chrisvoncsefalvay/vaers-outcomes huggingface dataset:
arm began to get very sore; Every joint and muscle in my body aching; Every joint and muscle in my body aching; chills; shaking; Skin was on fire felt like a sunburn only no redness; heart was racing; Headache; fatigued; weakness; sick; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 53 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 16Aug2021 12:15 (Lot number: FD8448) at the age of 53 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: B COMPLEX [VITAMIN B COMPLEX]; VITAMIN C COMPLEX [ASCORBIC ACID;RUTOSIDE]. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 16Aug2021 21:30, outcome "recovered" (18Aug2021), described as "arm began to get very sore"; ARTHRALGIA (non-serious), MYALGIA (non-serious) all with onset 16Aug2021 21:30, outcome "recovered" (18Aug2021) and all described as "Every joint and muscle in my body aching"; CHILLS (non-serious) with onset 16Aug2021 21:30, outcome "recovered" (18Aug2021), described as "chills"; TREMOR (non-serious) with onset 16Aug2021 21:30, outcome "recovered" (18Aug2021), described as "shaking"; SKIN BURNING SENSATION (non-serious) with onset 16Aug2021 21:30, outcome "recovered" (18Aug2021), described as "Skin was on fire felt like a sunburn only no redness"; PALPITATIONS (non-serious) with onset 16Aug2021 21:30, outcome "recovered" (18Aug2021), described as "heart was racing"; HEADACHE (non-serious) with onset 16Aug2021 21:30, outcome "recovered" (19Aug2021), described as "Headache"; FATIGUE (non-serious) with onset 16Aug2021 21:30, outcome "recovered" (19Aug2021), described as "fatigued"; ASTHENIA (non-serious) with onset 16Aug2021 21:30, outcome "recovered" (19Aug2021), described as "weakness"; ILLNESS (non-serious) with onset 16Aug2021 21:30, outcome "recovered" (18Aug2021), described as "sick". Therapeutic measures were not taken as a result of pain in extremity, arthralgia, myalgia, chills, tremor, skin burning sensation, palpitations, headache, fatigue, asthenia, illness.  Additional Information: If covid prior vaccination was reported as no. If covid tested post vaccination was reported as no. Known Allergies was reported as no. If other vaccine in four weeks was reported as no. Past Drug Event was reported as no. Other medications in two weeks: Multivitamin, Complete B Complex and Vitamin C. My heart was racing all night but not sure from reaction or how scary this was. No fever i kept checking. No fever she kept checking. Headache and very fatigued/weakness lasted 3 days. other symptoms lasted 2 days. Was terrible I am afraid to get second if it will be worse i have never been this sick before. Got the shot on A monday did not feel herself until Friday. My 22 year old daughter also got first shot next day and she was very ill as well as had two quarter size lumps on her neck for several days.  No follow-up attempts are possible. No further information is expected.
This spontaneous report as received from a medical assistant refers to a 4-year-old patient of unknown gender. No concurrent conditions, medical history, concomitant medications and drug allergies were reported. On 05-AUG-2015, the patient was vaccinated with a dose of improperly stored PROQUAD (Merck) (lot number L005297, expiration date: 17-AUG-2016, albumin status HSA; dose and route not reported). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Patient received a 3rd dose of Moderna. 1st dose on 1/13/21, 2nd dose on 2/10/21, and 3rd dose on 7/30/21.
Information that was reported in a published article (article not provided) has been received from VAERS concerning a female who on an unspecified date was vaccinated with a dose of MMR II. Three weeks after vaccination she developed Kawasaki disease. She was treated vigorously, and received IVIG, but went on to develop a left descending coronary artery aneurysm. The patient was described as having slow motor skills and it was reported that she was in an early intervention program. Hypokinesia was noted. At the time of the report the patient had not recovered. No further information was provided. Upon internal review the patient's left descending coronary artery aneurysm was considered an other important medical event. No further information is available.
Narrative: 02/29/2020 influenza A pcr result: negative 02/29/2020 influenza B pcr result: negative 11/13/2020 COVID swab, result; not detected COVDI infection following COVID vaccine series 01/19, Pfizer, dose #1 02/08, Pfizer, dose #2 08/08 pt cc: chills, cough, fatigue, headache, myalgias, dyspnea, sore throat exposure: unknown 08/09 COVID swab, result: detected 08/10-08/18 symptoms continue 08/19 clinically resolved
For 3 days after vaccine slept much more than normal and seemed to have less tone when picked up. Once his sleepiness resolved his tone improved but he started to have high pitched crying and inconsolability.
Patient received flu vaccine approximately between 2-3 PM. No signs or symptoms reported at time of vaccine administration. No bleeding upon administration. Patient has received flu shots in the past without difficulty. Patient reports approximately 12 hours or so after vaccine she woke up with her hands shaking. States that is all she remembers. Said she was awake but was like she couldn't snap out of shaking. Patients reports husband told her that her entire body was shaking for a few minutes. States she then has had a horrible headache. States she is going to follow up with her physician today. States once she left the clinic she said she had some bleeding at injection site. States she has been tired since waking up and continues with a headache. States she has not done anything different or taken anything different except for this flu shot.
This spontaneous report as received from a pharmacist refers to a 67 years old female patient. The patient had none pertinent medical history. The patient had none drug allergies. "About 20 years ago", in approximately 1992 the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # not reported) "with no problem". On 10-NOV-2012 the patient was administered intramuscularly another dose of PNEUMOVAX 23 (lot # reported as H010515, expiration date reported as 13-FEB-2014). Concomitant medications included ZOLOFT and LUMIGAN. Beginning on 11-NOV-2012 the patient developed pain at the injection site, swelling in the arm in which the vaccine was injected, as well as itching in that arm. The patient sought for medical attention by coming into the pharmacy and speaking with the reporting pharmacist. Oral BENADRYL was given as treatment. Lab diagnostics studies performed were reported as none. It was reported that at the time of reporting, on 15-NOV-2012 these adverse events were improving but had not fully resolved. The present patient status was recovering. Additional information has been requested.
REACTION STARTED ON THE ARM, PT STARTED TO LOSE PIGMENTATION ON THE ARM AND SPREAD TO OTHER PARTS OF BODY INCLUDING CHEST.
All patients received Expired Moderna COVID-19 vaccine from a vial that was stored in the refrigerator beyond 30 days; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (All patients received Expired Moderna COVID-19 vaccine from a vial that was stored in the refrigerator beyond 30 days) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (All patients received Expired Moderna COVID-19 vaccine from a vial that was stored in the refrigerator beyond 30 days). On 30-Dec-2021, EXPIRED PRODUCT ADMINISTERED (All patients received Expired Moderna COVID-19 vaccine from a vial that was stored in the refrigerator beyond 30 days) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were provided No treatment medications were provided.
Re'cd covid vaccine in 1/2021. Became covid positive 7/16/21
Two weeks after my booster Moderna shot, I suddenly had symptoms like hives, itchy and red skins of my upper body, neck and face. One day later, my face and eyelids became very swollen. Then whenever I felt hot, parts of my body skin felt acupuncture from hundreds of small needles. After 4-5 days, my swollen face and eyelids got better and my face skin were peeling. Then my upper lip became numb and tight. My left half face feel less painful when pinched by fingers than the other right face. The numbness of my lip and half face are still existing, and have lasted for 10 days now.
pt recv vax;exp localized lesions at inject site,described as a red area w/ several raised bumps;
This spontaneous report as received from a pharmacist refers to a patient of unknown age. On an unknown date the patient was vaccinated with expired MMR II lot # 0184AE, expiry date 18-JAN-2014, 0.5 ml, subcutaneous for an unknown indication. Anatomical location of vaccination and dose number were not reported. No adverse events were reported. Action taken, outcome and causal relationship were not reported. Additional information has been requested.
Patient experience entire body rash 6-8 hours after second dose of Moderna COVID vaccine.  Patient self treated with oral Benadryl.  Symptoms did improve with Benadryl therapy.  Slight rash still evident on 6-2-21
Patient is a 74 y.o. male with past medical history of diet-controlled diabetes mellitus type 2 who presents emergency department for worsening symptoms of COVID-19.  Symptoms began a little over week ago and consist of fevers, chills, sore throat, nasal congestion, shortness of breath, productive cough, chest pain elicited by coughing, and mild nausea with vomiting.  Symptoms have slowly been worsening to the point where he is now dyspneic while at rest.  He tested positive on 9/30 and received monoclonal antibodies and 10/1. Patient was vaccinated with J and J vaccine in April.  In the emergency department he was mildly hypoxic with SpO2 currently stable on 2 L nasal cannula.  Labs are fairly unremarkable.  CTA thorax negative for PE but does show bilateral extensive bronchopneumonia with features typical of COVID infection. Hospital is admitting the patient for further evaluation and management.
Pericardial effusion; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; influenza vaccine (FLU [INFLUENZA VACCINE]), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 4 (BOOSTER), SINGLE; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunization.  The following information was reported: PERICARDIAL EFFUSION (medically significant), outcome "unknown".  Clinical course: Reporter stated, "My mom got the Bivalent COVID Vaccine (Pfizer COVID-19 Vaccine), the last one, the fifth shot that she was supposed to get. At the same time as the high dose Flu shot. She is having Pericardial effusion. I was calling to see if you have any reports of pericardial effusion?" Reporter stated, "I do not know what the Flu shot (Hence suspect captured as Unspecified Flu shot) whatever the high dose Flu shot they give, the pharmacy. I think they were a few days apart but for instances and purposes they were almost."      No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
She began experiencing regular arm numbess on the 3rd when she received the vaccine and it became fully developed by the next day. Over the next week or so the arm numbness became arm and hand numbness. The arm and numbness was intermittent, but the finger numbness has continued to persist. No treatments performed.
administered Kinrix to a patient, Date of birth Feb 14th 2009; administered Kinrix/Boostrix was the vaccine indicated; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 12-year-old male patient who received DTPa-IPV (Kinrix) (batch number 3DZ45, expiry date 15th January 2022) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 8th September 2021, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 8th September 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. A health care professional administered Kinrix to a patient, when Boostrix was the vaccine indicated for the patient. The reporter consented to follow up. This was 1 of 6 cases reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021201378:same reporter US-GLAXOSMITHKLINE-US2021201377:same reporter US-GLAXOSMITHKLINE-US2021201379:same reporter US-GLAXOSMITHKLINE-US2021201375:same reporter US-GLAXOSMITHKLINE-US2021201373:same reporter US-GLAXOSMITHKLINE-US2021201376:same reporter
A temperature excursion happened with the vaccine that this patient received. The vial was stored in the freezer past the 2 weeks of provided stability info.
3/10/21   5:00 p.m.    extreme body/abdominal pain;    3/11/21 a.m.   pain & abdominal and back (kidney area spasms)  p.m.    Fever of 101.2; . itchy rash started in arm pits 3/12-3/15 extreme body and internal back pain and itchy rash continue 3/16 p.m. doctor prescribed Simethicone 125 mg. (I added Acidophilus & Bifidus) one capsule each after each meal 3/25 Itchy rash gone; extreme pain gone, continued stomach  tenderness and low inner back pain.
Patient remained in the store after administration. She returned to RX dept approximately 20-30 minutes after the shot saying that she felt like her lips were swelling. No rash, hives, itching, nor swelling or reaction at injection site. No dyspnea or cough or difficulty swallowing. Stated she cannot take diphenhydramine due to a heart condition (could not recall name of condition) but that her doctor told her ZYRTEC was ok. Gave patient 10mg cetirizine tablet. Patient had told us she is afraid of needles before the shot was given. Patient told us after lip began swelling that she is prone to panic attacks and thought she might be starting one, but she seemed to keep herself calm throughout. She called her family to come get her since she was told not to drive. After sitting with her for 30 minutes with no changes or progression, patient said she thought she was OK. I told her it is recommended that they take her to the ER even if she feels OK right now due to risk the reaction might continue. I called patient on 4/29/18 and she says she went to a nearby urgent care with her family after leaving store and they gave her an oral syrup (did not know what) that would stop the reaction. She reports that swelling did continue until she went to the urgent care. Also reports arm soreness. However, she thinks the swelling as of today has gone down mostly.
Patient with prolonged crying (8 hours), shaking legs, lethargy for 48 hours, Fever less than 102 for 48 hours. On Tylenol and Motrin.
Pt developed varicella on his back, face and ears subsequent to receiving one dose of varicella virus vaccine.
Information has been received from a physician and a consumer concerning her 4 year old son patient with possible seasonal allergies and a history of double jointed fingers who on 25-SEP-2009 was vaccinated with a dose of VAQTA (lot # 664767/0605Y). There were no concomitant vaccinations and no concomitant therapy. Subsequently, later that night the patient experienced a fever and vomiting. The patient then came back into the office later and was experiencing a stiff neck and body aches. On 8-OCT-2009, the patient's mother reported that the patient was still experiencing joint and neck stiffness, a lower fever and fatigue. The patient had blood tests for hepatitis B, liver function, glucose, kidney function, meningitis and Epstein-Barr. All tests had been negative except an elevated white count. On 8-OCT-2009, the child was seen by an infectious disease specialist for possible lowered immune system or infection. At time of the report, the patient was recovering. Additional information has been requested.
20 days following 1st Moderna dose, I experienced significant vertigo (have never had previously), onset included complete loss of balance, dizziness, nausea, vomiting, which improved to dizziness and feeling of motion sickness throughout the first 24 hours. Nausea and motion sickness persisted, at varying levels, for the following 5 days. Dramamine provided some relief.
My girlfriend is also feeling like her stomach is burning, but it could be from having to poop all the time; hot and cold with sweats; hot and cold with sweats; chills; This is a spontaneous report from a contactable consumer. A 67-years-old female patient received unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number was not reported), via an unspecified route of administration on 21Jul2021 as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Reported that reporter and his girlfriend (withheld) got it at the same 21Jul2021, and my girlfriend is going through the same thing. We got at the same time. My girlfriend is also feeling like her stomach is burning, but it could be from having to poop all the time. Wanted to know if anyone else reported anything like this. On an unspecified date in 2021, the patient experienced my girlfriend is also feeling like her stomach is burning, but it could be from having to poop all the time, hot and cold with sweats, chills. Th outcomes of events were unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Pt received Boostrix on 3/08/21 in the afternoon and the rashes appeared about  two to three hours after the vaccination. Pt didn't report the symptoms to our pharmacy til today. There is a very light brown circular patch with  some raised purple rashes around the injection site on upper left arm. He had some tingling sensation on the left arm but it has subsided. Pt was going to see his primary doctor yesterday but the appt got cancelled. He might go to see a doctor at a local urgent care today.
Mild Nausea; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Oct2022 as dose 4 (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 (DOSE 1, SINGLE MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: NAUSEA (non-serious) with onset 19Oct2022, outcome "unknown", described as "Mild Nausea". It was unknown if therapeutic measures were taken as a result of nausea.  Additional Information-It was unknown if patient received any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient had not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sweating; Weakness; Fever of At Least 99.4; Exhaustion; Headache; Initial Report Received on 05-Aug-2021 and 03-Sep-2021  A 30 year-old male patient (race and ethnicity not provided) in the US (CT) reported fever, sweating, weakness, exhaustion, and a headache the day after receiving a dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.  Relevant medical history included asthma, hemorrhoids, and irritable bowel syndrome symptoms.   Relevant concomitant medications included vitamin D, magnesium, ibuprofen, multivitamin, and oral steroids (unspecified).  On or around 30-Jun-2021, the patient received the first HEPLISAV-B injection (Lot #, expiration date, NDC #, and site not available). He woke up the next day with a fever of at least 99.4 degrees Fahrenheit with sweating, weakness, exhaustion, and a headache. The fever resolved by the time he got to his doctor's appointment that day; the weakness, exhaustion, and headache all resolved by the next day.   On an unspecified date, the patient received the second dose of HEPLISAV-B injection (Lot #, expiration date, NDC #, and site not available).  No further information was provided.  Company Comment: The company assessed the events as non-serious.; Sender's Comments: The company assessed the events as non-serious.
A few hours after vaccine uncontrollable shaking, fever up to 103.0 F,  Sweating, SEVERE headache,  urinary incontinence,  insomnia, and body pain,  extreme joint pain in my hands.   Tried Tyelnol which did nothing,  Fever continued x 2 days,  Severe Headache continued X 4 weeks with nothing that would give relief,  joint pain continued x over 3 weeks and had to take a Medrol Dose Pack,  Mental Confusion and unable to remember began 1 week post vaccine and is continuing to this day.   Now also have elevated blood pressure with some readings getting has high as 160/100 - never had any issues with blood pressures before.   Short of breath when going up  stairs.
Pain and swelling under right arm. Large swollen lymph node, red skin, duration 48 hours.