chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Report received on 10.May.2012 from an Infectious Disease Clinic and forwarded by Crucell, ref. no. CV-026-2012. This case concerns a female patient who received VIVOTIF (batch number not reported) on an unspecified date. The patient's medical history and concomitant medications were not reported. The patient took VIVOTIF 2 to 4 months before the time of this report. She then traveled. It was reported that she was not sick. On an unspecified date, the patient was tested positive for salmonella typhi O type 6 antibodies. No further details were provided. The case was considered non-serious.
NO ADVERSE REACTION REPORTED. A PFIZER VACCINE WAS ADMISNISTERED TO A PATIENT AFTER BUD OF 7/22/22. PATIENT, RECIEVED A PFIZER BOOSTER SHOT 6 DAYS AFTER BUD. The medical/safety team at Pfizer WAS CONTACTED AND indicated THE DISCOVERING PHARMACIST they do have stability but not efficacy data on the adult Pfizer vaccine beyond 72 days when stored in a refrigerator. They recommended that our rph contacts the CDC and inquires about repeating doses for these patients. Speaking with the CDC employees, our rph was given the same information as above and referred to the immunization division at the DOH.  Our rph contacted the DOH in the state, but she was asked to confer with either pharmacy's Medical Doctor or the standing order physician. Our rph was able to interact with the latter, and she was given the guidance of re-vaccinating . In the context of the guidance from the standing order physician, the patient will need to repeat the dose. Regular schedules for series completion/booster doses will be observed if/when warranted.
Case recieved dose 1 of Moderna on 2/1/21 and dose 2 of Moderna on 3/1/21. On 12/4/2021 she was admitted to Hospital for DKA and subsequently tested positive by PCR upon admission.
Received vaccine 2/2/2021 at 12 pm. By 8 pm that day I felt very tired and went to bed until 1 am, when I woke up with Flu, cold, and GI symptoms. I had a fever a little over 100 degrees F, full body aches and chills, vertigo like symptoms that made me vomit every time I changed position. This continued until 2/5/2021 when the vomiting got worse and I could not keep down water. I went to urgent care and was given IV fluids and felt a lot better. When I woke up on the 6th, I was feeling mostly back to normal, just tired, as after any illness.
DTP/OPV/HIB given on 22JAN91; Approx 6 hrs p/immun pt developed temp 105.0;
Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Body Aches Generalized-Severe, Systemic: Chills-Severe, Systemic: Confusion-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fever-Severe, Systemic: severe flu-like symptoms-Severe, Systemic: Headache-Severe, Systemic: Weakness-Severe, Additional Details: husband reported patient had severe flu-like sypmtoms
Patient's wife called to clinic, states he has been in the hospital for two days and is moving to the ICU, they suspect Guillain-Barre syndrome.
5/3/12: upon waking noticed hot, red swollen size of half dollar spot at injection site. also itchy legs in patches. 5/5/12: eye swollen shut, extremely swollen lips, rash under breasts, and at waist, tongue swollen.
Local reaction and cellulitis at injection area.. .went to urgent treatment care and was put on Keflex and Prednisone...went to Emergency Room a week and a half later for severe headaches and was diagnosed with a Tranverse Sinus Venous Thrombosis3/9/09-records received for DOS 2/20-2/23/09-DC DX: Transverse sinus thrombosis.  C/O headache consistent with migraines began 4 days prior to admission.
Patient verbally reported age of 18 years old, staff did not catch that patient was only 17 years old. When filling out the vaccine paperwork the patient put 17 on the front of the sheet but marked that she was between 18 and 49 years old on the back of the sheet. She was administered a Johnson and Johnson vaccine dose without our staff realizing she had not yet turned 18 years old this year.
Information has been received from a physician concerning a patient who was vaccinated with a dose of Varivax. Subsequently the patient experienced an unspecified adverse reaction. Unspecified medical attention was sought. A product quality complaint was not involved. Additional information has been requested.
Booster given 12 hours after vial puncture; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Booster given 12 hours after vial puncture) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Booster given 12 hours after vial puncture). On 10-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Booster given 12 hours after vial puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medications were reported.  No Treatment details were reported.  Patient received booster shot 12 hours after vial puncture   This case was linked to MOD-2021-416295 (Patient Link).
patient was given 3 Liter of oxygen via nasal cannula. patient complained of not being able to breathe. patient complained of severe lower back pain, severe thigh pain that was alternating back and forth. Denies shooting pain down legs . patient complained of chest pain. Vital were taken, 211/133 pulse 90. Attempted to get second B/p. patient took off b/p cuff stating is was hurting her non-dominate arm. Denies tingling in any extremities. After 20 minutes patient complained of numbness in her toes. Denies any pain radiating down or upward for local pain locations.
Information has been received from a consumer concerning her 10 year old son with an allergy to ibuprofen (MOTRIN) and no other medical history who on 17-JUN-1998 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (lot number was not available). There was no concomitant medication. On 14-SEP-2007 the patient developed a mild case of chickenpox approximately 9 years later. Unspecified medical attention was sought. No lab or diagnostic studies were performed. Subsequently, the patient recovered. There was no product quality complaint. This is one of several reports from the same source. Additional information has been requested.
Patient is a 78 y.o. year-old female who  has a past medical history of Asthma, Depression, Liver mass and Type 2 diabetes mellitus who present to ED due to weakness, decreased PO intake, abdominal pain, and nausea for one month, found to be COVID-19 positive.   #) Acute hypoxic respiratory failure requiring supplemental oxygen secondary to COVID 19 PCR Test positive on 9/22 at Hospital /Plan: - Continue Oxygen per nasal canula. Titrate O2 for 92-96% - Airborne precautions, including use of N95 masks, face-shields, gown, gloves - Acetaminophen 650mg PO Q6h PRN for fever - Guaifenesin - Pantoprazole   # Viral pneumonia secondary to SARS/CoVID-19 pneumonia - PCR Test positive on 9/22 at Hospital - Acetaminophen 650mg PO Q6h PRN for fever - Guaifenesin - Pt has been on room air and did not require dexamethasone or remdesivir  Discharge Disposition/Condition Disposition: Rehab facility (specify) Condition: Stable (s/sx potential problems absent or manageable)
Swelling of right extremity from DTaP injection. No pain. Normal mobility. Motrin/ Tupin 24-48
Headache, tiredness, nausea, arm stiff/sore the eve of and day following the shot.  Approx 1 week later had scratchy throat and fatigue followed by headache, body ache and nausea which lasted for a couple of days.  Out of concern was tested for Covid-19 and test results were negative.
7 hours after dose given developed headache, chills, fatigue, body aches. Temp up to 102.2  at approximately 14 hours after vaccine administered
This medically confirmed spontaneous report (initial receipt 29-SEP-2014) concerns a female patient. On 16-SEP-2o14, the patient received AFLURIA (batch number not provided). On an unknown date, two days post vaccination, the patient experienced aching pain in her whole left arm which was not just at the injection site. The patient treated herself with naproxen but it did not work. The patient will try using Advil (ibuprofen) for the pain. Outcome was reported as unknown.
Case number PHEH2014US003813 is an initial spontaneous report received from a pharmacist on 21 FEB 2014. This report refers to an 11-year-old male patient who was inadvertently vaccinated with FLUCELVAX (batch number: 004011A and expiry date: JUN 2014) intramuscularly at a dose of 0.5 ml on 06 JAN 2014. No adverse event was reported following this administration error (inappropriate age at vaccine administration).  Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 21 FEB 2014: The BPI labeling of the event "inappropriate age at vaccine administration" changed from listed to unlisted and added second indication as Adult product administered to child.
Face and Neck red, swollen and hot to the touch.; Face and Neck red, swollen and hot to the touch.; Face and Neck red, swollen and hot to the touch.; Face and Neck red, swollen and hot to the touch.; Face and neck red, swollen and hot to the touch.; Similar to a Cortisone flush.; This is a spontaneous report from a contactable consumer, the patient. A 66-year-old female non-pregnant patient started to received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/lot number: EL3246), via an unspecified route of administration in the left arm on 29Jan2021 at 16:00 (at the age of 66-years-old) as a single dose for covid-19 immunisation. Medical history included diabetes mellitus, renal disorder fibromyalgia and hypersensitivity (allergies to medications, food, or other products). 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 received multiple concomitant medication (unspecified). The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31Jan2021 at 14:00 the patient expereinced face and neck red, swollen and hot to the touch, similar to a cortisone flush. On 31Jan2021 the patient underwent lab tests and procedures which included blood pressure measurement: normal and body temperature: 97.3 (normal). The patient was treated for face and neck red, face and neck red, swollen and hot to the touch similar to a cortisone flush with 50mg of benadryl (MANUFACTURER UNKNOWN). The outcome of the events was recovering.   No follow-up attempts are possible. No further information was expected.
I started feeling kind of sinus congestion with my ears pretty congested and hurting; I definitely felt under the weather almost like feverish; Feeling like a bad sinus cold; I started feeling kind of sinus congestion with my ears pretty congested and hurting; I started feeling kind of sinus congestion with my ears pretty congested and hurting; I definitely felt under the weather almost like feverish; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6206, Expiry date: unknown), via an unspecified route of administration on 12Mar2021 as dose number unknown, single for covid-19 immunisation. The medical history and concomitant medications were not reported. The patient experienced kind of sinus congestion with the ears congested and hurting, felt under the weather almost like feverish, did not have a fever but felt like a bad sinus cold on an unspecified date. So, was wondering if it was safe, can take Ibuprofen but can decongestant be taken. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
pt recvd vax;was irritable;high pitched cry;fontanel slightly full;had sz & was in full status epilepticus;limp;pale & breathing very shallow eyes rolled back;not responsive;acidotic;twitching;jerking;encephalitis; gaestroenteritis;dehydrat
Eight days after the first injection a slight, itchy rash developed under the site. The morning after the second dose I woke with a headache, which I still have four hours later and the injection site is more sore than the first injection.
I am reporting my COVID-19 symptoms 11/04/2021. My symptoms was moderated. A very bad cough that would cause me to start vomiting. I had fatigue, lost of taste and smell, fever and running nose. My symptoms last until 11/13/2021. I still have some symptoms with the lost of taste and smell. And as of January I was still having some breathing problems. I believe that my breathing is a lot better. I haven't notice any in a few months. The doctor had prescribe albuterol and benzonatate. I have completed that treatment of medicine.
Acute nausea & retching. Unable to eat or drink. Temperature of 103 degrees on onset. Took next day to bring temperature down. Went to urgent care. Was given intravenous fluids for several hours & ZOFRAN for acute nausea. Was given prescription of COMPAZINE.
Arm pain that did not resolve as of this day ( 10/27/21) and now is in my elbow, forearm, and causing me occasional tingling in my palm. The pain has become severe and is worse at night, sometimes prevents me from regular activities such as working out, putting on a shirt, washing my hair.
Pt. states that after receiving the 1st dose of Phizer 08/04/2021, started experiencing symptoms 08/04/2021 immediately after of Burning at injection, passed out, burning in the leg left Difficult to walk, 08/07/2021 Urgent Care, ER 08/08/2021 X-Ray. MRI 08/18/2021 Primary visit.
Patient was found in clothing section of store from friendly person who noticed. Patient reports not hitting their head. Patient was moved back to pharamcy to sit at bench to assess them. Pt reports having this happen before after vaccination. Patient was conscious and aware of surroundings. Patient was instructed by wife to stay put until she got to the pharmacy. Patient appeared to be of sound mind after leaving pharmacy.
pt recvd vax & lab tests done, revealed anti HBs & HBc pos;
back is hurting severely; body aches; feels horrible; This case was reported by a consumer via call center representative and described the occurrence of back pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st July 2021, the patient received the 1st dose of Shingrix. In July 2021, less than a week after receiving Shingrix, the patient experienced back pain, general body pain and feels awful. On an unknown date, the outcome of the back pain, general body pain and feels awful were not recovered/not resolved.   The reporter considered the back pain, general body pain and feels awful to be related to Shingrix.  Additional details were provided as follows: This case was reported by patient herself. The age at vaccination was not reported. The patient received 1st dose of Shingrix and experienced body aches, back was hurting severely and was unable to go to work because she felt horrible.
I had a stuffy and runny nose, I was sneezing. I thought it was allergies, it started to feel different than allergies. I took a home COVID-19 test that came back positive. I had just moved, so I called to my prior doctor and consulted with the office they phoned in a prescription of the Paxlovid. I had a sore throat, within a day of starting the medication I was feeling much better.
"Yesterday after my shot I started getting sore about 4 o'clock. Today my left arm is very sore, my lymph nodes under my arm are swollen and I have redness and a knot where she gave me my shot." Advised patient to apply ice for 20 minutes at a time intermittently and notify MD. Also advised to go to ER for rash, hives, difficulty breathing.
Presented to  ED on 2/13/2023 with a two day history of body aches, vomiting, fevers, headache, and myalgias Pt noted to be awake and alert, however acting strangely; neurologic status acutely decompensated tachycardic in 180s-190s and hypotensive, emergently intubated and started on norepi infusion.  CT as noted below.  Loaded with 1g Keppra. Neurosurgery consulted, exam notable for nonreactive pupils, no corneal/cough/gag reflexes and no motor response to noxious stimuli. Pt was taken emergently for decompressive hemicraniectomy. She received 100g mannitol intraoperatively. no recovery of brainstem reflexes. Loaded with Keppra and started on maintenance. Post op CToH with expected diffuse cerebral edema and diminished grey-white. LP performed 2/14 to evaluate infectious etiology which was negative. Terminal extubation on 2/15/23
This spontaneous report as received from a pharmacist refers to a male patient of unknown age. The reporter stated that the patient received his first dose of GARDASIL (0.5  ml, intramuscular (reported as IM) on 22-APR-2014, received his dose 2 of GARDASIL on 22-MAY-2014 and received dose 3 on 24-JUN-2014. Pertinent medical history and concomitant medications were not reported. No adverse effects reported. The outcome of the events was unknown. No further information was available. Additional information has been requested.
Fever and headache exactly 24hr later; Red swollen warm itchy circle at injection site several days later
Headache Narrative: Employee is under a Dr. for her continued Migraine H.A. since she had 2nd vaccination on 1/28/21. She reports she has had 7 migraine H.A.,  each one knocks her out for the day. She has to take prescription medication for  relief. She is concerned about long term effects.   Other Relevant History
Atrial fibrillation, dizziness, difficulty breathing, profuse sweating, pulse 110, very high blood pressure starting approximately 10 minutes after injection. Transferred to emergency room.
Pt developed severe systemic juvenile rheumatoid arthritis seven months p/vax w/MMR;
Patient is fainting right after getting the vaccine and lasts for 1 minute and then recovered back after tapping on the patient and then fainting second time and then recover from fainting. Then he said he felt nauseous and after giving some water he recovered gradually. EMS was dispatched to the scene and they checked on his blood pressure and pulse oxygen and was confirmed to be going back to normal. He refused to go to the hospital then EMS and police left the scene
chin became red and swollen; pain in their eyes and between the eyes; in the left arm itched; redness of 8cm by 2cm in size in the left arm; the left arm hurt; high fever of up to over 103°F; bad headaches; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (chin became red and swollen), EYE PAIN (pain in their eyes and between the eyes), VACCINATION SITE PRURITUS (in the left arm itched), VACCINATION SITE ERYTHEMA (redness of 8cm by 2cm in size in the left arm) and VACCINATION SITE PAIN (the left arm hurt) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 29-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-May-2021, the patient experienced SWELLING FACE (chin became red and swollen), EYE PAIN (pain in their eyes and between the eyes), VACCINATION SITE PRURITUS (in the left arm itched), VACCINATION SITE ERYTHEMA (redness of 8cm by 2cm in size in the left arm), VACCINATION SITE PAIN (the left arm hurt), PYREXIA (high fever of up to over 103°F) and HEADACHE (bad headaches). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 02-Jun-2021, EYE PAIN (pain in their eyes and between the eyes), PYREXIA (high fever of up to over 103°F) and HEADACHE (bad headaches) had resolved. At the time of the report, SWELLING FACE (chin became red and swollen), VACCINATION SITE PRURITUS (in the left arm itched), VACCINATION SITE ERYTHEMA (redness of 8cm by 2cm in size in the left arm) and VACCINATION SITE PAIN (the left arm hurt) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were provided As reported patient used cortisone for the arm only the following day after vaccination and fomentations (compresses) for the arm.
I want to say that I received my first vaccine on January 2021, started having headaches for three weeks. Then I got second vaccine in February I also had headaches. On the third vaccine I got a fever on November 06, 2021 with more intense headaches. Last week I was not able to work 02/02/2022 to 02/04/2022, had disability note. I  had MRI on 02/12/2022 I have migraine headaches, really bad. I had an MRI came back normal. I am under medication to suppress the migraines.  I also have muscle aches and pain. I also took OTC Ibuprofen as pain mediation. I start having a bad headache on 01/22/2022, left side of my head feels very very high pressure and tingling sensation and numbness to the inside of my nose, only my left side and I started worrying. I went to ER stayed there 3 hours and then released me. On  January 26, 2022, with the same symptoms of my migraines and high blood pressure. On the 01/26/2021, my blood pressure was 107/90. I was not able to leave my work on 01/28/2022 due to a meeting and I told my supervisor I had to go again to the ER. On 01/30/2022 I went again to the ER due to my migraine headaches and took labs, was given IV and I stayed there for 5 hours and then the nurse told me that your PCP needs to see you. On 01/31/2022 I was put IV and I was sent to the neurologist and I will give you a week off from work. On 02/10/2022 I went to see a neurologist and that is when they start me on medication for my migraines. I got an MRI on 02/12/2022 of the brain. MRI did not show any abnormal findings.
UPON WITHDRAWAL OF THE INJECTION NEEDLE FROM THE LEFT DELTOID AREA, PATIENT DEVELOPED VASOVAGAL SYNCOPY. PATIENT WAS PLACED IN SUPINE POSITION WITH HIS LOWER EXTREMITY SLIGHTLY ELEVATED. PATIENT RECOVERED WITHOUT LOOSING CONCIOUSNESS. BP 123/83, HR 55. PATIENT VERBALIZED THAT HE DID NOT HAVE BREAKFAST BEFORE VACCINATION. PROVIDED WATER AND ORGANIC APPLE SAUCE. PATIENT LEFT CLINIC FEELING WELL.
This initial spontaneous report was received from a registered nurse referring to 7 unspecified patients of unknown ages and genders. There was no pertinent medical history, concurrent conditions, concomitant medications or drug allergies/drug reactions described. The reporter stated that on unspecified dates between 13-NOV-2015 and 17-NOV-2015, the patients were administered improperly stored doses of PEDVAXHIB injection (lot # L030864 with expiration date 07-JUN-2018; dose and route were not reported). No adverse effects were reported. It was unknown if the patients sought medical attention. Product quality complaint (PQC) was not involved. Additional information has been requested.