chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from product quality group. The reporter is the patient.  An 80-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Sep2022 at 12:45 as dose 5 (booster), single (Lot number: GH9694) at the age of 80 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 18Oct2021 as dose 3 (booster), single (Lot number: FH8020), in left arm and on 23Apr2022 at 14:00 as dose 4 (booster), single (Lot number: FM9992), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Osteoarthritis" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing), notes: Known allergies: Sulfa. Concomitant medication(s) included: SIMVASTATIN, stop date: 16Oct2022; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; FLUTICASONE PROPIONATE; OMEPRAZOL; CALCIUM; MAGNESIUM; CRANBERRY; BIOTIN. Past drug history included: Codeine, reaction(s): "Known allergies: Codeine", notes: Known allergies: Codeine. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (21Oct2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19: Paxlovid.   Follow up information has been requested.
Started with a fever of 100, chills, body aches and fatigue.  Fever lasted 12 days, was only kept under 100 by using Tylenol.  Sever fatigue lasted 17 days.  Very uncomfortable back pain, near kidneys.
patient came in to receive TUBERSOL and accidentally received IPOL intradermally instead with no adverse event; patient came in to receive TUBERSOL and accidentally received IPOL intradermally instead with no adverse event; Initial information received on 31-May-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 19 years old female patient who came in to receive tubersol and accidentally received ipol intradermally instead with no adverse event while receiving vaccine IPV (VERO) [IPOL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 31-May-2022, the patient received a dose of suspect IPV (VERO) at a dose of 0.1 ml (lot T1D482M and expiry date: 25-Jul-2022; strength: unknown) via intradermal route in unknown administration site as prophylactic vaccination.  On 31-May-2022, the patient came in to receive tubersol and accidentally received ipol intradermally instead with no adverse event (wrong product administered) and incorrect route of product administration) (latency: same day) following the administration of IPV (VERO).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the events  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. 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.
Expired vaccine used; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 15-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment information was not provided.   This case was linked to MOD-2021-392935 (Patient Link).
Vertigo, body aches, blur vision, ear ache, and extreme soar arm.
I had severe stomach pains six days after vaccine (on April 30th) and ended up at a walk-in clinic who sent me to the ER on May 3rd.
12:30PM  ADMINISTERED MODERNA COVID-19 VACCINE INTRAMUSCULAR TO LEFT DELTOID 12:31PM APPEARED TO BE PALE POST VACCINE; MEDICS QUESTIONED PT, COMPLAINS OF BEING NERVOUS 12:35PM PT STARTED BREATHING HEAVIER AND JUST COMPLAINS OF CONTINUED NERVES 12:45PM PT COMPLAINED OF FAST HEART RATE TO MEDICS AT 146BPM 12:50PM PT INSTRUCTED TO TAKE SLOW, DEEP BREATHS. VITAL OBTAINED .  HR 140, SPO2 100% LUNG SOUNDS CLEAR 12:55PM BP 131/77, HR 123, SPO2 100% PT HYPERVENTILATING RR 30'S. 1:00PM  STATES THROAT AND CHEST ARE FEELING TIGHT. TACHYCARDIA CONTINUED. 1:02PM 0.3MG OF EPINEPHRINE ADMINISTERED 1:05PM PT APPEARS TO BE CHILLED AND IS SHAKING. 1:10PM BASE SECURITY/FIRE DEPARTMENT ARRIVES. VITAL SIGNS STABLE 1:15PM EMS ARRIVES. HR 129 SPO2 100% ROOM AIR. CARE TAKEN OVER BY EMS. 1:20PM TRANSPORTED TO HOSPITAL VIA AMBULANCE.
Myalgia, Fever, Chills, Fatigue, Pain at injection site Narrative:
This spontaneous report as received from a registered nurse refers to a 47 year old female patient. On 22-NOV-2013 the patient received the first dose of VARIVAX (lot # J008229, expiry date: 15-MAR-2015 dose 0.5 ml, subcutaneously) for "school requirement". On 21-JAN-2014 the patient received the 2nd dose of VARIVAX (lot# J008229, expiry date: 12-JULY-2015, dose 0.5ml subcutaneously). The patient was seen in the office on 26-MAR-2014 and stated that, on unspecified date in 2014, had titers drawn at her community college which showed her to have borderline immunity. The titers were re-drawn on 26-MAR-2014 and results received on 28-MAR-2014 showed a value of less than 0.9 which was considered negative. The outcome of the events was unknown. The relationship of the events to VARIVAX was unknown. Additional information has been requested.
6 x 7 cm area of mild erythema, warmth + mild induration. Onset 04/03/2008.  Treatment: warm compress, Motrin, Benadryl.
About 8 hours after start feeling dizzy; hard to breath; Tingling around lips fingers and toes; Tingling around lips fingers and toes; This is a spontaneous report received from a contactable consumer (Patient). A 16-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EW0189), Solution for injection, via an unspecified route of administration, administered in Arm Right on 17Apr2021 08:00 (at the age of 16-year-old) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received unspecified medication in two weeks.The patient was not diagnosed with COVID-19 Prior to vaccination. The patient had not been tested for COVID-19 Since the vaccination. The patient previously took codeine and experienced codeine allergy. On 17Apr2021 20:00, about 8 hours after start feeling dizzy, hard to breath, tingling around lips fingers and toes. Benadryl and IV fluid were received as a therapeutic measure to treat adverse events. Ae resulted in emergency room/department or urgent care visit. The events were recovered on an unspecified date in Apr2021.   No follow-up attempts are possible. No further information is expected.
-Redness/warmth at The site swelling -fever/chills, body aches & fatigue -Cellulitis was started on Cephalexin 500 mg 8-18-20
Initial slight rash after receiving vaccine that seemed to diminish after 48 hours.  Six days later, significant large rash appeared, red and itch and is just now diminishing.
Large local reaction at site of injecton (L) 12 cm, red, slight tender. No specific treatment.
Pt. given FLUMIST while pregnant (did not know was pregnant at time of vaccination). Instructed pt to contact OB doctor for monitoring.
Redness and inflammation with pain rt upper arm. IN the PM of 8-9-07, pt came into office was seen and given Prednisone dose pack.
Left arm raised, red, painful and hot starting 11/15/20,  Both arms red Monday, low grade fever started on 11/16/20 with general feeling of malaise. Not treatment at this time.  Reported incident to Health Clinic.
Patient started feeling ill on Thursday night with flu symptoms and a chest tightness. Later after patient went to bed the skin of his arms, torso and head got really warm and the skin of his thighs got extremely warm to the touch. Patient also got the shakes - not like shivering, patient describes the feeling was like getting an electric charge. It kept him awake. It stopped after 4 hours, but then started up again about 20 minutes later. It finally ended about time to get up, but then the flu symptoms were still worse, so patient stayed in bed all day Friday.
sore arm; it felt like a fibromyalgia flare; This is a spontaneous report from a contactable consumer, the patient. A 29-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on 28Jan2021 as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that she took 400 mg of Advil 1.5 hours after the dose because of a sore arm and added "it still hurts a lot. It was ok the first 15 mins after the shot, then within 45 mins it felt like a fibromyalgia flare." Caller is asking if it was ok to take the Advil after the vaccine. She used a nasal spray and she wants to know if using the nasal spray will interact with the vaccine. The outcome of the event- it felt like a fibromyalgia flare was unknown, while that of the sore arm was not recovered at the time of report.  Information about batch/lot number has been requested.  Follow-up attempts are completed. No further information is expected.
This non-serious initial spontaneous case was received on 28-Aug-2017 from a pharmacist, concerning a 71-year-old elderly, female patient. The patient had left side of her face swollen several weeks ago. Current condition included sleep problem from an unspecified date. Concomitant medication included BENADRYL for sleep. On 25-Aug-2017, the patient was administered with FLUAD (TIV) (dose: 0.5 ml, route of administration: intramuscular, batch no. reported as 178301, expiry date: Apr-2018 and anatomical location: not reported). On 26-Aug-2017, one day after vaccination, the patient had facial swelling (reported as left side of her face was swollen). It was reported that she noticed that in the morning of 27-Aug-2017 when she woke up and was treated with BENADRYL for the same. The patient also had similar reaction several weeks ago and her physician was aware of that. At the time of this report, adverse reaction persisted and she had not yet recovered from the event. The reporter assessed the report as non-serious.
Deltoid muscle ache for 40 hours, beginning right after injection; flu like symptoms (chills, sweats, muscular aches all over, fatigue, restless sleep, lack of appetite) beginning 6 hours after injection and lasting 24 hours. Stayed in bed for 19 hours.
Chills Headache Weakness Fever Body aches Arm redness Took Tylenol, Benadryl, water
Flu-like symptoms: achy joints, sore muscles, severe headache, high fever (106 at the highest), swollen lymph nodes in underarm of arm where vaccine was given. I was very tired, felt horrible,and had trouble staying awake for any length of time during the day after I got the vaccine. This was my second Shingrix vaccine, and the side effects were worse with this one than the first one.
Patient came into the pharmacy on 9/16/19 complaining of redness, soreness, and swelling of his arm. Upon inspection, patient's arm was swollen from shoulder to hands. Pharmacist on duty advised patient to visit an urgent care and get it checked out. The following day, pharmacist called patient to check up. Patient stated he did not end up seeking attention but did take ibuprofen and applied ice to the spot which improved his symptoms greatly.
This spontaneous report as received from a Medical Assistant refers to a patient of unknown age and gender. Medical history and concurrent conditions were not provided. On an unknown date, the patient was vaccinated with a dose of improperly stored GARDASIL (dose and route were not reported) lot # J015378, expiry date 09-APR-2016. There was no concomitant medication provided. No adverse effect reported. Additional information has been requested.
Information has been received from a physician and a practice manager via company representatives referring to a patient of unknown age and gender. On 11-JUL-2016, the patient was vaccinated with an improperly stored dose of VAQTA, pediatric (PED), lot # L004743, expiration date 01-JUN-2017 (dose and route unspecified). This specified lot number vaccine was exposed to temperature excursions twice. The storage criteria was refrigerator (R). The total cumulative excursion times (hour), the lowest recorded temperatures (Fahrenheit degree) and the type of excursions (R/F) were as following: the first time excursion 936, 34 and R; the second time excursion 168, 32 and R. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Body Aches Generalized-Medium, Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Headache-Medium, Systemic: Hypotension-Medium, Systemic: Nausea-Medium, Systemic: Weakness-Medium
Hives - mother noticed approximately 9 hours after injection with mild increased temperature.  Given antihistamine by family physician.
pt ran temp 101 & lump below lt arm;pt fussy;had knot;ear infect;knot on back of childs neck;
This spontaneous report was received from a physician via a Company representative concerning to an unspecified patients of unknown age and gender. Medical history and concurrent conditions were not provided. On 15-DEC-2015, the patients were vaccinated with an improperly stored doses of RECOMBIVAX HB lot # K020336, the expiration date: 17-AUG-2017 (dose and route were not reported). The total cumulative hours out of range were 64 hours with 48 degrees C as the highest recorded temperature. On the other hand, the total cumulative hours out of range were 328 hours with 29 degrees C, 304 hours with 33 degrees C, 88 hours with 30 degrees C, 40 hours with 34 degrees C as the lowest recorded temperature. The storage type was refrigerator. There was no concomitant medication provided nor no Product Quality Complaint(PQC) involved. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
pt c/o itching several hrs p/vax & by the next day had hive-type lesions on multiple areas of body
Severe Arm pain 12hours following injection. Extremely painful to move arm Severe Abdominal pain, felt like burning sensation in stomach, bent over in pain. Occurred within window of 12 hours to 24 hours post shot. Skin color turned pail white, including lips during abdominal pain and diarrhea. Explosive Diarrhea occurred 12 through 24 hours post injection. Symptoms were most intense and lasted 12 hours through 24 hours post injection, all self resolved within 30 hours post injection.
First my concussion (Oct 8) had given me issues concentrating, issues with visual processing (specifically my peripherals or when I'm moving my neck left-right), neck pain, sleep issues, tinnitus, and issues with emotional regulation. Most of my symptoms had cleared up to a large extent by Dec 1. However about 12 hrs. after this booster, I felt far worse than I had during Covid (Mar 2020) or during my previous 2 Covid vaccines. It was among the worst pains of my life, mainly a large dull pain. I had nausea in the morning (which I hadn't had for prior vaccines) and body aches for about 48hrs (which I had had for prior vaccines). Certain neck positions made me feel particularly nauseous. Advil cleared up some of it. I wasn't able to concentrate on my work well for 2 weeks, and my neck pain and sleep issues were worse than ever in my concussion recovery. It set back most of my concussion symptoms about a month. My neck pain and tinnitus have been at their worst since the vaccine booster. Since then many of my symptoms have cleared up; I can concentrate well again, but my neck pain and sleep issues are still worse than before the booster. The lasting regression in my symptoms was worrying. It may have exacerbated some inflammation in my brain and in my neck from my concussion. If this is a pattern for other people with concussions (especially those that are cervical in nature) then caution should be urged.
15 hours after receiving the vaccine I started having severe body aches all over and in my bones, moderate headache,  fatigue, dizziness.  Then 21 hours after receiving the vaccine I developed a temperature of 100.5.  I treated the fever and pain with ibuprofen 600 mg orally every 6 hours.  I was ill and not able to work or get out of bed for a total of 1 1/2 days.
Booster shot, Pfizer, same brand as first two shots in April/May 2021. No reactions or major symptoms from first two shots. This Pfizer booster shot on 12/18, I had an allergic reaction only at the site of the shot on my left arm. It swelled up into a hard lump that I could feel below the surface of my skin within 24 hours after the booster shot. My skin turned red around the area of the shot (about the size of the palm of my hand), and that area was itchy. It did not spread anywhere else on my body, so it was localized to the site of the shot. It was more itchy the first 24 hours. I took one benadryl that night. Have not taken anything else since. The itchiness has slowed and redness is slowly subsiding and lump is slowly getting smaller.
Information has been received from a health professional via a drug wholesaler concerning a patient who was vaccinated with a dose of pneumococcal vaccine 23 polyvalent. It was reported that the patient contacted the office post vaccination and noted that he or she had streaks appearing down the arm. The patient had sought medical attention for the experience. It was also reported that another patient developed injection site ecchymosis post vaccination with pneumococcal vaccine 23 polyvalent (WAES01111508). Additional information has been requested.
reported "weird" sensation in her body and "like a pulsing in my chest".  1337 - Patient reports weakness,
Case number PHEH2012US025005 is an initial spontaneous report received from a pharmacist on 14 Dec 2012. This case refers to a 48-year-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1207201) intramuscularly on 13 Dec 2012. Few hours later, she began to experience an accelerated heart rate that resulted in not being able to sleep. The reporter stated that this patient was not familiar to her, so the reporter does not know if the patient had any underlying health condition that might have contributed to this event. The events were ongoing at the time of this report. No other information was reported.
Flu like symptoms; Very tired; Severe headache; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), FATIGUE (Very tired) and HEADACHE (Severe headache) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), FATIGUE (Very tired) and HEADACHE (Severe headache). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms), FATIGUE (Very tired) and HEADACHE (Severe headache) had resolved.            No concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Sep-2021: Follow up contains no new information
pt recvd vax 11JUL95 & 20JUL95 pt exp fever, vomiting & a few spots or lesions on vaginal area & face;21JUL95 pt's fever & vomiting persisted & had a total of approx 25 spots, w/o blisters, that look like mosquito bites;
Sudden death on 10/25/20, 9:15AM.  Patient's adult daughter reports patient awoke on 10/25/20 AM feeling unwell and eventually lost consciousness.  Had to be resuscitated and eventually intubated.
Narrative:  COVID infection following COVID vaccine series 12/29.2020, Pfizer, dose #1 01/19/2021, Pfizer, dose #2 08/27/2021, Pfizer, dose #3 COVID swab, result: detected 09/24 pt cc: cough, fatigue, myalgias, dyspnea, fatigue, fever, exposure: unknown clinically resolved
A magnet stuck to the injection site; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of DEVICE CONNECTION ISSUE (A magnet stuck to the injection site) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.     On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DEVICE CONNECTION ISSUE (A magnet stuck to the injection site). At the time of the report, DEVICE CONNECTION ISSUE (A magnet stuck to the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment information was provided.
08/22/05 Chicken Pox disease, sibling had chicken pox disease 2 weeks ago with secondary infection.