chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received on 17-JUL-2017 from a medical assistant regarding a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 16-JUN-2017 the patient was vaccinated with ROTATEQ lot # M046000 expiration 27-JUN-2018 for prophylaxis which was improperly stored. No adverse effects reported. The vaccine was stored at the temperature of 50 degrees Fahrenheit for the time frame of 16 hours. There was no previous temperature excursion. The call was made due to a data logger. No further information was provided. Additional information has been requested.
only the liquid portion of PENTACEL was administered to a patient and the Acthib portion (lyophilized) was not reconstituted or used with no reported adverse event; Initial information received on 29-Sep-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 15 months old female patient who was administered only the liquid portion of pentacel and the acthib portion (lyophilized) was not reconstituted or used with no reported adverse event while receiving vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) and INFLUENZA VACCINE INACT SPLIT 3V (FLULAVAL), both for Prophylactic vaccination.  On 27-Sep-2022, the patient received 0.5 mL dose of dose 4 of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (formulation and strength not reported; lot U7256AB and expiry: 13-May-2023) via intramuscular route in vastus lateralis for prophylactic vaccination.  On 27-Sep-2022, (latency: same day) only the liquid portion of pentacel was administered to a patient and the acthib portion (lyophilized) was not reconstituted or used with no reported adverse event (single component of a two-component product administered) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Pt recv vax on 12/28/98; on 1/6/99 pt exp fever (105), rash, fussy, not walking, appetite loss, sleepy, crying & combative, not social; tx=Amoxicillin, Pediazole; no response to IVF or Motrin; dx=possible viral encephalitis
This spontaneous report as received from a pharmacist refers to a 73 years old female patient. The patient was vaccinated with AFLURIA. Other suspect therapies included PNEUMOVAX23. No concomitant medications were reported. On an unknown date the patient experienced pain in unspecified arm after an unspecified inactivated influenza vaccine (unknown if AFLURIA specifically, brand name and manufacturer unspecified) was administered on an unspecified date. Pharmacist also reports that a dose of PNEUMOVAX-23 was administered "approximately 3 weeks prior" to the influenza vaccination, in the patient's same arm. No treatment information was reported. The outcome of pain in arm is unknown. The relatedness for pain in arm is unknown for AFLURIA. Additional information has been requested.
At 1010, reports feeling like her throat is swollen. No SOB, able to swallow and drink water.  No signs of distress.  Pox 100, BP145/72. Continued to monitor, checking pox and BP every 5 minutes x 3 - stable.  No increase or decrease in symptoms reported.   50 mg benadryl liquid given PO at 1033.  Continued to monitor.  No change in symptoms, Vital signs stable. 1050- reports slight decrease in symptom.  VSS, no SOB, no distress.  Taking PO without difficulty.   1051- DC back to work at the hospital with  coworker present.  Instructed to report to the emergency department immediately with any increase in symptoms.  When she returns for her second dose, informed that she should plan to stay for monitoring for an extended period of time.
The physician reported that on 10/22/2000 the patient presented with chickenpox. The patient had 200 papular lesions, 5 vesicular lesions, and fever of 103F for 24 hours. Unspecified medical attetion was sought. Additional information has been requested.
Difficulty breathing, high blood pressure and heart rate.  Very sick for the next 3 days...bedridden due to sickness; nausea, shaking, weakness, muscle aches, joint aches, severe headache, stomach pain, skin blisters, fever and chills, injection site pain, tiredness, dizziness.  By the 4th day I am still weak and now I have skin blisters on my body in various places. Today is the 5th day and I still feel weak and slightly sick, nausea and fatigue and more skin blisters, fever.
h/a x 2 wks; sore throat x 2 wks; prev allergic react to PNC; prev exema (rash) exasberated; insomnia x 2wks;
fever; body aches; headache; sore throat; severe arm pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 02Oct2022 at 15:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 59 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "no" (unspecified if ongoing). Concomitant medication(s) included: BUPROPION; SYNTHROID; TOPIRAMATE. Past drug history included: No, reaction(s): "Allergy". Vaccination history included: Covid-19 vaccine (Primary immunization complete, unknown manufacturer), for COVID-19 Immunization; Covid-19 vaccine (Dose 3, unknown manufacturer), for COVID-19 Immunization. The following information was reported: PAIN (non-serious) with onset 03Oct2022 at 08:00, outcome "recovered", described as "body aches"; PYREXIA (non-serious) with onset 03Oct2022 at 08:00, outcome "recovered", described as "fever"; HEADACHE (non-serious) with onset 03Oct2022 at 08:00, outcome "recovered"; PAIN IN EXTREMITY (non-serious) with onset 03Oct2022 at 08:00, outcome "recovered", described as "severe arm pain"; OROPHARYNGEAL PAIN (non-serious) with onset 03Oct2022 at 08:00, outcome "recovered", described as "sore throat". Therapeutic measures were not taken as a result of pyrexia, pain, headache, oropharyngeal pain, pain in extremity.  Additional information: Covid prior vaccination: No. Covid tested post vaccination: No. Known allergies: No. Other medical history: No. No other vaccine in fourweeks.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
pt has had a migraine since 17DEC96;pt had a burning sensation on face 18DDEC96 which has resolved;pt also has chest pain;
Narrative: Symptoms:  Rash & SHORTNESS OF BREATH AND SWELLING OF THROAT Treatment:  METHYLPREDNISOLONE 125 MG ONCE ,FAMOTIDINE 20MG MG ONCE
PATIENT PRESENTED WITH HIS MOTHER, WHO PURPOSELY DOCUMENTED AN INCORRECT DOB ON THE CONSENT FORM, MAKING THE PATIENT APPEAR TO BE 16 YEARS OLD. IN FACT, AT TIME OF THE INJECTION, PATIENT WAS ONLY 15 YEARS OLD AND NOT APPROVED TO RECEIVE THE VACCINE.  WE WERE NOTIFIED BY THE IMMUNIZATION REGISTRY ON 4/16/2021 THAT THERE WAS A DISCREPANCY, AND WE CONTACTED THE MOTHER ON 4/16/2021 WHO ADMITTED OVER THE PHONE THAT SHE LIED ABOUT HER SON'S AGE SO THAT HE COULD RECEIVE THE VACCINE.  AS OF 4/16/2021, THE PATIENT REPORTS NO ADVERSE EVENT OR REACTION, BUT IT WAS RECOMMENDED BY THE IMMUNIZATION REGISTRY THAT WE DOCUMENT THIS THROUGH VAERS. PATIENT IS ALSO AWARE THAT, PER INTERIM GUIDANCE, THEY WILL NOT RECEIVE THE SECOND DOSE UNTIL THEY TURN 16 YEARS OLD, OR IF THERE IS APPROVE A LOWER AGE GROUP FOR THE SERIES.
Cellulitis in her arm; Arm started to itch; This spontaneous case was reported by a consumer and describes the occurrence of CELLULITIS (Cellulitis in her arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced CELLULITIS (Cellulitis in her arm) (seriousness criterion medically significant) and VACCINATION SITE PRURITUS (Arm started to itch). At the time of the report, CELLULITIS (Cellulitis in her arm) and VACCINATION SITE PRURITUS (Arm started to itch) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medication provided. Treatment included self-administered Advil.  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.   This case was linked to MOD-2021-073856 (Patient Link).; Sender'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.
severe swelling of lt arm where inj was given-severe swelling lt side of face-severe burning of skin w/o rash weakness, swollen eyes & mouth, SOB;
Mucous membranes inflammatory reaction. Mouth became raw within several hours. Continued to get worse over the next 48 hours. followed by 2-3 days of diarrhea with stringy mucous.
SMALL BLISTER WITH ITCHING AND BURNING SENSATION. NO PAIN/ NO RASH/ NO FEVER. APPEAR 1 DAY AFTER VACCINE. 2/26/18- THE BLISTER GONE DOWN, NO OTHER SYMPTOM.
Very disoriented; Equilibrium was off; BP was 244; Extreme fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DISORIENTATION (Very disoriented), BALANCE DISORDER (Equilibrium was off), HYPERTENSION (BP was 244) and FATIGUE (Extreme fatigue) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     The patient's past medical history included Hysterectomy.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jan-2021, the patient experienced DISORIENTATION (Very disoriented), BALANCE DISORDER (Equilibrium was off), HYPERTENSION (BP was 244) and FATIGUE (Extreme fatigue). On 14-Jan-2021, DISORIENTATION (Very disoriented), BALANCE DISORDER (Equilibrium was off), HYPERTENSION (BP was 244) and FATIGUE (Extreme fatigue) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Jan-2021, Blood pressure measurement: 244.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient was 40 years old when she had a hysterectomy, which was the only surgery she had in her life. That time she felt her equilibrium was off, which lasted days. Not until 16-Jan-2021, she was able to walk unassisted. She saw her physician on 12-Jan-2021 and her pressure had gone down. She was feeling better. She was not allergic to anything. The patient had a follow up appointment with her physician on 26-Jan-2021. Concomitant medications were not provided. Treatment information was not reported.
Chills, fever 101.3 Back, shoulder, neck pain Headache General malaise
No Adverse Event; They have given patient an expired Moderna vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (They have given patient an expired Moderna vaccine) and NO ADVERSE EVENT (No Adverse Event) in an elderly patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 066H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    In April 2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In April 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (They have given patient an expired Moderna vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (They have given patient an expired Moderna vaccine) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (They have given patient an expired Moderna vaccine).    This case is for 7th patient from 13 patient's case.  Concomitant product use was not provided by the reporter. It was unknown if patient receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. Vials went from freezer to room temperature on days of administration. Dates of administration of vaccine were 14-Apr-2022, 21-Apr-2022, and 28-Apr-2022. Vial did not undergo any temperature excursions. 13 doses total given from 3 vials. Multi dose vial size was 5.5mL. Age group of patients were mostly over 65 and they did report all of them in the VAERS website. Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-696547 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-696547:Master case
lethargy; Severe heaviness in limbs; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on 24May2021 as single dose for Covid-19 immunization. The patient's medical history was not reported. Concomitant medications included lithium chloride 400 mg twice a day, sertraline hydrochloride (ZOLOFT 150 mg) at 150 mg, quetiapine fumarate (SEROQUEL 200 mg) at 200 mg and lorazepam (ATIVAN 1 mg) at 1 mg. Caller reported that she received vaccine last Monday. She took the following medications: lithium, ZOLOFT, SEROQUEL and ATIVAN. Caller would like to know if there was a possible interaction with those medications and would like to know if there was a drug interaction with lithium chloride. Caller reported that she was experiencing lethargy and severe heaviness in limbs. The caller was fine she had felt lethargic to a degree that she was concerned. The caller also had severe heaviness in her limbs. The caller declined to file a safety report, no further information or details were captured at this time. The caller was provided with phone number, option 3, and hours of operation of Monday through Friday, 8 AM to 8 PM EST, 9 AM to 3 PM Saturday and Sunday, prior to warm transfer. Seriousness reported as No. Outcome of the events was recovered on an unspecified date in May2021.  Information about lot/batch number has been requested.
Information has been received from a nurse practitioner concerning a patient who was vaccinated with a second dose of VARIVAX (Oka/Merck). The nurse practitioner reported that a patient received the second dose of VARIVAX (Oka/Merck) and developed "a reaction". The patient was hospitalized. The type of reaction unspecified and reason for hospitalization unspecified. There was no product quality complaint. Additional information has been requested.
By 4:00 pm, I was in excruciating pain from head to toe.  Muscles in legs were most affected--couldn't walk at times.
no adverse reaction but the vaccine was not dilute properly prior to administration. pt reports arm pain and nothing else
Initial information received on 07-Jan-2019 regarding an unsolicited valid non-serious case received from a Nurse. This case involves a two months old (unknown gender) patient who received first dose of PENTACEL (lot C5451AC, expiration date: 17-Dec-2018 via unknown route in the right thigh on 07-Jan-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included was HEPATITIS B VACCINE (HEPATITIS B VACCINE) and ROTARIX. It was an actual medication error due to expired vaccine used. A two month old patient received PENTACEL which was expired. It was unknown whether patient experienced any adverse event following vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Myalgia & NauseaVomiting Narrative: She had covid in the past 90 days and has body aches like she felt during the Covid illness
CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient via a company representative concerned a patient of an unspecified age, sex, race and ethnicity The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry were not reported) dose was not reported, 1 total administered almost 3 months ago to the reported date 25-JUN-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient reported that IGA antibody test was completely negative (confirmed immunological vaccine failure). Laboratory data included: SARS-CoV-2 IgA antibody test: Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000224730 The suspected product quality complaint has been confirmed to be the reported allegation could not be determined. A manufacturing related root cause could not be identified based on the PQC evaluation/investigation performed.; Sender's Comments: V0: 20220408605-COVID-19 VACCINE AD26.COV2.S-Confirmed immunological vaccine failure. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Initial unsolicited report received from a nurse on 26 January 2016. This case involves 16-month-old (reported as 1-year-old) female patient who was vaccinated with second dose of INFLUENZA QUADRIVAL A-B VACCINE (Fluzone) (batch number-U5338BA, expiry date- 30 June 2016) intramuscularly on thigh on 13 November 2015. The patient had also received second dose of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (Daptacel) (batch number-C4781AA, expiry date- 25 July 2017) intramuscularly on thigh and third dose of HEPATITIS A VACCINE (HEP A.) (batch number not reported) intramuscularly on thigh on 20 January 2016. The patient's medical history includes vaccination with three doses of Pentacel and had not experienced any adverse events and illness at time of vaccination, birth defects, medical conditions were reported as none. The patient's pre-existing physician diagnosed allergies were reported as no known allergy. The patient's concomitant medications were not reported. On 17 November 2015, four days following the vaccination with FLUZONE vaccine, the patient had experienced diffuse urticaria initially concentrated to her trunk. On an unspecified date, the patient had experienced facial swelling, hand swelling and diffuse hives. On an unspecified date, 4 days following the vaccination with Hep A and Daptacel vaccine, the patient had experienced hives again. The patient required ER/doctor visit. Laboratory data was not reported. Initially the patient had received CLARITIN and ranitidine and later on the patient had received OTC medications as corrective treatment. The patient was recovered from event urticaria on trunk. The outcome of events facial swelling hand swelling and diffuse hives was reported as not recovered. List of documents held by sender: none.
I am testing positive too and I still fine/ I had the Pfizer shot; I am testing positive too and I still fine/ I had the Pfizer shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; bnt162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), 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: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "I am testing positive too and I still fine/ I had the Pfizer shot". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (15Sep2023) Negative, notes: I came back negative; (unspecified date) Postive, notes: I am testing positive too and I still fine; (unspecified date) Postive, notes: she still tested positive for Covid; (unspecified date) Negative, notes: She tested negative already. Paxlovid was taken as treatment for COVID-19  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5, bnt162b2 has been requested and will be submitted if and when received.
Patient reported going to the hospital on 3/11/21 and spending 3 days at the hospital.  They were able to get his atrial fibrillation under control.
Satellite lesion in vaccinated lab worker. See attached records. Believed to be first dose of smallpox vaccine pt has received. Report received via CDC rash illness surveillance. Pt presented with a primary vaccine "take" with a 1.5cm vesicle with surrounding erythema. No systemic symptoms or lymphadenopathy. On day 11 post vaccination, she noticed a second blister 3 inches from the primary lesion, about 1cm in diameter. Not itchy. She had kept the vaccination site covered. She recalled playing field hockey about 4 days after vaccination and was sweating at that time. She does not recall touching the primary lesion. History of asthma uses albutamol PRN, no steroids, no history of eczema. Physical exam-no significant finding apart from lesions as described. No fever or constitutional symptoms. Discussed likely diagnosis of satellite lesion caused by vaccinia virus. Pt instructed re local care and physician will re-evaluate her in 24 hrs and call back if there is progression.
Patient experienced normal adverse reactions in the first two days after receiving their first dose of the vaccine including arm pain, headache, fatigue, low grade fever, and nausea. On the third day, patient experienced major body pain, chills, body sweats, and reported fainting. Patient reports feeling so nauseous that she can't even make it to the bathroom anymore. Symptoms continue to persist 3 weeks after the first dose. It is unclear if patient received any treatment for symptoms.