chrisvoncsefalvay/vaers-outcomes huggingface dataset:
whole arm of the injection is hurting really bad/hurting so bad behind arm/The patient was under a lot of pain and it was hard to understand her when she spoke; under armpit there's a big bruise that keeps growing and growing/purple bruising; under her armpit there's a big bruise that keeps growing and growing and there are bumps under the bruise; under her armpit there's a big bruise that keeps growing and growing and there are bumps under the bruise/This morning it started to swell; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (under her armpit there's a big bruise that keeps growing and growing and there are bumps under the bruise/This morning it started to swell), PAIN IN EXTREMITY (whole arm of the injection is hurting really bad/hurting so bad behind arm/The patient was under a lot of pain and it was hard to understand her when she spoke), CONTUSION (under armpit there's a big bruise that keeps growing and growing/purple bruising) and AXILLARY MASS (under her armpit there's a big bruise that keeps growing and growing and there are bumps under the bruise) in a 30-year-old female 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Oct-2021, the patient experienced SWELLING (under her armpit there's a big bruise that keeps growing and growing and there are bumps under the bruise/This morning it started to swell). On an unknown date, the patient experienced PAIN IN EXTREMITY (whole arm of the injection is hurting really bad/hurting so bad behind arm/The patient was under a lot of pain and it was hard to understand her when she spoke), CONTUSION (under armpit there's a big bruise that keeps growing and growing/purple bruising) and AXILLARY MASS (under her armpit there's a big bruise that keeps growing and growing and there are bumps under the bruise). At the time of the report, SWELLING (under her armpit there's a big bruise that keeps growing and growing and there are bumps under the bruise/This morning it started to swell), PAIN IN EXTREMITY (whole arm of the injection is hurting really bad/hurting so bad behind arm/The patient was under a lot of pain and it was hard to understand her when she spoke), CONTUSION (under armpit there's a big bruise that keeps growing and growing/purple bruising) and AXILLARY MASS (under her armpit there's a big bruise that keeps growing and growing and there are bumps under the bruise) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported. No treatment information was provided by the reporter.
Dose 1 on 12/29/2021; dose 2 on 1/24/2022 and dose 3 on 2/12/2022. Patient should not have received a third dose. Questionable if patient actually received dose on 1/24/2022.
They gave a full dose to a patient,instead of giving a booster shot.; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL OVERDOSE (They gave a full dose to a patient,instead of giving a booster shot.) in a  patient of an unknown age and gender 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ACCIDENTAL OVERDOSE (They gave a full dose to a patient,instead of giving a booster shot.). At the time of the report, ACCIDENTAL OVERDOSE (They gave a full dose to a patient,instead of giving a booster shot.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant information was not provided. Treatment information was not provided.
pt recv vax 1AUG97 & pt became pregnant;LMP 28AUG97;EDC is 5JUN98;the pregnant confirmed by home pregnancy test & clinical test;eval by ultrasound @ 7wk, 3 days & 19 wk, 2 days nl;pt exp severe pre-eclampsia & HELLP synd @ 32wk gestation;
Information has been received from a healthcare worker concerning an adult female patient who in November 2004 (date not reported), was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot 649914/0578P). Approximately two days post vaccination, the patient developed a cellulitis type reaction at injection site, warmth, redness and painful. It was also reported that the patient sought unspecified medical attention. There was no product quality complaint involved. It was also reported that 3 other adult female patients experienced the same adverse event following administration of pneumococcal 23v polysaccharide vaccine (lot 649914/0578P) (WAES0412USA00679, WAES0501USA00531, WAES0501USA00533). Additional information has been requested.
This spontaneous report received from a registered nurse via company representative refers to a 13 year old patient of unknown gender. The patient's medical history, current conditions and concomitant medications were not reported. On 02-SEP-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9, lot # M009378 (dose, frequency, expiry date were not reported), for prophylaxis. The vaccine was purchased with private funds/ insurance. On 01-SEP-2016, temperature excursion of the vaccines occurred in the fridge and was not discovered until 26-SEP-2016. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one the several reports received from  the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1609USA014830.
On 7-5, I started having a itchy rash on my upper body such as neck and shoulders. On 7-8, I started having slight shortness of breath that increased in severity and I thought it was my blood thinner so I stopped taking it. On 7-15, I noticed the rash and breathing improving. On 7-17,  even tho the symptoms had slightly improved, they were not gone so I stopped taking Atorvastatin. On 7-18, I called my cardiologist. I went in today on 7-19 to see my cardiologist who suggested I start taking aspirin. He said it was ok to continue to hold the 2 meds ( atorvastatin/eliquis). He prescribed praluent (alirocumab). He scheduled an XRAY and stress test that are scheduled for 7-27. He also ordered lab to be drawn on 7-20. We have been working together to figure out a good medication regimen so I am unsure if these symptoms are due to the vaccine but thought I would report it.
Pulmonary Embolism, blood clot in leg. Was hospitalized in ICU several days. Given heparin. Now on Eliquis long term. Also had severe headaches, chills, body aches.
10 mins p/the inject devel itchy red rash in anticubital area of both arms; treated w/Atrarx & resolved in 1 wk;
VARICELLA VACCINE BREAKTHROUGH. DIAGNOSED ON 4/7/08 WITH VARICELLA.  HAD ABOUT A DOZEN VESICULO-PAPULAR LESIONS ON TRUNK.
Initial information received on 01-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to case 2018SA304367 (same reporter). This case involves six months old female patient who was vaccinated with a 0.5 ml dose of PENTACEL (batch number: C5456AA, expiration date: 31-Dec-2018) via intramuscular route in the left thigh, on 25-Oct-2018, which was not stored in appropriate temperature ranges. Concomitant medications included PREVNAR 13. The patient's medical history was not reported. It was an actual medication error due to incorrect product storage. It was unknown whether the patient had any adverse event. 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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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. List of documents held by sender: none.
Headache; Dizziness - Tiredness - Almost passed out; Pain in Stomach; Nausea; Diarrhea; Low Pressure; Unable to Sleep; Body Aches.
Changes in vision and very fast heartbeat immediately following the injection. Subsided in 5-10 minutes and I felt heat wave through the body for the next 30-45 min and later at night. The next day - March 18th, My gums started bleeding suddenly  and I had an upset stomach.
I had trigeminal neuralgia and transverse myelitis after the booster dose. I was put on Gabapentin 1600mg. I went numb from the neck down lost feeling in arms and legs. I had banding across my chest. I lost body motion. Went to the hospital. Stayed for 3 days and was put on high levels of steroids and prescribe Dexamethasone.
Got my Booster 10/21/2021. On December 7th 2021, I experience sharp excruciating pain in my left hip. Within an hour it radiated down my lower back and down both legs. Within 2 hours both legs were numb, couldn't pass urine or # 2. Was taken to Hospital. Couldn't walk.Hospital did a CAT scan and said I needed to be transferred where they had a Neurosurgeon and Neurologist. Was transferred. 3 MRI, not structural damage to my spine. Blood test ruled out most know neurological diseases - Lyme disease, MS, Lupus, Untreated STD's Aids etc. MRI of my spine with contrast noted inflammation one the Lumbar area of my spine. Spent 6 days in the hospital- IV steroids was main treatment. Still experience numbness in both legs soles of my feet and buttocks and groin area. walking with difficulty. Upper area of my body in unaffected from the waist up. Follow up care with Neurologist, PT, Urologist, and Opthalmology. Diagnosis - Acute Transverse Myelitis without underlying disease.  I am still unable to walk and return to my normal life as of the time of typing.
Sore arm at the injection site; Exhaustion; Achy body; Low-grade fever; This is a spontaneous report from a contactable consumer (patient). A 76-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL8982 and expiration date not provided), via an unspecified route of administration (left arm) first dose on 26Jan2021 14:30 at single dose for Covid-19 immunization administered at Hospital. The patient's medical history Have a stent in my heart, mild heart attack 2+ years ago, and Covid-19. The patient's concomitant medication included acetylsalicylic acid (BABY ASPIRIN) at 83 mg, metoprolol, and evolocumab (REPATHA). On 26Jan2021 21:30, the patient experienced Sore arm at the injection site, exhaustion, achy body, low-grade fever. The patient did not received treatment for the events. The reporter assessed the events as non-serious. The outcome of the events was recovering. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has not been tested for COVID-19
Patient was administered with vaccine that was beyond use date after the thaw process; This spontaneous case was reported by a paramedic and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered with vaccine that was beyond use date after the thaw process) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 27-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 27-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered with vaccine that was beyond use date after the thaw process). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was administered with vaccine that was beyond use date after the thaw process) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that the age of patient was 27 years 6  months. No concomitant medications were reported It was unknown if patient had acute illness at the time of vaccination and up to one month before. It was unknown if patient had been diagnosed with or tested positive for COVID-19, nor if patient had chronic or long lasting health conditions. Patient had reported no adverse reactions after the administration of vaccine. Treatment details was not reported by the reporter. It was reported that the vaccine 1 Ndc Code.
APPROXIMATELY 2 DAYS AFTER VACCINATION PAYMENT ARM BECAME VERY SORE AND TENDRER, AT TIMES UNABLE TO MOVE, TINGLE IN FINGERS. CONTINUES TO THIS DAY.
Drowsiness, sinus headache, vertigo, slight chill, dizziness, sweat. persisted over the night into the early morning, receding mostly 24 hours later.
PATIENT RECEIVED VACCINE 7 HOURS AFTER THE VIAL WAS FIRST PUNCTURED
Woke up with pain and swellig base of left neck with a firm, slightly cystic feeling, rounds and slightly tender mobile mass (3 cm) anterior to left clavicle
Client walked in on 7/27/21 for the Pfizer vaccine. After giving it to him we were entering it into  and saw that he already got the Jansen vaccine in April. He was still in our waiting area so I asked him about it. He said he was signed up for it but did not get it on that day. I called  Health Department to ask about it and have them check to see what happened. They were able to find his vaccine record and he did indeed get the Jansen vaccine on 4/7/21. He lied to staff about previously getting a COVID vaccine at another clinic. He has gotten two different COVID vaccines.  notified and second dose not advised.
Physician ordered a 7 year old male patient to be given tetanus booster, patient was given DtaP but should have been given TdaP due to his age, (over 7 years of age).
1-2" red, hot to touch, itchy area. Pt had applied BENADRYL which had helped and counseled to add hydrocortisone. No systemic effect.
pt recv vax 7JAN98 & the next day exp soreness of rt inj site & chills, dizziness, abd pain, nausea & aches/pains over whole body;sx resolved by 10JAN98;
10/28/09 H1N1 vaccine give to student in school via nasal spray. 10/30 student c/o headache, sore throat and poor appetite since 10/28/09. T 98 degrees, lungs clear. Throat is normal. NAD. SN called mother to inform her of students complaints and nasal assessment. Mother also informed of report to VAERS.
THROAT SWELLING STARTED 01/08/05 ADMITTED TO  HOSPITAL 01/11/O5 DIAGNOSIS AS EPIGLOTTITIS IN ER. ON 01/12/05 ENT DR DIAGNOSIS DID NOT CONFIRM EPIGLOTTITS. HIS DIAGNOSIS WAS A VIRUS (SPECIFIC TYPE OF VIRUS NOT KNOWN). Discharge summary states tissue swelling. msv
No adverse effects were reported. Patient was in facility and was observed for 48 hrs after vaccine was administered.
Myocarditis. Chest pain started 2 days after the 2nd shot. Elevated troponin and went upto 20. Near syncope and tiredness.
Progressive injection site reaction.  First shot: minimal.  Second shot:  increased bruising, bleeding, soreness.  Third shot:  significant bruising, bleeding, soreness.  Rating:  1 - 4 - 7, respectively, per shot, on a 10 point scale.
PAIN RADIATING DOWN RIGHT ARM WITH TINGLING FINGER TIPS, SORENESS AND TENDERNESS TO RIGHT AXILLA  Narrative:    Other Relevant History:
High fever for 48 hours Vomiting Large lesion on injection sight of vaccine that appeared 48 hours after receiving vaccine
Dizziness, drowsiness, decreased BP 75/S slow pulse. Please rule: Pt needle/shot phobia. Was very nervous. Does experience panic attacks. Was in sun all day w/o food.
Very sore arm in area of injection; sore underarm area; body aches; muscle aches; headache; lingering fatigue; slightly elevated temperature; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Oct2022 as dose 4 (booster), single (Lot number: GJ6742) at the age of 46 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Covid" (unspecified if ongoing), notes: If covid prior vaccination: Yes. Concomitant medication(s) included: FLU VACCINE VII taken for immunisation. Vaccination history included: Covid-19 vaccine (Dose 1, Unknown manufacturer), for Covid-19 immunization; Covid-19 vaccine (Dose 2, Unknown manufacturer), for Covid-19 immunization; Covid-19 vaccine (Dose 3, Unknown manufacturer), for Covid-19 immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 04Oct2022, outcome "unknown", described as "Very sore arm in area of injection"; PAIN (non-serious) with onset 04Oct2022, outcome "unknown", described as "body aches"; HEADACHE (non-serious) with onset 04Oct2022, outcome "unknown"; FATIGUE (non-serious) with onset 04Oct2022, outcome "unknown", described as "lingering fatigue"; MYALGIA (non-serious) with onset 04Oct2022, outcome "unknown", described as "muscle aches"; BODY TEMPERATURE INCREASED (non-serious) with onset 04Oct2022, outcome "unknown", described as "slightly elevated temperature"; AXILLARY PAIN (non-serious) with onset 04Oct2022, outcome "unknown", described as "sore underarm area". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of vaccination site pain, axillary pain, pain, myalgia, headache, fatigue, body temperature increased. Additional information included: Very sore arm in area of injection including sore underarm area, body/muscle aches and headache within 12 hours of vaccination, with lingering fatigue, body aches, slightly elevated temperature and headache 24 hours after injection. No follow-up attempts are possible. No further information is expected.
Adverse Event: Diagnosed with Plasmablastic Lymphoma February 9, 2022 Treatment: Biopsies, spinal taps, hospitalization, . , Radiation therapy Outcomes: left with a non-growing mass in my leg, osteoarthritis, nerve damage from mass, fatigue. Emotional effects on myself, my husband, and 8 children.  Follow-up: needs for frequency scans every 3 months to observe Less than two months after the vaccine, I started to experience pain in my left lower leg; initially, I thought I had pulled a muscle.  On December 5, 2021, I bumped my leg, which should have resulted in a small bruise or an unnoticed bump.  Due to extreme leg pain after the bump and no relief from what I thought had been a pulled muscle, I d
received a birth dose of hepatitis B vaccine  /  hepatitis B on 03/JUN/2020; Extra dose administered; This case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 1-year-old female patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis and Hepatitis B vaccine for prophylaxis.   Previously administered products included Hepatitis B vaccine (received 1st dose), Pediarix (received 1st dose on 3rd February 2020) and Pediarix (received 2nd dose on 3rd April 2020).   On 28th August 2020, the patient received the 4th dose of Pediarix and Pediarix Pre-Filled Syringe Device. On 3rd June 2020, the patient received the 5th dose of Hepatitis B vaccine. On 3rd June 2020, not applicable after receiving Pediarix and Pediarix Pre-Filled Syringe Device and unknown after receiving Hepatitis B vaccine, the patient experienced extra dose administered. On 28th August 2020, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered and extra dose 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 patient received extra dose of Hepatitis B vaccine and Pediarix., which led to extra dose used.. The reporter consented to follow up.
Hospitalized (9.11.21);  COVID-19 positive (9.11.21);  fully vaccinated  Admission Date: 9/11/2021 Discharge Date: 09/13/2021;  Discharge Disposition:  home or self care  DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: AKI (acute kidney injury) Acute vomiting Hypotension due to hypovolemia  HOSPITAL COURSE: Patient is a 51 yo female with PMH of hypertension, obstructive sleep apnea, type 2 diabetes mellitus, and proximal atrial fibrillation status post ablation who was admitted for acute kidney injury and COVID infection.  Patient had several days of nausea, vomiting, and diarrhea preceding her presentation.  She was also unable to hold down any food or drink fluids.  She also understood 3 day history of dysuria, urgency, and frequency.  She was also taking her home Lasix despite poor oral intake.  In the emergency department, patient was noted to be hypotensive and tachycardic.  She received 4 L of IV fluid with improvement.  She had a creatinine of 1.49 (normal baseline).  UA was also positive.  She was also noted to be COVID-19 positive.  She was admitted to the general medicine service for IV fluid hydration and started on IV ceftriaxone for uncomplicated urinary tract infection.  The patient quickly improved and her AKI resolved.  She reported resolution of her dysuria, nausea, and vomiting.  Of note, patient reports chronic diarrhea for the last 3-4 months with loose stools for which she has seen a gastroenterologist and plans to continue to follow-up with them.  Patient remained in stable condition on room air with no symptoms on day of discharge.  Urine culture was still pending at discharge, however given her resolution of symptoms and 3 days of IV ceftriaxone patient was not continued on any oral antibiotics on discharge.  She was counseled to adequately hydrate herself and self quarantine.  She was discharged home in stable condition on 09/13.
Myalgia Employee reports: ""The usual sore arm, light muscle ache but the next day on the 30th is when I had the full body aches & chills." Narrative:
2 different type rashes developed about 5 days after getting  vaccines first reaction was a rash that started on the cheeks and slowly  encapsulated the entire body down to feet was a red rash and lasted for about a week.  Then 3 days later developed another rash that was raised pustule like rash noted and had a low grade fever of 100 the entire time.