chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Donor had 4th shot on 5/9/06. Donor called on 5/10/06 and reported that she had red whelps where her shots were given and that she is running a fever 101, having chest pains and feeling achy all over. Advised donor to go to the ER immediately.
My left arm aches along with my lymph nodes in my armpit and chest. I have a headache.
I woke up at 1 am the next morning with the chills which turned into a fever of 100-103 which lasted for the next 3 days. I could barely stand and eat for the following day. I woke up on Thursday morning with half of my throat swollen. The next day, the other half of my throat was swollen as well. My throat was covered in pus and was visibly swollen.
devel hives, phlegm in throat contacted own personal MD by phone called prescription for DPH;all sx resolved 10/7/99;
This is a spontaneous report from a contactable RN called on behalf of the provider at a doctor's office. A 85-year-old patient of an unspecified ethnicity and gender received PREVNAR 13 Lot R33239; Expiry Date 31Mar2018, via an unspecified route of administration on 16Feb2017 at 0.5 ml, single in Deltoid Right for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced rash around the injection site on the right shoulder on 21Feb2017 with outcome of unknown.
This spontaneous report was received from a physician via a company representative and refers to a 65-year-old male patient. No information was provided regarding the patient's concomitant medications, pertinent medical history and drug reactions or allergies. On 30-AUG-2013, the patient was vaccinated with ZOSTAVAX injection (dose, route of administration, lot number and expiration date were not reported), to prevent shingles. On 25-MAY-2017, the patient developed the shingles. He developed a rash on his forehead and into the right eye area, which caused the eye to swell, impairing his vision. The eye was not directly affected. The patient sought medical attention and was treated at an ophthalmologist's office (details not provided). No product quality complaint (PQC) was involved. The outcome of the events was not recovered at the time of this report. The causality assessment between the events and ZOSTAVAX was not provided. Additional information has been requested.
Vaccinated with Tdap on 10/31/06 and within a few hours begin to have flu-like symptoms and soreness in arm. Pain in arm gradually got worse with swelling, erythema and induration at injection site. Had some slight decrease in ROM from pain and numbness and tingling in arm. Recommend OTC Ibuprofen and cold compress for pain relief. Dsecribed s/s of systemic allergic reaction that require emergent medical attention.
Initial reaction was pain, redness and swelling at the injection site which lasted 10 days. Several days later, after the injection,  I woke up and had the most severe pain in my groin on the left side. For two days I could not walk. I tried ice, muscle cream and Advil, but the pain would not go away. On the third day I felt better and by the fourth day, I had no pain in the groin.
On the morning of 10/27/2022, I was alone in my son's home, just sitting on the sofa, looking at my phone, when I developed sudden, crushing chest pain. I was having trouble breathing, I was sweating, and I had pain in my neck and into my throat. When I finally got on the phone with 911, I was having trouble talking due to the chest pain. The ambulance and two other rescue groups came. They treated me as if I were having a heart attack and gave me baby aspirin. They transported me to the emergency room. My blood pressure was going very high. The chest pain subsided in around 45 minutes, but they kept me over night and wanted to do either a stress test or catheterization. When my EKG changed, they decided to do the catheterization. My blood pressure at that time was 220 over 110. I wanted to go to a different hospital because I had been to one before for catheterization. I was flown by helicopter to that hospital. At 06:00PM on 10/27/2022, I had the catheterization done. My left anterior descending artery was completely blocked, and they were able to get a stint in and open it up. My blood pressure became normal once they opened up the artery. I stayed in the hospital overnight and stayed in that state for a few more days before driving to my home state to begin a cardiac rehab program, which I just finished.
This case was reported by a nurse via call center representative and described the occurrence of injection site lump in a 17-year-old female patient who received BEXSERO) (batch number 16G101, expiry date 31st May 2019) for prophylaxis. On 15th June 2018, the patient received the 1st dose of BEXSERO .5 ml. On an unknown date, several days after receiving BEXSERO, the patient experienced injection site lump, injection site pain, erythematous rash and mass. On an unknown date, the outcome of the injection site lump, injection site pain, erythematous rash and mass were recovered/resolved. It was unknown if the reporter considered the injection site lump, injection site pain, erythematous rash and mass to be related to BEXSERO. Additional information was reported as follows: The patient developed a apple sized lump at the injection site. The injection site lump lasted for two weeks, however it was painful for four weeks. The patient also stated that she had red rash on her left shoulder and neck. She also developed three lumps in the area between the shoulder and her neck. All the symptoms started a couple of days after the injection.
stiffness; soreness; numbness; tingling; his skin feels sensitive to touch in both arms; This case was reported by a pharmacist via call center representative and described the occurrence of stiffness in a 66-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number GA5Z5, expiry date 3rd May 2020) for prophylaxis.   On 12th December 2019, the patient received Boostrix. On an unknown date, less than 2 months after receiving Boostrix, the patient experienced stiffness, pain, numbness, tingling and touch sensitivity increased. On an unknown date, the outcome of the stiffness and pain were unknown and the outcome of the numbness, tingling and touch sensitivity increased were not recovered/not resolved.   It was unknown if the reporter considered the stiffness, pain, numbness, tingling and touch sensitivity increased to be related to Boostrix.  Additional details were provided as follows: After receiving Boostrix, the patient experienced the patient experienced stiffness and soreness.  The patient was also had numbness and tingling below the injection site which he also was experiencing in his left arm.  The patient's skin felt sensitive to touch in both arms. The reporter was consented to follow up.
Pt vaccinated with DTP developed febrile seizure, turned purple, got stiff, r/o early otitis media, r/o seizure.  Shortly /p shot child became limp, purple-no seizure noted
Syringe had a crack in it where it connected to the needle and the vaccine leaked out onto patient's arm instead of being administer. Patient was then given another dose because the patient received very little if anything at all of the initial dose
The patient received a 0.25mL booster dose of the Moderna COVID vaccine on 1/6/22 that had actually been drawn up the day prior and was therefore expired by 1/6/22. No side effects noted.
Muscle soreness at the administration site began almost immediately after vaccination and got worse as the day went on. It was still present, but milder the next day, and completely resolved on day 3 after vaccination.  Approximately 100 degree fever, chills, and headache started around 6 hours after vaccination and lasted for at least 7 hours until bedtime. Woke up during the night with sweats. The fever, headache, chills and sweats were gone upon waking up the next morning.  Around bedtime that same night on the day of vaccination, throat began mild aching. The mild aching progressed into a sore throat the next day with swollen tonsils and neck lymph nodes. The swelling and pain steadily got worse until the 5th day of symptoms, when the swollen lymph nodes also ached. On day 6 (today), the pain and swelling are marginally less than the previous day, but it is yet unclear if this indicates a trend to recovery. The pain and swelling fluctuate throughout the day and respond well to NSAIDs.
MENTAL CONFUSION, ELEVATED BP, UNABLE TO COMMUNICATE VERBALLY, CHILLS, NAUSEA, DIZZINESS, UNSTEADY,
CONSTANT HEADACHES AS LONG TERM SIDE EFFECTS; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on NOV-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced constant headaches as long term side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from constant headaches as long term side effects. This report was non-serious. This case, from the same reporter is linked to 20211258623.
I have suffered with abdominal bloating, I had pain at the beginning but not much pain with it my stomach is just distended.  My stomach feels crampy on and off. I saw my PCP  and she ordered an abdominal X-Ray and results came back normal.
This spontaneous report as received form a Licensed Practical Nurse refers to a patient of unknown age. On an unknown date the patient was vaccinated with an expired dose of ZOSTAVAX (route, dose, lot number and exp date were not reported). Additional information is not expected.
Arm became stiff, sore, painful, and red at site of injection. A few hours after receiving the injection the redness started spreading, a hard lump formed under the skin, it was hot to the touch, and  a rash developed that is very itchy. The next day it spread more, the lump getting larger as well. As of today, 7/21/2021 the redness has continued to spread and it?s about 2.5-3.0 inches by 2.5 inches. The site itches, is still hot to the touch, has a large lump, is painful, and tingles. I also have neck/shoulder stiffness on the same side of the injection. The day after my vaccination I had flu like symptoms; a fever, complete body aches and joint pain, drowsiness, headache, and overall ill feeling.
Progress Notes APRN (Nurse Practitioner) ? ? Infusion Center Cosign Needed Expand AllCollapse All    COVID VACCINE CLINIC 3/16/2021    Patient:                                                                        DOB:   Date:  3/16/2021                                                                                           MRN:     Subjective Patient is a 34 y.o. female who was seen at COVID Vaccine Clinic today for her second  dose of the COVID 19 vaccination.    She was given the Pfizer vaccination in the left deltoid muscle.   During her 15 minute waiting period after the injection, the patient began to experience lightheadedness.  She denied rash, hives, shortness of breath   This provider was notified of patient reaction and she was then assessed in the emergency bay area.   Monitored patient for severe reaction symptoms, including but not limited to blood pressure abnormality  and chest pain, SOA, rash. Pt felt light headed, diaphoretic   PMH of vaso vagal syncope. No event with Dose #1 of 2     ALLERGY REVIEW OF SYSTEMS:  Patient complains of chills and ear popping   Patient denies facial swelling, ear pain and runny nose       Previous Reactions: vasovagal syncope    Objective    Vitals Vitals:   03/16/21 0926 BP: 98/55 Pulse: 68 SpO2: 100%            Physical Exam Constitutional:      Appearance: She is diaphoretic.     Comments: In chair, pale, diaphoretic, hyperventilating  HENT:     Nose: Nose normal.     Mouth/Throat:     Mouth: Mucous membranes are dry.  Cardiovascular:     Rate and Rhythm: Normal rate.  Pulmonary:     Effort: Pulmonary effort is normal. No respiratory distress.     Breath sounds: Normal breath sounds.  Musculoskeletal:        General: Normal range of motion.     Cervical back: Normal range of motion.  Skin:    Capillary Refill: Capillary refill takes less than 2 seconds.     Coloration: Skin is pale.  Neurological:     General: No focal deficit present.     Mental Status: She is alert.     Motor: No weakness.  Psychiatric:     Comments: Anxious, hyperventilating.     PMH "vasovagal syncope". No issues with Dose #1 of 2. Pt pale, diaphoretic and hyperventilating. Initial BP 98/55-HR 68. Pt provided water, ice pack to base of neck and placed supine   BP improved 10 109/68. HR 70. Pt sat 45 degrees x 10", became light headed again. BP 97/60. HR72/min. Returned to supine position, encouraged to eat granola bar. Position change after 45"observation: BP 11/74. HR 74/min. Pt discharged ambulatory without event    Assessment/Plan  Treatment included: snacks, prolonged observation and slow position changes Follow up response to treatment: excellent. Patient discharge: Stable to go home and follow up with PCP.  Differential Diagnosis: Vaccine-Related Anxiety (include misc mental health) Ddx: Vasovagal response       APRN Electronically Signed 3/16/2021 9:28 AM
Hospitalization involving some serious health conditions; blood clot removed from legs; second dose has passed over 28 days; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HOSPITALISATION (Hospitalization involving some serious health conditions) and THROMBOSIS (blood clot removed from legs) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Cardiac transplant in 2004. Concomitant products included TACROLIMUS and MYCOPHENOLATE MOFETIL (MYCOPHENOLATE) for Prophylaxis against heart transplant rejection, APIXABAN (ELIQUIS) for Thrombosis prophylaxis.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HOSPITALISATION (Hospitalization involving some serious health conditions) (seriousness criterion hospitalization), THROMBOSIS (blood clot removed from legs) (seriousness criterion medically significant) and PRODUCT DOSE OMISSION ISSUE (second dose has passed over 28 days). The patient was treated with Surgery (blood clot removed) for Thrombosis. At the time of the report, HOSPITALISATION (Hospitalization involving some serious health conditions) and THROMBOSIS (blood clot removed from legs) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (second dose has passed over 28 days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information not provided.  It was reported that, the patient missed an appointment for his second dose due to hospitalization involving some serious health conditions. The patient was in the hospital for extended period and underwent surgery to get blood clot removed from legs during the hospitalization.  Very limited information has been provided for the event at this time. However, details of hospitalization and compliance with anti-coagulant therapy is required for further evaluation. This report also This report refers to a case of product dose omission issue for mRNA-1273, lot # unknown with no associated AEs.; Sender's Comments: Very limited information has been provided for the event at this time. However, details of hospitalization and compliance with anti-coagulant therapy is required for further evaluation. This report also This report refers to a case of product dose omission issue for mRNA-1273, lot # unknown with no associated AEs.
190 patients (9 different lot numbers) received a vaccine past the beyond used by date; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (no adverse event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date).    No concomitant medicine were reported. No treatment medicine were reported. This case was for 19th out of 190 patients reported.   This case was linked to MODERNATX, INC.-MOD-2023-704335 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  MODERNATX, INC.-MOD-2023-704335:MASTER  CASE
patient may have received a dose / that was incorrectly reconstituted with sterile water; patient may have received a dose / that was incorrectly reconstituted with sterile water; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 11-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA379A, expiry date 31st July 2022) for prophylaxis.   On 19th May 2021, the patient received the 1st dose of Menveo. On 19th May 2021, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The patient received menveo that was incorrectly reconstituted with sterile water, which led wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. No symptoms were reported. There were 3 possible patients, but the health care professional was not sure which 2 received the incorrectly reconstituted doses. The reporter consented to follow up. This case was linked case US2021111533 and US2021111535 reported by the same reporter. The batch number was reported as AMXA379A for Menveo which was updated to AMVA379A as per sales data sheet.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021111535:Same reporter US-GLAXOSMITHKLINE-US2021111533:Same Reporter
LYMPHOMA LEFT SIDE SWELLING EYE EAR AND NECK OPHTHALMOLOGIST MRI
at about 3am (15 hours after vaccinated), I had the chill, I was freezing from the shoulder down. I had to put on 2 coats and 3 blankets because I was shaking/tremoring. also, headache and body ache. I whole body is hot and my back felt weak. the chill was more apparent toward the night.
No additional adverse effect reported; Physician called to report a 5 year old patient received GARDASIL 9 inadvertently.; This spontaneous report was received from a physician and refers to a 5-year-old patient of an unknown gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On 27-AUG-2020, the patient was inadvertently vaccinated with the HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) lot number reported as 5023475 but upon internal validation was confirmed to be valid as S023475, expiration date 26-MAR-2022 (exact dose, route and site of administration were not provided) for prophylaxis. No additional adverse effect was reported.
Information has been received from a RN concerning a 70 year old female who was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. The RN reported that, immediately after being vaccinated, the pt developed erythema and swelling at the injection site. The pt was subsequently sent home with ice as treatment. The following day, the pt returned to the physician's office and a diagnosis of cellulitis was made. At the time of this report, the outcome was unknown. Additional information has been requested.
Gout flare up within several hours after the second dose. Peak of flare up was about two days after I received the second dose.
Patient received Moderna Covid vaccine on. 4/26/2021 approximately at 10:30am. After  10:00 am the next day, 4/27/21. Patient said he went to the restroom and noticed dark red clots in his urine. Patient took a picture which is on his phone. Patient says he has some discomfort in the lower left pelvic area. Patient stated that he has the urge to use the restroom to urinate more frequently.  I advised the patient to see a doctor right away for diagnosis.
Patient presented  about a week after her vaccine  for erythema and heat, no fever or other symptoms.   She was treated with Keflex x 5 days to cover for cellulitis.  She then return to clinic on her 5th day of antibiotics with nearly unchanged presentation. She states there are no symptoms at this time.
Shot on Tues-started  with headache on Fri and pain in left arm to neck-chest  pain and light headed started on Sat  to Hosp  on Mon-transferred  to hospital with symptoms of  high B/P  angiogram and ultra  sound  of liver, gall bladder and pancreas was normal. Took 6 wks  till previous health returned.
Expired vaccine administrated to patient. Vaccine expired on 4/4 and administered 4/5
Systemic: Patient reported at day of receiving 2nd dose. Had inflammation of lymphs of left arm. ER doctor treated and advised patient to still receive 2nd dose.