chrisvoncsefalvay/vaers-outcomes huggingface dataset:
2 separate nose bleeds. Patient stated she had to go to the ER during the second nose bleed, because she couldn't get it to stop bleeding after an hour.
Had J and J and had Moderna for boosters; No adverse event; This spontaneous case was reported by a consumer and describes the occurrence of EXPOSURE VIA BODY FLUID (Had J and J and had Moderna for boosters) and NO ADVERSE EVENT (No adverse event) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) for COVID-19 prophylaxis.    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 and first dose of COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPOSURE VIA BODY FLUID (Had J and J and had Moderna for boosters) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPOSURE VIA BODY FLUID (Had J and J and had Moderna for boosters) had resolved and NO ADVERSE EVENT (No adverse event) outcome was unknown.     This case was considered for father of the 2nd grandson.  No concomitant and treatment medications were reported.  He received J and J and had Moderna for boosters.  His partner (mother of the 1st grandson) received COVID-19 vaccinations, however it is not sure if she received Moderna.   This case was linked to US-MODERNATX, INC.-MOD-2023-722093 (Linked Report). This case was linked to MOD-2023-722088 (Parent-Child Link).   See case MOD-2023-722088 for details regarding the child case.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-722093:Case for Mother of 2nd grandson
This spontaneous report as received from a medical assistant refers to a 7 week old patient of unknown gender. The patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 14-SEP-2018, the patient was vaccinated with improperly stored dose of ROTATEQ 2 ml tube, orally (lot # N022015, expiry date: 10-MAR-2019) for prophylaxis. The vaccine was exposed to the temperature of 32.21 degree Fahrenheit (°F) (32F to 35 F) and time frame was 3.5 hours from 06-SEP-2018. Previous excursion was 50.37 °F for 4.5 hours as recorded by a data logger. No adverse effect was reported. No product quality complaint was involved. This is one of the several reports received from the same reporter source.; Sender's Comments: US-009507513-1809USA002868: Original Case : 1809USA002868 US-009507513-1902USA009324: Original Case : 1902USA009323. US-009507513-1902USA009323:Original Case : 1902USA009323 US-009507513-1902USA009326:Original Case : 1902USA009323
Dose administered >12 hours post puncture; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered >12 hours post puncture) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039D21A) for COVID-19 vaccination.     Concomitant products included PREDNISONE for an unknown indication.  On 06-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered >12 hours post puncture). On 06-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Dose administered >12 hours post puncture) had resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered EXPIRED PRODUCT ADMINISTERED (Dose administered >12 hours post puncture) to be possibly related.    No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 12-Oct-2021: Significant follow-up received: Concomitant medication was added and outcome was updated.
No additional adverse event; the patient was inadvertently administered a dose of GARDASIL 9; This spontaneous report was received from a nurse practitioner (also reported as nurse prescriber), referring to a 40-year-old female patient. The patient's pertinent medical history, concurrent conditions, previous drug allergies or reactions and concomitant medications were not reported.      On 05-MAR-2020, the patient was inadvertently vaccinated with an expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection as prophylaxis (strength, dosage regimen, route of administration, and anatomical location were not reported; and lot number R022533 has been verified to be valid, expiration date reported and validated as 12-NOV-2019) (expired product administered). No additional adverse event.
Patient presented to the ER with complaints of low 02 while in her PCP's office for sore throat. Patient tested positive for Covid-19. Patient had a coughing spell while at PCP where O2 sat dropped to 82%, patient was visibly dypneic, after receiving o2, oxygen sat returned to 97%. Patient came to the ER with daughter per PCP recommendation. ED evaluation revealed patient positive for COVID-19.  BP 192/99, HR 117, R 26, temp 97.9°, SpO2 95% on 3 L nasal cannula.  Mild leukocytosis, AST 63, troponin 0.037, BNP 107. CXR showed atypical pneumonia. NS 1 L bolus, azithromycin, Rocephin, Decadron 10 mg IV given in ED. While in ED, patient experienced intermittent hypoxia and increased work up breathing, O2 was subsequently upgraded to high-flow Airvo.  Patient admitted to ICU level of care for medical management of acute respiratory failure with hypoxia and pneumonia secondary to COVID 19 infection. Following admission, patient became more hypoxic with increased work of breathing and respiratory failure, requiring emergent intubation.  Code blue called shortly following intubation, ROSC was not achieved, and patient's daughter, at bedside, requested to stop code blue efforts.
Shingrix adjuvant only without the lyophilized antigen; Shingrix adjuvant only without the lyophilized antigen; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, the patient received a dose of the Shingrix adjuvant only without the lyophilized antigen, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. No symptoms reported. The reporter was not in the office at the time of report and did not have any of the patient's information at that time. The reporter consented to follow up. This case was 1 of 12 linked cases, reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR179302:Same reporter US-GLAXOSMITHKLINE-US2021AMR179303:Same reporter US-GLAXOSMITHKLINE-US2021AMR179297:Same reporter US-GLAXOSMITHKLINE-US2021AMR179299:Same reporter US-GLAXOSMITHKLINE-US2021AMR179307:Same reporter US-GLAXOSMITHKLINE-US2021AMR179306:Same reporter US-GLAXOSMITHKLINE-US2021AMR179298:Same reporter US-GLAXOSMITHKLINE-US2021AMR179300:Same reporter US-GLAXOSMITHKLINE-US2021AMR179301:Same reporter US-GLAXOSMITHKLINE-US2021AMR179305:Same reporter US-GLAXOSMITHKLINE-US2021178442:Same reporter
Shingles on arm (mild case); Burning; Itching; Pain; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, 2 years after receiving Shingles vaccine, the patient experienced shingles, burning sensation, pruritus and pain. The patient was treated with paracetamol (Tylenol), capsaicin (Capsaicin Cream) and non-drug therapy (Ice Pack (No Medication)). On an unknown date, the outcome of the shingles was recovering/resolving and the outcome of the burning sensation, pruritus and pain were unknown.   It was unknown if the reporter considered the shingles, burning sensation, pruritus and pain to be related to Shingles vaccine.     Additional Information: GSK receipt date: 14-Oct-2022 Reporter's comment: The case was received from the patient's wife via interactive digital media. The patient had shingles shot and 2 years later got the shingles on his arm. The physician said that it was a mild case but you could not prove them by him.  Less than 2 years after vaccination, the patient had the burning, itching and pain. The patient got tylenol, capsaicin cream, ice packs but it's been almost a month and it was still not entirely gone. The patient stated that he will get the second shot in 2 months.  The patient did not want to go through that agony. Additional supportive information: The follow-up could not be possible as no contact details were available. Tylenol, capsaicin cream and ice pack were coded as treatment medication as per reported narrative chronology. As it was clearly reported that the patient was recovering from it (it's still not entirely gone), there 2nd shot was not coded as suspect with medication errors. Time to onset for burning, itching and pain was captured as less than 2 years as it was reported that 2 years later after vaccination the patient had shingles i.e., in between this duration the patient had these events.
Client immediately suffered syncope episode after injection of GARDASIL. She was pale, clammy to touch and non-responsive for approx 1 minute. BP 77/54. Client awoke, was given sprite to drink and was observed for approx. 20 min. Client appeared fully recovered when she left with her mother. Followed-up 6/26/09, mother states client is well.
Heart attack, stints inserted, triple bypass, pulmonary embolism, fatigue, leg and arm tremors, headache, low blood pressure
Nose stuffed up; head/face hurt; head/face hurt; This is a spontaneous report from a contactable consumer or other non hcp. A 63-year-old female patient received first dose bnt162b2 (BNT162B2, Formulation: solution for injection, Batch/Lot Number and Expiration date was not reported) via an unspecified route of administration on 15Jul2021 18:15 (age at vaccination 63-year-old) as DOSE 1, SINGLE for covid-19 immunization. Medical history included allergy: mold, allergy: dust. Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store. There were no other vaccine received within 4 weeks prior to the COVID vaccine. There were no other medications the patient received within 2 weeks of vaccination. 4th day following initial vaccine - Nose stuffed up and head/face hurt. Took a Claritin which did not help - maybe it made it worse.  Stayed in bed all day on 5th day. No vaccination prior to the patient diagnosed with COVID-19. Since the vaccination, has the patient been tested for COVID-19: No. The patient's concomitant medications were not reported. On 19Jul2021 the patient experienced nose stuffed up, head/face hurt, head/face hurt. There were no other vaccine in four weeks. There were no other medications in two weeks. Adverse event 4th day following initial vaccine - Nose stuffed up and head/face hurt. Took a Claritin which did not help - maybe it made it worse: Stayed in bed all day on 5th day. There were no other treatment for ae. There were no other covid prior to vaccination. There were no other covid tested post to vaccination. There were known allergies with mold, dust. Therapeutic measures were taken as a result of head/face hurt, head/face hurt. The outcome of events were recovered on aug2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected
Shot given 10/10/07. On 10/11/07 seen for swelling in (L) arm. Had facial swelling on 10/18/07 - placed on Prednisone and Clarinex 5mg. Symptoms resolved after that. Yeast infection (vaginal) by 10/30/07. Placed on Keflex and Benadryl.
Information has been received from an RN concerning a 34 year old white female pt who was vaccinated with a 1st and 2nd dose of Hep-B vaccine recombinant on 8/12/98 and 10/2/98, respectively and an hour, post vax, on 10/2/98, the pt experienced increased heart rate, weakness, dizziness and joint pain. It was reported that these symptoms lasted for 1.5 days. Consequently, on 10/3/98, the pt recovered. On 7/12/99, the pt was vaccinated with a 3rd dose of Hep-B vaccine recombinant. There were no adverse experiences reported with the 3rd dose.
Bruising and it was in black and blue; Tingling; This spontaneous case was received on 05-Oct-2020 from a pharmacist via Health Authority (reference number: SEQW20-02859) and concerned a 49-year-old, female patient.   The patient's medical history was not reported. The patient's concomitant medications included vitamin D and gabapentine, both used for unreported indications. The patient experienced tingling after all the vaccines she received in the past.   On 28-Sep-2020, the patient was vaccinated with Flucelvax QIV (influenza vaccine, subunit influenza virus vaccine polyvalent, dose: 0.5 ml, route of administration: intramuscular and anatomical location: deltoid) for flu prophylaxis. The batch number reported was 276532, expiry date: 03-Jun-2021.    On the same date, immediately after receiving Flucelvax QIV, the patient felt tingling. Shortly after, she noticed bruising and she said that it was in black and blue. The patient applied ice to the bruising.   On 03-Oct-2020, reported as Saturday, the patient came to the pharmacy and the bruising was still there.  At the time of initial reporting on 05-Oct-2020, the patient had not recovered from the event of 'vaccination site bruising'.  The outcome of event tingling was not reported.   The reporter did not provide a causality assessment   The reporter assessed the case as non-serious.  Case updated on 02-Dec-2020: Correction made to information received on 05-Oct-2020: Coding for event bruising and it was in black and blue changed from LLT 'Bruising' to LLT "Vaccination site bruising'. Narrative amended accordingly. Company comment amended accordingly.  Company comment: The patient developed vaccination site bruising and paraesthesia on the same day after vaccination with the suspect product, Flucelvax QIV.  Chronology seems highly suggestive for both events. The patient's medical history was not reported while concomitant medications included vitamin D and gabapentine, both used for unreported indications. The patient experienced tingling after all the vaccines she received in the past. Causality is assessed as possibly related for both events.; Sender's Comments: The patient developed vaccination site bruising and paraesthesia on the same day after vaccination with the suspect product, Flucelvax QIV.  Chronology seems highly suggestive for both events. The patient's medical history was not reported while concomitant medications included vitamin D and gabapentine, both used for unreported indications. The patient experienced tingling after all the vaccines she received in the past. Causality is assessed as possibly related for both events.
Pt had second dose of Pfizer COVID vaccine, initial sx of just arm pain/soreness at injection site. Three days later, went to ER due to shortness of breath, chest pain for evaluation. She had chest xray, labs, EKG that were all normal. Given albuterol and ibuprofen with improvement in the ER and sent home. She took a few doses of albuterol and ibuprofen the same night and by next day symptoms had all resolved. She previously did not have any reactive airway, allergy or respiratory history. She did not have any of these reactions with the first dose.
"A nurse stated that a 5 month old female received Rota Shield, DTAP, HIB and IPV vaccines on 7/6/99. On 8/4/99, she vomited once and developed watery diarrhea. Stool "culture" was positive for rotavirus."
From telephone contact on 1/30/02 it was reported a 50-year-old woman received TD Adult in right deltoid and next day presented to the doctor with large local reaction at the site with redness and pain. It looked like cellulitis so doctor placed her on antibiotic.
Started experiencing chest pain and palpitations on 8/8. Admitted to Emergency Room on 8/11. Diagnosed with Pericarditis by Dr. and discharged on same day. Treated with 600 mg Ibuprofen, 3 times a day. Followed up with PCP  Dr. who recommended reducing the dosage after 10 days. However, had a recurrence of the issue on 9/2.  Still on Ibuprofen, 400 mg, 3 times a day. Follow up scheduled with Cardiologist on Oct 1st.
menstrual bleeding occurred after receiving the shot, this was early for the cycle; menstrual bleeding occurred after receiving the shot, this was early for the cycle and lasted 2-3 days.; This is a spontaneous report from a contactable Other HCP (patient). A 33-year-old female non-pregnant patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9267) via an unspecified route of administration, on 17Feb2021 at 07:45 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. The patient medical history was reported as none. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient concomitant medication included multivitamin, ascorbic acid (VITAMIN C), colecalciferol (VITAMIN D), cyanocobalamin (VITAMIN B12). The patient did not receive any other vaccine within 4 weeks prior to the vaccine. The patient previously took Tetracycline and experienced allergy. On 17Feb2021, at 11:00 the patient experienced menstrual bleeding after receiving the shot, this was early for the cycle and lasted 2-3 days. The patient did not receive any treatment for the event menstrual bleeding occurred after receiving the shot, this was early for the cycle and lasted 2-3 days. The outcome of the event was recovered on an unknown date in Feb2021 while for other event menstrual bleeding occurred after receiving the shot, this was early for the cycle (Irregular menstruation) was unknown.
This spontaneous report as received from a 62 year old female nurse via company representative refers to herself. The reporter stated that she was sensitive to any unspecified injections. On 24-OCT-2014 the patient was vaccinated with ZOSTAVAX (subcutaneous, dose/frequency was reported as normal dose/one time injection in left deltoid area) for prevention of shingles. Concomitant therapies included unspecified blood pressure medication and CLARITIN (dose and frequency unknown). On 24-OCT-2014, the patient experienced tingling on the day of injection in her left arm and fingers in her left hand. After approximately 10-12 hours later the patient experienced tingling on the left side of her face. Finally the patient also experienced hot and itchy sensation at the injection site in her left deltoid area for about 3-4 weeks. BENADRYL 50 mg was given as the treatment for the events. The outcome of the events was unknown. The causal relationship between the events and ZOSTAVAX was not reported. No further adverse event information was provided. Additional information has been requested.
This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age. On an unknown date, the patients were vaccinated with improperly stored VARIVAX (Merck), (dose, route, lot number not provided). No adverse effects reported. Additional information has been requested.
His face and head swelled up; His face and head swelled up; discharge started coming out of his face; face started getting oily; rubbery texture to his face; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), in 2021 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SWELLING (non-serious), SWELLING FACE (non-serious) all with onset 2022, outcome "unknown" and all described as "His face and head swelled up"; DISCHARGE (non-serious) with onset 2022, outcome "unknown", described as "discharge started coming out of his face"; SEBORRHOEA (non-serious) with onset 2022, outcome "unknown", described as "face started getting oily"; SKIN TEXTURE ABNORMAL (non-serious) with onset 2022, outcome "unknown", described as "rubbery texture to his face".  Additional information: The patient received Pfizer vaccine around the same time last year. About 6-8 months later Jan2022-Apr2022, might have been Feb2022 he was out somewhere and his face and head swelled up and discharge started coming out of his face. He normally had dry skin over his face started getting oily. In that moment there was a weird rubbery texture to his face. The patient noticed that it started happening only in certain environments and certain locations. He believed in 5-8 years it would go away but he did not want to have to deal with it his whole life.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Central nervous system: Chills, fatigue, fever, headache, irritability, malaise, nervousness, sleep disturbance. Dermatologic: Contact rash, dermatitis, diaper rash, dry skin, eczema, generalized varicella-like rash, heat rash, itching, urticaria. Gastrointestinal: Abdominal pain, appetite decreased, cold/canker sore, constipation, diarrhea, nausea, vomiting. Hematologic: Lymphadenopathy. Local: Injection site reaction, varicella-like rash at the injection.
pt developed leg pain 4-5 days after vaccination and + d-dimer and doppler (DVT) on 3/17/2021
Beginning morning after vaccine: sore throat, increased heart rate, difficulty breathing, hives, dizzy, nauseous, lasted 2 weeks (hives longer).
mom states child recv vax 20APR99 & that noc noticed red area sl larger than fifty cent piece in lt upper arm muscle & swelling in the muscle;mom states that today the swelling & redness have dec;now smaller than fifty cent piece;hot & red;
10/11/16 - Flu vaccine and PPD admins. 3-4 hrs. hives, 3-4 m later swelling lips, vomiting. Approx. 10pm pt gave self EPIPEN, 12.5 mg BENADRYL. Did not seek medical treatment. 10/13/16 - Pt began having vomiting, swollen lips at 7:30 pm, went to Hospital ED. No admission to hosp. Steroids, BENADRYL. F/U w/allergist.
Ten days after getting my booster, my palms and head started itching during the night.  In the morning, I noticed hives on my inner thighs and on my arms and belly. They also itched. Today is day two of the itching. No more hives, but I do have patches of red where it itches. They are linear and also splothy. . I itch almost everywhere.