chrisvoncsefalvay/vaers-outcomes huggingface dataset:
PROQUAD underwent a temperature excursion and was administered; This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. On 11-JUN-2021, the patient was vaccinated with a dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (lot # T036562 exp date 26-APR-2022) rHA (dose and route not reported) that underwent a temperature excursion. Previous temperature of excursion was 6°F to 14°F (14F) for 2 hours, 14°F to 46°F (45.5F) 1 hour and 30 minutes and 6°F t o14°F (14.4F) for 2 hours.  This is one of several reports received from the same source.; Sender's Comments:  US-009507513-2106USA006475: US-009507513-2106USA006476: US-009507513-2106USA006477: US-009507513-2106USA006478: US-009507513-2106USA006479: US-009507513-2106USA006480: US-009507513-2106USA006481: US-009507513-2106USA006482: US-009507513-2106USA006483: US-009507513-2106USA006484: US-009507513-2106USA006485: US-009507513-2106USA006486: US-009507513-2106USA006487: US-009507513-2106USA006488: US-009507513-2106USA006489: US-009507513-2106USA006490: US-009507513-2106USA006064: US-009507513-2106USA006492: US-009507513-2106USA006493: US-009507513-2106USA006494: US-009507513-2106USA006495: US-009507513-2106USA006496: US-009507513-2106USA006497: US-009507513-2106USA006498: US-009507513-2106USA006458: US-009507513-2106USA006459: US-009507513-2106USA006460: US-009507513-2106USA006461: US-009507513-2106USA006462: US-009507513-2106USA006463: US-009507513-2106USA006464: US-009507513-2106USA006465: US-009507513-2106USA006466: US-009507513-2106USA006467: US-009507513-2106USA006468: US-009507513-2106USA006469: US-009507513-2106USA006470: US-009507513-2106USA006471: US-009507513-2106USA006472: US-009507513-2106USA006473: US-009507513-2106USA006474:
booster; chills; chest pain; they would stop my breathing for a second or more but ended after 5 minutes; Heartrate was over 130; at 11:30 blood pressure was measured 128/88 1:30 124/82; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 16 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 19Dec2021 12:00 (Batch/Lot number: unknown) at the age of 16 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (prev dose product=COVID 19,, prev dose brand=Pfizer,, prev dose brand_unknown=False,, prev dose lot unknown=True,, prev dose lot unknown reason=Misplaced/discarded,, prev dose administration date=12Jun2021, prev dose dose number=2,, prev dose vaccine location=Left arm), administration date: 12Jun2021, when the patient was 15 years old, for Covid-19 immunization, reaction(s): "heartrate at over 100"; Bnt162b2 (prev dose product=COVID 19,, prev dose brand=Pfizer,, prev dose brand_unknown=False,, prev dose lot unknown=True,, prev dose lot unknown reason=Misplaced/discarded,, prev dose administration date=21May2021, prev dose dose number=1,, prev dose vaccine location=Left arm), administration date: 21May2021, when the patient was 15 years old, for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 19Dec2021 12:00, outcome "unknown", described as "booster"; CHILLS (non-serious) with onset Dec2021, outcome "recovered", described as "chills"; CHEST PAIN (non-serious) with onset Dec2021, outcome "recovered", described as "chest pain"; DYSPNOEA (non-serious) with onset Dec2021, outcome "recovered", described as "they would stop my breathing for a second or more but ended after 5 minutes"; HEART RATE INCREASED (non-serious) with onset Dec2021, outcome "recovered", described as "Heartrate was over 130"; HYPERTENSION (non-serious) with onset Dec2021, outcome "recovered", described as "at 11:30 blood pressure was measured 128/88 1:30 124/82". The events "chills", "chest pain", "they would stop my breathing for a second or more but ended after 5 minutes", "heartrate was over 130" and "at 11:30 blood pressure was measured 128/88 1:30 124/82" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of chills, chest pain, dyspnoea, heart rate increased, hypertension.  Additional information: The patient underwent lab tests and procedures which included Nasal Swab of COVID-19 virus test,- Negative COVID-19 test on 28Dec2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a nurse practitioner for the pregnancy Registry for GARDASIL, concerning a female patient with no known drug allergies or pertinent medical history, who on 09-MAY-2008 was vaccinated intramuscularly with a 0.5 ml first dose of GARDASIL (Lot: 659964/1978U). On 21-JUL-2008 the patient was vaccinated intramuscularly with a 0.5 ml second dose of GARDASIL (Lot: 660553/0070X) and on 03-JUN-2009 the patient was vaccinated intramuscularly with a 0.5 ml third dose of GARDASIL. There was no concomitant medication. In March 2009, the patient had her last menstrual period (LMP), her estimated delivery date (EDD): December 2009. No adverse effect was reported. On 05-JUN-2009, the patient underwent a comprehensive metabolic panel, complete blood count, lipids, insulin level, TSH and hCG quantitative (lab results not reported). At the time of this report, this patient's outcome was unknown.  Follow up information was received from a nurse practitioner indicated that the patient was a 17 year old female. The patient received a third dose of GARDASIL (Lot: 661441/0631X valid for varicella virus vaccine live (Merck) (MSD)), while she was pregnant. The patient had an ultrasound on 24-JUN-2009: which reported "19 6/7 e 14 2/7" with an estimated date of delivery of 12-NOV-2009. There were no previous pregnancies or births. Follow up information received from a nurse practitioner indicated that on 23-NOV-2009 at 41 2/7 weeks from her last menstrual period, the patient gave birth to a normal female, who weighed 7 pounds and 6 ounces. The baby's length was 19 3/4. It was reported that the baby experienced nuchal cord and fetal bradycardia (WAES # 0906USA03366B1). Concomitant medication used during this pregnancy included prenatal vitamins. On an unspecified date, the patient developed anemia and reflux. She was prescribed ferrous sulfate for the anemia and ranitidine for the reflux. The patient had a seasonal influenza virus vaccine (unspecified) shot on 09-SEP-2009 and a H1N1 shot on 26-OCT-2009.  The patient's outcome was unknown. Attempts to obtain additional information regarding the infant have been unsuccessful. No further information is available.
Severe rash on right side of stomach area. Increased after 2nd shot.  Some pain/discomfort.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Patient's pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/allergies were reported. On 11-MAY-2016, the patient was vaccinated with improperly stored dose of GARDASIL 9 (lot # L043213, expiration date 28-AUG-2017) (strength, dosing details and anatomical location were not reported). No adverse effects were reported. No product quality complaint was involved. This is one of the several reports reported by the same reporter. Additional information has been requested.
Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Systemic: arm redness, warm to touch-Medium, Additional Details: patient told if worsening symptom to seek emergency room,  told to put on cold compresses  if no relief contact ER/MD
joint pain; muscle fatigue; chills; headache; fatigue; This is a spontaneous report from a contactable healthcare professional (patient herself). A 25-year-old female patient received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot number: EH9899), via an unspecified route of administration in the right arm on 21Dec2020 16:00 at a single dose for COVID-19 immunization. The patient is vaccinated in a hospital facility. Medical history included Nail-patella syndrome. Concomitant medications included ethinylestradiol, levonorgestrel (LESSINA) and escitalopram. The patient previously had known allergies with amoxicillin. First dose came with moderate muscle fatigue and joint pain, chills, headache, and fatigue. Events occurred on 28Dec2020, 7 days post vaccination. The patient did not receive any treatment for the reported events. The outcome of the events was recovering.
on 4/19/23 pt received mono-valent Pfizer instead of bi-valent. no adverse rxn, just received incorrect vaccine
pt recv vax & 2 days p/vax exp gen aching type pain in both knees, going down leg to feet;
Pt given HIB and Prevnar in right leg.  On 2/28/07 mom noticed redness in thigh, swollen thigh and a red streak extending from immunization site.  Pt also with fever > 101.2 F.
This case was reported by a nurse via call center representative and described the occurrence of shingles in a 63-year-old male patient who received SHINGRIX (batch number 9NJ59, expiry date 8th February 2021) for prophylaxis. The patient's past medical history included shingles (experienced in 2014). Concomitant products included SHINGRIX. On 20th July 2018, the patient received the 2nd dose of SHINGRIX. In July 2018, 3 days after receiving SHINGRIX, the patient experienced shingles, tingling, pain burning, back pain and erythropapular rash. The patient was treated with antivirals for systemic use (Antiviral). On an unknown date, the outcome of the shingles, pain burning, back pain and erythropapular rash were unknown and the outcome of the tingling was not recovered/not resolved. It was unknown if the reporter considered the shingles, tingling, pain burning, back pain and erythropapular rash to be related to SHINGRIX. Additional details reported as follows: The healthcare professional reported that the patient developed burning pain and tingles on his left trunk and back 3 days after receiving his second dose of SHINGRIX. The patient had Shingles in 2014 in the same area and stated that this felt the same. On 30th July 2018, the was seen in the office where less than a month after vaccination a mild erythematous rash with a few papules was noted on the involved area. Antivirals were prescribed. The patient was contacted by phone on 1st August 2018, and stated that the rash was no worse. On 3rd August 2018, he reported that the rash was larger.
Little bit pain in the arm; Feel dizzied; felt awful; frequent urination; Had 101.1 and felt awful; Violent chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Little bit pain in the arm), DIZZINESS (Feel dizzied), FEELING ABNORMAL (felt awful), POLLAKIURIA (frequent urination) and PYREXIA (Had 101.1 and felt awful) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included High cholesterol and Blood pressure high. Concomitant products included multivitamin (MULTIVITAMINS, PLAIN), LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) and ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Little bit pain in the arm), DIZZINESS (Feel dizzied), FEELING ABNORMAL (felt awful), POLLAKIURIA (frequent urination), PYREXIA (Had 101.1 and felt awful) and CHILLS (Violent chills). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE, PARACETAMOL (TYLENOL PM EXTRA STRENGTH) for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Little bit pain in the arm), DIZZINESS (Feel dizzied), FEELING ABNORMAL (felt awful), POLLAKIURIA (frequent urination), PYREXIA (Had 101.1 and felt awful) and CHILLS (Violent chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
This spontaneous report was received from a healthcare worker and refers to an unspecified number of patients of unknown ages and genders. No pertinent medical history, drug reactions/allergies or concurrent conditions were reported. On an unspecified dates in 2016 (reported as starting on or after 28-MAR-2016), unspecified patients were vaccinated with doses of improperly stored GARDASIL 9 (which had a lot # of L048237 and an expiration date of 08-MAY-2017; However, dosage number and route of administration were not reported). Although, no adverse effects were reported. Another batch of GARDASIL 9 (which had a lot # reported as L026602 and an expiration date of 19-OCT-2017) had also been improperly stored and administered on unspecified dates and patients. The vaccines experienced the following temperature excursions: 27.7 F for 42 hours and 45 minutes on an unspecified date. Reportedly, there had been no previous temperature excursions and the aforementioned ones were no identified due to a data logger. Furthermore, no product quality complaint was involved. This is one of two reports received from the same reporter. Additional information has been requested.
Accidentally administered 0.5 mL instead of 0.3mL. Reported to the patient and asked them to submit a VAERS report if they have any adverse effects.
SUSPECTED COVID-19 INFECTION; SINUS ISSUE; This spontaneous report received from a patient concerned a 39 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: nonsmoker, and non alcohol user. The patient had no medical conditions, no known allergies and no history of drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821286 expiry: UNKNOWN) 0.5 ml, 1 total administered to right arm on 01-AUG-2021 for prophylactic vaccination. No concomitant medications were reported.  On 05-AUG-2021, Laboratory data included: COVID-19 virus test (NR: not provided) Negative. On 07-AUG-2021 Saturday, the patient stated that he felt like he got a sinus issue and a little bit of fatigue.  On 10-AUG-2021,the patient tested positive and he stated that he gets tested everyday at work. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sinus issue, and suspected covid-19 infection. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000189168. The suspected product quality complaint has been confirmed to be void: Y (does not meet product quality complaint criteria). Based on the time elapsed between administration of the vaccine and the positive covid-19 test, there was insufficient time for the consumer to achieve immunity. This report does not meet the criteria for lack of effect, therefore this record is approved for void based on the PQC evaluation/investigation performed.; Sender's Comments: V0: Medical assessment comments not required as per the standard procedure as the case is assessed as non-serious.
lightheadedness; Feels "like he's high" or "like he's on a roller coaster" everyday since receiving his second dose vaccine; This is a spontaneous report from a contactable consumer (Patient mother).  A 26-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 30Mar2021 as SINGLE DOSE for covid-19 immunisation.  The patient medical history and the concomitant medications were not reported.  The patient has been experiencing lightheadedness, and feels "like he's high" or "like he's on a roller coaster" everyday since receiving his second dose vaccine. The outcome was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
can I get second dose, it has been 7 months; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 28-Mar-2022 Reporter's comment: This case was reported via interactive digital media. The reporter wanted to know could he/she get the 2nd dose of Shingles vaccine if it had been 7 months.
Patient developed redness at injection site. As patient remained in waiting area the redness increased and began to itch. I contacted the physician and applied diphenhydramine spray. Patient remained in pharmacy for 40 minutes. Redness and itching were the primary symptoms. No shortness of breath reported.
Fever, confusion.  He received the vaccine about 10:30 AM. He worked in the yard during the day and seemed to be doing fine. After eating dinner, he seemed to be unusually drowsy. Over the course of the evening, the wife realized that he was very confused and was too weak to ambulate. She summoned EMS, and he was taken to ED.   Of note, he had an episode of confusion lasting several days in 2/2021. No fever at that time. Evaluated in ED on 2/20/2021. CT Head and labs unrevealing. Released to home.  Initial vital signs 4/30/2021 at 00:59:  Temperature-100.4°, blood pressure-133/68, pulse-110, respirations-18, room air O2 saturation-97%. He subsequently had a T-max of 102.8°.  He received empiric therapy with dexamethasone, vancomycin, ceftriaxone, ampicillin, acyclovir on the evening of 4/30.  The morning of 5/1 he was afebrile, alert, oriented x3. Steroids and anti-infective discontinued. He was observed in the hospital for another 24 hours and had no recurrence of fever, confusion.
09/08/22 presents to Hematology/Oncology for "chemo". PMHx of "Kappa light chain multiple myeloma/plasma cell leukemia"
Information has been received from a physician concerning a female patient who was vaccinated with a first dose of Gardasil. The patient developed a rash all over the body after the injection. Unspecified medical attention was sought. The patient's outcome was unknown. Additional information has been requested. This is in follow-up to report(s) previously submitted on 4/6/2007.  Initial and follow-up information has been received from a physician concerning a 24 year old female patient with no known food or drug allergies, who was vaccinated with a first dose of GARDASIL.  The patient developed a rash all over the body approximately 10 days after the injection.  The physician characterized the rash as "raised, non-itchy and non-painful".  Unspecified medical attention was sought.  The patient recovered about 10 days later.  Additional information has been requested.
I have been sneezing for no reason.  I have felt soreness in my right thigh but no wounds or injuries. It has progressed to my leg .  It is more sensitive when lying down. I have not seen a doctor or suffered severe reactions to the vaccine.
On 10/3/2012 at 4:30 am, mother notes red spots in a circular pattern. At 7:30pm mother noted a dark red "ashy" 3-inch diameter circle at injection site on right arm (deltoid) when she picked child up after work. Arm felt warm and had a tough leathery feeling. Child had mild low grade fever. Took child to ER; Treated by ER with PO Benadryl and Ibuprofen.
Pt p/w a 5 day hx of diarrhea, nausea chills, dry consistent cough w/some intermittent cramping of bilat lower abdomen.  COVID test positive (4/28) despite receiving Moderna vaccines (2/4 & 3/3/21). Given drops in her O2 saturation, admitted for medical management of acute hypoxic respiratory failure secondary to COVID-19. Received dexamethasone, tocilizumab during admission and ceftriaxone for catheter-related UTI.  Pt recovered and ultimately was discharged on 5/11 with followup.
Information has been received from a health department nurse concerning a 5 year old female who on 2/24/05 was vaccinated with a dose of varicella virus vaccine live (lot # 632371/1464J). The nurse reported a case of break through varicella between May and July 2004. The case appeared mild. It was unknown if medical attention was sought or if treatment was required. A product quality complaint was not involved. Follow up information was received from the nurse who reported that on 6/16/04, the patient developed varicella after being exposed at her day care to an infectious, unvaccinated 5 year old male child who had a fever and greater than 100 lesions and vesicles on his face, chest, back, arms, and legs. The patient had a fever for about one week and about 40 lesions in the hairline, axilla, torso, behind the knees, and feet. The patient recovered and returned to school on 6/28/04. The nurse reported that there were no adverse experiences related to vaccine, but rather evidence that the vaccine prevented the child from developing a severe case of varicella. No further information is expected.
Patient fainted after vaccine administration. 911 was called and EMTs responded, patient was observed by pharmacist on duty, did not need further medical support.
"COVID ARM" itchy red painful splotch at injection site about 9 days after injection, and facial flushing showed up around the same time. The flushing has reduced, but the red splotch is still going strong
PT STATED GOT FLU AND PNEUMONIA SHOT; WENT TO ER NIGHT OF INJECTION; WAS TOLD HE HAD CELLULITIS; WENT TO MD THIS AM AND GIVEN ANTIBIOTICS.
Itchy/painful large welt and knot under skin at injection site 1 week post injection
Uncontrollable chills; body aches; lower and frontal headache; upper back pain; neck pain; hives on legs; This is a spontaneous report received from a non-contactable other hcp. A 26-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EN5318), intramuscular on 28Jan2021 as single dose for COVID-19 immunization. Medical history included COVID-19 from an unknown date and unknown if ongoing. Concomitant medications were not reported. The patient did not receive any other vaccine in four weeks. The patient did not have any known allergy. Post vaccination, the patient not tested for COVID. On 28Jan2021, patient experienced uncontrollable chills, body aches, lower and frontal headache, upper back pain, neck pain and hives on legs. It was unknown if the patient received any treatment for AE. The symptoms lasted for 2-3 days and approximately on an unknown date in 2021, patient recovered from all events.  No follow up attempts are possible. Information about Lot/batch number cannot be obtained.
Broke out in hives all over stomach, arms, and neck  a few hours after vaccine. Took Benadryl and woke up in the middle of the night very hot with another round of hives all over.
Severe rheumatoid- Like arthritis. Oct 2000-present, multiple joint deterioration. One knee replaced.
About 12 hours after vaccines, 2 seizures (3 minutes and 10 minutes long). Fever of 106 noted in ambulance. Since the urine culture was lost we are not sure if fever was from a UTI or from vaccines.  DOS 10/11-10/12/06 DC DX: Fever, probably UTI. Cultures pending, if cultures are negative fever may have been secondary to immunization reaction. final cultures not submitted. Temp in ER 99.8 (R). Temp in ambulance 106 (R). Episode during night approximately 3 minutes then second episode approximately 10 minutes, no noted eye deviation. Pt on ceftriaxone for possible pyelonephritis.