chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Not sure if her husband received the first dose; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL UNDERDOSE (Not sure if her husband received the first dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, the patient experienced ACCIDENTAL UNDERDOSE (Not sure if her husband received the first dose). At the time of the report, ACCIDENTAL UNDERDOSE (Not sure if her husband received the first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications details were not reported by the reporter. Treatment details was not reporter by the reporter.
sicked than a dog, it got worse each day; Liver enzyme over 100- diagnosed with Elevated alkaline phosphatase level; broke my knee; allergies; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 81 year-old female patient received bnt162b2 (BNT162B2), administration date 02Feb2021 (Batch/Lot number: unknown) at the age of 80 years as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ENTOCORT EC, start date: 19Feb2021, stop date: 19Feb2021; COREG; ELIQUIS; LIPITOR; NITROSTAT; VITAMIN B-12; LOMOTIL [ATROPINE SULFATE;DIPHENOXYLATE HYDROCHLORIDE]; FOLVITE [FOLIC ACID]; MAGNESIUM POSITIVE.   The following information was reported: ILLNESS (hospitalization), outcome "unknown", described as "sicked than a dog, it got worse each day"; BLOOD ALKALINE PHOSPHATASE INCREASED (hospitalization), outcome "unknown", described as "Liver enzyme over 100- diagnosed with Elevated alkaline phosphatase level"; LOWER LIMB FRACTURE (medically significant), outcome "unknown", described as "broke my knee"; HYPERSENSITIVITY (non-serious), outcome "unknown", described as "allergies". The patient underwent the following laboratory tests and procedures: hepatic enzyme abnormal: over 1000.  Clinical course: Patient was discharged with diagnosis with elevated alkaline phosphatase level. Medication Prescribed as Loperamide (Imodium) 4 times daily as needed for diarrhea (100 doses remaining),Tylenol (acetaminophen 325 MG tablet) 2 tablets by mouth every 4 hours as needed for Pain Maximum allowable Acetaminophen amount = 4 Grams (4000 mg) / 24 hours, ZOFRAN (ondansetron 4 MG tablet) 4 mg by mouth every 8 hours as needed. Ventolin HFA 108 (90 Base) MCG/ACT inhaler (albuterol HFA) Inhale 2 puffs by mouth every 6 hours as needed  The lot number for bnt162b2 was not provided and will be requested during follow up.
Patient is a 5 Y female  Pt came for her PFIZER MONOVALENT VACCINE 5-11y/o 2ND DOSE.  PFIZER MONOVALENT VACCINE 5-11y/o was not diluted with 1.3ml of normal saline prior to use and pt received a concentrated dose at 1604.  Dose given by LVN  PFIZER MONOVALENT VACCINE 5-11y/o LOT # GD1857 EXP 03/08/2023  No immediate adverse effect noted.   Pt full of energy skipping around the room, no palor or respiratory distress noted.   Pt was able to have a full conversation with this writer.   Dr. was notified at 1615.   Dr. said to observe her for the full 30 minutes and if she feels fine she can go home.   Mother expressed concerns for her daughter especially "at night."  Reassured her that most side effects happen in the first 30 minutes post administration and Dr. also mentioned that they should look at for a rash, respiratory distress and/or GI symptoms if she were to have any symptoms.   Manger was notified as well.  At 1640, pt VS were checked prior to leaving for home.   BP: 92/54 HR: 99  Pt reported no pain and no distress.  Apologized to the parents again for the error and informed them that the error will be documented in her chart.   Information created and reported medication error to state as well.  Copied PCP to note to inform her of the error.
Patient called to say she experienced tingling and swelling of lower lip and swelling of eye approx 26 hours after receiving shots. But had also eaten nuts in ice cream same day of tingling/swelling. Also pain (swelling for 5 days at site of Tdap (left deltoid)).
This spontaneous report as received from a physician refers to a patient of unknown age and gender. There was no information about patient's concomitant medications and pertinent medical history reported. On 13-NOV-2015, the patient was vaccinated with a dose of improperly stored PROQUAD (Merck) lot # L011080, expiry date 01-OCT-2016, (dose, route and site of administration were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Initial case report received from a consumer via Novartis Pharma GmbH on 12 NOV 2009. A female patient of unknown age was vaccinated with an unspecified influenza virus vaccine (manufacturer unknown, batch no. unknown) in 1999. The patient developed chronic bronchitis in 1999. The patient had persistent damage. This case was previously reported as MA2009-4059. Follow up received from a consumer on 04 Feb 2010: Patient demographics were added. On an unspecified date, the patient underwent bronchoscopy and was diagnosed with a rare Staphylococcus.
Pt in with swelling, redness, and heat to right arm following her flu and Pneumococcal 23 vaccine in the right deltoid on 12/31.  Redness and swelling noted from shoulder to down her arm 22 cm and at the widest it was 10 cm about mid arm. Area is warm and painful to touch.  Dr in to see pt. Dr wrote a script for Prednisone 20 mg BID x 5 days for pt to bring into pharmacy.  Pt also encouraged to take  Benadryl and ice the affected area. Pt discharged in good condition.
Patient received mixed series. Initially received Moderna vaccine for first dose and then got Pfizer for the second.
This is a spontaneous report from a contactable physician via Pfizer sales representative. A male patient (age: 16, unknown unit) of an unspecified age and ethnicity received TRUMENBA, (Lot # S85201, Exp 31Dec2019) via an unspecified route of administration at single dose on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported. The patient was given a TRUMENBA and fell back on the table, fainting on an unspecified date with outcome of unknown. Information about lot number already provided.
Large red/dark red circle/oval on left arm around injection site. Had this after first moderna shot but did not associate it to vaccine
stuffed up head/my head is like I have a very bad cold; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), 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: NASOPHARYNGITIS (non-serious), outcome "unknown", described as "stuffed up head/my head is like I have a very bad cold".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a physician concerning a female who on 11-SEP-2007 was vaccinated with a 0.65 ml dose of Zostavax. Concomitant therapy included unspecified antibiotics for an unspecified reason. Subsequently the patient experienced a shingles rash. The patient was seen by the physician. At the time of the report the patient was recovering. No further information was provided. There was no product quality complaint involved. Follow up information from the physician indicated that the patient who had allergies to sulfa, grass and dust, was vaccinated on 11-SEP-2007. On 12-SEP-2007 the patient saw podiatry for an unspecified reason and was treated with cephalexin (KEFLEX) x 10 days. Then on 24-SEP-2007 the patient was treated with levofloxacin (LEVAQUIN) x 7 days as well as a dose of fluconazole (DIFLUCAN) for an unspecified reason. The patient was also treated with famciclovir (FAMVIR) x 7 days. On 01-OCT-2007 the patient presented to the office with complaints of a painful rash in the right flank area (at approximately T10-T12 dermatome) consistent with herpes zoster that began on 29-SEP-2007. There were no lab studies performed. The patient recovered on 09-OCT-2007. Additional information is not expected. The reporter considered the patient's shingles to be an other important medical event.
20 minutes post vax, the pt developed acute facial/hand swelling and urticaria on hands and face. Pt got Benadryl, then began to wheeze; got epinephrine and Solu-Medrol.
cough; started to feel chills; Fever; Upper respiratory infection; This is a spontaneous report. A contactable physician reported that a 70-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on 15Jan2021 at SINGLE DOSE for covid-19 immunization. Patient does not have other relevant medical history. There were no concomitant medications. On 17Jan2021 21:00, the patient experienced upper respiratory infection. She experienced fever and started to feel chills on 18Jan2021. Then on an unspecified date, paient experienced cough. The outcome of events upper respiratory infection and fever was recovering whereas events cough and started to feel chills was unknown.   Follow-up attempts are completed. The following information on the batch number has been requested.
Received MMR and Varicella on 2/19/07 and next day noted to have upward rolling of eyelids lasting only for a few seconds. No color change, no tonic/clonic movement of extremities.
Information was received from a lawyer regarding a case in litigation. A patient, gender and age unspecified, was inoculated with ZOSTAVAX on 02-MAY-2016 at a pharmacy as recommended for routine adult health maintenance and for prevention of shingles. The vaccine did not prevent shingles as intended and subsequently the patient contracted a persistent strain condition of herpes zoster. On or about 09-JUN-2016 the patient was treated (by an unspecified health care professional) at a medical group office for the onset of a vesicular rash, which was diagnosed as shingles. On or about 14-FEB-2017, the patient sought subsequent treatment by a physician at a dermatology office for a further diagnosis of continued and worsening shingles. As a direct and proximate result of ZOSTAVAX vaccine, and or despite receiving ZOSTAVAX for long term prevention of shingles, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering and other damages. The reporter considered the events to be related to ZOSTAVAX. Additional information has been requested.
Symptoms: Itching hands, head, lips, ears, swelling of the lips,  feeling hot, Treatment: took Benadryl and Pepcid at home and received Benadryl and  solu-medrol  at Urgent care Timeline: went to Urgent Care 1 and 1/2 hours after event started
Questionable reaction to DTAP. Urticarial lesions on face, no shortness of breath. Gave 18 mg of benedryl.
first dose < 25 days ago; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose < 25 days ago) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939676 and 939676) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In July 2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose < 25 days ago). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose < 25 days ago) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient did not experience any adverse event or reaction.  No concomitant medications were provided by the reporter.  Treatment information was not provided.
nausea; slight headache; bad body aches; chills; fever; I felt like the flu/ Flu like symptoms; My body has that creepy crawly feeling; Mainly feels like body and joint ache; Fatigue; This is a spontaneous report from a contactable consumer or other non hcp.    A 64-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 19Mar2021 (Batch/Lot number was not reported) as 2ND DOSE, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications. It was reported that, Consumer stated, had my second Covid-19 vaccine the Pfizer on Monday morning. It is third day, and still experiencing side-effects, is that normal to have 3 days later I still have flu like symptoms, Chills, Fever, my fever does get down, mostly body aches, chills and headache, a very mild headache, but mainly feels like body and joint ache, fatigue, again my fever did get away when I took Tylenol just wanted to know if it is normal because had it on Monday here it is Thursday and feel like it's just the side-effects. Consumer stated, On Tuesday felt the flu persisting all day. Yesterday went to work and I didn't had fever but had body chills, still have Body aches, chills, fatigue and slight headache. Consumer stated, "The first night took Aspirin and Caffeine 250 mg for headache and this morning I took acetaminophen 2 tablets at once, 650 mg. That's the only thing she have taken. The outcome of the events was unknown.  follow-up attempts are possible; information about lot/batch number cannot be obtained.
A report was received from a health care professional on 01/07/03 concerning a 15 month old female vaccinee who was inadvertently administered 0.25ml Fluvirin intramuscularly on 01/07/03. No adverse reaction was noted. There was insufficient information to determine the reporter's causality assessment.
About 5 minutes after vaccine, I had onset to headache starting in the back of my head and over my top and it very quickly escalated - to felt like someone hit me in the back of my head. I hunched over; I was shaky and light- headed and needed help standing up and they put me in a wheelchair. I was feeling very confused and they caused me an Emergency response team at the Hospital. They did vitals and I don't remember what they were. My BP may have been a little elevated. I was nauseous; I had light sensitivity. They checked my blood sugar which was fine. They had me lay there and rest for an hour. The light headedness went away and the nausea went away and I had the headaches for the next two solid days. No treatment. I did have fevers as high as 102 almost - 101 something. Typical flu like symptoms with severe migraines. I was having all the curtains closed, couldn't look at a screen for two days - I was down with the migraine.  The third day, I was better which was my day off. They kept me out of work until the 26th, I think I was back to work by the 27th.
Continuing pain, 2 months later at injection site. Position causes pain when lifting object or turning arm. No change in intensity over time. Feeling extremely fatigued and weak. Unable to do activities I could do before the 2nd vaccine
Headache; sore arm; This is a spontaneous report from a contactable consumer (patient) reporting oneself.  A patient of unspecified age and gender received (BNT162B2, formulation: Solution for injection, Lot Number: UNKNOWN), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history included tension headache from an unknown date and unknown if ongoing. And the patient concomitant medications were not reported. It was reported that patient experienced headache, sore arm after the first vaccine due to which the patient delayed second vaccine. Upon follow-up(21Sep2021); it was reported that, the patient reported that he/she get tension headaches and had a long day, so the headache could be attributed to that as well. The sore arm was for over a week. It was reported that, patient administered second dose on an unspecified date and did fine with the second shot. The clinical outcome of the events was unknown.  This lot number for the vaccine, [BNT162B2] was not provided and will be requested during follow-up.
Sick with flu, received Fluarix and Influenza vaccine/Suspected vaccination failure; Sick with flu; This case was reported by a consumer via other manufacturer and described the occurrence of vaccination failure in a patient who received Flu Seasonal TIV Dresden (Fluarix) for prophylaxis.   Co-suspect products included Flu unspecified (Influenza vaccine) for prophylaxis.   On an unknown date, the patient received Fluarix and Influenza vaccine. On an unknown date, unknown after receiving Fluarix and Influenza vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the influenza was recovered/resolved.   It was unknown if the reporter considered the vaccination failure and influenza to be related to Fluarix and Influenza vaccine.     Additional Information: GSK receipt date: 19-Jan-2023  Reporter's comment: The patient of unknown age and unknown gender who experienced was sick with flu for 14 days after receiving vaccines fluarix and influenza vaccine by unknown manufacturer (strength, formulation, dose, expiration date and lot number not reported) vis unknown route in unknown administration site . The patient's past medical history, medical treatments, vaccinations and family history were not provided. Lab data was not reported Corrective treatment was not reported for the event (was sick with flu for 14 days). Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of influenza were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Chills started 7 hours after shot, subsided around 12 hours after shot. Fever of 103 started 10 hours after shot, subsided 30 hours after shot. Fatigue and muscle aches for 36 hours after shot. No particular pain or aches at site of injection, aches were more general.
VEIN BULGING; BILATERAL NUMBNESS ON LEGS; LEFT THIGH PAIN; LOST CIRCULATION; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982, and batch number: 1808982 expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced lost circulation. On 13-APR-2021, the subject experienced vein bulging. On 13-APR-2021, the subject experienced bilateral numbness on legs. On 13-APR-2021, the subject experienced left thigh pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from left thigh pain on 14-APR-2021, had not recovered from bilateral numbness on legs, and the outcome of vein bulging and lost circulation was not reported. This report was non-serious.; Sender's Comments: V0-Medical assessment comment is not required as per standard operating procedures, as case is assessed as non-serious.
Erythema rt thight @ inject site; Warm to touch; Applying cold to warm compresses & giving APAP for fever;
per pt's family, pt c/o abdominal pain before sudden loss of consciousness; EMS arrived; pt in asystole; after interventions; intubated; brought to ED where pt passed away; there had been a recent hospitalization at another hospital with diagnosis of CVA and COVID infection ( tested positive 12/8/21); per death certificate pt died in the ED with cause of death:  CVA, COVID 19, thromboembolism, HTN.
Narrative:  COVID infection following COVID vaccine series 03/31, Pfizer,  dose #1 04/21, Pfizer, dose #2 11/10, Pfizer, dose #3 12/27 COVID swab, result:  detected 12/25 pt cc: cough, diarrhea, headache, rhinorrhea, sore throat exposure:  unknown 12/30 clinically resolved
COVID breakthrough case. I received my 2nd booster shot on 04/18/2022 and my adverse event started on 05/10/2022 at night slight stuffy nose. The next day when I woke up I have more of a stuffy nose and a scratchy throat. On the 05/11/2022 I tested positive for COVID. 05/12/2022 I stuffy nose cleared up. 05/13/2022 in the morning I couldn't breathe, I had a dry cough, stuffy nose. On Friday 05/13/2022 I contact my doctor she prescribed me PAXLOVID for 5 days. I started taking PAXLOVID the same night. 05/14/2022 I started to feel better my stuffy nose had gotten better and  I still had dry cough but was getting better.
Death Narrative:  Death on 12/22/20. 1st dose administered 5 days prior to serious event. Patient passed of chronic illness while in facility. There are no indications that death was related to the vaccine.
I was just diagnosed with pneumonia; I was just diagnosed with pneumonia; This is a spontaneous report from a contactable consumer reported for him/herself.   A patient of unspecified age and gender received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) at single dose on unspecified date in 2019 (Nov2019-Dec2019) via unspecified route of administration, for immunization. In Feb2020 the patient was diagnosed with pneumonia. The outcome of the event was unknown. The outcome of the event was unknown.   Information on the lot/batch number has been requested.
Local inflammatory reaction with induration, this increased over the course of 48 hours to be the size of an "orange."  She also had a fever as high as 101 (measured at home).  She was advised to move the arm frequently, apply ice packs x20 minutes several times a day, and take Ibuprofen PRN.  On 4/12 she presented to office with complaint of extreme fatigue. Checked CBC/ESR.  Local reaction significantly better.  Advised she continue fluids/rest and NSAIDs.
Patient presented to emergency department on 10/3/2021 with reports of dizziness. She was found to be COVID-19 positive and was admitted for further management. She was discharged to a rehab facility on 10/13/2021.
devel irritability,t101,high pitched cry x 24hrs p/vax followed by dec appetite x addl 24hrs;
Information has been received regarding a case in litigation concerning a patient who was vaccinated with a dose of Recombivax HB (Lot #'s 614560/015D; 614817/1405B; and 614567/0280D). Subsequently the patient experienced an adverse event. Additional information has been requested.