chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 05-SEP-2017, two siblings (captured in 1709USA004215) were vaccinated with an improperly stored dose of GARDASIL 9 lot # N019923 and expiration date of 28-APR-2019 0.5 ml, intramuscularly for prophylaxis. No adverse effects were reported. The vaccine was exposed to a temperature excursion of  -1°C or colder, with a time frame of 1 day 13 hours 30 minutes. There was previous temperature excursion of 9°C to 25°C for 7 hours 20 minutes. A "data logger" was involved.; Sender's Comments: US-009507513-1709USA004215:u
Patient developed a large round, hard, inflamed spot at both injection site 4 days later.
On 06/2/2005 mom brought patient in with chief complaint of lump on left leg, possibly from vaccine given 3 weeks prior to visit. Referred to surgery. 6/8/05 pt was seen for fever, cough and abscess on thigh was given Keflex. pt did not return for follow up.
Swollen/red/painful arm, headache, rapid heart rate, chills, metallic taste in mouth, hives on arms & legs, restless sleep.
Nausea, vomiting, diarrhea, joint, muscle aches, L breast pain. Symptoms x 6d.
Patient received dose 1 of the Pfizer 5yo to 11yo COVID vaccine (lot FK5127) at approximately 1200 when she should have received the Pfizer 12 yo and up COVID vaccine. At 1205, RN and ancillary appracohed PHN to inform of the error. PHN called PHN Supervisor and texted the Vaccine Operations Leads for medical consult from the COSD medical team. PHN informed the patient's father of the error. PHN Supervisor texted back the pertinent CDC clinical interim guidance. PHN updated patient's father that per CDC guidance, the patient would receive the 12yo and up Pfizer COVID vaccine dose at 21 days after 1st dose. PHN counseled RN on double checking correct patient and vaccine during administration. Both Pfizer vaccinators wrote down the DOB range for 5yo to 11yo to reduce further error.
felt sick the next day; body ache; sore arm/painful arm; feeling like I could have the flu; nausea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 13Feb2021 (Batch/Lot number: unknown) at the age of 59 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Thyroid medication" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE [LEVOTHYROXINE SODIUM] taken for thyroid disorder. Vaccination history included: Bnt162b2 (First dose, Lot: E11283 , E1123 or E11283., Anatomical site of administration: Right arm), administration date: 23Jan2021, for Covid-19 immunisation. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "felt sick the next day"; PAIN (non-serious), outcome "unknown", described as "body ache"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm/painful arm"; INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "feeling like I could have the flu"; NAUSEA (non-serious), outcome "unknown", described as "nausea".  Additional information: Investigation Assessment: No. Laboratory Test and Treatment for Adverse Event reporter stated as None.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
lump in right breast before 24 hours had passed.  outside right of breast, where lymph nodes are.
I had my appointment to receive the second dose of the Moderna vaccine on 06/01/2021 at 10 am at the local clinic. I had just recently been hired at my now current job and was scheduled to begin my first day of training that same day at 11 am where the training store was located. I arrived at the clinic promptly at 10 am and was given the second Moderna vaccination in my left upper arm. Afterwards I proceeded to the waiting room to sit and wait along with the other patients for the required 15-20 minutes. After my time was up, I then got in my car and began to drive to work. I felt perfectly fine on the drive over there, no symptoms at all. I remember slowing down and pulling into the parking lot of the parking lot , and looking at my dashboard and it was 10:56. And then everything went black. Turns out I had experienced a grand mal seizure. I was taken to the hospital by ambulance.
This spontaneous report was received from a registered pharmacist concerning an approximately 80 year old male patient. Current condition of the patient included lisinopril allergy. There was no pertinent medical history. On 18-JUL-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot number and expiry date were reported as J002777 and 07JUN-2014 respectively, dose and route unspecified). Concomitant therapies included unspecified maintenance medication. On 18-JUL-2013, the patient developed pain at the injection site. There was no rash, redness or swelling at the injection site. The patient did not seek any medical attention. An unspecified over the counter medications were given for pain. No lab tests were performed. The patient was not recovered from pain at the injection site as the patient was still having pain (it still hurts). The relatedness for the event was unknown for ZOSTAVAX. Additional information has been requested.
pt recvd vax 23MAR94 on 4APR94 came to the MD w/symptoms of fever & fussiness x 2 days; came in w/a fever of 102.4 & large red, hot rash on lt thigh; dx w/cellulitis;
the practitioner who administered the vaccine damaged the nerve in the shoulder; sharp nerve pains in my left arm/ severe pains every night and cannot sleep on the side where I took the shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Oct2023 as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete;  unknown manufacturer), for covid-19 immunization. The following information was reported: VACCINATION SITE NERVE DAMAGE (non-serious), outcome "unknown", described as "the practitioner who administered the vaccine damaged the nerve in the shoulder"; NEURALGIA (non-serious), outcome "unknown", described as "sharp nerve pains in my left arm/ severe pains every night and cannot sleep on the side where I took the shot".  Additional information: The patient had been suffering from sharp nerve pains in the patient's left arm where the patient just received the new booster COVID about three weeks ago. The patient strongly believed the practitioner who administered the vaccine damaged the nerve in the shoulder. The patient suffered severe pains every night and cannot sleep on the side where the patient took the  shot.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Information has been received from a healthcare worker referring to multiple unspecified patients of unknown age and gender. Their medical history, concurrent condition and concomitant therapy were not provided. On unknown dates, the patients were administered improperly stored PROQUAD (rHA (recombinant human albumin), strength, dose, frequency and route were unknown; lot number M012986 with expiration date as 12-SEP-2017 and M015698 with and expiration date as 26-SEP-2017. No adverse effects were reported. This is one of the two reports that received from the same source. Additional information has been requested.
Severe chills lasting greater than 8 hours, nausea, vomiting, Deja vu lasting several days. Loss of appetite, severe headache, body aches.
Pt recvd 3 doses of Engerix-B vax 20JAN90 & 22FEB90 & 23JUL90 & 20DEC91 it was determined that pt did not respond to the vax series; no tx was given;
The day following receiving the vaccine I had no appetite whatsoever and was fatigued. The symptoms were similar to when I had Covid in November 2020 except I also had fever at that time. I did not treat the symptoms and they went away by the next morning.
Information has been received froma public health registered nurse who received a call from a school nurse concerning a sixsth grader who during the week of 05/07/01 was vaccinated with MMRII. Subsequently, 2 days later, in 05/2001, the patient was diagnosed with varicella. It was unknown whether the child ever received Varivax. Additional information has been requested.
Starting 04/10/2022, I developed really loud Tinnitus and it has continued to this day. I have had this condition since before the vaccine but it has become much worse and intolerable. I will be seeing my PCP soon in regards to it.
This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 65-year-old female patient who received SHINGRIX (batch number 353S5, expiry date 29th May 2021) for prophylaxis. On 8th February 2019, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional case details were provided as follows: The patient received the dose of SHINGRIX in left deltoid and experienced left arm soreness. According to sale data sheet, the batch number was updated to 353S5 from 3535S.
After 15 minute observation period, pt went home without difficulty. After returning home, began c/o headache, nausea, heart racing. Returned to vaccination site. Fire chief onsite administered care. BP 140/90, P-76, regular, R-29, short, Pulse Ox 93-97%. O2 delivered via nasal cannula. 12 lead EKG WNL. Transported to hospital via ambulance for observation/evaluation.
1. Pain in the lymph node near the site of the injection (right axillary). It started a week after the vaccination and the symptoms lasted 4 days and resolved.  2. Shingles (herpes zoster) outbreak on the right upper buttock. This is accompanied by pain in the groin lymph node on the right side (side of the vaccination). Symptoms started 12 days after the vaccination and are still ongoing.
Hospitalized 9/1/2021; COVID-19 positive (9/16/2021); fully vaccinated  Patient is a 26 y.o. male who presented with fatigue, fever and chest pain. Patient has a history of HTN, OSA, and obesity. Patient had onset fever, body aches and fatigue night of 9/14/2021. Patient took tylenol and motrin with continued symptoms. Cough and congestion started on 9/16/21 with increasing shortness of breath. Notified of recent work exposure for COVID and was found to be positive on 9/16. Patient is fully vaccinated with moderna in early 2021, with sister who was also vaccinated ended up intubated with COVID 1 month prior. Patient also reported rash onset 9/17 after recent exposure to son who had HFMD. Rash is found on face, hands, feet, and truck with sores to inner lips and sore throat. Increased shortness of breath, chest pain and cough on night of 9/17, in which prompted him to seek further care. Patient denies abdominal pain, nausea, vomiting or urinary symptoms.  In the ED, patient was found to have unremarkable laboratory findings.  EKG showed sinus tachycardia with normal tropinins. CT thorax completed without evidence of PE. Although no acute findings, patient was admitted to hospitalist service for COVID due to continued tachypnea and tachycardia for continued monitoring and symptomatic treatment.    9/19/2021 at 0304 I patient with acute stroke findings. Last known normal established das 0247 when RN administered tylenol. BP 145/96, glucose 131. Patient with obvious left side hemiparises, no facial asymmetry, protecting airway, led visual field defect. NIH 14. STAT imaging ordered at 0311.    Nursing escorted patient down to CT.  Neurology  and recommended tPA if no bleed or other contraindication and transfer to neuro ICU barring large vessel occlusion. Radiology called backed, no bleed noted on CT head, normal perfusion  Study, CT angio with some findings felt 2/2 poor timing of contrast. tPA ordered and administered.   He is transferred in stable condition via ground to another facility on 9/19/21. Currently  hospitalized, Patient stable now, awaiting discharge to inpatient rehab.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter (Consumer or other non-HCP). The reporter is the patient.  A 68-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Sep2022 as DOSE 5 (BOOSTER), SINGLE (batch/lot number: unknown) at the age of 68 years, administered in the left arm for COVID-19 immunization; Covid-19 vaccine (COVID-19 VACCINE), as DOSE 1, SINGLE (batch/lot number: unknown), as DOSE 2, SINGLE (batch/lot number: unknown), as DOSE 3 (BOOSTER), SINGLE (batch/lot number: unknown) and as DOSE 4 (BOOSTER), SINGLE (batch/lot number: unknown) for COVID-19 immunization. The patient's relevant medical history was not reported. Concomitant medication included: NEXIUM [ESOMEPRAZOLE SODIUM], start date: 01Jan2006, stop date: 13Jan2023. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "Treatment of COVID-19." The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Dec2022) Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of Drug Ineffective, Covid-19.  The information on the batch/lot number for [BNT162B2, BNT162B2 OMI BA.4-5] has been requested and will be submitted if and when received.
gastrointestinal symptoms; fever; shivering; fatigue; headache; myalgia; This case was reported by a consumer and described the occurrence of gastrointestinal symptom nos in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23rd December 2020, the patient received the 2nd dose of Shingrix. On 24th December 2020, 1 days after receiving Shingrix, the patient experienced gastrointestinal symptom nos, fever, shivering, fatigue, headache and myalgia. On an unknown date, the outcome of the gastrointestinal symptom nos, fever, shivering, fatigue, headache and myalgia were not recovered/not resolved.   It was unknown if the reporter considered the gastrointestinal symptom nos, fever, shivering, fatigue, headache and myalgia to be related to Shingrix.  Additional details were provided as follows: The reporter was patient's wife. The age at vaccination was not reported. On the day of reporting, in morning the patient experienced gastrointestinal symptoms, fever, shivering, fatigue, headache and myalgia. The reporter did not consent to follow-up.
7APR96 pt exp pinpoint, morbilliform rash;pt also exp pain in the rt wrist & ankle joints & rt hand swelling;A lump devel on lt wrist which resolved;devel some pains in toes w/stiffness & tenderness in thumb;arthralgia & dec grip stre
This case was reported in a literature article and described the occurrence of myositis in a 17-month-old female subject who was vaccinated with DTP vaccine (manufacturer unspecified). On an unspecified date, the subject received an unspecified dose of DTP vaccine (route unknown, left thigh, batch number not provided). 10 days after vaccination with DTP vaccine, the subject experienced myositis, edema, unable to bear weight on her left leg, soft tissue swelling (without osseous abnormality) and sterile abscess. No constitutional symptoms, fever, weight loss, night sweats, rash or history of trauma. The subject was hospitalised and discharged without receiving antibiotic therapy or invasive surgical procedure. Physical exam demonstrated a fullness with measured asymmetry to her left thigh. Radiographs of the left femur demonstrated soft tissue swelling but no osseous abnormality. The initial concern was for a soft tissue neoplasm such as lipoma, lipoblastoma, rhabdomyosarcoma, liposarcoma, or metastatic neuroblastoma. Although there was no history of witnessed trauma, hematoma was an additional consideration. Complete blood count yielded a white blood cell count of 12,300 with 32 neutrophils, 49 lymphocytes, 9 monocytes and 10 eosinophils. There was elevation of the creatine phosphokinase and minimal elevation of the aspartate aminotransferase and alanine aminotransferase. Sedimentation rate was 12 and c-reactive protein was minimally elevated. Magnetic resonance imaging demonstrated myositis involving the vastus medialis, vastus intermedius and vastus lateralis muscles with edema and a central serpigenous collection of fluid. The subject was treated with gadolinium. After that, there was prompt hyperemic enhancement of the muscles, with an area of low signal representing the abscess and surrounding ring enhancement. There was no mass identified. Within 7 days, the events were resolved.
Within 12 hours of vaccination I had 24 hours of: fever as high as 103.7, regular tachycardia 120 at rest (likely fever related),  generalized headache, malaise, fatigue, diffuse joint pain, severe right arm pain without redness/warmth radiating down my right arm and up to the right trapezius.
inflated pectoral area with discomfort; Caller said the swelling at that time looked like a swollen lymph node located in the left arm under the armpit and was not that severe; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 42 year-old male patient received bnt162b2 (COMIRNATY), administration date 26Oct2021 (Batch/Lot number: unknown) at the age of 41 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DISCOMFORT (non-serious) with onset 2021, outcome "unknown", described as "inflated pectoral area with discomfort"; LYMPHADENOPATHY (non-serious) with onset 2021, outcome "unknown", described as "Caller said the swelling at that time looked like a swollen lymph node located in the left arm under the armpit and was not that severe".  Additional information: Caller wanted to know if the patient can take aspirin and Tylenol in case the swelling continues. The patient is a 42-year old male. The patient received the 1st dose of Comirnaty on 26Oct2021 and had an inflated pectoral area with discomfort. Patient received the 2nd dose on 16Nov2021 and experienced the same thing. Caller and patient wanted to know more information about that, they were thinking it might be the lymphatic area they have read in the brochure. As per caller, the patient was 41 when he got the 1st dose. Caller said the swelling at that time looked like a swollen lymph node located in the left arm under the armpit and was not that severe. For the 2nd dose, the swelling is more sever. Caller mentioned "you can see it at first sight." Caller added that the patient experienced more pain, had muscle pain, as well as headache. Caller asked what they should do as it has been 72 hours since the patient got the 2nd dose. Caller also mentioned that this looks worse than the 1st one. Caller asked to clarify if in the information given to him, the swollen lymph node can be up to 10 days. Caller asked if the patient had to go the ER, who would be paying for that.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Approx. 24 hours after flu shot I became itchy and covered neck to feet in hives. Went on Benadryl.
Patients mother told us he looked pale and came to the pharmacy. The nurse who was administering vaccines left to help child, found him sitting down and pale but conscious. She took his vitals and bp and found both a strong pulse and bp of 120/64. Patient was able to drink water and stand, mom said she laid him down when he looked pale, pt and mother left store walking with color returned to patient face
This is a spontaneous report from a contactable consumer (patient) via COVID-19 reporting system. A 69-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL926), via an unspecified route of administration, administered in arm left on 02Feb2021 16:30 (at the age of 69-years-old) as a single dose for covid-19 immunization. Medical history included Stroke in December of 2017, patient was also allergic to Phenothiazines from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Concomitant medication(s) included: unspecified antibiotics, acetylsalicylic acid (ASPIRIN) 81 mg; clopidogrel 75 mg; tetryzoline (LISINE) taken for an unspecified indication. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient was tested for COVID-19 on 12Jan2021 via nasal swab procedure and the test was negative. On 03Feb2021 at 04:00, the patient experienced soreness in area of shot, itchiness throughout body, tiredness, dryness in skin and increase in pimples. No therapeutic measures were taken as result of the events. Post vaccination, the patient had been tested for COVID-19. The outcome of the events was not resolved. Follow-up attempts are completed. No further information is expected.
Patient appeared to clinic 7 days post vaccination with a picture of arm. Easy to tell there was redness and appeared to have been raised. She stated painful, warm to touch some swelling in lymph nodes in under arm. Upon examination on 2/18/2019 there was slight redness, no induration and still some tenderness. No palpable lymph nodes on 2/18/19.
Heavy arms feel, dizzy observation. Patient states she has high blood pressure; no meds given/patient states feeling fine
Bilateral Nerve pain  in both feet present 1-2 weeks after first dose. Still ongoing
Five minutes after vaccine was given the patient experienced a tightness in her jaw. Her mouth was very dry and also she experienced an unpleasant taste. This was immediately reported to the head nurse. She was given 25 mg of Benadryl po which she swallowed without difficulty. Her VS were monitored. her BP was 154/48 , P was 86 and O2 sat 95%. She was monitored for 20 minutes and she her symptoms resolved 10 min after taking the Benadryl. Her Bp was 154/74, P was 86 and O2 Sat 94%. Patient was also on her own oxygen via nasal cannula at 3 liters. She did not feel sleepy and stated she felt comfortable to drive home. Her symptoms were resolved and she was in no distress. she was discharged after 20 min.
Patient received a moderna booster, but was not immunocompromised. Should have received a pfizer booster instead.
Soreness of arm, difficulry sleeping, very swollen red arm. Went to hospital - diagnosed with cellulitis of upper left arm.
Information has been received from a registered nurse (RN) concerning a kindergarten entry aged patient of approximately 5-years of age patient who was vaccinated with a first dose of varicella virus vaccine live (Oka/Merck). Subsequently, "two weeks after vaccination" the patient developed a chickenpox like rash. It was unspecified if medical attention was sought. No further information was available at the time of this report. No product quality complaint was involved. Additional information has been requested.
Having seizures, incontinent of urine foaming at the mouth, fever with temp up to 103, and no memory of the 3 days of symptoms! (Husband stayed with her, gave her clear liquids and medications.)