chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Felt like having a stroke; Could not think correctly; Could not write with right hand; hard to ambulate; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (Felt like having a stroke) and MENTAL IMPAIRMENT (Could not think correctly) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 06-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 an unknown date, the patient experienced CEREBROVASCULAR ACCIDENT (Felt like having a stroke) (seriousness criterion medically significant), MENTAL IMPAIRMENT (Could not think correctly) (seriousness criterion medically significant), DYSGRAPHIA (Could not write with right hand) and GAIT DISTURBANCE (hard to ambulate). At the time of the report, CEREBROVASCULAR ACCIDENT (Felt like having a stroke), MENTAL IMPAIRMENT (Could not think correctly), DYSGRAPHIA (Could not write with right hand) and GAIT DISTURBANCE (hard to ambulate) had resolved.            Concomitant medications included a unspecified high dose steroid prior to receiving the vaccine. The patient confirmed with a Pulmonologist and received permission to receive the vaccine.   Treatment information was not reported.  On unknown date, a few days post-vaccination, the patient experienced stroke like symptoms. The patient reported experiencing difficulty ambulating, could not write with right hand and was not able to think clearly for at least 3 days.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
I21.4 NSTEMI (heart attack) overnight hospital stay required stent placed urgently
aching pain in left arm. Painful enough I cannot sleep on my left side. Aches to left arm
72 hours after receiving that vaccine she started experiencing vertigo; This spontaneous case was reported by a patient and describes the occurrence of VERTIGO (72 hours after receiving that vaccine she started experiencing vertigo) in an elderly female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Flu shot, COVID-19 VACCINE (Dose 3), COVID-19 VACCINE (Dose 2) and COVID-19 VACCINE (Dose 1). Past adverse reactions to the above products included No adverse event with COVID-19 VACCINE, COVID-19 VACCINE, COVID-19 VACCINE and Flu shot.    On 28-Oct-2023, the patient received fourth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced VERTIGO (72 hours after receiving that vaccine she started experiencing vertigo). At the time of the report, VERTIGO (72 hours after receiving that vaccine she started experiencing vertigo) had not resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  Patient received 3 prior COVID-19 vaccines before receiving her first Moderna COVID-19 vaccine. 72 hours after receiving that vaccine she started experiencing vertigo which has been persisting until today. She has not taken any medications or treatments to help with her symptoms. Online she read 60 percent of people reporting side effects were also reporting vertigo.   Most recent FOLLOW-UP information incorporated above includes: On 13-Nov-2023: Follow-up information included dosage text updated and reference number added.
Some ringing in both ears. Not all the time. I haven?t yet seen a doctor or done anything to treat it. Seems louder today (3 days after vaccination)
Severe chest pain started a and led to externally heavy chest feeling, currently in hospital. Evening of vaccine very weak and muscle aches. Within days extreme chest pain, weakness, heavy ness in chest.constant pain and breathing problems
Pt. is 4 months old and had Kinrix administered instead of Pediarix.  No adverse s/s noted at this time.
In Am following vaccination, pt had left arm swelling, erythema from shoulder to elbow, Also low grade temp to 99.6 also pruritus and small maculo-papular rash at areas scratched. Pt given Polio #4 and Dtap #5 in left arm and MMR #2 in right arm. Pt seen on 12/27/06 symptoms resolving. Prescribed Benadryl 50.
Pt. received FLUZONE HD morning of Tues 9/13/11. About 6-7 hrs later, pt called stating he had an itchy throat, voice change, feeling he need to clear throat. Advised pt to go to ER. He received Prednisone po. Home that evening.
surface blisters, like deep blisters all over her body/blistering rash all over; Hives; Itchy tongue; Headache; This is a spontaneous report from a contactable nurse (patient). A 44-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK4176 and expiry date: unknown), via an unspecified route of administration on 12Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  After receiving the vaccine, patient had hives and an itchy tongue on an unspecified date in Jan2021. Patient received some Benadryl at site. She spoke for about two hours and it seemed to ease a little bit. Patient came home and slept a quite a bit. As soon as she woke up, patient had the itchy tongue and hives again, so she took another the Benadryl. She woke up and then had a blistering rash all over on Jan2021. But the blisters were like surface blisters, like deep blisters all over her body. She went to the urgent care and received some IM steroid and Benadryl as treatment. Patient also had the headache on Jan2021. Outcome of the events was unknown. Patient was asking if she should get her second dose as back in the emergency room, they said they would not suggest to get the second dose.; Sender's Comments: Based on the time association, the blistery rash is possibly related to suspect BNT162B2 administration. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Tingly; Weakness; Joint Pain; Muscle Pain; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingly), ASTHENIA (Weakness), ARTHRALGIA (Joint Pain) and MYALGIA (Muscle Pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L209) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PARAESTHESIA (Tingly), ASTHENIA (Weakness), ARTHRALGIA (Joint Pain) and MYALGIA (Muscle Pain). At the time of the report, PARAESTHESIA (Tingly), ASTHENIA (Weakness), ARTHRALGIA (Joint Pain) and MYALGIA (Muscle Pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided Treatment Tylenol, Motrin
Information has been received from a pharmacist concerning an 87 year old hospitalized female with drug hypersensitivity to macrolide, diazepam, aspirin, morphine, codeine, carbamazepine, and gemfibrozil who on 1/1/05 was vaccinated with pneumococcal 23v polysaccharide vaccine 0.5ml IM (lot number 650087/0815P). On 1/5/05, the patient developed redness, warmth and tenderness at the injection site. On 1/18/05, the patient's injection site was described as necrotic area the size of a quarter which wad debrided by a surgeon. The pharmacist reported that the patient was placed on levofloxacin 250mg and wound care was ordered. The pharmacist reported that the patient remained in the hospital and was not recovered. Upon internal review, necrotic injection site requiring surgical intervention was determined to be an other important medical event (OMIC). The pharmacist expressed a concern regarding the lot. The records of testing prior to release of this lot have been checked and found to be satisfactory. The lot complies with the standards and was released. Additional information has been requested.
Patient felt dizzy 30 minutes post vaccination. Rested for an additional 15 minutes and felt better
Started w/expected ache in arm-at and below site on entry, later swelling and warm to touch. At bedtime, around 10pm-whole body aches (severe) headache. Midnight and later sore throat, feverish. Took temp at 4:55 am. 99.5 took temp at 7am 99.8. My normal body temp 97.8 next day symptoms continued, plus light headed. Took 200 mg Ibuprofen for fever and headache. Both reduced by afternoon 8/17/17. Body aches reduced as well, then sore throat gone. Arm stayed warm and swollen and achy until 8/18/17.
Axillary pain just after injection.  The next day noted decrease left shoulder range of motion.
Full body itching and hives. Swelling throughout entire body. Currently over a month since booster shot and still taking medicine daily to prevent body hives and itching.
The following morning the headache started - right-sided, intense - staying for the better part of the past 2 days;    R-sided numbness/tingling;   Dizziness/lightheadedness - at times disorienting - most of the day after the dose.  That night my temperature rose to 100-100.7;  By morning 2 days after the dose the fever was gone, as was the tingling and dizziness; but the headache remains.   Excedrin XS and drinking a lot of water helped to relieve some of the symptoms. There's still some pain at injection site, but I expected that.
Patient missed 2nd dose; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient missed 2nd dose) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient missed 2nd dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient missed 2nd dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not reported. Treatment information was not provided.
Systemic: Body Aches Generalized-Medium, Systemic: Nausea-Medium, Systemic: Seizure-Medium, Additional Details: patient was taken to er after having a seizure. patient has been feeling sick ever since injection and has missed her period. The physicians at the Emergency room said they could not find anything wrong with her. But mother is convinced something is not right. she is seeking a second opinion from different hospital
Varicella - Information  has been received from a physician concerning a 6 year old caucasian female who on 24 Jun 1997 was vaccinated SC with the first dose of varicella virus vaccine live (site unknown) Lot # 621195/0638e. On 24 Mar 2000 the patient developed a fever of 104 F and chicken pox like lesions.  The patient sought unspecified medical treatment and was diagnosed with varicella.  Additonal Information has been requested.
Received MMR and Tdap on 05-02-06. First immunizations received in life time. On 05-12-06 C/O of aches and weakness then, on 5-14-06 c/o arms and legs going numbpain. Hospitalized with leukopenia per lab results. Mother reports that was only diagnosis from hospitalization.
No adverse event. There was a recall issued for this lot number after administration, no adverse event was reported
LOCALIZED RXN TO SMALLPOX IMMUNIZATION. LEFT DELTOID SWOLLEN AND ERYTHEMATOUS. LEFT AXILLARY LYMPHADENOPATHY. NO EVIDENCE OF ABCESS. FEVER/CHILLS AND SORE THROAT ON 3/12/07. PT SEEN IN ER ON 3/13/07. TX'D WITH BENADRYL AND MOTRIN. ROUTE/SITE OF ADMINISTRATION WAS SCARIFICATION PROCESS TO LEFT ARM.
Infant had a seizure that lasted 10 minutes. Diagnosed with a complex febrile seizure (in the ER); This non-serious spontaneous safety report, with reference number 02262838, was received by a partner on 05-OCT-2022 and forwarded on 06-OCT-2022, from a physician.  The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported event "Infant had a seizure that lasted 10 minutes. Diagnosed with a complex febrile seizure (in the ER).".   Further information is expected.
This case was reported by a pharmacist and described the occurrence of injection site pain in a subject of unspecified age and gender who was vaccinated with BOOSTRIX (GlaxoSmithKline). On an unspecified date the subject received a dose of BOOSTRIX (details unknown). At an unspecified time after vaccination with BOOSTRIX, the subject experienced injection site pain "described as arthritic". At the time of reporting the outcome of the event was unspecified.
expired daptacel being administered to a patient with no reported adverse event; Initial information received on 08-Mar-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 4 months old female patient who was administered expired Diphtheria-15/Tetanus/5 AC Pertussis vaccine [Daptacel] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 07-Mar-2023, the patient received 0.5ml, 1x dose (dose 1) of suspect Diphtheria-15/Tetanus/5 AC Pertussis vaccine Suspension for injection of standard strength, lot C5774CA and expiry: 18-09-2022 via intramuscular route in the right thigh for immunization.  On 07-Mar-2023, the patient developed a non-serious event expired daptacel being administered to a patient with no reported adverse event (expired product administered) (same day) following the administration of Diphtheria-15/Tetanus/5 AC Pertussis vaccine.  No lab data was reported.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event expired daptacel being administered to a patient with no reported 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 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.
Patient states that she woke with swollen and itchy arm with a rash that Benadryl is not helping; states the rash goes from around her elbow to her wrist.
This spontaneous prospective pregnancy report as received from a physician via company representative refers to a female patient of unknown age. The patient's concurrent condition, medical history and concomitant medication were not provided. On an unknown date, the patient was vaccinated with GARDASIL 9 (dose, route of administration, lot # and expiry date were not reported) for prophylaxis. The patient was inadvertently administrated GARDASIL 9 instead of intended flu shot. It was unknown why there was confusion between the two products. The patient became pregnant. The last menstrual period (LMP) and estimated date of delivery (EDD) were not provided and could not be calculated. The pregnancy outcome was pending. This is one of two reports received from the same reporter (1812USA003886).; Sender's Comments: US-009507513-1812USA003886:
This spontaneous report as received from a physician refers to unspecified number of patients of unknown age. Current conditions and medical history was not reported. On an unknown date, the patients were vaccinated with GARDASIL (dose, route, lot number and frequency were not reported). Concomitant medications were not reported. On an unknown date, GARDASIL was improperly stored for an unspecified amount of time and administered to an unspecified number of patients. No adverse effects reported. The outcome was unknown. Product quality complaint was not reported. No further information provide. This is one of several reports received from the same reporter. Additional information has been requested.
Hand tremors; weakness in hands; Chronic fatigue; unbalanced; Crohn's disease came out of remission; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old male patient received BNT162b2 (BNT162B2), on 04Apr2021 as dose 2, single (Lot number: EW0153) at the age of 56 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Type two diabetes" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "Crohn's disease" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "Known allergies: Black pepper" (unspecified if ongoing); "Known allergies: lactose" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Cephalexin, reaction(s): "Known allergies: Cephalexin". Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: Unknown. EP7534, Location of injection: Arm Left), administration date: 23Mar2021, when the patient was 56-year-old, for COVID-19 Immunization; Humira, reaction(s): "Known allergies: Humira". The following information was reported: FATIGUE (hospitalization, disability) with onset 25Apr2021, outcome "not recovered", described as "Chronic fatigue"; CROHN'S DISEASE (hospitalization, disability) with onset 25Apr2021, outcome "not recovered", described as "Crohn's disease came out of remission"; TREMOR (hospitalization, disability) with onset 25Apr2021, outcome "not recovered", described as "Hand tremors"; BALANCE DISORDER (hospitalization, disability) with onset 25Apr2021, outcome "not recovered", described as "unbalanced"; ASTHENIA (hospitalization, disability) with onset 25Apr2021, outcome "not recovered", described as "weakness in hands". The patient was hospitalized for tremor, asthenia, fatigue, balance disorder, crohn's disease (hospitalization duration: 4 day(s)). The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: Nasal Swab. Therapeutic measures were taken as a result of tremor, asthenia, fatigue, balance disorder, crohn's disease. Clinical course: No other vaccine in four weeks, no vaccination before. AE treatment: IV fluids, antibiotics, colonoscopy, blood tests.
Patient complain soreness, lump at inj site below skin surface, no exudate, no fever, soreness inflamed.
about 2 hours after injection I got very itchy, face, arms torso red and itchy lasted for twos even with Bendryl. End of second day had sore "fiery" throat. Felt like throat was on fire lasted for a week. Nothing made it better.
I am experiencing an odd smell/taste in the back of my throat. It's been constant, even after brushing and using mouthwash. (It smells like smoked garlic!)  I haven't lost any sense of taste or smell, however. It's just an added sense on top of what I already smell.
Patient got Pfizer vaccine at 2:00 pm and she had reaction to the vaccine at 3:30 pm from the vaccine. Patient had difficulty breathing, light headed, her lips and nose turn blue to deep red color. Patient's blood pressure was 179/ 100 then second reading was 180/ 115 mmHg with Heart beat of 96. Patient felt chest tightness and hot flashes, she stated that she is going through menopause as well. Administered  three ammonia, ice pack, and later on had patient to drink. Called 911 and they came in the mean time. Patient started coming back to normal status and her blood pressure was 130/ 89 with heart beat of 84. Patient agree to go with Ambulance to do full body check up.  We will follow up with patient and her PCP to make sure she will be ok.
Swollen lymph node armpit on left arm, fever , runny nose , body ache and pain on arm
Redness around sight about 3 inches in diameter. Raised/swollen. Hard to the touch. Warm to the touch.
At 3:00 AM for 2 hours I experienced extreme shivering, muscle ache and headache. I took 2 TYLENOL.
On 03/02/2021, I had no local symptoms from the injection. The evening of my vaccination, I started to get extreme fever somewhere between 100 and 101. I went to sleep and the next morning the tachycardia kicked in. I could not control it after an hour to 1 1/2 hours. That's when I went to the emergency room. At the Hospital, they gave me IV fluids and the tachycardia stopped on it's own.
Patient received Monovalent Covid vaccine 4/20/23 during transition phase of discontinuation of Monovalent vaccine. No adverse effects reported.
This spontaneous report as received from a medical assistant refers to unknown number of patients of unknown age. On unknown dates patients were vaccinated with GARDASIL (dose, lot no. and route unknown). No concomitant medication was reported. The patients were inadvertently administered vaccine that had been improperly stored. No adverse effects were reported. The outcome of events was unknown. This is one of several reports from the same reporter. Additional information has been requested.
The pt was taken to the ER with a 1 3/4 inch raised red area at the injection site with some itching. No pain or SOB. The pt was told it was a reaction. No treatment ordered.
severe pounding headache. Headache throbbed with heart beat. Saw red and yellow bright spots with each pulse.
This vaccine was given to a 16 y/o patient.  This vaccine is only FDA approved for 18 years old and older.  Pt had fever, 100.8, loss of appetite for 2 days.
I received the Covid 19 Johnson & Johnson shot which is not available to select above.   I experienced severe illness after this shot, I was not expecting to be this ill, I  honestly don't think I have ever felt this bad with any illness.  I had Covid in October 2020 and have had one of the strains of flu before and never felt this bad.  I had severe chills, body aches, exhaustion, dizziness, nausea, the worst headache I think I have ever had, and a fever that reached 102.4.  I was in extreme misery all night long.  Also, today 4/8/21 I'm noticing a heightened sense of smell which is unsettling.  If I would have know how sick I was going to be I would not have gotten this shot.  If boosters are expected in the future I will not get elect to get one.   I just want to share my experience so medical staff is aware.
Patient came down to employee health to get moderna booster shot. She explained to LPN that she finished her 2 dose series 7 months ago. Patient received 0.25ml of moderna in left deltoid. While writer was inputting information into database writer had realized patients last pfizer vaccine was 09/21/22 making her not eligible for the booster until 02/21/2022. Patient was made aware that she received the booster prior to her scheduled time. At this time patient has no side effects or issues and feels fine. Vaers completed over phone with patient.