chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pneumovax 23. Rash away from injection site. Unusual intense pain above injection site, specifically at shoulder joint.
Reports tongue and roof of mouth feels itchy about 20 mins after 2nd H1N1 injection. Reports slight relief after about 1 hour. Child monitored until parent arrived.
I noticed in the evening I started to be very itchy, and I could tell I was getting hives. This is the same reaction I have whenever I come in contact with amoxicillin. I took a BENADRYL and an ALVINO bath to calm the itching. Saturday morning, I woke up and went to urgent care. They said it was hives I was given a steroid shot which helped along with PEPCID. I was also given a prescription and that night I felt them coming back. I took the PEPCID, prednisone, and ALLEGRA and I have been fine since.
Initial misuse report received from a Healthcare professional on 22 January 2014. the case was received on 21 March 2014. A patient inadvertently received expired TETANUS TOXOID, ADSORBED vaccine. No adverse event was reported. List of documents held by sender: none.
Extreme fatigue, sleeping 22 hours per day. Up briefly twice daily for food. Severe itching over 75% of skin area unrelieved by oral antihistamines or topical aloe Vera gel application
positive hepatitis B test; This case was reported by a consumer via call center representative and described the occurrence of hepatitis b test positive in a 59-year-old male patient who received HAB (Twinrix adult) for prophylaxis.   Previously administered products included Hepatitis B vaccine (unknown hepatitis B vaccine received 10-15 years before the date of reporting).   On 11th June 2019, the patient received the 1st dose of Twinrix adult (intramuscular). On 14th June 2019, 3 days after receiving Twinrix adult, the patient experienced hepatitis b test positive. On an unknown date, the outcome of the hepatitis b test positive was unknown.   It was unknown if the reporter considered the hepatitis b test positive to be related to Twinrix adult.  Additional details were provided as follows: The had blood work done. It was reported that, the patient tested positive for Hepatitis B, however, the health department believed it was detected in his blood due to him receiving the vaccine 3 days prior to testing.
abnormal PAP smear after receiving GARDASIL or GARDASIL 9/ high rates for subtype HPV and a diagnosis of low-grade intraepithelial lesions; adenomyosis of the uterus; diagnosis of low-grade intraepithelial lesions; high rates for subtype HPV; This spontaneous report has been received from a company representative and refers to a 32-year-old female patient.  The patient's pertinent medical history, other drug reactions or allergies, concurrent conditions and concomitant therapies were not reported.  On an unknown date (also reported as back in 7th grade), the patient was vaccinated with either quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) intramuscular injection, or hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, she could not remember, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided).  On 20-SEP-2023, the patient was made aware of an abnormal Papanicolaou test (PAP) smear after having completed the dosage regimen back in 7th grade (smear cervix abnormal). Such PAP smear showed high rates for subtype human papilloma virus (HPV) (human papillomavirus test positive) and a diagnosis of low-grade intraepithelial lesions (cervical dysplasia) and that it might have been adenomyosis of the uterus (adenomyosis). At the time of reporting, the patient had not recovered from the events.  The causal relationship between the events and the suspect therapies was not established.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. On 08-JAN-2013, the patient was vaccinated with live ZOSTAVAX (lot # not reported) instead of live (Merck) VARIVAX. It was unspecified whether the patient sought for medical attention. No adverse effects were reported. The outcome was unknown. Additional information has been requested.
Information has been received from a health professional concerning a 55 day old male who on approximately 14-AUG-2008 was vaccinated with a first dose of ROTATEQ (Lot # 660926/0308X), 2 ml, PO. Subsequently the patient experienced bloody stools. No medical attention was sought. There is no product quality complaint. The event of bloody stools is considered an other important medical event. Additional information has been requested.
Patient is a 63-year-old female who presents the ED today for further evaluation of fever, and recent initiation of chemotherapy.  Patient states that she was instructed to come in by her chemo physicians, states that she has been having mild cough, chest pain, back pain, abdominal pain.  Patient states that she has had some nausea and vomiting as well, is fed primarily through her G-tube, states that she has been able to take care of herself at home.  Acute hypoxic respiratory failure 2/2 COVID-19 infection with underlying emphysema  -COVID+ test (12/31/21). Has lymphopenia on admission. CRP -47>>51, LDH-wnl. Ferritin 574, DDimer -1.1>>1.3 -CXR showing right lower lobe airspace disease. personally reviewed . Noted on prior CXR in 10/21. -RSV, flu-negative. -blood cultures from peripheral and port-NTD  -01/03: started Remdesivir x 5 days and dexamethasone 6 mg PO daily x 10 days. Discharged with dexamethasone to finish total 10 days course. -procalcitonin - low, less likely bacterial infection. However, given immuno-compromised status, given IV ceftriazone and azithromycin until cultures result and discontinued on discharged. -on the day of discharge, she feels better. She required 2 L NC on exertion. Recommended to check home oxygen twice a day. Discharged with albuterol prn and tessalon prn for cough.  Discharge Disposition/Condition Disposition: Home with Home Health Condition: Stable (s/sx potential problems absent or manageable)
Pt. states that after receiving the 2nd dose of Phizer 10/08/2021, started experiencing symptoms 10/11/2021 of lower back pain, muscle spasms (continuous), and discomfort. No noted Primary visit.
Patient received Pfizer COVID19 vaccine at 1650 and was directed to remain in observation for thirty (30) minutes. At 1719, patient complained of itchy throat and itchiness on trunk, no shortness of breath, no difficulty breathing. Patient reported a history of anaphylaxis to amoxicillin and that she carries her own Epipen but had never used it prior. PHN activated emergency action plan, patient was moved to treatment room, and on-site manager contacted emergency medical services at 1724. Vital signs at 1726: pulse 72, respiratory rate 24, pulse ox 99%. Patient with wheezing and occasional cough. At 1728 PHN administered 0.3mg of epinephrine via Epipen auto-injector (cont)
Day of injection patient was experiencing fever and chills, also had sore arm. 2 days after the injection the patient was found dead
Swollen and red arm from below the vaccination spot to fingers. It was very painful and burning.  Nausea, low grade fever. All lasted for 4 days.
Left upper arm , at the injection site,  hard, warm to touch , erythematous, swollen, tender and measures 6cm X 9 cm. The reaction started after 24 hours of vaccine and called the Nurse line and they recommend urgent care / PCP visit for possible infection. Recommend hydrocortisone OTC  to apply for the local reaction at the vaccine site and started on Cephalexin for possible cellulitis related vaccine administration.  Recommend  follow up with the clinic if the symptoms get worse with fever, chills, n/v.
pt recv vax 2PM & around 11Pm woke up w/burning sensation in entire body broke out in hives over entire body;on way to ER began having breathing diff;ER tx consisted of Epi & atarax,Pred
Patient received 0.2 ml of pfizer covid 19, tris-sucrose 30 mcg (12 yr+) vaccine instead of 0.3 ml dose
Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 12-Feb-2022; Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 12-Feb-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 12-Feb-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 12-Feb-2022) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2022 at 4:09 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 12-Feb-2022 at 4:09 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 12-Feb-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 12-Feb-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 12-Feb-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 12-Feb-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant information was reported.  Patient allergies to medications, food and other products was unknown.The patient received booster dose. Its 30 days Expiry date vaccine went into 2 to 8 °C thaw state on or about to 20-Dec-2021, this vaccine administered until its Mfg date of 04-Apr-2022.   No treatment information was reported.   This case was linked to MOD-2022-542869.
Since 2 days after the shot, I have been very tired and worn down. Period chills, lower back pain,  headache,  exhausted.  Not feeling like I normally do. Symptoms not being better. Getting worse and will contact doctor.  I am a very active individual with no major health issues.
Sudden infant death approximately 72 hours following receipt of vaccines.  Nurse follow up on 06/18/04 states: "Add: Chronic lung dx."
PATIENT PRESENTED WITH TEMP OF 104.1, STIFF NECK, & ELEVATED WBC COUNT ONE WEEK AFTER ADMINISTRATION OF IMMUNIZATIONS.  6/15/09 Hospital records DC summary received DOS 5/6/09 to 5/7/09. FINAL DIAGNOSIS: Viral Illness, NOS. Patient presents with stiff neck per parents. Fever. Anterior cervical chain lymphadenopathy.  ICD-9 Codes: Neck Pain with Fever 780.60 Viral Illness NOS 079.99
This spontaneous report as received from a nurse refers to an unspecified number patients of unknown age and gender. On an unknown date in 2014 (reports as since 08-AUG-2014), the patients were vaccinated with VARIVAX (Merck) which was improperly stored, (strength, dose, lot numbers and route were not reported). No adverse effects were reported. Follow up information has been received 27-OCT-2014 from the registered nurse who stated that it will take some time to get the VARIVAX (Merck) information (patient identifiers, lot numbers, expiration dates and dates of vaccine administration) together and that she may send the information at a later time. Follow up information has been received on 13-NOV-2014 from the registered nurse concerning a patient (age range reported as 9, units not reported) of unknown gender. On 10-NOV-2014, the patient was vaccinated with a dose of VARIVAX (Merck) which was improperly stored (lot number K005180, expiration date 10-APR-2016; dose number, dose and route were not reported). The reporter stated that this was the information that they could find and provide and anything further would be much too difficult and time consuming due to their record keeping and tracking system. This is one of several reports received from the same reporter. Additional information is not expected because follow up has been obtained.
This spontaneous report as received from a Licensed Practical Nurse referring to an unspecified patient of unknown age. The patient's pertinent medical history, drug reactions and allergies were not reported. Information regarding concomitant therapies was not provided. The nurse reported that the patient inadvertently received two doses of ZOSTAVAX. The first dose of ZOSTAVAX was given on 17-JAN-2017(strength, dose, frequency, route of administration, lot number and expiration date were not provided) for prophylaxis and the second dose of ZOSTAVAX was given on 28-APR-2017 (strength, dose, frequency, route of administration) were not provided (lot M037653, expiration 29-NOV-2017) for prophylaxis. No adverse effects reported. No further details provided. Additional information has been requested.
rash, red, fine began on stomach 23MARPM;24MAR AM rash over torso back, face & legs, red throat;saw MD negative strep test;MMR rxn;
Was like something sitting on her chest holding her throat closed; Chest tightness; Arm swelling up; Arm pain/Sore arm; Lymph nodes very swollen; Arm pain at injection site: 5 to 6 hours after it was pretty intense; Sounded hoarse; Joint pain; was like something sitting on her chest holding her throat closed; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 42-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: EW0202, Expiry date was not reported) dose 2 via an unspecified route of administration on 28Jun2021 as DOSE 2, SINGLE for covid-19 immunisation. Patient's medical history (including any illness at time of vaccination) and family medical history relevant to adverse events were none. The patient did not take concomitant medications (No other products). Patient previously had first dose of BNT162b2 (Batch/lot number: EW0185) at left arm around shoulder on 04Jun2021 (at age of 42-years old) for covid-19 immunisation and experienced fatigue which started 8 hours after the first dose and treatment - took acetaminophen, Body aches which was started - 8 hours on 04Jun2021 to 09Jun2021 and she just had a sore arm as well that was super mild at the injection site. No adverse evets following prior vaccinations. No prior vaccinations (within 4 weeks. No additional vaccines administered on same date of the pfizer suspect. On 28June2021 she was okay right after the second shot for the first 5 to 6 hours, she felt normal and only had arm pain. They did inject it in the same arm. Arm pain at injection site: 5 to 6 hours after it was pretty intense, she did well with the first one. Arm swelling up: It was not mild swelling it was the size of a large grapefruit. Treatment, they advised her to put ice on it and to take ibuprofen. She looked in the mirror and her lymph nodes very swollen and she sounded hoarse and had chest tightness. She experienced it was like something sitting on her chest holding her throat closed. Lymph nodes very swollen was started at bedtime 8 or 9 pm 28Jun2021 and treatment was she went to urgent care and they sent her to the hospital. Chest tightness was started at 10pm on 28Jun2021. She had pain and tightness. Treatment was she went to the urgent care and they sent her to the hospital. She was really concerned about the lymph node swelling, joint pain, and chest and asked them what treatment there was and what could she do to feel better. The urgent care suggested going to the Emergency Room. There was no relevant tests. The outcome of the events chest tightness and chest pain was recovering, arm swelling up and lymph nodes very swollen are not recovered and rest of all events was unknown.
Reporter is unaware of type of flu shot given, it was administered at another clinic (see #17 above).  Please contact patient's mother for more information about the shot Patient has tachycardia and hypertension as well as tremors and internal feelings of heat/flushing without fever or diaphoresis.
pains in her left side about 2 inches above her waist that went around to her back; shingles; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (pains in her left side about 2 inches above her waist that went around to her back) and HERPES ZOSTER (shingles) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026l20A) for COVID-19 vaccination.     The patient's past medical history included Cancer and Lymphedema. Concomitant products included LISINOPRIL and ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, the patient experienced MYALGIA (pains in her left side about 2 inches above her waist that went around to her back) and HERPES ZOSTER (shingles). The patient was treated with FAMCICLOVIR at an unspecified dose and frequency. At the time of the report, MYALGIA (pains in her left side about 2 inches above her waist that went around to her back) and HERPES ZOSTER (shingles) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Fever (99.9 F), fatigue, headache.  Severe burning, throbbing muscle pain extending from the left elbow to the neck and left shoulder blade.  Inability to use left arm or move arm voluntarily. Fever controlled with ibuprofen. Muscle pain mildly attenuated with ibuprofen. Severe pain and fever lasted approximately 12 hours. Day 4 following vaccine (today), continued mild left arm muscle pain.
This spontaneous report as received from a pharmacist refers to a 65 year old female patient. The patient had no drug allergies. On 21-AUG-2013 the patient was vaccinated with ZOSTAVAX lot # J002869, 0.65 ml, administered subcutaneously. It was not reported if the patient took any concomitant or co-suspected medications. The pharmacist noted that, on 22-AUG-2013, the patient experienced an injection site reaction after receiving ZOSTAVAX on 21-AUG-2013. The patient noted on 22-AUG-2013 that the injection site was red, swollen and warm to the touch. The patient called the pharmacist on 23-AUG-2013, to report the previous day's findings and to also report that she was now experiencing tingling from the unspecified injection site down to her fingers. The pharmacist instructed the patient to call her physician, to have her arm evaluated. The adverse events did not resolve. A causality assessment was not provided. The action taken with ZOSTAVAX was not applicable. Additional information has been requested.
Zero adverse events- Resident psych pt. Displays numerous psychosomatic complaints. Information from missing data report states: there was no adverse effects from vaccine. Client psych pt.
allergic reaction; red itchy rash/red bump; red itchy rash; This case was reported by a other health professional via call center representative and described the occurrence of allergic reaction in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 24 hrs after receiving Shingrix, the patient experienced allergic reaction, itchy rash and red rash. On an unknown date, the outcome of the allergic reaction, itchy rash and red rash were unknown.   It was unknown if the reporter considered the allergic reaction, itchy rash and red rash to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient at clinic who developed a red itchy rash like bumps 24 hours after his first shingles shot that occurred all over his body, including arms and stomach and not face, throat, or mouth.  The reporter was wondering if this contraindicates him from receiving the second dose. Based on the recommendation to not receive it if you had an allergic reaction to a previous injection, would assume that patient should not get it, but would like to confirm.
Brain on fire. Headaches. Right side pain. Weak. Numb. Blurring vision. Seizures. Dizzy. Loss weight.  Body aches. Fever. Hip pain. Hurts to stand. Rash. Hard to breathe.
pt recv vax & devel a papular rash that lasted for approx 3wk;
A nurse reported that a pt received an injection of Flu Shield '00-'01 on 11/16/00 and subsequently developed an injection site reaction characterized by burning, "severe" pain, redness and swelling. This is 1 of 5 pts from this office who experienced an adverse event with the administrating of Flu Shield. No further information was available at the date of this report.
ARM SORENESS; CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 37 year (age at the time of primary vaccination was 36 year) old white and non Hispanic or Latino male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: 201A21A, expiry: UNKNOWN) dose was not reported, 1 total, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, following vaccination with covid-19 vaccine ad26.cov2.s, the patient experienced arm soreness which was like any type of shot in that area (Dose number in series 1), The patient received booster dose of mrna 1273 (Moderna) vaccine (Dose number in series 2) (form of admin, route of admin, batch number and expiry date were not reported) dose was not reported, administered on 08-DEC-2021 for prophylactic vaccination. On 17-JAN-2022, the patient experienced minor congestion and light cough and tested positive for COVID-19 at home test (Dose number in series 1). Then he went to his doctor office and took a saliva PCR (polymerase chain reaction) test and received the positive results on 19-JAN-2022 (confirmed clinical vaccination failure, and confirmed covid-19 infection) (Dose number in series 1). Laboratory data included: COVID-19 PCR test (NR: not provided) positive, and COVID-19 rapid POC test (NR: not provided) positive (Dose number in series 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the arm soreness, confirmed covid-19 infection and confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000212981. Sender's Comments: V0:20220137673-COVID-19 VACCINE AD26.COV2.S-Confirmed clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS.
Right thigh 7cmx7xm redness, mild induration, no pain. ROM and gait WNL.
Pt felt her arm become itchy and warm and redness spread into a circle. Currently just itches this morning.
SHE FELT ITCHING SENSATION IN HER LEFT ARM AFTER GETTING THE VACCINE. IT DID GO AWAY AFTER 15 MINUTES.
REALLY BAD GAS, ROLLING BELLY, BELCHING, SHORTNESS OF BREATH, DIARRHEA, EXTREME FATIGUE, ELEVATED GLUCOSE, VOMITING. (ALL THAT LASTED FOR A WEEK) THE NEXT WEEK HE HAD DIARRHEA 2-3 TIMES A DAY, ABDOMINAL BLOATING. THE THIRD WEEK THE HAD MORE DIARRHEA, BELCHING, AND ABDOMINAL DISCOMFORT.  OVERALL, IT TOOK HIM A MONTH TO START FEELING BETTER.