chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report has been received from a nurse practitioner referring to a 4 month old male patient. The patient did not have pertinent medical history, drug reactions/allergies, concurrent conditions or concomitant medications. On 07-APR-2018, the patient was vaccinated with the second dose of ROTATEQ by oral route (strength, dose, lot number and expiration date were not provided) for vaccination. Approximately on 16-APR-2018 (reported as "one week after the first twin showed symptoms"), the patient developed a milder case of "bloody streak in his stool, which was very mucous-like" (haematochezia). Although medical attention was sought, none laboratory studies were performed and no treatment was given. The outcome of haematochezia was reported as not resolved. The causality assessment between therapy with rotavirus vaccine, live, oral, pentavalent(ROTATEQ) and the event was not reported. Upon internal review, haematochezia was determined to be medically significant. This is one of two cases from the same reporter.; Sender's Comments: US-009507513-1804USA012023:
severe illness; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "severe illness".  Additional information: Caller was calling about the Pfizer COVID-19 vaccine. She mentioned that she completed her shots and never had COVID because she takes vitamins. She added that she lost her nephew due to a severe side effect and a heart attack after getting the vaccine and her niece got a severe illness from taking bad shots of the vaccine. She also said why we are giving this to people and it's having side effects because it was not tested.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
hives on arms legs, back of my neck  hive started on right wrist; Looks crusty; rash, rash on arms, rash on legs, rash on back of my neck,rash started on right wrist; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives on arms legs, back of my neck  hive started on right wrist), SCAB (Looks crusty) and RASH (rash, rash on arms, rash on legs, rash on back of my neck,rash started on right wrist) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030H21B, 046B21A and 0121A21A) for COVID-19 vaccination.     Concurrent medical conditions included Shellfish allergy, Penicillin allergy and Drug allergy (erythromycin).   On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced URTICARIA (hives on arms legs, back of my neck  hive started on right wrist), SCAB (Looks crusty) and RASH (rash, rash on arms, rash on legs, rash on back of my neck,rash started on right wrist). The patient was treated with HYDROCORTISONE (CORTIZONE 10) for Product use for unknown indication, at an unspecified dose and frequency; AVENA SATIVA FLUID EXTRACT (AVEENO) for Product use for unknown indication, at an unspecified dose and frequency and PARAFFIN (VASELINE [PARAFFIN]) for Product use for unknown indication, at an unspecified dose and frequency. At the time of the report, URTICARIA (hives on arms legs, back of my neck  hive started on right wrist), SCAB (Looks crusty) and RASH (rash, rash on arms, rash on legs, rash on back of my neck,rash started on right wrist) had not resolved.            No concomitant medications were reported  Patient stated that events were fade and if she wash in hot water they come up again. She used cortisone cream, nothing seems to take it away.
Immediate headache and pressure at base of skull into neck. L Arm stiffness/weakness/tenderness that goes down into my hand and left side neck tightness/stiffness (muscular), upper back & B/L shoulder aching and muscular stiffness.  Feels almost like a dull  ?electrical shock? feeling  across my upper back and down my left arm. Joint pain on the L side of my body-elbow, hip and knee.  All symptoms continue into the night on day 2 after the vaccine (past 24 hrs after receiving).
I developed a rash ten minutes after receiving the second dose. On my neck and it trailed down to chest area. They took me to Urgent Care and they gave me Benadryl and the Rash went away.
Started with severe diarrhea for 14 days, elevated liver enzymes up in the 200's. Then after diarrhea 2 wks clay colored stools. Several tests were done symptoms of diarrhea and bowel issue still evident with no cause, no diagnosis. Now speech regression.
no additional AE'S; mproperly Stored; Administered; This spontaneous report was received from a licensed practical nurse referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/ allergies were not reported.  On 01-APR-2021,  the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # 1687290, expiration date was reported as 02-SEP-2022, but upon internal validation established as 06-SEP-2022; dose and route were not reported) for prophylaxis, the vaccine was temperature excursion (product storage error). No additional AE reported.   The administered dose of the vaccine experienced a temperature excursion of 28.34 Fahrenheit (F) for 1 hour and 2 minutes. There was previous temperature excursion (30.28F for 19 minutes; 34.81F for 35 minutes). The digital data logger was involved. Device of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not available for evaluation (obtain was false).  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.  devicelotnumber: 1687290; expirationdate: 06-SEP-2022; deviceage and unit: 0 ; malfunction: Unknown; productavailableforevaluation: No; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2104USA002505: US-009507513-2104USA002840: US-009507513-2104USA002841: US-009507513-2104USA002847: US-009507513-2104USA002849: US-009507513-2104USA002850: US-009507513-2104USA002851:
Pt. lost consciousness and fell in the waiting room. She immediately regained consciousness and is doing fine.
Swollen thighs, non stop crying, cold and clamy, decreased appetite, limp.
Left arm became warm, red, swollen on inside of arm on upper arm and extending down about 2 inches below elbow.
Employee complains of chills, fatigue, nausea, diarrhea, body aches, possible low grade temp, has not taken temperature. Has taken two ALEVE.
I went into a severe event of Atrial Fribruation that lasted until I received a Cardioversion treatment 5 days later at Hospital. the cardioversion put me back in rhythm. During the time of my A-Fib event, my pulse was averaging about 150-160 BPM. I had never had a long-lasting event such as this before. I had an ablation 6 years ago and it is quite infrequent that I am out of sinus rhythm. I did go into A-Fib soon after my 1st vaccination for a period of 1 1/2 days.
Pt recv vax on 9/21/98; on same day pt exp inconsolable crying, vax site redness, swelling & warmth
How long can side effects last after the shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (How long can side effects last after the shot) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (How long can side effects last after the shot). At the time of the report, VACCINATION COMPLICATION (How long can side effects last after the shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications was reported.  Treatment information was not provided.
Patient has cellulitis to left arm, red & swollen at the vaccine site. vaccine were given at a different provider office.
All over body ache day after vaccination; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP).  A 41-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 41 years for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose : 03, Manufacturer: Unknown), for Covid-19 immunization; Covid-19 vaccine (Dose : 02, Manufacturer: Unknown), for Covid-19 immunization; Covid-19 vaccine (Dose : 01, Manufacturer: Unknown), for Covid-19 immunization. The following information was reported: PAIN (non-serious) with onset 09Sep2022, outcome "recovering", described as "All over body ache day after vaccination". It was unknown if therapeutic measures were taken as a result of pain.  Additional information: Product: COVID 19, brand; Pfizer BioNTech Omicron Booster.Since the vaccination, the patient had not been tested for COVID-19. It was unknown if patient receive any other vaccines within 4 weeks prior to the COVID vaccine; and unknown Prior to vaccination, was the patient diagnosed with COVID-19. Since the vaccination, patient was not tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient given ADACEL at 8:38 AM on 5/5/2010.  Pt began having headache, lightheadedness, dizziness, nausea, fevers, chills intermittently starting at 7 PM on 5/5/2010.  Had doctors appt on 5/6/2010 at 12:30 PM and was without fever.
Pt stated on 09/25/2021 that he had not received any previous covid 19 vaccines.  No previous history of covid 19 vaccines found in database.  On 10/16/21(scheduled 2nd dose appt for Pfizer) patients immunization history in database shows that he did received a moderna vaccines in january  and February of 2021.   This was confirmed with facility that client did indeed received moderna in jan and feb of 2021. No additional doses of Pfizer given.
CRAMPS; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported per procedure no follow up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced cramps. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of cramps was not reported. This report was non-serious.
This spontaneous case, initially received on 03-Oct-2018 from other health professional (nurse), concerns a 59-year-old, adult female patient. On 03-Oct-2018, the patient was administered expired FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 195126, expiry date: 30-Apr-2018) (explicitly coded as expired vaccine used).  At the time of this report, the patient had not experienced any adverse event. The reporter assessed this case as non-serious. This case 201804266 was cross-linked to case 201804267 due to the same reporter. Follow up received from other health professional (nurse) on 30-Oct-2018: The patient's age (59 years) was added. The reporter confirmed that, the patient had not experienced any adverse event. The narrative and case comment were amended accordingly.
CHILD IDENTIFIED IN IMMUNIZATION REGISTRY. TOO YOUNG FOR VACCINE ON 6/4/2021.
Information has been received from a physician concerning a female patient who was vaccinated with three doses of GARDASIL. It was reported that patient was positive for HPV r11 6 11 16 18 vlp after getting all three doses of vaccination. The patient did not get the vaccination in the reporting physician's office. No other information to report. The patient was positive for hpv r11 6 11 16 18 vlp at the time of this report. Additional information has been requested.
This is a spontaneous report from a contactable consumer via Pfizer sales representative. A female patient of unspecified age and ethnicity received TRUMENBA, on an unspecified date at single dose. On the same day the patient felt like she was going to faint. The nurse asked her to lay down and put her feet up. She recovered after eating a cracker and getting a drink of water. She did not have anything to eat the day of vaccination, which could've contributed to the feeling of faint. The patient medical history and concomitant medications were not reported. No follow up attempts possible. No further information expected.
4th DTP given, only vax administered; pt reacted normally, went limp while mom carrying to car; brough back to clinic laid on floor arms contracted for @ least 3-4mins; breathing very shallow, apical pulse remained strong; pupils dilated;
About 2:30PM Hep A #1 given LA. After injection, stated she was dizzy and tip of tongue numb. Color pink. 2:35PM HR 34 R 20 BP 110/60 talking without difficulties. BS clear no wheezing lying on exam table. Reports blurry vision. 3:00PM tongue numbness resolving. Reports difficulty breathing inside hard to get air in and out. BS clear color pink HR 84 R 20 ambulance called - mom aware - will come to school. Ambulance arrives about 3:15 PM.
FOURTEEN DAYS AFTER RECEIVEING PROQUAD DEVELOPED FEVER UP TO 103.0 AND A BUMPY, BLISTERY RASH ON HIS FACE, CHEST, BACK AND ARMS.
Received PNEUMOVAX and FLUVIRIN in the left arm over 1 in apart. Patient developed redness, warmth. She was informed to use BENADRYL and ice. It helped relieve symptoms.
Pain at injection site, sudden ringing in ears, tunnel vision, light headed/fogginess, moving in slow motion, headache, dizziness, fainting.
incapacitated for 3 weeks from the 2nd vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, unknown manufacturer ), for COVID-19 immunization. The following information was reported: LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious), outcome "unknown", described as "incapacitated for 3 weeks from the 2nd vaccine". The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Numbness of the lips hands and feet. Swelling of the hands purple red rash a long arms. Highly elevated blood pressure. Tunnel vision. Shaking. 30 minutes after receiving second vaccine for Covid.
This spontaneous report as received from a Registered Nurse referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, previous drug reactions, allergies, concurrent conditions or concomitant medications. On 31-JUL-2018, the patient was vaccinated with improperly stored PEDVAXHIB lot # M020100 with expiration date on 07-MAR-2019 for prophylaxis (dose, route of administration and anatomical location date were not reported), and with ROTATEQ by oral route lot # N022017 with expiration date on 10-MAR-2019 for prophylaxis (dose was unknown). The doses of PEDVAXHIB and ROTATEQ were exposed to a temperature excursion of 47 degrees Fahrenheit (°F) to 77 °F during a time frame of 14 minutes, which was detected by the data logger. There was no prior temperature excursion and no adverse events were reported.
Patient reports symptoms of diarrhea, vomiting, flu like reaction, muscle weakness, muscle site pain, dehydration, joint swelling, congestion, coughing, sneezing, sputum production, and disorientation. Patient required two separate visits to Urgent Care and a follow up to with is general physician for these symptoms.
sore left shoulder; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE JOINT PAIN (sore left shoulder) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 031M20A) for COVID-19 vaccination.     Concurrent medical conditions included Cancer.   On 13-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) (Intramuscular) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced VACCINATION SITE JOINT PAIN (sore left shoulder). At the time of the report, VACCINATION SITE JOINT PAIN (sore left shoulder) outcome was unknown.            No concomitant drugs are provided and treatment drugs are also not provided by the reporter.; Sender's Comments: This case concerns a 66-year-old male patient with current cancer, who experienced a non-serious unexpected event of vaccination site joint pain. The event occurred on the same day of the second dose of mRNA-1273. The rechallenge is not applicable as patient experienced AEs after second dose and no information about the first dose is available and no additional dosing will be given. The benefit-risk relationship of mRNA-1273, is not affected by this report.
No additional AE reported.; Nurse reported administration of ROTATEQ after temperature excursion; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender.  No information regarding the patient concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On 23-JUL-2020, the patient was vaccinated with improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 2 milliliter, orally, lot number 1676324 has been verified to be valid lot number for rotavirus vaccine, live, oral, pentavalent, expiration date: 21-APR-2021 for prophylaxis.  It was reported that the dose of the product administered to the patient was not stored properly for the time frame of 20 hours in the temperature 8.83 degrees Celsius on unknown date prior to administration. There was no previous temperature excursion. Digital Data Logger was involved.  No additional adverse event was reported. The outcome of medication error was unknown.
Outgoing call to patient's father to discuss incorrect dose amount of Moderna 23/24 6m-11 given on 10/25/23. Patient's ordered dose was 0.25mL but was given approximately between 0.4-0.5mL. Patient's father expressed understanding. Instructions provided to monitor patient for additional or prolonged side effects with call back number for Nursing Supervisor. A message sent to patient's PCP informing them of error. Patient is being seen by pediatrician, Dr, on 11/1 for knee pain (~ 3 weeks according to appointment notes). Message sent to Dr informing of medication error as well. Inbound call from the mother, who had additional inquiries regarding the recent incident. She is seeking information about the follow-up procedures following the error, as well as any reporting protocols in place for vaccine-related mistakes. During the conversation, the mother was educated about the Vaccine Adverse Event Reporting System (VAERS) and expressed a desire to know if there are mechanisms in place to ensure that the process has been successfully concluded. To provide reassurance and document the interaction, the mother will receive a confirmation email from VAERS forwarded to her once the process is finalized.
Patient given pediatric Covid vaccine instead of adult dose. No symptoms. Patient, Pfizer and CDC notified. CDC instructed pt can get correct dose at any time.
Had a very heavy menstrual period 4 days after receiving 2nd vaccination (received 2nd dose on May 4, cycle started on May 8, which would have been the expected date that was normal for me). My next cycle came very early on May 21,  just 13 days after the prior cycle. That period was also unusually heavy. After that May 21 menstrual cycle, my periods have returned to regular intervals (normal for me) and of normal flow.  So I had 2 abnormally heavy periods after vaccination, and one cycle post 2nd vaccination that came 2+ weeks early.
fever; fatigue; malaise; This case was reported by a consumer via call center representative and described the occurrence of fever in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pyrexia (received 1st dose on an unknown date, refer case US2019109624).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fever, fatigue and malaise. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the fever, fatigue and malaise were recovered/resolved.   It was unknown if the reporter considered the fever, fatigue and malaise to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient's friend. The age at vaccination was not reported. The patient received Shingrix and, the patient developed fever, fatigue, and malaise that lasted approximately 2 to 3 days. The reporter did not provide any additional information. The reporter stated that the patient is in his 60's.
This spontaneous report as received from a physician refers to a 11 year old male patient. The patient's concurrent condition included asthma. The patient had no drug reactions/allergies. On 03-DEC-2017, the patient was vaccinated with GARDASIL 9 intramuscularly (lot # N017686, Expiry date: 02-FEB-2020) for prophylaxis. There was no concomitant medications administered. On 05-DEC-2017 (reported as within 2 days), the patient developed a hard mass in the chest which was causing the rib cage and overlying flesh to protrude outwards. On an unknown date, an x-ray was performed and the mass was not found by x-ray. Thus, an echocardiogram was performed on an unknown date and the mass was found to be 5 cm by 8 cm and located between the heart and the rib cage. There was no treatment given for the adverse event. The outcome of mass was reported as not recovered/not resolved. The reporter did not provide the causality assessment for the event. There was no product quality complaint involved.