chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a nurse concerning to a 3 months old patient of unknown gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 08-JUN-2015, the patient was vaccinated with an improperly stored dose of ROTATEQ injection (lot # K023534, expiration date: 22-MAY-2016) (strength and dose were unspecified), the route was defaulted to oral. No concomitant medications were reported. No adverse effect had been observed or reported. The outcome of the event was unknown. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sore at the injection site in her left arm; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore at the injection site in her left arm) and FATIGUE (Fatigue) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 vaccination: Flu shot in October 2021; for Product used for unknown indication: Allegra. Past adverse reactions to the above products included Bone disorder with Allegra; and No adverse event with Flu shot. Concurrent medical conditions included Blood pressure high, Cholesterol, Antihistamine therapy and Seasonal allergy (summer allergies). Concomitant products included CETIRIZINE HYDROCHLORIDE for Antihistamine therapy, LISINOPRIL for Blood pressure high, ROSUVASTATIN for Cholesterol, GLIPIZIDE for an unknown indication.    On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, the patient experienced VACCINATION SITE PAIN (Sore at the injection site in her left arm) and FATIGUE (Fatigue). On 16-Feb-2021, VACCINATION SITE PAIN (Sore at the injection site in her left arm) and FATIGUE (Fatigue) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No treatment medication was reported. Patient had never COVID positive test or diagnosis. No medical history was relating to mentioned AE and both acute and Chronic illnesses at the time of vaccination. It was reported that patient did not seek for medical care for AE. It was reported that many years ago she took Allegra D but it kind of dried her bones out, so she started to take Cetirizine. Patient could barely walk in yesterday.   This case was linked to MOD-2022-638956, MOD-2022-638958 (Patient Link).
caller already had two boosters and he was diagnosed with COVID-19 early this month; caller already had two boosters and he was diagnosed with COVID-19 early this month; 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.  An 80-year-old male patient received BNT162b2 (BNT162B2), on 26Jan2021 as dose 1, single (Batch/Lot number: unknown, FL9265 or maybe EL9265), on 16Feb2021 as dose 2, single (Batch/Lot number: unknown, EL9267 or might be EI9267), on 27Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown, FE2588 or FI2588) and on 06May2022 as dose 4 (booster), single (Lot number: FJ9943) at the age of 80 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 07Oct2022, outcome "recovered" and all described as "caller already had two boosters and he was diagnosed with COVID-19 early this month". Patient already had two boosters and he was diagnosed with COVID-19 early this month 07Oct2022. Patient also stated that he took a complete course of Paxlovid, though he was symptom free from the second day on. Patient had an appointment for the gray cap bivalent Pfizer BioNTech COVID 19 vaccine and asked if he should get it. 07Oct2022, was diagnosed with Covid-19. Symptoms were very mild and only lasted for 1 day. Doctor put him on Paxlovid, the 5 day regimen, that it helped immensely. By the second day, the symptoms were gone. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (07Oct2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
mom reported 17JAN95 that w/in 1st 48 hrs p/vax on 22NOV94 that pt exp periods of apnea; states did not notify any medical personnel; states p/48 hrs pt quit having period of apnea; had no fever;
Pain and sensitivity for 24 hours, now gone, followed by spreading, itchy red rash, 10 days now
Arm pain since vaccination was administered intermittent joint pain with in 1 day hands, knees, fingers. No arm pain after injection until approximately 4 days later.
Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Nov-2021 at 5:48 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 16-Nov-2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). At the time of the report, PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  No treatment medication information was provided.  The facility had a temperature excursion for the Moderna Covid-19 vaccine.  The patient was given doses from a vial that were stored in an ultracold freezer which is colder than the standard storage conditions.   This case was linked to MOD-2021-402935 (Patient Link).
8 hours after vaccine patient had a severe headache and nausea. Gradually over the course of the next 24 hours the headache became unbearable and the patient went to the ER where he was diagnosed with iritis/uveitis , given prescription drops and told to follow up with primary care physician.
pt recvd vax;exp rash on face & hands; rash did not clear w/ hydrocortisone; to take to MD if rash cont; 3rd dose of EngB adm w/o event
Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 02-Feb-2022; Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 02-Feb-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 02-Feb-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 02-Feb-2022) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2022 at 2:00 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 02-Feb-2022 at 2:00 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 02-Feb-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 02-Feb-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 02-Feb-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 02-Feb-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Patient allergies to medications, food and other products was unknown. It was reported that patient ethnicity reported. The patient received Moderna vaccine on 02-Feb-2022 14:00:09, past its30 day of expiry date. Vaccine went into 2-to-8-degree Celsius thaw state on or about 24-Dec-2021. This vaccine was administered up until its manufacturing expiry date of 04-Apr-2022.  No treatment medications were provided.   This case was linked to MOD-2022-542869 (Patient Link).
No adverse event; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) and NO ADVERSE EVENT (No adverse event) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020F21A and 002CZ14) for COVID-19 prophylaxis.     No Medical History information was reported.   On 22-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 07-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 07-Sep-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered).    No concomitant medications were reported. It was unknown whether the patient ever been diagnosed with/ tested positive for COVID-19. It was unknown whether patient had Chronic or long-standing health conditions and Acute illnesses at the time of vaccination and up to one month before. No treatment medications were reported.   This case was linked to MOD-2023-716874 (Patient Link).
Information has been received from a physician concerning a 13 year old female with a history of asthma who on 28-MAR-2008 was vaccinated with the first dose of Gardasil (lot# not reported).  Concomitant suspect therapy included Varivax (Oka/Merck) (MSD) (lot# not reported).  Other concomitant therapy included Tdap (lot # not reported) and Hep A (unspecified) (lot# not reported).  On 28-MAR-2008 the patient urinated on herself and was dazed for about 10 minutes after receiving the first dose of Gardasil.  Subsequently, the patient recovered from having urinated on herself and being dazed.  The patient sought unspecified medical attention in the physician's office.  No other information is available at this time.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 04/14/2008. Information has been received from a physician concerning a 13 year old female with a history of asthma who on 28-MAR-2008 was vaccinated IM in the left arm with the first dose of GARDASIL (658182/1757U). Concomitant suspect therapy included SC vaccination in the left arm with VARIVAX (lot# 659940/1798U). Other concomitant therapy included IM vaccination in the left arm with ADACEL (Sanofi Pasteur) (C2904AA), IM vaccination in the right arm with HAVRIX (GSK)(AHAVB223AA) and IM vaccination in the right arm with MENACTRA (Sanofi Pasteur) (U2546AA). On 28-MAR-2008 the patient urinated on herself and was dazed for about 10 minutes after receiving the first dose of GARDASIL. Subsequently, the patient recovered from having urinated on herself and being dazed. The patient sought unspecified medical attention in the physician's office. No other information is available at this time. Additional information received from B-form (18-APR-2008). The patient became light-headed and was incontinent of a large volume of urine. The patient remained listless for 3-4 minutes and responded within another 2 minutes. Additional information is not expected.
From telephone contact received on 11/20/02, it was reported by a nurse that a 48 year old female received Fluzone (lot number U0966AA) administered IM in the left deltoid on 11/14/02 at 1:45 pm. The patient reported that on 11/19/02, she started having numbness in her thighs. The patient has not seen a doctor. The symptom has not yet resolved.
Case number PHHY2012US051496 is an initial literature report received on 12 Jun 2012. Authors searched VAERS for reports of adverse events (AEs) in pregnant women who received trivalent inactivated influenza vaccine from 01 Jul 1999 through 30 Jun 2009. This case refers to a pregnant female patient (age not specified). She was vaccinated with trivalent inactivated influenza vaccine (seasonal influenza vaccine, manufacturer and batch number: unknown) at an unknown gestational age, on an unspecified date between 01 Jul 1999 through 30 Jun 2009. On an unknown date after vaccination, the patient developed pregnancy induced hypertension. The outcome of the event pregnancy induced hypertension and outcome of pregnancy were not known. The causality was not reported. The VAERS system does not allow for active follow-up of adverse events among present women; thus, pregnancy outcome data are not available for women who had an adverse pregnancy event. Authors concluded that no unusual patterns of pregnancy complications or fetal outcomes were observed in the VAERS reports of pregnant women after the administration of trivalent inactivated influenza vaccine.
Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Severe, Systemic: Allergic: Itch Generalized-Mild
Information has been received from a nurse concerning a 22 month old patient who on 11-AUG-2011 was vaccinated with a dose of VARIVAX (Merck) (lot # 669918/0112AA). The nurse mentioned that on 04-JUN-2012 the patient had outbreaks of varicella. The patient had contacted the office. At the time of the report, the patient's status was unknown. This was one of the several reports from the same source. A lot check has been initiated. A follow up information has been received from a registered nurse refers to a 22 months (reported also a 1 year old) male patient. The patient's medical history included cellulitis and colic, patient had none illness at the time of vaccination. The patient was vaccinated subcutaneously in right leg with first dose of VARIVAX (Merck) (dose not reported, lot # 669918/0112AA) on 11-AUG-2011. It was reported that on an unknown date, patient came to clinic with a rash described as "macular, vesicular rash over trunk. No excoriation marks were noted". Diagnosed was chickenpox. At the time of the report the patient's status was unknown. None lab diagnostic tests were performed. This is one of several reports from the same source. Additional information is not expected.
NEARLY KILLED WITH COVID VACCINE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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: Unknown) 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 nearly killed with covid vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of nearly killed with covid vaccine was not reported. This report was non-serious.
Patient called after arriving home to complain of facial numbness and significant redness/hotness to her face and was referred to ER for immediate care where patient developed itching/rash of the face. She was treated with hydroxyzine and steroids at clinic and released.
ATYPICAL FORM OF GUILLAIN-BARRE SYNDROME/ AXONAL TYPE ACUTE INFLAMMATORY POLYNEUROPATHY; This spontaneous report received from a health care professional concerned a patient of 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 not reported, batch number: Unknown and expiry: Unknown) dose was not reported, 1 total administered on MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. It was reported that 2 weeks after vaccination the patient started developing signs of a fulminant inflammatory peripheral neuropathy. On AUG-2021 the electromyogram testing performed on patient confirmed an atypical form of guillain-barre syndrome/ axonal type acute inflammatory polyneuropathy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of atypical form of guillain-barre syndrome/ axonal type acute inflammatory polyneuropathy was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210902802-covid-19 vaccine ad26.cov2.s-atypical form of Guillain-Barre syndrome/ axonal type acute inflammatory polyneuropathy. This event(s) is considered related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and is scientifically plausible. There is no information on any other factors potentially associated with the event(s).
Systemic: Exhaustion / Lethargy-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: pt said his throat felt dry, but had no issues swallowing or breathing.
1st dose 2014, 2nd 2019; 2nd dose in 2019, 3rd not yet; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 63-year-old female patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis, HAB (Twinrix) for prophylaxis, hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis and HAV (Havrix) for prophylaxis.   Previously administered products included Havrix (received first dose of Havrix in 2014) and Twinrix (received first dose of Twinrix in 2014).   On an unknown date, the patient did not receive the 3rd dose of Twinrix, Twinrix Pre-Filled Syringe Device, the 2nd dose of Twinrix, Twinrix Pre-Filled Syringe Device and the 2nd dose of Havrix. On an unknown date, unknown after receiving Twinrix, Twinrix Pre-Filled Syringe Device and Havrix, the patient experienced drug dose administration interval too long and incomplete course of vaccination. On an unknown date, the outcome of the drug dose administration interval too long and incomplete course of vaccination were unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 13-Jan-2023 Reporter's comment: The pharmacist reported that the patient received first dose of Havrix in 2014 and second dose in 2019. After 2nd line consult it was mentioned that she was not sure if it was havrix or possibly twinrix. The patient had no proof of documentation so was trying to figure all this out and what to do next. The reporter consented to follow-up. Additional supportive information: The patient received the second dose of Havrix and Twinrix later than the recommended interval, which led to lengthening of vaccine schedule. Till the time of reporting, the patient did not receive the third dose of Twinrix, which led to incomplete course of vaccination. As per reported information, it was not clear whether the patient had received Havrix doses or Twinrix doses therefore in worst approach, the case was kept valid with both Havrix and Twinrix considering that the patient received both the vaccines and had medication error and for further clarification query was raised.
Patient has been treated with Humira for four years and remained symptom free. Received Pfizer Covid vaccinations on 8/16/2021 and 9/20/21. Within one week of receiving second dose Crohn's symptoms returned and Humira was no longer effective. Patient was hospitalized for Crohn's in January 2022. Per patient she feels that vaccine caused Humira to no longer be effective for controlling her Crohn's disease.
About 5cm redness at site of injection. Not tender. No mass or abscess noted at 48 hours post injection.
about 5 min after receiving vaccine pt complains of tingling on entire left side of face - no facial dropping and lifting arms without difficulty and speech is not slurred - injection site unchanged - neuro check neg - BP 150/80 (systolic usually 140 per pt), Pulse Ox 99%, HR 71 - pt not eaten today (10 am) and had coffee  stayed in chair with feet up (kept in recovery for 30 min) was able to stand withour difficulty, gait normal, told to seek medical attention if symptoms return
This initial spontaneous case, was received from nurse on 10-Oct-2017, concerning a 25-year-old adult female patient. The patient's medical history and concomitant medications were not reported. On 05-Oct-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, batch number: 195128, expiry date: Apr-2018, route of administration: intramuscular, anatomical location: deltoid). On the same day, within an hour of vaccination, the patient had headache, dizziness, warmth and itchiness at injection site. The patient received BENADRYL for the events. The outcome of all the events was reported as recovered. The reporter assessed the events as non-serious. Follow up received on 21-Nov-2017: The gender of the patient (female) and outcome of all the events from not reported to recovered were updated. The narrative was amended accordingly.
lightheaded, dizzy, now wheezing, tightness of chest or throat; local react of hives; treated w/Epi & resolved in 30 mins; 14DEC93 f/u lightheadedness, chills & fever, myalgia which occurred w/in 15 mins of inject;
-MODERATE-SEVERE BODY/MUSCLE & JOINT ACHES AND PAIN -BEGAN 1/23/21 AROUND 10PM AND ENDED 1/24/21 AROUND 5PM
Hep A #1 given 3/10/06. Presented in office 3/16/06 with swollen left arm at Hep A injection site, arm red, swollen and warm to touch at injection site. Swelled after using Lachydrin on injection site.
PT EXP PAIN, STINGING, ERYTHEMA AND INDURATION AT SOI AFTER ENGERIX-B.  TREATMENT:  PT COUNSELING.  DOSE #2 09Feb90 PT COMPLAINED SIMILARLY OF PAIN AT SOI.