chrisvoncsefalvay/vaers-outcomes huggingface dataset:
terrible pain in my hips; my hip joints; off label; Dose 5; This is a spontaneous report received from a 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 27Sep2022 as dose 5 (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; MANUFACTUERER UNKNOWN; Lot number: unknown), administration date: 21Feb2021, for COVID-19 Immunization; coviD-19 vaccine (DOSE 2, SINGLE; MANUFACTUERER UNKNOWN; Lot number: unknown), administration date: 27Feb2021, for COVID-19 Immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE; MANUFACTUERER UNKNOWN; Lot number: unknown), administration date: Sep2021, for COVID-19 Immunization; Covid-19 vaccine (DOSE 4 (BOOSTER), SINGLE; MANUFACTUERER UNKNOWN; Lot number: unknown), administration date: Apr2022, for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 27Sep2022, outcome "unknown", described as "Dose 5"; OFF LABEL USE (non-serious) with onset 27Sep2022, outcome "unknown", described as "off label"; ARTHRALGIA (non-serious) with onset 28Sep2022, outcome "not recovered", described as "terrible pain in my hips; my hip joints".  Additional information: Patient had the 5th shot which was a booster on Tuesday and by Wednesday, Thursday and Friday and today was having terrible pain in hips. Patient wanted to know if that was normal. Patient stated it was a Pfizer booster, third booster. Patient had the main shot on 21Feb then had a follow up on 27Feb, then first booster on Sep2021 and then had another booster on Apr2022 and the 5th shot on 27Sep2022. It says Bivalent Pfizer, it was stamped on the patient's card. (Captured as Covid-19 vaccine Bivalent). Patient stated that today was Saturday and patient was still in pain. Patient have been in pain for 3 days. Just wanted to know if this was normal or not. Consumer was requested to call or visit the nearest physician in case of emergency.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Mom states with last immunizations, child broke out in hives 1-2 hrs after shots (lasted for 1 1/2 days); gave Benedryl--did not take to doctor.
No adverse event; Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use date) and NO ADVERSE EVENT (No adverse event) in a 35-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 042J21A) for COVID-19 prophylaxis.     No Medical History information was reported.  On 23-Feb-2022, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 23-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.     For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use date).    Concomitant product use was not provided by the reporter.  Pharmacist reported that they have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 days beyond use date.  The lot number for the monovalent vaccines with their corresponding BUD dates were 027C21A (BUD - 21-May-2021), 053C21A (BUD - 01-Jul-2021), 939902 (BUD - 02-Sep-2021), 011F21A (BUD - 04-Nov-2021), 012H21B (BUD - 23-Dec-2021), 056M21A (BUD - 12-May-2022), 082B22A (BUD - 08-Sep-2022).   The lot numbers for the bivalent vaccines with their corresponding BUD dates and the interval period of administration. 052D22A (BUD - 17-Nov-2022), dates of administration 18-Nov-2022 to 28-Nov-2022, 023H22A, (BUD - 15-Dec-2022), dates of administration 16-Dec-2022 to 20-Dec-2022.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-704416 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 24-Jan-2023: Live follow-up information received contains non-significant information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704416:Master case
approx 15min p/vax mom & grandma states that pt was jerking as if having sz but another nurse & reporting nurse noted no sz in child but advised mom to take pt to MD immed;next day 17FEB98 grandma phoned & stated advised to take child to ER
shortened of breath; Wheezing; bronchospasm; This is a spontaneous report from a non-contactable nurse. (patient).  This 33-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), from lot El3246 at the left arm on 15Jan2021 12:45 at SINGLE DOSE for COVID-19 immunization. Medical history was none. The patient was not pregnant at the time of vaccination.No COVID prior vaccination.  Concomitant medications were not reported. On 15Jan2021 17:00, the patient experienced wheezing and shortened of breath. The patient visited physician office for the event and treatment for the events  was received, Albuterol for bronchospasm. The events were assessed as non-serious. The patient had not been tested for COVID post vaccination. The outcome of the events was recovering.   No follow-up attempts are possible. No further information is expected
Patient received a second booster dose prior to recommended interval. She is fine, not experiencing any adverse side effects.
patient came to the pharmacy got 2 shots in the same arm. the next day she could not move her arm and went to her dr and doctor diagnosed her with muscle atrophy.
Pressure/pain in the Left side of chest around heart, Increases in pressure/pain with physical activity.  Increased pressure in the  morning but subsides during the day/night.  Dull pain that is inconsistent and varies throughout the day but is always constant at a 1-2 / 10 for  pressure/pain
Experienced nausea at about 2230 on 12/30/20.  This resolved by midnight.  Arm injection site noted to be red, hot to touch and indurated on 12/31/20 at 0600.
Breakthrough case admission after 3 vaccines Moderna 2/8/21 Lot# 013M20A;  Moderna 3/8/21 Lot# 030A21A;  Moderna 11/18/21 Lot# 091D21A
Patient under 65 received Fluad QIV; Soreness in the arm; Fever; This spontaneous case received on 05-Nov-2020 from other health professional (nurse) via Agency (reference number: SEQW20-04815) and concerned a 33-year-old, female patient.   The patient had no relevant medical history. The patient's concomitant medications were not reprorted.   On 29-Sep-2020, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59, dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid) (explicitly coded as 'Inappropriate age at vaccine administration') for influneza prophylaxis. The batch number reported was 286592. .   On an unspecified date in 2020, unknown time after receiving Fluad Quadrivalent, the patient experienced soreness in the arm and fever. There was no corrective treatment  The outcome of the events was not reported.  The reporter did not provide a causality assessment.  The case was assessed as non-serious.  The case is linked to the cases 202004845, 202006068, 202006069, 202006072, 202006074, 202006077, 202006080, 202006081, 202006084, 202006085, 202006086, 202006087, 202006089, 202006090, 202006091, 202006092, 202006095, 202006097 and 202006098 (the same reporter).  Company comment: A 33-year-old, female patient was vaccinated with Fluad Quadrivalent. An unknown amount of time after receiving Fluad Quadrivalent, the patient experienced pain in extremity and pyrexia. With information available, causal role of the suspect vaccine is assessed as possibly related. Product administered to patient of inappropriate age is assessed as not related, per company's conventions.; Sender's Comments: A 33-year-old, female patient was vaccinated with Fluad Quadrivalent. An unknown amount of time after receiving Fluad Quadrivalent, the patient experienced pain in extremity and pyrexia. With information available, causal role of the suspect vaccine is assessed as possibly related. Product administered to patient of inappropriate age is assessed as not related, per company's conventions.
The day of my first vaccination, I got a painful red lump at the injection site and it was warm to touch. Today is 1/20/21 and I'm still experiencing the same reaction- it hasn't gone away,  the red lump is less swollen and warm to touch. I also experienced moderate fatigue and weakness, constant headache, and loss of smell and I'm still experiencing these symptoms.
25 doses of expired Moderna COVID-19 vaccine were administered to patients.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (25 doses of expired Moderna COVID-19 vaccine were administered to patients.) in a 66-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 016J21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Apr-2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 29-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (25 doses of expired Moderna COVID-19 vaccine were administered to patients.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (25 doses of expired Moderna COVID-19 vaccine were administered to patients.) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  The vial did not undergo any temperature excursion. The vial was stored in refrigerator on 29-Apr-2022.  No treatment medications was reported.
Prickly rash started on the face, cheeks, chin and slowly spread to my neck. The rash is still on my face and neck and it has a burning sensation.
Patient c/o dizziness, motion sickness- BP was normal and symptoms lessened a few hours later but still lingered 2 days later.
Arm pain   - day 2 through 4 Lymphadenopathy left neck - day 5 and contiues Shoulder Ache - day 5 and continues
Received BOOSTRIX Tdap IM (L) deltoid on 6/24/15. Returned to office today. Stated within 24 h after injection his arm became painful, swollen, and red to 1-2 inches below elbow. ROM with elbow limited. today arm appeared normal on exam with no swelling or tenderness. However, he still has 15-20% deficit with inability to straighten arm at elbow.
Recent shipments of the Moderna COVID-19 vaccine have been shipped with two types of syringes with attached needles.  One is Retractable Technologies VanishPoint 1 and 3 ml syringes with 1 inch needle.  The other is Smiths Medical 3 ml syringe with needle protection device with 1.5 inch needle.  With this product, the orange needle protection feature sticks out from the barrel of the syringe at an angle.  There is a luer lock between the syringe barrel and the needle protection device, and a luer lock between the needle protection device and the needle itself.  In the vaccine kits, the ratio of the Retractable VanishPoint syringes with 1 inch needed to the Smiths Medical syringe with 1.5 inch needle is about 5:1. The COVID-19 vaccine is drawn up into syringes in the cleanroom in the pharmacy.  As our population has a low incidence of obesity, we avoid using the Smiths Medical syringes with 1.5 inch needle when possible.  On 25 Jan 21, when our supply of VanishPoint syringes with 1 inch needles was exhausted, 130 doses were drawn up into the Smiths Medical syringes with 1.5 inch needle.  Pharmacy staff routinely package 10 doses/syringes of vaccine in 5 x 8 inch amber bags for distribution to the vaccination clinic.  The fit is tight when trying to insert ten of the Smiths medical syringes with the needle protection devices into this size bag, and the needle protection devices got tangled with each other.  In addition, the pharmacy tech reports that some of the devices have a loose luer lock connection between the needle protection device and the needle. Of the 130 doses prepared during that batch, four needles became dislodged from the syringe unit sometime after leaving the pharmacy, and the doses had to be wasted. A better ratio of syringes with 1 inch needle to syringes with 1.5 inch needles would be 10:1 when vaccinating health care providers and active duty soldiers at this facility.
Dizziness, palpitations, HR 210bpm 15 mins post vaccination Vital signs BP:111/66 HR:204     MAX 210 SPO2: 100% Ice applied to head/neck transferred to the ED by rapid response team
Swollen lymph node under left armpitSwollen lymph node left side of neck; Swelling bottom corner or left eye; Swollen toes; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6204) via an unspecified route of administration in the arm left on 23Mar2021 at 18:30 (at the age of 48-year-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EW0164) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. Medical history included von willebrand's disease. Concomitant medication were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 19Apr2021 at 18:00, the patient experienced swollen lymph node under left armpit, swollen lymph node on left side of neck, swelling bottom corner or left eye and swollen toes. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the reported events. The clinical outcome of the events swollen lymph node under left armpit, swollen lymph node left side of neck, swelling bottom corner or left eye and swollen toes was not recovered at the time of this report.
10 minutes after receiving 1st dose of Moderna COVID 19 vaccine patient experienced itch on left side of neck associated with redness. no shortness of breath, nausea.  bp 150/96, HR 86.  No stridor no wheeze cardiac regular administered diphenhydramine 50 mg, famotidine 20 mg itch and redness extended onto left arm, above eyes. still no other symptoms. No improvement after 20 minutes. referred to ER for observation.  Patient stated similar reaction when receiving any medication containing alcohols
Patient was given a Ped Hep B. Called IR, per IR not enough antigens in vaccine, OK to give adult dose of Hep B same day.
18 yo M with syncopal event post vaccination. Assessed and evaluated by EMS at the scene. Has history of similar reactions to medical procedures
felt sick; Injury/right shoulder; Weakness; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4108585-00.  A 72 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 03Jan2021 (Batch/Lot number: unknown) at the age of 72 years as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), first regimen subcutaneous (ongoing) (Batch/Lot number: unknown) at citrate free and second regimen subcutaneous (Batch/Lot number: unknown) at citrate free for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MALAISE (medically significant), outcome "unknown", described as "felt sick"; LIMB INJURY (medically significant), outcome "not recovered", described as "Injury/right shoulder"; ASTHENIA (medically significant) with onset Feb2021, outcome "recovered" (Feb2021), described as "Weakness". The action taken for adalimumab was dosage not changed.  The reporter considered "felt sick" related to bnt162b2. The reporter considered "weakness" not related to bnt162b2.  Reporter causality assessment for Humira with respect to events felt sick, shoulder injury and weakness was reported as no reasonable possibility and Reporter causality assessment for Pfizer BioNTech COVID-19 Vaccine (Tozinameran) with respect to events felt sick was possible, shoulder injury was not reported and weakness was reported as not related.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the available information, there is a reasonable possibility of a causal relationship between the suspect vaccine BNT162B2 (COMIRNATY) and reported events which cannot be fully assessed/excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
woke up in middle of the night with chills, leg cramps and body aches all over.  She also had a headache (only lasted 12-24 hours).  Felt well on 11/15/09
On 7/13/06 pt came in for 2nd of Hep B Series and on 7/14/06 (in the morning) pt. became ill and noticed a few clear bumps around the injection site. Pt received Hep B vaccine around 2pm 7/13 and by 6 pm had a headache, nausea & vomitting.  Today pt feels just as bad with constant headache, aches, bumps to L arm at injection site.  NAD, A/O x3, GCS 15/15, head NCAT, CNII-XII intact, speech WNL, gait normal, coordination normal, no oropharyngeal edema.  No facial edema.  Lungs CTAB No wheezes. Heart RRR.  Abd NTND BS+ x 4 quads.  VSS bP 128/72, pulse 70, rr16, temp 97.2.  L deltoid regsion mildly HP, no ecchymosis, no errythema, 3 small surrounding vessicles.
Patient had right arm injection 10/3. She finished antibiotics approximately 1 month ago. She has 1/10 pain. She denies fever or chills.
12-15-2018 woke up with both shoulders painful, both elbows painful,. Both wrists and fingers very painful. Hard to move fingers. Both eyes felt they were on fire. This situation lasted for about a 24 Hr. period.
Very sore arm, shoulder. Increasing numbness and pain down into hand. Has continued and worsened over 10 days, with numbness beginning in opposite hand/arm.
Post vaccination the pt developed a local injection site reaction which resulted in cellulitis. The pt sought unspecified medical attention.
8-31-12 developed red rash at injection site & fever started approximately 100.0 degrees F. Fever persisted through Sunday, while rash & swelling extended laterally down her arm to take elbow. Arm painful through 9-2-12.
both eyes swollen esp lower lids;no SOB noted;refer to MD;Epi & PDH given
Case number PHEH2015US003394, is an initial spontaneous report from a pharmacist on 17 Feb 2015. This report refers to an 84 year old male patient. He was vaccinated with FLUVIRIN (batch number: 1411001) intramuscular on 10 Sep 2014. On the same day post vaccination he continued to experience intermittent pain in arm at the injection site. Outcome of the event was unknown. Seriousness and causality assessment was not reported. No further information was available.
Small hives that started three days after my second dose, on my upper back, chest, belly, scalp, and throat. Two weeks later, the hives are not gone; they are mostly scabbed over, but still itch. There have been a few new hives but not like the first outbreak at all, maybe 6 or 7 new ones as opposed to more than 30 in the first round. Worse, however, my torso, belly, upper back, scalp and under my arms will not stop itching, even though most of that area is now clear skin. It is constant, there are only small breaks in which the sensitive skin bothers me but I can hold off scratching for a few minutes at a time. I have tried Benedryl, Claritin, and  Zyrtec, plus calamine lotions, and nothing helps. In fact, the new "clear skin" itching seems to be getting worse as time goes on, and I have scratched myself raw in a couple spots. I will be visiting Urgent Care tomorrow (3/31/2021) to see if there is anything a doctor can do to relieve my symptoms.
Patient had a rash on L leg approximately 3-4 inches in length, approximately 1 inch below injection site. Rash look like little white heads that combined into a large area. Patient also had a 102 temperature and his face was very red and puffy
The Pfizer vaccine was diluted with 1.4mL diluent instead of 1.8mL. The client received an additional 22.22% of vaccine in the 0.3mL dose. The error was immediately recognized and client was notified of the error and the potential for strengthened local and systemic side effects. The client had many good questions. These were all answered.
Symptoms gradually developed and intensified after 2nd and 3rd doses. Bilateral tenosynovitis, pain in fingers, arms, neck and shoulders, chest pain, shortness of breath, extreme fatigue, unable to exercise without delayed muscle inflammation, phlebitis, tinnitus, neuropathy,  easy bruising, head aches, mental fatigue, mental fog, insomnia, chills in late afternoon and evening. All these symptoms are ongoing and have no diagnosis.
Dizziness that continued and palpitations. Joint pain and inflammation. Weak, tired, fever. Headache that lasted a week. I really don't remember when I saw the doctor, or if I even did after this first shot. I did see Dr. after my next shot and was put onto a CPAP machine. I did have Covid twice.
Circumferential thigh swelling, focussed around more proximal of 2 injection site. Elevated at DPT, started 18 hours after shot, already resolving after 48 hours but left leg still 4cm bigger that the right leg, very local, erythema and some tenderness. Child has remained active. Recovering well at 48 hours.
Headache: 4.5 days - current Nasal Congestion: 4.5 days - current Fatigue: 4 days Sensitive Skin: 2 days Nausea: 8 hours Muscle soreness: 1 day
A morning after vaccine, back pain from center of back , down pelvic area and leg on left side.  This is day 2 and not getting better.  Sharp needle like pain going down left back and legs.   I've been taking meds that I had from a shoulder surgery.  Not wanting to go to Dr right now.   Previously had Covid in August 2020
Child became warm and dizzy after having received his flu vaccination. He vomited once, then felt better after a short period of rest.