chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt stopped back in the office several hours after vaccination. The right side of her face was red, a bit swollen and tingling. Pt does not have SOB, hives or any other symptoms. Pt states she did not take any medication or eat anything unusual this morning. Pt told to go to Urgent Care/ ER to be assessed for potential allergic reaction to vaccines. Patient went to ER and was evaluated.  Prescriptions were given for Predisone 5-day pack, Benadryl PRN, and also given a script for an Epi Pen.  On 01-04-2023 patient states the swelling is resolved and most of the redness and tingling is resolved / improving. Patient requested that only minimal PHI be used for this report.
Patient came in for 2nd dose of Shingrix at pharmacy on 11/20/20 and reported left arm soreness in deltoid area that began the same dame as vaccine administration (09/09/20) and has persisted since then. Patient received his first Shingles vaccination in the right arm and his yearly flu shot in the left arm on 09/09/20. Patient said the pain was from his Shingles shot, but the Immunization Registry has the Afluria documented as being given in the left arm. It is most painful when he lays on his arm at night. Patient also reported feeling fatigued and achy for about three days after getting the vaccines, which I explained to him was a normal response to the Shingrix vaccine. I encouraged the patient to check in with his provider to determine the source of his shoulder pain (if vaccine administration-related or other) and recommended acetaminophen OTC and ice in the mean time to help.
RN drew up in syringe Tdap, which was administered.  Spoke with mother; baby did not experience fever, was not cranky, irritable, did not have redness at site.  Baby breastfed/bottle fed normal; slept normal.
REDNESS AND PAIN AND SENSITIVITY TO THE SITE OF VARICELLA INJECTION.
I started to have a cough, and my eyes felt like they were stinging. I had a fever of 101. I took Tylenol to reduce the fever and it helped to bring it down, but my fever kept coming back.  I took a COVID-19 test the next day and it came back positive. Over the next few days my symptoms had gotten worse, and I felt really tired.  I had a telephone visit with a doctor on 2/27/2023 and I was prescribed Paxlovid. I was unable to get my prescription for the medication until 3/2/23. My symptoms lasted for about 6 weeks.
After the initial soreness stopped, patient states that about 2 days later the area on the right arm of the TWINRIX began to swell and become red. Today the patient contacted us and stated the arm is painful, still red and swollen, and is interfering with daily activities. Patient has not yet sought any treatment but has been referred to her primary care.
At approximately 1:45PM this patient was advised she could leave after her 15 minute wait time post vaccination. At that time when the patient attempted to stand she stated she felt extremely dizzy and was having heart palpitations. At this time RN assessed this patient took her vitals signs at approximately 1:50PM and they were as follows: Oxygen-94, Pulse 77, BP 132/84. The patient was given water and observed for 15 minutes longer, then complained of chest pain and continued dizziness, patient was assisted to private car via wheelchair and advised to seek emergency medical attention. She declined an ambulance at the time.
sx of covid ST fever body aches/+ rapid AG test; sx of covid ST fever body aches/+ rapid AG test; Booster; This is a spontaneous report received from a non-contactable reporter (Nurse).  A 34-year-old male patient received bnt162b2 (BNT162B2), administration date 08Oct2021 (Lot number: FF2589) at the age of 34 years as dose 3 (booster), single, administration date 06Apr2021 (Lot number: EL3247) as dose 2, single and administration date 04Mar2021 (Lot number: EL3247) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Unknown if other vaccine in four weeks. Unknown if covid prior vaccination. The following information was reported: IMMUNISATION (medically significant) with onset 08Oct2021, outcome "unknown", described as "Booster"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 01Jan2022, outcome "recovering" and all described as "sx of covid ST fever body aches/+ rapid AG test". The patient underwent the following laboratory tests and procedures: AG home/Home Ag: (01Jan2022) positive; (03Jan2022) positive. It was unknown if therapeutic measures were taken as a result of covid-19.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product bnt162b2 to the reported vaccination failure and COVID-19 cannot be ruled out.
This case was reported by a other health professional via sales rep and described the occurrence of shingles in a female patient who received Shingrix for prophylaxis. The patient's past medical history included shingles. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 7 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to Shingrix. Additional information was reported as follows: The age at vaccination was not reported. The patient experienced second round of Shingles after vaccination with Shingrix.
Client reported a history of syncope after vaccinations to RN prior to receiving the vaccine today. The client was vaccinated while seated in the anti-gravity chair. At 7:35 PM the client reported feeling lightheaded. RN responded. RN reclined the anti-gravity chair to a low-fowler's position. RN noted the client close her eyes and her body relax for about one second. The client opened her eyes and RN provided the client with an alcohol swab to smell. The client reported "dizziness, tingling on ears, and seeing spots." The client stated all of these symptoms are normal for her after receiving and injection. Vitals obtained at 7:35PM were as follows: automatic BP 93/58, HR 68, O2 99%. The client reported a history of hypotension. The client stated that her systolic blood pressure is usually under 100. Repeat vitals obtained at 7:45 PM were as follows: BP 111/66, HR 70, O2 99%. The client denied any symptoms at that time. RN provided education regarding s/s of anaphylaxis and when to seek EMS. The client voiced understanding of this education. RN adjusted the anti-gravity chair to a high fowler's position. Repeat vitals obtained at 8:01PM were as follows: BP 105/70, HR 75, O2 99%. The client denied any symptoms at that time. The client left the vaccination site at 8:05PM. The client ambulated unassisted with a steady gait.
4/15/08 Recieved Zostavax vaccine.  24 days later developed scattered lesions.  A few on arm and a few on legs. She felt it was related to her gluten intolerence.  Her PCP started her on Topicort.  On 5/14/08 she developed 2 areas of lesions right above her RUQ. They gradually spread along the right side to her back. She went to the ED on 5/27/08. She was diagnosed as having Shingles.  She was prescribed Valtrex and given Oxycodone for pain.  As of my interview today the lesions are scabbed and no new outbreaks occuring.  She has postherpetic neuralgia.  Rated a 10 on a pain scale.
Zostavax "VZV" was administered to a 17-year-old patient; Literature Report.  This literature marketed report as received from the authors of a published literature article, titled as stated above, and refers to a 17-year-old female with congenital Shone complex with post-operative complications resulting in moderate heart failure with reduced ejection fraction (HFrEF; EF less than 40%).  On an unknown date in 2009, the patient was vaccinated with influenza vaccine, measles, mumps and rubella  (Wistar RA 27-3) Virus Vaccine, Live (MMR), diphtheria vaccine toxoid, pertussis vaccine acellular, polio vaccine inact and tetanus vaccine toxoid (DTaP/IPV) and zoster Vaccine Live (VZV) (strength, dose, route of administration, anatomical location, lot number, and expiration date were not reported) (product administered to patient of inappropriate age).  A copy of the published article is attached as further documentation of the patient's experience.
8 days of strong fatigue with some confusion and some high blood pressure .. I haha even CFS and this seems to be  a strong extension of my condition.. Will it end? Treatment is rest  , hydrate  .. also some very strong migraine like head aches ..My fear it won?t go away since the CDC mentions nothing for prolong symptoms
A serious report of hypoxia, exacerbation of asthma, and positive for influenza A and B has been received from a physician concerning an eight- year-old male. The patient had a medical history of asthma and was seen in the physician's office on 20-NOV-2007, for a wheezing episode that occurred on 27-Nov-2007. No concomitant medications were reported. The patient received FLUMIST on 28-Nov-2007. On 06-Dec-2007, the patient was hospitalized with hypoxia and exacerbation of asthma. On 09-Dec-2007, the physician tested the patient for influenza and a nasopharynx wash was positive for influenza types A and B. The patient currently remains in the hospital. No outcome for the events was provided by the reporter. The patient did not experience a rechallenge while receiving the suspect product. The reporter provided no causality assessment for the events. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.
This spontaneous report was received from a registered nurse referring to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, beginning sometime in 2016, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # M031557, expiration date 07-APR-2019 (dose and route of administration were not reported) for prophylaxis. There were no symptoms reported. Administered doses of GARDASIL 9 were exposed to a temperature excursion of 0°C to 1°C for 20 hours 75 minutes. Data logger was involved. There were previous excursions but the reporter did not have the details. Additional information has been requested.
Woke up with severe pain yesterday at right upper arm injection site. Mom called nurse and discussed. Temp 100. Redness and tight area as big as Mom's palm present today. Dr at walkin clinic stated area  very  inflamed or infected and gave antiobiotic. Augmentin given. Told Mom to return in 48 -72 hours if not inproved.
1. Extreme sleepiness- slept from 2:00 to 7 the next morning. Then slept over 14 hrs next three days. I continued to feel very sleepy for around 5 months, not exhausted but just sleepy 2. Severe arm pain. Could not lift my arm at all. Arm pain shooting if I moved. It got to where I could lift my arms to shoulder level without severe pain, but I still have shooting pain in both arms if I raise my arms above shoulder level. I haven't gone to a doctor because I kept thinking it would go away. 9 months later it?s not going away. I guess I'll have to make a dr appt for this. Really weird soreness that continues.
seizures at night after first HPV dose, then a witnessed daytime seizure after second HPV dose was given on 2/21/23. ED visit after seizure on 2/27/23
Nausea and vomiting immediately, then ceased overnight and resumed at 4am the next morning, ongoing every 30 minutes for hours
Expired dose was given to a patient; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 31-year-old female patient who received HAB (Twinrix) (batch number P9LT9, expiry date 1st January 2023) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 13th February 2023, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On 13th February 2023, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 13-FEB-2023 Reporter's Comment: The reporter was medical assistant. The reporter called to report that an expired dose of Twinrix was given to a patient and provided information about vaccines and patient. Information was read and reporter agreed to receive it by e-mail. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.  Additional Supportive Information: The reporter called to report that an expired dose of Twinrix was given to a patient, which led to expired vaccine used.
sweating bad; feels hot and cold; shakes like she was nervous; hoarse; nauseated; throwing up; headache; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweating bad), FEELING OF BODY TEMPERATURE CHANGE (feels hot and cold), TREMOR (shakes like she was nervous), DYSPHONIA (hoarse) and NAUSEA (nauseated) 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.     Concurrent medical conditions included Shellfish allergy, Seafood allergy, Penicillin allergy, Iodine allergy, Drug allergy (Phenergan.) and Blood pressure high. Concomitant products included AMLODIPINE, FLUOXETINE and GABAPENTIN for an unknown indication.   On 22-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, the patient experienced HYPERHIDROSIS (sweating bad), FEELING OF BODY TEMPERATURE CHANGE (feels hot and cold), TREMOR (shakes like she was nervous), DYSPHONIA (hoarse), NAUSEA (nauseated), VOMITING (throwing up) and HEADACHE (headache). The patient was treated with ONDANSETRON (ZOFRAN [ONDANSETRON]) for Nausea, at an unspecified dose and frequency. At the time of the report, HYPERHIDROSIS (sweating bad), FEELING OF BODY TEMPERATURE CHANGE (feels hot and cold), TREMOR (shakes like she was nervous), DYSPHONIA (hoarse), NAUSEA (nauseated), VOMITING (throwing up) and HEADACHE (headache) outcome was unknown.
Extreme anxiety, agitation, and suicidal ideation. Patient self administered 30 mg diazepam 1 hour after onset. Symptoms have not yet resolved. Patient is currently under outpatient psychiatric care.
Inability to stand or walk without falling.  After calling 911 I was taken by ambulance to the hospital after firefighters carried me down the stairs from my bedroom.  I was in the emergency department in a room for 24 hours receiving every neurological and cardiovascular test available,  including MRI, CT Scan, MRA, ECG, and some I cannot recall.  I was given IV medications, fluids, etc for the duration of this 24 hour period.  Finally, I was discharged with a diagnosis of "Vertigo" which I had never experienced before in my lifetime.  It was a horrible, uncomfortable, scary ordeal I would never want to live through again.
Burning red hives all over body. Pt took ATARAX that she had to offset the allergic reaction.
Approximately 8 hours after my vaccine the back of my knees were swollen/puffy.  As of today June 26th I still have puffiness/swelling behind my knees.  Some days it is less puffy/swollen and other days more so.  I have never had this symptom ever before.
Two days after round 2 of vaccine: Severe chest pain and shortness of breath, followed by low energy and drowsiness. Felt just like  Pericarditis that I had back in February.  This was confirmed with EKG.  Chest X-Ray unremarkable.    Pericarditis earlier diagnosed on February 16th, assumed by medical professional that likely had COVID at that time based on recurrence after vaccine.  No previous occurrence of Pericarditis prior to Feb 2021
Patient currently admitted at (6) days starting 11/20/2021. Patient is a 61 y.o. male who presents today with progressive shortness of breath. Began last Thursday with fatigue, cough, exertional dyspnea, and malaise. Progressed to significant shortness of breath with diarrhea for last 3 days and poor PO intake due to loss of taste. Patient has been trying to drink gatorade and eat small amounts of crackers or toast when he can but it has been challenging. He tested his oxygen saturation at home (wife works in hospice) the last few days and he was in the 80's and decided to come in. Heis vaccinated except for his booster shot, but knew he had covid19 after he was helping customers in the sporting goods store he works at who were coughing without masks around him and sounded sick. Admits some blood tinged sputum from cough 2 days prior, and watery stools. He denies chest pain, vomiting, blood in urine/stool, abdominal pain, swelling/pain in legs or extremities.    ED course: On arrival he was hypoxic at 57% and tachypneic, normotensive, aox3, breath sounds clear. He was placed on NRB which improved his saturations to around 90, and subsequently switched to HFNC 60L at FiO2 of 100% which brought his saturations up to 90's. Cultures and labs were drawn, Covid test was obtained and positive. ECG showed NSR with isolated t-wave inversion in lead 3. CXR showed extensive bilateral lung infiltrates. WBC normal, no fever. Lactate was elevated to 2.1. Procal mildly elevated. He received Decadron 6mg IV and was admitted to general floors with acute hypoxic respiratory failure secondary to covid19 pneumonia.
Information has been received from an "about 60" year-old female with a history of breast cancer who on 14-JUN-2007 was vaccinated with a dose of Zostavax (Oka/Merck).  "After receiving the vaccination, she experienced a sore arm around the injection site area."  After a week, on approximately 21-Jun-2007, she experienced rash-like symptoms and consulted a dermatologist who diagnosed her with a case of hives.  The patient was prescribed antihistamines and prednisone.  The outcome is reported as not resolved.  No product quality complaint was involved.  Additional information has been requested.
Fever, chills, muscle aches, joint pain, nausea, headache, injection site pain, swelling, redness, itchiness
Papules, vesicles, but mostly scabs primarily on trunk, few on face, more on legs and arms office visit 5/15/06.
Vomiting for 5 days post immunization. Keeping hydrated. No immunization site reaction.
Systemic: Dizziness / Lightheadness-Medium, Additional Details: Patient felt extremely dizzy/light headed after vaccine. Patient improved within 5 minutes but did call family member for ride home.
The day of the vaccine I had a sore arm. The following day after the vaccine I got body aches all over my body, severe joint pain in my hands where I could barely open a door, slight headache and cold sweats and that was happening throughout the day for an entire week. I went to a walk in clinic on 10/07/2021 and they put me on 20mg of Prednisone to help alleviate some of the symptoms my costochondritis is now out of remission as well. I am still in pain and I have to get my second dose, and I am worried about that as well.
chills; swollen lymph nodes in neck; mouth dry; stomach pain; not feeling well-felt warm; tingling in legs; body aches; generally feeling unwell; pain at injection site; she felt like it knocked her down; ;made her feel sick; This is a spontaneous report from a non-contactable consumer (patient).   A 76-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: not reported), via an unspecified route of administration on 24Feb2021 as dose 2, single for covid-19 immunization. Patient had no relevant medical history. The patient concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1, on an unspecified date for covid-19 immunization. Recently received 2nd dose of pfizer covid vaccine yesterday and experienced side effects: pain at injection site, chills, swollen lymph nodes in neck, mouth dry, stomach pain, not feeling well-felt warm; body aches; tingling in legs and generally feeling unwell. Caller did not know whether to be concerned. Asking if what the patient feeling was normal. Had no issues at all with the first dose. With the second dose, the patient felt like it knocked her down; made her feel sick. The outcome of the events was unknown.   No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
patient reported stiff neck, headache, pain in spine above her buttock and has lasted 24 hours
Boostrix given in 2018 and 2022; This case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 15-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number GC5NG, expiry date 1st April 2023) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included boostrix (dose received on 25th June 2018).   On 15th November 2022, the patient received the 2nd dose of Boostrix and Boostrix Pre-Filled Syringe Device. On 15th November 2022, unknown after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 17-NOV-2022 Reporter's Comments: Licensed practical nurse reported on 16th November 2022, that male patient received a dose of Boostrix on 15th November 2022 and they had not realized that the last dose of Boostrix was administered on 25th June 2018. Did not consent to follow-up. The Vaccine Administration Facility was the same as Primary Reporter. Additional Supportive Information: the patient received 2nd dose after receiving 1st dose on 25th August 2018, which led to extra dose administered.
Individual received second dose of COVID19 Pfizer vaccine on 02/24/21 and tested positive for SARS-CoV-2 (COVID-19) PCR 14 days later on 03/10/21
Nurse calling to report VARIVAX was administered to patient while it had a temperature excursion. Exact date of administration not provided.; No additional AE; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's historical medications, medical history, concurrent conditions and concomitant medications were not reported.  On an unknown date, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot number W031813, expiration date 05-OCT-2023, dose 1 (route of administration not reported) for prophylaxis. No adverse event was reported.  The temperature excursion was of 24.4 degrees Fahrenheit for 5 hours and 51 minutes. No other excursions were detected.
Vaccine derived case of rubeola on 12/27/99, vaccine given on 12/16/99.