chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Case number PHEH2016US029316, is an initial spontaneous report received from a nurse on 07 Nov 2016. This report refers to a 29 years old female patient. Past medical history and concomitant medications were not reported. The nurse stated that first temperature excursion of FLUCELVAX Quadrivalent at 52F for 1 hour occurred on 18 Oct 2016. Second temperature excursion occurred on 23 Oct 2016, dropped low 06 times to 34F and lasted 30 minutes each time. The patient was vaccinated with FLUCELVAX Quadrivalent (batch number: not reported) at a dose of 0.5 ml intramuscularly on 26 Oct 2016. Third temperature excursion occurred on 02 Nov 2016, down to 32.2F three times over the course of 12 hours. Vaccine had been administered. It was unknown if vaccine was frozen. Nurse did not know which lot was given to which patient. No adverse event was reported following this administration error.
FEELING CRAPPY; This spontaneous report received from a vaccine facility via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown, and batch number: UNKNOWN expiry: UNKNOWN) .5 ml, administered on 10-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 10-MAR-2021, the subject experienced feeling crappy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of feeling crappy was not reported. This report was non-serious.
Swelling and rash at the injection site. Also sore, itchy and pain. Itchiness started a few hours after injection,  other symptoms a day after injection. Took Tylenol the day after for pain
client completes 15 min observation wait , c/o of N/ dizziness and lightheadness to nurse. Ems and doctor paged to observation site. VS taken 02- 97% BP- 116/81 Hr 67. Client states improvement in condition after a few min. client was advise to wait an additional 20 min and to drink lots of fluid. Client leaves site 11:56 AOX4 ambulating and states he feels 100percent better
Information has been received from a physician concerning a 10-year-old male who on 18-DEC-1996 was vaccinated with varicella virus vaccine live. On 25-SEP-2005 the patient developed a papular lesion believed to be chicken pox. There was a known exposure to the disease in school. The lesions were on her face, trunk, back and extremities. The patient was put on gentamicin. The adverse event improved and the patient is recovering. There was no product quality complaint reported. Additional information received on 18-OCT-2005 reported that the patient had chickenpox after having received varicella virus vaccine live years ago. No further information is expected.
neck pain; shortness of breath; concerned about liver; hot burning sensation in middle of chest; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (hot burning sensation in middle of chest), NECK PAIN (neck pain), DYSPNOEA (shortness of breath) and HEPATIC PAIN (concerned about liver) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, the patient experienced CHEST PAIN (hot burning sensation in middle of chest). On 11-Apr-2021, the patient experienced NECK PAIN (neck pain), DYSPNOEA (shortness of breath) and HEPATIC PAIN (concerned about liver). At the time of the report, CHEST PAIN (hot burning sensation in middle of chest), NECK PAIN (neck pain), DYSPNOEA (shortness of breath) and HEPATIC PAIN (concerned about liver) outcome was unknown. Not Provided   Treatment information was provided i.e., Advil   DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Apr-2021, COVID-19: Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
7 mo old infant experienced unconsolable high-pitched cry and four episodes of vomiting within 24 hrs after immunization.  Infant was afebrile.  Given tylenol at time of immunization.
I had extreme fatigue - it lasted up until I had the stroke on May 2nd. I had some light headedness.  I was dragging for two weeks. I just wasn't right. We went to cabin in and my arms swelled and itched - a week after getting the vaccine. It was beyond big and itched. It was hard to sleep. I called the doctor. He told me to take antihistamine and topical Benadryl on it. Had the stroke on May 2nd and waited four hours and I went to Care ER part of. I was admitted and stayed two days at that point. Gave me IVs and Aspirin treatment and Lipitor. They sent me home to take Lipitor and baby aspirin. I have seen specialists after that - cardiologists and neurologists etc. They confirmed a TIA - a mild stroke. I had to be put on a heart monitor for 10 days. I have not gotten the results back from that yet. Again, because of the stroke I have had extreme fatigue ever since the shot and from the stroke. It's really bad. I have to go to the speech therapist - for Aphasia symptoms. My brain isn't working right.  I almost passed out four days after I was released. I had a synchrony event on May 7th. Went to the hospital again for one day.
Flu-like symptoms; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   In August 2022, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix.     Additional Information: GSK receipt date: 21-OCT-2022 Reporters comment: The patient self-reported this case. The reporter did not consent to follow-up.
anaphylaxis; This is a literature report for the following literature source(s).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, 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: ANAPHYLACTIC REACTION (medically significant), outcome "unknown", described as "anaphylaxis". In another study, anaphylaxis was confirmed after the first dose in 7 patients who received BNT-162b2 vaccine and 9 patients who received mRNA-1273 vaccine. The CDC had reported a rate of 2.5 cases per million doses.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported event: "Anaphylactic reaction" and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.   The impact of this report on the benefit/risk profile of the Pfizer drug 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-202200681973 Same article/ drug/event and different patient:
Use of an expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Use of an expired vaccine) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051C21A and 051C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Jul-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Use of an expired vaccine). On 16-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Use of an expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant information was reported. No treatment information was reported. Reporter has stated that patient has received his second dose of expired vaccine after day of its expiry in fridge.   Most recent FOLLOW-UP information incorporated above includes: On 31-Jul-2021: Follow up received on 31-07-2021, contains new information. Updated patient gender as female.
so sick almost died; suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sickness (serious criteria life threatening), vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the sickness, vaccination failure and shingles were unknown.   It was unknown if the reporter considered the sickness, vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was patient's son/daughter. The age at vaccination was not reported. The reporter stated that her mother got the shingles shot and it made his/ her mother so sick that she almost died and still experienced shingles 5 times. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were not provided. This case has been linked with the case US2021AMR190621 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR190621:same reporter
PT SHOWED ME HIS ARM. THERE WAS A CLERA BUBBLE BLISTER AT THE SITE OF INJECTION. HIS FULL TOP PORTION OF HIS ARM WAS RED AND SWOLLEN. PT COMPLAINED OF SORENESS OF HIS FULL UPPER ARM. THE UPPER ARM APPEARED REA AND WITH RAISED RASH LIKE IRRITATION. PT DID NOT COMPLAIN OF PAIN, JUST SORENESS.
Information has been received from a licensed practical nurse concerning a 24 week old male who on approximately 13-JUN-2007 (reported as 10 weeks ago) was vaccinated with the first dose of Rotateq, which was reported as older than the recommended age. It was reported that the patient was to receive the second dose on 22-AUG-2007. There was no product quality complaint. Unspecified medical attention was sought. Additional information has been requested.
Axillary swelling, severe pain at the site of injection, axillary lymphadenopathy
This spontaneous report as received from a medical assistant refers to a 18 year old patient of unknown gender. The patient's drug allergies and pertinent medical history was not reported. On 17-JUL-2014 the patient was vaccinated with VAQTA (dose, frequency and route of administration were not reported) (lot # J014584 and expiry date: 16-JAN-2016) which was stored improperly. No adverse effects were noted. No product quality complaint was reported for VAQTA. This case is linked to 1407USA010956, 1407USA012902, 1407USA012903, 1407USA012904, , 1407USA012905, 1407USA012906, 1407USA012907, 1407USA012908, 1407USA012909, 1407USA012910, 1407USA012911, 1407USA012912, 1407USA012913, 1407USA012914, 1407USA012915, 1407USA012916, 1407USA012917, 1407USA012918, 1407USA012919, 1407USA012920, 1407USA012921, 1407USA012922, 1407USA012923, 1407USA012924, 1407USA012925, 1407USA012926, 1407USA012927, 1407USA012928, 1407USA012929, 1407USA012930, 1407USA012931, 1407USA012932, 1407USA012933, 1407USA012934, 1407USA012935, 1407USA012936, 1407USA012937, 1407USA012938, 1407USA012939, 1407USA012940, 1407USA012941, 1407USA012942, 1407USA012943, 1407USA012944, 1407USA012945, 1407USA012946, 1407USA012947, 1407USA012948, 1407USA012949, 1407USA012950, 1407USA012951, 1407USA012952, 1407USA012953, 1407USA012954, 1407USA012955, 1407USA012956, 1407USA012957, 1407USA012958, 1407USA012959, 1407USA012960, 1407USA012961, 1407USA012962, 1407USA012963, 1407USA012964, 1407USA012965, 1407USA012966, 1407USA012967, 1407USA012968, 1407USA012969, 1407USA012970, 1407USA012971, 1407USA012972, 1407USA012973, 1407USA012974, 1407USA012975, 1407USA012976, 1407USA012977, 1407USA012978, 1407USA012979, 1407USA012980, 1407USA012981, 1407USA012982, 1407USA012983, 1407USA012984, 1407USA012985, 1407USA012987, 1407USA012988, 1407USA012989, 1407USA012990, 1407USA012991, 1407USA012992, 1407USA012993, 1407USA012994, 1407USA012996, 1407USA012997, 1407USA012998, 1407USA012999, 1407USA013000, 1407USA013013 and 1407USA01304 (same reporter link).
Drunken feeling/light headedness(2 days-unsafe to drive), light chest pain(1 day), right earache(1 day), slight headache(1 day-took tylenol), severe left arm muscle pain(2 days) then light left arm muscle pain(2 more days)
Did not feel well (lt arm was reddened & sore on 19OCT91 had t101; 20OCT91 temp of 100F; took aspirin every 4-5 hrs; afebrile 21OCT91; redness of arm only slight;
Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 23-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Date of refrigeration was on 07-May-2021. Concomitant medication use was unknown Treatment information was unknown   This case was linked to MOD-2021-364355 (Patient Link).
Arm pain; Dizziness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm pain) and DIZZINESS (Dizziness) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 1. On 08-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm pain) and DIZZINESS (Dizziness). At the time of the report, PAIN IN EXTREMITY (Arm pain) and DIZZINESS (Dizziness) was resolving. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Jan-2021, SARS-CoV-2 antibody test negative: negative negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
According to family and certificate of death, patient suffered from an acute mid-brain cerebrovascular accident and died on 6/24/2021.
Extreme muscle soreness, low grade temp. Within 30 hours excessive vomiting started & continued for over 12 hours, resulting in dehydration, leading to trip to ER.
8 days post smallpox vaccine administration, patient developed increasing redness, pain, swelling around site. Treat with Levaquin 750mg PO daily for 5 days.
AFTER RECEIVING THE DOSE 1 OF THE MODERNA COVID VACCINE AND WAITING IN THE OBSERVATION AREA FOR 15 MINUTES, PT LEFT THE STORE AND ABOUT 45 MINS LATER, HER HUSBAND CALLED STATING THAT SHE WAS DRENCHED IN SWEAT, LOSS MUSCLE MOVEMENT/CONTROL OF HER HANDS, FELT LIKE SHE WAS GOING TO PASS OUT, COULD NOT GET OUT OF HER CAR WITHOUT ASSISTANCE, AND WAS VERY WEAK, DIZZY, AND NAUSEOUS.
inadvertently given a double dose of the Adacel prefilled syringe, no advesre event; Initial information received on 19-Jun-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 7 years old male patient who was vaccinated with a 0.5 ml dose of vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot number U6103AA and Exp. Date 25-Oct-2020) via unknown route in unknown administration site on 13-Jun-2019 and again inadvertently received a dose of same vaccine on 14-Jun-2019 (lot number, route and site of administration not reported.)  The patient's medical history not reported and concomitant medications included HEPATITIS A VACCINE (HEPATITIS A VACCINE); HPV VACCINE VLP RL1 4V (YEAST) (GARDASIL); MENINGOCOCCAL VACCINE A/C/Y/W CONJ (CRM197) (MENVEO); MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) and MENINGOCOCCAL VACCINE B RFHBP/NADA/NHBA OMV (BEXSERO) all for Immunisation.  It was an actual medication error case due to extra dose administered.  At the time of reporting, the patient did not experienced any adverse event post vaccination.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested for second dose.  List of documents held by sender: none.
The patient was an unfortunate 59-year-old male, who was recently admitted to Regional hospital for intracranial hemorrhage.  This was managed nonoperatively.  He had a prolonged complicated hospital course.  There was significant for respiratory failure requiring intubation, pneumonia secondary to Acinetobacter, septic shock, altered mental status, and abnormal LFTs.  He underwent G-tube placement on October 12, 2022 and tracheostomy tube placement on October 14, 2022.    On October 19, 2022, he was transferred to alternate facility for further evaluation and management.  He was maintained on mechanical ventilatory support.  Tube feeds were continued.  DVT prophylaxis was provided.  He never really made much progress in terms of ventilator weaning.  He remains very poorly responsive.  He was felt to have a probable upper GI bleed at one point with acute blood loss anemia.  This stabilized.  After extensive discussion with the family, it was decided to make him DNR and withdrawal of ventilator support.  He was made comfort care.  He was pronounced dead at 12:58 p.m
This spontaneous report as received from a physician refers to an unspecified number of patients have injection site reactions from PNEUMOVAX 23 (Lot#, dose and route unspecified). The reporter stated in his experience, he has only seen patients have a local injection site reactions if they have been given PNEUMOVAX 23 a dose in the past, and patients do not have this reaction if they have never been given PNEUMOVAX 23. The outcome of these patients were not reported. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available.
Severe breathing difficulty.  Lasted 9 days which required use of albuterol inhaler every ~4-6 hours for the first 7 of the 9 days. Breathing difficulty slowly went away over many days after the first 7-9 days. Resting heart rate was also elevated (near 130-140) as well as lightheaded feeling for a few days when breathing difficulties were most severe. Now breathing is back to normal.
Developed cellulitis in arm vaccine given. Seen in ER and by PCP. Started on ATB.
BREAKTHROUGH COVID INFECTION. TESTED POSITIVE ON 09/23/2021. PATIENT WAS FULLY VACCINATED ON 02/23/2021.
Pt developed swelling on right arm all the way little bit above elbow, all the way back and right breast. Very hot and unable to lift the arm. Pt taking BENADRYL.
Moderna COVID-19 vaccine EUA Soreness/Pain on the injection site for 2 days On and Off headache for almost 40 hours
Severe arm pain in shoulder and interior deltoid that has not gone away. Receiving physical therapy for pain.
Head ache; his t cells are messed up; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 22-Jun-2021 and was forwarded to Moderna on 22-Jun-2021.    This spontaneous case was reported by a patient family member or friend and describes the occurrence of T-LYMPHOCYTE COUNT ABNORMAL (his t cells are messed up) and HEADACHE (Head ache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced T-LYMPHOCYTE COUNT ABNORMAL (his t cells are messed up) and HEADACHE (Head ache). At the time of the report, T-LYMPHOCYTE COUNT ABNORMAL (his t cells are messed up) and HEADACHE (Head ache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported No treatment medication were reported.
Lightheaded sensation, nausea, sweating, normal HR, O2, BP, no fainting/vasovagal concerns; drank water and used a cool washcloth on her neck, rested and felt better. Was observed x 30 minutes. No SOB/HIVES/STRIDOR/SWELLING.