chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On the morning of April 4th 2019, around ~11:00am, give or take 15 minutes, I began to notice a slight abnormality in my ability to conjure facial expressions on command. The noticeable lack of voluntary control of my facial muscles on the left side of my face worsened into the evening by which I time I researched how to check myself how for a stroke. Upon awakening the following morning, the symptoms were still present and have not changed since - near complete paralysis of the left side of my face with the small benefit of being able to close, but not blink, my left eye. As of Wednesday April 10, and at the time of writing this on the 11th, I am feeling an onset of pain in the muscular attachment sites around the left side of my face and along the bones of the upper and lower jaw, as though I have been punched or impacted my face upon a wall.
patient was administered expired Pentacel , no AE; Initial information regarding an unsolicited valid non-serious case was received from an other healthcare professional.  The case is linked to 2020SA348576 (same reporter).  This case involves a 14-months-old male patient who was administered with 0.5 mL dose of expired DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot number UJ021AAA and expiry date: 21-Oct-2020 (also reported as 30-Nov-2020)) once via an unknown route in the left thigh for prophylactic vaccination in error (expired product administered) on 27-Nov-2020.  Medical history, past medical treatment, vaccination, and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13), INFLUENZA VACCINE (FLU), MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR VACCIN) and VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for prophylactic vaccination.  This was an actual medication error case due to expired vaccine used (latency: same day).  At the time of reporting, no adverse event was reported.  The reporter would like to know if the patient must be revaccinated.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
I have had a worsening of the muscles, joint and body pain I had before. The treatment was a 6 day steroid treatment which was not effective. I have an appointment coming up with my doctor for further treatment. I have also been scheduled to have an MRI performed in the future. The symptoms have not shown any improvements. They have become worse since having the vaccine. An X-Ray was performed at the providers office but the results were normal.
c/o tightness in chest with pain extending in to back. Refused to go to ER or to have ambulance called. Went home with husband. Within 1 hour of arriving home developed her typical allergy symptoms, congestion and throat tightness. She took "2 Benadryl and kept Epipen close at hand".
couldn't move; flu like symptoms; headache; in bed all day; This case was reported by a consumer and described the occurrence of influenza-like symptoms in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th January 2021, the patient received the 2nd dose of Shingrix. On 29th January 2021, less than a day after receiving Shingrix, the patient experienced influenza-like symptoms, headache, bedridden and mobility decreased. The patient was treated with naproxen (Aleve). In January 2021, the outcome of the influenza-like symptoms, headache and bedridden were recovered/resolved. On 31st January 2021, the outcome of the mobility decreased was recovered/resolved.   The reporter considered the influenza-like symptoms, headache, bedridden and mobility decreased to be related to Shingrix.  Additional details were provided as follows:  After receiving 2nd dose of Shingrix, the patient experienced reaction like flu like symptoms, she was in bed all day with a headache and couldn't move. The patient went to bed at 6:30 pm the day of the vaccination and awoke at 9:30 am the following morning. By that Sunday afternoon, the patient could get up and move again. The reporter consent to follow up.
patient reported that the site of administration (right deltoid) was red, and felt hot 24 hours after administration.  Redness extended on bicep and deltoid.  Patient had consultation and MD prescribed Cephalexin 500 mg capsules.
seriously sick; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (seriously sick) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form, third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form, fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and fifth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (seriously sick). At the time of the report, ILLNESS (seriously sick) outcome was unknown.    No relevant concomitant medications were reported.   Patient had all five Moderna and has been seriously sick, about a week or two weeks. On the fourth day, really really bad. Patient was not sure if he had to go to the hospital or not. He had his blood analysis and (unintelligible). The third vaccine from Moderna, he was concerned whether it was a life-or-death situation. It was that bad. The first flu shot that he got was the avian flu shot. He was concerned, but not as concerned as he was with Moderna.  No treatment information was provided.
swollen right ankle. Had a slight headache but that went away after 2nd day. Ankle is still swollen. Not severe but it noticeable
I got 3 doses of the Pfizer vaccine: 3/20/2021 Lot # EN6207; 4/10/2021 Lot #ER8729; 10/29/2021 Lot #301308A. About a week later after the booster, my heart started to race on and off. By the third week of (November 17th, 2021, I started to have chest pain, shortness of breath and fast heart beat) On November 18th I went to hospital. My heart enzymes were at 84. I spent the night in hospital. They did a number of tests on me and discharged me having Myocarditis. I am better, however I still do get the fast heart beat.
Headache; chills; fever; Rash at injection site; swollen face; Fatigue; chest Congestion; Cough; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), CHILLS (chills), PYREXIA (fever), INJECTION SITE RASH (Rash at injection site) and SWELLING FACE (swollen face) in a 57-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.     No Medical History information was reported.    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-2021, the patient experienced HEADACHE (Headache), CHILLS (chills), PYREXIA (fever), INJECTION SITE RASH (Rash at injection site), SWELLING FACE (swollen face), FATIGUE (Fatigue), CHEST DISCOMFORT (chest Congestion) and COUGH (Cough). At the time of the report, HEADACHE (Headache), CHILLS (chills), PYREXIA (fever), INJECTION SITE RASH (Rash at injection site), SWELLING FACE (swollen face), FATIGUE (Fatigue), CHEST DISCOMFORT (chest Congestion) and COUGH (Cough) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Pt recv vax & devel diarrhea w/black stools,skin rash,abd pain/cramps & sensitivity to the sun;no further details were provider
Vaccine administered after temperature excursion; stored in a freezer which temperature range was at all times from 24.3°F to 24.7°F; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion) and PRODUCT STORAGE ERROR (stored in a freezer which temperature range was at all times from 24.3°F to 24.7°F) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033F21A) for COVID-19 vaccination.     No Medical History information was reported.    In November 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In November 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion) and PRODUCT STORAGE ERROR (stored in a freezer which temperature range was at all times from 24.3°F to 24.7°F). In November 2021, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion) had resolved. At the time of the report, PRODUCT STORAGE ERROR (stored in a freezer which temperature range was at all times from 24.3°F to 24.7°F) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication reported.  No treatment medication reported.  It was reported that 10 vials out of 15 doses each were stored in a freezer whose temperature range was at all times from  24.3 degree Fahrenheit to 24.7 degree Fahrenheit.  The healthcare provider mentioned that they always had the freezer between this temperature range. Two vials were used to administer to healthcare provider's office employees. All doses were injected intramuscularly in deltoid muscle.  Vaccine administration dates were reported as 23-Nov-2021 and 27-Nov-2021.  The vaccine was administered after been frozen at 23 degrees Fahrenheit since receipt.  The patient did not experience any adverse events after receiving the booster dose of vaccine and the healthcare provider was informed that the vaccine could be used until the date of expiration.   This case was linked to MOD-2022-474544 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-Feb-2022: Significant Follow up received, contains updated narrative.
Pt recvd vax & the next day exp flu sx & vomiting; vax reports that pt had a cold  @ the time of vax but vax made it much worse;
Pt developed hive-like itchy rash to forehead, hands, and feet/ankles.   Had joint pain at same time.  All symptoms resolved 48 hrs after symptoms started.   Pt took an antihistamine which helped.
Wheal of body & face w/in 2 hrs post immun disappeared prior to being seen in ER; reappeared following day; To MD; tx histimine; also vomiting; nausea, vomiting;
Extreme Muscular cramps across neck and spine and rotating parts of body for over 8 days; tightness around heart; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 29Sep2021 11:00 (Lot number: ff8841) at the age of 66 years as dose 1, single for covid-19 immunization. Relevant medical history included: "allergies: iodine" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTIN.  The following information was reported: MUSCLE SPASMS (non-serious) with onset 30Sep2021 12:00, outcome "not recovered", described as "Extreme Muscular cramps across neck and spine and rotating parts of body for over 8 days"; CHEST DISCOMFORT (non-serious) with onset 30Sep2021 12:00, outcome "not recovered", described as "tightness around heart". The events "extreme muscular cramps across neck and spine and rotating parts of body for over 8 days" and "tightness around heart" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of muscle spasms, chest discomfort.  Additional Information: There was no other vaccine in four weeks. Other medications in two weeks: included atorvastin. It was reported that patient had extreme Muscular cramps across neck and spine and rotating parts of body for over 8 days tightness around heart. The adverse event resulted in doctor or other healthcare professional office/clinic visit. The patient did not had covid prior vaccination. The patient had tested for covid post vaccination included test name: abbott test type: Nasal Swab (test date 01Oct2021) with Negative result.  Follow-up attempts are completed. No further information is expected.
Second Moderna vaccine administered on April 28. All good, no side effects for seven days. Then May 6, my body revolts. Severe headache and neck soreness, followed by fever of 103, sweats, nausea, muscle and joint pain. I was forced to stay in bed in the dark. My body had a delayed violent reaction to the first vaccination. It's been brutal. This is the first time I can look at a screen long enough to post. I hadn't eaten in days but drank tons of ice  water. I lost $500 in earnings for the second time in a month.
pt devel t105 evening p/vax; cranky & lethargic @ times; saw MD 4MAY95;
Following administration of COVID-19 vaccine, patient experienced "tingling in throat and lower legs" plus dizziness. After monitoring for 30 minutes, patient reported symptoms started to resolve.  Upon follow-up, patient reported that tingling in lower legs had resolved after 3 days.
Fever, Chills, Cold sweats, headache, sore arm, general weakness.
Unprovoked throwing up and headaches.  Slept it off.  2 other times - I had blurred vision in one eye,  macular  migraines. Went away with rest.
Pain in the bones; Headache; A lot of chills; Fever; Nausea; Diarrhea; Stomachache; J&J Covid-19 vaccine as primary vaccination series (in March).; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), ABDOMINAL PAIN UPPER (Stomachache), BONE PAIN (Pain in the bones), HEADACHE (Headache) and NAUSEA (Nausea) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Previously administered products included for COVID-19 vaccination: J&J Covid-19 vaccine in March 2021. Past adverse reactions to the above products included No adverse reaction with J&J Covid-19 vaccine. Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID] and LOSARTAN for an unknown indication.    On 24-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (J&J Covid-19 vaccine as primary vaccination series (in March).). In November 2021, the patient experienced DIARRHOEA (Diarrhea), ABDOMINAL PAIN UPPER (Stomachache) and NAUSEA (Nausea). On 27-Nov-2021, the patient experienced BONE PAIN (Pain in the bones), HEADACHE (Headache), CHILLS (A lot of chills) and PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Fever, at an unspecified dose and frequency. In 2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (J&J Covid-19 vaccine as primary vaccination series (in March).) had resolved. On 28-Nov-2021, BONE PAIN (Pain in the bones), CHILLS (A lot of chills) and PYREXIA (Fever) had resolved. At the time of the report, DIARRHOEA (Diarrhea), ABDOMINAL PAIN UPPER (Stomachache), HEADACHE (Headache) and NAUSEA (Nausea) had not resolved.            Concomitant drugs included  diabetes medication and anxiety medications.
Headache & NauseaVomiting Narrative: fatigue, HA, nausea, jaw pain (occured 8 days after injection)
On 1/22 I developed a rash at the injection area. The rash spread and swelled slightly over the next 24 hours. It got to around 2.5 inches  across.
02/25/2021: Patient received 1st dose of Moderna 03/17 ? 3/19: 20 days after 1st dose, c/o progressively worsening bilateral lower extremity weakness of several weeks? duration. Patient had also suffered from recurrent falls over the preceding several days prior to admission. subsequent CT scan of the abdomen and pelvis revealed severe hepatic steatosis and a CT angiogram of the chest revealed bilateral pulmonary emboli. She subsequently had a duplex ultrasound of the lower extremities that revealed a right lower extremity DVT. MRI of the lumbar spine was performed for further evaluation of her bilateral lower extremity weakness that revealed some moderate bilateral neuroforaminal narrowing with mild spinal stenosis at L3-L4 and moderate spinal stenosis at L4-L5 with some degenerative endplate changes at similar levels. Dx: Pulmonary embolism - discharged home on Xarelto for complete treatment of her DVT/PE. 3/25: 2nd dose of Moderna given at Primary care - referred to ER for complaints. 3/25: ER encounter - She has been experiencing heavy vaginal bleeding, passing large clots at times, for the past six days. She reports that she usually has regular menstrual cycles, regulated on oral contraceptive pills. Dx: Menorrhagia with regular cycle, Anticoagulated ? treated and discharged on TXA 3/28 ? 4/4: 3 days after 2nd dose. presents with ongoing vaginal bleeding complicated by lightheadedness with standing, generalized weakness and fatigue, and dyspnea on exertion. Patient states she has been bleeding for almost 2 weeks vaginally. Dx: severe symptomatic anemia due to dysfunctional uterine bleeding / Menorrhagia and need for anticoagulation, Folate deficiency anemia, Venous stasis. Rx: Transfused 3 units, Provera, Due to recent VTE in stable hemoglobin cautiously started heparin, Oral contraceptives stopped, resumed Xarelto, folic acid supplement.
190 patients (9 different lot numbers) received a vaccine past the beyond used by date; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) 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)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date).    This case contains information for the 105th of 190 adult patients described by the reporter.  Concomitant Medication use information was not provided by reporter.  It was unknown if patient receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Treatment Medication use information was not provided by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-704335 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704335:Master case
Ascending paralysis. Major electrolyte imbalance. Morbid hypokalemia. Acute renal failure. Still under treatment. (Diag: GBS Guillain Barre Syndrome).
The next day 11/6/2021, my left shoulder got stiff and seemed to painfully lock up. This lasted for 2 solid weeks, so my Dr. sent me for an X-ray and it showed that I have an Impingement. I'm currently going to Physical Therapy. The 10 sessions I've had now has really helped.
INFANT RECEIVED 2ND DTP/OPV IMMUN 10-16-89. WITHIN 24 HOURS AFTER IMMUN PT EXPERIENCED BLOODY DIARRHEA LASTING 2 DAYS.PT EXPERIENCED SIMILAR EPISODE AFTER FIRST DTP/OPV IMMUN ON 8-18-89. RECHALLENGED
Zoster recombinant sub-unit 2 dose (IM) - this is what was listed on my medical record regarding the 2nd dose. Starting around 7:00 p.m. on 1/6/19 I started feeling unwell. Tired, dragging, not 100%. Went to bed at 10:00 p.m. and at around 11:00 p.m. I got severe chills - that lasted a few hours. I took a MOTRIN after an hour and it took awhile to help. I was fine for awhile and then I got the sweats real bad - then that subsided. Felt fine when I woke up in the morning. Around 8:30 the chills returned but not as severe - I went to work and just kept my coat on. When I received the vaccine the first time on 6/13/2018 I did not experience chills but felt unwell and tired for almost 2 weeks. I am a healthy individual and have never experienced side effects from any shot or immunization.
Client called in 24 hours after shot to report a "feeling of overall anxiety" that began approx. 2 hours after shot and continued into the next day. Now feels that is resolving. State arm was not sore or swollen. Reviewed other possible adverse reactions which client denies. Client states is usually very sensitive to medications, even OTC items like vitamins can make him feel odd. Informed client we would document his experience and advise that next shot he could wait at office after shot to monitor for any anaphalactic reactions.
pt recv vax 17SEP98 & 8hr later began exp a systemic rxn;10AM on 18SEP98 hosp w/a fever of 105, hypotension (BP 80/40, n/v, h/a, thrombocytopenia & leukopenia;pt recovered & was discharged p/2 to 3 days;
Subjective: 15:45 Patients's mother informed RN patient was having itching at the injection site Left Deltoid during observation period. No hives or rash noted. RN instructed mother to stay 15 minutes additional past previous time for further observation.   Objective: 15:55 Patient complained of itchiness at site. 16:00 Patient described lump in the throat.  No hives or rash noted. Redness from itching site. 16:00 Patient itching at bilateral legs, right forearm. Itching to neck.   VS:  BP 93/73, HR 76, RR: 18, Temp 99.1, Sp02: 99% Wt: 70lbs  Assessment/Diagnosis: Mother reports that patient gets anxious. Patient in no distress. 50mg PO benadryl given. Patient sent home with mother to follow up with observation. Advised to call 911 for signs and symptoms worsening. Patient reported feeling better.
about 6PM pts throat began to swell; called MD & was advised to take DPH; swelling subsided;