chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a Registered Nurse referring to a 2 year old patient of unknown gender. Information about patient's concurrent conditions and medical history was not reported. On 19-JUN-2015 the patient was vaccinated with a dose of improperly stored PEDVAXHIB (route not reported, lot # K025002 with expiration date 20-JUL-2017, dose 0.5 (unit not provided). Concomitant medications were not provided. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Disease recurrence; Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 31Oct2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 53 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 03Jun2022, outcome "unknown" and all described as "Treatment of COVID-19"; DISEASE RECURRENCE (medically significant) with onset 13Jun2022, outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (03Jun2022) positive; (10Jun2022) Negative; (13Jun2022) Positive; (Jun2022) Negative, notes: I had tested negative, was feeling fine; (Jun2022) Positive, notes: had symptoms again and tested positive a few days after having tested negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Information: Reporter stated that, No Other medication in 2weeks. Anti viral details product was mentioned as COVID 19 Treatment, treatment started on 03Jun2022 and stopped date=08Jun2022, indication was Treatment of COVID-19. vaccine lot unknown reason was mentioned as Unable to locate or read the details. Patient was tested positive for COVID on 03Jun2022.  Patient took Paxlovid (53-years-old and have asthma). tested negative on 10Jun and symptoms had disappeared by then. However, three days later on 13Jun, developed pink eye, had a bad headache and felt tired. Patient  did another COVID test and tested positive on 13Jun. Patient had symptoms this second round for about 4 days. This is not an adverse effect but more a prolonged COVID case. Patient had tested negative, was feeling fine and then had symptoms again and tested positive a few days after having tested negative. her husband tested positive at the same time and recovered much quickly than she did. her symptoms were different in the first infection than in the second phase. patient only had pink eye and headache the second time she tested positive. Adverse event start date was 13Jun2022, Patient was recovered. Adverse event stop date was reported as 7Jun2022. No treatment Ae.. No Known allergies. Device timestamp: 23Jul2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pt recvd vax & less than 5 mins later a localized react consisting of redness & swelling & wheas noted @ inject site; pt in no acute distress; laughing & playful too;
Swelling around eyes and on neck (e.g., inflammation and swelling of the dermal tissues).
On December 11, 2021, I broke-out in hives. It started on my legs, then spread to my back and torso. I took Benadryl, which lessened the itching. Hives continued to occur in the evenings every day for 2 weeks with gradually lessening intensity. Also had red blotches on my face and other parts of my body where I itched. Red blotches would come and go. I also had a retinal tear in my right eye and so did my wife after we received the Moderna  vaccine. My retinal tear occurred on December 1, 2021. I saw my optometrist on December 2, 2021. He made the diagnosis of a retinal tear that resulted in a large floater in my eye. I also had unusual, frequent urination for a 12-hour period on December 2, 2021.
nausea; vertigo; This is a spontaneous report from a Contactable consumer (Caregiver) via Medical Information Team. This consumer reported for her aunt (patient).   A female patient of (age: 89, Unit: Unknown) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on 24Feb2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for COVID-19 immunisation. Medical history included vertigo and concomitant medications were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for COVID-19 immunisation. The reporter stated that her aunt (patient) received the Pfizer covid vaccine second dose on Wednesday, and she was having really bad nausea and vertigo (she has vertigo before also), her aunt could not get out of the bed due to it and was given her vertigo medication (treatment). The reporter wanted to know about it. The clinical outcome of event Vertigo was not recovered and of event nausea was unknown at the time of this report.   No follow-up attempts are possible; information about batch/ lot number cannot be obtained.
Patient received vaccine and about 2-3 minutes after vaccination began sweating profusely.  His wife was with him and alerted our staff that something was wrong.  Our staff pharmacist,  immediately attended to him and noticed that his tongue looked enlarged.  He was not speaking for himself and was very disorientated.  , RPh administered and Epi-Pen 0.3mg injection in the patient's thigh.  The patient quickly stopped sweating, became more oriented and began talking. EMS was called and came to the pharmacy.  EMS observed him for a short time then took him to the ERD
I was vaccinated by a nurse whose name I don't know on December 4, 2003.   My doctor was not informed.  I suffered adverse symptoms which included headache, slight fever and intestinal upsets for approximately 1 week.   The headache and fever lasted only 1 day, but the intestinal problems were daily, no diarreha, but a little vomiting and frequent bowel movements and a stomach ache every time I would eat.  A tiredness also accompanied these symptoms.  I took Motrin and Alleve and that helped somewhat.   I still have a bit of discomfort after eating in my stomach but that is gradually disappearing and I feel almost back to normal.
CLIENT WAS GIVEN A 2ND BOOSTER OUTSIDE RECOMMENDED AGE. CLIENT NOT IMMUNOCOMPROMISED. STATE ADVISED VAERS REPORT.
Immunizatino given at 8:30a.m. on 12/3/03. Per mother, at 8:30p.m. on 12/3/03 child's eyes were moving from side to side, left arm shaked, and left eye drooped. Child was foaming at the mouth. Mother took child to hospital, with temp of 101. Blood and urine specimen were taken and child was monitored for a few hours and "tylenol" was given. Child sent home and mother told to see pediatrician the next day.
pt recv vax 18SEP97 & 8OCT97 pt exp erythema & swelling @ inj site;
shaking; could barely walk, it hurt to walk; hot and cold sweats; cold sweats; 104°F fever; body aches,had muscle pain; chills; joint pain; Four days later she had no mobility from the hip down; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (shaking), GAIT DISTURBANCE (could barely walk, it hurt to walk), HYPERHIDROSIS (hot and cold sweats), COLD SWEAT (cold sweats) and MOBILITY DECREASED (Four days later she had no mobility from the hip down) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018B21A and 022M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Family history included ALS (family history of ALS and Guillain-Barre syndrome (great grand father, grand father and father).) and Guillain-Barre syndrome (family history of ALS and Guillain-Barre syndrome (great grand father, grand father and father).).   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Mar-2021, the patient experienced TREMOR (shaking), HYPERHIDROSIS (hot and cold sweats), PYREXIA (104°F fever), MYALGIA (body aches,had muscle pain), CHILLS (chills) and ARTHRALGIA (joint pain). 30-Mar-2021, the patient experienced GAIT DISTURBANCE (could barely walk, it hurt to walk). 30-Mar-2021, the patient experienced COLD SWEAT (cold sweats). On an unknown date, the patient experienced MOBILITY DECREASED (Four days later she had no mobility from the hip down). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Fever, at an unspecified dose and frequency. In April 2021, TREMOR (shaking), GAIT DISTURBANCE (could barely walk, it hurt to walk), HYPERHIDROSIS (hot and cold sweats), COLD SWEAT (cold sweats), MOBILITY DECREASED (Four days later she had no mobility from the hip down), PYREXIA (104°F fever), MYALGIA (body aches,had muscle pain), CHILLS (chills) and ARTHRALGIA (joint pain) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Mar-2021, Body temperature: 104 (High) 104°F fever. In April 2021, Laboratory test: normal (normal) everything came back normal. In April 2021, X-ray: normal (normal) everything came back normal.         Concomitant product use was not provided by the reporter.  Patient did not have side effects after the first dose.  Patient had a hospital visit four days later. Patient reported that ten days after the hospital visit,everything went back to normal (legs and everything).
pt had temp of 102 & cranky afternoon of vax;had 105 temp following day mom called ER told to give APAP;still had 104-105 temp;to MD found nothing wrong;cont med;Friday cont to have T104 to MD found ear infect given ATB;
Arthralgia, Fever, chills, high grade fever of 103f Narrative:
patient received an expired dose of Daptacel, no AE; Initial information was received on 27-Nov-2019 regarding an unsolicited valid non-serious case from a consumer/non-hcp.  This case involves a patient who received an expired dose DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] lot number not reported via unknown route in unknown administration site, on an unknown date.   The patient's medical history, past medical treatments, vaccinations and family history were not provided.   It was an actual medication error due to expired vaccine used.  At the time of reporting, the patient had no adverse 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 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.  Information on the batch number was requested.
24 hours after Dtap developed erythema induration at site, no fever. Rx Benadryl symptoms improved. 2 days later increased spreading induration. Rx KEFLEX. Induration and erythema 3-5d.
expired dose of Fluzone HD administered to the patient, no AE; Initial information received on 24-Sep-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to cases 2019SA268361, 2019SA268355, 2019SA268356, 2019SA268357, 2019SA268346, 2019SA268359, 2019SA268360 and 2019SA268362 (same reporter).  This case involves a 65 years old female patient who received 0.5 ml dose of expired vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (lot UI994AA, Exp. Date 09-Apr-2019) via intramuscular route in the left deltoid, on 13-Sep-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of actual medication error due to expired vaccine used.  At the time of reporting, no adverse reactions 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 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.
Pt states after receiving the vaccine she experienced a slight seizure and then has had tingling and numbness in arm since then
REGULAR TWITCHING UNDER LEFT EYE; This spontaneous report received from a patient via a company representative via social media concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient had not been sick nor had covid-19 symptoms after vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on JUL-2021 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 JUL-2021, the patient experienced regular twitching under left eye. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of regular twitching under left eye was not reported. This report was non-serious.
Malaise; Orientation was really off; Felt like equilibrium was off balance; Strange feelings; States first dose was 15Mar2021 and second was 26Mar2021; This is a spontaneous report received from contactable reporter (Consumer). The reporter is the patient.  A 62-year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 26Mar2021 07:30 (Lot number: ER8727) at the age of 62 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: bnt162b2 (Dose 1, single (Lot Number: EN6205, Expiration Date: Unknown) in the right arm), administration date: 15Mar2021, when the patient was 62 years old, for Covid-19 immunisation, reaction: "Denies any symptoms". The following information was reported: FEELING ABNORMAL (non-serious) with onset 26Mar2021 11:30, outcome "not recovered", described as "Strange feelings"; MALAISE (non-serious) with onset 29Mar2021, outcome "not recovered", described as "Malaise"; DISORIENTATION (non-serious) with onset 29Mar2021, outcome "not recovered", described as "Orientation was really off"; BALANCE DISORDER (non-serious) with onset 29Mar2021, outcome "not recovered", described as "Felt like equilibrium was off balance"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 26Mar2021 07:30, outcome "unknown", described as "States first dose was 15Mar2021 and second was 26Mar2021".  Additional Information: The patient received COVID Vaccine for inoculation. The patient got his second shot in his left arm shoulder this past Friday (26Mar2021) and about four hours later, he began experiencing strange feelings and had gone online to look up his symptoms. This morning 3 days later (29Mar2021), he felt malaise, his orientation was really off, and when he got out of bed, he felt like his equilibrium was off balance. He wanted to know if this was normal, and how long it would last. His symptoms were all persisting. He denied any symptoms after first vaccine. The patient did not receive additional vaccines on same date of the Pfizer suspect. The patent did not receive prior vaccinations within 4 weeks and did not experience adverse events following prior vaccinations. No relevant tests were done by the patient.  No follow-up attempts are possible. No further information is expected.
Patient received the first COVID-19 vaccine in left arm on 11/29/2021. Patient noticed an enlarged superficial cervical lymph node on the same side on 12/6/2021. Denied any other symptoms. Tender-to-touch, otherwise does not bother her.
Swollen gland in armpit; flu like symptoms; This is a spontaneous report from a contactable consumer (patient). A 34-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration on 24Apr2021, (at age of 34-year-old) in left arm as single dose for COVID-19 immunisation. Medical history included asthma and turmeric allergy. Patient did not receive concomitant medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. On 03May2021, at 08:00PM, patient experienced swollen gland in arm pit, flu like symptoms. Events were considered non-serious by the reporter. Patient received second dose of vaccine on 15May2021 at 10:30AM in left arm. It was unknown if the patient received treatment for the events. Outcome of the events were unknown.  Information on the lot/batch number has been requested
Agency discovered the patient and his family that abused the system and obtained numerous COVID vaccinations most likely for financial gain of the $25 store gift cards issued at each patient encounter.
No adverse event; First dose on 22-Dec-2020 and second dose on 27-Jan-2021; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 22-Dec-2020 and second dose on 27-Jan-2021) and NO ADVERSE EVENT (No adverse event) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029K20A and 025J20A) for COVID-19 prophylaxis.     It was reported that patient had no illness at the time of vaccination and up to one month before. It was also reported that patient had no chronic or long standing health conditions. It was unknown if the patient was on any Prescriptions, over-the-counter medications, dietary supplements, or herbal remedies being taken at time of vaccination and/or at the time of the adverse event.    On 22-Dec-2020 at 12:27 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 27-Jan-2021 at 8:37 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 27-Jan-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 22-Dec-2020 and second dose on 27-Jan-2021). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 22-Dec-2020 and second dose on 27-Jan-2021) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), 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 (First dose on 22-Dec-2020 and second dose on 27-Jan-2021).    No concomitant medication was reported.  No treatment medication was provided.   This case was linked to MOD-2022-657250, MOD-2022-655862 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 11-Oct-2022: Follow up received contains no new information.
Redness and warm to touch at site of injection with fever on 2/12/03. Pt presented red blotchy rash on upper thigh where injection give with swelling of entire upper thigh-warm to touch-afebrile was weight bearing.
dizziness; headache; nausea; vomited; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DIZZINESS (dizziness), HEADACHE (headache), NAUSEA (nausea) and VOMITING (vomited) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (dizziness), HEADACHE (headache), NAUSEA (nausea) and VOMITING (vomited). At the time of the report, DIZZINESS (dizziness), HEADACHE (headache), NAUSEA (nausea) and VOMITING (vomited) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. no treatment drug was reported
Patient received two Moderna booster dose one month apart by mistake.  He had received Moderna primary series and a booster dose and was up to date with COVID 19 vaccines. While admitted in the hospital  they were ordered for a booster dose when in fact they were up to date and did not need any additional doses.
On the day after the vaccination I experienced pain in my left upper arm that got progressively worse . On  day 4 and 5 after the vaccination the pain  was intense requiring over the counter pain medication.  Range of motion was also compromised (abduction of left arm).  It is now day 14 post-vaccination. Range of motion (abduction) is still compromised. Pain is still present but not as intense.
Case number PHEH2014US021522 is an initial spontaneous report from the nurse received on 23 Oct 2014. This report refers to a 09-year-old male patient. He was vaccinated with FLUVIRIN (batch number: 1412501) intramuscularly on 19 Oct 2014. On 20 Oct 2014, 24 hours after vaccination his injection site became red, itchy and swelling. It was reported that the patient was tested for allergic reaction to flu vaccine and it was negative, but when he received the full dose he reacted. The injection site initially looked like a bug bite, but increased to a local 2 inch rash that was discomforting to the patient at the site. The final outcome of the events was unknown. The seriousness and causality of the events were not reported.
The patient reported to the pharmacy with difficulty breathing. The patient described a heavy sensation within the chest and difficulty breathing. The patient appeared short of breath.  The patient reported experiencing these symptoms within 20 minutes of receiving the vaccine.  The patient reported to the pharmacy at a later time. The site of injection had no unusual appearance.  The patient did not appear seem to have elevated temperature.  The incident occurred over approximately 2 hours. The patient was immediately instructed to sit down, and 911 was alerted.
Information has been received from a healthcare worker referring to two unidentified patients of unknown age and gender. On unknown dates (range between 18-FEB-2015 to 30-MAR-2015) the patients were possibly vaccinated with one dose of (Oka/Merck) VARIVAX (lot # J014228, expiration date 08-NOV-2015, dose and route were unknown). No adverse effects reported. This is one of several reports received from same source. Additional information has been requested.