chrisvoncsefalvay/vaers-outcomes huggingface dataset:
yappy feeling; felt lousy/not feeling good; headaches; This spontaneous case was reported by a consumer and describes the occurrence of LOGORRHOEA (yappy feeling), MALAISE (felt lousy/not feeling good) and HEADACHE (headaches) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 041L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ATORVASTATIN, ASPIRIN [ACETYLSALICYLIC ACID], CALCIUM, DILTIAZEM, DULOXETINE, GABAPENTIN, LETROZOLE, LEVOTHYROXINE, MODAFINIL, MELATONIN, INSULIN ASPART (NOVOLOG), OLMESARTAN MEDOXOMIL (BENICAR), OMEPRAZOLE, OXYCODONE, INSULIN GLARGINE (TOUJEO), EICOSAPENTAENOIC ACID ETHYL ESTER (VASCEPA), LIRAGLUTIDE (VICTOZA) and RIVAROXABAN (XARELTO) for an unknown indication.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Feb-2021, the patient experienced MALAISE (felt lousy/not feeling good) and HEADACHE (headaches). On an unknown date, the patient experienced LOGORRHOEA (yappy feeling). On 13-Feb-2021, MALAISE (felt lousy/not feeling good) and HEADACHE (headaches) had resolved. At the time of the report, LOGORRHOEA (yappy feeling) outcome was unknown.            Other concomitant medications include over-the-counter fiber supplement, over-the-counter multivitamin. No treatment medications were reported.   This case was linked to MOD-2021-329130 (Patient Link).
Chest tightness, increased heart rate from 66 at time of initial assessment to 106 after Tdap injection, feeling of doom, sweat, tingling down spine.
Fever started 10 hours post injection. Fever was 99.1.  Also body aches. Next day was fatigued and had small rash at the base of my neck in front.
Admitted to the hospital on 4/23/22 for elevated troponins. Had weakness, fatigue, nausea, and palpitations that started 1 week prior, Moderna booster (3rd vaccine) was given 10 days prior. EKG was NSR with lateral wall ST-T wave abnormalities. Had known history of PVCs. ECHO showed EF of 32% with severe global Left Ventricular hypokinesis. Heart catheterization showed no obstructive coronary artery disease, diagnosed with nonischemic cardiomyopathy. She was given a LifeVest on discharge.
I received the Moderna Booster on 11/10/2021, and on 11/20/2021, I began experiencing spontaneous urticaria (hives) throughout the day and night. The hives appear on my neck, back of my lower head, chest, stomach, head, wrists, palm of my hands, inner thighs, and bottom of my feet. The hives appear randomly over my body and last about 20 - 30 minutes, with an itching/burning sensation.  I have not had any prior allergic reactions similar to this and there has been no change in my diet or environment.  I began taking Allegra 24 Hour Tablets on 12/04/2021 and have seen a reduction in the hive flare ups, but I do have some still break through.
No adverse event; received her second Moderna Covid 19 vaccine booster dose on 13-Jun-2022 and received an additional booster dose of the Moderna COVID-19 vaccine on 7-Jul-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received her second Moderna Covid 19 vaccine booster dose on 13-Jun-2022 and received an additional booster dose of the Moderna COVID-19 vaccine on 7-Jul-2022) and NO ADVERSE EVENT (No adverse event) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 066K21A, 059A22A, 047C21A, 043L20A and 037K20A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Jun-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Jul-2022, received fifth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Jul-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received her second Moderna Covid 19 vaccine booster dose on 13-Jun-2022 and received an additional booster dose of the Moderna COVID-19 vaccine on 7-Jul-2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received her second Moderna Covid 19 vaccine booster dose on 13-Jun-2022 and received an additional booster dose of the Moderna COVID-19 vaccine on 7-Jul-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received her second Moderna Covid 19 vaccine booster dose on 13-Jun-2022 and received an additional booster dose of the Moderna COVID-19 vaccine on 7-Jul-2022).    No concomitant product reported by the reporter. No treatment medication reported by the reporter.   This case was linked to MOD-2023-698246 (Patient Link).
Possible immunization error.  Pt may have been given VARIVAX vaccine in error instead of HEP A d/t mislabeling of syringe.
Caller is still not feeling well ( chills, pain, feels tired); Caller is still not feeling well ( chills, pain, feels tired); Caller is still not feeling well ( chills, pain, feels tired); Caller is still not feeling well ( chills, pain, feels tired); This is a spontaneous report from a Pfizer-sponsored program Support from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 15Feb2021 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient was still not feeling well (chills, pain, feels tired) after the 1st dose of Covid-19 vaccine last 15Feb2021. Patient was scheduled for 2nd dose on 13Mar2021. The outcome of events was not recovered. No follow-up attempts are possible. Information about lot/batch number cannot be obtained.  No further information is expected.
abdominal pain; bloating; diarrhea; headache; nausea; dizziness; abdominal discomfort; This is a spontaneous report from a contactable consumer. A 57-year-old female patient received (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN5318 (maybe ENS318)) via an unspecified route of administration on 27Jan2021 as a single dose for Covid-19 immunisation. The patient medical history included irritable bowel syndrome (IBS) and allergic reaction to a penicillin antibiotic (previously had one allergic reaction to a penicillin antibiotic). The patient's concomitant medications were not reported. It was reported that, at 9:30 PM the night of the vaccine (Day1) on 27Jan2021, the patient suddenly got a headache, nausea, dizziness, then an hour later abdominal pain, bloating and diarrhea for several hours. Bloating and abdominal discomfort continued on Day 2 and Day 3. The patient was tested negative for Covid on 29Jan2021 post vaccination. The events were resolving at the time of report.  Follow-up attempts are completed. No further information is expected.
Arm became sore at injection site 10 hours after vaccine administration; Started getting chills; Body aches; Loss of appetite; Had a temperature of 100.0 F, still had chills/aches.32-34 hours had temperature of 100.7, still had chills/aches; This is a spontaneous report from a contactable consumer (patient). This 36-year-old male consumer received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection Lot number: EN5318), via an unspecified route of administration on left arm on 16Feb2021 at 09:30 AM (at age of 36-year-old) as a second single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had no allergies. The patient previously received first dose BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection Lot number: EN5318), via an unspecified route of administration on left arm on 27Jan2021 at 08:30 (at age of 36-year-old) as a first single dose for COVID-19 immunisation. The patient had not received any other medications 2 weeks prior to the COVID vaccine. The patient had not received any other vaccine 4 weeks prior to the COVID vaccine. On 16Feb2021, 10 hours after vaccination with second dose the patient's arm became sore at injection site, 12 hours after vaccination started getting chills and body aches, loss of appetite, 22 hours after vaccination, the patient had a temperature of 100.0 F, and still had chills/aches. After 32-34 hours had temperature of 100.7, still had chills/aches. After 48 hours after 2nd dose, temperature returned to normal, and chills/aches went away. Patient was not received treatment for adverse event. Patient was not prior vaccination covid. Patient did not covid tested post vaccination. The outcome of the events arm became sore at injection site, loss of appetite was recovering and the outcome for rest of the events was recovered on an unknown date in Feb2021.  Follow-up attempts completed. No further information expected.
Misadministration. Pt was given a 2nd dose of ZOSTAVAX 1st dose was 6/24/10.
Patient admitted with acute onset of abdominal pain and bloating. Hx of multiple previous extensive abdominal surgeries. CT on admission was concerning for pSBO, constipation, and some thickening of the small bowel. She wa started on an aggressive bowel program and had good results with resolving symptoms. ED visit and hospital admission within 6 weeks of receiving the COVID vaccine.
Woke up next day (3/19/21)after vaccination with a sore throat. Around noon that day, fever of 100.3 Called pediatrician to let them know what was going on.  Had a Telehealth visit that afternoon.  Doctor scheduled a Covid test and a Strep test for next day,(3/20/21) Saturday AM.  On Saturday, fever continued, it would go down to 99.3 and no higher than 101.0 . Sore throat lessened but then severe cold and congestion symptoms started.   Rapid Covid was negative but PCR  and Strep sent out. Sunday, (3/21/21)Congestion and runny nose and low grade fever continued all day. Monday 3/22/21 no fever just congestion.   PCR test for Covid came back negative and Strep came back negative. Tuesday 3/23/21  very minor congestion. All symptoms gone by Wednesday 3/24/21. During the time of symptoms my son took zyrtec daily, saline nasal spray as needed, tylenol  as needed, nasacort nasal spray, dimetapp cold and allergy 20ml twice a day on 3/ 20 and 3/21.
2 days p/vax pt had red patch about 4", warm to touch, hard area in center;tx apply cool compress & advil;
This case was reported by a physician and described the occurrence of ataxic gait in a 48 year old male subject who received Twinrix. On 4/26/05, the subject received the 2nd dose of Twinrix (AHABA026AA. On 4/27/05, at 05:30, the pt contacted the physician and reported an abnormal ataxic gait. The physician reported that, "the afternoon of 4/27/05, a follow-up phone call revealed that the pt's gait is normal; ataxia is gone". The reporting physician considered the ataxic gait to not be related to vaccination with Twinrix. This vaccinee had no adverse events following receipt of the 1st dose of Twinrix.
No immediate reaction day of vaccination. By evening had an increase in mast cell symptoms including, dizziness, nausea, severe headache, stomach pain, mild chest pain, fluish feeling, very fatigued.  Also severe left leg pain in calf (not a normal mast cell symptom for me). Symptoms still very prevalent by April 13, leg pain was worse, now in both legs. Saw primary physician Dr. He saw no swelling in legs and no treatment done at this time. April 18th headaches and leg pain was so severe went to ER. They ran a D Dimer test to test for blood clots and it was normal. Spoke with my mast cell specialist, Dr. by phone on April 19th and he prescribed 40 mg Prednisone daily for 5 days. Started prednisone on April 24th. When treatment course was finished my mast cell symptoms came back even worse than before, Had throat swelling, in addition to above symptoms. Went to Urgent Care on May 2nd, and they prescribed 60 mg Prednisone for 5 days. After this course of treatment, same thing happened,symptoms returned. Dr. suggested I follow up with my primary physician to make sure there wasn't something else going on besides mast cell symptoms. Dr. ran blood tests on May 14th,  including another D Dimer which was negative. Since tests were normal Dr. prescribed a long term taper of Prednisone which I am currently on as of June 9, 2021. Saw Dr on June 1st for follow up. Continuing prednisone taper for an additional 3 weeks. Symptoms as of June 9, 2021-still very sick. I still can't eat foods I was eating prior to vaccination, worsening of mast cell symptoms and leg pain is now mild and intermittent which is better. Still have headaches but they are not as severe as they were.
Swelling the size of peach at injection site, later swelled further down the arm to wrist, slowly resolved over several days, had low grade fever for 2d. Now one week later and still trace swelling but feeling well again.
No adverse events were reported.; received one improperly stored dose of PNEUMOVAX 23 on an unspecified date.; This spontaneous report has been received from a pharmacist concerning to 1 of 19 patients, a 68-year-old male patient. The patients' historical condition, concomitant medications and drug reactions or allergies were not reported.   On 20-SEP-2019, the patient was vaccinated with an improperly stored dose (product storage error) of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose, route and frequency were not reported) lot # S012245, the expiration date: 09-FEB-2021 for prophylaxis.  The administered dose experienced a temperature excursion at lowest temperature below 36-degree Fahrenheit (32F) for 6 hours. Previous excursions were unknown by reporter. The temperature excursions were not detected by a data logger. No adverse events were reported.  This is one of several reports received from the same reporter. # 1909USA001561, 2003USA005392, 2003USA005393, 2003USA005395, 2003USA005396, 2003USA005397, 2003USA005398, 2003USA005399, 2003USA005400, 2003USA005401, 2003USA005402, 2003USA005403, 2003USA005404, 2003USA005405, 2003USA005406, 2003USA005407, 2003USA005408 and 2003USA005409. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: Unspecified; manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S012245; expirationdate: 09-FEB-2021; deviceage and unit: 0 ; operatorofdevice: Health Care Professional; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: No; reasonfornoneval: 81 Other; reasonfornonevalother: No information about the availability; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-1909USA001561: US-009507513-2003USA005392: US-009507513-2003USA005393: US-009507513-2003USA005395: US-009507513-2003USA005396: US-009507513-2003USA005397: US-009507513-2003USA005398: US-009507513-2003USA005399: US-009507513-2003USA005400: US-009507513-2003USA005401: US-009507513-2003USA005402: US-009507513-2003USA005403: US-009507513-2003USA005404: US-009507513-2003USA005405: US-009507513-2003USA005406: US-009507513-2003USA005407: US-009507513-2003USA005408: US-009507513-2003USA005409:
PATIENT REPORTS SLIGHT NAUSEA FOR PART OF THE DAY AFTER 3RD DOSE
Red runny eyes, cough, rash that started on her feet and spread up the body, very noticeable on knees, tops of toes, inside of bicep, inside of thighs and tops of feet. Pain in right leg at injection site so severe child couldn't walk. Fever for 7 days, rash for 4 days, pain in leg started with rash and has continually worsened through 7/15/08. Child given tylenol, ibuprophen, oatmeal bath, hydrocortisone, heating pad, staining and peeling on feet still 7/22/08.
10/30/13 - Unable to stand/support weight. 10/31/13 - Topples over when sitting. 11-10-13 - Unable to support head, torso, progressive dystonia, hypotonic torso, arrested speech, choking when eating, hyperirritability. 3 spinal taps, mult. hospitalizations, G-button placement for FTT.
2/10-Chills around 2:30 am (did not take temperature); fainting spell around 7:00 am and temp of 100.1; chills, fluctuating temperature (99.5-100.1), sore arm, redness at injection site, and fatigue all day. 2/11-mild arm soreness, redness at site injection, and temperature between 98.4-99.6 (higher than normal for me. I take my temp every day for work and am usually 97.3-97.8).
No additional AE reported.; Incorrect product storage; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions or allergies was provided.  On an unknown date in 2022, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # W017567, expiration date of 29-NOV-2023, for prophylaxis (strength, dose and route of administration were not reported) (product storage error). No adverse effects were reported.     It was stated that the vaccine underwent a temperature excursion as following:  Temperature: 7.7°F (Fahrenheit) (Affected Product's Most Recent Temperature Excursion had occurred on 19-AUG-2022).  Time frame: 10 Minutes (Affected Product's Most Recent Temperature Excursion had occurred on 19-AUG-2022).  Previous temperature excursion reported as following: 03-AUG-2022: (6°F up to 14°F) (7.5°F) for 10 Minutes; 04-AUG-2022: (6°F up to 14°F) (7.2°F) for 9 Minutes; 08-AUG-2022: (6°F up to 14°F) (7.0°F) for 9 Minutes; 09-AUG-2022: (6°F up to 14°F) (7.3°F) for 10 Minutes.   Reporter was unable to further clarify.; Sender's Comments:  US-009507513-2209USA000716:02238205
H1N1 vaccine 1 1/2 wks ago-started breaking out with rash 2 days ago on arms-now all over body. Back, chest -arms and legs.  See by doctor -11/3/09 -ZYRTEC 10mg qd to get allergy testing once rash resolved.
98 DEGREES, 116-20, 90  WEAKNESS, NAUSEA, PROFOUND FATIGUE, FALLING ASLEEP-THESE SYMPTOMS STARTED 8-12 HOURS AFTER RECEIVING H1N1, SEASONAL AND PNEUMOCOCCAL VACCINES.  TREATED WITH 1000 CC IV FLUIDS, VITAMIN B-12 1000 MG IM
Covid PCR: Positive; Covid PCR: Positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 17Feb2021 15:45 (Lot number: EN6200) at the age of 62 years as dose 2, single and administered in arm right, administration date 27Jan2021 15:45 (Lot number: EL9264) as dose 1, single for covid-19 immunisation. Relevant medical history included: "kidney donor" (unspecified if ongoing); "Known allergies: nuts oranges, grapefruit" (unspecified if ongoing); "Known allergies: Mold" (unspecified if ongoing); "Known allergies: Dust" (unspecified if ongoing); "Known allergies: mushrooms" (unspecified if ongoing). Patient didn't have COVID prior vaccination. Concomitant medication(s) included: ESTROGEN patch, 0.375 mg. No other vaccine was administered in four weeks. Past drug history included: Oxycodone, reaction(s): "Known allergies: Oxycodone". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 06Dec2021, outcome "unknown" and all described as "Covid PCR: Positive". The event "covid pcr: positive" was evaluated at the physician office visit. Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient underwent the following laboratory tests and procedures: sars-cov-2 antibody test: (18Nov2021) positive, notes: Blood test; sars-cov-2 test: (14Jul2020) negative; (24Sep2020) negative, notes: Nasal Swab; (05Mar2021) negative, notes: Nasal Swab; (09Jul2021) negative, notes: Nasal Swab; (19Aug2021) negative, notes: Nasal Swab; (19Aug2021) negative, notes: Nasal Swab; (29Aug2021) negative, notes: Nasal Swab; (20Oct2021) negative, notes: Nasal Swab; (06Dec2021) positive, notes: Nasal Swab; serology test: (14Jul2020) negative, notes: Blood test; (20Dec2020) negative, notes: Blood test; (16Jan2021) negative, notes: Blood test; (03Apr2021) negative, notes: Blood test; (18Nov2021) negative, notes: Blood test.   Follow-up attempts are completed. No further information is expected.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31-year-old male patient received BNT162b2 (BNT162B2), on 22Mar2021 as dose 1, single (Lot number: ER8727), in left arm, on 12Apr2021 as dose 2, single (Lot number: EP7533), in left arm and on 23Sep2021 as dose 3 (booster), single (Lot number: 301308A) at the age of 31 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) unknown results, notes: Treatment of COVID-19; (26Jun2022) Negative, notes: Tested positive on COVID test three days after testing negative; (29Jun2022) Positive, notes: Tested positive on COVID test three days after testing negative. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Tested positive on COVID test three days after testing negative. Completed Paxlovid course two days earlier than last negative test. Experiencing mild symptoms.
Information has been received from a certified medical assistant concerning a 16 week old male who on 22-JAN-2009 was vaccinated with the first dose of ROTATEQ (lot # not provided)  On 20-MAR-2009 the patient received the second dose of ROTATEQ twice.  This infant is a twin.  The patient was not experiencing any known symptoms.  Follow up information received on 28-MAY-2009 from a certified medical assistant stated that it was a white patient with mile soy protein intolerance and a history of pulmonary branch stenosis, born at 34 weeks (premature), who on 20-MAR-2009 at 16:15 was vaccinated with two doses of ROTATEQ, orally (lot # 1160X, valid for PREVNAR.  On the same date at 16:15 the patient was also vaccinated with a second dose of poliovirus vaccine inactivated (unspecified) (manufacturer unknown) (lot # A1229-2), intramuscularly into the left thigh, a second dose of DAPTACEL, (lot # C308AA), intramuscularly into the right thigh and a second dose of ACTHIB (lot # DUFS11AA) IM into the left thigh.  Another dose of ACTHIB with lot #VUFU67AA was also listed.  Additional vaccinations received at the same time and date included a second dose of PREVNAR (lot # C7197S), intramuscularly into the right thigh.  On 26-MAR-2009, the patient experienced 5-6 loose watery stools daily; the patient was treated with diet changes and PEDIALYTE SOLUTION).  No laboratories studies performed.  The patient recovered in 1-2 days, date of recovery listed as 27-MAR-2009 to 28-MAR-2009.  No further information is available.