chrisvoncsefalvay/vaers-outcomes huggingface dataset:
DIARRHEA - SEVERAL TIMES; BODY ITCHING; INJECTION SITE SWELLING; INJECTION SITE ITCHINESS; SEVERE HEACHACHE- JACKHAMMER LIKE; FULL BODY MUSCLE ACHES; FATIGUE; FEVER; INJECTION SITE REDNESS; INJECTION SITE PAIN; INTENSE NECK PAIN; LYMPH NODES IN THE NECK SWOLLEN; This spontaneous report received from a patient concerned a 40 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1800185, expiry: UNKNOWN) dose was not reported, administered on 25-MAR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. On 26-MAR-2021, the subject experienced intense neck pain. On 26-MAR-2021, the subject experienced lymph nodes in the neck swollen. On 26-MAR-2021, the subject experienced injection site swelling. On 26-MAR-2021, the subject experienced injection site itchiness. On 26-MAR-2021, the subject experienced severe headache- jackhammer like. On 26-MAR-2021, the subject experienced full body muscle aches. On 26-MAR-2021, the subject experienced fatigue. On 26-MAR-2021, the subject experienced fever. On 26-MAR-2021, the subject experienced injection site redness. On 26-MAR-2021, the subject experienced injection site pain. On 27-MAR-2021, the subject experienced diarrhea - several times. On 27-MAR-2021, the subject experienced body itching. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 99.6 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from intense neck pain, lymph nodes in the neck swollen, diarrhea - several times, severe headache- jackhammer like, full body muscle aches, and fatigue on 27-MAR-2021, had not recovered from body itching, injection site swelling, injection site redness, injection site pain, and injection site itchiness, and the outcome of fever was not reported. This report was non-serious.; Sender's Comments: V0:  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious
Approximately 10 months, post vax, I developed osteoarthritis in both hands, without any previous symptoms, prior to vaccinations.
Information has been received from the registered nurse on 02-JAN-2014. It was reported that GARDASIL vaccines were stored in improper temperatures and were administered to overall number of 132 patients. This report revers to one of the patients involved: a patient of unspecified age and gender, who had been administered dose of GARDASIL on 21-MAY-2013 (lot number: H011350; exp date: 21-FEB-2015) (dose, frequency, route and site of administration were not reported). No adverse event was reported. This is one of the reports from the same source. Additional information is not expected.
12/10 - approximately 12/20 - Flu-like symptoms. 1/1/11 - Went to walk-in clinic, treated for cold/flu-like symptoms. 1/14-1/18 - Flu-like symptoms were not getting better, pain in back radiating to legs & feet. 1/18-1/23 Pain increasing in back & legs. 1/05 Admitted to Hosp. Diagnosed w/ Guillain-Barre Syn.
patient developed joint pain <24 hours after with itching but no rash. <48 hours awoke with eye lid swelling and itching of hands and feet, spead to hives on elbows.
Pt. describes getting all side effects on VIS sheet; Pt. fainted, couldn't swallow well. Arm red, swollen, tender to touch.
This patient had the series of Moderna. He did not inform that he had a previous dose of Janssen on 3/12/21 at another facility.
Pt didn't want the second dose. We found out that he said he had a heart attack 2-3 weeks after first shot. He's not sur if it was related to Covid vaccine
Low grade fever, body aches, weakness, arm pain (Lt ARM) where injection wAs given. ARM was stinging, felt warm, swelling
Information has been received from a nurse concerning a 17 year old female with no pertinent medical history or drug reactions or allergies who on 28-AUG-2008 was vaccinated intramuscularly with the first 0.5 ml dose of GARDASIL (lot no. 659184/0843X). Concomitant therapy included LOESTRIN 24 FE. Subsequently the patient passed out when she was signing out at the front desk to leave.  The patient was observed and recovered and went home. On the same day, urine pregnancy test was performed and the result was negative. Additional information has been requested.
24hrs after receiving the vaccine I had fatigue and sortness of breath, 72hrs after severe flu symptoms with a fever of  101.5 lasted 3 days,  severe diarrhea  and mild to moderate cramping in the stomach and just below for the last 4 days.
Extreme chills, sweating,headache, severe muscle and joint pain, all beginning within 6 hours of dose administration.   Extreme flu-like symptoms. The severe symptoms lasted 24 hours. Currently I feel very weak and fatigued with some remaining chills.  I experienced these same symptoms with the previous 2 covid vaccines( all Pfizer)
Documentation shows received Janssen vaccine 04/08/2021. Also, shows received Pfizer vaccine 07/02/2021 and 07/23/2021. Unknown type of facility vaccinated at.
This is a spontaneous report from a contactable pharmacist reported through a Pfizer sales representative. A male patient of an unspecified age and ethnicity received PREVNAR 13, via an unspecified route of administration at single dose on 09Feb2016. The patient medical history and concomitant medications were not reported. On an unspecified date in Feb 2016, the patient experienced fainted, collapse, elevated blood pressure. The outcome of the events was unknown.
Patient called and stated that the site was warm to touch and some swelling. At location of shot there was a red dot.
Sedation of tongue swelling approx 10 minutes after injection. VSS. Recommend transport to local ED for evaluation NAD at vaccine site prior to transport
developed symptoms of what appears to be hyperthyroidism that started within a week of her getting the second COVID-19 vaccine booster; her ankles were swelling up; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), on 14Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "injury to ankle " (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer Unknown), for covid-19 immunisation; Covid-19 vaccine (Dose 2, Manufacturer Unknown), for covid-19 immunisation; Covid-19 vaccine (Dose 3, Manufacturer Unknown), for covid-19 immunisation. The following information was reported: HYPERTHYROIDISM (medically significant), outcome "unknown", described as "developed symptoms of what appears to be hyperthyroidism that started within a week of her getting the second COVID-19 vaccine booster"; SWELLING (non-serious), outcome "unknown", described as "her ankles were swelling up". The patient underwent the following laboratory tests and procedures: Blood thyroid stimulating hormone: 0.01, notes: less than 0.01. Therapeutic measures were not taken as a result of hyperthyroidism, swelling. Additional information: The patient actually called a few weeks ago and told me that her ankles were swelling up and she had previous injury to her ankle (Intent: History), that would probably have been maybe last week of April and we thought it was just something going on with her ankle but was really thought and figured it out and the connection with her having had the vaccine yesterday during conversation with her. No, it was sort of partially diagnosed at this point in time and her doctor was on vacation and they have not started any treatment.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
p/vax pt devel erythema, warmth, tenderness 6x4cm of lt deltoid area p/vax;tx keflex, cold compress, APAP;
Severe body and skin pain to the point of can't walk. Fevers 103. Chills. Cough.  All still occurring.
I had my vaccination on 10/27/2022. On 01/15/2023 I got a viral infection which brought coughing, loss of voice and sinus pressure. I was diagnosed with Sinusitis on 01/18/2023. I loss my hearing on 01/22/2023.  I saw my NP on 01/28/2023 with ear drops as I had a ruptured ear drop. I tested COVID-19 Negative on 01/28/2023.
Topical swelling at the injection site left arm. Treatment hydrocortisone topical cream 1%, Benadryl. (dyphedramine) 25mg  1-2 caps BID
Elevated blood glucose over 400 mg/dL for multiple days starting around 5 days post-injection. I also observed elevated blood glucose 24 hours after the first dose, but these returned to normal with 24 hours.
Tiredness and fever started shy of 24 hours after vaccination, lasted about 8 hours then went away heart palpitations started about 29 hours after vaccination, lasted about 30 minutes then went away.
ADULT OBSTRUCTIVE SLEEP APNEA 4/13/2023 ACUTE HYPERCAPNIC RESPIRATORY FAILURE ACUTE HYPOXEMIC RESPIRATORY FAILURE 4/20/2023 ACUTE HYPERCAPNIC RESPIRATORY FAILURE ACUTE HYPERCAPNIC RESPIRATORY FAILURE 4/13/2023 ACUTE HYPERCAPNIC RESPIRATORY FAILURE
Case previously recorded as MA2009-4030. Initial case report received form a physician via MedCom on 05 NOV 2009. A 28 year-old female patient was vaccinated during pregnancy with 0.5 mL of S-OIV FLUVIRIN (batch no. 100738) i.m. on 03 NOV 2009. No adverse events were reported. MedCom reference no.: NA09-007596.
possibly frozen product was administered on accident with no adverse event; Initial information was received on 29-Sep-2021 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional via Medical information (under reference number - 00814790).  This case involves 52-years-old female patient who was accidently vaccinated with possibly frozen suspect INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV] with no reported adverse event (product storage error).  The patient's medical history, past medical treatment(s), concomitant therapy, vaccination(s) and family history were not provided.  On 16-Sep-2021, the patient received a 0.5ml {total} dose of suspect INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV] (injection, lot number UT7330LA and expiry date 30-06-2022) via intramuscular route at an unknown administration site for prophylactic vaccination (also reported as left).  It was reported "the doses were accidently used before realizing the shipment was frozen due to the doses used were at the top and were not frozen; that the packages underneath were frozen; that the entire rest of the shipment was frozen and likely all the product was frozen at some time; that 2- FLUZONE QUADRIVALENT doses and 13- FLUZONE HIGH-DOSE doses were administered from the frozen shipment."  It was case of an actual medication error due to product storage error temperature too low (latency was on same day)  At the time of report, no adverse event was reported.  Event outcome was unknown.  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.
No adverse events reported. Patient initially received Covid 19 Moderna vaccine on 4/1/21 (LOT: 041L20A) then received second dose of PFIZER on 5/11/21 (LOT EW0171). Need to know next step for patient.
Swollen lymph node in armpit that was very painful, chills, fever, body aches, rash on lower arm last 6 weeks and still not gone(being treated currently)
Incorrect positioning of the vaccine given. Per the medical staff she spoke with it was given to low. She has tingling in her hands, feets and legs. Muscle spasms in her legs and also numbness. She has balance issues. She told the pharmacist it was to low. She called and spoke with her doctor and she sent him pictures and he stated that she could possibly have nerve damage.
Patient had hives, nausea, vomiting resulting in checking into the ER. Patient has had symptoms for 6 days now and is still having some swelling.
Rash all over body. Swollen face and lips. (BENADRYL)
I received my COVID-19 vaccine on 12/20/2020, all was fine despite a sore arm. Around the 48-hour mark, I developed extreme dizziness and I received medical care at ER on the 23rd of December.
On 09/22/2022 and 09/23/2022 had a scratchy sore throat. On 09/24/2022 woke up with really sore throat and clogged up head. I stayed at my house where I was visiting. I did not have any breathing problems or wheezing. The next day I was out in the backyard and my sore throat got bad and on 09/25/2022 I took a home COVID-19 test and it was positive. I did call my doctor and left a voicemail. I did a portal and messaged my doctor Sunday night telling them I was positive for COVID-19. They texted me back and I did a video chat and I was prescribed PAXLOVID. The worst days were Sunday and Monday where I had a fever and I started taking ibuprofen and ADVIL and after I saw my doctor they told me to take ibuprofen every 4 hours and TYLENOL every four hours. The PAXLOVID medication felt better by the end of the week. By the next week I started to feel much better.
A few days, post vax, pt developed a post vaccination rash with a small number of lesions. The pt sought unspecified medical attention. A household contact, contracted chickenpox following exposure to the pt. No further information is available.
pt recv vax & felt dizzy & fell on the floor;p/about 2sec pt opened eyes & started talking again; pulse 68, BP 116/80;seen by MD, observed for 1/2hr;
10 hours after injection I immediately spiked a 101 fever I had chills, joint pain, nausea, vomiting, diarrhea, confusion, dizziness, blurred vision extreme chest pain, difficulty breathing, swollen fingers and toes, headache, loss of taste and smell , itchy throat , a cough and blood in my mucus. These side effects persisted until 7 am the next morning... currently I still have a headache , bodyaches, confusion weakness and extreme sensitivity to light ... unbearable I felt like I was dying... I tried sleeping it off but only laying bed all day drinking water was what I was forced to do as I could not drive myself to a healthcare facility
Large area of upper right arm very red, hot, and painful. Doctor advised her to take TYLENOL and BENADRYL.
Paient c/o chest tightness  post vacciination while being observed.Face flushed,v/s  6:48p BP 138/92 P74 R20 Pulse ox 98%  6:49pm BP 147/94 P73 R20 Pulse Ox 98% 7pm BP 138/83P69R18 Pulse Ox 99%
headache; Nausea; Abdominal Cramping; This is a spontaneous report from a non-contactable physician (reporting for himself). A 68-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247), via an unspecified route of administration (left arm) on 14Jan2021 (10:30) at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had other unspecified medications received within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 14Jan2021 (20:30) the patient experienced headache, nausea and abdominal cramping. There was no treatment received for the adverse events. The outcome of events was recovered on an unspecified date. The patient has not been tested for COVID-19 since the vaccination. This case is non-serious.  No follow-up attempts are not possible. No further information is expected.
swelling on the right foot; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team for a sponsored program. The reporter is the patient.  A 77 year-old male patient received bnt162b2 (BNT162B2), administration date 20Apr2021 (Batch/Lot number: unknown) at the age of 77 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:1), administration date: 30Mar2021, when the patient was 77 years old, for Covid-19 Immunization, reaction(s): "pain in right upper inner thigh". The following information was reported: PERIPHERAL SWELLING (non-serious) with onset 07May2021, outcome "not recovered", described as "swelling on the right foot".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Shortness of breath, dizziness, weakness and small wheals (urticaria) on thigh and hip area.
Anaphylaxis 10 mins after admin. previous adverse event 2007: planned observation in ED. Experienced angioedema, SOB at 10 mins - txd with IV BENADRYL & SOLU-MEDROL.
Patient is having no adverse symptoms, but the two doses were administered only 17 days apart which is outside of the standard dosing interval.
Severe tinnitus began about 0100 on 02/11/2021, waking me out of a sound sleep, and keeping me awake for the rest of the night.  Symptoms persist, and seem to be worse at night, while at home and not at work.  PCP has me taking Lipo-Flavonoid Plus, to help with the symptoms, which help eliminate some of the loud buzzing, but not all of it.
Just felt lazy for a day; little sleepy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A 77-year-old female patient received BNT162b2 (BNT162B2), in Jan2022 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Received two Pfizer COVID Vaccines , Dose 1, Single), administration date: Jan2021, for COVID-19 immunization; Bnt162b2 (Received two Pfizer COVID Vaccines , Dose 2, single), administration date: Jan2021, for COVID-19 immunization. The following information was reported: LAZINESS (non-serious) with onset 2022, outcome "recovered", described as "Just felt lazy for a day"; SOMNOLENCE (non-serious) with onset 2022, outcome "recovered", described as "little sleepy". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient mentioned that she was tested for bloodwork which appeared that she has high antibodies and so her doctor does not recommend her getting another booster dose. When received first Booster Pfizer COVID Vaccine, just felt lazy for a day or so, you know a little sleepy. Then bounced right back after a day or two. Has been no problems.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Severe case of diarrhea; This is a spontaneous report from a contactable consumer(reporter's wife). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on Jan2021 at single dose for COVID-19 immunization.  The patient medical history and concomitant medications were not reported.  The patient had the shot one week ago and he has severe case of diarrhea today a week later on Jan2021. Outcome of event was unknown.    Information on the lot/batch number has been requested.
Large generalized case of urticaria on right side of back. Very hot to touch. Complained of stinging, burning. Patch bright red in color, raised in texture. Still present four days after it popped up. It popped up three days after after vaccination.  It is now peeling like a severe burn. Patient did c/o a severe headache the day after the vaccination for about 24 hours.
The baby was born via emergency C-section; however, she was healthy. My mother repeatedly during our 5 day stay and even I as a nurse questioned the nurses about a bluish tinge around my newborns mouth. The nurses all responded with "That's normal for her age".
NauseaVomiting Pain/Discomfort and swelling at injection site Narrative:
Systemic: Abdominal Pain-Mild, Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Chills-Mild, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Medium, Systemic: Nausea-Mild, Systemic: Shakiness-Mild
patient tested positive for COVID-19 in Feb2022; This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (patient tested positive for COVID-19 in Feb2022) in an 87-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's medical history included multiple orthopedic problems. The patient had no allergies to medications, food, and other products.  Concurrent medical conditions included Blood pressure high.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2022, the patient experienced COVID-19 (patient tested positive for COVID-19 in Feb2022). At the time of the report, COVID-19 (patient tested positive for COVID-19 in Feb2022) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2022, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported.  No treatment information was provided.  Company Comment: This is a spontaneous case concerning an 87-year-old male patient with no relevant medical history, who experienced the unexpected, non-serious adverse event of special interest of COVID-19 (tested positive for COVID-19), after receiving a dose of mRNA-1273 vaccine. Date of vaccinations, clinical course and treatment details were not provided in the case. The outcome of the event was unknown at the time of the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-564774 (Patient Link).; Sender's Comments: This is a spontaneous case concerning an 87-year-old male patient with no relevant medical history, who experienced the unexpected, non-serious adverse event of special interest of COVID-19 (tested positive for COVID-19), after receiving a dose of mRNA-1273 vaccine. Date of vaccinations, clinical course and treatment details were not provided in the case. The outcome of the event was unknown at the time of the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Ever since 2nd dosage, I have been having temp in high 99s. After the booster shot, I have been very lethargic. My temp would reach up to 100 after 3 weeks. A day or so after the booster, I noticed a dull pain in collarbone area and saw a golf ball size lump on left collarbone. Lump on collarbone has subsided but now experiencing pain in armpits (more on right-side) and seems swollen. Pain radiates to back area.