chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a healthcare professional via Pfizer refers to a male patient of unknown age. The patient's concurrent conditions included multiple sclerosis. The patient's medical history and concomitant medications were not reported. On 17-SEP-2013(also reported as 17-SEP-2017), the patient was vaccinated with first dose of PNEUMOVAX 23 for prophylaxis (strength, lot#, expiry date, dose, anatomical location, route of administration was not reported). On 12-APR-2018, the patient was vaccinated with second dose of PNEUMOVAX 23 (lot# N030987, expiry date 15-MAY-2019) when the patient was supposed to get PREVNAR 13 (wrong product administered). It was reported that the patient did not have any side effects (no adverse event).
No additional AE; ROTATEQ was administered after a temperature excursion; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 24-FEB-2023, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, once, lot #W029695, expiration date: 29-JAN-2024, administered orally for prophylaxis (anatomical location was not provided), after the temperature excursion happened (Product storage error). Administrated rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was stored at 18.0 Celsius degrees (C) for 3 hours and 50 minutes, no previous temperature excursion were reported.  There were no adverse events reported (no adverse event). This is one of several reports received from the same reporter.
Patient came in 4/11/13 at 4pm to report redness at the injection site that spanned about 3 inches in diameter with soreness. No other symptoms.
Severe pain in R/arm, resulting in doctor visits & therapy. Dx: frozen shoulder.
5OCT95 530AM pt noticed rash near rt elbow; 6OCT & 7OCT rash had progressed to torso;pt noticed hands had begun to swell & sun am 18OCT95 went to ER; Atarax;seen by MD; hives diminished
Pt. received 0.5ml injection of Pneumovax on 4/24/08 at approx. 0930 in L Deltoid.  Pt states his arm began swelling later that day and has gotten progressively worse. Pt. evaluated by his primary care physician today and was diagnosed with cellulitis.
Itchy; Had a rash and it was red; Swollen at the injection site; This is a spontaneous report from a contactable pharmacist.  A 77-year-old female patient received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13, lot number: X13847, expiration date:Jul2020), intramuscular on  03May2019 at 0.5 ml, intramuscular in the right deltoid muscle for immunisation .  Medical history included glaucoma, High blood pressure, hypertension, Anxiety, Fluid retention, Anticoagulation, all ongoing. Concomitant medication included latanoprost for glaucoma,  labetalol  for Blood pressure high,alprazolam for Anxiety, hydrochlorothiazide for hypertension and fluid retention and clopidogrel for anticoagulation. Pharmacist stated to report an adverse event associated with the Prevnar 13 vaccine on 10May2019. She just had a rash and it was red and swollen at the injection site but it did not occur until one week after the injection. Reporter was not 100% certain but it occurred at exactly where she received the injection but it did not populate until about a week later. She received the injection on May the 3rd but she said the rash did not come up until May the 10th that she noticed because it was itchy.  Patient did not receive any treatments for the adverse event. Outcome of the events was unknown.
Felt her legs were tired; Wanted to stay in bed and not do much; Tiny bit of pain in her arm; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (Felt her legs were tired), ASTHENIA (Wanted to stay in bed and not do much) and PAIN IN EXTREMITY (Tiny bit of pain in her arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MUSCULAR WEAKNESS (Felt her legs were tired), ASTHENIA (Wanted to stay in bed and not do much) and PAIN IN EXTREMITY (Tiny bit of pain in her arm). At the time of the report, MUSCULAR WEAKNESS (Felt her legs were tired), ASTHENIA (Wanted to stay in bed and not do much) and PAIN IN EXTREMITY (Tiny bit of pain in her arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medication details were reported. Treatment medication included natural remedies.   This case was linked to MOD-2022-440647 (Patient Link).
At 1520 patient reported generalized itching and feeling hot. At 1538 50mg PO Benedryl given. At 1540 patient began having difficulty breathing and tightness in her chest. 0.3mg Epi given. First Response called. Transported to ED
Following day, mother describes fever to 104F, hives - welts size of mosquito bites over anterior thighs, legs, and upper arms, along with lethargy.
This spontaneous report as received from a nurse practitioner refers to an approximately 60 year old male patient. Patient's medical history included chickenpox, knee operation and melanoma removed. No drug reactions or allergies were reported. On an unknown date, in approximately October 2015 (reported as '3 to 4 weeks ago'), the patient was vaccinated with a dose of ZOSTAVAX (dose, route of administration, lot number and expiration date were not reported) in the right arm and with a dose of Influenza virus vaccine (unspecified) (manufacturer unknown) (dose, route of administration and lot number were not reported). The patient received the doses at a pharmacy at another location. No concomitant medications were reported. On an unknown date, in approximately October 2015, a week after the vaccination, the patient 'broke out in a rash'. According to the reporter, patient's rash appeared to be a varicella-zoster rash, in that it was vesicular, papular, erythematous and pruritic. On 30-OCT-2015, the rash was spread to patient's right thigh. No lab diagnostic studies were reported. PQC was not involved. Patient sought medical attention. On 30-OCT-2015, he visited nurse practitioner. At the visit, nurse practitioner planned to prescribe an antiviral medication for the patient to start at the same day. The outcome of events was reported as not recovered. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
I had an EKG in Jan 2022 for thumb surgery and my EKG readings came up low. After the surgery, the dr.'s thought I went into AFIB. I went to my PCP afterwards and did another EKG which was low and she recommended I see another Dr., a cardiologists. I saw Dr. and did stress test and echogram and received a RX.
A report has been received from a Health Professional concerning an 8 year old, male subject, who had been receiving FLUMIST (Intranasal). FLUMIST (Intranasal) started on 25-Mar-2014. The Medical Assistant reported that patients received expired FLUMIST on 25-Mar-2014. No symptoms reported. The outcome of the event of ADMINISTERED EXPIRED FLUMIST is unknown. The report was considered to be non-serious by reporter.
Child received immunizations in the am and in the pm of the same day broke out in hives on her arms, legs, and face. the next day the hives disappeared for 2 hrs and then returned. Mom has applied Calamine lotion and given 1/4 tsp doses of Children's Benadryl, but it "didn't help". On 5/26 child developed runny nose, fever which progressed to chest congestion. She started Robitussin 5/28. Mom was encouraged to take child to Dr. or bring her to WCCHC. She did not come to WCCHC.
Patient hospitalized;  COVID-19 positive (8.29.21);  fully vaccinated  Admission Date: 8/29/2021 Discharge Date: 09/01/2021 DISCHARGE INSTRUCTIONS Discharge Disposition: Home with services - Nursing Discharge Recommendations:  1. Covid-19: Will complete 3 days of decadron treatment outpatient.  2. UTI: Will complete 3 days of Omnicef treatment outpatient. 3. Follow up with PCP within 1-2 weeks regarding Covid-19, UTI, and CHF DETAILS OF HOSPITAL STAY Hospital Course: Patient is a 80 y.o. male with PMHx of DM2, CHF, CKD and multiple co-morbidities who presented with 2 days of fatigue, weakness, fevers, and cough with slight mucus production.    In the ED, he had elevated RR, hypoxic requiring 2L NC. Covid testing was positive. He was slightly anemic with thrombocytopenia and absolute lymphopenia. His blood sugars were 219, UA was concerning for infection, BNP elevated, CXR consistent with CHF. He was given fluids and started on Rocephin. He was admitted for Severe Covid-19 infection with acute hypoxic respiratory failure, abnormal UA, and acute on chronic CHF exacerbation.   On the unit, he was started on decadron and remdesivir. He initially required 2L NC. We continued rocephin for his abnormal UA and followed cultures. We started him on Lasix 40mg for Acute on Chronic CHF exacerbation.    Patient respiratory status improved during hospital stay, weaned to room air. Urine cultures grew Group G B-hemolytic Streptococci and he continued treatment with rocephin. Toward the end of his hospital stay, he had a significantly elevated d-dimer, though he was asymptomatic. Subsequent bilateral doppler USV of UE and LE was negative for DVT. Patient was able to be discharged and placed on 3 days of decadron and 3 days of Omnicef. Length of Hospital Stay: 3  Condition on Discharge: Stable and improved.
MD CALLED THE PHARMACY TO INFORM THAT THE PATIENT HAD POSTULES ON THE LEFT ARM WHERE THE PNEUMOVAX WAS INJECTED.
experienced numbness on the right side of the face which started from the eyelid up to the forehead and moving up the scalp; pinch her hair and scalp but she doesn't feel anything, not even any pain; arm is hurting; feeling really weak; numbness initially started in her eyelid up until her forehead, but now the numbness is going up until her scalp; feel numbness in her lip as well; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 15Feb2022 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: HYPOAESTHESIA (non-serious), outcome "unknown", described as "experienced numbness on the right side of the face which started from the eyelid up to the forehead and moving up the scalp"; SENSORY LOSS (non-serious), outcome "unknown", described as "pinch her hair and scalp but she doesn't feel anything, not even any pain"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm is hurting"; ASTHENIA (non-serious), outcome "unknown", described as "feeling really weak"; EYELID SENSORY DISORDER (non-serious), outcome "unknown", described as "numbness initially started in her eyelid up until her forehead, but now the numbness is going up until her scalp"; HYPOAESTHESIA ORAL (non-serious), outcome "unknown", described as "feel numbness in her lip as well".  Additional information: It was reported that, she received the second dose of the Pfizer BioNTech COVID-19 vaccine last night and experienced numbness on the right side of the face which started from the eyelid up to the forehead and moving up the scalp. she tried to pinch her hair and scalp but she does not feel anything, not even any pain. her husband stated that, arm is hurting, that is normal, and that caller does not feel like she was vomiting. Upon follow-up (16Feb2022) Updated Information Include: Reporter Information (true reporter), Historical vaccine, biological product, vaccine facility information. She took the COVID-19 shot. She explains she got the second shot last night. She woke up feeling really weak, sore arm and she understands that is normal. She has numbness in her face, clarified as the right side of face. The numbness initially started in her eyelid up until her forehead, but now the numbness is going up until her scalp. She can pinch her hair on her scalp and she doesn't feel any pain. She is starting to feel numbness in her lip as well.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Entire body rash Swollen lymph nodes Swollen throat Gynecomastia Fatigue Chills
pt reports numb sensation and tingling left upper arm following covid vaccine; continues.  no trouble with range of motion.  NOTE:  PT IS NOT SURE OF ACTUAL DATES, THOSE ENTERED ARE APPROXIMATE
he only had a "sore arm"; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team.  A 25-year-old male patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "he only had a "sore arm"".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Breakthrough COVID-19 infection. Pfizer received on 3/25/21 and 5/1/21
Swelling at site of injection approximately 5 cm in diameter began within 6 hours of injection and remains same size 4 days later, reddened area exceeds 5 cm and hot to touch. Treatment with ice pack has not decreased swelling.
Redness near injection site, fever 99.6, achy muscles, tiredness, chills
Headache, Myalgia, SWOLLEN LYMPH NODES/TIRED Narrative:
The pt experienced a red blanchable rash on the palms, soles, arms and legs. It started on the chest and abdomen and in the diaper area.
Initial report received from a nurse on 21 October 2010. A child (age not reported) had received a 0.5 mL dose of FLUZONE No Preservative 2010-2011 on 20 October 2010 and at an unspecified amount of time later had swelling from the injection site all the way down to the wrist along with some cellulitis. It was not reported whether the patient had any diagnostic tests or laboratory data completed/performed. The recovery status was not reported. Documents held by sender: None
Adverse Event: lower than authorized dose volume administered due to equipment failure leakage of syringe hub Symptoms: N/A Outcome: Patient was administered authorized dose in the opposite arm (R) per CDC guidance; the proportion of the dose could not be estimated at the time of the equipment failure
Due to language barriers the patient was given different manufacturer as 2nd dose - when he later told us that he was vaccinated before and was showed us his first vaccine card. Patient was asked in Spanish the series of questions including whether or not he had received any Covid vaccines already. He answered no. We proceeded with the other questions and he answered no to all. We proceeded with the vaccine. When providing the follow up information he pulled out a first vaccine card which showed he received a one manufacturer as a first vaccine. We reported the incident to the chain of events that resulted in this issue to Lt.. He brought an EMT in who translated again to the patient and walked him out to determine next steps. Reporter.
a lttle soreness in arms; Initial information regarding an unsolicited valid non-serious case was received from a non-health care professional via social media on 14-Dec-2020.  This case involves a patient of an unknown demographics who had a little soreness in arms (pain in extremity), after receiving INFLUENZA VACCINE.  The patient's medical history, past medical treatments, past vaccinations, family history and concomitant medications were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiration date not reported) via an unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient had a little soreness in arms (pain in extremity), (non-serious event) (unknown latency) following the administration of INFLUENZA VACCINE.   No laboratory data was reported.  It was not reported if the patient received a corrective treatment.  At the time of report, the outcome was unknown for the event.  There will be no information available on the batch number for this case.
He received a dose of MMR II via the intramuscular route.; Pharmacist reported he felt tired and experienced gastrointestinal upset.; Pharmacist reported he felt tired and experienced gastrointestinal upset.; This spontaneous report was received from a 51 year old male patient who is a pharmacist reporting on himelf. The patient's medical history, concurrent conditions, and historical drugs were not reported, the patient had no reactions or allergies. The patient took as a concomitan medication an unspecifed cholesterol medication. Patient reported he received a dose of zoster rgE vaccine (mammalian)( SHINGRIX) (lot number and expiration date unspecified) on an unspecified date in 2019 (reported as "9 to 10 weeks ago"). He also reported that he "felt totally wiped out" and that he "felt like I had a mini flu" and that he experienced muscle aches and tiredness on unspecified dates.  On 06-MAY-2019 (reported as "2 days ago"), the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) intramuscular route (strength, dose, frequency, anatomical location, lot # and expiration date were unknown) for prophylaxis reconstituted with an sterile diluyent.     On 07-MAY-2019, the patient reported he felt tired(fatigue) and experienced gastrointestinal upset (abdominal discomfort) but he did not sought for medical attention.  At the time of the report, the outcome of fatigue and abdominal discomfort was reported as resolving. The patient did not mention the causality assessment between the events and Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live(M-M-R II) vaccination.
FEVER, HEADACHES, BODY HURTS, HEART BID, CHEST PAIN AND SKIN REACTION (RASH) FOR 2 DAYS
This is a spontaneous case from a contactable consumer who reported for herself. This 23-year-old female patient received on 17MAy2015 the first single dose of meningococcal group b rip2086 (manufacturer unknown) (lot number and expiration date not available). Concomitant medications and medical history were not reported. On 18MAY2015, the patient experienced extreme  nausea, lower back pain swelling, injection location very sore and extreme headache. On the same date the patient had the shakes a little bit. The consumer was instruction by the pharmacist to call manufacturer. Outcome was not recovered.  Follow-up (17JUL2015): Follow-up attempts completed. No further information expected.
Information has been received via medical records from a physician concerning a 9 week old American Indian Native female baby with diarrhea at the time of vaccination, with abdominal hernia, candidiasis, constipation, dry skin, eczema, jaundice neonatal, nasal congestion and decreased weight (MSD WAES # 0707USA01947). On 12-MAY-2008, the baby was vaccinated with HIB conj vaccine (OMPC) and pneumococcal vaccine (manufacturer unknown). On 27-JUN-2008 the patient developed diarrhea for 2 days. On 29-JUN-2008, the patient had a fever. The baby had vomiting 3 days ago now resolved but still has diarrhea and a slight cough. The baby was treated with acetaminophen and PEDIALYTE. The baby had a well child visit on 28-JUL-2008. The mother stated that the baby is doing well but gets irritated due to teething. Otherwise mother expressed no acute health concerns at this time. The baby was treated with acetaminophen and ENFALYTE. On 28-JUL-2008 the baby was vaccinated with diphtheria-tetanus-pertussis, pneumococcal vaccine (manufacturer unknown), HIB conj vaccine (OMPC) and vaccine for poliomyelitis. Additional information is not expected.
Within 12 hours I was nauseous, headache and low grade fever.  Within 24 hours I had thrown up and ached all over.  Within 48 hours I had swollen lymph nodes under my right arm,  at my wrist and my skin felt as if it had been burned.  This lasted for almost 2 full days.  By day five my symptoms had gone away.  I had no adverse reactions of any kind to the first two shots.
circular red puffy rash appeared on injection site 8 days after. Warm to the touch but relatively painless, mildly itchy. Has not impacted day-to-day activity. Benadryl and ibuprofen have helped reduce  swelling and size. Ice pack has also helped.
Had some soreness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Had some soreness at the injection site) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 027A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Feb-2021, the patient experienced VACCINATION SITE PAIN (Had some soreness at the injection site). At the time of the report, VACCINATION SITE PAIN (Had some soreness at the injection site) had resolved.            No concomitant medications were provided by reporter. No treatment details were provided by reporter. Patient did not get any side effects after the second dose.
Initial report received from a health care professional on 13 Aug 2010: This patient was vaccinated with MENVEO (batch number 100001), intramuscularly, on an unspecified date. The reporter stated that the patient was administered with only 0.4 ml of MENVEO (correct dose is 0.5 ml). However, no adverse events occurred. The outcome of the event was not reported.
Within 10 hrs. of receiving the shot, drowsy and tired.  By following morning, 100,7 fever, drowsy, tired, lethargic.  Sore arm at injection site the following day.
The rash is itchy; Mild rash developed in lower back area about 3x4 inches the size of the palm of hand above the butt crack and rash is bumpy; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (The rash is itchy) and RASH (Mild rash developed in lower back area about 3x4 inches the size of the palm of hand above the butt crack and rash is bumpy) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088D22A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH PRURITIC (The rash is itchy) and RASH (Mild rash developed in lower back area about 3x4 inches the size of the palm of hand above the butt crack and rash is bumpy). At the time of the report, RASH PRURITIC (The rash is itchy) and RASH (Mild rash developed in lower back area about 3x4 inches the size of the palm of hand above the butt crack and rash is bumpy) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   No concomitant medication was given. No treatment medication was given.  It was reported that, patient was scared about getting the Moderna second vaccine.  She did state that her vaccine paperwork from where she went for her vaccine, was documented as the left arm, but said it was given in the right arm.