chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a physician refers to a 65 year old male patient with none pertinent medical history and none drug reactions/allergies. In 2008 the patient was vaccinated with ZOSTAVAX (dose, strength, route and site of administration not reported). Concomitant therapies included aspirin (reported as baby aspirin) and unspecified prostate medications. On an unspecified date in June 2013 the patient developed a zoster rash on his face and eyelid. There were unspecified ophthalmology examination performed. The events were treated with VALTREX. The outcome of "zoster rash" on his face and eyelid was reported as recovering/resolving. The relatedness between ZOSTAVAX and "zoster rash" on his face and eyelid was not reported. Additional information has been requested.
slept all day; weak; tired; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (slept all day), ASTHENIA (weak) and FATIGUE (tired) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high. Concomitant products included APIXABAN (ELIQUIS) for Anticoagulant therapy, LISINOPRIL for Blood pressure high, TAMSULOSIN for an unknown indication.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced SOMNOLENCE (slept all day), ASTHENIA (weak) and FATIGUE (tired). At the time of the report, SOMNOLENCE (slept all day), ASTHENIA (weak) and FATIGUE (tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications were not reported.   This case was linked to MOD-2021-162202 (Patient Link).
School clinic conducted; this principal came near end of clinic for H1N1 injectable. Has health issues and some allergies but received seasonal flu annually and 9/09 without any problem. 2 hours after injection got hives on R chest, arms with increased itching. Nose started running. Took BENADRYL and all symptoms resolved.
Patient with 2 Moderna COVID vaccinations on therapy unit post surgery for cervical disc issues who became mildly symptomatic for COVID (sore throat and weakness) and tested detected for COVID.  Provider note: "He was diagnosed with covid, and was generally asymptomatic although he had 1-2 bad days last week of worsening function that resolved after we dc baclofen.  He was on a low dose of baclofen (5mg and had only 3 total doses in 24 hours), so unsure whether the change was from covid or baclofen.  Regardless, he returned to baseline and has had no symptoms for over a week and has completed his quarantine"
Information has been received from a healthcare worker referring to a patient of unknown age and gender. The patient's medical history was not reported. On 04-FEB-2015, the patient was received improperly stored VARIVAX (Merck) (lot # K007979, exp date 03-JUN-2016, dose and route unknown). Concomitant medication was not reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
3-4 days after vaccine, pt said she came down with chills, vomiting, diarrhea and a stiff neck, lasting for 2-3 days. She is now without symptoms.
Wife reported events 3/18/13. About 48 hours after shot patient developed a large hematoma on the arm. Then, severe cough and chest congestion began gradually. Symptoms progressed, so pt went to pharmacy clinic. Treated with something for chest congestion. MD later prescribed Z-Pak. Persistent cough still present.
Patient became lightheaded and woozy approx. 5 min after injection. Pt has a hx of low BP, denies diabetes. Patient began to feel better but states if she turns her head she feels "weird". Vitals taken: 164/72, HR 74, SP02 98% at 0936. Patient laid down and was given water and a granola bar. Repeated vital signs and were improved at 0951: 129/74, HR 66. Patient states that the repeat BP was closer to baseline. Pt observed until 10am. Patient stated feeling better and back to normal.
3/12/21 Sudden cardiac arrest at home; unable to be resuscitated at scene (Brother)  Caller is a family friend who was asked by family to call and report incident. If f/u is needed, please contact him first. Current Medical History: unknown by caller Current Medications: unknown by caller
Patient called c/o redness of biceps with some swelling-tender to touch only- was itchy previous night. Area 3 in x 3 in warm. Treated with Medrol Dose Pack
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 03Oct2022 as dose 5 (booster), single (Lot number: gj6739) at the age of 61 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications, also reported as no other medication in 2 weeks. Patient had no known allergies. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (Jan2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received COVID-19 Treatment with Paxlovid (Lot number: gf6426) from 01Jan2023 to 02Jan2023. The noxious taste that the Paxlovid created in mouth was untenable and unbearable for patient. After three doses patient had to stop. However it was now day 14 and she was still testing positive and still have symptoms and wonder if that's because she only took three doses of Paxlovid.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 81-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Jan2021 as dose 1, single (Lot number: EL9262), on 20Feb2021 as dose 2, single (Lot number: EN6201) and on 25Oct2021 as dose 3 (booster), single (Lot number: EWO177) at the age of 81 years, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (COVID-19 VACCINE MODERNA), on 11Apr2022 as dose 4 (booster), single (Lot number: 001M21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "post MI with stent", start date: Aug2021 (unspecified if ongoing), notes: post MI with stent 21Aug; "arthritis" (unspecified if ongoing); "hyperthyroid" (unspecified if ongoing); "heartburn" (unspecified if ongoing); "Lichen sclerosus" (unspecified if ongoing). Concomitant medication(s) included: LIPITOR, start date: 27Aug2021, stop date: 19Jul2022; BAYER LOW DOSE, start date: 27Aug2021; TOPROL XL, start date: 27Aug2021; ZESTRIL, start date: 27Aug2021; SLEEP AID, start date: 09Mar2021; D3, start date: 14Oct2021. Past drug history included: Prilosec, start date: 11Apr2018; Levothyroxine, start date: 17Sep2008, notes: levothyroxine 0.112 mg. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 31Jul2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: I took Paxlovid when I first got Covid; (27Jul2022) Negative; (31Jul2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Patient's wife had a virtual provider with APRN on 022222 and reported that her husband (patient) "passed away three weeks after getting the booster". The patient reportedly had no other chronic health problems but reportedly took doxazosin according to what was reported to the virtual provider. No autopsy was performed.
3AM Fri felt dizzy, eyes had nystagmus - mild nausea and lasted 1 wk. - Daily x 3 days assoc with ? vertigo. Now occur every 3 d' and felt like I was having a stroke.
Within 24 hours, post vax, cried with pain from knee to toes and aching in joints. Has persisted for 3 days; so far unresponsive to Advil, Tylenol with codeine. No fever. No erythema or swelling at injection sites. Normal neurological exam; muscle strength and coordination. No abnormalties on PE or neurological.
At the time of the injection I had a swollen arm it was hot to the touch it was itchy it was red and bruised After about 2 Weeks I developed what they're saying is viral or bronchitis or really bad cough congestion, used a nebulizer for my asthma Got very dizzy
woke up with chills and fever at 3am morning after vaccination, took ibuprofen and helped, left work early that day due to fever, chills and weakness. Arm hurt for about a week at injection site.  3 weeks after vaccination I developed blood in my stool and diarrhea, it has cleared up now.
Soreness where shot was given, fatigue. By next morning, additional symptoms include itchy eyes, cough, hoarseness, headache. Still experiencing all symptoms 10/03/2014 8:00 AM.
Was standing passed out and fell to ground.  Vital signs: @13:15 B.P=100/50      118/80  HR: 70  Pso2:100% @13:45   B.P. 97/50 Trending hypotension Recorded by staff
Initial information received on 30-Nov-2018 regarding an unsolicited valid non-serious case received from a pharmacist via phone. This case is linked to case 2018SA331501. This case involves an elderly male patient who was vaccinated with a 0.5 ml dose of FLUZONE HIGH DOSE (Batch number: UJ04AB, expiration date: 20-Jun-2019, site of administration: right deltoid and route was not reported) on an unknown date instead of Pneumonia vaccine. The patient had also received a prior FLUZONE HIGH DOSE (Batch number, expiration date, site of administration and route was not reported) at her HCP's office in Sep-2018. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to wrong vaccine administered and extra dose administered. FLUZONE HD vaccine was administered today to a husband and wife for the second time this season instead of the Pneumonia vaccine. 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.
Narrative:  Patient was not previously Covid positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Patient was admitted to Hospital on 3/11/21 with dyspnea. He was transferred from a rehab facility as he could no longer care for himself due to being bed-bound. He lost 27 pounds over last 6 months due to progressive dysphagia limiting PO intake. PMH significant for dementia, CAD, HTN, COPD.
DEATH; This spontaneous report received from a consumer via a company representative via media concerned a male of unspecified age, race and ethnicity. 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, batch number and expiry date were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. 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 patient died. It was reported as "Your Covid shot killed my brother". On an unspecified date, the patient died from unknown cause of death. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0-20221060412-DEATH. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
expired dose of Kinrix was administered to a patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 4-year-old male patient who received DTPa-IPV (Kinrix) (batch number H9FM5, expiry date 07-MAY-2023) for prophylaxis.   On 10-MAY-2023, the patient received Kinrix. On 10-MAY-2023, an unknown time after receiving Kinrix, the patient experienced expired vaccine used (Verbatim: expired dose of Kinrix was administered to a patient). The outcome of the expired vaccine used was 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: 10-May-2023 The reporter consented to follow-up via email. The patient received an expired dose of Kinrix, which led to expired vaccine used.
Large swollen lymph nodes on the left upper extremity. Locations- neck, armpits, above the clavicle.
Moderna Covid-19 vaccine while pregnant; A spontaneous report was received from a healthcare professional concerning herself, a female patient of unspecified age who received Moderna's COVID-19 Vaccine and was pregnant/Exposure during pregnancy.  The patient's medical and pregnancy history was not provided. No concomitant medications were reported.  On an unknown date, the patient received the first dose of mRNA-1273 for prophylaxis of COVID-19 infection.   The date of the patient's positive pregnancy test and first day of the last menstrual period were not reported. The estimated date of conception and due date were not reported.  Action taken with mRNA-1273 was not applicable.  The outcome of the event Moderna Covid-19 vaccine while pregnant was recovered.; Reporter's Comments: This is a case of product exposure during pregnancy with no associated AEs for this female of unspecified age. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
My arm hurt for a few days; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient stated that his/her arm hurt for a few days. No other side effects. The follow-up could not be possible as no contact details were available.
Swollen eyelids Intense fatigue Swollen tongue Pressure in head  Tinnitus
Pt arrived to clinic at 1328 for 11 year old vaccines. Confirmed with mom that pt will receive Tdap, Meningococcal A, and HPV vaccines. Mom present and confirmed. Tdap and MenQuadfi given in L deltoid; HPV given in R deltoid. Pt initially tolerated well, then had brief syncope episode with self arousal. MD notified of event. MD at bedside to assess patient. Pt had hypotension and nausea. No concerns for WOB. No other symptoms. Laid patient down on exam table. Blood pressure rechecked after 10 minutes and improved. Pt sat up, rechecked and improved. Pt awake and answering questions, stating that she feels better. Confirmed with MD, ok to discharge pt. Advised pt to let mom know if not feeling well again. Advised to call back with any further questions or concerns. Mom ok with discharge and agreed with plan.
I got lightheaded and flushed about 15 minutes after initially taking the vaccination. I woke up one morning and got really lightheaded. My heart started racing and I checked my heart rate, and it was elevated to 108 beats per minute. It went away but came back again. I also had nausea as well. I called my doctor, and they told me to keep track and go into the emergency room if it starts again. I have had lightheaded off and on since this incident. I have an appointment set up November 15, 2022. I also have extreme fatigue which started after the 1st dose. These symptoms could be related to me having long COVID-19 symptoms or dose 1 of the vaccines.
This spontaneous report a received from a certified medical assistant (C.M.A.) refers to multiple unspecified patients of unknown demographics. On an unknown dates, the patients were vaccinated with a doses of improperly stored VARIVAX lot # M023380 and expiration date: 11-MAY-2018; (strength, dosage and route unspecified). No adverse effect reported. No product quality complaint involved. No further information provided. This is one of three reports received from the same reporter. Additional information has been requested.
Left arm tingling; Physically "out of it"; Mentally "out of it", felt like it could kill patient; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PARAESTHESIA (Left arm tingling), MALAISE (Physically "out of it") and FEELING ABNORMAL (Mentally "out of it", felt like it could kill patient) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder NOS and Blood pressure high.   On 05-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, the patient experienced MALAISE (Physically "out of it") and FEELING ABNORMAL (Mentally "out of it", felt like it could kill patient). On 13-Mar-2021, the patient experienced VACCINATION SITE PARAESTHESIA (Left arm tingling). At the time of the report, VACCINATION SITE PARAESTHESIA (Left arm tingling) had not resolved and MALAISE (Physically "out of it") and FEELING ABNORMAL (Mentally "out of it", felt like it could kill patient) was resolving. Not Provided          Concomitant medication use included thyroid medication and high blood pressure medication. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not applicable.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: No specific follow-up information recorded.
arm became very sore like razorblades cutting inside arm (not injection site pain), became red and swollen to the size of a softball,
last booster was done in his thigh; Had COVID-19 in Aug 2022; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (Had COVID-19 in Aug 2022) and PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (last booster was done in his thigh) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 02E21A, 048A21A and 015M20A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2022, the patient experienced COVID-19 (Had COVID-19 in Aug 2022). On an unknown date, the patient experienced PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (last booster was done in his thigh). At the time of the report, COVID-19 (Had COVID-19 in Aug 2022) and PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (last booster was done in his thigh) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2021, SARS-CoV-2 test: Positive. In August 2022, SARS-CoV-2 test: Positive.         Concomitant medications were not reported.   Patient had no allergies.  Patient and her wife was searching for some place for most recent booster that will inject her husband in his thigh muscle. The last booster was done in his thigh by a hospital clinic service.   Patient had not experienced a similar event in the past.  No treatment information was provided by the reporter.   This case was linked to MOD-2022-666579 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 31-Oct-2022: Live Follow-up received include patient details added, suspect product coding updated, Event added, iNarrative updated.
5e very next morning I got hit with major vertigo on the right side of my head.  It has been spinning non stop.  I have not had vertigo episodes for over 18 years.  I feel tired. Off balance and dizzy.
Arm has been an extreme pain and now it is paralyzed fingers and arm. Left leg is weak very very weak I have fallen several times and couldn't get up because I can only use one arm
8 days after getting 4y vaccines, pt started looking "sluggish" and had a syncopal episode. Dad caught pt and put him down and pt began to arch back, became very stiff (no jerking) that lasted for 1 minute (pupils dilated with him staring straight forward, but non-responsive). Pt's body then relaxed, but he remained unresponsive with eyes open for an additional 30 s. Pt then acted confused and started crying for "a minute or two". Pt was back to normal self (baseline) 30 minutes later. No lip smacking, drooling, excess salivation. 1 day later (9 days after vaccines) pt had just woken up from a nap and trying to talk to mom. When mom went into his bedroom, mom states he was slurring his speech for approximately 2 minutes. Mom gave PEDIALYTE (she was concerned that maybe he had low sugar) and this seemed to help. Each of these 2 episodes, the patient had just woke up from taking a nap and pt was hungry.
swollen Glands  ? Facial Pain  ? POST NASAL DRIP ? Sore Throat
pt recv vax JUL96 & SEP96 respectively;p/dose 2 pt exp a bruise @ the posterior part of arm, where had recv inj;plan to give 3rd dose IM;
Patient first Pfizer covid vaccine 10/1/21 and accidentally received second covid vaccine early on 10/13/2021. No symptoms yet.