chrisvoncsefalvay/vaers-outcomes huggingface dataset:
At the time of the injection, I immediately felt pain at the injection site and a cold sensation that ran down my arm. My three middle fingers were hurting, as well. My fingers were cramping for a few hours post-injection.  That same night, I fell asleep for a few hours and woke up with intense nerve pain in the face, arm, hands, tongue,  and feet  The nerve pain/sensation continued for forty days post-injection   Three days after the injection, I had intense skin flushing on my left arm, chest, and face, and my lips and tongue tingled and felt like they were vibrating.  The skin flushing (with redness) was consistent for about 45 days and then became less intense.  Since the injections, I have had flare-ups that last about 3 to 5 days when my skin on my left arm, chest, and face will burn and itch
Small patch of red [bumps] at the injection site and just north of the site; Small patch of [red] bumps at the injection site and just north of the site; This is a spontaneous case, initially received from other non-health professional on 15-Dec-2018, concerning a 66-year-old, elderly, female patient.   On an unspecified date in 2018, the patient was administered Fluad (TIV) (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59, dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number and expiry date: not reported) for influenza prophylaxis.  It was reported that, it was patient's first influenza vaccination.  On the same day, after vaccination, the patient developed a small patch of red bumps at the injection site, which was at north of the site. The patient did not receive any treatment.  At the time of this report, the patient had not yet recovered from the events.  The reporter assessed this case as non-serious.  Non-significant follow-up received from other non-health professional on 09-Jan-2019: It was reported that, the phone provided by the consumer was from one of the Seqirus' locations. Therefore, the consumer could not be followed up. Med info number (SEQ19-0068) was added in the additional information tab. No changes were made in the narrative.  Significant case amendment (receipt date: 15-Dec-2018): Description to be coded and preferred term of the verbatim' Small patch of [red] bumps at the injection site and just north of the site' was changed from 'Injection site swelling to Injection site rash' in event tab. The case comment was amended accordingly.; Reporter's Comments: A 66-year-old, female patient developed injection site redness and rash, on the same day after receiving Fluad (TIV). The company assessed the causality of the events as related to the suspect vaccine due to the plausible temporal relationship between the events and suspect vaccine.
The patient presented to the clinic for her scheduled apt, per the apt note, booster, Bivalent if available. After confirming the patient's Name and DOB, and verifying that the patient was here to receive the booster, the administration of the booster was completed.   When filling out the patient's card for COVID injections, a date read of 10/4/22. When asking the patient about getting the booster before, the patient states that she doesn't remember getting the booster that day. Per the patient's chart, it is dated that she received this injection on 10/04/22. The injection on 11/29/22 was also charted. The patient was notified of this and of the CDC's recommendation per Moderna to not get any more booster injections. The patient again stated that she doesn't remember getting the vaccine on 10.4.22 The patient then states that she appreciated being called.  The patient was advised to call the clinic with any concerns. At the time of the call, there were no concerns voiced.
Initial information received on 25-Sep-2018 regarding an unsolicited valid non-serious case received from other health professional (physician's assistant). This case involves 25 patient(s) who was vaccinated with a 0.5 ml dose of FLUZONE HIGH DOSE (lot: uj006ab) via intramuscular route in the deltoid (not specified) from 14-Sep-2018 to 24-Sep-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to deteriorated drug administered because of cold chain management had been broken since shipping was delayed before receipt of product. It was not reported whether the patient experienced any adverse events following the vaccinations 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 party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none
Patient had severe swelling and redness to joint of left knee the following day after vaccine.    It then worsened to include swelling to both knees and ankles although the left knee remained the most swollen, red and painful.
5/19/2021: Fever, Chills, headache, cough.   5/20/2001:  Chills persist, fever & headache resolve 5/21 /2021 at 0300:  Severe Chest pain, fever recurs,  admitted to hospital where ST elevation seen on EKG, Echocardiogram shows pericardial enhancement, normal function , no abnormalities.  troponin high at  832, proBNP high at 308, CKMB 54.6
10DEC98 pt recv vax & Friday evening took the bandaid off & on lt leg had a blister @ the site of inj;also had a fever & was irritable;the blister never broke & was gone by the next wednesday;
LETHARGY, FEVER, COUGH DEVELOPED WITHIN 24 HOURS.
On 5/20/21 the patient was at home with his mother when he had acute nausea, light-headedness, and abdominal pain. He presented to the ED by ambulance. Excerpt from ED notes od MD follows: "Initial ED interventions: iv fluids, low dose iv ativan, iv toradol, iv zofran.  ED course: patient arrives very anxious, writhing on bed, difficult to redirect. With chronic tonicity, not seizing. Mother arrives, and he recognizes her, seems to be consoled somewhat by her presence, but she is unable to direct him, and describes his behavior as irregular, and events acute this evening at her home.  Patient rests, and then HR decrease to 50s on monitior and patient found to be pulseless - I immediately start chest compressions, and achieve ROSC after PEA arrest with administration of EPI/compressions. Patient intubated per procedure note without complication. L femoral central attained per procedure note without complication. CPR performed over ED course intermittently (always PEA arrest) with ROSC achieved with administration of EPI, EPI drip started in addition to sedation meds, and iv fluids. No obvious STEMI on ECG to administer lytics, with suspicion of dissection and AAA prominent. I am able to stabilze and accompany patient to CT suite, where I recognize B/L massive PE immediately. I discuss with Dr. of Cardiology, who agrees with admininstration of alteplase. I disucss risks with mother who consents verbally. Patient without response to alteplase, and with continued pattern of PEA arrest following bradycardia. I discuss etiology of presentation with mother,and that patient is with very poor prognosis of survival, and likely poorer prognosis of neurological status, and patient is made comfort care, and fentanyl drip increased, patient is taken off of ventilation and drips. Pronounced deceased at 22:00.  MDM: Initial concern for but not limited to appendicitis, AAA, diverticulitis, renal stones, pyelonephritis, musculoskeletal pain, pancreatitis, toxic ingestion, ACS, obstruction, perforation, sepsis (2/2 PNA, UTI, meningitis, intra-abdominal infection), AAA, dissection, PE - as ED course progresses, differential narrows and consider more likely PEA arrest secondary to ACS, PE, dissection, AAA, necrotic pancreatitis, tension PNX (less likely). Considered but do not suspect seizures, stroke. Imaging studies reviewed - CXR with ETT in place, no acute pathology. CTA chest/A/P remarkable for massive proximal B/L PE. Labs reviewed. ECGs without STEMI, with sinus tach initially, LBBB after initial ROSC, and then AFib in RVR on subsequent ECG. Per above, patient suffered massive B/L PE, with subsequent cardiac arrest, despite heoric efforts including thrombolysis. Death called art 22:00.  Diagnosis: massive B/L PEs, PEA arrest.  Disposition: deceased."
Information has been received from nurse practitioner concerning a 35 year old male who receive his first dose of MMR II as a child, the exact date and exact product that the patient received as a child were unspecified. In 2009 the patient had a negative titer for rubeola (measles). In July 2009 (also reported as September 2009) the patient was vaccinated with second dose of MMR II (lot # not reported). On 19-JAN-2011 the patient again had a negative titer for rubeola (measles). No adverse event were noted other than the failure to seroconvert to rubeola (measles). Immunity to the other components of the MMR II was not in question. Blood work for immunity to measles, mumps and rubella was performed. The patient sought a medical attention to the office. No further information is available.
severe rhabdomyolysis/urinating the color of Coca-Cola and could not walk/CK level of 209,000 U/L; Pain in my left arm from vaccine started on Wednesday; Wednesday I worked on upper body and arm/chest/back muscle pains began/On Thursday, I worked on legs and severe quad/glute/hip muscle pain began; This is a spontaneous report from a contactable consumer (Patient). A 26-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 23Mar2021 13:30 (Batch/Lot Number: EN6204) as single dose for covid-19 immunisation. The COVID-19 vaccine was administered at Pharmacy or Drug Store. Medical history included reported as none. Concomitant Therapy included multivitamin, joint suppliment. The patient was hospitalized with severe rhabdomyolysis a few days after receiving his first dose of the Pfizer vaccine. He received the vaccine Tuesday 23Mar2021 and went to the gym Wednesday 24Mar2021 and Thursday 25Mar2021. Pain in his left arm from vaccine started on Wednesday and additional muscle pain was induced post workout on both days. Wednesday he worked on upper body and arm/chest/back muscle pains began. On Thursday, he worked on legs and severe quad/glute/hip muscle pain began. Saturday (27Mar2021) he began urinating the color of Coca-Cola and could not walk. Sunday (28Mar2021) he was hospitalized with a creatine phosphokinase (CK) level of 209,000 U/L with no preexisting health conditions that would cause his CK levels to be so extreme. Adverse event severe rhabdomyolysis was started on 27Mar2021 09:00 AM and resulted in Emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event). Patient was hospitalized for 7 days. Therapeutic measures were taken as a result of severe rhabdomyolysis included IV fluids. The outcome of the events was recovered.
stomach cramp; A spontaneous report was received from a consumer concerning a 80 year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced stomach cramps.    The patient's medical history was not provided. No relevant concomitant medications were reported.    On 30 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (039K20A) intramuscularly for prophylaxis of COVID-19 infection.   On 31 Dec 2020, the patient began to experience stomach cramps. The cramps were ongoing, but getting better, as reported by the patient. Treatment for this event included paracetamol (one at last night and one today morning).    Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event was considered recovering/resolving.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
mild fever; achy; This case was reported by a consumer and described the occurrence of fever in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of blood glucose increased (1st dose received on 29th September 2020, reference case US2020206840) and Influenza vaccine quadrivalent 2020-2021 with an associated reaction of blood glucose increased (Received on 15th September 2020, reference case US2020206840).   On 28th December 2020, the patient received the 2nd dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced fever and pain. On an unknown date, the outcome of the fever and pain were unknown.   It was unknown if the reporter considered the fever and pain to be related to Shingrix.  Additional details were provided as follows: The patient experienced mild fever and she felt achy. The doctor seeing the patient seven days after the 2nd dose of Shingrix. The consent to follow-up was granted.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020206840:same patient
Swelling of neck, muscle twitching (leg, arm, neck, jaw), muscle soreness, diarrhea. SX gradually improved over next 6 days. Treated with 10mg diazepam at night. Muscle twitching was clinically evident on FU Exam.
Moderna COVD-19 Vaccine EUA  Major Arm pain and soreness moving into Left Pec around 8 PM, Naseua and Tiredness starting after that, vomiting at 6 AM, tiredness and weakness after that.
exposed to covid; not feeling well; This spontaneous case was reported by a consumer and describes the occurrence of EXPOSURE TO SARS-COV-2 (exposed to covid) and MALAISE (not feeling well) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced EXPOSURE TO SARS-COV-2 (exposed to covid) and MALAISE (not feeling well). At the time of the report, EXPOSURE TO SARS-COV-2 (exposed to covid) and MALAISE (not feeling well) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
No adverse event noted yet except tiredness. When I called to tell them that they administered the 3rd flu shot (I was not at the appt) they could not tell me what adverse effects she may experience from a 3rd dose of the vaccine.
Initial information received on 04-Oct-2018 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional. This case involves an eight months old male patient and reported that 8 months, received an early dose of FLUZONE QUADRIVALENT, 0.25 ml, while he received vaccine FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On 14-Sep-2018, the patient received a first 0.25 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number: UT6259NA and expiry date: 30-Jun-2019) (dose in series, route and site of administration was not reported). It was a case of actual medication error due to Inappropriate schedule of vaccine administered. It was unknown if the patient had any adverse event. 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. List of documents held by sender: none.
Blister on lower lip/ appeared the next day; This case was reported by a pharmacist via call center representative and described the occurrence of lip blister in a 64-year-old female patient who received Herpes zoster (Shingrix) (batch number 3K743, expiry date 7th November 2022) for prophylaxis.   On 26th May 2021, the patient received the 1st dose of Shingrix (intramuscular) 50 µg. On 27th May 2021, 1 days after receiving Shingrix, the patient experienced lip blister. On an unknown date, the outcome of the lip blister was not recovered/not resolved.   It was unknown if the reporter considered the lip blister to be related to Shingrix.  Additional details were provided as follows: The pharmacy intern called and reported that the patient received the 1st dose of Shingrix on left arm and 1 day after the vaccination patient experienced a blister on lower lip. On 28th May 2021 the patient visited pharmacy to show the blister. The patient stated that blister appeared the next day after receiving Shingrix vaccine.
experiencing low-grade fever for over 48 hours already.; This is a spontaneous report from a Pfizer Sponsored Program. A contactable consumer (patient herself) reported that an unspecified aged female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection) via an unspecified route of administration on 11Apr2021 at single dose for COVID-19 immunization. Patient medical history and concomitant medications were not reported. Patient previously took COVID-19 vaccine. Patient had her 2nd dose of the Pfizer Covid-19 vaccine on 11Apr2021, and she mentioned that today she has been experiencing low-grade fever for over 48 hours already on an unspecified date in Apr2021. Outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
After immunization patient said she felt dazed, hot when the needle went in and dry mouth. I gave patient water and she sat for 15 minutes and felt fine to leave.
Ringing in my ears began gradually and has increased in loudness and severity. Now on a scale from 1 to 10 it is a 7 and is extremely uncomfortable. Most noticeable in right ear. Also some light headedness after the second shot on 4/5/21.
Patient was 17 years old at the time of receiving his first dose of Moderna. Attempted to call patient with phone number on record-no contact made.
TESTED POSITIVE FOR COVID ON 12/30/20 AFTER GETTING VACCINE ON 12/28/20
Initial report was received from a consumer, who was also the patient, on 21 September 2013. A 56-year-old female patient had received an intradermal injection in the left deltoid of FLUZONE Intradermal (lot number not reported) on 13 September 2013. The night of the vaccination, the patient stated she didn't feel well and her bones ached. Her pain level was a 7-8 and she took prescribed meds hydrocodone and XANAX. The next day, the patient felt fine. A few hours into her day, the left deltoid became painful, swollen and itchy. On the right arm she developed two bumps the size of golf balls and broke out in pink round bumps scattered on her upper body. They were painful, swollen and itchy pink round bumps. She was seen at an urgent care center and prescribed Clindamycin. The rash was beginning to improve. The patient had a history of pain and reflex dystrophy. Outcome was not recovered. Documents held by sender: None.
I had a bilateral mastectomy on 1/28/2021 after being diagnosed with breast cancer on the L side. A sentinal node was removed as well. I have tissue expanders as placeholders. I had the shot on the left side. The day after I had very bad headache but following day, the whole left breast was red, swollen and the nodes all around the breast were swollen. The breast was also hot to the touch. This morning nodes aren't swollen. Breast is less red and looks a bit bruised, still a little hot to the touch.
Erythematous, papular rash to right arm. Tx: Prednisone taper 20mg. Cough & congestion, which wasn't addressed at urgent care. On 10/25 visit, rash was worse; never given Claratin script, as mentioned. Pt. still has rash & deep cough.
Information has been received from a consumer and a physician, for pregnancy registry for GARDASIL, concerning a 17 year old female patient with penicillin allergy, sulfonamide allergy, attention deficit/hyperactivity disorder, left side of heart enlarged and asthma and a history of ventricular septal defect and USD, who on 27-SEP-2007, was vaccinated with the first dose of GARDASIL, and was pregnant (LMP- sometime around 11-DEC-2007, ECD- 07-SEP-2008). Concomitant therapy included ADHA medication, heart medication. Other medications used during pregnancy were albuterol on 18-AUG-2008 for wheezing. Subsequently, the patient experienced gonorrhea and chlamydia infection. AFP was performed with the result of negative, and fetal scan was also performed. On 12-DEC-2007, the patient was vaccinated with the second dose of GARDASIL. On 09-SEP-2008, the patient had a normal male infant. The Apgar score was 9/9. No congenital anomalies or complications were noted. Additional information is not expected.
Symptoms started with mild soreness at injection site, however by Sunday AM 11/16/2014 there was a red, raised area about 5cm in diamter. The area was warm to touch, hard in middle, very tender, and swollen. By Monday 11/17/2014 6:00 AM the area was 10cm in diameter, very tender, warm to touch, and swollen. Monday 10:00 AM went to clinic for advice--low grade fever present.
Vaqta was administred to a 6 month old infant; No patient experienced symptoms; This spontaneous report was received from a physician via a company representative regarding a 6-month-old infant. The patient's pertinent medical history, concurrent conditions, concomitant medications, and drug allergies or reactions were not reported.   On an unknown date, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) injection (strength, dose, route of administration, anatomical location, lot number, and expiration date were not reported) for prophylaxis (product administered to patient of inappropriate age). No adverse events were reported, nor product quality complains involved.   This is one of the two reports received from the same reporter.; Sender's Comments:  US-009507513-2007USA001379:
sore throat. chills, fever, pain in entire arm where injection was given, pain in neck and chest area.
sicker; felt really sluggish; Initial information received on 08-Oct-2020 regarding an unsolicited valid non-serious case received from a social media consumer (patient).  This case involves patient (unknown demographics) who experienced sicker (illness) and felt really sluggish (sluggishness), while he/she received vaccine INFLUENZA VACCINE.  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date: not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious sicker (illness) and felt really sluggish (sluggishness), (unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data not reported.   It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome of events was reported as unknown.  There will be no information on the batch number for this case.