chrisvoncsefalvay/vaers-outcomes huggingface dataset:
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; FEELING WEIRD; DEHYDRATED; This spontaneous report received from a patient concerned a 36 year male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient initiated treatment with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204B21A and expiry: 11-DEC-2021) dose was not reported, 1 total administered on 17-AUG-2021 (between 19:00 to 23:00 hours) to right arm for prophylactic vaccination. No concomitant medications were reported. On 26-JAN-2022, the patient started feeling weird while at work and around 12:00 AM, followed by patient started having chills and was freezing. On the same day around between 14:15 and 14:30 hours, the patient did home covid test (Unspecified test) and got positive result in less than 5 minutes which was  suspected clinical vaccination failure and suspected covid-19 infection. After 15:00 hours, patient experienced headache, gunk in his throat, and was dehydrated. Laboratory data included: COVID-19 virus test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the feeling weird, dehydrated, suspected clinical vaccination failure and suspected covid-19 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint number: 90000214020.; Sender's Comments: V0.20220150702-covid-19 vaccine ad26.cov2.s -Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS.
On 11/5/21 my second Covid injection was administered subcutaneously and not in the preferred location of the Deltoid muscle. My vaccine was placed inches above my elbow. I did not have any symptoms until 9:30pm. Around 9:30pm on 11/5/21 I became lightheaded, dizzy, teeth chattering chills, extremely short of breath with intermittent chest pain, and the right side of my throat was swelling up. I went to a local emergency room where my temperature was over 101, my heart rate sustained in the 140-170s for several hours. I received IV fluids, labs, chest X-ray, d-dimer and was closely monitored for hours. My injection site became extremely swollen inside my arm and outside my arms for days and my arm hurt when trying to slightly move it. I had a temperature for four days after receiving the COVID vaccine and was extremely short of breath.
VACCINE WAS GIVEN  ON 3/24/21 AND 4/14/21 TO INDIVIDUAL UNDER AGE OF 16 .  FOLLOW UP WAS PERFORMED WITH INDIVIDUALS MOTHER AND SHE VOICED SHE WANTED HER CHILD TO HAVE IT BECAUSE SHE (MOTHER) WORKS IN HEALTHCARE.  NO ADVERSE REACTIONS OR EVENTS WERE COMMUNICATED.  VERBALIZED TO CALL IF ANY REACTIONS OCCUR AND TO PLEASE REPORT TO HER PHYSICIAN THAT HER CHILD WAS VACCINATED UNDER THE AGE OF 16.
swollen arm, 3 days p/vax;pain started 10/14;stopped hurting then pain re-emerged on10/19 in arms;mom has been trying to relieve pain by rubbing alcohol on arms;
States redness, and knot at site. C/O fatigue for several months after vaccine.
One week after the vaccine, I developed new soreness and swelling at the injection site and a red rash-like skin reaction. The redness feels prickly and hot. It surrounds the injection site and is about 4 inches in diameter. It has enlarged slightly since the day of onsite (currently 3rd day since it started).
pt recvd vax in AM & noticed face esp forehead, swelling w/small knots in it & got lump inside throat that could feel when pt swallowed; stomach became sore; seen by MD who felt these sx due to Td; advised not to take another;
Cold; Neck pain; Headaches; Muscle pain; Fever of 100 degrees; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Cold), NECK PAIN (Neck pain), HEADACHE (Headaches), MYALGIA (Muscle pain) and PYREXIA (Fever of 100 degrees) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced NASOPHARYNGITIS (Cold), NECK PAIN (Neck pain), HEADACHE (Headaches), MYALGIA (Muscle pain) and PYREXIA (Fever of 100 degrees). At the time of the report, NASOPHARYNGITIS (Cold), NECK PAIN (Neck pain), HEADACHE (Headaches), MYALGIA (Muscle pain) and PYREXIA (Fever of 100 degrees) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Feb-2021, Body temperature: 100 degrees (High) High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jul-2021: Follow up received on 15 JULY 2021 and contains Non significant information.
Covid-19; diarrhea for 4 hours; got a rash; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Covid-19), DIARRHOEA (diarrhea for 4 hours) and RASH (got a rash) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     Concurrent medical conditions included Seafood allergy (Shrimps) and Meat allergy.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In December 2021, the patient experienced COVID-19 (Covid-19). On an unknown date, the patient experienced DIARRHOEA (diarrhea for 4 hours) and RASH (got a rash). At the time of the report, COVID-19 (Covid-19) outcome was unknown and DIARRHOEA (diarrhea for 4 hours) and RASH (got a rash) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2021, SARS-CoV-2 test: positive (Positive) Positive.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       No concomitant medication was reported.  The patient experienced a similar event in the past because of some food. The symptoms were improved after 2 months.  No treatment information was reported.  Company Comment: This spontaneous case concerns a 52-year-old female patient with no relevant medical history reported, who experienced the unexpected non-serious AESI of Covid-19 which occurred approximately 1 year after the first dose of mRNA-1273 vaccine. Incomplete course of vaccination is also noted as the nurse at the vaccination facility did not want to vaccinate the patient as the patient told them about the allergic reaction of rash and diarrhea she had after the first dose. The current pandemic situation of COVID-19 may remain as confounder to the event Covid-19. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 52-year-old female patient with no relevant medical history reported, who experienced the unexpected non-serious AESI of Covid-19 which occurred approximately 1 year after the first dose of mRNA-1273 vaccine. Incomplete course of vaccination is also noted as the nurse at the vaccination facility did not want to vaccinate the patient as the patient told them about the allergic reaction of rash and diarrhea she had after the first dose. The current pandemic situation of COVID-19 may remain as confounder to the event Covid-19. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
PATIENT ALREADY RECIEVED PFIZER BIVALENT VACCINE AND GOT ANOTHER DOSE
Injection 3/31/21 3:00pm - 4/1/21, diarrhea all day, 10:00am - 1:30pm. slight headache. 4:00pm - 10:00pm, chills & body aches.  After 10:00pm, back to normal!
Severe headache and fever well over 100 for 12 hours. Increased heartbeat. Sweats and cold chills. Irregular feeling in chest and heart area and head "chills". Fever wore off after 12 hours, but headache persisted for 48 hours. Symptoms went away after 3 days.
This spontaneous report as received from a registered nurse refers to an unknown number of patients of unknown age and gender. There was no pertinent medical history, drug reactions/allergies and concomitant medications provided. On 29-APR-2015, the patient were vaccinated with an improperly stored dose of PROQUAD (dose, route, lot # and expiration date were not reported). There was no adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
No signs or symptoms reported; Excursions occured; This spontaneous report was received from an administrator referring to a patient (age and gender unspecified). There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 11-MAY-2021, the patient was vaccinated with an improperly stored dose of yeast)(GARDASIL 9) prefilled syringe, dose and frequency reported as 1 time dose with lot # T026168 (expiration date: 04-DEC-2022) or 1691180 (expiration date: 15-NOV-2022) for prophylaxis (dose and route of administration were not reported). The administered dose of the vaccine experienced a temperature excursion of  49 and 48 degrees Fahrenheit on 09-APR-2021 and on 23-APR-2021 respectively  for 1 hours/ 15minutes. It was not recorded by a data logger and not previous temperature excursion was reported. No signs or symptoms reported.  This is one of several reports received from the same reporter combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T026168; expirationdate: 04-DEC-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
had very minimal pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 79 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 10Aug2021 (Lot number: EW0168) at the age of 79 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "was a smoker" (unspecified if ongoing), notes: Verbatim: was a smoker. Concomitant medication(s) included: TRELEGY taken for ex-tobacco user (ongoing). The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "had very minimal pain". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Time the vaccination was given between 10:30 and 10:45 in them morning. Anatomical location of administration of piizer vaccine was left arm below the shoulder. They really haven't diagnosed her with COPD but, she thinks she has COPD. She had blood work and everything was perfect and that was about 6 months ago. No prior Vaccinations (within 4 weeks). She has never had a flu vaccine in life.  Follow-up attempts are completed. No further information is expected.
SOB, chills, runny nose achy and sore throat reported after PPSV 23 administered. This was reported the next day to the provider. ER visit 1 day later for persistent SOB/cough. Dx with acute bronchitis.
aches pains hands,knees and feet; Neck and back pain; Neck and back pain; headaches; aches pains hands,knees and feet; This is a spontaneous report from a contactable consumer (patient) reported for herself that. A 56-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0161) via an unspecified route of administration, administered in Arm Right on 21Apr2021 11:00 (age at vaccination 56-years-old) as DOSE 2, SINGLE for covid-19 immunisation. Concomitant medication included trazodone (TRAZODONE) 50mg; amlodipine (AMLODIPINE) 10mg; fluoxetine (FLUOXETINE) 40mgreceived within two weeks. The patient previously took Codeine and Tylenol and experienced drug hypersensitivity. The patient historical vaccine includes bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EP7533) via an unspecified route of administration, administered in Arm Right on 31Mar2021 11:00 (age at vaccination 56-years-old) as DOSE 1, SINGLE for covid-19 immunisation. On 23Apr2021, patient experienced Neck and back pain, headaches, aches pains hands, knees, and feet. For Ae treatment received was unknown. AE results in Physician Office Visit. Patient has stated that she had not been diagnosed with COVID -19 prior to vaccination and not been tested since the vaccination. Outcome of the event was unknown.  Follow-Up (30Jun2021): Follow-up attempts are completed. No further information is expected.
The next day I had a severe headache, exhaustion, and body aches. I was bedridden for five days.  A hard, painful, marble-sized lump appeared at the injection site. The lump didn't start to recede until two weeks later. The lump is smaller; however, still present and painful after almost four weeks.
MY LEFT ARM HURT WHEN I GOT THE VACCINE AND MY ARM STILL HURTS FOUR MONTHS LATER. THE PAIN IS EVEN IN THE SHOULDER .
Itching /Swelling around eyes and mouth started approximately 6 hours post first dose of Moderna.  Swelling and itching continued  over next 48 hours.  Took Benadryl every 4-6 hours.   Swelling has decreased slightly and skin around mouth and eyes is very dry.
Headaches, dizziness, near syncope 2 days after vaccination. Severe pain at injection site 1 day after vaccination.
On 6-11-17 I woke up and had sore aches in shoulders, on upper arms - lower arms - wrist and hands which really were painful. I took ALEVE it helped a little. Also took some TYLENOL. Saw my doctor on 6-29-17 and he prescribed ibuprofen 600 mg tablet 3 times a day for pain but then I felt worse after a week went back to Dr and got Furosemide for getting rid of water that I was retaining in body. So far I feel much better, but my hands still are painful at times as I have arthritis!
Information has been received from a physician concerning a 10 year old female child who in approximately 2001 was vaccinated with a dose of varicella virus vaccine live. On approximately 05/14/03, the child developed a mild case of chickenpox. Unspecified medical attention was sought. It was noted that "no details about the experience were available".  There was no product quality complaint reported.  Additional information has been requested.
broke out in several rashes on legs and back of neck.  Also broke out with several cold sores on mouth and fibramiaglia has flared up.
Severe Chills, Fever to 103 F, myalgias, fatigue, axillary lymphadenopathy
COULD NOT MOVE AND WAS PARALYZED FOR 3 DAYS; HEART RACING; FOGGY; CHILLS; WEAKNESS/NOT HAVING THE STRENGTH; HIGH FEVER(NOT SPECIFIED); FATIGUE; This spontaneous report received from a consumer concerned an 80 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included ovarian cancer 4 years ago., hay fever, non alcohol user, and non-smoker, and other pre-existing medical conditions included patient did not have drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1865020, and expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 19-MAR-2021, the subject experienced could not move and was paralyzed for 3 days. On 19-MAR-2021, the subject experienced heart racing. On 19-MAR-2021, the subject experienced foggy. On 19-MAR-2021, the subject experienced chills. On 19-MAR-2021, the subject experienced weakness/not having the strength. On 19-MAR-2021, the subject experienced high fever (not specified). On 19-MAR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from could not move and was paralyzed for 3 days on 22-MAR-2021, had not recovered from fatigue, foggy, high fever(not specified), and heart racing, and the outcome of chills and weakness/not having the strength was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
After the vaccine shot I felt fine except for minor arm soreness. I woke up at 2 AM to use the bathroom.  Lost muscular control in my legs and body, sank down to the floor (didn't fall), and was unable to get up from commode.  Had to drag myself back to bed due to complete loss of muscle control.  Woke up in the morning and was fine after that.
Pt came in showing her arm was bruised. She said it was really sore & is starting to get better.
Myocardial infarction probable silent after acute and sustained  symptoms of upper arm and leg discomfort.  Elevated diastolic bp and heart pounding.  No prior history suggestive of CAD.
Left leg hard and hot to touch. Skin with red blotches. Leg swollen.  Mother administered Tylenol and applied ice to affected area.
The client came back to the vaccination site and notified PHN about the adverse reactions. PHN observed hives developed on face and neck to chest. No other adverse reactions reported or observed. Diphenhydramine 25 mg x2 pills (PO) given to the client. PHN reassessed the client 30 minutes later. The symptoms resolved and the client stabilized. PHN followed up with the client in the following day. The client reported no recurrent hives. PHN advised her to take BENADRYL 50 mg two more times within 48 hours from the event.
Severe arm pain that has increased with time, treated with prednisone, awaiting EMG (5/23/22)
Patient felt lightheadedness and dizziness. EMS standby crew took vital signs which were all within normal limits for patient. Patient was given  a bottle of water and started to feel better quickly.
coughing; abdominal wall hernias; Flu; Initial information received on 19-Nov-2019 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 65 years old patient who experienced coughing (cough), abdominal wall hernias (abdominal hernia) and flu (influenza), while  received vaccine INFLUENZA VACCINE.  The patient's past medical history included Abdominal operation. The patient's past medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Neoplasm malignant.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site.  On an unknown date, the patient developed a non-serious coughing (cough), abdominal wall hernias (abdominal hernia) and flu (influenza) (Unknown latency) following the administration of INFLUENZA VACCINE.  (Other relevant tests included no lab data.) Final diagnosis was flu, abdominal wall hernias and coughing.  It was not reported if the patient received a corrective treatment.  The event outcome is reported as Unknown for all the events.  Information on the batch number was requested.
Tested positive for COVID-19 after Receiving  full 2 doses of COVID-19 vaccines on 1/3/2021 and 1/23/2021.  He had tested positive for COVID-19 previously on  12/3/2020.  Both COVID tests were PCR tests.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 11-DEC-2015 at 15:36, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L025738, expiry date: unspecified (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high and low temperature were 6.8 and 5.8 (units unspecified) respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent.; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent.) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and 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 UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent.) and NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent.) 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 UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent.).    No concomitant medicine were reported. No treatment medicine were reported.   Most recent FOLLOW-UP information incorporated above includes: On 27-Dec-2022: Live follow up updated.
Patient received vaccine on 10/30/13 and noticed a small raised bump at the injection on 11/1/13. Patient took Ibuprofen and BENADRYL to help with inflammation. On 11/4/13 patient went to MD; the site of inflammation was very large, raised, red, and hot. The MD gave ABX for infection.
Headaches; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headaches) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headaches). At the time of the report, HEADACHE (Headaches) outcome was unknown.            No relevant concomitant medications were reported. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not applicable.
Information has been received from a consumer concerning her 14 year old daughter with asthma, sulfonamide allergy and an allergy to codeine who on 12-OCT-2007, was vaccinated IM with a second dose of Gardasil.  Concomitant therapy given on 16-OCT-2007, included MENACTRA, hepatitis A virus vaccine (unspecified), Varivax (MSD) and allergy shots that she continually receives.  On 12-OCT-2007, the patient passed out at home when they returned home from the physician's office. Unspecified medical attention was sought.  It was also reported that in November 2007, her daughter had also experienced pain in her arm and had gone to her primary physician where they ran a test (magnetic resonance imaging (MRI)) that determined she had a tumor on her left arm and had abnormal blood vessels.  At the time of this report, the patient had not recovered.  No product quality complaint was involved.  Additional information has been requested.