chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Confusion; Very sore arm; This spontaneous case was reported by a consumer and describes the occurrence of CONFUSIONAL STATE (Confusion) and PAIN IN EXTREMITY (Very sore arm) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced CONFUSIONAL STATE (Confusion) and PAIN IN EXTREMITY (Very sore arm). At the time of the report, CONFUSIONAL STATE (Confusion) and PAIN IN EXTREMITY (Very sore arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medications were reported.
body aches; sweating; low grade fever; sleepy, could not function; sick; a large painful bubble under his left armpit.; painful lump under left armpit; This is a spontaneous report from a contactable male consumer (patient).   A 60-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, Batch number was unknown) via an unspecified route of administration on 09Apr2021 (age at vaccination 60 years) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, Batch number was unknown) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient stated that, he received his 2nd dose last Thursday, on 09Apr2021 and on an unspecified date, the patient felt really out of it and was sick until Sunday. That Sunday, the patient took a shower and he noticed that there was a large painful bubble under his left armpit. The patient got the shot on his left arm. The patient mentioned that all other symptoms improved but the lump was so painful that he can not even lift up his left arm. The patient was asking how long should this last. On 08Apr2021, the patient experienced body aches, sweating, low grade fever, sleepy and could not function. On 11Apr2021, the patient experienced painful lump under left armpit. The seriousness of the events was unspecified. The outcome of the event a large painful bubble under his left armpit was unknown while the outcome of the events body aches, sweating, low grade fever, sleepy, could not function and painful lump under left armpit was not recovered. The outcome of the event sick was recovering.  Information about batch/lot number cannot be obtained. No further information is expected.
Initial report received from a healthcare professional on 21 November 2012. An 83-years-old female patient, whose medical history was hypothyroid, osteoporosis and was taking Iodipine. Illness at the time of vaccination was not reported. Patient had no known allergies. Received a dose of Tetanus Toxoid Ads (Lot number: U3919BA, dose number and site of vaccination not reported) intramuscularly on 01 November 2012. The patient also received Flu Vaccine (Lot number, dose number, route and site of vaccination were not reported) on an 23 October 2012. It was reported on 08 November 2012 is one week after vaccination, the patient noticed hair loss. Relevant diagnostic test and laboratory data was unknown. Corrective medications were not reported. The outcome of the event was unknown on an unspecified date. Documents held by sender: none. Follow-up information received from a healthcare professional on 13 March 2013. The patient's outcome was recovered on an unspecified date.
Client called to report that injection site on left arm began feeling itchy PM of injection and proceeded to develop swelling, redness and heat down to the elbow and on the inner upper arm. States she had a PNU vaccine 6 yrs ago at PP's. Referred to call private MD to follow up. 10/12 follow up call to client, states her arm is back to normal and redness and swelling is gone. Dr. did not put her on meds. Not able to identify previous PNU date.
One week post vax, the pt experienced arm soreness, neuropathy, joint pain, stiffness, elevated blood pressure (150/80), fatigue, nausea, tingling toes, a sense of blood rushing in her right (injection) arm, and painful feet. EMG studies on 11/11/1999 were normal. Her IgM was 1111 for anti-hepatitis B. A different IgM was 711 mg/dl and polyclonal. ESR was 17 mm/hr. She was diagnosed with vasomotor instability and prescribed a beta blocker. However, she felt ill and discontinued this on her own. 11/29/1999 physician visit: Her reticulocyte count was slightly elevated. SPEP showed no monoclonal spike. IgA was 132, IgG was 1021, and IgM was elevated at 590 mg/dl. Immunofixation and test for cryoglobulins were pending. In summary, physician stated she had an elevated IgM which is slowly decreasing. In the past it was shown to be polyclonal and the physician saw no reason why that should change. Most likely this is a delayed hypersensitivity reaction to the hepatitis B vaccine. In the meantime, physician started the pt on Claritin for relief of her paresthesias. She still experienced fatigue, tingling toes, and painful feet. The most recent information received reports the condition of the pt as unknown.
Occurred 3 days after receiving vaccine was seen by MD. Area of erythema to (R) arm. Treated with KEFLEX 500mg 1 cap TID x 20 days.
received post-exposure prophylactic covid-19 monoclonal antibody treatment; This case was reported by a nurse via call center representative and described the occurrence of covid-19 in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 6 months after receiving Shingrix, the patient experienced covid-19. The patient was treated with monoclonal antibody (nos). On an unknown date, the outcome of the covid-19 was unknown.   It was unknown if the reporter considered the covid-19 to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. After receiving 1st dose of Shingrix, the patient had Covid 19. On 07th September 2021, the patient received post-exposure prophylactic covid-19 monoclonal antibody treatment.  On the date of reporting, the patient was in clinic due for dose 2 of Shingrix. It was unknown if patient received 2nd dose of Shingrix on 22nd October 2021. The reporter did not consent to follow-up. The reporter attempted to call healthcare professional regarding additional details but unable to reached healthcare professional.
left lymph nodes swelling at left armpit; swelling in both left and right ankle; soreness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING (swelling in both left and right ankle), VACCINATION SITE PAIN (soreness at the injection site) and LYMPHADENOPATHY (left lymph nodes swelling at left armpit) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     The patient's past medical history included Pacemaker insertion (cardiac). Concurrent medical conditions included Hypertension (He takes medication for his hypertension and high cholesterol) and Cholesterol.   On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 24-Feb-2021, the patient experienced VACCINATION SITE PAIN (soreness at the injection site). On 01-Mar-2021, the patient experienced JOINT SWELLING (swelling in both left and right ankle). On 07-Mar-2021, the patient experienced LYMPHADENOPATHY (left lymph nodes swelling at left armpit). On 09-Mar-2021, LYMPHADENOPATHY (left lymph nodes swelling at left armpit) had resolved. At the time of the report, JOINT SWELLING (swelling in both left and right ankle) and VACCINATION SITE PAIN (soreness at the injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and 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.   treatment medication were provided that icing and elevating
Muscle/Body aches, Swollen lymph nodes in neck (bilaterally), sore throat, Congestion, Fatigue, Dizziness.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021 at 10:13 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Apr-2021 at 10:13 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 69.89 years. No concomitant medications were reported. Batch number 030B21A  underwent temperature excursion on 03-Apr-2021 with temperature 34 degrees Fahrenheit at 09:00 AM. The vial was initially moved to the fridge on 30-Mar-2021 and proposed beyond use date was 29-Apr-2021. Product moved to clinic on 03-Apr-2021. 6 vials were sent to clinic. Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour. No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).
Right lower leg sudden onset severe swelling, pain, redness. Went to urgent care doctor who then performed assessment, blood work and ultrasound. Placed on Xarelto 15mg twice daily for 21 days.
A report has been received from a Health Professional concerning multiple patients of unknown gender, who had been receiving FLUMIST Quadrivalent (intranasal), 0.2 milliliters, unknown. FLUMIST Quadrivalent started on an unknown date. It was reported that an office staff is seeing an abnormally high number of children, at least 10 to 20 kids between the ages of 2 to 16 years of age with severe vomiting after receiving the FLUMIST Quadrivalent. This event has been happening for a week and a half or two weeks Oct-2015. Today 28-Oct-2015 another child was vomiting. The vomiting starts approximately one hour up to the next day after receiving the FLUMIST Quadrivalent. The patients are vomiting up to 6 times or more and throughout the night. The outcome of the event of severe vomiting was unknown. The report was considered to be non-serious. Follow-up of insignificant information receiving by AstraZeneca/MedImmune on 17-Nov-2015 from HCP: Reporter details were updated. Correction in database only. Formulation was updated from spray to nasal spray. Manufacturer was added.
angioneurotic edema, swelling of tongue secondary Prinivil & flu vax;upper airway compromise/obstruction-intubation;Solumedrol & DPH;versed Morphine given;pt improved-extubated;
0.3 ml dose was drawn up from Pediatric Pfizer vial and administered to patient. Patient received 0.3 ml of the Pediatric Pfizer vaccine instead of 0.3 ml of the adult Pfizer. The patient was notified as soon as it was discovered and advised to return to get 0.3ml of the 12+ adult pfizer vaccine Patient returned on 12/03/202 and was given the replacement dose of 0.3ml of the adult pfizer vaccine Lot number 30145BA expiration 12/31/2021 to Left deltoid No adverse events were reported.
14 hours after injection had fever of 101.2, six hours later 101.7. Fever broke then at 100 until 4pm.  Fever of 101 again at 7pm till midnight. I have now been 9 hours without a fever. Only other symptoms injection site tenderness with mild redness, no swelling and intermittent severe headache.
Developed fever 102 degree and increase heart rate 109 bpm. Patient currently symptom free.
Patient with syncope post vaccination. Placed on 3L O2 NC. Appeared to be in respiratory distress. BP initially 98/72. Recovered to 145/86. MD at bedside and discontinued O2 since patient alert and O2 ok. After a few minutes patient began to desat occasionally and appeared in respiratory distress. Placed on NRB 15L. IV placed and given Zofran 4mg IVP. EMT's at bedside and did EKG. Patient said "my heart hurts." Transferred via ambulance to ED.
I started with a sore throat on the evening of 12/25/2022 the next day my throat hurt worse and I began to run a fever as high as 102. I had chills all over body aches headache and nausea very fatigued. By the third day my throat was very sore and hurt to talk. I was tested for strep which was negative and was told to use OTC for symptom control, my sore throat lasted for approximately two weeks. I never had any chest or nasal congestion no runny nose or cough.
tachycardia; fatigue; muscle weakness; irritability/anxious; irritability/anxious; This is a spontaneous report from a contactable nurse reported for herself. A 41-years-old non pregnancy female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number was not reported) via an unspecified route of administration in Arm Left on 27Apr2021 16:15 (age at vaccination 41years old, Pregnant at Time of Vaccination: No) as single dose for covid-19 immunisation. Medical history included raynaud's phenomenon from an unknown date and unknown if ongoing. The patient did not have any allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and patient did not receive other medications within 2 weeks of vaccination. The patient's concomitant medications were not reported. Since the vaccination, the patient has been tested for COVID-19. On 01May2021 the patient experienced tachycardia, fatigue, muscle weakness, irritability/anxious. The patient did not receive any treatment for the adverse events. The clinical outcome of the event was not recovered.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Information has been received from a consumer concerning her cousin's daughter with no relevant medical history reported who in approximately 2002 was vaccinated with a dose of MMR at 15 months of age (lot number not available). It was reported that the patient developed symptoms of autism right after she was vaccinated with MMR vaccine live. The reporter was unable to describe the symptoms. Unspecified medical attention was sought. The patient was recently diagnosed with Autism. The physician's had her on a strict diet because carbohydrates trigger the Autism. At the time of this report, the patient was 2 years old. Upon internal review, the patient's autism was considered an other important medical event (OMIC). Additional information is not expected.
Very uncomfortable; Wrist and knuckle joints are having pain; This is a spontaneous report from a non-contactable consumer, the patient. A 62-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534/ER8729), via an unspecified route of administration in the right hand on 10Apr2021 (at the age of 62-year-old), as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not receive any other medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 12Apr2021, the patient experienced very uncomfortable and wrist and knuckle joints are having pain. It was reported that the patient could not even wash face with the right hand due to pain. The pain was bearable but very uncomfortable when it comes to doing things. The events resulted in doctor/other health care professional office/clinic visit. No therapeutic measures were taken for the events. The clinical outcome of very uncomfortable and wrist and knuckle joints are having pain was not recovered at the time of this report.  No follow-up attempts are possible. No further information is expected.
Patient exhibited redness and swelling on the left arm from the deltoid muscle and down 120mm. Area was warm to touch and slightly hard and raised. The affected area measured approximately 120 x 85 mm. Mother did not give TYLENOL or apply ice to area. Mother stated patient scratched area.
moderna #1 2/6 , 9 days later she developed a large red spot on her arm, 8 inch long, lasted a week and since faded,  New sx started for about 1 week Neck feels stiff over mid line, not into shoulders, sore to touch on one side, and same into hips, stiff, no pain into arms or thighs, no fevers, no specific joints are swollen, no headache or vision changes, no pain in jaw with chewing or talking   She started first with tylenol, switched to voltaren oral and thinks is helping some, getting up in am and up from supine/prone is her worst time  she was started on prednisone for possible PMR, she started at 40mg daily but not recovering  after 1 week, increased to 60mg with relief and decreased in crp, she continued on 60mg for 2 weeks, then tapered to 40mg , 30 mg and 20mg every 2 weeks,  she has now tapered to 10mg daily every 2 weeks by 2.5mg was seen in office today with complete resolution of symptoms
Pain on left deltoid area bruising after 3 days in upper deltoid area & middle left forearm.
Information has been received from a physician concerning a 2 1/2 year old female who was vaccinated with a dose of varicella virus vaccine live. Subsequently the patient experienced shingles. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested.
The following morning I had a severe headache. Extreme pressure and felt out of it.  The pain was towards the back, internal part of my head.  It felt like a migraine except that the pressure was not felt in my forehead  as I normally feel with migraines. Nothing relieved my pain except for sleeping.  I also had soreness of the arm and pins, needle like pains on and off.  I had both the COVID booster vaccine and the flu vaccine administered at the same time.  When I had COVID, the headache felt very similar except that with the booster my headache only lasted about 24 hours.
This spontaneous report was received from a physician, via company representative, and refers to a patient of unknown age and gender. Pertinent medical history, concurrent conditions, drug reactions or allergies and concomitant therapies were not reported. On 30-NOV-2015, the patient was vaccinated with a dose of PNEUMOVAX 23, lot # L002310, expiration date 08-JUL-2016, (route and anatomical location of administration were unspecified) which was improperly stored in refrigerator to a temperature excursion of 1.1 Celsius degrees for 208 hours with lowest temperature recorded of 34 Fahrenheit degrees. No adverse effects were reported and no product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
flu; Initial information received on 16-Nov-2020 regarding an unsolicited valid serious case received from social media consumer (patient) .  This case involves patient (unknown demographics) who experienced flu (influenza), when received INFLUENZA VACCINE.  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date: not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a serious flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE. The patient was hospitalized for this event.  Details of laboratory data not reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome of event was unknown.  Information on the batch number was requested.; Sender's Comments: This case concerns a patient (unknown demographics) who had influenza, after and despite vaccination with INFLUENZA VACCINE (unknown manufacturer). The time to onset is unknown. Additional information regarding patient's medical history, condition at the time of vaccination, immune status, product brand name would be needed for complete assessment of the case. Based upon the reported information, the role of the vaccine and a case of vaccination failure cannot be assessed.
1. Cold chills in store, had to use restroom and urinate immediately. 2. Cold chills at home, started to shiver, jaw rattling, immediately had hot tea and wrapped in blanket. 3. Nosebleed, very unusual for me, 7 am. 4. Nosebleed, severe tinnitus, nausea, had to get out of bed and get to restroom, immediate bowel movement, severe dizziness vertigo getting back to bed. Slight tinnitus day after while writing report. Still have low nausea. 5. Sore arm for 4-5 days.
35 weeks pregnant, about 20 hours after receiving dose I had vision issues: bright lights, blacking out, dizziness, feeling of racing heart and shortness of breath.
p/vax pt presented w/varicella-like rash that consisted of less than 50 lesions & no fever;
I had a raw throat, sinus pressure, and was just feeling unwell. Saturday, I felt like I was getting worse and was having nose bleeds. That is when I decided to go to the doctor. They gave me a Dexamethasone Steroid injection. I was prescribed Doxycycline Monohydrate, and Benzonatate. I am feeling better, but I still have some of the symptoms.
Left arm leg and face numbness  bilateral legweakness Vaccine given at 915 am Symptoms started at 11 am  Called Pfizer to report at 1151 am  Saw primary doctor at 2 pm Return to primary md again 12/22/20 Referral to neurosurgeon 11/22/20  Hospitalized 11/22/20 to 11/24/20 lepto Meningeal inflammation  hospital
Day 1 - Developed rash in a concentrated cluster around the diaper strap on his right hip. Day 2 - Fever of 102 and a few pox on the trunk in addition to the clustered area. Day 3 - Continued fever of 101 and pox all over trunk, face, and neck with sporadic pox on the legs and arms.