chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received via a company representative from a physician referring to a female patient over 65 years old. On an unknown date the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # L029113, expiration date: 27-MAR-2017, first dose, intramuscular, dose was unknown). On an unknown date the patient experienced fever, soreness, muscle tenderness, and extreme redness after receiving PNEUMOVAX 23. The patient sought medical attention via phone call or office visit for the events. The outcome of the events was reported as recovered/resolved. The causality between the events and PNEUMOVAX 23 was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
twitching arm spasms in the same are; severe headache; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE TWITCHING (twitching arm spasms in the same are) and HEADACHE (severe headache) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MUSCLE TWITCHING (twitching arm spasms in the same are) and HEADACHE (severe headache). At the time of the report, MUSCLE TWITCHING (twitching arm spasms in the same are) and HEADACHE (severe headache) outcome was unknown.            Concomitant medication information were not provided. Patient had severe headache off and on every day. No treatment information were given. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable.
localized pain & swelling site noted immed, felt like needle hit something, a buzzing feeling, like it filled something up;over 2 days was stable;48hr later noted pain in neck radiated down neck;dec strength & ongoing pain;
Severe eruption of infected, bleeding skin ulcers on face and chest (qty- 6-7).  Wound treatment revealed blood clots.  Increased in severity after second Moderna injection. Ulcers are being treated with antibiotics and are nearly, but not yet fully, healed 3 months later (August 2021).
Information has been received from a registered nurse concerning a 5 year old male with reactive airway disease (since December 2002), history of premature birth and no allergies who in January 2003, was vaccinated IM with a first 0.5 ml dose of MMR II and on 25-AUG-2007 was vaccinated IM with second 0.5 ml dose of MMR II (Lot# 656527/0285U). Concomitant therapy included albuterol as needed. On 25-AUG-2007, soon after vaccination the patient experienced hives on face, wheezing, dyspnea, chest tightness, swollen eyelids and erythema on face, hands and back. It was reported that the patient was immediately treated with Benadryl IM, Decadron IM, epinephrine IM and nebulizer treatment. The patient was also given prednisone and albuterol as needed. On 25-AUG-2007, after soon vaccination the patient experienced hives on face, wheezing, dyspnea, chest tightness, swollen eyelids and erythema on face, hands and back. It was reported that the patient was immediately treated with Benadryl IM, Decadron IM, epinephrine IM and nebulizer treatment. The patient was also given prednisone and albuterol inhaler. Flovent was later added as needed. It was reported that the patient did not experience any adverse event with first dose of the vaccination. No diagnostic laboratory test was undertaken. At the time of report the patient had recovered. A product quality complaint was not involved. The patient's experiences were considered to be life threatening and an other important medical event by the reporter. A lot check has been initiated. Additional information has been requested.
Tested positive for COVID-19, mild achy, mild fever, mild sore throat, some fatigue all x3 days.
Patient received AFLURIA vaccine on 10/12/11 (3:30 PM) and later that night fell 4 different times (remained conscious), had fever of 105.2 degrees, chills, weakness, and skin began to jaundice. Patient went to the hospital during the night. MD concluded rxn was due to AFLURIA.
adverse effect from booster bad rash 50% of body, non desquamating, nodular then scaley
Vaccines that were administered beyond use date after thaw process; This spontaneous case was reported by a paramedic and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccines that were administered beyond use date after thaw process) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 29-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccines that were administered beyond use date after thaw process). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccines that were administered beyond use date after thaw process) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided by the reporter  Patient age was reported as 24 years and 9 months.  Ndc Code was mentioned. It was reported that on 10-Jun-2022 Medical was notified of an audit that was done and were then made aware of vaccines that were administrated beyond use date after the thaw process. There was no patient that had any adverse reactions and no reports of any reactions after the administration of the vaccines.  No treatment medication was provided by the reporter.
Difficulty breathing. Coughing. Diarrhea. Symptoms started about 2-3 hrs after injections lasting next 24 hr. No treatment.
On the week of March 14, symptoms started mild and by the following week they were unbearable.  On both legs, my muscles from my hips to my ankles became fatigued and got burning sensation when I was just standing up or sitting down.  The pain was mostly relieved when laying down.   I did not sleep well. Also, I got fevers only at night when asleep.  Measured about 101 degrees temperature.  Got up with tee shirt wet with sweat.  On March 22, I went to my doctor and did some blood work and was told I had a lot of inflamation.  Started on Prednisone.  Went to RA doctor at Rheumatology  on March 30, and went to an infectious disease doctor. I was told that I had an auto-immune response.  I was on Prednisone from March 25 to May 16.
At a covid vaccine clinic the patient was given a bivalent booster when they were not eligible to receive one. The youth received a bivalent booster last on 10.28.2022. The administering nurse did not confirm this prior to administration of the Covid 19 bivalent booster. The director reached out to the youths parents to let them know the error had occurred and what if any potential side effects the youth could expect.
Left arm swelling at injection site., unable to fully articulate arm, acute cellulitis spread down deltoid muscle to anticubtal area, shovers, felt warm, light headed. Took shower to relieve discomfort. 2/10/2021- pain in arm, swollen, and read, headache, - not relieved by oral meds. Blurry vision out of work 3 days. 2/11- arm pain 5-7 out of 10, hands that were numb improving,  2/11 better
Feeling unwell; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Feeling unwell) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (While the patient was at hospital patient) in December 2020 and Platelet rich plasma therapy in December 2020.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, the patient experienced MALAISE (Feeling unwell). At the time of the report, MALAISE (Feeling unwell) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided  by the reporter.  Treatment information was not provided.; Sender's Comments: Based on the current available information which includes a strong temporal association between the use of mRNA-1273 and the start date of the reported events, a causal relationship with the event cannot be excluded.
Patient had been diagnosed with COVID-19 on Dec. 11th, 2020. Symptoms were thought to have started on 12/5/2020. Received Moderna vaccine on 12/23. Unexpected death on 1/8/2021. Resuscitation attempts unsuccessful
pt became very faint p/vax;knees buckled & pt passed out & was assisted into chair;pt had sx became very pale & diaphoretic for 1 to 1 1/2min then became responsive although initially as disoriented;
14 hours later she was sick; classic body ache; heart palpitation; high blood pressure; weak in both legs; felt dizzy; Fatigue; Fever; Vomiting; Nausea; very bad headache; Chills; arm hurt a little; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (14 hours later she was sick), MYALGIA (classic body ache), PALPITATIONS (heart palpitation), HYPERTENSION (high blood pressure) and ASTHENIA (weak in both legs) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0251(L)20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure high. Concomitant products included AMLODIPINE for Blood pressure high.    On 16-Feb-2021 at 9:00 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ILLNESS (14 hours later she was sick), MYALGIA (classic body ache), PALPITATIONS (heart palpitation), HYPERTENSION (high blood pressure), ASTHENIA (weak in both legs), DIZZINESS (felt dizzy), FATIGUE (Fatigue), PYREXIA (Fever), VOMITING (Vomiting), NAUSEA (Nausea), HEADACHE (very bad headache), CHILLS (Chills) and VACCINATION SITE PAIN (arm hurt a little). At the time of the report, ILLNESS (14 hours later she was sick), MYALGIA (classic body ache), PALPITATIONS (heart palpitation), HYPERTENSION (high blood pressure), ASTHENIA (weak in both legs), DIZZINESS (felt dizzy), FATIGUE (Fatigue), VOMITING (Vomiting), NAUSEA (Nausea), HEADACHE (very bad headache), CHILLS (Chills) and VACCINATION SITE PAIN (arm hurt a little) outcome was unknown and PYREXIA (Fever) had not resolved.
Caller states after first injection she had lymph node swelling under the arm she received the injection in; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 49 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LYMPHADENOPATHY (non-serious), outcome "unknown", described as "Caller states after first injection she had lymph node swelling under the arm she received the injection in".  Additional Information: Caller confirms question with me and adds that these symptoms have lasted for 3 months. Caller states after first injection she had lymph node swelling under the arm she received the injection in and she is uncertain if these symptoms have anything to do with the vaccine or not but wants to know has anyone else reported whole face swelling.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow-up (30Dec2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
During a community vaccination Clinic he came through the screeners - the paperwork checked but didn't catch his birthdate- sent to the vaccinator who didn't catch the birthdate either
Pt was administered H1N1 intranasal instead of intramuscular. No symptoms noted as of 12/16/09. Thinking that this is protocol no MD order in place.
The injection site has a big red circle around it. It goes away and then comes back, three time so far
Nurse confused this patient with another patient and gave incorrect immunizations.  Infant tolerated the immunizations well, however they were incorrect and not appropriate for infant's age
PATIENT WAS ADMINISTERED BOOSTRIX, THOUGH SHE HAD REQUESTED TO RECEIVE A FLU SHOT.   WHEN THE ERROR WAS DISCOVERED, THE PATIENT WAS CONTACTED HAD INDICATED HER ARM WAS SORER THAN SHE ANTICIPATED WITH THE REQUESTED VACCINE.  UPON FURTHER FOLLOW-UP WITH THE PATIENT, SHE INDICATED SHE ALSO HAD SOME BRUISING AND WAS EXPERIENCING EMOTIONAL DISTRESS.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Jan2021 at 14:45 as dose 1, single (Lot number: EK9231), in right arm, on 26Jan2021 at 13:15 as dose 2, single (Lot number: EL3249), in left arm, on 16Aug2021 at 14:00 as dose 3 (booster), single (Lot number: FC3181), in right arm and on 18Apr2022 at 14:00 as dose 4 (booster), single (Lot number: FK9894) at the age of 67 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "COPD" (unspecified if ongoing); "bicuspid aortic valve" (unspecified if ongoing); "Known allergy:nickel" (unspecified if ongoing), notes: Known allergy:nickel. Concomitant medication(s) included: ADVAIR, start date: 01Dec2020, stop date: Jun2022; ROSUVASTATIN, start date: 02Jan2021, stop date: Jun2022; PROTONIX [OMEPRAZOLE], start date: 06Nov2020; SINGULAIR, start date: 05Dec2020. Past drug history included: Avelox, reaction(s): "Known allergy:Avelox", notes: Known allergy:Avelox; Thimerosol, reaction(s): "Known allergy:thimerosol", notes: Known allergy:thimerosol. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01Jul2022) positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. ae treatment paxlovid, Sudafed, albuterol, cough med, known allergies Avelox, nickel, thimerosol, other medical history Asthma, COPD, bicuspid aortic valve.; Sender's Comments: As there is limited information in the case provided, the causal association between the events, vaccination failure and covid 19 and the role of suspect drug cannot be ruled out. The case will be reassessed once new information is available.
Rt arm warm, red, tender. Night sweats. Fever. Started 09/19/13 - received injection 9/17/13. Seen in office 09/20/13. Started on doxycycline 100 mg bid x 14 days.
with post-vaccine diarrhea/rotavirus infection;   Information has been received from the authors in a published literature article titled as stated above concerning to a child patient of unknown age and gender who was enrolled in a study to analyze the group A Rotavirus (RVA) genotype prevalence during consecutive RVA seasons (2014-2016). The patient's pertinent medical history, concurrent conditions, drug allergies/drug reactions and concomitant medications were not reported.       On an unknown date the patient was vaccinated with an unspecified dose (1-3) of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), (dose, frequency, Lot # and expiration date not provided) oral for prophylaxis.         On an unspecified date in 2015 (season reported as 01-DEC-2014 through 30-NOV-2015), the patient experienced post-vaccine diarrhea (Rotavirus infection) and was hospitalized. A Rotaclone enzyme immunoassay was performed in 2015 by using stool sample or eluted fecal material from diaper which tested positive for Rotavirus of group A (RVA) and unspecified genotype.  The authors reported the importance of continuous RVA surveillance post-vaccine licensure to identify emergent RVA genotypes and other gastrointestinal pathogens causing Acute Gastroenteritis (AGE) and to guide treatment and intervention strategies.   At the time of the report, the outcome of rotavirus infection was unknown.    The reporting authors considered rotavirus infection to be related to Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ).     A copy of the published article is attached as further documentation of the patient's experience.  This is one of several cases from the same article (US-009507513-2104USA007698, US-009507513-2104USA007699).; Sender's Comments:  US-009507513-2104USA007698: US-009507513-2104USA007699:
on Feb 22, 2022 patient felt the need to spit...bright red blood came out.  No known illness or symtpoms at the time whatsoever,  she continued to spit blood and a large clot from her mouth.  Again at the end of May 2022 child felt the need to spit and tasted blood in her mouth...a few drops of bright red blood and a small clot came up.
itchy at the injection site; developed an area of redness; A spontaneous report was received from a physician concerning a 73- year old female patient who received Modena's COVID-19 vaccine (mRNA-1273) and developed an area of redness and itchy at the injection site.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 09 Jan 2021, approximately nine days prior to the onset of the events the patient received her first of two planned doses of mRNA-1273 (Lot number: unknown) for prophylaxis of COVID-19 infection.  The patient was fine for a week however, on 17 Jan 2021, she developed an area of redness and itchiness at the injection site which measured 3 by 6 inches. She had her next injection scheduled in 2 weeks. The physician wanted to know whether the reaction to the vaccine was usually seen a week after the vaccination and howthe patient would be treated and when could she get the second dose of the vaccine.  No laboratory data and treatment drugs were reported.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events developed an area of redness and itchy at the injection site was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the events, a causal relationship cannot be excluded.
Urinary symptoms that began within 72 hrs of second dose, increased frequency, pain during urination, lower back and flank pain, pain in lower abdomen, no signs of infection or bacteria were found in several urinalysis. Cognitive issues and a cloudiness, fatigue and tinnitus. Severe flare up of RA symptoms, especially in hands.
I got the flu shot and still got the flu; Initial information received on 30-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a Consumer/Non-Health Care Professional.  This case involves Adult and unknown gender patient who experienced I got the flu shot and still got the flu after receiving vaccine Influenza Vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect Influenza Vaccine produced by unknown manufacturer (with dose, strength, formulation, expiry date, lot number not reported) via unknown route in unknown administration site for prophylaxis.  On an unknown date the patient developed a non-serious I got the flu shot and still got the flu (influenza) (unknown latency) following the administration of Influenza Vaccine.  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.
This spontaneous report was received from a physician via a company representative, referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 03-AUG-2016, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 "23-10pk-0.5ml-SD PFS LLok w Tip" which had a lot number of M005287 and expiration date on 08-OCT-2017 (route of administration and anatomical location were not reported). There were no concomitant medications provided. No adverse effect reported. No product quality complaint was involved. On an unspecified date, the PNEUMOVAX 23 had two temperature excursions; one for 32 hours with lowest recorded temperature of 34 F (1.1 celsius) and other one for 24 hours with lowest recorded temperature of 32 F (0 Celsius). The lowest recorded temperature was 32 F (0 Celsius) and the highest recorded temperature was not mentioned. The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator(R)". This is one of several cases from the same reporter. Additional information has been requested.
Couple of red rashes around my stomach which is going up; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 ((PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number was not reported), via an unspecified route of administration on 16Mar2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 27Mar2021, patient see there are couple of red rashes around stomach which is going up. So, this was the concern of patient to take have second dose which is coming up in next 2 weeks should go or not. The outcome of the event was not recovered.    No follow-up attempts are possible. Information about lot/batch number cannot be requested. No further information is expected.
This is a spontaneous case, initially received from other healthcare professional (pharmacist) on 25-Oct-2018, concerning an elderly, female patient of unspecified age. On 15-Sep-2018, the patient received the co-suspect vaccine: FLUZONE (dose, route of administration, anatomical location, batch number and expiry date; not reported). Later, it was reported that, the pharmacist was not sure whether the patient had received FLUZONE or Pneumonia on 15-Sep-2018 but was investigating on the same at the time of the report. On 25-Oct-2018, the patient was administered FLUAD (TIV) (dose: 0.5 ml, batch number: 250795, expiry date: 30-Apr-2019, route of administration and anatomical location: not reported). No adverse reactions were reported after the vaccine administration. The reporter assessed the case as non-serious.
Hypertension 165/92 for several days. Sporadic  dizziness. Muscle aches especially in left arm near injection area. I experienced some partial blindness in both eyes the third day that lasted for 30 minutes. This even happened about 72 hours after first injection. These symptoms have occurred for the second shot on 04/23/2021, and were especially pronounced after the third shot booster of Pfizer given on 10/04/2021. After fives days all soreness and symptoms gradually diminished and my BP stabilized to 118/75.