chrisvoncsefalvay/vaers-outcomes huggingface dataset:
vomited like 30 times; super fatigue; pale; achy; shaky; fever of 101 °F; This is a spontaneous report from a contactable consumer (patient mother) reported for her son. A 15-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot/Batch number: unspecified, Pfizer NTEC), via an unspecified route of administration on an unspecified date as 2nd dose, single dose for covid-19 immunization (at the age of 15-years-old). Medical history included peanut allergy (he has a peanut allergy). The patient's concomitant medications were not reported. The patient historical vaccine included first dose of BNT162B2 for COVID-19 immunization. On an unspecified date in 2021, the patient received the second dose and at 5 o clock the next morning he vomited like 30 times, had a super fatigue, pale, achy, shaky fever of 101 degree Fahrenheit. He slept but was still feeling feverish. The clinical outcome for the events was unknown.  Information on Lot/Batch number has been requested.
A few minutes after taking the 2nd dose, I developed a fever. I was dizzy and had a headache. My blood pressure was high. I had to lay on a cot and had to be monitored. Two hours later, I was allowed to leave.  After 4 hours of the shot, I started to feel better.
7/26/2007 Phone call from patient stating that she has found out that is pregnant since receiving the vaccine. I advised her to notify her OB doctor and that I was completing a VAERS form.
Patient had axillary lymph node swelling on side of injection, also malaise, myalgia, and abdominal pain. Lymph node swelling resolving at time of follow up visit. Labs ordered to rule out other etiology.
Information has been received from a registered nurse concerning a 6 month old patient who on 25-MAR-2008 was vaccinated PO with the third dose of Rotateq (lot# not available).  On that same day the patient developed a rash, swollen eyes and experienced diarrhea.  The patient sought medical attention through an office visit.  The rash was worse the next day.  The infant was treated with BENADRYL.  On 27-MAR-2008 the infant's eyes were no longer swollen and the rash improved.  The patient was noted to be recovering from the rash and the outcome was unknown for diarrhea.  Dates of administration for the first and second doses of Rotateq (lot numbers not available) were not available.  There was no product quality complaint.  Additional information has been requested.
Flushing/sweating, neck stiffness. BP 178/94 (pulse 94). F/u BP 147/80.
rheumatoid arthritis flare up; This is a spontaneous report from a contactable nurse. A patient of an unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number not provided), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient's medical history included rheumatoid arthritis. Concomitant medications were not reported. The patient had a rheumatoid arthritis flare up on an unspecified date. The outcome of rheumatoid arthritis flare up was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the information provided by the reporter, it appears unlikely that subject vaccine contributed to the event of rheumatoid arthritis flare up.  The reported event likely represent intercurrent medical condition.   There is limited information provided in this report. This case will be reassessed upon receipt of follow-up information.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Approximately 6-8 weeks after each Gardasil injection, I was hospitalized with debilitating pelvic pain, ovarian cysts, nausea, vomiting & weight loss. I received IV fluids and pain medications, as well as multiple day stays to stabilize electrolytes. Exploratory surgery was also performed due to extreme pelvic pain brought on by the course of the three (3) HPV shot series, and a diagnosis of Endometriosis was made. No prior history before HPV series of endometriosis, pelvic pain or ovarian cysts.
This is a spontaneous report from a contactable consumer (mother). A 20-year-old male patient received first single dose of TRUMENBA around 1600 on 19Oct2015. Concomitant medication included an unspecified blend allergy shot, one injection administered every three weeks (last dose before the event was on 16Oct2015). Concurrent condition included allergy. On 19Oct2015 the patient experienced chills and muscle weakness from 16.00 to around 23.00. Later he went to sleep and was okay the next morning. These events recovered completely on an unspecified date in Oct2015 (uncertain whether the end date was 19Oct2015 or 20Oct2015). Outcome of the event bruise at the injection site was unknown. Follow-up (06-FEB-2016): Follow-up attempts are completed. No further information is expected.
I woke up in the middle of night shaking and teeth did not stop shaking. It lasted for a couple of hours and I was fine after it went through its course.
This spontaneous report was received from a pharmacist and refers to a 56 year old male patient. No information regarding the patient's medical history, concurrent conditions and concomitant therapies was provided. On 25-SEP-2015, the patient was vaccinated with a shot of PNEUMOVAX 23 (lot #, expiration date and exact dose were not reported), subcutaneously. The next day, on 26-SEP-2015, the patient developed a rash and experienced redness and swelling in the arm in which the shot was given. It was reported that the patient went to his family doctor. No PQC (product quality complaint) was involved. The outcome of the events was reported as recovering. The relatedness between the events and PNEUMOVAX 23 was not provided. Additional information has been requested.
Pain, swelling, erythema, and mass R upper outer breast, Ultrasound and pathology of biopsy indicates abscess
10 minutes post dose, had chest tightness, was laid on cot by Staff. EMS were called. EMS arrived very quickly. EKG was done and showed normal sinus rhythm. Symptoms lessened. Attendee left on her own
Patient reported a bruise about 2x2inches, started immediately after she received the vaccination. When she came inon 11/8/17, bruise still very visable. She stated her arm was very sore for 2-3 days, but the bruise is healing now and arm feels better. Patient just wanted us to be aware. She is not on any anticoagulation medications, aspirin or OTC NSAIDS. She states she doesn't bruise abnormally easy.
This case was reported by a consumer via call center representative and described the occurrence of adverse event in a 70-year-old female patient who received 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 adverse event. On an unknown date, the outcome of the adverse event was recovered/resolved. It was unknown if the reporter considered the adverse event to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient had bad reaction lasted for days after 1st vaccination of SHINGRIX. The patient asked, should she expect the same for the 2nd vaccination.
Uncomfortable tingling in both feet and both hands especially lying down for sleep Overall body intermittent tingling including all extremities during the day  Swollen lymph nodes left side of upper body  Intensity has lessened - have not had second dose yet
3 little dots on face on 2/4/01; 3 dots on arm on 2/5/01 and all over body on 2/6/01. Saw pediatrician on 2/6/01. Rash continues over body but not on palms of hands. Is fading at the present time. No fever.
Patient had no adverse reaction, submitting report because vaccine given was an adult dose administered for a pediatric patient. HEPLISAV-B vaccine not approved for 19 and under.
little bit sick; Runny nose; I get like allergies such as sneezy; I get like allergies such as sneezy; little bit of coughy; lot of phlegm like in throat; Flu; This is a spontaneous report from a contactable consumer or other non hcp (patient).  A patient of unspecified age and gender received BNT162B2 (PFIZER BIONTECH COVID VACCINE, solution for injection, Batch/Lot number: unknown) via an unspecified route of administration on 13May2021 as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient previously received first dose of BNT162B2 (PFIZER BIONTECH COVID VACCINE, solution for injection, Batch/Lot number not reported) via an unspecified route of administration on unspecified date as DOSE 1, SINGLE for covid-19 immunisation. On an unspecified date in May2021, patient experienced little bit sick, runny nose, i get like allergies such as sneezy, little bit of coughy, lot of phlegm like in throat, flu. Patient got second dose and patient feel okay about it but recently little bit sick like you know the normal like runny nose, patient had not a fever but runny nose, patient got like allergies such as sneezy and a lot of a little bit of coughy, lot of phlegm like in throat, flu. Reporter's seriousness was unspecified for all events. The outcome of events were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
INFANT HAD BLOODY STOOLS 2 WEEKS AFTER THE ORAL DOSE
This case was reported by a healthcare professional (nurse) and described the occurrence of diarrhea in a 2-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline), PENTACEL (non-gsk) and pneumococcal vaccines (non-gsk). Concurrent medical conditions included possible gastrointestinal virus. Concurrent vaccination included hepatitis B vaccine recombinant ;manufacturer unspecified; intramuscular;unknown given on 16 April 2012. On 16 April 2012 the subject received 1st dose of ROTARIX (intramuscular, unknown), unspecified dose of PENTACEL (intramuscular, unknown), unspecified dose of Pneumococcal vaccines (Non-GSK) (intramuscular, unknown) and experienced inappropriate route of vaccination with ROTARIX. The ROTARIX was administered by intramuscular injection instead of orally as indicated. On 16 April 2012, 2 days after vaccination with PENTACEL, Pneumococcal vaccines (Non-GSK) and ROTARIX, the subject experienced diarrhea and fussiness. According to the nurse, the subject had watery diarrhea for 12 days, but the nurse reported the recovery date for water diarrhea as 18 May 2012 and indicated that it could be a concurrent condition. The nurse noted the events could have been associated with exposure to gastrointestinal (GI) virus in the physician's office. No action was taken with ROTARIX series. The subject received first oral dose of ROTARIX at 4 month well check up on 18 June 2012 and "no problems occurred". The nurse planned for the 2nd ROTARIX oral dose to be given at 6 month well check up in August 2012. Relevant test results included stool culture with normal flora on 10 May 2012 and OVA and Parasite negative on 16 May 2012. On 20 April 2012 the fussiness was resolved and on 18 May 2012 the watery diarrhea and GI virus were resolved. The healthcare professional explained that the vaccine was reconstituted correctly and a new needle and syringe were used to withdraw the vaccine from the vial and administer intramuscularly. The healthcare professional noted that the maladministration occurred because the nurse did not attend training in services or read given literature on ROTARIX. It was reported that six subjects were administered ROTARIX by intramuscular injection. See cases A0981435A, A0983047A, A0983051A, A0983052A, and A0983053A for details regarding the other five cases.
Had Typhoid, Anthrax, and smallpox shot on 08/09/03.  On 08/12/03 had rash on my entire body.  Spoke to clinic and she said could to to ER if I wished.  Found out to be hives.
Patient experienced extreme soreness from elbow of right arm all the way to her neck muscles. Her arm from the elbow to her shoulder became red and inflamed. She also visited the emergency department on 10/30/17 due to high fever of 104-105F, which the patient does not believe was related to the immunization. They prescribed antibiotics for suspected bacterial infection.
Very fatigued, chills, fever for 4 days following vaccine. A week after receiving the vaccine I developed white itchy bumps on my legs. Three weeks later I still have incredibly itchy legs and lots of bruising. Doctor diagnosed today as a virus reaction to the covid vaccine.
Bumps formed under armpits and groin.  These bumps lasted about a week.
Developed fatigue, nausea and arm soreness for 48 hours post vaccination. 1 week after vaccination, developed a rash 4 cm below injection site- non-itchy, non expanding. Monitoring, ibuprofen for treatment, and rash resolved within 48hrs.
It expired on 08Jun2023 (30th day)/(6 doses of Moderna Covid-19 bivalent were Administered.); No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (It expired on 08Jun2023 (30th day)/(6 doses of Moderna Covid-19 bivalent were Administered.)) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7184B) for COVID-19 prophylaxis.     No Medical History information was reported.  On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (It expired on 08Jun2023 (30th day)/(6 doses of Moderna Covid-19 bivalent were Administered.)) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (It expired on 08Jun2023 (30th day)/(6 doses of Moderna Covid-19 bivalent were Administered.)) and NO ADVERSE EVENT (No adverse event) outcome was unknown.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (It expired on 08Jun2023 (30th day)/(6 doses of Moderna Covid-19 bivalent were Administered.)).    Concomitant medication use information was not provided by reporter.  Vaccine expired on 08-Jun-2023 (30th day). (6 doses of Moderna Covid-19 bivalent were Administered.)  Treatment medication use information was not provided by reporter.  This case contains information for the second patient out of six patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-729005 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-729005:Master case
Patient noticed swelling at the site the following day that kept increasing in size and became hot to the touch.  On 10/11 patient f/u at urgent care and was started on Cephalexin 500mg 1 tid x 7 days for cellulitis. On 10/16 patient's arm looks remarkably better, little to no redness and just a little "tight" at the site or a "tough spot".  Definitely improving.
Patient had an allergic reaction to the flu immunization and had to receive treatment at the ER. She was given prednisone and Benadryl. After vaccination patient reported feeling light headed and tingling in her arm.
Information has been received from a physician's assistant concerning a male who was vaccinated with a first dose of VARIVAX (Oka/Merck). The patient developed ophthalmic shingles during and unspecified time period after the patient received the initial dose of VARIVAX (Oka/Merck). The patient now had no current symptoms or treatment and the outcome was reported as recovered. No product quality complaint was involved. The physician's assistant was not interested in the VZV analysis by Polymerase Chain Reaction because there were no current lesions. Additional information has been requested.
Continued fevers after 24 hrs after injection and body aches; Continued fevers after 24 hrs after injection and body aches; This is a spontaneous report from a contactable nurse(patient). The 25-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on 22Dec2020 09:45AM at single dose(dose number was 1) at left arm in workplace Clinic for covid-19 immunisation. Medical history and concomitant medications were none. She was not pregnant, no known allergy to medications, food, or other products. There is no Covid prior vaccination, no covid tested post vaccination. There is no other vaccine received in four weeks, no other medications in two weeks. The patient experienced continued fevers after 24 hours after injection and body aches on 23Dec2020 06:00AM. There is no treatment received. Outcome of events was not recovered. Case considered non-serious. Information on the Batch/Lot number has been requested.
h/a, sweating, vertigo, nausea/vomiting; s/s for approx 2 days; tx-rest;
Right arm was sore; Have stuffy Nose; Had Chills; Headaches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Right arm was sore), NASAL CONGESTION (Have stuffy Nose), CHILLS (Had Chills) and HEADACHE (Headaches) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006B21A and 037B21A.) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced PAIN IN EXTREMITY (Right arm was sore), NASAL CONGESTION (Have stuffy Nose), CHILLS (Had Chills) and HEADACHE (Headaches). On 14-Mar-2021, PAIN IN EXTREMITY (Right arm was sore) and HEADACHE (Headaches) had resolved. At the time of the report, NASAL CONGESTION (Have stuffy Nose) and CHILLS (Had Chills) had not resolved.            .Patient took Tylenol for headache Action taken with mRNA-1273 in response to the event was not applicable   This case was linked to US-MODERNATX, INC.-MOD-2021-079284 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-079284:Case for dose 2
Pneumonia; Initial information was received on 12-Nov-2020 regarding an unsolicited valid serious case received from a consumer/non-health care professional .  This case involves female patient (age not specified) who had pneumonia, while she received INFLUENZA VACCINE.  Medical history, medical treatment(s), past vaccination(s) concomitant medication 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 were not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a serious pneumonia (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant. The patient was hospitalized for this event.  Laboratory data was not provided.  It was not reported if the patient received a corrective treatment.  At the time of reporting the outcome of event was unknown.  There will be no information available on batch number for this case.; Sender's Comments: This case concerns a female patient who had pneumonia after vaccination with INFLUENZA VACCINE. The time to onset is unknown. Additional information regarding patient's past medical history, condition at the time of vaccination, lab data excluding other predisposing etiologies, information on causative organism would be needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.
Although patient's symptoms (H/A, depression) appeared at a time (3/14) distant from the last of her GARDASIL shots (6/5/13), her mother has requested I report it now because her personality change has been so dramatic over the past year, mother has read of a similar set of symptoms appearing in an adolescent female of similar age as patient's, eventually attributed (? by whom) to the temporally-proximate GARDASIL vaccine for that young lady. Pt. continues H/A's with sx suggestive of depression. Seen recently at hospital for interpretation of an equivocal MRI. Neurologists there said, "Don't worry." (Pt. is also followed by peds neuro locally). Mom worries about ? (-) effect of GARDASIL series.
Moderna COVID-19 vaccine EUA 12 hours after 2nd shot- chills, headache, nausea & heartburn lasting 36 hours 17 days later- itchy rash on arms, legs & torso lasting 5 days. Took Zyrtec 2X/day to relieve itching and reduce rash.
Information has been received from a RN concerning a 67 year old female with type II diabetes mellitus and an allergy to pain medications (not further specified) who on 24Aug05 was vaccinated IM in the left deltoid with a 0.5mL dose of pneumococcal 23v polysaccharide vaccine (lot 649979/0531P). Concomitant therapy included fosinopril sodium (Monopril), amlodipine besylate (Norvasc), potassium chloride, insulin glargine (Lantus), insulin lispro (Humalog), ascorbic acid, cyanocobalamin, calcium (unspecified) (+) magnesium (unspecified) (+) zinc (unspecified), quinlin sulfate, and HCTZ/triamterene. Two days after vaccination, on 26Aug05, the pt presented to the physician's office with erythema, her whole upper left arm was swollen, and her left arm movement was restricted. She was noted to be afebrile. She was treated with cephalexin (500mg) and recovered on an unspecified date. No diagnostic laboratory tests were performed. A product quality complaint was not involved. Erythema, whole upper left arm swollen, and left arm movement restricted were considered to be disabling and other important medical events (OMIC) by the nurse. Additional information has been requested.
Hives all over lower trunk and thighs, bad itching, gradually going away & itching better but its been 5 days, cortisone creme-
No immune response from his testing.; immune disorder; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored program. A 76-year-old male patient received the second dose of BNT62B2 (PFIZER BIONTECH COVID-19 MRNA VACCINE, Lot number: EM9810) via an unspecified route of administration on 11Feb2021, as a single dose for COVID-19 immunization. Medical history and concomitant medication were not reported. The patient previously received the first dose of BNT62B2 (PFIZER BIONTECH COVID-19 MRNA VACCINE, Lot number: EL9262) via an unspecified route of administration on 21Jan2021, as a single dose for COVID-19 immunization. On an unspecified date (reported as 2 days ago), the patient had no immune response, his doctor told that he has immune disorder. The patient underwent lab test for blood work: No immune response, on an unknown date. Patient was wondering about what should he do now. Patient wanted to get a third booster shot. However, he was informed that the vaccine was not approved for use other than a 2 dose series. The seriousness of the events was reported as non-serious. The outcome of the events was unknown.   No follow-up attempts are needed. No further information is expected.