chrisvoncsefalvay/vaers-outcomes huggingface dataset:
After my first vaccination, my hand started to tingle, and I got a sharp pain in my head. I was moved to a triage room and given Benadryl. I was sent to the ER and stayed for 3 hours. After the second shot, I had the same thing. My arm hurt for a long time; it was tender, hot, and red for 2-3 weeks. After a few days, the tingling stopped, and the pain stopped in my head. In July, I got sick and tested negative for COVID, but I had an upper respiratory virus. I was prescribed a Medrol pack, inhaler, and an antibiotic.
about 2hrs p/vax pt began to exp irritability & a fever of 102;w/in 24hrs the sx went away;
I can tell there is fever in it just by touching it; Big knot on my left arm where I got my shot at; It itches but it hurts for me to scratch it; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (I can tell there is fever in it just by touching it), VACCINATION SITE INDURATION (Big knot on my left arm where I got my shot at) and VACCINATION SITE PRURITUS (It itches but it hurts for me to scratch it) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 07LB21A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 17-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jul-2021, the patient experienced VACCINATION SITE WARMTH (I can tell there is fever in it just by touching it), VACCINATION SITE INDURATION (Big knot on my left arm where I got my shot at) and VACCINATION SITE PRURITUS (It itches but it hurts for me to scratch it). At the time of the report, VACCINATION SITE WARMTH (I can tell there is fever in it just by touching it), VACCINATION SITE INDURATION (Big knot on my left arm where I got my shot at) and VACCINATION SITE PRURITUS (It itches but it hurts for me to scratch it) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported.  Treatment medications were not reported.   This case was linked to MOD-2021-288661 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 16-Aug-2021: Reporter details and events outcome were updated for dose 1.
Developed uncontollable diarrhea on 3 thru 5 days, body aches, hiccups, nausea, extreme fatigue . 8/15 thru 8/20 then dialy diarrhea,  body aches, hiccups, nausea 6 more days to around 8/27
Redness, heat, swelling that lasted for a week. Swelling went to around 3 inches circumference around the injection site. Now a lump under the skin and the start of a bruise forming.
None. Form completed to report wrong vaccine given. Hep A adult vaccine administered to 4 yr. old.
CONSENT FORM SAYS MODERN VACCINE 3RD DOSE ; WAS GIVEN PFIZER BIOTECH VACCINE INSTEAD   WAS OK NO SIGNS OR SYMPTOMS AND MD NOTIFIED AND SAID NOTHING WILL HAPPEN
pneumonia; This spontaneous report was received from a pharmacist regarding a 74 year old female patient. Information on medical history, concurrent condition, concomitant medications and drug reactions/ allergies were unknown.  Approximately on an unspecified date in 2014 when she was over 65 years of age, (Also reported as about five years ago), the patient was vaccinated with first dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (strength, dose, frequency, therapy duration, route, anatomical location, lot # and expiry date were unknown) for prophylaxis.   Approximately on an unspecified date in 2018 (Also reported as last year), the patient experienced pneumonia. On an unspecified date, the patient was hospitalized due to event for an unspecified period of time. The patient received unspecified treatment for the event.  The outcome of the event pneumonia was reported as recovered. The causality assessment was not provided. There was no product quality complaint associated with this reported.    Upon internal review, the event pneumonia was determined to be medically significant.
dizzy- passed out while in chair.    Blood sugar-92,   Patient given fluids, feet elevated After 15 minutes patient able to sit safely. Monitored additional 30 minutes without issue
flushing of neck, tightness of throat and swelling and numbness of tongue, shortness of breath
Pt with anaphylactic reaction following administration of vaccine (FLULAVAL). Pt presented and was discharged home after fluids, BENADRYL, epinephrine, steroids, albuterol, and famotidine. Pt. was sent home on albuterol, BENADRYL, prednisone and was compliant with meds at home; however re-presented with systemic allergic reaction the following evening (10/11/17) and again required epinephrine, steroids, and famotidine and fluids. (BENADRYL and albuterol were given prior to arrival). Pt. improved but was however admitted for observation.
2 days after Adacel injection in left arm, pt's arm turned red, swelled up, and turned painful.  Pt wen't to dr and was given doxycyline for treatment.
top part of her arm was very red, a little circle and then larger; sort of warm; sort of itchy; a little circle and then larger; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (top part of her arm was very red, a little circle and then larger) and VACCINATION SITE WARMTH (sort of warm) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, the patient experienced ERYTHEMA (top part of her arm was very red, a little circle and then larger) and VACCINATION SITE WARMTH (sort of warm). On 01-Feb-2021, ERYTHEMA (top part of her arm was very red, a little circle and then larger) and VACCINATION SITE WARMTH (sort of warm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported.  Patient applied unspecified antihistamine cream as treatment.
Patient received a 2nd Flu shot this Flu season. First dose was 9/23/21.  Received 2 doses in 1 season at <9 years of age on 9/27/17 and 11/22/17.  Patient currently has localized reaction of arm soreness and mild cold symptoms.
17-year-old female with a history of chronic abdominal pain who was in her normal state of health until presenting to the ED with the complaint of weakness, decrease sensation, and muscle aches after receiving meningococcal vaccines (MENOMUNE ACWY and MenB) at the County Health Department yesterday. The patient states after IM injection of MENOMUNE ACWY and MenB she returned home, laid down then awakened to a phone call and was noted to have decreased sensation, weakness, and muscle aches in her lower back, shoulders, and bilateral lower extremities and was unable to get out bed. Patient also complains of a sore throat, numbness and tingling from the upper thighs down into her legs bilaterally, but denies a history of trauma, cough, runny nose, shortness of breath, new rashes, recent travel, nausea, vomiting, diarrhea, urgency, frequency, loss of bowel or bladder control, tick bite, recent camping, sick contacts or fevers. On exam in the ED, patient was alert and in no acute distress. He was normotensive, afebrile at 98.5 degrees Fahrenheit with a pulse rate at 113 beats/minute, respiratory rate at 18 breaths/minute and oxygen saturation at 100% on room air. A CBC revealed no leukocytosis with WBC at 9.12 K/ul and platelet count at 169. The iStat BMP was normal. Pediatric Neurology was consulted, imaging and admission were recommended. The MRI with and without contrast of the lumbar and thoracic spine were negative. She was admitted for further care and management.
Invalid dose (less than 0.5mL); This spontaneous case was reported by a health care professional and describes the occurrence of INCORRECT DOSE ADMINISTERED (Invalid dose (less than 0.5mL)) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced INCORRECT DOSE ADMINISTERED (Invalid dose (less than 0.5mL)). On 15-Mar-2021, INCORRECT DOSE ADMINISTERED (Invalid dose (less than 0.5mL)) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Upon in internal review on 24 May 2021, the age was corrected to unknown age.
Swollen and achey lymph nodes under left arm starting on 2/4/21 and continued to worse up to today, 2/7. On day of 2/7 started experiencing flu-like symptoms, headache, sore throat, and red, raised, and hot patch of arm on injection site.
Malaise, dyspnea, swelling at injection site, redness, low grade temp.
Strange red patch in axilla on the same side of vaccine. Circular. noticed about a week after. Seems to be resolving.
"in PM, p/AM vax, devel high temp 105.6 even w/APAP;mom called pediatrician who prescribed advil;fever was down by next day;"
This is a spontaneous report from a Pfizer sponsored Program, by a contactable consumer (patient's husband). A female patient of an unspecified age and ethnicity received PREVNAR 13) via an unspecified route of administration at single dose on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced pneumonia, PREVENAR 13 didn't work with outcome of unknown. No follow-up attempts possible. No further information expected. Information about batch/lot number cannot be obtained.
HPV #3 given 3/28/12 at 6P in (L) deltoid - pt had mild soreness/swelling at site. On 3/29/12 at 6A child has redness/swelling/pain of (L) wrist & hand.
itchiness started on the neck, and face; can not sleep; my face and neck skin completely wrinkled; This spontaneous case was reported by a nurse and describes the occurrence of PRURITUS (itchiness started on the neck, and face), INSOMNIA (can not sleep) and SKIN WRINKLING (my face and neck skin completely wrinkled) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A and 022M20A) for COVID-19 vaccination.     Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN 81), METOPROLOL, LOSARTAN, CLOPIDOGREL, ATORVASTATIN, CARBAMAZEPINE, CALCIUM and COLECALCIFEROL (VIT D [COLECALCIFEROL]) for an unknown indication.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PRURITUS (itchiness started on the neck, and face), INSOMNIA (can not sleep) and SKIN WRINKLING (my face and neck skin completely wrinkled). At the time of the report, PRURITUS (itchiness started on the neck, and face), INSOMNIA (can not sleep) and SKIN WRINKLING (my face and neck skin completely wrinkled) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medications were reported.  Action taken with mRNA-1273 in response to the events was not Applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-133981 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-133981:
fevers, chills, shortness of breath (acute respiratory failure requiring intubation) 1 day after vaccine administration
Patient called the clinic today, 8-5-19, stating on the evening of 8-1-19, several hours after receiving his 2nd dose of Bexero Men B he began feeling cold, experiencing body aches, and began to get a mild headache. Patient states at that time he took one Tylenol and began feeling better. Patient states the next morning, Friday 8-2-19, he woke up with body aches and a headache so he took another Tylenol. Patient states that he continued with body aches and a headache off and on on Saturday but Sunday he felt better all day. Patient states that today, 8-5-19, he woke up with body aches and "feels a lump behind my sternum that can only be felt on the inside" and coughing up phlegm. Patient denies symptoms or illness prior to vaccine administration on 8-1-19. Patient denies averse reaction to any previous vaccine including 1st Bexero Men B dose.       Patient unable to say if he has a fever accompanying the body aches and chills.
Approx. 1-1/2 mos. after dose #2 on 3/22/2021, my right breast implant became encapsulated. I visited my doctor  and he asked in which arm I received the vaccine. I replied ?the right?. He informed that other surgeons had reported patients with my problem after the shot. I now must have surgery to release the scar tissue at my expense.
Arm got red, swelled up, and created a fluid pocket around injection site, injection site pain for at least 4 days
High dose vaccine at clinic followed by mild viral syndrome that resolved in 48 hours. Then 96 hours later woke and had fever, severe debilitating myalgias (arms, legs, back) and felt weak. Did not notice rash. Very fatigued. Very slow to resolve - sx still present 11-18-11. Suspect serum sickness rxn.
Severe headache, similar to a sinus headache but much worse, severe nausea, extreme fatigue, red rash on clavicle bone, red rash on and around upper right arm vaccination site, heat and swelling around site. No treatment of any kind. All symptoms began clearing on Wednesday, May 26, 2021. All symptoms cleared on Friday, May 28, 2021.
This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Potentially got their doses from vials punctured longer than 12 hours ago) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034F21A) for COVID-19 vaccination. No Medical History information was reported. On 15-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Potentially got their doses from vials punctured longer than 12 hours ago). On 15-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Potentially got their doses from vials punctured longer than 12 hours ago) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.No concomitant medication reported. No treatment information was provided.
severe headache; body aches; could not sleep; chills; dizziness; fever up to 104 Fahrenheit; This is a spontaneous report from a contactable nurse (patient) received via COVID-19 Vaccine Adverse Event Reporting System. A 21-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in the left arm on 13Jan2021 (Lot Number: EL3302; at the age of 21 years old) as dose 2, single for COVID-19 immunisation. Medical history included mononucleus on an unspecified date in 2017. The patient has no known allergies. She was not pregnant and she was not diagnosed with COVID-19 prior to vaccination. Concomitant medication included spironolactone. She did not receive any other vaccines within four weeks prior to vaccination. The patient previously received the first dose of BNT162B2, administered in the left arm on 23Dec2020 (Lot Number: ENJ1685; at the age of 21 years old) for COVID-19 immunisation. About 12 hours after injection (on 13Jan2021, at 21:00), the patient got a severe headache, body aches, could not sleep, chills, dizziness, and fever up to 104 Fahrenheit. It was reported that the symptoms lasted for about 24 hours. The patient underwent lab tests and procedures which included body temperature: up to 104 Fahrenheit on 13Jan2021; and nasal swab, COVID test: negative on an unspecified date in 2021. The patient recovered from the events on an unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.
Vomiting and diarrhea immediately following vaccine administration. Seen in office day after, transported directly to Medical Center. Diagnosed with intussusception, 2 surgeries performed.
Asthma, Nausea.  1/20/09 Reviewed GYN medical records of 12/15/08. FINAL DX:none provided.  Normal GYN exam. Records reveal patient experienced asthma like symptoms reported by phone.
PATIENT CLAIMED FELT LIGHT HEADED AND DIZZINESS AND WHEN AT HOME HAD PASSED OUT FOR 5 MINUTES.
Information has been received from a registered pharmacist concerning a 65 year old female patient, who on 25-FEB-2011 was vaccinated with a standard dose of ZOSTAVAX (Merck) (Lot # 669535/1506Z EXP 02-FEB-2012) SQ. The pharmacist reported that the patient developed redness at the injection site after receiving ZOSTAVAX (Merck). The patient sought unspecified medical attention. At the time of the report, the patient was recovering. Additional information has been requested.
About 11 hours after shot - Nausea, fever,  chills, body aches, headache, tiredness
Information has been received from a nurse concerning a teenager female patient who on an unknown date, was vaccinated with a dose of GARDASIL.  The nurse reported that the patient experienced vaginal break through bleeding and spotting after receiving GARDASIL vaccine.  The patient sought unspecified medical attention.  Additional information has been requested.
a 16 month old was administered an expired dose of Daptacel, no AE; Initial information received on 18-Oct-2019 regarding an unsolicited valid non-serious case received from an other health care professional.  This case involves a 16 months old female patient who received a 0.5 ml dose of expired vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (lot number: C5254AA and expiry date: 18-Sep-2019) via intramuscular route in the left thigh.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HIB VACCINE CONJ (TET TOX) (ACTHIB) and PNEUMOCOCCAL VACCINE CONJ (PNEUMOCOCCAL CONJUGATE VACCINE).  It was an actual medication error due to expired vaccine used.  At the time of reporting, 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.
Injection site pain that continued for two weeks. Inching and pain 6 inches behind injection site on back of shoulder. Progressed of open sores and throbbing pain. Nerve pain to shoulder and up neck. On left side. Progress3d to several scattered hive like spots in. Idle back, center chest , inner thigh, on side of head
After last HPV had ongoing nausea and vomiting for over 6 months. Had 1st seizure May 2013. Seizures have continued. Normal development milestones with above avg intelligence.
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 37-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Ornithine transcarbamoylase deficiency" (unspecified if ongoing); "known allergies: Shrimp" (unspecified if on-going), notes: known allergies: Shrimp. Concomitant medication(s) included: ACETAMINOPHEN EXTRA STRENGTH; TYLENOL; VITAMIN D3; ZINC received in 2weeks. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of drug ineffective, covid-19. Anti viral details: [product COVID 19 Treatment, brand Paxlovid], treatment start date: 13Jun2022, indication: Treatment of COVID-19. Adverse event: Wicked bad taste in mouth, similar to the taste when Tylenol or vitamins get caught in the throat mid-swallow. No treatment received for adverse events.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received. ; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to drug ineffectiveness and COVID-19 cannot be ruled out.
fever; large traces of Tramadol present in urine; This spontaneous case was reported by a consumer and describes the occurrence of URINE ABNORMALITY (large traces of Tramadol present in urine) and PYREXIA (fever) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047B21A and 003B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included OXYCODONE HYDROCHLORIDE, PARACETAMOL (OXYCODONE AND ACETAMINOPHEN), VENLAFAXINE, LAMOTRIGINE, LEVOTHYROXINE and FERROUS SULFATE for an unknown indication.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced URINE ABNORMALITY (large traces of Tramadol present in urine). On an unknown date, the patient experienced PYREXIA (fever). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, URINE ABNORMALITY (large traces of Tramadol present in urine) and PYREXIA (fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Mar-2021, Urine analysis: normal (normal) urine test on 24Mar2021 was clear.. On 15-Apr-2021, Urine analysis: positive (Positive) tested positive for large traces of Tramadol.         This case was linked to MOD-2021-109389 (Patient Link).
Right leg swelling, approximately 20% larger than left leg. Pt given acetaminophen. No erythema or rash. No fever of fussiness.
Myalgia, Fever, CHILS AND INJ SITE PAIN Narrative:  Other Relevant History:
Constant fatigue since one day post vaccine. Developed shingles 02-10-21.