chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Arm sore after Moderna booster; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm sore after Moderna booster) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    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 and RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced VACCINATION SITE PAIN (Arm sore after Moderna booster). At the time of the report, VACCINATION SITE PAIN (Arm sore after Moderna booster) outcome was unknown.            The concomitant medication was not reported by reporter. Patients arm sore after Moderna booster and flu shot.  It was unknown if he was enrolled in a COVID-19 vaccine trial. The treatment medication was not reported by reporter.   This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2021-625103 (Patient Link).
Patient received the Zoster vaccine at the clinic 2/5/09. At his f/u visit 3/3/09 he reported he'd developed a shingles rash approx 10 days after the vaccine. An exam noted a rash on the tight mid-back and on anterior right chest approximately the T3 dermatome - consistent with a shingles rash. Patient reported mild pain (pins and needles type) and itching.
Myalgias, erythema, warmth about vax site 6 days p/administraion of DT;
Received vaccine in the am was fine the rest of the day. Monday am woke up felt like I was ran over w a truck achy ,  fatigue took tylenol.  Monday night I went to take a bath and noticed my left axilla enlargement the  size of a softball.  I immediately called my husband because even as a Nurse it alarmed me.  I had been achy there all day assuming it was reactive lymph nodes doing there job.  This was definately lymphadenapathy. went to bed that evening woke up at 130 am with chills took tylenol did not check fever but I am sure i had a fever.  The following day Tuesday still felt bad low grade fever 99.0f achy chills terrible fatigue , lympadenapathy somewhat better /smaller.  Currrent date thursday 8/11 4 days post vaccine lymphadenapathy improving slow prob the size of a lemon today somewhat firmer but soft slightly painful.  All the rest of the symptoms have resolved somewhat tired .
Seizure- Saturday night 4/1/2023 baby woke up from nap, had bottle she had jerking of upper body/ lower body and noise from mouth mom unsure of time- estimates 10 minutes  neighbor called EMS then baby seemed lethargic, slowly crying when ambulance came, she was crying - still not normal eyes closed but then opened however, in ambulance, she seemed back to normal, she was sitting mom mom's lap, alert and acting herself she was screaming/ crying very loud in ambulance VSS and 02 level normal (no temp taken) she did not go to ER- the ambulance asked mom and gave her options, but mom did not take her to ER mom denies and trauma/ fall and denies any possibility of ingestion   Recent Vaccine- MMR was 8 days before event No documented fever day of event (no temp was taken) She developed fever 4/2/2023- Sunday night fever 101.8- mom gave tylenol 3.75 ml monday 4/3/ she had tacile temp x1 then resolved, no fever since then  she has been her normal self since monday, no more fever earing drinking welll active, playful, eating drinking
Had flu like symptoms with fever; Had flu like symptoms with fever; Fatigue; This is a spontaneous report from a non-contactable Other-HCP. This Adult male Other-HCP reported for himself. An adult male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: EN6200) via an intramuscular route of administration in Arm Left on 26Feb2021 11:30 as single dose for covid-19 immunisation. Medical history included urogram from an unknown date and unknown if ongoing IVP contrast dye. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received Other medications in two weeks reported as none. The patient's concomitant medications were not reported. The patient had historical vaccine of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: EL9265) via an intramuscular route of administration in Arm Left on 06Feb2021 11:00AM as single dose for covid-19 immunisation. Since the vaccination, the patient had not been tested positive for COVID-19. The patient experienced had flu like symptoms with fever, fatigue on an unspecified date. The patient received treatment for the adverse events with antinausea meds. The clinical outcome of the events was recovering. Therapeutic measures were taken as a result of had flu like symptoms with fever, fatigue.  No follow-up attempts are possible. No further information is expected.
Was given Bivalent Pfizer COVID as first dose and not the monovalent (submitting this to be on safe side since was incorrect vaccine given, technically). No symptoms or side effects known at the time of vaccination or after.
Swollen, painful glands/neck area lasting over 1 week. Flu-like symptoms (lethargy, chest pain, uneasy breathing). Tuesday evening the pain was so bad, I took 50 mg Vioxx and 20 mg Ambien to fall asleep.
This case was reported by a pharmacist and described the occurrence of dizziness in a 40-year-old male subject who was vaccinated with ENGERIX B, (GlaxoSmithKline).  On 22 September 2009 the subject received a dose of ENGERIX B (.5 ml, unknown), and experienced an under dose.  Within 24 hours of vaccination with ENGERIX B, the subject experienced dizziness and nausea.  The subject was monitored at a clinic.  The events were resolved on an unknown date.  The pharmacist considered the events were possibly related to vaccination with ENGERIX B.  This is one of three cases reported by this pharmacist where all three subjects experienced the same events with same lot number provided, see cases A0809418A and A0809419A for more details.  No further information was provided.
Pt experienced muscle twitching, SOB and stiff joints. Pt was observed only. No treatment necessary/given.
It was very sore at the site and surrounding area and then it became red hot, very itchy; It was very sore at the site and surrounding area and then it became red hot, very itchy; It was very sore at the site and surrounding area and then it became red hot, very itchy; swelling and then after about a week it moved to down the arm and then went to the wrist; This is a spontaneous report from a contactable pharmacist.  A female patient of an unspecified age received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13, lot number: X93809 and expiration date: 28Feb2021), via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported.  Patient described the adverse events as very sore at the site and surrounding area and then it became red hot, very itchy. The patient added that she experienced swelling and then after about a week it moved to down the arm and then went to the wrist. It did not go to the hand on unknown date. The patient reported the events lasted for 3 weeks. The outcome of the events was unknown.
Tired easily,  rapid heart beat. Symptoms are better at this time, but not completely gone.  Symptoms started one week after vaccination, better at this time.
pt mom recvd MMR vax & had congential catracts; addtl info is being requested;
16APR94 c/o sore arm was swollen down to elbow of the rt arma; no temp noted was able to move it; could not raise it up;
they did not experience any side effects; PROQUAD that was administered to 17 year old. PROQUAD should not be administered to anyone over the the age 12; Route of Administration: IM; This spontaneous report was received from a nurse referring to a 17 years old male patient. The patient's pertinent medical history, drug reactions or allergies and concomitant medication were not reported.  On 02-MAR-2020, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin) (PROQUAD) (0.5 ml, strength was not reported, lot # T025508 has been verified as valid, expiration date 23-JAN-2022) intramuscularly (IM) (incorrect route of product administration) for prophylaxis. According to reporter's information, measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin) (PROQUAD) should not be administered to anyone over age 12. The patient did not experience any side effects. The outcome of the events were unknown.
Legs felt very heavy like they weighed 500 pounds; hurt all over; chills; Eyes became swollen; Face became swollen; This spontaneous case was reported by a consumer and describes the occurrence of EYE SWELLING (Eyes became swollen), LIMB DISCOMFORT (Legs felt very heavy like they weighed 500 pounds), PAIN (hurt all over), SWELLING FACE (Face became swollen) and CHILLS (chills) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced EYE SWELLING (Eyes became swollen) and SWELLING FACE (Face became swollen). On 25-Mar-2021, the patient experienced LIMB DISCOMFORT (Legs felt very heavy like they weighed 500 pounds), PAIN (hurt all over) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, EYE SWELLING (Eyes became swollen), LIMB DISCOMFORT (Legs felt very heavy like they weighed 500 pounds), PAIN (hurt all over), SWELLING FACE (Face became swollen) and CHILLS (chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, COVID-19: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
Vomited 1/2 hour after vaccine & 3 more times that day. Started mild swelling at site. No other reactions (10-20-10 pt recounted it to us).
CHIEF COMPLAINT:   From nursing, low BG this morning, 30 mg/dL. Per EMS was given glucagon, 91 mg/dL en route. 81 mg/dL at triage. Blood in urine x2 days and "abnormal labs" per EMS from staff. CAO x3.   HISTORY OF PRESENT ILLNESS:     81 years old female with history of diabetes sent in for evaluation of low blood sugar.  Also on arrival patient found to have blood in the Foley's catheter.  Patient was given glucagon and juice during transport and on arrival fingersticks around 81.  Presently in the ER patient states feels fine and has no specific complaint except states he has some blood in the urine.  No associated abdominal pain backache headache nausea vomiting chest pain shortness of breath or other symptoms.  Denies being on blood thinners.
I don't have an exact onset time so the one above reflects when the shot was given.  The patient's report was actually quite vague and I have difficulty attributing his shoulder pain to the vaccination. Patient came in to pharmacy today (12/14/2015) and complained that his shoulder has been hurting since he got the flu shot back in October.  His wife was not aware that it was bothering him until recently.
Patient was due for a Pneumovax vaccine, order was placed and vaccine given by RN on 11/6/21. Vaccination documentation was not reviewed or discussed with other RN in clinic, another dose of Pneumovax was given to patient on 11/16/21. This near miss was noticed during monthly documentation checks. MD notified. Patient not symptomatic with vaccine.
08Jan98 pt recv 1 dose vax. 25Jan98 pt exp rash of 20 pruritic vesicular lesions on scalp,trunk,arms & legs. 05Feb98 pt recovered.
Felt "wonky and lightheaded"; Felt weak and lacked energy.; Itchy all over her body.; Cold cold chills then got hot hot hot; hot, itchy, cold all the time, and sick to the stomach.; As "having the flu."; Coughing a lot; Also has a running nose; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Felt "wonky and lightheaded"), ASTHENIA (Felt weak and lacked energy.), PRURITUS (Itchy all over her body.), FEELING OF BODY TEMPERATURE CHANGE (Cold cold chills then got hot hot hot) and ABDOMINAL DISCOMFORT (hot, itchy, cold all the time, and sick to the stomach.) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced DIZZINESS (Felt "wonky and lightheaded"), ASTHENIA (Felt weak and lacked energy.), PRURITUS (Itchy all over her body.), FEELING OF BODY TEMPERATURE CHANGE (Cold cold chills then got hot hot hot), ABDOMINAL DISCOMFORT (hot, itchy, cold all the time, and sick to the stomach.), INFLUENZA LIKE ILLNESS (As "having the flu."), COUGH (Coughing a lot) and RHINORRHOEA (Also has a running nose). At the time of the report, DIZZINESS (Felt "wonky and lightheaded"), ASTHENIA (Felt weak and lacked energy.), PRURITUS (Itchy all over her body.), FEELING OF BODY TEMPERATURE CHANGE (Cold cold chills then got hot hot hot), ABDOMINAL DISCOMFORT (hot, itchy, cold all the time, and sick to the stomach.), INFLUENZA LIKE ILLNESS (As "having the flu."), COUGH (Coughing a lot) and RHINORRHOEA (Also has a running nose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Fever, Cough, Shortness of breath, loss taste, Nausea, Diarrhea, fatigue,. did not feel well and breathing became hard, called 911 and was transported to the hospital. Was admitted with Hypoxia and Covid Pneumonia. Was in the hospital 6 days. Sent home and use oxygen at 4 liters.
loss of appetite; pain in arm; nausea; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A female patient in her 40's received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1), for Covid-19 Immunisation. The following information was reported: DECREASED APPETITE (non-serious), outcome "unknown", described as "loss of appetite"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "pain in arm"; NAUSEA (non-serious), outcome "unknown", described as "nausea".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Initial swelling to arm.  Chills to the bone.  But on 4/1/2021 arm began to itch.  Cortisone was applied. Itching and redness persisted with spread of redness. Swelling and lump becoming more severe. Benadryl taken by mouth to prevent persistent itching.  Throbbing, large area of redness and discomfort began today.
Patient states that lips started to swell on 3/19/21, two days after administration of Moderna. He says he did not start any other new meds. Lips were still swollen as of 4/2/2021.
Medical assistant administered incorrect vaccine dose ( adult dose) to pediatric patient. medical assistant Medical assistant didn't verify dose being provided. Advised parent to go to ER if signs of adverse reaction and to notify pediatrician.
on day 6 patient began experiencing arm redness, soreness, swelling distal to injection site that appears outside of normal expectations.
This spontaneous report as received from a nurse refers to a 3 month old female patient. On 24-APR-2013 the patient was vaccinated with RECOMBIVAX HB (dosing regimen and frequency unknown) (lot number and expiry date unknown) for an unknown indication. No concomitant medications were reported. On 11-JUN-2013, the patient was administered with the second dose of RECOMBIVAX HB and on 31-JUL-2013 a third dose of RECOMBIVAX HB was administered. No adverse events were reported. No product quality issue was reported. Additional information has been requested.
Patient received Fluad on 12/12/19. On 12/13/19, she states that she was standing in her kitchen and fainted backwards onto a floor tile.  She was taken to the ER with a shoulder injury and had a CT scan done.  Pt believes that the inceident was due to the flu shot.  Patient called and reported this incident on 01/22/2020.
Skin irritation - redness and swelling, bug bite like sores. Occurred during lunch immediately following an outdoor walk. Additionally, just bug bite sores when consuming tomatoes. Went away within 10 minutes of food being rinsed off.
Migraine: headache to the right side of the head, temple, behind the right eye.; Nausea: more severe at night; This is a spontaneous report from a non-contactable consumer, the patient. A 34-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3181) via an unspecified route of administration on 13Aug2021 at 12:30 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 15Aug2021 at 22:00, the patient experienced migraine, headache to the right side of the head, temple, behind the right eye and nausea, more severe at night. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events migraine, headache to the right side of the head, temple, behind the right eye and nausea more severe at night were not resolved at the time of this report.   No follow-up attempts are possible. No further information is expected.
Pt states she experienced weakness, heart palpitations and hypertension beginning 2 days after first dose. Pt was seen in ER, and it is unclear whether her symptoms were a result of the oral vaccine.
administrated with engerix-b batch recall; administrated with engerix-b batch recall; This case was reported by a nurse via call center representative and described the occurrence of recalled drug administered in a patient who received HBV (Engerix B) (batch number CP23D, expiry date 7th December 2023) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Engerix B and Engerix B Pre-Filled Syringe Device. On an unknown date, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced recalled drug administered and drug dispensing error. On an unknown date, the outcome of the recalled drug administered and drug dispensing error 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 Information: GSK Receipt Date: 18-APR-2022 Reporter's comments: No patient's identifiers were provided.  The nurse reported that a patient was administrated with Engerix B batch recall for October.  The reporter had been on maternity leave and had just found out about it. No vaccination date was provided. No adverse event was reported. The reporter consented to follow up. Additional Supportive Information: The nurse reported that a patient was administered with Engerix B batch recall, which led to recalled drug administered and drug dispensing error. The Vaccine Administration Facility is the same as primary reporter. This is 1 of the 8 cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR068024:Same reporter US-GLAXOSMITHKLINE-US2022066344:Same reporter US-GLAXOSMITHKLINE-US2022AMR068022:Same reporter US-GLAXOSMITHKLINE-US2022AMR068023:Same reporter US-GLAXOSMITHKLINE-US2022AMR068021:Same reporter US-GLAXOSMITHKLINE-US2022AMR068026:Same reporter US-GLAXOSMITHKLINE-US2022AMR068027:Same reporter
Light chills for the first hour, gone now; This spontaneous case was reported by a non-health professional and describes the occurrence of CHILLS (Light chills for the first hour, gone now) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CHILLS (Light chills for the first hour, gone now). At the time of the report, CHILLS (Light chills for the first hour, gone now) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Based on the current available information and temporal association between the use of the product and the start date of the event,a causal relationship cannot be excluded.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event,a causal relationship cannot be excluded.
PATIENT RECEIVED VACCINE IN OFFICE 03/23/06 AT APPROXIMATELY 10:30 AM BEGAN TO BREAK OUT IN HIVES APPROXIMATELY 3 HOURS LATER ON TRUNK AND ARMS. PARENT CALLED THE OFFICE AND WAS DIRECTED TO URGENT CARE WHERE SHE WAS GIVEN A BENADRYL INJECTION. PARENT CALLED OFFICE AGAIN THIS MORNING 03/24/06 REPORTING THAT HIVES HAD WORSENED NOW SPREAD OVER TRUNK DOWN LEGS TO ANKLES ONTO FACE EARS TURNING RED AND PATIENT SOUNDS RASPY. RASH NEVER SEEMED TO GET BETTER AFTER INJECTION. PARENT WAS TOLD TO TAKE PATIENT TO URGENT CARE AGAIN DUE TO RASPINESS OF VOICE. PATIENT MAY NEED STEROID TREATMENT.
bursitis; hives; inflammation with the joints; This spontaneous case was reported by an other health care professional and describes the occurrence of BURSITIS (bursitis), URTICARIA (hives) and ARTHRITIS (inflammation with the joints) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. UNK) for COVID-19 vaccination.     The patient's past medical history included torn rotator cuff. Concurrent medical conditions included Hives (Hives cleared before recurring again).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BURSITIS (bursitis), URTICARIA (hives) and ARTHRITIS (inflammation with the joints). At the time of the report, BURSITIS (bursitis), URTICARIA (hives) and ARTHRITIS (inflammation with the joints) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient had a torn rotator cuff years ago.   Patient was on steroid treatment for hives and inflammation of joints.
Nausea, vomiting, dizzy, lightheaded, PCP determined to be an allergic reaction and added to allergy list.
Customer reported to pharmacy, shows and reports redness, mild swelling, and itching at injection site. She reports knot in muscle under injection site.