chrisvoncsefalvay/vaers-outcomes huggingface dataset:
got sick with the flu; Initial information received on 28-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/Non-HCP.  This case involves an unknown age and unknown gender patient who got sick with the flu after receiving vaccine INFLUENZA VACCINE.  The patient's past medical history included COVID-19. The patient's past medical treatment(s), vaccination(s) and family history were not provided. It is unknown if the patient had any medical history, concomitant disease or risk factor.   On 15-Dec-2022, the patient received a  dose of suspect influenza vaccine produced by unknown manufacturer (form, strength, dose, frequency, lot number, expiry date: unknown) via unknown route in unknown administration site for Prophylactic vaccination.  On 26-DEC-2022 the patient got sick with the flu (influenza) 11 days following the administration of INFLUENZA VACCINE.  Reportedly, On December 15 I got my flu shot on December 26 I got sick with the flu ! To me the flu is worst than the Covid, I've had the Covid twice and to me the flu is worse.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (got sick with the flu).  At time of reporting, the outcome was Unknown for the event got sick with the flu.
Dose was given after being in syringe >12 hours. Aseptic technique was used
Reported 2 days later. Evening of - reports was red, swollen. 9-4-14 charge RN looked at swollen, red at site, burning from site to elbow. 9-5-14 swollen, red, warm at site welt 4mm-7 1/2mm. She had only used ice 1-2x.
Reported that patient experienced some form of paralysis (per reporter it is like Giullain-barre) on an unspecified date of May 2021 after receiving johnson vaccine. Patient is out of country right now. Patient aunty provided consent to contact for furthur information if needed. Adverse reaction had not been resolved yet, however patient is able to walk with walker. Patient was hospitalized on ICU because of this adverse event on May-28-2021 and dischagre on 04-Jun-2021
Redness and swelling 2" diameter appeared 6/8/13 getting smaller by 6/10/13 (L) thigh. Fever 99.8-100.1 started 6/8/13 and still present 6/10/2013. Nausea and stomach ache onset 6/9/13 and is present 6/10/2013.
Flumist vaccine was administered to patient during the school day on 12-2-09. Following vaccination there were no immediate adverse reactions or distress observed during the remainder of the school day. On 12-3-09 the patient's mother presented the School-Based Health Center and reported that the patient had an episode of facial swelling and an acute asthma exacerbation at home the prior night (12-2-09). The mother reported that she administered albuterol and BENADRYL to the patient and all symptoms resolved. The patient returned to school the following morning with no complaints or distress. Mother was advised to follow up with primary care provider if needed.
On 11/13/2022 I started getting COVID-19 symptoms; migraine headaches I developed a head cold and coughing, fever 100.00; diarrhea; fatigue; joint pain; lightheadedness for 3 days. On 11/16/2022 I tested positive for COVID-19 I lost my sense of smell and taste. I called the doctors and was prescribed a 5 day course of PAXLOVID.
pregnancy patient; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (pregnancy patient) in a 38-year-old female patient (gravida 4) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     Concurrent medical conditions included Gestational diabetes. Concomitant products included CITRANATAL HARMONY and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for an unknown indication.   On 02-Mar-2021 at 1:15 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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. The patient's last menstrual period was on 23-Nov-2020 and the estimated date of delivery was 30-Aug-2021. On 02-Mar-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (pregnancy patient). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  fourteenth week of the pregnancy.  On 02-Mar-2021, MATERNAL EXPOSURE DURING PREGNANCY (pregnancy patient) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Jan-2021, Pregnancy test: positive (Positive) Positive.         Conception date of patient was on 05-Dec-2020. Number of fetus was found to be one.   On ??-Feb-2021, lab tests also included ultrasound scan and gluten tolerance, however the results were not provided.  Treatment information was not provided.
Completed GARDASIL vaccine series. Dose #1 GARDASIL 4 - no symptoms - Dose #2 GARDASIL 4 - fatigue, weight loss, mild joint pain. Dose # 3 GARDASIL 9 bilateral ankle swelling, joint pain, dizziness, abnormal labs, referred to pediatric Rheumatologist - attached notes.
hard to sleep; if she moved her arm the soreness came out; She felt achy; a little soreness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (hard to sleep), PAIN IN EXTREMITY (if she moved her arm the soreness came out), MYALGIA (She felt achy) and VACCINATION SITE PAIN (a little soreness at the injection site) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced INSOMNIA (hard to sleep), PAIN IN EXTREMITY (if she moved her arm the soreness came out), MYALGIA (She felt achy) and VACCINATION SITE PAIN (a little soreness at the injection site). At the time of the report, INSOMNIA (hard to sleep), PAIN IN EXTREMITY (if she moved her arm the soreness came out), MYALGIA (She felt achy) and VACCINATION SITE PAIN (a little soreness at the injection site) outcome was unknown.            No concomitant medications were reported. No treatment details were reported.   This case was linked to MOD-2021-406400, MOD-2021-406409 (Patient Link).
1437.  Patient complained of feeling dizzy and having heart palpitations.  Immediately evaluated by NP and onsite EMS.  1439:  VS #1: HR 110; BP 137/85; R 22. O2 SAT on RA 99.  Stated she felt dizzy 1449  VS #2. 130/84; HR 82; R 18. O2 Sat 98%  Dizzyness improving 1510  Patient reported dizzyness had stopped.  Discharged with her boyfriend at 15:17.  Teaching done regarding other s/s of Iodine reaction and need to follow up with PCP or ER if symptoms return.
Devel swelling of posterior cervical lymph nodes bilaterally 10 days p/inject along w/mildly enlarged anterior nodes; also stiffness rt shoulder informed clinic by phone devel generalized body rash 16MAY92;
I started feeling off within a few hours of receiving the vaccine, but not bad enough to keep me in bed. This lasted the first couple days, along with being more tired, a sore throat,  and injection site soreness.  But I have continued to have a headache and felt lethargic since. Again, I am functioning,  just not feeling good.
Reporter states pt did not seroconvert p/recvd Engerix-B series; All injects were administered IM;
Sunday, late afternoon.  Receive shot at 4pm. Within an hour or two there was soreness and redness.  By later, about 7 or 8 pm , I had temp of 101.6, chills, general malaise.   Monday morning, I experienced more swelling of the site, redness and  heat.   Temp was 99.6.  No appetite. Very tired Tuesday morning:  Same symptoms but increased redness and swelling. Went primary care physician.  She felt there was an infection and prescribed an antibiotic.  Spoke with pharmacist and he recommended reporting the reaction.  Wednesday morning:  Felt  much less tired. Redness gone. Swelling and site soreness are almost gone.
GARDASIL 9 was administered to 5 year old; no additional AE; This spontaneous report was received from a vaccine coordinator via vaccine representative (described also as field representative) and refers to a 5-year-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On an unknown date, the patient was vaccinated with a dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (exact dose, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis (inappropriate age at vaccine administration). No additional adverse event (AE) was reported.
After having an allergy attack that involved about an hour of coughing, patient developed headache, chills, body aches and fever of 102 degrees F. The reaction started about 3 hours after receiving vaccine and resolved about 24 hours after injection.
Pt. presented w/known vagal response. Pt. had <10 sec. LOC. PT. history & vitals obtained and monitored for 30 mins. PT. refused glucose test. PT. stated normal heart rate between 50 -60 Bpm. PT. monitored for 30 mins and released with advice to call 911 w/any further problems.
He had like reaction like face is swollen; like inflammation in his eyes; swollen eyes like for the face he has a swollen face especially in the eyes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A male patient received bnt162b2 (BNT162B2), administration date 13Nov2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SWELLING FACE (non-serious) with onset Nov2021, outcome "unknown", described as "He had like reaction like face is swollen"; EYE INFLAMMATION (non-serious) with onset Nov2021, outcome "unknown", described as "like inflammation in his eyes", EYE SWELLING (non-serious) with onset Nov2021, outcome "unknown", described as "swollen eyes like for the face he has a swollen face especially in the eyes".   Additional information: The patient mother stated that her son got vaccine yesterday (13Nov2021). When probed for the confirmation vaccine name as Covid-19 Vaccine and she stated that, her son had reaction like face was swollen like inflammation in his eyes and also had a swollen face especially in the eyes.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
body ache?;Bell's palsy; ascending paralysis, paresthesia, numbness;60 day follow-up dated 2/21/01 provided states that the pt had Guillain Barre which is most resolved with mild weakness. Annual follow-up dated 12/12/00 pt still has mild residual weakness.
Headache, NauseaVomiting, HYPERtension & Tachycardia Narrative:  EMPLOYEE HAD NAUSEA/VOMITING THE EVENING AFTER 1ST DOSE THAT LASTED 2 DAYS. AFTER 2ND DOSE, NAUSEA AND HEADACHE STARTED WITHIN 5 MINS. BP 154/110 AND PULSE 95 @0822. EMPLOYEE HAD 1 EPISODE OF VOMITING. AFTER 15 MINS. BP 140/96. EMPLOYEE WAS MONITORED FOR 30 MINS AND LEFT WITH MILD NAUSEA AND HEADACHE.
Patient inadvertently received the Fluad vaccine for patients over 65 despite being <65 years of age. Patient reported feeling pain at injection site the morning after vaccination (11/11/2023). She also noted swelling in the lymph nodes on the left side of her neck on 11/12/2023 and some slight fatigue which she states is typical for her following vaccination. She states her symptoms were not severe enough for her to find it necessary to take anything to help with pain.
Delayed onset injection room site reaction 12 days after injection.  Large, red raised patch to injection site.  Slightly itchy, warm to touch.  Resolved without treatment 2 days later.  No reaction at time of vaccine
Initial information received on 22-Oct-2018 regarding an unsolicited valid non-serious case received from a consumer. This case involves 63-year-old female patient who was vaccinated with a dose of FLUZONE HD (batch number, expiration date, dose, route and site of administration was not reported) on an unspecified date. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to inappropriate age at vaccine administration and overdose. It was unknown whether the patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in 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. List of documents held by sender: none.
Pt recvd vax on 5OCT92 & on 6OCT92 devel swelling, redness, & tenderness on the elbow of the inject arm; sx described as cellulitis;
Vertigo has not resolved; This case was reported by a consumer and described the occurrence of vertigo in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th August 2021, the patient received Shingrix (intramuscular). On 20th August 2021, 2 days after receiving Shingrix, the patient experienced vertigo. On an unknown date, the outcome of the vertigo was not recovered/not resolved.   It was unknown if the reporter considered the vertigo to be related to Shingrix.  Additional details were provided as follows: The case was reported by the GlaxoSmithKline employee for a friend. The age at vaccination was not reported. The patient's DOB  (date of birth) was unknown by the reporter. The patient received the dose of Shingrix in unknown arm and 2 days after the vaccination the patient experienced vertigo. The reporter and patient gave permission to be contact by GlaxoSmithKline. The reporter consented to follow up.
Localized immunization reaction; allergic reaction symptoms: lumps on left & right neck & shoulder, joint pain, right abdominal pain, trembles, weakness, fatigue, and fever. Also, elevated blood pressure. Duration for all symptoms, 3 days.
My daughter was sick. She was complaining about pain in her stomach, she was vomiting for previuos 4 days. So I decided to take her to her pediatrician and check what is wrong with her. Instead she was given 5 vaccines at her pediatrician office. He said that she is fine. She was given second dose of H1N1, HIB, Hepatitis A, varicella and tuberculosis shot. Since this time she was uncontrollable crying and she was being in constant pain. She could not keep the food. She was throwing up. The next day she collapsed, she stop breathing, she was unconscious. My wife call the ambulance. In a hospital doctors said that she had bleeding on one side of her brain. They transfer her from one hospital to another. She was still unconscious but moving her limbs. The next day morning doctors decided to perform surgery on her brain because of the bleeding. She never came out from that. The brain was dead. She was dead...
Patient admitted with Acute respiratory failure with hypoxia.  Started on Zosyn in the ER and transitioned to cefepime.  Overnight she had escalating oxygen requirements and is transferred to ICU.  She is seen by pulmonary medicine and started on heated high flow oxygen.  She is started on steroids for suspected inflammatory lung injury related to gemcitabine. Given timing of COVID-19 vaccination and symptom onset 2 days following there is concerned about multisystem inflammatory syndrome. Follow-up 1 week with pulmonary, referred for follow-up in 1 week. ED visit and hospital admission within 6 weeks of receiving the COVID vaccine.
11:10 pt went to school nurse-hives on arms & upper chest;11:20 hives on face, tightness in throat;911 called;11:40 emergency crew gave 02 @ school DPH given in route;
Per the patient: "I waited approximately 25 minutes. As I drove home. I started to experience a scratchy throat and broke out in hives. The reaction started approximately 40 minutes are the injection. By the time I had an increase in the scratchy throat, with constant clearing of my throat. I administered my epi pen and continued on, due to being closer to. I was observed (in the ED) and discharged home with a prescription for Prednisone."
The patient was incorrectly given a moderna vaccine; the pharmacist called and scheduled a visit to vaccinate a patient in the household. When the pharmacist arrived at the scheduled date and time frame the caretaker (grandson) let the pharmacist inside. The pharmacist asked to do the vaccination for the patient by stating the name and showed the caretaker the label (patient name, date of birth, address, and type of vaccination - the label does not list gender). The caretaker took the pharmacist to the patient's room and when the pharmacist asked the patient about the vaccination the pharmacist noticed the patient is not fully cognitive. The pharmacist showed the label again to the caretaker and asked to proceed with the vaccination. The caretaker signed off on the vaccine consent for the patient and allowed the pharmacist to proceed. The patient did not show any signs of a reaction and currently, the pharmacy has not been told of any adverse reactions. It was only a few hours later that the pharmacy was notified by the intended patient that the wrong person was vaccinated. The pharmacy scheduled a visit with the intended patient and notified the patient of what had happened. The pharmacy filed an ADR on VAERs. The pharmacy also alerted the unintended patient health team as to what had occurred.
Blood pressure drop, paleness, lips turned purple, weakness, dizziness, and nausea.  He was laid down and a pillow was put under his legs to lift them up, and ice in the back of his neck. He was monitored for about 30 to 45 minutes checking his pulse, blood pressure and oxygen level.  He was also given a Sprite to take short sips.  After not feeling light headed anymore and all the symptoms passed, he was released.
Symptoms: Dizzines, Vertigo Treatment: Dramamine 50mg, Scapolamine pach
patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion) in a 59-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.   This case was linked to MOD-2022-501575 (Patient Link).
Right arm swelling, warmth, pain, redness starting about 1.5-2  inches below injection site.  About 4 inches in circumference and continuing to worsen
OV 05/18/05, noted 312 lesions over body. Chest is tender. Acyclovir 800mg QID x 5 days ordered. Advised to call office with follow up.
Smallpox vaccine was administered on 3/14/2003. Approximately 2 weeks later developed SOB with activity. Seen in employee health, by own PCP, and by cardiologist. Chest xray, echo, and stress test negative. Had abnormal T waves on EKG which resolved on follow up. Pt was found via active surveillance.
I had fatigue, slept a lot, sneezing, runny nose, low grade fever, headache, sore throat, chills, and lower back pain. I'm still experiencing a runny nose, sneezing, some coughing, stuffy nose, and chills up to last night.
Had low grade temp of 99.5 on 12/30 @ 6pm. Took Tylenol 1000 mg before bed around 9pm. Woke up with chills and fever of 101.2 at 4 am.  Continue to have fever once meds wear off and body aches.
14AUG92 pt recvd vax & w/in an hr devel several petechiae w/no other sx;
Really swollen lymph nodes in my neck; Got really sick much worse than with the previous two shots; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Got really sick much worse than with the previous two shots) and LYMPHADENOPATHY (Really swollen lymph nodes in my neck) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Sep-2021, the patient experienced LYMPHADENOPATHY (Really swollen lymph nodes in my neck). In September 2021, the patient experienced ILLNESS (Got really sick much worse than with the previous two shots). At the time of the report, ILLNESS (Got really sick much worse than with the previous two shots) and LYMPHADENOPATHY (Really swollen lymph nodes in my neck) outcome was unknown.            No concomitant products were reported. No treatment information was reported by the reporter.   This case was linked to MOD-2021-319590, MOD-2021-319587 (Patient Link).
Two days after receiving the second dose of Pfizer I got a swollen lymph node underneath my right armpit.  This lasted for seven days