chrisvoncsefalvay/vaers-outcomes huggingface dataset:
warm to touch at the injection site; soreness; Redness; swelling; Chills; Headache; Body ache; fever of 101; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE WARMTH (warm to touch at the injection site), VACCINATION SITE PAIN (soreness), VACCINATION SITE ERYTHEMA (Redness), VACCINATION SITE SWELLING (swelling) and CHILLS (Chills) in a patient of an unknown age and gender 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 was reported.     On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (warm to touch at the injection site), VACCINATION SITE PAIN (soreness), VACCINATION SITE ERYTHEMA (Redness), VACCINATION SITE SWELLING (swelling), CHILLS (Chills), HEADACHE (Headache), MYALGIA (Body ache) and PYREXIA (fever of 101). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (warm to touch at the injection site), VACCINATION SITE PAIN (soreness), VACCINATION SITE ERYTHEMA (Redness), VACCINATION SITE SWELLING (swelling), CHILLS (Chills), HEADACHE (Headache) and PYREXIA (fever of 101) outcome was unknown and MYALGIA (Body ache) was resolving.        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  information was  provided.
Five minutes after getting the vaccine, I started experiencing mild sweating in my palms, a symptom which has continued to flare up since. A half hour later, when walking up the stairs, I felt unusual skin sensitivity in response to the wind blowing, and a strange proprioception problem: when I reached my right hand out to grab the railing, I missed it, for the first time ever. A few hours later, I felt a pain behind my right eye. The next day I felt my heart pounding in my chest and a sharp head pain in the rear right occipital area (bottom of my skull).  My tinnitus began to worsen. Four days later, when I stood up from a sitting position, I experienced dizziness and fast heart rate (postural tachycardia). Since that time, my heart rate has spiked when standing up, from 71 lying down to 108-110 standing up. Several times I've felt extreme heaviness in both my legs while walking. I've also experienced more dizziness and lightheadedness, especially when moving, like making a turn in my car or lying on a moving hammock. Lying down with my legs supported on pillows  seems to help. Today I went on a brief walk and felt like my nervous system wasn't working properly; I actually had to mentally force myself to put one foot in front of the other. It was a very scary feeling.  I've been reading about vestibular nerve inflammation, postural orthostatic tachycardia syndrome, dysautonomia, and other autoimmune conditions, and my sense is that the vaccine triggered an autoimmune reaction throughout my nervous system.
This spontaneous report as received from a medical assistant refers to a 67-year-old female patient. The patient had no pertinent medical history, concomitant medications, drug reactions, or allergies. On 04-OCT-2017, the patient was vaccinated with a dose of PNEUMOVAX 23 (intramuscularly; lot # N012840, expiration date: 20-JAN-2019). On the same day, the patient felt achy, warm and there was redness at injection site, and the redness spread to neck and breast. Patient had swelling, and was unable to lift arm due to pain. The patient was sought medical attention and on 04-OCT-2017 at 08:00 at night, she was calling to the physician's office. On 05-OCT-2017, the patient visited physician's office and was administered prednisone (manufacturer unknown) taper and KEFLEX (500 mg every 8 hours for 7 days). No laboratory diagnostic studies were performed. The outcome the adverse events and the relatedness between the adverse events and PNEUMOVAX 23 were not provided.
felt sick; was sleeping all day; injection site swollen, warm, and hurts; injection site swollen, warm, and hurts; injection site swollen, warm, and hurts; booster; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 49-year-old female patient received bnt162b2 (BNT162B2 Formulation: Solution for injection), via an unspecified route of administration, administered in arm left on 05Oct2021 at 11:00 (Lot Number: FC3183) as dose 3 (booster), single (age at vaccination 49-year-old) for covid-19 immunization. Medical history included ongoing diabetes, Gastroparesis, Blood pressure high and Carcinomic tumour in colon from an unknown date and unknown if ongoing. It was confirmed that all of her medical conditions mentioned were diagnosed prior to the COVID vaccine/booster shot. Concomitant medication included semaglutide (OZEMPIC) taken for diabetes mellitus, start and stop date were not reported. Historical vaccine included first dose of bnt162b2 on 24Feb2021 (lot number: EL3247, Route, Anatomical Location: probably right arm) and second dose of bnt162b2 on 17Mar2021, lot number: EN6207, Route, Anatomical Location: probably right arm) (age at vaccination 48-year-old) for covid-19 immunization. The other product was not reported. No additional vaccines administered on same date of the Pfizer suspect. No other vaccinations within four weeks prior to the first administration date of the suspect vaccine. No AE following prior to vaccinations. The patient experienced injection site swollen, warm, and hurts on 06Oct2021 and felt sick and was sleeping all day on an unspecified date. The patient stated she does not know what happened to her, she guesses the side effects got her. It was stated the first 2 shots wasn't as bad, but after booster, she had injection site, was still swollen and warm and still hurts. The patient wanted to know how many more days she will felt like she was about dead. She should not have said she was about to die and clarified she just felt sick. The patient stated that yesterday was not a good day. She did not know what was wrong with her, she was sleeping all day. She was told to take Acetaminophen instead of Ibuprofen because she needs inflammation or something like that. However, she doesn't want to take that, Acetaminophen/Tylenol does not do absolutely nothing for her. Ibuprofen does better for her, and she asked can she take Ibuprofen. Emergency Room and physician Office visit not required due to events. The outcome of event was sleeping all day was unknown and outcome of other events was not recovered.   Follow-up attempts are completed. No further information is expected.
Case number PHEH2015US010041, is an initial spontaneous report from a health care professional (pharmacy technician) received on 21 May 2015 with follow-up information from a health care professional (pharmacy technician) received on 25 Jun 2015. This report refers to a 23-year-old female patient. Medical history included pregnancy. Concurrent condition included allergy to sulfa drugs. Her vaccination history included administration of FLUVIRIN (batch number: unknown) on 14 Oct 2013 which was well tolerated. On 20 May 2015 the patient was vaccinated with a prefilled syringe of FLUVIRIN (batch number: 145621, expiration date: 30 Apr 2015) at a dose of 0.5 ml intramuscularly into right deltoid that expired on 30 Apr 2015. No adverse event was reported. Follow-up information from a health care professional received on 25 Jun 2015: Patient's demographics (weight and height), medical history, vaccination history and vaccine details (batch number, dose and site_ were reported.
This spontaneous report was received from a physician and refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies, and concomitant therapies was provided. On 09-MAY-2017, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (lot#,  expiration date, dose, route of administration and anatomical location were not reported). Administered dose of vaccine experienced the temperature excursion of 48 Fahrenheit degrees for 30 minutes. Data logger was not involved. There were no previous excursions reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA001661:  US-009507513-1704USA000587: US-009507513-1704USA001660:
upset stomach; arm bothered her; itchy; heart rate is up; loose stool; felt like some someone was sitting on her chest; fever of 99 degrees Fahrenheit; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (upset stomach), LIMB DISCOMFORT (arm bothered her), PRURITUS (itchy), PALPITATIONS (heart rate is up) and DIARRHOEA (loose stool) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY), LANSOPRAZOLE (PREVACID), ZOLMITRIPTAN (ZOMIG), FAMOTIDINE (PEPCID AC), ATENOLOL, LEVOTHYROXINE SODIUM (SYNTHROID), MONTELUKAST and FLUTICASONE FUROATE (ARNUITY ELLIPTA) for an unknown indication.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced ABDOMINAL DISCOMFORT (upset stomach), LIMB DISCOMFORT (arm bothered her), PRURITUS (itchy), PALPITATIONS (heart rate is up), DIARRHOEA (loose stool), CHEST DISCOMFORT (felt like some someone was sitting on her chest) and PYREXIA (fever of 99 degrees Fahrenheit). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at an unspecified dose and frequency and LANSOPRAZOLE (PREVACID) at an unspecified dose and frequency. At the time of the report, ABDOMINAL DISCOMFORT (upset stomach), LIMB DISCOMFORT (arm bothered her), PRURITUS (itchy), PALPITATIONS (heart rate is up), DIARRHOEA (loose stool), CHEST DISCOMFORT (felt like some someone was sitting on her chest) and PYREXIA (fever of 99 degrees Fahrenheit) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Mar-2021, Body temperature: 99 (High) 99 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
HYPOXIA  1/23/2023 -- RECURRENCE OF SAME SYMPTOMS
Was later diagnosed with Multiple Sclerosis, symptoms started 1 day after my second dose. All doctors visited seem to believe this is due to an adverse reaction to the covid shot. No documented proof or testing.
a female patient received Flublok that was out of range for more than 24 hours because they donot have data logger/No AE; Initial information and additional information received on 20-Sep-2019 regarding an unsolicited non-valid non-serious case received from a consumer (office staff).  This case is linked to cases 2019SA267191, 2019SA267208, 2019SA267209, 2019SA267210, 2019SA267211, 2019SA267212, 2019SA267213, 2019SA267214, 2019SA267215, 2019SA267216, 2019SA267217, 2019SA267218, 2019SA267219, 2019SA267220, 2019SA267221, 2019SA267222, 2019SA267223, 2019SA267224, 2019SA267225, 2019SA267226, 2019SA267227, 2019SA267228, 2019SA267229, 2019SA267230, 2019SA267231 and 2019SA267232.  This case involves a female patient (age unknown) who received INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] that was out of range for more than 24 hours because they do not have data logger (lot number and expiry date not reported).  It was an actual medication error due to incorrect product storage.  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 holders 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.  Information on the batch number was requested.  List of documents held by sender: none.
Patient admitted with shortness of breath and productive cough. Patient required up to 3L of nasal cannula oxygen.
Patient states arm was red and warm to touch at injection site. Per pharmacist's advice she took 25 mg Benadryl 2 hours after presenting to pharmacy. Benadryl helped the redness temporarily but arm was increasingly warm, itchy, and was developing a firm lump the next morning. Denies any systemic symptoms (fever, facial swelling, dyspnea). I advised her at that time to see her PCP, as she likely has a mild case of cellulitis. Advised patient to follow up with us so we know her status.
This spontaneous report was received from a other health professional via Pfizer (E2B # US-PFIZERINC-US19012812) and refers to a currently 91-years-old female patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date (reported as in 204), the patient was vaccinated with dose of PNEUMOVAX 23 injection (exact dose, dose number, route and site of administration, lot # and expiration date were not reported). On an unknown date the patient experienced severe burning at the injection site, but did not present swelling, fever or shortness of breath. The outcome of the event and the relatedness between the event and PNEUMOVAX 23 were not reported.
Intussusception.  2/23/09 Received hospital medical records of 1/8-1/9/2009. FINAL DX: Intussusception Records reveal patient experienced  intermittent crying & lethargy x 5 days, periods of inconsolability, abdominal distention & pain, oral intake reduced, c.onstipation  Surgery consult done.  Tx w/water soluble contrast enema successfully.  Admitted overnight for observation.  Progressed well & d/c to home
Information has been received from a physician concerning a 96 year old female who in October 2008 was vaccinated with PNEUMOVAX (Lot# 662599/1076X, therapy date, route, site unknown).  "In the last 10 days", approximately 19-OCT-2008, the patient developed severe local reactions in the injection arm.  She experienced welts and swelling on the arm.  She also developed a fever and had trouble breathing.  She sought medical attention and was hospitalized for the fever but has since been released.  A lot check is requested for PNEUMOVAX lot # 662599/1076X.  At the time of this report on 29-OCT-2008, the patient was recovering.  This is one of several reports received from the same source.  Follow-up information was received from the physician and medical records that the patient was a 95 year old female with hypertension, anaemia, depression, headache, osteoporosis, hyponatraemia, hypocholesterolaemia and osteoarthritis and a history of cerebrovascular accident and transient ischaemic attack who on 22-OCT-2008 was vaccinated with PNEUMOVAX on left deltoid (Lot# 662599/1076X, therapy route unknown).  Concomitant therapy included NORVASC, aspirin, ZOLOFT, PRILOSEC, XALATAN and multivitamin.  The patient retired and had no smoking or drinking.  On 23-OCT-2008 the patient experienced chills, cough, dyspnea and redness of upper extremity.  She sought medical attention and was hospitalized for 2 days from 23-OCT-2008 to 25-OCT-2008.  At the hospital, the patient was started prior to admission on nitrofurantoin for urinary tract infection.  Discharge summary reported principal diagnosis as "small left pleural effusion atelectasis".  Other diagnoses included: "transient febrile, Pneumovax, Redness of upper extremity status post pneumonia injection, urinary tract infection, hyponatremia, hypertension".  A standard lot check investigation was performed.  All in-process quality checks for the lot number in question were satisfactory.  The lot met the requirements of the research center and was released.  No further information is available.  All available medical records will be provided upon request.
Initial report received from a healthcare professional on 10-Oct-2013. A 66-years-old patient administered with FLUZONE ID. (No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 2006, a healthcare provider administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 17-SEP-2016, the patient was treated by a healthcare provider for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the zoster vaccine live (ZOSTAVAX) vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death; aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered.  Additional information has been requested.
my cousin just "died" taking the Moderna shot; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (my cousin just "died" taking the Moderna shot) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.            The concomitant medication was not reported by reporter. The treatment medication was not reported by reporter.  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.  Company Comment: This spontaneous case concerns a patient, of unknown age and gender, with no medical history reported, who experienced the unexpected, serious event of death. The event occurred unknown number of days after receiving an unspecified dose of the mRNA-1273 vaccine. Of note, the vaccination date and the event onset date were not provided, hence, the onset latency could not be assessed. It was reported that the patient "just 'died' (further not clarified) taking the Moderna shot". No further details were provided. The cause of death was not provided. It is unknown if an autopsy was performed. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a patient, of unknown age and gender, with no medical history reported, who experienced the unexpected, serious event of death. The event occurred unknown number of days after receiving an unspecified dose of the mRNA-1273 vaccine. Of note, the vaccination date and the event onset date were not provided, hence, the onset latency could not be assessed. It was reported that the patient "just 'died' (further not clarified) taking the Moderna shot". No further details were provided. The cause of death was not provided. It is unknown if an autopsy was performed. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Reported Cause(s) of Death: my cousin just "died" taking the Moderna shot
administered vaccine after only 4-6 minutes from being taken out of the refrigerator; A spontaneous report was received from a pharmacist () concerning a 54-year-old patient, unknown gender, who was administered a dose of the Moderna vaccine after only 4-6 minutes from being taken out of the refrigerator/ Product preparation error.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 01 Mar 2021, the patient received their first of two planned doses of mRNA-1273 (Batch number: 013A21A) intramuscularly for prophylaxis of COVID-19 infection.   On 01 Mar 2021, a patient was administered a dose of the Moderna vaccine after only 4-6 minutes from being taken out of the refrigerator. No adverse event was reported by the patient after being given the vaccine. No treatment information was provided.     Action taken with mRNA-1273 in response to the event was not provided.  The event, administered vaccine after only 4-6 minutes from being taken out of the refrigerator, was considered recovered on 01 Mar 2021.; Reporter's Comments: This report refers to a case of Product preparation error for mRNA-1273(Batch number: 013A21A) , with no associated AEs.
Gardasil #1 received 4/9/07 woke up 4/10/07 with acute torticoillis.
J96.00 ACUTE RESPIRATORY FAILURE 4/11/2023 ACUTE RESPIRATORY FAILURE
Anterior L thigh red and swollen 3x4 cm after getting shots on 8/25/2006
Started feeling unwell Monday night and sick by Tuesday night. Extreme fatigue Tuesday AM, nausea & fatigue & headache. By Tuesday night, very sore throat and extreme fatigue. Wednesday very congested, sore throat, swollen and painful lymph nodes. Went to urgent care & swabbed for COVID and strep. Both negative (tests were rapid and PCR). Since Wednesday continuing through today 12-28-20 - congestion, sore throat, coughm, swollen painful lymph nodes, some GI issues, headache, and fatigue. Return to PCP on 12-29-20
Patient received dose of flu vaccine 11/6/2022 after receiving a flu vaccine on 8/2/22
Noticed a low grade fever (100.5), fussiness, & poor appetite. I treated fever with 1 dose of Advil. Low grade fever (99.8) the following day treated with single dose of Advil. The next day, 9/1/13 notice bumps popping up on legs, arms, and face with clusters of bumps/pox (7-8/cluster) on upper outer thighs at vaccine injection sites on both legs. Still fussy and not acting like himself. Also between the day of vaccine & onset of symptoms we flew cross country on 8/28/13, and he had significantly less consistent sleep, poorer nutrition due to traveling, and stress of lots of young children/cousins/relatives around.