chrisvoncsefalvay/vaers-outcomes huggingface dataset:
HEADACHE; TOOTH PAIN/PIERCING PAIN; OVER NIGHT FEVER; This spontaneous report received from a patient concerned a 60 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: alcohol user, and non smoker, and other pre-existing medical conditions included: The patient had no known allergies, no history of drug abuse or illicit drug use. She was healthy. The patient received their initial vaccination (dose number in series 1) with covid-19 vaccine ad26. cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 04-APR-2021 for prophylactic vaccination. No adverse event was reported after series one dose.  The patient mentioned she did dental cleaning on 24-SEP-2021, where the hygienist was very hard on her. He triggered a broken tooth that she was waiting to fix the next year due to insurance coverage. That caused her severe pain. She suffered from that dental pain from 24-SEP-2021 to 24-OCT-2021, as constant pain like storm. The patient received booster dose (dose number series 2) covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: 1855194, expiry: unknown) dose was not reported, frequency time 1 total administered on 10-NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-NOV-2021, the pharmacist injected the dose aggressively and the patient experienced over night fever which was not checked by thermometer. On 11-NOV-2021, the patient experienced headache, that went away same day at evening time. After booster dose, her tooth pain came back in the same area. That pain was still there till the day of report, it was piercing pain, from one tooth (lower jaw), toward the whole side of the mouth. At the same level of the initial pain patient told the dentist about the incident.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from over night fever, and headache on 11-NOV-2021, and had not recovered from tooth pain/piercing pain. This report was non-serious.
Mild Flu-Like symptoms , Cough, Fatigue, Runny nose ,and Sore throat Self Supportive care  with OTC Medications cough medications and OTC throat spray, Symptoms lasted four days from onset of immunization
pt recv vax 4/2/99 pt awoke & noted difficulty closing rt eye & moving rt side of mouth;seen 4/27/99 by MD & dx w/rt sided Bells palsy;MRI showed enhancement of the 7th nerve on rt;
Swelling of entire lower extremity without redness, tenderness or pain.  Onset 8 hrs post vaccine.  Lasted 24 hours.
CHILD'S DATE OF BIRTH WRITTEN UNSPECIFIED DATE AND AGE WRITTEN AS 12 ON CONSENT SIGNED BY INDIVIDUAL IDENTIFYING AS FATHER. CHILD IDENTIFIED IN SYSTEM WITH DATE OF BIRTH AS UNSPECIFIED DATE. CHILD TOO YOUNG FOR VACCINE.
The patient is a 54-year old male, who presents to the office via consult from Dr., Cardiology, for further evaluation and recommendations following significant cardiac issues in the setting of recent Smallpox vaccination #3 vaccine received on 22 Jan 2014 (Manufacturer ACAM 2000; 15 jabs percutaneous, left arm, Lot # VV04-003A). The patient denied any immediate symptoms and reports no significant LLR or robust take was noticed with this vaccination (which was his third documented smallpox vaccine). However, from Mar - Jun 2014, he began to note a decline in exertional tolerance. Review of clinical notes show his first visit for such complaint was 1 June 2014. He was evaluated with ECG and echocardiogram which demonstrated decreased LVEF and severe MR. He subsequently had an evaluation at Medical Center, with the key finding of dilated non-ischemic CM with severe MR thought to be secondary to posterior leaflet restriction due to underlying inferolateral wall motion abnormality. He was sent to another Medical Center where cMRI was performed which showed global LV hypokinesis with dilated LV and a focal area of hyper-enhancement of undetermined etiology but thought to perhaps be secondary to his recent SPV. Patient has since had surgical intervention (Mitral valve repair) and cardiac rehabilitation. He is currently followed by Dr. (Cardiologist) and another Cardiology. Patient desires causality assessment. He denies any previous AEFI and specifically denies any previous problems with prior Smallpox Vaccine. No personal or family h/o autoimmune disease. No previous work-up for viral causes of cardiomyopathy. No other complaints.
felt ill for a day; This case was reported by a consumer and described the occurrence of feeling unwell in a 68-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of malaise (1st dose, refer case US2020AMR042565).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced feeling unwell. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the feeling unwell was recovered/resolved.   It was unknown if the reporter considered the feeling unwell to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient felt ill for a day. This case has been linked to US2020AMR042554 and US2020AMR042562, reported by the same reporter.
Narrative: Patient received 1st dose of COVID-19 Pfizer vaccine and developed a "lump" in her throat that was mildly itchy and tight. Refused to go to ED after 3x and was observed for 1 hour. Took Benadryl when she arrived home and slept and later said she is feeling better.
Rash, non-tender, 4cm x 8cm. No treatment per Dr.
Swollen lymph node, visualized, soft and without redness or tenderness. Does complain of neck strain. No intervention other than tylenol and ibuprofen
Patient was seen in the ER and discharged for abdominal pain initially on 11/17/09 at 23:27. Came into our office on 11/18/09 because the abdominal pain was still occuring and getting worse. Went to another hospital and was diagnosed with Intussusception.
Rash on my chest up to my neck; A spontaneous report was received from a consumer who of unknown age and gender who received Moderna's COVID-19 Vaccine (mRNA-1273) and who experienced a red rash on my chest up to my neck/rash.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On an unspecified date, approximately 6 hours prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) for prophylaxis of COVID-19 infection.  The next day after vaccination, patient had a red rash on chest up to neck about 6 hours after vaccination rashes resolve on its own.  Treatment for the event included some allergy medicine not specified.  Action taken with mRNA-1273 in response to the event was not provided.  The events, red rash on chest up to neck, was considered recovered on an unspecified date.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Patient called 04/06 stating he had a nodule that has developed at the injection site. Denies any complaints of fever, warmth, or rash at the location.
3/14/21 woke  up with Rash/Purpura below knees, both  legs. Fever in evening of 102.5,  resolved with aspirin. Rash/Purpura faded by the time I followed up with PA on 3/22/2021. Some light discoloration remains.
Pins and needles through whole body including eyes, lips, tongue, and throat within five minutes of vaccination; Swollen lymph nodes; throbbing pain throughout whole body; booster; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 18 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 28Nov2021 09:45 (Batch/Lot number: unknown) at the age of 18 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Iron deficiency anaemia" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing); "COVID" (unspecified if ongoing), notes: if covid prior vaccination: Yes. Concomitant medication(s) included: VITRON C; IRON. Past drug history included: Pseudoephedrine, reaction(s): "Known allergies: pseudoephedrine"; Phenylephrine, reaction(s): "Known allergies: phenylephrine"; Cefalexin, reaction(s): "Known allergies: cefalexin". Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Not with me , Location of injection: Arm Left, Vaccine Administration Time: 09:00 AM), administration date: 13May2021, when the patient was 18 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Vaccine card not with me , Location of injection: Arm Right, Vaccine Administration Time: 09:00 AM), administration date: 22Apr2021, when the patient was 18 years old, for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 28Nov2021 09:45, outcome "unknown", described as "booster"; PARAESTHESIA (non-serious) with onset 28Nov2021 10:00, outcome "recovering", described as "Pins and needles through whole body including eyes, lips, tongue, and throat within five minutes of vaccination"; LYMPHADENOPATHY (non-serious) with onset 28Nov2021 10:00, outcome "recovering", described as "Swollen lymph nodes"; PAIN (non-serious) with onset 28Nov2021 10:00, outcome "recovering", described as "throbbing pain throughout whole body". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of paraesthesia, lymphadenopathy, pain.  Additional information: Patient didn't had any other vaccine in four weeks. Patient had Covid test post vaccination.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Quarter size red elevated macular rash around injection site, slightly irregular. Pt given bactroban, Augmentin XR, Elocon
Received booster on 9-24 in left arm, and a week later started getting leg pain in left calf with shortness of breathe. Pain got worse so went to the doctor.  She ordered an ultrasound for both legs and they found a clot in my left calf. U
I had terrible insomnia and the worst headache Wednesday night. When I finally went to sleep I tossed and turned and was cold and hot. I woke up with barely any strength. I slept from 8am-1:30pm Thursday. I had body aches, an upset stomach, muscle aches, and overall felt yucky. Friday I went to work for a presentation and was feeling awful. I had a fever and took some ibuprofen. My injection site was swollen and warm to the touch. I was dripping sweat last night Friday night. My lymph nodes are still swollen under my arm where I got the vaccine and my neck.
headaches, body aches, sore throat, hoarse voice, loss of sense of taste and smell
Patient has anxiety with vaccines and shots. Patient was fine after receiving the vaccine but vomited while they were waiting for any potential side-effects.
Initial information received on 28-Aug-2018 regarding an unsolicited valid non-serious case received from a Nurse. This case involves a four months old female patient who was received 0.5 ml dose of PENTACEL (HIB Lot number C5506AA, Expiry date 05-Sep-2019 and DTap-IPV Lot Number C5324AC and Expiry Date 05-Sep-2019) intramuscularly in right thigh on 27-Aug-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PREVNAR 13 for Immunisation; and ROTATEQ for Immunisation. It was a case of actual medication error due to inappropriate reconstitution technique. It was reported that HIB component was reconstituted with sterile diluent and given to patient. 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 holders 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.
UTI; Mortons calluses on her right foot; Sciatic issues; tiredness; she had a reaction to it with chills; everything hurt; This spontaneous case was reported by a consumer and describes the occurrence of URINARY TRACT INFECTION (UTI), HYPERKERATOSIS (Mortons calluses on her right foot), SCIATICA (Sciatic issues), MYALGIA (everything hurt) and FATIGUE (tiredness) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product LENVATINIB MESILATE (LENVIMA) for Endometrial cancer.    Concurrent medical conditions included Endometrial cancer.   On 19-May-2022, the patient LENVATINIB MESILATE (LENVIMA) (unknown route) dosage was changed to 14 milligram. On 24-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient started LENVATINIB MESILATE (LENVIMA) (unknown route) 10 milligram. In October 2022, the patient experienced MYALGIA (everything hurt) and CHILLS (she had a reaction to it with chills). In November 2022, the patient experienced FATIGUE (tiredness). On an unknown date, the patient experienced URINARY TRACT INFECTION (UTI), HYPERKERATOSIS (Mortons calluses on her right foot) and SCIATICA (Sciatic issues). The patient was treated with SULFAMETHOXAZOLE, TRIMETHOPRIM (BACTRIM) for UTI, at an unspecified dose and frequency. In October 2022, MYALGIA (everything hurt) and CHILLS (she had a reaction to it with chills) had resolved. In December 2022, SCIATICA (Sciatic issues) had resolved. At the time of the report, URINARY TRACT INFECTION (UTI) outcome was unknown and HYPERKERATOSIS (Mortons calluses on her right foot) and FATIGUE (tiredness) had resolved.            The concomitant medication was not reported.  Patient stated she might be starting to have another episode of urinary track infection. The sciatic issue remained for 2.5 months and went away. The patient had three Mortons calluses on the right foot which a podiatrist carved. Applied urea cream which helped.
27APR redness on lt hand, swelling of lt shoulder, arm & hand; c/o pain on bone of lt arm moved side of breast; 28th hand still swelling & hard red knot on arm 3cm of erythemia & swelling; 5MAY swelling purple; out of work until week of 3MA
***VAX IS COVID MODERNA SPIKEVAX*** I am running a headache, to day is worst than it was yesterday, I am aching all over, feeling and hot and cold. I am also going through menopaused, so I am going back and forth a lot. I am really tired and don't feel good. I feel nauseous. I have thrown up twice, once last night and once this morning, with diarrhea. Fever started and I am running a temperature 101. I have pain at the injection site.
Local swelling, erythema of most of thigh (left) with increased heat to palpation. No tenderness. Review of hosp. d/c summary confirms diagnosis of CELLULITIS
The patient was to receive Moderna Bivalent; instead Moderna Pediatric age 6-11 was administered
started fever 1PM; c/o throat hurting, swelling on rt side; under jaw restless-shaking & jerking; called MD APAP ordered; took pt to ER;
Patient began noticing rash on chest, spreading to arms, flanks & legs.  Reports that rash does itch.  Patient also stated that she has been utilizing tanning bed 03-01-09.
Fever T 101 degrees taken by ear thermometer 1/11/11 approximately 11 PM. Hives noted 1/12/11 8:30 AM came in for evaluation & rash - urticaria still present 3:20PM 1/12/11.
Tightness in chest. Heaviness in chest. Shortness of breath. Neck pain. This is only so far because it's just been a week. No pain relief yet at all. Increasing pain in chest. Final outcome is unknown at this date (11/12/21)
2-3 hours after vaccination developed a "weird feeling" or brain fogginess. At 1545 she developed body aches, chills, dizziness, and chest tightness prior to falling asleep on her couch. She woke up drenched in sweat and took some Emergen-c. Overnight she developed a headache which woke her up and she took Excedrin. This AM se continues to have body aches, dizziness, and a slight headache, but denies feeling any disorientation now.
5/16/23  I started with congestion and cough. It got really bad during the night. I woke up the next day and had a headache, coughing a lot and some congestion. Every day it progressively got worse.  On 5/19/23 I was coughing up dark red phlegm. I went to the doctor and was referred to the emergency room because I had a urine test which showed a high level of keystones.  At the emergency room, they did blood work, chest x-Ray and EKG. I had a temperature of 102.7. Bloodwork was abnormal, main issue was low sodium.  I was diagnosed with a nonspecific upper respiratory infection, Ketosis, UTI, tachycardia and sepsis. I had starvation ketones because I had not eaten in 3 days.
Expired Pediarix administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a patient who received DTPa-HBV-IPV (Pediarix) (expiry date 05-MAR-2023) for prophylaxis.   On 06-MAR-2023, the patient received Pediarix. On an unknown date, an unknown time after receiving Pediarix, [the patient experienced expired vaccine used (Verbatim: Expired Pediarix administered). 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: 07-MAR-2023  The pharmacist reported a patient was administered a dose of expired Pediarix, which led to expired vaccine used. The health care professional (HCP) did not had details at time of call but said he could get them, follow-up ok via email above in HCP details. The reporter consented to follow up.
Patient called to report that after receiving her vaccinations (Hepatitis A and Hepatitis B) on 9/28/07 later that evening developed dizziness and felt like the room was spinning; two additional episodes of dizziness were experienced on 9/29/07 and 9/30/07; she similarly had short episodes of this same feeling on 10/9/07 and 10/10/07; denies other symptoms other than a "sore right arm" for a couple of days; does not recall having these symptoms after her first dose of Hepatitis A; Informed patient to notify primary MD of these and prior to any additional doses of Hepatitis B she would need to get this addressed; she agreed and will call area where appointment with provider can be made; informed that in the meanwhile if symptoms persist or worsen that she will present at a local urgent care facility. VAERS report sent.
Information has been received from a physician concerning a female (age unknown), who was vaccinated with a dose of Gardasil. After being vaccinated the patient had "GI problems and fatigue." The patient sought unspecified medical attention. At the time of the report, the patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested. Initial and follow-up information has been received from a physician and a nurse practitioner concerning a female who was vaccinated with a dose of GARDASIL. On 01-APR-2007 the patient experienced "GI problems" of diarrhea and abdominal cramps and fatigue. It was reported that the "c-pl" test was normal and the stool giardia antigen test was negative for giardia. The patient was last seen on 02-JUN-2007 and the patient's "GI problems" of diarrhea and abdominal cramps and fatigue persisted. Additional information is not expected.
itchy rash to arms and legs with throat tightness. Took oral Benadryl, symptoms resolved and did not return.
Patient had a syncopal episode,  pallor; VS taken- bradycardia; 4 lead and 12 leads EKG done- abnormal rhythm. ASA and oxygen given. Paramedics called.
I had the injection at 11am., 2am I woke up with a severe headache, body aches, nausea along with 101.4 temp.  This lasted until mid day, then just fatigue.  Wednesday  I got a large fever blister on my lip ( have had history in the past, not in some time though)  Since then I have had an additional  3.  2 very large and not on my lip.  Under by nose and as of yesterday on my lower cheek area. I was given Valtrex 1000mg  take 2 then additional 2.  Because of the frequent out breaks in the past several weeks, I started 500 mg daily.  I am due for my next vaccine on Feb 9th, but I am concerned.  ( I did have Covid 4/15/20 )
Was exposed to Covid-19 on 9/22/21. Was test and experienced symptoms on 9/26/21. Tested positive on 9/27/21
c/o pain in hips & legs; has had trouble w/sleep, all 5 days p/flu vax in lt deltoid; seen by MD 18OCt93 recvd dx of sciatic arthritis, arthritis meds given to pt; 8NOV93 phone call placed to pt & stated felt well;
Client received flu shot on 11/18/03 at health department at approximately 11:00 AM. Cient states that after receiving vaccine his arm was sore. Since 11/13/03. Client states that left arm is weaker than right arm and is unable to carry heavy objects with left arm. Limited range of motion of left arm. He also states that he experiences a tingling sensation down his left arm at times.
Right arm where MMR was given was swollen and red-almost 2-3 inch diameter. Tylenol and Benadryl was given.
Hospitalization - pneumonia due to COVID-19 virus; non-traumatic rhabdomyolysis; acute kidney injury; hypothermia; elevated troponin
Small fiber peripheral neuropathy. Went for accupuncture and h wave therapy. Helped but has gotten it better. Went on for 8 months and I still have some symptoms. Also had some visual disturbances the first couple of months