chrisvoncsefalvay/vaers-outcomes huggingface dataset:
An 81 year old female received RSV vaccine or placebo and Influenza vaccine on 10/30/02 and 107 days later came into the office with weakness, shortness of breath, malaise. She presented with BP 92/50 and weight loss of 20 lbs over the last month. She had not been eating very well. She was sent by ambulance to the hospital and admitted on 2/14/03. Signs/Symptoms/Diagnosis included esophageal dysfunction 9scheduled to have barium swallow in hospital), CHF, depression. The patient was treated with IV fluids and Prevacid. There was one episode of CHF due to over vigorous hydration which resolved. She refused to eat. Evaluated by psychiatry, transferred to psychiatry 2/20/03. The patient was prescribed Remeron from 2/20/03 until death. Patient was not responding in treatment program for depression. Found unresponsive in bed 3/1/03. CPR initiated there was no response and she was pronounced dead. Diagnosis was : Depression, Anxiety, Atrial Fib, Mitral Regurgitation. Cause of death was given as probable myocardial infarction. No autopsy will be performed. The investigator assessed the events as unrelated to the study products. Further information is expected. Additional information received on 10/7/03: Copy of death certificate: signed 3/1/03; date of death:3/1/03. Cause of death: lethal arrythmia - approximate interval between onset and death - 30 minutes. Secondary cause: atrial fib - approximate interval between onset and death - 5 years. Other significant conditions contributing to death but not resulting in the underlying cause given in Part 1 - Mitral valve regurgitation. No autopsy performed. A 15-day follow up report received 10/23/2003 adds: 10/17/2003: No new info is anticipated. Case is closed. Death Certificate received on 10/27/2003 states COD was arrthymia and atrial fibrillation.
I have a pulsating sound in my right ear. It originally occurred about a month after my first shot. It is not constant. It comes and goes but has been occurring multiple times a day and is extremely frustrating.
First shot of Pfizer COVID vaccine on Sat 4/10/2021, appx 2:15pm.  Developed mild stinging and burning sensation Thurs 4/15/2021.  Developed pink edematous eruption Sun 4/18/2021.  Eruption became more erythematous and  developed vesicles late evening Tues 4/20/2021.  Started oral valacyclovir  in morning of Wed 4/21/2021.
Red, Swollen, itchy, warm to touch area developed on arm on 2/1/21, injection was given on 1/21/21.  Patient followed up with PCP on 2/3/21, diagnosed with Cellulitis of injection site.  Prescribed Doxycycline 100mg , twice a day for 7 days.
The patient  looked at arm in the mirror and noticed a pinkish or reddish, 2x3" area in a teardrop shape near the injection site; Muscle aches; Stiffness in the arm; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Stiffness in the arm), VACCINATION SITE ERYTHEMA (The patient  looked at arm in the mirror and noticed a pinkish or reddish, 2x3" area in a teardrop shape near the injection site) and MYALGIA (Muscle aches) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 071F21A) for COVID-19 vaccination.     Concomitant products included CENTRUM SILVER PRO for an unknown indication.    On 01-Nov-2021 at 11:00 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 ml. On 01-Nov-2021 at 4:00 PM, the patient experienced MUSCULOSKELETAL STIFFNESS (Stiffness in the arm). On 02-Nov-2021 at 7:00 AM, the patient experienced MYALGIA (Muscle aches). On 04-Nov-2021 at 10:00 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE ERYTHEMA (The patient  looked at arm in the mirror and noticed a pinkish or reddish, 2x3" area in a teardrop shape near the injection site). On 04-Nov-2021, MYALGIA (Muscle aches) had resolved. On 05-Nov-2021, MUSCULOSKELETAL STIFFNESS (Stiffness in the arm) had resolved. On 06-Nov-2021, VACCINATION SITE ERYTHEMA (The patient  looked at arm in the mirror and noticed a pinkish or reddish, 2x3" area in a teardrop shape near the injection site) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered MUSCULOSKELETAL STIFFNESS (Stiffness in the arm), VACCINATION SITE ERYTHEMA (The patient  looked at arm in the mirror and noticed a pinkish or reddish, 2x3" area in a teardrop shape near the injection site) and MYALGIA (Muscle aches) to be possibly related.    The patient stated he had not taken any medications or treatments.   This case was linked to MOD-2021-375541, MOD-2021-375520 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-Nov-2021: Follow up received includes concomitant medication added, updated outcome of all events and causality was updated.
a 17 months old was given Quadracel/No AE; Initial information was received on 01-Jul-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 17 months old male patient who was vaccinated with DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] (lot number C5688AA, dosing details: single fourth dose 0.5 ml and expiry date 26-NOV-2021) via intramuscular route in the left thigh on 01-Jul-2020 for prophylactic vaccination.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HIB VACCINE and PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) on an unknown date for prophylactic vaccination.  It was an actual medication error case due to inappropriate age at vaccine administration  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 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.
This employee came to the flu clinic to receive the COVID booster and was accidently given the flu shot.  She had the flu shot already a few weeks ago.
Pt had poor appetite, fussy, decreased eating for 2 days following Prevnar vaccination.
I63.9 - Acute ischemic stroke (CMS/HCC) I63.9 - Ischemic stroke (CMS/HCC)
Chills, loss of mental ability, overall pain, pain at injection site, headaches, loss of balance. Took Tylenol. Lingering - worse symptoms than when I actually had COVID-19.
Delayed (3 days after dose) itching on ankles, elbows, fingers, hands,  arms, legs for 1.5 days
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE  ACUTE RESPIRATORY FAILURE  9/3/2022 --  RECURRENCE OF SAME SYMPTOMS
Vaccination was given in the right dorsogluteal site. No adverse reaction noted at time of adminstration.
pt devel high fever, cough, chest congestion soon p/vax;temp to 104 onset 24hrs p/vax;sxs cont, now 10 days post vax fever, cough
L deltoid became very swollen/red/hard hot from shoulder down to the elbow. Onset was a little before 7 pm; painful referred by oncall physician to urgent care. Confirmed local reaction and prescribed steroid cream.
Moderna COVID-19 vaccine, bivalent on 02-AUG-2023 after a temperature excursion; No adverse event; Vaccine was administered after temperature excursion; This spontaneous case was reported by a consumer and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine was administered after temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine, bivalent on 02-AUG-2023 after a temperature excursion) and NO ADVERSE EVENT (No adverse event) in a 40-year-old male patient who received mRNA-1273 BIVALENT .222 (SPIKEVAX BIVALENT ORIGINAL / OMICRON BA.4-5) (batch no. AS7644C) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 vaccine on 23-Jun-2021; for Product used for unknown indication: Pfizer vaccine on 18-Jan-2022. Past adverse reactions to the above products included No adverse event with Moderna COVID-19 vaccine and Pfizer vaccine.    On 02-Aug-2023, the patient received third dose of mRNA-1273 BIVALENT .222 (SPIKEVAX BIVALENT ORIGINAL / OMICRON BA.4-5) (unknown route) 1 dosage form. On 02-Aug-2023,  after starting mRNA-1273 BIVALENT .222 (SPIKEVAX BIVALENT ORIGINAL / OMICRON BA.4-5), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine was administered after temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine, bivalent on 02-AUG-2023 after a temperature excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine was administered after temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine, bivalent on 02-AUG-2023 after a temperature excursion) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (SPIKEVAX BIVALENT ORIGINAL / OMICRON BA.4-5) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Vaccine was administered after temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine, bivalent on 02-AUG-2023 after a temperature excursion).    Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. No concomitant medication was reported.  No treatment information was reported.
itching at injection site, pt reported slight itch after about 4 minutes. gave 12.5ml of liquid benedryl. pt didnt want a larger dose.  no redness or visible signs of reaction. called pt 45 min later after waiting 30 min and she was fine
Pt recd 3 doses of Engerix-B 24MAY91, 21JUN91 & 3DEC91 & it was determined that pt was a non-responder;
chills; tiredness; joint aches; left side of face tingle; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the left arm on 01Apr2021 at 16:30 (at the age of 51-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had intermittent shellfish allergies and only certain shellfish trigger allergic reactions but it's very rare. Concomitant medications included famotidine (MANUFACTURER UNKNOWN) 20 mg taken once daily from an unknown date for an unknown indication. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 02Apr2021 at 10:00 the patient experienced chills, tiredness, joint aches and left side of face tingle. The events did not result in doctor or other health care professional office/clinic visits, and the emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events chills, tiredness, joint aches and left side of face tingle were recovered on an unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.
Pt developed flushing in fall left side neck pain few moments after shot. Later on heaviness in chest-fumar EPI shot IM. Benadryl 3 tsp po. Refer to hospital for observation. Discussed with Allergist and he suggested next shot to be given at Allergist Clinic to R/O if reaction to shot.
red around my arm, at the injection site; itching; it was terrible; Dizzy; Arm was real red; Arm was swollen , huge; Arm was painful; little bump in her arm; This spontaneous case was reported by a consumer and describes the occurrence of MASS (little bump in her arm), PRURITUS (itching), FEELING ABNORMAL (it was terrible), DIZZINESS (Dizzy) and ERYTHEMA (Arm was real red) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced PRURITUS (itching). On 16-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (red around my arm, at the injection site). On an unknown date, the patient experienced MASS (little bump in her arm), FEELING ABNORMAL (it was terrible), DIZZINESS (Dizzy), ERYTHEMA (Arm was real red), PERIPHERAL SWELLING (Arm was swollen , huge) and PAIN IN EXTREMITY (Arm was painful). At the time of the report, MASS (little bump in her arm), PRURITUS (itching), FEELING ABNORMAL (it was terrible), DIZZINESS (Dizzy), ERYTHEMA (Arm was real red), PERIPHERAL SWELLING (Arm was swollen , huge), PAIN IN EXTREMITY (Arm was painful) and VACCINATION SITE ERYTHEMA (red around my arm, at the injection site) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       The patient stated that on 16-Mar-2021, it started to be more itchy. She stated her adverse events lasted 4-5 days, but she has since recovered and is okay now.  Concomitant medications were not provided. Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Event information updated.
Blurry vision; Nauseous; This spontaneous case was reported by a consumer and describes the occurrence of VISION BLURRED (Blurry vision) and NAUSEA (Nauseous) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included LEVOTHYROXINE 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 13-Feb-2021, the patient experienced VISION BLURRED (Blurry vision) and NAUSEA (Nauseous). On 13-Feb-2021, VISION BLURRED (Blurry vision) and NAUSEA (Nauseous) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
this is a male who was recently diagnosed with covid who was prescribed paxlovid. Apparently when getting up this am to use the bathroom he felt dizzy, and apparently after sitting down, he apparently did per his wife have a brief episode of syncope. NO n/v/d, no shortness of breath. He is one of our former respiratory therapists. Patient states his heart rate often is about 40s. he did not take his bp meds this am per the patient.
Day 1: soreness at injection site Day 2: rash developed on left side of neck, shoulder and underarm, extremely itchy, swollen lymph nodes to left side of neck Day 3: rash is still itchy and present  Day 4:  I felt normal  Day 5: spontaneous, severe left arm weakness, pain and numbness tingling to fingers withexcrutiating pain to joints and muscles  Day 6: muscle aches still present, less severe, mild tingling to left arm extremities  Day 7: notibale localized pain to rt breast, lymph nodes swollen, very tender to the touch
Patient was suppose to Receive a Menactra shot. However, a Havrix shot was given. No adverse events reported.
Rotavirus: Diluent given without vaccine component. Per parent report: pt was asymptomatic. Feeding and behaving normally.
Ten min after pt vac w/ MMR, dev. a welt about 1 inch above injection site. Notified MD ordered Benadryl, warm compresses & to watch child 30 min. 5 min later began to vomit more welts developed vomited once more. Seen by MD given Benadryl.
At the injection site it got itchy; At the injection site it got swollen; At the injection site it got red; At the injection site it got very painful; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (At the injection site it got itchy), VACCINATION SITE SWELLING (At the injection site it got swollen), VACCINATION SITE ERYTHEMA (At the injection site it got red) and VACCINATION SITE PAIN (At the injection site it got very painful) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.  On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (At the injection site it got itchy), VACCINATION SITE SWELLING (At the injection site it got swollen), VACCINATION SITE ERYTHEMA (At the injection site it got red) and VACCINATION SITE PAIN (At the injection site it got very painful). At the time of the report, VACCINATION SITE PRURITUS (At the injection site it got itchy), VACCINATION SITE SWELLING (At the injection site it got swollen), VACCINATION SITE ERYTHEMA (At the injection site it got red) and VACCINATION SITE PAIN (At the injection site it got very painful) had not resolved. Not Provided    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No relevant concomitant medications were reported. Treatment for the events included cortisone cream.
Red, raised circle around injection site, soreness of injection arm, spot of injection hotter than rest of arm.
Patient called us today at approximately 1:20pm to let us know after receiving the vaccine on stated date, she felt off all afternoon and had no appetite.  Her stomach was upset and she wasn't right.  That evening her friend drove her to the ER and she was hospitalized for 5 days.  She was said to be dehydrated, put on dialysis and her Kidney function was 11 and creatinine was 95 according to patient.  She stated MD told her she is lucky she went when she did.  She just wanted to make us aware and I told her I would report the issue
peripheral neuropathy; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 75-year-old male patient received BNT162b2 (BNT162B2), on 23Oct2021 at 13:00 as dose 3 (booster), single (Lot number: 30125BA) at the age of 75 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "HBP" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL; OLMESARTAN; CRESTOR. Vaccination history included: BNT162b2 (Lot no: EL9231, time=08:00 PM, location=Left arm; 4 days after 1st dose vertigo and ongoing headaches and brain fog lasting 4 months), administration date: 24Dec2020, when the patient was 75-year-old, for Covid-19 immunization, reaction(s): "brain fog", "vertigo", "headaches"; BNT162b2 (Lot no: EL3249, vaccine location=Right arm), administration date: 13Jan2022, when the patient was 75-year-old, for Covid-19 immunization. The following information was reported: NEUROPATHY PERIPHERAL (medically significant), outcome "recovering", described as "peripheral neuropathy". The event "peripheral neuropathy" required physician office visit. The patient underwent the following laboratory tests and procedures: Magnetic resonance imaging: (unspecified date) unknown result; SARS-CoV-2 test: (19Apr2022) Negative, notes: covid test type post vaccination=Nasal Swab. Therapeutic measures were taken as a result of neuropathy peripheral.  Clinical information: The patient was treated with MRIs and unspecified meds. The patient did not had any other vaccine in four weeks. No COVID prior vaccination. No known allergies.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events and the use of suspect product BNT162B2 cannot be fully excluded. 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.
This spontaneous report as received from a nurse refers to a unknown numbers of patients of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date the patients were vaccinated with (Oka/Merck) PROQUAD, lot # reported as K006771, expiration date 07-NOV-2015, and lot# J014236, expiration date 07-MAY-2015. Dose and route were not reported. The nurse reported an excursion of 13.64F for 1h 15 minutes affecting (Oka/Merck) PROQUAD. Nurse reported that there have been multiple excursions to this product over the past two years, potentially over 15F. The product had been administered post excursion. There have been no reports of adverse effects to any patient. Patients did not seek medical attention. This is one of several reports from the same source. Additional information has been requested.
Red spot at injection site; Little itchy; muscle in her left arm is still a little bit sore; "her left arm still hurts a little bit"; "Moderna COVID Arm" (left arm); left arm was swollen; left arm hurt; left arm red; felt lightheaded/dizziness; vertigo; fainting feeling; nervous; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Red spot at injection site), PRURITUS (Little itchy), DIZZINESS (felt lightheaded/dizziness), VERTIGO (vertigo) and PRESYNCOPE (fainting feeling) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Latex allergy (Allergic to latex), Pollen allergy (Allergic to pollen), Dust allergy (Allergic to dust) and Grass allergy (Allergic to grass).    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced DIZZINESS (felt lightheaded/dizziness), VERTIGO (vertigo), PRESYNCOPE (fainting feeling) and NERVOUSNESS (nervous). On 06-Mar-2021, the patient experienced PERIPHERAL SWELLING (left arm was swollen), PAIN IN EXTREMITY (left arm hurt), ERYTHEMA (left arm red) and VACCINATION SITE REACTION ("Moderna COVID Arm" (left arm)). On 31-Mar-2021, the patient experienced MYALGIA (muscle in her left arm is still a little bit sore) and PAIN IN EXTREMITY ("her left arm still hurts a little bit"). On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (Red spot at injection site) and PRURITUS (Little itchy). On 27-Feb-2021, DIZZINESS (felt lightheaded/dizziness), VERTIGO (vertigo), PRESYNCOPE (fainting feeling) and NERVOUSNESS (nervous) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (Red spot at injection site), PRURITUS (Little itchy), PERIPHERAL SWELLING (left arm was swollen), PAIN IN EXTREMITY (left arm hurt), ERYTHEMA (left arm red), MYALGIA (muscle in her left arm is still a little bit sore), PAIN IN EXTREMITY ("her left arm still hurts a little bit") and VACCINATION SITE REACTION ("Moderna COVID Arm" (left arm)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Relevant concomitant medications were not reported.  Treatment information was not provided.
Upon reviewing screening questions with pt she informed me that she developed severe swelling under the arm in which the 1st dose of the vaccine was given (right arm) 1-2 weeks after receiving it. She is a breast cancer survivor. She consulted with her PCP (Dr.) and was using ice packs. The swelling eventually went down after 3 weeks.
Patient was given Moderna Bivalent vaccine when she should have received the Moderna Monovalent vaccine.  She denies any adverse reactions.