chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Felt like a low grade fever (no thermometer available) because I was sweaty and just felt feverish for 2-3 hours, Muscle aches and tiredness lasted 11:30am until I went to bed. Most of the muscle aches were in my back. Advil had no effect/didn't help, but Tylenol seemed to ease some of the muscle aches. I took Tylenol PM to sleep and felt back to normal the following morning. I had a sore throat on and off (lasted about 20-30 minutes) Friday (1 day after) in the evening and again a few times throughout the day Saturday.
Fever, dizziness fatigue, b/l wrist arthritis, periorbital edema. hand and pedal edema. Annular rash on trunk.
Some of the vaccine sprayed out; Vaccine sprayed out on skin; Vaccine sprayed out on skin; This is a spontaneous case, initially received from pharmacist via Agency (reference number: SEQ19-03446) on 27-Sep-2019, concerning a patient of an unspecified age and gender.   The patient's relevant medical history, drug reactions or allergies and concomitant medications were not reported.  On 27-Sep-2019, the patient was administered with administered Fluad vaccine [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 expiration date: not reported] for influenza prophylaxis. As reported, during vaccine administration, some of the vaccine sprayed out on the reporter and the patient (explicitly coded as incomplete dose administered', exposure via skin contact' and accidental exposure to product').   The reporter assessed the case as non-serious but did not provide causality assessment.  Significant case amendment (27-Sep-2019): Accidental exposure to product and Exposure via skin contact added as events. Narrative amended accordingly.  Non-significant follow-up reported by other health professional from Agency  [reference number: SEQ19-07076] on 27-Dec-2019: Additional reference number added. No changes in narrative.; Sender's Comments: The patient was administered incomplete dose of Fluad (TIV). Reportedly, during vaccine administration, some of the vaccine sprayed out on the reporter and the patient's skin which was coded as accidental exposure to product and exposure via skin contact. It was not reported whether the patient experienced any adverse event. All three events are assessed as not related per company's conventions.
Around the first week of January, I started to notice a large amount of scalp hair on the bathroom floor and sink area. I have always had thick hair. I started finding it in other places as well. In just a few days, I could tell there was a lot less volume in my hair. Around the second week of January, I experienced scalp discomfort and tenderness, along with headache pain that was as though I was wearing a headband. When I combed through my hair with my fingers, I noticed more scalp. The dermatologist told me that it could have been a stressful event that occurred in my life, two to three months prior, that may have caused this, but I'm not sure. This was not a gradual thing, it was abrupt. I continue to lose hair in the shower and notice this daily.
Per pt: Noted slight headache at 10pm went to bed, but woke up at 2:10am with sharp stabbing pain in head - occurring at least 5 - 10 mins apart. Pain levels "12". Went to ER at 3:30am, B/P (174/108). Rec'd Tx for HR and increased B/P (IV fluids when B/P decreased). CT scan done with neg. findings. D/C from ER with insts to F/u with PCP and referral to Neurology, No Na diet, Rx: TRAMADOL and rest. Today (11-12-10: pt report with above report and no complaints.
Within a few minutes of injection pain at injection site began.  Within 2 hours of injection pain was significant and could not lift arm above shoulders.  Treatment was massage of arm until pain was too much to take any pressure.  After that avoiding touching and avoiding lifting arm was only way to avoid pain.  No medication was taken.  Pain lasted 48 hours from time of injection.
Loss of appetite morning after vaccine, headache, body aches, chills, face flushed. Fever started afternoon. 99.4. Took Tylenol but it gradually rose to 102.3. Took 3 hours for fever to go down. By 5:30 fever was gone & I was feeling better. Next day I felt great but by three days later I had a fever blister & very sore, dry and stuffy nose which lasted two weeks. And headache as well. I?m thinking because of stuffy nose. I did have Covid last March/April 2020 so I have heard that I would have side effects.
Vaccinated on 21-SEP-2004, 29-NOV-2004, 21-JAN-2005, 22-SEP-2010; Vaccinated on 21-SEP-2004, 29-NOV-2004, 21-JAN-2005, 22-SEP-2010; This spontaneous report has been received from a lawyer and physician, via a fact sheet and immunization record from a case in litigation for HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (2303USA000650), concerning a 9-week-old female patient (pt). The pt's pertinent medical history or concurrent conditions were not reported.   On 21-SEP-2004, 29-NOV-2004, 21-JAN-2005 and 22-SEP-2010, the pt was vaccinated with Hepatitis B Vaccine (manufacturer unknown) (exact dose, anatomical location, route of administration, lot # and expiration date were not reported) for prophylaxis, which was considered an inappropriate schedule of vaccine administered.   The pt's vaccines also included: haemophilus b vaccine (manufacturer unknown) (administered on: 29-NOV-2004, 21-JAN-2005, 25-MAR-2005, 27-DEC-2005), unspecified diphtheria (+) tetanus (+) pertussis (DTaP) vaccine (administered on: 29-NOV-2004, 21-JAN-2005, 25-MAR-2005, 27-DEC-2005, 24-SEP-2009), unspecified inactivated Poliovirus vaccine (IPV) (administered on 29-NOV-2004, 21-JAN-2005, 27-DEC-2005, 24-SEP-2009), unspecified pneumococcal conjugate-7 vaccine (PCV7) (administered on: 29-NOV-2004, 21-JAN-2005, 25-MAR-2005, 22-SEP-2005), measles (+) mumps (+) rubella (MMR) vaccine (manufacturer unknown)(administered on: 22-SEP-2005, 24-SEP-2009), varicella vaccine (manufacturer unknown) (administered on: (22-SEP-2005, 24-SEP-2009), hepatitis A vaccine (manufacturer unknown) (administered on:22-MAR-2006, 26-SEP-2006), unspecified meningococcal conjugate vaccine (MCV4), unspecified influenza vaccine (administered on: 03-OCT-2012, 16-OCT-2013, 01-OCT-2014, 01-OCT-2015, 03-OCT-2016), unspecified diphtheria vaccine toxoid (+) pertussis vaccine acellular (+) tetanus vaccine toxoid vaccine (TDAP) (administered on 01-OCT-2015), HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (administered on 03-OCT-2016), unspecified hpv vaccine (manufacturer unknown) (administered on 03-OCT-2017).   This is one of the three reports concerning the same patient.; Sender's Comments:  US-009507513-2309USA001194: US-009507513-2303USA000650:
This spontaneous report was received from a licensed vocational nurse and refers to a 5 year old male patient. No information regarding the patient's medical history and concomitant medications was reported. On 02-NOV-2015 at 02:42 pm, the patient was vaccinated with an improperly stored dose (it was patient's first dose) of PROQUAD (Merck) lot # K009891, expiration date 11-JAN-2016, subcutaneous in the right arm (strength and dose were not provided). Concomitant vaccinations included the first dose of KINRIX lot # reported As S4L2R, intramuscular in the left arm and the first dose of influenza virus vaccine (unspecified) lot # reported as DF92Z, intramuscular in the left arm (both given on the same time as the suspect vaccine). There was no illness at the time of vaccination. No adverse effects were reported. The patient was vaccinated at public health clinic/hospital and the vaccine was purchased with public funds. This is one of the several reports received from the same source. Additional information is not expected as all correspondence was received.
Patient developed erythema, swelling, and pain around injection site. Patient took diphenhydramine and erythema and swelling subsided but pain remains.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 73-year-old male patient received BNT162b2 (BNT162B2), on 03Mar2021 as dose 1, single (Lot number: EN6202), in left arm, on 25Mar2021 as dose 2, single (Lot number: EP7533), in left arm, on 27Sep2021 as dose 3 (booster), single (Lot number: FE3592), in left arm and on 18Apr2022 as dose 4 (booster), single (Lot number: FM9992) at the age of 73 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ATORVASTATIN, start date: Aug2018, stop date: 19Jul2022; VALSARTAN, start date: Aug2018; ASPIRIN 81, start date: Aug2018; VITAMIN D3, start date: Aug2018.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Took vaccine. Took other medication in 2 weeks. The reason to answer all these questions was to say patient  had a Covid rebound occurrence from 21Jul2022 to 27Jul22. Anti viral details: Product: COVID 19 Treatment, Brand: Paxlovid, Indication: Treatment of COVID-19.
10/22/09 Swelling - elbow to shoulders. Hot and red. Used TYLENOL & iced area. Notified physician- Rx-Z-pack. Redness remained until 10/27. Swelling resolved on 10/26.
DIZZINESS; FALLEN; COULD NOT SLEEP; DID NOT FELT GOOD; SLIGHT NAUSEA; FLU-LIKE SYMPTOMS; This spontaneous report received from a patient concerned a 55 year old male of unspecified race. The patient's weight was 155 pounds, and height was 69 inches. The patient's past medical history included knee surgery, shoulder surgery, blacked out, and panic attacks, and concurrent conditions included arthritis, alcohol user: two beers, and smoker: four cigarettes. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, expiry: 24-JUL-2021) dose was not reported,1 total, administered on 21-MAR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. Patient reported that he did not felt real good for the weekend after getting vaccine on 21-MAR-2021. He had Flu-like symptoms and nausea. Dizziness started approximately one week after the vaccine injection that came on but it hit like a freight train by the end of the week more moderate and continued to the degree that was consistent. He mentioned he could not eat marijuana gummies but due to the dizziness, he felt like he did. He described as if he took four hits off a joint and severe as if he took LSD. He had a fall on the golf course from the dizziness and since then avoided driving which impacted on work. He also mentioned that if he worked really hard like in construction, his dizziness had gone away but when he stopped or as soon as he stepped into his car, it came back. He said that he could not sleep. He said he did not wanted to lose his ever loving mind. Physician gave him a medication after hospital discharge but it made him felt off like a bad acid and he discarded it. Laboratory data (dates unspecified) included: CT scan (NR: not provided) was negative for stroke. He made a trip to the emergency room, and made several VA visits to try to manage the symptoms. VA physician cleaned his ears which did not helped. He mentioned among his medical history that he had almost ten surgeries mostly on his knee and on his shoulder and he had arthritis because of that. He stated that he had blacked out couple of times in the past prior to being vaccinated. Physicians thought that it was related to his heart but he said his heart was strong. It seemed from the conversation that he had panic attacks in the past but he knew what controlled them. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the dizziness, flu-like symptoms, slight nausea, did not felt good, fallen and could not sleep was not reported. This report was serious (Hospitalization Caused / Prolonged). This case, from the same reporter is linked to 20210755402.; Sender's Comments: V0:20210754977-COVID-19 VACCINE AD26.COV2.S-Dizziness. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Pfizer 4/7/21, 4/10/21, 4/23/21. Positive on 6/13/22
Extreme sharp pain in right eye; excessive tearing to a great degree; eye swollen; eye felt scratchy, as if scratched by sand.
Began with dizziness, and just feeling of being off with in 15 hours of vaccination (starting approximately 7:00 the following morning, and continued through the day. Around 1800 dizziness increased, nausea started (no emesis) and moderate chills, fever through the night. Woke at 0300 am feeling better physically but felt lump on my back 4-16-21. My husband  took a photo and it looked like a rash; the rash was confirmed shingles today in two areas on my back.
The pt broke out with severe hives. Beginning at 4:30am and gradually worsening with a fever of 103.7 deg. F. He received an injection that afternoon of antihistamine but continued to worsen until hospitalized on 03/08/2002. Given IV meds then Benadryl. Developed joint pain 24hrs later, so referred to clinic for injection. Again 48hrs later with joint pain for injection. Subsequently needed Benadryl only intermittently for 10 days.
Within 1 hour of receiving the vaccine c/o itching, hives, vomiting, headache- seen by MD given cortisone injection and Rx to take oral cortisone.
patient received an expired dose of Menactra/ NO AE; Initial information received on 22-Jun-2021 regarding an unsolicited valid non-serious case received from a pharmacist via call center via Agency (Reference number- 00651603).  This case involves a patient of (unknown demographics) who was vaccinated with an expired dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot number and expiry date not reported) via an unknown route in unknown administration site a month ago (expired product administered) on an unknown date for prophylactic vaccination.  The patient's past medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.   It was an actual medication error case due to expired vaccine used (latency: same day).  At the time of reporting, 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.  There will be no information available on the batch number for this case.
VOMITING, BLOODY DIARRHEA  5/25/07 Received vax records from pcp which confirm RO lot # & dose as reported.  6/1/07 Received partial hospital medical records with note that patient is still inpatient. Records indicate patient admitted 5/18/06 for vomiting, bloody stools, lethargy & dehydration.  Seen in PCP office earlier same day & was pale & very lethargic w/an episode of projectile vomiting in office.  Sent to hospital for admission.  Barium enema revealed intussusception but was unable to reduce.  Surgical consult done on day of admission revealed colicky abdominal pain.  TO OR for exp lap, reduction of ileocolic IS & appendectomy on 5/18.   FINAL DX: none available beyond IS.  Will contact hospital for D/C summary.  6/15/07 Received D/C Summary which reveals patient admitted 5/18-5/23/07 after bloody stool & abdominal pain.  Unable to reduce w/barium enema & taken to OR.  Findings at time of surgery include ischemic bowel which pinked up w/warm stimulation & was not resected.  Observed in hospital on IV antibiotics & had slow but uncomplicated recovery.  D/C to home. FINAL DX: Ilial-ilial intussusception & ileocolic intussusception, surgically reduced.
patient had severe arm redness and soreness at injection site of vaccine patient will follow up with primary care provider
After her first dose at another facility she said her throat felt numb but she was okay and advised by her physician to get the second dose. Within 5 minutes of receiving her second dose she felt like her throat was numb and tight. She did feel like her throat may close but not having difficulty breathing at that moment. Her speech did sound slurred (like after having mouth numbed). Due to history of anaphylactic reactions to certain foods, clinics epipen was used immediately in her right thigh. Immediately symptoms began to improve. Patient given 50mg bendryl liquid once able to swallow. VS monitored continuously and stable. Patient transported POV by her husband to the hospital that is 1 mi away. She arrived safely and was monitored further there.
Chills; Fever; Muscle aches; This is a spontaneous report from a non-contactable nurse, the patient. A 61-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8737) via an unspecified route of administration in the left arm on 09Apr2021 at 14:00 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Medical history included history of cancer, no chronic conditions and COVID-19. The patient did not have any allergies to medication, food or other products. Concomitant medications included curcuma longa rhizome (TURMERIC) and multivitamin (Unspecified); from an unknown date for unknown indication and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration in the left arm on 19Mar2021 at 14:00 as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 09Apr2021 (also reported start time as 23:30), 10 hours after vaccine, the patient experienced chills, fever and muscle aches. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the events chills, fever and muscle aches were resolved on 11Apr2021 (lasting 2 days).  No follow-up attempts are possible. No further information is expected.
This spontaneous report received from a healthcare worker refers to patients of unspecified demographics. On 05-MAY-2014, excursion occurred 14 of 33.8 Fahrenheit (F) (rounded to 34 F) for 8.31 minutes affecting GARDASIL (lot number J006236, expiry date 25-FEB-2016). It was reported that the excursion product was supported. On 05-MAY-2014, the unspecified number of patients were administered GARDASIL (dose unspecified) post excursion. Concomitant therapy was unspecified. No product quality complaint was involved. No adverse effects noted by any patient. The outcome of the event was unknown. No additional information was available. This is one of the several reports from same reporter. Additional information has been requested.
01/11/22 presents to ED for "multiple fall at home". PMHx of "MS complicated by worsening neurological function (gait disturbance, ataxia, spasticity)"
Systemic: Dizziness / Lightheadness-Medium, Systemic: Nausea-Mild, Additional Details: She said she gets nervous about vaccines. she started getting dizzy and pale and not feeling well a few minutes after the vaccine. she was sitting in chair. Gave her some water and she took some bites of granola bar. she felt better after about 15-20minutes and left.
Cough; Tenderness; Swelling; Bump had spread under armpit; Pain in my armpit on right side / tenderness  in my armpit on right side; Hard to put arm down; Bump on the injection site/bump of almost 2 and half inch from the shot; Chest pain in right side; Chill; Fever; Tired; Headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Bump on the injection site/bump of almost 2 and half inch from the shot), CHEST PAIN (Chest pain in right side), COUGH (Cough), TENDERNESS (Tenderness) and SWELLING (Swelling) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical history was provided by the reporter.     On 22-May-2021 at 12:00 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-May-2021, the patient experienced HEADACHE (Headache). On 22-May-2021 at 10:00 AM, the patient experienced VACCINATION SITE MASS (Bump on the injection site/bump of almost 2 and half inch from the shot), CHEST PAIN (Chest pain in right side), CHILLS (Chill), PYREXIA (Fever) and FATIGUE (Tired). On an unknown date, the patient experienced COUGH (Cough), TENDERNESS (Tenderness), SWELLING (Swelling), SKIN MASS (Bump had spread under armpit), AXILLARY PAIN (Pain in my armpit on right side / tenderness  in my armpit on right side) and PAIN IN EXTREMITY (Hard to put arm down). At the time of the report, VACCINATION SITE MASS (Bump on the injection site/bump of almost 2 and half inch from the shot), CHEST PAIN (Chest pain in right side), COUGH (Cough), SWELLING (Swelling), AXILLARY PAIN (Pain in my armpit on right side / tenderness  in my armpit on right side), HEADACHE (Headache), CHILLS (Chill), PYREXIA (Fever) and FATIGUE (Tired) outcome was unknown and TENDERNESS (Tenderness), SKIN MASS (Bump had spread under armpit) and PAIN IN EXTREMITY (Hard to put arm down) had not resolved.            No Concomitant medication was reported. No treatment medication was reported.
Administered IPV and Varicella vaccinations - SQ right arm site. Noted swelling at injection site. Presented in the office w/ ice pack applied at site.
The patient was waiting 15min in the observation area when she advised an attendant that she was not feeling well. A&Ox4, speaking & answering questions appropriately, skin was warm & dry. The patient appeared anxious and stated that she felt anxious after the vaccine. Vital signs  (147/106 BP right arm, 124 HR, 22 RR) Denies pain, headache or dizziness. Worked on slowing breathing for several minutes, stated she felt better. Allowed pt to relax, vital signs after 10 minutes ( 140/88 BP right arm, 98 HR, 18 RR, skin warm/ dry, A&Ox4).  Patient wished to leave, feeling fine, advised to follow up via VAERS and physician.