chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Severe chest pain; racing pulse (103); extreme fatigue; rash; headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 79 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 10Jan2022 13:45 (Lot number: FL3198) at the age of 79 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "RA" (unspecified if ongoing); "HTN" (unspecified if ongoing); "NAFL" (unspecified if ongoing); "osteoarthritis" (unspecified if ongoing); "spinal stenosis" (unspecified if ongoing); "Known allergies: IVP dye" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Morphine, reaction(s): "known allergies: Morphine"; Demerol, reaction(s): "known allergies: Demerol"; Enbrel, reaction(s): "known allergies: Enbrel"; Xeljanz, reaction(s): "known allergies: Xeljanz"; Cipro, reaction(s): "known allergies: Cipro". Vaccination history included: Moderna vaccine, reaction(s): "known allergies: Moderna vaccine". The following information was reported: CHEST PAIN (non-serious) with onset 11Jan2022 16:00, outcome "unknown", described as "Severe chest pain"; HEART RATE INCREASED (non-serious) with onset 11Jan2022 16:00, outcome "unknown", described as "racing pulse (103)"; FATIGUE (non-serious) with onset 11Jan2022 16:00, outcome "unknown", described as "extreme fatigue"; RASH (non-serious) with onset 11Jan2022 16:00, outcome "unknown", described as "rash"; HEADACHE (non-serious) with onset 11Jan2022 16:00, outcome "unknown", described as "headache". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of chest pain, heart rate increased, fatigue, rash, headache.   Additional information: The patient received Pepcid, Zyrtec as treatment for Adverse events. The patient took other medications in two weeks, including Med to offset reaction. The patient had not received any other vaccine within 4 weeks prior to Covid-19 vaccine. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination.
Information has been received from a registered nurse referring to an unspecified number of patients of unknown age and gender. No relevant medical history or concurrent conditions were reported. Since 01-OCT-2015 these patients were inadvertently vaccinated with improperly store GARDASIL (lot # K014191, expiration date 10-MAY-2017; dose, frequency and route not reported). No adverse experiences had been reported. This is one of two reports received from the same reporter. Additional information has been requested.
Rph reports that a 16 year old patient received 1st dose of vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Rph reports that a 16 year old patient received 1st dose of vaccine) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Rph reports that a 16 year old patient received 1st dose of vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Rph reports that a 16 year old patient received 1st dose of vaccine) 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 provided by the reporter.
Additional shot of booster administered - first booster received 10/14, additional booster dose given 12/1
Arthus reaction- pain, erythema, swelling 5cmX7cm at injection site, now present for 4 days.
T12 dermatomal, painful rash, Right sided, 1 week after vaccination Acyclovir, lidocaine gel, Norco 5-325 mg, (Baclofen for back strain).
Received COVID 19 vaccine second dose on 3/4/21. Says started having redness, swelling and pain at the site of injection on 3/6. Associated with some diarrhea, but this resolved in 2 days. But left arm pain and swelling was worsening and so came to E.R on 3/8 and was d/ced home with oral Keflex. Says, since started using Keflex, started having nausea and vomiting and so came back to E.R last night
pt devel rash, fever, irritability, arthritis onset tx w/NSAIDS for 2yr;
Injection site immediately grew a red spot after vaccination. This spot turned into hard red bump with a hight temperature that was painful to the touch. Over the course of the next 10 days, the bump increased in size until it was about 5 inches in diameter. On day 9, the swelling and hardness went away but the arm became numb. On day 10, arm feels heavy and sluggish, but the spot has begun fading away from red but is showing a purplish tint growing in it's spot.
Immediate arm paining mild dizziness followed by 4+ days of extreme fatigue, mild difficulty breathing, fever, chills, body aches (pain level 5/6), difficulty focusing, vomiting, diarrhea, and an on & off migraine
Vaccinations (IPV, DTaP) given in LA IM. Through night pt arm from elbow to shoulder began to swell with redness and "burning" - seen in clinic this am.
significant numbness of both feet.  Especially noticeable when laying down.  This began after the following sequence. 1. Moderna vacc. #1 2. Moderna vacc. #2 3. Tetanus vacc (was received 30 days after Moderna vacc. #2)
13-hour migraine; This is a spontaneous report from a contactable other healthcare professional (patient).  A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: El3246, via an unspecified route of administration on Left arm from 07Jan2021 10:00 to 07Jan2021 10:00 as SINGLE DOSE (first dose) for COVID-19 immunisation.  The patient medical history was not reported. Concomitant medication includes prenatal vitamins. The patient previously took amoxicillin and experienced allergies. The patient is not pregnant. The patient experienced 13-hour migraine the day after the vaccine on 08Jan2021.  The outcome of the event was recovered.
Mother stated that child developed a fever 101, nausea, and bronchospasm. (after 3rd dose). Mother also stated that fever/nausea followed 1st 2 doses.
Arm swollen, ache everywhere including eyes and fingers. Headache. Chills.
This case was reported by a consumer via call center representative and described the occurrence of feeling unwell in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 1 day after receiving SHINGRIX, the patient experienced feeling unwell. On an unknown date, the outcome of the feeling unwell was recovered/resolved. It was unknown if the reporter considered the feeling unwell to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. Next day, after receiving SHINGRIX, the patient did not felt well. The patient felt yucky but she was fine afterwards. The reporter did not have any details of the patient.
diarrhea; flu-like symptoms; no appetite; numbness tongue; body ache; fatigue; headache; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), INFLUENZA LIKE ILLNESS (flu-like symptoms), DECREASED APPETITE (no appetite), HYPOAESTHESIA ORAL (numbness tongue) and PAIN (body ache) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (Pat medical history not provided) since an unknown date. Concomitant products included PANTOPRAZOLE and CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) for an unknown indication.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced DIARRHOEA (diarrhea), INFLUENZA LIKE ILLNESS (flu-like symptoms), DECREASED APPETITE (no appetite), HYPOAESTHESIA ORAL (numbness tongue), PAIN (body ache), FATIGUE (fatigue) and HEADACHE (headache). At the time of the report, DIARRHOEA (diarrhea) and HYPOAESTHESIA ORAL (numbness tongue) had not resolved and INFLUENZA LIKE ILLNESS (flu-like symptoms), DECREASED APPETITE (no appetite), PAIN (body ache), FATIGUE (fatigue) and HEADACHE (headache) 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.   Treatment activities for event included taking Advil :2 on Wednesday when symptoms started, 2 on the next day. concomitant medication included blood pressure medicine
Site: Bruising at Injection Site-Medium, Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: patient's armed bubbled up and one of the bubbles popped-Medium
This is a pregnant patient who was given 2 doses of MMR by this clinic.  The first dose was on 6/15/2021, and second dose on 7/19/2021.  She presented to our hospital the day after dose 2 with a diffuse rash.  I contacted the clinic to verify they had administered the doses and they did.   They stated they would give it to any pregnant woman with a doctors note.  She did not have one and only verbally told them she did.  She primarily speaks another language and thought she had to have them for school but the clinic gave them knowing she was pregnant.
No adverse event; The patient was received a Moderna bivalent booster dose of 0.25ml instead of 0.5ml; This spontaneous case was reported by a physician and describes the occurrence of UNDERDOSE (The patient was received a Moderna bivalent booster dose of 0.25ml instead of 0.5ml) and NO ADVERSE EVENT (No adverse event) in a 21-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 024422A) for COVID-19 prophylaxis.     The patient had no allergies to medications, food, and other products.  Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE and Janssen COVID-19 vaccine. Past adverse reactions to the above products included No adverse event with Janssen COVID-19 vaccine and PFIZER BIONTECH COVID-19 VACCINE.    On 30-Nov-2022 at 11:00 AM, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .25 milliliter. On 30-Nov-2022 at 11:00 AM, the patient experienced UNDERDOSE (The patient was received a Moderna bivalent booster dose of 0.25ml instead of 0.5ml). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (The patient was received a Moderna bivalent booster dose of 0.25ml instead of 0.5ml) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for UNDERDOSE (The patient was received a Moderna bivalent booster dose of 0.25ml instead of 0.5ml).    No concomitant medications were reported.  It was unknown whether the patient ever been diagnosed with/ tested positive for COVID-19. The patient had no acute illnesses at the time of vaccination and up to one month before. It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-707980, US-MODERNATX, INC.-MOD-2023-732971 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2023: Follow-up information received included no new information. On 14-Jul-2023: Upon internal review on 25-Jul-2023, significant corrections performed to update narrative and historical vaccine.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-707980:Case for patient 1 US-MODERNATX, INC.-MOD-2023-732971:Monovalent
Pt recvd 3 doses of Engerix-B on 16APR90, 18MAY90 & 10OCT90 & was found to be a non-responder;
She got her vaccine, was doing fine, and then that evening around 8:00 PM she started jerking very badly like a puppet.  It was difficult for her to walk, had to hold onto furniture or walls.  She does not remember what else went on during that evening.  She did not sleep well.  On Tuesday she was still having the same reaction, she called the pharmacy first and they told her that they had not heard of any of those AE.  She called Dr. who sent her to the ER.  She was still jerking/spastic, they tested her to see if she had alcohol in her system which she did not .  Her BP was off the charts high, and she does not remember a whole lot.  She spent the night in the ER, her BP was still high and was waiting to get in a room.  She had severe headache about a 10, nausea and starting to vomit.  The nurse did not leave her, she was given IV pain medicine, Norco for her headache which did not help.  Then gave her Dilaudid and that started easing the headache, but her BP was still being too high.  They did finally say on Friday that she could go home.  They let her walk out, did not take her out on a wheelchair, but then started having a headache which she felt might be due to her stay.  She went home, she started feeling bad, her BP was high.  She called the hospital, and they told her to call her PCP.  He increased her Alopurinol and then to recheck in 2 hours and to see if it had gone down.  It did, but then the next morning it was high again 2__/1__.  He then called her in Clonidine .1 mg, and told her to take this BP if her BP goes 160/80 and to take every 8 hours.  Throughout the night she did not feel well, her BP was 144/103.  Then she got up at 6:45 took her medicine, and then she took her BP again it was 249/113.  She took the other medication (fast acting), and had called 911 and it was coming down it was 198/1__, and once she got to the hospital it was coming down to a more normal range.  She is weak, lethargic, she works part-time, and she moves a lot on her job and is not able to do that, cannot do her roommate's hair and her arms have no strength.  Her BP is now under better control.  She has adjusted how she takes her medication to prevent the overnight spikes.    She is going to call her Cardiologist to see him about the BP issues.  She had an A-Fib issue come up at the end of June, and now she has the issue with her BP.
Ulcerative Colitis flare after 8 years of remission from the disease.
Several hours after the injection, he became slightly weak, clammy and nauseous.  The right arm was painful and he was/ is unable to raise it up or to the side.  He took aspirin and iced the area.  It is somewhat better today with a bit greater range of motion, but still painful enough to call out of work
Systemic: loss of taste/smell-Medium, Additional Details: Patient insists that the vaccine caused a loss in taste and smell.  I explained that a symptom of COVID and not a reaction from vaccine.  Advised patient to get tested, but she wanted reported as she does not believe could have gotten COVID.  Explained again how symtoms may appear after exposure and vaccine not fully effective.
I feel irritable; don't have motivation and depressed; don't have motivation and depressed; body temperature was 95.5; This is a spontaneous report from a Pfizer-sponsored program Acaria Xeljanz Program. A contactable consumer (patient) reported that a 63-year-old female patient received tofacitinib citrate (XELJANZ XR, strength: 11 mg), oral from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at 11 mg, once a day for an unspecified indication; BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 05Jul2021 (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunization. Age at vaccination was 63-year-old. Medical history included penicillin allergies, rheumatoid arthritis, and depression. Concomitant medications included metoprolol tartrate, fluticasone propionate, atorvastatin calcium, clopidogrel bisulfate (PLAVIX), ascorbic acid, calcium pantothenate, nicotinamide, pyridoxine hydrochloride, riboflavin, thiamine hydrochloride (B-COMPLEX + VITAMIN C), pantoprazole sodium, folic acid, ascorbic acid (VITAMIN C), tramadol hydrochloride, acetylsalicylic acid (ASPIR LOW), alendronate sodium, lisinopril, fish oil, solifenacin succinate (VESICARE), sumatriptan succinate, fluticasone furoate, vilanterol trifenatate (BREO ELLIPTA), naproxen, prednisone, colecalciferol (VITAMIN D 3), cyanocobalamin (VITAMIN B12), and vitamin D2. Patient indicated she had already started Xeljanz six months ago. As per patient she was fully vaccinated with the Pfizer COVID-19 vaccine. Her second dose was on 05Jul2021.She reported that she was temporarily off Xeljanz between vaccine doses as instructed by her physician but "although she has a history of depression" this feels different. She feels irritable, like she has a fever although her body temperature was 95.5, she doesn't have motivation and depressed. Patient reported she lives alone and confirmed she does not have thoughts of hurting herself or others. Reviewed dose, frequency and administration route. Patient wanted to know if these new symptoms could be related to DDI from Xeljanz and COVID-19 vaccine. The action taken in response to the events for tofacitinib citrate was unknown. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
TRANSIENT CEREBRAL ISCHEMIA RIGHT FACIAL MUSCLE WEAKNESS 12/16/2022  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
On Sunday, May 29, 2022,  about 7:00pm I was in the hot tub and started feeling exhausted.  I sweated that night in bed.  The next morning I had a bit of chest and nasal congestion.  The next day I didn't go out of my room because I felt lousy.  I did a home COVID-19 test but it was negative for 3 days.  On Wednesday I was having a hard time breathing.  My pulse-ox finger indicator indicated my oxygen level was low.  The next day my chest and nasal congestion was much worse.  I increased my liquids.  I also had a headache.  ON June 3rd I was not better but June 4th I was dramatically better.  By June 5th I felt like I was improving.  On June 20th I had a virtual visit that had already been scheduled.  The doctor stated that even though my test was negative, based on the symptoms and the outbreak in my apartment building, I definitely had COVID-19.
Patient with history of diabetes and CHF came in for non-ST elevated myocardial infarction on 8/3/21 for Left Heart Cath. Another admission on 8/8/21 for stroke-like symptoms, CT scan of head revealed acute-subacute infarction. Patient had extended stay in hospital, suffering a second stroke. Then underwent vascular surgery on either 8/25/21 or 8/26/21 to remove thrombus (blood clot) in one leg. After surgery went to ICU for recovery, and was transferred to floor bed after one day. He expired (passed away) on 8/27/21.
Day one - extreme fatigue, head ache, both leg pain, diarrhea, and once I did wake up around 10 pm I had insomnia that same night.  Since then I have been having extreme fatigue loose bowel movements which I?m usually constipated and insomnia. Today 12/8/21 started with Hot flash fatigue, felt like I was going to pass out. I?m very off balance stomach pain and nauseated. I?ve been going to the bathroom number two more than 4 times a day.  I don?t feel like I did before. I have no health problems I am not pregnant I?ve had my tubes tied.
injection site is sore; Injection site is swollen; Injection site is red; Got the 3rd dose for immunocompromised patients even though he is not immunocompromised; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (injection site is sore), VACCINATION SITE SWELLING (Injection site is swollen), VACCINATION SITE ERYTHEMA (Injection site is red) and INCORRECT DOSE ADMINISTERED (Got the 3rd dose for immunocompromised patients even though he is not immunocompromised) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. Lot # 07C21B, 010M20A and 003A21A) for COVID-19 vaccination.     Concurrent medical conditions included Dementia and Stroke.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Nov-2021, the patient experienced VACCINATION SITE PAIN (injection site is sore), VACCINATION SITE SWELLING (Injection site is swollen), VACCINATION SITE ERYTHEMA (Injection site is red) and INCORRECT DOSE ADMINISTERED (Got the 3rd dose for immunocompromised patients even though he is not immunocompromised). On 05-Nov-2021, INCORRECT DOSE ADMINISTERED (Got the 3rd dose for immunocompromised patients even though he is not immunocompromised) had resolved. At the time of the report, VACCINATION SITE PAIN (injection site is sore), VACCINATION SITE SWELLING (Injection site is swollen) and VACCINATION SITE ERYTHEMA (Injection site is red) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.
Information has been received from a consumer concerning her 3 year old daughter with no reported medical history and no known drug allergies who, at age 18 months, in approximately November 2003, was vaccinated SC with a dose of Hib conj vaccine (OMPC) (manufacturer unknown) (Lot # not reported). Secondary suspect concomitant vaccinations included a dose of diphtheria toxoid (+) pertussis vaccine (unspecified) (+) tetanus toxoid and a dose of pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (CRM197) (Prevnar). Subsequently, "just after vaccination," the daughter had a rash break out on her leg. No medical attention was sought. No diagnostic laboratory exams were performed. The mother reported that her daughter recovered a "day or two later." There was no product quality complaint involved. Additional information is not expected.