chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report received from a contactable consumer (patient's friend). A patient, of unspecified age and gender, received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, batch/lot#, expiration date and NDC number: not reported), via an unspecified route of administration, right arm (shoulder), on an unspecified date, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. On an unspecified date, patient was knocked-out. Patient had a temperature, aches, pains, headache, sore right shoulder (where he got shot) and brain fog (it went away). The outcome of all the events recovered. The lot number for the vaccine (BNT162B2), not provided and will be requested during follow-up.
I received a flu shot in my right arm and a pneumonia shot in my left arm. I experienced no pain in my right arm but immediately exclaimed as I was receiving the pneumonia shot that the shot in my left arm was painful. The pharmacist said it should not have hurt, but I told her it did. My arm continued to hurt and be painful for the rest of the day. By the evening, I could no longer lift my arm or use my left arm in a meaningful way.  The pain has been excruciating and I'm unable to use my left arm.  I made an appointment with a ortho doctor the next morning. I went to the doctor today.
flu; Initial information received on 25-Dec-2022 regarding an unsolicited valid social media non-serious case received from a consumer/non-healthcare professional (hcp).  This case involves an unknown age and unknown gender patient who experienced flu after receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received suspect INFLUENZA VACCINE produced by unknown manufacturer (strength, formulation, route, dose: unknown) (lot number and expiry date: not reported) in unknown administration site for Prophylactic vaccination (Immunisation).  On an unknown date, the patient Got the flu shot and currently have the flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It is unknown if the patient experienced any additional symptoms/events. It is unknown if the patient had any medical history, concomitant disease or risk factor. It is unknown if there were lab data/results available.   Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (flu).  At time of reporting, the outcome was Unknown for the event flu.
At 6:30 p.m. the day after receiving my first dose I began my period 6 days early.
patient was so fatigued that he could not get to the bathroom without holding the wall/Patient slept for nearly 24 hours; fever; chills; sweats; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweats), FATIGUE (patient was so fatigued that he could not get to the bathroom without holding the wall/Patient slept for nearly 24 hours), PYREXIA (fever) and CHILLS (chills) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A, 037A21B, 071F21A and 027L21A) for COVID-19 prophylaxis.             No Medical History information was reported.   On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Mar-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced HYPERHIDROSIS (sweats), PYREXIA (fever) and CHILLS (chills). On an unknown date, the patient experienced FATIGUE (patient was so fatigued that he could not get to the bathroom without holding the wall/Patient slept for nearly 24 hours). At the time of the report, HYPERHIDROSIS (sweats), FATIGUE (patient was so fatigued that he could not get to the bathroom without holding the wall/Patient slept for nearly 24 hours), PYREXIA (fever) and CHILLS (chills) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Body temperature: 103.5 Degree Fahrenheit.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was provided. The patient reports that he did well after all of his Moderna Covid-19 vaccinations however after his second Moderna Primary Series Dose the patient had several Adverse events. Patient reported adverse reactions of fatigue on the next day March 14, 2021.  After 26 hours the symptoms went away for patient. Patient reported adverse reactions of low level fatigue for a day with first Moderna Covid 19 vaccine booster dose and second Moderna Covid 19 vaccine booster dose.    No treatment medications was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-712256 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-712256:Monovalent case
This case was reported by a other health professional and described the occurrence of stiffness in arm in a adult female patient who received FLUARIX QUADRIVALENT (batch number 7LE2S, expiry date 30th June 2015). On 4th September 2014 14:00, the patient received FLUARIX QUADRIVALENT. On 4th September 2014, less than a day after receiving FLUARIX QUADRIVALENT, the patient experienced stiffness in arm and mild pain in injected limb. On an unknown date, the outcome of the stiffness in arm and mild pain in injected limb were recovered/resolved. The reporter considered the stiffness in arm and mild pain in injected limb to be probably related to FLUARIX QUADRIVALENT. Additional information received on 06 October 2014: The caller was a nursing student. Her nursing class received Flu Vaccines about a month ago. They received the vaccines on the same day. This patient experienced side effects (stiffness and mild pain in the affected arm) subsequent to the vaccine. The nursing student reported that this patient pain has alleviated quite a bit. When she first received the vaccine she had some pain, then the pain alleviated a bit for a few days, and then it got worse, and now the pain is mostly better about a week and a half later. The caller reported that this patient gave herself some physical therapy (moved her arm around a bit) and the patient reported to her that the pain went away after this self-therapy.
Developed significant swelling on the L thigh after vaccine. Pain same to restrict and limit walking with limp, no fever. L thigh thru the size as compare to R. No erythema, no induration.
GENERALIZED PAIN/BODY ACHES THROUGHOUT; HEADACHE; FEVER 101F; This spontaneous report received from a patient concerned a female of unspecified age. 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 not reported, batch number: 1822809 expiry: UNKNOWN) dose was not reported, administered on 24-SEP-2021 for covid-19 prophylaxis. No concomitant medications were reported. On 24-SEP-2021, the patient experienced generalized pain/body aches throughout, headache, and fever 101f. Laboratory data included: Body temperature (NR: not provided) 101 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from generalized pain/body aches throughout, and headache on 27-SEP-2021, and fever 101f. This report was non-serious. This parent/child case is linked to 20220901626.
Lost control of left leg - for an hour and a half she could not stand, walk, or put any weight on the leg.   It went away suddenly and has not returned.  The vaccine was the NASAL H1N1 vaccine, so it was not a localized reaction from an injection.
Approximately 6 hours after immunization, patient phone the pharmacy complaining that the immunization site was red and tender and starting to swell.
1. soreness in L arm about an hour later.  2.  whole body muscle aches increasing in severity ~8 hours later.  3. HA/ fatigue 12 hours later.  4.  Chills/ fever 100.3 ~20 hours later.  Treated muscle aches and fever with alternating Tylenol and Ibuprofen, drank plenty of fluids, rested.
Symptoms:  Redness, edema from site of injection to elbow, pruritis,, tenderness Treatment:  PREDNISONE   10 mg twice a day  for 3 days, CETIRIZINE 10 mg  twice  a day for 5 days, Benadryl Cream to skin for itching.
body ache; headache; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (body ache) and HEADACHE (headache) in a female patient of an unknown age 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Sep-2021, the patient experienced MYALGIA (body ache) and HEADACHE (headache). At the time of the report, MYALGIA (body ache) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. Treatment drugs were not reported.
sx of mild stuffy nose 30Dec am then AG post at home 02Jan2022; sx of mild stuffy nose 30Dec am then AG post at home 02Jan2022; received moderna dose 1 and 2/Pfizer dose 3, booster dose; Booster; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP) from product quality group.  A 39 year-old male patient received bnt162b2 (BNT162B2), administration date 10Dec2021 (Lot number: FF2589) at the age of 39 years as dose 3 (booster), single for covid-19 immunisation; covid-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), administration date 01May2021 (Batch/Lot number: unknown) as dose 2, single and administration date 03Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. It was unknown whether the patient was diagnosed with Covid-19, prior to vaccination.  The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 10Dec2021, outcome "unknown", described as "received moderna dose 1 and 2/Pfizer dose 3, booster dose"; IMMUNISATION (medically significant) with onset 10Dec2021, outcome "unknown", described as "Booster"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 30Dec2021, outcome "recovering" and all described as "sx of mild stuffy nose 30Dec am then AG post at home 02Jan2022". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (02Jan2022) positive, notes: AG post at home. It was unknown if therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.
PATIENT STATED THAT SHE HAD A BURNING SENSATION IN HER ESOPHAGUS AND PERSISTENT VOMITING.
Patient was asked to wait in pharmacy for 15 minutes in case of a reaction. Within the 15 minute window, patient reported feeling very dizzy. We sat him down in a chair. He was profusely sweating and said he felt nauseated and that he was about to pass out. Patient was given sips of water. We also wet down a paper towel for patient's forehead. We asked the patient if he would like to go to the hospital and he said he did, so we called the ambulance.
hives devel initially on opposite arm of vax @ elbow-approx 1 1/2 hr p/inject; back to MD office 24 hrs later w/hive like eruptions on all four extremities; specifically @ elbows & knees;
Noted tremors in hands and increased pain and fatigue in upper extremity. Limited patient's ability to do school work or play classical guitar due to fatigue and pain in arms. Still continues 5 months later.
Patient reported to pharmacy on 2/27/20 stating reactions to vaccine administered on 2/6/20 started the next day on 2/7. Started with pain in left thumb, traveling to the right ankle and eventually spreading to all joints in the entire body. Pain was so severe that patient could not move or walk. Patient stated she had a fever in the middle of the night and woke up with sweating, also stated she had hallucinations. Joint pain resolved one week ago. Patient experienced severe headache that lasted until the day she came to pharmacy to report. (2/27)
Bruise and sore muscle for the first couple of days but the sore muscle has continued.
This is a 66y.o. male with PMHx CAD s/p stent x6, s/p CABG (LIMA-LAD, left radial-OM, SVG-RCA), HTN, T2DM, initially presented to a HCF with abdominal pain, nausea, vomiting, and jaundice on 7/12. Found to have elevated LFTs and was positive for acute hepatitis B, transferred to another facility. Patient does have a distant history of drug abuse. He was started on tenofovir.  Of note, his pre-transplant cardiac cath 7/20/22 showed varying stenosis of LMA, LAD, LCX, and RCA as well as 100% occlusion of the RCA in the mid segment. ECHO 7/20/22 with EF 55%, intermediate LV function. He does have an ICD. Last device check 8/1/22. He underwent liver transplant on 8.3.22, and was transferred to ICU post op.  There was concern  for anaphylaxis to blood vs zosyn vs HBIG during OR as he experienced hypotension and became difficult to ventilate.  This again occurred while he was in ICU.  At that time is was speculated that he was having a reaction to Zosyn therefore Zosyn was placed as an allergy in his medical record.  The patient returned to OR the following day for exploration and washout(1L fresh blood in abdomen and ~2L clot evacuated from abdomen upon entry)   He received daily infusions of hydrocortison/benedryl/HBIG post op.  He developed an ileus on approximately day 7 requiring an NGT. This resolved several days later.  Induration and erythremia were noted to the left side of the abdominal incision, an abdominal CT was completed as well as blood cultures,  several staples were removed and the wound cultured (+ VRE bacteremia/ Klebsiella in wound).  Vancomycin/Azatreonam  were continued thru 8.24.22.  While on 5 center his appetite was poor.  He agreed to a corpak which was discontinued at discharge.  At the time of discharge he had 3 areas of his incision that needed to be packed with continuous piece of dampened Saline.  He wife was taught wound care, and received teaching from the clinic staff and pharmacist.  HOme care/PT/OT were requested thru care mangement.
A couple hours after receiving the Pfizer Booster, I started to experience my heart rate accelerating while resting. This continued into the next day, but after that, it stopped. It never occurred again after the next day.
Severe pain in abdomen; pancreatitis; Swelling in gallbladder; Swelling in kidney; weakness; A Spontaneous report was received from a Consumer concerning a male patient of 78-year-old who received a dose of Moderna's COVID-19 vaccine (mRNA-1273) and experienced Pancreatitis, Asthenia, Abdominal pain, Gall bladder edema, Hydernephrosis.  The patient's medical history included heart problems, 13 stents, high blood pressure, high cholesterol, borderline diabetic, thyroidectomy (28 years), bilateral knee replacement, and arthritis. Allergy history included sulfa.  Concomitant medications included metformin, metoprolol, lisinopril, levothyroxine, clopidogrel for unknown indication.  On 25 Feb 2021, the patient received her first of two planned doses of mRNA-1273 (lot/batch: 023M20A) on left arm for prophylaxis of COVID-19 infection.   The patient had experienced difficulty in exercise and weakness, after first dose of vaccination.  On 17Mar2021 he had severe pain in abdomen and hospitalized for seven days until 23 MAR 2021. The patient was diagnosed with pancreatitis and the patient also had swelling in gallbladder and kidney. The patient was treated with intravenous fluids but other meds were not reported. Laboratory details were not provided.   Action taken with mRNA-1273 in response to the events was not reported.  On date of this report, the outcome of the events Pancreatitis, Asthenia, Abdominal pain, Gall bladder edema, Hydernephrosis unknown.; Reporter's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.
This spontaneous report as received from a nurse refers to unspecified number of patients of unknown age and gender. Pertinent medical history and concomitant medications were unspecified by reporter. On an unknown date unspecified number of unspecified patients vaccinated with PEDVAXHIB (route of administration, anatomical location, dose and lot number was unknown) that were exposed to temperatures outside of the proper storage range (stored temperatures were unspecified by reporter). No adverse effect reported. The outcome of the events was unknown. No further information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report as received from a healthcare worker (also reported as medical assistant), refers to a unspecified patients of unknown age and gender. On an unknown dates, the patients were vaccinated with a improperly stored doses of M-M-R II (lot # L024268, expiration date 01-JUL-2017; lot # L012479, expiration date 10-APR-2017; Lot# L030162, expiration date 11-AUG-2017) ( doses not reported). No adverse effects reported. Additional information has been requested.
Congestive heart failure; This is a spontaneous report from a contactable consumer or other non hcp.  A 73-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# unknown), via an unspecified route of administration single dose on 18Jan2021 for covid-19 immunisation. Age at vaccination was 72-year-old. Medical history included ongoing cardiac disorder (for years). The patient's concomitant medications were not reported. He was having trouble breathing and his face and stomach just kept getting bigger, so they admitted him for congestive heart failure, onset date 06Feb2021. The patient was hospitalized from 06Feb2021. He lost 13 pounds since they removed fluid from him in the hospital. The event outcome was unknown.  Information on the lot/batch number has been requested
pt recvd vax 26JAN95 & 2FEB95 exp febrile seizure 7th day p/vax;
First shot - Tiredness, muslce pain, injection site soreness (1 month), injection arm lockup when above shoulder height,   Second shot - Extreme Tiredness, liver pain, bloating.
varicella - information has been received from a physician concerning a 20 moth old caucasian female who on 18 Aug 1999 was vaccinated sc with the first dose of varicella virus vaccine live in the right arm Lot 631169/0711J.  Concomitant therapies included the third dose of hepatitis b vaccine recorbinant yeast Med lot 628414/1478H in the left deltoid and tuberculin.  On 23 Mar 2000 the patient was diagnosed with full blown chicken pox.  The patient was treated with a cyclovir (zoviraz) 2.5 ml four times a day for 5 days .  Subsequendly.  the patient recovered.
A little tenderness under my left arm - closer to rib cage; Red raised very itchy spot on my arm at the site of the injection.; Patient received dose 4 of Comirnaty; Patient received dose 4 of Comirnaty; This is a spontaneous report from a contactable reporter (consumer or other non-hcp). The reporter is the patient.  A 67-year-old female patient (not pregnant) received bnt162b2 (BNT162B2) on 23Jul2022 at 15:30 as dose 4 (booster), single (Batch number: FJ4989), in the left arm, at the age of 67 years, for COVID-19 immunisation. Relevant medical history included: "Pemphigus foliaceous" (unspecified if ongoing), notes: Pemphigus Foliaceous but has been in remission basically since Rituximab in 2016/2017. Concomitant medications included: LOSARTAN; AMLODIPINE; PREMARIN and COQ10. Past drug history included: Cyclosporine, reaction: "Drug allergy"; Hydrochlorothiazide, reaction: "Drug allergy"; Tetracycline, reaction: "Drug allergy" and Rituximab, for Pemphigus foliaceus, notes: Rituximab in 2016/2017. Vaccination history included: COVID-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 immunisation; COVID-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for COVID-19 immunisation and COVID-19 vaccine (DOSE 3 (BOOSTER), MANUFACTURER UNKNOWN), for COVID-19 immunisation.  The following information was reported: OFF LABEL USE (non-serious), IMMUNISATION (non-serious) all with onset 23Jul2022 at 15:30, outcome "unknown", and all described as "Patient received dose 4 of Comirnaty"; VACCINATION SITE URTICARIA (non-serious) with onset 23Jul2022 at 20:30, outcome "not recovered", described as "However, later that day I noticed that I had a red raised very itchy spot on my arm at the site of the injection"; AXILLARY PAIN (non-serious) with onset 25Jul2022, outcome "unknown", described as "I am also noticing a little tenderness under my left arm - closer to rib cage". Therapeutic measures were not taken as a result of vaccination site urticaria and axillary pain.  Additional information: The patient was pretty healthy generally. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient said that it was about the size of a silver dollar. She would say that it was even itchier the following day. She had never experienced a reaction to any other vaccine, COVID-19 or otherwise. This was a first. She was also noticing a little tenderness under her left arm - closer to rib cage, but she could not see anything. (This was first observed on the morning of, Monday, July 25). Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care.
vaccine was given week ago and pt has had pain at injection site, red rash that is growing, and difficulty in raising left arm, with joint pain
Took Vivotif capsule after temperature excursion; A spontaneous report was received from a 26-year-old female on 20SEP2023 along with the additional information received on 22SEP2023 who "took Vivotif capsule after temperature excursion" (PT: Product storage error). The patient took Vivotif capsules (typhoid vaccine live oral Ty21A; lot number: 3003852) for immunisation.  The patient's medical history, concomitant medications, or allergies were not reported.  It was reported that the patient placed the Vivotif capsules in the cold packs when she was out for four hours. She believed that the first cold pack lasted for one hour and another cold pack was applied until the Vivotif capsules were kept in the refrigerator, few hours later. Reportedly, the capsules were at room temperature possibly that was in between 70-74 degrees Fahrenheit (with AC on) for about 1 to 2 hours, potentially 2.5 hours. On 20SEP2023, morning, the patient administered the first dose of Vivotif on an empty stomach followed by the second dose on 22SEP2023, morning.  The outcome of the reported event was not applicable. The action taken with Vivotif with respect to the reported event was not applicable.  No additional information was reported.  Company comment: It was reported that a consumer took Vivotif capsule after temperature excursion (product storage error). Further information regarding the medical history and concomitant medications is limited. The causality of product storage error is assessed as not applicable with Vivotif. The case is considered non-serious as per medical assessment.; Sender's Comments: It was reported that a consumer took Vivotif capsule after temperature excursion (product storage error). Further information regarding the medical history and concomitant medications is limited. The causality of product storage error is assessed as not applicable with Vivotif. The case is considered non-serious as per medical assessment.