chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Diarrhea; Flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms) and DIARRHOEA (diarrhea) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History Information was reported.  Concomitant products included PRIMIDONE, MELATONIN, DIPHENHYDRAMINE HCL, COLECALCIFEROL (VITAMIN D3), ACETYLSALICYLIC ACID (BABY ASPIRIN), DICLOFENAC SODIUM, LEVOTHYROXINE, ROSUVASTATIN CALCIUM (CRESTOR), SERTRALINE and QUETIAPINE FUMARATE (SEROQUEL) 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 05-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms). On 08-Feb-2021, the patient experienced DIARRHOEA (diarrhea). On 05-Feb-2021, INFLUENZA LIKE ILLNESS (flu like symptoms) had resolved. At the time of the report, DIARRHOEA (diarrhea) had resolved.        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.   Other Concomitant medication included CoQ10 No Treatment information was provided   This case was linked to MOD-2021-305232 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 24-Sep-2021: Non-significant follow-up
Admitted to hospital on 01/09/2022 with shortness of breath and cough.
Initial unsolicited report received from an other healthcare professional on 15-May-2018. This case involves a patient (age and gender not reported) who was vaccinated with an expired dose of ACT-HIB (Batch number, expiration date, dose, dose in series, route and site of administration were not reported) on an unknown date. It was of actual medication error due to expired vaccine used. It was unknown whether adverse event occurred or not. 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. Documents held by sender: none.
pt recv vax & exp h/a, low grade fever, malaise, & lymph node swelling;pt recovered;
9 year old patient was inadvertently administered a dose of QUADRACEL with no reported adverse event; Initial information received on 09-Aug-2022 regarding an unsolicited valid non-serious case via health professional. (GMI number: 01227747)  This case involves a 9-year-old female patient who was inadvertently administered a dose of Diphtheria-15/Tetanus/5 Hybrid AC Pertussis/IPV (MRC5) Vaccine [Quadracel] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Varicella Zoster Vaccine (Varicella Vaccine) for Immunization.  On 28-Jul-2022, the 9 years old patient received suspect Quadracel vaccine at dose 0.5 ml once via intramuscular route in the left thigh (lot U7526AA, expiry date: 07-Sep-2024) for prophylactic vaccination with no reported adverse event (product administered to patient of inappropriate age) same day latency".  It was reported that "Caller reporting a 9-year-old patient was inadvertently administered a dose of QUADRACEL. Caller reporting the patient is now caught up on her vaccinations but had been behind. Caller with questions on whether QUADRACEL counts as a valid dose of DTAP. This situation is reported as a medication error due to patient receiving dose outside of approved age range on PI. No further information provided by the reporter.   Action taken: Not applicable.  At time of reporting, the outcome was Unknown.     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 the guidelines. 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.
Symptoms my taste and smell have been off I can?t eat certain things including chocolate, potato?s, chips, coke, sprite, marinara sauce,  basically any soda besides with my smell even my perfume stinks now laundry soaps
Backache; Headache; Pain in the injection site; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Backache), HEADACHE (Headache) and INJECTION SITE PAIN (Pain in the injection site) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in April 2020.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jan-2021, the patient experienced BACK PAIN (Backache), HEADACHE (Headache) and INJECTION SITE PAIN (Pain in the injection site). At the time of the report, BACK PAIN (Backache), HEADACHE (Headache) and INJECTION SITE PAIN (Pain in the injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by investigator o No treatment medications provided by the reporter.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
Vaccine administered to PULA 1 day later area was red & raised and warm the area spread to 8 cm circle around the arm. Pt. saw MD 2 days later and was given BENADRYL & hydrocortisone cream. Pt. also reported general itching.
After his Moderna mRNA vaccines he developed headaches. Then about two months after the Moderna mRNA vaccine series, he developed COVID like symptoms and was seen in the Urgent Care. COVID testing negative. He was found to have very high blood pressure and sent to the ER and admitted to the hospital with elevated cardiac enzymes, abnormal EKG, diagnosed with Posterior reversible encephalopathy syndrome (PRES), Acute Kidney Injury and heart attack (NSTEMI).
Awakened Friday am and noticed heat in right arm and round reddened area at injection site;  pt took Tylenol and applied ice to site.  On Monday, 5/17/10, pt reports redness is "almost gone".
Patient described altered vision, "like looking through yellow glasses" for approximately 12 hours the following day.
Redness and warm to the touch at injection site. Patient was prescribed antibiotics for infection prevention. Outcome pending.
Patient has experienced pain in the left shoulder since vaccination.  Pain comes and goes.  Patient has not received any treatment for this condition.  Patient mentioned he heard a "weird" noise during the vaccination that sounded like a squeegee.
On 12/17/2021, I began to have vaginal itching, burning, and swelling. I had previously experienced this, along with abdominal swelling, after I received my second Moderna vaccination. The vaginal symptoms had been successfully treated with boric acid suppositories I was prescribed after a diagnosis of Candida norvegensis. I went to my regular gynecologist, who did a culture and reported back to me that I had bacterial vaginosis. I was then given antibiotics, but the symptoms persisted. I then saw another gynecologist, That gynecologist did another culture and afterwards told me he was "not convinced" that I had bacterial vaginosis. He then increased my amitriptyline dosage from 10mg to 30mg (to relieve the discomfort) and advised me to use boric acid suppositories regularly until I see him again on 3/3/2022.
immediately after giving the dose the patient began to feel dizzy; he was not feeling good; This spontaneous report has been received from other health professional via company representative concerning a 16-year-old male patient.  The patient's concurrent conditions, medical history, concomitant therapies and drug/allergy history were not reported.  On an unknown date in 2023 (reported as "on an unknown date last week"), the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), 0.5 milliliter (ml), once, administered intramuscularly (IM) in the left deltoid, (lot # X005044, has been verified to be a valid lot number, expiration date reported and upon internal validation established as 02-JAN-2025) for human papillomavirus (HPV) prophylaxis.  On an unknown date in 2023, immediately after the vaccine dose was given, the patient began to feel dizzy and was not feeling good. He sat and rest in the office for a few minutes and recovered. Additionally, he received water. The patient said he was "ok" and then left the office. This was the 3rd of 3 similar cases that have occurred in the office. In all 3 instances, hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was the only vaccine given with the same lot number.  The causal relationship between hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) and the events was unknown.  This is one of several cases from the same reporter. ; Sender's Comments:  US-009507513-2308USA003657:
She felt bad; Runny nose; Metal taste in her mouth; Both lips tingling; Numb mouth; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (She felt bad), RHINORRHOEA (Runny nose), DYSGEUSIA (Metal taste in her mouth), PARAESTHESIA ORAL (Both lips tingling) and HYPOAESTHESIA ORAL (Numb mouth) in a female patient of an unknown age 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 No adverse event (No Historical condition reported).   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced FEELING ABNORMAL (She felt bad), RHINORRHOEA (Runny nose), DYSGEUSIA (Metal taste in her mouth), PARAESTHESIA ORAL (Both lips tingling), HYPOAESTHESIA ORAL (Numb mouth), PYREXIA (Fever) and CHILLS (Chills). At the time of the report, FEELING ABNORMAL (She felt bad), RHINORRHOEA (Runny nose), DYSGEUSIA (Metal taste in her mouth), PARAESTHESIA ORAL (Both lips tingling), HYPOAESTHESIA ORAL (Numb mouth), PYREXIA (Fever) and CHILLS (Chills) outcome was unknown.            No relevant concomitant medications were reported.  No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not applicable.
The patient experienced lightheadedness, chills, and perfuse sweating within a minute after receiving the RECOMBIVAX HB vaccine. The patient felt as if they were going to pass out and continued feeling dizzy without being able to see clearly for about 30 minutes after (was seeing white splotches that gradually fused into solid white). Throughout the rest of the day, the patient has experienced fatigue and continued mild dizziness when walking for short lengths.
Two febrile seizures within 10 days of the MMR/V. 01/25/07-ER records received. Temp in ER 96.5. In usual state of health except for some mild URI symptoms. In ER after 2 suspected febrile seizures. Seen initially at Arlington ED with temp 104.3, urine and blood tests negative. DC home late last night, at 2:00 am medicated with Tylenol at home, began seizure movement. Rash at injection site. ER notes indicates in FH recent chicken pox. DC summary not included.  01/25/07-Additional progress notes received,  Assessment:fever most likely either viral or secondary to the MMRV. Questionable febrile seizure first event much less typical second much more classic.
Severe headaches once in a while, high blood pressure, one of the counts was 191/102, a lot of dizziness, other counts were 170 /89, 174/89 and so on, nausea sometimes, stomach discomfort, body pain in different areas. I DO NOT WANT to get the second dose
Pt developed red, shingles-like rash at site of vaccine injection on left arm and wrapping counter-clockwise around to involve area over left tricep and left shoulder. Pt advised to seek consultation with her PCP.
Initial report received from a healthcare provider (nurse) on 27 August 2013. A male patient, was vaccinated with an unspecified meningococcal vaccine, manufacturer not reported on an unreported date. The batch number, route and site of administration were not reported. On an unreported date the patient felt like he was losing his vision, was unable to walk, passed out and then fainted. The patient's medical history and concomitant medications were not reported. Laboratory tests were not reported. The patient outcome was not reported. Further details were not available at the time of this report. Documents held by sender: None.
Massive headache,  dizziness,  nausea, exhausted (3 days), joint pain, severe pain in right knee like prior to having the stem cell work. Symptoms from brain injury came back after vaccine. Didn't have these for 6 mths prior.  Hasn't recovered from this yet
Bell's palsy-absence of muscular control of right facial muscles-upper, middle, lower face-Drooping eye and mouth.
On October 6th, patient had 2 syncopal episodes, was noted to have low BP and bradycardia.  Taken to Med Ctr.
Menstrual Cramps/Period Started; Body Aches; Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of DYSMENORRHOEA (Menstrual Cramps/Period Started), CHILLS (Chills), MYALGIA (Body Aches) and HEADACHE (Headache) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HEADACHE (Headache). On 13-Apr-2021, the patient experienced CHILLS (Chills). On 14-Apr-2021, the patient experienced DYSMENORRHOEA (Menstrual Cramps/Period Started) and MYALGIA (Body Aches). On 14-Mar-2021, HEADACHE (Headache) had resolved. On 14-Apr-2021, CHILLS (Chills) had resolved. At the time of the report, DYSMENORRHOEA (Menstrual Cramps/Period Started) and MYALGIA (Body Aches) outcome was unknown.            Treatment information not provided. List of concomitant medication were not given.
Head pressure, fatigue, rise in temperature without fever, chills w/o shaking  arm pain. Was able to work tho didnt feel great.
m.d. rpt pt was vax on 7JUL98 & on 22JUL98 pt exp rash, diarrhea, saw public health nurse & dx w/measles on unspecified date.
Pt had unconsoleable crying for 3 hrs following administration of 1st vax;
Patient states liquid felt "thicker" going in to arm, next day 103 fever. States fever has rarely went under 99 since recieving. States arm was more painful than it should be and has body aches since shot. Also says she experience lesions on her bottom, eyes swollen with pus during first week.
pale, limp, hypotonic, hyporesponsive; very inactive since vax; persistant crying; stared from 1130AM to 8PM on 11MAY92;
Abdomen may be swollen; This is a spontaneous report from a contactable consumer (patient).   A 59-years-old female patient received first dose of  bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EP7534, expiry date: not reported) via an unspecified route of administration on 16Mar2021 (at the age of 59-years old) as dose 1,single for covid-19 immunisation. Medical history included  Low thyroid, Restrictive lung disease. The patient was not taking any treatment for the condition reportedly. Concomitant medication included levothyroxine sodium (TIROSINT) taken for hypothyroidism. On an unspecified date, the patient experienced abdomen may be swollen.  The patient had never felt this way before and it happened since the patient had the first dose. Therapeutic measures were taken as a result of the event with Advil, 200 mg. The outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.
Chill,  Fever (100.8) for 2.5 days, Nausea and episodes of violent vomiting for 3 hours overnight after shot, episodes of sweating for 5 days, malaise for 5 days. Pressure in chest when resumption of walking routine after the 4th day.
Patient was fainted and found on the floor. Patient was black out for 2 second, regained consciousness. Patient was able to provide answers to questions appropriately, alert oriented x4. Stat Vital signs taken; pulse 90, BP 130/62, Spo2 99% on room air, respiration rate 20.  Head to toe assessment done, no sign of injury noted. With assist, transferred patient with wheel chair and lay down on gurney. Patient stated that she felt anxious before receiving vaccine, denied of any other distress at this moment. I monitored patient for 45 mins at observation area. Patient is asymptomatic, denied of any dizziness, SOB, and pain. Assisted patient to her car with wheelchair. Patient is stable at this time and going home accompanied by her family.
After vaccine patient felt like her throat was tightening up - very shaky.  states she is allergic to morphine and felt like this was a similar reaction.  Says this reaction is not as fast but she feels it.  We were with patient for approximately 30 minutes and she presented as stable.   Patient was ultimately transported to a local hospital by EMS
Vomiting, fever, then chest pain -> documented acute myocarditis with increased CK (MB fxn), increased Troponin, increased BNP, marked ST elevation admission 2d after vaccine. Also with 2d increased T & HA after vaccine. No rash. USV infectious w/u being pursued feel enterovirus most likely. Nasal viral panel negative DFA for influenza & other resp viruses; CX positive.
Covid injection given subQ 12/22/20. Red, swollen, and  warm to touch. Large knot under the skin. Injection site red and swollen for 3 days. Area of redness returned 12/30/20 the size of large egg, hard and warm to touch. Advised to see PCP for cellulitis
About 15 min of receiving it I started to feel out of sorts, and the right side of my body has been tingling for about 2.5 hours.  The right side of my tongue is tinglng and my eye feels weird. Hand, arm, leg and foot on the right side also tingling. I am considering going to the hospital if this doesn't subside.
Vomiting  Light headed  Body aches  Chills  Short of breath (still lasting)
Atrial fibrillation requiring cardioversion. I received 1st dose of the C19 vaccine on 02/05/2021 and had the first occurrence of afib requiring cardioversion on 03/07/2021. Received second dose 03/12/21 and had the second occurrence of afib requiring cardioversion on 06/15/2021. Total body soreness after both vaccinations until August 2021, soreness subsided and no additional afib occurrences as of 10/5/2021.
Approx 2-3 hrs /p inject-noted hands swelling /w redness-during next 12 hrs-sx progressed /c lips & tongue swelling, face flushing /w macular red-rash erupting on trunk /w erythema /w rise in T 102F-12 hrs/p inject along/w malaise..see WORM
Excruciating pain in the right knee joint; Could barely walk; Knee joint swelled, so right knee measured 1 inch greater than left knee.; Left knee was sore; This is a spontaneous report from a contactable consumer, the patient. A 74-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: GL8982) via an unspecified route of administration in the left arm on 11Feb2021 at 09:30 (at the age of 74-years-old) as a single dose for COVID-19 immunisation and received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration in the left arm on 04Mar2021 at 09:30 (at the age of 74-years-old) as a single dose for COVID-19 immunisation. Other medical history was reported as none. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included angelica sinensis root (DONG QUAI), tocopheryl acetate (VITAMIN E), vitamin b complex (VITAMIN B), calcium (MANUFACTURER UNKNOWN), magnesium (MANUFACTURER UNKNOWN) and hormone replacement therapy; all from unknown dates for unknown indications and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 11Feb2021 at 16:30, the day of the first shot, the patient experienced excruciating pain in the right knee joint, pain was 9 on the pain scale of 10, the patient could barely walk, knee joint swelled, the patient's right knee measured 1 inch greater than left knee. For four weeks the patient was in pain, just walked to the car, went up and down stairs one leg at a time. The patient's right knee got better after five weeks. On an unknown date in 2021, the patient experienced left knee was sore. Pain level was about a 4 on the scale of 10. Before the shot, the patient was walking regularly about 10 miles a week but walking was now limited to several blocks' maximum. Since the right knee improved over 5 weeks, the patient had to assume the left knee would also improve. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events which included treatment with multiple acupuncture, chiropractic, physical therapy treatments, ice, salonpas patches and ibuprofen. On 11Feb2021, the patient underwent pain scale assessment and the result was 9 on the pain scale of 10. On an unknown date in 2021, the patient underwent pain scale assessment and the result was 4 on the pain scale of 10. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events excruciating pain in the right knee joint, could barely walk, right knee joint swelled and left knee was sore was recovering at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
pt recvd vax; local rxn to lt arm; area very red & hot to touch;
Morning after receiving immunization member's mother called.  Member started having stomach pains, headache, felt like chest was being compressed.  Member escorted to ER at Loveless. Given Tylenol & Tylenol#3.  Advised to not get flu vaccine again.  This was member's first flu shot.
DEFECTIVE SYRINGE. CONTACTED COMPANY ABOUT EVENT. SYRINGE DID NOT ADMINISTER DOSE PROPERLY. PLUNGER FULLY DEPRESSED. WHEN NEEDLE REMOVED OVER HALF OF DOSE SPRAYED ACROSS THE VACCINATION BOOTH.
Woke up shaking with racing heart. Went to dr a week after this did not stop