chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from the authors in a published literature article, title below, regarding a 20 month old male child. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unknown date, at the age of 13 months, the patient was vaccinated with varicella virus vaccine live (oka/merck) (manufacturer unknown) (dose, strength, frequency, route of administration, lot number and expiration date were not provided) in the right thigh for prophylaxis. He was symptom free until he developed a rash 7 months later. The rash was beefy red, vesicular, and localized to his right thigh and lower back, mainly along dermatome L3. He was examined twice in the outpatient clinic. No neurologic deficits were apparent either time. The exanthem worsened for 1 week, then slowly cleared over the following 2 weeks. The inflamed skin appeared to be painful, since the child avoided sleeping on that side. He was not admitted to the hospital nor was he treated with acyclovir and the patient was diagnosed with herpes zoster (shingles). Because of the severity of his rash, serology studies were performed to measure Varicella zoster virus (VZV) antibody and he was positive for both IgM (more than 1:64) and IgG (more than 1:256) by the fluorescent antibody to antigen assay. The exanthem worsened for 1 week, then slowly cleared over the following 2 weeks on an unspecified date. The author considered the events to be related to the suspect therapy. The author stated in some immunized children, virus reactivates within a few months to a few years to cause the dermatomal exanthem known as herpes zoster (shingles). Herpes zoster induced by varicella vaccination usually occurs within months to a few years after the vaccination in immunocompetent children. This is one of 3 cases from the same literature article 1901USA011678, 1902USA002563 and 1902USA002564. A copy of the published article is attached as further documentation of the patient's experience. Sender's Comments: US-009507513-1901USA011678.
Received approximately 0.1mL; A spontaneous report was received from pharmacist concerning a male patient, who received Moderna's COVID-19 vaccine and received approximately 0.1mL.  The patient's medical history was not reported. Concomitant medication use was not reported.  On 23 Dec 2020, the patient received their first of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection.   On 23 Dec 2020, there was a malfunction with the needle so the patient received less than 0.5mL of the vaccine. The reporter believes the needle was not on correctly and the administration error was due to user error. The nurse noticed 0.4 left in the syringe, so the reporter believes the patient received approximately 0.1 mL of the vaccine. The vaccine did not leak on the provider and the needle fell onto the floor during administration. The patient did not contact his healthcare provider and has not reported any adverse reactions or symptoms during administration. Treatment information was unknown.   Action taken with mRNA-1273 in response to the event was unknown.   The event, received approximately 0.1mL, was considered resolved on 23 Dec 2020.; Reporter's Comments: This report refers to a case of incorrect dose administered for mRNA-1273.  There were no reported AEs associated with this case.
Injection site pruritus; Injection site redness; A Spontaneous Report was received from consumer concerning herself of age 76 years, who received Moderna's COVID-19 vaccine and experienced Injection site itching and Injection site red ness. The patient's medical history was not provided. Concomitant product use was not provided. On 14 Feb 2021 prior to the onset of the events the patient received their first of two planned doses of mRNA-1273(Unknown batch number) via Intramuscular route for prophylaxis of COVID-19 infection. On 14 Feb 2021  the patient had events Injection site itching and Injection site redness  Treatment information was not provided. Action taken with the mRNA-1273 in response to events is unknown. Outcome of the events Injection site itching and Injection site redness were unknown.
Approx 22 hrs p/shots given child began screaming could not be consoled; t100; Given APAP,lump in Rt leg size approx 1 inch; Seen by MD stated was allergic rxn;
This case was reported by a healthcare professional (the subject's mother) and described the occurrence of swelling arm in a 4-year-old female subject who was vaccinated with INFANRIX (SmithKline Beecham). On 24 June 2003 the subject received 5th dose of INFANRIX (.5 ml, unknown route, left arm). On 24 June 2003, less than one day after vaccination with INFANRIX, the subject experienced swelling arm and hive. The circumference of her arm increased with swelling, and she could not help but scratch the itch. The healthcare professional reported that it took 2-3 weeks for swelling of her arm to resolve. On 7 July 2003, the events were resolved. The healthcare professional considered the events were probably related to vaccination with INFANRIX. The subject had not had any reactions to any vaccinations before or since.
Client is an adult male who came in for a Pfizer booster and received a Pfizer pediatric (5-11 year old) dose. Client was made aware of the error 12/8/21 @1626 by the lead nurse. Client to come in for a revaccination on 12/13/21.
5 min after receiving flu vac , pt c/o flushed face, feeling warm and thickness in throat. Pt taken to ER. Alert - oriented. Has never received flu shot.
Diarrhea persisted 24 hours with mucous and bloody mucous after all fecal material was exhausted.; Did have one episode of chills; This is a spontaneous report from a contactable physician.  A 51-year-old female patient received the first dose of bnt162b2 (BNT162B2) lot no: EK9231, intramuscular on 23Dec2020 09:45 at a single dose for COVID-19 immunization in workplace clinic. Medical history included hypothyroid, allergies from bee sting, and covid-19 from Apr2020, all unknown if ongoing. Concomitant medication included levothyroxine sodium (SYNTHROID). The patient did not receive other vaccine in four weeks. On 25Dec2020, in the late evening at 11:45 PM-almost midnight, the patient experienced diarrhea, severe, without nausea or vomiting. Did have one episode of chills that resolved. Diarrhea persisted 24 hours with mucous and bloody mucous after all fecal material was exhausted. The patient had COVID-19 in Apr2020 and had positive antibodies in Jun2020 with high titers. She confirmed with their ID chief that she should proceed to receive the vaccine. Diarrhea resolved in 24 hours. Some lingering increased GI activity. No fever (temp 99.0F) (Dec2020). The patient recovered from events without treatment in Dec2020. The events were reported as non-serious. The patient was not tested for COVID-19 post vaccination.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of diarrhea, severe cannot be excluded, considering the plausible temporal relationship and the known adverse profile of the suspect product.  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
Edema, erythema, induration of left deltoid seen 5-21-10, 2 days after injections.
Pt received 4 vaccines on that visit to Clinic. The other 2 vaccines were in the R thigh. On 9/22 he presented to the ER with fever and pain and tenderness and redness on the L thigh. An abscess was found and ultimately required surgery and IV antibiotics. Strep pyogenes Group A grew from the wound.
fever (tmax 101.5); severe nausea and vomiting; severe nausea and vomiting; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the parent.  A 13-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Dec2022 as dose number unknown (booster), single (Lot number: GJ6665) at the age of 13 years for covid-19 immunisation. The patient's relevant medical history included: "Down Syndrome" (unspecified if ongoing); "mild sleep apnea" (unspecified if ongoing), notes: mild; "congenital heart defect" (unspecified if ongoing), notes: congenital heart defect. Concomitant medication(s) included: MIRALAX. Vaccination history included: Covid-19 vaccine (Primary immunisation complete, manufacturer unknown), for Covid-19 immunisation. The following information was reported: PYREXIA (non-serious) with onset 14Dec2022, outcome "unknown", described as "fever (tmax 101.5)"; NAUSEA (non-serious), VOMITING (non-serious) all with onset Dec2022, outcome "unknown" and all described as "severe nausea and vomiting". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: On evening of 14Dec2022 she developed a fever (tmax 101.5) and about 40 hours after the dose developed severe nausea and vomiting. Event took place after use of product.
CHILLS; HEADACHE; FEVER; This spontaneous report received from a consumer via a company representative concerned a 23 year old female. 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 (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced chills, headache, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, headache and fever was not reported. This report was non-serious.
Headache, fever, chills, body aches, sore throat, hives, extreme fatigue
Patient stated she had redness and swelling after injection. The redness / swelling progressed down her arm to the elbow. She went to ER and was diagnosed with cellulitis and prescribed keflex for 7 days
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 81-year-old female patient who received SHINGRIX for prophylaxis. On 27th July 2018, the patient received the 1st dose of SHINGRIX. On 28th July 2018, 1 days after receiving SHINGRIX, the patient experienced injection site pain, injection site erythema and injection site swelling. On an unknown date, the outcome of the injection site pain, injection site erythema and injection site swelling were recovered/resolved. It was unknown if the reporter considered the injection site pain, injection site erythema and injection site swelling to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient for herself. The patient received SHINGRIX in the arm. After receiving SHINGRIX, her arm got quite sore, slightly swollen and quite red. All symptoms happened from the injection site downward but not all the way down to her elbow. The patient saw a primary care physician about this. The events started the day after the injection, they got worse for 2 to 3 days and then started easing up. The patient has denied permission to contact their physician.
Pharmacist mixed 4 vials of Pfizer vaccine using one vial of diluent instead of using a new bottle of diluent to mix each vial. All 4 vials of Pfizer vaccine were mixed one after the other, no time lag between mixing of the vials using the same diluent vial. All vials were properly mixed with 1.8ml of diluent to one vial of Pfizer vaccine.  No adverse effects have been reported.  The 24 vaccines given were a combination of first and second doses.
Patient received the vaccines around 11L30am on 9/13/2019. She had soreness, swelling, heat and delineated redness in area around injection site of left arm by that evening. States the symptoms were worse on day 2 including redness and swelling of the upper arm spreading to bicep area, hardness of the upper arm.  She came to pharmacy on day 3 to report her symptoms and said her left upper arm isn't as swollen but redness has spread. Still feels soreness/pain as well as heat on the upper arm. Patients is directed to follow-up with her PCP or go to urgent care/ED if new symptoms present. Otherwise, no tightness of the chest or difficulty with breathing per patient.
Hip fracture due to a fall at home, felt to be due to a bloodclot to lung.
IRRITABLE; HEAD PAIN; EXTREME FATIGUE; STABBING PAINS IN ABDOMEN; This spontaneous report received from a patient concerned a 68 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A expiry: 23-JUN-2021) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced stabbing pains in abdomen. Treatment medications included: paracetamol. On 12-APR-2021, the subject experienced head pain. On 12-APR-2021, the subject experienced extreme fatigue. On 21-APR-2021, the subject experienced irritable. Laboratory data included: COVID-19 virus test (NR: not provided) Negative, and PCR (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from stabbing pains in abdomen on 17-APR-2021, was recovering from extreme fatigue, and had not recovered from head pain, and irritable. This report was non-serious.
WARM SWELLING TO LEFT DELTOID WHERE VACCINE WAS RECEIVED  AREA ALSO RED AND TENDER.   TOLD TO APPLY ICE TO AREA AND GIVEN MEDROL DOSE PACK TO TAKE AS DIRECTED.  PATIENT FOLLOWED UP IN ONEDAY AND WAS IMPROVING.
PATIENT COMPLAINED OF FEVER, BUT HAD NO WAY TO ACTUALLY MEASURE HER TEMPERATURE AND SWELLING IN THE ARM AT THE INJECTION SITE. PATIENT HAD USED IBUPROFEN AND ICE ON THE SITE. PATIENT WAS ADVISED TO CONTINUE TREATMENT AND SEEK MEDICAL ATTENTION IF SYMPTOMS CONTINUE. ALSO COUNSELED PATIENT TO TRY TO OBTAIN A THERMOMETER TO SEE IF PATIENT WAS RUNNING FEVER.
Chills. Fever. Muscle aches and weakness. Headache. Weakness. Irratibility.
Severe headaches as reported by mom 12-14 hrs after shot. 50 X 55 warm swelling.
blocked artery in your brain; soft plaque; real bad headaches; This is a spontaneous report from a contactable consumer (patient).  A male patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), intramuscular on 11feb2021 as single dose for covid-19 immunisation. The patient medical history and the patient's concomitant medications were none. The patient received the first dose of vaccine on 24Jan2021 and experienced no adverse effect. The patient experienced blocked artery in brain on an unspecified date with outcome of unknow, soft plaque (cerebral arteriosclerosis) on an unspecified date with outcome of unknown, real bad headaches on an unspecified date with outcome of unknown.  The clinical course was as follows the patient was a disabled veteran. "A week after the second dose of vaccine the patient started having a real bad headaches and his head started hurting more and more the patient did a CAT scan with contrast for his ear because he had a problem on the side of his ear. The ear was ok, but the problem was on the left side of his head, he got a blocked artery in his brain which was called soft plaque, he never had this problem before till he had these shots."  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Pt presented with erythema, tenderness, warmth and itchiness to vaccine site where varicella vaccine was administered. MD diagnosed pt with adverse vaccine reaction on 1/29/20. Prescribed Benadryl and Hydrocortisone cream.  Pt to return the following day (1/30/20) for follow up; site marked to monitor if erythema increases.
Unable to move. Falling on the floor. Lying on back on floor and vomiting clear liquid for aprox. 3 hours . finally able to move after four hours.
This spontaneous report as received from a physician via company representatives and an unspecified reporter, refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 16-APR-2014, the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23 "10 Single dose 0.5mLVls 10SDV" and lot number J011998 with expiration date of 12-FEB-2015 (route of administration was unknown), which was stored at -6.66 Celsius Degrees for 260 hours. The type of excursion was refrigerator and the vaccine status in excursion. No concomitant therapies nor adverse effect were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
Vaccine at 1:30pm on 4/26/21. At 8:30pm my left arm was sore,  I couldn't lift it up. I worked that night 4/26/21 at 9:00 pm. At 3:00am on 4/27/21 i was very fatigue. By the time i got home from work at 5:30am which was only 1.9 miles away I had a massive headache, fever 101.9, chills, body aches, joint pain.  I could not go to work that night, I called in sick on 4/27/21. At 7:30am on 4/28/21 mild diarrhea and left arm is still sore
This spontaneous report was received from a female patient of unknown age regarding herself via a company representative. Approximately on an unknown date in 2013 (reported as just before 04-JUL-2013), the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date, dose and route unspecified). No concomitant medications were reported. Approximately on an unknown date in 2013, the arm of the patient was hot, red and swollen from the shoulder to the elbow after she received the ZOSTAVAX at a clinic. The patient did not seek any medical attention (patient did not contact healthcare provider). No treatment was provided. It was unspecified if any lab tests were performed. The outcome of all the events was unknown. The relatedness for the events was unknown for ZOSTAVAX. Additional information is not expected.
pt recvd vax 10AM on 5DEC94; 2AM 6DEC94 pt awakened w/fever of 105 R;
I have been experiencing a tingling and numbness in my right arm. It starts in the front part (anterior) of my right shoulder and continues down through my elbow and forearm into my right hand.  The worst numbness and tingling in my right hand is in my right thumb. I couldn't understand what is causing this tingling and numbness until I  read news reports about a rare connection between the Covid-19 vaccine and these types of symptoms. I wanted to report this right away.
Pt at chair, received vaccination and proceeded to pass out, Placed in wheel chair and elevated feet.  ammonia spirits under nose. groggy but able to answer questions. very pale and sweaty.  knew where he was and his name. Strong pulse noted.  Pt moved to stretcher to Observation room @11:45  BP 105/58, Pulse 58, RR 24 Pulse Ox 100. 11:31 BP 111/66, Pulse 58, RR 28 Pulse Ox 100.  Vital signs remain stable for next 15 minutes.  started to take sips of apple juice and water.  Head of bed raised bits at a time.  Felt dizzy at drastic head of bed elevations.  11:55  BP 110/65 Pulse 51, RR 20, Pulse Ox 100.  Pulse dipping to high 40s but pt states that this is his normal.  Wife at bedside.  reports feeling nausea and did eventually vomit.  feels better after emesis. 1230 BP 126/74 pulse 53 RR 20 PO 99.  eventually sitting and standing up. 12:50 BP 134/79 pulse 64 RR 20 po 96.  felt good.  walked with pt and wife out to exit.  Discharged to home with wife.
After each shingrix vaccine, first and second, I got sick. Three weeks after the second shot, my throat closed on me and I was in hospital on ventilator. After each shot I lost a cap on a tooth.
small bumps; both arms itchy; hives; Itchy hives; redness; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the right arm on 09Apr2021 at 09:15 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma and restless leg syndrome. The patient did not have any allergies to food, medications, or other products. Concomitant medications included magnesium (MANUFACTURER UNKNOWN), ethinylestradiol, ferrous fumarate, norethisterone acetate (LOESTRIN FE), cyanocobalamin-tannin complex (B12), multivitamin and rubus idaeus leaf, sambucus nigra flower, sambucus nigra fruit ELDERBERRY; all for unknown indication and from unknown start date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 09Apr2021 at 12:00, the patient experienced redness itchy hives around both ankles. Therapeutic measures were taken as a result of event redness itchy hives around both ankles and included treatment with soap and water. On 09Apr2021 at 17:00, the patient experienced small bumps and both arms itchy. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event redness itchy hives around both ankles was recovered on an unknown date in 2021. The clinical outcome of the event small bumps and both arms itchy was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Plaque psoriasis; This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (Plaque psoriasis) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    There was no reported medical history.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced PSORIASIS (Plaque psoriasis). At the time of the report, PSORIASIS (Plaque psoriasis) had not resolved.     No concomitant medications were reported.  The patient did not have plaque psoriasis until she took covid vaccination in Jan-2021. It started as something on leg and then arm.  It was unknown if patient was enrolled in a covid-19 vaccine trial.  No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Patient had swelling, soreness, pain, redness, hot to touch. This happened fairly quick and patient went to urgent care. Patient was treated for possible cellulitis and given BACTRIM. Patient is doing much better and reports that reaction is getting much better.
pt felt hot and dizzy. instructed pt to lie down and rest for a few minutes. VS obtained and stable. pt was feeling better within a few minutes. VSS at recheck. pt left for home in stable condition after designated observation period
Patient presented to the ED and was subsequently hospitalized for acute cystitis with hematuria, sepsis within  6 weeks of receiving covid vaccination.