chrisvoncsefalvay/vaers-outcomes huggingface dataset:
As if it was paralyzed; He couldn't lift it for 3 days; Very painful; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (As if it was paralyzed), LIMB DISCOMFORT (He couldn't lift it for 3 days) and AXILLARY PAIN (Very painful) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (As if it was paralyzed), LIMB DISCOMFORT (He couldn't lift it for 3 days) and AXILLARY PAIN (Very painful). The patient was treated with ACETAMINOPHEN ongoing since an unknown date at an unspecified dose and frequency. On 09-Feb-2021, VACCINATION SITE MOVEMENT IMPAIRMENT (As if it was paralyzed), LIMB DISCOMFORT (He couldn't lift it for 3 days) and AXILLARY PAIN (Very painful) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       It was reported patient used ice to relieve the symptoms.  Concomitant product use was not provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 04-Jun-2021: Follow up received on 04 Jun 2021contains event outcome and patient declined further follow-up; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Pt stopped at clinic 10/22/02 14:30-states on 10/18/02 approx 20:00 L upper arm became reddened and tender. On 10/19/02 redness spread and had a lump on arm below bandaid that covered inj. site. Unable to contact MD by phone so pt went to ER 10/20/02-dx with cellulitis from Pneumovax in L deltoid. Started on Keflex. Today on exam red circle quarter size about 3/4" inferier to inj site.
I was getting ready for bed (around 2am, early night for me) and suddenly felt dizzy, nauseous, and incredibly hot. I was very stressed about it and it had been six days since the shot, so I just assumed I was either having a heart attack or a really bad panic attack. I did a meditation and chewed a couple aspirin just in case.  There was extreme tightness in my chest. Breathing was difficult. The dizziness, nausea, and inability to control my body temperature went away within a couple hours and I managed to sleep. But the chest tightness and difficulty breathing persisted for about 3 or 4 days.  I also noticed it hurt more whenever I was sitting upright or forward, and it hurt almost zero when I leaned back or laid down.
Client returned to clinic morning after vaccine was done the day before. Hive-type rash, urticaria noted on left upper arm and on face, forehead area. Left upper arm warm to touch. Also c/o nausea. No s/s of respiratory distress, states s/s began the evening same day of vaccine. Referred to PMD. Dx: allergic reaction and ordered warm compresses and Clarinex. Also noted swollen lymph node. Left Ax area. Hx of PCN allergy. Also c/o pain left arm.
Angioedema numbness and tingiling around mouth Narrative: ems was called but employee declined transport. as of 1/11 still reports facial swelling and will seek care from PCP.
mom reports crying non-stop longer than 3 hrs; poor appetite, refused to eat for 24 hrs; t103; visit to ER could not be confirmed by checking records & calling hosp'
started as diff swollowing 3hr p/vax;then thraot swollen, stridor 45min later w/achyness & inc temp 3-4hr later;resolved p/taking Codinal;@ work next day & only feels tired;no other changes in habits;1st time for flu vax;
Patient received both flu vaccine and HPV dose 2 today. After receiving his injections, he sat in the chair next to his mother while his sister received her immunization. He started to slump down and lay his head on his mother. He had LOC for about 30 seconds reported by nursing and became still in his body. He also had urinary incontinence. Physicians and nurses came in for aid and he was awake, yet sluggish. he was oriented to time, person, place. BP was mildly low.
A non-serious spontaneous report of neck pain, glandular pain, lethargic, high fever, body aches, and chills has been received from a consumer, patient's father, concerning a 26-month-old male subsequent to FLUMIST. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. The patient's medical history and concomitant medications were not reported. The patient received FLUMIST on 04-Nov-2009. On 07-Nov-2009, the patient experienced neck pain, lethargic, high fever of 100.5, body aches and chills. The reported stated the patient was "feeling better". Required follow up attempts have been performed, requested information unable to be obtained.  23-Feb-2010.
Case number PHEH2014US024294, is an initial spontaneous report received from a nurse on 02 Dec 2014, with a follow up report received from the nurse on 19 Jan 2015. This report refers to a 34 year old female patient. Her medical history and concomitant medication were not reported. Her previous vaccinations (unspecified) were well tolerated. She was vaccinated with her initial application of FLUVIRIN, (batch number: 14511P, expiry date: Mar 2015) intramuscularly at a dose of 0.5 ml in left deltoid on 05 Nov 2014. Nurse reported that PFS of FLUVIRIN was stored at 49 degree F for 1 hour and 15 minutes. Patient did not experience any adverse event. No adverse event was reported following this maladministration (incorrect storage of drug). No further information was provided. Follow up report received from the nurse on 19 Jan 2015: Updated vaccination history, recent vaccination site and reporter's statement.
MAY HAVE EXPERIENCE VAGAL SYNCOPE BUT UNABLE TO CONTACT PATIENT TO CONFIRM
Almost immediately She said her arms were very sore for a long time after with a very large red spots on each arm.  Within days after the 1st round of these vaccines she bagan headaches. She described them as headaches worse than she ever had before and she said her muscles were very weak. A Few more days passed and she began to lose hair and have stomach problems. Pain in stomach nausea and diarrhea.  Soon after she was discharged she found a lump in her right breast that was very painful growing rapidly they did surgery to remove it said it was benign.  When She was in the employer reception and when she would go to the clinic they would give her something for headache and do nothing else. She came home 08/2018 and is not well yet the uncontrollable vomiting and diarrhea began 05/2018 and continues to today 03/26/2020 .   They've tried many bouts of antibiotics and medications nothing has helped her they have said they found H pylori (that they can't get rid of with any medicine as of today) and she also has the worst case of IBS any GI has ever seen so far this is where she is at. She was also 128 lbs when she came home an 18 year old and at 20 she is now 94 lbs and cannot eat hardly anything cannot take liquid medication anymore without vomiting, and is now allergic to amoxicillin where her throat closed up and she could not breath.
Cellulitis, redness and warm to touch down left upper arm on Oct 3rd.  Being treated with AUGMENTIN 875/125 BID x 10 days and ZYRTEC QD.
This spontaneous report was received from a physician assistant via company representative refers to a patient of unknown age(reported as appropriate age range to receive the vaccine). On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX, (lot number, expiry date and route was not reported). Concomitant medications were not reported. On an unknown date, the patient experienced rash after receiving ZOSTAVAX. The outcome of rash was unknown. The patient sought medical attention (office visit). Additional information has been requested.
Initial information was received from a health care professional on 19 August 2008.  An 11 year old female patient with no reported past medical history received an injection of MENACTRA (U2550AA) intramuscularly in the left deltoid and an injection of ADACEL (C2904AA) intramuscularly in the right deltoid on 19 August 2008.  "Two minutes after receiving the MENACTRA injection she was found in the exam room with her head down.  She woke up after two minutes and was wringing her hands.  She complained of blurred vision."  Her blood pressure and pulse pre and post vaccination were 80/40 and 68.  No other symptoms were reported according to the physician.  The patient "fainted" and was "unconscious".  The patient's recovery status was unknown.
This spontaneous report as received from a 58 year old male consumer and a pharmacist refers to the patient. The patient had diabetes, a history of having a stroke, triple bypass surgery and an implant in the heart. The patient had no drug allergies. On 24-SEP-2013 the patient was vaccinated with PNEUMOVAX23 (lot # 0709AE, expiration date 04-JAN-2014) (total daily dose not reported) in the arm. Other suspect therapies included FLUZONE (lot # not reported) (total daily dose not reported) vaccinated in another arm. Concomitant therapies included COUMADIN, insulin pump, cilostazol, furosemide (manufacturer unknown), simvastatin (manufacturer unknown), finasteride (manufacturer unknown), tamsulosin, omeprazole (manufacturer unknown), KLOR-CON, metoprolol, gabapentin, calcium, vitamin D, dapsone, folic acid, Men's Ultravitamin, aspirin (manufacturer unknown), fluticasone and VICODIN. The patient stated that on 25-SEP-2013, he developed red "spot" at the both of the injection sites after receiving the dose of PNEUMOVAX23 on one arm and FLUZONE on the other arm. Both of the red spots disappeared after 2-3 days but the purple mark appeared where he received the PNEUMOVAX23. He still had the purple mark and it seemed to be spreading. He did not feel pain at the purple site. The patient sought for medical attention by seeing the physician. No treatment was given. Lab diagnostics studies performed were reported as none. The outcome was reported as not recovered. Additional information has been requested.
Patient had nodules at each injection site (total of 3 sites) for 2 months.  No cellulitis, erythema, or signs of infection.
24 hrs p/vax pt devel 10 cm induration on site of inoculation assoc to burning, pruritus, heat & erythema; induration resolved in 4 days; erythema, heat & pruritus spreaded to the whole arm; react persists 1 wk p/inoculation
Patient reports experiencing bright red blood in stool beginning ~ 30 hours after 1st dose of Covid19 Moderna Vaccine. She also reports experiencing fatigue and headaches. Stool guaiac positive on exam. Referral to GI and lab tests conducted today, lab tests pending. Pt has a history of iron deficiency anemia requiring IV Feraheme transfusion.
cant lift arm past 45 degrees; arm sore/pain in left arm at the injection site; A spontaneous report (United States) was received from a healthcare professional concerning a 83-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events arm sore/vaccination site pain, cant lift arm past 45 degrees/muscular weakness.  The patient's medical history included a mastectomy ten years ago. No relevant concomitant medications were reported.  On an unknown date, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) via unknown route for prophylaxis of COVID-19 infection.  On 16 Feb 2021, prior to the onset of the events the patient received second of two planned doses of mRNA-1273 (lot/batch: unknown) via unknown route in the left arm for prophylaxis of COVID-19 infection.  On 16 Feb 2021, the patient experienced the events, arm sore, cant lift arm past 45 degrees. The patient could take other hand and use it to assist in order to raise left arm, but cannot lift higher than 45 degrees without assistance  Treatment details included Tylenol.  The patient received both the doses of mRNA-1273  prior to the events, therefore action taken against the drug in response to the events was not applicable.  The outcome of events, arm sore, cant lift arm past 45 degrees was unknown.
1/4 Vaccination. 12 hours later; arm pain, lump on arm with redness. Within 24 hours, lump was larger. Lymph nodes swollen. Lump was about size of a softball, all lymph nodes swollen. Symptoms about a week. Sought attention from NP. She stated to ice and Ibuprofen.
PATIENT LEFT UPPER ARM BECAME SWOLLEN, RED AND PAINFUL SEVERAL HOURS AFTER INECTION. SYMPTOMS LASTED FOR ABOUT A WEEK.
Diffuse hyperpigmented, pruritic plaques on trunk and back, some with mild ecchymosis
I began having a really bad allergic reaction and I was itching all over my body. That same night I began having a horrible headache, and my muscles and joints began aching and hurting. It felt like I was holding a two ton rock over my head when I would try to walk. I took Benadryl and used Sarna lotion for the itching, and took tylenol for the headache and muscle aches. IF symptoms don't subside, then I will visit the clinic at my job to be treated and see what they could recommend.
This spontaneous report was received from a certified medical assistant referring to a two patients of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 20-MAY-2016, the patients were vaccinated with an expired dose of VAQTA lot #: L018498, expiration date on 28-APR-2016 (strength, dose number, route and anatomical location were not provided). There was no concomitant medication described. No adverse effects were reported. Additional information has been requested.
I had chills, exhaustion, running nose, muscle aches and sneezing. I took NYQUIL before I knew it was COVID-19. I tested positive for COVID-19. I talked to a doctor and said I would be fine to ride it out. I tested positive again for COVID-19 on 12/09/2022. I had fatigue, brain fog, chills, and coughing when I laid down. I went to the urgent care, and she said I would be fine if I just rested. I still have brain fog.
NURSE ADMINISTERED VACCINES- LEFT ROOM AS LAB TECH WAS ENTERING. CHILD OON THE TABLE AND ALREADY PALE.  ASKED CHILD IF SHE FELT OK- CHILD STATED "NO I FEEL LIKE SICK." IMMEDIATELY THE CHILD WAS LAID DOWN AND COLD COMPRESS APPLIED.  MOM IN ROOM AND CHILD INSTRUCTED TO RELAX AND BREATHE. AFTER ABOUT 5 MINS- LAB TECH LEFT THE ROOM TO GET A COLD DRINK. MOM STOOD AT HER SIDE WHILE STAFF NOT PRESENT. DR NOTIFIED AND LAB TECH AND DR ENTERED ROOM TOGETHER. CHILD ASSESSED AND RELEASED BY DR AFTER FURTHER 15 WAIT. TOTAL TIME OF EVENT25 MINS
COVID-19, mRNA, LNP-S, PF, 100 mcg/0.5mL dose or 50 mcg/0.25mL dose (Moderna COVID-19 vaccine) Date Administered: 11/01/2021 Manufacturer: MODERNA US,INC. Lot Number: 076C21A  Patient died of COVID 08/11/2022
Pain in arm, next day headache, fatigue, overall sick feeling, cleared up by day 4.    Then day 8 redness appeared at the injection site.  Also hives appeared on lower back and thigh at the same time.
Since receiving the vaccine on 05Mar2021 I've been feeling discomfort pressure in my brain; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP).  A 36 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 05Mar2021 (Batch/Lot number: unknown) at the age of 36 years as dose number unknown, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported HEAD DISCOMFORT (non-serious) with onset 05Mar2021 23:00, outcome not recovered. Therapeutic measures were not taken as a result of head discomfort. The patient has no known allergies. The patient has not been diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 post vaccination.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
EXTREME BODY ACHES; COULD NOT GET OUT OF BED FOR A FULL DAY; FEVER; NAUSEA; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's past medical history included: covid-19. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on APR-2021 for prophylactic vaccination. 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 patient experienced extreme body aches, could not get out of bed for a full day, fever, and nausea. The action taken with covid-19 vaccine was not applicable. The patient recovered from extreme body aches, could not get out of bed for a full day, fever, and nausea. This report was non-serious.
This spontaneous report was received from an unspecified reporter via a company representative and refers to a male patient of unknown age. The patient's concurrent conditions included diabetes mellitus and an unknown heart condition. The patient's medical history and concomitant therapies were not reported. Approximately in 2007 (also reported as "approximately 10 years ago"), the patient was vaccinated with a dose of ZOSTAVAX (concentration, dose, frequency, lot# and expiration date were not provided), to prevent shingles. On 18-DEC-2017, the patient was diagnosed with shingles. Therefore, the patient went to the Emergency Room and was treated with unknown pain medication and unknown antibiotic medication. At the time of reporting, the patient did not recover from herpes zoster. The reporter did not provide a causality assessment between ZOSTAVAX and herpes zoster.
Patient is unsure of the exact day and time of covid shot. She threw away the card. She believes it was July 8th at 1pm, 20 minutes later she started to get symptoms. Went to ED around 6pm that same day. Blood pressure was 200/120, blurred vision,chest pain, numbness in arms and legs. Thought she was having a stroke. The next day she felt like she had a mini stroke-left side numbness.  Was treated with anti-hypertensive medications that were raised 2 days later, but subsequently weaned off with no residual numbness.
After the vaccines lost temperature they were administered; A spontaneous report was received from a nurse concerning a White, 70-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the event, after the vaccines lost temperature they were administered.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 11 Jan 2021, a refrigerator in a vaccine clinic lost power and rose up to room temperature overnight. At approximately 9 p.m., the vaccines inside the refrigerator reached room temperature.  On 12 Jan 2021, after the vaccine lost temperature, the patient received their first of two planned doses of mRNA-1273 (Lot number: 027L20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.  No treatment information was provided.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.  The event, after the vaccines lost temperature they were administered, was considered resolved on 12 Jan 2021.; Reporter's Comments: This report refers to a case of out of specification product use for mRNA-1273, lot # 027L20A. There were no reported AEs associated with this case of out of specification product use.
This case was reported by a nurse via sales rep and described the occurrence of cough in a adult female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced cough, pain, stiffness, chest abnormal feeling of, fever, injection site erythema and hives. The patient was treated with salbutamol sulphate (Albuterol). On an unknown date, the outcome of the cough was not recovered/not resolved and the outcome of the pain and stiffness were recovered/resolved and the outcome of the chest abnormal feeling of, fever, injection site erythema and hives were unknown. It was unknown if the reporter considered the cough, pain, stiffness, chest abnormal feeling of, fever, injection site erythema and hives to be related to SHINGRIX. Additional details were provided as follows: The reporter did not know batch number of SHINGRIX. The age at vaccination was not reported, but the patient could be 64 or 65 years old. The patient post vaccination was achy and stiff for three days and then was fine. The patient had weird feeling in chest and a cough and she was still coughing using albuterol and fever. The patient had redness at injection site and hive on leg. The patient wanted to get the next shot of SHINGRIX.
Intussusception one day after receiving PO Rotavirus vaccine. Required air enema reduction and hospitalization.
DECREASE SENSE OF TASTE, FATIGUE, INJECTION SITE PAIN Narrative:
passed away; short of breath; unwell & very unwell; extremely thirsty; dry mouth; This spontaneous case was reported by a pharmacist and describes the occurrence of DEATH (passed away) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Oxygen therapy (Required Oxygen Assistance in the office). Concurrent medical conditions included Diabetes and Brain tumor.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2021, the patient experienced DYSPNOEA (short of breath), MALAISE (unwell & very unwell), THIRST (extremely thirsty) and DRY MOUTH (dry mouth). The patient died on 16-May-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, DYSPNOEA (short of breath), MALAISE (unwell & very unwell), THIRST (extremely thirsty) and DRY MOUTH (dry mouth) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information is not provided. Concomitant medication is not provided. Reporter states that the friend stated that the patient had other underlining conditions, patient needed oxygen assistance in the office,friend advised patient to go to the ER and Patient refused Action taken with mRNA-1273 in response to the events was not Applicable.  Company Comment: Very limited information regarding this events has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding this events has been provided at this time.  Further information has been requested.; Reported Cause(s) of Death: unknown cause of death
Information has been received from a medical assistant concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not provided. On 16-JAN-2017, the patient was vaccinated with GARDASIL (lot #: K005881 with expiration date: 14-JAN-2017) (dose, dosage schedule and anatomical location were not reported) intramuscularly, for prophylaxis. The administered vaccine was expired. No adverse effects were reported. This is one of two cases from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1702USA001584:
Swelling, redness, hard right upper arm also warm to touch. Treat with Motrin 3 times per day until clear. Started one day post immunization.