chrisvoncsefalvay/vaers-outcomes huggingface dataset:
weakness in legs; some shortness of breath; This spontaneous case was reported by a nurse and describes the occurrence of MUSCULAR WEAKNESS (weakness in legs) and DYSPNOEA (some shortness of breath) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history information was provided.  Concomitant products included LISINOPRIL and FUROSEMIDE for an unknown indication.    In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, the patient experienced MUSCULAR WEAKNESS (weakness in legs) and DYSPNOEA (some shortness of breath). At the time of the report, MUSCULAR WEAKNESS (weakness in legs) and DYSPNOEA (some shortness of breath) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.   This case was linked to MOD-2021-222370 (Patient Link).
This is a spontaneous report from a contactable nurse and physician communicated to a Pfizer sales representative. This nurse and physician reported similar events for two patients. This is the first of two reports. A female patient of an unspecified ethnicity received TRUMENBA on an unspecified date at single dose, and flu vaccine. The patient medical history was and concomitant medications were not reported. The patient experienced, fever, body stiffness and nausea on an unspecified date 3 or 4 days after vaccination, with outcome of unknown. Follow (20May1016): Follow-up attempts completed. No further information expected.
BLOOD CLOTS; NERVE DAMAGE; SEVERE PAIN; RASHES; This spontaneous report received from a patient via a company representative from social media concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: not reported) dose was not reported, 1 total, start therapy date was not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced blood clots, nerve damage, severe pain and rashes. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the blood clots, nerve damage, severe pain and rashes was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210922003-JANSSEN COVID-19 VACCINE Ad26.COV2.S- Blood clots . This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
That evening client began to have swelling hand. The following day client noticed swelling in her face and tongue. Rash on chest, neck and face. No difficulty breathing.
pt was given an expired dose; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 40-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number Amva520a, expiry date 30th April 2022) for prophylaxis.   On 20th June 2022, the patient received Menveo (intramuscular) .5 ml. On 20th June 2022, unknown after receiving Menveo, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 21-JUN-2022 Reporter's Comments: The pharmacist reported that a dose of Menveo was given to the patient in an unknown arm and it was already expired. The reporter did not report that the patient was experiencing any side effects.  This was one of two cases, reported by the same reporter. The reporter consented to follow up. Additional Supportive Information: The use of Menveo dose which was already expired on 30th April 2022, which led to expired vaccine used. This case has been linked to US2022095701, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022095701:Same reporter
Booster dose; Gastrointestinal side effects/vomiting; This is a spontaneous report received from contactable reporter(s) (Other HCP and Physician) from medical information team. The reporter is the parent. Other Case identifier(s):PFIZER INC-202101647307 (Pfizer).  A 16 year-old female patient received bnt162b2 (BNT162B2), administration date 22Nov2021 (Batch/Lot number: unknown) at the age of 16 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:01), when the patient was 16 years old, for COVID-19 immunization; Bnt162b2 (Dose:02), when the patient was 16 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 22Nov2021, outcome "unknown", described as "Booster dose"; VOMITING (non-serious) with onset 2021, outcome "unknown", described as "Gastrointestinal side effects/vomiting".  Additional Information: Question: Practice manager said she has a patient who is concerned that her 16-year-old daughter received the booster dose of the Pfizer-BioNTech Covid-19 Vaccine. She said she is worried because the booster has not been approved for individuals 16 years of age yet. She said the daughter is having the regular side effects. She wants to confirm if the booster dose is really not approved for individuals 16 years of age. I was about to provide her the information, but after I got back on the line, I couldn't hear anything anymore. I waited for a few minutes but to no avail. I said I would hang up and call her back. A single booster dose of the vaccine may be administered at least 6 months after completion of a primary series to individuals 18 years of age and older. I would tell her that there is no information about the booster dose being administered to patients below 18 years of age. Question: Call initiated by practice supervisor. She put the doctor on the phone. Do you have information on a 16 year old receiving a booster dose of the vaccine? Etransmitting possible duplicate/additional AE info. HCP states that a healthy 16 year old patient received a booster dose of the Pfizer COVID 19 vaccine at a pharmacy and is experiencing gastrointestinal side effects. She's vomiting. Response: Spoke from SRD: COMIRNATY and the Pfizer-BioNTech COVID-19 Vaccine (purple or gray cap) are authorized for use under from FDA to provide a third primary series dose in individuals 12 years of age and older who have been determined to have certain kinds of immunocompromise and as a single booster dose in individuals 18 years of age and older who have completed a primary series with Pfizer-BioNTechCOVID-19 Vaccine or COMIRNATY Faxing SRD, per request.  The lot number for bnt162b2 was not provided and will be requested during follow up.
injection site pain, headache, muscle pain, joint pain, fever, feeling unwell, swollen lymph nodes
"Went into shock, could barely move, could not lift hand or arm to call ambulance. I was basically frozen in the bed for 10 hours or more. Now 3-4 days later I am short of breath, tired, and weak. Fogginess. "
As soon as I got the vaccine Legs had a sensation like they were falling sleep and then they went numb. They told me to visit urgent care. Vitals were taken. Blood pressure taken- 163/100 HR was 100. I was given 1 liter IV fluid, they also gave me Benadryl, told me to continue prednisone, my BP increased to 184/120. It came down to 153/94 after the treatment. The next day I was having pressure in the chest. I experienced migraines, I have never had migraines before. I had nausea due to these headaches. I had also experienced fatigue, chills, fever, body aches but those were short term, probably about 2 weeks. The numbness, tingling, chest flutters and swollen lymph nodes were swollen and painful but it has all subsided. This all lasted until around April and then it subsided. I have not recovered from the headaches, but they are very mild as compared to what they were.
Patient claims she experienced a burning pain for about an hour after the vaccination. Then she noticed a raised "pus-like" rash at the injection site one day after the vaccine. She applied heat to it before noticing the rash. No systemic symptoms that she complains of. (She still has the rash today).
Information has been received from the mother concerning her 16 year old daughter with no medical history and no allergies reported, who on an unspecified date was vaccinated with the first dose of GARDASIL. On 12-DEC-2007, the patient was vaccinated with her second dose of GARDASIL, 0.5 ml. Concomitant therapy included prenatal vitamins. On 28-DEC-2007, the patient found out she was pregnant. Her last menstrual period (LMP) was on 06-DEC-2007 ("8 weeks 5 days" ago). The patient sought medical attention. On an unspecified date, the patient had blood work performed (unspecified). Her estimated date of delivery is 11-SEP-2008. The third dose of GARDASIL was not administered. Follow-up information was received on 09-MAR-2009 from a female at a pediatrician's office, who reported that on 16-SEP-2008 the patient delivered a healthy normal, female, who weighed 10 lbs 1 oz, by cesarean section for a failed induction of labor at 41 weeks gestation. It was noted that the patient had a maternal pregnancy weight gain of 60 lb. The patient brought her baby to the physician's office. The physician said the baby was "fine and well-no problems". It was reported that the patient had recovered from the c-section on an unspecified date and was "doing well also". Upon internal review, cesarean section was determined to be an other important medical event. No further information is available.
pt states he started feeling "funny" around 9-10 minutes after receiving vaccine. Pts wife came and got clinic staff. Pt became unresponsive, weak thready pulse, clammy, pts color grey/pale. Sternal rub completed- pt unable to state name or follow commands. 911 called by clinic staff. Pharmacy staff also present. HR/pulse ox unable to detect reading, manual pulse in the 50s. Pts neck repositioned and breathing improved. Pts wife standing beside him throughout. Pt became responsive- a & o x3 within 2-3 minutes. Pts color improved, HR in 60s, pulse +2 bilaterally radially. EMS arrived within approximately 5-7 minutes. Pt refused to go with EMS. Pt states "this has happened to me before" "I have an aversion to needles" Discussed this is likely adverse reaction to vaccine. Advised he should not get second dose. Pt was given coke and sat in chair with wife. Pt left store around 727pm.
My Left Shoulder and entire arm was filled with intense pain and shooting nerve pain.  I massaged and iced the areas.   I have seen several doctors and am currently in physical therapy.
Large red swollen area at injection site, hot to touch very itchy- 104 degrees-105 degrees Temp.
I've had two different events. I'm not sure if they're related. The first event started with what I thought was a cramp in my right calf. It lasted almost all day before it went away. A week or two later, it came back. It lasted two or three days. A week or two later, it came back even worse. It was severe and extremely painful. It lasted a week. I went to the doctor. He said I ruptured a vestigial tendon in my calf. He stated the initial cramp was most likely the beginning of the rupture, and the final very painful one was the final rupture. I haven't had any pain there again, and I seem to have normal function. Although now, I'm experiencing pain in both thighs. He's planning to send me to an Orthopedist. In the last three weeks, I've developed a new symptom. After sitting for a period, I experience dizziness and numbness of the entire right side of my body upon standing. I have an appointment this Wednesday to discuss these new symptoms further.
Light redness, swelling distal to inj site. Itching in that area. Pt did not treat, feels it is improving at this point (2 days after vacc).
Patient called on 11/29/21 after receiving dose on 2/17/21.  She reported her brain screaming with noise, tinnitus, nerve pain, joint pain, exhaustion and fatigue.  She stated she has been seen by many doctors and no one is able to find anything wrong with her.
30 minutes, post vax, tetany noted with severe pain, lasting 12 hours; intermittent tetany still remains with pain in left deltoid and radiates to hand and at times, to left clavicle, up left side of neck. Condition remains sporadic to this date.
Headache, Arthralgia, Fever, NauseaVomiting, inj site sore/red diffuse pattern, chills, lymph node swelling Narrative:  soreness to inj site with diffuse redness after 2 days, fever of 101F, HA lasting 5 days, lymph node swelling under L axilla started 5 day after vaccine
Pt came to hospital for decreased fetal movement. Ultrasound verified no cardiac activity in fetus, diagnosed intrauterine fetal demise at 34 weeks, 2 days gestation. Pt reported she had received her second covid vaccine on 9/23/21, after it was mandated for her job.  She reported last feeling baby move on 9/25/21.
Information has been received from a consumer concerning her 6 year old son who on an unknown date was vaccinated with the first dose of MMR II. It was reported that after getting the measles virus vaccine the patient experienced fever of 104 degrees that lasted for 4 days, diarrhea, lost of appetite and lost of eye contact. The patient sought unspecified medical attention. At the time of reporting the patient was recovering. The patient subsequently developed antibody response negative after receiving rotavirus vaccine (WAES # 0903USA02368). No further information is available.
pt died of SIDS between 1130PM 1DEC & 6AM 2DEC-mom reported sore thigh @ inj site 29NOV then was fine on 30NOV;
Swelling on left side of face; This is a spontaneous report from a contactable consumer reporting for self. A 92-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283), via an unspecified route of administration in left upper arm on 23Jan2021 at single dose for covid-19 immunisation. Medical history included osteoporosis and Kidney disease. There were no concomitant medications. The patient experienced swelling on left side of face on 23Jan2021 occurred shortly after the shot, it is going down, she was taking antihistamines. Outcome of event was recovering.
caught COVID; caught COVID; This is a spontaneous report from a contactable Nurse. A contactable Nurse reported similar events for 2 patients. This is 2 of 2 reports. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: not reported), unknown dose via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient caught covid from an unvaccinated individual. Reportedly, patient experienced symptoms. Symptoms were at worse point on day 7. Event took place after use of product. The patient underwent lab tests and procedures which included covid: caught COVID from an unvaccinated individual on an unspecified date. The outcome of all the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. ; Sender's Comments: Based on the information in the case report and a plausible temporal relationship,  a possible causal relationship between the events of  DI ,Covid 19 and suspect drug BNT162B2 cannot be excluded
Arm pain and stiffness,  red rash on arm near injection site, body and muscle aches, swollen lymph nodes behind ears, fever as high as 100.6, stomachs ache, bloating and nausea, severe headache that lasted two days. Took one 500mg Tylenol tablet three times over two days. Medication helped. Symptoms resolved completely after approx 60 hours.
no adverse event; vaccinated with pneumonia 13 on 2015 and pneumonia 23 on 2016; This spontaneous report was received from a 76-year-old female patient, concerning to herself. The patient's medical history, previous drug reactions or allergies and concomitant medications were not reported.  On an unspecified date in 2015, the patient was vaccinated with pneumococcal 13v conj vaccine (CRM197) (reported as pneumonia 13) and On an unknown date in 2016, the patient was vaccinated with pneumococcal Vaccine, Polyvalent (23-valent) (manufacturer unknown) (reported as pneumonia 23) for prophylaxis (inappropriate schedule of product administration), for bot vaccines (strengths, doses, anatomical locations, routes of administration, lots numbers, and expirations date were not reported). No adverse event reported.  This is one of two reports received from the same patient.; Sender's Comments:  US-009507513-1903USA006184:
I received my vaccine at my work place,  on February 17, 2021. Once I received the injection, my arm was sore and I had cold like symptoms (stuffy nose, sore throat, etc) for a few days. Body aches started the following week along with a cough and sinus drainage and night sweats. Headaches started that Friday and progressed into what I thought were migraines over the weekend. Monday, March 1, 2021, I couldn't lift my upper body out of bed. I couldn't move my head from side to side. The headache pain was as if I had been hit in the back of the head with a hammer behind my right ear. I called out of work that morning and had an online doctor's visit. The doctor urged me to go to the ER thinking I had meningitis since I couldn't touch my chin to my chest. Once I arrived to the ER, my right leg went numb. I couldn't lift it during my exam. They performed MRI, CT, Spinal, along with blood tests, etc and found I had blood clots in my brain. They administered heparin but I had an allergic reaction to it.
received yellow fever and havrix 25u on 7-22-03.  On 8-2-03, 11 days later, he developed a "ball" just left of the midline underneath the jaw bone on the anterior submental region.  It was just slightly tender, but the overlying skin was normal with no erythema or warmth.  S/s were reported on 8-4-03, examined on 8-5-03 and symptoms gone, only a 1cm submental node was palpated. No treatment given.
-Trouble walking - low grade fever - Cant lift arms up  - Bodyaches - Tremors   - Weakness.
12:30am woke up & couldn't stop shaking.  On and off fever 100.5. Coughing. Lethargic.
Redness + irritation at injection site lasting 2-3 days, hard lump formed with tenderness at injection site lasting 2+ weeks (ongoing).
Between 09MAY2022 ad 22SEP2022, 16 personnel received a 3-shot series of RabAvert for pre-exposure prophylaxis.  During this time, medical department personnel were unaware that the CDC guidance for pre-exposure prophylaxis had been revised, and that a 2-shot series was now indicated.
Recieved the vaccine rec'd 2nd dose on 3/9 and the evening of the 11th day I started getting mild vertigo, and ended up completely disabled by the next morning, I couldn't open my eyes and I would vomit after I'd open my eyes, I was completely bedridden on the 12th.    today I can get around using a walker but have to be very careful not to fall, and it's been a week now.
Received Tdap vaccination on 4/13/09 in upper left arm. Injection site is still painful on 4/17/09, but real issue is pain caused by two pea sized nodules that have formed since 4/15/09. The nodules are 3-5 inches from the injection site over my left shoulder blade. Skin is slightly red over the area, but pain is constant, and worsens if touched.
red rash; itchy; warm to touch; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (red rash), PRURITUS (itchy) and FEELING HOT (warm to touch) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised. Concomitant products included TOCILIZUMAB (ACTEMRA) for Immunodeficiency.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced RASH ERYTHEMATOUS (red rash), PRURITUS (itchy) and FEELING HOT (warm to touch). The patient was treated with PARACETAMOL (TYNELOL) at an unspecified dose and frequency. At the time of the report, RASH ERYTHEMATOUS (red rash), PRURITUS (itchy) and FEELING HOT (warm to touch) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Follow-up information received and contains significant information. outcome of the events red rash, itchy, warm to touch was updated from unknown to Recovered/ resolved and declined further follow-up.
Patient with relapsing remitting MS, on Tecfidera. 3 days after 2nd Moderna covid19 vaccine, patient woke up with hand motion visual acuity in left eye with some pain in the eye. Prior, patient had high fevers as a result of the vaccine. SLowly improving in month since vaccine. Unfortunately no MRI or visual field or ophto exam at time of symptom onset. MRIs pending. Clinically optic neuritis OS.  Neuro-ophthalmologist Neurologist
High RBC, high sed rate, arm still hurt; its been 3 weeks. At first I was numb then my muscles got tight everywhere. Now I am still in pain.
pt recv vax;devel maculopapular rash over trunk & extremities;severe urticaria;tx w/ meds;to er w/ SOB,eyelid swelling & severe urticaria;2oct95 returned to er for severe urticaria;tx dph & oth meds;
Day 1 - 8:50am Soreness in left arm at injection site; 12:00pm Body aches Day 2 - 5:00am Fever, Tiredness, Body aches; 8:00pm Tiredness, Body aches, Tooth sensitivity on upper left side of mouth Day 3 - 5:30am Soreness in left armpit, Tooth sensitivity on upper left side of mouth
hospitalized on 7/30. discharged 8/2 Moderna on 12/29/20 and 1/22/21. Positive on 7/23/21
Patient was administered a pediatric Pfizer Orange cap  dose instead of a Pfizer Gray Cap.
GOT OMICRON; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient was previously treated with covid-19 vaccine ad26. cov2. s (unspecified manufacturer) (dose number in series 1) (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on an unspecified date for covid-19 prophylaxis. It was unknown whether the adverse event reported following to first dose of vaccination (dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 01 total, administered on JAN-2022 for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported.  On JUL-2022, the patient experienced got omicron (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of got omicron was not reported. This report was non-serious. This case was associated with product quality complaint:
Chest cavity very sore, coughing, sore throat, throat congested, nose congested, fatigue, back pain and leg pain?
Father of client reports onset of fever 100 degrees, fatigue and low back pain onseta at 10am 2-27-07. Reports client was sitting in chair and had lower back muscle spasms.  Back pain was severa enough that he had a hard time walking.  Father gave cleint tylenol which he said relieved the efever and helped relieve the back pain. 2-28-07 client was dizzy but pain and fever had improved.
The called and reported she ended up going into the ER on Friday, March 5th for atrial fibrillation.