chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Injection site cellulitis This case was reported by a nurse and described the occurrence of injection site cellulitis in a 5 year old female patient who received diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed (Infanrix). At the time of the administration of Infanrix on 06 April 2005, the patient "had strep throat." Concurrent medications included Amoxicillin "for the strep." On an unspecified date in April 2005, on or before 08 April 2005, the patient received a dose of Infanrix on the left arm (dose number not specified lot AC14A009BA). At an unspecified time following the administration of Infanrix on 06 April 2005, the patient experienced injection site cellulitis in the arm of the Infanrix injection. The patient was seen at a physician's office and was treated with diphenhydramine and an unspecified "topical medication." The nurse considered the injection site cellulitis to be related to vaccination with Infanrix.
mom & dad relate epiosde of crying unconsoled for 5 hrs or more; south no medical attention that noc;
feel lousy; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of feeling bad in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 13-JUL-2023, the patient received the 2nd dose of Shingles vaccine. In JUL-2023, an unknown time after receiving Shingles vaccine, the patient experienced feeling bad (Verbatim: feel lousy). The outcome of the feeling bad was not resolved.   It was unknown if the reporter considered the feeling bad to be related to Shingles vaccine.     It was unknown if the company considered the feeling bad to be related to Shingles vaccine.   Additional Information: GSK receipt date: 14-JUL-2023 This case was reported by a patient via interactive digital media. The patient got 2nd vaccination the day before reporting and made the patient feel lousy. But the patient stated that he/she would be ok in few days. The follow-up could not be possible as no contact details were available.
Mild to moderate bone and joint pain lasting throughout following day. Swelling, redness in shoulder of injection. Muscle stiffness. Symptoms mildly improved with 600mg ibuprofen.
Hives to face, chest and upper extremities beginning after receiving vaccination. Patient took Claritin and Benadryl with mild relief in symptoms. Patient was prescribed Prednisone steroid taper: 10mg 3 tablets daily for 5 days. Outcome is undetermined as of todays date as treatment with steroids has not yet be completed.
mild pain; swelling; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (mild pain) and VACCINATION SITE SWELLING (swelling) in a male patient of an unknown age 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (mild pain) and VACCINATION SITE SWELLING (swelling). At the time of the report, VACCINATION SITE PAIN (mild pain) and VACCINATION SITE SWELLING (swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
no adverse effects; patient received improperly stored PROQUAD; This spontaneous report was received from a medial assistant and refers to a 4 year old patient of unknown gender. Information about the patient's medical history, concurrent conditions, concomitant medications and drug reactions or allergies was not provided.      On 12-SEP-2019, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # S002494 with an expiration date in 23-JUL-2020), for prophylaxis (strength, dose, route and frequency were not provided), that underwent a temperature excursion from 6 degrees Fahrenheit to 14 degrees Fahrenheit ,during a time frame of 50 minutes, and was reconstituted with properly stored    sterile diluent. No previous temperature excursion was reported, Digital data logger was involved. No adverse effects were reported.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-1909USA005231:
viral exanthem very consistent w/rubella;macular papular;rash-face, chest & back, arms w/minimal lesions;rt conjunctivitis;+ lesions soft palate;+sore throat;+vesicle posterior pharynx;
A onetime episode of hives without angioedema or airway involvement that resolved with the administration of Benadryl and steroids. There is an automatic concern for anaphylaxis when hives occur, however anaphylaxis involves more than one body system. 2 ½ hours prior to the event he received his first influenza immunization (AFLURIA) and his second TWINRIX.
9/12/03: Arm very red and swollen, with 5-6 vesicles, fever (not sure how high), went to ER 9/14/03. Treated with Keflex and fever med.
pt recvd vax 1NOV93 & on 14NOV93 devel a rash on face & back; No further details were provided
Initial report received from a health care professional on 21 December 2007. A 75-year-old male patient with a medical history of COPD, heart disease and penicillin allergy, had received an intramuscular left deltoid injection of FLUZONE, lot number U2511AA on 06 November 2007 and an unspecified amount of time later, developed "difuse" myalgias and arthralgia, generalized throughout the body. The patient was unsure exactly when the symptoms began and had not been ill at the time of vaccination. It was unknown if the patient had experienced any prior events with past Influenza vaccinations. The patient was evaluated by their physician who prescribed Mobic. The patient did not feel any improvement and Mobic was discontinued. The patient was then prescribed "Altram" on 20 December 2007. Laboratory testing was performed (date not provided) and included total CK, LDH, Chem12, CRP and Sed Rate; results pending. At the time of the report, the patient had not recovered from the event. Follow-up information was received from the reporter on 02 May 2008; this additional information was determined to meet seriousness criteria. SERIOUSNESS CRITERIA: OTHER - MEDICALLY SIGNIFICANT. The patient, who reported receiving the flu vaccine yearly, experienced significant muscle aches and pain "a short time" after receiving FLUZONE in November 2007. An arterial doppler performed on 20 November 2007 was within normal limits. Treatment with Mobic was initiated on 29 November 2007, and discontinues 20 December 2007. Ultram (previously reported as "Altram") was initiated 20 December 2007. Laboratory testing performed on 20 December 2007 revealed an elevated sed rate and elevated C-reactive protein (CRP). Repeat testing showed an improved CRP on 27 December 2007, and both the sed rate and the CRP were within normal limits by 20 February 2008. The patient's final diagnosis and Polymyalgia Rheumatica. Additional treatment included Vicodin as needed, and Prednisone. According to the reporter, the patient had recovered from the muscle aches and pains, but continued to take low-dose Prednisone.
6/6 27y.o. G1P0 at 38w3d by L=8.4wk US. Estimated Date of Delivery: 6/16/22  Presents to hospital for schedule IOL - CHTN.  Dx 13 wks C-section birth, baby boy
This spontaneous report was received from a pharmacist regarding an unspecified patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 14-JUN-2015, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (dose and route of administration were not reported, lot number K010535 with expiration date 27-AUG-2016 or lot number K020216 with expiration date 17-SEP-2016). There were no adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Was fine immediately after, lips felt tingling several hours later and have not stopped tingling (48-hours later, sense of numbness and tingling in fingertips, increased awareness of sounds, brain fog,  onset of pain at injection point later day of vaccine sore but manageable, excessive fatigue, deep muscle and joint aches, nerve sensations continuing.
Kinrix was given to a 2-month-old patient instead of Dtap; Kinrix was given to a 2-month-old patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 2-month-old female patient who received DTPa-IPV (Kinrix) (batch number 7D2Y4, expiry date 22-AUG-2025) for prophylaxis.   On 21-AUG-2023, the patient received Kinrix. On 21-AUG-2023, an unknown time after receiving Kinrix, the patient experienced wrong vaccine administered (Verbatim: Kinrix was given to a 2-month-old patient instead of Dtap) and inappropriate age at vaccine administration (Verbatim: Kinrix was given to a 2-month-old patient).  The outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 21-AUG-2023 The reporter reported that the 2 months old patient received Kinrix vaccine instead of Dtap, which led to wrong vaccine administered and  inappropriate age at vaccine administration. The vaccine administration facility was the same as primary reporter. The reporter was unsure if patient was supposed to be given infanrix or pediarix. The reporter mentioned that patient did not had any prior doses of Dtap or IPV. The reporter did not consent to follow up.
Covid; Covid; This is a spontaneous report received from a contactable reporter(s) (Physician) from product quality group. The reporter is the patient.  A 70-year-old male patient received BNT162b2 (BNT162B2), on 08Mar2022 as dose 4 (booster), single (Lot number: FK9895) at the age of 70 years, in left arm 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) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "Known allergies: penicillin" (unspecified if ongoing); "Known allergies: sulfa" (unspecified if ongoing). Concomitant medication(s) included: NEVIBOLOL DCI, start date: 01May2022, stop date: 28May2022. The patient experienced Covid-19 on an unspecified date. The patient received PAXLOVID orally from 17May2022 to 21May2022 as Covid-19 treatment. The patient underwent the following laboratory tests and procedures: Covid-19 test: Unknown results. The outcome of the event was unknown. Product Quality Group provided investigational results on 02Jun2022 for BNT162B2: the complaint for "PFIZER-BIONTECH COVID-19 VACCINE" was investigated. The investigation included reviewing the involved batch records, deviation investigation, an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot FK9895. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. PGS (site withheld) concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed.; Sender's Comments: Based on the information currently available, lack of efficacy of the suspected vaccine BNT162B2 cannot be completely excluded.,Linked Report(s) : US-PFIZER INC-202200771991 same reporter/pt, different drug/event
Pulmonary embolism; immobile; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Covid-19 vaccine for Covid-19 Immunization, reaction(s): "Covid-19", notes: Primary series of immunization complete., Manufacturer: Unknown. The following information was reported: PULMONARY EMBOLISM (hospitalization, medically significant), outcome "unknown"; IMMOBILE (hospitalization, medically significant), outcome "unknown". Clinical information: The caller was told by her friend about the friend's mother. The friend stated that they think her mother's pulmonary embolism was caused by the friend's mother's booster dose of the Pfizer BioNTech Covid 19 Vaccine. Caller stated that the friend's mother is hospitalized and immobile, the issue is serious. Pulmonary Embolism: Caller stated that the patient was in (withheld) when the event occurred. She was hospitalized in (withheld) for a few weeks until she was stable enough to be moved to a hospital back home in (withheld). Caller states that it has been 72 days that the patient has been diagnosed and hospitalized related to the Pulmonary Embolism. The patient was in a hospital in (withheld) and a hospital in (withheld). The patient is in a rehab facility currently per the caller. Caller reported this event occurred after the booster dose of the Pfizer BioNTech Covid 19 Vaccine, but information related to previous doses of the vaccine was unknown by the caller. Prior Vaccinations (within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s):  None  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Lost sense of taste and smell; Lost sense of taste and smell; This is a spontaneous report from a contactable other HCP (patient herself). An 50-year-old female patient non pregnant)received a first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number:EN6201 and expiration date: unknown) via intramuscular route of administration in left arm on 11Feb2021 at 09:00 AM as single dose for COVID-19 immunisation. The medical history included Depression and allergy to cephalosporins. Concomitant medications were not reported. Patient did not take any other vaccine in four weeks. No COVID prior vaccination and did not tested COVID post vaccination. On 11Feb2021 at 19:00, the patient experienced lost sense of taste and smell. The patient did not take any corrective treatment for the adverse event. The outcome of the events was not recovered.
SKIN BREAKOUT; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced skin breakout. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of skin breakout was not reported. This report was non-serious.
Shot given on 5/21/04- on 5/24/04 arm red & swollen twice the size after inspection.
Dizziness, blacking out, high fever, body aches, sore throat, headache
Hep B was administered to patient rather than Hep A as ordered. Dr was made aware and the parent of the patient was counseled by the Dr. Hep A was administered to the patient. There are no adverse effects expected per Dr nor are there any effects to report at this time. Mother verbalized understanding.
Pt presented to ER with left arm swelling, warmth, and tenderness. Pt also had transient abdominal pain and nausea on 10/3/09 only, but no edema, vomiting, other skin lesions. No redness. No fevers. In ER 10/3/09 was given ceftriaxone x 1 and started on keflex for possible cellulitis vs vaccine reaction. Pt not given benadryl. Per nursing, arm better by 10/5/09 when PPD was checked, and seen by myself 10/6/09 with normal exam, and no pain or tenderness.
Swollen, red, hot deltoid, cellulitis.  Follow up on 10/28/04 states: "Problem at pneumovax site."
Information has received from a registered nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medication were not provided.  On 25-SEP-2016, the patient was vaccinated with improperly stored VARIVAX subcutaneous injection (lot # M012990, expiration date 14-MAR-2018, 0.5 ml, once, subcutaneously) for prophylaxis. On 25-DEC-2016, the vaccine was exposed to 28 Fahrenheit degree for 2 hours and 10 minutes. No adverse effects were reported. Data logger was involved. There was no prior excursion. On 06-DEC-2016, the registered nurse provide contact details to contact other nurse who could provided additional information about the patient. This is one of several reports received from the same reporter.Additional information has been requested.; Sender's Comments: US-009507513-1610USA009079: US-009507513-1610USA009080: US-009507513-1610USA009085: US-009507513-1610USA009082: US-009507513-1610USA009083: US-009507513-1610USA001984: US-009507513-1610USA009078: US-009507513-1610USA009081:,MERCK 1610USA009084:Mfr number.
A knot in my arm at the injection site; Knot is bigger and redder and a bit sore (size of a coin); Knot is bigger and redder and a bit sore (size of a coin); Soreness and stiffness in my joints; Soreness and stiffness in my joints; This is a spontaneous report from a contactable consumer (Patient). A 40-years-old non pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number not provided), via an unspecified route of administration on 19Jul2021 at 14:00 administered in Arm Left as a single dose for COVID-19 immunisation At Pharmacy or Drug Store. Medical history included allergies to sulfa from an unknown date and unknown if ongoing. Concomitant medication(s) included esomeprazole sodium (NEXIUM); famotidine (PEPCID); levothyroxine sodium (LEVOTHYROXINE) (all taken for an unspecified indication, start and stop date were not reported). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.On 27Jul2021 at 22:00 pm, after one week and one day I redeveloped A knot in my arm at the injection site last night (size of coin). This morning the Knot is bigger and redder and a bit sore (size of a coin). It's a bit annoying but not affecting my quality of life at the moment. I do still have Soreness and stiffness in my joints but it's very manageable. No treatment was given for the events. The outcome of the events was unknown.  Information on the lot/batch number has been requested.  Follow-up activities closed. Batch/lot number not available for [Vaccine, BNT162B2], F/UP closure to be managed as significant.
Severe arm pain after shot.  Woke me out of sleep night after shot.  Unable to lift arm horizontal to shoulder, knot size of walnut.  Diarrhea x 24 hrs, headache, low grade temp, wheezing day 4, shortness of breath noted upon exertion day 3-7.  Expiratory wheezing.  Much better (able to walk without shortness of breath day 7).  Laryngitis day 2-6.  Went to ER.  Received IVF for low potassium and dehydration due to diarrhea.  T max 99.9.
After vaccination in right deltoid, area began to swell and became erythematous. Patient returned to office two days after vaccination due to continued swelling at vaccination site.
Elevated Temp. Increased Heart Rate. Pale. Lethargic. Headache.
Myalgia, Diarrhea 12/31 severe body aches (back,neck,hip aches), GI distress (diarrhea) 12/31 severe body aches (sometimes happens using laptop): back, neck, and hip aches, GI distress (diarrhea). 1/1 faded away. previous Covid positive 3/23/2020. Patient reports these were the symptoms he had when he had  COVID
p/vax pt ran a fever;T104.5;called MD who said to treat w/APAP alternating w/Ibuprofen & fever should no longer than 48hr;fever elevated;visit to MD showed bilat OM;tx w/ATB;
Breakthrough bleeding with severe cramps, I have an IUD due to endometriosis and have not had a menstrual cycle for a few years. Bleeding lasted 1 day and stopped, have not had reoccurrence although stomach/uterus area does feel sore, will make appt with doctor.
3 seizures: 1/12 excessively tired, 1/13 woke up with 2 cuts on tongue so we suspect seizure over night, 1/13 headache in morning, seizure at about 11:00 in school followed by another seizure in emergency room at about 1:00.
Painful at injection site, pain continued for several months until approx. March, 2012.  Shoulder lost much range of motion for approx 6 months.
10JUL c/o sore throat, rhinitis, cold hands & feet, sweaty;11JUL dizziness & diarrhea, tired, nausea, h/a;no local rxn of vaccination site;
Second COVID immunization from Pfizer at 0930 sat.  (No symptoms at all with first immunization) Symptoms of fatigue began approx. 12 hrs. late,  then fever after midnight, chills, body aches, severe headache, abd cramping, and extreme fatigue. Highest fever recorded was 101.8 the next day (Sunday) around  4pm.  Didn't take Tylenol or Motrin.  As of writing this (Monday 12:07 pm) my fever is gone but headache and extreme fatigue remain. Injection site still sore and today I notice I have a very swollen and painful lymph node left axilla opposite injection site.  I had to call in sick today and possible will tomorrow if the extreme fatigue and headache don't go away.
Pt was admitted to hospital in respiratory failure from pneumonia and probably congestive heart failure on 12/1/02. Hosp dis: pneumonia, renal insufficiency, atrial fibulation.
red rash--at least a hand width wide; fatigue; injection site itching "driving me crazy"; joint pain...it was bad; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (red rash--at least a hand width wide), FATIGUE (fatigue), ARTHRALGIA (joint pain...it was bad) and VACCINATION SITE PRURITUS (injection site itching "driving me crazy") in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, the patient experienced ARTHRALGIA (joint pain...it was bad). On 19-Apr-2021, the patient experienced RASH ERYTHEMATOUS (red rash--at least a hand width wide), FATIGUE (fatigue) and VACCINATION SITE PRURITUS (injection site itching "driving me crazy"). On 19-Apr-2021, ARTHRALGIA (joint pain..it was bad) had resolved. At the time of the report, RASH ERYTHEMATOUS (red rash--at least a hand width wide), FATIGUE (fatigue) and VACCINATION SITE PRURITUS (injection site itching "driving me crazy") outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment taken included A&D Diaper Rash Ointment, and also baking soda -- neither helped with the itching.