chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Body aches, very high fever, nausea, headache, loss of appetite. Treated with rest and Tylenol every 4 hours, wasn?t extremely effective. Symptoms subsided after exactly 12 hours to symptom start time
Pt was administered Gardasil 9 on 8-13-16. After about 60 seconds pt fainted. He did not require any medical treatment. He awoke with no memory of the previous events after about 60 seconds of being passed out.
Syringe was loose; Received invalid dose; A spontaneous report was received from a consumer concerning a 50-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a loose syringe/syringe connection issue and received invalid dose/vaccine underdose.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 27-JAN-2021, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 02-MAR-2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 02-MAR-2021, The patient stated that the syringe was loose and they received an invalid dose during the administration of the second dose.  Laboratory details were not provided.  No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, syringe connection issue and vaccine underdose were considered recovered/resolved.; Reporter's Comments: This report refers to a case of syringe connection issue and vaccine underdose for mRNA-1273, lot # Unknown with no associated AEs.
Not adverse event, rather child was accidentally given DTAP today, rather than DTAP ordered.
Left deltoid at injection site, red, swollen, tender x 2 days-treatment: warm compress, Keflex 250 mg-6 ml po every 6 hr x 7 days, Ibuprofen 100/5 ml 7.5 ml po and 6 hr prn
pt states devel red spots w/in a couple of hr of inj-progressively worse & devel severe itching-now has red spots all over body;has nausea;some redness & swelling @ inj site;no fever;
Patient received Pfizer Bivalent Booster rather than Pfizer Monovalent for second dose in Primary Series.  No adverse affects.
A few minutes after my first injection shot, I experienced a wave of nausea, flushing, and a metallic taste. I waited for 30 minutes and was assured everything was stable. During the next several days, I experienced high fevers, nausea, vomiting, myalgia, and minor neuropathy (legs/feet). Over the next few weeks, I continued to have intermittent fevers, nausea, myalgia,  and episodes of numbness and tingling in my hands and feet. I consulted with my PCP on 1/28 to see if I should continue with the 2nd dose and was advised to do so. After receiving the second dose, I experienced a similar reaction as the first, with high fevers, nausea, vomiting, myalgia, and minor neuropathy in my legs and feet. One new symptoms following the second dose was muscle twitching in the legs. Approximately two weeks after the second dose, I experienced acute paresthesia of both legs. It began with a bubbling sensation for two days and then progressed to an abrupt onset of burning and tingling. The muscle twitching in both legs increased and also began to appear in my arms. It is now 3 months past the second dose and I continue to have all over muscle twitching and chronic paresthesias of both legs, arms, hands, and tongue (worse in legs). I also have extreme pain in all of my fingertips,  intermittent electric shock sensations in my face and mouth, and internal vibration/buzzing sensations. My POTS symptoms which I had previously managed with adequate hydration and TriOral rehydration salts (no medication) have all been exacerbated. On a side note, I also experienced two menstrual cycles in both months that I received the vaccine and continue to have spotting between periods. I do not have a history of irregular menstrual cycles or spotting. I am currently scheduled for an ultrasound and endometrial biopsy to further assess these symptoms.
PT REPORTED TO CLINIC ON 03/10/2021 TO RECIEVE HIS ANTHRAX VACCINATION. AFTER SCREENING THE PATIENTRECORD, WE NOTICED THAT INPUTED INTO SYSTEM TRANSCRIBED FOR A TDAP ON 01/09/2021 AND A TD WAS ADMINISTERED AT CLINIC IMMUNIZATIONS ON 02/04/2021.
6/22/21 Awoke with chest pain and stomach pain. Chest pain persisted.  Went to Urgent care on 6/23 then seen by cardiology and referred to emergency department and admitted to PICU 6/24 after having positive troponin test.  Chest pain improved on ibuprofen.  Discharged on 6/25/21 on motrin and following with cardiology.
Sore arm and mild fatigue day of injection(booster). Fatigue again the day after. Mild metallic taste in mouth two days after. Itch at injection point. Fatigue not debilitating.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 17-JAN-2008, a healthcare provider administered the ZOSTAVAX (dose, route, and lot # not provided) to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related injuries. On 02-DEC-2016, the patient was treated by a healthcare provider for herpes zoster. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX, the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was unknown. Causality assessment was related.
Had allergic reaction to the Pfizer Covid vaccine on 3/10/2021 and advised by physician to get the JNJ vaccine as the second dose. 3:55 pm Following the JNJ vaccine she had itching and hives around the lt. nipple, itching and redness across the forehead, lt. arm, neck and waist.  B/P 150/90, P. 93 O2 Sat 99%.  Given Benadryl 50 mg po. 4:20 B/P 142/82, P. 82, O2 Sat 98%.  Instructed to contact physician if she becomes worse or go to the emergency department.  Told she may take another dose of Benadryl 50 mg later this evening as needed.
Patient reports arm soreness and nerve pain (including tingling, numbness and shooting pain) in body, arms, legs, and lower back for several days post vaccination. Patient follow up with primary care provider and received a prescription for a prednisone taper as a result of this nerve pain.
covid vaccine breakthrough case  dose 1 Moderna 1/7/21  011L20A dose 2 Moderna 2/4/21  012L20A
First RotaTeq administered past 15 weeks of age. No side-effect noted.
temperature is now 103 to 104; got sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (005570). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Sep2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 Immunization. The following information was reported: ILLNESS (non-serious) with onset 24Sep2022 at 03:00, outcome "unknown", described as "got sick"; PYREXIA (non-serious) with onset 26Sep2022, outcome "not recovered", described as "temperature is now 103 to 104". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient was having a flare up of all the other side effects again and  just trying to figure out is this normal or adverse.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Severe Pain in right arm (arm that vaccine was given) that I could not lift or move my arm. I felt like I had the flu-temperature of 102.7, very bad headache, severe pain all over body, freezing cold and wrapped in blankets (it was 95 degrees F outside and my air conditioner was shut off), I had sinus pain, throat pain, terrible fatigue and dizziness when not laying down. This went on severe with fluctuating temperature for three days.
Patient is a 64-year-old male who has received 2 doses of the pfizer coronavirus vaccine.  He received his last dose last week and started having pain in the shoulder which gradually spread to include the upper back and neck region.  The pain would radiate down into the arm. he describes the pain as a very deep constant ache with no real aggravating factors.  The pain is worse when he is lying down at night. It is best when he is up and active.  He has no specific pain with movement of the neck, back, or arms/shoulder.  He denies any lumps or bumps at the injection site.  He denies any color changes in the overlying skin or swelling.  He feels numbness in the entire hand in a stocking glove distribution.
This spontaneous report as received from a Licensed Practical Nurse refers to a 4 year old patient of unknown gender. On an unknown date, the patient might or might not have been vaccinated with a first dose of PROQUAD (Merck) (Lot number, expiry date, route and dose were not reported). Nurse reported that another unspecified nurse in the office stated she gave the patient an unspecified vaccine but the patient's mother was stating the child received PROQUAD (Merck). No adverse effects was reported. Additional information has been requested.
Patient felt nauseate, tired and had a headache. Patient woke up with a fever and body aches.
2 days, post vax, pt had pink, raised rash starting at forehead and covering body. Temperature was 104F for 4 days.
She received her shot around noon and by dinnertime, her leg was swollen, her fever was 103, she wouldn't eat, very fussy. This is common so it was upsetting but not worrisome. I treated her with cold compresses and children's MOTRIN. However, that evening she awoke after going to bed and cried a piercing, screaming cry for six straight hours. I emailed her doctor who said he was sleep to hear it and brushed off my concerns, saying the vaccines do more good than harm. MOTRIN did nothing. Her crying continued off and on for two weeks. She woke crying frequently at night. Her fever lasted five days. She did not want to eat or play. She was withdrawn and definitely not herself for at least two weeks and my husband and I were very concerned. She honestly seemed like a different child. It was incredibly upsetting and worrisome and I hated that the doctors office was more concerned with making sure I brought her back for more shots than making sure she was actually okay. I have not done any vaccines since.
Information has been received from a nurse practitioner concerning a 56 day old breast fed male who on 08-JUN-2009 was vaccinated with the first dose of ROTATEQ (Lot # not provided) orally. On the same day the patient experienced fever and discolored stool. On 13-JUL-2009, he was administered the second dose (lot # not provided) orally. On 24-JUL-2009 the patient experienced blood in stool on two occasions including clumps and streaks. The third dose was not given. Concomitant medication included "additional required vaccines". A culture was done and no bacteria were found. Blood work also came back normal. After stopping therapy, adverse events improved. The patient sought unspecified medical attention. As of 06-AUG-2009 the patient was believed to be recovering. Upon internal review, blood in stool was considered to be an other important medical event. Additional information has been requested.
Headache, Dizziness, Lightheaded and nauseas after vaccination. Evaluated by TCA ambulance, Patient signed off.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old male patient received BNT162b2 (BNT162B2), on 03Mar2021 as dose 1, single (Lot number: eng198), in left arm, on 24Mar2021 as dose 2, single (Lot number: ep7534), in right arm, on 02Oct2021 as dose 3 (booster), single (Lot number: 30130ba), in left arm and on 20Apr2022 as dose 4 (booster), single (Lot number: fk9895), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes type 2" (unspecified if ongoing), notes: Diabetes type 2; "Mild COPD" (unspecified if ongoing), notes: Mild COPD. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant) with onset 22May2022, outcome "unknown", COVID-19 (medically significant) with onset 22May2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (22May2022) Positive; (28May2022) Negative; (07Jun2022) Positive. Therapeutic measures were taken as a result of covid-19.  Clinical information: Other medication in 2weeks was Unknown. Patient has taken COVID 19 treatment with Paxlovid .Treatment start date 23May2022 and stop date: 27May2022. Rebound Covid after taking Paxlovid. Positive on 22May, started Paxlovid on 23May2022. Neg. tested on 28May2022 with improved symptoms. Symptoms back but less intense on 05Jun2022 and tested positive again on 07May2022.
15 minutes  after injection started to feel numbness and pressure in left nostril/sinuses.  Then progressed to numbness on left side of mouth, cheek, and eye.  Lasted about 1 hour, then had slight headache rest of the day. Swelling and soreness at injection site for a day or 2.
This spontaneous report as received from a pharmacist refers to a male patient of unknown age. Patient had no previous pertinent medical history and drug allergic reactions. On 18-FEB-2014 the patient was vaccinated with ZOSTAVAX vial, single dose with lot # J002693 and expiry date 07-JUN-2014, (dose unit unknown) subcutaneously in the left arm for vaccination. No concomitant medications were administered. On 18-FEB-2014, the patient experienced developed redness, pain, itching, swelling, warmth and induration at the injection site. Patient visited pharmacy and no treatment was given for the events. No laboratory tests were performed. The outcome of developed redness, pain, itching, swelling, warmth and induration at the injection site was reported as not recovered/not resolved. Additional information has been requested.
Diarrhea (suspected side effect of flu vaccine as this never occurred with previous 4 COVID shots), fatigue, mild soreness/redness/swelling at injection site, fever 102.5°F
Red, swollen, warm to touch left upper arm size id a softball.  Started on BACTRIM D5 800-160 1 po bid
feeling very sick; feeling very bad; being hurt in bed/aches; can't do anything; chills; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (feeling very sick), FEELING ABNORMAL (feeling very bad), PAIN (being hurt in bed/aches), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (can't do anything) and CHILLS (chills) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022c21a, 001r21a and 031m2a) for COVID-19 vaccination.     Concomitant products included MELOXICAM and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.   On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Dec-2021, the patient experienced ILLNESS (feeling very sick), FEELING ABNORMAL (feeling very bad), PAIN (being hurt in bed/aches), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (can't do anything) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, ILLNESS (feeling very sick), FEELING ABNORMAL (feeling very bad), PAIN (being hurt in bed/aches), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (can't do anything) and CHILLS (chills) had not resolved.            Concomitant medications included cholesterol medication, blood pressure medication and regular medication.
Fever 101*F and higher  Extreme body aches  No energy  Nauseated
COVID 19; COVID 19; Dose 5 Pfizer BioNTech , Dose 4 Moderna; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Sep2022 at 21:00 as dose 5 (booster), single (Lot number: GH9693) at the age of 52 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 20May2022 at 16:00 as dose 4 (booster), single (Lot number: 038A22A), 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) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Obstructive sleep apnea" (unspecified if ongoing), notes: Other medical history: Obstructive sleep apnea; "psoriasis" (unspecified if ongoing); "psoriatic arthritis" (unspecified if ongoing); "ADD" (unspecified if ongoing). Concomitant medication(s) included: POTASSIUM CITRATE [CITRIC ACID;POTASSIUM CITRATE], start date: 03Mar2020; CRESTOR, start date: 07Jul2020; CONCERTA, start date: 05Oct2020; STELARA, start date: 06Oct2020. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 20Sep2022 at 21:00, outcome "unknown", described as "Dose 5 Pfizer BioNTech , Dose 4 Moderna"; DRUG INEFFECTIVE (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: (unspecified date) Positive, notes: COVID 19 Treatment; (31Oct2022) Negative; (02Nov2022) Negative; (06Nov2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Headache, severe nausea, loose stools, hand cramps, unable to move fingers, loss of appetite, weakness
COVID-19; Muscle ache; coughing; chills; Headache; Fatigue; Nasal congestion; Loss of taste; Loss of smell; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19), NASAL CONGESTION (Nasal congestion), AGEUSIA (Loss of taste), ANOSMIA (Loss of smell) and COUGH (coughing) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced CHILLS (chills). On 16-Apr-2021, the patient experienced COUGH (coughing). On an unknown date, the patient experienced COVID-19 (COVID-19), NASAL CONGESTION (Nasal congestion), AGEUSIA (Loss of taste), ANOSMIA (Loss of smell), MYALGIA (Muscle ache), HEADACHE (Headache) and FATIGUE (Fatigue). On 14-Apr-2021, CHILLS (chills) had resolved. At the time of the report, COVID-19 (COVID-19), NASAL CONGESTION (Nasal congestion), AGEUSIA (Loss of taste), ANOSMIA (Loss of smell), COUGH (coughing), HEADACHE (Headache) and FATIGUE (Fatigue) had resolved and MYALGIA (Muscle ache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Apr-2021, Chest X-ray: normal (normal) Chest x-ray came back normal. On 22-Apr-2021, SARS-CoV-2 test: positive (Positive) Nasopharyngeal positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: HCP information added as secondary reporter, confirmed positive COVID-19 test On 19-Jun-2021: Follow-up questionnaire provided AE details.
This spontaneous report was received from a pharmacist via a company representative referring to a female patient of unknown age. The patient's concurrent conditions and concomitant medication were not reported. The patient's medical history included several past episodes of shingles. On an unknown date, the patient was vaccinated with ZOSTAVAX 19400 PFU (dose, route of administration, lot number and expiration date were not reported) for prophylaxis. The patient stated that usually, she had an outbreak of shingles every time she had a surgical procedure, because when she had surgical procedures that situation stressed her out. On an unspecified date, after receiving the ZOSTAVAX, the patient experienced a case of shingles, but, she reported that it was much milder. Additionally, the patient stated that she was pleased because her case of shingles was milder than her previous cases. At the time of reporting, the outcome for the event shingles was not reported. The causal relationship between the event and the suspect vaccine was not reported. Additional information is not expected because there was no consent to contact the reporter.
6MAY inc temp @ 210PM 102.6, vomited x 2; 7MAY93 vomited x 1 choking, ? sz; taken to ER;
15min p/vax pt had redness about 3" across @ site;no other problem;BP 116/70;seen by MD & given med;redness w/o itching appeared on neck & upper body & chest;no wheezing, tightness in throat or other rxn sx;p/35min of observation BP 100/70;
Information has been received from a consumer concerning a child who, on an unspecified date, was vaccinated with MMR. The consumer reported that she had heard of a child that developed autism shortly after receiving the vaccination. The outcome of the event was not reported. The consumer also reported the experiences of her grandson after vaccination with MMR. Upon internal review, the autism was considered to be other important medical event (OMIC). No further information is available.