chrisvoncsefalvay/vaers-outcomes huggingface dataset:
0n Saturday March27, 2021, 7 days after vaccine I noticed a buzzing , hissing sound in my left ear. There was also a feeling of fullness in that ear and a muffled quality to my hearing. I waited to see if it would go away but when it didn?t I went to Audiology, 3/31/2021.   My left ear had hearing loss and since my right ear was perfect I was sent to a ENT who referred me to an MRI with contrast, which was done 4/3/2021. . This was WNL but the hissing buzzing ringing continued.  It improved on April 10,2021 but the day after I received the second dose it returned.
I experienced the morning of had fever, chills and was feeling vey weak. I went back to bed and few hours later I woke up the same, feeling light headed and passed out. I collapsed and had to go to the ER because I busted open my lip and needed stitches. My BP was very low and could not get it back to normal. After some IV fluids and medications they were able to stabilize me and go home. The doctor told me to stay home for 1-2 days to rest.
a patient they believe received the diluent only and did not receive the Hib portion of Pentacel, no adverse event; Initial information received on 26-Sep-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 4 months old female patient who received the diluent only and did not receive the hib portion of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 20-Aug-2019, the patient received a second dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot U6187AA/U6137AA Exp date: 06-Feb-2021, via unknown route in the right thigh.  It was a case of actual medication error case due to Inappropriate reconstitution technique.   lot details: Lot #--The administering LPN documented the lot given as U6187AA with expiry 06Feb2021. The practice knows that the lone lyophilized Hib portion of Pentacel found in the refrigerator was UJ060AA from carton UJ060AAA, expiry 04Oct2020. PQC provided the corresponding diluent as lot U6137AA. The nurse documented everything the same with the exception of the "8" which she stated perhaps was supposed to be a "3". She says this LPN is known to have such errors in documentation. This is the closest lot that the practice can find to the one provided by PQC as corresponding to the lone Hib and carton that was found.)  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Documents held by sender: none.
Severe shoulder and arm pain, bad rash on 08/09/2000. Treatment with prednisone 10mg, Lot: 35DAT by physician. Physician stated that this was caused by vax. Breath problems (mild) also occurred.
inconsolable piercing scream/crying;periods of stopping breathing-no d/t crying;arched back;eyes glaring;
Per Patient/Employee has a history of chronic illness and after receiving 2nd dose of Pfizer COVID vaccine on 9/22/2021 at 0830 AM she started feeling heaviness, tingling, numbness of left leg with difficulty walking and unsteady gait that started on 9/23/2021 at 1100 AM.
Local reaction in left arm at site of TD booster injection, 3 days before. Had redness, inflammation and aches. Local infection at site, 5 days later, requiring antibiotics.
felt worse; itchy at the injection site; red arm, has extended down and to the bicep area, inside of his right arm; fever; headache; arm hurt; felt terrify; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt worse), PAIN IN EXTREMITY (arm hurt), FEELING ABNORMAL (felt terrify), VACCINATION SITE PRURITUS (itchy at the injection site) and VACCINATION SITE ERYTHEMA (red arm, has extended down and to the bicep area, inside of his right arm) in an 89-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in March 2020. Concurrent medical conditions included UTI, High cholesterol and Blood pressure. Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm hurt), FEELING ABNORMAL (felt terrify) and HEADACHE (headache). On 07-Feb-2021, the patient experienced PYREXIA (fever). On 11-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (itchy at the injection site) and VACCINATION SITE ERYTHEMA (red arm, has extended down and to the bicep area, inside of his right arm). On an unknown date, the patient experienced FEELING ABNORMAL (felt worse). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and CORTISONE for Itchy, at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (felt worse), PAIN IN EXTREMITY (arm hurt), FEELING ABNORMAL (felt terrify), VACCINATION SITE PRURITUS (itchy at the injection site), VACCINATION SITE ERYTHEMA (red arm, has extended down and to the bicep area, inside of his right arm), PYREXIA (fever) and HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101.3 (High) 101.3 degree F usual temperature is 98 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication include urinary tract pills, blood pressure pills and one more medication.
STROKE; LITTLE BIT OF JOINT PAIN ON LEGS; This spontaneous report received from a patient concerned a 41 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included ulcerative colitis, and psoriasis. The patient received guselkumab (solution for injection, subcutaneous, batch number was not reported) 100 mg, 1 time every 8 weeks, strength 100 milligram per milliliter from 2020 for psoriasis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin) dose, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included vedolizumab for ulcerative colitis.  On an unspecified date, (13 days after vaccination), the patient had stroke. In APR-2021 (recent to this report), the patient had a little bit of joint pain on legs especially after exercising. The action taken with covid-19 vaccine ad26.cov2.s, and guselkumab was not applicable. The outcome of the stroke and little bit of joint pain on legs was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210438989-covid-19 vaccine ad26.cov2.s-stroke. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). 20210438989-guselkumab-stroke. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
She got the vaccine, and had no problems until Wednesday 3/17/21 at 3:00 AM she started coughing and could not coughing.  She finally got up and went into the bathroom and by 3:30 had coughed up little round, clear jellyfish.  Then she stopped coughing and went back to bed for 15 minutes, and then at 3:45 started getting diarrhea which she had until 10:30 AM.   She called Pfizer and reported her reaction and talked to them. During that time she had a lot of diarrhea and her body was starting to ache, joints and muscles.  She did not take her temperature and went back to bed, and slept until she could get up and go to the bathroom.  She then took her temperature and it was 100.7, which her normal is 97. 3.  She slept from 11:00 PM Wednesday until 11:00 AM Thursday.  She could not stay awake for long  before falling back to sleep.  Yesterday she did sleep most all of the day, and did not eat anything since Tuesday evening and did have a piece of toast yesterday.  Today, 3/19/21 she is able to get up, dressed and gotten downstairs to get something to eat and has lost 6# in this time period.  She is feeling wimpy, and her temp is down to 97.3, her pulse ox is 98%, pulse in the 70s.  She's achy, and has rubbed on Aspercreme  and has taken Tylenol a couple of times.  She is still very weak, probably dehydrated and going to get something to eat as she has just gotten up.  She is foggy thinking, but feels that once she rests, eats and gets strength she will be fine.
- 10/5/09: patient received Tdap - 10/11/09: patient developed R upper arm redness, pain, swelling and pruritis. patient diagnosed with cellulitis secondary to vaccine administration and placed on Keflex
Approximately 10 minutes after vaccination, the client complained of dizziness, shakiness, difficulty walking, and blurred vision. Blood pressure was 144/104. Patient reported a history of high blood pressure and that she had not eaten prior to vaccination. While attending to the client after she began feel ill, I noticed that she smelled like marijuana. After approximately 30 minutes the client had a small improvement in symptoms but her blood pressure remained elevated at 142/98. She called family for a ride home and required 2 staff members to walk her to the car. On 11/9/17, the client called the clinic and told us that she went to the hospital and was admitted due to her elevated blood pressures.
h/a, fever, photophobia; tx w/ med;to ER 14AUG;CT of head, CBC & chem 21;UA also done;
The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 11-JAN-2018, 13-MAR-2018 and 22-MAY-2018, the patient was vaccinated with an improperly stored dose of ROTATEQ (strength were unknown) (lot# N003984 and expiration date 19-NOV-2018; lot# M022173 and expiration date 15-MAR-2019; lot# N024295 and expiration date 24-MAR-2019) orally for prophylaxis, respectively (Incorrect product storage). The sterile diluent (MERCK) (lot# and expiration date were unknown) was properly stored. No adverse event was reported. The excursion temperature on 08-NOV-2017, 16-NOV-2017, 23-JAN-2018, 06-JUN-2018, 03-JUL-2018 and 14-AUG-2018 was 47 degree Celsius for maximize 15 hours. The excursion temperature on 07-DEC-2017 was 50 degree Celsius for maximize 8.75 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA003709: US-009507513-1810USA001951: US-009507513-1810USA001952: US-009507513-1810USA001953: US-009507513-1810USA001954: US-009507513-1810USA001955: US-009507513-1810USA001956: US-009507513-1810USA001957: US-009507513-1810USA001958.
Initial information received on 23-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked with 2018SA296383, 2018SA297471, 2018SA297470, 2018SA297472, and 2018SA297473 (same reporter). This case involves a four-year-old patient (gender not reported) who received 0.25 ml of vaccine FLUZONE QUADRIVALENT (lot UT6259JA and expiration date 30-Jun-2019) (frequency once, Suspension for injection) instead of the 0.5 ml via unknown route in the right thigh on an unknown date (reported as in between Sep-25 to Oct 12). It is an actual medication error case due to vaccine underdose. It was not reported whether the patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Itching at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itching at the injection site) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Aug-2021, the patient experienced VACCINATION SITE PRURITUS (Itching at the injection site). At the time of the report, VACCINATION SITE PRURITUS (Itching at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Relevant concomitant medications were not provided. Treatment information was not provided.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE HYPOTENSION 11/22/2022 --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Dose 0.2ml/10mcg administered. Based on vaccination status, 0.25ml/25mcg is recommended.
Pt experienced the following morning: fever (100 F) chills, malaise, nausea, and numbness in hands at 0624 and 0836. Pt went to hospital at 1000, tx with IV fluids.
I had the UTI and the last time I saw Dr was Jan 5th. Dec 7th I went in for the UTI and then my entire body got inflamed. First I went to the surgeon who did the surgery on my right surgery between the booster and my flu shot. He gave me the 1sr antibiotic and I had a lot of pain and he told me to stop that one and he would send me a new one. I started physical therapy and steriod. I took it for 2 days and the majority of the pain was gone.
got a flu shot still got it; Initial information received on 30-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.   This case involves an patient of unknown age and gender who received a flu shot still got it.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a Unknown dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number, Strength, formulation, Expiry date was not reported) via unknown route in unknown administration site for prophylactic vaccination..  No lab data was reported.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.
This patient received his first Covid dose on  04/28/2021 Moderna Lot #047B21A. He received his second dose on 6/2/2021 which was Pfizer Lot #EW0179. The CDC was contacted and they told him to return in 6 weeks and to receive another dose of either Moderna or Pfizer to complete his series.  There was no apparent adverse outcome.
17.5 yr old patient was given FluBlok Quadrivalent/ no AE; Initial information received on 04-Mar-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves 17 year 4 month 22 days (17.5 years) old female patient who received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 16-Nov-2019, the patient received a dose of suspect 0.5 ml INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot QFAA1924 and expiry date: 30-Jun-2020 via intramuscular route in right arm for prophylactic vaccination.  It was a case of actual medication error due to inappropriate age at vaccine administration (Product administered to patient of inappropriate age).  At the time of reporting, no adverse event reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Chills, Headache for 3 days, Muscle and Joint pain, loss of appetite, large lymphoid, soreness at injection site, fatigue.
it was rpt fr registered pharm concerning pt who was vax & subsequently pt exp measles. no further info avail
Right arm was red-swollen per mom 9/23/02 and felt very hot. See in medical center ER. Treated with antibiotics.
felt pain in the chest; tachycardia; affect his breathing; constant headache; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (felt pain in the chest), TACHYCARDIA (tachycardia), DYSPNOEA (affect his breathing) and HEADACHE (constant headache) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001j21-2a, 016c21a and 044b21a) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Jan-2022, the patient experienced CHEST PAIN (felt pain in the chest), TACHYCARDIA (tachycardia), DYSPNOEA (affect his breathing) and HEADACHE (constant headache). At the time of the report, CHEST PAIN (felt pain in the chest), TACHYCARDIA (tachycardia), DYSPNOEA (affect his breathing) and HEADACHE (constant headache) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2022, Electrocardiogram: results not provided (Inconclusive) Results not provided. In 2022, Heart rate: abnormal (abnormal) sometimes feel his heart beat fast and other slow. In 2022, Myocardial necrosis marker: results not provided (Inconclusive) Results not provided.         Concomitant medications includes Blood pressure pills. Patient stated that the symptoms worsened. There were no history related to to mentioned AE and both Acute and Chronic illnesses at the time of vaccination. No treatment information details were reported. Lab data includes cardiac test results not provided.
Pt recvd 3 doses of Engerix-B vax APR91, MAY91 & OCT91 & it was determined that pt did not respond to vax series;
no additional AE was reported following administration; ROTATEQ in series of three doses was administered to a patient aged 9 months 1 day; This spontaneous report was received from a medical assistant concerning to a 9 month old patient. The patient's medical history, concurrent conditions and concomitant therapies were not provided.    On 28-AUG-2020, the patient was vaccinated with the third dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 2 milliliter (lot # 1676327 and expiration date since it makes match with the autopopulated expiration date: 19-APR-2021) (route of administration was not provided),  for prophylaxis.         The vaccination occurred when the patient had 9 month 1 day of age. No additional adverse event was reported
during night sleep I heard my ownvoice from a distance saying a wordloudly, then another.; This is a spontaneous report from a contactable consumer, the patient. A 78-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN8727) via an unspecified route of administration in the left arm on 25Mar2021 at 00:15 (at the age of 78-years-old) as a single dose for COVID-19 immunisation. Medical history included osteopenia, eye floaters, penicillin allergy and blueberries allergy. Concomitant medications included alendronate sodium (FOSAMAX), calcium (MANAFACTURER UNKNOWN), multivitamin, flax seed meal (MANAFACTURER UNKNOWN), calcium (MANAFACTURER UNKNOWN) all from an unknown date for an unspecified indication. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6201) via an unspecified route of administration in the left arm on 03Mar2021 at 12:15 (at the age of 78-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 29Mar2021 the patient experienced during night sleep heard own voice from a distance saying a word loudly, then another. The patient did not receive any treatment for the event. The clinical outcome of the event during night sleep I heard my own voice from a distance saying a word loudly, then another was recovered on an unspecified date in 2021.   No follow-up attempts are needed. No further information is expected.
tested positive for Hepatitis B after blood donation.  I have been donating blood for over 20 years and have never been rejected for anything in the blood.  I tested positive after the third vaccine.
patient described to have a lump larger than usual in her arm.  it is swollen and hot to the touch.  She stated she has a large bruise around the injection site.  after questioning she stated she does not have any limitations in movement or pain in her arm.  Explained it may be normal injection reaction but to watch for fever or any unusual pain/ limitation to movement
administered dose past the manufacture expiry date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered dose past the manufacture expiry date) in a 51-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered dose past the manufacture expiry date). On 15-Oct-2021, EXPIRED PRODUCT ADMINISTERED (administered dose past the manufacture expiry date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications provided. No treatment medications provided.