chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Bleeding; IBD; Diarrhoea; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 21-Apr-2021 and was forwarded to Moderna on 22-Apr-2021.    Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HAEMORRHAGE (Bleeding), INFLAMMATORY BOWEL DISEASE (IBD) and DIARRHOEA (Diarrhoea) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Autoimmune disorder.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HAEMORRHAGE (Bleeding) (seriousness criterion hospitalization), INFLAMMATORY BOWEL DISEASE (IBD) (seriousness criterion hospitalization) and DIARRHOEA (Diarrhoea) (seriousness criterion hospitalization). At the time of the report, HAEMORRHAGE (Bleeding), INFLAMMATORY BOWEL DISEASE (IBD) and DIARRHOEA (Diarrhoea) outcome was unknown.            For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments.  No concomitant medications reported.No treatment information provided.  The patient received both scheduled doses of mRNA-1273 prior to the event(s), therefore action taken with the drug in response to the event(s) is not applicable  Based on current available information and the temporal association between product use and start date of the events a causal relationship cannot be excluded.Based on current available information and the temporal association between product use and start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product use and start date of the events a causal relationship cannot be excluded.
Pt got severe swelling at injection site (size of half of a plum) within 30 sec. of administration. Once pt complained of SOB - EPIPEN was administered and swelling slow down instantly.
The patient was missing a polio vaccine and I gave Quadracel as per Dr. order. Our office does not carry a vaccine with only polio. I prepared Quadracel along with Fluarix and Bivalent for 12+ patients. Once in the room, I went over the vaccines with the parent and handed the VIS to them. The patient's parents will be contacted and notified of the error.
Systemic: Dizziness / Lightheadness-Severe, Additional Details: Dizziness and patient fell.  pharmacy call 911.  Pt requested parametic.
While at counseling appointment on February 17  patient had witnessed sudden cardiac arrest and was not able to be resuscitated. She was pronounced dead at 12:09. At the time of death her glucose was about 500.
This spontaneous report was received from a physician via a company representative and refers to a male patient of unknown age. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (dose, route of administration, lot# and expiration date were not reported) for prophylaxis. The vaccine was reconstituted with sterile diluent. On an unknown date (reported as "1 week later"), the patient experienced non-injection site rash. The outcome of rash was unknown. The causality assessment was not provided.
Patient was given Proquad & Kinrix on same day in (L) forearm. Swelling & pain & redness 2 x 4inches at the site of injection of Kinrix. Seen pt in office on 10/14/2020 - given ibuprofen & -Benadryl, condition improved
Extreme soar arm the day after the vaccination,  headache in subsequent days (at least for four days), mild fever
my left arm and breast were tender with some mild body aches and low grade headache/Arm soreness; my left arm and breast were tender with some mild body aches and low grade headache/ left breast was increasingly painful with swollen palpable lymph nodes; my left arm and breast were tender with some mild body aches and low grade headache/ left breast was increasingly painful with swollen palpable lymph nodes; my left arm and breast were tender with some mild body aches and low grade headache/ left breast was increasingly painful with swollen palpable lymph nodes; my left arm and breast were tender with some mild body aches and low grade headache; body soreness and stiffness; This is a spontaneous report from a contactable healthcare professional.  A 34-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), via an unspecified route of administration on 18Dec2020 at single dose for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient stated, "the day after the injection, my left arm and breast were tender with some mild body aches and low grade headache. Sunday Arm soreness went away but left breast was increasingly painful with swollen palpable lymph nodes, with body soreness and stiffness. Monday left breast is still remarkably tender with palpable lymph nodes" on 19Dec2020 (reported as Seriousness criteria-Caused/prolonged hospitalization: Yes, on an unspecified date in Dec2020). The outcome of the event was not recovered.; Sender's Comments: The reported information is limited. Based on the close temporal relationship and the description of the events, there is a reasonable possibility that the events are related to BNT162 vaccine. 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.
patient came in stating that she had experienced fever and light headedness.  pt also stated that she developed a spotty rash on both legs from the ankles to her knees.  the rash happened on saturday, 02/12/22. pt went to er, was looked over at the er and no medicines were prescribed for the pt.
Felt fine this morning (2/15/19). Then started feeling tired, chills, aches, a little lightheaded and then nauseated. Just kept feeling worse as afternoon went on. It is now 7 pm  on 2/15/2019. I don't feel any better.
This spontaneous report as received from a medical assistant refers to unspecified patients of unknown age. An unspecified number of patients received either VAQTA that was improperly stored by being exposed to 34F for 3 days, 33F for 2 days, 34F for 2.5 days, 32F for 0.5 days, and 30F for 30 minutes. The medical assistant stated the vaccines dropped down to 32 F and 30 F for a total of 13 hours on 02-AUG-2012. The temperatures listed for 34 F and 33 F were prior to 02-AUG-2012. VAQTA (lot number reported as 1228AA, expired date 16-JUN-2014) administered on 10-AUG-2012, 20-AUG-2012, 24-AUG-2012 and 31-AUG-2012. The dates of the temperature excursions were unspecified. No known adverse effects. This is one of several reports received from the same source. Additional information has been requested.
They had a headache; This is a spontaneous report from a contactable reporter (consumer or other non HCP).  An adult female patient (not pregnant) received bnt162b2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN) (Lot number: unknown) as dose 1, single for COVID-19 immunisation and bnt162b2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN) (Lot number: unknown) as dose 2, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "They had a headache".   Additional information: The reporter reported this out of caution as this was something the reporter remembered on the day of report. The patient described this past summer or autumn one evening that they had a headache. The reporter realized this might have been probably after they were vaccinated (since reporter believed this past year she was likely fully vaccinated at least). This might have been not recognized as an adverse event at the time. She did not explicitly say the vaccine was the cause of headache, and did not know if date was close to vaccination date(s). The patent was in early 20s. Extremely likely had recovered. Original awareness for headache would have been in the summer/fall when first notified.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Upper right arm at injection site and below injection site almost to my elbow, began itching and feeling ?tight? and slightly sore at approximately 11:30 pm on Thursday, February 25, 2021. The area is warmer to the touch than surrounding skin, with redness and visible swelling at the injection site and extending almost to my elbow. This area feels hard to the touch, as if my muscle is contracted. I am reporting on day 2 and there have been no changes except itching has subsided.
5-22-06 Benadryl given PO prior to med administration. Developed swelling, erythema - both legs and urticaria on all extremities and trunk immediately. As a result no further vaccines administered.
COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Jan2021 as dose 1, single (Lot number: EL3247), on 10Feb2021 as dose 2, single (Lot number: EL9269), on 02Oct2021 as dose 3 (booster), single (Lot number: FF2589) and on 06Apr2022 as dose 4 (booster), single (Lot number: FJ5683) for covid-19 immunisation. The patient's relevant medical history included: "OSTEOARTHRITIS" (unspecified if ongoing); "SEASONAL ALLERGIES" (unspecified if ongoing). No known allergies. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of vaccination failure, covid-19.
PATIENT CAME UP TO THE PHARMACTY ON 03/19/20 AND REPORTED ARM HURTING AT SITE OF INJECTION AND RED. SHE ALSO STATED THAT THE ARM HURTS A LITTLE WHEN MOVING AND IS SLIGHTLY SWOLLEN AT INJECTION SITE AND IT STARTED THAT MORNING AT 10AM .  tHE VAERS SITE CRASHED LAST NIGHT SO i COULDN'T COMPLETE THE REPORT.
felt a tiny bit under the weather/was feeling under the weather on and off; headache/had a headache which he describes as very slight, nothing crazy; with the exact same thing happening to his big toe on his right foot; felt like gout on the back or heel of his left foot; The joint was sore and not feeling right; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (felt like gout on the back or heel of his left foot), LIMB DISCOMFORT (with the exact same thing happening to his big toe on his right foot), MALAISE (felt a tiny bit under the weather/was feeling under the weather on and off), HEADACHE (headache/had a headache which he describes as very slight, nothing crazy) and ARTHRALGIA (The joint was sore and not feeling right) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Aug-2021 at 5:03 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Aug-2021, the patient experienced LIMB DISCOMFORT (felt like gout on the back or heel of his left foot) and ARTHRALGIA (The joint was sore and not feeling right). On 18-Aug-2021, the patient experienced LIMB DISCOMFORT (with the exact same thing happening to his big toe on his right foot). On an unknown date, the patient experienced MALAISE (felt a tiny bit under the weather/was feeling under the weather on and off) and HEADACHE (headache/had a headache which he describes as very slight, nothing crazy). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, LIMB DISCOMFORT (felt like gout on the back or heel of his left foot) and ARTHRALGIA (The joint was sore and not feeling right) had resolved and LIMB DISCOMFORT (with the exact same thing happening to his big toe on his right foot), MALAISE (felt a tiny bit under the weather/was feeling under the weather on and off) and HEADACHE (headache/had a headache which he describes as very slight, nothing crazy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant drugs were reported
Same day post vax, the pt developed soreness in arm at area around injection site and inability to pick things up and right hand swollen. Pt reported that injection site itched for 2 hours.
PATIENT COMPLAINS OF A BILATERAL RED RASH ON UPPER EXTREMITIES AND UPPER CHEST. REDDNESS SHOWED UP THIS EVENING AFTER HIS SHOWER. NO ITCHING, NO ORAL SWELLING, NO HIVES, NO TROUBLE BREATHING INVOLVED.  I RECOMMENDED THAT HE CONSIDER TAKING AN ANTIHISTAMINE SUCH AS BENADRYL OR CLARITIN AND TO REACH OUT TO HIS PRIMARY CARE DOCTOR. IF HIS SYMPTOMS WORSEN HE SHOULD SEEK CARE AT THE HOSPITAL.
Had four vaccines for covid , one Janssen then three moderna.  Had b cell lymphoma with metastatic cancer on chemotherapy and came to hospital  12-5-22  where he was subsequently intubated for flu and pneumonia and was Not covid + until 1-6-23.    Later was transferred to hospice where he passed on 1-18-23.   Complicated hospital course
Extreme coldness 12/4/21 6:00pm Trouble catching breath 12/4/21 through the night Hallucinations 12/4/21 through the night Swollen arm at shot location 12/5/21 4:00pm
tired; pain in arm; Fever; This is a spontaneous report from a contactable consumer or other non hcp. An elderly (65+Years) male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) via an unspecified route of administration on an unspecified date, dose number unknown as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. Reporter stated that after receiving the dose of vaccine on 07Feb2021 the patient experienced pain in arm and stated that it was virtually painless if relaxed in the right position so sleep unaffected and it hurts some on using the arm or putting any pressure on it and also experienced fever and stated that patient never got an official fever but had a fever in the sense that his temperature was up from his normal level and patient was tired and slept about 10 or 11 hours on last night. Today the worst was over, and patient was starting to get back to normal. On 07Feb2021, the patient underwent lab tests and procedures which included body temperature which result showed temperature was up from normal level. The outcome of all the events was recovering.   Information on the lot/batch number has been requested.
about a week after the booster was administered, I began experiencing pain in the area between my shoulder and the point of the shot.  I can still barely move my arm above 90 degrees.  I was examined by my doctor, and he prescribed physical therapy.  I can still feel the exact point of the shot.  I have never, ever had this happen before in my life with any shot of any type.  so I would like to know if you are receiving other reports like this. my activities are somewhat limited;  things like putting on my seatbelt, dressing, reaching.
muscle pain in my left arm; swelling of the lymph nodes in my left armpit; This is a spontaneous report from a contactable other health professional reported for herself. A 46-Year-old, non-pregnant, black female patient received second dose of BNT162B2 (Pfizer-BioNTech COVID-19 Vaccine, formulation: Solution for injection, lot number: EL 9262) via intramuscularly in Left arm on 29Jan2021 at 10:45 AM (at the age of 46 years) as DOSE 2, SINGLE for COVID-19 immunisation. Medical history included toothache from an unknown date and unknown if ongoing (Advil Duo and amoxicillin for toothache, had a root canal performed 4days after 2nd dose of vaccine), allergies to Walnuts. Concomitant medication(s) included ibuprofen (ADVIL) taken for toothache, start and stop date were not reported; amoxicillin (AMOXICILLIN) taken for toothache, start and stop date were not reported. The patient was performed with a root canal 4days after 2nd dose of vaccine. The concomitant medications included ibuprofen (ADVIL) and amoxicillin for toothache. The patient historical vaccine included BNT162B2 (Pfizer-BioNTech COVID-19 Vaccine, formulation: Solution for injection, lot number: EL-1284) via intramuscularly in Left arm on 08Jan2021at 08:00 AM, as DOSE 1, SINGLE for COVID-19 immunisation. After the first dose, the patient had sporadic muscle nerve pain in left arm and left leg for a few days following the injection. Also experienced headaches during that time. The patient did not diagnose with COVID-19 prior to vaccination. After receiving the second dose of vaccine on 31Jan2021, the patient experienced had muscle pain in my left arm and swelling of the lymph nodes in my left armpit for about 4 days. The patient did not receive treatment. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was recovered on an unspecified date in 2021.  Follow-up attempts completed. No further information expected.
01/10/07 Came to receive a Flu vaccine.  Used lot #U2285AA in Rt. Deltoid.  Came today 1/30/07 stating that Rt. Shoulder and forearm has been hurting since vaccine given.  Pt. c/o having pain on posterior area of Rt. Deltoid muscle area.  No mass, no redness or warm to area.
HYPOTENSION HYPOXIA 2/16/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Also congested from an allergy; It's annoying; Right eye swell up/in the beginning looked like a bug bite; Throat swell up; This spontaneous case was reported by a consumer and describes the occurrence of IRRITABILITY (It's annoying), NASAL CONGESTION (Also congested from an allergy), EYE SWELLING (Right eye swell up/in the beginning looked like a bug bite) and PHARYNGEAL SWELLING (Throat swell up) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002F21A) for COVID-19 vaccination.     Concurrent medical conditions included Multiple sclerosis and Systemic lupus erythematosus.    On 11-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Aug-2021, the patient experienced IRRITABILITY (It's annoying). 12-Aug-2021, the patient experienced EYE SWELLING (Right eye swell up/in the beginning looked like a bug bite) and PHARYNGEAL SWELLING (Throat swell up). On an unknown date, the patient experienced NASAL CONGESTION (Also congested from an allergy). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency and MONTELUKAST SODIUM (SINGULAIR) for Adverse event, at an unspecified dose and frequency. At the time of the report, IRRITABILITY (It's annoying) and NASAL CONGESTION (Also congested from an allergy) outcome was unknown, EYE SWELLING (Right eye swell up/in the beginning looked like a bug bite) was resolving and PHARYNGEAL SWELLING (Throat swell up) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication included Gesimppa, once a month injection, a new drug to treat multiple sclerosis and lupus.
inadvertently administered with 1.0 ml of the vaccine; This spontaneous case was reported by a health care professional and describes the occurrence of ACCIDENTAL OVERDOSE (inadvertently administered with 1.0 ml of the vaccine) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, the patient experienced ACCIDENTAL OVERDOSE (inadvertently administered with 1.0 ml of the vaccine). On 10-Apr-2021, ACCIDENTAL OVERDOSE (inadvertently administered with 1.0 ml of the vaccine) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.
This case was reported by a nurse and described the occurrence of welts in a 34 year old female patient who received hepatitis B vaccine recombinant (Engerix-B). On 26 October 2004, the patient received the first dose of Engerix-B. On "the afternoon of 29 November 2004," the patient received the second dose of Engerix-B in the left arm (lot AHBVB034BA). "The evening" of 29 November 2004, the patient experienced "small, red, raised welts that started on the ankles and spread to the whole body." The patient was seen at a physician's office on 30 November 2004 and was prescribed desloratadine (Clarinex). The welts were ongoing at the time of initial reporting. The nurse considered the welts to probably be related to vaccination with Engerix-B.
On 5-31, 2022 I started having a sore throat and nasal drainage. The next day on 6-1, I continued with same symptoms but also started coughing, had fatigue and brain fog. I took a home Covid test with positive results. On 6-2, I started having a fever of up to 102.0. I took ibuprofen and Mucinex as needed. I noticed my throat pain was increasing in severity. That night, I could not sleep because my throat hurt so much. On 6-3, I called the doctors office and they suggested alternating Tylenol and ibuprofen as needed. They prescribed a steroid x7 days and codeine cough syrup. On 6-11, I started having vertigo. I am still experiencing brain fog and fatigue. I am reporting a breakthru case of covid.
The patient has a 3 inch diameter red swelled area on her right arm where the injection was given and states that she feels itchy all over her body, no other redness or rash is present other than her arm.
I did not have an adverse event after receiving the vaccine. I tested positive for COVID-19 in 01/2023. I started with a headache and a fever, so I contacted my doctor and got a prescription for PAXLOVID. I tolerated the medication without any complications. I did have a rebound case of COVID-19 and it was all in my sinuses. I had a green discharge from my nose for about two weeks. As of today, I do not have any lingering symptoms of COVID-19.
Involuntary movements to both feet while feet off of floor. Constant and non stopping . It?s getting worse over time and now both arms/hands have the involuntary movements. Trier Gabapentin, Slow Fe, Amantadine, Cogentin.
Pt. given Flu shot Fluarix Quad at same visit and in same arm as Covid-19 Moderna vaccination
Patient received both vaccines.  She then slumped down in her chair and was briefly unresponsive. She awoke confused.  She stood and walked to a chair outside the vaccination room and then slumped in the chair again with chin forward.  Emergency services were called from Clinic. Her BP was taken and she was monitored for at minimum 30 minutes. She was sent home with no further explanation.
Pt had vax 13JUL92, began having temp in PM; APAP given 4 hrs t101; also mom states pt legs appear swollen & does not want to bear weight on legs;
24JAN97 @ 4-5PM c/o itching on legs per father;pt denies hives on legs, back, chest-described by pt as pencil eraser sized raised w/irregular borders & clear points;referred to MD for possible chickenpox;
Rash the size of my hand/area is hot to the touch, the affected area is tender