a spontaneous report from a contactable consumer, the patient. A patient of unknown  gender and age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 05Mar2021 at 09:00 as a single dose for COVID-19 immunisation. Medical history and concomitant medication was not reported. 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. On 05Mar2021, the patient experienced dizziness, nausea and sore arm. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcomes of the events dizziness, nausea and sore arm was not resolved at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a elderly female patient who received SHINGRIX for prophylaxis. In April 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site erythema, injection site warmth and injection site swelling. On an unknown date, the outcome of the injection site erythema, injection site warmth and injection site swelling were unknown. It was unknown if the reporter considered the injection site erythema, injection site warmth and injection site swelling to be related to SHINGRIX. Additional details were provided as follows: The health care professional stated that female patient received her 1st dose of SHINGRIX in April 2018 and had a large area of redness and swelling at injection site. The patient also stated that the area was warm to the touch. The health care professional did not see this reaction but patient came in to get their 2nd dose of SHINGRIX (not administered yet) and told the health care professional about her reaction to her first dose of SHINGRIX she had back in April 2018.
pt recv vax; devel thrombocytopenic purpura; recovered; did not recv 3rd vax;
82 year old woman admitted to the ICU for management of worsening acute hypoxic respiratory failure secondary to severe COVID 19 pneumonia on 6/17/21.  Patient was originally hospitalized for treatment of COVID 19 in the beginning of June 2021.  She was discharged on 6/10/2021.  She presented to the emergency room on 6/12/2021 for syncopal episode at home.  Head CT was negative for any acute intracranial pathology.  12 lead EKG did not demonstrate any arrhythmias, nor any ST to T changes, and echocardiogram demonstrated EF=70% with no wall motion abnormalities.  She was admitted to the hospitalist service continued work up for syncope.
Left deltoid 3x5cm erythema, heat and tenderness. No induration, no axillary adenopathy. Was prescribed Keflex.
1/28/2021 02:38:41 PM > 1410: Patient c/o numbness and tingling to L arm approximately 7 minutes after receiving injection with no other complaints, nurse added additional 10 minutes to observation time. 1430: Patient states numbness is getting better, nurse encouraged patient to go to nearest ER if problem persisted. RN 1/29/2021 08:55:46 AM > contacted patient to f/u, message left
Information has been received on 19-JAN-2017 and 25-JAN-2017 from a medical assistant regarding an unspecified number of patients of unknown ages and gender. The patients' concurrent conditions, medical history and concomitant therapy were not reported. On unspecified dates since October 2016, doses of ROTATEQ (lot number, expiration, dose, and route not reported) and GARDASIL 9 (lot number, expiration, dose, and route not reported) which were improperly stored were administered to unspecified patients for prophylaxis. The medical assistant reported multiple temperature excursions >46degrees F but <77degrees F since October 2016. No adverse effects have been reported. No additional information was provided. Follow up was received on 25-JAN-2017 from a medical assistant. On 01-NOV-2016, 23-OCT-2016, and 12-JAN-2017, doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot number M025565 expiration 06-NOV-2017 (dose and route not reported) were administered to patients which were stored at 46.65 degrees for 3 months (2160 hours, onset 01-OCT-2016.) On 28-DEC-2016, 29-DEC-2016 and 05-JAN-2017, doses of GARDASIL 9 (lot number M032650 expiration 31-MAR-2019 (dose and route not reported) were administered to patients which were stored at 46.65 degrees for 3 months (2160 hours, onset 01-OCT-2016.) No additional information was provided. Additional information has been requested.
Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Nov-2021 at 5:50 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 19-Nov-2021 at 5:50 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). At the time of the report, PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  The patient was given dose from vial that was stored in an ultracold freezer which was colder than it should have been.The vial undergone temperature excursions for one month. The vial was in frozen state at the time of the excursion (Vials in question stored in a super cold freezer) and minimum reached temperatures was negative 82 degrees Fahrenheit. The vial moved from freezer to refrigerator on 19-Nov-2021, it was a day when the Moderna COVID-19 vials went from the super cold freezer to the refrigerator. The reporter stated that total 70 vials were still in the ultra cold freezer and 8 vials were in the refrigerator. No vaccine state changes were noticed. The vaccine was never refrozen. None of the vials were punctured. No previous temperature excursions was reported.  No treatment medications were provided.   This case was linked to MOD-2021-402935 (Patient Link).
I got my flu shot on October 15, 2019.  Since then, when I move my left arm (where I got the shot), on scale of 1 to 10 (10 being the greatest pain), I experienced #8 pain level.  I would not be able to abduct my arm beyond 45 degrees.  Now (December 9), almost 2 months later, I am experiencing #3 or 4 pain level when moving my arm back. Last year, I also had the high dose fluzone and recalled similar painful experience in my arm.  The pain did go away after several months from the time of the flu injection.