chrisvoncsefalvay/vaers-outcomes huggingface dataset:
feels sick; body ache; congestion; fatigue; sore throat; bad headache; felt weak; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (bad headache), ASTHENIA (felt weak), OROPHARYNGEAL PAIN (sore throat), VACCINATION COMPLICATION (feels sick) and MYALGIA (body ache) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included FLUOXETINE HYDROCHLORIDE (PROZAC), METHYLPHENIDATE HYDROCHLORIDE (RITALIN), ONDANSETRON (ZOFRAN [ONDANSETRON]), OMEPRAZOLE and HYDROXYZINE for an unknown indication.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Jan-2021, the patient experienced HEADACHE (bad headache) and ASTHENIA (felt weak). On 10-Jan-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat). On 12-Jan-2021, the patient experienced VACCINATION COMPLICATION (feels sick), MYALGIA (body ache), NASAL CONGESTION (congestion) and FATIGUE (fatigue). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, HEADACHE (bad headache), ASTHENIA (felt weak), OROPHARYNGEAL PAIN (sore throat), VACCINATION COMPLICATION (feels sick), MYALGIA (body ache), NASAL CONGESTION (congestion) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications Prozac, Ritalin, Zofran, omeprazole, hydroxytine; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
Lump at injection site, 1 inch x 1 inch, with erythema and warm to touch, noted day after injection.  Ongoing and no treatment sought to date.
Vaccine recipient received her first dose of the Moderna COVID-19 vaccine on 4/23/21 at one of our pop-up clinics. Patient was age 16 at the time of her vaccine, which is an unauthorized age group. The error was discovered upon data entry of vaccines and reported. Recipient was observed for 15 minutes post-vaccination.  Per CDC guidance, recipient will be advised to receive second dose of vaccine.
EXTREME ARM PAIN INTO COLLAR BONE AREA AND THROUGHOUT SHOULDER & INTO NECK FOR 3 DAYS.
Dec 2021:  Shock-like feeling in chest when lowering head, lasted 2 weeks.  Dec 2021:  Intermittent swelling of right ankle, continues.  Jun-Jul 2022:  Skin eruption of outside right side of nose resulting scabbing for one week.  Jun 2022:  Body itch on back of neck, shoulders, upper arms, eyes, nose, face and head, continues.  Sep 2022:  Skin eruption on right side of left eyebrow resulting in scabbing for one week.  Aug 2022:  Bruise-like feeling under occipital bone, 3 days.  Jul-Aug:  Vertigo like dizziness for 5 weeks.  Sep 2022:  Small lump under fleshy skin on the left under jaw, 2 days.
Suspected vaccination failure; From what I have see from other people's cases of the breakout phase...; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in an unspecified number of patients who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows The age at vaccination was not reported. After receiving Shingles vaccine, the unspecified number of patient's had shingles breakout. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation were not provided.   This was 1 of 3 linked cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR151406:Same reporter. Cousin's case. US-GLAXOSMITHKLINE-US2021AMR151420:Same reporter. Reporter's case.
Arm swelling and where they put the shot is red; Arm swelling and where they put the shot is red; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administered in arm left, administration date 21May2021 (Lot number: EW0170) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose), administration date: 29Apr2021, for Covid-19 Immunization. The following information was reported: PERIPHERAL SWELLING (non-serious), VACCINATION SITE ERYTHEMA (non-serious) all with onset May2021, outcome "unknown" and all described as "Arm swelling and where they put the shot is red".  No follow-up attempts are possible. No further information is expected.
fatigue; Fever; Generalized aching; Injection site pain; This case was reported by a consumer and described the occurrence of fatigue in a 56-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included adalimumab (Humira) for crohn's disease.   Concurrent medical conditions included crohn's disease.   On an unknown date, the patient received Shingrix. On 24th April 2020, the patient started Humira (subcutaneous) at an unknown dose and frequency. On an unknown date, unknown after receiving Shingrix, the patient experienced fatigue, fever, generalized aching and injection site pain. Humira was continued with no change. On an unknown date, the outcome of the fatigue, fever, generalized aching and injection site pain were unknown.   It was unknown if the reporter considered the fatigue, fever, generalized aching and injection site pain to be related to Shingrix.  Additional details were reported as follows: The age at the vaccination was not reported. The patient received shingrix on unknown date. In 2020, the patient experienced fatigue, fever, generalized aching and injection site pain. The patient received humira for moderate to severe crohns disease. Less than 3 months, after receiving humira, patient experienced all events. No information related to conmed medications and medical history was reported. It was unknown if the reporter considered the fatigue, fever, generalized aching and injection site pain to be related to Humira.
This spontaneous report was received from a 67-year-old female patient who was reporting on herself. The patient had no pertinent medical history. The patient had an allergy to penicillin. She received trazodone hydrochloride, propranolol and pantoprazole as concomitant medications. On 03-OCT-2018, the patient was vaccinated with PNEUMOVAX23, one injection, route of administration was reported as injection (dose, lot# and expiration date were not reported), to prevent pneumonia. On the same day, the patient experienced redness, swelling and a hot feeling in her arm and body aches for several days after injection. The patient seek medical attention. No treatment for the events was given and no lab diagnostic studies were performed. The outcome of injection site redness, swelling and hot feeling in her arm and body aches was reported as recovered/resolved on an unknown date in October 2018. The relatedness between the events and PNEUMOVAX23 was not reported.
Pt received Hep-B and PPD and went to bathroom. Pt was in bathroom complaining of feeling sick, hot, nausea and shaking. BP once she was laying down was 120/80, HR 72, Resp 24. Then 5 minutes later, HR 2, resp 12 and BP 120/80. No shaking, nausea or feeling hot. Pt wanted to sit up. BP sitting up was 160/100. Pt layed back down and starting shaking again and complained of being cold. BP laying down was 120/80. Talked to pt's MD and he requested 10 mg Benadryl be given IM. Pt was given the Benadryl and sent by family to MD's office.
PT RECEIVED PFIZER VACCINE WHEN HE WAS BELOW 12 - PT'S FATHER INFORMED ME HE WAS 12 AND WHEN I LOOKED AT PASSPORT THE MONTH AND DAY OF BIRTH WERE REVERSED SO BELIEVED HE WAS 12.
Patient is a 66 y.o. female with history of CAD, COPD, DVT requiring thrombectomy, HTN, OSA, DM II presented to Medical Center with fever, BLE swelling and pain .   Lower extremity edema BL pain in LE Symptoms for a few days, no claudication symptoms or calf/thigh pain D-Dimer 0.72; pBNP wnl, CTPA 12/31 negative, no symptoms of claudication, symptoms improved significantly since admission. Venous dopplers neg for DVT.  A1C of 6.3%.      Covid-19 Virus Infection Date of onset of symptoms: 12/27 Symptoms present on admission: cough, fevers, dyspnea Date of covid positive test: 12/31 Vaccination status: vaccinated Imaging: CTPA mild bronchitis Oxygen requirements on admission: None Current oxygen requirements: 2L Medical therapy: starting remdesevir and dexamethasone 1/1 Consultants following:   Anticipated special isolation end date:  Underwent walking 02 assessment by primary RN taking care of patient.  Found to not require any oxygen  Discharge home.      HTN, controlled Hypokalemia Cont home Norvasc, Lasix, Lisinopril, hydrochlorothiazide Would hold diuretics if getting volume depleted with COVID Dose with KCl today, may need long term treatment while on diuretics  DM II; controlled A1C chronically ~6.6 Home Metformin held On correctional humalog   Morbid obesity BMI 56, outpatient follow up
Intense fever, low blood pressure, fainting (the day after) Fever lasted two days Extreme nauseous and dizziness for a week and a half Severe headaches for 4 weeks
received pfizer and moderna vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (received pfizer and moderna vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    No Medical History information was reported.   On 20-Mar-2021, the patient started TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) dosage form. On 03-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INTERCHANGE OF VACCINE PRODUCTS (received pfizer and moderna vaccine). On 03-May-2021, INTERCHANGE OF VACCINE PRODUCTS (received pfizer and moderna 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.   No concomitant drugs were reported. No treatment medications were reported.
patient stated she had itching on both arms 5 minutes after receiving the vaccination and a sore throat, no further progression after 25 minutes. . there was no rash. Customer then took 50mg diphenhydramine liquid by mouth. 5 minutes after the diphenhydramine, the itching started to decrease. patient was observed for 40 minutes total.
At 9 pm, took a shower and immediately after shower had terrible chills for about an hour. Experienced shakes that last for about 1 day.
This spontaneous report as received from a health professional refers to a patient of unknown age and gender. On 11-FEB-2015 the patient was vaccinated with a dose of ROTATEQ oral (dose and lot # not reported) that had undergone temperature excursions. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Aches early this morning; Patient stated he is experiencing fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Aches early this morning) and PYREXIA (Patient stated he is experiencing fever) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004m20a) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 18-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, the patient experienced PAIN (Aches early this morning) and PYREXIA (Patient stated he is experiencing fever). At the time of the report, PAIN (Aches early this morning) and PYREXIA (Patient stated he is experiencing fever) outcome was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Fever is consistent with the product safety profile.
Right anterior thigh local reaction raised, red, hot (5x4cm). Child walked without limp, only tender to touch.
24 Hours after Varicella injection, mom noticed child's leg at site of injection, warm, red, area redness 1 1/2" x 3", no fever.
My lymph node under my left arm is swollen to the size of a big lemon & it hurts. My bra bothers it.
Woke with nausea, vomiting, climbing fever upto 103, body aches, chills on 4/5/21. Symptoms resolved but felt tired on 4/6/21. Morning of 4/7/21, woke with shortness of breath and chest pain. Negative COVID-19 test.  Went to hospital and did a cardiac workup and blood work, CT scan followed that showed several blood clots in lungs.  Was given heparin bolus, and continued for an additional day, then switched to Eliquis.  Hospitalization duration was 2.5 days.
Information has been received from a female consumer concerning her daughter, a 2 year old female patient. The patient had nervous twitch 3 or 4 weeks. A physician advised for the patient to get vaccine, so on 08-JAN-2016 (also reported as 28-JAN-201), the patient was vaccinated with a dose of M-M-R II, lot # K007108 (expiration date and route unspecified), 1 shot, by the physician. Concomitant therapies included ethinyl estradiol, levonorgestrel (daily) and vitamins (unspecified). On 13-JAN-2016, the patient experienced vomiting for 10 days following the vaccination. In addition on the same day, the patient also experienced an ear infection, runny nose, cough and diarrhea. The patient sought medical attention by office visiting on an unknown date in January 2016. Treatment was given for the events, and the physician prescribed an unspecified antibiotic for the vomiting and diarrhea. M-M-R II was not reintroduced. The outcome of the events was reported as not resolved. The relatedness of the events and M-M-R II was not provided. Additional information has been requested.
Pfizer:  date 04/07/2022 administered on 4/18/2022. Pfizer could not provide stability data beyond 04/09/2022 and recommended revaccination
Patient received a second dose of Hib 7 days after his first dose. First dose did not show on Immunization Record for unknown reason. This was discovered during inventory reconciliation.
Patient reported Significant joint and nerve pain that developed within 7 days of 1st Booster vaccine (pain primarily located behind knees and in wrists (on both sides of body)).  Prescriber gave motrin, but symptoms still present currently (5/9/22).
mom stated pt started to cry & scream around dark on day of vax; mom stated it was different cry for pt; pt very difficult to console; stated had to walk w/pt to calm; crying stopped around 10PM;
At first warm flu like feeling followed by severe flu like feeling without fever. Ear pressure pain and severe ringing in head. Increase in severe muscle weakness in arms and legs for 3 months  plus  high blood pressure weakness
Chills, fever, body aches, headache, tiredness- during first night of vaccination Tiredness and arm hurt (hard and itched at injection site) - for 2 days total after vaccination Lymph Nodes extremely swollen and hurt - for 6 days total after vaccination
Narrative:  Patient received first dose of Moderna COVID19 vaccine 1/22/21. No reported adverse effects. Second dose received 2/19/21. Patient presented to clinic 2/26 with chief complaint of intermittent rash/hives, itching since the day before, along with some nausea that morning. Denied shortness of breath, difficulty swallowing, wheezing and felt his normal self otherwise. Stated the rash was better that morning. Was prescribed prednisone, cetirizine, and ondansetron for outpatient pharmacy pick up and discharged from clinic. At PCP visit 3/24, symptoms had resolved and no additional treatment documented.
Shaking, Headaches, Palpitations. Weakness, Flaccid R. arm, Immobility. Was picked up and taken to emergency care.
Severe headache starting 10 days after vaccine and lasting one week; also developed "cold sore" and pt never had one of these before.
Swollen 3" X 2 1/2", left thigh, red and painful, started the evening of IZ's, 1/21/03.
Partial frozen shoulder developed in the months following injection.  Injection hurt for several days when received at this location.  Following injection at CVS did not hurt.  Over several months starting in July or late June, I lost about half of 180 degrees of rotation flexibility/movement and experience extreme pain from sudden negative movement.  Conditions remain as of the date of this report.  I firmly believe that the administration of the vaccine was the problem, not the vaccine itself.  The first dose must have been administered properly into the shoulder joint.
My right ear start Tinnitus the second day after the vaccination. My left ear appears fine and no humming sound.
Don?t know if relevant or not as i have had ocular migraine before ? but mot for some time ? and developed this case only some 36 hours after receiving Moderns COVID-19 Vaccine EUA
Fever; Body aches; Body chills; Severe headache; Dehydration; This is a spontaneous report from a contactable consumer, the patient. A 18-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 19Apr2021 at 09:00 (at the age of 18-years-old) as a single dose for COVID-19 immunisation. Medical history included known allergy to penicillin. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 19Apr2021 at 21:00, the patient experienced fever, body aches, body chills, severe headache and dehydration. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fever, body aches, body chills, severe headache and dehydration was not resolved at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
-Thursday 6/3, received 2nd Moderna vaccine here in clinic before lunch -Friday 6/4, reported to work but left within an hour on sick leave -Saturday 6/5, severe malaise, SOB, numbness/tingling hands, fever (would not reduce), diarrhea/stomach cramps reported to ER  approx.. 1600 ? given IV fluids, potassium, discharged approx. 2300 with diagnosis probable severe vaccine reaction OTC meds. -Sunday 6/6, malaise and diarrhea/cramps, NO SOB, NO fever, NO hand numbness/tingling -Monday 6/7, still has malaise and stomach cramps, but they are improving
Initial report of a cluster of five cases received from a health care professional on 26/Sep/2005. It was reported that three employees complained of pain and swelling at the injection site. One employee had redness at the injection site and two other employees complained of pain and swelling and had an egg shaped lump at the injection site (and one of these reported feeling flushed without fever). All reported the area was warm to touch. Symptoms for all patients except one had resolved by 26 September 2005. All patients had received the flu shot in the past with no reactions. This case involves a female patient (age not reported) who developed a knot and soreness at the injection site after receiving the intramuscular injectionof Fluzone, lot number U177AA in the deltoid on 21/Sep/2005. Onset date of symptoms and treatment received was not reported. As per reporter the symptoms had resolved by 26/Sep/2005 and patient recovered. Follow up information received on 02/Dec/2005. It was reported that the patient was 19year old at the time of the events. Further information is not expected. Same reporter in cases 2005-01922, 2005-01924, 2005-01927.
Coughing, tongue and underneath of tongue swelling, throat scratchy. Took two BENADRYL 25mg each took an hour to become comfortable. Next morning eyes were extremely red with some swelling in mouth area. General feeling of being unwell since.
pt recv vax 29NOV95 &  24JUL97 devel a herpes zoster-like rash on rt leg/anterior thigh @ L3-L4 dermatomes w/central lesions;rt buttock contained red, circular patches;all lesions contained mult small vesicles;pt scratched rash & limped
6 episodes of blurred vision 1-4 weeks after shot Numbness in left hand 1-8 weeks after shot
At 4:00pm the patient became anxious immediately after receiving the COVID-19 Moderna vaccine and after a minute of being observed he complained of sweats, feeling feverish, light headedness, muffled hearing. seeing spots and sudden urge to urinate.  Blood pressure was 132/80 at time of event.  Immediately he was given Gatorade and water and visibly became less diaphoretic and anxious after five minutes.  By 4:20 pm the patient stated he was feeling "back to normal" and was assessed by a physician and was released after 30 minute of observation.
Headache  Low grade fever Muscle aches (back) Fatigue  Night sweats  Diarrhea