chrisvoncsefalvay/vaers-outcomes huggingface dataset:
CLIENT REPORTED ADVERSE REACTION FOLLOWING COVID-19 VACCIANTION THAT WAS SIMILAR IN HER WORDS TO CELLULITIS. AREA AROUND INJECTION ISTE WAS RAISED, RED, HARD, WARM TO TOUCH, AREA MEASURED APPROX. 2"X2: AREA TURNED YELLOW AROUND SITE AND REACTED WTO SUNLIGHT BECOMING 'BLISTERY' TREATED WITH TRIPLE ANTIBIOTIC OINTMENT AND RESOLVED AFTER SEVERAL DAYS
Information has been received from a pharmacist concerning a female (age not reported) who was vaccinated with Gardasil.  Concomitant therapy included chemotherapy (ABVD) ADRIAMYCIN PFS, bleomycin, vinblastine and dacarbazine.  It was reported that the patient is in the middle of her Gardasil series.  The type of cancer and the date that the cancer was diagnosed was unknown.  Unspecified medical attention was sought.  Additional information has been requested.  Upon internal review cancer is considered to be an other important medical event.  6/27/08 Reviewed medical records from Oncology. FINAL DX: Hodgkin's lymphoma, stage IIA Records reveal patient diagnosed 1/25/2008.  Left cervical lymph nodes had been swollen since previous summer.  Exam revealed left adenopathy: cervical, axillary & supraclavicular.    6/27/08 Reviewed surgeon medical records of 1/25/08.   FINAL DX: Hodgkin's lymphoma, stage IIA Records reveal patient w/left posterior cervical supraclavicular adenopathy worseing over approx 6 mos.  7/11/08 Reviewed PCP medical & vax records. FINAL DX: Hodgkin's lymphoma, stage IIA. Records reveal patient had tender & swollen left neck x 1-2 wks prior to vaccination on 8/2/2007.  Tx w/antibiotics but lymphadenopathy continued unchanged.  Referred to heme/onc. Tx w/chemo & rad tx.
Pt recvd vax in JUL92 & devel an urticarial eruption w/a diffuse burning;
l developed chills, extreme headache, fever, soreness in arm where shot was administered was not feeling well for 3 days. Developed red sores on both arms the next day, that are still there today. Sores where red blotchy and broke open to secret liquid, they are now scabbing over and look terrible. They have still not cleared up.
1st two doses were Pfiser had NO side effects. Did not have tooth abscess during either This Moderna booster caused my Systolic Blood Pressure to exceed 200 for 3 days in a row with fast heart rate above 100 putting me in the ER and lucky to survive. My significant other became EXTREMELY sick for 10 days and got her booster the same time I did.  We are still trying to recover from 2 weeks ago. What a nightmare! There must be something wrong with that Moderna Lot # and please let us know asap.
COVID; COVID; very sick after getting her covid vaccination; had a bad cough; sore throat; was under the weather; voice was hoarse; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4476548-00.  A 53-year-old female patient received BNT162b2 (BNT162B2), on 10Apr2021 as dose 1, single (Batch/Lot number: unknown) and on 08Jul2021 as dose 2, single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation; risankizumab (SKYRIZI [RISANKIZUMAB]), (Batch/Lot number: unknown), subcutaneous for psoriasis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DYSPHONIA (non-serious) with onset 2022, outcome "unknown", described as "voice was hoarse"; MALAISE (non-serious) with onset 2022, outcome "not recovered", described as "was under the weather"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "COVID"; ILLNESS (non-serious), outcome "unknown", described as "very sick after getting her covid vaccination"; COUGH (non-serious), outcome "unknown", described as "had a bad cough"; OROPHARYNGEAL PAIN (non-serious), outcome "unknown", described as "sore throat". The action taken for risankizumab was unknown. The patient was very sick after getting her covid vaccination. She was under the weather and had a bad cough and sore throat and voice was hoarse.  Causality for Skyrizi (Risankizumab): The reporter's causality for the events of COVID and Under The Weather with Skyrizi (Risankizumab) was no reasonable possibility. The reporter's causality for the event of Hoarse Voice was not provided.   The reporter considered "covid", "was under the weather", "voice was hoarse" and "very sick after getting her covid vaccination" not related to BNT162b2. The reporter's assessment of the causal relationship of "had a bad cough" and "sore throat" with the suspect product(s) BNT162b2 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.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the available information and considering the temporal chronological association  the Company considers these adverse events as not related to study drug BNT162b2. Potential confounding factor for cough, malaise and oropharyngeal pain (included in the safety profile of the drug) represented by risankizumab although treatment detail are missing in the report.
A non-serious spontaneous report of administration of H1N1 LAIV to 18 month old was received from a registered nurse/healthcare professional concerning a 18-month-old female. Neither past medical history nor concomitant medication have been reported for this patient. On 01-Oct-2009, the patient was administered H1N1, Intranasal. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments were not applicable, and the event was considered resolved.
difficulty breathing, wheezing, cough, paleness, fast heart beat, dizziness, weakness in legs and felt like legs going to give away with walking, chills, lethargic
Fatigue; Fever; Chills; Nausea; This spontaneous case was reported by a physician and describes the occurrence of FATIGUE (Fatigue), PYREXIA (Fever), CHILLS (Chills) and NAUSEA (Nausea) in a 33-year-old female patient 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (Fatigue), PYREXIA (Fever), CHILLS (Chills) and NAUSEA (Nausea). At the time of the report, FATIGUE (Fatigue), PYREXIA (Fever), CHILLS (Chills) and NAUSEA (Nausea) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported.  The reporter had a patient who after the after the first Moderna Covid-19 vaccine experienced fatigue, fever, chills, and nausea. It was not known which arm the patient received their first Moderna Covid-19 vaccines in.  No treatment information was provided.   This case was linked to MOD-2022-511201, MOD-2022-511202 (Patient Link).
Patient had 3 doses of Moderna vaccine on 12/20/21, 2/17/21, and 1/20/21, and was hospitalized for COVID pneumonia on 1/19/22.  Patient is still hospitalized today, 1/20/22, and will likely be hospitalized for several days.
Patient became nonresponsive to caregiver, became pale and vomited after vaccine. Vital signs initially BP 100/60 pulse 100 RR20 Pulse Ox 99-100. BP decreased to 86/60 HR 56 RR18. EMS called and patient transported to ER. Possible vagal response vs adverse response to medication used to treat behavioral D/O (clonidine AM dose recently increased by pt's psychiatrist) vs seizure (pt has hx of Sz D/O but has been off meds for several years and has not  had any Sz in several years).
Patient's whole arm began to tingle and then became weak.  Soon after the patient began to experience extreme pain.
Moderate arm soreness 5-48 hours post-injection.  Second, on the evening of 1/4/2021, noticed red rash, currently continuing to enlarge at time of this report. Intermittent light pruritis, mainly to palpation.
Dizziness and feeling increased HR. BG checked, 213. HR 115. Pt released after some time w/o further intervention
Narrative:  HEADACHE STARTED 4HR AFTER INJECTION AND GONE THE NEXT A,M. NAUSEA STARTED DAY AFTER INJECTION
2/12/21 2nd round; 2/13/21:  Woke up with chills, then sweats, fever of 102 fluctuated, aches and pains, stayed in bed for 4 days. It took a week to become active again.  Called my doctor's office several times. I was told it was normal, part of the vaccine reaction.  Worse reaction was my leg bones feeling like metal strips of a toy erector set. The taste of metal in my mouth lasted 4 days. Difficulty walking because of leg weakness and dizziness.  Loss of appetite. 5/1/21 - 5/3/21 Hospitalization for diagnosis of Acute Pulmonary Embolism and Deep Vein Thrombosis
3 DAYS AFTER IMMUN /W/ 2ND INJECTION OF ENGERIX-B, PT EXP FINE RASH, TONGUE FELT HEAVY, EYES SWELLED. PHYS GAVE ORAL BENADRYL BUT WITHOUT EFFECT. SYMPTOMS CLEARED AFTER INTRAVENOUS EPINEPHRINE WAS ADMINISTERED.
Notes 1/14/2021                                                                                              Subjective 47 y.o. female who was seen at COVID Vaccine Clinic today for her first dose of the COVID 19 vaccination.    She denied any history of previous adverse reactions to vaccines.   She was given the Moderna vaccination in the left deltoid muscle.   During her 15 minute waiting period after the injection, the patient began to experience lightheadedness and syncope.  She denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling.   This provider was notified of patient reaction and she was then assessed in the emergency bay area.   Monitored patient for severe reaction symptoms, including but not limited to abdominal pain, blood pressure abnormality , chest pain, collapse, drooling, hypotension, increased swelling, rapid progression of symptoms, respiratory distress with dyspnea, skin changes, tongue swelling and vomiting.     ALLERGY REVIEW OF SYSTEMS   Previous Reactions: Patient states that she has a hx of vaso-vagal symptoms with blood draws.    Objective    Vitals Vitals:   01/14/21 1128 01/14/21 1141 01/14/21 1204 01/14/21 1229 BP: 118/65 123/71 130/72 121/77 Pulse: 71 66 65 92 SpO2: 97% 98% 99% 100%     Orthostatic Vitals at 1147a Sitting B/P: 127/71 Sitting Pulse: 70 Standing B/P: 113/62 Standing Pulse: 83     Blood Sugar 103 collected at 1119     Physical Exam Vitals signs reviewed.  Constitutional:      Appearance: Normal appearance.     Comments: Alert but drowsy  HENT:     Head: Normocephalic and atraumatic.     Nose: Nose normal.  Cardiovascular:     Rate and Rhythm: Normal rate and regular rhythm.     Pulses: Normal pulses.     Heart sounds: Normal heart sounds.  Pulmonary:     Effort: Pulmonary effort is normal.     Breath sounds: Normal breath sounds.  Abdominal:     Palpations: Abdomen is soft.  Musculoskeletal: Normal range of motion.  Skin:    General: Skin is warm.     Capillary Refill: Capillary refill takes less than 2 seconds.  Psychiatric:        Mood and Affect: Mood normal.        Behavior: Behavior normal.        Thought Content: Thought content normal.        Judgment: Judgment normal.         Assessment/Plan  Treatment included: water, cold packs, granoloa bar. Follow up response to treatment: good. Fully alert Patient discharge: Stable to go home and follow up with PCP.            1/14/2021 12:31 PM
Pt developed stria, elevated bilirubin and has become light sensitive and more irritable since getting HPV series. Will refer to peds endocrinology -> done -> dx thyroiditis.
14 days after varicella vaccine had 6 small vesicles at the vaccine site. Tx supportive care only.
This 55 year old patient reported receipt of annual influenza vaccination (CSL lot # P59007) on 10/14/2012 to upper posterior left deltoid. He stated he was standing when the shot was given and thought the shot was given further back and higher than past vaccinations. He did not receive any other vaccines and returned to (administrative duties). Later that evening his left shoulder was sore and he took ALEVE for the discomfort. This 6-7/10 dull sore ache persisted over the next week with increasing difficulty lifting his left arm overhead without any other adverse reaction reported (headache, fever, chills, malaise, et al). He denied any redness, swelling or discoloration to vaccine injection site, no recent travel, trauma or injury to left arm/shoulder/neck, and was not lifting at work or home. He had no numbness, tingling or loss of sensation to left arm/fingers and his grip was intact but pain did affect weight of objects picked up and had difficulty putting on his coat. He returned to work first weekend of November (11/2-3/2012) and his command sent him to medical to evaluate this ongoing shoulder pain. Over the next year (11/2012-11/2013) he was seen by Orthopedic providers and treated with oral NSAIDs, steroid injections to left shoulder and physical therapy with temporary relief of pain but no reported improvement in overhead ROM. An MRI completed on 1/31/2013 noted mild supraspinatus impingement with partial tearing of the supraspinatus tendon. Plain film X-ray of left shoulder showed no acute osseous abnormality with minimal degenerative changes to the superolateral aspect of the humeral head and degenerative changes of the AC joint. On 11/18/2013 he had surgery to his left shoulder with providers documenting fraying of superior labrum and full thickness tear of mid-portion of supraspinatus tendon which was repaired including a complete subacromial bursectomy where a rotator cuff tear was visualized and repaired. On 11/22/2013 he contacted the Vaccine Healthcare Center for a causality assessment. He advised he received his 2013 influenza vaccination (SK lot #79GHS) to his right arm by his PCP on 11/4/2013 with no adverse reactions.
6/25/21 -> ED abd swelling/leg swelling/SOB admitted Heart failure/uterine mass Echo EF 35-40% cardiomyopathy Rd sided Heart failure viral vs COVID vaccine induced
14:08 While washing hands I heard commotion in the other section of the observation area.  Noticed pt. on the floor, next to his chair.  He was having "shaky" movements, unresponsive, diaphoretic and very pale.  Also noticed he was hitting head twice on wall.  After protecting his head, he regained consciousness in approx. 15 sec.  Staff had been called and 911 was activated.  My oximeter read pulse of 40 to 45 and saturation between 96 to 98%.  Pt. claimed it wasn't his first time after "needles" passing out.  Said he had a good breakfast and lunch.  He declined having his parents called.
Death about 2 days after 4 month vaccination, no apparent cause know. Autopsy pending.
Fever; Headache; Fatigue; This is a spontaneous report from a non-contactable healthcare professional, the patient. A 32-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF2587) via an unspecified route of administration in the right arm on 17Sep2021 at 13:00 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medication included bupropion hydrochloride (WELLBUTRIN) for an unknown indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0198) via an unspecified route of administration in the left arm on 25Aug2021 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. On 18Sep2021 at 02:00, the patient experienced fever, headache and fatigue. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fever, headache and fatigue was not resolved at the time of this report.   No follow-up attempts are possible. No further information is expected.
Info has been received from a physician concerning an adult female pt who "within the last 2 months" in approx October 2002 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (Lot #643249/0358M). Subsequently in approx October 2002, the pt developed very sore arms, redness and swelling that went from her shoulders down her entire arm. The pt sought unspecified medical attention and was treated with anti-inflammatory agents (unspecified). Subsequently, all of the pt's symptoms resolved. The physician indicated that in his "many, many years" of experience with vaccinations, he had never seen such "an inordinate amount of reports" of "severe reactions" to pneumococcal vaccine 23 polyvalent as he had recently. He requested a lot check of Lot #643249/0358M. The records of testing prior to release of this lot have been checked by Compliance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. The physician also mentioned that 2 other female pts (WAES #0306USA02608 and 0306USA02609) and a male pt (WAES #0211USA00320) had experiences following vaccination with pneumococcal vaccine 23 polyvalent (Lot #643249/0358M). Additional info has been requested.
This spontaneous report was received from a medical assistant referring to multiple unspecified patients of unknown age and gender. Information about concomitant medication and medical history was not provided. On unknown dates, the patients received improperly stored PROQUAD (rHA, injection, lot # L032760, expiration date 24-FEB-2018, dose and route unknown) for prophylaxis. The vaccines were exposed to temperature excursion of minus 10.2 degrees centigrade(C) for 37 hours and 29 minutes. Data logger was involved. There was previous temperature excursion of minus 12.9 degrees centigrade(C) for 11 hours and 24 minutes. No adverse effect had been reported. No product quality complaint was involved. Additional information has been requested.
Started w/low grade fever 24MAR, progressed to 105 on 25MAR seen in ER for red ears; had fever x 3days; given APAP & Antibiotic by ER;
Vaccine 1- 2-3 days of nausea, vomiting, malaise, headache, site tenderness. One 3 day episode abnormal vaginal bleeding Vaccine 2-  four days of nausea, malaise, weakness, headache, some site tenderness. I did not vomit with the 2nd injection but did feel more sickly.  Two episodes of abnormal vaginal bleeding.
I woke up at 2AM with bad muscle pain and shivering so hard my hands were shaking. This did no happen with the first vaccine. My arm has a large sore swollen red hard warm area.
sore arm; swollen arm; felt like all her joints on the left side; left hand swelled up; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), PERIPHERAL SWELLING (swollen arm), ARTHRALGIA (felt like all her joints on the left side) and VACCINATION SITE SWELLING (left hand swelled up) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Apr-2021, the patient experienced PAIN IN EXTREMITY (sore arm), PERIPHERAL SWELLING (swollen arm), ARTHRALGIA (felt like all her joints on the left side) and VACCINATION SITE SWELLING (left hand swelled up). The patient was treated with IBUPROFEN for Pain, at a dose of 1 dosage form. At the time of the report, PAIN IN EXTREMITY (sore arm), PERIPHERAL SWELLING (swollen arm), ARTHRALGIA (felt like all her joints on the left side) and VACCINATION SITE SWELLING (left hand swelled up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.   Reporter did not allow further contact
Very painful injection. Shoulder very stiff and sore immediately following injection. Increasing pain in following weeks. Range of motion not very good. Given steroid pack 11/18/2013. Had a little relief for the week of steroid pack. Pain came back after completion of steroid pack.  Referred to orthopedic surgeon. Was given a cortisone injection 12/3/2013 and started physical therapy. Some pain relief but not complete. Surgery performed 3/18/2014 followed by physical therapy.
Information has been received from a physician via a pharmacist and a health professional at a physician's office concerning a 78 year old male with diabetes, hypertension and high cholesterol who on an unspecified date was vaccinated intramuscularly with Pneumovax 23 (lot # 654977/0888F).  Subsequently the patient developed cellulitis at the injection site.  Unspecified medical attention was sought.  At the time of this report, the outcome of the event was unknown.  Additional information has been requested.
- Malaise, headache, fever, pain at injection site. Symptoms began about 12 hrs after injection.