chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a other health professional via call center representative and described the occurrence of fever in a 69-year-old female patient who received SHINGRIX. Concomitant products included Rifampin, ESTRING, VAGIFEM. On an unknown date, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever and bone pain. On an unknown date, the outcome of the fever and bone pain were recovered/resolved. It was unknown if the reporter considered the fever and bone pain to be related to SHINGRIX. Additional details were provided as follows: This case was reported by an office manager. The prescription was written on 28th December 2017 and sent to the pharmacy but the reporter did not know the specific day it was given. The patient received SHINGRIX in late December 2017 to January 2018. The patient experienced a low grade fever. The symptoms lasted about 1 day. At the time of reporting, the patient was due for her 2nd dose and was wondering if she should get it based upon the previous side effects.
BODY ACHES; CHILLS; FEVER; HEADACHE; .This spontaneous report received from a consumer concerned a patient of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.  On an Unspecified date the patient was previously treated with covid-19 vaccine ad26. cov2.s (unspecified manufacturer) (suspension for injection, route of admin not reported, batch number: Unknown, expiry: Unknown) dose was not reported, (Dose Number in Series: 1), 1 total administered for prophylactic vaccination. The patient had not reported any adverse events (dose series 1). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: Unknown) dose was not reported, (Dose Number in Series: 2) 1 total administered, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced body aches, chills, fever, and headache (dose series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, body aches, fever and headache was not reported. This report was non-serious. This case, from the same reporter is linked to 20210432349.
rash, itching, pain rt ear otitis externa started 28JUL98;saw MD 28JUL & started on ATB for ear-hadn't shown rash to MD;came to employee hlth where got vax erythematous lesions-pustular on scalp, chest, back, arms, feet;had swelling;
Child received immunizations approximately 4pm. Mom returned to office and stated that the pt was having trouble breathing, eyes were swelling. Sneezing in exam room. Wheeze cleared.
Vaccinated 3/12/13. Developed red vesicular rash (R) T8-10 dermatome 3/15/13. (Shingles).
When administering a PFS of flublok to patient, the fluid would not expel from the syringe. Placement and needle patency were reviewed, unable to determine cause of issue.
Fever the morning following vaccine then development of chest pain.  Found to have elevated Trop levels and ST elevation on EKG.  Elevated CRP, Sed Rate and Cardiac MRI consistent with Myocarditis.
Patient started to experience dizziness, profuse sweating, pale-ashen colored face, and nausea three minutes after the vaccine was administered. Offered to call EMS, but patient declined and remained conscious. Symptoms subsided after approximately 10 minutes. Patient returned home with his girlfriend.
Mom states pt developed redness, heat, soreness to walk and itching to right thigh 06/05/02. Seen 06/06/02, 10 X 14 area erythema with induration, bruises, tenderness, no palpable hematoma, no streaking right thigh. Allergic reaction to DTaP. Treated with cool compresses, Benadryl BID x 4 days, return if T > 101 deg F, streaking and increased pain.
approx 1 hrs p/vax mom reports pt lips & fingers turned blue & pt taken to hosp; pt had 13,000 WBC & was tx for this w/ATB; t99.4;
Fever, chills, felt like throat was closing up-approx. 7 hr after administration lasting approx. 12 hours. This is in follow-up to report (s0 previously submitted on 11/14/2007. Initial and follow up information has been received from a registered nurse and a licensed practical nurse, concerning a 21 year old female patient with no known allergies, who on 20-SEP-2007 was vaccinated IM in the left deltoid with the first dose, 0.5ml, of GARDASIL (lot #654939/0742U). There was no illness at the time of vaccination. Immediately following the vaccination, she felt lightheaded, faint, dizzy, and was diaphoretic. She was monitored at the physician's office, and them left. Seven hours after she left the office, on the same day, she also developed a fever, had chills and felt like her throat was closing up (this was relayed to the physician on an unrelated visit on 25-SEP-2007). The patient did not seek medical attention. Subsequently, the patient recovered from the events "12 hours later." This is one of two reports received from the same source (WAES #0710USA00464). Additional information is not expected.
10 days p/vax pt awoke w/bright red, flat rash on abdo which spread to neck & groin areas; t105 R, lethargic had to wake to take temp; cont to be lethargic until 5MAR; mom states the lethargy is from teething doesn't feel MD is necessary;
Day vaccine administered patient with episode of weakness and muscle rigidity. Not able to stand up straight, falling over. No LOC. No eye rolling. No vomit. No headache episode < 10 mins. Then had fever, tired, sleepy, decreased appetite. Better next day. Seen in office for evaluation: No tx.
3/6/07 1:30am headache, crying, low grade fever, 3/6/07 10:15 am headache, crying temp 99.1, 3/6/07 3:45 pm headache, crying temp 101.1, 3/8/07 9:00 am headache, sore throat, to Dr office temp 99.4.
generalized pruritus, onset 5-10 minutes after the vaccine, no other symptoms, vitals stable
Mild lip muscle weakness started around 1/18/2021. Symptoms started upon chewing and went away when chewing stopped. Symptoms lessened around 1/29/2021. Second vaccine on 2/1/2021. Symptoms returned around 2/18/2021 and more noticeable. Symptoms diminished around 5/1/2021. Tested positive for SARS-CoV-2 on 5/28/2021. Symptoms returned stronger with the addition of tongue muscle weakness. Muscle weakness right side of mouth right eye muscles appeared around 8/25/2021.
PFIZER COVID 19 VACCINE EUA: ADMINISTRATION ERROR.  INDIVIDUAL RECEIVED VACCINE DOSE FROM VIAL STORED FOR MORE THAN 12 HOURS AFTER PUNCTURE BUT LESS THAN 24 HOURS OF PUNCTURE.  PFIZER STATED THEY HAD ADDITIONAL STABILITY INFORMATION FOR UP TO 24 HOURS AFTER PUNCTURE OF VIAL BUT NO EFFICACY DATA FOR THIS OFF LABEL USE.  RECOMMENDED MEDICAL DIRECTOR AND NURSING FACILITY DISCUSS WITH INDIVIDUAL THAT THEY MAY BE REVACCINATED IF THEY CHOOSE BASED ON LACK OF EFFICACY DATA.  BOOSTER DOSE OF VACCINE WAS ALSO GIVEN 1 MONTH TOO SOON (1ST BOOSTER CAN BE GIVEN 5 MONTHS AFTER PRIMARY SERIES COMPLETED).
light fever; headache; body aches; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 35-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number and expiration date was not reported), via an unspecified route of administration on 01Apr2021 (Age at vaccination was 35 years) as dose 1, single for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. On 02Apr2021 the patient experienced headache, body aches and light fever, the patient also asks it would be possible to take over the counter (OTC) medications such as Tylenol to alleviate his symptoms. The outcome of all the events was unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Patient developed urticaria and pruritis approximately 4 hours after the vaccination. Symptoms got better 24 hours later. Symptoms have continued but are mild for past 3 days. Treatment is antihistamines.
This spontaneous report was received from a nurse and refers to a currently 10 years old male patient. Information on patient's pertinent medical history, concurrent condition and drug allergies/reactions were unknown by reporter. On an unknown date in 2013, the patient was vaccinated with RECOMBIVAX HB of strength 5/0.5 microgram per milliliter, intramuscularly (dose, frequency, lot# and expiration date were unknown) for vaccination. Concomitant therapies included ZYRTEC and NASACORT. The nurse reported that the patient developed Henoch-Schonlein purpura after receiving a dose of a RECOMBIVAX HB (also reported as Hepatitis B Vaccine(manufacturer unknown). The involvement of Merck products could not be ruled out). No further adverse event(no adverse event) was reported. The outcome of Henoch-Schonlein purpura was reported as recovered. The outcome of no adverse event was unknown. Causality assessment for the event Henoch-Schonlein purpura was not reported.
Fever, Chills, Severe Muscle Cramps, Headache, Extreme Fatigue, Dizziness, Inflammation
Mother states after immunization Hep B 1 on 07/22/2005 child was agitated, fatigued, changed mental status, this was reported when came in to get 2nd immunization on 08/26/2005 child had never had any previous vaccines at all.
Sudden nausea getting out of shower and vomited. Stretched out on sofa with two hard ginger candies to help with queasy feeling.
within about 10 minutes I felt terrible, hot, flushed, tachycardic, and developed significant hives on my face and neck and swelling around my eyes.  I was taken to a room and had vitals and was hypertensive and tachycardic with a worsening headache, I was given 50 mg Benadryl and put ice on my face and neck for about 20 minutes as I felt I was burning up. I remained at the clinic for an hour for monitoring. I never had difficulty breathing , and it was mostly resolved in about 45 minutes except for the mild headache and my face was still red and my eyes were swollen for at least an hour.
Tues 48APR emesis x2;sweating & shaking, very weak;9APR sluggish, achy, h/a, Thursday & Friday noc & headed, nausea;t99.8 fever, weak;Monday lt side h/a, pain in spine;repots achiness lt side of head & down toward spine remains weak;
This spontaneous report was received from a medical assistant and refers to a 12 month old (reported also as 2 year-old), female patient who did not have any known drug reactions or allergies. There was no information about the patient's concomitant therapy or medical history provided. The patient did not have any illnesses at the time of vaccination. On 09-OCT-2015 at 13:00 (reported as 1: 00 pm), the patient was vaccinated with improperly stored dose of VARIVAX lot # L013068 in the right thigh for prophylaxis (dose, route of administration and expiration date were not reported). No adverse event was reported. The vaccination was in privates doctor's office/ hospital and administered VARIVAX was purchase with public funds. Previous temperature excursions, the range and time of temperature excursion the administered VARIVAX experienced were not reported. It was unspecified if a digital data logger was involved. A signed informed consent form was not obtained. This is one of several reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1611USA014213: US-009507513-1702USA004104: US-009507513-1702USA004102: US-009507513-1702USA004103: US-009507513-1702USA004110: US-009507513-1702USA004109: US-009507513-1702USA004108: US-009507513-1702USA004107: US-009507513-1702USA004106: US-009507513-1611USA008278.
Migraine from hell, lump and redness on arm, feel like I have a cold, fever, and also hard time breathing
I got the Moderna rash about 3 days after my first injection.  It is eight days later and getting larger.  I was putting hydrocortisone cream on it but now I am taking a antihistamine.
dose was administered to a patient that contained contents from two different Moderna COVID19 Vaccine vials; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTRATION ERROR (dose was administered to a patient that contained contents from two different Moderna COVID19 Vaccine vials) in a 72-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 04-Nov-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (dose was administered to a patient that contained contents from two different Moderna COVID19 Vaccine vials). On 04-Nov-2021, PRODUCT ADMINISTRATION ERROR (dose was administered to a patient that contained contents from two different Moderna COVID19 Vaccine vials) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   A vial punctured for 20 times , but for the 20th dose, only drew 0.20 ml. Withdrawn another 0.05ml from another vial. The dose was administered to a patient that contained contents from two different Moderna COVID19 Vaccine vials. No concomitant medication were given. No treatment information were given.
arm is now pink and not as red as before; itchy around the site of injection; red around the site of injection; fatigue; chills; arm rash, it was itchy around the site of injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (arm rash, it was itchy around the site of injection), ADMINISTRATION SITE DISCOLOURATION (arm is now pink and not as red as before), INJECTION SITE PRURITUS (itchy around the site of injection), VACCINATION SITE ERYTHEMA (red around the site of injection) and FATIGUE (fatigue) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 07-Feb-2021, the patient experienced VACCINATION SITE RASH (arm rash, it was itchy around the site of injection), INJECTION SITE PRURITUS (itchy around the site of injection), VACCINATION SITE ERYTHEMA (red around the site of injection), FATIGUE (fatigue) and CHILLS (chills).   On 11-Feb-2021, the patient experienced ADMINISTRATION SITE DISCOLOURATION (arm is now pink and not as red as before). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency and CORTISONE for Adverse event, at an unspecified dose and frequency. On 07-Feb-2021, CHILLS (chills) had resolved.   On 10-Feb-2021, FATIGUE (fatigue) had resolved.   At the time of the report, VACCINATION SITE RASH (arm rash, it was itchy around the site of injection), ADMINISTRATION SITE DISCOLOURATION (arm is now pink and not as red as before), INJECTION SITE PRURITUS (itchy around the site of injection) and VACCINATION SITE ERYTHEMA (red around the site of injection) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.  Patient's treatment details included Cold compresses. Concomitant product use was not provided by the reporter.
Extreme bone pain and muscle aches, fatigue, worsening overnight, dizziness when lying down, fever of 101.3 when felt well enough to sit up and take temp. Bone pain was worse primarily in legs and arms hurt to move or not to move. At time of this report temp is finally down to 99 and able to sit up at 3 am on 9/5/15 took Excedrin to alleviate bone pain prior to taking temperature.
The first side effect appeared around 8:30 pm. I felt extremely cold and got chills. I put an additional sweater on but the chills increases. I developed a fever by 10 pm. My entire body started shivering by 11:30 pm and I was feeling extremely cold. Additionally, I had extreme body and joint pain. The joint pain were especially in me knees, elbows, and my back. I felt sick to my stomach but did not vomit. The next day (Jan 20) I still had extreme body and joint pain, a strong migraine, fever, and felt very fatigue.
crying inconsolably x 4hr @ time of MD was contacted advised to give APAP, Motrin & observe;call PRN no steady imporvement;8MAR97 pt was improved;
Patient had a hard swollen muscle and redness where shot was administered. Patient also experienced tingling in the left hand and thumb and left forearm. Dr was notified and he prescribed prednisone.
she was given the hep A shot first , then the HPV in the left arm, then I switched to give her the men B shot in the right arm, she said that she felt light headed.  She was given the Men B shot  she said she felt really light headed and we noticed that she was becoming very pale.  about 1 minute after receiving the Men B shot she went rigid  this lasted a minute or 2.  When she came around she knew where she was but did not remember after receiving the injections.  She said that she still felt very light headed and she had a bad headache.
Following immunization, patient developed severe (10/10) pain in (L) upper arm, shoulder. ROM has been limited 2 degrees this pain. Patient states she is "unable to sleep because of the pain". Has tried Naproxen without relief.
This spontaneous report was received from a physician, via company representatives, and refers to a patient of unknown age and gender. Information about the patient's pertinent medical history, drug reactions or allergies and concomitant medications was not reported. On 18-MAR-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23, which had the lot # K010465, with the expiration date 23-MAR-2016 (dosage number and route of administration were not reported). No adverse effects were reported and no product quality complaint was involved. On unspecified dates, the vaccine experienced temperature excursions of 16 hours. The lowest recorded temperature was 33 F (0.555555556 Celsius degree). The vaccine status was reported as "in excursion". The vaccine storage criteria and the storage type were reported as "Refrigerator(R)". This is one of the several reports received from the same reporter. Additional information has been requested.
2 days after the vaccine, I developed a metallic taste in my mouth which I still have today. A week after the vaccine I had some tingling on my right foot, 3rd digit and did not think any thing of it until at one point my whole right foot was tingling. A few days later my left foot had some numbness and tingling. I am still experiencing these intermittently. I am able to function but the numbness and tingling is quite obvious when it happens
Drowsiness and headache.    I slept three hours after I arrived home from 2:30-5:30 and took tylenol.
pt recv vax; 3 wk later, noted rt supraclavicular/cervical lymphadenopathy w/o constitutional symptomatology;
Exacerbation of Morvan Syndrome symptoms including muscle twitching, Hyperhidrosis (excessive full-body sweating), extreme fatigue, loss of equilibrium, falling into a dream-like state, quivering hands, muscle weakness.
On 03/13/2023, around midday, I had a slight cough. I had great difficulty sleeping. I never had a fever, though I felt warm. The cough was the major thing. On 03/14/2023, I tested positive for COVID-19 at home. I spoke with the medical group and the told me to take SUDAFED and they prescribed a cough suppressant.
Patient presented to the Clinic on 4/20/2018 stating that he felt some burning and bumps on his right side the day before in the shower. Noticed discomfort during the night also prior to presenting to the clinic. Physical exam on the right T5 dermatome reveals a group of vesicles on the posterior and anterior aspect. It does not cross the mid-line, no streaking noted. Culture of the vesicles was performed that returned positive for Herpes Zoster.
Pt called 4/24/17 to report his left arm has had pain since he got his tetanus injection in January 2017.
Anaphylactic reaction; This case was reported by a pharmacist via call center representative and described the occurrence of anaphylactic reaction in a 61-year-old female patient who received DTPa (Reduced antigen) (Tdap Vaccine) for prophylaxis.   On an unknown date, the patient received Tdap Vaccine. On an unknown date, unknown after receiving Tdap Vaccine, the patient experienced anaphylactic reaction (serious criteria GSK medically significant). On an unknown date, the outcome of the anaphylactic reaction was unknown.   It was unknown if the reporter considered the anaphylactic reaction to be related to Tdap Vaccine.  Additional details were provided as follows: The age group was not reported but was captured as adult as per the vaccine indication. The age at vaccination was not reported. After receiving Tdap vaccine, the patient experienced an anaphylactic reaction. The reporter would like to know if this patient was able to receive 1st dose of Shingrix.  The reporter was consented to follow up. No further details were provided.
Dizziness, muscle ache and fatigue. Fever and chills. Condition lasted through 11/09/2002
Had soreness for a few hours but it went away the same day; Achiness; Malaise; She also had some chills; Low grade fever that went up and down that night around 17:00; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Had soreness for a few hours but it went away the same day), PAIN (Achiness), MALAISE (Malaise) and CHILLS (She also had some chills) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination.     Concurrent medical conditions included Chronic lymphatic leukemia (Oncologist said she got it because she was not taking any cancer medications.). Concomitant products included FAMOTIDINE (PEPCID AC) for Esophagitis and Gastritis, LEVOTHYROXINE for an unknown indication.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced PAIN (Had soreness for a few hours but it went away the same day), PAIN (Achiness), MALAISE (Malaise) and CHILLS (She also had some chills). The patient was treated with IBUPROFEN ongoing since an unknown date at a dose of UNK dosage form. On 29-Jan-2021, PAIN (Had soreness for a few hours but it went away the same day) had resolved. On 31-Jan-2021, PAIN (Achiness), MALAISE (Malaise) and CHILLS (She also had some chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
PATIENT GOT VACCINE THEN DURING WAIT PERIOD AFTER HIS HEAD GOT DIZZY AND ROLLED BACKWARDS AND HE EXPERIENCED LOSS OF CONSCIOUSNESS (SYNCOPE) FOR COUPLE MINUTES THEN HE REGAINED CONSCIOUSNESS SHORTLY. AT THAT TIME SINCE I HAD REQUESTED THE TECHNICIAN TO CALL 911 - EMT PERSONNEL WERE ALREADY ON SITE AND MONITORING PATIENT FOR BLOOD PRESSURE ,HEART RATE AND OVERALL ALERTNESS.
lethargic; very irritable; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (lethargic) and IRRITABILITY (very irritable) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     The patient's past medical history included Generalized anxiety disorder and Gastric bypass in June 2020. Concomitant products included DIAZEPAM, DULOXETINE HYDROCHLORIDE (CYMBALTA) and ALPRAZOLAM (XANAX) for an unknown indication.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced LETHARGY (lethargic) and IRRITABILITY (very irritable). At the time of the report, LETHARGY (lethargic) and IRRITABILITY (very irritable) outcome was unknown.               Reporter did not allow further contact
Pt vax w/ hepta B; exp n,D, h/a, abdo cramps, achiness, & low grade fever.