chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pt awoke morning p/inj w/redness, induration & pain @ the site;9x9cm area of induration & redness noted;given med;31AUG all induration, pain & redness had resolved sl discoloration remained;
she fell 3 weeks; small concussion; This spontaneous case was reported by a patient and describes the occurrence of FALL (she fell 3 weeks) and CONCUSSION (small concussion) in a 68-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.   On 04-Feb-2021, the patient received first dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On 04-Mar-2021, received second dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. On 28-Apr-2022, received third dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. On 07-Nov-2022, received fourth dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. In October 2023, the patient experienced FALL (she fell 3 weeks) and CONCUSSION (small concussion). The patient was treated with Wound care (needed some stitches) for Concussion. At the time of the report, FALL (she fell 3 weeks) and CONCUSSION (small concussion) outcome was unknown.            No concomitant medication was reported. Patient fell 3 weeks before and had a small concussion and needed some stitches.   This case was linked to MOD-2023-749081 (Patient Link).
CARDIOGENIC SHOCK 2/28/2023 -- RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Pt came to clinic 2 days after receiving MMR, area with erythema, swelling, warmth, and tender to palpation. Pt diagnosed with cellulitis, treated with AUGMENTIN 875 mg/125 mg BID x ten days.
JOINT PAIN and SORENESS OF ARM AROUND THE INJECTION OF COVID-19 SECOND SHOT; JOINT PAIN and SORENESS OF ARM AROUND THE INJECTION OF COVID-19 SECOND SHOT; SPINAL STENOSIS; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (JOINT PAIN and SORENESS OF ARM AROUND THE INJECTION OF COVID-19 SECOND SHOT), VACCINATION SITE PAIN (JOINT PAIN and SORENESS OF ARM AROUND THE INJECTION OF COVID-19 SECOND SHOT) and SPINAL STENOSIS (SPINAL STENOSIS) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.  No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced SPINAL STENOSIS (SPINAL STENOSIS). On an unknown date, the patient experienced ARTHRALGIA (JOINT PAIN and SORENESS OF ARM AROUND THE INJECTION OF COVID-19 SECOND SHOT) and VACCINATION SITE PAIN (JOINT PAIN and SORENESS OF ARM AROUND THE INJECTION OF COVID-19 SECOND SHOT). At the time of the report, ARTHRALGIA (JOINT PAIN and SORENESS OF ARM AROUND THE INJECTION OF COVID-19 SECOND SHOT) and VACCINATION SITE PAIN (JOINT PAIN and SORENESS OF ARM AROUND THE INJECTION OF COVID-19 SECOND SHOT) had resolved and SPINAL STENOSIS (SPINAL STENOSIS) outcome was unknown.         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.  No concomitant medication information was provided.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No treatment medication was provided.   This case was linked to MOD-2021-620470 (Patient Link).
Started to have Pain in middle of rib yesterday. Showed the area to friend, pediatrician, who stated "you have shingles", started to have blisters under bra staps with straight band shape rashes/blisters in L upper trunk, side chest and upper back.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results, notes: Indication: Covid-19 treatment; Positive, notes: Positive rapid antigen test for COVID 19. Therapeutic measures were taken as a result of drug ineffective, covid-19.Clinical course: No other medication in 2weeks.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Within a few minutes of the vaccine, patient felt face flushing, metallic taste in mouth. Benadryl 25 mg po given without improvement in symptoms. Benadryl 25 mg po repeated and patient taken to ED. Was discharged home. Returned to ED about an hour later for chest pressure which resolved prior to arrival. Given Prednisone 40 mg po in ED and discharged home. Recommended no second dose of covid vaccine.
Dizziness 48 hrs after vaccine; This is a spontaneous report from a contactable consumer, the patient. A 27-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: En6203) via an unspecified route of administration in the left arm on 26Feb2021 at 19:45 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. Medical history included hypertension. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included lisinopril (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date and unknown if ongoing. On 01Mar2021 at 07:00 the patient experienced dizziness 48 hours after vaccine. It was unknown whether any therapeutic measures were taken as a result of the event. The adverse event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event dizziness 48 hours after vaccine was unknown at the time of this report.  No follow-up attempts are possible. No further information is expected.
Per mom, client work up at 4AM on 3/19 with stomach cramps, nausea/vomiting, diarrhea and fever of 102.1 F. Client also developed a flat red spot on left temple. Site of injection looks fine, no redness, pain or swelling. Mom to treat with fever reducer, increased fluids and monitor symptoms. If no improvement will seek medical attention.
Sunday started with swollen tender lymph node in neck near collarbone and that afternoon I got rly tired. Slept horribly that night, went home early from work. Fever of 100.8 on Mon night and chills, took advil, slept horribly again. Tuesday was itchy blotchy rashes on inners thighs, wrists and inner forearm, back of knees. Felt warm but took advil and went to work in afternoon. Legs started to ache so I had to keep takinv advil every 6 hours. Slept horribly again, hot and sweaty. Wed i stayed home, rashes were bad and advil was a must. Today rashes are just on right wrist and thigh and legs still ache, no temperature.
Full amount of the dose was not fully administered; Some of the vaccine leaked down the patient's arm; A spontaneous report was received from a healthcare professional concerning an 80-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the full amount of the dose was not fully administered (LLTs: vaccine underdose / syringe connection issue).   The patient's medical history was not provided. No concomitant medications were reported.  On 04 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: not provided) intramuscularly for prophylaxis of COVID-19 infection.   On 04 Feb 2021, a physician's assistant administered the Moderna COVID-19 vaccine to a patient and stated, that the full amount of the dose was not full administered. Some of the vaccine leaked down the patient's arm.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the events, full amount of the dose was not fully administered issue and some of the vaccine leaked down the patient's arm, were considered resolved on 04 Feb 2021.; Reporter's Comments: The reporter refers to a case of vaccine underdose and syringe connection issue for mRNA-1273 vaccine, batch number not provided, with no associated AEs. Causality of these events is not applicable.
I had blurred vision the first day; ear aches; body aches; have not stopped bleeding; had lots of blood clots; I've been menstrating for 2 weeks straight, a week extra; This is a spontaneous report from a contactable consumer (Patient). A 46-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ER8730, Expiration date was not reported), via an unspecified route of administration, administered in Arm Right on 01Apr2021 14:00 (age at vaccination was 46 years) as dose 1, single and dose 1 via an unspecified route of administration, administered in Arm Right on 01Apr2021 (Lot Number: EW0162) as dose 1, single for Covid-19 immunization. Medical history included Alpha thalassemia minor carrier, Anxiety /depression, ongoing Menorrhagia, Known allergies: Penicillin allergy. Concomitant medication(s) included escitalopram oxalate (LEXAPRO); bupropion hcl (BUPROPION HCL); one a day allergy; naphazoline hydrochloride (ALLERGY [NAPHAZOLINE HYDROCHLORIDE]); calcium carbonate, colecalciferol (CALCIU D3). Prior to 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 vaccination. On 22Apr2021 16:00 the patient reported blurred vision the first day, ear aches, body aches, have not stopped bleeding, had lots of blood clots, she has been menstruating for 2 weeks straight, a week extra. She do have menorrhagia but this is not usual for me to have so many clots and bleeding that has not lightened. so she had been menstruating for 2 weeks straight, a week extra. Patient did not receive any treatment for occurred event. The outcome of events was not resolved.  Follow-up (19Jul2021): Follow-up attempts completed. No further information expected.
Mom states that pt had a nose bleed 4 days post gardisil #1. States pt has never had nose bleed int the past "It gushed and woke her up-we got it to stop after a few minutes". States pt had another that day and it gushed while blowing her nose, the third one was scant when she was playing. States no more since then. Denies any othe signg or symptoms. Denies hx of blood/clotting dyscrasia.
Case number PHEH2015US026396, is an initial spontaneous report received from a physician on 15 Dec 2015. This report refers to a 64-years-old female patient. Past medical history included sore throat and swelling on eucalyptus oil and Vitamin D3 and angiotensin 2 receptor blocker (unspecified) as historical drug. Current condition included kidney transplant on 13 Oct 1992, drug allergies and codeine allergy. Concomitant medications were not reported. She was vaccinated with seasonal influenza vaccine (manufacturer unknown and batch number: not reported) on an unknown date. She experienced rash and swelling on an unknown date. On 28 May 2015, she received valsartan (manufacturer unknown) at an unknown dose and experienced allergy to red dyes and migraines (please see case# PHEH2015US010768). The outcome, seriousness and causality of the events was not reported.
8 hrs. post vaccination, fever, chills and severe generalized muscle aches. Sx lasted about 16 hrs. (until next am). Little relief with TYLENOL. Sx returned in afternoon of second day but not as severe. About 36 hrs. after vaccination, noticed a flat red rash (no hives or anaphylactic sx). Rash seemed to start under breasts and armpits and on neck. Spread down chest to abdomen and groin. On third day, rash had spread down both arms. No further fever or aches after 2nd day. No pain or redness at injection site today.
Over the course of two weeks after vaccination and present, I have no feeling of heart functioning. My heart is functioning good though. I can't feel any normal heart patterns such as when exercising,  or adrenaline increases, I can't feel my heart rate increase. Which is dangerous. I also can't feel my heart strings when I get emotional in my heart. When I get sad, I can cry but no longer feel it in my heart. I had an EKG and full panel blood tests done on 6/72021, all came back normal. This all started after the last vaccination. There is a disconnect to my heart.
problem with her throat/ felt an intense heat in her throat and chest; problem with her throat/ felt an intense heat in her throat and chest; ringing in her ears; at the vaccination site, they applied ice pack; This is a spontaneous report received from a contactable nurse from medical information team. The reporter is the parent.  A 38-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administration date 10May2021 (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. Relevant medical history included: "sensitivity to latex" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Methyl-chloro-isolthiazolinone, reaction: "alergy to a preservative". The following information was reported: THROAT IRRITATION (non-serious), FEELING HOT (non-serious) all with onset May2021, outcome "recovered" (May2021) and all described as "problem with her throat/ felt an intense heat in her throat and chest"; TINNITUS (non-serious) with onset May2021, outcome "recovered" (May2021), described as "ringing in her ears"; VACCINATION SITE REACTION (non-serious) with onset May2021, outcome "recovered" (May2021), described as "at the vaccination site, they applied ice pack". Therapeutic measures were taken as a result of throat irritation, feeling hot, tinnitus, vaccination site reaction.  Additional information: The reporter stated she and her daughter are nurses. She explained her daughter had problem with her throat after vaccination and then resolved one hour after taking diphenhydramine hydrochloride (BENADRYL). She later described that her daughter felt an intense heat in her throat and chest, with ringing in her ears. She explained at the vaccination site, they applied ice pack for one hour behind her neck and her chest and it resolved.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient was ok day of and following days of the vaccine until today (11/18/2017) when the area got very red and warm to the touch. It also was a little painful for her. Mom came in to report this reaction.
Initial unsolicited report received from a healthcare professional on 18 March 2015. A 65-year-old male patient, whose medical history and concomitant medications were not reported, had received a dose of Tetanus Diphtheria (batch number, dose, dose number, expiry date and site of administration were not reported) via intramuscular route on unspecified date. It was reported that the Patient had a large reaction in childhood to horse serum and patient can't take Tetanus or Tetanus containing products. No information about prior exposure to vaccine was not reported. Laboratory investigations and corrective treatments were not reported. At the time of this report the patient outcome was recovered. Documents held by sender: none.
Information has been received from a nurse referring to an unknown number of patients of unknown age and gender. In 2015 these patients were vaccinated with doses of PROQUAD (Merck) (lot # K022446 with expiration 13-MAY-2016; lot# L017140 with expiration 13-NOV-2016; dose, frequency and route were not reported), which had been improperly stored since January 2015. No adverse effects were reported. This is one of several cases received from the same source. Additional information has been requested.
Patient needed 1st dose of Hepatitis B series. She is pregnant with 3rd child, due in November for estimate date of delivery. Heplisav-B was chosen and administered to patient inadvertently over other preferred brands.
I received the vaccine in my left arm. I immediately felt a shooting pain and my left arm became heavy. My left hand experienced the same shooting pain followed by tingling in my fingers. My right arm them experienced the same pain and tingling. I then began to sweat, get dizzy and felt like fainting. I have had pain and tingling in my hands and feet ever since, along with sensitivity. I also have pain in my joints and legs similar to what I imagine arthritis would feel like. I also have throbbing chest pain and pain in my legs since vaccination.
Localized redness, swelling, and itching spread from the injection site almost completely down the patient's bicep before stopping. As of 7/19/15, the redness had not shrank significantly, but there is some improvement.
bright pink discoloration, itchy and sore injection site, patient used cold compresses and light messages.  Immunization was administered on 5-24-21 and patient is still having slight discoloration, itching and soreness around injection site as of 6-5-21 when patient asked us to report her adverse reactions. We suggested that patient would follow up with her physician. Patient indicated that it was getting a little better every day and she did not feel that she needed to check with her physician.
Redness and Induration 3 inches x 2 1/4 inches 20 hours after vaccination. No joint involvement. Tenderness at site, touch easily tolerated. No activity impairment. Afebrile. Cool compresses to site recommended.
Information has been received from a consumer concerning her daughter with coeliac disease who on an unspecified date, was vaccinated with the second dose of Hep B (manufacturer unknown). Subsequently, on an unspecified date, after being vaccinated twice with Hep B (manufacturer unknown) the patient had failed to developed immunity. The patient's mother stated that "it was not unheard of for people with celiac disease to fail to develop titers when vaccinated for hepatitis B". At the time of the report the patient's outcome was not reported. It was unspecified if the patient sought medical attention. Additional information is not expected.
Starting 5 minutes from vaccination left sided arm numbness and tingling down the arm into the fingers. Felt the entire day. 12/21/20, symptoms improved but again returned today.
Pfizer COVID-19 Vaccine EUA. At 1317 (18 minutes after vaccine administered) Patient observed to have rash to chest and neck. Patient stated she felt "warm in her neck and inner thighs". Rash progressed to ears and face. Patient stated she was having "tingling in the mouth w/progression to her face and eyes.  Patient taken to triage area for observation, VS Q 5 mins. Patient noted to have tachycardia PR 103 and elevated BP 178/100 on initial VS. Pulse rate decrease after 5 minutes to 95. BP remained elevated. Patient placed on gurney in recumbent position and water given. Patient given a mirror to view face and patient stated " my face is swollen slightly". Absent selling to lips or tongue. EPI pen 0.3mg/0.3ml auto injector administered at 1339.patient transported to site ED for further evaluation. O2 applied enroute to ED at 4L/min via NC when patient stated she felt a little lightheaded. Patient care transferred to ED and report given.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was provided regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 16-APR-2012, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) as recommended for routine adult health maintenance and for the prevention of shingles. ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 30-JUN-2016, the patient was treated at urgent care for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles with complications. The patient was prescribed valacyclovir hydrochloride (VALTREX) and acetaminophen/codeine for management of her painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
a breakthrough case of COVID after receiving 4 shots; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (a breakthrough case of COVID after receiving 4 shots) in a 75-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch nos. AS7165b, 030l20a, 029a21a and 069721a) for COVID-19 prophylaxis.    Co-suspect product included non-company product LEVOTHYROXINE for an unknown indication.    Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine on 02-Feb-2021, Moderna COVID-19 Vaccine on 02-Mar-2021 and Moderna COVID-19 Vaccine on 19-Nov-2021. Past adverse reactions to the above products included No adverse event with Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine and Moderna COVID-19 Vaccine.   On 02-Feb-2021, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On 19-Nov-2021, received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On 19-Oct-2022, received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient started LEVOTHYROXINE (unknown route) at an unspecified dose. On 28-Nov-2022, the patient experienced COVID-19 (a breakthrough case of COVID after receiving 4 shots). At the time of the report, COVID-19 (a breakthrough case of COVID after receiving 4 shots) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Nov-2022, SARS-CoV-2 test: COVID test on 11/28/2022.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   It is unknown if any other vaccines in the 4 weeks prior to COVID-19 vaccine. Consumer reported that PAXLOVID for 5 days was taken which was consider a mistake CONCOMITANT levothyroxine. No Concomitant medication was provided by reporter. No Treatment medication was provided by reporter.
Patient c/o low back pain and hip pain and hard to walk and weak in that leg joint post COVID vaccination x1.
Day 1-4 large raised bright red injection site warm to touch Day 3 Bright red raised rash all over face and scalp, going down neck