chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient states, 'So I started feeling sick last Wednesday evening with just a little bit of a headache; which it is very unusual for me to get a headache.' 'Typically, I think my temp runs around 97.' 'Typically if I am feeling feverish it is 99 or 100 and typically the headache will get bad enough. However, 'this time the headache wasn't too bad.' 'However, the fever got pretty high last Thursday and has been 'pretty high since then.' 'It has been regularly going up to 102 or 103. 'I don't know if it would go higher if I hadn't taken Tylenol. Usually 1-2 hours later temp will be down to 99 or 100. She has been resting quite a bit. The fever, headache and just not feeling good when she would stand up and walk was feeling floaty or dizzy. Yesterday and today the fever hasn't been going up quite as fast and staying down a little longer.            Then, she broke out in a rash that was noticed when she came home from lunch today. It has progressively been getting worse.            She has had a little bit of a cough which has been slightly congested as well as slightly congested nose. She has also had a little bit of diarrhea. Appetite has been decreased, as well. She has been drinking a little bit of water and quite a bit of sports drink.
pain at injection site; This is a spontaneous report from a contactable consumer. A 78-year-old male consumer received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EC9267, Expiration date: unknown) via an unspecified route of administration on 27Feb2021 13:30 on left arm at single dose for COVID-19 Immunization. The patient's medical history included Multiple Sclerosis and allergies to Solumedrol. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since vaccination, patient had not tested for COVID-19. Patient received too many lists of medications in two weeks (not specified). On 27Feb2021 13:45, Patient experienced pain at injection site. Patient did not receive any treatment for the event. The outcome for the event was recovering.  No follow-up attempts are needed. No further information is expected
April 3 - vaccine,  April 5 - allergy patch test , April 8th - rash on back and stomach;  dr prescribed hydroxyzine and Xyzal and Clobetasol lotion.  April 18 - started experiencing rapid heart rate and chest tightness - lasted for 4-5 hours. April 19 - saw allergist, blood pressure was elevated, started with rapid heart and chest tightness again. Went to ED, did EKG and blood work. No issues. April 20 - same symptoms went back to ED, EKG and blood work normal. April 23 - Urgent Care, saw Cardiologist for blood pressure, prescribed labetalol. Said it appeared to be chest wall inflammation. April 24 - chest tightness and high blood pressure, went to ED. Gave me a shot of anti inflammatory. April 26 - dr had me go back to ED for CT scan. ED ran blood work and determined I did not need CT scan. April 27 - chest pain, difficulty taking a deep breath and feeling like food stuck in esophagus - went back to ED, gave me a GI cocktail to numb the esophagus. April 30 - chest pain again gave me another GI cocktail and referred me to gastroenterologist.  May 6 - chest pain, back to ED, another GI cocktail. May 7 - endoscopy. Will receive results on 5/14
Patient was given PPD and HPV Immunization and had vasovagal reaction 10 mins later. Patient got up on his own and was sent to ED for further evaluation.
She also had an adverse reaction on 1-23-2006 her first round (second time receiving the first dose). It states only change was vaccines.
I have had severe reactions to ALL Covid vaccines since 2021.  body aches, fever, headache, nausea and bad rashes on arm plus swelling of lymph nodes under arm.  I had the current Moderna vaccine on Oct 5, 2023. Yesterday October 19 i noticed a rash beginning on my neck and upper chest.  2 weeks after taking the vacinne!!  A slight rash did develop on left arm but it did not spread.  Now the rash is coming out on my neck and chest!  Rash seems t be getting worse since yesterday (today is Oct 20)  ocassionaly a bit ichy.    never had rash on neck before.
This spontaneous report as received from a physician refers to an unspecified number of patients of unknown ages and genders. On an unknown dates the patients were vaccinated with PEDVAXHIB (route, dose number, dosage and lot number unknown) that was improperly stored. No adverse effects were reported. The physician also reported that improperly stored GARDASIL (MARRS no. 1410USA003800) and VAQTA (MARRS no. 1410USA006929) were also administered. This is one of three reports on the same reporter. Additional information has been requested.
Pt had 1st dose of VARIVAX vaccine at age 5. Currently was diagnosed  with shingles
STRONG metallic taste in mouth that began shortly after receiving the shot and has still not ceased 9 hours later.  Confusion and general malaise.
This spontaneous report was received from a physician refers to an unspecified patients of unknown age and gender. No pertinent medical history was reported. On an unknown date, the patients were vaccinated with improperly stored (Oka/Merck) VARIVAX (lot # L006384 and expiration date 25-FEB-2017) (dose and route were not reported). No adverse effects reported. No Product Quality Complaint (PQC) was involved. Additional information has been requested.
Antibody titers form the pt revealed that her seroconversion following two doses of varicella vaccine was transient.
Pt presented to the physician in our office for rash on left arm. Reffered for same day appointment with the other doctor who diagnosed shingles (Varicella zoster).
Information has been received from a health care facility concerning a 10 year old female pt who on 08/11/1995 was vaccinated with a dose of Varicella virus vaccine live. On 03/25/2001, the pt developed chicken pox with more than 70 lesions and fever. The pt sought unspecified medical attention. Additional information has been requested.
Welps all over entire body. Mother reports he c/o feet itching when they left here.  In a little while noticed welps all over.  No wheezing or respiratory symptoms. Significant itching. Was given 18.75 mg Benadryl by mouth at 11AM. At 11:25 am gave 15 mg Orapred by mouth.  Released at 12:30 pm. Welps still apparent and still no respiratory issues.  Gave Rx to give Orapred ODTs 15 mg bid x 3 days. Text from mother at 2:00 pm same day (7/19/2011) and welps and redness were completely gone.  Text from mother at my request 7/20/2011 at 3:00 pm - no further welps, redness or itching.
Sore arm where shot was given.  Swollen location of shot.  Redness at shot location.  Warmth at shot location.  Feeling tired.  Body ache.  Muscle pain.   Switch from heat to chills and vice versa.  Foggy headed.
received a 3rd dose fo Shingrix; This case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 80-year-old female patient who received Herpes zoster (Shingrix) (batch number 9pr2p, expiry date 17th April 2023) for prophylaxis.   Previously administered products included shingrix (1st dose and 2nd dose received on an unknown date).   On 14th March 2022, the patient received the 3rd dose of Shingrix. On 14th March 2022, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.    Additional Information: GSK Receipt Date: 24-May-2022 Reporter's Comments: The patient received a 3rd dose of Shingrix.  The reporter asked any safety information for the patient regarding this situation. The reporter consented to follow up. Additional Supportive Information: The patient received 3rd dose of Shingrix vaccine, which led to extra dose administered.
No adverse event; The medical assistant reports that she gave the wrong vaccine to two patients today 22Feb2023.; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (The medical assistant reports that she gave the wrong vaccine to two patients today 22Feb2023.) and NO ADVERSE EVENT (No adverse event) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018C22A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (Dose 2) and PFIZER BIONTECH COVID-19 VACCINE (Dose 1). Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE.    On 22-Feb-2023, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 22-Feb-2023,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced WRONG PRODUCT ADMINISTERED (The medical assistant reports that she gave the wrong vaccine to two patients today 22Feb2023.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (The medical assistant reports that she gave the wrong vaccine to two patients today 22Feb2023.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (The medical assistant reports that she gave the wrong vaccine to two patients today 22Feb2023.).    No concomitant medications were reported. It was reported that they were supposed to get the adult bivalent, but she accidentally gave them the 6-11 year old monovalent vaccine.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-712443 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-712443:2nd patient case
Patient presented to the ED and was subsequently hospitalized within 6 weeks of receiving COVID vaccination. Diagnosis was neutropenic fever.
On 02/09 had to take him to doctor for sinus drainage and chronic cough. Was instructed to give him OTC antihistamine and OTC cough meds. On 02/11 took him to walkin clinic and was prescribed an antibiotic and prescription cough suppressant. Symptoms persisted for 4 days and then he was able to return to school. Chronic sinus drainage persisted for another 2 days.  03/13 had stomach virus and missed 4 days of school.  06/01 had kindergarten exam and everything was good  August he ran slight fever a few different days.  09/14 developed diarrhea and he was taken to PCP on 09/22 and 09/28.  Flu shot was given 10/10/2022  09/25 went to Hospital and was diagnosed with Flu B and pneumonia. Was prescribed antibiotics and to alternate Tylenol an motrin.  12/04 tested positive for Flu A. Lethargic, no appetite, and poor color.
arm now has a hard lump under the skin; arm now has a hard lump under the skin; This case was reported by a other health professional via interactive digital media and described the occurrence of upper extremity mass in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   In February 2020, the patient received Shingrix. In February 2020, 3 days after receiving Shingrix, the patient experienced upper extremity mass and induration. On an unknown date, the outcome of the upper extremity mass and induration were unknown.   It was unknown if the reporter considered the upper extremity mass and induration to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The age group was captured as adult as per vaccine indication. The patient had Shingrix shot three days before the time of reporting. The patient's arm had a hard lump under the skin. The patient wanted to knowif this was a normal side effect.
high temp was given APAP q 4 hrs by mom but fever would not come below 102-phone call was made by mom to MD told mom to double the APAP given;
Narrative:  A 70yo male with known PMH and current Medical history that included DM and HTN Per Unit pharmacist and nursing documentation, He received his first Pfizer Covid - 19 vaccine per policy and protocol and without complication First dose on March 24, 2021 and the second dose on May 17, 2021 on April 5, 2021 he presented to the ED with complaint of swelling/ pain to BLE an ulcer to top of right foot. Upon examination the patient was found to have new DVT in LT lower extremity, and tachycardia with elevated troponin. CTA showed bilateral PE with pleural effusion and pulmonary edema. BNP was elevated with suspect of acute heart failure. He was started on heparin drip and admitted to PCU Other abnormal labs included Cr of 1.7 with dx of AKD and elevated Liver Enzymes On May 7, 2021 he was reported by the unit's NP with Covid - 19 vaccine induced severe edema for which he had to present to the ED on April 5, 2021 with confirmed femoral vein thrombus,, LV thrombus and PE,
Classic varicella rash with fever due to vaccine strain VZV (confirmed by PCR testing).
No adverse effect reported; unknown doses of improperly stored GARDASIL 9 were administered; This spontaneous report as received from a nurse refers to a 11-year-old patient of unknown gender. No information regarding the patient's pertinent medical history, concomitant medication, drug reactions and allergies was provided.  On 01-JUL-2019, the patient was vaccinated with improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # R027577, expiration date 23-JUN-2021 (dose and route of administration were not provided) for prophylaxis. The vaccine was stored in the lowest registered temperature below 36 Fahrenheit degrees (30.60 F) for total 59 minutes and the highest registered temperature above 47 Fahrenheit degrees (49.10 F) for total 30 minutes. Previous temperature excursion was registered when the vaccine was stored in the temperature between 36 and 46 (45.5) Fahrenheit degrees for 1 hour. The digital data logger was involved.  No adverse effects were reported.; Sender's Comments:  US-009507513-1907USA012222: US-009507513-1907USA012231: US-009507513-1907USA012224: US-009507513-1907USA012225: US-009507513-1907USA012226: US-009507513-1907USA012227: US-009507513-1907USA012228: US-009507513-1907USA012229: US-009507513-1907USA012230: US-009507513-1907USA012221: US-009507513-1907USA012220: US-009507513-1907USA012219: US-009507513-1907USA002267:
This spontaneous prospective pregnancy report as received from a nurse practitioner for PROQUAD (Merck), a Pregnancy Registry product, refers to a female patient of unknown age. On an unknown date the pregnant patient was vaccinated with the dose of PROQUAD (Merck) (dose, route of administration and lot number were not reported). The last menstruation period (LMP) and estimated delivery date (EDD) were not known. The pregnancy outcome was pending. Additional information has been requested.
suspected Guerre barre syndrome; droopy lip; This spontaneous case was reported by a pharmacist and describes the occurrence of GUILLAIN-BARRE SYNDROME (suspected Guerre barre syndrome) and FACIAL PARALYSIS (droopy lip) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058H21A, 045B21A and 027C21A) for COVID-19 vaccination.     Concurrent medical conditions included Dementia and Communication disorder.   On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Dec-2021, the patient experienced GUILLAIN-BARRE SYNDROME (suspected Guerre barre syndrome) (seriousness criterion medically significant) and FACIAL PARALYSIS (droopy lip) (seriousness criterion medically significant). At the time of the report, GUILLAIN-BARRE SYNDROME (suspected Guerre barre syndrome) and FACIAL PARALYSIS (droopy lip) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment information was not provided. The patient was fine Tuesday night but when she woke up on the 15Dec2021, it started to get worse, the patient could not walk, lift a spoon/fork and needed assistance walking (needed husbands to help). The Pharmacist suspected Guerre barre syndrome and instructed the caller to go the hospital. The Pharmacist indicated that according to the patient's license, she has a droopy lip and may have other neurological issues. Company Comment This case concerns a 91-year-old, female patient with relevant medical history of dementia and troubling communicating, who experienced the unexpected events of Guillain-Barre syndrome and facial paralysis. The events occurred 1 day after the third dose of mRNA-1273. The rechallenge was not applicable since the events happened after the third dose. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2021-416025, MOD-2021-416026 (Patient Link).; Sender's Comments: This case concerns a 91-year-old, female patient with relevant medical history of dementia and troubling communicating, who experienced the unexpected events of Guillain-Barre syndrome and facial paralysis. The events occurred 1 day after the third dose of mRNA-1273. The rechallenge was not applicable since the events happened after the third dose. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Pt reported numbness, tingling in hands, anxiousness, and syncopal episode in personal vehicle in post-vaccination waiting area. Pt then walked to EMS staff in waiting area . Second syncopal episode witnessed by EMT.
Administered expired vaccine to the patient, after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to the patient, after the manufacture date of expiration) in a 64-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 070H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 08-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to the patient, after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to the patient, after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported by the reporter. It was reported as unknown when the vial was initially stored in the refrigerator. The vial did not undergo any temperature excursions. No treatment medications were reported by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: The follow-up document contains non-significant information.
Breakthrough CV19 + on 19Aug2021; Breakthrough CV19 + on 19Aug2021; This is a spontaneous report from a contactable other hcp. A 57-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL3247), via intramuscular route of administration, administered in Arm Right on 27Jan2021(at the age of 57-years-old)  DOSE 1, SINGLE, patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL3247), via intramuscular route of administration, administered in Arm Right on 15Feb2021 (at the age of 57-years-old) as DOSE 2, SINGLE for covid-19 clinic. The patient medical history was not reported. The patient's concomitant medications were not reported. It was unknown if patient received any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that Prior to vaccination, it was unknown was the patient diagnosed with COVID-19. Since the vaccination, the patient was tested for COVID-19. The patient experienced breakthrough COVID-19 positive on 19Aug2021. Therapeutic measure were taken as no as a result of event. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 18Aug2021 (Nasal Swab). Outcome of event was Not recovered.  No routine follow-up attempts are foreseen for reports received from WEB. Information about lot number has already obtained. No further info is expected.; Sender's Comments: Based on the available information in the case, the causal association between the events vaccination failure, COVID-19 and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.
After about 6 or 7 days of receiving dose #1 of Pfizer vaccine in my left arm, I experienced sharp/severe left-chest and upper left-back pain for a few days and the pain gradually decreased until it was finally gone as on 04-07-2021.
Within seven minutes of vaccine administered, patient cried out that she thought she would pass out. She was lightheaded, arms tingling, felt hot then cold. We had her lay down on the floor and held her feet in the air. Within three minutes of doing this, she felt much better. She sat up on the floor and ate some Chex-mix and drank some water. She stayed thirty  minutes and felt good. She left and we made sure she made it home.
102.5 Degr Fever  Blood Pressure 148 over 102 Heart Rate 100 for appr. 14 Hours Extreme Pain in left Arm where Vaccine was administered, Arm severely swollen.  Pain slowly subsiding after about 18 hours but still sensitive to the touch after three Days. Swelling started to subside after about 48 Hours.  MR received from vax. provider which reveals a pre-op eval on  Nov. 15 2006.  Spoke with patient/reporter-no treatment sought for AE.
Side effects; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (Side effects) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Side effects). At the time of the report, IMMUNISATION REACTION (Side effects) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medications were reported.  Patient reported that they had very little side effects with previous Moderna vaccines.  No treatment medications were reported.   Reporter did not allow further contact
Patient felt dizzy while smoking, weakness chills and ended up passing out, once awake oxygen was 85 ended up resuming to normal after just a few minutes
Pt developed a urticarial rash with swelling of hands and feet.  No stridor noted.  consistant with serum sickness in earlt stages.  of note patient also received syagis with the other vaccines.
Sudden, unexpected death; found unresponsive in an adult bed with adults the day after receiving Rotavirus, Prevnar, HIB, and Pediarix (not otherwise specified in medical record) at 2 month well child check
Moderna Covid-19 Vaccine EUA Persistent rash on both arms, hands, fingers, and face Swelling behind left ear, swelling around left eye on face, severe swelling on both hands, and fingers.   Severe itching on arms.   Treatment used cortizone cream, and Tylenol.  Allergic symptoms persisted for 8 days, gradually improving after day 6.
Sore at site immediately at time of shot. C/O of soreness at site 3/9/07 which progressed all week. Went to doctor 3-16-07 could not move arm or shoulder pt believes shot was given to high "Above deltoid and slightly to the back"