chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a Licensed Practical Nurse refers to a patient of 12 months old infant patient and unknown gender. On 02-SEP-2014 the patient was vaccinated with a dose of an improperly stored VARIVAX (Merck) (lot J009002, expiration date 19-JUL-2015) (dose, route, were not reported. No adverse effect was reported. The outcome of events reported was unknown. No product quality complaint was involved. This is one of several report received from the same source. Additional information has been requested.
delayed scheduled for Ipol vaccine, with no adverse event; Initial information received on 12-Aug-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves Infant male patient who had delayed scheduled for ipol vaccine, with no adverse event after receiving vaccine IPV (VERO) [IPOL].  The patient's past medical history, medical treatment(s), concomitant medication, vaccination(s) and family history were not provided.   On an unknown date, the patient received a 0.5ml dose of suspect IPV (VERO) (strength, formulation, lot number and expiry date was unknown) via unknown route in unknown administration site for Immunization.  On an unknown date the patient developed a non-serious event of delayed scheduled for ipol vaccine, with no adverse event (inappropriate schedule of product administration) (latency: unknown) following the administration of IPV (VERO). Reportedly stated that reporter asks does Ipol contain mercury or thimerosal, She asks if it is a MDV and what does that mean, How was maintained for cleanliness if accessed more than once , Is it only good for 30 days, Is it given in the thigh or arm and  Is there still proper immunity if given off schedule.  Action taken : not applicable.  Outcome: Unknown for inappropriate schedule of product administration   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 guidelines. 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.
Vaccinate on Sept 27. Arm sore within 16 hours. Discomfort (itching, heat) accompanied by redness spreading in size to an area of about 4" by 3" by Sept 30 at the injection site.  Reported this reaction by phone to PCP on Sept 30.  Heat is an unusual side effect of an injection for me, although a bit of soreness is not. Such a large sized red patch reminds me of a tick bite, but this redness is oddly rectangular-not round as a tick bite might be.  Discomfort somewhat reduced by cool, damp compresses, naproxen and diphenhydramine (50 mg). Called primary care provider to report symptoms.
Pain in Left Upper Arm, Numbness and tingling in left hand, High heart rate, Right temporal lobe pulsating headache, Joint pain, incontinences of the bladder (Unable to keep bladder from leaking ) Nausea, Fatigue,  Fever, Dizziness, Body Aches, Body weakness.
I experienced a significant temporary dip in my breastmilk supply from about 24 hours to 72 hours after my second dose. It returned to pre-vaccine levels after 4 days. I was producing at least 8 oz less breastmilk each day.
Initial report received from a health care professional in on 01 December 2008. A female patient (age not reported) received a dose of TYPHIM VI (lot number route/site of administration not reported) a few months ago and continues to have a "divet" at the injection site which is painful when pressed. The event required a doctor visit. Patient outcome reported as unknown. The patient had a TYPHIM VI booster four years ago with no reaction. No further details were provided. Follow-up information received on 03 December 2008 from a physician. A copy of the doctor letter describing the event was provided. This 30-year-old female was in good health without chronic or recent acute illness prior to receipt of the TYPHIM VI booster which was received on 12 July 2008 intramuscularly in the left deltoid. The patient also received the same day an intramuscular right arm injection of ENGERIX-B (manufacturer GlaxoSmithKline, lot number AHBVB596AA). The patient recalled mild local site tenderness to the left deltoid injection site after vaccination, but denied any redness, swelling, erythema, distal paresthesia, or systemic symptoms. Approximately four weeks later (13 September 2008) she noted a painless "divot" at the injection site without inflammation. She believes the "divot" increased in size over the first month, but has since remained stable. The patient denied and trauma to the area before or after her vaccination on 12 July 2008. She denied muscle weakness, or paresthesia. There is no family or personal history of collagen vascular or rheumatoid disease, skin disease, atrophy, psoriasis, or Raynaud's syndrome. The patient received first TYPHIM VI in 2004 without difficulty. An ultrasound of the injection site on 22 September 2008 showed small ill-defined echogenic region in the subcutaneous fatty tissues in the area of symptomology. "Most likely diagnosis for this appearance would be an area of traumatic fat necrosis." Diagnostic studies also included laboratory work up on 24 September 2008 dsDNA, SSA, SSB, Scl-70; Jo-1; Ribo-P; Chromatin and Centromere antibodies; ESR, us-CRP; and complement studies that were all normal; A punch biopsy on 10 November 2008, "mild superficial perivascular dermatitis with mild sclerosis of dermis; Histologic features were non-diagnostic and my represent a normal variant, a mild sclerotic reaction to a vaccine, or subtle changes of early morphea. A comparison to surrounding adjacent normal appearing skin may help". If the condition worsens or persists, a repeat biopsy may aid in clarifying the diagnosis." The recovery status of the patient was not reported. Due to this new information, this case met seriousness criteria and was upgraded to serious. Documents held by sender: Doctor letter.
Patient received a second flu shot  on 10/30. His first shot was on 10/02 . No immediate adverse reaction. Upon follow up on Monday 11/1 at 4:50pm in the pharmacy drive up, patient confirmed no reaction at all. Patient was wanting to receive a covid vaccine on 10/30, even after discovery of double flu shot, but pharmacy recommended waiting a week. (Just to clarify, no adverse reactions occurred. This is simply to report that he mistakenly asked for and received a second flu shot)
Swelling, redness, warm to touch and pain when moving it. (L) arm. Cold compress, BENADRYL PRN itching, Ibuprofen PRN pain.
Hands would be really really cold; Chills; Fever/fever 102 F; COVID hands; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL COLDNESS (Hands would be really really cold), CHILLS (Chills), PYREXIA (Fever/fever 102 F) and MYALGIA (COVID hands) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 030M20A) for COVID-19 vaccination.     Concomitant products included CALCIUM (VIACTIV [CALCIUM]) for an unknown indication.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Mar-2021, the patient experienced PERIPHERAL COLDNESS (Hands would be really really cold), CHILLS (Chills), PYREXIA (Fever/fever 102 F) and MYALGIA (COVID hands). The patient was treated with NAPROXEN SODIUM (ALEVE) ongoing from 12-Mar-2021 for Fever, at a dose of UNK, qd, noon. On 15-Mar-2021, PERIPHERAL COLDNESS (Hands would be really really cold), CHILLS (Chills) and PYREXIA (Fever/fever 102 F) had resolved. At the time of the report, MYALGIA (COVID hands) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Mar-2021, Body temperature: 102 f (High) Fever.         concomitant medication Viactiv used for bone health.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Follow up received on 14-JUL-2021.Concomitant medications were added and event outcome was updated.
Pt stated that she felt arm being sore on 8/22 along with feeling hot to the touch at the same time. PHN observed arm along with NP right arm hot to the touch, swollen in deltoid area along with red raised areas dispersed through out the deltoid area to approx 3 inches above right elbow.
Injection was in left arm.  My lymph nodes swelled up in my left armpit. The pain was unbearable for 2 days. It's been a week now and the pain is still there but diminishing
5th booster dose of BNT162B2 administered; sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 06Oct2022 at 16:00 as dose 5 (booster), single (Lot number: GJ6665) at the age of 76 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Seasonal allergies" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot number: EN6204), administration date: 11Mar2021, when the patient was 74-year-old, for COVID-19 Immunization, reaction(s): "sore arm"; BNT162b2 (DOSE 2, SINGLE; Lot number: ER8733), administration date: 31Mar2021, when the patient was 74-year-old, for COVID-19 immunization, reaction(s): "sore arm"; BNT162b2 (DOSE 3 (BOOSTER), SINGLE; Lot number: EW0172), administration date: 15Nov2021, when the patient was 75-year-old, for COVID-19 Immunization, reaction(s): "sore arm"; BNT162b2 (DOSE 4 (BOOSTER), SINGLE; Lot number FJ6369), administration date: 25Apr2022, when the patient was 75-year-old, for COVID-19 Immunization, reaction(s): "sore arm"; flu (With the flu shot, just a sore arm, nothing to whine or complain about.), administration date: 26Oct2021, when the patient was 75-year-old, for Immunization, reaction(s): "sore arm". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 06Oct2022, outcome "recovered" (07Oct2022), described as "sore arm"; INCORRECT DOSE ADMINISTERED (non-serious) with onset 06Oct2022 at 16:00, outcome "unknown", described as "5th booster dose of BNT162B2 administered".  Additional information: It was reported the person got bivalent vaccine and had no side effects other than sore arm. She had no problems with the first 4 doses, there was a bit of sore arm and she had less of a sore arm with this one and it was maybe just overnight and by the next night was fine. It was nothing she really noticed that evening and when she went to bed was when she noticed it, it was a little less than the others. It was totally gone at most in 24 hours. No additional vaccines administered on same date of the Pfizer suspect. The adverse events did not require a visit to emergency room and physician office.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201241911 same reporter/patient/AE, different dose;US-PFIZER INC-202201241912 same reporter/patient/AE, different dose;US-PFIZER INC-202201241913 same reporter/patient/AE, different dose;US-PFIZER INC-202201241914 same reporter/patient/AE, different dose;
Patient given DTaP/Polio/Hep B. Patient was due for TDaP at age 7 in addition to the Hep B and Polio. Age of patient at time of event: 7 years 3 months.
Administered Moderna Bivalent Dark pink cap (yellow label) after being notified that monovalent covid vaccines were no longer authorized. Was administered prior to recommendation of using dark blue Moderna bivalent cap (gray label) . Received 2nd dose of Moderna Bivalent Dark pink cap instead of dark blue cap.
No symptoms were reported by the patient/no additional AE was reported; a temperature excursion of VARIVAX had been administered to the patient; This spontaneous report has received from a registered nurse concerning a 7 years old patient of unknown gender. The patient's pertinent medical history, drug reactions/allergies, concurrent condition and concomitant medication were not provided.     On 11-AUG-2021, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX), which occurred a temperature excursion (lot# T037643 has been verified to be a valid lot number and expiration date was 06-NOV-2022; dose reported as 1 (unit unknown); strength, frequency and route were not reported) for prophylaxis (product storage error). The administered dose experienced a temperature excursion of 8 degrees Fahrenheit for 2 hours and 15 minutes. There was no previous temperature excursion. No symptoms were reported by the patient. No additional adverse event was reported.     This is one of the three reports received from the same reporter.; Sender's Comments:  US-009507513-2108USA003810: US-009507513-2108USA004106:
headache and body pains lasting about 20 hours.  leg pains about 1 week late that have not gone away.  leg pains in both legs and tingling in feet.
The nurse incorrectly reconstituted the Pfizer COVID vaccine (59267-0078-04) using 0.22 mL of diluent, instead of the correct 2.2 mL. The correct volume of 0.2 mL was administered to the child, but due to incorrect reconstitution, the dose (mcg) was higher than desired.  Only 1 dose was administered from this vial. The error was identified when the nurse was drawing up the remaining doses to waste and only got 2.5 doses, instead of the expected 9 more to equal 10 total. Thus we estimate the dose administered was appoximately 3x the desired, or close to 10 mcg - the dose appropriate for 5-11 year olds. The patient's mother was notified and counseled appropriately. No adverse reactions noted.
No pain after injection. Later in evening left shoulder achy. Saturday morning - left side stiff, achy up neck to the ear and down left arm to the middle finger. Later Saturday right side of jaw locked up (hx TMJ). Patient took ALEVE and rested. Symptoms decreasing over next few days. Mild achy on Wednesday 1/21/15.
This spontaneous report as received from a pharmacist refers to a 66 year old female patient. The patient's relevant medical history and past drug history were unknown. On 16-AUG-2014, the patient received one injection of PNEUMOVAX23 (lot number reported as J006246, expiration date reported as 03-AUG-2014 (dose and route not provided). There were no co-suspect therapies. Concomitant therapies included NORVASC, hydrochlorothiazide (manufacturer unknown) and LOPRESSOR. The pharmacist reported that on 16-AUG-2014, the patient accidentally received an expired dose of PNEUMOVAX23. The patient's relevant tests or laboratory data were unknown. As of 25-AUG-2014, it was unknown if the patient would received PNEUMOVAX23 again and the outcome of receiving an expired dose was unknown. The pharmacist reported that the patient had not called to report any adverse events. Lot number J006246 is not valid for PNEUMOVAX23. This case is linked to cases MARRS# 1408USA015182 and MARRS#1408USA015409 (same reporter link). Additional information has been requested.
this patient got covid mild covid on Jan 3rd, was then vaccinated on Feb 9th, and then had a witnessed cardiac arrest on the bus at Feb 24th. CPR was attempted, but he was unable to be resuscitated on site or at hospital where he was pronounced.
Developed fever to 102, and marked tenderness and erythema of right upper arm, around vaccination site. Fever has lasted up to time of report (7/30/2014-8:00 PM), but is slowly improving.
Vertigo; raised alt liver numbers; FACILITATED COLLECT  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4244517-00 (AbbVie).  A 58 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administration date 02Aug2021 (Batch/Lot number: unknown) as dose 1, single, intramuscular, administration date 23Aug2021 (Batch/Lot number: unknown) as dose 2, single and intramuscular, administration date 29Dec2021 (Batch/Lot number: unknown) as dose 3, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) for psoriatic arthropathy, uveitis. The patient's relevant medical history was not reported. Concomitant medication(s) included: REPATHA. The following information was reported: VERTIGO (hospitalization) with onset Dec2021, outcome "unknown", described as "Vertigo"; ALANINE AMINOTRANSFERASE INCREASED (non-serious) with onset 2021, outcome "unknown", described as "raised alt liver numbers". The patient was hospitalized for vertigo (start date: Dec2021). The event "vertigo" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: alanine aminotransferase: raised. The action taken for adalimumab was unknown.  Additional Information: The patient reported that she had Raised alt liver numbers began increasing. She also taking Repatha. She was hospitalized in Dec2021 for vertigo. Patient agreed to have MD contacted. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.No further information is expected.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine cannot be excluded for the reported events of Vertigo, Alanine aminotransferase increased but also consider possible contributory effects from patient's medical history and/or concomitant medications. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Blood in urine D68.9 - Coagulopathy (CMS/HCC) R31.0 - Gross hematuria D64.9 - Anemia, unspecified type
Breakthrough case after three admissions Pfizer 7/1/21 Lot# Ew0181;  Pfizer 7/22/21 Lot#FA7485;  Pfizer 1/25/22 Lot# FL3209
PATIENT CAME IN TO GET COVID VACCINE - SAID IT WAS HER FIRST SHOT AND HER FORM ALSO SAID THE SAME. ASKED PT WHICH VACCINE SHE WANTED AND SHE REQUESTED PFIZER. WHEN TYPING THE VACCINE LATER IN THE EVENING, GOT A REJECTION FROM THE INSURANCE SAYING PT GOT 1ST DOSE 02/26/21. CALLED PT # AND SPOKE TO HER DAUGHTER, WHO SAID SHE RECEIVED A MODERNA DOSE ON THAT DATE. TOLD DAUGHTER TO MAKE SURE HER MOTHER KNOWS NOT TO COME IN FOR ANOTHER DOSE OF PFIZER.
Golf sized red area on injection site accompanied by mild pain. Pt. iced site, took Tylenol and antihistamine. Symptoms have greatly improved, not yet resolved. Pt. also fatigued.
Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Weakness-Medium
Patient complains of immediate sharp pain at injection site.  She went to see Dr. on 10-19-2022 who diagnosed bursitis secondary to influenza vaccination.  Patient was given acetaminophen 500mg 2 tablets three times a day.  The note says patients symptoms are improving.  She was instructed to follow up if symptoms continued or worsened. She then followed up with physician assistant on 11-1-2022 who performed an X-Ray of the shoulder which did not show anything other than arthritis.  The note says possible superficial nerve involvement.  Patient has been refered to physical therapy and is restricted to light duty at work.
pt became pale, cyanotic, lethargic, limp, apneic & bradycardic heart rate 60's, given blow by 100% flow then positive pressure ventilation;MD notified pt responded to ventilation then placed on nasal cannula;
SORE ARM AT INJECTIONS SITE CONTINUING FOR 2 WEEKS POST IMMUNIZATION.
Redness and swelling below injection site; Redness and swelling below injection site; This is a spontaneous report from a contactable consumer (patient). A 29-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EN9581) via an unspecified route of administration in left arm on 07Feb2021 15:00 (at the age of 29-years-old) as single dose for COVID-19 immunisation. Medical history included covid-19. The patient did not receive other vaccine in four weeks prior to vaccination and other medications in two weeks. Concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EL3246) in the left arm on 17Jan2021 15:00 for COVID-19 immunisation and amoxicillin and had known allergies. On 08Feb2021 08:00, the patient developed redness and swelling below injection site similar to the "covid arm" from the Moderna vaccine. No treatment was received for the adverse events. The patient did not test COVID post vaccination. The outcome of the events was recovering.
Information has been received from a healthcare worker concerning a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 23-APR-2015, the patient was vaccinated with a dose of improperly stored PROQUAD (Merck), lot # L002419, expiration date 23-JUL-2016 (dose and route not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected because the physician did not wish to be contacted.
Information has been received from a medical assistant concerning a 10 year old female who approximately 22-OCT-2007 was vaccinated with her first dose of GARDASIL vaccine (yeast). On approximately 22-OCT-2007 the patient experienced a rash from the injection site in the deltoid down to her elbow, on both legs and on her mouth. Subsequently, the patient's mother gave her diphenhydramine hydrochloride (BENADRYL) and she recovered from the rash. The patient sought medical attention by calling the office. Additional information has been requested. This is in follow-up to report(s) previously submitted on 11/14/2007; 1/7/2008.  Information (and additional information via agency) has been received from a medical assistant concerning a 10 year old female with an amoxicillin allergy who on 27-AUG-2007 was vaccinated intramuscularly in the left deltoid at 10:00 am with her first dose of GARDASIL (lot# 658094/0524U).  On the evening of 27-AUG-2007 the patient experienced a rash from the injection site in the deltoid down to her elbow, on both legs and on her mouth and it was itchy.  Subsequently, the patient's mother gave her BENADRYL and she recovered from the rash.  The patient recovered on approximately 02-SEP-2007.  (a week later).  The patient sought medical attention by calling the office.  Additional information is not expected.