chrisvoncsefalvay/vaers-outcomes huggingface dataset:
arm  so heavy she could not lift her arm  for 14 days; arm  turned bright red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (arm  turned bright red) and LIMB DISCOMFORT (arm  so heavy she could not lift her arm  for 14 days) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (arm  turned bright red) and LIMB DISCOMFORT (arm  so heavy she could not lift her arm  for 14 days). On 16-Feb-2021, VACCINATION SITE ERYTHEMA (arm  turned bright red) outcome was unknown and LIMB DISCOMFORT (arm  so heavy she could not lift her arm  for 14 days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were provided  No treatment medications were provided.   This case was linked to MOD-2021-348400 (Patient Link).
After administration of the vaccine, patient started getting pale. Then passed out for 2 seconds and came too. Gave patient a bottle water and food to help become more aware. Called EMS but patient denied ambulance. Patient hung around for 30 minutes and felt better. Color was normal , and was talking and walking.
Stored Moderna vaccine in their refrigerator and administered vaccine on 01-Feb-2022 past the BUD date 01-Nov-2021; The patient administered vaccine on 01-Feb-2022 past the BUD date of 01-Nov-2021; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The patient administered vaccine on 01-Feb-2022 past the BUD date of 01-Nov-2021) and PRODUCT STORAGE ERROR (Stored Moderna vaccine in their refrigerator and administered vaccine on 01-Feb-2022 past the BUD date 01-Nov-2021 ) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 011F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Feb-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 01-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (The patient administered vaccine on 01-Feb-2022 past the BUD date of 01-Nov-2021). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Stored Moderna vaccine in their refrigerator and administered vaccine on 01-Feb-2022 past the BUD date 01-Nov-2021 ). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The patient administered vaccine on 01-Feb-2022 past the BUD date of 01-Nov-2021) and PRODUCT STORAGE ERROR (Stored Moderna vaccine in their refrigerator and administered vaccine on 01-Feb-2022 past the BUD date 01-Nov-2021 ) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. The BUD date was reported as 01-Nov-2022 and CDC expiration was reported as 19-Mar-2022. No treatment medications were reported.
Hard time thinking, can't write well, can't spell, can't comprehend good, can't walk right (falls) per patient.
Pt states that starting about about 10 days after the vaccine her arm was "swelling, throbbing, hot and sore".  She is having difficulty lifting her arm.
1 1/2 days of pale color, poor appetite, temp of 100.8, fussiness and lethargy.
Had severe chest pain and fainted. Was diagnosed with an esophageal spasm and released.
flu; sore throat; sick to the stomach; achy body; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (flu), OROPHARYNGEAL PAIN (sore throat), ABDOMINAL DISCOMFORT (sick to the stomach) and MYALGIA (achy body) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Multiple sclerosis. Concomitant products included OCRELIZUMAB (OCREVUS) for Multiple sclerosis.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA (flu), OROPHARYNGEAL PAIN (sore throat), ABDOMINAL DISCOMFORT (sick to the stomach) and MYALGIA (achy body). At the time of the report, INFLUENZA (flu), OROPHARYNGEAL PAIN (sore throat), ABDOMINAL DISCOMFORT (sick to the stomach) and MYALGIA (achy body) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication was reported.
With my previous two Pfizer vaccines, the only side effect I had was fatigue. With this third shot, I had the fatigue the same night as the shot, but then, around 1 a.m., I started getting severe chills which lasted several hours. At 6:30 a.m., once the chills subsided, I developed a fever. I've been lightheaded and continue to experience chills and fever.
Patient received 1st  Moderna Covid vaccination at 645pm, patient was transitioned to waiting area chair.  Once seated the patient lost conciousness and slid out of chair to floor for approximately 5 seconds, then regained concoiousness.  Patient advised me that he as done this during previous blood draw and immunizations.  Patient did not want to seek additional medical attention and in my professional opinion was of sound mind to make that decision.  His brother in law was with him and agreed that no further treatment was necessary at that time.  Monitored patient for approximately 25 minutes and patient left under his own power.
This spontaneous report as received from a female patient of unknown age refers to herself. On 27-DEC-2013 the patient was vaccinated with ZOSTAVAX vial (dose, frequency and lot# unknown) at her physician's office (name and location unspecified). On 14-JAN-2014, 19 days after onset of therapy the patient was diagnosed by her physician with "Shingles". The patient had sought medical attention via office visit. The outcome of shingles was unknown. Additional information is not expected.
Dexcom Continuous Glucose Sensor failed. Contacted Dexcom explained the problem (failed sensor). They declined to help and blamed Tandum and transferred to them. They said NO NO this is a Dexcom problem and transferred me back! Dexcom identified the problem and offed to send a replacement vis 3-7 days vis ground shipping! A week without a CGM sensor!!! I expressed concern and asked for overnight. One week ago I got the Moderna vaccine and suffered Diabetic Ketoacidosis. Failed sensor has resulted in elevated BG. Last week I had Ketoacidosis following moderna Covid-19 vaccine. Being without continuous BG testing is dangerous. Raised my concerns with Dexcom. Asked for call back and action.
Blood pressure went from 120 to 189/35 too high and too low; Blood pressure went from 120 to 189/35 too high and too low; Chemical reaction/diagnosed with chemical intolerance; This spontaneous case was received on 08-Feb-2021 from other non-health professional (consumer) via Agency (reference number: NUS2021US019543) and concerned a 70-year-old, male patient.  The patient's medical history and concomitant medications were not reported.  On an unknown date, the patient was vaccinated with influenza virus vaccine monovalent (brand not specified; indication, dose, route of administration and anatomical location: not reported). The batch number was not reported.  On an unknown date, an unknown amount of time after receiving influenza virus vaccine monovalent, the patient had chemical reaction and he was diagnosed with chemical intolerance. The patient's blood pressure went from 120 to 189/35 too high and too low.  The outcome of the events was not reported.  The reporter assessed the events as related to receiving influenza virus vaccine monovalent. The patient took the Novartis H1N1 vaccine and it caused a chemical reaction and he was diagnosed with chemical intolerance and his blood pressure went from 120 to 189/35 too high and too low.  The events of 'blood pressure diastolic decreased' and 'blood pressure systolic increased' were considered to be medically significant by a Physician within Seqirus's Pharmacovigilance and Risk Management Department.  Company comment:The patient developed blood pressure diastolic decreased, blood pressure systolic increased and allergy to chemicals on an unknown date and unknown amount of time after receiving the suspect product, influenza virus vaccine monovalent. Chronology is unclear. More information regarding temporal relationship, concomitant medications and underlying medical history is needed. Causality for all events is assessed as unassessable due to lack of information.; Reporter's Comments: The patient took the Novartis H1N1 vaccine and it caused a chemical reaction and he was diagnosed with chemical intolerance and his blood pressure went from 120 to 189/35 too high and too low.; Sender's Comments: The patient developed blood pressure diastolic decreased, blood pressure systolic increased and allergy to chemicals on an unknown date and unknown amount of time after receiving the suspect product, influenza virus vaccine monovalent. Chronology is unclear. More information regarding temporal relationship, concomitant medications and underlying medical history is needed. Causality for all events is assessed as unassessable due to lack of information.
Shortness of breath, rapid heart beat,  weakness, near fainting.  Symptoms started after the 15 minute observation period and I left the facility.   I took 50 mgs of Benadryl and symptoms were gone within 30 minutes.  This could have been an anxiety attack and unrelated to the vaccine.  I have never reacted to a vaccine before.  Unsure if I should receive the second dose of this vaccine.
Got shots Monday 10/03/2016 and her arm got swollen and complains that it itches.
high temp 104-105 14-21 days p/vax; this happenend 2x, & did not occur when DT alone was given;
Patient reports redness and itching in disc surrounding injection site spanning roughly 7 inches in diameter around where the injection was given on her left deltoid. She also reports muscular pain and weakness in the same arm. No other problems reported.
chills on left side of face; soreness on left side of chest; soreness on eft hand; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills on left side of face), CHEST PAIN (soreness on left side of chest) and PAIN IN EXTREMITY (soreness on eft hand) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced CHILLS (chills on left side of face), CHEST PAIN (soreness on left side of chest) and PAIN IN EXTREMITY (soreness on eft hand). At the time of the report, CHILLS (chills on left side of face), CHEST PAIN (soreness on left side of chest) and PAIN IN EXTREMITY (soreness on eft hand) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medicines were reported. No treatment information were reported.
Dull headache, right arm where shot was given swollen, I had a dazed-out feeling day given vaccination, had a very hard time going to sleep on the day I got the vaccine, next night I slept 10 hrs, arm is still stiff 3 days later
Pregnancy at time of vaccination; This spontaneous prospective pregnancy case was reported by a physician assistant and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnancy at time of vaccination) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011L20A and 030L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to dosage form. The patient's last menstrual period was on 05-Jan-2021 and the estimated date of delivery was 13-Oct-2021. On 11-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnancy at time of vaccination). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy.  On 11-Jan-2021, EXPOSURE DURING PREGNANCY (Pregnancy at time of vaccination) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular),is not applicable.; Sender's Comments: This case concerns a 26-Year-old female, Para1 gravida 2, who received mRNA-1273 while pregnant (vaccine exposure during pregnancy) The patient's last menstrual period was 05-Jan-2021 a, estimated date of conception was 13-Oct-2021and estimated due date is 13-Oct-2021. the event of vaccine exposure during pregnancy is assessed as not applicable
Influenza vaccine and Tdap were administered at 12:20 pm 10/27/14 (while an inpatient) in (L) deltoid. Rt deltoid - pneumococcal vaccine administered as well 10/27/14 12:20 p seeing MD today not treated yet. Lt deltoid noted redness on 10/30/14. Continues to be red/warm and raised area approx size - baseball in diameter.
ON 3/21/15 CLIENT STATED SHE HAD A SORE THROAT. ON 3/21/15 CLIENT STATED SHE NOTICED FLULIKE SYMPTOMS. 3/22/15 SYMPTOMS CONTINUE. 3/23/15 SPAT BLOOD STREAKED SPUTUM IN AM CLIENT STATED THIS HAPPENS WHENEVER SHE HAS A COLD THIS ALWAYS OCCURS. CLIENT STATED SHE WAS TOLD BY A DOCTOR THAT THIS WAS NORMAL. 3/24/15 SHE SPAT BLOOD AGAIN IN THE AFTERNOON. 3/25/15 CLIENT CALLED DOH AND WENT TO URGENT CARE AND STATED SHE WAS ADVISED THAT THESE SYMPTOMS MAY CONTINUE FOR A FEW FOR MORE DAYS.
had the first dose of the COVID-19 vaccine last 24Dec2020 and the second dose is scheduled on 14Jan2021/tested positive for COVID-19; had the first dose of the COVID-19 vaccine last 24Dec2020 and the second dose is scheduled on 14Jan2021/tested positive for COVID-19; This is a spontaneous report from a contactable Nurse (patient). A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on 24Dec2020 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient had the first dose of the COVID-19 vaccine last 24Dec2020 and the second dose is scheduled on 14Jan2021. However, last 04Jan2021, the patient tested positive for COVID-19. The patient was looking for recommendations on when he/she can take the COVID-19 vaccine. The patient underwent lab tests and procedures which included COVID-19 test: positive on 04Jan2021. The outcome of the event was unknown.   Information on the Batch/Lot number has been requested.
I STARTED GETTING A LOT OF CONGESTION AND POST NASAL DRIP, CONGESTION IN CHEST AS WELL, P.A. SUGGESTED ALLERGY MEDICATIONS, EXPECTURANT TO COUGH OUT PHLEGM, DRINK FLUIDS AND TEA, AND TO SLEEP WITH A HUMIDIFIER.  TREATMENTS SEEM TO BE WORKING AND SYMPTOMS ARE ALMOST CLEARED UP. Hx of problems with allergies, and congestion.
Bilateral numbness from the waist down; Developed the shingles rash and was diagnosed with shingles; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 60-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included tingling of extremity.   On 12th February 2020, the patient received the 1st dose of Shingrix. On 14th February 2020, 2 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the patient experienced numbness. On an unknown date, the outcome of the shingles was not recovered/not resolved and the outcome of the numbness was unknown.   It was unknown if the reporter considered the shingles and numbness to be related to Shingrix.  Additional details were reported as follows: The reporter stated that patient was sent to the pharmacy by the Health Care Professional to took Shingrix vaccine because he was having tingling in the four extremities. The patient received 1st dose of vaccine and developed the shingles rash and was diagnosed with shingles. The patient still had shingles at the time of reporting. The patient also had bilateral numbness from the waist. The reporter consented to follow up.
Herpes outbreak worse than never broke out like this ever in my vaginal area. Started October 23 to now October 30 2021 My doctor prescribed me Acyclovir 400mg and the upped it to Acyclovir 800mg. Pain, fever, and extreme itchiness.
Patient was given Gardasil, Influenza Vac and PPD. Few minutes after the injections patient fainted and fell to the floor. Mother and the medical assistant were in room. Patient sustained a laceration to her left upper lip and her one incisor broke. Patient needed treatment for laceration at the emergency room after she was transported by paramedics. She also required dental treatment. Full dental treatment has not been done yet. She has seen the dentist, she had xrays. She needs a crown, a root canal in the affected tooth. 12/11/08-records received for DOS 10/28/08-immediately after receipt of vaccine fainted, fell and broke her upper lip and front left incisor. Fainting a second time. Seen in ED. 12/17/08-ER records received for DOS 10/28/08-syncope-lip laceration. loose teeth.
No symptoms , called mother 08/20/2021 she states child has  no side effects to date
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 25-MAR-2016, the patient was vaccinated with an improperly stored dose of ROTATEQ (reported lot # L008990, exp. date: 01-DEC-2016) and RECOMBIVAX HB (lot # L018501, exp. date: 22-JUN-2017) (for both: dose number and route were not reported). The dose of ROTATEQ and RECOMBIVAX HB were stored in 1.4 Celsius degree for 2 hours and 41 minutes. There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
throwing up/ nauseated; Chills; Diarrhea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 46 year-old female patient received bnt162b2 (BNT162B2), administration date 23Apr2021 (Batch/Lot number: unknown) at the age of 46 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hypertension" (ongoing), notes: Verbatim: Blood pressure high, 2 years ago diagnosed; "slight stroke" (unspecified if ongoing), notes: Verbatim: slight stroke, 2.5 years ago. Concomitant medication(s) included: BISMUTH SUBSALICYLATE. Vaccination history included: Bnt162b2 (1st dose.), for COVID-19 Immunization. The following information was reported: NAUSEA (non-serious) with onset 27Apr2021 11:00, outcome "not recovered", described as "throwing up/ nauseated"; CHILLS (non-serious) with onset 27Apr2021 11:00, outcome "not recovered", described as "Chills"; DIARRHOEA (non-serious) with onset 27Apr2021 11:00, outcome "not recovered", described as "Diarrhea". Therapeutic measures were not taken as a result of nausea, chills, diarrhoea.  Additional information: The reporter told her daughter to go to urgent care or the ER, but she had not. She was calling today to see if these are normal side effects. Caller doesn't know the patient's height or weight. Her daughter did not have a prescribing doctor . Her daughter is a Veteran and got the vaccine through the VA hospital. Her daughter did take Pepto Bismol.  She was unsure of the date of the first vaccine. There were no any previous immunization with the Pfizer vaccine considered as suspect. There was no Additional Vaccines Administered on Same Date of the Pfizer Suspect. There was no visit to Emergency Room or physician office. There were no Prior Vaccinations within 4 weeks. There were no relevant diagnostic and confirmatory test results for events. Reason for no lot number of COVID 19 vaccine was Complainant did not have the product with them at the time of call.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Hearing loss and tinnitus in my left ear since getting the first dose of covid vaccine Moderna.
Woke up 7 days after the vaccine with hives all over my body, I have had hives for 3 days, they are now subsiding.
This spontaneous report as received from a licensed practical nurse refers to a 6 months old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 08-FEB-2016, the patient was vaccinated with dose of ROTATEQ (orally, lot # L013202; dose and expiration date were not reported) that had experienced a temperature excursion. No adverse reaction was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Pt admitted with a STEMI three days after vaccination with pzifer COVID-19 vaccine. Short time (<2hr) between symptoms onset and medical care. PCI on 1/14. Acute subtotal occlusion of proximal LAD and severe diffuse disease extending to distal LAD.  Two DES to LAD (99% occluded) but RCA 50% and OMI1 60-65% also stenosed. Echo cardiogram 1/15. Pt noted to have severe wall motion abnormalities (severe hypokinesis of anterolateral and anteroseptal wall; akinesis of mid to distal anterior wall extending to the apex and distal inferior wall ) on echo. EF 30-35%. Received life vest on discharge.
This spontaneous report as received from a health professional refers to a patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL (dosing information and route were not provided) lot # J003727, expiry date 07-NOV-2015. GARDASIL was improperly stored. This information was stated on a vaccination list of improperly stored vaccines. Additional information has been requested.
Sense of taste/smell has been off since ~3/14.  Certain smells/tastes like scented shampoo & soap, minty toothpaste, the taste of meat are weird to me now.
VAXELIS administered since temperature excursion above 8.5° (10 mins)/Previous temperature excursion on 12-APR-22 above 8°C (10 mins); This non-serious spontaneous report with reference numbers 02197725 / 02197588 was received by partner on 05-JUL-2022 and forwarded on 06-JUL-2022 from a consumer.    The causal relationship between Vaxelis and the reported event "multiple doses of VAXELIS administered since temperature excursion" was assessed as not applicable due to the nature of the event.    Further information is expected.  FOLLOW-UP INFORMATION was received by a partner on 01-AUG-2022 and forwarded on 03-AUG-2022, from a HCP. The case is maintained as non-serious.  The reporter confirmed that there were no Adverse Events following Vaxelis administration to the patient.  Due to the nature of the event, the causality between the event "VAXELIS administered since temperature excursion above 8.5° (10 mins)/Previous temperature excursion on 12-APR-22 above 8°C (10 mins)" and Vaxelis remained not applicable.  For reference purposes this case is linked to MCM-003725, MCM-003726, MCM-003729, MCM-003734, MCM-003735, MCM-003737, MCM-003738, MCM-003724, MCM-003740, MCM-003741, MCM-003742, MCM-003743, MCM-003744, MCM-003747, MCM-003749, MCM-003751, MCM-003752, MCM-003753, MCM-003757, MCM-003759, MCM-003760, MCM-003761, MCM-003763, MCM-003766, MCM-003767, MCM-003769, MCM-003770, and MCM-003772, due to same reporter.  No further information is expected.
COVID-19 Vaccine treatment under Emergency Use Authorization(EUA): Dizziness, Palpitations, Fatigue, Cold like Symptoms.