chrisvoncsefalvay/vaers-outcomes huggingface dataset:
tightness in her chest; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 02Mar2021 (lot number and expiry date: unknown) at the age of 58-years-old, as dose 1, single, for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced tightness in her chest on 02Mar2021. This patient was administered with the first dose of Pfizer-BioNTech COVID-19 Vaccine on 02Mar2021. She remained under monitoring on site for 30 minutes following the vaccine administration. She left the site and about 15 minutes later, she had onset of tightness of chest. By the end of 02Mar2021 the event was better, by 03Mar2021 it was a lot better and by 04Mar2021 event went away. She was now concerned if this event is going to happen again with the second dose. The patient recovered from the event on 04Mar2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information expected.
Within the 50 hour period after vaccination: Sore arm,  fatigue, fever, chills, mild body aches Within 8 days of vaccination: rash on left arm where injection was given. Rash started out small at at about 2 inches long, was light red, and was more hard/firm than  the surrounding  skin.  It has continued to spread, and is now 5 inches long, bright red and blotchy, is mildly swollen,  and is quite warm to the touch.
Day of shot, slightly sore arm. Next day, very sore arm so much so that I was unable to sleep on that side, plus  mild headache, feverish, chills, and body aches. The headache, feverish, chills and body ache lasted all day until I took 400 mg of ibuprofen.
Child received Tdap - BOOSTRIX Lot# C2770AA; Instead of Dtap INFANRIX Lot# AC14B060AB; Mother was notified on 09/08/08
the needle detached and remained in the patient with a portion of the syringe; the needle detached and remained in the patient; poor quality device used; This spontaneous report was received from a Registered Nurse via a company representative, referring to a 12 year old male patient. The patients concurrent conditions, pertinent medical history or concomitant medications were not reported.   On 15-SEP-2020, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) which had a lot # S026371, with expiration date on 01-APR-2022, via intramuscular in the right deltoid for vaccination.  The nurse reported that while procedure the tip of the syringe broke off inside of the needle attachment (needle issue) sometime during/after administration. When she removed the syringe after administration (syringe issue), she found that the needle detached and remained in the patient with a portion of the syringe intact inside as well (poor quality device used). There were no loose shards or missing pieces, for which she carefully inspected: this was a "clean" break.   it was not related to sudden movement by either the nurse or the patient. The patient did not require any treatment after the dose and did receive the full dose of the vaccine. The nurse disposed of the needle which was still attached to the tip of the syringe per sharps maintenance protocol, but she did keep the broken syringe for retrieval. There were a product quality complaint involved. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; manufacturername: Merck Sharp & Dohme Corp.  devicelotnumber: S026371; expirationdate: 01-APR-2022; deviceage and unit: 0 ; malfunction: Unknown; productavailableforevaluation: Yes; deviceusage: Unknown; evaluatedbymfr: No; reasonfornoneval: 02 Device evaluation anticipated, but not yet begun; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Peeling of both hands starting the day after vaccine was received.  He states the first layer of skin is coming off on both hands.
Fever immediately following vaccination as well as the following symptoms beginning 7/27/2014: Full body rash, fever, Otitis Media and onset of speech delay.
according ot father who called pt had no fever, was acting well & feeding well; pt was found in crib w/no signs of life @ about 2AM & taken to the local ER where was pronounced DOA;
Swelling, redness and itchy around site of injection.  Swelling and redness spread about 1-2 inches around site.
Got Shingrix in left arm at 2:30 PM Jan 28. Felt fine the rest of that day. Injection site increasingly sore and quite painful by bedtime. Slept well. Woke up 7:00 AM feeling achey all over. Got up and felt fine to brush teeth and take meds but then went back to bed. 9:00 AM felt hungry, went to kitchen but got lightheaded and had to sit down on kitchen floor. Then felt suddenly nauseous. Went to bathroom thinking I would vomit. Sat on floor next to toilet with back against wall. The next thing I know I?m lying flat on my back on the bathroom floor and was confused and disoriented.  Not sure how long I was out; my husband thinks maybe 5 minutes. He had to help me back to bed and noted that my clothing was soaked with sweat. Temp was 99.7 degrees F. Back in bed I noticed that both feet felt achey on the bottoms almost to the point of cramping. I went to sleep for a couple of hours.  Dozed on and off all day. No more nausea. Eventually I was able to eat, drink water, and take some ibuprofen. 9:00 PM and I?m feeling quite a bit better.
PATIENT GIVEN PEDIATRIC DOSE OF PFIZER COVID-19 VACCINE, PFIZER VACCINE REPEATED WITH ADULT DOSE
Information has been received from a consumer concerning her 16 year old daughter with no pertinent medical history who on 21-JUN-2009 was vaccinated with the first dose of GARDASIL (dose, route and LOT# not reported). Concomitant therapy included ZYRTEC and ZANTAC. Four weeks after vaccination, the patient developed hives and her lips and mouth swelled up. The patient was taken to the emergency room. The consumer also reported that her daughter's physician did "bloodwork" and a skin biopsy (results not reported). The "bloodwork" showed that the patient was "allergic to everything now". At the time of the report, the patient had not recovered. No further information is available.
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old male patient received BNT162b2 (BNT162B2), on 03May2022 at 04:30 as dose 4 (booster), single (Lot number: FM9992) at the age of 59 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High Blood Pressure" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course- The patient previously received a COVID-19 Vaccine. There was list of other medications the patient received within 2 weeks of vaccination. Device Date: 13Jun2022  No follow-up attempts are possible. No further information is expected.
Pt recvd series of 3 Engerix-B on 21MAR91, 6MAY91 & 30SEP91 titer checked 24OCT91, 1 wk earlier than usual because pt had a needle stick;
After my second day of receiving my J&J vaccine, I felt very tired. On the 3rd and 4th day, I went to see my PCP and went for a  routine check up where I was found to have a low heart rate. My heart rate had dropped to 34. I went to the ER due to my low heart rate and not because of the J&J vaccine. Also due to my anorexia condition, I could not sleep, drink fluids and also had diarrhea.  To this day I still have low heart rate.
Red, non-pruritic, non-raised rash on chest that spread to the abdomen and trunk. Submitted photos of rash via text message to primary care doctor. Patient spoke on the phone with primary MD after he saw the photos. MD prescribed Prednisone 20 mg daily x 5 days. Rash cleared by day 3 of prednisone course.
about to faint; dizzy/light headed; numbness and pain in left arm; numbness and pain in left arm; on Friday ECG was abnormal, but on Sunday ECG was normal; chest pain became intermittently severe; develop slow and gradual trouble breathing/still having trouble breathing; This is a spontaneous report from a contactable consumer (patient's husband).  A 38-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot #ER8735, Exp date 31Jul2021) intramuscularly in arm right on 30Apr2021 09:45 (at the age of 38-year-old) at single dose for COVID-19 immunisation. Relevant medical history included wheezing (during school age she had trouble breathing/wheezing but has not had trouble since then). Family medical history relevant to the event includes that her father is diabetic and heart patient. Concomitant medications were not reported. The patient had not prior vaccination within 4 weeks. After receiving the first dose of COVID vaccine the patient began experiencing slow and gradual trouble breathing on 01May2021 and chest pain on 02May2021. Breathing difficulties worsened and chest pain became intermittently severe, it was on and off. The patient presented to ER on 07May2021 and 09May2021. She had no previous history of chest pain or breathing difficulties. Five days after the shot in the evening she felt dizzy and lightheaded and about to faint. Until then trouble breathing had been mild, that is when she went to the ER. Chest pain was severe on the day she went to the ER, prior to that it was mild. She also developed numbness and pain in left arm. The first day she went to ER (07May2021) they did blood work, ECG, and x-ray. After 3 to 4 hours she became a little normal and they came back home. It was busy in the ER and they were not able to meet the doctor on that day. She had to go back to emergency room on 09May2021 because of the same symptoms and the same trouble breathing. All tests were repeated and then they were able to meet the doctor on 09May2021. On 07May2021 ECG was abnormal, but on 09May2021 it was normal. When she had the dizziness and severe symptoms by the time she was waiting and relaxing her vital went back normal. Nothing was found in the test they did so far. Chest pain and issues with breathing had not resolved, while outcome of the other events was unknown.
Resident passed away7/6/2022 0805: Resident found unresponsive in her bed when approached for breakfast in the am. All V/S had ceased.
2 h after flu vaccine administration, rash/hives developed to arm and left side of face.  BENADRYL administered by mother.  Continued BENADRYL dosing every 6 h X 24h.  Symptoms subsided.
This is a spontaneous report from a contactable medical assistant reporting on behalf of a medical practice. This medical assistant reported similar events for 3 patients. This is the second of 3 reports.  A 65-year-old female patient received PREVNAR 13) Lot. N34935, Expiry Date Oct2017) via an unspecified route of administration, at 0.5 ml, single in the left arm on 06Dec2016 for immunization, at physician office. Relevant medical history was none. Concomitant medications were not reported. No additional vaccines were administered on same date or within 4 weeks. In Dec2016, the weekend after receiving the vaccine, the patient experienced redness, swelling, heat and pain at the injection site.  She went back into the office, on 13Dec2016, and was treated for cellulitis. The patient recovered on an unspecified date.; Sender's Comments: A causal relationship between the administration of PREVNAR 13 and the occurrence of the reported events cannot be excluded based on the temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2017005456 Same repoter/product/events, different patients;US-PFIZER INC-2017005460 Same repoter/product/events, different patients.
This spontaneous report as received from a female consumer (patient's age reported as 67, height reported as 5'14 and weight reported as 170 units unspecified) with allergic to sulfa novacaim, abnormal blood pressure and thyroid disorder, refers to herself. On 05-MAR-2014 the patient was vaccinated with ZOSTAVAX (dose, lot #, expiration date and route of administration not reported). Concomitant therapies included multivitamin, fish oil, blood pressure pills and thyroid medicine. On 05-MAR-2014 (reported as the same day of vaccination), the patient experienced redness and itching at site of insertion right away. On 06-MAR-2014 (reported as the next day), the patient experienced lumps around the insertion site and headaches lasting all day. There was no treatment given for the events. The outcome of the events was not reported. The relatedness between the events and ZOSTAVAX was not reported. Additional information is not expected.
PCR confirmed Monkeypox; Case reference number US-BN-2022-004664, is a spontaneous case report initially received from a phycisian (reference number: USBAV22-1943) on 11-Nov-2022 and concerns a patient of unknown gender or age.  The patient's medical history included human immunodeficiency virus (HIV) with CD-4 lymphocytes, at 645 (units not provided).  The patient's concomitant medication was not provided.  On unspecified date, the patient was vaccinated with the first dose of Jynneos (Smallpox and Monkeypox Vaccine, Live, Nonreplicating, batch number: unknown), at unknown dose, route of administration and anatomical location, for indication reported as to decrease the incidence of monkeypox.  On unspecified date, reported as six days after Jynneos vaccination, a polymerase chain reaction (PCR) test confirmed the patient had monkeypox.   At the time of this report, outcome of event monkeypox was unknown.  The reporter assessed the event monkeypox as non-serious and as possibly related to Jynneos vaccination.   Additional information received from the physician on 11-Nov-2022: New information included seriousness and causality assessment for event monkeypox.  Additional information received from Bavarian Nordic on 14-Nov-2022 included the case ID.  This case is linked with US-BN-2022-004662, US-BN-2022-004663, US-BN-2022-004665, US-BN-2022-004666, US-BN-2022-004667, US-BN-2022-004668 and US-BN-2022-004669 (same reporter).; Reporter's Comments: A patient of unknown age and gender developed serious event monkeypox (medically significant) six days after the first dose of Jynneos vaccine was administered. Monkeypox is unlisted. The patient's medical history included human immunodeficiency virus (HIV). Concomitant medications were not reported. Considering that the vaccine is non-replicating and does not contain monkeypox virus, monkeypox has been assessed as not related to Jynneos.; Sender's Comments: A patient of unknown age and gender developed serious event monkeypox (medically significant) six days after the first dose of Jynneos vaccine was administered. Monkeypox is unlisted. The patient's medical history included human immunodeficiency virus (HIV). Concomitant medications were not reported. Considering that the full course of vaccination has not been yet completed at the time of confirmed monkeypox infection via PCR the case is considered not related to vaccine.
04/01/2021 - Vaccinated at 3:00 pm . Waited 15 mins and then returned home. Around 3:30 pm I developed a metallic taste in my mouth. Around 3:35 pm I became very itchy with no rash or hives. Itching feeling felt like it was below the skin.  Approx 3:45 pm I called called Primary Care Physician and let them know what going on.  Around 4:05 pm my lips, tongue and mouth felt numb ( Novocaine like )   Around 4:15 pm  My Dr's office called me back and after describing my symptoms they told me to go to to the ER.  Immediately Went to Emergency Department.  Was seen by doctor and others. Skin had now began going back and forth from pale to red. Itching had increased .  Skin color began changing going from bright red to pale white and then back and forth. I was also now very light headed and very nauseous along with. I still had the metal taste in my mouth, was extremely itchy, and my lips and tongue were still numb.  Around 5:14 pm they gave me Pepsid, Vistaril, Deltasone.  We stayed there about another hours and I was released.  Was give a script for Deltasone that I had  filled that night.  I went home and went to bed.  04/02 - Woke up and had lost all sense of taste and smell. I was still itchy, tired, nauseous, lips and tongue we still numb. I called my Dr and they said they would see me on Monday 04/05. The symptoms continued all weekend and on Sunday 04/04 i developed a burning feeling in my lungs.  Monday 04/05 I went to see the Dr . The Dr prescribed hydrOXYzine . I did not do well on so it was changed to Zytec. Rested and tried to take it easy. Feeling in the lips and tongue came back.  No longer  nauseous .  I was still light headed from time to time. My lungs were still bunring and I was very short of breath. On 04/23 went to the doctor because I still am not better.  My lungs were still burning, I was  tired all of the time, I and  I was still light headed from time to time. They did blood work, EKG and a chest X ray.  On 04/24 I had a CTA because ( abnormal coagulation profile shortness of breath.  I was prescribed Albuterol in hopes it will be better.  I have a follow up on 05/10 unless things get worse. 04/27 This are not worse, but they are not really improved.  I am still tired all of the time. I still have shortness of breath,  my lungs are still burning, and I still get light headed from time to time.
Expired Pediarix administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 5-year-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number 4977T, expiry date 5th September 2022) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 6th September 2022, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On 6th September 2022, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 6-SEP-2022 Reporter's Comments: The reporter stated that that an expired dose of Pediarix was administered to a patient on the reporting day. The reporter consented to follow up. Additional Supportive Information:  The patient received expired dose of Pediarix which leads to expire vaccine used. This case has been linked to the US2022128919 case reported by the same reporter.; Sender's Comments:  US-GSK-US2022128919:Same reporter
I was hospitalized on 11/18 with a ?2nd degree AV block? that led to a pacemaker being implanted on 11/21/21
This case was reported by a pharmacist via call center representative and described the occurrence of bruising of arm in a 69-year-old female patient who received SHINGRIX (batch number MX2LT, expiry date 29th May 2021) for prophylaxis. On 3rd March 2019, the patient received SHINGRIX (intramuscular). On 3rd March 2019, unknown after receiving SHINGRIX, the patient experienced vaccine administered at inappropriate site. In March 2019, the patient experienced bruising of arm. On an unknown date, the outcome of the bruising of arm and vaccine administered at inappropriate site were unknown. It was unknown if the reporter considered the bruising of arm to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in her left arm. The pharmacist reported that due to the larger size of the patient, it was difficult for her to locate the deltoid muscle of the patient's arm and the vaccine might have been administered slightly outside of the deltoid region, which led to vaccine administered at inappropriate site. Less than a month after receiving vaccination, the patient complained of bruising on the side of her left arm. Onset date of bruising was not provided.
I experienced moderate to severe heart pain following both of my Moderna Covid vaccinations. On April 12, 2021, I began feeling moderate to severe heart pain following the first. I left work and went to an urgent care facility where I was encouraged to go to the emergency room. I was seen at Emergency Room where they ran several diagnostic test to determine if I was having a heart attack which was ruled out. On May 10, 2021, I experienced the same heart pain following the second Moderna Covid vaccination.
Ten (10) minutes after receiving injection, patient's arm became swollen and uncomfortable.  No redness, rash, SOB or other symptoms noted.  Ice pack was applied to site and patient was observed for an additional 15 minutes.  In follow up calls, family reported that patient's arm remained swollen and red for several days but she remained asymptomatic, otherwise.  Note:  though patient and family had denied any prior adverse reactions to flu vaccines, subsequent conversations revealed that she had had a similar event in past at another office.  Family attributed reaction to patient receiving both a flu shot and a pneumonia vaccine in the same arm.
I started having symptoms 4 days after the vaccine, Diagnoses with Pulmonary Embolism, given shots of Blood Thinners for 2 weeks, prescribed, experienced breathing issues 6 weeks posted vaccine. Heart problems due to Pulmonary Embolism. Given 3rd dose in December, experienced shortness of breath for about 1 week after booster.
Pt was given DTAP #5/Polio #4 (KINRIX) IM, (R) deltoid on 8/28/12. He developed swelling & redness at inj site at 7 pm on 8/29/12. Was seen at urgent care today - 8-30-12. Per Dr, a 3-4 inch indurated red area has developed at inj site no other sx.
Patient had scheduled an appointment and filled out paperwork to receive flu shot. Was inadvertently given booster dose of Moderna COVID 19 vaccine. No adverse effects were reported, and patient was informed of error. Patient had completed doses 1 and 2 of Moderna vaccine 6 months prior, so timing was appropriate.