chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Left arm injection site tenderness from 01/12/2021 through 01/19/2021. Severity on 1-10 scale = 5. Resolved with no intervention.  Fatigue from 01/12/2021 through 01/21/2021. Severity on 1-10 scale = 7. Resolved with rest. No residual.  Received 2nd dose on 02/01/2021 in right deltoid at 1:22 pm. Temp on day of dosing was 97 degrees - normal for me. 02/02/2021 AM right arm soreness, achy all over, and chilled. By 1 PM temp was 100.1. Took 500 mg of Acetaminophen, fLuis?s and rest
Uveitis in left eye developed a few hours after COVID vaccine. Currently being treated with steroid eye drops. Symptoms: red eye, pain, blurry vision in left eye. Still being treated.
swelling, redness, discoloration of arm, swollen lymph node under lt arm;1 bout of vomiting 2 days post vax;
TOOK TWO DOSES IN A ROW; A spontaneous case report was received from a consumer on 22-Jul-2019 for two consumers.  Based on the information obtained from the consumer, two individual case safety reports PVX201907-000615 (PVX2019-1882; wife) and PVX201907-000616 (PVX2019-1883; husband) were created and cross-linked in the database.  This case describes a 66-year-old male consumer who "took two doses in a row" (PT: Inappropriate schedule of product administration), during therapy with Vivotif for an unknown indication.  Case report: The consumer took two doses of Vivotif in a row. The doses were taken on 18-Jul-2019, 20-Jul-2019, and 21-Jul-2019, respectively.  Action taken with Vivotif was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "took two doses in a row" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took two doses in a row" was considered as not applicable. US-PaxVax Berna GmbH-PVX201907-000615:
ACUTE DVT OF LEFT LEG, UNSPECIFIED VEIN HYPOTENSION ACUTE RESPIRATORY FAILURE ACUTE PULMONARY EMBOLISM 1/24/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Pt awakened with total body pruritus - no urticaria. (Came to clinic on 5/5. Mild erythema of skin. Lungs - clear,  Heart - S1, S2, no murmur. Abd - soft, NT.  Given Loratadine 10mg po qd.
Found seizing approximately 48 hours after vaccine.  It was confirmed that he had a stroke on 3/12/21.
After obtaining flu shot my arm radiating up to my left side was hurting and a hole formed on side of mouth which has to be closed on 11/6/17.
Flu and PPV given 10-11-13 - now with tender irregular bordered patch at 3" below (L) deltoid.
pt recv vax &  arm became red & splotchy;had unusual behavior which lasted approx 12hr;c/o pain all over especially in arm;c/o lt leg felt heavy & weak & didn't want to walk on it;pt would cry & laugh intermittanly;felt strange;pain inj sit
Information has been received from a pharmacist concerning a 66 year old female with hypothyroidism and arthralgia and a history of abdominal pain and diverticulitis, and allergic reaction to CIPRO, hydrocodone, guaifenesin, codeine, amoxicillin, who on 22-AUG-2010 was vaccinated with a dose of PNEUMOVAX 23 (667134/0738Z). Concomitant therapy included SYNTHROID, morphine and ZOFRAN. On 23-AUG-2010 it was noticed that there was an area of erythema which was getting bigger around the injection site area. There was pain and tenderness. The area was "palm-sized" now. This was causing difficulty in mobility. There were no labs or diagnostic tests performed. BENADRYL was given. The patient sought unspecified medical attention. The patient had not recovered at time of report. An area of erythema which is getting bigger around the injection site area, pain and tenderness and difficulty in mobility were considered disabling. Additional information has been requested.
Injection on Mar. 13, around 10:40 am. Slight chills starting around 7 pm, approx 8 hours after injection. Later that night around 10 pm had severe chills, teeth chattering that lasted till approx. 3 am the next morning. Chills so bad I had a hard time walking to the bathroom. Mar. 14, low-grade fever, 99.4, aches, tired, flu-like symptoms all day, took Tylenol. Mar. 15 feeling much better, flu-like symptoms gone, still a little tired, left arm finally sore. Wifes's arm hurt for 2 days.
p/vax pt exp streptococcal pneumonia & sepsis (cult from blood) & was hosp;Annual follow-up dated 3/28/01 states that the record was voided as the pt did not receive a Merck vaccine. Information has been received from a physician's assistant concerning a patient who in approximately 1989 was vaccinated with PNEUMOVAX 23. In approximately 1999 the patient experienced streptococcal pneumonia ans spells (cultured from blood) and was hospitalized. Another patient was reported with a similar experience (WAES 99091802). No further information is available.
blood pressure went from 120/70 to 130/100 to 180/110; felt lightheaded; frightened; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE FLUCTUATION (blood pressure went from 120/70 to 130/100 to 180/110), DIZZINESS (felt lightheaded) and FEAR (frightened) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced BLOOD PRESSURE FLUCTUATION (blood pressure went from 120/70 to 130/100 to 180/110), DIZZINESS (felt lightheaded) and FEAR (frightened). At the time of the report, BLOOD PRESSURE FLUCTUATION (blood pressure went from 120/70 to 130/100 to 180/110), DIZZINESS (felt lightheaded) and FEAR (frightened) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 120/70 normal and 180/110 High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. No treatment information provided.   Most recent FOLLOW-UP information incorporated above includes: On 02-Aug-2021: Event outcome and reporter's mail ID were updated.
On 3/8/21, patient presented to the ED with cough, fever > 103, chills, SOB, all starting 9 days ago (2/27/21) about 3 days after 2nd dose of Pfizer vaccine. Patient was admitted to the hospital with main diagnosis COVID-19 pneumonia and patient expired on 4/8/21.
This spontaneous report as received from a health professional refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 06-NOV-2015, the patient was vaccinated with improperly stored (exposed to the following temperatures and cumulative time frames colder than 36 F; In September of 2015, the coldest temperature was 34 F for 346.7 hours (over 14 days); In October of 2015, the coldest temperature was 34 F for 492.6 hours for a total of 839.3 hours (35 days); In November of 2015, the coldest temperature was 34 F for 192 hours, for a total of 1,031.3 hours (43 days) VAQTA injection, 0.5 ml (Lot # L018499, exp. date: 25-FEB-2017)(route and strength unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Woke the second morning with huge gastroissues symptoms included vomiting.; Woke the second morning with huge gastroissues symptoms included nausea; Woke the second morning with huge gastroissues symptoms included incredible sweating.; Woke the following morning with a sore arm; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the right arm on 06Apr2021 at 11:45 (at the age of 57-year-old) as a single dose for COVID-19 immunisation. Medical history included diabetes, seizures, bipolar, ulcerative colitis, gastric ulcers, etc. Concomitant medications included  daily medications and over the counter (OTC) vitamins. The patient had several unspecified allergies. 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 did not receive any other vaccines within four weeks prior to the vaccination. On 07Apr2021, the patient woke up with a sore arm which was not a big deal. On 08Apr2021 at 06:00, the patient woke up with huge gastro issues and was in bed the entire day. Symptoms included vomiting, nausea and incredible sweating. No therapeutic measures were taken as a result of the adverse events. These events did not result in doctor or other healthcare professional office/clinic visit, emergency room/ department or urgent care. The clinical outcome of the events sore arm, vomiting, nausea and incredible sweating was recovering at the time of the report.  No follow-up attempts are needed. No further information is expected.
Injection site pain, swelling redness and heat from elbow to axilla, unable to move LUE.
After getting the Vaccination of Covid-19 Booster - Comirnaty) along side of Flu shot at the same time from medical center. There was a mouth sore started on the upper right gum just close to the No. 1 tooth in formation of 1/2 of an inch square shaped formation. red at the center and slight white at the edges. Health care provider reviewed the case and referred to head and Neck Surgery/ENT for further evaluation and treatment options on 24th October, 2023. We are still awaiting a call from the ENT.
4 documented fevers. One fever a week for 4 weeks for approximately 2-3 hours each time. Temperature max 102.3. went away without medication. Body aches and chills with fever but went away after fever was gone.
Sore Throat 10 days long from 06/05/2021, sinus infection; determined Antibiotic.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Additional Details: Patient recovered in about 20 to 25 minutes.
Moderate anaphylaxis, sneezing, very runny nose, coughing, asthmatic episode
Rec'd H1N1 vaccine L deltoid 12/01/2009- Woke up 12/2/09 with slight HA. Went to get H20- Tongue felt thick and twisted, eyes felt like "pressure" L cheek felt tight. R side of mouth drooping- Drool when drinks H20. Felt like she was having a stroke HA continues.
pt recvd vax & 1 wk p/vax pt exp flu-like sx (fatigue & swollen lymph nodes) & an elevated Epstein-Barr antigen;
Site: Redness at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Nausea-Medium, Systemic: Vomiting-Medium, Systemic: Weakness-Medium
New nodules now in upper and lower lips; Swelling in right mid cheek area; new nodule lateral to tear trough; multiple nodules in the injection areas; This is a spontaneous report received from contactable reporter(s) (Physician). GL-021122-3676. A 29 year-old female patient received bnt162b2 (BNT162B2), administration date Oct2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation; hyaluronic acid, lidocaine (RESTYLANE L), since 05Nov2021 (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 2, SINGLE), for Covid-19 immunization; Bnt162b2 (DOSE 1, SINGLE), for Covid-19 immunization. The following information was reported: INJECTION SITE NODULE (non-serious) with onset 14Dec2021, outcome "recovering", described as "multiple nodules in the injection areas"; SKIN MASS (non-serious) with onset 20Jan2022, outcome "recovering", described as "new nodule lateral to tear trough"; SWELLING FACE (non-serious) with onset 03Feb2022, outcome "recovering", described as "Swelling in right mid cheek area"; NODULE (non-serious) with onset 08Feb2022, outcome "unknown", described as "New nodules now in upper and lower lips". The events "multiple nodules in the injection areas", "new nodule lateral to tear trough", "swelling in right mid cheek area" and "new nodules now in upper and lower lips" were evaluated at the physician office visit. Therapeutic measures were taken as a result of injection site nodule, skin mass, swelling face, nodule.  Additional information: Physician reported a patient had injections of Restylane L in the left and right anterior medial cheeks and upper and lower lips on 05Nov2021 and patient was seen back in the office for follow up on 14Dec2021 complaining of multiple nodules in the injection areas. Physician provided the following mitigation efforts. On 14Dec2021: Colchicine 6.8 mg BID, ibuprofen 400 mg TID for 5 days. On 11Jan2022, nodules had improved with Colchicine and ibuprofen but then had a recurrence of the nodules. Treated that day with Hylenex and prednisone, 20 mg for 7 days. On 20Jan2022, nodules improved but not resolved and new nodule lateral to tear trough. Treated with Hylenex and prednisone, 20 mg. On 25Jan2022, Improvement in nodules but still present. Treated with Hylenex and increased prednisone to 40 mg for 3 days. On 03Feb2022, Swelling in right mid cheek area was better. Treated with Hylenex again. On 08Feb2022: New nodules now in upper and lower lips. Treated with 40 mg prednisone for 3 days then 20 mg prednisone for 3 days. 1 1/2 vials of Hylenex to the lips and cheeks. Patient received Pfizer Covid-19 vaccinations 1 and 2 on unknown dates and then the booster two weeks prior to the November Restylane-L injection.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
The patient expressed nervousness before getting the vaccine, but very much wanted to get it done.  She took some deep breaths and we administered the vaccine in her left arm, after which she was ok.  I stayed to talk to her for 5 minutes while she was still seated.  After 5 minutes of talking, she told me she felt like she was going to pass out and that her arm was tingling.  She kept sitting and a minute later told me she was having cold sweating all over while feeling hot and also seeing spots.  I helped her lay on the ground and we called 911.  While waiting for paramedics, she recovered while laying down and spoke to her mother on the phone.  Once paramedics arrived they checked vitals several times with normal results.  She was then transported to the hospital at her request, although feeling better.
1334 c/o scratchy throat, voice "rough", cough. because of hx of allergies rapid response called and associate give 50mg Benadryl IM to Right Deltoid, RR 24, continued cough, unable to get b/p due to b/p cuff did not fit arm.  1337 c/o shortness of breathe. staff administered epi pen to left thigh 1340 rapid response arrived and associate removed from scene and transported to ED on stretcher by rapid response team member.
Received Varivax 5-14-07, started with local reaction of swelling, itching about the size of a quarter. Progressed to about 8cm redness
Rash/hives on knees, elbows and shoulders - took Benadryl and applied aloe vera  gel with lidocaine - rash/hives not present in the morning  Return of rash/hives following evening on knees, back of arms and back - took Benadryl and applied aloe vera gel with lidocaine
Hand sized area of redness and marked swelling distal to immunization injection site involving distal upper arm circumferentially. Tenderness at site and swelling and redness started about 8 hrs after injections - worsening  over first 36 hrs. Still with mild redness and warmth on 8/12/10 but resolving.
I was on my period when I received the vaccine.  I got another period in 14 days of the first day of my last period.  I got another period 25 days later.  I'm usually about 33 days between periods.  My next period was 25 days.  The next period was 17 days.  The next period I missed.  The next period was 37  days.  Then my next period was 40 days.  My days of bleed have become longer also.
Positional vertigo two weeks after first vaccine; This is a spontaneous report received from a contactable consumer, the patient. Regulatory authority. Safety Report. A 63-year-old male patient received first single dose of BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; lot no: Fm9809) via an unspecified route of administration in the left arm on 15Feb2021 at 06:30 PM and the patient received second single dose of BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; lot no: Enc199) via an unspecified route of administration in the right arm on 03Mar2021 at 04:30 PM for COVID-19 immunisation. Facility where the COVID-19 vaccine was administered was pharmacy or drug Store. Information about patient ethnicity and race were reported. The patient was having allergy to sulfa products. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 since having the vaccine. Concomitant medications includes PRILOSEC, lisinopril (MANUFACTURER UNKNOWN), aspirin (MANUFACTURER UNKNOWN), CRESTOR. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 28Feb2021, at 12:00 AM, the patient experienced positional vertigo and no therapeutic measures were taken for this event. Clinical outcome of the event positional vertigo was recovering at the time of this report. No follow-up attempts possible. No further information expected.
Febrile seizure the following day.  Died 3 days later of unknown causes.
This spontaneous report received from a consumer, concerning a patient who received the Moderna COVID-19 (mRNA-1273) vaccine and experienced sore arm, a fever that night and  body did not hurt as badly as it hurt when had COVID. The patient's medical history not provided. No relevant concomitant medications reported. On Jan 13, 2021, prior to the onset of the events, patient received the first of two planned doses of mRNA-1273 (lot/batch# unknown), intramuscularly, for prophylaxis of COVID-19 infection. On Jan 13, 2021, patient experienced sore arm and a fever that night. On an unknown date, patient experienced: body did not hurt as badly as it hurt when had COVID. No treatment information provided. Action taken with mRNA-1273 in response to the events not reported. The outcome of sore arm, a fever that night and body did not hurt as badly as it hurt when had COVID not reported.
0.25ml influenza vaccine administered as first dose for the 2017-2018 flu season. 0.5ml is the recommended dose for this vaccine. No adverse reaction was observed or reported. Parents were contacted to return to clinic for re-vaccination at no cost.
feverish; lightheaded; tingling in my fingers; night sweats; This is a spontaneous report from a contactable other hcp. A 34-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), intramuscular in left hand on 30Dec2020 14:15 at a single dose for COVID-19 immunization. Vaccination occurred in a Nursing Home/Senior Living Facility. The patient's medical history was not reported. Concomitant medication included vitamin c [ascorbic acid] (VITAMIN C), colecalciferol (VITAMIN D), and zinc (ZINC). The patient was feverish, lightheaded, had tingling in fingers and had night sweats on 01Jan2021 with outcome of recovered. The patient underwent lab tests and procedures which included sars-cov-2 test-nasal swab with a negative result on 04Jan2021.    Information on the lot/batch number has been requested.
Onset of head and eye pain diagnosed two days later as an outbreak of shingles involving the left eye and forehead. Treatment: Oral Valacyclovir (Valtrex), eyedrops of Tobramycin+Dexamethasone, and opthalmic ointment of Erythromycin to be used on eyelid and facial rash.
Red  -  swollen  - hot to tough  -   measured in two areas 18x20 and 50x50.
A non-serious case of inadvertent administration of expired product was received from a nurse concerning an adult male coincident with FluMist. No medical or drug history was provided. FluMist was administered on 14-Jan-2008. The FluMist expired four days earlier on 10-Jan-2008. No signs or symptoms were present at the time of the report. No additional dosing is indicated. The reporter did not provide a causality assessment. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.
Following vaccination I initially had a sore arm, nothing unexpected.  Later in the day, late evening I could barely lift the arm that had received the injection; I also developed severe headache, fever (T max 101.9), sever body aches and chills/sweats.  I was nearly unable to get out of bed the following day, called out from work due to symptoms.  Nearly 48 hours later, still not feeling well, went to work but left early due to symptoms.  By Friday, 2/5 I was much improved.
Fever of 102.2 axillary starting at 1230am and extending throughout the day. On 10/14/16 fever was down to 101.4 axillary and pt started to present with a fine rash over trunk and extremities. On 10/15/16, fever was gone and rash was worse. By 10/17/16 rash was gone.
Patient describes pain, swelling, redness, difficulty moving arm.  Doctor documented it as an allergic reaction to the PSV23.
Patient states she had arm swelling/redness/warmth at injection site radiating down to "bicep" area. no pain associated with this per ED notes. ED Physician noted faint erythema and the appearance of a large hive but nontender. Treated at local ED for site reaction from 2 vaccines. given Benadryl 50mg one time dose in ED and Icepack. dispositioned to home after ED visit
Fully vaccinated and boosted on 10/23/21 with breakthrough COVID infection and inpatient hospital stay.
Side effects included rash near injection area, muscle pain, felt tired/weak, headache, shivering, fever. Lasted about 2 days.
This RN was reviewing immunization records for all patients scheduled on 03/12/2021 and while reviewing this patient's record in reporting system  noted that the Proquad (MMRV) given on 04/17/2019 was flagged as an "invalid dose." After reviewing reporting system and the chart, child was given an MMRV on 04/17/2019 that had expired on 04/09/2019 and will now require redosing.
numbness & tingling in both arms w/in a few hrs p/vax; No other sx;
On the left one there was a burning feeling; Both calfs hurt; This spontaneous case was reported by a patient and describes the occurrence of BURNING SENSATION (On the left one there was a burning feeling) and PAIN IN EXTREMITY (Both calfs hurt) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BURNING SENSATION (On the left one there was a burning feeling) and PAIN IN EXTREMITY (Both calfs hurt). At the time of the report, BURNING SENSATION (On the left one there was a burning feeling) and PAIN IN EXTREMITY (Both calfs hurt) outcome was unknown.            Relevant concomitant medications were not reported.  Patient received second dose of Moderna COVID-19 vaccine and both calf felt hurt and on the left one there was a burning feeling.  Treatment information was not provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2022-624237 (Patient Link).