chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Over several weeks, had intermittent symptoms of burning and numbness in legs. Change in vision (spots) once. Difficulty swallowing several times. Sudden onset (12/17/14) difficulty walking, loss of balance, cognitive function, orthostatic hypertension requiring trip to ER. Received IV steroids 1000mg x3 days after approx.  One week in hospital and po until 1/9/14. Given for ataxia, significant clonus reflex, hypereflexia, labile autonomic nervous response, myelopothy. Also placed on Toprol XL 12.5mg daily.
4-9-13 2 hrs after receiving started having headache. Took migraine medicine with no help - name unknown. 4-10-13 developed "hives" blotchy red areas on arms and legs. Called and FNP referred to ER. Per pt. left ER without being seen "hives went away". 4-11-13 no rash. No headaches.
After 25 minutes of having the shot at 1:45pm, I experienced a tightness around my left rib cage below my breast. I then experienced slight tightness on my chest. The tightness eventually became intermittent and was gone after 30-40 minutes.
Case number PHEH2044US020228, is an initial spontaneous report from a consumer (patient's mother) received on 06 OCT 2014. This report refers to a 10-year-old female patient. Past medical history and concomitant medication were not provided. She was inadvertently vaccinated with FLUCELVAX 2014/2015 (batch  number: unknown) intramuscularly on 03 OCT 2014. NO adverse event was reported following the maladministration (inappropriate age at vaccine administration).
Information has been received from a pharmacist concerning a male (age not reported) who on an unspecified date was vaccinated with pneumococcal 23v polysaccharide vaccine (manufacturer unknown). Subsequently, the patient developed an adverse event and was hospitalized. It was reported that the patient was hospitalized for three weeks. At the time of reporting, the outcome of the event was unknown. Additional information has been requested.
Pain at injection site that has persisted for over 2 weeks. Pt. States that soreness in left arm worsens throughout the day. Spoke to Pt. on 9/16/16 regarding congestion.
This case was reported by a physician via sales rep and described the occurrence of phantom pain in a male patient who received SHINGRIX for prophylaxis. The patient's past medical history included amputee. Previously administered products included SHINGRIX with an associated reaction of phantom pain (1st dose received on an unknown date, for tolerance refer case US2018181723). Concurrent medical conditions included phantom pain. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a day after receiving SHINGRIX, the patient experienced phantom pain and condition aggravated. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the phantom pain and condition aggravated were unknown. It was unknown if the reporter considered the phantom pain and condition aggravated to be related to SHINGRIX. Additional details were provided as follows: This case was reported via text message to the Regulatory Authority. The age at vaccination was not reported. The physician had an amputee patient with a pre-existent condition of phantom pain. The phantom pain became severe on the day of the vaccination. The pain was so severe that he had to be put on medication (not specified). No additional details were provided.
3 weeks after vaccine, right sided parotitis without other symptoms; symptoms mild. Did also have Kinrix 10/9/17.
Symptoms started a week after 1st COVID dose on 8/4/2021. Reported bilateral numbness and tingling in the palms of his hands and soles of his feet, which progressively worsened. Right-sided facial droop and difficulty drinking out of a cup.
minor was given initial Pfizer Covid vaccine on 11/16/22, next vaccine Moderna requires a 4 week interval and vaccine was given at 3 weeks so will not be valid
Information has been received from a consumer concerning her 21 year old daughter with no medical history or allergies reported, who on 29-FEB-2008 was vaccinated with the first dose of GARDASIL. There was no concomitant medication. On 29-FEB-2008, after receiving her first dose, the patient became very sleepy and developed a rash across her breast line and under her neck. The patient sought unspecified medical attention with a gynecologist. At the time of this report the patient's outcome was not recovered. No product quality complaint was involved. No further information is available.
Pt stated she was unable to walk and had dizziness.  She had to be assisted to  chair.  BP was 170/60 and a pulse was 60 bpm.   Pt stated that she was breathing but felt unable to take a deep breath. Pt stated that she had problems opening eyes and leaving them open. also reported headache . Pt reported chilling and was having tremors possibly related to being cold.
This spontaneous report as received from a physician refers to a 68 year old male patient. The patient did not have any pertinent medical history or drug reactions or allergies. On an unknown date approximately in February 2015 (also reported as approximately 14 months back) the patient was vaccinated with first dose of ZOSTAVAX (lot number and expiry date unknown) (dosing regimen and frequency unknown) for shingles prevention. The patient was not taking any medications concomitantly. The physician stated that the patient did not experience any adverse events following the first dose. On 13-APR-2016 the patient was inadvertently vaccinated with second dose of ZOSTAVAX (lot # L015414 and expiry date 01-AUG-2016) (dosing regimen and frequency unknown) for shingles prevention. On an unknown date approximately in April 2016 (after the administration of the second dose) the patient experienced fatigue and insomnia. It was reported that the patient sought medical attention and called the physician. No lab diagnostics studies were performed. No treatment was given for the events. The action taken with the therapy with ZOSTAVAX was unknown. The outcome of fatigue and insomnia was reported as not recovered. The relatedness of the events to the therapy with ZOSTAVAX was unknown. There was no product quality complaint reported. Additional information has been requested.
Autoimmune Disorder; still feel like really fatigued; weak; still lowly; This spontaneous case was reported by a consumer and describes the occurrence of AUTOIMMUNE DISORDER (Autoimmune Disorder) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039H21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Autoimmune disorder, Rheumatoid arthritis and Fibromyalgia.   On 01-Apr-2021, 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) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced FATIGUE (still feel like really fatigued), ASTHENIA (weak) and FEELING ABNORMAL (still lowly). On an unknown date, the patient experienced AUTOIMMUNE DISORDER (Autoimmune Disorder) (seriousness criterion medically significant). At the time of the report, FATIGUE (still feel like really fatigued), ASTHENIA (weak), FEELING ABNORMAL (still lowly) and AUTOIMMUNE DISORDER (Autoimmune Disorder) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided.  The patient did not receive any treatment
Extremely heavy menstrual period, intense cramping and menstruated cycle has lasted 13 days as of today which is highly unusual.
The patient received the shot with no issues and walked away from the pharmacy with no issues.  I was notified that the patient had fainted while shopping in the store.  Mom states the patient looks very pale and fell to the ground.  Mom was able to catch her fall.  She was laying down in the aisle when I was notified of the reaction.  Her eyes were open, but she was difficult to arouse.  She did respond that she was open, but had a few moments of confusion.  With time she became more alert and oriented.  An ambluance did respond to the event and took her to the van to take vitals.
Pt. states that after receiving the 3rd dose of Moderna 12/21/2021, started experiencing symptoms 12/22/2021 of fatigue, body aches, sore throat, and headache. No noted Primary visit/communications. Still experiencing symptoms.
The patient called the pharmacy on 11/14/19 to report he had a fever of  101.9 F and his arm was very hot but not swollen. He also said he had a itchy back but no rash. I told him to take a 800mg Ibuprofen. After several hours he said the fever had decreased.  On 11/15/19 I followed up with the patient and he felt better but still needed to take the Ibuprofen to keep the fever away.
Headache, lightheaded, dizziness, bilat foot and arm numbness, chest pain, SOB
9NOV98 10PM noted some itching;by 6PM 10NOV98 had a baseball size redness & swelling @ inj site;saw MD on 11NOV98 p/4:00;stated had a definite rxn;ear temp 92;told to never have vax again;devel cold or pneumonia;bruise;c/o cold sx & cough;
This spontaneous report as received from a licensed practical nurse refers to a 12 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 13-JUL-2015, the patient was vaccinated with the dose of GARDASIL (lot # K004204, expiration date 12-JAN-2017; dose and route were not reported) that had experienced an excursion. No adverse reaction was reported. This is one of several reports received from the same reporter. Additional information has been requested.
3 days after receiving HPV vaccine, patient developed tremors in both hands that lasted 2-3 hours, she had fever for 24 hours.
With in 6 minutes of receiving the injection my thyroid began to swell and the paramedic came to our car. He let us go because my throat wasn't swelling. When I got home, we noticed that my thyroid was so swollen we could see a heart every time I swallowed. That swelling continued for 4 hours and then the next day I couldn't move my arm. Over the weekend, I got so sick I was unable to leave the bathroom.
Around 6pm my arm starting getting sore. All night it hurt really badly and kept me awake. I took Tylenol around 3am and that helped. When I woke up the day after I had a HUGE lump on my arm at the injection site. It looked like a golf ball. It was red and hot. It stayed this way for about 3 more days and finally started to go down. The red mark at the injection spot remained though and continued hurting until about day 9 after the shot. Then it started getting itchy but remained red. I am now over 2 weeks post shot and the red mark is still slightly there but not very visible and the pain and itchiness has gone away.
Eight hours after vac: Body aches, followed by low grade temp, headache, fatigue, resolved after 36 hours, then followed by moderate diarrhea.
MISSED A DOSE; This spontaneous case (PVX2019-1440) was received from a pharmacist on 04-Jun-2019. It describes a male consumer who "missed a dose", while being on Vivotif for an unknown indication.  Case report: The consumer missed a dose of Vivotif that was due on 03-Jun-2019.  Action taken with Vivotif was not applicable.  The clinical outcome of the event "missed a dose" was unknown.  Company's Comment: The causality of the event "missed a dose" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "missed a dose" was considered as not applicable.
Pt reported side effects approx. 12/23/2008 at 5:00pm of severe headache, vision changes, pain and swelling in left arm.  Pt said pin then radiated throughout body.  Pt reports used TYLENOL for pain.  Pt reports sxs improved on 12/26/08
Tiny little red dots on legs; Rash on face, neck, torso, top of feet, leg and injection site; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Tiny little red dots on legs) and RASH (Rash on face, neck, torso, top of feet, leg and injection site) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025L20A and 030L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 01-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Jan-2021, the patient experienced ERYTHEMA (Tiny little red dots on legs) and RASH (Rash on face, neck, torso, top of feet, leg and injection site). At the time of the report, ERYTHEMA (Tiny little red dots on legs) and RASH (Rash on face, neck, torso, top of feet, leg and injection site) had resolved.            Concomitant medication not provided. Treatment medication not provided. Awaiting for Linked Case ID
Patient requested/scheduled to received 0.5 ml of COVID 19 Moderna Bivalent booster. Patient was given 0.5ml of COVID 19 Moderna monovalent pediatric dosage for ages 5-11 years old. Patient reports no symptoms at this time. Moderna Manufacturer notified of event, awaiting further instructions from manufacturer. Patient notified of event, and will be updated with further instructions for future COVID 19 vaccines doses, as per manufacturer instructions.
Pain, itching, redness, and swelling at inject site. Patient also reports dizziness.
pneumonia, SOB (Shortness of breath), chills, fever; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (pneumonia, SOB (Shortness of breath), chills, fever) in a 73-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7165B) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Spikevax (Dose 1: Lot number 011J20A) on 09-Jan-2021, Spikevax (Dose 2: Lot number 028L20A) on 06-Feb-2021, Spikevax (Dose 3: Lot number 058E21A) on 20-Aug-2021 and Spikevax (Dose 4: Lot number 107T065Y-21A) on 04-Jul-2022. Past adverse reactions to the above products included No adverse event with Spikevax, Spikevax, Spikevax and Spikevax.    In October 2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 05-Mar-2023, the patient experienced PNEUMONIA (pneumonia, SOB (Shortness of breath), chills, fever) (seriousness criterion medically significant). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, PNEUMONIA (pneumonia, SOB (Shortness of breath), chills, fever) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. The patient took things at home including ibuprofen, breathing in steam, rest, and a lot of water. She did not take any prescribed medications for her symptoms. The patient had chest X-ray at local emergency room. On SEP-2023 the patient had been scheduled to receive a flu vaccine  Company comment: This spontaneous case concerns 73-years old female patient, with no medical history information provided, who experienced unexpected serious (medically significant) event of pneumonia. The event occurred approx. 5 months after fifth dose of Spikevax bivalent BA.4/BA.5. As reported, patient's symptoms included chills, fever, and SOB (shortness of breath). The patient took things at home including ibuprofen, breathing in steam, rest, and a lot of water. The patient did not take any prescribed medications for her symptoms. The patient had chest X-ray at local emergency room (no results provided). Considering the reported information, non suggestive temporal association, nature of event (infectious nature) and lack of biological plausibility for such event to be caused by Spikevax vaccine, the event of pneumonia is assessed as not related per Company assessment. The benefit-risk relationship of the Spikevax bivalent BA.4/BA.5 is not affected by this report.
High fever (ranging from 102-103.7 for 2.5 days after shot), extreme soreness at area of shot, rash around area of shot.
I had just itching and it was like deep inside itching. Kind of like when you've been in a tanning bed. It was on my scalp, bottom of my feet. I was just itching all over.  About 11 days later is when I came down with something else. I was having body aches and diarrhea. I was seen in the ED. By Monday late evening I was starting to feel back to normal.
Fever, pain throughout body, diarrhea, weakness all over, brain fog, drowsiness, knots on arm by injection sight for 4 days,  5th day all the same symptoms but seems to be let up some.
No adverse events noted.  Pt received adult dose of Hepatitis B instead of pediatric dose. She was 17 years old at date of vaccination.
This spontaneous report as received from a medical assistant regarding a patient of unknown age and gender. Information on the concurrent condition, medical history and pertinent drug allergies of the patient were not reported. On 18-NOV-2015 the patient was vaccinated with improperly stored RECOMBIVAX HB (lot # L018501, expiry date-22-JUN-2017) (dose #, route, dose units and anatomical location were not specified). Concomitant medication was not reported. No adverse events were reported. There were no Product Quality Complaint (PQC) involved. This is one of several reports received from the same reporter. Additional information has been requested.
accidentally administered a 5th Pentacel injection exactly 1 month following her 4th Pentacel injection/no AE; accidentally administered a 5th Pentacel injection/no AE; Initial information received on 19-Jun-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a female patient of unknown age who received vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] and reported that accidentally administered a 5th Pentacel injection exactly 1 month following her 4th pentacel injection/no AE and accidentally administered a 5th pentacel injection/no AE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR).  On an unknown date, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot number not reported via unknown route in unknown administration site.  It was a case of actual medication error due to inappropriate schedule of vaccine administered and extra dose administered.  It was unknown if 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.  Information on the batch number was requested.  List of documents held by sender: none.
Initial report received from a health care professional on 16 November 2011. A female patient (age not reported) received an injection (route and site not reported) of INFLUENZA VACCINE, manufacturer and lot number not reported, on an unknown date. The patient has never had an adverse reaction to the flu vaccine and has received one previously. Her medical history and concomitant medications were not reported. The day after the vaccination the patient became very sick and was admitted to the hospital following laboratory testing which showed an elevated creatine. She was experiencing kidney problems and needed to go on steroids and chemotherapy as part of her treatment. She was currently in the hospital. The patient was being treated by an infectious disease doctor who stated that this was extremely rare. The outcome was not reported. Documents held by sender: None.
ITCHING; SWELLING ON FACE; BURNING SENSATION; HIVES; RASH; BUMP; FEVER; BODY ACHES; CHILLS; This spontaneous report received from a patient concerned a 23 year old female. The patient's height, and weight were not reported.  The patient's concurrent conditions included asthma, and alcohol user. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 08-APR-2021 17:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On NOV-2020, Laboratory data included: COVID-19 (NR: not provided) Positive. On APR-2021, Laboratory data included: Body temperature (NR: not provided) 101.4 F, 98.8 F. On 09-APR-2021 02:00, the subject experienced body aches. On 09-APR-2021 02:00, the subject experienced chills. On 09-APR-2021 02:00, the subject experienced fever. On 15-APR-2021, the subject experienced itching. On 15-APR-2021, the subject experienced swelling on face. On 15-APR-2021, the subject experienced burning sensation. On 15-APR-2021, the subject experienced hives. On 15-APR-2021, the subject experienced rash. On 15-APR-2021, the subject experienced bump. Treatment medications included: cortisone, and diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, chills, and fever on 10-APR-2021, and itching on 16-APR-2021, was recovering from hives, rash, swelling on face, and bump, and had not recovered from burning sensation. This report was non-serious.
I started with a scratchy throat and a headache which is unusual for me, I just was not feeling the best so I took a home test on Saturday and it was negative. I had started running a fever so I went to have a COVID-19 PCR test completed and it came back positive. By that time I was having a deep dry cough, headache, fever, and muscle soreness. I called the nurses hotline at my doctor off and was prescribed PAXLOVID on August 02, 2022. My symptoms improved after taking the medication as I have 3 doses remaining. The cough is better but I am still experiencing some coughing. I have not made a complete recovery but I am much better. I no longer have a temperature either. I still have diarrhea that I assume is a side effect from the medication.