chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Cause of blood clot in leg of this coworker's sister's leg.; This spontaneous case was reported by a non-health professional and describes the occurrence of THROMBOSIS (Cause of blood clot in leg of this coworker's sister's leg.) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) 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 THROMBOSIS (Cause of blood clot in leg of this coworker's sister's leg.) (seriousness criterion medically significant). At the time of the report, THROMBOSIS (Cause of blood clot in leg of this coworker's sister's leg.) outcome was unknown.            Concomitant Medication use information was not provided by reporter.  Treatment Medication use information was not provided by reporter.  Company comment: This spontaneous case concerns a female patient of unknown age with no reported medical history, who experienced the serious (medically significant) unexpected AESI of Thrombosis (Cause of blood clot in leg of this coworker's sister's leg) which occurred unknown days after receiving a dose of mRNA-1273.222 bivalent vaccine. No other information regarding clinical course, investigations, treatment, outcome was reported. The benefit-risk relationship of mRNA-1273.222 bivalent vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-713514 (E2B Linked Report). Sender's Comments:  US-MODERNATX, INC.-MOD-2023-713514: Coworkers case.
Injection site was bruise about 2 inches around and whole top arm was swollen and hard for 4 days. Could not raise arm without being in pain. Tired, headache behind the eyes, hard time breathing, chills (no fever) and dizziness. Still have headache and some dizziness and it has been a week and 2 days since the shot. Have not gone to the doctors. I have been treating myself with my inhalers and migraine medicine. Arm is better as far as soreness, but still have some bruising.
Felt weak, dizzy -> syncope episode less than 1 min, pt alert responsive after. Had pt rest supine 5-15 min. BP S to SLP. Felt fine within 5 min, orthostatic RPS normal. Pt discharged no other of s/sx of reaction.
mom states that 2NOV94 pt's aunt & uncle stated pt "stopped breathing" for a few seconds, & stiffened; they shook the pt & pt started breathing nl & began to cry;
45 Days post First Vaccine, No Second Dose yet; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (45 Days post First Vaccine, No Second Dose yet) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jun-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (45 Days post First Vaccine, No Second Dose yet). At the time of the report, PRODUCT DOSE OMISSION ISSUE (45 Days post First Vaccine, No Second Dose yet) had resolved.        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.   No concomitant and treatment medications were reported.    This case was linked to MOD-2021-213150 (Patient Link).
Information has been received from a pharmacy student concerning a 5 year old female patient who on 12-JUL-2010 was inadvertently given a dose of ZOSTAVAX (Merck) instead of VARIVAX (Merck). There was no adverse event reported. Additional information has been requested.
Received vaccine on 2/11 around 2:30pm.  About 5 days later she had some redness to her arm ( whole upper portion of arm from elbow to shoulder ) and was very itchy. Lasted for several days.
I had pain in neck almost after the shot, and pain in my arm where it hurt to move it. The next day I was nauseous on and off, had a extremely bad migraine.
A few days later Soreness and lump under arm receiving vaccine; A few days later Soreness and lump under arm receiving vaccine; This is a spontaneous report received from a contactable consumer (patient). A 64-years-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot Number: EL9269), via an unspecified route of administration administered in left arm on 06Feb2021 at single dose for COVID-19 Immunization. Medical history included physical urticaria past 12 years. Concomitant medications included lisinopril from an unspecified date (several years) and ongoing for high blood pressure, and sertraline from 31Dec2020 and ongoing for anxiety. The patient previously took the first dose of bnt162b2 (Lot number/Expiry Date: EL3248) administered in right arm on 16Jan2021 at single dose for COVID-19 immunization and experienced warm feeling/Getting a warm feeling and changed to cooler clothing, used cool cloth sat under fan; itching; face was really swollen/face was really swollen and red, looked like sun burnt, skin was blotchy; broke out in hives on her face, arms, and chest; a few days later Soreness and lump under arm receiving vaccine; skin was blotchy/face was really swollen and red, looked like sun burnt, skin was blotchy, took quercetin to prevent hives, and took loratadine (CLARITIN)/famotidine (PEPCID) from 17Jan2021 to an unspecified date. Patient had a history of physical urticaria and had been taken the supplement quercetin for several years to prevent hives when warm, On 17Jan2021 patient began taken loratadine (CLARITIN)/famotidine (PEPCID) again instead of quercetin. Before taking second dose on 06Feb2021 the allergist advised that 2 days before, on 04Feb2021 patient took loratadine 3 x a day and continue famotidine 2 x a day. Her vaccine was scheduled for 11:20 am. Patient took one loratadine 08:00 am and one at 11:00 am. The pharmacist there advised that patient also take one diphenhydramine hydrochloride (BENADRYL) before her vaccine. Patient had no occurrence of hives with the second dose of vaccines. A few days later (2020) soreness and lump under arm receiving vaccine same for second vaccine on alternate arm. The adverse events did not require a visit to emergency room and physician office. Outcome of the events was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021051378 same patient, different events on different dose of vaccine
Mom states infant had swelling and whelping/hives all over body. Mom states infants lips turned blue and had hives around mouth as well. Fever up to 102 degrees F.
Redness and swelling in arm, away from infection site. Pt went to urgent care where abx were prescribed for suspected cellulitis, however, pt stated cellulitis ruled out by physician in office visit next day. Prednisone ordered for reaction by physician.
a slight outbreak of topical dermatitis; This is a spontaneous report from a Pfizer-sponsored program. A female reporter reported for herself.  A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number, Expiry date was not reported), dose 2 via an unspecified route of administration on 03Mar2021 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient was previously received first doseBNT162B2 (PFIZER BIONTECH Covid 19 Vaccine, Solution for injection, Lot Number: unknown), via unknown route on an unknown date as dose 1, single for covid-19 immunisation. On an unspecified date 2021, the patient had slight outbreak of topical dermatitis. The patient would like to take antibiotics as she had a slight outbreak of topical dermatitis. The patient also enquired about the drug dupixent is an immunosuppressant as she consulted with her doctor. The clinical outcome of the event was unknown at the time of report.   Follow-up(5Mar2021): This is a follow-up spontaneous report from a Pfizer sponsored program. A contactable consumer reported: The patient experienced an event under suspect product bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE). Clinical information was added.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
p/vax pt w/aching bones, chills;had noticed large reddened area on lt deltoid;measured 60mm;
myocarditis; irregular heart beats; This is a spontaneous report received from a contactable reporter (consumer) for a Pfizer-sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, lot number unknown) as dose 3 (booster), single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYOCARDITIS (medically significant), outcome "unknown", described as "myocarditis"; HEART RATE IRREGULAR (non-serious), outcome "unknown", described as "irregular heart beats". The patient underwent the following laboratory tests and procedures: heart rate: irregular. Clinical course: The patient reported having irregular heartbeats after the booster shot and the patient was scared asking what to do about it. The patient also mentioned reading about this on a social media app as myocarditis. The patient asked for help as it occurs off and on, mostly at night.  The lot number for bnt162b2 was not provided and will be requested during follow-up.
After vaccine was administered, patient experienced an allergic reaction to the  covid-19 vaccine (Modern) boost lot number 026A21A. The patient complained of  red itchy skin which was warm to touch and radiate heat around 13:50.   Pharmacist  gave 2 capsules of diphenhydramine 25 mg, one capsule was given  immediately, and the second capsule was given to the patient to take home. Dr.  educate the patient on how to take diphenhydramine capsule and what to  expect from the medication. Dr personally checked on the patient every 5  minutes, and kept the patient for 30 minutes for observation. Dr explained  to the patient about angioedema symptoms and the need to come back to the  emergency department right away if symptoms worsen. Dr gave patient a call  around 16:40 and left a message to the patient to call back if she need anything  else.
on day 10 devel raised bumps on body & bright red patch on forehead that w/in 4 hr spread across forehead & onto lt cheek; patch was not raised; seen @ clinic & ER & r/o other causes;day 13 was fussy, cranky, no appetite, t100.4 seen by MD
Guillan - Barre syndrome.  Respiratory problems.  Weakness and fatigue.  Therapy. 12/7/2009 DC summary and MR for 1/12-1/18/2009, patient with c/o's ataxia, weakness and fever, cardio consult for tachycardia, neuro consult, Tx: IVIG   12/7/09 ER records received for date 9/7/09 to 11/11/09. Multiple ER visits for dental trauma due to accidental hit in the mouth, tooth extraction. ER visit 4/12/09 for fever. DX: viral syndrome. PMH: GBS dx 1/09. 12/7/09 ER records received for date 1/3/09 to 1/5/09. DX: ataxia, muscle weakness. ER visit on 1/3/09 for c/o not walking x2days, back pain. Assessment: mild gait disturbance. DX: muscular weakness. Admitted. ER visit 1/5/09 ER visit for decreased appetite x2wks, unsteady gait, "looks different", incontinent. Parent stated after several diagnostics did not want further testing, did not want pt to stay. DX: ataxia, muscle weakness. Parent signed pt out AMA. Assessment note for 1/5/09. parents state received vax 12/3/08 and for next 3 days pt. had fever which resolved, then pt began c/o weakness and leg pain while walking 12/31/08. parent states decrease appetite, not acting like self, refuses now to walk. Parent signed pt out AMA.
24 hours of severe headache, chills, muscle aches; day 2 swollen and tender lymph nodes in underarm to chest of left side/injection side
Patient requested the moderna 3rd dose and we gave her the Pfizer as the booster shot
This spontaneous report as received from a Certified Medical Assistant refers to a 9 month old patient of unknown gender. The medical assistant reported that on 16-AUG-2010, the patient was administered the first dose of M-M-R II (route unspecified, lot number and expiration date not reported) at less than 12 months of age (9 month old). There was no concomitant medication reported. The medical assistant also reported that on 27-SEP-2012, the patient was administered the second dose of M-M-R II (0.5 ml subcutaneous, lot number and expiration date not reported) at less than 4 to 6 years of age (34 month old). No adverse events were reported. Additional information is not expected.
Received the smallpox vaccine on 28 Nov 2003. Developed dry cough 5-6 days later. Symptoms increased and on day 7 developed a fever of 102.7, body aches, chills, stiff neck, headache, and dizziness. Denied any visual disturbances or altered sensation. Went to emergency later that pm on Dec 5. Had blood work and chest x-ray and was told he had pneumonia.  Denies having lumbar puncture or any imaging of head.   Did not require admission and was sent home with Tylenol, Zithromax and a decongestant. Was told to rest and increase fluids.   Currently reports that he is feeling better, no fevers since Dec 6. Cough is dry. States that his back is sore from coughing and lying around and that appetite is returning. Denies being around anyone with similar symptoms and did have influenza vaccine this year. States that his wife is now starting to experience similar symptoms.
Left sided facial numbness and tingling. Dizziness and lightheadedness. Mild headache.  Mental fogginess.
pain at injection site, shoulder and jaw; body aches, overall skin sensitivity, chills, lower back pain, headache, fatigue
pt recv vax 19APR93 & 19APR94 pt exp rheumatoid arthritis & fibromyalgia;pt could not move or get out of bed & felt achy & sore;pt also exp swelling;arthritis was in all joints;pt thought was dying;dx rheumatoid arthritis w/fibromyalgia;Annual follow-up dated 11/27/00 provided no additional data.
2 wks post vax Rubella vax rash on abdomen rt wrist swelling w/o fever or erythema;
Dizziness, Myalgia,  ITCHY/HOT/ELEVATED BP AT TIME OF ADMINISTRATION, RESOLVED DURING 30 MINUTE OBSERVATION Narrative:
Patient describes burning sensation immediately after receiving injection that since then has not decreased in pain severity. It radiates down her arm to her fingertips. It is painful for her to cross her arm to the other side of her body. She describes her arm as a "dead shoulder". She does state that TYLENOL ES does seem to help the pain, and she does notice the pain when she forgets to take her medicine. She is going to plan on continue to take APAP and attempt to use her arm more to dissipate the pain.
WELP ON LEFT THIGH, REDNESS, SWELLING. PLACED COOL COMPRESS ON PATIENT AND GAVE BENADRYL / TYLENOL.
No signs or symptoms in first 12 hours after injection.  Injection site pain at 7 on the pain scale decreasing to 1 in 72 (at time of this report) from time of injection.   Onset of extreme fatigue, headache (pain x7) and overall body aches (x7) started 12 hours after injection increase increase for 8 hours then began reducing.   No headache 16 hours after onset.  No body aches 24 hours after onset and no fatigue 36 hours after onset.  Chills and sensation of body heat up to 24 hours post-injection.  Mild sore throat onset at 67 hours after injection, pain at 1 on a scale of 1-10.
Rec'd shot IIV 9/27/16 11:45 am. Sleeping and woke up with head itching, eye swollen, lips swollen, no problems breathing approximately midnight. She took PO BENADRYL. Went to ED where rec'd IV steroids and D/C home W/steroid dose pack.
Heartburn all day everyday since receiving the vaccine. I don?t normally get heartburn very often and can normally treat it easily with over the counter meds.
contracted COVID two days after receiving vaccine; contracted COVID two days after receiving vaccine; This is a spontaneous report from a non-contactable nurse. A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient got their first dose of the COVID vaccination. The patient contracted COVID on an unspecified date two days after receiving the vaccine. The outcome of the events was unknown.  No follow-up attempts are possible. Information about lot/batch could not be obtained. No further information is expected.; Sender's Comments: A causal association between reported event and suspect BNT162B2 cannot be excluded.
Noted Reaction Type Reactions Pfizer Covid-19 Vaccine [covid-19 Vacc,mrna(pfizer)(pf)] Allergy/hypersensitivity   Heart racing, couldn't talk, felt need to pass out, felt weak, and not able to talk because tongue felt heavier  As of 04/16/2021 still complaining of Now having palpitations, feeling weak--- this happened again on the following Sunday, again for few minutes Has chest uncomfortable but no chest pain Felt like her speech was slower
painful swelling of the left supraclavicular lymph node; painful swelling of the left supraclavicular lymph node; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration in the left arm on 19Apr2021 at 15:45 (at the age of 37-year-old) as a single dose for COVID-19 immunisation. Medical history included depression. The patient did not have any known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included nefazodone (MANUFACTURER UNKNOWN) and venlafaxine (MANUFACTURER UNKNOWN) both from an unknown date for an unknown indication and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 20Apr2021 at 20:00, the patient experienced painful swelling of the left supraclavicular lymph node. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events painful swelling of the left supraclavicular lymph node was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
MENACTRA WAS inadvertently given subcutaneous instead of the recommended intramuscular route with no reported adverse event; Initial information received on 12-Nov-2021 regarding an unsolicited valid non-serious case from a Pharmacist via non-healthcare professional via Agency (Reference number- 00856094).  This case involves adult female patient (unknown age) who received MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] via subcutaneous route (incorrect route of product administration).  The patient's medical history, medical treatment, vaccination, concomitant medication and family history were not provided.  On 12-Nov-2021, the patient received a 0.5 ml dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot U7191AA and expiry date: 18-Jan-2023) (Frequency: once) via subcutaneous route at an unknown administration site for prophylactic vaccination.  It was a case of actual medication error due to inappropriate route of vaccination (same day latency).  It was reported "Pharmacist reporting that MENACTRA was inadvertently given subcutaneous instead of the recommended intramuscular route, she is questioning if the dose is valid".   At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Pain at injection site spread up to my left jaw, headache, and fatigue for a couple days.  15 days after receiving vaccine I got a rash around the injection site (upper left arm).
Patient briefly fainted after covid vaccination administered by pharmacy technician. Patient was sitting down. EMT arrive but patient refused ambulance transport to hospital. No anaphylaxis or other symptoms.
On 01/05/21 at 6:30 A.M. the patient woke up and noticed facial right side quivering.  On 01/08/21 the patient noticed right side of mouth raised on Sat. 01/09/21 the patient noticed at 4:30 P.M. right side drooping of right mouth corner.   The patient went to to the emergency room at Medical Center at 2:30 P.M.    The patient was treated with prednisone 20 mg 3 times a day for 5 days.
day 2: bad headache. day 3: bad headache +sore throat.  day 4: same + chills.  day 5: headache, sore throat, red raised rough rash, cough.  day 6: slept 18 hours. day 7: slept 18 hours. upset stomach and itching began 1-2 days later, and generalized peeling 1-2 days after that.  Headache is now milder.
5 min after injection pt got hot and very sweaty and faint. I had pt lay down. Checked blood pressure 100/50, strong pulse, called 911, EMT determined pt had anxiety rxn. husband took pt home
Patient presents with mother due to On Saturday patient got his MCV and TDAP vaccines as per mom by the afternoon it was swollen patient started with fever mother took patient to Urgent Care. 11 yr old M presents to clinic for f/u after urgent care visit for adverse reaction TDAP and MCV vaccine. Pt was seen in clinic Sept 22 for 11 yr WCC, during that visit he received TDAP and Meningitis vaccine on the left arm via IM routes (Both vaccines on the same route, two different syringes and needles). Within 24 hours of getting the vaccine Mother reports patient developed redness, swelling, and warmth to the left arm where patient received the vaccine. Pt was seen in urgent care September 23 where he was diagnosed with a localized allergic vaccine reaction and family was recommended to use cool compress to the area and BENADRYL. On day of presentation Sept 24 patient reported less redness but endorsed swelling and warmth to the region. No pain per patient. Pt denied fever, chills, difficulty breathing, nausea, emesis or abdominal pain. No difficulty moving the arm. No discharge. 11 yr old M presents to clinic for left arm swelling, induration and erythema 2/2 adverse reaction to TDAP and Meningitis vaccine (unclear which vaccine as both vaccines given in same region). History and physical most consistent with localized allergic reaction-counseled mother to continue with ice packs to the area and BENADRYL prn. As area significantly red and indurated will treat for possible cellulitis with Cephalexin x 10 day course. If symptoms worsen informed mother to RTC or seek medical attention (red streaks, more swelling or redness, fever any discharge or pain to the area). History and physical not consistent with severe allergic reaction or anaphylaxis. Case discussed with employee at CDC who advised that this would be mild-moderate adverse reaction. Patient is not contraindicated to receive TDAP/Meningitis vaccine in the future.
10:33 Pediatric Hep A ( Havrix ) was inadvertently given to adult patient. no sign and systems observed on site. no treatment warranted at this time.  Consult with provider and received approval from provider to proceed with administration of Adult Hep A vaccine while patient remain in clinic.
Fever - Tmax 103 (decreased with anti-fever meds) x 1.5 days