chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse reactions reported by patients mother. Patient received two doses of Hepatitis B at well child check on 3/7/2013. Advised patients mother to call office should any reactions occur.
administered an adult dose of Havrix; administered an adult dose of Havrix; This non-serious case was reported by a nurse via call center representative and described the occurrence of overdose in a 17-year-old female patient who received HAV (Havrix 1440) (batch number 95DB2, expiry date 13-DEC-2024) for prophylaxis.   On 14-AUG-2023, the patient received the 1st dose of Havrix 1440. On 14-AUG-2023, an unknown time after receiving Havrix 1440, the patient experienced overdose (Verbatim: administered an adult dose of Havrix) and inappropriate age at vaccine administration (Verbatim: administered an adult dose of Havrix).The outcome of the overdose and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 06-SEP-2023 The reporter reported that a 17-year-old patient was administered an adult dose of Havrix, which led to overdose and inappropriate age at vaccine administration. The Vaccine Administration Facility was the same as Primary Reporter. No PQC (product quality complaint) was reported. No additional adverse event was reported. The reporter consented to follow up.
Prolonger on going neck/should discomfort and dull pain.  Prolonged swollen lymph nodes in neck.
The HEP A and HEP B Vaccinations were given after the series completion dates of HEP A: 19OCT2000 AND HEP B: 25MAR1997.
Patient said he felt the soreness right away when the vaccine was given and that he can "feel" the place where the needle was inserted.
Tongue swelling through the night. Did not seek treatment. Went away next morning. Rash area on arms and legs.
p/taking capsule of live typhoid vax pt threw up in 1 hr & vomited nonstop for 18hrs;had diarrhea & cramping,rash on cheeks;no fever;required phenargan & lomotil
Welt 6 inches by 2 inches raised 1/4 inch. This lasted for 48 hours. It has decreased in size. 5 days after shot minimal reaction remains.
Diabetic ketoacidosis; A spontaneous report was received from a physician concerning a unknown patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced diabetic ketoacidosis.   There was no medical history provided. Concomitant medication included ixekizumab for unknown indication.  On an unspecified date, the patient received her first of two planned doses of mRNA-1273 (Batch # unknown) intramuscularly, for prophylaxis of COVID-19 infection.   On an unspecified date, the patient experienced diabetic ketoacidosis. The patient was sent to intensive care unit (ICU) and the ICU physician determined, event may have been cause by a combination of the vaccine and concomitant mediation. The patient was treated for diabetic ketoacidosis at the ICU. The patient was better at the time of this report and physician wanted more information prior to second dose. It was not confirmed if the patient was still hospitalized at the time of this report.  Action taken with mRNA-1273 in response to the event diabetic ketoacidosis was not provided.  The outcome for the event diabetic ketoacidosis was unknown.  The reporter causality assessed as probably related between the event and Moderna's COVID-19 vaccine.; Reporter's Comments: This case concerns a patient, who experienced event of diabetic ketoacidosis. The event occurred on an unknown date after the first and last dose of mRNA-1273 vaccine administration. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded and the event is assessed as possibly related.  Concomitant medication ixekizumab is a confounding factor. Further information have been requested.
Arm soreness, Sever chills lasting hours, would subside for a few hours, and come back again for a few hours.  This cycle lasted for 24 hours.
Broke out in rash; This spontaneous case was reported by a patient and describes the occurrence of RASH (Broke out in rash) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030A21A and 037B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE for an unknown indication.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Apr-2021, the patient experienced RASH (Broke out in rash). At the time of the report, RASH (Broke out in rash) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   no treatment details reported.   This case was linked to MOD-2021-085776 (Patient Link).
Four days, post vax, infant developed generalized body rash. On 9/22/00, he had petechiae over body and was seen by MD who sent him to hospital for blood work. He was there until results were received. He continues to be followed by MD who recommended no further IZ's be given until he has been evaluated by an immunologist, probably at about 1 year (per mother). Mother states that petechiae developed with any skin pressure. (Phone call reporting reaction received on 10/24/00). Dx'd with hypersensitive vasculitis.
Vaccine expired 5/25/21.  Medication given 5/26/21 at 2:45pm.
That evening i began to get extreme soreness in the muscles of the shoulder and back (NOT at the injections site) of the arm where i had the shot particularly in the TRAPEZIUS muscles it continued to feel like it was very painful - masssage did eliminate it temporarily (for an hour) but it kept coming back and then 2 weeks later i started with a nerve tingle feeling from that area of my trapezius across my upper back to the other side similiar to how it felt when i had shingles 24 years ago ( diffferent area i had that ) both symptoms keep occurring the pain in trapezius is less but the nerve pain keeps occurring more frequently now. I had never had these issues before it all started after the shot and only on the shot side.
Polyp growth within the left nostril, which was surgically removed, and was diagnosed as olfactory neuroblastoma.
Day 1 no issues, day 2 arm slightly sore, day 3-7 no symptoms, day 8 awoke to left arm itching at injection site and a huge round swollen knot on my left deltoid that is red, warm, painful to touch, throbbing and hard.
Patient developed rash on 06/03/2014, at first family thought it was bug bites, but quickly spread over body and appeared very classic like chickenpox. She had between 50-75 pox over body with majority on lower trunk/genital area.
Patient developed left leg pain on date noted, which progressed despite analgesia. Admitted for IV analgesia 6/28. MRI showed bone marrow edema, underwent a bone biopsy on 6/30 (normal pathology). Also on 6/30, developed vesicular rash on left lower back extending onto thigh (L3 or L4 distribution). Also had scattered vesicular lesions on trunk and right leg (including a group of vesicles on right leg). Diagnosis: disseminated herpes zoster. Treatment: IV acyclovir x 4 days, PO valacyclovir x 12 days, oxycodone and gabapentin for pain. Also had suspected RUL pneumonia, treated with cefepime and then completed course with levofloxacin. Course complicated by leukopenia (low WBC was 3600) and neutropenia (low ANC was 900).
This spontaneous report as received from a registered pharmacist refers to a 77 years old female patient with no pertinent medical history and no drug reactions/allergies. The patient was vaccinated subcutaneously with 0.65 ml ZOSTAVAX (lot number not reported) on 02-AUG-2012. There was no concomitant medications. In August 2012, a couple of days after injection of ZOSTAVAX the patient developed rash at the injection site. No treatment was given for the event. No lab diagnostics studies were performed. The patient sought medical attention by contacting the pharmacist. The outcome of rash at the injection site was reported as not recovered/not resolved. The causal relationship between the rash at the injection site and ZOSTAVAX was not reported. Additional information is not expected.
Vaccination site erythema; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Vaccination site erythema) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (Vaccination site erythema). At the time of the report, VACCINATION SITE ERYTHEMA (Vaccination site erythema) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided. Treatment details were not provided.
DID NOT GIVE BIVALENT AS THE 3RD dose gave regular as 3rd dose  NO REACTIONS.
The vaccines were applied to patients after being refrozen, Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (The vaccines were applied to patients after being refrozen, Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vaccines were applied to patients after being refrozen, Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen). At the time of the report, PRODUCT STORAGE ERROR (The vaccines were applied to patients after being refrozen, Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were provided  No treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 20-Sep-2021: Follow up received contains NNI
Dizzy, elevated  BP.  Her other vitals were normal. Pt was disoriented. Had taken BP meds that morning, had not eaten food since previous evening. During time pt was being monitored approx 45mins, she became nauseous, SOB, lightheaded and had chest pain with exertion.
Patient made appointment for and received Pfizer vaccine as second dose of COVID vaccination, first dose was the Moderna vaccine.
Red swollen area on deltoid of right arm. Progressed over 48 hours, at exam, measured 1 1/2 inches circular raised erythema, warm to touch. No streaking or other lesions/illness noted.
While sitting with her daughter post vaccine she started to feel nauseous.  No vomit. Given Zofran 4mp SL VSS. Discharged with improvement.
Patient reported fever, left arm pain, swelling and redness, nausea, vomiting approximately 2 days after vaccination with ADACEL & PNEUMOVAX.  Seen at Urgent care, treated with KELFEX & ROCEPHIN injection 1 gram IM.
nausea & dizziness; clammy, diaphoretic; pallor;   TX - mask removal / air flow; increased air condition; car seat recline; cool cloth to forehead; emotional support; after 15 mins, returned to upright position after symptoms much improved - no further dizziness; given water;  1625-assisted to passenger seat by 2 .   Wife drove off observation lot.
Entire upper arm red and warm to the touch, swollen, unable to move arm at all, pain went into shoulder blade and clavicle area, large swollen area under arm and inside upper arm, metallic taste in mouth. Fever 101+, twin sister had same shots and same reaction ended up in the ER and put on Bactrim DS, I opted to go with the antibiotics I have on hand and not go to ER so far.
Expired HPV9 given to client. Expired 6-15-19 and vaccine given 7/10/19. No adverse effects expected. Client scheduled for revaccination of HPV9 on 8/7/19. Mother notified 7/11/19 when she returned VM from 7/10/19. Stated c/o sore arm only.
Information has been received from a licensed practical nurse concerning an 8 year old female patient who on 17-JUN-2009 was vaccinated with the first dose of VAQTA (lot number, route and site not reported).  There were no medical history and concomitant medication.  On 17-JUN-2009, the patient developed a fever as high as 100.9 F and 6-8 varicella like lesions.  The patient had sought unspecified medical attention by contacting nurse.  At the time of the report, the patient did not recover.  Additional information has been requested.
pox-like lesion on thigh, observed many more lesions on mainly on midriff, but also behind knee, a couple on the arm and lesions are raised, but not itchy or painful; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) in the left arm on 17Mar2021 at 10:15 (at the age of 51-year-old) as a single dose for COVID-19 immunisation and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) on 07Apr2021 at 10:45 (at the age of 51-year-old) as a single dose for COVID-19 immunisation. Medical history included Hashimoto's disease. The patient did not have allergies to medications, food, or other products. Concomitant medications included sertraline hydrochloride (ZOLOFT) and levothyroxine (MANUFACTURER UNKNOWN) all from unknown date, for unknown indications.  Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 05Apr2021 the patient experienced pox-like lesion on thigh and on 08Apr2021 approx. 24 hours after second vaccine dose, the patient observed many more lesions on mainly on midriff, but also behind knee, a couple on the arm and lesions are raised, but not itchy or painful. It was unknown whether therapeutic measures were taken as a result of the event. The events resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event pox-like lesion on thigh, observed many more lesions on mainly on midriff, but also behind knee, a couple on the arm and lesions are raised, but not itchy or painful was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Initial report received from nurse on 13 Jan 2010: A dose (0.5 ml) of H1N1 (batch no. unknown) was administered to a 6 months old boy on 13 Jan 2010. No adverse effect was reported.
Pt recvd vax & had pruritus followed by macular rash on arms;
covid-19; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (covid-19) in a patient of an unknown age and gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.  On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. In September 2023, the patient experienced COVID-19 (covid-19). At the time of the report, COVID-19 (covid-19) outcome was unknown.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.   For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Reporter was asking how long they should wait before they can give the Spikevax to patient who had Covid in Sep2023. HCP stated that patient had previous Moderna Covid-19 vaccines.  No treatment medications were reported.  This case referred to Patient 4 out of 4 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-748266 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-748266:Patient 1 out of 4
Patient became pale and limp after shots. No loc. Patient vomiting. After assisted patient to lie down. Patient better after lying down, VS stable, no trouble breathing. Dx with vasovagal reacation
Five minutes post vax the patient started having total body itching, worst at the head and neck areas. The patient was treated with Benadryl and improved. The patient also had nausea and emesis.
pt recv vax 5DEC96 & on 8JAN97 pt devel chickenpox lesions while in the bath tub;devel 15 lesions, which were mainly on trunk, w/a couple of legs & head;did not have a fever;
I got a skin rash. These symptoms is still ongoing since my booster shot. I went my doctor about this.
6 hours after injection: chills, body ache, mild headache, loss of appetite, injection site soreness 11 hours after injection: chills, severe body ache, severe headache, fever of 101.2F, loss of appetite , injection site soreness 13 hours after injection: 350mg of Ibuprofen taken day following vaccine: slight headache, fatigue, injection site soreness, additional 350mg of Ibuprofen 2nd day following vaccine: only injection site soreness
Information has been received from a pharmacist referring to a 63 year old female patient with high blood pressure and celiac disease. There was no drug allergies. On 17-MAY-2016 the patient was vaccinated with a dose of ZOSTAVAX (lot#, dose and route not reported) for to prevent Shingles. On 18-MAY-216, following the administration of ZOSTAVAX, the patient developed a fever, chills, a headache and a heat rash. No treatment was given. No lab diagnostics studies were performed. At the time of reporting, the outcome of all even was not recovered. Additional information has been requested.
Fell twice and looks like he may have had a stroke; Fell twice and looks like he may have had a stroke; This is a spontaneous report from a Pfizer-sponsored program "Pfizer First Connect" from a contactable consumer (patient's wife). A 77-year-old male patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, on 15Jan2021, at single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient fell twice and looks like he may have had a stroke on 16Jan2021 with outcome of unknown.  The information on the lot/batch number has been requested.
L upper extremity become erythematous, warm, painful and pruritic the day following administration.  Over the course of two days, development of vesicles filled with serous fluid developed in the center of erythema.  Patient received clindamycin x 2 doses IV, became more erythematous, recieved 4 doses vancomycin at Q8H dosing.  After one day, became less erythematous, less warm.  IV antibx d/c'd, patient given 10 day course of bactrim.  MR received for DOS 10/13-15/2007 with D/C DX: Infected injection site.  Hypersensitivity reaction to Tdap or VZV.  Pt presented to ER with 2 day hx of arm swelling, pain and pruritis.  In ER pt had temp of 99.2'F and crusty lesions noted at injection site with erythema and induration 10cm in diameter.  Vesicles contain serous fluid. Admitted with dx cellulitis due to progression after starting abx. Txd with abx and Benadryl with improvement eventually noted.
lt migratory polyarthralgias & myalgias x 2-3 wk;afeb;vital signs stable;tx large joint inj, PO pred; NSAIDS & Darvocet;
Breakthrough COVID infection in fully vaccinated patient. Positive date 08/18/2021.
I was given the vaccine at 11:10am and by 5:30pm I was beginning to feel tired and unwell. At 6:45 I had a fever, body aches, pain in my arm, headache, and chest pain. These symptoms continued for three days and my fever reached 102.7.  After three days the fever and body aches subsided but the fatigue and chest pain continued. The chest pain has continued with increased heart rate during small bursts of activity. I called the clinic that administered my shot on April 9th and was told chest pain was normal up to 10 days and if it continued to be a problem to go to the ER. After 11 days of chest pain I went to the ER on April 13th and they did an EKG, CT with contrast, and blood work. They concluded I was fine. I was told it could be esophagitis so to take 2 15mg Prevacid a day which I have done with no relief. I was also informed it could be muscle related so I have iced, taken anti-inflammatory medication, and have not exerted myself.  It is now April 19th and I am still experiencing chest pain and racing heart rate with minimal exertion.
Employee recvd inject & then returned next day w/tingling on the rt side of face, nausea & h/a; on exam noted swelling & mouth drooping;
Information has been received from a registered medical assistant (RMA) concerning a patient of unknown age and gender. No information was reported regarding the patient's concurrent condition, medical history and concomitant therapy. On 12-SEP-2018 the patient was inadvertently vaccinated with PROQUAD with sterile diluent injection via intramuscular route (dosage unknown, Lot # of R001541 and expiration date of 15-JUL-2019) for prophylaxis. No adverse effects were reported.
pt recvd vax & was found to be a nonresponder; addtly was found to have a pos hep B E antibody & a pos Hep B core antibody;
The site of injection itching; the site of injection is swelling; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PRURITUS (The site of injection itching) and INJECTION SITE SWELLING (the site of injection is swelling) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced INJECTION SITE PRURITUS (The site of injection itching) and INJECTION SITE SWELLING (the site of injection is swelling). At the time of the report, INJECTION SITE PRURITUS (The site of injection itching) and INJECTION SITE SWELLING (the site of injection is swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Acute onset of severe vertigo requiring emergency department visit.  Further workup by primary physician and neuro-otologist has not determined the cause.   Patient has difficulty standing due to the vertigo.  Symptoms have not abated despite treatment with Antivert. Vestibular therapy has been ordered.