chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old male patient received BNT162b2 (BNT162B2), on 02Mar2021 as dose 1, single (Lot number: EN6200), in left arm, on 24Mar2021 as dose 2, single (Lot number: EP6955), in left arm, on 16Nov2021 as dose 3 (booster), single (Lot number: FF2593), in left arm and on 24Mar2022 as dose 4 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Treatment of COVID-19; (unspecified date) Positive, notes: Rebound COVID symptoms and positive test; (26Jul2022) Positive, notes: Originally tested positive on 26Jul2022,; (01Aug2022) Negative, notes: tested negative 01Aug2022; (05Aug2022) Positive, notes: tested positive 05Aug2022. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information:- The patient had no known allergies. The patient had not received other medication in 2 weeks. Patient received paxlovid covid-19 treatment on 26Jul2022 and the treatment stop date was 31Jul2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Vaccine administered after temperature excursion; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion). On 02-Apr-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment medication information was provided.
Public Health called to inform us we gave the patient a 4th dose of Pfizer. She answered a booster dose on her consent form stating it was her 3rd dose. Public health wanted a VAERS reported
04/20/2005-5:29 PM- ? Seizure after vaccine. Mom called last night and spoke with MD. Child was having "jerking movements" and had head to side. Was still breathing and looking at mom, but not responding. Lasted for few minutes, then stopped. MD recommended calling 911 if persisted and transport to ER for eval. Jerking movements stopped, pt slept well did fine overnight. Did have low grade temp 99. This morning saw pt during sibling eval. Good color, alert, playful, NAD. Complete exam including reflexes, tone, toes, ongoing. Exam WNL. Continue to observe. Mom also remembers pt being pale and listless after 2 month shots, but no reaction after 4 month shots.  Has tried to bring her in during mornings for shots in case of adverse events. Has also tried to give Tylenol and feed prior to vaccines, not able to do this yesterday. 5:35 PM tonight Mom called. Pt having jerking movements again and unresponsive. Breathing, but head turned to one side. Recommended 911 and transport to ER. No fever per mom. No family history of seizure. Pt is  a 4 month old female who had seizure-like activity six hours after receiving DPT and oral polio vaccine. This occurred the day prior to admission. Each episode lasted two to three minutes with shaking of the head and arms, with baby sleepy and fussy approximately 10-15 minutes after the shaking episode. There were rapid arm movements and leg movements. The pt had three more episodes on the day of admission, all within a 60 minutes period. The pt had a maximum temperature of 99.5 degrees rectally. All other symptoms were normal. Hospital course: The pt was admitted for observation and inpt EEG. She was given regular diet until midnight before EEG, where she was kept NPO for six hours and placed on IV fluids. The pt was given a sleep and awake EEG, no focal findings, read as normal EEG. Cultures taken including CSF cultures and blood cultures- no growth to date. On the day of discharge, the pt was at baseline per mother and father, taking the usual PO and having 2 bowel movements and a regular number of wet diapers. No episodes occurred during hospital stay. Pt discharged to home. The pt will follow up with PCP in 1-2 days. Follow up with neurology not necessary unless further episodes occur. The parents were given instructions to return to ER or PCM sooner if developed fever greater than 101 degrees or seizure like activity. 04/22/2005- TC to mom yesterday and today. Admitted to hospital. Full septic work up done, although no fever. Also had CT scan-WNL. EEG compeltely normal. Does not need neurology follow up unless happens again. Likely vaccine reaction. Has f/u here on Monday. Receive no further pertussis vaccine. Will also do VAERS. Home today. Per mom, doing well. No further episodes durning hospitalization.
syncope; extra dose of MENQUADFI was administered to a patient; Initial information received on 07-Apr-2023 regarding an unsolicited valid  serious case received from a consumer/non-hcp (Non-healthcare professional).  This case involves a 17 years old female patient who was administered an extra dose of Meningococcal A-C-Y-W135 (T Conj) Vaccine [Menquadfi] and experienced syncope.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 20-Mar-2023, the patient received 0.5 ml (Dose 3) of suspect Meningococcal A-C-Y-W135 (T Conj) Vaccine Solution for injection (lot number: U7449AA, Expiry date: 23-SEP-2024) (Frequency-once; Strength- standard)  via intramuscular route in the left deltoid for prophylactic vaccination (Immunisation).  On 20-Mar-2023, the patient was administered an extra dose of Meningococcal A-C-Y-W135 (T Conj) Vaccine (extra dose administered) (Latency: same day) and experienced syncope (syncope) (Latency: same day).  Supervisor reported an extra dose of MENQUADFI was administered to a patient who had a syncope episode after the administration. Caller is inquiring about safety information. This situation is reported as a medication error due to an extra dose of MENQUADFI being administered.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the events (syncope)  Outcome: Unknown for the reported event   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 2001/83/EC and Module VI of the Good Pharmacovigilance 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.  Seriousness Criteria: Medically significant for syncope.; Sender's Comments: Sanofi company comment dated 11-Apr-2023: This case involves a 17 years old female patient who was administered an extra dose of Meningococcal A-C-Y-W135 (T Conj) Vaccine [Menquadfi] and experienced syncope. Furthermore, information regarding condition at the time of vaccination excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
8 days after receiving MMR, varicella & Hep A, clients' guardian reported client had a rash on his fingers, fever, and swollen glands in his neck. Guardian took him to Dr. He was tested for influenza- Neg. Guardian states "tonsils were swollen".
No wheal formed on 1st dose/attempt. 2nd dose given; wheal form on 2nd attempt/dose
Pt recvd 1st Engerix-B on 22JUN91; immediately (w/in 5 min) inject site became red, swollen, warm to touch; Seen in ER; tx Seldane;
Anaphylaxis immediately after administration of the Flucelvax; This spontaneous case was received on 18-May-2023 from a physician (reference number: SEQW23-01397) and concerned a patient of unreported age and gender.  The patient's medical history and concomitant medications were not reported.   On an unspecified day in Oct-2022, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4v; dose: 0.5 ml, route of administration and anatomical location: not reported) for prevention of influenza disease. The batch number was not reported.  On the same day, immediately after receiving influenza vaccine, the patient experienced anaphylaxis.  The outcome of the event was not reported.   The reporter did not provide causality assessment.  The event of 'anaphylaxis' was considered to be medically significant by a Physician within Seqirus's Pharmacovigilance and Risk Management Department.  Company comment: A patient of unreported age or gender experienced anaphylaxis immediately after vaccination with influenza vaccine. Information regarding the underlying medical history and concomitant medications has not been provided. Information regarding the related diagnostic findings was not provided. Causality is assessed as possibly related based on suggestive temporal relationship. Limited information precludes assessment of Collaboration criteria for anaphylaxis.; Sender's Comments: A patient of unreported age or gender experienced anaphylaxis immediately after vaccination with influenza vaccine. Information regarding the underlying medical history and concomitant medications has not been provided. Information regarding the related diagnostic findings was not provided. Causality is assessed as possibly related based on suggestive temporal relationship. Limited information precludes assessment of Collaboration criteria for anaphylaxis.
Low grade temperature of 100.9, fussy. Vomited x1 after receiving Tylenol infant. Seen in our office 10/09/04 following drops above and again on 10/11/04. Doing much better.
mom states p/vax 13NOV96 pt became limp, had a fever of 103, had four seizures;on office visit to MD on 14NOV96 was sent to ER for EEG-p/5hr of observation was sent home;
This case was reported by a consumer via call center representative and described the occurrence of influenza in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced influenza and headache. On an unknown date, the outcome of the influenza and headache were unknown. It was unknown if the reporter considered the influenza and headache to be related to SHINGRIX. Additional information received as follows: The age at vaccination was not applicable for this report. The age group was not reported but was selected adult as per vaccine indication. The patient did not want to provide any details on herself or the vaccines. She called because she was concerned about getting the SHINGRIX vaccine. The patient had talked to the people that have had the flu and headache with SHINGRIX vaccine. This has been linked to the case US2018179209, reported by the same reporter.
Patient reports 15 minutes after administration of Booster COVID vaccine 10/08/2021  she developed numbness to her tongue and lower lip.  Reports she immediately took Zyrtec-D.  Patient states she also developed left arm pain and a raised warm welt over vaccine injection site.  Patient states she went to be the night of the vaccine, and when she woke up the next day 10/09/2021 the numb sensation to tongue and lower lip resolved.  Reports she continues to have a welt to her left arm.
patient with chronic pain to bilateral lower extremities and is followed by wound care. During visit, 6/24/21 an ultrasound of bilateral lower extremities was ordered due to the pain and wounds to both heels. The ultrasound indicated acute occlusive DVT left mid femoral vein segment.
Patient lost consciousness immediately after vaccination for < 10 sec. Eyes rolled back and hands clinched per mother of child. Was not witnessed.
Breakthrough COVID Case: I think I contracted COVID while flying. I stopped wearing my mask and I flew the week prior to testing positive. My wife was diagnosed the prior weekend having a sinus infection. She has since tested positive as well for COVID. I believe we both contracted COVID that the same time. Her symptoms started a few days before mine. Mine started the afternoon of May 9th. I tested positive Tuesday morning. I contacted my physician due to diabetes and she prescribed Paxlovid. I started the first dose was Tuesday evening, May 10th, and last dose was Monday morning. May 16th. Symptoms include sore throat, headache, body aches, chills, and congestion. I just went to the doctor again this morning, Tuesday May 17th, because I still have lots of congestion and a sore throat and pink eye. Symptoms of pink eye started Sunday, May 15th. Have been prescribed a Z-Pak and an antibiotic for the pink eye.
20 min after injection patient developed. a rash/hives mid chest to laterally of right chest wall and mid axilla. This also occurred upon her neck and face. She described a burning, "hot" sensation over her chest, neck, face and down her right arm. She was taken to the ER via her supervisor, admitted to the ER, given IVF's, steroids and Benadryl. She was monitored and was released later. MD stated she had an allergic reaction to this vaccine. She has had many Flu vaccines over the years and never had a reaction before.
I reported this through the system.  A agency representative called me and recommended I report this. For both dose 2 and dose 3 I had a severe migraine headache  (I am an established, stable migraineur, on therapy I get 0-1 headaches per YEAR). that lasted 4 days each time with a 2-week loss of sleep from the additional symptoms I experienced at night after the shots (shaking chills, nausea, dry heaves).
My lymph node in my neck swelled to the point it stuck out like a robin egg; sores in mouth (roof, gums, and inside lips); sores in nostril; sores on nose and lips; sores on nose and lips; Face swelled significantly on my left side; pink eye; severe headache; sinus pain; jaw main and numbness in my molars; severe shooting nerve pain in my front teeth; This is a spontaneous report from a contactable consumer (patient). A 47-year-old non-pregnant female patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; lot number: EL9262; expiration date: unknown), via an unspecified route of administration right arm on 23Jan2021 18:45 at a single dose for covid-19 immunization. Medical history included breast cancer survivor as of 11Sep2019. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medication included venlafaxine hydrochloride (EFFEXOR), clonazepam, anastrozole (ARIMIDEX), vitamin D3, calcium, vitamins NOS (MULTIVITAMIN), "It Works" and "Fat Fighter". The patient previously took fentanyl but had allergies. The patient did not receive other vaccines within 4 weeks prior to the COVID vaccine. The patient reported that her lymph node in her neck swelled to the point it stuck out like a robin egg. It was mentioned that it was more swelled there as well and super sensitive to touch. These reactions occurred only on left side of her face, sores in mouth (roof, gums, and inside lips) and sores in nostril. She had sores on nose and lips. The patient mentioned that her face swelled significantly on her left side. She had pink eye, severe headache, sinus pain, jaw main and numbness in her molars, severe shooting nerve pain in her front teeth. The events were considered as non-serious and adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient has not been tested for COVID-19 since vaccination. The events required treatment for the adverse events that included Keflex, Bactroban, prednisone, Valtrex, and lidocaine viscous-aluminum &magnesium hydrAM. The outcome of the events was recovering.
My face felt hot; face and lip were slightly swollen; face and lip were slightly swollen; This is a spontaneous report from a contactable other HCP (patient). A 52-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Ek4176) via an unspecified route of administration at left arm on 12Jan2021 17:00 at single dose for COVID-19 immunization. Medical history included COVID prior vaccination. Concomitant medication included unspecified medications. The patient previously took hydrocodone bitartrate paracetamol (VICODIN) and experienced known allergies. After approximately 45 minutes after vaccination, her face felt hot and her face and lip were slightly swollen from 12Jan2021 18:00. No treatment received. No other vaccine in four weeks. No COVID tested done post vaccination. The outcome of the events was recovering.
My arm was sore, 3/3/2021 headache on top left and to behind my eye and between eyebrows and it was hurting bad, sharp pains on my head. Then the pain was on top of my head and below my eyes; Migraines. I never had this before. I saw my doctor in May or June2021.
Sudden onset of hives 5 days after administration of vaccine, that it itches. Turned into a patchy, scaly skin rash that itches and burns.
Syringe came off of needle in arm without any medication administered.  New dose was then given per nursing student.
I got my first shot on 1/5/2021.  I had no adverse effects from the first shot.  Three weeks later I got my second shot on 1/26/2021.  Three days after that, on 1/29/2021, I became quite ill.  I had sudden onset of total body weakness, I was unable to sleep for 4 days, I developed a constant frontal headache, I felt like my body was electrified, my eyes started twitching and feeling like my eyelids were being pulled, my face felt like it was being pulled on one side, my nose became runny and hasn't stopped.   To this day I have no energy and am not like my old self before the shot.  I have gone downhill incredibly fast.  My doctors don't know what to do with me and I don't think things are going to get better.  My day to day life is a struggle.  I have no energy to do things.    One of the only things I have not had is a fever.    My eye doctor told me he thinks I had a GROSS IMMUNE SYSTEM REACTION to the vaccine.   0 I would appreciate it if there is anything you can do to help me.    Thank you,
Patient admitted to hospital  for altered mental status, was fully vaccinated for COVID. Course complicated by  COVID+ multifocal pneumonia, profound metabolic acidosis, AKI, and a CT A/P , CVVH to HD. Patient was discharged to rehab.
Headache and body ache - took 1 tab of Tylenol 12 hours apart to no effect Swollen lymph nodes - no treatment
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 02-FEB-2015 the patient was vaccinated with VARIVAX (Merck) (0.5 ml, subcutaneously) that underwent two temperature excursions. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Medical history, concurrent conditions and concomitant medications were not reported. On 10-JAN-2014, the patient was vaccinated with a dose of improperly stored PEDVAXHIB (lot number # J005672, Expiry date: 05-DEC-2015) (dose and route were not reported). No adverse experiences were reported. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients were inadvertently vaccinated with doses of GARDASIL (lot # reported as 003520 exp April 2015) that were improperly stored. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Severe sore arm for 2 days after vaccine. Rash/hives for 3 days after vaccine
Approximately 5-10 minutes after below immunizations c/o "not feeling well, itching" red rash to forehead and along right side facial/neck region. MD present, and 1 1/2 tsp (12.5 mg/5 ml) oral Benadryl at 10:15a. Br sounds - clear bil, no SOB/cough. Left deltoid region (DTaP site) sl redness, no rash. Vital sign remain stable; 02 Sat 99%. Dc'd at 10:30a, instructed to give Benadryl PO q6 hours per ER if symptoms return.
Fever (Tmax 38.9), rash, inconsolable for 3 hrs, seizure for 2-3 min. consisting of shaking of trunk and lips & eyes rolling into the back of his head, events occurred about 1-hr after vaccine was administered.
I started feeling twinges of pain on my lip inside the roof of my mouth and in the corner of my eye on Friday April 9th. This got progressively worse through weekend and I started having a rash or raised bumps in those areas. On Monday April 12th I saw my dermatologist and was diagnosed with shingles.
pt stated w/in 3 days of receiving vax devel fever, nausea, diarrhea, malaise; sx presented for approx 10 days; also had joint pain, lt shoulder pain; 5-7 days later but this could have been related to other activities;
> 35 day after the first dose; Was COVID positive after the first dose; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Was COVID positive after the first dose) and PRODUCT DOSE OMISSION ISSUE (> 35 day after the first dose) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, the patient experienced COVID-19 (Was COVID positive after the first dose). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (> 35 day after the first dose). At the time of the report, COVID-19 (Was COVID positive after the first dose) and PRODUCT DOSE OMISSION ISSUE (> 35 day after the first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment medications were reported.
varicella area where varicella  was given resulted in a 1"x1.5" rash, RPh instructed to take  Benadryl, watch for increase  in rash area & Tylenol/ice if needed
Tired; Headache; Low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Tired), HEADACHE (Headache) and PYREXIA (Low grade fever) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced FATIGUE (Tired), HEADACHE (Headache) and PYREXIA (Low grade fever). At the time of the report, FATIGUE (Tired), HEADACHE (Headache) and PYREXIA (Low grade fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
7-8 after receiving PNEUMOVAX, pt had rash on injection site w/c progressively increased in size prompting ER consult. Rx CEPHALEXAN and PREDNISONE.