chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The Medical Assistant reported a temperature excursion for refrigerated vaccine.; This spontaneous report was received from a Medical Assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported.  On 01-MAR-2021, the patient was vaccinated with an improperly stored dose of hepatitis rotavirus vaccine, live, oral, pentavalent(ROTATEQ) dose 1 (units not provided), per oral route (strength, dose #, frequency, and anatomical location were unknown) with lot # 1691301 and expiration date 12-DEC-2021 for prophylaxis.The patient was asyntomatic.  The administered dose of vaccine experience the temperature excursion on one of these dates, 22-FEB-2021, 25-FEB-2021, 02-MAR-2021, 05-MAR-2021, 09-MAR-2021, 15-MAR-2021, and 19-MAR-2021, of 35.6, 35.7, or 35.9  degrees Fahrenheit for 15 minutes; on 17-MAR-2021, the temperature excursion of 35.7 degrees Fahrenheit for 30 minutes;  on 18-MAR-2021 and 28-MAR-2021, of 35.2 and 35.9 degrees Fahrenheit for 45 minutes; on 25-MAR-2021, of 35.2 degrees Fahrenheit for 4 hours and 15 minutes; on 26-MAR-2021, of 35.4 degrees Fahrenheit for 2 hours and 45 minutes; or on 27-MAR-2021, of 35.9 degrees Fahrenheit 1 hour and 30 minutes.  There was no digital data logger involved, and no previous temperature excursion. The program did an audit, and they were unaware of the excursions.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2105USA002850: US-009507513-2105USA003496: US-009507513-2105USA003497: US-009507513-2105USA003498: US-009507513-2105USA003499: US-009507513-2105USA003500: US-009507513-2105USA003501: US-009507513-2105USA003502: US-009507513-2105USA003503: US-009507513-2105USA003504: US-009507513-2105USA003505: US-009507513-2105USA003506: US-009507513-2105USA003507: US-009507513-2105USA003508: US-009507513-2105USA003509: US-009507513-2105USA003510: US-009507513-2105USA003511: US-009507513-2105USA003512: US-009507513-2105USA003513: US-009507513-2105USA003514: US-009507513-2105USA003515: US-009507513-2105USA003516: US-009507513-2105USA003517: US-009507513-2105USA003518: US-009507513-2105USA003519: US-009507513-2105USA003520: US-009507513-2105USA003521: US-009507513-2105USA003522: US-009507513-2105USA003523: US-009507513-2105USA003524: US-009507513-2105USA003525: US-009507513-2105USA003526: US-009507513-2105USA003527: US-009507513-2105USA003528: US-009507513-2105USA003529: US-009507513-2105USA003530: US-009507513-2105USA003531: US-009507513-2105USA003532: US-009507513-2105USA003533: US-009507513-2105USA003534: US-009507513-2105USA003535: US-009507513-2105USA003536: US-009507513-2105USA003537: US-009507513-2105USA003538: US-009507513-2105USA003539: US-009507513-2105USA003540: US-009507513-2105USA003542: US-009507513-2105USA003541:
Narrative: after Moderna covid vaccines 2/23/2021 and 3/23/2021 has had three episodes of severe vertigo,diarrhea,headaches,loss of tast/smell,fever. He reported this on June 2,2021. Still continues to have his taste and smel go in and out since getting the shots
getting very high wbc 15,000; This is a spontaneous report received from contactable reporter(s) (Other HCP) for a Pfizer sponsored program.  A 57 year-old male patient received bnt162b2 (BNT162B2), administration date Aug2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Xeljanz, start date: 2021, stop date: 2021, notes: TAB 5MG. Vaccination history included: Bnt162b2 (Dose 1), administration date: 2021, when the patient was 57 years old, for COVID-19 Immunization. The following information was reported: WHITE BLOOD CELL COUNT INCREASED (non-serious) with onset 2021, outcome "unknown", described as "getting very high wbc 15,000". The event "getting very high wbc 15,000" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of white blood cell count increased. Additional Information: Completed xeljanz d/c call with pt. Patient reports taking medication as prescribed. Stated he does not know what was going on, if the medication was losing it was effectiveness or if he was having SE from the covid vaccine. Stated he had his second dose in Aug and 2 weeks after that he started getting very high wbc 15,000. Stated he was seeing a hematologist now and they are trying to figure out what was going on. Stated they put him back on the Leflunomide. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Diagnosed with covid on 6/12. Received Paxlovid. Admitted on 6/25/22 for hyponatremia, weakness, edema, hyperglycemia, hypertension.  Sent to ICU from the ED sodium level 119. Sent back to floor 6/26 and was discharged on 7/5/22. Readmitted on 8/18/22 for hypertension and is still currently in the hospital.
Approximately 5 minutes after receiving vaccines, patient's right arm turned red/purple color. Dr. and FNP assessed patient. Approximately 15 minutes after arm changed color it changed to red, the 10 minutes later color was back to normal. Vitals were normal.
Day after receiving vaccine, my entire body was extremely sore. I also felt dizzy and almost passed out. I am now 1 week post vaccine and have developed COVID arm. I have a rash near my injection site. I have also noticed little red itchy spots on parts of my body as well. No treatment had been done. Hoping it will resolve on its own.
Around 1:30 am 3/6/21 I woke up nauseous.   Did not vomit.  When I got up around 8:30 am the nausea had eased up a lot.  Later in the morning I started experiencing  muscle aches in my neck, shoulders, back and arms along with a headache.  Late afternoon I took my temperature and it was 100.6.  I felt like crap!  Went to bed around 9:00 pm  still feeling bad Saturday night.   I was much better when I woke up 9 hrs later.
large amount of swelling( little larger than a softball), redness(small amount), itching, and pain.
Red itchy rash; Red itchy rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Red itchy rash) and RASH ERYTHEMATOUS (Red itchy rash) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included CARVEDILOL (COREG), ROSUVASTATIN CALCIUM (CRESTOR), LEVOTHYROXINE SODIUM (SYNTHROID), CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) and SPIRONOLACTONE for an unknown indication.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced RASH PRURITIC (Red itchy rash) and RASH ERYTHEMATOUS (Red itchy rash). At the time of the report, RASH PRURITIC (Red itchy rash) and RASH ERYTHEMATOUS (Red itchy rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.
7PM day of vax pt was fussy, did not eat normally & would fall asleep & then wake up crying; this lasted 3 days;
Pt developed varicella after having both the VARIVAX vaccine and the MMRV.
Patient with localized swelling to left thigh with rash. Started 2 days after immunization.
After receiving shots started experiencing chest pain that was constant all day, malaise, cough with clear phlegm and pain at shot sites with left > right and limiting range of motion, because it persisted and patient was diabetic she was sent to the ER on 6/4/08
She felt 'weird'.; she noticed a cooling effect at the bottom of her ribcage; This is a spontaneous report received from a contactable female consumer (Patient) and a contactable consumer (husband).   A 78-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 08Mar2021 15:50 (Batch/Lot Number: EN6206) as  single dose for covid-19 immunisation.   Medical history included hypothyroidism from an unknown date and unknown if ongoing. Concomitant medication included levothyroxine (LEVOTHYROXINE) taken for hypothyroidism from an unspecified start date and ongoing and multivitamins.  The patient experienced she felt 'weird'. (feeling abnormal) (non-serious) on an unspecified date with outcome of unknown, she noticed a cooling effect at the bottom of her ribcage (feeling cold) (non-serious) on 09Mar2021 with outcome of not recovered.    Follow-up attempts completed. No further information expected.
Just under 15 minutes after vaccination, patient started to experiences nausea, lightheadedness, hot flashes, and thought she might pass out.  Blood pressure was high, pulse was rapid.  Individual vomited.  After about 20 minutes after the nausea started, she then felt very chilled and was shivering.  Patient felt better and went home.  About 1 hour after vaccination she noticed her lips were swelling.  Patient never had trouble breathing.  She sought medical where she was treated with Benadryl.  Blood pressure and pulse were normal.  Swelling in lips lasted about 1 hour but has come and gone since that time.   Patient continued to experience hot flashes, and vomit throughout the night, but reports feeling much better 1 day after vaccination.
Patient woke up on the sixth day following vaccination unable to move head.  He complained of stiffness/tightness from the injection in left deltoid up the trapezius muscle to the back of the neck.  He told his wife he could not move his neck & she began to massage the neck muscle. The muscle gradually loosened up with continued massage.  He also applied topical muscle rub (Tiger Balm) to the area and took some ibuprofen. When he reported to work later that morning he continued to complain of tightness and some discomfort in the left arm leading to the back of his neck, although from visual observation he did not to appear to be in any pain or discomfort or have any trouble moving his neck. Symptoms persisted for apx. two more days and was treated with topical rub, massage, and ibuprofen.
About 4 weeks after booster, I was driving to a store and all of a sudden I heard what sounded to be a fire engine honking its horn but I couldn't find so I pulled into a parking lot.  Shortly thereafter I realized it was tinnitus albeit extremely loud.  Initially it was intermittend but has become almost constant.    I can no longer understand what people are saying unless they are close (within a few feet or no other noise around.
PATIENT STATED THAT SHE EXPERIENCED NERVE PAIN THE EVENING AFTER RECEIVING THE VACCINE. SHE WENT TO ER AND GOT GABAPENTIN TO TREAT THE PAIN
Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 67-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported  No treatment medications were reported
the patient has had no known side effects; inadvertently gave PROQUAD and VARlVAX instead of MMR-11 and VARlVAX resulting in the 1 year old patient getting an extra dose of varicella; This spontaneous report was received from a medical assistant and refers to a 11-month-old (also reported as 1 year old) patient of an unknown gender. Information regarding the patient's drug reactions or allergies, concomitant therapies and pertinent medical history was not provided. On 04-NOV-2021, the reporter inadvertently gave the patient measles (+) mumps (+) rubella (+) varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) (lot # T032150, expiry date 20-MAR-2022) and varicella virus vaccine live (oka/merck) (VARIVAX) (lot # U010399, expiry date 01-APR-2023), both: 0.5mL (1 dose), subcutaneously, for prophylaxis (formulation, concentration, dose number, frequency for both vaccines were not reported) instead of measles (+) mumps (+) rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and varicella virus vaccine live (oka/merck) (VARIVAX), resulting in the patient getting an extra dose of varicella. The patient has had no known side effects at this time.
Severe chills, went to bed and slept well.  Felt better in morning.  Sluggish later in afternoon; took very long nap and felt substantially better.  Also, off and on for several days was soreness and skin sensitivity especially on right nipple area.
Patient's boyfriend is in military and received smallpox vaccine on 2/15/2010. Patient had contact with his vaccination wound on 2/20/2010 and developed vaginal lesions on 2/23/2010. Lesions were clinically and epidemiologically compatible with inadvertent inoculation of vaccinia. We do not have the boyfriend's contact information, nor do we have information about where the boyfriend was vaccinated.
very mild headache; tired; twice as sore shoulder; sore stomach muscles; This is a spontaneous report from a contactable consumer (patient)  reported for himself. A 65-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number and Expiration date was not provided), via an unspecified route of administration on unspecified date as 2ND DOSE, SINGLE DOSE for COVID-19 immunization. The patient medical history included allergies to any cillin. The patient concomitant medications were not reported. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EN6201, Expiration date: not reported) via an unspecified route of administration in left arm on 04Mar2021 at 08:30 AM, as 1 ST dose, single for COVID-19 immunization. The patient has not received any other vaccinations in four weeks nor other medications in two weeks. The patient was not diagnosed with Covid prior to vaccination. The patient has not been tested for Covid post vaccination. On an unspecified date patient had experienced very mild headache, twice as sore shoulder, sore stomach muscles, and tired. Patient had not received any treatment for events. The outcome of events reported as recovering.   No follow-up attempts are possible; information about lot/batch number cannot been obtained.
starting  1st day of  injection pain at  injection site  and  radiating  up  to  shoulder  with  swelling around  the  site  area. Nausea .  starting  days  2 & 3  pains increased up further on left  side of  the  arm  to neck (left side only) ,  switched  from  taking   Ibuprofen  800mg throughout the  day   after   day 3 - 4 body  aches  and  pains  in  left  leg/thigh muscles  , switched  to  Tylenol 1000mg  everyday  from day 1 rubbing  down  multiple  time  daily with  rubbing  alcohol  , nightly alcohol with Epsom  bath  soaks. pains  for  about 2 weeks before  relief. May 11 no pain  just  still tiredness . Yesterday and  today believe  all resolved .
Pt developed swollen glands 9 days after with fatigue and low grade fever. Full body rash 13 days later. pt had body aches. Pt states 14 days later symptoms are resolving.
This spontaneous report as received from a male patient of unknown age refers to himself. On an unknown date the patient was vaccinated with ZOSTAVAX (lot# unspecified). On an unknown date the patient experienced very bad bruising and itching. The outcome of very bad bruising and itching was unknown. Additional information is not expected.
SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on AUG-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced suspected covid-19 infection. Laboratory data (dates unspecified) 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 suspected covid-19 infection was not reported. This report was non-serious. This report was associated with product quality complaint: 90000192647.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non serious
immediate headache, sleepy and high blood pressure after 1st injection. Monitored BP for 40 minutes and released when BP lowered and stable. Headache gone after 24 hrs and BP normal. One week later on  3/13 "COVID Arm" with bad itching and bad headache. On 3/15 additional symptoms of back ache and fatigue. No response to ibuprofen. Experiencing all symptoms to date, 3/15 pm.
Suspected vaccination failure; had a very mild case; just itchy; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pruritus. On an unknown date, the outcome of the vaccination failure, shingles and pruritus were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pruritus to be related to Shingles vaccine.  Additional details were provided as follows: The patient had reported for him/herself. The age group was not reported but was captured as an adult as per the vaccine indication. The age at vaccination was not reported. After receiving Shingles vaccine, the patient had mild shingles which were itchy. The patient further commented on post as bummer'. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation were not provided.
Reported approx. 30 minutes after vaccine given client became shaky and weak and fell to ground in twitching type movements per witness. Writer went to clients class room right away and client was walking down the hall in his own accord when seen. Skin was warm and dry ;vital signs stable. Client states he didn't eat breakfast . Did become teary eyed and stated he had a headache. Mom made aware and did pick up client.
This 71 year old male received the Covid shot on  3/29/21 and died on 5/6/21 with the diagnoses listed below Covid-19
pt recvd vax; devel redness, swelling, itching & soreness;
Information has been received from a 25 year old female patient with no other known drug allergies who on 13-AUG-2010, was vaccinated with a single 120 mcg dose of GARDASIL. Concomitant therapy included BENADRYL. On 13-AUG-2010, the patient experienced red and itchy on both of her hands. The patient stated the injection site was fine without any pain or redness. She only had the itching and redness on both of her hands without any other symptoms. The reaction did not subside until she took BENADRYL the next day. No lab diagnostics studies were performed. The patient was unsure if she would finish the injection series and would consult with her physician. At the time of reporting, the patient was recovering from itching and redness on both of her hands. The patient did not seek medical attention. No further information is available.
I was 13.6 week pregnant at time of vaccine. Pregnancy viability and EDD confirmed at 12 weeks. Due date 04/08/21. At 19.6 weeks, I went for 20 week ultrasound and no fetal heart tones were noted. Infant measured at about 15 weeks gestation (size)- fetal heart tones were heard at 16 weeks. Fetal death estimated to happen around 2 weeks after vaccine- although this cannot be confirmed.
fatigue/tiredness; headache; chills; dizziness/dizzy; nausea; feeling unwell; weakness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A 78 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 10Mar2021 (Batch/Lot number: unknown) at the age of 78 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Parksinson's" (unspecified if ongoing), notes: takes Parkinson's medication that she had and took it before the shot. The patient took concomitant medications. The following information was reported: FATIGUE (non-serious) with onset 10Mar2021, outcome "not recovered", described as "fatigue/tiredness"; HEADACHE (non-serious) with onset 10Mar2021, outcome "not recovered", described as "headache"; CHILLS (non-serious) with onset 10Mar2021, outcome "not recovered", described as "chills"; DIZZINESS (non-serious) with onset 10Mar2021, outcome "not recovered", described as "dizziness/dizzy"; NAUSEA (non-serious) with onset 10Mar2021, outcome "not recovered", described as "nausea"; MALAISE (non-serious) with onset 10Mar2021, outcome "not recovered", described as "feeling unwell"; ASTHENIA (non-serious) with onset 10Mar2021, outcome "not recovered", described as "weakness". Therapeutic measures were not taken as a result of fatigue, headache, chills, dizziness, nausea, malaise, asthenia.  Additional information: It was reported that events were all ongoing. Headache, chills, nausea, feeling unwell and dizzy all worsened. Reporter was concerned about having the second one on 31Mar2021 and if the patient should take it.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I received the shot as well as husband approx 6 pm. It takes us approx. 20-30 mins after shopping and getting home. As soon as I got home I became dizzy, legs gave way - couldn't walk disoriented - blurry vision -then double.
Within 5 minutes of Moderna #1 covid vaccine injection, pt developed severe abdominal pain, arm numbness, nausea, severe vomiting.  Called 911 went to ED was treated with Zofran, Benadryl, Pepcid. Did not need epipen. Was discharged from ED after 5 hours of observation. Pt developed severe abdominal pain next day and went to ED again. Lab showed elevated D dimer. Was discharged after CT chest showed no PE. Pt returned to her normal self after 2 days.
Approximately 2 hours post vax, while eating chicken nuggets and honey mustard, the pt began to develop a rash around the mouth and tongue began to swell. Pt had no difficulty breathing. Pt was referred to Hospital. ER physician diagnosed oversensitivity.
[COVID-19 Vaccine] treatment under Emergency Use Authorization(EUA): He presented 10 days after first COVID-19 Vaccine with Progressive neurological deficits with bulbar manifestations - dysarthria, dysphagia and bilateral arm weakness and incoordiantion, worse on right. MRI brain was negative for acute stroke and MRI cervical, showed degenerative changes. Transferred from community hospital to tertiary center where the diagnosis was made of AIDP. He was intubated at that time in Neuro ICU. Given Steroids and IVIG but no improvement and was either will need to have Trach and PEG vs CMP and family honored the patient's wishes and made him CMO. signs of severe demyelination and AIDP was diagnosed.