chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Covid Arm; Swelling at the site of the injection; rash at the site of the injection; A spontaneous report was received from a consumer concerning mother, who is a 92-years-old female patient received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events covid arm, swelling at the site of the injection, rash at the site of the injection.  The patient's medical history was not provided. Concomitant medications reported were hydrocortisone ointment, metoprolol, apixaban, atorvastatin, omeprazole, clonazepam, gabapentin, tramadol, vitamin b complex, preservision ared 2 for drug use for unknown indication.  On 5 Mar 2021, prior to the onset of the events the patient received second of two planned doses of mRNA-1273 (lot/batch: 040A21A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the events covid arm, swelling and rash at the site of the injection.  Treatment information was not provided.  Patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in response to the event was not applicable.   The outcome of event covid arm, swelling at the site of the injection, rash at the site of the injection was unknown.
Pt recvd vax & contracted mumps following vax w/MMR/DTP; no further detials were provided;
First noted 2 small red bumps 3/29/14. Developed into red round patch which became hard and warm to touch, over next 24 hours. Seen in office 3-30-14. No treatment needed.
Hospitalized;  COVID-19 positive (8.27.21) - after being fully vaccinated   Discharge Provider:  Primary Care Provider:  Admission Date: 8/27/2021 Discharge Date: 8/31/2021 DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Acute cystitis without hematuria  Sepsis, due to unspecified organism, unspecified whether acute organ dysfunction present  COVID-19  Sepsis due to COVID-19    HOSPITAL COURSE:   Patient is 80-year-old male past medical history significant for hypertension, AFib/flutter on Eliquis, coronary artery disease/PCI, systolic heart failure, history of CVA-right-sided residual weakness and macular degeneration presents to the hospital on 08/27 from assisted living facility due to cough, RUQ pain, chest pain and positive COVID test at the facility on the day presentation.  Patient was brought in for monoclonal antibodies which he received in ER.  When they were ready to discharge him back to assisted living, it was decided to get a urinalysis which showed urinary tract infection even though he did not have any symptoms and hence antibiotics were started and admission requested. Chest pain/right upper quadrant pain, unclear etiology.  EKG without any acute changes, troponins was borderline elevated, was felt to be at baseline.  Chest x-ray was negative for any acute disease. COVID-19 infection.  Patient without any symptoms however did have SIRS POA (tachypnea, leukopenia) which was more attributable to urinary tract infection than COVID-19.  He did not need any oxygen.  Received monoclonal antibody in ER.  Did not need dexamethasone or remdesivir. Urinary tract infection:  This was done at the request of daughter, was found to be positive however patient did not provide any symptoms, is also true that patient is a poor historian.  Admitted and received 5 days of Rocephin, cultures did not grow anything.  Renal ultrasound was negative for hydronephrosis.  Postvoid residuals were negative as well. PT/OT recommended subacute rehab.  History of CVA with residual right-sided weakness.  Patient also with chronically poor oral intake and has been a struggle recently per daughter.  Patient is on Eliquis for anticoagulation.  Patient is do not resuscitate per daughter with a DPOA Consultations: None Procedures: Right upper quadrant ultrasound negative Renal ultrasound negative Cause of sepsis on admission was UTI
PT ADMINISTERED SMALLPOX AND HE DID NOT NEED IT.  PT WAS VACCINATED IN SEPTEMBER 2008 WITH SMALLPOX.
Three days after receiving started with hives, they last one day and went away. Pt left with a reddened one inch around hard spot. Advised to use warm moist soaks, and motrin and to call back if worsened.
headache, joint pain, chills, swollen lymph gland (right armpit), low grade fever, fatigue, insomnia
Patient had a form of syncope about 10 minutes after receiving vaccination. after getting up she complained of nauseousness and was pale and generally not feeling well.
Injection arm is sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Injection arm is sore) in a patient of an unknown age and gender 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,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (Injection arm is sore). At the time of the report, VACCINATION SITE PAIN (Injection arm is sore) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided. Treatment information was not provided.
A few hours after my vaccination I felt very fatigued and had a headache and the next morning after I woke up, I had severe flu like symptoms such as: sore throat, body ache, headache, fatigue and had a fever of 101 and the following day I still had the same symptoms and had swollen lymph nodes in my neck and these all lasted for 2 days. I did not take anything; I just rested and drank a lot of fluids. It took me a total of 3 and a half days to recover.
Patient returned 2/29/16 to pharmacy with red, swollen arm - heat and pain reported by patient - redness approximately 6-8 inches across.
The patient received the Janssen vaccine on 5-29-21 and had previously well controlled asthma. The patient presented to ED on 6-1-21, 6-13-21, 6-28-21, and 7-19-21  with acute asthma exacerbation. On 7-21-21 the patient was admitted into the ED and later ICU with cardiac arrest related to asthma acerbation and pronounced deceased on 7-25-21.  Symptoms: - Wheezing -Shortness of breath - Onset following the day after vaccine administration  Treatments: - Albuterol/ipratropium nebulizers - Prednisone -Albuterol inhaler
This spontaneous report was received from a health professional refers to a patient of unknown age and gender. The patient's medical history and concomitant medications were not reported. On 07-JUL-2016, the patient was vaccinated with VAQTA (lot # L015460, expiry date: 20-JUL-2017) for prophylaxis (dose and route was not reported), which was stored improperly.
Fever over 105 for days, non-stop crying, vomiting, rash. He developed seizures and Lennox Gestaut Sydrome. He is 4 right now but has daily seizures. Seizures varies between 20-100 per day, including drop, infantile spasms, tonic clonic. He also has autism.
received the second shingles shot, residual itching from getting it/suspected vaccination failure; getting it; itching; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pruritus. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the vaccination failure, shingles and pruritus were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pruritus to be related to Shingles vaccine and Shingles vaccine.  Additional details were reported as follows: The case was reported by patient's friend. Age at vaccination was not reported. The 1st vaccine which eventually proved to be about 30 percent effective.  After getting the shingles the patient received the 2nd shingles shots and had residual itching from getting it (shingles), not pleasant. The reporter also said people, get their vaccinations This case was considered as suspected vaccination failure as details regarding time to onset and laboratory confirmation were unknown at the time of reporting. No contact details were available. For tolerance in 1st dose refer case US2021AMR187058.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR187058:same reporter
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. Information about concurrent conditions and medical history was not provided. On 15-OCT-2014 the patient was vaccinated with an expired M-M-R II lot # H018181, dose 0.5 ml, expiration date 05-OCT-2014, route subcutaneous. Co-suspect and concomitant therapies were not reported. No adverse effects were reported. Additional information is not expected because the reporter did not want to be contacted.
I have a bleeding disorder; bruising after my second shot; I have little red dot all over the part of my hands; dizziness/ I became extremely dizzy; This is a spontaneous report from a consumer (patient) via a Pfizer sponsored program COVAX US support. A 53-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EW0217, Expiration date: not reported, Age at vaccination: 53-year-old) via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021, patient experienced bleeding disorder, legs, my arms and my torso broke up in bruises/ broke out with bruising, little red dot all over the part of my hands and dizziness/dizzy. She got her first dose back in June and she has bruising all over her legs, her arms and her torso. She got that a week after she got her first vaccine (Later consumer clarified consumer got bruising after the second shot) and on the second dose all she got was dizziness. She had a bleeding disorder (Further clarification was unknown if consumer had bleeding disorder after getting the vaccine or not) and she was on a blood thinner (Intent: treatment). Her doctor thought, it is best that she get the shot, within one week after taking both shot, on the last shot that we got afterwards (Further clarification was unknown) her legs, her arms and her torso broke up in bruises and she had little red dot all over the part of her hands. Consumer stated, The second dose EW0196 (Clarified as LOT#). Consumer stated, It is 09May1968 (Not clarified). So she broke out with bruising after her second shot. Also after the second shot she became extremely dizzy. Patient stated, So you want people started dying started having this side effect which they already are, the place where I work, most people are having the same bruising. The outcome of events was unknown.  Follow-Up (23Aug2021): Follow-up attempts are completed. No further information is expected.
could not stand on her feet.; severe dizziness; the dizziness was so bad that she could not walk short distances inside the house (from the kitchen to the bedroom); This is a spontaneous report from contactable consumers (one is patient's husband). A 73-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 07May2021 (Lot Number: EW0167) at 73 years old as single dose for covid-19 immunisation.  Medical history included thyroid, glaucoma, heart, blood pressure and vertigo. Concomitant medication(s) included ongoing amlodipine besilate taken for Blood pressure; ongoing levothyroxine sodium taken for thyroid; ongoing atenolol taken for heart; ongoing latanoprost taken for glaucoma. The patient previously took flu vaccine over 20 years ago and she got like hot, like hitting herself, like her head was burning; took the pneumococcal vaccine, maybe 3-4 years ago. 2 days after (8May2021) the patient received the vaccination she started to feel severe dizziness, the dizziness was so bad that she could not walk short distances inside the house (from the kitchen to the bedroom).  Patient stated this began on 08May2021 around nighttime, says it was not too much. The following day was really crazy, said she never felt anything like this before. She has had vertigo, but never this kind of dizziness, she experienced this for two or two-and-a-half days. It started about day-and a-half after the vaccine for two days. Patient stated the dizziness was gone, but may have lasting effects, she was not sure. What she went through those two days, she thought she was dying and could not stand on her feet. No emergency room or physician office visit. The patient had to see the doctor for a year because of her thyroid, he made her take a blood test to see if the thyroid was working properly. The outcome was unknown.
Patient was given Covid-19 vaccination and 5-10 mins later patient had a seizure. Appeared to be an absent seizure and came to after about 3-5 mins. Patient was sweaty and clammy to the touch. EMS was called and took over. Patient did not fall and was breathing at all times.
hives; Initial information received on 28-Sep-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 88 years old male patient who experienced hives after receiving vaccine influenza quadrival A-B high dose HV vaccine [fluzone high-dose quadrivalent].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date in 2022, the patient received a 0.7 ml dose of suspect influenza quadrival A-B high dose HV vaccine (lot number, strength, expiry date and form not reported) via unknown route in unknown administration site as immunization.  On an unknown date in 2022, the patient developed hives (urticaria) (unknown latency) following the administration of influenza quadrival A-B high dose HV vaccine.  It was reported "A Clinic wanting to know is there any protocol for administering the FLUZONE Quadrivalent High-Dose in two doses a week apart due to having an 88-year-old male consumer being told that after having the FLUZONE Quadrivalent High-Dose and getting hives, last year, to break the dose in half next time one-week apart."  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.
I have continually suffered from severe aching legs above knees on both legs; This is a spontaneous report from a contactable Other HCP(Patient). A 55-years-old non pregnant female patient received second dose of bnt162b2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EL9269), via an unspecified route of administration on 11Feb2021 at 10:30(at the age of 55-years-old) into left arm as a single dose for COVID-19 immunization. The patient had received first dose of bnt162b2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EL1283), via an unspecified route of administration on 12Jan2021 at 10:30 am (at the age of 55-years-old) into left arm as a single dose for COVID-19 immunization. Medical history included arthritis reactive from an unknown date and unknown if ongoing. Concomitant medication(s) included Estradiol. The patient previously took iodine and experienced iodine allergy. On 12Feb2021 at 03:00 AM, Day after second dose the patient continually suffered from severe aching legs above knees on both legs. Hoped it would abate after a time, but it has not. Prior the vaccination, the patient was not diagnosis with COVID. Post vaccination, the patient was not tested for COVID. The patient did not receive any vaccine in four weeks. No treatment was received for the event. The patient was visited to Doctor or other healthcare professional office/clinic visit for the event. The outcome of the event was not recovered.
nurse practitioner reported localized reaction on the site of the Fluad and Pneumovax23 that they deemed possible cellulitis.
Patient was injected with Boostrix that had expired 08/30/2022, no adverse event at time of reporting
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. There was no information about patient's concomitant medications and pertinent medical history reported. On 28-APR-2017, the patient was vaccinated with an expired dose of PROQUAD, lot number L040411 with expiration date 13-APR-2017; the vaccine was reconstituted with sterile diluent, lot number reported as L015433 with expiration date 24-JAN-2018, (dose, route and anatomical location were not reported for the above products described) for prophylaxis. Additional information has been requested.
On the morning of the day after my Moderna I woke up with a very swollen red arm  at the  injection site which was tender and warm to touch. I also experienced left ear pain with a slight headache.
Patient received the second dose of the vaccine more than 36 days after the first dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the second dose of the vaccine more than 36 days after the first dose) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042021A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Jul-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the second dose of the vaccine more than 36 days after the first dose). On 02-Jul-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the second dose of the vaccine more than 36 days after the first dose) had resolved.            No concomitant medications were reported.  Treatment information was not provided by the reporter.
Usual process was not followed for verifying previously administered vaccines due to distraction; patient did not remember he had received flu vaccine in September, and an additional dose was given today by mistake
Information has been received from a registered nurse regarding a patient of an unknown age and gender. On 04-MAR-2013 at 18:00, ZOSTAVAX lot # H019999 was exposed to an exact T not recorded but noted as equal to or > 12C for an estimated total time out of range of 10.5 hours. On 12-MAR-2013 at 17:00, ZOSTAVAX lot # H019999 was exposed to -14C for an estimated total time out of range of 9.25 hours. On 13-MAR-2013 at 18:00, ZOSTAVAX lot # H019999 was exposed to -14C for an estimated total time out of range of 10.5 hours. On 25-APR-2013 at 7:35, ZOSTAVAX lot # H019999 was exposed to -14C for an estimated total time out of range of 14 hours. On 13-JUN-2013, the patient was vaccinated with an out of range dose of ZOSTAVAX (dose and route administration were not provided) (Lot number H019999). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
Skin around injection site bright red and warm to touch.  Onsent within 2 hr of injection redness peaking at 36 hr. At peak, redness measured 9 cm. Duration of redness 4 days. No treatment.
Patient experienced a hypertensive emergency on 8 APR, two days after receiving the vaccine. They were seen at the ER on 8 APR for the issue. An EKG at 0219 and AP chest X-RAY at 0235 were preformed. Patient was administered STAT Pantoprazole 40mg PO at 0158. Patient was discharged at 0411 on 8 APR.
I received the first shot of the Gardasil vaccine series on Friday, August 10 at 12:30pm. The nurse asked me to stay five minutes to see if I had any reaction to the vaccine, but I chose not to and left after I scheduled my second shot for October 5, 2007. A few minutes after I got in my car to leave, I started to feel strange and it felt as if my throat and tongue were swelling. It was not severe, but enough to make me question what was happening. I waited to see if it would subside, it did not, and 15 minutes later I took a Benadryl and that helped. After an hour of sleep, I felt fine. I just wanted to let you know about this experienced and I have called your office this morning to discuss with the nurse if I should proceed with the next two shots. I am waiting on a call back from the nurse.
died after hpv vaccine; HPV 16,11,18 (first vial tested and turn out to be positive); PQC Present: Yes; This spontaneous report was received from a consumer via social media referring to a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) (dose, route, lot# and expiry date were not reported) for prophylaxis. On an unknown date, the patient died after administration of quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL). It was reported that the first vial was sent to the reporter by the local paediatrician. The reporter tested the vial and was turned to be positive (Human papilloma virus test positive and product quality issue). Cause of death was unknown and it was unknown whether autopsy was performed. The outcome of papilloma viral infection and product quality issue was unknown. The reporter considered the event of death and human papilloma virus test positive as related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL). Causality assessment for product quality issue was not reported.  This is one of the several reports received from the same reporter.; Sender's Comments:  US-009507513-0807USA02497:Same reporter US-009507513-1609USA002149:Same reporter; Reported Cause(s) of Death: unknown cause of death
Fever to 102F (oral), approx 36h duration, with accompanying myalgias and chills and soreness at site of vaccine administration, all resolved without use of antipyretics
Information has been received from a physician concerning a 12 year old (also reported as 11 year old) female patient who on 28-OCT-1997 and 25-APR-2001, was vaccinated with the first and second doses of MMR II (HSA) respectively. On 05-DEC-2009 the patient experienced mumps. On 07-DEC-2009, the patient was diagnosed. The patient was afebrile and had left parotitis. On 07-DEC-2009, the first blood work was performed, with IgM <1:10, IgG 4.13 and serum amylase 162. At the time of the report, the outcome was unknown. No further information is available.
Injection site IMMEDIATELY felt hot, felt flushed from chest up to face, felt throat tightness, got tachypneic, tachycardic and lightheaded/weak. Throat tightness diminished after less than 30 seconds. I was immediately attended to. Was hypertensive 160/110's, pulse 140's, SPO2 100%. Less than five minutes later I developed uncontrollable generalized intermittent rigors. I was given IM Benadryl at that time. I was transferred to ED approximately 10min after initial reaction. Throat tightness came back again while in ED, EpiPen administered. PO Famotidine and 1L IV fluids given. Rigors diminished but lasted approximately two hours. I was observed in ED for four hours, felt well, VSS, was discharged home. Once home approximately six hrs post inoculation I developed more intense throat tightness, radiating to right jaw, no difficulty breathing. It resolved on its own in less than five minutes. Developed a mild headache the next day.