chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Hospitalization: 3/6/2023 - 3/10/2023 (4 days) Presentation to the ED: generalized weakness and fever up to 104 F COVID + date: 3/6/2023  Treatment: broad-spectrum IV antibiotics including vancomycin and Zosyn Discharge to: home.  EL9265 2/19/2021 EN6200 3/12/2021
Right shoulder and upper arm pain began after vaccine administration. The pain worsened affecting activities of daily living and disrupting sleep.
Information has been received from a pediatric physician concerning a 14 year old female who was vaccinated with a dose of GARDASIL. Subsequently the patient developed Guillain-Barre syndrome which he thought was "pain and paralysis in the legs" or a "nerve-related syndrome that can last between 6 months to a year." Unspecified medical attention was sought. The patient's outcome was unknown. Upon internal review, Guillain-Barre syndrome was considered to be an other important medical event. Additional information has been requested.
Swelling of Whole right shoulder - soft ball size, swelling down to elbow, blue and red in color from shoulder to elbow, hot to touch, fever
Left arm/shoulder around injection site swollen; Small dime sized rash around the injection; Arm pain to the touch; Rash was itchy; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the left arm  on 13Apr2021 at 14:30 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. Medical history included May-Thurner syndrome, birth control pills, occasional ibuprofen use and known allergy to penicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included ethinylestradiol, norgestimate (generic ORTHO TRI-CYCLEN); as birth control pills from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the left arm on 19Mar2021 at 17:15 (at the age of 38-years-old), as a single dose for COVID-19 immunisation. On 14Apr2021 at 17:00, the patient experienced left arm/shoulder around injection site swollen, a small dime sized rash around the injection and arm pain to the touch. This was about 24 hours later, a little more. After a few days, on an unknown date in Apr2021, the rash was itchy. 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. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events eft arm/shoulder around injection site swollen, small dime sized rash around the injection, arm pain to the touch and rash was itchy was resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Right arm  became increasingly sore and stiff starting approximately 4 hrs. post vaccination.  The pain and stiffness progressed to all joints  of the body.  I developed a fever and chills during the night and had trouble rising  from the bed during the night.  I was in extreme pain and wished that I could die.  I have never felt so miserable following a vaccination.  I took 650 mg Naproxen Sodium at 3:30 p.m. which did nothing to relieve the joint and muscle pain.  I was somewhat improved by 5:30 a.m., but no longer having chills.  My right shoulder is still sore 26 hrs. later, but I can now raise my elbow above my head.  All of my joints are still painful.
I went home and 2  1/2 hours later while doing nothing  heard a loud painful pop in right arm not doing  anything. Never  had this problem before inflammation created by vaccine caused the break. Went to er and they said fractured prescribed pain meds and sling. I followed up following  Monday  with dr dyas  bone specialist.
Tested positive for COVID 1/23/21. Was asymptomatic at the time and was tested due to positive household members. Developed symptoms (headache) 1/25/21. Developed sensation change (pins and needles) in left arm 1/31/21. Was seen in Emergency Room and kept overnight for observation. No obvious cause for symptoms was found.
Information has been received from a 44 year old female registered pharmacist, with no pertinent medical history and no drug reactions or allergies, who on 29-OCT-2010 after finishing injecting a dose of ZOSTAVAX (Merck), (lot # 664669/0152Z, expire date 28-MAR-2011) into a patient 5 minutes ago, inadvertently stuck the needle into her left thumb. There was not concomitant medication. The thumb was swelling. The patient did not seek medical attention. At the time of the report the patient had not recovered. There were no laboratories diagnostics studies performed. Additional information has been requested.
12/15/2021 ER admittance. Possible Sepsis. 6 days admitted. Massive doses of antibiotics. CT/MRI/Doppler. Portal vein multiple thrombosis in liver.
Patient had a seizure - eyes rolled back, arms legs and neck extended stiffly and face stiffened.
Heart attack on 7/24/21 along with confusion, loss of bowels. Diagnosed with broken heart syndrome. Hospitalized. Then suffered a stroke on 8/22/21.  Passed away from heart stopping on 9/12/21.
Fever 101.2, chills, severe headache, fatigue  Tylenol 6 doses over 2 days, I dose aspirin
Woke on 11/21 with diffuse hives, periorbital edema, no fevers
Patient came in 24 hours after vaccine was administered to show bruising on her arm that vaccine was given. The bruise began below the vaccine site and was darker the further away from the site.  No treatment was given. Advised patient to contact the pharmacy or health care provider if it becomes worse.
Mom was shopping with the child, his hip started to swell and he had a bit of a cough. Mom gave him BENADRYL, symptoms improved.
Left thigh induration, blistering rash on face, trunk, hands, and feet. Diaper rash. DX: 1) Hand, foot, mouth, 2) Impetigo. RX: Cephalexin, mupirocin.
Patient is a 79 year old male with a past medical history of hypertension, type-2 diabetes & obstructive sleep apnea who presented to ED on 4/19/22 with concerns related to sharp right-sided abdominal pain that began that same morning. Radiologic evaluation revealed a duodenal perforation. General surgery was consulted for evaluation & Patient was boarded/consented for a laparoscopic omental repair of perforated duodenal ulcer & repair of umbilical hernia. The operation went well without complication 7 a 19F Blake drain was placed in the right upper quadrant for post-surgical drainage. Patient was sent to the general medical floor in stable condition afterwards with an NG tube in place & a strict NPO order. He remained NPO throughout the day 4/20/22 & progressed well clinically. An Upper GI study was ordered 4/21/22 (POD#2) for evaluation of a leak at the repair site which did not identify any evidence of a leak. He was started on a clear liquid diet after this & his NG tube was removed. He continued to progress well & his diet was advanced to soft foods on 4/22/22 which he tolerated well throughout the day. At the end of the day 4/22/22 Patient was having consistent bowel function, tolerating a diet well & his pain was well-controlled. His right upper quadrant drain was pulled at the bedside & dressed. It was decided at this time that Patient could discharge home with instructions to follow up in the emergency general surgery clinic in 2 weeks for an in-person appointment. He was discharged on Robaxin PRN Q6H for 5 days for muscle spasm as a new medication. He was instructed to no longer take his NSAID medications from home (Naproxen & Aspirin) due to his duodenal ulcer perforation.   Physical therapy & occupational therapy teams worked with Patient throughout the entirety of his hospital stay when clinically appropriate who recommended he get discharged home when clinically appropriate with home health services. Care management assisted in the coordination of this for him at home.
it's not just pain; still has swelling in her arm--like a knot; like a knot/it's not just pain, it's a knot and it looks like it's gotten bigger over the day, I couldn't lift my arm because it was so swollen. It's going from my arm to my breast area; This is a spontaneous report from a contactable consumer(patient) via Medical Information Team. A 36-years-old female patient received bnt162b2 (COMIRNATY, Solution for injection, Expiry Date, NDC number: not provided), dose 1 via an unspecified route of administration on 12Sep2021 at around 12pm (Sunday) (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunization. The patient medical history and other products were not provided. The patient stated, on an unspecified date of 2021, she still has swelling in her arm-like a knot, it was not just pain, it was a knot and it looks like it was gotten bigger over the day, she could not lift my arm because it was so swollen, it was going from her arm to breast area and asked was this normal. The patient further stated that her arm was still swollen really really big, and she asked if it was normal for arm to be swollen and a knot on her arm was supposed to be this big. The patient took (treatment) Tylenol and Motrin for events. The outcome of events was not recovered.   This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
shaking for 24 hours; a terrible fever for 24 hours; very tired for 24 hours; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (shaking for 24 hours), PYREXIA (a terrible fever for 24 hours) and FATIGUE (very tired for 24 hours) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Patient says he had Covid on Christmas 2020 for 2 days , It was mild.) on 25-Dec-2020.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced TREMOR (shaking for 24 hours), PYREXIA (a terrible fever for 24 hours) and FATIGUE (very tired for 24 hours). At the time of the report, TREMOR (shaking for 24 hours), PYREXIA (a terrible fever for 24 hours) and FATIGUE (very tired for 24 hours) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided treatment information was not provided   This case was linked to MOD-2021-294606 (Patient Link).
8 years old patients received a HPV vaccines. HPV age recommendation to receive the first dose of the HPV vaccine is   9 years old. Provider spoke to mother and explain to her that the patient received HPV vaccine by error too early. Provider explain to mother this will not cause any harm to patient. patients was seen in office after the Vaccine was administered and no further follow up or treatment is need it.
HEADACHE; MUSCLE AID; NAUSEA; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, vaccinated on left deltoid, administered on 16-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 16-MAR-2021, the subject experienced headache. On 16-MAR-2021, the subject experienced muscle aid. On 16-MAR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, muscle aid, and nausea. This report was non-serious.
left clinic walking-nl condition p/vax;came back 10min later w/father father described that p/5min leaving clinic got stiff, out of it for 5 sec, wak to walk, gave 02 called EMT transported to hosp dx vasovagal rxn not a vax rxn;
This spontaneous report as received from a physician via a company representative refers to a female patient of unknown age. On an unknown date the patient was vaccinated with a dose of GARDASIL (dose, route and lot # not reported). The patient experienced immediately flu-like symptoms after administered a dose of GARDASIL. The patient sought medical attention in office. It was unknown if treatment was given. The outcome of immediate flu-like symptoms was unknown. Additional information has been requested.
CLIENT RECEIVED PEDIATRIC PFIZER FORMULATION (PEDS) OF 0.2ML  AT 12YO. CLIENT SHOULD'VE RECEIVED GRAY CAP FORMULATION OF 0.3ML DUE TO AGE.
Doses of Menactra and Adacel were administered to patient post temperature excursion of 32-degrees Fahrenheit temperatures with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from the other health professional via Agency (Reference number- 00676408) and transmitted to Sanofi on 09-Jul-2021.  This case is linked to cases 2021SA229197 and 2021SA230017. (Same reporter)  This case involves a 4 month old male patient who was received MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] and DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] post temperature excursion of 32-degrees Fahrenheit temperatures (product storage error).   Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included HPV VACCINE VLP RL1 4V (YEAST) (GARDASIL).  On 08-Jul-2021, the patient received a 0.5 mL dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [total, once, lot U6927AA, expiry date: 28-Jan-2023] via an intramuscular route at the left arm and a 0.5 mL dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [lot U6921AB, expiry date: 17-Apr-2022] via an intramuscular route at the right arm for prophylactic vaccination.  It was a case of actual medication error due to product storage error temperature too low. (Latency: on the same day of vaccination)  At the time of report, no adverse event was reported.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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.
SORENESS DOWN TO LEFT ELBOW; BODY ACHES; CHILLS; LOW-GRADE FEVER; PAIN AT INJECTION SITE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, and hayfever, and other pre-existing medical conditions included patient had no known allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular,  batch number: 1802072 expiry: 25/MAY/2021) .5 ml, administered on 06-MAR-2021 05:00 to Left Deltoid for prophylactic vaccination. Concomitant medications included acetylsalicylic acid. On 06-MAR-2021, the subject experienced pain at injection site. On 06-MAR-2021 10:00, the subject experienced low-grade fever. On 06-MAR-2021 10:00, the subject experienced chills. On 07-MAR-2021, the subject experienced soreness down to left elbow. On 07-MAR-2021, the subject experienced body aches. Laboratory data included: Body temperature (NR: not provided) 99.6 degree F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills on 07-MAR-2021, and had not recovered from pain at injection site, low-grade fever, body aches, and soreness down to left elbow. This report was non-serious.
Nausea; My right side went numb from waist up; stroke-like symptoms; dizziness; felt like I was in a wave pool; migrane headaches;  the top of my head vibrating; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of DIZZINESS (dizziness; felt like I was in a wave pool), MIGRAINE (migrane headaches;  the top of my head vibrating), HYPOAESTHESIA (My right side went numb from waist up; stroke-like symptoms) and NAUSEA (Nausea) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029C20A and 039K20A) for COVID-19 vaccination.     No medical history provided by the reporter.  Concomitant products included VITAMIN B NOS (B-COMPLEX [VITAMIN B NOS]) for an unknown indication.   On 23-Dec-2020 at 10:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021 at 2:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Mar-2021, the patient experienced DIZZINESS (dizziness; felt like I was in a wave pool). 01-Mar-2021, the patient experienced MIGRAINE (migrane headaches;  the top of my head vibrating). On 19-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HYPOAESTHESIA (My right side went numb from waist up; stroke-like symptoms). On an unknown date, the patient experienced NAUSEA (Nausea). The patient was treated with MECLIZINE [MECLOZINE] for Dizziness, at a dose of 1 dosage form and PREDNISONE for Adverse event, at a dose of 1 dosage form. On 19-Apr-2021, HYPOAESTHESIA (My right side went numb from waist up; stroke-like symptoms) had resolved. On 01-May-2021, DIZZINESS (dizziness; felt like I was in a wave pool) and MIGRAINE (migrane headaches;  the top of my head vibrating) had resolved. At the time of the report, NAUSEA (Nausea) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Apr-2021, Computerised tomogram: normal (normal) normal- no indication of a stroke.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient reported trying meclizine and Sea bands for the dizziness, but neither therapy caused the dizziness to disappear. The migraine headaches were almost constant, not intense but always there to some degree. Both the dizziness and headache lasted about 8 weeks.  The stroke-like symptom only occurred once. The patient went to the ER and had a CT scan done. The patient was prescribed prednisone; the patient reported that the symptoms disappeared about 10-14 days after the steroid was initiated.   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Additional events/event details provided, outcome  of all events updated to recovered/resolved (except dizziness) On 14-Jun-2021: Completed ADR Form updated patient's demographics and provided event and treatment details
Arm was hurting; got sick; Throwing up; This is a spontaneous report from a contactable consumer (patient). A 55-year-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EW0185, Expiry date not reported), via an unspecified route of administration, administered in deltoid left on 13May2021 (age at vaccination was 55 years) as unknown, single for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient experienced arm was hurting on 14May2021 with outcome of recovering, got sick on 14May2021 with outcome of recovering, and throwing up on 14May2021 with outcome of recovering. The patient underwent lab tests and procedures which included blood for TB test: unknown results on 13May2021. The events were reported as non-serious.  No follow-up attempts are needed. No further information is expected.
I have redness & swelling with pain and  warmth at injection site.  The area in question was considered "definitely not normal" and is 4 inches wide x 2.2 inches in height.  Raised slightly.  Painful.  Itching began today (8-12-2019).    I had my shot at the local Pharmacy.  I had redness and swelling at 22 hours and 36 hours.  Today is the third day. I was told to take Benadryl (I can only take children's liquid); put triamcinolone cream on it, and to ice it.  I was also told they want me to get the 2nd shot.  I'm concerned that the 2nd shot might be worse than this is.
4yo child died fr Haemophilus Meningitis 1991; Immunized 2 yrs ago in 1989;
Received MMR and VARIVAX on 1/30/09.  Fever that night for 2 days.  Atend of fever had prominent myoclonic jerks with sleep for one day then recovered finally.
Expired Dose of Heplisav-B was Given; Initial Report Received on 09-Aug-2021  A pharmacist reported that a 19 year-old female (race and ethnicity not provided) received an expired dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.   Relevant medical history was not reported.    Relevant concomitant medications were unknown.  On 03-Aug-2021, the patient received an expired dose of HEPLISAV-B (Lot # 933094, expiration date 17-Apr-2021, NDC # 43528-003-05, and serial # 368019294006) to the left deltoid at a pharmacy. This was the first dose of the series. No adverse effects were reported. At the time of reporting, no additional information was provided.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
aches; Painful to Touch; swollen lymph node above collar bone on left side; Fever; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (aches), ALLODYNIA (Painful to Touch), LYMPHADENOPATHY (swollen lymph node above collar bone on left side) and PYREXIA (Fever) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 026L20A) for COVID-19 vaccination.     Concurrent medical conditions included Parkinson's disease.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Feb-2021, the patient experienced MYALGIA (aches), LYMPHADENOPATHY (swollen lymph node above collar bone on left side) and PYREXIA (Fever). 27-Feb-2021, the patient experienced ALLODYNIA (Painful to Touch). The patient was treated with IBUPROFEN ongoing from 28-Feb-2021 for Adverse event, at a dose of 1 dosage form. At the time of the report, MYALGIA (aches), ALLODYNIA (Painful to Touch), LYMPHADENOPATHY (swollen lymph node above collar bone on left side) and PYREXIA (Fever) had resolved.            The patient stated they were taking 130 pills a week for different issues.   Most recent FOLLOW-UP information incorporated above includes: On 01-Jul-2021: event outcome of Lymphadenopathy changed to recovered.