chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a pharmacist and refers to a 25 year old female patient whose medical history, past drugs, concurrent conditions, concomitant medications, drug reactions and allergies were reported as unknown. On 02-OCT-2017, the patient was vaccinated with PNEUMOVAX 23 lot # N011867, expiry date: 08-NOV-2018, (one dose) intramuscular in the left arm for prevention of pneumococcal disease. On an unspecified date in October 2017, the patient developed bursitis in her left elbow and bursitis in her right elbow. It was unknown if patient had any lab tests. It was unknown if any treatment was received by the patient for the adverse events. The patient called pharmacist to sought medical attention. On an unspecified date in October 2017, bursitis in the left elbow was resolved. The outcome of bursitis in her right elbow was not reported. The reporter did not provide the causality of events with PNEUMOVAX 23. Product Quality Complaint (PQC) was not involved.
This case was reported by a other health professional via sales rep and described the occurrence of generalized rash in a 19-year-old female patient who received BEXSERO. On an unknown date, the patient received BEXSERO. On an unknown date, unknown after receiving BEXSERO, the patient experienced generalized rash. On an unknown date, the outcome of the generalized rash was unknown. It was unknown if the reporter considered the generalized rash to be related to BEXSERO. Additional details were provided as follows: This case was reported by medical assistant (MA). The age at vaccination was not reported. The patient developed rash all over after receiving dose of BEXSERO. No further information was available or reported regarding the event.
Pt experienced excrutiating pain around 11 am on 12/9/19, couldn't move arm/shoulder. Did not have this reaction on the first shot.
Pfizer Covid vaccine administered to 15 year old.  Patient and/or mom falsified information on consent and release form stating patient's DOB was 1 year before pt's real DOB and age was 1 year older than patient's real age.  * * * NO adverse reaction reported. * * *
Slight numbness injection site on left arm; Head is congested; Jaw area muscle tightness; Feels a little off; Slight ache in head; 2nd Shot after 42 Days; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd Shot after 42 Days), INJECTION SITE HYPOAESTHESIA (Slight numbness injection site on left arm), HEAD DISCOMFORT (Head is congested), MUSCLE TIGHTNESS (Jaw area muscle tightness) and FEELING ABNORMAL (Feels a little off) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B21A and 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd Shot after 42 Days). On 21-Apr-2021, the patient experienced INJECTION SITE HYPOAESTHESIA (Slight numbness injection site on left arm), HEAD DISCOMFORT (Head is congested), MUSCLE TIGHTNESS (Jaw area muscle tightness), FEELING ABNORMAL (Feels a little off) and HEADACHE (Slight ache in head). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd Shot after 42 Days), INJECTION SITE HYPOAESTHESIA (Slight numbness injection site on left arm), HEAD DISCOMFORT (Head is congested), MUSCLE TIGHTNESS (Jaw area muscle tightness), FEELING ABNORMAL (Feels a little off) and HEADACHE (Slight ache in head) outcome was unknown.            Concomitant product use was not provided by the reporter.  Treatment medication was not provided.
The patient is 16 years old. He was giving 6 difference vaccines on 06/30/21 to catch up on vaccines. He was given an adult dose of Hep B, Energix by mistake. The adult dose should be administered to patients 19 years old and over and he is only 16 years old. The pediatric dose is 0.5 ml and the adult dose is 1 ml. The patient and parent were called but the phone number is not a working number. The patient waited in the waiting room for 15 minutes after the vaccines were administered, without an adverse event in the office.
Stiff muscle in neck and shoulder on left side. Next day had a fever and body aches. Pain in left side under arm pit. When I use the arm to much I have pain go in my left Brest.
Pt reported difficulty breathing and hoarse voice almost immediately after receiving Tdap. RN & MD consulted immediately. Pt given 25 mg BENADRYL initially, no effect. Then EPI PEN (adult) - improvement, then relapse. 40 mg DEPOMEDROL IM. No improvement. Repeat EPI PEN. Improvement in Sx. Vitals & O2 sats good. Oral course of 40 mg prednisone x 3 days. Pt completely recovered.
Patient was a 25 y/o female with no reported PMHx/PSHx. She was screened and vaccinated with 3rd dose of Pfizer Bio-N-Tech Vaccine at 0800. Patient was monitored in observation by a healthcare professional after receiving vaccine and became altered with uncontrolled, unilateral movement of the right side. Patient was assessed and brought to treatment care room within the clinic for further evaluation. Patient was assessed by APRN and nursing staff. Patient did not report loss of consciousness, loss of bowel/bladder function, and regained alertness and orientation within <15 secs of the event. Patient remained cognizant following the event and reported that she had a history of seizures but had not been diagnosed with seizures and did not take anti-epileptic medications. Patient stated that these symptoms do occur in rooms with larger crowds and stress. The patient noted that these events did not occur during her previous Pfizer vaccinations for Dose #1 and Dose #2. Patient also reported not having eaten since last night. Patient was assessed by healthcare staff on sight prior to release and vital signs were reassessed. MD was notified. Patient was instructed to follow-up with PCM for ongoing care management and to return to the nearest ER if symptoms worsened, persisted, or became more severe. Patient and husband were educated to return to the emergency room should any new symptoms including but not limited to chest pain, shortness of breath, difficulty breathing, or N/V develop. Patient and husband both vocalized understand and the patient was escorted home by her husband with stable vital signs.
Rash appeared near injection site approximately 7 days after vaccination. Rash was oblong, about 3" long, and slightly itchy.  Not painful.
Pt called the call center.  Reporting cold like symptoms"coughing, body aches, chills, both arms hurting, fatigue" after J&J covid vaccine 4/9/2021. Pt is taking ginger tea for symptoms but no medication. Pt denies emergency s/sx.  Urgent Care appt made but pt no showed on4/21/21. New appt scheduled for 4/23/21. COVID test negative on 4/23/21.
This non-valid spontaneous report was received from a medical assistant referring to an unspecified patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 26-MAR-2019, the patient was vaccinated with an improperly stored dose of VARIVAX, for prophylaxis lot # N027995 expiring on 01-OCT-2020 (strength, dose, dose number and route of administration were not reported).   Varicella virus vaccine live (oka/merck)(VARIVAX) was reconstituted with properly stored diluent.  The administered dose of the vaccine experienced a temperature excursion of 6°F to 14°F for 13 hours, as recorded by a data logger. The vaccine had a previous temperature excursion of 6.6°F for 2.5 hours.  There was no adverse effect reported. No product quality complaint was involved.  Lot number (N027995) is an invalid lot number for varicella virus vaccine live (oka/merck)(VARIVAX).
My COVID-19 symptoms started on 07/14/2022 in the morning . I had a sore throat, fatigue , loss of appetite, fever,  and headaches. I did a home test on the same day which was positive. I called my doctor right away. He prescribed me Paxlovid  for 5 days. I took Tylenol for fever and my regular medication.  I  completely recovered from COVID-19 infection within 3 weeks. I was sick for 2 weeks.
Little bit pain/body pain; Rednesss on arm; Pain on the arm; Muscle pain; Swelling; A spontaneous report was received from a 38-year-old female consumer who developed redness on the arm/vaccination site erythema, pain on the arm/vaccination site pain, muscle pain/myalgia, little bit pain/body pain'/pain and swelling/vaccination site swelling after receiving Moderna's COVID-19 vaccine (mRNA-1273).  The patient's medical history or concomitant product use was not reported.  On 29 Dec 2020, the patient received her planned doses of mRNA-1273 (batch number: not provided) intramuscularly for prophylaxis of COVID-19 infection. She developed redness and pain on the arm, muscle pain, little bit pain, body pain and swelling.   She did not take any treatment in response to the events.  Action taken with mRNA-1273 in the response to the events redness on the arm, pain on the arm, muscle pain, little bit pain/body pain and swelling was not known.  The outcome of the events redness on the arm, pain on the arm, muscle pain, little bit pain/body pain and swelling was considered as resolved on 30 Dec 2020.; Reporter's Comments: This case concerns a 38-year-old female who had nonserious events of unexpected pain and expected vaccination site pain, vaccination site erythema, vaccination site swelling and myalgia.  Event onset 2 days after the first dose of mRNA-1273. Treatment not reported. Events resolved. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments:  US-MODERNATX, INC.-MOD-2020-002099:
Had 5 shots on 08/01/2003: DTAP, IPV, Prevnar, Comvax, Varivax.  Came back to office on 08/13/2003 with a rash (vesicular lesions) around neck and body (very mild) maybe 8-10 bumps.
Facility clinic thru pharmacy provider gave the HCW a booster Pfizer vaccine in the left arm  6 inches below the acromion process, which is below the deltoid muscle. The injection went into the tissue below the deltoid  resulting in pain, discomfort, redness, swelling, and warmth to area from site of injection for 48 hours.
third vaccine; This case was reported by a consumer via call center representative and described the occurrence of extra dose administered in a 81-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 2nd dose on 18th December) and Shingrix (received 1st dose on 18th June).   On 12th August 2021, the patient received the 3rd dose of Shingrix. On 12th August 2021, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were provided as follows:  The patient had reported the case for himself/herself. The patient received third dose of Shingrix, which led to extra dose administered. The patient enquired if there were any problems after receiving this third dose.
HYPOTENSION 10/22/2022,  10/24/2022,  11/22/2022  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
On the third day after the vaccination I felt very itchy at the injection site. 7 days after the injection (4/9/2021), a red, swollen, hard, and very itchy spot developed at the injection site. My glands that are under the armpit are also swollen and they hurt.
No adverse event. Would like to report administration of inactive/expired/subtherapeutic vaccine. Lot # 0876Y had been deemed subtherapeutic by Merck in Nov 2010, expired 20Dec2010.
Myalgia, NauseaVomiting, CHILLS Narrative:  Other Relevant History:
Swelling, itching, pain, burning, redness, and warm to the touch at vaccination site on upper left arm. Fever fluctuating between 100 and 102 lasting 3 days. Headache for 3 days. Chills on first day of symptoms lasting about 10 hours. Sporadic pain in center of chest on second day of symptoms lasting about 8 hours.
Arm where injection was administered felt pins and needles and then went numb, vision changes and extreme light headedness, confusion - all felt within minutes of shot and lasted for only 25 minutes. Exhaustion followed.
I developed a sore throat, but didn't have a fever. I waited to see if a fever to see if it was strep throat but one never came in. My voice gradually became hoarse, so I decided to visit my clinic. They told me my thyroid seemed to be enlarged during examination and conducted a throat swab on me to test for viral and bacterial infections. It came back positive for strep throat, and I was prescribed me Azithromycin 500mg for 5 days for recovery. This is the second time this has happened in between vaccinations of contracting a strep throat.
Patient has a a swollen lymph node near her right shoulder blade, reporter clarifies it is parallel to patients shoulder blade.; Body aches; This is a spontaneous report from a contactable consumer. This consumer (patients husband) reported for a 67-year-old female patient received 2nd dose of BNT162B2 (Pfizer covid 19 vaccine) on 08Apr2021 at 8:00AM in right arm for covid-19 immunization. Medical history was Cancer survivor, her brother, mother and sister died of cancer. Concomitant drug was not reported. Historical Vaccine was First dose administered on 10Mar2021 at 12:00PM in right arm. Patient had a swollen lymph node near her right shoulder blade, reporter clarifies it is parallel to patients shoulder blade from 09Apr2021. Second dose received greater than 21 days after first dose. After the second dose of the covid vaccine, patient had body aches. The swollen lymph node is not painful or uncomfortable for patient, it is just there. No Emergency Room, no Physician Office visit. Patient is now back to her normal aches and pains. Outcome of the event body aches was recovered on 10Apr2021, for swollen lymph node was not recovered.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Employee was diagnosed with Bells Palsy 10/16/15 after receiving flu shot 10/14/15. Diagnosis is not permanent.
Reaction following immunizations (Hepatitis A, Tdap/left deltoid arm IM and PNEUMOVAX, Influenza right deltoid arm IM. No reaction after 30 min but patient reported swelling, soreness, pain. Within 24 hours post injections/right arm very painful, some hives, tingling in right hand/right arm, some shortness of breath Wed night. Visited clinic on 11/30/13. Notes attached. Student treated with BENADRYL, ADVIL, ice. Returned to another clinic 12/2 - slight swelling still present. Still had slight < 20mm swollen area top of right arm.
pt was given 0.5 of Moderna rather than 0.25 mls.
cardia arrest Narrative:  76 yo with CAD, carotid artery stenosis, abdominal aortic aneurism, history of MI, DM. Patient was given both COVID vaccinations with the 2nd and most recent on 2/27. On 3/20, patient was admitted to an outside local emergency room with cardiac arrest and passed away at the facility. They were unsure if this had anything to do with his covid vaccinations but thought we should at least report it.
Information has been received from a company representative by a physician concerning an 18 year old female who on 13-Nov-2007 was vaccinated in the right deltoid with her first dose of Gardasil (lot #654540/0800F).  Concomitant therapy included Concerta and Zoloft.  On 13-Nov-2007, within a few hours after vaccination, the patient experienced pain in her arm at the injection site, and the pain extended down to her fingers, chest tightness, nausea and vomiting.  There was no redness at the injection site.  The physician saw the patient the next day and she was still experiencing the severe pain in her arm, but the chest tightness, nausea and vomiting had improved.  Blood tests were performed.  No further information available.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 12/14/2007. Initial and follow-up information has been receiveed from a physician and a registered nurse concerning an 17 year old white female student who on 13-NOV-2007 at 14:30 was vaccinated in the right deltoid with her first dose of GARDASIL (lot # 654540/0800F). Concomitant therapy included CONCERTA and ZOLOFT. On 13-NOV-2007 at approximately 18:00, the patient experienced increased pain in her arm at the injection site, chest tightness, shortness of breath and severe nausea and vomiting. It was reported that the pain extended to entire arm and shoulder. There was no redness at the injection site. The physician saw the patient the next day and she was still experiencing the severe pain in her arm, but the chest tightness, nausea and vomiting had improved. Blood tests were performed. On approximately 16-NOV-2007, the patient recovered. Additional information is not expected.
Breakthrough case of Covid. Tested positive on 05/25/2022- home test. My partner has cancer, so we live a very Covid cautious life. After swim team we went to get Covid tested before a road trip on 05/24/2022-PCR test came back negative. That night he was a little sniffy, I did not worry to much about it, thought it was allergies. The next morning, we were getting ready to leave for a road trip. We received notification from a neighbor that her son was positive, so we all tested, and his test came up positive immediately. He had a little congestion, and he was coughing, and had stridor so we brought him to the ER this was Friday 05/27/2022 12:30am when he woke up with difficulty breathing, we went to the Hospital, dx croup. Given steroids and the cough is almost gone now.
was not feeling well when took shot; (irritable bowel); started feeling achy & not feeling well; felt very cold; sl h/a, sore throat, congestion w/sl cough, post nasal drip; has constipation; soreness of arm;
This spontaneous report was received from an immunization official referring to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent condition, drug and allergy history were not reported. The reporter stated that from 25-APR-2017 to 09-MAY-2017, improperly stored doses of PROQUAD lot #N002915, expiration date 24-JUL-2018 (dose and route was not reported) for prophylaxis, were administered to unspecified patients. The patients' concomitant therapies were not reported. The reporter stated that the sterile diluent used to reconstitute the vaccine was not improperly stored. No adverse effects were reported. On an unspecified date, the digital data logger registered a temperature ranges between -9° Celsius (°C) to 8°C during a time frame of 666 hours with no previous temperature excursion. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1705USA009808.
Fever, fatigue, joint pain, localized pain, redness, swelling, and warmth to touch.
On 01/31/2002, pt's father brought him to the clinic with right arm above elbow-below shoulder red and raised areas. Pt described arm as "itchy." No reaction on other arm.
COVID 19 Treatment; COVID 19 Treatment; vaccine dose number=1, vaccine brand other=J&J/vaccine dose number=2, vaccine brand other=Moderna/vaccine dose number=3, vaccine brand=Pfizer / BioNTech; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 34-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Oct2022 as dose 3 (booster), single (Lot number: 6H9703) at the age of 34 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 31Oct2021 as dose 2 (booster), single (Lot number: 939904), in left arm for covid-19 immunisation; coviD-19 vaccine nrvv ad26 (jnj 78436735) (JANSSEN COVID-19 VACCINE), on 12Mar2021 as dose 1, single (Lot number: 1805031), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Grave's disease" (unspecified if ongoing), notes: Other medical history: Grave's disease. The patient's concomitant medications were not reported. Past drug history included: Vicodin, reaction(s): "Known allergies: Vicodin", notes: Known allergies: Vicodin; Doxycycline, reaction(s): "Known allergies: Doxycycline", notes: Known allergies: Doxycycline.  The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 01Oct2022, outcome "unknown", described as "vaccine dose number=1, vaccine brand other=J&J/vaccine dose number=2, vaccine brand other=Moderna/vaccine dose number=3, vaccine brand=Pfizer / BioNTech"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 13Nov2022 to 18Nov2022.
Face swelling; Itchy eyes; Red flushing on face and chest; Tongue numb; Rash on arms; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the left arm on 06Apr2021 at 15:00 (at the age of 50-year-old) as a single dose for COVID-19 immunisation. Medical history included allergic to cats. The patient did not receive any concomitant medication within two weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 06Apr2021 at 15:30, the patient experienced face swelling, itchy eyes, red flushing on face and chest, tongue numb and rash on arms. It was unknown whether any therapeutic measures were taken as a result of the events. The events resulted in doctor or other healthcare professional office/clinic visits. The clinical outcome of the events face swelling, itchy eyes, red flushing on face and chest, tongue numb and rash on arms were not recovered at the time of the report.   No follow-up attempts are needed. No further information is expected.
This spontaneous report as received from the patient's cousin refers to the female patient of unknown age. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (lot #, expiration, dose and route unspecified). On an unknown date the patient broke out in a red rash at the injection site. The event outcome was unknown. Additional information is not expected.
Started an hour after with feeling loopy then progressed at 4pm to chills,fast climbing fever. Reached 104 by 7pm. Felt lethargic. The fever scared me. I still have a 101 fever. Very bad migraine and can?t focus
Runny nose; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (Runny nose) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20-2A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced RHINORRHOEA (Runny nose). At the time of the report, RHINORRHOEA (Runny nose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Jan-2021, SARS-CoV-1 test positive: positive (Positive) Positive.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant product use was not provided by the reporter.   No treatment details were reported.