chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Oct-2021 at 10:54 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 27-Oct-2021 at 10:54 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 71.10.  Concomitant products were not provided.  On 27-Oct-2021, At excursion time 09:00 AM, temperature was 29, total doses given for the day was 116 and at 10:00 AM, temperature was 32, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 29-Sep-2021, 05-Oct-2021, vial was moved to clinic on 27-Oct-2021. 2, 4 vials were sent to clinic with vaccine BUD date was 29-Oct-2021 and 04-Nov-2021 respectively.  Vial was stored on cooler 1, on 27-Oct-2021, Excursion duration At 8 AM: 41, 9 AM: 29, 10 AM: 32, 11 AM: 43, 12 PM: 43, 1PM: 43, 2 PM : 46, 3 PM: 46, 4 PM: 46and 5 PM : 45.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a traceable temperature monitor at every hour. It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Onset of pain and redness to R deltoid injection site; by morning of 09/23/2010 onset of nausea, vomiting, and generalized body aches with blistering of skin at injection site (skin remained intact); temperature of 101.4 on during the entire day of 09/24/2010 which resolved by 09/25/2010; symptoms have essentially resolved by 09/29/2010.
High fever w/ muscle pain in the legs. MD contacted. TYLENOL was administered to decrease temperature.
pt recv vax 2MAY96 & 23MAY96 pt exp swollen parotid glands;
Light Headed, tingling limbs and face plus throw up plus pain in chest and left arm and other more semingly random areas. Went to emergency room on 6/22/2012 for 11-hours and ruled out stroke with MRI and also heart check.  Symptoms lessened some on 6/23/2012 but increased on 6/24/2012.
Soreness, Fatigue, Headache, Sweats, Muscle Aches, Chills -- symptoms subsided within 24-48 hrs.
6:00 am - shivers All day - muscle aches, fatigue, headache, sore arm Treatment - ibuprofen
injection site was sore; body aches for 3-4 days; Lymph nodes under both arms were big / He specified the lymph node under the left arm was bigger; Lymph node under the left arm was sore; chills; slight headaches; really bad diarrhea; This is a spontaneous report received from a contactable reporter (Consumer) from medical information team. The reporter is the patient.  A 57-year-old male patient received BNT162B2 (BNT162B2), administration date 05Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INJECTION SITE PAIN (non-serious) with onset Mar2021, outcome "recovered" (Mar2021), described as "injection site was sore"; PAIN (non-serious) with onset Mar2021, outcome "recovered" (Mar2021), described as "body aches for 3-4 days"; LYMPHADENOPATHY (non-serious) with onset Mar2021, outcome "recovered" (Mar2021), described as "Lymph nodes under both arms were big / He specified the lymph node under the left arm was bigger"; LYMPH NODE PAIN (non-serious) with onset Mar2021, outcome "recovered" (Mar2021), described as "Lymph node under the left arm was sore"; CHILLS (non-serious) with onset Mar2021, outcome "recovered" (Mar2021), described as "chills"; HEADACHE (non-serious) with onset Mar2021, outcome "recovered" (Mar2021), described as "slight headaches"; DIARRHOEA (non-serious) with onset Mar2021, outcome "recovered" (Mar2021), described as "really bad diarrhea".  Additional Information: The patient had side effects for a week after vaccination. He said that he was fine that day and the injection site was sore. He said that he had body aches for 3-4 days and the lymph nodes under both arms were big. He specified that the lymph node under the left arm was bigger and sore when he would touch it and when he was putting his arm down. He added that he had: no fever, chills, slight headaches, and a really bad diarrhea until Saturday. He explained that his second dose was due on 26Mar2021 and asked if he should get it.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
The pt developed Autism. The pt experienced every symptom of autism, identical to mercury poison. The accumulative effect of mercury in vaccine.
21NOV phone call to clinic stating pt had 4" x 5" rash, swelling, aching, itchy rt deltoid;pt instructed to take DPH & put cold pack, on MD notified;24NOV pt called by RN stated swelling better now instructed to wait 15mins p/flu vax
aphasia; This is a spontaneous report from a non-contactable consumer (a patient family member or friend), based on information received by Pfizer. This case was split from master case #2021689327 for a male patient taking COVID-19 vaccine and experienced aphasia.   A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date as an unknown, single dose for COVID-19 immunisation. The patient medical history included PE (pulmonary embolism), started from 2010 and unknown if ongoing. Concomitant medications were not reported. The patient previously took warfarin sodium for clot blood (started from 2010 and unknown if ongoing). The patient experienced aphasia on an unspecified date. The outcome of the event was unknown.   Follow up not performed as no contact information available.
Symptoms were arm soreness at vaccination location, tiredness, headache, chills. Took tylenol which improved headache. Slept several hours which improved chills and tiredness.
Left arm red, hot, swollen hard, 13 x 13 cm left lateral upper arm, Rocephia 700 mg given IM.
12 days after vaccine pt developed blisters/swelling on 3 fingers of left hand that turned black then spread to other hand a few weeks later. Pt also developed shingles a few weeks after vaccination.
Pt is a 53yrs. female who looks clinically dehydrated with acute kidney injury and a mild lactic acidosis, after around 48 hours I decreased oral intake, nausea and vomiting, and significant output from her ileostomy.  She also had a day of preceding fatigue, mild headache, and general malaise and subjective low-grade fevers.  She is vaccinated for COVID.   On exam she looks clinically dehydrated.  She arrived mildly tachycardic but no concerning fever or hypotension.  She is chronically undergoing chemotherapy for a diagnosis of brain cancer earlier in the year.  Her last dose was around 4 days ago.  Luckily she has no acute neurologic deficits and she has a benign abdominal exam.   Port was accessed and labs were drawn, including lactic acid, which is mildly elevated at 2.4.  White blood cell count is mildly decreased with her lymphocytes decreased as well.  She has acute metabolic derangement, including acute kidney injury with her creatinine up to 2, as well as hyponatremia and hypokalemia.   We infused 2 L of lactated Ringer's, Zyprexa via IV for nausea, GI cocktail for acid reflux symptoms, and IV potassium.  She is feeling mildly improved, but still very symptomatic and lightheaded with malaise.   Her Covid test has come back as positive, which I think adequately explains her symptoms.  She is vaccinated, so hopefully her symptoms will be as severe as if she was not vaccinated.  Luckily she is not having any current respiratory symptoms or hypoxia, so I do not think she needs any steroids at this time.   Given the metabolic derangement, including the acute kidney injury, and the continued ostomy output and nausea, I think patient meets inpatient criteria.  She will be placed on Covid full barrier precautions.  She understands the current assessment and plan.  She will be admitted inpatient to the hospitalist.
Headache, Myalgia, Arthralgia & SkinRash Narrative: Mild rash on legs and buttocks
I took both vaccination with very few side effect; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (I took both vaccination with very few side effect) in a 47-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (I took both vaccination with very few side effect). At the time of the report, VACCINATION COMPLICATION (I took both vaccination with very few side effect) outcome was unknown.        mRNA-1273 (Spikevax) (Unknown) dosing remained unchanged.       No concomitant medication was reported by the reporter.  No treatment medication was reported by the reporter.   This case was linked to MOD-2022-508849, MOD-2022-508853 (Patient Link).
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and genders. The reporter stated that, on an unspecified date, an unknown number of doses LIQUID PEDVAXHIB (dose, lot#, expiration dates not provided) that were stored at 48 degrees F for 20 minutes, then exposed to 47 degrees for 9 minutes have been administered. No adverse effects were reported. Follow up information has been received on 22-JUL-2014 from a receptionist. The reporter stated that there were two different lot numbers of LIQUID PEDVAXHIB that were included in the temperature excursion: Lot # J016188, expiration date: 02-OCT-2016 and lot # J015437, expiration date: 09-OCT-2016. The receptionist did not have any additional information to share with Merck. Follow up information has been received from the registered nurse who provided patient's details. This report refers to a 6 months old infant patient of unknown gender. On 20-JUN-2014, the patient was vaccinated with a dose of LIQUID PEDVAXHIB lot number J016188, expiration date: 02-OCT-2016, (dose and route were not reported) that was improperly stored. No adverse effects reported. This is one of several reports received from the same reporter. Additional information is not expected because follow up has been obtained.
APPROXIMATELY 2 WEEKS AFTER RECEIVING THE SECOND MODERNA VACCINE, I DEVELOPED CHRONIC AND ACUTE DIARRHEA WITH EVERY BOWEL MOVEMENT AND IT CONTINUES TO PERSIST TO THIS DAY.  I RECEIVED IV FLUIDS FROM MY LOCAL CATHOLIC MEDICAL CENTER IN MANCHESTER ON JULY 23, 2021.  IT SEEMED TO HAVE SLIGHTLY IMPROVED THE FREQUENCY OF MY DIARRHEA, HOWEVER, I CONTINUE TO HAVE WATERY STOOLS TO THIS DAY.
Pt recvd vax & exp h/a; approx 1 wk p/vax exp numbness in legs progressing to arms;
This spontaneous report as received from a pharmacist refers to a 60 year old female patient with none drug reactions or allergies. On 20-NOV-2013 the patient was vaccinated with the dose of ZOSTAVAX (lot # J007854, expiration date 28-SEP-2013) 0.65 ml injection, subcutaneously. Concomitant therapies included Celexa, vitamin D (unspecified), Synthroid, Reglan, Cymbalta, metoprolol, simvastatin (manufacturer unknown), Lamictal, Cozaar. In November 2013 the patient experienced swelling in the arm where the patient received ZOSTAVAX. The patient sought medical attention and called the pharmacy. No treatment was given for adverse event. None lab diagnostics studies were performed. The outcome of swelling in the arm was reported as not recovered/not resolved. The relatedness between vaccination with ZOSTAVAX and swelling in the arm was not reported. Additional information has been requested.
low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (low grade fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Jan-2021, the patient experienced PYREXIA (low grade fever). At the time of the report, PYREXIA (low grade fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant drugs were not reported.  Treatment information was not provided.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested
Fever between 100-102.5 for four days, swelling of 2 inch diameter around the injection site, rash of 2 inch diameter around the injection site.
Swollen lymph nodes were obvious under breasts/inside of arms/arm pits both side and on top of rib cege/Swollen glonds/nodes were felt behind ears/on neck and around the top of my shoulders; left upper arm was sore and swollen; left upper arm was sore and swollen; shoulder to elbow raised and remained red and swollen for about 10 days; shoulder to elbow raised and remained red and swollen for about 10 days; Headache; sweats; loss of appetite; This is a spontaneous report from a contactable consumer (patient). A 44-year-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EW0186) via intramuscularly, administered in Arm Left on 30Jun2021 13:30 as DOSE 2 (age at the time of vaccination was 44-year-old), SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Hisorical vaccine included 1st Dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EW0173) via intramuscularly, administered in Arm Left on 08Jun2021 at 09:20 DOSE 2, SINGLE for COVID-19 immunisation and experienced event under Loss of taste and smell, Swollen bottom lips and cheeks, Sweats and headaches/migraine, Loss of appetite due to all food and liquids testing like salt or metal effects from first dose lasted 32 hours and then they stopped. On an unspecified date of 2021, the patient experienced swollen lymph nodes were obvious under breasts/inside of arms/arm pits both side and on top of rib cege/swollen glonds/nodes were felt behind ears/on neck and around the top of shoulders, left upper arm was sore and swollen, shoulder to elbow raised and remained red and swollen for about 10 days, headache, sweat and loss of appetite. Patient body appears back to its normal stages on the 27th/28th Jul2021. On an unspecified date in July 2021, the outcome of events was recovered.  Follow-up attempts are completed. No further information is expected.
Headache, Myalgia, Fever, fatigue, left arm sore Narrative:
I experienced frozen shoulder for 2 weeks after my shot. I could not move my arm more than a couple centimeters for 2 weeks. 1 month later mobility is back but still not 100% and i still experience a lot of pain moving it.  I believe I was injected too high on the arm and not in my muscle.
migraines constant; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (migraines constant) in a patient of an unknown age and gender 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MIGRAINE (migraines constant). At the time of the report, MIGRAINE (migraines constant) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment medications were reported.
Fast heart rate/heartbeat after booster shot; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Fast heart rate/heartbeat after booster shot) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033H21A, 006B21A and 043B21A) for COVID-19 vaccination.     Concurrent medical conditions included Heart murmur.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In December 2021, the patient experienced PALPITATIONS (Fast heart rate/heartbeat after booster shot). At the time of the report, PALPITATIONS (Fast heart rate/heartbeat after booster shot) outcome was unknown.            No Concomitant medication was reported.    No treatment medications were reported. After second shot the doctor prescribed anxiety medicine.   This case was linked to MOD-2021-416109 (Patient Link).
Case number PHEH2014US018991 is an initial spontaneous report received from a Healthcare Professional on 19 SEP 2014. This report refers to a 74 year old male patient. His medical history and concomitant medication were not reported. He was intramuscularly vaccinated with FLUVIRIN 2014/2015 (batch number: 1411301) on 15 SEP 2014 and a second dose on 19 SEP 2014. No adverse event was reported following this administration error (inappropriate schedule of vaccine administered).
Five minutes after I received the vaccine, I fainted in my chair for 1-2 minutes. I awoke in a sweat, and the pharmacist called 911. The paramedics checked my vitals and cleared me to go.
Information has been received from a clinical manager concerning a female who on "13-DEC-2006 or 14-DEC-2006" was vaccinated with HPV rL1 6 11 16 18 VLP vaccine (yeast). On 13-DEC-2006, or 14-DEC-2006, the patient fainted almost immediately after receiving the vaccination.  The patient sought unspecified medical attention.  Additional information has been requested.
Patient complained of a pain in the arm (left) used to administer vaccine which he continued to experience for > 3 weeks after administration.
Severe fatigue and subjective fevers, with bilateral upper extremity pain, unable to raise arms above shoulders for 2 weeks, malaise, fatigue and body aches persisting for ~ 18 days but improving.    Had received the following vaccines recently: Moderna 2/4/2021, 1/7/2021 Shingrix 12/16/2020, 03/01/2021
This spontaneous report was received from a medical assistant refers to an unknown number of patient of unknown demographics. Medical history, concurrent conditions and drug reactions/ allergies of these patients were not reported. On unspecified dates, these patients were inadvertently vaccinated with improperly stored GARDASIL (it was confirmed that the suspect product was not GARDASIL 9). Concomitant medication was not reported. No adverse effects were reported. This is one of the five reports received from the same reporter. Additional information is not expected, no contact details were provided.
pt recv vax 27AUG97 & 11AUG97 pt exp fever of 102 & what looks like a classic case of measles over body;pt was seen by MD & a physical exam revealed Koplick spots type lesions in buccal mucosa & nasal congestion;15AUG97 pt recovered;
When administering vaccine, the most of the fluid leaked from syringe and unsure if any was administered into patient's arm. Per CDC's guidelines, immediately administered a dose in the opposite arm. Patient education provided. Supervisor informed.
slight sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 30Jan2021 (Lot number: EL9264) at the age of 70 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Breast cancer", start date: 1988 (unspecified if ongoing); "Ovarian cancer", start date: 2015 (unspecified if ongoing), notes: went into remission and came out of it and now she is on a maintenance drug; "lymph nodes removed from left arm 30 years ago" (unspecified if ongoing). Concomitant medication(s) included: LYNPARZA taken for ovarian cancer (ongoing). The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "slight sore arm".  No follow-up attempts are possible. No further information is expected.
Severe debilitating cervical spine pain to base of skull including trapezious muscles - both sides - pain causing limited motion of my head. Head was held in a slightly downward slant and I was unable to turn head left or right without severe shooting pain in trapezious muscles. Lasted for 2 days and slowly subsided with headache as its replacement.  Left side of head pain that seemed sinus/pressure related which lasted over a week. About 2 weeks after vaccine, pain in right sternum to rib cage. This pain was so severe I considered it may have been heart related. Intermittent angina pains and shortness of breath. A one day spell of sudden dizziness. Large amounts of mucus congestion/runny nose.
I have developed a hard very sore lump starting on day 5 after my vaccine. The lump is below the injection site to the right of my bicep and it is about the size of a large grape and very sore. I have heard of others developing a lump in the area of their lymph notdes under their arms but my lump is not in that area.
On the 20th, I noticed skipped heartbeats and PVCs much more frequent than I've noticed in the past. It turned out 15% of the heart beats were contractions. I went through a number of cardiac evaluations related to that, including a heart monitor. I did a sleep apnea study. I also did a cardiac stress test. That came out okay. I also had an echo cardiogram. The pulmonary doctor did my apnea study. I went to see my doctor on 02/24. He put on an Epact monitor for 7 days at home. I am still having PVC's.