chrisvoncsefalvay/vaers-outcomes huggingface dataset:
vaccine administered to 16 year old; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (vaccine administered to 16 year old) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (vaccine administered to 16 year old). On 21-Apr-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (vaccine administered to 16 year old) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided. Action taken with mRNA-1273 in response to the event was not applicable.; Sender's Comments: This report refers to a case of Product administered to patient of inappropriate age for mRNA-1273, lot # 045B21A,  with no associated AEs.
Pt fell at 1458 and hit the head. Pt looked sweaty. The paramedic advised to F/U with PCP. Pt agreed to be taken to the hospital for further evaluation. Pt left the center with the paramedics at 1522. Past history of syncope and family cardiac history (specially when flying).
Fever to 103.5 deg F, somnolence, dehydration. A recent recipient of smallpox vaccine was admitted to medical center on 3/3/03 with an admitting diagnosis of possible post-vaccinial encephalitis. He was given primary vaccinations with both smallpox vaccine and anthrax vaccine on 2/21/03. On 2/24 while playing basketball he fell, striking head and back without loss of consciousness. Evaluation ER found no problems other than lumbar contusions. By 2/28 he had developed fever to 101 deg F, myalgias, malaise, arthralgias, headache, and sore throat. By 3/3 he had developed fever to 103 deg F and had become somnolent. Although ostensibly oriented when aroused he felt confused and weak. He denied nausea, vomiting, or stiff neck. He was admitted through the emergency dept. Physical exam was grossly normal, without focal neurologic findings, meningismus, or significant mental status deficits other than somnolence. Hospital course: the pt received conservative medical therapy including antipyretics and rehydration. He defervessed and within less than a day had  had essentially a clear neurlogic/mental status, including normal alertness and cognitive functions. His bacterial CSF culture had a final result of no growth. Within a day of admission he was discharged to home.
Left deltoid was sore initially, then pain progressed upward into left neck up to just under left ear; Left deltoid was sore initially, then pain progressed upward into left neck up to just under left ear; Also felt a little stiffness in that neck area; This is a spontaneous report from a contactable nurse, the patient.  A 62-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number EH9899) via an unspecified route of administration, in the left arm, on 19Dec2020 at 07:00 AM (at the age of 62-year-old) as a single dose for COVID-19 immunization. Medical history was none. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19.  Concomitant medication taken within two weeks of vaccination included fish oil (OMEGA 3 FISH OIL), calcium carbonate, colecalciferol (VITAMIN D 2000). The patient did not receive any other vaccines within four weeks prior to the vaccination. On 20Dec2020, at 08:00 AM, the patient experienced left deltoid was sore initially, then pain progressed upward into left neck up to just under left ear, she also felt a little stiffness in that neck area. The neck pain lasted 24 hours. The events were reported as non-serious. The patient did not receive any treatment for left deltoid was sore initially, then pain progressed upward into left neck up to just under left ear, she also felt a little stiffness in that neck area. The clinical outcome of the events left deltoid was sore initially, then pain progressed upward into left neck up to just under left ear, she also felt a little stiffness in that neck area was recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
fever; couldn't move my arms or legs; Pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 43 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for Covid-19 Immunization, reaction(s): "My body goes crazy", "I was very sick". The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "fever"; HYPOKINESIA (non-serious), outcome "unknown", described as "couldn't move my arms or legs"; PAIN (non-serious), outcome "recovered", described as "Pain". Therapeutic measures were taken as a result of pain.  Additional information: It was reported that patient received Cosentyx prescription the pain was gone. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
All symptoms occurred at the 12-24hr mark: metallic taste, chest tightness, limb (needle like) itching, cold sweats, body ache/pain, chills, nausea. All symptoms resided except for malaise after the 24hr mark. Malaise current through today(11JAN21)
First dose of Covid Vaccine 3/14 had reaction chills and temp; Temperature; Sharp pains in head stll have sliight headache.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 14Mar2021 (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: CHILLS (non-serious), outcome "recovered", described as "First dose of Covid Vaccine 3/14 had reaction chills and temp"; BODY TEMPERATURE (non-serious), outcome "recovered", described as "Temperature"; HEADACHE (non-serious), outcome "unknown", described as "Sharp pains in head stll have sliight headache.".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Intractable hiccups for 11 hrs  Fever of 100.8 Body aches Pain at injection site
A nurse reported that a female pt "in her fifties" received an injection of flu shield on 11/15/2001 and an injection of pnuimune23 on 11/16/2001. Approx. 10 hours following pnuimune23 administration, the pt went to a local emergency with a fever of 106 deg F.; however, the pt was not hospitalized. No further info was available at the date of this report.
Excessive irritability, fever. Follow up:  Irritability, subsided after 5 days.  No site reaction.  Tylenol.
arm pain; Nausea; Dry heaves; Fatigue; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 01, Single), for COVID-19 Immunization, reaction(s): "arm pain".The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "arm pain"; NAUSEA (non-serious), outcome "recovered", described as "Nausea"; RETCHING (non-serious), outcome "recovered", described as "Dry heaves"; FATIGUE (non-serious), outcome "recovered", described as "Fatigue".  Additional information: The patient had arm pain following second injections for 24-48 hours. Patient also experienced nausea, dry heaves and fatigue for 24 hours after second dose. Optional Information: No significant underlying medical conditions.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER_INC-202101408013 Same reporter, patient and drug / different dose and events
Mild heat flashses without fever began 28 hrs after injection.  Redness below injection site noticed 38 hrs after injection. Moderate Ear pressure, not able to clear by self, started 42 hrs after injection. Pressure cleared  7 hours later while eating. TINNITUS IN LEFT EAR WAS NOTICED UPON PRESSURE CLEARING AND REMAINS ~6 hrs after it started. And is causing sleep difficulty, hence this submission.
Fairly severe joint pain and muscle stiffness experienced for approximately 5 hours at 24 hours after injection.
On awakening 9/22/05 discovered slight swellins and itchiness at injection site.  At about 5PM started feeling dizzy and light-headed and VERY thirsty.  She went to bed.  Woke up on 9/23/05 feeling ok, with both lightheadedness/dizzyness and redness/swelling at site gone.  No treatment except she put some lotion on the injection site.
Myalgia, NauseaVomiting & SORENESS AT INJECTION SITE ACETAMINOPHEN 1300 MG ONCE
Immediate burning sensation to left deltoid. Patient given ice for application with positive effect. Patient remained in observation for 30 minutes and was without discomfort at discharge.
The morning after receiving the second COVID19 vaccine, I had the usual side effects of fever (spiking at 103), chills, muscle soreness, etc. However, when those symptoms subsided by the afternoon, I then developed intense chest pains and pressure that lasted multiple hours. At the direction of my primary care doctor, I went to an urgent care where my blood pressure was around 140/80 (I do not have a personal history of high blood pressure, and it was just checked at a normal rate at few weeks prior to receiving the vaccine) and my resting heartrate sat in the high 140s. The urgent care I went to at the time did not have a working EKG; however, they monitored my vitals and provided Motrin for the pain. After about an hour at urgent care, my resting heartrate lowered to 130s and the pain subsided. By the next morning, it still hovered around 110 and my blood pressure remained slightly elevated; however, the chest pains and pressure had completely subsided. The timeline for pain lasted roughly 5 hours, the timeline for heightened resting heart rate and blood pressure lingered for about 12 hours.
shingles; vision loss; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unspecified age. Information about the patient's concurrent condition, concomitant medication or medical history was not provided. In or around September 2017 the patient was vaccinated with zoster vaccine live(ZOSTAVAX) (strength, dose, route, lot # and expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unspecified date in 2017 (reported as shortly after the vaccination), the patient suffered shingles and vision loss. As the result of vaccine live(ZOSTAVAX), the patient suffered severe, 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. She also suffered medical expenses, the loss of accumulations and other economic and non-economic damages. The outcome of shingles and vision loss was not recovered. The reporter considered the events to be disable and related to Zoster Vaccine Live(ZOSTAVAX).  Upon internal review, vision loss was determined to be medically significant.
Retropharyngeal abscess; she got a throat infection, like an abscess; sore throat; This is a spontaneous report from a contactable consumer (patient). A 21-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (at 21 years of age), via an unspecified route of administration, administered in arm left on 18Apr2021 08:15 (Batch/Lot Number: EW0161) as 1ST DOSE, SINGLE for COVID-19 immunisation. Medical history included allergies. The patient had no other medical history but mentioned diabetes and high blood pressure as family history. Concomitant medication included cetirizine hydrochloride (CETRIZINE) which the patient does not take every day, only randomly for allergies and had been taking it for years (ongoing). She had no history of previous immunizations with the Pfizer vaccine. There were no additional vaccines administered on same date of the covid vaccine was given. She had no prior vaccination within four weeks of covid vaccine. The patient received the first dose on 18Apr2021. Then about a week later, she got a throat infection, like an abscess (on 30Apr2021). She had been taking antibiotics and steroids since Friday. She started feeling her sore throat on 27Apr2021, which was a little more than a week after the Covid vaccine. She doesn't know if the sore throat was because of the vaccine or not. She went to the doctor on 30Apr2021, they told her she had an abscess behind her pharynx, it was clarified as a retropharyngeal abscess. She was given antibiotics and steroids, which she has been taking since 30Apr2021. She does not know if the throat infection she had was in correlation with the vaccine or if it was a coincidence. She just wanted to know if it is safe to take the second dose. When they gave her the antibiotics and the steroid, the medication started working that same exact day. The next day, clarified as Saturday (01May2021), she didn't have the sore throat anymore. The second dose of the vaccine was scheduled for this Sunday. She was wondering if it was safe to still take the second dose even if she was taking antibiotics and the steroids. When asked about the tests she mentioned that she thought it kind of looked like Covid symptoms since she had a sore throat, but it came back negative. She also had a Mono test which was negative and a strep test which was negative. The doctor then looked in her throat and said that it looked like an abscess so that was how it was determined she had a retropharyngeal abscess. It was then that she was put on the antibiotics and the steroids. She clarified that the steroid was prednisone and the antibiotic is clindamycin. She is still taking both. Therapeutic measures were taken as a result of the events. The outcome of sore throat was recovered on 01May2021 while the outcome of other events was recovering.  Information on Lot/Batch number was available. Additional information has been requested.
Patient got vaccination for PPSV23 along with the flu shot each in separate arms. At the time patient did not receive any pain for the flu shot, but was mildly irritated from the PPSV23 shot in the other arm when the vaccine was shot in, but not when the needle entered. I told the patient that she can wait around for 20 minutes if she wanted to take caution or just let the pharmacy know as soon as possible, so patient left, but was feeling mild pain but did not complain about it while leaving. Hours later patient comes in crying and reports radiating pain only on the side with the PNEUMOVAX shot, but no pain with the flu shot side to the other pharmacist on duty, and the pharmacist tells the patient to go to urgent care. Have not heard from patient since that night...
ECHO FEB 8, 2021;  EF 55%.  REREAD AGAIN IN APRIL AND EF 55% CONFIRMED. ON MARCH 5, HE PRESENTED WITH A 5 DAY HX OF SOBOE, ORTHOPNEA AND SEVERE PRECORDIAL CHEST PAIN.  HE DESCRIBED THE ONSET AS SUDDEN, ABRUPT AND SO SEVERE THAT HE WAS UNABLE TO CALL 911.    THE SEVERITY OF THE CHEST PAIN DISSIPATED SOMEWHAT, BUT THE DYSPNEA AND ORTHOPNEA HAD WORSENED.  HE TRIED ALBUTEROL AEROSOLS BUT THESE ONLY GAVE HIM VERY PARTIAL RELIEF. PHYSICAL EXAMINATION REVEALED A NEW CARDIAC S4, CLEAR CHEST TO AUSCULTATION BUT HE WAS UNABLE TO TAKE A DEEP INSPIRATION DUE TO TO THE PLEURITIC CHEST PAIN.  HIS WEIGHT WAS UNCHANGED.  NO PERIPHERAL EDEMA NOTED.  EKG SHOWED RBBB, LPFB; BIFASCICULAR BLOCK.  NO PREVIOUS EKG FOR COMPARISON.
Patient was administered the smallpox vaccination two weeks before conception.  Patient had a SAB February 2000.
Immediate Reactions: - Paresthesia at right hand followed to the left hand too  - Hives at both forearms - Itchy scalp - Headache 10 Minutes after administration - Systolic B/P at 140 (after 10 minutes)-- > usually my normal blood pressure is 106/68  -redness hands' palms -itchy scalp and face -weakness at the right arm Later in the day - sudden diarrhea -palpitations at rest -persistent paresthesia at both hands -persistent itchy (despite Benadryl administration) -"heavy" right shoulder -"foggy" brain -fatigue/exhaustion -left eyelid slightly lower than the right one
Per patient, she is being treated for cellulitis by her MD. Reaction on same arm as pneumovax given.
This spontaneous report was received from a pharmacist via a company representative referring to a female patient of unknown age. The patient's pertinent medical history, concurrent conditions and drug reactions/allergies were unknown by reporter. On an unknown date, the patient was vaccinated with one dose of PNEUMOVAX 23 intramuscularly, to prevent pneumonia (strength, lot # and expiration date were not reported). The PNEUMOVAX 23 was administered concomitantly with an unspecified influenza virus vaccine, also reported as "Flu ad shot" by reporter. On an unknown date, also reported as after being administered PNEUMOVAX 23, the patient became sick (malaise). The patient was hospitalized at an unknown location for an unknown duration and it was unknown if she received any treatment for the adverse experience or if any laboratory study was performed. The present status of the patient was reported as improved. The causality assessment between the malaise and the vaccination with PNEUMOVAX 23 was not provided.
2pm chills - temp. 99.8, heart rate - 100, nausea. 3:30pm itching of lips, eyes, and neck, throat itching. Took Benadryl 50mg at 5pm. Itching relieved after Benadryl. Skin appeared mottled - no hives.
approx 2 days p/revd pt was noted to be unresponsive to verbal & tactile stimuli; then started to have t/c sz activity x 2-3 mins w/5 mins of postictal lethargy;
Patient is a 50-year-old male who is seen in consultation for Dr for evaluation of left arm injection site reaction. Patient states he had left arm vaccination injection on 10/3/18. States the injection site became inflamed following vaccination. States the area drained on its own. Reports that the drainage was a yellow/white/bloody fluid. Denies fever, sweats, chills. Rates pain as 1/10. States the area has decreased in size over time. Follow-up PRN.
Came down with chicken pox.  Docter submitted blood sample but actual results not yet received.  He indicated it appeared to be chicken pox.
Four hours after vaccination experienced extreme fatigue followed lay fever, diarrhea and vomiting that lasted 12- 16 hours, felt like having the flue for 3 days, then had rash beginning on legs then the total torso, used Advil and Benadryl along with dexamethasone took a week to clear up in addition right upper arm at site of injection was bruised and extremely sensitive to touch for eight weeks
Patient started to be sore on the arm the night of receiving the vaccine and also developed hives, rash all over the body with itching. She started taking BENADRYL but did not help so see saw a clinic doctor who gave her a shot and prescribed steroid dose pack with no improvements as well.  This condition continued for approximately 9 days before symptoms improved this past Sunday.
c/o rash appearance resembles chickenpox area under arm pits, under breast under neck & a few spots under/around thigh;pt was advised to start on DPH;
Within 5 minutes of injection, he fainted and fell on the floor. Symptoms appeared like seizure. Paramedic came within 5 minutes of incident.
Shingles; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via an unspecified route of administration in the left arm on 15Mar2021 at 12:00 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. Medical history included thyroidectomy. The patient had no known allergies to medications, food, or other products. Concomitant medications included cetirizine hydrochloride (CETRIZINE) and levothyroxine sodium (UNITHROID); taken for unknown indications from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via an unspecified route of administration on 22Feb2021 at 12:00 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. 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. On 07Apr2021, the patient experienced shingles. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of shingles and included treatment with VALTREX, naproxen (MANUFACTURER UNKNOWN) and gabapentin (MANUFACTURER UNKNOWN). The clinical outcome of the event shingles was recovering at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Child vomited once, felt nauseous after, resolved after 15 minutes with drinking Gatorade and eating peanut butter. Patient reported not eating anything that day.
Information has been received from author of a published article titled as above, concerning a 2 year old patient with a history of umbilical cord compression (emergency cesarean section was performed) and resuscitation at birth, who on 05-FEB-2003 and 25-MAY-2006 was vaccinated with a first and second dose of MMR II. In approximately 2004 the patient developed delayed speech. The author commented as follows: "we do not look forward as if on the date the patient's documented speech delay to decide whether his condition necessarily would result in autism. We know that delayed speech does not invariably presage and autistic disorder, but that is not the proper focus inquiry. Instead, we look back from the date the petition was filed to determine, as a historical matter, when the symptoms of the autism that we know will eventually be diagnosed were established in the record. The statute of limitations begins to run from the date that the symptoms of autism appeared that would generally be recognized in the medical community". Upon internal review it was determined that autism was considered to be an other important medical event. At the time of the report the patient had not recovered. No further information is available. A copy of the published article is attached as further documentation of the patient's experience.
Patient had second Moderna vaccine on Sunday, 5/23, and later that day started having body aches, tired, and  fever of 99.5. She stated she gave him Tylenol, and temperature went down to 98.5. Today he has a fever of 100.5, and has body aches and is tired. RN asked if he had any SOB or chest pain, and Mother stated he has not. Mother stated he is taking Tylenol every 12 hours. Reviewed supportive care and if temperature does not go down or increases call provider.