chrisvoncsefalvay/vaers-outcomes huggingface dataset:
no other AE; temperature excursion; This spontaneous report was received from a medical assistant and an office manager and refers to a patient of unknown age and gender (number reported as 65496). There was no information about their concurrent conditions, concomitant therapies or medical history provided.  On 09-MAR-2021 (reported also as reported as between 04-MAR-2021 and 25-MAR-2021), the patient was vaccinated with a dose of improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) dose/frequency: 1, lot # T021823, expiration date 25-JUN-2022 (exact dose, route of administration and anatomical location were not reported) for prophylaxis. The vaccine was stored in a temperature of 13.5 Fahrenheit degrees (F) for 40 minutes. There was no previous temperature excursion reported. Digital data logger was involved. No additional adverse event was reported.  As of 28-MAY-2021, no further information was available as the office manager stated she was not familiar with the case and the medical assistant has not been working at the facility anymore.  This is one of several reports from the same reporter.
Received S Zostavax and within an hour the area of the inocculation on the right arm, was sensitive to touch and ached.  By the next day the area was red, swollen and aching.  The swelling extended up the arm.  Pain developed in the arm, neck and head.  General aches & pains in joints and muscles in the entire body.  I returned to the doctor and began using Benadryl for the reaction and ice on the swollen area.  I developed ringing in my right ear that is still loud enough to be a interference in my hearing.  I have been seeing chiropractor for pain in my neck, back, shoulder and hip joints.  I have had 3 incidents of dizziness where I can't lay down to sleep and have difficulty walking.  I can not drive, during these incidents, as if I turn my head, the world spins and I could wreck.  I have missed several days of work on and off due to medical appointments, pain, and confusion. I have started back on antiverts today to try to alleviate the dizzines and nauseau.  I may need to visit an ENT to discuss the ringing in my ear. I did not have the painful joints, neck pain, headaches and dizzy spells prior to this shot.  I had a cat skan to rule out stokes or other brain desease.  I have had blood work, urine test and complete physical.  My energy levels are low and I can't do the physical activities that I have enjoyed in the past.  I know these are not the normal side effects, but I have discussed this with my physican and she feels what I have been suffering could be caused from a virus.  I believe this virus is the shingles/chicken pox.
received vaccine which  was product of temperature excursion with no reported adverse event; received vaccine which was product of temperature excursion with no reported adverse event; Initial information received on 27-Jun-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 54 years old male patient (162 cm and 103.4 kg) who received vaccine which was product of temperature excursion with no reported adverse event and the  vaccine involved was DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was reported that the patient had received the  vaccine which was product of temperature excursion with no reported adverse event  (product temperature excursion issue)  (onset and latency: unknown)     On 16-Mar-2022, the patient received a 0.5 ml  dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE, once ( lot number and expiry date; not reported) via intramuscular route in the deltoid nos for prophylactic vaccination (poor quality product administered) (latency: same day)   Action taken : not applicable for both events.  Outcome: unknown for both the events   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 the guidelines. 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.; Sender's Comments:  SanofiPVPortal20220628000730: SanofiPVPortal20220628000755: 2022SA136253:
Axillary adenopathy; 1st dose: 11Jan2021; 2nd dose: 04Mar2021; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 71-year-old male patient received BNT162b2 (BNT162B2), on 04Mar2021 as dose 2, single (Lot number: EN6201) at the age of 71 years intramuscular, in left deltoid for covid-19 immunization. The patient's relevant medical history included: "Adult onset atopic dermatitis", start date: 10Jan2012 (unspecified if ongoing), notes: Pertinent Details: Treat with narrow beam UVB. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 1, Anatomical Site of injection: Left Deltoid, Route of administration: Intramuscular, Batch/Lot number: EN6201), administration date: 11Jan2021, when the patient was 71-year-old, for Covid-19 immunization. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 04Mar2021, outcome "unknown", described as "1st dose: 11Jan2021; 2nd dose: 04Mar2021"; LYMPHADENOPATHY (non-serious), outcome "unknown", described as "Axillary adenopathy".  Amendment: This follow-up report is being submitted to amend previously reported information: added event 'Axillary adenopathy'.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300023904 same patient, different dose and event.
I received the vaccine shot at approximately 2:30pm in the afternoon on 9/13/21. Around 8pm that same evening, I started having very intense chills and my whole body felt freezing. I then started to experience whole body shaking similar to what women experience post-childbirth. This lasted for about 30-60 minutes. I also developed an intense headache and I became extremely tired. I took 800mg of ibuprofen and 1000mg extra strength Tylenol and went to bed at 9pm. My headache became worse overnight and pretty much lasted all night. My body hurt all over and the aches were so intense that I tossed and turned all night because I could not get comfortable. I have a 6 month old so when she woke up at 2am I went to tend to her. I came back to bed and my head hurt so badly that I couldn't really fall back asleep. I took 1/4 tablet of a doxylamine succinate tablet (unisom) and tried to go back to bed. At 5:40am my daughter awoke again so I got up to go tend to her. When I got into her room (which is down the hall) I picked her up and as I went to sit down in the rocking chair my vision started going out. By that I mean it got blurry, I started seeing spots, I felt very flushed/hot/sweaty/nauseous. Eventually I couldn't see at all. I almost threw up but didn't. I was able to stand up and put my daughter back in her crib and then I must have passed out or fallen on the floor because my husband heard a "thud" from down the hall. He came down to her room and asked if everything was OK. I could hear him but still could not see anything. I told him that I didn't feel well at all. He had to pick me up and carry me down the hall back to our bedroom because I could barely walk. At this point my vision was still gone - I literally could not see anything. I got very hot and flushed. My husband checked my temperature but I was not feverish. Clammy skin. I must have had a vagal response of some sort even though I had drank lots of water the previous day. In total my vision was probably black for at least 5 minutes, if not 10 minutes. My vision finally started to come back and my body temperature returned to normal. I continued to lay on the floor and I then had the worst headache of my life. It felt like my head was in a vice - it throbbed and was 11/10 on the pain scale. My husband helped me back to bed and I laid there for another hour until I felt well enough to get up and go downstairs. I took 800mg ibuprofen and 1000mg of Tylenol around 7:30am for my headache and drank a tall glass of water. My body continued to ache the rest of the day.
Expired vaccine was stored in refrigerator on same date of Administration.; patient received expired vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received expired vaccine) and PRODUCT STORAGE ERROR (Expired vaccine was stored in refrigerator on same date of Administration.) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received expired vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Expired vaccine was stored in refrigerator on same date of Administration.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient received expired vaccine) and PRODUCT STORAGE ERROR (Expired vaccine was stored in refrigerator on same date of Administration.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug was reported. Date of the vial initially stored was reported as same as administration date. The vial was pulled from freezer and thawed in room temperature on the day of vaccination, then discarded. It was reported that the vial did not undergo any temperature excursions. No treatment drug was reported.
p/pts 4mo old shots had seizures 25 days from shots-hospitalized; abn EEG's, developmentally delayed;PC from parent-pt exp apnea;
Headache & Myalgia Narrative: on 7th day after the vaccine, then had a headache that lasted for 9 days. Had pain at site of injection for 3 days.
On 4/8/21 patient reported increased difficulty speaking, increased dizziness, and vision changes.  Reports new headache rated 8/10 that started at 11am 4/8.  Hx of stroke 2018 with residual right side symptoms.  BP 162/104, HR 80, O2 sat 97% room air at 1740.  Sent to a Medical Center ER and admitted with stroke symptoms and new onset diabetes.
9 days after the injection patient developed erythematous, warm, swollen, itching at location of injection on  left upper arm. symptoms started to improved one day after the reaction
she felt significantly more pain han the previous 3 doses; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (she felt significantly more pain han the previous 3 doses) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 613A21A and 024M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (she felt significantly more pain han the previous 3 doses). At the time of the report, VACCINATION SITE PAIN (she felt significantly more pain han the previous 3 doses) outcome was unknown.            Concomitant product use was not provided by the reporter. It was reported that the patient felt pain during every dose of the vaccine. Treatment information was not provided.   This case was linked to MOD-2022-555535, MOD-2022-555540, MOD-2022-555523 (Patient Link).
Post vax, on 2nd shot, was off 1 day due to fever, chills and nausea. Post vax, 3rd shot, for 11 days now, I have a lump in my arm about the size of a half dollar down to a nickel now. Pain in arm, itching and sore around shot site.
This spontaneous case was reported by a consumer and describes the occurrence of WEIGHT INCREASED (Weight gain after 2nd shot), LETHARGY (Lethargy after 2nd shot) and VACCINATION SITE PAIN (Sore left arm after 2nd shot) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 038A21A) for COVID-19 vaccination. The patient's past medical history included Thalassemia. On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Apr-2021, the patient experienced WEIGHT INCREASED (Weight gain after 2nd shot), LETHARGY (Lethargy after 2nd shot) and VACCINATION SITE PAIN (Sore left arm after 2nd shot). On 14-Apr-2021, LETHARGY (Lethargy after 2nd shot) and VACCINATION SITE PAIN (Sore left arm after 2nd shot) had resolved. At the time of the report, WEIGHT INCREASED (Weight gain after 2nd shot) outcome was unknown. Concomitant medications was not provided by the reporter. Treatment information was not provided. This case was linked to MOD-2022-511431, MOD-2022-511410 (Patient Link). Reporter did not allow further contact
maculopapular rash on trunk, extremities.  Spares palms and soles.  None in oral cavity.  runny nose and cogestion one week prior.  Rash occurred 10 days post MMR vaccine
17 Papular with wide erythematous base. 2-3 with vessicles (small) pruritic on trunk, behind ear, scalp, under arms.
11/4/21 presents "as transfer from hospital for COVID pneumonia and superimposed bacterial pneumonia". PMHx "hypertension, chronic back pain with opiod dependance"
possible the patient has an active case of shingles; Bumps appear to be pustules, and some have blood in them; Bumps appear to be pustules, and some have blood in them; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 51-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included anxiety. Concomitant products included alprazolam (Xanax) and sertraline hydrochloride (Zoloft).   On 9th April 2019, the patient received the 1st dose of Shingrix. In April 2019, less than 6 months after receiving Shingrix, the patient experienced shingles, papule and pustule. On an unknown date, the outcome of the shingles, papule and pustule were unknown.   It was unknown if the reporter considered the shingles, papule and pustule to be related to Shingrix.  Additional case details were reported as follows: The vaccine lot number was not readily available at the time of this call. The patient had bumps present when he received the first Shingrix dose. The bumps never resolved completely, but would flare up at times.  The patient did not have evaluation from a dermatologist and informed the reporter that the bumps improve if he takes his anxiety medications, Zoloft or Xanax.  The reporter stated at the time of reporting the bumps appear to be pustules, and some had blood in them.  The reporter was wondering if it was possible the patient had an active case of shingles. The reporter consent to follow up.
Severe anxiety ( Pt has never had anxiety before in her life), Pain in arm tremendous, numbness in arm.   Pt still having  Anxiety.
Initial unsolicited case received from a consumer on 12 March 2015. A male patient received Typhoid vaccine (lot number and manufacturer not reported) and Anthrax vaccine (lot number not reported, other manufacturer) on an unspecified date. He subsequently developed an aggressive, catastrophic form of multiple sclerosis, and had been hospitalized due to an inability to walk. Outcome was not reported. Documents held by sender: None.
No additional edverse effect reported; PROQUAD underwent a temperature excursion and was administered; Information has been received from a registered nurse, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 21-JUN-2021, the patient was vaccinated with an improperly stored dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) lot number: U002529, expiration date: 24-JUL-2022 (dosage regimen, administration route and anatomical location were not provided) for prophylaxis. No adverse effects were reported.  The vaccine had temperature excursions of -14 (Celsius) to 10 C (-11.44 C) for 1 hour and 15 minutes. The reporter stated that a digital data logger was involved.
Headache, Myalgia, Arthralgia, Fever, NauseaVomiting, fatigue, injection site soreness, chills, pain inferior to left axilla Employee reported mild fever 02/02/21, moderate headaches 02/01/21 until 02/04/21, mild fatigue with mild nausea 02/02/21 until 02/04/21. In addition reported mild bilateral elbow joint pain 02/02/21, mild pain inferior left axilla 02/02/21 and 02/03/21, moderate body aches 02/02/21 unttil 020/04/21. Did not seek medical attention for the symptoms.
Moderna COVID?19 Vaccine  About 8 hours after receiving the second dose of Moderna, almost all of the side effects came in full force including headache, dizziness, fatigue, full body aches, injection site pain, chills, and elevated temperature. The peak severity lasted about 4-5 hours. It wasn't possible to sleep at all the night after the shot. After that 5 hour period, lingering side effects included headache, fatigue, and aches. About 22 hours after the shot, I decided to take some Tylenol to help get rid of the residual side effects. At 24 hours after the shot, it appears most effects have subsided but there is residual dizziness and some fatigue and weakness.
"Covid Arm" reaction - warm and itchy large red patch about two inches in diameter, painful to touch, and swollen
Shacking Hypotension Weakness Stomachache   Give loratidine 10 mg 11:45 am Epinephrine 0.3 mg 12:05 pm  Called 911 11:35 am EMS took over 12:15 pm
Pt recv vax on 11/12/98; on 11/13/98 pt exp chills, fever, muscle soreness, joint pain, upset stomach, difficulty walking & standing x 72 hr
Right deltoid with swelling and erythema - site about silver dollar sized - Tylenol/Motrin PRN, Benadryl PRN, warm compress PRN.
Client received age inappropriate 0.5ml dose of Fluzone rather than 0.25ml in her right thigh. No adverse event or reaction has been reported at this time.
CHILD WAS ADMINITSTERED PROQUAD AND VARRICELLA DURING WELL CHILD VISIT.  SHOULD NOT HAVE BEEN GIVEN EXTRA VARICELLA.  NO ADVERSE EFFECTS WERE NOTED DURING OFFICE VISIT.
Site: Pain at Injection Site-Severe, Systemic: fluid pocket under right arm pit-Medium, Systemic: Lymph Node Swelling-Medium
Patient experienced rash and swelling around injection site starting about 7 days after vaccination. About 14 days after vaccination, patient experienced tingling and muscle spasms around site of injection. She states that the muscle spasms and tingling occur randomly, even now (29 days post-vaccination)
RECEIVED VACCINE DOSE THAT WAS IN A TEMPERATURE EXCURSION; INCORRECT PRODUCT STORAGE; This spontaneous report received from a health care professional concerned a 47 year old male. 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: 202F21A expiry: UNKNOWN) dose was not reported, administered on 26-JUL-2022 for covid-19 prophylaxis. The drug was associated with Medication error. Age at time of vaccination 47 years old. No concomitant medications were reported. On 26-JUL-2022, the patient experienced received vaccine dose that was in a temperature excursion, and incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the received vaccine dose that was in a temperature excursion and incorrect product storage was not reported. This report was non-serious. This case, from the same reporter is linked to 20220759250. This report was associated with product quality complaint:
Injection site is sore; Slight nasal pressure; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0170) via an unspecified route of administration in the left arm on 14May2021 at 09:15 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure and elevated cholesterol. The patient had no known allergies to medications, food or other products. Concomitant medication included verapamil (MANUFACTURER UNKNOWN) from an unknown date for an unknown indication. 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 COVID-19 vaccination. On 14May2021 at 15:00, the patient noticed slight nasal pressure not necessarily related to the vaccine. On 14May2021 at 16:15, (7 hours later) the patient reported that the injection site was sore. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events injection site sore and slight nasal pressure was recovering at the time of report.  No follow-up attempts are possible. No further information is expected.
Admission Date: 9/18/2022 Discharge Date: 09/22/2022  DISCHARGE DIAGNOSES 1. Generalized weakness - improved 2. COVID 3. Multiple Sclerosis 4. Essential HTN 5. Depression  HOSPITAL COURSE: Patient is a 61 y.o. male who presented with generalized weakness in the setting of severe multiple sclerosis and was admitted for observation. He did not have other significant COVID signs or symptoms. He is wheelchair bound at baseline, self sufficient in transfers, but on admission was not able to complete self transfers. Neurology recommended brain and cervical spine MRI to rule out any relapse of MS. MRI brain showed Moderate volume right matter signal abnormality compatible with history of multiple sclerosis. No lesion enhancement. Therefore, generalized weakness was attributed to COVID infection. Patient was started on started solumedrol 40 mg IV q8 on 9/20 to help improve symptoms due to COVID, and given his history of multiple sclerosis.  Patient continued to improve with working with PT/OT, and it was determined that he could be discharged home safely with home health.    Patient sent home to complete 7 day course of oral prednisone 40 mg. Patient discharged with home health/PT in place. He was discharged in stable condition, back to near baseline function.
Patient stated she received the second COVID Moderna vaccine on 3/9/21, at Stadium ( she thinks) She stated after the first one she just had a sore arm, however this time she had a fever for a day, sore arm, and chills this AM. She stated under the vaccination site there is a red spot about the size of a half dollar, that is warm to the touch. She denies any other side effects.   Lot number not available at time of this documentation. ????
pt recv vax 14AUG96 & on 9FEB97 pt devel a pruritic rash on face which progressed to trunk, arms, & legs;it was reported that pt also devel a low grade fever;
Developed neck swelling, scratchy throat and tingling in throat 2-3 days after receiving COVID 19 vaccination. Swelling in neck area persisted for 2-3 days and then thyroid remained swollen for the past month. Employee saw PCP today and he stated that she had an autoimmune response to the COVID 19 vaccination and caused the neck swelling and enlarged thyroid. Employee is being referred to an endocrinologist for evaluation.