chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a nurse practitioner (NP) and registered nurse (RN) concerning a 9-year-old female student with seasonal allergies and allergies to milk, nuts and eggs and no drug allergies who on 19-JAN-1998 was vaccinated SC in the left leg with the first 0.5 mL dose of Varivax (Lot#624447/1419E). There was no illness at the time of vaccination. It was also noted that a dose of MMR II was given at an allergist's office (date no provided). Concomitant therapy included loratadine (CLARITIN) and fluticasone propionate (FLONASE). It was reported that on 01-JUN-2006, the patient was seen in the physician's office with breakthrough chickenpox characterized by a rash with 30 small scattered pustules with an erythematous base mostly on her trunk. No fever or itching was noted. The patient was treated with diphenhydramine hydrochloride (BENADRYL) and oat (AVENO BATH). No laboratory/diagnostic tests were performed. Subsequently, the patient's chickenpox resolved. Additional information is not expected.
Redness starting below vaccination site and extending all the way around the arm and down to the elbow. Red area was hot and tender to the touch. Started the evening after the vaccine and started to improve by 11/13/17.
Syncope, seizure with rigidity urinary incontinence > in pt vehicle reported by mother. Pt tx'd with O2 and IV flds.
This is an initial spontaneous report from a contactable nurse. This nurse reported that her daughter, a 5-year-old, female child, received PREVNAR. The nurse reported the event of pneumonia on three different occasions. This is the third of three reports of pneumonia occurring in Sep2010. The child received 4 doses of PREVNAR, beginning on 04AUG2005 (first dose) through 31MAY2006 (fourth dose). A total of 4 injections were given at the appropriate and designated times as per the pediatric immunization schedule. The fourth dose was received at 12-months. The patient developed bilateral pneumonia in Sep2010 (at age 5 years). The patient was treated as an outpatient for pneumonia in September 2010. Titers were drawn to check immunity of pneumococcal injection. As reported, it was shown that she does not have immunity. The child's relevant medical history included neurocardiogenic syncope since an unknown date for which she was hospitalized. The child is not on any medications for this. The patient has no drug allergies. The patient also has a history of hospitalization for pneumonia in June 2008 and November 2008. The relevant laboratory tests included CBC, results not reported, on an unknown date, a few weeks ago. The nurse stated the patient did not get immunity with the PREVNAR injections and believes there is a causal relationship with the event pneumonia. At the time of this report, the patient has recovered from pneumonia. The therapeutic measures taken as a result of the event included administration of the first dose of PREVNAR 13 0.5 mL on an unknown date, 4 weeks ago. According to her pulmonologist, the child should receive another dose. Her pediatrician suggested that she should receive two additional doses of PREVNAR 13. Follow-up (15FEB2011): New information was reported from a contactable nurse regarding a 5-year-old female patient. This nurse reported the event of pneumonia on three different occasions. This is the third of three reports. Additional information included, medical history, dates of vaccine administration.
This spontaneous report as received from a nurse refers to a newborn patient of unknown age. The patient was vaccinated with the first dose of RECOMBIVAX HB (0.5mcg/0.5ml, Lot # and expire date unspecified) intramuscularly on 07-AUG-2012 and vaccinated with the second dose of RECOMBIVAX HB "9 days after the first dose of RECOMBIVAX HB on 16-AUG-2012. No other co-suspects were reported. No concomitant medications were reported. No adverse effect reported. No treatment information was reported. It was unknown if the patient had sought medical attention. Additional information has been requested.
Dizziness; Funny feeling in my head; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 18Mar2021 11:00 (Batch/Lot number: unknown) at the age of 28 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Kidney stones" (unspecified if ongoing), notes: other medical history: Kidney stones, anxiety; "Anxiety" (unspecified if ongoing), notes: other medical history: Kidney stones, anxiety; "COVID-19" (unspecified if ongoing), notes: if covid prior vaccination: Yes. Concomitant medication(s) included: TYLENOL; ATIVAN. The following information was reported: DIZZINESS (non-serious) with onset 20Mar2021 04:00, outcome "not recovered", described as "Dizziness"; FEELING ABNORMAL (non-serious) with onset 20Mar2021 04:00, outcome "not recovered", described as "Funny feeling in my head". The events "dizziness" and "funny feeling in my head" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of dizziness, feeling abnormal.  Additional information: The patient was not received other vaccine in four weeks. The patient was not tested for covid post vaccination. The patient not had known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Shingrix administered after temperature excursion; This case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a male patient who received Herpes zoster (Shingrix) (batch number 09cd9, expiry date 24th September 2023) for prophylaxis.   On 16th October 2022, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt Date: 18-AUG-2022 Reporter's Comment: This case was reported by pharmacist. Pharmacist reported on October 18th, 2022 that Shingrix was exposed at a below temperature excursion reaching a minimum temperature of 29.2 degree F and it was administered to a patient on October 16th 2022. Reporter did not consent to follow up. The vaccine administration facility is the same as primary reporter. Additional supportive information: As Shingrix was exposed below temperature excursion reaching temperature of 29.2 degree F which led to incorrect storage of vaccine.
A report has been received from a Health Professional concerning a, male subject, who had been receiving FLUMIST QUADRIVALENT (intranasal). FLUMIST QUADRIVALENT (intranasal) started on an unknown date. Patient received expired FLUMIST QUADRIVALENT which started on 04-Dec-2014. The outcome of the event of administration of expired FLUMIST QUADRIVALENT is unknown. The report was considered to be non-serious.
This spontaneous report as received from a registered nurse (R.N.) refers to an unknown number of patients of unknown age and gender. No relevant medical history or concurrent conditions were reported. On unknown dates, the patients were vaccinated with improperly stored GARDASIL 9 (lot# K026246, expiration date 28-JAN-2017; lot# L007560, expiration date 15-JUN-2017; lot# L017407, 15-AUG-2017; dose and route were not reported). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
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 (shingrix) for prophylaxis. Previously administered products included shingrix (1st dose received on an unknown date). On an unknown date, the patient received the 2nd dose of shingrix. On an unknown date, unknown after receiving shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown. Additional details were provided as follows: The case was reported by reporter for his/her doctor. The age at vaccination was not applicable for this report. The reporter reported that till the time of reporting, the patient never received the second shingrix vaccine which led to incomplete course of vaccination. The follow-up would not possible as no contact details were available. This case had been linked to the case US2022AMR003234, reported by the same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2022AMR003234:same reporter.
AAA (abdominal aortic aneurysm) without rupture. Hospital admission, procedure. This visit is within 6 weeks of receiving the COVID Vaccine.
A patient under the age of 65 years received FLUZONE HIGH-DOSE QUADRIVALENT with no AE; A patient under the age of 65 years received FLUZONE HIGH-DOSE QUADRIVALENT with no AE; Initial information regarding an unsolicited valid non-serious case was received from a physician via pharmacist via consumer/non-health care professional via Medical Information (Reference number- 00782671) and transmitted to Sanofi on 23-Sep-2021.  This case involves a male patient (unknown age) who was under the age of 65-year-old received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (product administered to patient of inappropriate age) (accidental overdose).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  The patient had no other vaccines.   On 23-Sep-2021, the patient received a 0.7 ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (batch number and expiry not reported) via intramuscular route in unknown administration site for prophylactic vaccination.  It was a case of an actual medication error due to Inappropriate age at vaccine administration and Overdose accidental (latency same day).  It was reported "Caller wants to know if there are any adverse events regarding the FLUZONE high dose (HD). Pharmacist asks what adverse reactions can occur as a result of a patient under 65 years of age receiving FLUZONE QUADRIVALENT HIGH DOSE. Pharmacist reports an adverse event (AE). Pharmacist states that a male patient either aged 48 or 53 (she could not remember) received the FLUZONE QUADRIVALENT HIGH-DOSE vaccine in error due to an unknown reason."  No additional adverse events (AE's) were reported.    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 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.  There will be no information available on the batch number for this case.
COVID-19; COVID-19; 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 53-year-old male patient received BNT162b2 (BNT162B2), on 19Jan2021 as dose 1, single (Lot number: EL3249), on 09Feb2021 as dose 2, single (Lot number: Em9810), in right arm and on 21Sep2021 as dose 3 (booster), single (Lot number: FF2588) at the age of 52 years, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 25Apr2022 as dose 4 (booster), single (Lot number: 005m21A), in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: DESCOVY, start date: 26Jan2022; PANTOPRAZOLE; ROSUVASTATIN. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (11May2022) Positive; (May2022) Negative; (May2022) Negative; (May2022) Negative; (May2022) Negative. Therapeutic measures were taken as a result of covid-19.  Additional Information: Anti-viral details: Product=COVID 19 Treatment. Brand=Paxlovid. Treatment start date=30Apr2022.Treatment Stop date=04May2022.Indication=Treatment of COVID-19.Adverse event: Paxlovid Rebound.Adverse event country:. Adverse event start date: 10May2022.AE resulted in: None of the above.Not recovered.treatment AE: No.Other medical history: After taking Paxlovid for 5 days, I tested neg 4 times in 6 days and had no symptoms. 7 days after my last dose of paxlovid, I had new symptoms and tested positive again.
This case was reported by a consumer via patient support programs and described the occurrence of sickness in a adult female patient who received Seasonal Influenza vaccine. Co-suspect products included BREO ELLIPTA inhalation powder (batch number R740011, expiry date June 2017) for chronic obstructive airways disease exacerbated. Concurrent medical conditions included chronic obstructive airways disease exacerbated. On an unknown date, the patient received Seasonal Influenza vaccine at an unknown dose. In 2014, the patient started BREO ELLIPTA 100/25 ug at an unknown dose and frequency. On an unknown date, an unknown time after receiving Seasonal Influenza vaccine and BREO ELLIPTA, the patient experienced sickness (serious criteria hospitalization). The action taken with BREO ELLIPTA was unknown. On an unknown date, the outcome of the sickness was unknown. It was unknown if the reporter considered the sickness to be related to Seasonal Influenza vaccine and BREO ELLIPTA. Additional details were provided as follows: This case was received from the healthcare provider via GSK Access program for BREO ELLIPTA. The patient could not provide the exact date of when she started with BREO. She thought that it could be end of 2014 or might be in early 2015. The patient stated that she was not feeling well after getting a flu shot and became sick and had to be hospitalized for 2 to 3 days. She did not recall how long she was in the hospital and stated that she thought she was hospitalized in October 2015. Since she was in hospital she had been on oxygen.
This spontaneous prospective pregnancy report as received from a physician for GARDASIL a pregnancy registry product, concerning an 22 year old female patient with none pertinent medical history and none drug reactions/allergies. In September 2012 (exact date unspecified) the patient was vaccinated with the first dose of GARDASIL (lot number not provided) injection. The patient become pregnant with LMP of 31-DEC-2012 (currently 13 weeks pregna) and EDD of 07-OCT-2013. The pregnancy outcome was outcome pending. The lab diagnostics studies was performed: Ultrasound (mid February) and Blood test for pregnancy (date unspecified). In mid February 2013 (exact date unspecified) the patient experienced vaginal trichomonas infection. The patient contacted physician. The vaginal Trichomonas infection was treated with vaginal Metronidazole cream. The physician did not know if the vaginal Trichomonas infection had resolved at the time of the call. In March 2013 (exact date unspecified) the patient was vaccinated with the second dose of GARDASIL (lot number not provided) injection. The patient received the second dose of GARDASIL while pregnant. Additional information has been requested.
had a real bad reaction to the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (had a real bad reaction to the vaccine) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (had a real bad reaction to the vaccine). At the time of the report, IMMUNISATION REACTION (had a real bad reaction to the vaccine) outcome was unknown.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.   For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications details were reported.  It was reported that, caller stated his older brother had a real bad reaction to the vaccine. He had to be intubated but survived. No further information were provided as caller had to go back to work. Agreed with Safety follow up.   No treatment medications details were reported.
He started to run a mild fever the day of shots but day after it went really high about 104.7 and gave hime Pedia Care and a luke warm bath to break fever called the doctor and he told me to give him full dropper of medicine so I did now monitioring
CAME TO WORK FEELING OK, AFTER EATING BREAKFAST STARTED FEELING DIZZY AND NAUSEATED AND  VOMITED
This spontaneous report as received from a pharmacist refers to a 57 year old male patient with no drug allergies. On 28-MAY-2013 the patient was vaccinated with ZOSTAVAX 0.65 ml, (lot # J000433, Exp. 04-OCT-2014), subcutaneously in the "inside of the arm" (not the deltoid region) and had a sore arm. No treatment was given. The patient's wife called to the pharmacist. The outcome of sore arm was unknown. Additional information has been requested.
Extreme thirst, like nothing before/so thirsty; Tongue stuck to the roof of her mouth; Experienced arm soreness, it went away, then came back intermittently for 5 months; Joint pain in left hip; This spontaneous case was reported by a consumer and describes the occurrence of THIRST (extreme thirst, like nothing before/so thirsty), TONGUE DISCOMFORT (tongue stuck to the roof of her mouth), PAIN IN EXTREMITY (experienced arm soreness, it went away, then came back intermittently for 5 months) and ARTHRALGIA (joint pain in left hip) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 037K20A) for COVID-19 vaccination.     The patient's past medical history included Joint pain (experienced this problem 20 years old ago, the joint pain, but the pain went away when she reduced her salt intake.).   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced THIRST (extreme thirst, like nothing before/so thirsty), TONGUE DISCOMFORT (tongue stuck to the roof of her mouth), PAIN IN EXTREMITY (experienced arm soreness, it went away, then came back intermittently for 5 months) and ARTHRALGIA (joint pain in left hip). At the time of the report, THIRST (extreme thirst, like nothing before/so thirsty) and TONGUE DISCOMFORT (tongue stuck to the roof of her mouth) outcome was unknown and PAIN IN EXTREMITY (experienced arm soreness, it went away, then came back intermittently for 5 months) and ARTHRALGIA (joint pain in left hip) had resolved.            No concomitant product was provided by the reporter. No treatment medication was provided.   This case was linked to MOD-2021-377070 (Patient Link).
cannot raise my arm up my shoulder; my arm was really hurting, in my muscle, where the shot occurred/If I want to do anything in my right hand it really hurt; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (cannot raise my arm up my shoulder) and VACCINATION SITE PAIN (my arm was really hurting, in my muscle, where the shot occurred/If I want to do anything in my right hand it really hurt) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and 007M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Feb-2021, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (cannot raise my arm up my shoulder) and VACCINATION SITE PAIN (my arm was really hurting, in my muscle, where the shot occurred/If I want to do anything in my right hand it really hurt). The patient was treated with ACETAMINOPHEN for Adverse event, at a dose of 500 mg and AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) for Adverse event, at a dose of UNK dosage form. At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (cannot raise my arm up my shoulder) and VACCINATION SITE PAIN (my arm was really hurting, in my muscle, where the shot occurred/If I want to do anything in my right hand it really hurt) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No  Concomitant medications were reported.  It was reported patient sometimes move it okay, most of the times he could not.
Pt recvd booster dose of Engerix-B 12FEB92 & c/o w/in 12 hrs exp arthritic pain, muscles & joints really hurt; 13FEB92 pt recvd ASA; MD visit required; 17FEB92 had mod to severe bruising; MD states oth med pt has been on may cause purpura;
Pt was given 2 mo immunizations at 39 days of age. PENTACEL, PREVNAR 13, ROTATEQ should not have been given until 6 weeks of age (42 days). Hep B was also given but dates ok.
Large red swollen patch around injection site (5inches by 6 inches), tenderness, itching, swelling into armpit, body aches.
had a lot of pain; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient  (Age: 59; Unit: Unknown) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN (non-serious), outcome "unknown", described as "had a lot of pain". Therapeutic measures were taken as a result of pain.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Extremely painful to the touch. After about 2 days I developed red splotch around the injection site - was not perfectly round. About 2 to 3 days after that the redness and most of the soreness was gone but the site is now very itchy (it  is now 8 days since I received the shot)
mental status changes w/nocturnal screaming, laughing;daytime confusion & disorientation, hyperactivity;MRI & blood work nl;some subjective improvement 2wk later;sx started noc of vax;