chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial unsolicited report received from a nurse practitioner on 19 April 2016. This case involves a 12-year-old male patient who was vaccinated with a dose of TETANUS TOXOID (manufacturer: unknown, batch number, expiry date, route and site of administration were not reported) on an unspecified date. The patient is now 37 years old. The patient's pre-existing physician diagnosed allergies included horse serum allergy and birth defects, medical conditions was reported as not available. Illness at time of vaccination was reported as unknown. Concomitant medications were not reported. On unspecified date following the vaccination, the patient had experienced fever (105 degrees). On unspecified date, the patient was hospitalized. Other laboratory data was reported as unknown. The patient's corrective treatment was not reported. On unspecified date, the patient recovered from event. List of documents held by sender: none. Sender's Comments: This is a poorly documented case referring to a 37 years old male patient who at the age of 12 years received tetanus toxoid vaccine and experienced fever. Time to onset was not reported. Further information regarding the dates of administration of suspect vaccine and date of onset of the reported event were not provided, hence temporal association cannot be established. In this case very limited information was provided, no information regarding the concomitant medication, concurrent illness, course of hospitalization were provided. Considering the limited available information causality cannot be assessed.
Erythema, swelling, pruritus in a 5" x 5" area including (R) deltoid area and lateral upper (R) arm. Non tender, no c/o pain. Full ROM of (R) arm.
Initial information received on 02-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 42 years old female patient who received 0.5 mL dose of vaccine FLUZONE HIGH DOSE lot UI994AB, expiry date: 09-APR-2019 via intramuscular route in the right deltoid on 01-Oct-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was an actual medication error due to inappropriate age at vaccine administration and overdose. It was reported that 3 patients under the age of 65 had been given FLUZONE HD. Pre-filled syringes were used. It was unknown whether patient experienced any adverse reaction after vaccination. 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. Documents held by sender: none.
Right thigh red, swollen and painful; MD advised parent to try benadryl; patient evaluated in office - right lateral/posterior thigh with 2.5 cm x 4 cm area of firm induration, no tenderness, no erythema, no fluctuance.
#2 flu vaccine adm. R thigh on 1/9/04. 24 hrs post vacc. site became red, raised, individual, small bumps in localized area approx. 1.5" wide x 3-4" long. No apparent pain, itching, no fevers. No OTC meds or heat/ cold packs applied. No limit to activity. (+) warm to touch rxn appeared to be concentrated to skin surface. Site still visible. Skin rough, skaley almost excema appearance. Now applying (and had) lotion. (+) rxn to vaccine #1. Has eaten egg containing products w/o problems-no eggs alone consumed to date that father is aware of.
24 yo old male came to the pharmacy to receive his 2nd dose of Moderna. Pt fainted shortly after receiving their dose. I believe they also had a seizure. Pt was extremely anxious prior to receiving their dose. Pt was laid on mat and we called 911. Paramedics checked him out and monitored his BP, HR, and Mental Status. Pt was taken to the hospital upon his consent.
I had a bad headache eyes were sore, coughing, nasal congestion, I felt feverish, body aches, and fatigue. I tested positive for COVID-19 at home. I talked to my doctor and they prescribed me Paxlovid.
Around 15 hours after receiving my vaccine, I had fever like symptoms, and it was very difficult to sleep which I think is very typical. I also had arm pain that wasn't too severe. After that, on 10/06/2022, I experienced some terrible postnasal drip and severe fatigue. I couldn't keep my office hours because my arms and legs felt so weak. It felt like I had the flu. I went to a minute clinic on 10/10/2022 where I tested negative for Flu, COVID-19, and Strep Throat. This fatigue, postnasal drip, and muscle weakness lasted from 10/06/2022 to 10/14/2022. The doctor did not know what caused it other than possibly my vaccine or a cold as I had tested negative for everything, they tested had me for. However, I had recently recovered from a cold, so I find it unlikely that it was another cold.
Heart palpitations and SVT starting four days after vaccination, lightheadedness and shortness of breath ongoing. I am continuing to have palpitations and tachycardia and 2 afib events since. No previous heart issues before this.
Localized swelling, heat and pain. Benadryl 25 tid, Motrin 600 tid, Keflex 500 qid x 10d.
Rash, intense swelling, numbness of the hand, headches, fever, nausea, and dizziness
Day 1- felt hot, like skin was stretching, and itchy ankles and wrists. Headache onset in the evening and fever. Day 2- skin back to normal, itching gone. Headache continued and was not fixed by OTC medicine. Fever. Lethargy.  Day 3 - slight headache  Day 4 - no symptoms - return to normal
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. There was no information about patient's concomitant medications and pertinent medical history reported. On 07-AUG-2009, the patient was vaccinated with a dose of GARDASIL (dose, route and site of administration, lot#, expiry date were not reported). On 20-AUG-2015, the patient was vaccinated with a dose of GARDASIL 9 (dose, route and site of administration, lot#, expiry date were not reported) and another dose of GARDASIL 9 was administered on 08-DEC-2015 (dose, route and site of administration, lot#, expiry date were not reported). The reporter confirmed that the series was continued and completed with GARDASIL 9. No adverse effects were reported. Additional information has been requested.
On 8JUL92 pt devel a generalized rash w/pruritus & on 9JUL92 MD dx generalized erythema multiforme; rash lasted until 15JUL92; DPH was prescribed;
Patient said he developed a rash on his left shoulder and arm that he treated with hydrocortisone cream OTC. Also he felt tired and dizzy for 7 to 10 days after getting the shots, lost control of his bladder and peed himself during that time.
Patient began having multiple neurological symptoms. Progressive extremity numbness with loss of muscle strength and fine motor skill. Patient is currently 14 weeks pregnant. NIF breathing tests indicate weakness. Diagnosed with GBS. First dose of IVIG given on 2/4.
Deep pain and limited range motion in left shoulder ever since I received the second dose all the way up to today! It hasn't gotten any better. I've done research myself and it appears I have developed SIRVA which is a shoulder injury caused from vaccinations.
In error: administered 0.1. ml Td intradermal instead of PPD. Left forearm 50mmx20mm erythema with 10mm induration some tenderness; itchy reported.
Case number PHEH2014US019166 is an initial spontaneous report received from a nurse on 19 SEP 2014. This report refers to a 60 year old male patient. His medical history and concomitant medication were not reported. On 18 SEP 2014, he was inadvertently vaccinated with FLUVIRIN 2014/2015 (batch number: 1412001) intramuscularly at a dose of 01 ml instead of the recommended 0.5 ml dose. Currently no complain was received from the patient. No adverse event was reported following this maladministration (vaccine overdose).
(L) arm at site of pneumonia (pneumococcal) vaccine red, swollen, warm to touch.
SEVERE LOCAL REACTION WITH AXILARY INFLAMMATION.  PATIENT  UNABLE TO LIFT ARM SINCE SHE RECEIVED THE VACCINATION. PATIENT IS UNABLE TO WORK, WORSE AT NIGHT.  PRESCRIBED IBUPROFEN 800 MG PO TID PRN
Information has been received from a physician concerning a 6 month old female who was vaccinated with their third dose of oral ROTATEQ vaccine live (human-bovine), 2 ml, who experienced projectile vomiting within 4 hours of receiving the vaccine. Concomitant therapy included "routine vaccinations." It was reported that the "patient is fine now." Unspecified medical attention was sought. No product quality complaint. Additional information has been requested.
I developed severe tinnitus (loud and high-pitched) beginning on April 22, 2021, and continuing 24/7 to this day.  The pitch and volume seem to have decreased somewhat over time, but I have also grown used to the condition.  No previous tinnitus issues.
hair loss; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 35-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 22Jun2021 11:00 (Batch/Lot number: unknown) at the age of 34 years as dose 2, single for covid-19 immunization; bupropion (BUPROPION), since Jun2021 (Batch/Lot number: unknown). The patient had no relevant medical history. The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Location of injection: Arm Right, Lot number: unknown, Vaccine Administration Time: 11:00 AM), administration date: 25May2021, when the patient was 34 years old, for COVID-19 immunization. The following information was reported: ALOPECIA (non-serious) with onset 01Sep2021 12:00, outcome "not recovered", described as "hair loss". The action taken for bupropion was unknown. Therapeutic measures were not taken as a result of alopecia.  Additional information: other medication included long time vitamins, no other vaccine in four weeks, No Covid prior vaccination, No Covid post vaccination, No allergies. She stated that she started using bupropion the same week of vaccination, so she was not sure what is causing it. She also stated that during her research she had stumbled on people saying they are experiencing hair loss after their vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Administration of an expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of an expired vaccine) in a 51-year-old male 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 an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of an expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administration of an expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.
EMPLOYEE EXPERIENCED TACHYCARDIA, SHORTNESS OF BREATH, AND HAD A SYNCOPAL EPISODE APPROX 1 HOUR POST FLU VACCINATION - REQUIRED ER VISIT
12hr p/vax pt devel hives begin on trunk spreading to upper & lower extremities;self rx'd DPH;resolved 3hr later;pt denies allergy to egg/products;however has had allergic rxn in past to undetermined food product;
Fever, vomiting, headache, starting within 24 hours of vaccine. Reaction documented in chart during doctor visit on 12/24/08. Treatment included warm compresses and time to recover.
One hour after vaccine, I broke out in a rash that covered my chest, arm, neck and back. I also had nausea and diarrhea.
site swelling; pneumonia vaccine administered yearly; This spontaneous report has been received from a lawyer, regarding a case in litigation and refers to a currently 75-year-old female patient. Her concurrent conditions, medical history and concomitant medications were not reported.  On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (dose, route of administration, anatomical location, lot # and expiry date were not provided) administered yearly by a physician for prophylaxis.  On an unknown date, the patient experienced vaccination site swelling.   The outcome of vaccination site swelling was not reported.  The reporter considered vaccination site swelling to be related to pneumococcal Vaccine, Polyvalent (23-valent) (manufacturer unknown).   This is one of two reports regarding the same patient.; Sender's Comments:  US-009507513-1905USA008852:
5 hours after injection face and mouth felt numb and tingly. Throat felt like closing up.  Took Zyrtec at 7pm. Following morning after I ate a protein  bar my tongue, mouth and throat felt like burning tingly sensation.  Called nurse.  Instructed to take Benadryl. If symptoms do not improve by 48 hours after vaccine I am to call back.  I also notified store and left a voicemail on VAERS hotline
I had a strong pain in the back of my arm and shoulder blade, and by 7:00 pm had numbness in the shoulder area that extended to my waist. Now my axilla is swollen and feels burning.
Horrendous headache starting 13 1/2  hrs later. Then nausea, and I passed out. Came to and had extreme chills. After the 24 hr mark, just tired and had to stay in bed. Today 3/9, all good.
My legs was hurting; Tingling all over my body; weak; Tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57 year-old female patient received bnt162b2 (BNT162B2), administration date 27Jul2021 (Lot number: ER8732, Expiration Date: 31Jul2021) at the age of 57 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Acid reflux" (unspecified if ongoing). Concomitant medication(s) included: GABAPENTIN; AMLODIPINE; PROTONIX [OMEPRAZOLE] taken for gastrooesophageal reflux disease.  The following information was reported: ASTHENIA (non-serious) with onset 27Jul2021, outcome "unknown", described as "weak"; FATIGUE (non-serious) with onset 27Jul2021, outcome "unknown", described as "Tired"; PAIN IN EXTREMITY (non-serious) with onset 28Jul2021, outcome "unknown", described as "My legs was hurting"; PARAESTHESIA (non-serious) with onset 28Jul2021, outcome "unknown", described as "Tingling all over my body". Therapeutic measures were not taken as a result of asthenia, fatigue, pain in extremity, paraesthesia.  Additional information: Patient took the vaccine Tuesday this week,  this was her first vaccine and after she took it she was real weak and tired for rest of the all day,  she knew it was normal and the next day her legs, both herl egs were hurting real bad and it was one of the side effects also, okay tonight her legs was hurting and they started tingling all over her body." consumer stated, "I took gabapentin my daily medicine. I just took it 35-40  minutes ago, it is my daily medication." (Concomitant medication), While reconfirming treatment taken in response to event: consumer stated, "No, I have not." Consumer stated about other medications that, "Not tonight just one pill I took tonight, I am taking other medication but if the only thing I took tonight. I guess, I go to neurologist doctor, for neurology reason." (Further clarification unknown). Patient did not receive Prior vaccination (Within 4 weeks) .  Follow-up attempts are completed. No further information is expected.
Information has been received from a Registered Nurse, for the Pregnancy Registry for GARDASIL, concerning a 19 year old female with a history of childhood asthma. The patient had 1 previous pregnancy with full term delivery, no pre-term deliveries, no spontaneous abortions, no elective terminations or fetal deaths. There were no birth defects in previous pregnancies but the baby was reported to be born with low birth weight. On 03-AUG-2009, the patient was vaccinated with a first dose of GARDASIL (lot# 662404/0312Y) and was pregnant. Concomitant therapy included prenatal vitamins. The patient's last menstrual period was on approximately 25-JUN-2009 and the estimated delivery date was on approximately 01-APR-2010. On 14-DEC-2009, the patient was given prenatal vitamins, one tablet daily. On 28-DEC-2009, the patient was given VALTREX for the treatment of Herpes simplex type 1 (HSV 1). On 29-DEC-2009, an ultrasound was performed for fetal dates/survey and the estimated delivery date was reported as 23-MAR-2010. Additional information has been requested.
red rash appeared on my right arm below the deltoid muscle which is itchy, warm to touch and tender to touch; red rash appeared on my right arm below the deltoid muscle which is itchy, warm to touch and tender to touch; red rash appeared on my right arm below the deltoid muscle which is itchy, warm to touch and tender to touch; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 71-years-old non pregnant female patient received second dose of bnt162b2 (BNT162B2, Formulation: solution for injection, Lot Number: EL9269) via an unspecified route of administration in arm right on 12Feb2021 at 14:30 PM as 2nd dose single for covid-19 immunisation. Patient historical vaccine included received first dose of BNT162B2 (BNT162B2, lot number: EL3246) via an unspecified route of administration in Right arm on 22Jan2021 as 1st dose single for covid-19 immunisation. Patient medical history included bronchiectasis from an unknown date and unknown if ongoing. Patient concomitant medications included atenolol (ATENOLOL) taken for an unspecified indication, start and stop date were not reported; montelukast (MONTELUKAST) taken for an unspecified indication, start and stop date were not reported; calcium (CALCIUM) taken for an unspecified indication, start and stop date were not reported; vitamins (VITAMINS NOS) taken for an unspecified indication, start and stop date were not reported. Vaccine Facility information available. Ethnicity information was available. Race information was available. The patient had no allergies to medications, food, or other products. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 14Feb2021 at 10:00, The patient had red rash appeared on right arm below the deltoid muscle, the rash was approximately 2 inches in length and 1.5 inches in width. The rash, which was itchy, warm to touch and tender to touch. If the rash does not subside in a week, the patient will consult a physician. Treatment was not received for the adverse event. The events were considered as non-serious. The outcome of the events was reported as not recovered.  Follow-up (07MAY2021): Follow-up attempts completed. No further information expected.
Patient originally received 1st dose Moderna vaccine on  4/3/2021 at different location. Patient received Pfizer vaccine at pharmacy today 5/7/2021 as expected second dose.
Aching of entire body, chills resolved within about a day.  Arm pain at site of injection resolved after several days.
pt recv vax & next day began having swelling of ipsilateral arm & hand, followed by blisters on ipsilateral hand followed by peeling;blisters for several week & peeling up to 6wk;
Patient called me today. She received Spikevax 2 days ago. She said she was fine until yesterday morning. She said she "couldn't move...,couldn't walk to bathroom hardly...couldn't put leg on and walk around house...."  She said she was in a lot of pain and had to have someone come over to let her dog out since she couldn't.  She said she has some residual effects today, but can move around today.
This spontaneous report was received from a medical assistant concerning to a 5-year-old patient, of unknown gender. Additional patient's information was not provided. On an unknown date, the patient was vaccinated with M-M-R II (strength, dose, route of administration, lot # and expiration date were not provided) rather than PROQUAD lot # N031294, expiration date 21-AUG-2019, for prophylaxis (strength and dose were not provided). Other suspect therapies included sterile diluent for prophylaxis (strength, dose, route of administration, lot # and expiration date were not provided). No adverse effects were reported.
Patient was into the clinic on the afternoon of 2/23/21 for a COVID-19 vaccine.  He had a podiatry clinic visit after his vaccine same day.  It was reported by the patients family physician that patient stated he didn't feel well and suddenly collapsed at home at approximately 4:45 pm.  Emergency medical personnel were not able to revive him.   Patient died at approximately 4:45 pm on 2/23/21.
PATIENT REPORTED ON DAY #4 POST-VACCINE THAT HER NECK AND CHEST VEINS WERE PROMINENT BILATERALLY,  MORE SO ON SIDE OF VACCINE SITE (RIGHT).  HAD AUDIO TELEHEALTH APPOINTMENT WITH PROVIDER  ON POST-VACCINE DAY #3, 02/22/2021.  DID NOT BECOME AWARE OF  SYMPTOM UNTIL AFTER APPOINTMENT HAD CONCLUDED. ALSO REPORTED THAT INITIALLY HAD LOCALIZED REDNESS, RED STREAK, SWELLING AND ITCHING AT VACCINE SITE, BUT THAT THOSE SYMPTOMS WERE NOW RESOLVING. ADVISED EVALUATION BY PROVIDER, REPORTING TO CDC's  V-SAFE,  AND SEEKING URGENT/EMERGENT CARE IF NEEDED.
Site: Pain at Injection Site-Medium, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Hyperventilation-Severe, Systemic: Hypotension-Severe, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Shakiness-Medium, Systemic: Tachycardia-Medium, Systemic: Visual Changes/Disturbances-Medium, Additional Details: Pt has history of vaso vagal syncope. Patient entered an episode of syncope and quickly recovered. Paramedics arrived to futher consult patient to recovery.
Redness, swelling, itching at site of immunization lasting x 1 week. Secondary cellulitis treated with Abx.
On 9/19 /22 - several hours after vaccination, developed itching and redness at vaccine site. On 9/20/22 noticed bumps at the injection site. On 9/21/22 noticed had a red bumpy rash over entire body.  No swelling or difficulty breathing related to rash and itching.  On 9/26 reported to work, and told supervisor that she was experiencing a rash. Supervisor sent employee to Occupational Health office. Employee was evaluated by Dr. Prescriptions given to employee: fexofenadine 180mg BID; prednisone 20mg BID x 3 days. No work restrictions per MD and will return for follow-up visit in 1 week.  Employee states itching is better, but still has a rash over body.
Chills, headache, fever - 100 degrees, body aches, sore arm 2/10 & 2/11  Tylenol eased the symptoms