chrisvoncsefalvay/vaers-outcomes huggingface dataset:
had another report of "feeling high" after vaccination from a "20-something year old man".; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A male patient in his 20's received bnt162b2 (BNT162B2) (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: EUPHORIC MOOD (non-serious), outcome "unknown", described as "had another report of "feeling high" after vaccination from a "20-something year old man". The action taken for bnt162b2 was unknown.  Additional Information: Additional information: She mentioned this to her vaccination site when she returned, and they said they'd had another report of "feeling high" after vaccination from a "20-something year old man". Reporter stated she mentioned her experiencing of feeling high after receiving the COVID 19 vaccine to the nurse at the facility of where she got the vaccine, and she was told another guy in his 20s reported the same thing to them. Reporter seriousness for feeling high was unspecified. Report 2 of 2.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient called on 4/8/21 and reports that after her first COVID vaccine on Monday, she developed a "needle-like" rash on her arms and chest after receiving the vaccine. By today (Thursday), the rash has spread. Patient called her PCP and was told that it may be ITP (immune thrombocytopenia). Patient does state that she has been diagnosed with low platelets before. PCP told her to self-monitor. Pharmacist encouraged patient to reach back out to her PCP to update them on symptoms and ask for additional clinical guidance. Patient instructed on when to seek emergency services. Patient states she will call PCP and update us with any clinical changes.
Pt recvd Hep B vax series & it was determined that pt did not respond to vax series; reporter inidcated that the booster doses were given elsewhere;
Got the shot, got shingles/ Suspected vaccination failure; Shingles; This case was reported by a consumer via  interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient self reported the case. The age at vaccination was not reported. The patient received shingle shot and still got shingles. The follow up would not be possible as no contact details were available. This case was considered to be a suspected vaccination failure case, as the details regarding completion of primary vaccination schedule and time to onset and laboratory confirmation for shingles were unknown.
Intermittant chest pain, occasionally sharp, mostly dull.  Odd and persistent pressure sensation below sternum and occasionally in left and right chest.  Soreness of muscle and connective tissues between pectoral and sternum.  Symptoms were daily and consistent for about three weeks then began to decrease.    Went to urgent care on 9/20 and received a normal EKG reading and direction to go to ER.  Went to ER morning of 9/22 after worsening of symptoms over the previous 12 hours.  Received EKG, and chest x-rays (normal).  Checked for heart inflammation and blood clotting (negative).  Told to see my GP.  Went to GP on 10/1.  Currently six weeks past the date of the shot, and symptoms have mostly stopped, except for occasional minor pressure.
Bell's palsy on left, happened around 1/15/,22, sought care 1/22/22, started on steroids
PT told me he was experiencing ringing in both ears consistently all day today.  He had not experienced this ringing prior to today.
It felt similar to the beginning of an anaphylactic reaction I had a few years ago to a random food (never found out what the allergen was). About 20 minutes after receiving the vaccine, my throat felt strange, my sinuses started getting congested, my ears started plugging.  I felt dizzy when walking.  I spent extra time at the clinic under observation.  About 40 minutes after receiving the vaccine, I suddenly felt like I was being sucked into a vacuum and thought I was going to pass out.  I alerted the nurses, who checked my vital signs and put me on O2.  My heart rate was normal, my BP was high, my O2 sat was 100%.  After about 5 minutes I started to feel normal, they removed the O2.  They continued to observe me for another 15 minutes, until I felt better.  As I drove home (about 1 hour 10 min after receiving the vaccine), my face and lips became numb.  I continued driving home and the numbness resolved in about 10-15 minutes.  I notified my doctor of the event and she advised me not to get the second dose and to report the event.
Pt recvd Hep-B & a few hrs later became "jittery", arms & hands began to tingle resulting in numbness; Also numbness in upper & lower extremities; became stiff resulting in paralysis of short duration;
Muscle aches and joint pain all over body. Achy legs and lower back. Headache. Nausea, started around dinner time same day of flu shot. Woke up this morning with same symptoms to include weakness, uncomfortable feeling, extreme lower back pain, joint pain in hands and wrists. I did not feel like this prior to the vaccine. Still ongoing because it has not even been 24 hours. Not positive if Influenza type is correct***
This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 11-OCT-2012 11:34, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
2/3/04: Weakness in legs, difficulty walking Approximately 2/11/04 had fever, mild HA, difficulty speaking. 2/18/04 hospitalized for aphasia, difficulty walking, weakness, poor balance. Currently still hospitalized.Labs will be sent to CDC. From CDC: 2 samples were sent for testing: 1 is serum, 1 is CSF. 2/19/04 is serum: PCR is negative for YF RNA. IgM Elisa to YF P/N 3.0 SLE and West Nile Virus IgM negative. Igg Elisa is negative for YF, SLE, West Nile Virus, LAC and EEE. CSF collected 2/21/04. PCR negative for YF 17D RNA. IgM Elisa results consistent with an aseptic meningitis.  60 day follow up:Pt had a diagnosis of aseptic meningitis and encephalitis. It appears that the pt was sent to a rehab facility after discharge from the hospital on 12Mar04.
Cried forcefully immediately after receiving vaccines for approx. 5 minutes then suddenly stopped crying and fell asleep. The pt simultaneously broke out into an urticarial rash of the head, face and torso. The immediate Temp was 99.1 rectal. Immediate PE and subsequent PE's were normal. Pt was observed for approx. 2 hours in the office while he feed and rested easily.
Syncope: laid pt down, elevatated feet, cold pack, water. Approx 45 min later patient left pharmacy refusing any more care.
Information has been received from a medical assistant via a company representative concerning to a 12 year old male patient with prophylaxis. No medical history nor drug allergies were reported. In April 2017 (reported as "a couple of months ago"), the patient was vaccinated with dose 1 of GARDASIL 9 (Lot No. M040412, exp. date not reported) for prophylaxis. Concomitant medications included TDAP and MENVEO which were received on the same visit. After receiving the GARDASIL 9 the patient fainted, eyes rolled back and the patient experienced "jerky motions". The patient was laid down with his feet elevated and "vitals were checked". After resting the patient felt fine; however, the patient then experienced "Throwing up". The patient was kept longer, for a total length of office visit being of two hours and on leaving the office, the patient felt fine and left the office with no other events. The patient was prescribed with ZOFRAN. The patient did not die. The relationship between the aforementioned adverse events and therapy with GARDASIL 9 was not reported. Additional information is not expected as no consent to follow up was obtained.
pt c/o fatigue and general decline in energy; pt c/o fatigue and general decline in energy; This is a spontaneous report from a contactable healthcare professional. A 88-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 04Feb2021 (at the age of 88-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism (reported as hypothyroid), hypertension (reported as htn), high cholesterol (reported as high chol), Gastro-oesophageal reflux disease (gerd) and osteoporosis. It was not reported if the patient received any medication within two weeks of vaccination. The patient previously took cefalexin (KEFLEX) for unknown indication on unknown date and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient complained of fatigue and general decline in energy on an an unknown date in Mar2021. The events resulted in doctor or other healthcare professional office/clinic visit. No therapeutic measures were taken as a result of the events. The clinical outcome of the events fatigue and general decline in energy was not resolved at the time of this report.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Onset symptoms 1/25. Increase SOB. CP. Pain in middle of back. Dry cough. + covid test 1/28; Pneumonia due to COVID-19 virus; follow inflammatory markers CRP better ferritin all improving; completed remdesivir, Decadron and empiric antibiotics, discharged on doxycycline and Decadron for 3 more days per Infectious Disease recommendations; Elevated  D Dimer possibly error because only elevated for 1 day and normal after; CT angio chest and venous Dopplers negative for pulmonary embolism or venous thromboembolism; Remained on room air during stay
Mild aches; Fever; This is a spontaneous report from a contactable consumer (patient).  A 44-years-old non pregnant female patient received first dose of bnt162b2 (BNT162B2; Batch/Lot Number: EW0198) on 30Jul2021 at 16:30 PM intramuscularly in left arm, as DOSE 1, SINGLE for covid-19 immunisation (age at vaccination: 44-years-old). Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. On 30Jul2021 the patient experienced Mild aches and fever. Patient treatment in response to the events included: Advil. No hospitalization reported. The outcome of the events was resolving.   This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Approximately 2 months after booster I started finding cysts in the breast on the side the vaccine was given.  I?ve never had cysts in my breast(s) before.  I did have the swelling and soreness in the axilla right after injection.
Body and severe muscle aches  back and should pain, constant chills, headaches, nausea, dry cough, stuffy nose.
Redness and swelling and a hard lump at site of injection.  Redness continues to spread- as of 02/24/2016 at 10:20 AM the red area is about 3.5 inches" around in the shape of a circle.  Baby is also fussier than normal.
Moderna COVID-19 Vaccine EUA fever (99.9-101), chills, joint pain, body aches, fatigue, malaise, nausea, frequent urination - lasted about 14 hours; day 2 was just fatigue and some body aches later in day; day 3 no issues
flashes; fever; This spontaneous case was reported by a patient and describes the occurrence of PHOTOPSIA (flashes) and PYREXIA (fever) in a 73-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 29-Sep-2023, the patient experienced PHOTOPSIA (flashes) and PYREXIA (fever). At the time of the report, PHOTOPSIA (flashes) and PYREXIA (fever) had not resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported. Patient had fever and flashes in eyes. Treatment medication was not reported.
Patient is fully vaccinated.  COVID + 12/14/2021.  Hospitalized from 12/14-12/17.  79-year-old  white female presents with a 4-day history of nausea, vomiting, and loose  stools.  She reports that she admits to a low-grade fever off and on over the  past few days.  She also has developed a painful rash involving her left  buttock and left posterior thigh.  She was seen in Urgent Care Clinic earlier  today.  She was found with altered renal function.  She was found with altered renal function.Labs reveal  hypokalemia with potassium of 3.3.  Her BUN measured 23 with a creatinine of 2.14.She also has a  rash involving the left buttock and left posterior thigh consistent with acute  outbreak of herpes zoster. Admitting dx:  COVID -19 infection, herpes zoster, acute renal facilure, hypertensive cardiovascular disease, COPD, prior stroke with good recovery.  She will receive IV fluids for hydration.  Zofran has been  ordered to control her nausea and vomiting.  Because of her altered renal function, her Zestril and Lasix will be held.  Zovirax has been ordered because of her o utbreak of herpes zoster.  Her renal function will be closely  monitored. Discharged
BP 126/78;  HR 60:  O2 97% Patient was talking right before administration, but suddenly stopped talking and lowered head upon receiving the vaccine.  Color change noted.   Patient said he felt warm and light-headed. Patient improved quickly, and used his own personal inhaler (drug unknown).  He was observed for over 45 minutes before leaving facility.
patient developed myalgias 4 weeks after vaccine, and then dropped head (weaknes off cervical muscles), was extensively worked up including a muscle biopsy.  she recovered spontaneously after 8 weeks These happened again 4 weeks after the 4th dose given 4/11/2022. resolved after 8 weeks of physical therapy.
Initial unsolicited report received from a Non-healthcare professional on 31 March 2016. This case involves a female patient (age was not reported) who was vaccinated with a intramuscular dose of INFLUENZA QUADRIVAL A-B VACCINE (Fluzone QIV) (batch number U5036AA, expiration date 30 June 2015, dose and site of administration was not reported) in 2014 (unspecified date). Illness at time of vaccination and Pre-existing physician diagnosed allergies, birth defects, medical condition was not reported. Concomitant medications were not reported. On an unspecified date in 2014, following the vaccination, the patient had a severe reaction and had to go the emergency department. It was reported that at the emergency department patient was diagnosed with transient ischemic attack. It was reported that patient did not have specific symptoms. Patient required emergency room or doctor visit. Lab data and corrective treatment was not reported. On an unspecified date, patient was recovered from event. Upon medical review, the case was considered as serious due to important medical event: transient ischemic attack. List of documents held by sender: none. Sender's Comments: This case is poorly documented and non-medically confirmed. No symptoms were reported. Time to onset is not reported. Further information on patient's medical history, details of symptoms, time to onset, lab data confirming the diagnosis, etc. will be required for complete assessment. Based on the information available, a role of the vaccine cannot be assessed.
Flu and pneumonia vaccine give in same syringe. Currently in process of re-vaccinating per CDC.
Case number PHEH2014US025008 is an initial spontaneous report received from a nurse on 09 Dec 2014. This report refers to a 9 years old female patient. Past medical history and concomitant medications were not reported. The temperature excursion of FLUVIRIN (batch number: 145701) began around 16 Oct 2014 and the patient received the vaccine intramuscularly at a dose of 0.5 ml on 30 Oct 2014. It was reported that the vaccine administered was at 49 F 12 times over a period of 34 days. There were 12 separate temperature excursions lasting 30 minutes each in which the temperature was 46 to 49 F during each of those excursions. No adverse events were reported following the maladministration.
arm pain; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16th May 2020, the patient received the 1st dose of Shingrix. On 16th May 2020, less than a day after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and experienced arm pain. The reporter did not consent to follow up.
3/20/21 06:22 pm Resident c/o Nausea and feeling full- Tube feeding placed on Hold- Resident started vomiting- Zofran 4 mg  given- Positive outcomes. 03/21/2021- 0430 Resident found unresponsive on morning rounds- w/ weak pulse, shallow breathing. O2 via NC increased to 5 L, NP, Family  ( Code Status DNR)- Power of attorney ordered to send out- MR notified- Upon arrival no rhythm detected- Death pronounced at 0445
Opened vial for ipol-is to be stored at 2 Celsius-8 Celsius.  Temperature Excursion for this opened vial at 46.9F converted to Celsius is 8.28 Celsius for 30 minutes while door was opened to store vaccines in the fridge unit.  After the temperature excursion the ipol was administered to the patient.
Woke at 3am approximately 15 hours after receiving the vaccine with severe abdominal pain. I was unable to move freely for about 5 hours. The pain was in my epigastric area with a concentration in the Left upper quadrant. The pain continued for about 12 hours. It was accompanied by fever of 101 and fatigue. I was unable to eat for about 24 hours. I continued to have pain for about 3 days but it was to a much lesser degree.
this is 1 of 5 hosp employees, out of 280 vaccines, who devel an inj site rxn 24 to 48hr p/vax;
Fever 37.9 - 38.2 day after receiving vaccine. On rocephine previously for pneumonia.
Patient irritable/decreased appetite persisting >1 week after vaccination. Also with 2 hard indurated areas at vaccination site.
Felt suddenly hot,erythematous macular rash of chest with red ears and face, red eyes, spots in vision, chest pain, SOB, facial swelling, poor balance (nursing staff had to grab her to keep her from falling) within 2 minutes of pneumococcal 23 valent vaccine (Lot S017430, exp 2021 May18). Had pneumococcal 23 valent vaccine in 2010. Had diabetes so will need to be re-vaccinated in the future. Improving without any medication (she declined Benadryl due to wanting to be able to drive herself home). Pulse ox was 99%, bp 135/85, pulse 101. Improved greatly over 10 minutes.
Fever started 4 hrs after vaccine administration and pain followed 30 min. later at 7pm. Mother took pt to ER at 8:30pm with arm and neck pain. Back pain started while in ER. ER gave Ibuprofen. Left ER with only mild arm pain at injection site. Next morning only mild arm pain persisted.
Large somewhat circular raised red welt with extreme itching appeared on 3/25/21, around 8 days after the vaccine was given. Size is about 3 inches in diameter
Arm incredibly sore, extreme soreness, strong pain; Felt achy all over and extreme arm Soreness/still hurts when lifted; Couldn't lift arm, still hurts when lifted; Nauseated; Sleepy; This case was reported by a nurse and described the occurrence of pain in arm in a 51-year-old female patient who received Herpes zoster (Shingrix) (batch number 72P9H, expiry date 9th April 2023) for prophylaxis.   Concurrent medical conditions included fatty liver, blood pressure high, obesity and asthma.   On 23rd December 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 23rd December 2021, 2 hrs after receiving Shingrix, the patient experienced pain in arm, mobility decreased, nausea, sleepiness and general body pain. On an unknown date, the outcome of the pain in arm was not recovered/not resolved and the outcome of the mobility decreased, nausea, sleepiness and general body pain were recovered/resolved.   It was unknown if the reporter considered the pain in arm, mobility decreased, nausea, sleepiness and general body pain to be related to Shingrix.  Additional details were reported as follows: The patient received a dose of Shingrix and 2 hours later experienced extreme pain and soreness in arm and was unable to lift the arm at shoulder level. The extreme soreness lasted for 2 days. The first 24 hours of shot the patient experienced nauseated, sleepy and achy all over. The arm pain was not recovered until 6 weeks later after vaccine shot and still hurted while lifting arm. Consent to follow up was granted.
The usual side effects include swelling and pain at the injection site. I experience muscular pain that was not relieved with the traditional analgesics, i.e. Tylenol ES or Aleve. I am now experiencing a tremendous amount of tingling in my left arm and had along with intermittent periods of pain.
Lethargic, staring spell, abnormal eye movements, floppiness, transient.
A scabbed area with pus; not red; about the size of a 50 cent piece
My arm went  stiff 1 minute after injection. After 3 minutes my mouth and throat began to burn and create a feeling of very intense heat. As it went to my chest, I?m 5-6 minutes in I began to get hives all over my body. I then was sent to urgent care which was in the same building, given benydral and steroid shot on my butt. Then was call an ambulance by the physician to go to the ER right away. I now am having constant muscle aches, a headache and chest pain.