chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse effects; Received one dose of improperly stored VAQTA; This spontaneous report was received from a medical assistant refers to a patient of an unknown age and gender. The patient's pertinent medical history, concomitant medication and drug reactions or allergies were not reported.  On 20-JUN-2019, the patient was vaccinated with one dose of improperly stored hepatitis a vaccine, inactivated (VAQTA), lot # R035227 (expiry date: 01-JAN-2020) for prophylaxis (strength, anatomical location and route were not reported) (Product storage error). The vaccine was stored at a highest temperature above 47 degree Fahrenheit (F)/ 9 degree Centigrade (46.5F) for a time frame of 30 minutes. The patient did not experience any adverse effects. There was no previous temperature excursion. The call was because of a "data logger". No product quality complaint (PQC) was involved.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA009510: US-009507513-1906USA009082: US-009507513-1906USA009522:
pt recv 3 doses of vax & exp a failure to seroconvert w/a VZIG ELISA titer of 0.34;
Brain fog and confusion for 13 days Chills, aches, fatigue, headache, dizzy spells, and nausea for 18 days Freezing, couldn't get warm under 3 blankets for 2 days, then freezing and burning up alternating for maybe 2 weeks.
Patient began vomiting on 6/24/2022  Mother reports he vomited 10X     Left arm is swollen and he is in pain also  she reports to physician that he is Nauseous and had diarrhea but did drink 2 glasses of water
This spontaneous report was received from a registered nurse concerning an unspecified number patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On approximately 22-JAN-2017 (reported as "between 22-JAN-2017 and 20-FEB-2017"), the patients were vaccinated with improperly stored doses of VARIVAX (lot # L045956, expiration date 12-SEP-2017) (lot # M024680, expiration date: 18-MAY-2018) for prophylaxis (dose number, route and anatomical location of administration were unknown). The temperature excursion reported was: refrigerator: 49.8 Fahrenheit for 2 hours 30 minutes; freezer: 30.3 Fahrenheit for 4 hours. The previous temperature excursion reported was: refrigerator: 49.6 Fahrenheit for 31 minutes; freezer: 11.2 Fahrenheit for 48 minutes. Digital data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1702USA009652: US-009507513-1702USA009653: US-009507513-1702USA009654:
At Site of Vaccination... Swelling, redness, huge blotchy patch about 2 inches by 3 inches wide. Extreme pain at the site.
Patient passed out after receiving vaccine while waiting afterwards. He woke up disoriented, sweating. He said he had passed out previously and it felt the same. EMS checked him out and he left on his own.
I was given the second part of the SHINGRIX vaccine by my provider, along with an annual flu vaccine. 5 days later, I had an acute attack of vertigo and was subsequently diagnosed with vestibular neuritis which I continue to suffer from. The ENT theorizes that the SHINGRIX vaccine attacked a dormant virus sitting on my vestibular nerve.
Muscle ache at vaccination injection site radiating through neck to opposite arm after 6 hours. Tingling numbness in shoulders and arms and slight headache after 10 hours. Treated with 200mg ibuprofen. Slept a few hours. Sensations continued with ringing (buzzing ) in ears 20 hours after vaccination, took additional 200mg ibuprofen. Queasy and weak, no nausea, no diarrhea. Slept 5 hours. Chills with no fever.
Frequent PVCs associated with dyspnea, lightheadedness, and chest discomfort. Unrelated temporally to these symptoms, I have noticed new onset of muscle cramping in my legs and forearms. I posted date and time of onset above, but I am not sure of the precise time of onset. Symptoms increased rapidly and peaked on ~Sep 10-11. I saw my cardiologist Mon Sep 11. He felt the PVCs were univocal and he found no urgent or imminently life-threatening signs on exam or EKG. He ordered a 2 -week ambulatory monitor that is currently in progress. I had been on metoprolol titrate 12.5 mg for several years for occasional PVCs with good control; my cardiologist suggested increasing the metoprolol to 25 mg bid. The muscle cramps, PVCs and associated dyspnea, lightheadedness and chest discomfort seemed to have decreased over the last 5 days. I also had malaise and feverish feelings Sep 7.
Reported body aches, fever 100.6F, and headache. 1st dose administered on 1/28/21 Pfizer EL9262   /  2nd dose administered on 2/18/21 Pfizer EN5318
herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 94 years old patient (pt) of unknown gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 30-SEP-2010, the pt was prescribed and administered with the zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) by a healthcare provider at a health systems, for the long-term prevention of shingles and zoster-related conditions. On an unknown date, pt suffered herpes zoster resulting from the vaccination. Pt was treated by a healthcare provider at the health systems. The outcome of the event was unknown. The event was considered to be related to the zoster vaccine live (ZOSTAVAX).
intermittent itching, burning skin on different parts of the body, e.g., elbows, top of feet, hands, legs  - also happened with first dose and itching lasted 3 weeks, essentially until right before the second dose
A nurse reported that a 1 year old child received the 2nd dose of Typhoid vaccine, USP. Heat Phenol Inactivated and subsequently, developed a fever and chills. The fever was "hard to handle with Tylenol." The reporter declined to provide further information and declined to grant permission for follow-up investigation.
Cystoscopy with clot evacuation and fulguration. He remained inpatient on CBI for 2 days where urine cleared up and clamping trial was successful. Patient discharged home in stable condition. ED visit and hospital admission within 6 weeks of receiving the COVID vaccine.
Patient reported on 11-09-18 that her arm still is hurting from the shot she received on 10-12-18.
She includes that she usually had a soreness in her arms after receiving the previous Moderna COVID-19 vaccine; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (She includes that she usually had a soreness in her arms after receiving the previous Moderna COVID-19 vaccine) in a 76-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 030G22B) for COVID-19 prophylaxis.     Patient was not diagnose with COVID-19.  Concurrent medical conditions included Blood pressure high, Food allergy, Penicillin allergy and Drug allergy (Paxil).    On 12-Oct-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (She includes that she usually had a soreness in her arms after receiving the previous Moderna COVID-19 vaccine). At the time of the report, PAIN IN EXTREMITY (She includes that she usually had a soreness in her arms after receiving the previous Moderna COVID-19 vaccine) outcome was unknown. Not Provided          Concomitant product use was not provided by the reporter.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-748145 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-748145:Same patient (SPIKEVAX 2023-2024), master case
15 mins p/vax pt devel nausea/vomiting, lightheadness, tingling in arms, alternating chills & clamminess w/heat flashes & sweating; sx lasted 24 hrs;
pt recv vax & devel a fever of 103-104, twitching-responsive to mom @ times & not @ other times; was hallucinating that snakes are on him;
Pt reported that following administration of vaccine she began to develop small, localized red raised rash on neck, just below ears,  swollen anterior lymph nodes and mild sore throat.   Rash was not itchy and lasted several days.  Denies any cough, congestion, pain, d/c, h/a, n/v/d/f.  Resolved without medical intervention.
Next AM: Fever, cough, HA.  3 days later-COVID positive. Prescribed Paxlovid by PCM on day 3.  Symptoms improved on day 6.
Information has been received from a registered nurse concerning a 21 day old patient who had already a birth dose of hepatitis B virus vaccine rHBsAg (manufacturer unknown), on 20-JUN-2012, the patient was inadvertently vaccinated orally with the first dose of ROTATEQ (lot number not reported) and the second dose of hepatitis B virus vaccine rHBsAg 5 mcg/0.5 ml (route and lot number not reported). The registered nurse stated that there was no adverse effect reported. Follow up information has been received from a registered nurse refers to a 21 days (reported also as 3 week) old female patient. The patient was vaccinated with a first dose of ROTATEQ to early on 20-JUN-2012. Other suspect therapies included RECOMBIVAX HB with dosage information as (UNK ml, UNK), (dose not reported, Lot #1466AA during validation process) on 20-JUN-2012. No concomitant medications were reported. No adverse events followed. Parents were contacted the next day. On 20-JUN-2012 the patient experienced mild fever (it did not need medications). Mother was told to contact doctor if any problems and bring shot card. At the time of the report the patient's status was recovered (recovery date was 21-JUN-2012). Additional information is not expected.
She complains of tingling left arm immediately after injection- numbness. neuro neck of arm was ok.
I do know that it was about a month ago and that my symptoms began that night. There was nothing unusual about the actual shot. If course it hurt but no worse than any other. There was no muscle tenderness or knot at the injection site. That night in bed, the pain in my joint woke me out of my sleep. I could not move my arm or lie on it. The next morning I could not extend my arm past my bday more than 3-4 inches without experiencing excruciating pain. I took ibuprofen and later could move my arm more but not much without pain. Touching my shoulder and even pushing on it does not hurt but it is like engaging the joint is where the pain comes from. A month later it is somewhat better but still there. I can't wait for a morning when I wake up and can move my arm without this pain! I am otherwise healthy and active person and it is very frustrating to all of a sudden feel so feable and elderly because I took a shot basically forced on my by my job.
Skin rash 1 day after vaccination (8/15/2022 until 8/21/2022).
This case was reported by a consumer via out of hour services and described the occurrence of rash in a female patient who received SHINGRIX for prophylaxis. On 20th June 2018, the patient received the 1st dose of SHINGRIX. On 21st June 2018, 1 days after receiving SHINGRIX, the patient experienced rash. On an unknown date, the outcome of the rash was unknown. It was unknown if the reporter considered the rash to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. After receiving SHINGRIX, at the evening of 21st June 2018, the patient noticed a rash on her chest below her breastbone and on her stomach. The patient was not sure if it was related to the vaccine. Called and left message with patient.
Information has been received from a nurse concerning a 75 year old female with blood pressure high and cataract and no drug reactions/allergies who on 19-JUL-2010 was vaccinated subcutaneously with a dose of ZOSTAVAX (Merck) (LOT# 665530/0697Z, expiration date unknown). There was no concomitant medication. On 21-JUL-2010 the patient began to feel achy and tender in the right breast. That afternoon, she broke out in shingles--a thick patch of vesicles from the right breast around to the back. She reported to the office on 23-JUL-2010. Unspecified medical attention was sought. There was no lab diagnostics studies performed. At the time of this report, she had not recovered. This outbreak would prevent her from getting her cataract surgery on "Monday". No further information was available at this time of reporting. Shingles was considered to be disabling. Additional information has been requested.
broke out in whelps all over her body; swollen lips; A spontaneous report  was received from a consumer concerning a 67-year old, female  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and broke out in welts all over her body.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 25 Jan 2021, patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.     On an unknown date, the patient broke out in welts (reported as whelps) all over her body.Treatment details included diphenhydramine hydrochloride, and famotidine.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event, broke out in whelps all over her body,was unknown.; Reporter's Comments: 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.
Conception 2/2/2021 Due date 10/25/2021  This is my second pregnancy. First was a live birth and is a healthy 21 month old. No complications during that pregnancy.   At our June 1 anatomy scan, we learned that the baby is healthy and has all expected parts except for the umbilical cord, which has two blood vessels instead of the normal three. This is called SUA (single umbilical artery) and we're told it occurs in 1/100 pregnancies, and often leads to no other issues. So far, all other genetic and chromosomal scans have come back normal. The doctor explained that the umbilical cord forms and is visible by 8 weeks. The first dose was at 2.5 weeks so if the vaccine could have had an adverse effect on the cord during its formation, I received it within the window that it could have had an effect. Other potential problems are increased likelihood of low birth weight and maternal high blood pressure. All other signals point to a healthy mom and child so far.
pt recvd vax;mom states approx 12 hrs p/vax,pt broke out in a rash over head,chest & back;described it as red w/ bumps;no fever;no irritability;rash disappeared in approx 1 1/2 days
pt recv vax & 1 day post vax pt broke out w/eczema on face;
Case number PHEH2014US025076, is an initial spontaneous report from a nurse received on 09 Dec 2014. This report refers to a 15-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at a dose of 0.5 ml on 18 Nov 2014. The nurse reported that FLUVIRIN administered had 12 separate temperature excursions lasting for 30 minutes over a period of 34 days. The temperature excursion began on 16 Oct 2014 and the temperature was between 46 to 49 degree F during the excursion. No adverse event was reported following this maladministration.
This is a spontaneous report from a contactable physician via Pfizer sales representative. It was reported that a currently 4 and half year-old patient of unknown gender and ethnicity received the first dose of PREVNAR 13, via an unspecified route of administration on an unspecified date at single dose for immunisation, at 2 months of age. The patient received the second dose at 4 months of age, at single dose for immunisation, the third dose at 6 months at single dose for immunisation and the fourth dose at 12 months at single dose for immunisation. The patient medical history and concomitant medications were not reported. After receiving all four doses of PREVNAR 13 the patient had no immune response to the vaccine. The reporter is wondering how to revaccinate the patient. The information on the batch number has been requested.
Pt came into clinic next day (12/5/06) at 10:10am, c/o pain and limited ROM right arm, as well as redness around injection site, induration of tissue surrounding site and tenderness to touch at site and around site, and up into right shoulder blade (back). Pt was seen by physician at that time a order given for application of ice, pain medication. (Above c/o were same at assessments by nurse and physician).
One week after smallpox vaccination, patient developed mild generalized vesicular eruption on torso, face and arms consistent with generalized vaccinia. No specific treatment reaquired.
States felt burning, post vax. It went away but then about 1/2 hour after returning to work she complained of burning from right shoulder to wrist with stiffness in her shoulder. To use heat and exercise. 8/10/00, upper arm tight, like spasms. Tylenol #3 and exercise.
Shingles; rash on left side of chest under arm extending to sternum, deep chest and abdominal pain, minor skin itching; lasted three weeks
Wednesday after Wednesday getting shot, injection site started to feel pain and itchy. Thusday, very itchy like five mosquitoe bites barely see pink 2 inch by 1 (6 pm) .  Friday,  extreme itchiness,  4 inch by 2.5 reddish spot (noon).  Had to apply OTC cortisone in hopes of easing itch. First time using Cortisone in over 20 years.
Baby woke up with a rash of a bunch of small dots everywhere. Took her to the peds 2 days in a row, unable to get control of 104 fever so we went to hospital. They ran IV's and tests and ruled it as a reaction to MMR. I have pictures. Every inch of her body was covered, looked like regular measles. As of right now she still has rash just seems a little control with rx's er gave her.
May 28, 2011, Grand mal seizure @2PM, 30 seconds. Took to ER, CAT scan normal, sugar normal, temp normal, sent home. Grand mal seizure @6PM, 15 min stopped by medication. Took to ER CAT scan, EEG normal, temperature normal, sugar normal. August 5, 2011, Seizure, 30 seconds, 2:30 AM, general. Drove to ER, discharged at 5:00 am. Seizure, 1 min, 8:00 AM, general. Ambulance to ER, checked sugar - 78. Seizure, 1 min, 10:00 AM, general. Seizure, 4 min, 1:15 PM, general, later on right side of body, captured on EEG. EKG done. Medication administered to suppress seizures. Discharged from hospital Saturday evening. Neurologist diagnosed with epilepsy and now taking Trileptal 3mL 2x/day to suppress seizures.
RED, ITCHY, WARM TO TOUCH ON RIGHT ARM. ALSO TENDER. SPREAD TO INSIDE OF ARM AND DOWN ARM. ON THURSDAY STILL RED.
This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 03-OCT-2017, the patient was vaccinated with an improperly storage dose of VARIVAX lot # N009768 and expiration date of 24-MAR-2019 subcutaneously for prophylaxis (dose was not reported). No adverse effects were reported. The vaccine was exposed to a temperature excursion of -14°C to -10°C with a time frame of 2 hours and 5 minutes, while the sterile water diluent did not undergo a temperature excursion. There was no previous temperature excursion. A "data logger" was involved. This is one of the two reports received from the same reporter. Sender's Comments: US-009507513-1710USA002628.
Lethargic, fever 101F-103F, occasional vomiting until present (7days).
Pt devel red, warm, edematous lt upper arm 6JUN91 p/DTP inject 5JUN91; Area of redness, edema & warmth included area lt mid deltoid extending to elbow; Mom states pt irritable; on 9JUN91 pt examined by MD felt had local rxn to Pertussis;
Wasn't moving, crying a lot, not eating swelling right leg, rash on right leg, fever, diarrhea, dragging on (r) leg.
Pt. states that after receiving the 1st dose of Moderna 09/09/2021, started experiencing symptoms 09/12/2021 of pain, tingling throughout the left arm. No noted Primary visit. Symptoms still continuing.
This literature marketed report as received from a physician refers to a patient of unknown age and gender. Background: For mothers with chronic HBV infection, the Centers for Disease Control and Prevention recommends immunoprophylaxis to decrease perinatal transmission. However, its effectiveness and risk factors for failure have not been well-studied in community practice. Objective: To investigate the effectiveness of a contemporary immunoprophylaxis protocol. Design: Observational study. Patients: 4446 infants born to 3253 HBV-positive mothers between 1197 and 2010. Measurements: Adherence to immunoprophylaxis, follow-up testing rates, maternal risk factors for HBV transmission, and transmission rates. Tests for HBsAg (HBV DNA, e antigen, and liver function tests) were completed for 3353 (85%) of all infants, 2945 (85%) of the 3473 with maternal e antigen testing, and 837 (93%) of the 904 infants with both maternal viral load and e antigen testing (after 1 July 2007). Among all children, 0.75% (25 of 3353 tested) were HBsAg-positive as of January 2012. All these 25 patients had hepatitis B immune globulin (H-BIG) and the first dose of RECOMBIVAX HB (lot#, dose, route not reported) within 12 hours of birth. 19 of the 25 patients had the second dose within 24 to 62 days of birth and the other 6 received it within 70 days of birth. Most of the 25 children (22 of 25) also received the third dose within the recommended 164 to 214 days and the remaining 3 received third dose between 219 and 237 days (and received their second dose on time). Outcome of the event was unknown. The reporter considered the event to be related to RECOMBIVAX HB. This is one of 25 reports from the same source. Additional information has been requested.
DIARRHEA-12 HOURS, MALAISE-12 HOURS, FATIGUE-12 HOURS, HEADACHE-2 HOURS.
This is a non-serious spontaneous case from a pharmacist in the USA who reports a patient experienced burning sensation:  (Unlabelled, USA)  after receiving FluMist.  The reporter causality is not provided.  This case is submitted according the VAERS Safety Surveillance accelerated reporting agreement for FluMist. On 11/23/2004, a 46 year old male received FluMist intranasally and experienced loss of smell and taste as well as burning sensation in back of throat on 11/25/2004.  He was given Septra (sulfamethoxazole), Medrol (methylprednisolone), Allegra D (fexofenadine/pseudoephedrine), and Rhinecort (budesonide).  He self medicated with saline nasal spray.  All events continued into 11/26/2004.  The reporter states the loss of smell and taste has not improved.  However, the patient "thinks" he might be able to sense the taste of sweetness to some degree.  The patient has not yet recovered from loss of smell and taste but the burning sensation in back of throat has subsided slightly.
Large oval shape (approx. 10cm in length x 5cm) local redness and looked raised around the injection site.  No pain and no fever confirmed but patient is a limited English speaker. Left a message on daughter's phone number and asked to follow up with us.