chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a vaccine coordinator concerning a 17 year old male patient. The patient had no pertinent medical history, concurrent conditions, concomitant medications or drug/reactions allergies. On 16-AUG-2017, the patient was vaccinated with a dose of GARDASIL 9 lot # N003703, expiration date: 29-OCT-2019, as prophylaxis (Dose and route were not reported), on the same day, the patient experienced syncope. He received an unspecified treatment for the event. The outcome of syncope was reported as recovered on an unspecified date in 2017. The causality between syncope and GARDASIL 9 was not reported.
Rt arm redness, pain (not at site of injection) but lower on arm and to the inside. RPh advised icing area and maybe BENADRYL, and anti-inflame (but patient cannot take due to other meds that he takes regularly).
Patient was admitted for nonhealing wounds and was found to have osteomyelitis in her R hallux and required partial amputation. She is entering into hyperbaric treatments to speed her healing. Discharge to home. Hospital admission within 6 weeks of receiving the COVID vaccine.
Pfizer-BioNTech COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization/Death. Patient received Pfizer-BioNTech on 8/04/21 and 8/25/2021. Pt presented to ED with chest pain and SOB. Chest pain started the previous night to admission while lying in bed non-exertional, left-sided, lasting only a few seconds. Labs: ESR/CRP, Cr 4.26, K+ 4.1, CL = 94, BUN = 19, Bilurubin = 2.1, ALP = 21, Troponin negative , BNP of 280 ,Hgb of 10.3, Coronavirus COVID-19. Pt became unresponsive while completing EKG and code blue was called. Pt expired 10/30/22. Pt treated with decadron.
Disease Recurrence; have had 5 vaccines. Have had Covid 4 times; have had 5 vaccines. Have had Covid 4 times; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old patient received BNT162b2 (BNT162B2), as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "recovered" and all described as "have had 5 vaccines. Have had Covid 4 times"; DISEASE RECURRENCE (medically significant), outcome "unknown". Therapeutic measures were taken as a result of drug ineffective, covid-19, disease recurrence as Paxlovid treatment. Clinical course: Patient had Covid 4 times in May2022, Sep2022, May2023 and currently. Patient added If patient could be of help in any trial, please let patient know. Patient was so grateful for the vaccines and Paxlovid. Patient took it in May2022 and am took it again now.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300265595 same patient, different SD/AE;
Client left observation and returned to parking lot because she was not feeling well. Security returned vehicle to observation and flagged down a nurse. Client observed to be non-verbal and  only responsive to pain. Client transported.
Presented to our office 10/3/17 for follow up from osteomyelitis of left calcaneum. Mom reported a local reaction to flu vaccine, redness to injection site, 4cm in diameter, 1cm high- Tender. Lasted about 3-4 days.
Systemic: Allergic: Rash Generalized-Mild, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Mild
Pt received ADACEL injection on 4/22/10. Pt developed pain, redness, swelling at injection site on 4/26/10. Pt also developed tingling down arm and hand with difficulty gripping objects.
Most of left arm is puffy and feels edematous, pain in ulnar and radial nerves, mild localized pain, no inflammation.
Sore throat, fever, chills, body ached, severe fatigue,  congestion in lungs and nose, watery eyes. Non functional at work, lived off of cold medicine, cough drops and probiotics. Occured not even 24 hours later. I've never been so sick
soreness and swelling began the same day as the injection, on 3/30/2021, in the evening.  I noticed yesterday an increase in swelling, redness, and heat in the left arm in the general location I received the injection. It has been 8 days since receiving the injection.
My child complained on pain in leg at injection site and limped when walking. She said it hurt a lot and walked with both knees bent and I had to pretty much carry her because she would cry and say it hurt. She ran a low grade fever for about 2 days. Tylenol helped. On 6/8/2012 she had a large red, hot, swollen leg at the site of injection but she was walking better. On 6/9/2012 the hotness and swelling seemed to be going away some, but the actual red mark was larger-about 4 inches in diameter. Previously is was about 2 in. The morning of 6/10 I was advised to give her some Benadryl. This seemed to help tremendously and when she woke up after a 4 hour nap, the redness and swelling were much better and she was not complaining of pain any more. By 6/11-6/12 she was fine.
This study case was received from the investigator in the trial on 15 January 2013, and follow-up was received on 13 February 2013. A female subject (birth date not reported, age 20 years old on electrocardiogram) had received on 03 January 2013 ACAM2000 (lot number, and route not reported) in the right arm and an anthrax vaccine (manufacturer, lot number, route and site not reported). The subject had negative past medical history. On 07 January 2013 the subject reported mild ongoing chest pressure and shortness of breath with onset 2 and 5 days post ACAM2000 vaccine, respectively. She was referred to her primary care physician for care. Possible myopericarditis was considered. An ECG completed on 11 January 2013 was normal and it was less suspicious for myopericarditis, but there were no Troponin results and it could not be excluded as a diagnosis. No other adverse events were reported. The subject's outcome was reported as not recovered on 14 February 2013. According to the investigator, the event of possible myopericarditis was considered possibly related to vaccination. Documents held by sender: none.
Symptoms started around noon the next day and consisted of beginning with chills and then led to a fever of 101.6 for the rest of the afternoon.  Ached all over felt like been hit by a truck.  Around 9pm the fever broke and then just had slight headache.  I was fine the next day.
fever 104-105 6PM & through the noc; body jerks/but no sz; vomiting x1 rx APAP q 3-4 hrs; 13APR95 t101
At least one week after receiving the vaccination. The patient began to have pain in her left arm. The pain travels from her upper arm to her fingertips. This is not a constant pain, but a sharp pain that occurs unexpectedly with certain movements. Patient has a doctors appointment in a few weeks.
On 8/25/21 I experienced soreness on arm of the injection site as well as chills and digestive problems.  This lasted for about 3 weeks along with headaches, body aches, muscle spasms, Renaults flare-ups.  I experienced extreme digestive issues where I was constantly using the bathroom until Jan 2022.  I contacted my PcP but they told me there was nothing they could do but to wait out the symptoms.  My chronic fatigue started in Jan 2022 as well.
Malaise, nausea/vomiting, dizziness, left, lower back pain, chills, low fever, extremely sore injection site
Day after HPV she was weak, T.100, decreased eating, hives runny nose & sneezing.
Pain and swelling at injection site; Pain and swelling at injection site; Nausea; dizziness; fatigue; feeling unwell; itchy skin; This is a spontaneous report received from a contactable nurse, the patient. A 35-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6207) via an unspecified route in the left arm on 19Mar2021 at 09:30 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. The patient was allergic to bee stings. No concomitant medications were reported. The patient did not receive any vaccination within four weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. On 19Mar2021 at 11:45, the patient had pain and swelling at injection site, nausea, dizziness, fatigue, feeling unwell and itchy skin. The patient did not receive any treatment for the reported events. The adverse events did not result in doctor or other healthcare professional office/clinic visit. The clinical outcome of the events pain and swelling at injection site, nausea, dizziness, fatigue, feeling unwell and itchy skin was unknown at the time of reporting.    No follow-up attempts are needed. No further information is expected.
adult patient received a pediatric dose / on 21-Jan-2021 and a second pediatric dose / in 21-Feb-2021; adult patient received a pediatric dose / on 21-Jan-2021 and a second pediatric dose / in 21-Feb-2021; This case was reported by a pharmacist via call center representative and described the occurrence of underdose in a 57-year-old female patient who received HAV (Havrix pediatric) for prophylaxis.   On 21st January 2021, the patient received the 1st dose of Havrix pediatric (intramuscular). On 21st January 2021, unknown after receiving Havrix pediatric, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.  Additional details were reported as follows: The pharmacist reported that an adult patient received 1st pediatric dose of Havrix on 21st January 2021, which led to underdose and adult use of a child product. The second pediatric dose of Havrix was received on 21st February 2021, refer case US2021AMR143447. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR143447:Same reporter
Patient experienced leg swelling in the back of her knees. Time to event unknown; however, she went to an orthopedic to have the legs evaluated on 10/24 and 10/26. The doctor highly suspected the vaccine to be the issue because there were no signs from anything else.
started wheezing w/cont cough about 7PM on 16NOV93; nebulizer treatment w/rellief of sx; wheezing & coughing began again morning of 17NOV93; short term relief w/nebulizer; seen by MD 17NOV; inc frequency of nebulizer treatments @ that time;
Pt. states that after receiving the 1st dose of Phizer 05/27/2021, started experiencing eyes, ears, and tongue swollen. Feeling faint, body heaviness, dehydrated, blurry vision, difficulty swallowing lasting 4hrs. Treated with Benadryl and Advil, after a night sleep felt back to normal. Concerned about the 2nd dose.
Pt reports 2 days of lacy macular rash on Both thighs,arms, lower trunk (anterior and posterior) non pruritic. Follow by observation ? erythema multiforme.
09/26/2018 - Immediately after the injection, patient reports feeling some dizziness and was advised to stay in the clinic for monitoring, but patient left reporting feeling well enough to leave. Later that evening, patient reported that she had some muscle tightening especially in her neck area but all over her body and sent a message to the physician stating that she "had flu-like symptoms". 09/27/2018 - Another message received from patient noting that she is still very dizzy. 09/28/2018 - Pt then stated that she was not so dizzy but had trouble with the pain in her back and hips again. Pt also noted that she had difficulty walking requiring use of a cane/stick to help her walk. Pt took some Tylenol.  10/02/2018 - Pt notes that she had too much pain but still had some weakness and "heavy feeling" in her leg; pt continues to complain tired and fatigue. 10/11/2018 - Pt continues to complain about the weakness and muscle tension as her main symptoms since the vaccination.
My heart rate has been elevated since getting the vaccine. Prior to the vaccine my heart rate was in the range of 65-100 during normal daily activities. After the vaccine my heart rate is in the range of 95-130 during normal daily activities.
Body aches, chills, high fever (102.4), malaise, fatigue, loss of appetite. Lasted for about 24 hours then much improved. Took Tylenol every 6 hours to try and help relieve muscle and joint aches and pains
Swollen left shoulder down to elbow. No decreased range of motion. Tender to palpitations.
side effects/unevaluable event; This spontaneous case was reported by a consumer and describes the occurrence of UNEVALUABLE EVENT (side effects/unevaluable event) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product DUPILUMAB (DUPIXENT) for Atopic dermatitis.    Concurrent medical conditions included Atopic dermatitis.   In April 2021, the patient started DUPILUMAB (DUPIXENT) (Subcutaneous) 300 milligram every two weeks. On 19-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced UNEVALUABLE EVENT (side effects/unevaluable event). At the time of the report, UNEVALUABLE EVENT (side effects/unevaluable event) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No other concomitant medications were provided. No treatment information was provided.
Caused a bit more side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Caused a bit more side effects) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Caused a bit more side effects). At the time of the report, VACCINATION COMPLICATION (Caused a bit more side effects) outcome was unknown.            It was reported that the patient expected same side effects as of second Moderna vaccine but booster dose caused a bit more side effects. No concomitant medications were reported.  Treatment information was not provided.   This case was linked to MOD-2021-400299 (Patient Link).
No signs and symptoms of any kind.  Incorrect diluent was used to reconstitute HIB vaccine.
Patient stated that arm was very sore after vaccine and that soreness did not resolve. He has been seeing a physical therapist to help relieve the pain.
HEART FLUTTERING; VERY DIZZY; PALPITATIONS; SEVERE HEADACHE; This spontaneous report received from a patient via social media via company representative concerned a patient of unspecified age, sex, race and ethnic origin. 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 (dose series number 1) (suspension for injection, route of administration, and batch number were not reported, expiry: unknown) dose, start therapy date were not reported, 01 total administered for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced an adverse reaction, was very dizzy 15 minutes after inoculation, severe headache and palpitations followed. This lasted a couple of days, from then had been experiencing heart fluttering almost everyday, was so anxious to get a booster shot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from very dizzy, palpitations, and severe headache, and had not recovered from heart fluttering. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211245426-Covid-19 vaccine ad26.cov2.s- Heart fluttering. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
shingles; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (shingles) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001b21a) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced HERPES ZOSTER (shingles). At the time of the report, HERPES ZOSTER (shingles) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication was not provided.
In addition to fatigue, arm pain/numbness, fever, chills  and aches I had heart palpitations and felt as if my heart was swollen and going to burst out of my chest.
pt cried/screamed inconsolably for the following 7 days & cried as if in pain for the next 6wk;this was a change in pt behavior easily linked to vax;
Developed a non- itchy macular red rash on her chest; This case was reported by a pharmacist via call center representative and described the occurrence of erythromacular rash in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced erythromacular rash. On an unknown date, the outcome of the erythromacular rash was unknown.   It was unknown if the reporter considered the erythromacular rash to be related to Shingrix.  Additional details were provided as follows: The age at administration was not reported. The patient developed a non- itchy macular red rash but stated that it was not hive located on her chest. The reporter consented to follow up.
Fever of 102+, chills, shivering, headaches, nausea, dizziness, aches and pains
Excruciating left foot/ankle & shin electrical nerve shooting pain; Entire body muscle twitching & spasms.; Entire body muscle twitching & spasms.; Feeling of cramping in legs, calves & shins (primarily left leg); Feeling of needle stabbing in left calf; Severe left hip and lower back pain; Severe left hip and lower back pain; Left leg and ankle joint weakness; Myoclonic limb jerks; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 12Apr2021 13:15 (Lot number: EIN 0158) at the age of 51 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "No" (unspecified if ongoing). Concomitant medication(s) included: KRILL OIL; TURMERIC CURCUMIN; AREDS; VIT D3; VITAMIN K 2; PROBIOTICS.  The following information was reported: NEURALGIA (non-serious) with onset 19Apr2021 13:00, outcome "not recovered", described as "Excruciating left foot/ankle & shin electrical nerve shooting pain"; MUSCLE SPASMS (non-serious) with onset 19Apr2021 13:00, outcome "not recovered", described as "Entire body muscle twitching & spasms."; MUSCLE SPASMS (non-serious) with onset 19Apr2021 13:00, outcome "not recovered", described as "Feeling of cramping in legs, calves & shins (primarily left leg)"; PAIN IN EXTREMITY (non-serious) with onset 19Apr2021 13:00, outcome "not recovered", described as "Feeling of needle stabbing in left calf"; ARTHRALGIA (non-serious), BACK PAIN (non-serious) all with onset 19Apr2021 13:00, outcome "not recovered" and all described as "Severe left hip and lower back pain"; MUSCULAR WEAKNESS (non-serious) with onset 19Apr2021 13:00, outcome "not recovered", described as "Left leg and ankle joint weakness"; MYOCLONUS (non-serious) with onset 19Apr2021 13:00, outcome "not recovered", described as "Myoclonic limb jerks". The events "excruciating left foot/ankle & shin electrical nerve shooting pain", "entire body muscle twitching & spasms.", "feeling of cramping in legs, calves & shins (primarily left leg)", "feeling of needle stabbing in left calf", "severe left hip and lower back pain", "severe left hip and lower back pain", "left leg and ankle joint weakness" and "myoclonic limb jerks" were evaluated at the physician office visit and emergency room visit. Therapeutic measures were taken as a result of neuralgia, muscle spasms, muscle spasms, pain in extremity, arthralgia, back pain, muscular weakness, myoclonus.  Additional information: The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient received treatment included with Oral steroids & Gabapentin. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.  Follow-Up (25Aug2021): Follow-up attempts are completed. No further information is expected
Patient received 6 month - 4 year Pfizer monovalent for a third dose instead of 6 month - 4 year Pfizer Bivalent in error. Patient will return to office to receive correct dose
4 hrs after vaccine I had a scratchy throat and cough. I had chills and headache,next morning . Felt very fatigued. 2nd night I woke in middle of night with temp of 101, chills,  stuffy nose and wheezy cough,  Temp has not gone to normal since first night  even with Tylenol.  3rd day severe sore throat, coughing up very thick and sticky phlegm.  Fatigue, altered taste.  I did not seek help bc I initially thought it was side effects associated with vaccine but after no real improvement in 3 days I decided to report. Will seek help from MD tomorrow
About eight later, fever of 101, for 2 days. Wednesday afternoon, after not having a fever for three days, started having chills and felt fatigue. Temp never got above 99.4, felt bad fatigue until this morning. Feeling pretty good now.
Patient received PNEUMOVAX 23 and FLUZONE high-dose on 10/08/18 at approximately 2pm. Pt's wife call pharmacy at approx. 5pm on 10/09/18 saying that her husband's left arm was swollen, red, and hot. Redness extended to elbow. I said for him to go to walk-in or ER. Pt's wife called again this morning, 10/10/18; told me husband went to walk-in, who in turn sent her to ER. By that time the redness had progressed to his fingertips. Diagnosis: Cellulitis. Given antibiotics and seemed to be getting better today.
Redness, pain and  swelling at injection site 2" x 2" area on 1/20/23.  On 1/21/23 pain extended into lower arm and also there were 2 red / pink streaks coming out of red area of injection site that went toward underarm.  Very achy all over.
Swelling & erythema over deltoid extending to shoulder & down to elbow pain, decreased rang of motion, fever to 100.
2 hours later - fever 101.5; aches; chills; a little bit of fatigue (not as bad as the fever) - continued 2 days for fever; fatigue was 4 or 5 days (of not feeling good). 28th and 29th - body aches returned On the 30th, I woke up with a fever. I went in to get COVID test and it was positive for COVID. Didn't get second one because I was still symptomatic from COVID infection.
Hives on  hands, fever 100°, diarrhea,  dizziness, nauseous. Lasted total of about 36 hours. Applied topical antihistamine and took oral antihistamine.
Headache lasting over 15 hours, severe chills, pain in injection arm, fatigue resulting in 13 hours of sleep.