chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This medically confirmed literature report (initial receipt 22-Jul-2014) concerns a 36-year-old male. On an unknown date, the patient received flu vaccine (manufacturer and batch number not provided). On an unknown date, 6-8 hours following influenza vaccination, the patient developed local symptoms at the injection site. One week following the vaccination, the patient presented at the clinic with complaints of severe pain localised to the injection site following flu vaccination. There was a subjective decrease in range of motion due to pain. Physical examination was otherwise normal. A normal CBC with ESR was noted. BMI was recorded as 22 kg/m2. Findings on the shoulder magnetic resonance (MR) were completed 1 week after vaccination. MR results showed subcortical bone marrow edema involving the greater tuberosity (without associated cortical destruction), periosseous inflammatory changes, and small fluid within the subdeltoid bursa. No dominant mass lesion, hematoma, or abscess was present. Subcutaneous fat thickness at the proposed site of injection was measured to be 4.2 mm on the oblique coronal T1-weighted sequence. The MRI showed absence of bursal fluid and rotator cuff tear. The soft tissue signal showed intrasubstance deltoid edema and bone marrow signal showed subcortical high T2 signal. Laboratory testing did not support any infectious etiology. The patient was not actively anti-coagulated. Conservative treatment with short-term non-steroidal anti-inflammatory agents was initiated with complete resolution of symptoms within 2 months, and normal clinical exam at 2-year follow-up. Outcome was reported as recovered. Authors comment: A causal relationship between vaccine administration and deltoid bursitis has been formally established. It has been reported that unintentional injection of vaccine antigen into subacromial/subdeltoid bursa can trigger an inflammatory reaction. Due to variable body habitus and muscle size, the optimum point for vaccine injection may vary among individuals. An improper angle of approach of the needle or increased needle length may result in bursal or cortical penetration, particularly in those with low BMI.
swollen arm; like lyme disease; like bull's-eye; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 26-Apr-2021 and was forwarded to Moderna on 26-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swollen arm), VACCINATION SITE RASH (like lyme disease) and INJECTION SITE SWELLING (like bull's-eye) 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.    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 PERIPHERAL SWELLING (swollen arm), VACCINATION SITE RASH (like lyme disease) and INJECTION SITE SWELLING (like bull's-eye). At the time of the report, PERIPHERAL SWELLING (swollen arm), VACCINATION SITE RASH (like lyme disease) and INJECTION SITE SWELLING (like bull's-eye) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Medical History information was reported. Concomitant product use was not provided by the reporter. No treatment information was provided.   This case was linked to MODERNATX, INC.-MOD-2021-090348, MODERNATX, INC.-MOD-2021-023899, MODERNATX, INC.-MOD-2021-030815, MODERNATX, INC.-MOD-2021-090656 (E2B Linked Report).; Sender's Comments:  MODERNATX, INC.-MOD-2021-090348: MODERNATX, INC.-MOD-2021-023899: MODERNATX, INC.-MOD-2021-030815: MODERNATX, INC.-MOD-2021-090656:cross linked case
Pt had a possible seizure 8/21/09 had DAPTACEL and IPOL. Pt immediately stopped crying stiffened head then turned stiffly to the right and did not respond for 8-10 sec per mom, who did not report incident to us in office after vaccine. Reported to us 9/14/09.
pounding Headache, fever, redness and swelling at the site, fatigue, body pain and shoulder, and hip joint pain, muscle pain 2 weeks after vaccination. Then pounding headache, fatigue, shoulder, neck, and right hip joint pain never relieved and it's severe since the climate change.
Throat and mouth was swollen eye were red and had discharge coming from them. 4/21/08-office notes received for 12/13/07-C/O tongue and throat swelling. Dyspnea. DX: Anaphylaxis uncertain exact allergen. Symptoms began 3 hours after vaccination.
Refridgeration excursions identified; No adverse event; Temperature excursion product administered to the patient; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified), POOR QUALITY PRODUCT ADMINISTERED (Temperature excursion product administered to the patient) and NO ADVERSE EVENT (No adverse event) in a 63-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.     The patient had no allergies.  The information was unknown whether the patient ever been diagnosed or tested positive for COVID-19.     On 16-Sep-2022 at 1:58 PM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 16-Sep-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Temperature excursion product administered to the patient). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified), POOR QUALITY PRODUCT ADMINISTERED (Temperature excursion product administered to the patient) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified) and POOR QUALITY PRODUCT ADMINISTERED (Temperature excursion product administered to the patient).    The time of fourth dose administration was 03:58 pm. No concomitant medication was provided.  On an unknown dates, the patient had received dose 1, dose 2, dose 3 of Moderna vaccines. Route was Intramuscular and body site was deltoid for all three doses. The patient had received on deltoid body site for dose 4.   Date vial was moved from freezer to refrigerator on 7-Sep-2022.  The refrigeration excursions identified, state vaccine was housed in these units. There were excursions noted. Manufactures were notified and the local department and made aware of the situation.   Reportedly, the nurse called for a clinic where was assisting. The clinic had a similar issue with vaccines stored in their freezer. Vaccines stored in the refrigerator that underwent several temperature excursions going back to August 2022.   It was reported that no adverse reactions were reported to their knowledge for any patients.  Treatment medication was not provided by the reporter.
Pt developed fever 102 degrees and vomiting approx 6 hours after receiving vaccines. Pt developed high pitch, inconsolable crying lasting 1 1/2 hours approx 12 hours after vaccinated.
I experienced severe vertigo; severe vomiting X 4 hours; light-headedness/dizziness; losing my balance when walking or even standing still. ENT diagnosed; me with Vestibular Neuritis.; tinnitus; clogged ears; This is a spontaneous report from a contactable other hcp (nurse/Patient). A 63-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Lot Number: EN6203) via an unspecified route of administration in Arm Left on 04Feb2021 (age at vaccination 63-year) as dose 2, single for COVID-19 immunization. The patient medical history was not reported. Concomitant medications included Vit-D [vitamin d nos] (VIT D [VITAMIN D NOS]), Multivitamin, calcium supplement all taken for an unspecified indication, start and stop date were not reported. The patient previously took Aqua-Mephyton and experienced allergies. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Lot Number: EN9581) in left arm on an unspecified date at 08:00 AM at dose 1, single for COVID-19 immunization. The patient did not had COVID prior vaccination. The patient had not tested for COVID post vaccination. The patient had no other vaccine in four weeks. The patient stated that she experienced severe vertigo, severe vomiting x 4 hours on 25Mar2021 08:00 AM (This was one month after Vaccine 2), went to an ENT after 2 weeks as she continued to have dizziness, light-headedness when changing position from lying to sitting to standing, turning in bed, turning my head, especially to the right, losing my balance when walking or even standing still. ENT diagnosed with Vestibular Neuritis. Patient had not been sick for more than one year and have never been diagnosed with this. After taking Prednisone for one week symptoms improved but have not disappeared. Patient continued to suffer from vertigo, tinnitus, clogged ears, dizziness, light-headness, unable to turn/sleep on right side. Went to an ENT that specializes in vertigo on 08Jul2021. After doing Epley manuver, little improvement so far. After reading about the many cases of people who have Vestibular Neuritis after COVID or the vaccine, patient decided to report her symptoms. The AE resulted in Doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the adverse events medications included Meclizine, Zofran, prednisone. The clinical outcome of the events was recovered with sequelae (Recovered with lasting effects) on an unspecified date in 2021.
Difficulty breathing (wheezing). Fever, paleness, weakness, dizziness Dipharia, severe body aches.
Sore at injection site; This is a spontaneous report from a contactable consumer (patient herself). A 66-year-old non-pregnant female patient received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot/batch number and expiry date were unknown), via an unspecified route of administration in the left arm on 06Jan2021 15:30 at a single dose for COVID-19 immunization. The patient was vaccinated in a doctor's office/urgent care. The patient's medical history and concomitant medications were not reported. The patient did not 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. The patient is not pregnant at the time of vaccination. On 06Jan2021 16:00, the patient experienced sore at injection site with outcome of recovered on unspecified date in Jan2021. The patient did not receive treatment for the reported event. The case was considered non-serious.  Information on the lot/batch number has been requested.
Patient was alert/responsive throughout.  Several minutes after vaccine administration, patient lost balance and fell.  She tried to get up, but was unable.  She was helped to her feet and walked to a chair.  En route, patient's legs became weak and she was laid on floor.  After several minutes, she was helped to her feet and sat in chair with head down and warm cloth on her head.  Left pharmacy 17:00 under parental supervision.  Complained of warmth and nausea.  19:00 mom reported chills/fatigue.  21:00 patient reported arm weakness but ok.  Patient returned to work 11/29/2003, complained of injection site soreness only.
Numbness and tingling in arm for 1 1/2 wks. Also had significant amount of pain for > 1wk. Unable to lift arm.
Patient complained feeling faint and felt like she was going to pass out. Patient was observed to have heavier breathing than normal. She also complained of numbness in her left arm. EMS was activated immediately. Patient's blood pressure was 51/38 mmHg . Oxygen was measured at 99 % Sp O2, PRbpm 45. Emergency contact for patient was notified. EMS arrived and took over. Patient returned hours later to pharmacy to informed us she was okay. She was told she had experienced vasovagal syncope.
This spontaneous report was received from a licensed practical nurse and refers to an unspecified number of patients of unknown age and gender. The patients' pertinent medical histories, drug reactions or allergies and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of VAQTA injection, lot # M011116, expiration date 17-JUN-2017 (dose, route and site of administration were not reported). No adverse effects were reported. Product quality complaint was not involved. The administered doses of VAQTA were stored in the temperature of 13.98 degrees Celsius for 10 minutes and in the temperature of 10.58 degrees Celsius for 10 minutes. Data logger was involved. There were no previous temperature excursions reported. At the time of reporting, there was no further information to provide. This is one of four reports received from the same reporter. Additional information has been requested.
vaccinated 12-23-2020 on 12-25 had sore throat, cold symptoms and 12-29 fever and aches then tested positive for COVID
Body ache; redness (AE) between the elbow and the arm pit.; tenderness in arm; Patient reports it was administered in the fatty part of the back of her left arm (AE: Vaccine Administered at Inappropriate Site).; Fever; large lump(AE) , between a golf ball and a baseball size on the left arm/swollen (AE) between the elbow and the arm pit; This non-serious case was reported by a consumer via call center representative and described the occurrence of swelling arm in a 51-year-old female patient who received Herpes zoster (Shingrix) (batch number Y77XY, expiry date 21-AUG-2024) for prophylaxis.   On 23-AUG-2023, the patient received the 1st dose of Shingrix (left arm). On 23-AUG-2023, an unknown time after receiving Shingrix, the patient experienced vaccine administered at inappropriate site (Verbatim: Patient reports it was administered in the fatty part of the back of her left arm (AE: Vaccine Administered at Inappropriate Site).). On an unknown date, the patient experienced swelling arm (Verbatim: large lump(AE) , between a golf ball and a baseball size on the left arm/swollen (AE) between the elbow and the arm pit), general body pain (Verbatim: Body ache), fever (Verbatim: Fever), erythema of extremities (Verbatim: redness (AE) between the elbow and the arm pit.) and pain in arm (Verbatim: tenderness in arm).  The outcome of the swelling arm was resolved (duration 4 days) and the outcome of the general body pain and vaccine administered at inappropriate site were unknown and the outcome of the fever was resolved (duration 24 hrs) and the outcome of the erythema of extremities was resolving and the outcome of the pain in arm was not resolved.   It was unknown if the reporter considered the swelling arm, general body pain, fever, erythema of extremities and pain in arm to be related to Shingrix.     It was unknown if the company considered the swelling arm, general body pain, fever, erythema of extremities and pain in arm to be related to Shingrix.   Additional Information: GSK receipt date: 28-AUG-2023 The reporter was the patient . The patient reported it was provided at a clinic at a local pharmacy.  The patient reported it was administered in the fatty part of the back of her left arm, which led to vaccine administered at inappropriate site. The patient reported a large lump,  between a golf ball and a baseball size on the left arm.  The patient reported the lump started 12 hours after injection.  It last 4 days but the swelling has decreased .  The patient reported it was still tender.   The patient reported redness and swollen between the elbow and the arm pit.  The patient reported it was mostly gone, now (at the time of reporting). The patient reported body aches and fever.  The reporter consented to follow up.
Very loud shrill cry for 3-4 hrs; thrashing around for 6-8 hrs, fever 103 x 24 hrs;
Information has been received on 9/20/02 from a health care professional concerning a 15 year old male patient who was vaccinated with first dose of Td (lot number U0381AA) IM in the left deltoid and second dose of MMR (lot number 1480L) SQ in the right arm. No date of vaccination was provided. It was reported that 5 minutes after the vaccination, patient complained of feeling sick and slumped in chair, had petit mal seizure for 3-4 seconds and was unresponsive on the floor. Oxygen started at 2L/min via mask. Epinephrine was given SQ in the right arm. Vital signs: blood pressure - 100/60, pulse - 60, respiration 28. Ambulance arrived 10 minutes later to transport patient to the ER. Patient was stable. Diagnosed with vasovagal response. From additional info received on 9/29/03 from a telephone conversation with the reporter, the telephone number and fax number for the responsible physician was provided. The reporter stated that "the original info on the VAERS, other than the physician bio, was all they have regarding each individual adverse event case." She also stated that the five immunization clinics under public health stopped giving TD with MMR as policy and have not seen reactions as reported herein. The adverse event coding was updated. No further info is anticipated, this case is closed.
COVID-19 Treatment; COVID-19 Treatment; Vaccine dose number=1, vaccine dose number=2: Moderna, Vaccine dose number=3, vaccine dose number=4: Pfizer; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 22Jun2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 21Jan2021 as dose 1, single (Batch/Lot number: unknown) and on 24Feb2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "MS" (unspecified if ongoing); "High BP" (unspecified if ongoing), notes: high bp; "Thyroid (hypo)" (unspecified if ongoing), notes: Thyroid (hypo). No known allergies. The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 04Sep2021, outcome "unknown", described as "Vaccine dose number=1, vaccine dose number=2: Moderna, Vaccine dose number=3, vaccine dose number=4: Pfizer"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2022, outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Sep2022) Positive, notes: Day 0-9 tested positive; (Sep2022) Negative, notes: Day 10 tested negative; (Sep2022) Positive, notes: Day 11 tested positive. Therapeutic measures were taken as a result of drug ineffective, covid-19; Paxlovid was received since 08Sep2022 to 12Sep2022. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
muscle pain, joint pain, headache, chills, fatigue, pain at injection site, temp 99.4
This spontaneous report as received from a nurse refers to a patient of unknown age and gender> The reporter stated that on 25-JUN-2014 the patient was vaccinated with expired PROQUAD (Merck) (lot # H021358, expiration date: 29-MAY-2041, dose, units, anatomical location, route of administration were not reported). No adverse effect has been observed. This is one of several reports from the same reporter. Additional information has been requested.
This spontaneous report was received from a certified medical assistant and refers to a 10 week old, female patient. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 26-APR-2016 at 18:16, the patient was vaccinated with improperly stored first dose of ROTATEQ lot# L033543, expiry date 30-MAY-2017, orally (dose was not reported). No adverse symptoms were reported. The patient had no illness at the time of vaccination. Administered vaccine experienced temperature excursion of 34 degrees Fahrenheit for a total time of 65 hours. There was no previous temperature excursion. Digital data logger was not involved. This is one of several reports received from the same source. Additional information is not expected, as all scheduled correspondence was received.
11/26/2021 After my booster shot, I had arthralgia all over my body and issues with both of my hands from an arthritis flare up and I managed the pain with Ibuprofen. The inflammation had caused great pain in my hands. I did reach out to my cardiologist and they stated that a lot of people have gotten a lot of side effects due to the vaccine. I am going to be seeing a rheumatologist soon since my arthritis has gotten worse. I am still experiencing pain that is much more tolerable than the first few vaccines. I was unable to utilize my left arm for a while as well due to pain and soreness.
Within 15 minutes, felt extremely tired.  This was the same response when taking the 1st shot,  however, it didn?t seem as bad.  After waiting 30 minutes, began driving home, but within 10 minutes, began to feel like heart was racing, and whole body was kind of numb feeling.   I did check heart with  my watch  which only showed 89bpm.  After another 10 minutes, I arrived home, and I was shaking uncontrollably and my hands and feet were cold. Temp was only 97.4.   After another 20 minutes, the symptoms all went away.
Received a flu shot at 10:15 am on 10/11/17. At approx. 12:30 pm felt lightheaded with tingling in left arm, hand and middle fingers. Reported hand was splotchy. Took 2 ADVIL tabs and approx. 30 min later she felt better. Wellness nurse returned to clinic at 3:15 pm for welfare check. BP 114/76, pulse 84. No swelling, redness noted at injection site. No puffiness or splotches noted on left arm or hand.