chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Case number PHHY2012US051612 is an initial literature report received on 12 Jun 2012. Authors searched VAERS for reports of adverse events (AEs) in pregnant women who received INFLUENZA from 01 Jul 1999 through 30 Jun 2009. This case refers to a baby born (sex not specified) to mother (age not specified). The mother was vaccinated with INFLUENZA (manufacturer and batch number: unknown) at an unknown gestational age, on an unspecified date between 01 Jul 1999 through 30 Jun 2009 (see linked mother file: PHHY2012US051609). The fetus was exposed to this vaccine via transplacental route. On an unknown date at an unspecified gestational period the baby was born with birth defect, spina bifida. The causality was not reported. Authors stated that the VAERS system does not allow for active follow-up of adverse events among pregnant women; thus, pregnancy outcome data are not available for women who had an adverse pregnancy event. Authors concluded that no unusual patterns of pregnancy or fetal outcomes were observed in the VAERS reports of pregnant women after the administration of INFLUENZA.
ACUTE FALCCID MYELITIS; A spontaneous report has been received from the regulatory authority concerning a male child of Unknown ethnic origin.    No medical history was reported. No concomitant products were reported.    The patient received Fluenz Tetra (influenza virus vaccine live, intranasal) nasal, on 06-Oct-2018 for routine childhood immunisation.     On 16-Oct-2018, the patient experienced acute falccid myelitis (preferred term: Myelitis).     At the time of reporting, the event of  acute falccid myelitis was ongoing.    The event of  acute falccid myelitis was considered serious (hospitalised) by reporter.; Sender's Comments: This is case report concerning a male child patient with reported myelitis which is not listed in the company core data sheet for Live attenuated influenza vaccine (Q/LAIV). The event occurred 11 days after of administration. Due to limited information on patient's demographics (age), outcome of the event, concurrent diseases, concomitant medication and vaccination profile, relevant medical history, risk factors (such as infections, autoimmune disorders), etiologic and diagnostic workup (magnetic resonance imaging, lumbar puncture, blood test), it is not possible to make conclusive assessment of causal relationship of event with live attenuated influenza vaccine.
To hospital from nursing home with shortness of breath and a heart rate of 145. Was in Atrial Flutter with Rapid Ventricular Response. Admitted to ICU.  Remdesivir
Guillain-Barre syndrome; severe side effects/symptoms persisted/started after receiving the booster; This spontaneous case was reported by a consumer and describes the occurrence of GUILLAIN-BARRE SYNDROME (Guillain-Barre syndrome) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017E21A, 027A21A and 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced GUILLAIN-BARRE SYNDROME (Guillain-Barre syndrome) (seriousness criterion medically significant) and VACCINATION COMPLICATION (severe side effects/symptoms persisted/started after receiving the booster). At the time of the report, GUILLAIN-BARRE SYNDROME (Guillain-Barre syndrome) and VACCINATION COMPLICATION (severe side effects/symptoms persisted/started after receiving the booster) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported.  No treatment reported.  Company comment: This case concerns a  59-year-old, female patient with no relevant medical history, who experienced the unexpected serious event of Guillain-Barre syndrome. The event occurred on an unknown date after the third dose of Moderna CoviD-19 Vaccine. The rechallenge was unknown since no information about the events of the second dose was disclosed. The benefit-risk relationship of Moderna CoviD-19 Vaccine is not affected by this report.; Sender's Comments: This case concerns a  59-year-old, female patient with no relevant medical history, who experienced the unexpected serious event of Guillain-Barre syndrome. The event occurred on an unknown date after the third dose of Moderna CoviD-19 Vaccine. The rechallenge was unknown since no information about the events of the second dose was disclosed. The benefit-risk relationship of Moderna CoviD-19 Vaccine is not affected by this report.
Some adverse events included Sore left arm, left side unusual chest pains, unusual irregular heart beats developed, twitching in various areas of legs and arms . . . Report submitted via VAERS Adverse Event Reporting via text and also in a timely basis. I registered via online for VAERS services and supports as suggested.   TO DATE SOME NEW CONDITIONS INCLUDES: PAD/Venous Insufficiency multiple sites. Current treatment includes compression stocking and pneumatic compression device. Decrease mobility treatment is physical therapy .Shortness of Breath . . .   This is Report one of two adverse reports submitted.
Patient experienced tonic clonic seizure within a few minutes of receiving first dose. I was informed at upon arriving at the scene that she had history of seizure but I cannot validate this information. She was evaluated by the emergency department immediately.
9 days after administration of smallpox vaccine, pt presented with exertional chest discomfort and SOB, worse laying back, was admitted to ICU with diagnosis of smallpox induced myocarditis.  Cardiac catheterization was normal, cardiac echo was normal (no effusion), but the patient bumped his troponin I to a max of just over 1.0.  He was discharged after 4 days in ICU with significant improvement in symptoms and has done very well since. 8/27/08-records received for DOS 8/3-8/6/08-DC DX: Acute pericarditis, most likely from recent small pox vaccination. Presented with chest pain and ST elevation noted in lead II, III, a VR and troponin were high.
Tonsil stones, cellulitis, tonsillitis body bruising all over , open sores shoulders thigh back and bottom of feet inside outer ear elevated blood pressure
Patient broke out into hives a day after the vaccine. Father of patient stated that she has had flu shots in past and never had this happened.
Patient was having pain from shoulder to elbow - sore and painful - started 3 1/2 weeks after flu shot.
Body aches - particularly elbow, knees, and hands. Fatigue. Occasional light headedness.   All symptoms were gone by following morning!
This spontaneous report was received from a registered nurse refers to an unspecified patients of unknown age. On an unknown date, the patients were vaccinated with improperly stored (Merck) VARIVAX, (lot number and expiry date was not reported). No adverse effects were reported. Additional information has been requested.
felt very tired & slept about 18 hrs; woke up in a sweat; then was irritable & restless & still very tired, this began less than 24 hrs p/the shot; pain-arms hands fingers-joint pain major pain 5 days later-lasted 3 days;
Patient vaccinated on 1/5/21 in am.  Reports onset of symptoms on 1/9/21.  Patient says she experienced body aches, involuntary head nodding that she describes similar to muscle twitches.  Patient reports chills with no fever, nausea and diarrhea that has not stopped.  She also described pain in her spine that wrapped around into her chest like a sharp shooting pain and fatigue and a headache that feels like a band wrapped around her head.  Symptoms started 1/9/21 and are still present 1/12/21.
Employee received the intradermal flu shot and within minutes c/o itching all over, then felt face was swelling.
chills, muscle aches, runny nose, shortness of breath, difficulty breathing, chest pain, nausea, headache, fatigue, abdominal pain, diarrhea, new olfactory or taste disorder
Dizziness, Headache, Myalgia, Arthralgia, Fever, chills Narrative:
patient reports light headedness and numbness in left arm, fatigued. patient instructed lie flat worsening elevate feet. also encouraged to drink water. patient instructed to notify medical provider with worsening symptoms or unresolved symptoms. patient felt better after 5 minutes and left vicinity.
Reports weakness and tingling sensations in lower extremities.  Vital signs stable Refused and signed to be taken to ER Seen and cleared by EMS
Patient immediately felt dizzy, broke out in hives on bilateral arms from elbow up, chest, neck, mouth area, muscle weakness in bilateral lower extremities. Increased heart rate from 110 at lying to standing at 146 bpm. Administered 25 mg of Benadryl By mouth with water. Within 20 minutes hives on face disappeared but remained in all other areas and none of her symptoms went away. Called 911 had her transported on a stretcher in an ambulance for further observation.
Information has been received from a registered nurse concerning a 14 month old healthy female who on 5/3/04 was vaccinated with a dose of MMR (lot # 646740/0822N). On 5/3/04, the patient was concomitantly vaccinated with a dose of varicella virus vaccine live and poliovirus vaccine. On 5/6/04, the patient developed a fever . The patient was seen at an urgent care center for unspecified medical attention. The mother was told that the patient must have had 2 vaccinations of MMR on the same day to have developed the rash. The nurse reported that she was not aware and had no records indicating that the patient received 2 vaccinations on 5/3/04. Additional information has been requested.
Persistent nausea; vomiting; fatigue; brain fog; headache; difficulty sleeping; body soreness; lack of appetite
Headache soreness at injection site, fatigue Narrative:  Approx. 4 hrs after second dose, employee reports a headache. Also feeling fatigued generally, and some mild soreness at the site of the injection.
Information has been received from a medical assistant concerning her 10 months old daughter, who on approximately 15-SEP-2010 was vaccinated with her third 0.5 mL dose of RECOMBIVAX HB (lot # unknown). The medical assistant reported that her daughter received expired RECOMBIVAX HB. The child had been cranky and crying since vaccination. The mother did not know when the vaccine expired. The child was premature and spent her first month of life in the neonatal intensive care unit. The mother also reported that her child was cranky and cries a lot in general. At the time of report, the patient had not recovered. The patient sought medical attention by a call to the office. No further information is available.
taking naps after the Covid vaccine; felt a little tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SOMNOLENCE (non-serious), outcome "unknown", described as "taking naps after the Covid vaccine"; FATIGUE (non-serious), outcome "unknown", described as "felt a little tired".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Information has been received from a registered nurse reporting that she received an e-mail from a woman who stated that she received the complete GARDASIL series and has now tested positive for HPV. It was reported that the woman is not the nurse's patient. Attempts are being made to verify the existence of an identifiable patient and reporter. Follow-up information was received from the RN, who is a senior member of an HPV Health Board, and stated that she receives and responds to many anonymous emails. She indicated that on the patient's email, the woman mentioned that she was diagnosed with HPV but could not confirm the strain. The nurse stated that she is waiting for the woman to provide this information and will call back when/if she receives it. The nurse stated that there was no way for her to determine the name of the patient since the emails are anonymous. Additional information is not expected.
Pt recv vax on 1/12/99; on 1/13/99 pt exp fever, itchy arms, left ear swelling, whelps &hives on arms & legs; tx=Atarax
10:30am - Within 10 minutes of receiving vaccine, she fainted.  She began to experience severe pain in her left arm with numbness in her hands and fingers. She had feelings of impending dome.  11:30am - She returned to school approximately 1 hour after the injection, but her symptoms did not improve and worsened. She was unable to use her left arm do to the pain and lack of feeling/strength in her hand. She then had periods of hearing loss. She experienced nausea, vertigo, facial flushing, upper chest flushing, and profound fatigue.                             12:30pm - I returned her back to the MD office. There they did vital signs and administered Bendaryl by mouth.                                Her symptoms lasted 12 hours.  By the next morning, she back to normal.
Admit for fever, cough, SOB. Tx w/abx, steroids, remdesivir, zinc, singulair, O2. Hx HTN, obesity, DM. DC'd home on home O2.
This spontaneous report was received from a nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapy were not provided. On 10-SEP-2018, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (dose and route were unknown), lot # R012501 expiration date 08-JAN-2020 for prophylaxis. This was the first temperature excursion. There was no Digital Data Logger involved. This is one of several reports received from the same source. Sender's Comments: US-009507513-1809USA011221; US-009507513-1809USA004863.
Eczema lesion on upper right inner thigh was resolving using Eucrisa. Received the Pfizer vaccine on 01/20/2021 & within a few days the lesion became very excoriated & itchy. No weeping noted. Have discontinued using Eucrisa & applied OTC topical HC to area.
Started with severe bruising immediately. In less than 24 hours there was a red hot circle around the bruise and a massive bulged. Redness continues spreading. After assessment at hospital ER, diagnosed  with cellulitis
Notified by nurse triage on 10/27 at 8:15 pm that family was calling due to continued swelling and redness on leg at site of flu shot. No fever, no induration. Recommended cool compresses, pain med if needed, call office in AM for eval if worsening.
Headache mostly around my left eye; One week after 2nd Pfizer vaccine I smell smoke along with a headache mostly around my left eye. There is no smoke in my home but I smell it 24/7; This is a spontaneous report from a contactable consumer, the patient. A 72-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER ZU 13) via an unspecified route of administration in the left arm on 21Mar2021 at 10:00 (at the age of 72-years-old) as a single dose for COVID-19 immunisation. Medical history included diabetes2. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2U13) via an unspecified route of administration in the left arm on an unknown date, 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 been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 30Mar2021 at 09:00, one week after second dose of vaccination, the patient experienced smelled smoke along with a headache mostly around the left eye. There was no smoke in the patient's home but the patient smelled it 24/7. On 07Apr2021, the patient underwent nasal swab test and the result was unknown. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the events smelled smoke along with a headache mostly around the left eye was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
This spontaneous report as received from a nurse and refers to unspecified number of patients of unknown age and gender. Information on medical history, past drugs, concurrent conditions and concomitant medications were not provided. The nurse reported that on an unknown date, the patients were vaccinated with PROQUAD, (lot # N008825, Exp date:12-SEP-2018) for prophylaxis (Captured in MARRS # 1708USA009081) which were improperly stored. Other suspect therapies included VARIVAX, (Lot # N007930 Exp date: 08-MAR-2019) for prophylaxis which was also improperly stored, sterile diluent Merck injection. For both the products, temperature was between -9 (degree Centigrade) °C to 8°C. Time frame was 4 hours and 43 minutes. Previous temperature excursion was between -9°C to 8°C for 57 hours and 40 minutes. Between -14°C to -10°C for 23 hours and 57 minutes. It was reported that call was not because of a data logger. No adverse effects were reported. No additional information was provided. No product quality compliant (PQC) was involved. Outcome of event was unknown. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1708USA009081.
We got the injection last morning on the 26th in the morning like about 11 O' clock by night she developed pain in the arm like all of us did; 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 26May2021 (Lot number: EW0185) 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, SINGLE, Lot number: EW0175), administration date: 05May2021, for COVID-19 immunisation. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "We got the injection last morning on the 26th in the morning like about 11 O' clock by night she developed pain in the arm like all of us did". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible. No further information is expected.
felt sick; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that second vaccine was scheduled today. Caller did not go because she felt sick. Inquiring was it okay to miss the vaccine after 21 days. The outcome of the event was unknown.  Information about the lot/batch number has been requested.
warm and flushed, fever x one day (99), pain at site and pain in muscle   2 weeks  post vaccine more pain in muscle and experiences a hematoma 3 - 4 inches
This spontaneous report as received from a registered nurse refers to a 4 years old male patient. Medical history and current conditions were not reported. On 12-AUG-2014, the patient was vaccinated with (Oka/Merck) VARIVAX, lot # reported as J006106, expiration date: 17-MAY-2015 (route and dose were not reported) that was improperly stored on 04-SEP-2012, 06-NOV-2012, 21-MAR-2013 and 07-AUG-2014. The cumulative excursions were supported. Concomitant medications was not reported. No adverse effect was reported. This is one of several reports from the same source. Additional information has been requested. Event, Analysis was updated.
pt recv vax w/in the hr w/rash cont area distal to inj site; during the evening was taken to ER @ 11PM t102.0-101.5, whelp rash over body dx as allerg rxn given DPH; t102 AM 11MAY95;
Breakthrough case admission after 2 vaccines Pfizer 3/6/21 lot# El3248;  Pfizer 3/27/21 lot# EL9265
pt recv & devel flu-like sx characterized by nausea,vomiting,myalgia,& loss appetite lasting more than 24hrs;
serious allergic reaction; tightening of throat; cough; over excited immune system; had allergy reactions to a homemade burger\had allergy from eating frost flakes and milk; had allergy from eating frost flakes and milk; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID:. The reporter is the parent.  A 15-year-old female patient received BNT162b2 (BNT162B2), in Jan2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for Covid-19 Immunization. The following information was reported: HYPERSENSITIVITY (medically significant) with onset 22Feb2022, outcome "unknown", described as "serious allergic reaction"; COUGH (non-serious) with onset 2022, outcome "unknown"; MILK ALLERGY (non-serious) with onset 2022, outcome "unknown", described as "had allergy from eating frost flakes and milk"; FOOD ALLERGY (non-serious) with onset 2022, outcome "unknown", described as "had allergy reactions to a homemade burger\had allergy from eating frost flakes and milk"; IMMUNE SYSTEM DISORDER (non-serious) with onset 2022, outcome "unknown", described as "over excited immune system"; THROAT TIGHTNESS (non-serious) with onset 2022, outcome "unknown", described as "tightening of throat". Therapeutic measures were taken as a result of hypersensitivity, food allergy, milk allergy.  Clinical course: Patient injected Epipen for the event allergy reactions to a homemade burger with no additives, took Benadryl for the event allergy from eating frost flakes and milk as well . Reporter stated that, wonder if you have seen more cases of people developing serious food allergies after their booster shots. My kid (15) had her booster in Jan2022. Lately, patient had more and more episodes of allergic reactions to food (many of the food items she has had since birth, nothing really new). To a point whatever patient eats, her throat closes up and patient starts to cough. I wonder if it is because of the reaction for an over excited immune system from the vaccine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
After receipt of the Covid-19 vaccination, patient developed a scratchy throat and some tightness. Diphenhydramine 25 mg/mL and methylprednisolone 125 mg/2mL injections were administered and patient was observed for resolution of symptoms
Systemic: Dizziness / Lightheadness-Severe, Additional Details: Patient recieved booster dose and within a few minutes became dizzy/lightheaded/faint. Paramedics called. Patient did not pass out. She laid down with assistance. Patient maintained awareness of her surroundings and answered assessment questions by medical staff. No signs or symptoms of allergic reaction. Given patients age and past medical history, patient was transported to hospital for further evaluation.
Difficulty breathing 10 minutes after injection. Cleared up with allergy medicine. Extreme exhaustion that has continued for 3 days.
red arm, bluish tint, inflammation, fever in arm. instructed patient to take Benadryl, use hydrocortisone, and ice arm.