chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial report received from a physician on 03 October 2014. A 9-year-old male patient, with a history of hay fever and asthma, received an intramuscular injection of FLUZONE QIV (lot number UI191AB) at 4:30 pm on 01 October 2014. The patient had previously received six doses of influenza vaccine with no reported adverse events. At approximately 6:30 pm, the patient's mother called the physician to report that the patient was experiencing hives and facial swelling, and was "very itchy". She was instructed to take the patient to the emergency room. In the hour and one-half that they were waiting, the patient developed shortness of breath and his blood pressure dropped to 73/46. He was diagnosed with anaphylaxis and treated with fluids, intravenous steroids, and intravenous BENADRYL. The patient recovered and was discharged home. He was being referred to an allergist/immunologist. Follow-up information received from a physician on 06 November 2014. At the time of flu vaccination, the patient was taking concomitant medications with multivitamins daily and acetaminophen (at 5pm). The patient had not experienced adverse events following prior vaccinations. He has no siblings. There was no illness noted at the time of vaccination. The patient started to experience adverse events at 6:30 pm on 01 October 2014. He had decreased blood pressure of 73/46 on 01 October 2014. Shortness of breath was removed from the symptoms experienced by patient. Follow-up information for this unsolicited case was received from a physician (an allergist), on 01 December 2014. The patient's past medical history included allergic rhinoconjunctivitis (spring and fall), and asthma, primarily infectious. The event was clarified as anaphylaxis with angioedema, urticaria, and hypotension. Based upon the historical information, it was the reporter's conclusion that the anaphylaxis was induced either by the acetaminophen administered one hour prior to vaccination, or the influenza vaccine. The patient had no history of egg allergy and ingested eggs regularly without adverse reaction. Pulmonary function testing on 24 October 2014 demonstrated mild reversible small airway obstruction. The patient was provided a written anaphylaxis plan, and was instructed to use AUVI-Q as needed until the source of his anaphylaxis had been identified. The patient had been referred to another facility for additional allergy testing; the appointment was scheduled for 08 January 2015. Documents held by sender: None.
death Pt died in her sleep less than 48 hours from the time of vaccination.  No acute symptoms were occuring before death. No other medical procedures were done close to date of death, other than pfizer vaccine.
Swelling at site, headaches, nausea. Swelling of face, dizziness. Tx @ local hospital. Given BENADRYL dip and THOREDOL and released.
On 4/12 I started exp pain in legs shooting pain to my thighs and fatigue. I contacted a friend doctor stated that doesn't sound right might be a blood clotting issue.  I went for a visit on 4/13 in the clinic doctor said it seem ok. I was also exp nausea, headache and pain lower left leg. I went to the hospital on 4/14 had Blood Work, Ultrasound (legs) tests results was fine. Also still exp inflammation feeling in my legs a if I have lifted weights and tightness in my calves. I couldn't walk exp muscular pain, stiffness  between 4/14-/4/16. I normally have my menstrual 3-4 days for some reason it started over again on 4/10 for 10 days. I'm not sure if this was some sort of hormonal reaction. My normal daily activities have been limited I usually walk every morning with my husband since vaccine not able.As of 4/19 my headache is gone the pain is not as bad in legs.
Pain, tiredness, chills, fever, pain in arm, anxiety, acute urticaria and currently chronic urticaria. All treatments so far have been antihistamines but nothing takes away the urticaria and desperation
WOKE UP MORNING AFTER VACCINE AND FELT LIKE "GOT HIT BY A BUS," ACHY ALL OVER HIS ENTIRE BODY, DID NOT HAVE AN APPETITE AND COULD NOT SLEEP. FELT BETTER 2 DAYS LATER.
pt recv 1 dose varivax 5/3/97 & in 5/98 pt exp varicella. MD rpt approx 32 lesions.
75 yo F, history of asthma, depression, anxiety, atrial fibrillation, and hyperventilation syndrome secondary to psychiatric disease. Presented to the ed from assisted living for altered mental status found to have toxic and metabolic encephalopathy and covid 19. Labs remarkable for hypokalemia, hypomagnesemia, leukopenia, UA concerning for infection, urine culture contaminated. ABG with hypoxia. CXR with left left lower lobe pneumonia. Started on ceftriaxone and doxycyline for CAP. Saturating well on room air, dexamethasone and remdesivir held.    Patient developed lethargy after ativan administration for a panic attack AM of 1/18.    Blood cultures positive for GPCs resembling staph in 2/2 bottles and vanc started, speciated to staph hominis and staph epi, oxacillin susceptible. ID consulted and placed patient on unasyn. Repeat cultures negative. Repeat cxr with subsegmental mucous plugging and urine ag positive for strep.   SCR increased to 1.4 that resolved with MIVF.    Patient to complete course of clindamycin and levofloxacin for strep pneumonia and bacteremia per ID recs.Discharged on 1/28/22
date and clinic for vaccines unknown.  sick at home for 5-6 days prior to ED admit with SOB, pneumonia, fever 100.9, loss of appetite, cough tested + 8/25/2021; Remdesivir, Decadron, Lovenox, Azithromycin, Rocephin; O2
SM developed redness, swelling, itching, discomfort at ANTHRAX vaccination site within 24 hrs of the shot. Symptoms: Edema at injection site 50-120mm, Erythema, Pruritus, Swelling, Tenderness
patient was administered with Pediatrix then IPOL on the same day with no reported adverse event; She stated that this was only supposed to be the patient's 3rd dose. .   Initial information was received on 02-Nov-2023 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 19 months old female patient who was administered with pediatrix then ipv (vero) [ipol] on the same day with no reported adverse event while receiving vaccines diphtheria vaccine toxoid, hepatitis b vaccine rhbsag (yeast), pertussis vaccine acellular 3-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid (pediarix) and ipv (vero) [ipol].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect IPV (VERO) (route intramuscular) along with PEDIARIX on same day (dose, formulation, strength, and expiry date: unknown) (extra dose administered, latency same day) in unknown administration site for prophylactic vaccination (immunization).  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive and Regulatory Authority Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
This case was reported by a physician via sales rep and described the occurrence of myalgia in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a day after receiving SHINGRIX, the patient experienced myalgia. On an unknown date, the outcome of the myalgia was recovered/resolved. It was unknown if the reporter considered the myalgia to be related to SHINGRIX. Additional details were provided as follows: The age at the vaccination was not reported. The reporter developed myalgia the night after receiving the SHINGRIX vaccination. The patient also described that the myalgia felt like he would feel after having worked out. The myalgia lasted for two days. The reporter was unable to provide additional information.
This spontaneous report as received from a 39 year old non-pregnant female patient regarding herself. She did not have any pertinent medical history. Concomitant therapies included MICROGESTIN, folic acid, and methotrexate (manufacturer unknown). On 04-DEC-2014, the patient was vaccinated with ZOSTAVAX (1 dose, lot # J013137, expiration date: 17-JAN-2015) (route not reported) diluted with sterile diluent (manufacturer unknown) as recommended vaccine per her rheumatologist's recommendation. The patient received the vaccine prior to age 50 (inappropriate schedule of drug administration). On 10-JUN-2015, the patient's face became slack and she was slurring her words. On an unknown date in June 2015 (reported as about 6 months later after receiving ZOSTAVAX, the patient was taken to a hospital due to face becoming slack and slurring words. The patient sought medical attention. At the emergency room, the medical staff on duty performed many unspecified labs and test. She was later diagnosed with Bell's Palsy. On unknown dates (reported as since then), the patient had gained 40 pounds, developed high blood pressure, sleep apnea, and conjunctivitis. The patient confirmed that she did not have these issues prior to receiving ZOSTAVAX. Since receiving ZOSTAVAX, the patient was prescribed and treated with XIIDRA, PROZAC unspecified steroids, doxycycline, prednisone, acyclovir, TOPAMAX, carbamazepine, rizatriptan and sumatriptan (doses, frequencies, routes, lot#s, and expiration dates unknown) for the adverse events. On an unknown date, the patient experienced "too many side effects" due to which she stopped TOPAMAX. On an unknown date, the patient stopped sumatriptan due to the fact that it made her chest feel tight. The events did not cause hospitalization. Action taken with TOPAMAX was withdrawn for adverse event and sumatriptan (manufacturer unknown) was withdrawn for chest discomfort. The outcome of chest discomfort and adverse event was unknown and the outcome of other events was not recovered/not resolved. The patient considered the chest discomfort to be related to sumatriptan. The patient did not assess the causality of adverse event with TOPAMAX. The patient did not assess causality of all events with ZOSTAVAX. Product quality complaint was not involved. Upon internal review, the event facial paralysis was determined to be medically significant.
Rash in the Neck  area. Benadryl and cortisone cream.
Information has been received from a 65 year old male consumer with no known drug allergies who on 14-JUN-2008 was vaccinated subcutaneously with a 0.65 ml dose of ZOSTAVAX (Oka/Merck). On 16-JUN-2008  the patient experienced flu like symptoms and developed "chicken pox like rash" on legs below the knee. At the time of this report, the patient was recovering from the symptoms. The patient sought unspecified medical attention. Additional information has been requested.
reactions similar to the flu; chills; soreness; feel sick; Couldn't raise arm; This case was reported by a consumer via interactive digital media and described the occurrence of influenza-like symptoms in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of influenza like illness (received first dose on an unknown date and experienced Influenza-like symptoms, chills, soreness, mobility decreased and sickness, refer case US2022AMR009104).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced influenza-like symptoms, chills, pain, mobility decreased and sickness. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the influenza-like symptoms, chills, pain and sickness were unknown and the outcome of the mobility decreased was recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms, chills, pain, mobility decreased and sickness to be related to Shingles vaccine.     Linked case(s) involving the same patient:  US2022AMR009104.  Additional details were provided as follows: The patient self reported this case. The age at vaccination was not reported. The patient had reactions to the shingles shot similar to the flu, chills and soreness.  Could not raise his/ her arm for a week.  Still got the second shot and same thing happened.  The patient figured it was better to feel sick than to deal with shingles.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR009104:Same reporter
pt recv vax; mom states had sz; arms stiffened; eyes rolled back; no incontinence;called MD; no testing done; mom says PHn suggested poss "fear rxn..";
Information has been received from a pharmacist referring to a 68 year old male patient with diabetes. The patient had no known drug reactions/allergies. On an unknown date in October 2014, the patient was vaccinated with a dose of PNEUMOVAX23 (lot#, expiration date, dose and route unspecified). On 26-JUN-2015, the patient also vaccinated with a dose of PREVNAR 13 (lot#, expiration date, dose and route unspecified) (Inappropriate schedule of vaccine administered). On 12-JUL-2016, the patient was vaccinated again with a dose of PNEUMOVAX23 (lot#, expiration date, dose and route unspecified) (Inappropriate schedule of vaccine administered). The reporter called the patient a few hours after vaccination on 12-JUL-2016 and patient stated that he had a slight sensation of numbness around his lips. The patient did not seek medical attention. No treatment was given for the event numbness around his lips. No lab diagnostics studies performed. The outcome of the event numbness around his lips was unknown. Additional information has been requested.
He received 3 doses of Pfizer COVID vaccines on 2/27/21, 3/23/21, and 10/15/21. He was brought to the ED of Hospital with AMS, cough and fever on 5/21/22. He was tested positive with COVID  PCR and admitted on the same day. He was given steroids, Ceftriaxone, and Azithromycin. His mental status was improved significantly and was discharged home on 5/23/22.
Patient started to have a local injection site reaction on 1/10/21 at around 9:10am. The injection site had some redness and swelling. By the afternoon on 1/10/21 the red and swelling increased and by 1/12/21 the redness was the size of a half dollar and swelling just beyond the redness. The area is warm to touch. Pt also had symptoms of nausea, fatigue, and muscle pain. Pt was instructed to take Zyrtec BID & pepcid. When I talked to the patient on 1/13/2021, the injection site remains the same and still feels nauseated.
soreness that has extended beyond the injection site and down the arm; soreness at  injection site; chills; fever; sweating a lot; feeling like she was on fire; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (soreness at  injection site), CHILLS (chills), PYREXIA (fever), HYPERHIDROSIS (sweating a lot) and FEELING HOT (feeling like she was on fire) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. #003C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 07-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-May-2021, the patient experienced VACCINATION SITE PAIN (soreness at  injection site), CHILLS (chills), PYREXIA (fever), HYPERHIDROSIS (sweating a lot) and FEELING HOT (feeling like she was on fire). On 10-May-2021, the patient experienced PAIN (soreness that has extended beyond the injection site and down the arm). On 08-May-2021, CHILLS (chills), PYREXIA (fever), HYPERHIDROSIS (sweating a lot) and FEELING HOT (feeling like she was on fire) had resolved. At the time of the report, VACCINATION SITE PAIN (soreness at  injection site) and PAIN (soreness that has extended beyond the injection site and down the arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment Aleve taken on 08May2021 at 1pm
I95.9 HYPOTENSION 9/3/2021 AORTIC VALVE STENOSIS J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 9/3/2021 AORTIC VALVE STENOSIS R09.02 HYPOXIA 10/1/2021 AORTIC VALVE STENOSIS I95.9 HYPOTENSION 9/3/2021 SYNCOPE AND COLLAPSE J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 9/3/2021 SYNCOPE AND COLLAPSE R09.02 HYPOXIA 10/1/2021 SYNCOPE AND COLLAPSE I95.9 HYPOTENSION 9/3/2021 AORTIC VALVE STENOSIS J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 9/3/2021 AORTIC VALVE STENOSIS R09.02 HYPOXIA 10/1/2021 AORTIC VALVE STENOSIS I95.9 HYPOTENSION 9/3/2021 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 9/3/2021 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED R09.02 HYPOXIA 10/1/2021 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED
This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On an unknown dates in 2015 (reported as "between 01-SEP-2015 and 09-OCT-2015"), the patients received an unspecified doses in the immunization series of VARIVAX (Merck) (lot # L016127, expiration date 06-MAY-2017) (dose and route of administration were not reported) that were improperly stored. No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
This spontaneous report as received from a pharmacist refers to unspecified number of patient of unknown age and gender. On an unknown date the patients were vaccinated with GARDASIL 9 for prophylaxis. On an unknown date the patient experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to GARDASIL 9. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1707USA000510: US-009507513-1705USA009596: US-009507513-1707USA000511: US-009507513-1707USA000508.
8-26-15 0 when discussing completing the series, patient and mother stated she had headaches and dizziness on standing x months after the vaccine.
Axillary lymphadenitis in right arm and axillae; redness, swelling, tenderness, warmth.
Intense reaction to (R) arm from Meningitis - swelling - tender heat 2inch x 2inch welt.
Initial report received from a pharmacist on 24 July 2013. A 60 years old five adult patients, whose age, medical history and concomitant medications were not reported, had received a dose of FLUZONE (Lot number UH889AA, route and site of vaccination were not reported). On an unspecified date between August 2013 and October 2013. On an unspecified date, after receiving vaccines the patient experienced malaise, chills, fever and vomiting. Complementary investigation was reported as 'NA' and corrective treatment was not reported. At the time of this report the outcome of adverse event was recovered. Documents held by sender: none.
Fever to 102 F.  Chills.  Total body aches.  Severe headache.  Nausea.  All began around midnight, 16 hours post-shot.  Worsened throughout the night and began to diminish about 8 hours later.  After about 12 hours had only slight fever, more manageable headache, was achy all over and fatigued.  Back to baseline 36 hours after onset of symptoms.
Symptoms started 1 day after vaccine administration with generalized pain, worse on the left side and a shingles like rash on the left inner leg from the groin to mid calf.
p/vax pt broke out in hives (itchy) @ inj site the day p/vax;tolerated other vaccines in the past & does not have a known allergy to eggs;the reporting MD thought the rxn was caused by the vaccine;
Excessive hair shedding. Clumps of hair falling out during shower. Noticeable hair thinning; This is a spontaneous report from a contactable other healthcare professional, the patient. A 26-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0217) via an intramuscular route of administration in the left arm on 10Sep2021 (at the age of 26-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the vaccination. The patient did not receive any concomitant medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0178) via an intramuscular route of administration in left arm on 20Aug2021 (at the age of 26-years-old) as a single dose for COVID-19 immunisation. On 12Sep2021, the patient had excessive hair shedding. Clumps of hair falling out during shower and noticeable hair thinning. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. On 16Sep2021, the patient underwent an antigen test by nasal swab and the result was found to be negative. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had been tested for COVID-19. The clinical outcome of the events excessive hair shedding, clumps of hair falling out during shower and noticeable hair thinning was not resolved at the time of this report.  No follow-up attempts are possible. No further information is expected.
Tired, increased irritability, congestion, fever and headache developed 1/09, fever comtinues through 1/11, saw doctor 1/11 AM diagnosed pneumonia.
Swelling of the tongue, throat, and facial cheeks.  I could not eat solid food for two days. Could breath just fine. Body fatigue and significant lack of energy. Sore throat, and some coughing a few days later.
This is about the Moderna BOOSTER I received on 1/6/2022. Approximately 8 hrs following the vaccine injection (@ 10:30pm), my throat began to itch & felt a little tight. This persisted for the next ~30hrs. I experienced the typical/ known flu-like ashiness, fatigue throughout the evening & for ~ 30hrs. My throat continued to be itchy throughout this time. After 30 hrs, it subsided, along with my flu-like symptoms.
Began having jaw pain/subungual pain, neck stiffness/pain. Mom stated "he is acting odd". No fever. Was given Adacel during office visit for a laceration to his foot (2 days old). Cellulitis was diagnosed (foot) and Keflex rx but not filled until after adverse event. Mom gave Benadryl (40mg) at 1750 on 08/29/06 and symptoms resolved by 1830 8/29/06 entire event treated via telephone.
18Jan96 pt recv 1 dose vax. 19Jan98 pt devel a few maculopapular vesicles on back & hands. (possibly 10) & low grade fever of 100.2 Three other pts reported w/adverse exp (WAES 98020281,98021661,98021663)
Death J18.9 - Pneumonia N17.9 - Acute kidney injury (CMS/HCC) Cardiac Arrest J96.01 - Acute respiratory failure with hypoxia
Transverse Myelitis - feet became numb, lesions on my spine and brain.
PT CLAIN THAT AFTER MODERNA BOOTER  PLACED ON 11/5/2021  ON 11/16/2021,  HE STARTED WITH UNSTEADY  GAIT OF RT EXTREMITY
Pt devel a temp 5 hrs p/vax t105.2, vomited twice, had high pitch scream for 48 hrs & cont cry; listless & pale, eyes rolling back; no seizures; redness & swelling @ site of inject; temp ranged from 102-105.2; pt seen by MD;
Case number PHHY2011US44843 is an initial report from a health care professional received on 04 May 2011. This report refers to 3-patients. These patients received MENVEO (batch number 100023). Three patient were inadvertently administered with only MenCYW-135 liquid conjugate component of MENVEO, the patient did not received the MenA lyophilized conjugate component. No adverse event occurred.