chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional AEs reported.; Caller is a pharmacist reporting that he was informed a 20 month old received a dose of PROQUAD and VARIVAX.; This spontaneous report was received from a pharmacist, referring to 20-months-old patient, of unknown gender. The patient's pertinent medical history, current conditions, previous drug reactions or allergies and concomitant medications were not reported.   On 15-DEC-2020, the patient received a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) and varicella virus vaccine live (oka/merck) (VARIVAX) (formulations, strengths, vaccination schemes, routes of administration, anatomical sites of vaccination, lot numbers and expiration dates were not provided) (inappropriate schedule of product administration), both vaccines were administered as prophylaxis. No additional adverse events were reported.
Pt in office 6/21/13 stating she had "weeping & itching" blisters on abdomen. Pt in office 6/24/2013 after developed same type rash on top of lt wrist.
Hyper somnolent; Confused; Rapid heart rate; Hot and cold off and on; A spontaneous report was received from a physician concerning a female patient of unknown age, race who received Moderna's COVID-19 vaccine and experienced hyper somnolent, confused, rapid heart rate and hot and cold off and on.   The patient's medical history was not provided. No relevant concomitant medications were reported.    On 22 Dec 2020, approximately 30 minutes prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot # 025J20-2A) intramuscularly for prophylaxis of COVID-19 infection.  On 22 Dec 2020, within 30 minutes of receiving the vaccine, the patient began to experience feeling hot and cold intermittently, became hyper somnolent, confused, and had a rapid heart rate.  911 was called, but she did not go to the hospital. No treatment information was provided.  On 23 Dec 2020, she was better.   Action taken with mRNA-1273 in response to the events was not reported.   The events, hyper somnolent, confused, rapid heart rate and hot and cold off and on, were resolved on 23 Dec 2020.   The reporter assessed the events hyper somnolent, confused, rapid heart rate and hot and cold off and on as related to study drug.; Reporter's Comments: This case concerns a female patient who received their first of two planned doses of mRNA-1273 (Lot 025J20-2A), and who experienced the unlisted events of Hypersomnia, Confusional state, Heart rate increased, and  Feeling of body temperature change. The events were considered possibly related to the vaccine due to the temporal relationship and in agreement with the physician reporter.
Temp 100.2-102. Induration upper right arm 7 x 9 cm, w/erythema painful to touch and when raising arms. No nausea/vomiting/sob. No physical findings for abscess
spontaneous acute urticaria/hives. daily occurrences primarily on back, groin, backs of knees, armpits. Has progressed to palms, ears and neck. Very itchy with raised white marks.  Responsive to Benadryl and Zyrtec. Also used topical cortisone cream (1%).  Doctor recommended adding pepcid with Zyrtec.
Narrative:  COVID infection following COVID vaccine series 05/10 Janssen, dose #1 10/08 pt admit to medicine cc: fall dx: COVID-19 penumonia.LOS: 10 days 10/08 CXR impression: Hazy density in the left mid to lower lung zone with more subtle patchy density in the left mid lung, which could represent pneumonia. 10/08 CTA PE impression: 1. No CT evidence of a large central pulmonary embolism. 2. Diffuse glass opacities throughout the lung parenchyma.  Finding may be consistent with the patient's positive COVID status. 3. Emphysematous lung parenchyma. 4. Atherosclerosis. 10/08 BNP: 68.7 10/08 TROPONIN I: 0.037 10/08 COVID swab, result: detected 10/08 SARS-COV-2 Variant Sequencing result: pending 10/08 FIBRINOGEN: 384 10/08 DDIMER: 1.21 10/08 CRP: 15.527 10/08 ABG: i-pH 7.50, i-PCo2 37.3, i-PO2 46, i-HCO3 28.9 10/08 FIBRINOGEN: 281 10/08 DDIMER: 1.25 10/08 ESR: 19 10/08 FERRITIN: 753.8 10/09 PROCALCITONIN <0.05 10/09 LACTIC ACID: 0.91 10/09 SARS-COV-2 Variant Sequencing result: 2500.0 10/09 troponin i: 0.040 10/09 SARS-CCOV-2-IgG: 0.03 10/10 FIBRINOGEN: 378 10/10 DDIMER: 1.20 10/10 ESR: 33 10/11 FIBRINOGEN: 288 10/11 DDIMER: 0.97 10/11 ESR: 19 10/12 COVID swab, result: detected 10/12 pt cc: exposure: unknown 10/12 FIBRINOGEN: 308 10/12 DDIMER: 1.03 1012 ESR: 29 10/13 FIBRINOGEN: 242 10/13 DDIMER: 1.29 10/13 ESR: 31 10/14 FIBRINOGEN: 245 10/15 DDIMER: 1.50 10/15 ESR: 23 10/15 FIBRINOGEN: 208 10/15 DDIMER: 1.76 10/15 ESR: 21 10/16 FIBRINOGEN: 247 10/16 DDIMER: 1.71 10/16 ESR: 30 10/17 FIBRINOGEN: 255 10/17 DDIMER: 1.40 10/17 ESR: 15
breach of implied warranty; shingles; products liability - defective design; products liability - manufacturing defect; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a elderly female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. The patient was prescribed the Zoster Vaccine Live (ZOSTAVAX) vaccine by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 20-NOV-2014, the patient was administered the Zoster Vaccine Live (ZOSTAVAX) vaccine by a pharmacist. The patient was treated by a physician for the following injuries resulting from the patient's Zoster Vaccine Live (ZOSTAVAX) use: shingles. The patient claimed damages as a result of: Injury to themselves; Loss of consortium; Loss of services; Economic losses. The following claims were asserted: negligence; products liability - defective design; products liability - manufacturing defect; products liability-failure to warn; breach of express warranty; breach of implied warranty; fraudulent misrepresentation; fraudulent concealment; negligent misrepresentation; unjust enrichment; strict liability; consumer fraud; loss of consortium; punitive damages. The outcome of the event was not recovered/not resolved. Causality assessments were related.
First dose 5/28/21, second dose 06/17/21, "normal" second dose symptoms, fever, chills, headache, stomach pain, after 3 days still feeling pain, worse vommiting, pain above spleen, change in cheek coloring. Mom  took patient to ER and they did a CT and blood work, found nothing wrong and ruled out thrombocytopenia. Today she is feeling better still a headache and a bit nauseous. Mom called to make sure this incident was reported,
Vomiting, flushing/sweating, dizziness. Stable, released from vaccination site.
tested positive; tested positive; This is a spontaneous report from a Pfizer Sponsored Program Pfizer First Connect via a contactable female nurse reported for herself.  The female patient of an unspecified age received first dose BNT162B2(Covid-19) , via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization.  The patient medical history and concomitant medications were not reported.  The patient tested positive after she got the 1st vaccine, and got sick, both in Jan2021. Outcome of events was unknown.  Information about Lot/Batch has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. However, full immunity is only expected 2 weeks after the second dose.
Headache - moderate; Nausea- moderate; Injection site soreness; Fever-severe; Chills severe; Muscle aches- severe; Joint aches- severe; Severe sweating; Thirst drenched; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration in the arm left on 09Apr2021 at 14:00 (at the age of 46-year-old) as a single dose for COVID-19 immunisation. Medical history included depression and anxiety. The patient had allergies to penicillin. 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 did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included duloxetine hydrochloride (CYMBALTA), buspirone (MANUFACTURER UNKNOWN) and ethinylestradiol, norethisterone (NOTREL) all were from an unknown date for an unknown indication. The patient previously took the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in the arm left on 19Mar2021 at 15:00 (at the age of 46-year-old) as a single dose for COVID-19 immunisation. On 09Apr2021 at 18:00, within 4 hours after the vaccination, the patient experienced moderate headache, moderate nausea and injection site soreness. On 09Apr2021 at 01:00, within 11 hours after the vaccination, the patient experienced severe fever, chills, muscle aches, joint aches, continued moderate headache and nausea, severe sweating and thirst drenched. It was reported that the patient's pajamas in sweat 3X sheets and pillow sweated out. At 24 hours post-dose, fever was mild to moderate, chills mild to moderate, mild headache and nausea, severe muscle and joint aches and fatigue. Therapeutic measures were taken as a result of the events included treatment with 1000 mg Tylenol every 6 hours from 09Apr2021 at 23:00. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events headache, nausea, injection site soreness, severe fever, chills, muscle aches, joint aches, severe sweating and thirst drenched were recovering at the time of the report.  No follow-up attempts are needed. No further information is expected.
Vaccine administered on 10/13/14 and experienced the usual soreness at injection site.  After 3-4 days, discomfort extended to shoulder with pain raising arm overhead and abducting arm, limiting range of motion.  Has not worsened since then but has not improved either.  Occasional twinges of tingling/numbness in hand also reported.
Information has been received from pharmacist concerning a 75-80 year old male with elevated cholesterol and no known allergies who was vaccinated with a dose of varicella-zoster virus live.  Concomitant therapy included finasteride and pravastatin Na (PRAVACHOL).  Subsequently four weeks after vaccination the patient developed flu like symptoms.  The patient saw his physician and was treated with an unspecified antibiotic.  Subsequently, the patient recovered.  There was no product quality complaint involved.  Additional information has been requested.
Patient has known history of syncopal events after vaccine administration and phlebotomy. Administered vaccine in seated position and observed patient. After a few minutes, patient wasn't feeling great. I left to get her water and she had fainted in a seated position while I was away. She fell out of her chair onto the ground in front of it. Paramedics were called immediately. She awoke almost immediately after falling (less than 5 or 10 seconds of unconsciousness). She was alert and oriented to self, time, and place. She had no immediate complains other than the back of her head was sore (likely from fall). Paramedics arrived, she was elevated to a seated position in a chair, and her vitals were within normal limits. She declined a trip to the hospital. She was given water and was observed for about 30+ minutes. She left with her mother and father.
pt recv vax between AUG95 to FEB96;pt devel 25 lesions;
This case was considered medically important. Information regarding PREVNAR (unspec) was received from a healthcare professional regarding a 3-year-old female patient who developed lethargy and possible bacteremia. The patient received the fourth dose on an unspecified date. Relevant medical history was not provided. Product was administered on an unspecified date. Dose regimen was 1 dose 1 time per day (intramuscular). Additional suspect medication included Diphtheria/Tetanus Toxoids/Acellular Pertussis Vaccine and Hib-Titer Vaccine. Concomitant medications were not reported. On 04-nov-2007, the developed lethargy and possible bacteremia (drug ineffective). The patient recovered on an unknown date in Nov-2007. No additional information was available at the time of this report.
Patient received these immunizations on 5/30/14 following day 5/31/14 she developed hives on hands and arms and legs. No respiratory symptoms.
Woke up morning after injection (6am 4/10) to low grade fever chills, headache and body aches. Symptoms lasted throughout the day, even after alternating between Ibuprofen and Tylenol . Woke up in the early hours of the morning (3am, 4/11) with severe shaking (no temperature) that lasted approx. 10 mins. No symptoms throughout the day but low grade fever retuned during the evening and lasted approx. 3 hrs. No symptoms as of 6am on 4/12.
Seen in morning, mild cough, history of wheezing, but lungs clear. Given Prevnar vaccine. In the afternoon, pt had sudden onset of grunting respirations and wheezing. Breathing improved with albuterol nebulizer treatment X 2.
rash around the site about 2" in diameter and itchy was reported as worsened.; rash around the site about 2" in diameter and itchy; rash around the site about 2" in diameter and itchy; This is a spontaneous report from a contactable consumer reported for his wife (patient). A 70-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered in left arm on 13Mar2021 (age at vaccination was 70 years) as dose 2, single for COVID-19 immunization. The patient did not have any medical history. The patient's concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on an unspecified date (stated it was three weeks ago) (age at vaccination was 70 years) as dose 1, single for COVID-19 immunization. The caller stated that his wife and him both got the vaccine. The patient got her second dose on Saturday, 13Mar2021, afternoon. On 15Mar2021, the patient started getting a rash around the site and that day it was larger about 2" in diameter and itchy. The rash around the site about 2" in diameter and itchy was reported as worsened. The caller was thinking about putting some cortisone cream on it. The caller stated that he wanted to know if that was a normal reaction. The outcome of the event condition aggravated was unknown. The outcome of the other events was not resolved.  No follow up attempts are possible. Information about lot/batch number cannot been obtained.
rhinorrhea, cough, congestion, fatigue and body aches, upset stomach, sore throat
Patient received Influenza vaccine at 0730 on 12/07/2011. The injection was place in right deltoid. Patient was advised to take a dose of Acetaminophen 325mg to help with the injection site discomfort. Prior to the injection. Patient was asked if she was allergic to eggs -NO-,  Fever or Cough -NO-, Prior reaction to influenza -NO-, patient  stated this was the first flu shot she has ever received. 12/07/2011 at 1330 patient called to state she woke with high fever, chills, shortness of breath and back pain. I advised her to take dose of acetaminophen. I asked if she had any BENADRYL and if she did to take one immediately. I also advised her to go to the ER if her symptoms progressed. Information on Vaccine Product: FLUZONE Man: Sanofi-Pasteur Lot# UH453AA Exp. 30June12.
Felt like a truck ran over him; Headaches; Temperature of 101 degrees; Stiffness in joints; A spontaneous report was received from a 73-year-old, male patient, participating in the mRNA-1273 Emergency Use Program who experienced headaches, a temperature of 101 degrees, stiffness in joints and felt like a truck ran over him.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 23 Dec 2020 at 9 am, approximately 24 hours prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the right arm for prophylaxis of COVID-19 infection.   On the morning of 24 Dec 2020, the patient felt "like a truck ran over him." He experienced headaches, a temperature of 101 degrees and stiffness in joints. The patient stated he did not experience vomiting and no allergic reaction such as trouble in breathing. Treatment for the event, headache, included paracetamol.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, felt like a truck ran over him, headaches, a temperature of 101 degrees and stiffness in joints were not reported.; Reporter's Comments: This case concerns a 73 year old male patient who experienced a non-serious unexpected event of Malaise, and non-serious expected events of Headache, Pyrexia, and Joint stiffness. The events occurred approximately 24 hours after first dose of mRNA-1273 administration. Very limited information regarding the events has been provided at this time. Based on temporal association between the use of the product and the onset of the events, a causal relationship cannot be excluded.
Chest pain and fatigue started a little over a week after he received the vaccine. The next day he came to urgent care and felt a little improved. Mother reports no other symptoms. He attends school and had his first dose of Pfizer vaccine one week prior.
Shoulder area is hot; Shoulder area is bumpy; Shoulder area is a little itchy; Shoulder area is pink the size of a grapefruit; Arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Shoulder area is hot), VACCINATION SITE MASS (Shoulder area is bumpy), PAIN IN EXTREMITY (Arm was sore), PRURITUS (Shoulder area is a little itchy) and ERYTHEMA (Shoulder area is pink the size of a grapefruit) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm was sore). On 15-Mar-2021, the patient experienced FEELING HOT (Shoulder area is hot), VACCINATION SITE MASS (Shoulder area is bumpy), PRURITUS (Shoulder area is a little itchy) and ERYTHEMA (Shoulder area is pink the size of a grapefruit). On 07-Mar-2021, PAIN IN EXTREMITY (Arm was sore) had resolved. At the time of the report, FEELING HOT (Shoulder area is hot), VACCINATION SITE MASS (Shoulder area is bumpy), PRURITUS (Shoulder area is a little itchy) and ERYTHEMA (Shoulder area is pink the size of a grapefruit) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided by the reporter.   Treatment information was not provided.
Shingles in the same body region four times with normal immune system otherwise:  Sep2021, Dec2021, May2022, and Dec2022.; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 59-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Jan2021 at 12:00 as dose 2, single (Batch/Lot number: unknown) at the age of 59 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Glaucoma" (unspecified if ongoing); "known allergies: Sulfa" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing); "Known allergies: Doxycycline" (unspecified if ongoing); "Known allergies: Avelox" (unspecified if ongoing); "COVID-19" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Batch/Lot No: Unknown., Location of injection: Arm Left, Vaccine Administration Time: 12:00 AM, Route of Administration: Intramuscular), administration date: 01Jan2021, when the patient was 59-year-old, for COVID-19 immunization; shingrix, administration date: 23Oct2020, when the patient was 59-year-old, for Immunization. The following information was reported: HERPES ZOSTER (medically significant) with onset Sep2021 12:00, outcome "not recovered", described as "Shingles in the same body region four times with normal immune system otherwise:  Sep2021, Dec2021, May2022, and Dec2022.". The events "shingles in the same body region four times with normal immune system otherwise:  sep2021, dec2021, may2022, and dec2022." required physician office visit. Therapeutic measures were taken as a result of herpes zoster. Facility type vaccine  was pharmacy or drug store. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. There were no list of any other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was diagnosed as COVID-19. Since the vaccination, the patient had been tested for COVID-19.  The patient received valaciclovir hydrochloride (VALTREX), steroid injections, steroid cream for adverse event treatment.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information available and product safety profile, the reported event Hepes zoster is more likely due to intercurrent medical condition and unrelated to BNT162b2.  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-202300078592 Same patient/vaccine, different dose and events;US-PFIZER INC-202300078593 Same patient/vaccine, different dose and events;
Pt complained of swelling of the right arm from shoulder to elbow.  Said arm was red/swollen/painful.  Pt also complained of body aches where he had to take a pain medication.  By the time pt came in to show me his arm, it was no longer red and swollen.
9/6/13 student complained of redness left arm. Erythema measured 3cm x 5cm. Instructed to apply ice/cold compress.
Patient received a second 2nd dose of Pfizer COVID vaccine. Dates of vaccination: 1st dose: 03/26/2021 2nd dose: 04/09/2021 3rd dose: 04/16/2021
Pt. developed "upper body" itching, w/o rash within 24 hrs. of vax. No other sx's reported. Referred to Primary MD. Symptoms decreased by 11/4/99.