chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A report has been received from a pharmacist concerning a 3 year old, male subject who had been receiving FLUMIST Quadrivalent (intranasal). FLUMIST Quadrivalent started on 03-Sep-2014. The patient experienced sneezing which started on 03-Sep-2014. The outcome of the event of sneezing is unknown. The report was considered to be non-serious by reporter. Corrected report 21-Oct-2015: Key ingredient updated.
Within minutes bilat legs tingling (on and off for 3+ days), two to three hours after vaccine admin. bilat arms and crown of head tingling (on and off for approx 48hrs), three nights in a row when lying flat in bed sharp shooting pain on the top of bilat feet then pins and needles sensation with restlessness, morning after inj bilat neck lymph nodes swollen and sore throat both lasting for approx 4 to 5 days.
Swelling, hot to touch, welted and spreading.  Area 2x1 eventually reached 4" of redness.  Gave Benadryl and ibuprofen.  Neither seemed to do anything.  Also put on hot packs to area.
A non-serious spontaneous report of inadvertent administration of approximately 75% of H1N1 LAIV was received from a registered nurse concerning 138 children of unknown gender. No past medical history or concomitant medication was reported for these patient. On 18-Nov-2009, these patients received H1N1, Intranasal for an unknown indication. The nurse who was administering the vaccine, administered half of the dose to one nostril and then did not remove the clip before administering an additional 25% (approximately) of dose to the other nostril. There was no adverse event associated with this medication error; therefore, treatment and reported causality assessments are not applicable, and the event is considered resolved.
Tired, and arm red and itchy. Arm also warm to touch. Dr was contacted and pt was encouraged to see him and has an appointment with him this afternoon.
Patient describes a very sore arm. She cannot lift her arm above her shoulder. She is experiencing full body aches as well as heat and cold intolerance. Patient also experienced a migraine. She spoke with her primary care provider via telephone and was told that she can take tylenol for the aches and pains.
Experienced headache evening of IM injection; increased and next day 11/6 had fevers with H/A; 11/7 and 11/8 headaches so severe felt like " a knife was piercing my left eye". Increased pressure behind eyes. Pain and aching all joints especially base of neck.  Difficlt to move neck. 11/9/20 4pm RN urged him to go to Urgent Medical Care. He does not have PCP. Urged him to get tested for COVID19 also. He was seen by Urgent Care Quick test 11/9,  8;18pm COVID19  came back negative.  Tues 11/10 pressure behind eyes improved but feeling of improvement very intermittent then comes back worse than before. Temp 101.2, 11/10/20 highest. Returned to Urgent Care 11/12/20.  Emergency Room 11/14 for pain
SMALL RED PRICKLY RASH ON FACE;PATIENT WAS GIVEN SOLUMEDROL 20 MG IM
Patient called 4/2/2021 said she read an article online about "moderna arm" and she thought she had this.  Said she had painful, hot to touch, itchy spot about the "size of a medium cookie" and that it was swollen.  Had used ice and Benadryl gel, said she could not take oral Benadryl or Tylenol. Said it got worse about 3 days after the shot and had not improved. Patient wanted us to report this as a reaction
Other company reference number: WAES 1012USA03034. Initial information received from another company on 19 January 2011. The following information is verbatim from the other company's report: "Information has been received from a pharmacist concerning a 68 year old male patient who on approximately 06 December 2010 ("last week") was vaccinated with a a dose of flu vaccine (manufacturer unknown) in the right arm, and zoster vaccine live (Merck) in the left arm. On the same day the patient experienced radiating pain on the right side where the flu vaccine (manufacturer unknown) had been administered. Then it became pain all over the body. The patient called his pharmacist, explained the pain and stated that his extremities became blue. The pharmacist advised the patient to call 911. The 911 team provided the patient with oxygen and from then on he was feeling better. The patient decided not to go to the hospital. On the same day the patient recovered. Radiating pain on the right side/pain all over the body and extremities became blue were considered to be important medical events by the reporter. Follow-up information received from the pharmacist stated that the patient's concomitant medications were the following: MICARDIS and metoprolol for hypertension, simvastatin for cholesterol and vitamin D (unspecified). The patient also had implantable defibrillator. On 13 December 2010, the patient received zoster vaccine live (Merck) (lot number 665525/0695Z) and virus split virion 3v vaccine inactivated), lot # 43631AA). In the evening of 13 December 2010, the patient reported to the pharmacy that he had tingling and numbness. On 14 December 2010, the patient reported that he was nauseous and his hands turned "purple". Emergency services, (911) was notified and the patient was administered oxygen. The patient refused to go to the hospital. On 15 December 2010, the pharmacy contacted the patient by telephone. The patient stated that he felt better but felt 'run down'. This is one of several reports from the same source. Additional information has been requested." List of documents held by sender: none.
I just felt lousy with flu like symptoms. I was sneezing a lot and coughing a lot so I took a breathing treatment and laid down. After a while I started to itch all over the place. It was mostly on my back. The doctor gave me a prescription a topical medication called Triamcinolone Acetonide for the rash. I was very uncomfortable. Last week was the first day I did not have the itching. I had to take an albuterol treatments regularly. I started having issues with my asthma so my pulmonologist told me to test for COVID-19 and it was positive. I was not able to take the antivirals due to it conflicting with medication I took the previous day.
Dizzy and passed out. Amonia applied,feet up  and head supported. Ambulance called and patient transported in stretcher. Five mins later patient awake and stable . Patient discharge home with significant other.
12 hours following #3 rabies IM, developed swelling of throat, red blotches on face, swelling, redness, tenderness of left deltoid (injection site). Treated with ice and oral Benadryl. Symptoms resolved within 24 hours. Client had no problems with dose 1 and 2.
Information has been received from a physician concerning a 25 month old male who on 4/22/2004 was vaccinated with a dose of varicella virus vaccine live (lot 647521/1108N). On 5/31/2005 the patient had one or two pox marks break out on his face. No additional information was provided. The patients brother WAES0506USA02819 had a varicella rash after vaccination with varicella virus vaccine live.
About 30 minutes after receiving the 2nd dose my left elbow  hurt terribly (joint pain). After about another 30 minutes the external skin on my left elbow hurt as of it were scraped open. Evening of 2nd vaccine I became very exhausted. By the next morning  my left arm's injection  she hurt, I was exhausted, my body hurt, I was sick on my stomach, and I had a general sense of feeling "off". The symptoms worsened and I had to stay in bed for approximately 38 hours. On 4/11/2021 I began to improve but still remained nauseous and exhausted and my left arm still hurt tremendously. On 4/12/2021 my symptoms continued to improve, although the nausea, extreme fatigue, and arm pain persisted. By the evening of 4/13/2021 I began to worsen. By the morning of 4/15/2021 I felt horrible. My fatigue had gotten worse, my body was aching (joints/muscle/nerves), my elbow had started to hurt again, I had multiple migraines, and I began to experience brain fog for the first time. I was very nauseous and had ab overall feeling of "just feeling not right and feeling awful in a way that was hard to explain." My injection site began hurting again. This all frightened me and I made an appointment with my GP. Today is 4/23/2021 and I still have the following symptoms: injection site hurts badly (I cannot sleep on that side), nausea (inconsistent, it goes away then returns with intensity), joint/body pain if I exert myself (I exercise regularly and have no longer been able to do that since receiving the vaccine), elbow pain, and brain fog (for me it feels like I am spaced out and I cannot recall words).   A concern that I have is my mother has severe Sarcoidosis. I do not have it but I feel it is important for researchers to consider family and patient history.
Pt recv vax on 3/30/99; on 4/1/99 pt exp red/shiny  patch on left upper arm w/ edges bruised, skin peeled off
Myalgia Arm pain, fatigue Narrative:  Still experiencing unusual fatigue since 2nd dose.  Other Relevant History:
Patient fully vaccinated and is symptomatic. Tested positive for COVID as of 8/17/2021.
She stated she received a COVID vaccination on 4/55/2021. States nursing giving the vaccination hit her bone and since that time has had pain in left arm. Not able to lift arm above her head and difficulty with completing ADL's. Has seen primary care provider at a local healthcare facility. Completed two weeks of physical therapy. Had an Xray recently and MRI. MRI showed tear in rotator cuff and another injury. Has consult with orthopedic surgeon. Described emotional distress in feeling as though people do not believe her and also worried about being prescribed pain medication and fear of becoming addicted. Per immunization history, patient had COVID-19 vaccine (Pfizer) on 4/1/21 and 4/22/21 (left deltoid). Additional vaccines that the patient has received since that time include: Shingrix - 6/17/21 (site not documented), 9/14/21 (right deltoid).  Multiple clinic encounters between April and September for psychiatric care/counseling. First mention of shoulder pain/injury is 9/13/21 where patient reached out to the clinic indicating that since getting her second COVID vaccine she has been unable to lift her arm over head, has neck pain and intermittent hand numbness.  Office visit on 9/23 for deltoid arm pain. Noted to have tenderness over the deltoid region, in the left supracapsular region and some weakness to resistance. Treated with naproxen and Medrol dose pack. Also referred for occupational therapy. Social work notes from September also start to refer to patient's arm pain. MRI completed on 10/29: low grade partial thickness tearing of the supraspinatus tendon, bursal fraying, mild tendinopathy, degeneration and probably tearing of the superior glenoid labrum at the biceps anchor, mild bursitis. MRI findings of mild bursitis, low grade partial thickness tearing of the supraspinatus tendon (rotator cuff tear), bursal fraying, mild tendinopathy, and degeneration and probably tearing of the superior glenoid labrum at the biceps anchor. Patient has been treated with NSAIDs, steroids and referred to occupational therapy and orthropedic surgery consult. (Possible SIRVA secondary IM injection site technique).  In speaking with the patient on 11/26/21 she continues to report significant pain in her shoulder. She did reference that her shoulder still feels like she received the vaccination yesterday. She will see ortho on 12/9/2021.
Mom states that after 1st series of shots, child was very fussy for several days following. Mom states child also had some extended time of crying, but she was able to console child. child was not her normal self. This series,child cried for 5-6 hours. Taken to doctor at 6pm at that time child was fine. Pt recovered fully.
tiny red spot at the injection site; It's still a little sore; little tender; arm started with a little itching; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (little tender), INJECTION SITE PRURITUS (arm started with a little itching), VACCINATION SITE ERYTHEMA (tiny red spot at the injection site) and VACCINATION SITE PAIN (It's still a little sore) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 31L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included VITAMIN D [VITAMIN D NOS], FISH OIL and MANITOL for an unknown indication.  On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-2021, the patient experienced TENDERNESS (little tender), INJECTION SITE PRURITUS (arm started with a little itching) and VACCINATION SITE PAIN (It's still a little sore).   On 22-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (tiny red spot at the injection site). At the time of the report, TENDERNESS (little tender), INJECTION SITE PRURITUS (arm started with a little itching), VACCINATION SITE ERYTHEMA (tiny red spot at the injection site) and VACCINATION SITE PAIN (It's still a little sore) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information was provided.
Extreme shoulder pain, swelling, limited motion still 7 days after vaccine. Been back to my Dr twice in the week, Having ultrasound March 17th.
pt recv vax 530PM 23JUN97;24JUN97 9PM devel localized pain & induration w/ fever 101.8, chills, & myalgia;sx resolved morning 25JUN97 & reoccurred evening of 25JUN97;resolved morning of 26JUN97;tx w/APAP & advil;
PT HAS A PHOBIA OF NEEDLES SHE WAS LAYED DOWN FOR VACCINE BUT SHE HAS SEIZURE DISORDER, SHE TOOK KEPPRA BEFORE SHOT AND DID NOT EAT. HER CC IS DIZZINESS. NO MED HX EXCEPT SEIZURES AND NO OTHER MEDS EXCEPT KEPPRA. CODE GREEN CALLED ALL VSS 109/74 O2 100% HR 89. MONITORED X30 MIN, WHEELCHAIRED TO CAR, REFUSED HOSPITAL.
HEADACHE; UNWELL WITH CHILLS; SHAKING/TREMORS OF HANDS/ARMS; OVERALL ACHES; FELT UNWELL; NIGHT SWEATS (FEVER); TROUBLE SLEEPING AT NIGHT DUE TO THESE SYMPTOMS; FEVER; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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: 1805029 expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 16:30 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, treatment medications included: paracetamol. On 12-MAR-2021, the subject experienced trouble sleeping at night due to these symptoms. On 12-MAR-2021, the subject experienced night sweats (fever). On 12-MAR-2021, the subject experienced fever. On 12-MAR-2021 22:30, the subject experienced shaking/tremors of hands/arms. On 12-MAR-2021 22:30, the subject experienced overall aches. On 12-MAR-2021 22:30, the subject experienced felt unwell. On 12-MAR-2021 22:30, the subject experienced unwell with chills. On 14-MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shaking/tremors of hands/arms, trouble sleeping at night due to these symptoms, overall aches, felt unwell, night sweats (fever), unwell with chills, fever, and headache. This report was non-serious.
Patient describes throat and tongue swelling, tingling in hands, chest tightness and seeing spots  w/ in 5 minutes of vaccine with continuing severity,
Exhaustion, dizziness, nauseous, pain in legs and chest, sore throat, loss of appetite
5 min after - Hot, chest and neck started to break out in diffuse rash. To ER lightheaded, nausea, tachy (HR 130) - emesis - hives.
Nose was bleeding like a faucet/large amount of blood (estimates about 1/4 cup); Blood pressure was 175/85; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of EPISTAXIS (Nose was bleeding like a faucet/large amount of blood (estimates about 1/4 cup)) and BLOOD PRESSURE INCREASED (Blood pressure was 175/85) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A21A and 036A21A) for COVID-19 vaccination.   No medical history was provided by the reporter.  Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR) and VITAMINS NOS for an unknown indication.  On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-May-2021, the patient experienced EPISTAXIS (Nose was bleeding like a faucet/large amount of blood (estimates about 1/4 cup)) (seriousness criterion medically significant) and BLOOD PRESSURE INCREASED (Blood pressure was 175/85) (seriousness criterion medically significant). At the time of the report, EPISTAXIS (Nose was bleeding like a faucet/large amount of blood (estimates about 1/4 cup)) and BLOOD PRESSURE INCREASED (Blood pressure was 175/85) outcome was unknown.  DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-May-2021, Blood pressure measurement: 175/85 (High) 175/85. On an unknown date, Blood pressure measurement: 144/70 (Inconclusive) 144/70.  The reporter had she noticed a large amount of blood (estimates about 1/4 cup) around her computer tray and that her nose was bleeding like a faucet. Her husband took her to the ER, where her blood pressure was 175/85. Caller does not normally have high blood pressure, and is not on blood pressure medication. When she left the ER, her blood pressure was 144/70 and they clamped her nose and gave her some oxymetazoline nose spray for any break-through bleeding. Her husband maintains that the nose bleed was caused by the vaccine.  Treatment procedure in the Emergency Room (ER) included nose clamped and medication included oxymetazoline.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.   Company Comment: 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.; 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.
Daughter called stating her mother's arm where the vaccine was given was red, swollen and warm to the touch. She also stated that it looked like a rash but there was a lump present in the area as well. Advised pt to seek care from primary care physician/ urgent care facility but unknown if this happened after our initial phone call.
On 2/5/2021, he awoke with complaints of body aches/pains from head to toe that he rates as a 9 on a scale of 0-10, 10 being the worst. He also had a headache that he rates as a 4 on a scale of 0-10.  He did not want to eat, he slept due to fatigue during the day and night  on 2/5, 2/6 NS 2/7.  He developed diarrhea on the pm of 2/6 which lasted through the night of 2/7/2021. He pushed fluids and has remained hydrated. He was not aware of fever or chills. He did not go to work today 2/8/21 because he is still feeling fatigued, achey, and with a headache, but admits that he is feeling somewhat better.
Raised blister at injection site 3-4 mm x 7-8 mm.
I woke up with a moderate headache at 7am. My entire body began to ache by 10am. Full body chills began at noon. I was lethargic with full body aches, headache and chills for the remainder of the day. I checked my temperature throughout the day, but I never had a fever. My symptoms prevented me from working that day, but I did not take pain medication and I was able to eat meals normally. At some point during the night, I woke up in a sweat. The following morning, Feb 12th, the symptoms were gone. The injection site was sore for a few days more.
This case was reported by a pharmacist and described the occurrence of rash in a 51-year-old female subject who was vaccinated with HAVRIX (GlaxoSmithKline). Concurrent vaccination included Salmonella typhi Vi capsular polysaccharide vaccine; manufacturer unspecified; unknown given on 20 October 2012. Concurrent medical history included sulfa allergy. On 20 October 2012 the subject received 1st dose of HAVRIX (1 ml, unknown details). On 25 October 2012, 5 days after vaccination with HAVRIX, the subject experienced rash and itching. At the time of reporting the events were unresolved.
72 y/o female presents complaining of right arm pain. Received the Prevnar 13 vaccine this morning at 0900 during her yearly physical, tolerated it at that time. About 2 hours after the injection she began having soreness in the right shoulder at the injection site. Pain increased over the next couple of hours to the point that any movement of the shoulder causes severe shooting pains down the arm, she is now unable to forward flex her shoulder due to pain. No difficulties with elbow, wrist, and hand ROM. No numbness or tingling. Received the Pneumovax 23 valent vaccine in 2012 without difficulty and no prior adverse reactions to vaccines.
Information has been received from a pharmacist concerning a 70 year old female who on 08-OCT-2005 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine  (lot 650456/0974P).  On 08-OCT-2005, the patient developed large raised welts at the site of injection.  It was noted that hydrocortisone cream was ordered to reduce the welt in this patient.  At the time of this report, the patient's outcome was unknown.  No further information is available.
Client admitted to the hospital on 4/26/2021 with Covid symptoms, body aches, SOB and chest pain. Diagnosed with Covid -19 pneumonia. Antigen test positive for Covid-19 on 4/26/2021.  Subsequent admission on 5/4/2021 with cardiac arrest secondary to hypovolemic shock from UGI bleed, likely variceal. Client died 5/5/2021.
Patient fully recovered from natural SARS-COV-2 infection in early December 2020.  Patient was doing quite well between mid December and mid January.  Patient was hospitalized with congestive heart failure in late January 2021.  Received first dose of Moderna COVID19 vaccine shortly before being discharged around February 1 (not sure of exact date).  Patient was feeling well at that time.    Patient became quite ill within 24 hours of Moderna COVID19 vaccine. Patient steadily worsened during February 2021.  Was hospitalized in mid February (unsure of date) and diagnosed with kidney failure and liver disease.  Congestive heart failure rapidly worsened and previously stable leukemia flared up.  Patient was discharged from hospital February 19 and was placed in quarantine at Care Center.  Patient was considered terminal and was to go into hospice care.  Patient was administered second COVID19 vaccine on February 25, rapidly deteriorated, and died on March 1.
This report describes joint pain in a 40 year old female who received Lyme disease vaccine recombinant OspA. This report was received  from the vaccinee and her friend  and has not been verified by a physician or other health care profesional.  The subject's medical history and concurrent conditions were not specified. Concurrent medications included unspecified thyroid medication, daily multivitamin, vitamin b and vitamin E.. Reportedly, in 2000, the vaccinee received three subcutaneous injections of Lymerix. The patient reported that in May 2002, she experienced "joint pain starting in (her) neck", a "bent" right thumb, and swollen wrist. Additionally, it was reported that she experienced a low-grade fever and boils. The subject sought medical attention. As of 08/13/02, joint pain, "bent " thumb, and swollen wrist were reported as "unresolved". The low grade fever and boiler were reported as "worse". The adverse events "joint pain" and swollen wrist" do not meet serious criteria, but are being submitted as an expedited report by special FDA request the 06/28/00 letter.