chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Horrible pain in right arm, hands, shoulder and back area; Horrible pain in right arm, hands, shoulder and back area; Pain comes in waves; Feels like its poison; Horrible pain in right arm, hands, shoulder and back area; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Horrible pain in right arm, hands, shoulder and back area), BACK PAIN (Horrible pain in right arm, hands, shoulder and back area), PAIN (Pain comes in waves), FEELING ABNORMAL (Feels like its poison) and ARTHRALGIA (Horrible pain in right arm, hands, shoulder and back area) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Horrible pain in right arm, hands, shoulder and back area), BACK PAIN (Horrible pain in right arm, hands, shoulder and back area), PAIN (Pain comes in waves), FEELING ABNORMAL (Feels like its poison) and ARTHRALGIA (Horrible pain in right arm, hands, shoulder and back area). At the time of the report, PAIN IN EXTREMITY (Horrible pain in right arm, hands, shoulder and back area), BACK PAIN (Horrible pain in right arm, hands, shoulder and back area), PAIN (Pain comes in waves), FEELING ABNORMAL (Feels like its poison) and ARTHRALGIA (Horrible pain in right arm, hands, shoulder and back area) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant products included chemotherapy meds for an unknown indication. No treatment information was provided.
Narrative: 89 yo male patient with the following problem list: PROBLEM LAST MOD PROVIDER Acute non-ST segment elevation myocardial 02/05/2020 infarction (SCT 401314000) (ICD-10-CM R69.) 1/2020 CMH; no cardica cath. Medical mgmt Insomnia (SCT 193462001) (ICD-10-CM G47.00), 08/26/2019 Onset 00/00/2017 On elavil Squamous cell carcinoma of skin of ear (SCT 07/25/2016 403894000) (ICD-10-CM C44.229) Basosquamous carcinoma of skin (SCT 254702000) 07/25/2016 (ICD-10-CM C44.311) Hyperparathyroidism due to renal insufficiency 07/11/2016 (SCT 19034001) (ICD-10-CM N25.81) Chronic kidney disease stage 3B (SCT 700379002) 07/11/2016 (ICD-10-CM N18.3) Gastroesophageal reflux disease (SCT 235595009) 05/10/2016 (ICD-10-CM K21.9) Gastritis (SCT 4556007) (ICD-10-CM K29.70) 05/10/2016 Bilateral carotid artery stenosis (SCT 05/10/2016 293821000119107) (ICD-10-CM I65.23) Peripheral vascular disease (SCT 400047006) 05/10/2016 (ICD-10-CM I73.9) Hypertensive disorder (SCT 38341003) (ICD-10-CM 10/29/2015 I10). Hyperlipidemia (SCT 55822004) (ICD-10-CM E78.5) 10/29/2015 Hyperuricemia (SCT 35885006) (ICD-10-CM E79.0) 10/29/2015 Other disorders of bone and cartilage (ICD-9-CM 06/01/2015 733.99) (ICD-9-CM 786.05); Dyspnea * (ICD-9-CM 04/20/2009 786.05/786.09) (ICD-9-CM 701.1); Keratosis * (ICD-9-CM 701.1) 04/20/2009 (ICD-9-CM-436.); CVA (ICD-9-CM 436.) 04/20/2009 (ICD-9-CM 302.72); Male erectile disorder 02/23/2007 (ICD-9-CM 302.72/607.84) (ICD-9-CM 756.79); Gastroschisis (ICD-9-CM 02/23/2007 756.79) (ICD-9-CM 562.10); Diverticulosis * (ICD-9-CM 07/09/2004 562.10) (ICD-9-CM 433.10); CAROTID STENOSIS 04/30/2002 (ICD-9-CM 715.90); DJD * (ICD-9-CM 715.90) 04/30/2002 (ICD-9-CM 530.3); Esophageal stricture (ICD-9-CM 05/30/2001 530.3) (ICD-9-CM 564.0); Constipation 05/30/2001 Peptic ulcer of unspecified site, unspecified as 06/01/1999 acute or chronic, without mention of hemorrhage or perforation, without mention of obstruction (ICD-9-CM 533.90) Peripheral Vascular Disease, Unspecified 06/01/1999 (ICD-9-CM 443.9) Pt had received covid vaccines on 1/15/2021 & 2/28/2021. No info reported on cause of pt's death or events leading up to pt's death as pt died at home and no notes since 8/2021. This death is likely not related to the vaccinations due to patient's comorbidities, advanced age, and length of time from vaccine administration.
local reaction-entire deltoid rt area hot, red, swollen for 5 days w/low grade temp;
- Break out pruritic rash on hands, right eye, back of neck and head, and red rash around angiogram site. Patient was given cortisone injection and was told to take benadryl at night.
Patient is 14 years old and should have received the Pfizer vaccine but received the Moderna vaccine
Patient described reaction as lightheadness, jittery, warm/flushed,  hypertensive, set in within 15 minutes of vaccine. Treated with Benadryl, water and snack. Remained at clinic x2 hours until symptoms resolved.  Premedicated prior to vaccine with ibuprofen 400mg at 7:30am to avoid  side effects anticipated with the second dose. ?
Myalgia, Arthralgia, Fever, low grade temp Narrative:  Other Relevant History:
Hive over region of immunization. Coughing, runny nose, sneezing, watery eyes, diffuse erythematous rash with pruritis. Pt given Epinepherine, Benadryl, Zyrtec, and Prednisone.
Initial misuse report received from a health care professional on 03-OCT-2013. A patients whose gender, age, medical history, and concomitant medications were unknown, received a doe of FLUZONE (lot number, route and site of administration were unknown) or an unspecified date. When the patient pulled away FLUZONE vaccine, it caused half of the dose to run down the arm. List of documents held by sender: none.
pt recv vax 31OCT95 & 12AP97 pt devel a mild case of chickenpox w/around 12 lesions;pt recovered from sx;
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 04-MAY-2016, the patient was vaccinated with GARDASIL 9 (lot # L043213, expiry date: 23-AUG-2017) that was improperly stored. The vaccine was stored in refrigerator at a temperature of 14.2UC for 8 hours 30 minutes and at 1.5 UC for 26 hours 30 minutes and in freezer at a temperature of -12UC for 8 hours 30 minutes. There was  no previous temperature excursion. Digital data logger was involved. No adverse effects reported. The outcome of the events was unknown. This is one of the several reports received from the same reporter. Additional information has been requested.
ears feel like they are full of fluid; eye is swollen; This spontaneous case was reported by a consumer and describes the occurrence of EAR DISCOMFORT (ears feel like they are full of fluid) and EYE SWELLING (eye is swollen) 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) 1 dosage form. On an unknown date, the patient experienced EAR DISCOMFORT (ears feel like they are full of fluid) and EYE SWELLING (eye is swollen). At the time of the report, EAR DISCOMFORT (ears feel like they are full of fluid) and EYE SWELLING (eye is swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were provided  No treatment  medication were provided
Adult received pediatric dose; 10 mcg administered instead of adult dose/Adult received pediatric dose; This case was reported by a other health professional via call center representative and described the occurrence of underdose in a 73-year-old female patient who received HBV (Engerix B pediatric) (batch number K329E, expiry date 24th April 2023) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 8th June 2022, the patient received the 2nd dose of Engerix B pediatric 10 µg and Engerix B Pre-Filled Syringe Device. On 8th June 2022, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 1-Dec-2022 Reporter's comment: Practice manager called to inquired that the patient need to restart the series or just administer the other half of the dose. The reporter confirmed that the vaccine dose was administered in their facility. No additional details were provided. The reporter did not consent to follow-up. Additional supportive information: An adult patient was inadvertently administered a pediatric dose of Engerix as the second dose in the series, instead of the full adult dose, which led to underdose and adult use of a child product.
Initial report received on 14-NOV-2005 from a health care professional. A 42-year-old male patient with patient with a medical history of moderate asthma experienced congestion of the sinus and lungs, laryngitis, and felt feverish, 24 hrs following the influenza vaccine (Fluzone SV '2005-'2006) administration in the left deltoid. Signs and symptoms were less than 2 days ago but it still persisted at the time of the report. It was also reported the patient had dark sputum and he was not recovered at the time of the report. Patient was receiving yearly vaccination with the same vaccine since an unspecified time. Follow-up information received on 12/Jun/2006 from the patient. At the time of this report, the patient had recovered.
with several days of receiving the shot the following symptoms occurred:  severe headache backache severe pain in your abdomen or stomach pain in your chest leg pains joint pains shortness of breath
cold; This is a spontaneous report from a contactable consumer (patient's parent) from a Pfizer-sponsored program . A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number not provided), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first shot of the vaccine and had a cold after. It was recommended to get tested for COVID. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.?
Patient was given FLULAVAL vaccine 9/26/13 at 1500. At 0200 9/27/13 she awoke with (L) eye swollen shut red-flushed face, rash on neck, itching on face/neck. Denied trouble breathing.
Initial and follow-up information has been received from a health professional concerning a 17 year old white female student who on 07-FEB-2008 was vaccinated IM in the right deltoid with her second dose of GARDASIL (Lot# 659653/1448U).  There were no illnesses at the time of the vaccination.  On 07-FEB-2008 the patient experienced syncope with questionable seizure activity in the office.  The symptoms lasted less then 30 seconds.  The patient recovered in the office and was sent to the emergency room for evaluation.  Upon internal review the questionable seizure activity was considered to be an other important medical event.  Additional information has been requested.
At 24 hours, in a very short period of time, my temp went from normal to 104.9, I got chills; and  my fingers, hands and lips turned blue. I went to urgent and they think because my fever went up so rapidly, my blood vessels constricted. I went home, alternated Tylenol and Ibuprofen during the night. On the morning of the 22nd, I woke up and my face was really swollen along with swelling under my armpit. I was also really hoarse. I went back to urgent care and they put me on a steroid, Benadryl and Pepcid. After that, everything slowly improved. It took a while for me to recover fully.
Pt called stated she had a 3x4 inch red spot firm and itchy at insertion site of vaccine. Pt also stated she had another raised area similar  on the L scapula. no open vesicules. She saw a local Physician. She applied Benedryl to the affected areas.
10 patients administered vaccine past the beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (10 patients administered vaccine past the beyond use date) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939905) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (10 patients administered vaccine past the beyond use date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (10 patients administered vaccine past the beyond use date) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Treatment informations were reported.    This case was linked to MOD-2021-377975 (Patient Link).
This case was reported by a nurse via sales rep and described the occurrence of passed out in a 16-year-old female patient who received BEXSERO. Concomitant products included MENACTRA. On 28th July 2017, the patient received BEXSERO. On 28th July 2017, less than a day after receiving BEXSERO, the patient experienced passed out (serious criteria GSK medically significant) and syncope. On an unknown date, the outcome of the passed out and syncope were recovered/resolved. It was unknown if the reporter considered the passed out and syncope to be related to BEXSERO. Additional details were reported as follows: The patient received BEXSERO and MENACTRA on the same day and passed out following the administrations. The healthcare professional was not asked to be contacted but did not state they could not be contacted if a follow up was required.
LITTLE TIRED; This spontaneous report received from a consumer via social media via a company representative concerned multiple patients (reporter's family) of an unspecified age, sex, race and ethnic origin. The patient's weight, height, and medical history were not reported. The patients all received covid-19 vaccine ad26.cov2.s (dose number in series 1) (unspecified manufacturer) (suspension for injection, route of admin, batch number and expiry date were not reported) dose, start therapy date were not reported, 1 total was administered for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patients experienced little tiredness (dose number in series 1). It was reported that "I've had all the Coved shots and so for no reactions, no Covid. Only a little tired from the first shot. My family has been the same. I'm NOT suggesting anyone take it. I fully support the right to choice in THIS matter. God bless all. Stay safe and be fair". The patients received booster dose of covid-19 vaccine ad26.cov2.s (dose number in series 2) (unspecified manufacturer) (suspension for injection, route of admin, batch number and expiry date were not reported) dose, start therapy date were not reported, 1 total was administered for covid-19 prophylaxis. No adverse events were reported following vaccination with booster dose of covid-19 vaccine ad26.cov2.s (dose number in series 2) (unspecified manufacturer). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of little tired was not reported. This report was non-serious. This case, from the same reporter is linked to 20230103940.
Information has been received from an office assistant and a female patient who on 19-MAR-2009 was vaccinated the first dose of GARDASIL. Concomitant therapy included (LEXAPRO). After received her first dose of GARDASIL (LOT# not reported) she experienced genital irritation and swelling. She saw doctor and had a pap test was performed on 31-MAR-2009, results "come back as genital herpes". The event was not disability of life threatening and did not require hospitalization. She also stated that all other tests came back negative before GARDASIL was ever administered. At the time of the report the patient's condition persisted and the patient was treated with LEXAPRO. Additional information will be provided if available.
Red, raised, hard, and tender lump on arm just below injection site. Not warm to touch.
Hallucinations, joint pain, fever, vomiting. Pt is 28 weeks pregnant. EDC 5/22/16.
Information regarding Prevnar was received from a healthcare professional regarding a 4 month old male patient who experienced pneumococcal meningitis and drug ineffective. At 4 months of age, the patient received the second dose on 1/25/05. The patient also received second doses of Daptacel, IPOL, and Act-HIB on 1/25/05. The patient has a past history of premature baby (infant is part of a multiple birth (triplet)). Indication for Prevnar was immunization. Product was administered on 1/25/05. Dose regimen was 1 dose (IM). Concomitant therapy included Daptacel, Polio Vaccine, and Act-HIB. The patient experienced pneumococcal meningitis on 2/7/05. He was hospitalized and given unspecified IV antibiotics. As of 2/14/105, the infant was still hospitalized but doing better. The reporter considered the event to be life-threatening. The serotype still pending. No additional information was available at the time of this report.
Pt given DT to right deltoid muscle. Guardian stated site was inflamed and sore after administration but was resolving when they returned to the clinic. Incident occurred over a weekend. Guardian treated with Tylenol.
Later over in the night after the vaccine I had an excruciating headache for about 4 days causing me not to be able to get out of bed.  I developed a fever which broke about 1 1/2day after the vaccine.  I was really exhausted and my body ached really bad all over and after about day 6 I felt better.    8/13 I developed a runny nose.  By that Sat I got a really bad headache, my temp went to 104, my body ached so bad  all over.  I reached out to my PCP who advised I take a COVID-19 test and on 8/16 I test positive for COVID-19.  On 8/17 I was given the Regineron Antibiotics and began to feel better after about two weeks later.  I still have a nagging cough that wont go away but all other symptoms has diminished
Within 2 hours I felt feverish and my anxiety was elevated. I went to have my BP checked and it was high. It remained high for 6 weeks. My doctor sent me to the ER to get it checked out. They took my BP and did some bloodwork. Afterwards I was discharged and told to follow up with my primary doctor. No medication was administered
Patient received diluted pfizer vaccine drawn in syringe sitting at room temperature X 7 days. Brought patient back in to re-administer pfizer booster
He stopped smiling.  He stopped cooing and babbling.  He stopped making eye contact.  He stopped responding to people, including family.  He wouldn't sleep.  He cried for hours, even though I was holding/rocking/nursing him.
Patient got ZOSTAVAX on 7/19/17. On 7/20/17 she took off the Band Aid and had a mark from adhesive (allergy to adhesive) and everything else was fine. On 7/21/17 patient noticed her arm felt hot at injection site and it felt bruised when she moves muscle. There is no bruise but we can see a red area at site. There is no rash or itching at site, just hurts and feels hot. Patient does not feel like she needs to see a doctor at this point. She just wanted to let us know.
Information has been received from a registered nurse concerning a male with no drug allergies who on 12-Oct-2007 was vaccinated PO with a dose of Rotateq (lot #657661/0973U).  On approximately 14-Oct-2007 about two days post vaccination, the patient experienced vomiting and diarrhea that was greenish brown in color.  Unspecified medical attention was sought.  No labs or diagnostic studies were performed.  Subsequently, the patient recovered.  There was no product quality complaint.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 12/14/2007. Information has been received indicating that a 10 week old male with gastrooesophageal reflux who on 12-OCT-2007 at 13:15 was vaccinated PO with the first dose of ROTATEQ (lot# 657661/0973U). The patient has a history of GERD prior to vaccination. Concomitant vaccinations administered on that same day at 13:15 included the first IM dose of ACT-HIB (lot# 656518/0258U) in the right thigh, the first IM dose of PEDIARIX (lot# AC21B125AA) in the left thigh and PREVNAR (lot# 890143P) in the right thigh. On 15-OCT-2007 (also reported as approximately 14-OCT-2007), the patient experienced vomiting, greenish brown diarrhea and diarrhea. The patient did not seek medical attention. Subsequently, the patient recovered. It was noted that the patient received a dose of ROTATEQ in December 2007 with no problems of vomiting and diarrhea noted. Additional information has been requested.
HIGH FEVER, NAUSEA, VOMITING, SEVERE ABDOMINAL PAIN, SEVERE HEADACHE x 3 DAYS MULTIPLE SEVERE JOINT INFLAMMATION AND SEVERE PAIN OF ALL JOINTS WITHIN BODY WITH LIMITED RANGE OF MOTION OF EXTREMITIES x SEVERAL MONTHS WITH MILD SYMPTOMS STILL PERSISTING. INFLAMMATION OF COLON AND INTESTINES CAUSING HOSPITALIZATION. NAUSEA STILL PERSISTS SINCE MODERNA BOOSTER VACCINE
Extreme pain in one leg, inability to walk on that leg.  Took child to ER because of cold, purple limb and extreme pain. They admitted her to Hospital.  The next day she was transferred to another Hospital where more pediatric specialists could see her.  The symptoms spread to her other leg. She was hospitalized for 7 days and then referred to a 3rd hospital. The working diagnosis was reflex sympathetic dystrophy or chronic reflexic pain syndrome, but her neurologist disagreed with this diagnosis.  She spent 2 months in a wheelchair. After extensive physical therapy she was able to walk, first with crutches then without.  She was on high doses of narcotics and Neurontin but now, 3 years later takes only Neurontin.
Patient returned to pharmacy has large localized swelling in arm - entire bicep swollen. Advised BENADRYL OTC pt to come back in morning. PCP notified prescribed MEDROL dose pack.
I have vaccination on 04/16/2022. In 07/2022 started to have COVID like symptoms to include coughing, extreme, fatigue, headache. I was extremely fatigued. I was taking multiple tests and came home early from cruise. I went to urgent care and the test came back positive. I was also diagnoses with Acute Bronchitis. I was prescribed Paxlovid and I felt better in a few days.
Inflamed lymph node and pain moving arm. On Jan 27 went to urgent care with pain inhaling, diagnosed with pleurisy.
I have had muscle twitching in random parts of my body that are still continuing.  They are not constant, and there is no pattern to when or where they will happen.  My fingers and toes as well as one eye and muscles in other parts of my body seem to have a mind of their own.  It started about a week after my second vaccine injection and seem to be lessening over time, but still there.