chrisvoncsefalvay/vaers-outcomes huggingface dataset:
35 patints exposed to vaccine from which vial may have been punctured more than 20 times; Accidental underdose; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTRATION ERROR (35 patints exposed to vaccine from which vial may have been punctured more than 20 times) and ACCIDENTAL UNDERDOSE (Accidental underdose) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Nov-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (35 patints exposed to vaccine from which vial may have been punctured more than 20 times) and ACCIDENTAL UNDERDOSE (Accidental underdose). On 04-Nov-2021, PRODUCT ADMINISTRATION ERROR (35 patints exposed to vaccine from which vial may have been punctured more than 20 times) and ACCIDENTAL UNDERDOSE (Accidental underdose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication provided. A vial was punctured 30 times at the clinic. 10 patients who were administered the vaccine were affected. No treatment medication provided.
This spontaneous report was received from a nurse and refers to an 8 week old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 30-AUG-2017, the patient was vaccinated with improperly stored vaccines, RECOMBIVAX HB (dosing details not reported) (lot # N006321, expiry date: 08-NOV-2019) and ROTATEQ (dosing details not reported) (lot # M044397, expiry date: 20-JUN-2018, orally) for prophylaxis. No adverse effects were reported. The administered vaccines underwent a temperature excursion from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as 9 degree C to 25 degree C (10.9 degree C) for 3 hours 17 minutes. The call was because of a data logger. No product quality complaint was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA007011.
Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Additional Details: PT PASSED OUT SOON AFTER VACCINE STAYED IN CHAIR DID NOT FALL CAME TO IN A FEW SECONDS
Tetanus booster given 8/29/05 2 p.m. Around 4:30 a.m. I felt aches and pains in body and slight fever. By 6:15 it was 102 and my body hurt all over. By 7:30 temperature was up to 103.4 and getting no relief with Tylenol or Advil. Went back to doctor. They said they had never seen this reaction before and wanted to draw blood to test for West Nile Virus, Liver problems and other various viruses. I made them aware that it was from the tetanus shot. No treatment other than tylenol/advil/heat pack on body to relieve aches. Temperature rose to 103.8 that evening. Joints ached, spine hurt very bad. That night most of the fever broke. Next day I had temperature ranging from 100.4 to 101.4 but body still ached in joints as bad as day before. Head ache and weak too. Next day no fever, minor joint aches, but extremely weak. Dizzy.
Contracted covid months after taking the vaccine. The vaccine did not do a good job of preventing me from getting the virus. I had to consult my doctor but I did not get covid at all prior to taking the vaccines so I feel like the vaccine wasn't exactly helpful.
Difficulty sleepy, felt feverish, headache. Next morning  had severe body aches, headache and fatigue.
Vaccine was administered at 10am with no signs or symptoms. Patient went to bed at 930pm with no signs or symptoms. Patient awoke at 0100am on 2/17/21 with 102.7 fever, chills, nausea, severe full body muscle aches, headache, diaphoresis, and shortness of breath. Patient was unable to work on 2/17/21. Patient had residual side effects on 2/18/21 of minor headache and minor body aches. Patient did attend work. All residual side effects disappeared by 2/19/21.
soreness of the left arm; Tiredness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 56 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 12Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "soreness of the left arm"; FATIGUE (non-serious), outcome "unknown", described as "Tiredness".  Additional Information: Reported she had a quick question. She stated she got her first Covid-19 Vaccine (on 12Mar2021), and then was out of state when she was supposed to get her second Covid-19 Vaccine (on 02Apr2021). She said she called today to schedule her second Covid-19 Vaccine dose. She said the earliest she could get her second Covid-19 Vaccine would be either 08Apr2021 or 09Apr2021. Caller asked if it would be a problem for her to get her second Covid-19 Vaccine that long after her first Covid-19 Vaccine dose. Caller was advised she would be transferred to Pfizer Medical Information for further assistance.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Numbness, Heaviness and Spasms on vaccinated arm. Pain in the vaccinated area even after 1month from 1st vaccine. Is this normal? Will this eventually go away, its been over a month now.
15-year-old received Moderna COVID-19 vaccine; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (15-year-old received Moderna COVID-19 vaccine) in a 15-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 03621A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (15-year-old received Moderna COVID-19 vaccine). On 12-Nov-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (15-year-old received Moderna COVID-19 vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Treatment information was not provided.
Patient reports fever on the same day of administration and the day after administration of vaccine. Patient also states that she experienced arm swelling and redness the day after vaccination which started to resolve on day 3.
This spontaneous report as received from a physician via company representative refers to a female patient of unknown age. Patient's pertinent medical history, concurrent condition and concomitant medication were unknown. No previous drug reactions/allergies were reported. On an unknown date in DEC-2015, the patient was vaccinated with first dose of GARDASIL 9 in the three dose series, (strength, dosing details, anatomical location, lot# and expiration date were unknown). On an unknown date in JUN-2016, she received the second dose and on an unknown date in DEC-2016, she received the third dose in the series of GARDASIL 9 (inappropriate schedule of drug administration). Lab diagnostic tests performed was not known. The patient did not sought medical attention. No product quality complaint was involved. Additional information has been requested.
BODY ACHES; CHILLS; FEVER; This spontaneous report received from a health care professional 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, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced body aches, chills, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, chills, and fever. This report was non-serious. This case, involving the same patient is linked.
swollen arm; swollen lips; difficulty breathing; This spontaneous case was reported by a patient and describes the occurrence of PERIPHERAL SWELLING (swollen arm), LIP SWELLING (swollen lips) and DYSPNOEA (difficulty breathing) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047B21a and 031A21a) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Apr-2021, the patient experienced LIP SWELLING (swollen lips) and DYSPNOEA (difficulty breathing). On an unknown date, the patient experienced PERIPHERAL SWELLING (swollen arm). The patient was treated with EPINEPHRINE at a dose of UNK dosage form. At the time of the report, PERIPHERAL SWELLING (swollen arm), LIP SWELLING (swollen lips) and DYSPNOEA (difficulty breathing) outcome was unknown.            Concomitant product use was not provided. Treatment drugs include IV, Steroids.   This case was linked to MOD-2021-200440 (Patient Link).
I received the first dose of the COVID vaccine in my left arm on January 27, 2021. A very large (bigger than a quarter and visible to the eye) lump formed on my left collar bone. It was tender to the touch and for a while, it was uncomfortable even without touching it. I went to urgent care on February 3, 2021. The doctor examined me and said it was probably due to the vaccine, but to keep an eye on it and if it didn't go away I should see a doctor. The lump decreased in size a little - no longer visible to the eye, but easily felt and still a little tender. I received the second dose of the COVID vaccine in my left arm on February 24, 2021. The lump remained the same. I went to a doctor on March 15, 2021, and she ordered an ultrasound to confirm it was an enlarged lymph node. The ultrasound was performed on March 18, 2021, and confirmed it was an enlarged lymph node. My doctor told me to keep an eye on it - since it had decreased in size and had not grown. It is now July 7, 2021, and I still have a very small lump... but it is still there... 5+ months later. I'm going to the doctor tomorrow to talk with them about it.
Patient stated she felt some chest heaviness and some mild shortness of breath 5 minutes after receiving her vaccine. She also claimed she was light headed and had a wave of nausea right after her vaccine. She said she has never had a vaccine reaction like this before and claims she ate breakfast this morning. Upon our interview, her symptoms decreased. She denied any swelling, trouble speaking,  drooling.  We added 10 minutes on to her observation time and after that she was ready to go. When pt left, she did not have any chest tightness or SOB.
30y M w/no PMH s/p COVID-19 J&J vaccine <5min exhibited syncopal episode while seated, resulting in ground level fall from chair witnessed by relative associated w/prodrome of mild flushing and upward nystagmus, but w/no significant head trauma. On exam noted to be contracted in extension, nonverbal and with fixed gaze which resolved w/in 1-2min with nl return of mental status. Pt's knees were   slowly bent and the spine lightly placed in flexion, with slow transition to chair and finally legs elevated; no further complaints/events encountered.
Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. In or around 21-OCT-2015, the patient was inoculated with ZOSTAVAX, (lot# and route unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving ZOSTAVAX the patient suffered from hemoptysis, chronic obstructive pulmonary disease, and reoccurring instances of pneumonia requiring hospitalizations. As a direct and proximate result of ZOSTAVAX, the patient's symptoms have resulted in physical limitations not present prior to using ZOSTAVAX. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. As a direct and proximate consequence, the patient sustained serious personal injuries and related losses including, but not limited to, the following: The patient required and will continue to require healthcare and services; the patient incurred and will continue to incur medical and related expenses; and the patient suffered and will continue to suffer mental anguish, physical pain and suffering, diminished capacity for the enjoyment of life, a diminished quality of life, and other losses and damages. Upon internal review reoccurring instances of pneumonia was considered medically significant. Reoccurring instances of pneumonia, hemoptysis, and chronic obstructive pulmonary disease were considered medically significant events. Additional information has been requested.
Severe pain in jaw and ear on left side, identified 10 hours post injection and continuous  Pain at injection site, continuous and not subsided since injection
li also had a flu shot today but don't know which one. flu shot was in left arm. Shingles vaccine right arm. within 2 hours my right shoulder became very painful, to the point where i cannot use it.   i took tylenol at 1:00 ans starting icing it.  it hasn't helped.     it is now 7:00pm and i have a head ache and shivers, no fever at this time.
Between 4:30 and 5 PM I first had pain in my two wrists, ankles and heels followed shortly by awful chills (I had on a hoodie with the hood over my head wrapped in a quilt and was still cold). Then I started shaking, everywhere and hard. Got very thirsty and drank a bottle and one half of water. I decided to take my temperature and found I had a temp of 102 degrees. This lasted until about 8 PM when I started to feel better.
Respiratory distress, cough, chest tightness, shortness of breath and wheezing
Presumed MIS-C. beginning 24d after 2nd vaccine: severe headache, fatigue, then 2d later fever, then 2d later N/V/D, very high fevers 105F. Presented d8: elevated procal, CRP, nl ESR/ferritin, elevated troponin, BNP, neutrophilia, leukopenia, thrombocytopenia, hyponatremia. no rash, but ++diarrhea, some nausea, stool NAAT negative for Salmonella, Shigella, Ecoli, Campy
Patient under age 18 was vaccinated with Moderna, which is a vaccine error.  She is age 17 and will be 17 for the second vaccine. Troubleshooting: Scribe and vaccinator did not validate age;  screeners at the beginning of the process did not ask or turn away on a Moderna-only day.  All parties ignored the age restriction/confirmation of birthdate that was put in place to prevent this type of error, and patient falsified the encounter history question "Are you 18?"
pt recv vax 27NOV96 & 27NOV96 a pregnancy test was positive (LMP 1NOV96);estimated date of delivery 8AUG97;8wk from LMP approx DEC96 pt elected to terminate the pregnancy;
?Moderna COVID-19 Vaccine EUA? Joint pain, muscle pain, fatigue, fever, chills, headache, breast pain (lymph nodes?)
COVID Booster was given 2 days ago. Contacted primary healthcare provider about swelling above left collar bone with tenderness in both neck and collar bone area.
Narrative: Breakthrough Covid-19: Pneumonia due to coronavirus disease 2019 Acute respiratory failure with hypoxia
pt recv vax 16AUG96 1155PM & area of inj appeared blistered & oozing where prev charted smooth above & below inj site & along anterior surface;leg healing slowly;
Reported by Mom and Dad 10/10/18, 4pm noticed hives on face, fever not noted. 10/10/18, bedtime continued hives on face, swelling and redness in hands and feet, swelling not pitting, no fever noted.  Child given children's Benadryl. 10/11/18 parents contacted health center, continued rash on face, swelling and redness in feet, mom described swelling as "puffy", states feet are itchy. No pain, no difficulty breathing, fever 99.9. PHN advised parents to take child to see their primary care provider, if unable to see provider today go to urgent care. If condition worsens or child has difficulty breathing go strait to emergency room. Parents voiced understanding.
Patient is complaining of arm pain after the administration of Moderna COVID-19 vaccine.The vaccine was administered in the left deltoid muscle. She is stating that she searched SIRVA online and that is what she has.
FULL BODY ACHES, TEMP OF 101, HOT/COLD CHILLS, SWOLLEN ARM AT SITE RED AND RAISED (ABOUT 3" IN DIAMETER FULL CIRCLE), EXTREME EXHAUSTION, LACK OF APPETITE, NAUSEA, WICHING PAIN AT SITE (WHERE I SCREAM OUT AND CRY), BURNING STINGING SENSATION IF ARM MOVES... TREATMENT...TOOK TYLENOL AND ICED SITE.  NO RELIEF AND WENT BACK TO DOCTOR ON 6/28/10.  PRESCRIBED STEROID PILL FOR 3 DAYS.
Discharge Provider: DO Primary Care Provider at Discharge: DO  Admission Date: 6/16/2023 Discharge Date: 7/11/2023  DETAILS OF HOSPITAL STAY:   HOSPITAL COURSE: Patient is an 89 y/o man with history of CAD, SSS s/p AICD, AS s/p AVR, paroxysmal AFib on Eliquis and daily alcohol use who presented with acute hypoxic respiratory failure secondary to COVID 19. Had been having symptoms for about 2 weeks prior to admission. He was treated with steroids, remdesivir, and tocilizumab. He completed a course of empiric antibiotics for suspected bacterial pneumonia. His oxygen requirements worsened on 6/18 and he required HFNC at max settings. He had slow improvement in his respiratory status and was able to be weaned back to nasal cannula oxygen (3 L at rest, 6 L with activity). He was kept on prednisone at 40 mg daily, with slow taper. Due to prolonged use of higher dose of prednisone, he was also placed on Bactrim 1 SS PO daily.  He will remain on this for 14 days.   He was noted to have worsening thrombocytopenia, so Hematology was consulted. They recommended increasing dose of prednisone back to 40 mg. His Eliquis was held and not resumed, due to persistent platelet counts less than 50,000.   Due to slow improvement and stated goals of care, he and his son met with hospice on 7/11.  He elected to proceed with hospice services, and will be discharged on 7/11 with hospice care
This solicited report was received and was assigned manufacturer report number 13P-163-1063644-00 for HUMIRA. This was originally reported by a consumer and refers to a 61 year old male patient with hypertension. On 28-JAN-2013 the patient started using HUMIRA (injection, 40 mg) for ankylosing spondylitis. The patient's last HUMIRA injection was on 25-FEB-2013 and he was instructed to skip the 11-MAR-2013 injection due to shingles vaccine administration in the last week of February 2013. In the last week of February 2013 the patient was vaccinated with ZOSTAVAX (manufacturer unknown; reported as "shingles vaccine") and on an unknown date the PNEUMOVAX23 (manufacturer unknown; reported as "pneumonia vaccine"). Concomitant therapies included lisinopril (manufacturer unknown) for "blood pressure", VIAGRA for erectile dysfunction, oxycodone (manufacturer unknown)(30 mg every 4 hours as needed) for pain and PREVACID for acid reflux. On 11-MAR-2013 the patient experienced flu, fever and chills. The patient was advised to contact their physician. The patient will be discontinuing HUMIRA. On 12-MAR-2013 the patient experienced leg cramps, yellow nasal drainage, loss of appetite and body aches. The events were ongoing. Additional information has been requested.
Patient felt dizzy and black out for about 30 seconds. Patient was alert and talking in one minute.
ITCH AND HIVES SAME DAY OF VACCINATION. SWOLLEN FACE NEXT DAY.
Flu-like Symptoms; Fatigue; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On 13th July 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 14th July 2020, 1 days after receiving Shingrix, the patient experienced influenza-like symptoms and fatigue. On an unknown date, the outcome of the influenza-like symptoms and fatigue were recovering/resolving.   It was unknown if the reporter considered the influenza-like symptoms and fatigue to be related to Shingrix.  Additional details were provided as follows: After receiving Shingrix, the patient was fatigued and having flu-like symptoms The reporter did not consent to follow up.
This spontaneous report as received from a certified medical assistant refers to unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On 20-JUN-2016, 3 doses of improperly stored RECOMBIVAX HB lot# L048236 with expiration date: 31-MAR-2018 and 1 dose of improperly stored RECOMBIVAX HB lot# L044694 with expiration date: 04-FEB-2018 (dose and route of administration were not reported) were administered to the patients. Administered doses of RECOMBIVAX HB underwent temperature excursions at 49.5 Fahrenheit degrees for 1 hour. Data logger was not involved. Product quality complaint (PQC) was not involved. No adverse symptoms were reported. This is one of several reports received from the same source. Additional information has been requested.
Administered the first Moderna COVID-19 vaccine. No apparent concerns were found when reviewing the PQCF and talking with the patient prior to administering the vaccine. Patient verbally stated she'd never experienced a reaction immediately after receiving a vaccine and specifially referred to receiving flu shots annually. Vaccine was administered at 15:02, and the patient was seated in the designated "Post-vaccine waiting area" located directly in front of the pharmacy windows. At 15:04 patient began to feel nauseated with flacial flushing. CPhT was monitoring the patient. At 15:06, the patient began to exhibit s/s of syncope, including: facial flushing, profuse sweating, nausea, weakness, coldness of extremities, and visual disturbances. At 15:06, the patient's face/lips began to lose color while stating she was dizzy. Under her own power with aid, the patient was gently transferred from the chair to the floor and placed in the supine position with both feet propped up on the chair. She was given an ice pack and paper towels and remained on the floor for approximately 14 minutes. At 15:21, the patient stated she felt much better and wanted to try to sit up. After monitoring the patient for 34 minutes, she left the pharmacy area under her own power stating she felt much better and still plans on getting the second vaccine. Patient was counseled and questions were answered regarding this reaction.
Despite having received two doses of the Shingrix vaccine via two shots with the recommended time between injections, I have come down with two severe successive--almost overlapping--cases of very painful shingles. I have been suffering varying degrees of strong pain and discomfort from December 17 to the present date.