chrisvoncsefalvay/vaers-outcomes huggingface dataset:
fever of 101.4°F; facial swelling; hives all over the body/welts all over the body; allergic reaction with the PENTACEL; Initial information received on 18-Aug-2023 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp (Non-healthcare professional).  This case involves a 1 years old female patient who experienced facial swelling, hives all over the body/welts all over the body, allergic reaction with the pentacel and fever of 101.4°f after receiving Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 15-Aug-2023, the patient received 0.5 ml of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine Suspension for injection (lot number: UJ678AA) (Strength: Standard) (Frequency: Once) (1 X) (with an unknown expiry date) via intramuscular (Left Vastus Lateralis Intramuscular) route in unknown administration site for immunization.  On 15-Aug-2023, the patient developed events of facial swelling (swelling face), hives all over the body/welts all over the body (urticaria) and allergic reaction with the pentacel (hypersensitivity) (Latency: same day).  On 16-Aug-2023, the patient developed an event of fever of 101.4°f (pyrexia) (latency: 1 day).  Relevant laboratory test results included: Body temperature - On 16-Aug-2023: 101 F  It was reported, Patient's mother reporting an adverse event on behalf of her daughter. Patient's mother reported that her daughter had a sever allergic reaction to PENTACEL. Patient's mother reported that her daughter was given PENTACEL last 15Aug2023. Patient experienced facial swelling, hives and welts all over the body 2 hours after the vaccine was given. Patient was given IBUPROFEN and BENADRYL for the fever and hives as per the advise of her nurse. On 16Aug2023, patient's full body was covered with hives and had a fever of 101.4°F. Patient was rushed to the ER as per the HCP's advice. After a few hours that the patient was the patient was sent home from the ER, the patient had the hives again and patient's mother called back their doctor and the patient was given PREDNISONE and BENADRYL. Patient's mother reported that the patient's hives will re-appear if BENADRYL's effect would run out. Patient went back to the doctor and HCP confirmed that the patient had an allergic reaction with the PENTACEL. Patient's mother reported that the patient will undergo testing as per HCPs advice. Patient's mother was asking compensation for the laboratory tests and treatment that was done on her daughter. Customer relations number was given to the patient's mother. Case number was given to the patient's mother for reference  Action taken: not applicable.  The patient was treated with PREDNISONE (PREDNISONE) for Urticaria, DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) for Urticaria and IBUPROFEN (IBUPROFEN) for Pyrexia.  Outcome: Not Recovered / Not Resolved for the reported events
This spontaneous report as received from a pharmacist refers to unspecified number of patients of unknown age and gender. On an unknown date, unspecified number of patients may have been vaccinated with GARDASIL (strength, dose, route, lot number and expired date unknown) that was stored outside of the original box and exposed to light and no adverse effect was unkonwn. No further information was provided. This is one of several reports received from same source. Additional information has been requested.
Presented at doctor's office on 1-24-19. Leg was red and raised in the injection site on LVL - left thigh. There was no pain present upon touching and pressing. Fever was present in child of 101.3 oral. BENADRYL was recommended if itching became present. Child had all of the vaccines prior with no reaction except the KINRIX was a combined shot of DTAP and Polio. Child has had 5 doses of DTAP and 4 doses of IPV. 2 doses of varicella and 2 doses of MMR. Vaccines given on RVL - Rt thigh was MMR and LVL - Left thigh - KINRIX and varicella.
Patient was given vaccines and after approx. 1 min began to faint in chair, mother and nurse assisted patient with safety, nurse cooled patient with cool paper towels and fanned patient. Patient became more alert and was given saltines and 7.5 oz cherry cola.
11/7/16 - Pt received vaccine at 10:15 in (L) deltoid. - Eve warm, redness, swelling. 11/4/16 - Received call from mother RE.- Injection site from (L) acromial process to (L) elbow at 7am. Pt visited MD at 1145. Advised mother to elevate and ice intermittently. Mother will give BENADRYL and TYLENOL for a couple of days and F/U with PCP if necessary. 11/05/16-1050 call to mother Pt improving decreased SW.
Prolonged pain at site of injection (left deltoid) and surrounding area; had focal "knot" - now gone.
While administering vaccine, the the plunger of the Fluarix vaccine stopped and would not advance. Syringe removed. Family notified.  Vaccine dose repeated per CDC recommendations.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Severe, Systemic: Vomiting-Severe, Additional Details: about 10 minutes after receiving the vaccine the patient started sweating and vomiting
First / vaccine in / November 2020 or November 2019 / second / on 6-14-2021; Pain / at injection site; Redness at injection site; Nausea; Chills; Slight fever; Noticed spots all over her tongue; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose  in November 2020).   On 14th June 2021, the patient received the 2nd dose of Shingrix (intramuscular). On 14th June 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. In June 2021, the patient experienced injection site pain, injection site erythema, nausea, chills, fever and tongue pigmentation. On 16th June 2021, the outcome of the nausea, chills and fever were recovered/resolved. On an unknown date, the outcome of the injection site pain, injection site erythema and tongue pigmentation were not recovered/not resolved and the outcome of the drug dose administration interval too long was unknown.   The reporter considered the injection site pain and injection site erythema to be related to Shingrix. It was unknown if the reporter considered the nausea, chills, fever and tongue pigmentation to be related to Shingrix.  Additional details were provided as follows: 12 hours after receiving 2nddose of Shingrix, patient experienced injection site pain, injection site redness, chills, fever, nausea and 21 hours after receiving Shingrix, patient experienced spots on tongue. The patient received 2nd dose of Shingrix, more than the recommended interval, which led to lengthening of vaccination schedule. The reporter mentioned that, fever, nausea, chills resolved after about 12 hours. The reporter also mentioned that, injection site pain, injection site redness and spots on tongue were not resolved. No other information was given on spots on tongue. The reporter did not consent to follow up  Note- As start date for 1st dose was not clearly specified, November 2020 was being captured conservatively
BREAKTHROUGH INFECTIONS; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; This spontaneous report received from a social media via a patient via a company representative concerned an unknown number of multiple patients with unknown age, sex, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin, batch number and expiry were not reported) dose, start therapy date were not reported administered 1 in total for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. It was unknown whether patient had any adverse events following vaccination with covid-19 vaccine ad26.cov2.s (Dose number in series 1). Patient received multiple doses of non-company suspect vaccine included: covid-19 vaccine (unspecified manufacturer) (Dose number in series 2) (form of admin, route of admin, batch number and expiry were not reported), dose, start therapy date were not reported for covid-19 prophylaxis. No concomitant medications were reported.  On an unspecified date, the patient experienced breakthrough infections, and revaccination with different covid-19 vaccine following vaccination with covid-19 vaccine (unspecified manufacturer) (Dose number in series 2). reported that  "I wish you would release data on the efficacy of your COVID-19 vaccine: Everyone I know who got 1xJNJ + multiple mRNA boosters has experienced breakthrough infections. I received 2xJNJ + multiple other platforms and have not been infected. Do you have data on us 2xJNJers?". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the breakthrough infections and revaccination with different covid-19 vaccine was not reported. This report was non-serious. This report was associated with product quality complaint: 90000256536
The day of vaccination these symptoms started: fever up to 100.4 F (I've been taking Tylenol since then), chills, headache, loss of appetite, a bit of nausea, a little discomfort when swallowing, sore arm  One day after vaccination this symptom was added: Stuffed and runny nose, sneezing
24 hours after injection on left thigh, 3cm erythema papule with increased redness in center, medial to injection site; warm and tender to touch. Right thigh small 2-5mm erythema papule at shot site. 10/18/02 Mom called--increased redness, swelling and bruising on right leg and left leg bruising on thigh spreading. Keflex 500 PO BID for 10 days. Diagnosis - cellulitis vs sot reaction.
Information has been received from a registered nurse concerning a 6 year old male who was exposed 3 weeks ago to a child in his class who had chicken pox on 07/03/2000 was vaccinated with a 0.5ml dose of varicella virus vaccine live (Oka/Merck)(lot#634512/0436k).  There was no concomitant medication.  On 04/20/2004 the patient broke out in a rash of scattered red spots with blisters on his back, chest and neck.  On 04/21/2004 the patient sought medical attention and was diagnosed with varicella.  There was no fever.  The physician did not prescribe any treatment and no diagnostic studies were performed.  The patient has not yet recovered.  Additional information has been requested.
On am 1/25/03 noted elevated temp (did not measure), body aches. Also noted papular rash on chest, neck, scalp. Increased severity of body aches 2/26/03 body aches have mostly resolved by today. Now has papules, pustules (one with scab) on anterior neck, upper back, scalp, tongue. Generalized vaccinia.
turning dark pink color big circle around that area; arm started itching at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOLOURATION (turning dark pink color big circle around that area) and VACCINATION SITE PRURITUS (arm started itching at the injection site) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     Concomitant products included MULTIVITAMIN [VITAMINS NOS], ATORVASTATIN and ATENOLOL for an unknown indication.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE DISCOLOURATION (turning dark pink color big circle around that area) and VACCINATION SITE PRURITUS (arm started itching at the injection site). At the time of the report, VACCINATION SITE DISCOLOURATION (turning dark pink color big circle around that area) and VACCINATION SITE PRURITUS (arm started itching at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medicines were  not reported.
HYPOCHROMIA; HIGH WHITE BLOOD CELLS; DVT WITH INFLAMMATION AND SWELLING OF RIGHT LOWER LEG; RUNNY NOSE; BILATERAL WATERY EYES; LEFT ARM TENDERNESS POST IMMUNIZATION; URINARY TRACT INFECTION; LOWER BACK PAIN; This spontaneous report received from a patient concerned a 68-year-old female. The patient's height, and weight were not reported. The patient's concurrent conditions included baker's cyst, and reflux sympathetic dystrophy. The patient experienced drug allergy when treated with gabapentin, and prednisone, drug intolerance when treated with codeine, and ibuprofen. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805031, expiry: UNKNOWN) once a total dose was not reported, administered on 10-MAR-2021 at right arm for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced urinary tract infection. On MAR-2021, the subject experienced lower back pain. On 10-MAR-2021, the subject experienced left arm tenderness post immunization. On 11-MAR-2021, the subject experienced runny nose. On 11-MAR-2021, the subject experienced bilateral watery eyes. On 14-MAR-2021, the subject experienced deep vein thrombosis with inflammation and swelling of right lower leg. On 23-MAR-2021, Laboratory data included: Diagnostic ultrasound (NR: not provided) confirmed DVT right lower leg, Urinalysis (NR: not provided) Unknown, and White blood cell count high (NR: not provided) 10.35 increased and was previously 9.23 not reported. Treatment medications included: ciprofloxacin for urinary tract infection. On 24-MAR-2021, the subject experienced hypochromia. On 24-MAR-2021, the subject experienced high white blood cells. Additional treatment medications (dates unspecified) included: rivaroxaban for deep vein thrombosis. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from runny nose, and bilateral watery eyes on 12-MAR-2021, and left arm tenderness post immunization on 11-MAR-2021, had not recovered from deep vein thrombosis with inflammation and swelling of right lower leg, high white blood cells, and hypochromia, and the outcome of urinary tract infection and lower back pain was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20210348648-Covid-19 vaccine ad26.cov2.s-Deep vein thrombosis. 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).
No additional AE reported; A 15 month old infant was administered GARDASIL 9; This spontaneous report has been received from a nurse, concerning a 15-month-old patient of unknown gender. Information regarding the patient's concurrent conditions, medical history, and concomitant therapies was not reported.  On 10-MAR-2022 (reported as "today"), the patient was vaccinated by mistake with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot #1775808, expiration date: 20-AUG-2023 (strength, and route of administration were not provided) as prophylaxis (Product administered to patient of inappropriate age). No additional adverse events were reported.
This spontaneous report as received from healthcare worker refers to a patient of unknown age. The reporter stated that the patient received a second dose of VAQTA (50/1.0 IU/ML) injection. Healthcare worker stated the patient received VAQTA on 21-MAR-2013 and 16-SEP-2013. No adverse symptoms reported. No further information provided. No product quality complaint issue was reported. Additional information is not expected.
Chills/nausea; onset 2 hours post vaccine. Muscle aches during night; 2 days later neck muscles and those surrounding eyes. Neuralgia roots of hair. Low grade fever (99.6) when Tylenol not in effect. Continues through today 11/4. Eye/neck muscles still painful; muscle involvement continues to this day.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 03-MAY-2016, the patient was vaccinated with GARDASIL 9 (lot # L043213, expiry date: 23-AUG-2017) that was improperly stored. The vaccine was stored in refrigerator at a temperature of 14.2UC for 8 hours 30 minutes and at 1.5 UC for 26 hours 30 minutes and in freezer at a temperature of -12UC for 8 hours and 30 minutes. There was no previous temperature excursion. Digital data logger was involved. No adverse effects reported. The outcome of the events was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
1. Tinnitus in left ear, constant high pitch humming  2. Constant itching  on chest, stomach, back, arms
No additional adverse AEs; HCP administered expired dose of MMR II.; route of administration IM; This spontaneous report has been received from a physician via company representative, concerning to a patient of unknown age and gender.   The patient's medical history, concurrent conditions, previous drug reactions or allergies, and concomitant therapies were not reported.  On 02-SEP-2022, the health care professional (HCP) administered an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (dose was unknown by the reporter; strength, vaccination scheme frequency, route of administration and anatomical site of application and lot number were not provided, expiration date reported as on 01-SEP-2022) administered for prophylaxis (expired product administered).  No additional adverse event (AE) was reported (no adverse event).  This report was considered non-valid due to the lack of patient's identifiers.  Follow-up information has been received on 20-SEP-2022.  Report was regarding a 12 month-old male patient, who was vaccinated on 02-SEP-2022 with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(rHA) (M-M-R II) lot number T029550 intramuscularly (subcutaneous injection formulation administered by other route).
Low grade fever, headache and body aches approximately 16hrs after injection which resolved approximately 12-18hrs after onset. This report concerns sudden and progressive right ear pain in mastoid region beginning 8 days after immunization. Causing aching, tenderness, pain and pressure behind bottom of right ear and just below ear canal area which causes waking at night and pain throughout the day. Initial appointment with primary care MD for workup and treatment on 15April21.  Outcome pending at time of this report.
Not under her arm was sore but down the vaccination site; Couldn't breath; Legs could not hardly walk; This is a spontaneous report from a contactable consumer. This consumer reported for a female patient (Reporter's mother). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for COVID-19 immunisation. Medical history included covid-19 from an unknown date and unknown if ongoing she had Covid. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced not under her arm was sore but down the vaccination site, could not breathe, legs could not hardly walk. It was reported that reporter's mother (consumer), took Pfizer the shot yesterday and she had Covid already, but she had it in October, she still has a little bit of side effects with it, she said that under her arm was sore and she was having little bit of could not breath and her legs could not hardly walk. When paraphrased the concern, reporter stated, Yes, she said under her arm like down on the side, sore, not her arm but down the site of her the (vaccination) site where shot was. The outcome of the events were reported as unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Starting around 10/2021. I started having headaches, hair loss, insomnia and loss of appetite. I started having allergy issues. First, was peanuts, which I had not been allergic to prior to vaccination, and I had Dermal Hypoplasia as a result. Next, I discovered I was allergic to oregano, which I had not been allergic to prior to vaccination, and it resulted in me breaking out in hives. Also, I started having numerous flare ups of shingles. I never really had any flare ups of it until I had this booster shot. I went to the ER 10/05/2021 and they diagnosed me with a peanut allergy. I was treated and discharged after a few days. My symptoms continued after receiving the booster dose of Pfizer. I followed up with my doctor on 10/05/2022 for a check up. I am still having insomnia, occasional headaches, hair loss and allergy issues. They are unsure of what the cause of my issues are.
Migraine, fever, chills, extreme muscle weakness, shortness of breath intense muscle pain, kidney pain, blue lips, nausea
Friday, day after shot was sick to my stomach. Sick in bed all day Sat. stomach pain, chills & fever. Sunday was weak & my stomach was sore. Never had a problem before.
Narrative:  65yr male with a history of CLL (stable disease on most recent CT) followed by Hematology service and was on observation without active treatment. PLT prior to Moderna #1 (2/19/21) and Moderna #2 (3/19/21) was WNL (238, date 1/27/2021). Within 2 days of Moderna #2 reports to hematology bleeding easily and PLT count was obtained <2 (3/24/21). Patient was directly admitted to the hospital for ITP (common CLL complication though one case report of IPT post vaccination). Bone marrow biopsy done on 3/31/21 showed 40% CLL cells with low normal megakaryocytes on preliminary read. ITP Therapy: Continues on prednisone 1mg/kg, s/p IVIG 3/25-3/28, rituximab-pvvr on 4/1 (4 weekly doses) started MMF and TXA 650mg TID on 4/2 for ongoing mucosal bleeding and low PLT (<2), then eltrombopag 50mg daily started on 4/3 (PLT <2). PLT count on 4/6 <2 and Surgical team consulted for consideration of splenectomy. On 4/7 PLT 5000 ITP is refractory to steroids and IVIG, with ongoing severe thrombocytopenia on rituximab, MMF, eltrombopag. Surgical Consult: ITP in light of multiple medical treatments, a laparoscopic, possible open, splenectomy is warranted. Surgery is planned for 7:30AM on Thursday, 4/8/2021.
This spontaneous report was received from a female patient of an unknown age concerning herself. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On an unspecified date in 2008, the patient was vaccinated with PNEUMOVAX 23, 0.5 ml (route, anatomical location, lot# and expiry date were not reported) for prophylaxis. On an unspecified date in November 2018, the patient was vaccinated with booster shot of PNEUMOVAX 23, 0.5 ml (route, anatomical location, lot# and expiry date were not reported) for prophylaxis. On an unspecified date in 2018 (reported as the day after the vaccination), the patient's arm hurt at the injection site (Vaccination site pain) and 2 days following the vaccination all of her joints hurt (arthralgia). About a week later, the patient experienced swelling of her legs and her legs (peripheral swelling) hurt so much (pain in extremity) that she could barely walk. She could only take baby steps (gait disturbance). The patient stated that swelling gotten better and she could take slightly bigger steps. The outcome of events was reported as recovering/resolving. No causality assessment with respect to suspect product was reported.