chrisvoncsefalvay/vaers-outcomes huggingface dataset:
severe h/a, total body aches, congestion, coughing, runny nose, severe sweats, mild rash on face, sneezing (did not take temp); took over the counter products lasted 8 days;
Had a 4 minute seizure within 2 hours after the flu shot. He has had 4 other seizures to date.
Second Shingrix vaccine administered was expired on date of administration. Administered 01/20/2023, expired 11/7/2022. Discovered thru internal audit. Primary care physician has been notified, incident has been submitted, and patient has been notified. Patient will stop in this week to receive re-administration of 2nd dose (as per CDC guidelines)
That evening had a 100.2 degree fever, severe chills, redness, swelling, hot and painful to the touch.
Intermittent tingling in fingers, mostly left hand but some on right hand at times. Seemed to get a cold a few days after the booster, but I still feel like I'm fighting something.
Sx fever starting 3/14/06, woke with fever. Fever x 4 days 103. Highest reading at injection site c/o muscle soreness, felt like arm was going to fall off.
Pt called and said she had a rash this morning.  Around 4x6 inches area.  She said yesterday, it has some swelling and tenderness at the injection site. She is fine now...but just want to let us know.
fever, malaise, nausea, vomiting & arthralgia; bitten by a barn cat that was not captured; 4th dose now due; 23NOV92 f/u recovered; lot# not known; Not known if 5th dose given;
Presented to the ER 10/9 with c/o SOB; admitted 10/9 for acute hypoxic resp failure & PNA d/t COVID & tx w/steroids, zinc, Vit C, & pepcid; 10/10 added Zithromax; 10/11 added Cefipime; 10/12 tx to ICU d/t increased resp demand & increased WOB on Max AirVo settings.  Pt also developed AKI and was started on dialysis; 10/23 pt coded and ROSC unable to be achieved & pt expired.
he is not feeling well because of vaccine (malaise); This non-serious case was reported by a consumer via other manufacturer and described the occurrence of feeling unwell in a 61-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.  Previously administered products included DUPIXENT (On 21-MAY-2020, the patient started taking DUPIXENT Solution for injection subcutaneously, since 2020 (lot - 2F209A)). Concurrent medical conditions included atopic dermatitis.  On 02-MAY-2023, the patient received Shingrix. In MAY-2023, 2 days after receiving Shingrix, the patient experienced feeling unwell (Verbatim: he is not feeling well because of vaccine (malaise)). The outcome of the feeling unwell was resolving.  It was not reported if the reporter considered the feeling unwell to be related to Shingrix.  It was not reported if the company considered the feeling unwell to be related to Shingrix.  Additional Information: GSK Receipt Date: 01-JUN-2023 The initial information was received regarding a solicited valid non-serious case received from a consumer/non-hcp, while being treated with DUPILC MAB (DUPIXENT) via prefilled pen and VARICELLA ZOSTER VACCINE ROE (CEO) (SHINGRIX). The patient's past medical history, medical treatment(s), concomitant (s) and family history were not provided. On 21-MAY-2020, the patient started taking DUPIXENT (DUPILUMAB) Solution for injection (strength: 300 mg) with a dosage of 600 mg total, following with a dosage of 300 mg every other week (QC W) since 2020 for Atopic dermatitis. In MAY, 2023 the patient developed a non-serious event shingles vaccine 2 days ago, and that he was not feeling well because of the vaccine (malaise) (latency: approx. 3 years) following the first dose intake of DCPILUMAB and unknown latency with VARICELLA ZOSTER VACCINE RGE (CHO). It was reported that, the patient had administered the 300mg dose to his abdomen today (on the day of reporting), 04-MAY-2023, and it squirted out, he was asking whether it was a faulty prefilled pen, and if he should take another dose. He accepted to be transferred to his healthcare provider for further instructions. He also reported he had noticed an improvement in his symptoms since being on Dupixent. When asked if the patient was requesting replacement, the nurse stated that he would wait and consult his physician first, and if he needed another dose, that was when he would request for a replacement. The nurse also noted that the patient started the loading dose with a prefilled syringe, but now he was using the prefilled pen, the patient does not state, when he had switched from the prefilled syringe to the prefilled pen. Action taken: No taken for DUPILUMAB (DUPIXENT), and unknown for VARICELLA ZOSTER VACCINE RGE (CEO) (SHINGRIX). At time of reporting, the outcome was Unknown for the event shingles vaccine 2 days ago, and that he was not feeling well because the vaccine. Reporter causality: Not reported. Company Causality: Not reportable. The reporter consented to follow-up.
Redness, swelling, around left arm, covering 3/4 area itchy, hard, mildly tender.
This is a spontaneous report from a contactable physician from a  Pfizer sponsored program IBCC (Inbound Call Center for HCPs). A patient of unspecified age ethnicity and gender received 2 doses of PREVNAR 13 via an unspecified route of administration at single dose on unspecified date for immunisation. The patient medical history and concomitant medications were not reported. The reporter wanted to do allergen testing on as her patient had a rash after receiving two vaccines of the PCV-13.
Digestive distress with vomiting/diarrhea and pain; fever; fatigue; pain under in left underarm; lasted for 1-2 weeks
Fever of 101.9, muscle aches, headaches, chills and sweats, light headed and dizziness
PATIENT DEVELOPED EXTREME FATIGUE, JOINT PAIN, SORE THROAT, FEVER 48 HRS AFTER VACCINATION.
Information has been received from a physician concerning his son who on an unspecified date was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). On an unspecified date the patient developed a break through case of chickenpox. Unspecified medical attention was sought. No further information was provided. There was no product quality complaint involved. Additional information has been requested. This is one of several reports from the same source.
Case number Case number PHEH2016US023522, is an combined report initial spontaneous report received from a healthcare professional on 12 Sep 2016. This report refers to a 52 years old patient of unknown gender. Past medical history and concomitant medications were not reported. The patient was vaccinated with one single dose of FLUVIRIN (batch number: 1618701, expiry date: Apr 2017) at a dose of 0.5 ml, intramuscularly on 09 Sep 2016. It was stated that, patient received FLUVIRIN following 1st time temperature excursion of 52.9 Fahrenheit for 1 hour and 25 minutes. No adverse event was reported following this medication error (incorrect product storage).
Soreness and tenderness in both lower legs and ankle; Soreness and tenderness in back; Cheeks sore; Diarrhea; Both lower legs started to swell; Soreness and tenderness in both lower legs and ankle; Soreness and tenderness in both shoulders; Slight headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness and tenderness in both lower legs and ankle), BACK PAIN (Soreness and tenderness in back), FACIAL PAIN (Cheeks sore), DIARRHOEA (Diarrhea) and PERIPHERAL SWELLING (Both lower legs started to swell) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 39A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Sickle cell anemia.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced PAIN IN EXTREMITY (Soreness and tenderness in both lower legs and ankle), BACK PAIN (Soreness and tenderness in back), FACIAL PAIN (Cheeks sore), DIARRHOEA (Diarrhea), PERIPHERAL SWELLING (Both lower legs started to swell), ARTHRALGIA (Soreness and tenderness in both lower legs and ankle), ARTHRALGIA (Soreness and tenderness in both shoulders) and HEADACHE (Slight headache). At the time of the report, PAIN IN EXTREMITY (Soreness and tenderness in both lower legs and ankle), BACK PAIN (Soreness and tenderness in back), FACIAL PAIN (Cheeks sore), DIARRHOEA (Diarrhea), PERIPHERAL SWELLING (Both lower legs started to swell), ARTHRALGIA (Soreness and tenderness in both lower legs and ankle), ARTHRALGIA (Soreness and tenderness in both shoulders) and HEADACHE (Slight headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications and treatment information were provided.   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Follow up received; patient initial updated.
HEADACHE; STUMBLE WHEN GETTING UP FROM THE COUCH; DIZZINESS; HARD TIME WALKING; THROAT FEELS A BIT SCRATCHY; RIGHT ARM SORENESS/SORENESS IN THE RIGHT ARM; CHILLS; FATIGUE; This spontaneous report received from a patient concerned a 71 year old male. The patient's height, and weight were not reported. The patient's past medical history included aortic valve surgery, and concurrent conditions included arthritis.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, and expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced stumble when getting up from the couch. On 08-APR-2021, the subject experienced dizziness. On 08-APR-2021, the subject experienced hard time walking. On 08-APR-2021, the subject experienced throat feels a bit scratchy. On 08-APR-2021, the subject experienced right arm soreness/soreness in the right arm. On 08-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced fatigue. On 08-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from throat feels a bit scratchy, right arm soreness/soreness in the right arm, chills, and headache, and was recovering from dizziness, fatigue, hard time walking, and stumble when getting up from the couch. This report was non-serious.
imz was given 7hrs58mins after dilution.  pfizer was called about stability & pt was informed
flu like symptoms; headache; tired; lack of appetite; blotted/ loud stomach with bloating; loud stomach; muscle aches / muscle aching; woke up feeling like I had been hit by a truck; weak; chills; queasy; pain at injection site; This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th March 2020, the patient received the 1st dose of Shingrix. On 12th March 2020, less than a day after receiving Shingrix, the patient experienced injection site pain. On 13th March 2020, the patient experienced influenza-like symptoms, headache, tiredness, appetite absent, bloating, upset stomach, muscle pain, feeling abnormal, weakness, chills and queasy. On an unknown date, the outcome of the injection site pain, influenza-like symptoms, headache, tiredness, appetite absent, bloating, upset stomach, muscle pain, feeling abnormal, weakness, chills and queasy were recovering/resolving.   It was unknown if the reporter considered the injection site pain, influenza-like symptoms, headache, tiredness, appetite absent, bloating, upset stomach, muscle pain, feeling abnormal, weakness, chills and queasy to be related to Shingrix.  Additional details were reported as follows: The patient received 1st dose of vaccine on unknown arm and experienced injection site pain. The nurse told to patient that she might experience flu like symptoms and a sore arm for a few days after the vaccine. The patient worked that evening. On next morning, patient woke up feeling like she had been hit by a truck, weak, muscles aching, chills, headache, queasy, loud stomach with bloating. The patient also experienced influenza-like symptoms, , tiredness, appetite absent. This had been going on for a week but now patient felt somewhat better.  The patient stated that this would all be fine with her if we were not in the middle of a pandemic. The patient did not have any way of knowing what was actually going on with her and she wanted to know whether this vaccine caused this reaction in other people too. The patient planned to continue follow-up with her physician. The reporter consented to follow up.
Tightness in chest eyes fluttering rolled back face turned red stiffened up then passed out. Pharmacist administered benadryl when came to then proceeded to vomit. Taken by ambulance to hospital
The pt developed a hoarse voice lasting about 12 hours, rash all over whole body, blotchy spots, noticed the next morning. Duration of 24 hours.
On Day #8 after vaccination (1st dose) of Moderna Covid-19, developed a 3 cm sore red welt hot to the touch and minor pain in the area of vaccine inoculation.  I have applied  1% hydro cortisone cream and took benadryl 25mg and night and today on the morning.  Area is less red and swollen  but still hot to the touch. I still have fluocinonide cream that used on my nails. and  fingers after an allergic episode to UV light gel nail polish and recently applied to the area to see if it helps.
Hard chills 103.3 fever. Muscle pain. Bone pain. Headache. Fatigue.  Injection site very red and hot to touch. Injection site  itching.
I noticed this evening I have a rash all over my abdomen unlike any rash I?ve ever seen before on myself. It doesn?t itch or burn (yet?), it?s just there. It looks like someone splattered red paint on my stomach, it?s isolated only to the abdominal region on either side of my belly button, underneath my breasts but below my waist as well
The caller said that she took the 1st dose yesterday 08Apr2021, but she noticed that her blood sugar has been elevated last night and this morning; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A 59 year-old female patient received bnt162b2 (BNT162B2), administration date 08Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Type 1 diabetes" (ongoing). Concomitant medication(s) included: METFORMIN; INSULIN. The following information was reported: BLOOD GLUCOSE INCREASED (non-serious) with onset 09Apr2021, outcome "unknown", described as "The caller said that she took the 1st dose yesterday 08Apr2021, but she noticed that her blood sugar has been elevated last night and this morning". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient said that she took the 1st dose yesterday,08Apr2021, but she noticed that her blood sugar had been elevated last night and this morning. She also mentioned that she took Metformin and her insulin as she needed to take them every day. She Submitted a manual AE form. Unaddressed medical questions was referred or forwarded to Medical Information.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
an allergy; rash around the area where it was given; This case was reported by a consumer via interactive digital media and described the occurrence of allergy in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   In November 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced allergy and injection site rash. On an unknown date, the outcome of the allergy was unknown and the outcome of the injection site rash was recovered/resolved.   It was unknown if the reporter considered the allergy and injection site rash to be related to Shingrix.  Additional details were reported as follows: This case was reported by patient him/herself. The age at vaccination was not reported. The age group was not reported but was selected as an adult as per vaccine indication. The patient experienced a rash around the area where the Shingrix was given, which lasted about a week. The physician stated that it was an allergy. The follow-up would not possible as no contact details were available.
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041B21A) for COVID-19 vaccination.     Concomitant products included MULTIVITAMIN FOR WOMEN for an unknown indication.    On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant products used included Women's multivitamin and birth control pills.  No treatment medication was provided.  The patient was rescheduled to receive the 2nd dose on 14May2021. However, her partner will undergo an operation that day so she had to reschedule.The medical center rescheduled her on 08May2021 which was only 22 days after the initial dose.
Sore arm 1+1/2 days then hard swollen, is still swollen.
awful chills; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (awful chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 071f21a, 026a21a and 030M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Oct-2021, the patient experienced CHILLS (awful chills). At the time of the report, CHILLS (awful chills) outcome was unknown.            No concomitant medications were reported. No treatment information were reported.   This case was linked to MOD-2021-378388 (Patient Link).
Pt received adacel vaccine on 3/18/09. Today 3/20/09 noticed rash on left forearm that is itchy, raised, were 9 bumps initially, now only 3.   No other meds, no difficulty breathing , no new lotions,soaps or detergents.3 raised discrete bumps on left forearm, with tops scratched off, site of Tdap looks nl skin over deltoid, no erythema or tenderness or skin lesions of any kind, does have another lesion right hand, dorsum-predated this rash by a few days and is a fixed lesion, not itchy, lungs clear no angioedema
Patient was erroneously given undiluted vial of Pfizer COVID vaccine, equivalent to  5-6 doses.  Was monitored in clinic for 1.5 hours afterward with stable q15m vitals.  Patient felt clammy but otherwise no side effects.
Immediately following the second Pfizer shot, a large and very painful lump appeared on my collar bone, on the left side (had had my injection on the left). This swollen lymph node has remained enlarged to this day. The appearance of this lump was accompanied by intense pain radiating across my collarbone and into my throat. The right lobe of my thyroid swelled and then a goiter appeared. I was diagnosed with autoimmune thyroiditis a few months later, confirmed via ultrasound and bloodwork. Symptoms of thyrotoxicosis accompanied the appearance of the goiter. The thyroid was extremely inflamed and a burning pain would radiate across my collarbone, identical to the pain following the second Pfizer shot. The right lobe of my thyroid was eventually removed due to the appearance of a suspicious nodule. I have no personal history of thyroid dysfunction prior to the vaccine and there is no history of thyroid dysfunction in my family.
Mother called on 2/23/05 to report that physician states child has rubella from his vaccine and she should report it to the health department, therefore this report is being filed at the mother's request.   Mother states child received vaccines on 2/10/05.  On 2/12/05 child developed chicken pox.  Other children at the child's daycare center had chicken pox also.  Varicella resolved on 2/19 and on 2/20 child developed fever of 103 degrees with a red, raised, itchy rash over his entire body.  Also has cough, runny nose and bloodshot eyes.  Fever and rash are still present on 2/23/05.  Has appointment with family physician on 2/24/05.   Mother called on 2/24/05 and reported that physician feels he had an allergic reaction to the MMR and should never get that vaccine again. Mother treated child with Benadryl and acetaminophen.  Fever resolved and rash is fading.    It is mother's belief that older brother developed autism after his first MMR.
Nine (9) days after receiving my 1st Moderma shot my area where I received shot  (left arm)  started itching  and a patch of red appeared  around where I received the shot... No pain.
Blood clots; Shortness of breathe; Chest and throat pressure; Chest and throat pressure; This is a spontaneous report from a contactable other HCP (patient self). A 43-year-old non-pregnant female patient received first dose of bnt162b2 (BNT162B2, Batch/Lot Number: ew01g8), intramuscularly administered in Arm Left on 05Aug2021 at 16:00 at age of 43-year-old as single dose for covid-19 immunisation.  The patient's medical history and concomitant medications were not reported. Facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced blood clots, shortness of breathe, chest and throat pressure on 08Aug2021. Seriousness criteria of events were reported as Life threatening. The adverse event result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, life threatening illness immediate risk of death from the event. Since the vaccination, the patient had been tested for COVID-19 (Nasal Swab) on 16Aug2021 showed negative. The patient received heparin as treatment. The outcome of events was not recovered.; Sender's Comments: Based on the available information, the known safety profile and the temporal association of bnt162b2 administration to the events, a possible contribution of the drug to the events cannot be excluded.  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 appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.