chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine- Related Anxiety; experience shaky, feeling like she "was seeing stars but not passing out; Lightheaded; experience shaky, feeling like she "was seeing stars but not passing out; This is a spontaneous report from a non-contactable other hcp. A 20-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on 19Mar2021 (Batch/Lot Number: EN6207) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The reporter stated that during her 15 minute waiting period after the injection, the patient began to experience shaky, Feeling like she "was seeing stars but not passing out". Lightheaded on 19Mar2021. She denied rash, hives, welts, difficulty Breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, dizziness, facial Swelling, lip swelling and tongue swelling. Treatment included: water and snacks. The report considered as a non serious. Differential Diagnosis: Vaccine- Related Anxiety (include misc mental health) and Red flag symptoms. The outcome of the events experience shaky, feeling like she "was seeing stars but not passing out and Lightheaded was reported as recovered on 19Mar2021 and other event was reported as unknown.   No follow-up attempts are needed. No further information is expected.
91 y.o. female who presents with difficulty breathing onset 1 week ago.  States symptoms have worsened the last couple of days and has developed intermittent chest pain, at times on the right lower chest and today on the left upper chest.  Patient does have a history of stage III kidney disease, hypertension and was told many years ago that she had congestive heart failure.   3/31/21 admitted observation  dx chest pain , sob
Discomfort; Neck Pain; Arm Pain; This spontaneous case was reported by a consumer and describes the occurrence of DISCOMFORT (Discomfort), NECK PAIN (Neck Pain) and VACCINATION SITE PAIN (Arm Pain) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     Concomitant products included SITAGLIPTIN PHOSPHATE (JANUVIA [SITAGLIPTIN PHOSPHATE]), GLIMEPIRIDE, EMPAGLIFLOZIN (JARDIANCE), VALSARTAN, AMLODIPINE and SERTRALINE HYDROCHLORIDE (ZOLOFT) for an unknown indication.    On 23-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 DISCOMFORT (Discomfort), NECK PAIN (Neck Pain) and VACCINATION SITE PAIN (Arm Pain). At the time of the report, DISCOMFORT (Discomfort), NECK PAIN (Neck Pain) and VACCINATION SITE PAIN (Arm Pain) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment information provided.
Localized reaction to Left deltoid. Red,hot, swollen tight area where DTaP and IPV were given.
Head hurts; Sore arm; This spontaneous case was reported by a health care professional and describes the occurrence of HEADACHE (Head hurts) and VACCINATION SITE PAIN (Sore arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced HEADACHE (Head hurts) and VACCINATION SITE PAIN (Sore arm). At the time of the report, HEADACHE (Head hurts) and VACCINATION SITE PAIN (Sore arm) outcome was unknown.        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.   No relevant concomitant medications were reported. No treatment information was provided.
ModernaCovid-19 vaccine EUA On the 8th day, the small red spot on my arm at the vaccine site, which had been fading, suddenly flared up, got larger and started itching. It is currently about 3 inches in diameter and raised.
Two days post vaccination pt noticed a red rash on thigh. Fever 101-102 started two days post vaccination. Two days after that noticed a red raised rash on body. Had some generalized swelling.  Hx allergy to fish
covid vaccine breakthrough case  dose 1 2/10/21 Moderna 015M20A dose 2 3/10/21 Moderna 044A21A
Initial misuse report received from a healthcare professional on 12-Dec-2013. The patient had received FLUZONE. The nurse reported that temperatures went down to 27 F and vaccine administered to the patient. (No information was provided regarding the patient). No adverse event was reported. List of documents held by send: none.
5 minutes after receiving the second dose of the Moderna vaccine I experienced heart palpitations and acute chest discomfort that resolved shortly after. Throughout the day my arm became increasingly sore but I had no other symptoms. Nearly 10 hours after receiving the vaccine I experienced: Headache, chest discomfort, palpitations, bounding pulse, chills, weakness, fatigue, flank pain
left axillary edema.  no lymphadenopathy associated with this edema.  some pain.  no erythema, no signs of infection.
tested + for covid 1-2-22;  had constipation , loss of appetite, altered mental status, deceased on 1-9-22
Booster immunization given at 0.5 instead of 0.25.  Patient is tired, has chills/body aches, heavy chest and missed work 1/13/22 and 1/14/22
Pts right arm blistered at the site where the MMR vaccine was given in. Arm formed a nodule 10mm in size. Area 50mm around site became erythematic. No respiratory problems or blood pressure problems. Gave pt ice to apply to site. When pt stable and no nodule present sent pt to health center to Dr. called Dr before sending pt. Pt at clinic for 20 minutes. Pt went to Dr, but Dr did not do long visit. Dr prescribed an Epi Pen. Pt reported 9/1/06 that her arm muscle was still hardened and sore.
Pt fell forward on the table and was assisted to the ground; BP 135-137/92-94; HR 88-106; RR 18, SpO2 99%
Expired Vaccine administered to  patient; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Vaccine administered to  patient) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 054C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 20-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Vaccine administered to  patient). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired Vaccine administered to  patient) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant and  treatment medications were provided.  Action taken with mRNA-1273 in response to the event was not applicable.  This report refers to a case of expired product administered for mRNA-1273, lot #054C21A with no associated AEs.; Sender's Comments: This report refers to a case of expired product administered for mRNA-1273, lot #054C21A with no associated AEs.
He got the new 2 doseversion vaccine and came down with shingles/ suspected vaccination failure; Shingles; Covid; Pain; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had 9 years ago prior to the reporting). Previously administered products included Zostavax. Concurrent medical conditions included post herpetic neuralgia (nerve pain).   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. In MAR-2023, several years after receiving Shingles vaccine and Shingles vaccine, the patient experienced shingles (Verbatim: Shingles), covid-19 (Verbatim: Covid) and pain (Verbatim: Pain). On an unknown date, the patient experienced vaccination failure (Verbatim: He got the new 2 doseversion vaccine and came down with shingles/ suspected vaccination failure) (serious criteria GSK medically significant). The outcome of the vaccination failure was unknown and the outcome of the shingles, covid-19 and pain were not reported.   It was unknown if the reporter considered the vaccination failure, shingles, covid-19 and pain to be related to Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles, covid-19 and pain to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 17-MAR-2023 This case was reported by a patient wife via  interactive digital media. The reporter reported that patient received the two doses of the shingles vaccine.  The reporter stated that two weeks ago patient experienced Covid, then came down with shingles again.  The reporter stated that the vaccine made the pain manageable. The reporter reported that do not be surprised if you break out with shingles. She recently saw a commercial saying vaccine was 90 percentage effective, leave it to her husband to be in the 10 percentage that could still get shingles. This case was considered as suspected vaccination failure as laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Have had very brief dizzy spells ever since about a week after the first vaccine. They are short lived but happen maybe once per day. Only a few seconds long.
pt recv vax 5JAN95 & exp nausea, vomiting, diarrhea, paresthesia & elevated liver enzymes;reporter felt that there was a possible problem w/the lot#
Information has been received from a medical assistant concerning a patient of unknown age and gender. The patient's concurrent conditions, medical histories and concomitant therapies were not provided. On an unspecified date, the patient received with a dose of improperly stored ROTATEQ (lot # M019708, expiration date 25-Oct-2017; 2 ml once), orally. The vaccine was exposed to temperature excursion of 33.3 degrees Fahrenheit for 3 hours. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
The patient developed redness and itching at the injection site in an area 50mm long x 10mm wide. The patient was treated with cold packs and Claritin.
This case was reported by a consumer via call center representative and described the occurrence of rash in a 75-year-old male patient who received SHINGRIX for prophylaxis. Concomitant products included amlodipine, biotin, folic acid, Levothyroxine, Metformin, Pravastatin, ramipril, Vitamin B12, Vitamin B6, Vitamin D3, ZYRTEC, glimepiride and CoQ10. On 3rd May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 1st July 2018, 59 days after receiving SHINGRIX, the patient experienced rash, erythematous rash and pruritus. On an unknown date, the outcome of the rash, erythematous rash and pruritus were recovered/resolved. It was unknown if the reporter considered the rash, erythematous rash and pruritus to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient's wife. The age at vaccination was not reported. The patient received the SHINGRIX, on the left arm. The patient's rash was on his legs, groin and feet. The patient followed up with his physician.
pt exp local rxn 11cm x 11cm erythema, warmth, swelling;
Swelling of right thigh,  Prevnar injection, Area involved 5 cm X 2 cm, Erythema
Information has been received from a registered nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 08-JUL-2016 the patient was inadvertently administered an expired dose of ZOSTAVAX (lot #L006380, expired on 25-MAY-2016) subcutaneously. No adverse effect was reported. Additional information has been requested.
Information has been received from a nurse concerning her 1 year old son who has an allergy to amoxicillin, multiple food allergies, GERD and a history of asthma. It was reported that the child had problems with vomiting since birth and that the vomiting worsened as his diet changed. On 10/10/00, the child was vaccinated with the 1st dose of MMRII (lot 635919/0825K). There was no concomitant medication. Approx. 30 minutes, post vax, the child developed a rash and was reported to have projectile vomiting most of that night. Unspecified medical attention was sought. At approx. the end of 1/01, the child was hospitalized due to vomiting. The vomiting was thought to be related to the child's allergies which included eggs, all meat except for pork, soy products and dairy products. During this hospitalization, the genetic defect alpha-1 antitrypsin insufficiency was found. The child's fatty liver was related to the vomiting. It was reported that at the child's 1 year check-up his liver enzymes were "near normal". The outcome of the fatty liver, alpha-1 antitrypsin deficiency, rash and vomiting were unknown at the time of this report. Upon internal review, the hepatic function abnormality, fatty liver and alpha-1 antitrypsin deficiency were felt to be serious for an "Other Important Medical Event". Additional information has been requested. The nurse reported that a 36 month old male developed an allergic reaction, coughing, sneezing and his throat felt funny after vaccination with MMRII (see WAES01120223).
I noticed I was having a sore throat and I just thought I had allergies, and I had worked all weekend in my yard. On Monday I was having car issues and waited in the waiting room for 6 hours and still I felt fine but noticed the A/C was blowing on me and I noticed my throat was getting scratchy and I had a sore throat. The next day I was congested with a runny nose and had a productive cough but my throat was sore, I felt feverish but didn't have a fever. Later that afternoon my stomach was upset and I took a COVID-19 home test and that was negative and I woke up during the night coughing and couldn't stop coughing when I woke the next morning and my symptoms were still there and I felt off and I took another COVID-19 test and that test was positive. The next morning I called the doctors office and left a message of my positive result and wanted to know if I could take the Paxlovid and sent me a letter back later saying yes and called the prescription to the pharmacy.  I don't know if it was the drug or the COVID-19 but on the 28th I was still feeling lightheaded and my that I wear was saying my heart rate was 130's and my pulse ox showed the same. My heart rate was going high and low so I called the local EMT's and they said I was good to go and they thought it was the side effect of the medication.
On 10/28/02 child broke out with "2 spots on face." Was seen 10/29/02 by MD saw and diagnosed with chicken pox. Mom reports most of trunk and face covered with spots and blisters. Tx with Zovirax and Aveeno baths.
7/20/2022 I started feeling sick after being exposed to COVID. I went to the doctor on 7/22/2022. I was tested for FLU AV COVID, rapid strep test, throat culture and the COVID PCR test. All were negative. I continued to feel sick. On 8/6/22 I went into the doctor?s office and had a chest x-ray which was clear and my COVID test was positive. I started taking Paxlovid on 8/7/23. I took the full course. A few days after my course of Paxlovid, I was fully recovered, except for some chest congestion.
Got it again AFTER the vax / Got the shot, still get it; Got it. Got the shot, still get it; Hurts; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had shingles).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The patient got shingles again after vaccination and hurts. This case was considered as suspected vaccination failure, since completeion of primary vaccination schedule, time to onset for event and laboratory confirmation for shingles were not provided.
10/6/08 - erythematous papules (R) cheek, (L) knee, (R) forearm temperature 97.3 ax.  10/20/08 - Bullous lesions to face - erythematous rash to palms, soles, temp - 103.3 (R) some lesions size of a dime with black pigmentation in the center.  10/21 - 10/22/08 - hospital for rash, varicella, anemia.  10/24/08 - healing lesions in different stages, some pruritis.  11/25/2008 MR received for DOS 10/20-22/2008 with DX: Fever and rash likely related to viral syndrome of varicella due to recent vaccination. Baseline atopic dermatitis and impetigo of the varicelliform rash. Pt presented to ER with fluid filled blisters on face and arms, emesis x 3, fever.  PE (+) for erythematous dry skin with hyperpigmented papules, macules and scabbing. Recent cold and cough x 1 week. Tx with abx and d/c.
Patient filled out consent form to receive BOOSTRIX. He verbally verified he wanted BOOSTRIX with 2 pharmacy staff members. After receiving the shot, he told the pharmacist he just received BOOSTRIX at the Dr's office the same day and actually wanted Flu.
Client had influenza vaccine 11/30/04: by the end of the day right arm was stiff and sore, could not move arm above shoulder height. Arm ++painful, black and blue at injection site. By 12/1/04, the arm was red, "hot" inflamed. Patient took Aleve and applied ice. By 12/2/04, swelling and redness extended down to elbow. Patient denied fever. Patient was advised to apply ice to site, contact MD.
Had a vomit; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (Had a vomit) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VOMITING (Had a vomit). At the time of the report, VOMITING (Had a vomit) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate (72-Unknown per minute): >100 per minute High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
presents with cough, SOB, headache, congestion.  TX: decadron, remdesivir, O2, lovenox.  Symptoms improved and d/c'd home
This initial spontaneous report was received from a registered nurse regarding an multiple unspecified patients of unknown demographics. There was no pertinent medical history, concomitant medication, concurrent conditions or drug allergies/drug reactions described. On an unknown date, the patient received a dose of improperly stored GARDASIL 9 (lot # L011846, expiration date 16-JUN-2017 and lot # L025737, expiration date 28-JUL-2017 dose and route were not provided) (incorrect product storage). It was exposed to temperature of 47.4F for 1 hour and 4 minutes. Previously it was exposed to temperature of 50.3F for 1 hour and 20 minutes as well as 48.9F for 2 hours. The call was because of a data logger. No adverse effects were reported. It was unknown if the patient sought medical attention. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report as received from a licensed practical nurse refers to unspecified number of patients of unknown age and unknown gender. Patients concurrent conditions and relevant medical history was not reported. On unknown dates, unknown number of patients have been administered ROTATEQ (lot number, dose, frequency and route unspecified) which was improperly stored. Concomitant medications were not reported. No adverse effects were reported. The outcome of the events was unknown. The causality of the events with ROTATEQ was not reported. Product quality issue was not involved. This is one of the several reports from the same reporter. Additional information has been requested.
10min post vax h/a occurred followed by flushing & inc pulse rate; pt then hot light headed & sought medical help;
Fever 104, limp & unresponsive, Pt did not notify until child was due next immunization.
18 month old child came to doctor for well child check & to catch up on immunizations. Child was due a Dtap; however, child received KINRIX combo instead.
Pfizer BioNTech COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccines on 1/23/2021 and 2/23/2021. Patient presented to physician office on 9/3/2021 after developing COVID symptoms of cough, sore throat, congestion, loss of taste and smell 4-5 days prior, as well as reports that daughter had recently tested COVID positive. Patient received Casirivimab and Imdevimab on 9/6/2021.  On 9/28/2021 patient presented to the ED for altered mental status.  She was found to have a subarachnoid hemorrhage and was admitted with consultation to the Stroke team.  She was intubated on 9/30/2021. BCx2, Pneumonia Panel, Sputum culture without any organism found. She underwent diagnostic cerebral angiogram and subsequent coiling of the anterior communicating artery aneurysm on 9/30/20201.  On 10/01/2021 she was awake and following commands.  After completing a spontaneous breathing trial she was successfully extubated.  She was initially communicating, following commands, and A&O x 3.   Over the night of 10/02/2021 she had increasing O2 demands and was placed on HFNC.  She was tachycardic on 10/03/2021, she was more lethargic and would not swallow sips of water.   A sepsis work up was initiated along with DVT studies do to history of Essential Thrombocytosis.  She was found to have DVTs in BL upper extremities and R lower extremity. She required BIPAP to maintain ventilation. She was sent for CT/CTA of head which noted slightly increased intravenricular hemorrhage and vasospasm of the right ACA, left ACA, and left MCA.  CT Chest was consistent with multifocal pneumonia.  She was increased to subcutaneous heparin TID with ASA 81 mg.  On 10/4/2021 she continued to regress.  The morning of 10/05/2021 she would respond only to pain stimulus.  She was evaluated again with CT with worsening vasospasm.  Patient was intubated, after which her BP dropped  Two attempts were made with push dose Phenylephrine to increase BP with out success.  Her pulse was lost and compressions were started.  Code Blue was called.  Family was informed of the changes to her status and  they decided to stop chest compressions and let her pass peacefully.
Rash w/ head to toe papules, fever, diarrhea, pruritus, agitation, nasal secretions, ? koplick's spots.