chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID-19; Passed out; Diarrhea; Dizziness; Weakness; Low blood pressure; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044a21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No relevant medical history provided).    On 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced LOSS OF CONSCIOUSNESS (Passed out) (seriousness criterion medically significant), DIARRHOEA (Diarrhea), DIZZINESS (Dizziness), ASTHENIA (Weakness) and HYPOTENSION (Low blood pressure). On 26-Mar-2021, the patient experienced COVID-19 (COVID-19). At the time of the report, LOSS OF CONSCIOUSNESS (Passed out), DIARRHOEA (Diarrhea), DIZZINESS (Dizziness), ASTHENIA (Weakness), HYPOTENSION (Low blood pressure) and COVID-19 (COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Mar-2021, COVID-19 (positive-negative): positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment was given intravenous bamlanivimab monoclonal antibodies therapy in the emergency room  Based on the natural history of COVID-19, and the established information about the mRNA-1273 vaccine, a causal association between the event of Covid-19 and the product use is assessed as unlikely. The remaining events are assessed as a symptom of the disease and also assessed as unlikely related to mRNA-1273.; Sender's Comments: Based on the natural history of COVID-19, and the established information about the mRNA-1273 vaccine, a causal association between the event of Covid-19 and the product use is assessed as unlikely. The remaining events are assessed as a symptom of the disease and also assessed as unlikely related to mRNA-1273.
Elevated heart rate ( > 110 ), chest tightness for 5 days. Fever (100.7 deg) for 3 days  Went to Emergency Room on Tues 4/20 per recommendation from primary physician. CAT Scan , ECG, Blood work ,COVID test (negative) Tylenol, Zyrteck, Potassium Chloride  Zyrteck seemed to help.
dizziness on the verge of passing out; welts all over midsection from upper legs through hips and onto torso lasting for weeks; Intense headache; dizziness on the verge of passing out; flushed face and ears; This is a spontaneous report from a non-contactable other healthcare professional. This 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EL1283),  dose  1, single dose via an intramuscular route of administration in the left arm on 10Feb2021 at 10:30 AM (at the age of 44- years-old) for COVID-19 vaccination.  Medical history included complete thyroidectomy with neck dissection (removed lymph) for papillary thyroid cancer with neck dissection (removed lymph) for papillary thyroid cancer- otherwise healthy and penicillin allergy. The patient was tested for COVID-19 on 14Aug2020 by nasal swab and was negative. The patient was not pregnant. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included levothyroxine sodium (SYNTHROID). The patient did not receive  any other vaccine within 4 weeks prior to the vaccine. On 10Feb2021 at 10:30 AM, the patient experienced intense headache within 5 minutes, dizziness on the verge of passing out (waited in the lobby for 1 hour before leaving), flushed face and ears, headache for several days, welts all over midsection from upper legs through hips and onto torso lasting for weeks. The clinical outcome of headache, dizziness on the verge of passing out, flushed face and ears, headache and welts was unknown.   No follow-up attempts are possible. No further information is expected.
Information has been received from a physician concerning a patient (gender not specified) who was vaccinated with one dose of Varivax (site unknown). Concomitant therapy included on dose of MMRI. Subsequently, the patient developed a generalized rash over body. The patient sought unspecified medical attention. The physician requested a lot check on the lots because there were "more phone calls than ever before". For Varivax and MMRII, it was found that, "The records of testing prior to release of this lot have been checked and found to be satisfactory. This lot complies with the standard  and was released. FOLLOW-UP information on 03/07/02, from a physician noted there were no more adverse events  to report other than those that were previously reported. the physician stated that the reason she used the phrase "more calls than ever" was because she has been in practice for a number of years and always gave patient/parents standard information on the benefit/risks of a vaccine before its administration and also instructed them to call the office if the child experienced any problems post-vaccination. The physician reported that in all her years of practice, it has been her experience that parents rarely call their office to report a post-vaccination reaction. It was very unusual for their office to receive as many calls as they did in 01/02. including this patient and other patients who were vaccinated and experienced similar events  (WAES0201USA03018,0202USA00428, 0202USA00429, 0202USA00431 and 0202USA00432). The physician also  thought it was unusual that several of the adverse event seemed to be occurring at day 10 post-vaccination. It was noted that there were no additional cases reported and the increase in cells was just in the month of 01/02. They did not experience any unusual volume of calls in 02/02 or thus far in  03/02
Approximately 20 minutes after the shot he reported feeling lightheaded/dizzy and as if he was going to faint. He had to sit down for a few minutes and then reported he began to feel fine again.
expired vaccine was administered/no AE; Initial information received on 15-Apr-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 53 years old female patient who received expired dose of vaccine DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC].  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 14-Apr-2020, the patient received a 0.5 ml dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT lot U5882AA expired on 03-Aug-2020 via unknown route in unknown administration site.  It was of actual medication error due to expired vaccine used.  It was unknown whether adverse event was noted.  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.
Child had been ill with minor cold for 2 1/2 weeks when symptoms changed. Sat 9/8: intermittent rapid breathing, fever of 101.8, some rattle when breathing. Amoxycillin prescribed. Sun 9/9: Fever of 102.8, more frequent rapid breathing, appeared ill/behavior more lethargic/tired eyes. Mon 9/10: Went to Dr, no lung infection.  Fever of 103.4 Fussy, loose stools from Amoxycillin, less rapid breathing, continued runny nose, loss of appetite. Tues 9/11: Temperature down to 100.5, still somewhat fussy, low appetite Weds 9/12: Temperature around 100.5, fussy, low appetite, but improving. Thurs 9/13: Temperature 99.4, low appetite, measles-like rash on hairline, behind ears, back of neck, back, belly. Continues loose stools from ABX. Reported rash to doctor.
Numbness and tightness in the upper neck area; slight swelling in neck and face. Symptoms noticed 6 hours after injection and subsided 48 hours later.  Took Motrin and Benadryl for relief.
Rt thigh redness, edema, seizures, t104; pt recvd vax 19APR91 245PM & onset sz 15 sec stiffening & tonic/clonic 24APR AM;
Patient was given Pfizer first time, stated he got Moderna, and was given Moderna for 2nd dose.
Moderna dose administered after 30-day Use By Date/1 Patient was administered expired dose; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna dose administered after 30-day Use By Date/1 Patient was administered expired dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 084J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Mar-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna dose administered after 30-day Use By Date/1 Patient was administered expired dose). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna dose administered after 30-day Use By Date/1 Patient was administered expired dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication details were reported.  No treatment information details were reported.
app 18 min after injection pt started feeling tingling/swelling in mouth, denied sob.  pt was given benadryl 25mg po on onset of sx, dose repeated app 5 min later
pt recv vax 10AM &  5PM pt w/high fever &  8PM started throwing up-pt v 3 X by 11:30;called MD ofc advice give pt APAP;cont to v until 6AM;took pt to MD-said pt must have been getting sick;ear hurt;unable to raise arms or get up;ears sore
suspected vaccination failure; got shingles; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a male 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) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The case was reported by the patient's wife. The patient received the Shingles vaccine and still got shingles. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Fever nausea vomiting coughing diarrhea body aches congestion shortness of breath
diagnosed with cardiomyopathy; heart attack; difficulty breathing and chest pressure; difficulty breathing and chest pressure; This is a spontaneous report from a contactable consumer.  A 19-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1st single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Event took place after use of product. The patient was in great health and fitness. The patient received the 1st dose of Pfizer COVID vaccine and within 48 hours, he was having difficulty breathing and chest pressure. The patient was admitted to the Emergency Room (ER) with a heart attack. He was diagnosed with cardiomyopathy and admitted to hospital for 7 days. Troponin level was between 9-10 for 2 days straight. The patient will not be getting the 2nd dose of vaccine. The outcome of the events was unknown.  Information about batch/Lot number has been requested.
Mikd heartache, continous pain / tightness in chest, lasted 2 days.
Pt recvd vax 6NOV92 & 17NOV92 exp pain rt ankle & high liver function tests;
SWOLLEN ARMPIT; DISCOMFORT; GENERAL BODY PAIN; HEADACHES; INJECTION SITE PAIN; FEVER; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (form of admin and route of admin were not reported, batch number: Unknown) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced swollen armpit, discomfort, general body pain, headaches, injection site pain, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headaches, injection site pain, general body pain, swollen armpit, discomfort and fever was not reported. This report was non-serious.
Pt presented with weakness, fatigue and cough with diarrhea. pt treated with dexamethasone, and zosyn. Pt discharged to SNF.
Had a sore shoulder right after reviving vaccine.  Soreness was at about 2/10 to begin with.  Between 9 and 10 pm that night pain increased to about 7/10.  Still had 7/10 soreness the next morning along with a low grade fever around 100 F
12-14-18 Nurse Practitioner, showed me the SHINGRIX vials and expiry date. She injected on my left arm 2 inches below the arm pit. I could feel the vaccine spraying underneath my skin. This was a very difference experience compared to my first SHINGRIX shot on 9-7-18 administered by a different nurse practitioner. In my opinion, nurse did not follow CDC administering guidelines for SHINGRIX. 12-15-18 woke up at 1AM due to pain on injections site which now has a bump. Took TYLENOL at 2PM had fever and chills. Injection site swollen, red, warm. Had gross hematuria. 12-16/18 no more fever and chills. Injection site dark like sunburn, warm, painful. 12-17-18 9 AM showed my arm to employee health nurse at work. She advised me to return to advocate clinic at Pharmacy because I may need antibiotic. 12-17-18 4PM nurse practitioner diagnosed cellulitis and ordered cephalexin 500 MG for 10 days. 12-18-18 injection site less red. Swollen area diminished, smaller than original. 12-19-18 no more gross hematuria.
Pt recieved 2 vaccinations.  About 5 minutes later pt. felt sweaty and queasy.  Walked across room to desk and passed out.  Struck L side of head above L ear. Pt observed until 11:35 AM when pt. vomited and passed out again.  Pt. sent to Hospital for further evaluation.
Information has been received from a physician concerning a female (age not reported) who on an unspecified date was vaccinated with Gardasil (lot# unknown). On an unspecified date the patient developed an autoimmune hepatitis. Medical attention was sought. No further information is available. The outcome was not reported. Follow-up information was received. The patient was vaccinated with a first, second and third dose of Gardasil (lot # 657622/0388U, 658094/0524U and 658282/1263U) IM respectively. In August 2007 the patient was seen with a rash on the upper arms and chest. The patient also had elevated liver enzymes. The liver "bx was c/w" autoimmune hepatitis. The reporter felt that autoimmune hepatitis was related to Gardasil. At the time of reporting the patient had not recovered. Additional information is not expected.  02/05/2008 MR received from reporter/vax provider.  Pt reported fatigue following 1st Gardasil.  Several weeks after #2 pt reported rash on upper arm and chest as well as LFTs elevated c/w autoimmune hepatitis.  Txd with steroids.
Arm swelled almost immediately. Arm was real inflamed and sore, Next day arm swelling to twice ther size past the elbow and turned red and was really sore, Received shot of Decatron next day.
Patient presented back to office approximately 90 minutes after injection complaining of itchy and wet feeling in back of throat. Patient given Diphenhydramine 25mg IM, per provider order, patient tolerated well.  Patient reported symptoms improved but not fully resolved, still had wet feeling in throat.  Precautions reviewed, patient demonstrated understanding.
12/11-received vaccine    12/12-developed abcess behind right ear, was first noticed at 3 pm then cleaned and kept clear of babys hair  12/13 noon abcess looked very wet still and small red dots appeared on face and chest  12/13 8pm previous red dots have grown in size and abcess has spread to chest   12/14 taken to Dr's office at 9 am given perscriptions for oral and topical antibiotic, cefdinir 125, mupirocin 2% and sent to hospital for blood work. Results to be available Monday 12/17.
Vomiting; Medication Error/ Maladministration; Diarrhea. Follow-up information received from the pediatrician provided adverse event details, recovery status, patient date of birth, revised physician address, count of vaccine adminsitration and vaccine lot number. Information regarding Flumist (2003-2004 formula) nasal solution (frozen)) was received from a consumer regarding 4 year old male who developed vomiting and diarrhea after he was given Flumist inadvertently, due to human error. At 4 years of age, the patient received a dose on 24-Oct-2003. On 26-Oct-2003, two days post vaccination, the child developed vomiting and diarrhea, which lasted about 24 hours. He recovered. The patient was given Flumist inadvertently, due to human error /medication error.
Arm soreness; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm soreness) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm soreness). At the time of the report, PAIN IN EXTREMITY (Arm soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The Concomitant medications were not reported.  No treatment information was provided
Large red itchy rash on right arm below injection spot.   2nd dose Moderna Vaccine reaction - Red patch appeared 2nd day after injection and still there 4 days later.   On 2nd day, got low grade fever 99.4 F for 2 hours with chills.  Took Advil for relief.   Was extremely tired the evening of vaccination into the next day.
Parent and Patient put down on the consent form that the patient's birthday was date, making them 12 years old.  The immunization records show the patient's birthday is date, making them 11 years old.  The new FDA age limit for the Pfizer vaccine is 12 years old.  The patient does not meet the age limit per the FDA.
This spontaneous report was received from a registered nurse concerning a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 06-OCT-2014, the patient was vaccinated with a dose of VARIVAX (Merck) (dose number and route were not reported), 0.5 ml, lot # K005182, expiration date 10-APR-2014. Co-suspect and concomitant therapies were not reported. The registered nurse reported the 26 patients received doses of VARIVAX (Merck) (from lot # K005182, expiration date 10-APR-2014 only) that were improperly stored. No adverse effect reported for any of the patients. This is one (1) of twenty seven (27) reports from the same reporter. Additional information has been requested.
Warmth at the injection site; redness; rash; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (Warmth at the injection site), INJECTION SITE ERYTHEMA (redness) and INJECTION SITE RASH (rash) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 15-Feb-2021, the patient experienced INJECTION SITE WARMTH (Warmth at the injection site), INJECTION SITE ERYTHEMA (redness) and INJECTION SITE RASH (rash). At the time of the report, INJECTION SITE WARMTH (Warmth at the injection site), INJECTION SITE ERYTHEMA (redness) and INJECTION SITE RASH (rash) outcome was unknown.
Patient received Pfizer COVID 19 vaccine via intramuscular injection of the left deltoid at 14:03. Patient was coherent  and fully alert to person, place, event, and date. At 14:10 patient stated she felt as if she was having a panic attack and felt as if she might have an episode of syncope. Throughout the interaction, patient was fully alert, coherent and oriented; however she stated that she felt anxious. Patients vital signs were monitored at onset and every five minutes until interaction ended at 14:30. Patient stated she would have her friend pick her up and she was going home because she felt better. Patient denied EMS services called on her behalf.
Pt. states that after receiving the 2nd dose of Phizer 08/20/2021, started experiencing symptoms 08/21/2021 of swollen lymphoids and congestion. Primary visit 08/23/2021 treated with Ibuprofen for swelling, follow-up 2 weeks.
Patient states she started feeling very sick two days after getting both vaccines together. She has had the flu shot by itself and never had a problem before. This time she got the chills and was sweating a lot to the point she would wake up soaked in sweat. She is convinced it was due to getting both vaccines together. She is better now but came into the pharmacy to report the symptoms and to double check that there was no interaction from taking both at the same time.
This spontaneous report as received from a pharmacist refers to a 57 year old male patient with allergy to codeine. The patient's historical drugs included AFLURIA received in the left deltoid on 23-OCT-2013. On 27-NOV-2013, the patient was vaccinated with a dose of ZOSTAVAX lot number J008433, expiration date 11-OCT-2014, 0.65 ml, subcutaneous in the left arm. Concomitant medications were not specified. In December 2013, the patient left a phone message and reported that he still had soreness at injection site, especially when lifting his arm, where he received a flu shot, one month earlier. The reporter questions the accuracy of which injection site ZOSTAVAX or AFLURIA the patient referred to in a phone message. On an unknown date, the patient experienced pain at the injection site, of the left upper extremity, after receiving ZOSTAVAX. Treatment was not given for the event. The patient did not seek medical attention. The outcome of pain at the injection site, of the left upper extremity, after receiving ZOSTAVAX was not recovered/resolved, reported as continued. The relatedness between pain at the injection site, of the left upper extremity, after receiving ZOSTAVAX was not reported. Additional information has been requested.
Two weeks after receiving the ZOSTAVAX vaccine, developed 4 lesions characteristic of chicken pox. No other symptoms noted.