chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient reports having a low grade fever, vomiting, hoarseness, chills, and fatigue that started on Wednesday 9/14/17 at 11 pm and lasted until Friday 9/15/17. Patient self treated with Ibuprofen 400mg at home.
Received a dose on day 30 after the expiration time; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received a dose on day 30 after the expiration time) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 078C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received a dose on day 30 after the expiration time). On 25-Jul-2021, EXPIRED PRODUCT ADMINISTERED (Received a dose on day 30 after the expiration time) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Pharmacist reported that they gave five doses of the Moderna COVID-19 vaccine from a expired vial. They gave those dose on the 30th day (25-Jul-2021) after the time it expired that was 10:11 AM.  The vial was initially stored in the refrigerator on 25-Jun-2021. The vial did not undergo any temperature excursions. Total amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77° F): On 25-Jul-2021 it was exposed to room temperature from 10:30 AM to 16:30 PM.   Most recent FOLLOW-UP information incorporated above includes: On 28-Jul-2021: Additional information received: Patient initials updated.
Pt presented to the ED on 11/5 with CC of generalized weakness which has been getting worse and with frequent falls . She was admitted for Hypercarbia. During her hospital stay she received treatment for her DX, in addition to multiple comorbidities.   Plan was discharge to rehab facility however, pt's roommate in hospital came back positive for COVID 19.  Patient tested positive for COVID-19, was asymptomatic.  Patient did have some mild hypoxia but this was likely secondary bacterial pneumonia was started on Levaquin with good effect.   Her oxygen requirement has improved and has been weaned to 4 L.     Rehab facility delayed transfer,  would like pt monitored and afebrile for 72 hours prior to initiating prior authorization again for placement.  Pt started spiking fevers over the past 48 hours.  Suspect because she was retaining urine as since foley placed the fevers have resolved.   She was discharged  November 29, 2021 in stable condition.
Extreme heavy menstrual bleeding not associated with cycle. I have had heavy bleeding after both injections. The first round of bleeding last 18 days.
ADMINISTRATION OF VACCINE FOR MORE THAN 6 HOURS AFTER THE FIRST VIAL PUNCTURE (VIALS STORED IN THE FRIDGE AFTER PUNCTURE) (OUT OF SPECIFICATION PRODUCT USE); INCORRECT PRODUCT STORAGE; This spontaneous report received from a health care professional concerned multiple patients.  No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855191, expiry: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced administration of vaccine for more than 6 hours after the first vial puncture (vials stored in the fridge after puncture) (out of specification product use), and incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the incorrect product storage and administration of vaccine for more than 6 hours after the first vial puncture (vials stored in the fridge after puncture) (out of specification product use) was not reported. This report was non-serious. This case, from the same reporter is linked to 20220527916, 20220528115, 20220528178 and 20220528223.
Alpha-gal Syndrome (from a tick bite)/can't eat animals like lamb, pork, or beef/aking out all over stomach, under breast, itching and burning; Alpha-gal Syndrome (from a tick bite); This spontaneous case was reported by a patient and describes the occurrence of FOOD ALLERGY (Alpha-gal Syndrome (from a tick bite)/can't eat animals like lamb, pork, or beef/aking out all over stomach, under breast, itching and burning) and ARTHROPOD BITE (Alpha-gal Syndrome (from a tick bite)) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 065F21A, 038A21A and 026A21A) for COVID-19 vaccination.     Concurrent medical conditions included Sulfonamide allergy (Sulfa allergy), Drug allergy (Steroids, Lipitor, Simvastatin), Allergy to antibiotic (Augmentin, Amoxi-Clav), Diabetic (controlled), Bladder disorder NOS (Bladder problem) and Irritable bowel syndrome.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On an unknown date, the patient experienced FOOD ALLERGY (Alpha-gal Syndrome (from a tick bite)/can't eat animals like lamb, pork, or beef/aking out all over stomach, under breast, itching and burning) and ARTHROPOD BITE (Alpha-gal Syndrome (from a tick bite)). At the time of the report, FOOD ALLERGY (Alpha-gal Syndrome (from a tick bite)/can't eat animals like lamb, pork, or beef/aking out all over stomach, under breast, itching and burning) had not resolved and ARTHROPOD BITE (Alpha-gal Syndrome (from a tick bite)) outcome was unknown.            The patient never had COVID positive test or diagnosis. No other vaccines were given within 1 month prior to Moderna COVID-19 vaccine. No concomitant drug was reported. The patient was going to get the Moderna booster, but asked pharmacist if able to take that as the patient was diagnosed about 1 month ago with Alpha gal (from a tick bite) and could not eat animals like lamb, pork, or beef. It was reported that patient did not experience a similar event in the past. Patient visited Allergist and Dermatologist. No treatment was received.
Two days after I got my vaccine, my left arm started hurting really bad at my inner elbow. It was the same arm I received my vaccine on. The pain started to get so severe that I couldn't extend my arm. Then I noticed a bumpy mass that had formed there on my inner elbow. I went to my Dr., and was given antibiotics and was sent to a Radiology office for an Ultrasound of my arm. The results showed some kind of mass. I'm still not sure what the mass is. Although it's gotten smaller over time, it still remains a little sore.
This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), VOMITING (vomiting), CHILLS (chills), NAUSEA (nausea) and HEADACHE (headache) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) and VITAMINS NOS (DAILY VITAMINS) for an unknown indication. On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm), VOMITING (vomiting), CHILLS (chills), NAUSEA (nausea) and HEADACHE (headache). At the time of the report, PAIN IN EXTREMITY (sore arm) had resolved and VOMITING (vomiting), CHILLS (chills), NAUSEA (nausea) and HEADACHE (headache) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment medications were reported.
22 hours after vaccination (Novemeber 2)was given I began to break out in hives.  Went to ER and was given solumedrol IV (had taken 350mg oral benadryl) and was prescribed steroid dose pack.  The next morning, Nov 3, I went to medical center and received Decadron. I began the dose pack.  Thursday 11/4 the hives continued to cover more space over my body.  I take atarax to help with itching but the rash is still progressing. Friday 11/5 completely miserable and more percentage area of my body is cover with the hives.  Saturday 11/6 rash severe- went bac to ER this time to medical center IV pepcid, IV solumedrol and  written a new prescription of steriods  20mg bid for 3 days. Sunday the hives are some better. Supposed to have a call with Dr on Monday morning. Dr. says take 5mg steriod for up to 90days and continue atarax . to draw labs on Tuesday and repeat visit with dr on Monday.
Pt fine until 8 PM 2/25/10; then had fever > 104.  Lethargy, listless, rapid resps. eyes bloodshot; area of rash @ injection site.
fever (101-101.6), body aches, fatigue, loss of taste and smell, extreme sinus congestion w extreme sinus headaches, sinus area sensitivity
This spontaneous report has been received from a nurse practitioner regarding a patient of unknown age or gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated VARIVAX dose 1, (dose, lot # and expiry date unknown). On 12-JUL-2010, the patient was vaccinated with improperly stored VARIVAX dose 2 (dose unknown), from lot # 666851/0280Z with expiry date of 12-FEB-2012. No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review of records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one of the several reports received from the same reporter. Additional information has been requested.
Patient had her first varicella vaccine on 1/11/08. She had her second vaccine 2/20/08. She has a positive pregnancy test 3/14/08.
Patient reported feeling a lot of nausea immediately after receiving the vaccine. Patient reported history of Reynaud's and celiac disease. Patient also began reporting numbness and tingling to face, hands, and feet. Patient began to report an extreme headache to the left side of the head. EMS was called, patient's BP was found to be elevated. Patient was transferred to ED.
DEATH Narrative:  NO INFORMATION AVAILABLE AS PATIENT DID NOT RECEIVE CARE AT THE FACILITY ALL EXCEPT AUDIOLOGY CLINIC WITH THE LAST VISIT IN 2019 NO DEATH NOTE, NO AUTOPSY NOTED, PT HAD ONE AMBULATORY CARE NOTE IN 2012 NO DOCUMENTATION OF PREVIOUS COVID INFECTION, NO HOSPITALIZATIONS, NO ACUTE REACTION AFTER VACCINE. Most likely cause of death was advanced age, not related to vaccine.
Clammy feeling; nausea; Vomiting; Headache; Chills; This spontaneous case was reported by a consumer and describes the occurrence of COLD SWEAT (Clammy feeling), NAUSEA (nausea), VOMITING (Vomiting), HEADACHE (Headache) and CHILLS (Chills) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced COLD SWEAT (Clammy feeling), NAUSEA (nausea), VOMITING (Vomiting), HEADACHE (Headache) and CHILLS (Chills). At the time of the report, COLD SWEAT (Clammy feeling), NAUSEA (nausea), VOMITING (Vomiting), HEADACHE (Headache) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant information was reported. No treatment information was reported.
Pt complains of pain, swelling, and pruritus at injection site extending to elbow.
Felt lightheaded after covid vaccination given.  Gave apple juice and she started feeling immediately better.  She did state that she hadn't slept well the night before and that she hadn't eaten in a few hours.  After monitoring for 15 minutes patient stated she was feeling totally normal.  She was able to stand and walk without dizziness.  She stated that she did not feel that she needed further treatment at this time.
Weakness, muscle twitches, fatigue, muscle cramps, numbness, burning and tingling sensations.
Extreme fatigue and all over body aches for all of Saturday. Completely fine on Friday (Day of injection) and completely back to normal on Sunday.
12/1/08 Pt presented in pediatric clinic with a rash "all over his body" with fever for 3 days. Provider assessed rash to be allergic response to a vaccine (also by history). Prescribed Benadryl 25mg po TID.
Dizzy; Fever 99.8 and now 100.2; Super exhausted; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy), PYREXIA (Fever 99.8 and now 100.2) and FATIGUE (Super exhausted) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 22-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced DIZZINESS (Dizzy), PYREXIA (Fever 99.8 and now 100.2) and FATIGUE (Super exhausted). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DIZZINESS (Dizzy), PYREXIA (Fever 99.8 and now 100.2) and FATIGUE (Super exhausted) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Feb-2021, Pyrexia: 99.8 99.8 and 100.2 100.2.
Could not use hand, it did have movement but she was unable to grasp things; tingling in hand; This spontaneous case was reported by an other health care professional and describes the occurrence of MOTOR DYSFUNCTION (Could not use hand, it did have movement but she was unable to grasp things) and PARAESTHESIA (tingling in hand) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A-03) for COVID-19 vaccination.     Concurrent medical conditions included Incontinence. Concomitant products included PROGESTERONE from 01-Aug-2019 to an unknown date and ESTRADIOL for Incontinence, VITAMIN D3 for Vitamin deficiency NOS.    On 11-Mar-2021 at 11:50 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced MOTOR DYSFUNCTION (Could not use hand, it did have movement but she was unable to grasp things). 11-Mar-2021, the patient experienced PARAESTHESIA (tingling in hand). On 12-Mar-2021, MOTOR DYSFUNCTION (Could not use hand, it did have movement but she was unable to grasp things) and PARAESTHESIA (tingling in hand) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 16-May-2021: Follow up received included patient demographic details, Dosage Batch number, Concomitant medications, and  an event were added On 14-Jul-2021: Follow up received included no new significant information
Redness and swelling on Right arm Dx'd with Cellulitis treatment Keflex for 10days
tested positive for Covid-19; tested positive for Covid-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A 42-year-old patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 13Oct2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "never smoked" (unspecified if ongoing), notes: I have never smoked. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 27Oct2023, outcome "unknown" and all described as "tested positive for Covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (27Oct2023) Positive, notes: tested positive for Covid-19 with an at home test kit.  Additional information: Patient received the Pfizer vaccine on Friday, 13Oct2023 at local (clinic name). Patient became sick and tested positive for Covid-19 with an at home test kit on Friday, 27Oct2023. Patient was 42 years of age and healthy. Patient have never smoked, do not drink and take safety precautions such as masking and social distancing.   The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Mom reported her entire arm became purple and swollen following vaccine administration. Pt reported arm still feeling tender at most recent visit, 4 weeks after vaccine administration.
Pt fainted & fell on L/side of forehead on floor.  Regained consciousnes after 1 minute & taken to Obervation area per w/c to lie down.  BP116/68 P 60 R 16.  Hx of hypertension & seasonal allergies.  Abrasion on L/side of forehead cleaned & iced.        Pt talked about having a concussion in high school resulting in memory loss & out of school for 3 months.          1:50 pm Continued to be "sweaty" after 10 minutes while lying down. BP 114/75 P 54        2:40 Left walking w/o assistance.  Head injury instructions given.
Hands and feet itching and broke out in bumps underneath skin all over hands and feet. Patient was evaluated by a dermatologist, who told pt. it was an allergic reaction to AFLURIA. Started on PREDNISONE pack and fluocinonide cream.
I awoke in the very early morning hours today, January 23, not able to sleep. My head, neck, and body were pounding. I feel achy as if I have the flu. My nose is stuffy, much more congested than it has been.
I have maintained a low to mid grade fever every single day since the date of my vaccine, ranging from 100.1 to 102.3 with an enlarged lymph node in my right armpit. I reported these findings to my primary care physician and underwent a blood test which overall, was unremarkable.
Covid 19 test: Nasal Swab Result: Positive; Covid 19 test: Nasal Swab Result: Positive; Severe joint swelling oral viral sores left lung fluid exhaustion; Severe joint swelling oral viral sores left lung fluid exhaustion; Severe joint swelling oral viral sores left lung fluid exhaustion; This is a spontaneous report from a contactable Other HCP (patient). A 56-year-old non-pregnant female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular in the left arm on 24Dec2020 12:00 at a single dose for COVID-19 immunization at the hospital. Medical history included juvenile idiopathic arthritis (JRA). The patient was not diagnosed with COVID-19 prior vaccination. Concomitant medications included imipramine, nebivolol hydrochloride (BYSTOLIC), and topiramate (TOPAMAX). The patient received other vaccine within 4 weeks prior to the COVID vaccine which is J&J cv trial. The patient experienced severe joint swelling, oral viral sores, and left lung fluid exhaustion on 25Dec2020 06:00; it was reported that no treatment was given for these. The patient tested for COVID-19 post vaccination. The COVID-19 test post vaccination was a Nasal Swab (Abbott Binax) on 27Dec2020. The COVID-19 test result was positive. Outcome of the events severe joint swelling, oral viral sores, and left lung fluid exhaustion was recovering; for the other events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: The association between the event lack of effect (COVID-19 test positive) with BNT162b2 can not be fully excluded. Based on the close temporal relationship, the association between the event left lung fluid exhaustion with BNT162b2 can not be fully excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
After vaccines on 11/16 pt noticed redness and swelling that evening and the following day started to have malaise and severe pain at the site of injections, went to UC and was started on doxycycline and KEFLEX, followed at the clinic the following day since appeared to start forming an abscess but redness area was slightly improved since on antibiotic. Continued with Tx and a couple of days later it has been 40% improved. Pt gets allergy injections weekly on both arms, last dose the previous Monday.
36 hours after vaccination the backs of my knees became bumpy, red, and extremely itchy. Over the course of the next 48 hours, the rash spread to my lower legs, arms, and trunk. Small raised red bumps resulted accompanied by extreme itch. Methylprednisone dose pack was prescribed, as well as topical triamcinolone. Some resolution from methylprednisone, but itch has returned after completion of dose pack.
Pt c/o numbness/tingling in arm.  Assessment showed speech not slurred, equal grip bilaterally.  High BP is abnormal for patient, but pt stated anxiety due to shot.  Pt refused transport, advised to contact PCP if HTN, symptoms occurs
Pain and itchiness at left arm.  Pain felt like a very tight rubber band or rope was binding my arm.  I took pain killers for three days.  Pain and itching lasted 5 days.  Lotion only helped with arm on the fifth and last day. Extreme fatigue lasted four days.  My ability to do chores and concentrate was adversely affected. I would have filed this report sooner but I only found out about this web site yesterday.
extreme muscle pains on the first night prior to vaccination and extreme nausea when trying to eat that has lasted for, right now, 2 weeks. an inability to eat much now because of the nausea induced.
pt recvd vax 5DEC95 & no sx until 8AM 8DEC while riding in car w/mom;cried as if in pain,seemed dazed,but no LOC;activity level limited x 3hrs then back to nl
Patient received Pfizer COVID vaccine on 12/31/20 and 1/21/21. On 12/28/21, patient tested positive for COVID at home. On 1/7/22, patient admitted to our inpatient facility with acute respiratory failure with hypoxia likely due to both COVID-19 pneumonia and acute pulmonary emboli bilaterally with mild right heart strain. COVID PCR status upon admission on 1/7/22 was negative, but given recent positive test and progression of illness strongly suspect this is residual inflammation/pneumonia from COVID-19. Patient discharged home with oxygen and anticoagulation on 1/11/22.
Crying, listless, pale and dusky around the mouth, skin cold and clammy and was drowsy. He was given warm bath then took bottle 30 minutes later. Acted like himself like himself, 2 hours later.