chrisvoncsefalvay/vaers-outcomes huggingface dataset:
the "glass collar was broken" and caused the nurse to cut her finger; the "glass collar was broken" and caused the nurse to cut her finger; This spontaneous report as received from a nurse via company representative refers to a female patient of an unknown age. No information regarding patient's pertinent medical history, drug reactions or allergies and concomitant medications was reported.  On an unknown date, when the patient removed one hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) prefilled syringe from the packaging, injection, (lot # 1621934 has been verified to be a valid lot number, expiration date reported as 29-JAN-2020, but upon internal validation established as 29-JAN-2022), (exact dose and route of administration were nor provided) for prophylaxis; the "glass collar was broken" (product vial breakage) and caused the patient to cut her finger. The outcome of the event was reported as recovering "after washing cut with soap and water, no other medical treatment needed".   The relatedness between the event of cut the finger and the suspect vaccine was not provided.
1. Day after vaccine administration left arm red 2. 2 days after left upper arm swollen, red, hot with fluid filled blisters. Keflex 250 TID and Silvadene BID. 3. Day 3 - re-check swelling sown blisters open much improved.
Blood clot which was diagnosed via ultrasound on my top left calf on 06/07/21.   I began to experience swelling and pain on 06/03/21
PT REPORTED ANXIETY, HR 100. PT WAS ASKED TO DRINK WATER , RELAX, LAID DOWN WITH FEET RAISED. REASSED AFTER 20 MINUTES. HR WAS DOWN TO 69. OXY SAT 99%
booster shot after having a breakthrough case of covid and you were fully vaccinated with the first 2 moderna shots; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (booster shot after having a breakthrough case of covid and you were fully vaccinated with the first 2 moderna shots) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, 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 experienced COVID-19 (booster shot after having a breakthrough case of covid and you were fully vaccinated with the first 2 moderna shots). At the time of the report, COVID-19 (booster shot after having a breakthrough case of covid and you were fully vaccinated with the first 2 moderna shots) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient was fully vaccinated with the first 2 Moderna shots.  No relevant medical history provided. No relevant concomitant medication information provided. No relevant treatment medication information provided.  Company comment: This case concerns a patient of unknown age and gender, with no medical history,  who experienced the unexpected events of COVID 19. The events occurred approximately 1 day after the third dose of mRNA-1273.As reported, a patient had a breakthrough case of covid and was fully vaccinated with the first 2 moderna shots. Based on the current available information, the mRNA-1273 does not contain a virus capable of causing COVID-19 infection after vaccination. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case concerns a patient of unknown age and gender, with no medical history,  who experienced the unexpected events of COVID 19. The events occurred approximately 1 day after the third dose of mRNA-1273.As reported, a patient had a breakthrough case of covid and was fully vaccinated with the first 2 moderna shots. Based on the current available information, the mRNA-1273 does not contain a virus capable of causing COVID-19 infection after vaccination. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Pt recv vax on 12/31/98; on 1/3/99 pt exp aching arm, nausea, vomiting, fever x 7 day; 1/11 pt exp pain elbow to shoulder & armpit, vax site pain, unable to move arm; dx=RSD, Bursitis or auto-immune response
Noticed patient arm was red in spot of flu shot I asked her if it hurts and she said just itchy.
Symptoms: severe Tonsil swelling (left and right), Injection site swelling, injection site pain and rash, fatigue. Treatment with antihistamine made rash better. Treatment with ibuprofen against pain when swallowing.
2-3hrs p/vax recvd became lethargic & glassy eyed; Vomited 4 times, became pale & limp; t101 went to ER, appeared fine 12-14hrs p/vax;
Patient received exspired dose of Tenivac, No AE; Initial information received on 03-Feb-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 43 years old female patient who was vaccinated with expired 0.5 ml dose of vaccine DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] (lot number: UF854AA and expiry date: 25-Jan-2020) via intramuscular on 31-Jan-2020.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was actual medication error due to Expired vaccine used.  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.
Information has been received from a physician concerning a female who in approximately February 2000, was vaccinated with 1 dose of MMR. In approximately March, 2000, 14 day, post vax, the pt developed a rash which lasted 3 days. The pt sought unspecified medical treatment, subsequently, the pt recovered from the rash. Additional information has been requested. Follow up states patient developed a low grade fever.
Patient states arm was red and swollen the morning after the vaccine.  She took aleve and iced the area.  She presented to the pharmacy in the day after the vaccine was administered at approx. 4pm  there was some redness remaining and no swelling.
Information has been received from a registered nurse concerning a 16 year old female patient with a history of acne and no known drug allergies who on 27-JUL-2009 was vaccinated with a dose of GARDASIL (Lot: 661954/1496X). The patient did not receive any concomitant vaccines when the GARDASIL was administered to the patient. Concomitant therapy included tetracycline. There were no concomitant vaccines. On 27-JUL-2009, within five minutes of receiving GARDASIL, the patient became light headed, fainted and passed out while sitting in the waiting room with her mother. Her left arm had seizures movement and her right arm had slight seizure movement, the patient had a tonic-clonic seizure which lasted for 2 to 3 seconds. The patient abruptly awoke. The patient had not eaten prior to the physician's visit and prior to the GARDASIL vaccination. The nurse stated that the patient was given something to eat and drink after the incident had occurred. The patient was white and shaky for a while. On the same day, 27-JUL-2009, the patient recovered. The Registered nurse did not consider the patient's experience to be disabling or life-threatening. The registered nurse stated that she spoke with the patient's mother via a telephone call on 27-JUL-2009 and 28-JUL-2009. The patient's mother stated that the patient "was doing fine". Upon internal review tonic-clonic seizure was considered as other important medical event. Additional information has been requested.
Narrative:  80yo male died on 1/1/2021 during inpt hospital admission. Death caused by Septic Shock secondary to fulminant C diff infection. Pt had received covid vaccines on 2/8/21, 3/10/21, & 11/23/21. This death is not related to covid vaccines.
The only adverse event work on sore arm other than that everything is fine; This is a spontaneous report from a contactable consumer (patient, self-reported). A 65-year-old male patient (age at vaccination: 65 year) received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EN6200 and expiry date was not reported), via an unspecified route of administration, in Arm Left, on 05Mar2021 at 02:30 PM, as a single dose for COVID-19 immunization at doctor's office/urgent care. The patient's medical history and concomitant medications were not reported. The patient did not have any known allergies. The patient did not receive any other vaccine in four weeks. The patient was not diagnosed with COVID prior vaccination. The patient was not tested for COVID post vaccination. The patient reported that the only adverse event work on sore arm other than that everything was fine on 05Mar2021 at 04:30 PM. The patient did not receive any treatment for the event. Outcome of the event was recovered on an unknown date.  No follow up attempts are possible. No further information is expected.
Patients guardian falsified DOB when registering for vaccination, stating the minor's DOB. Guardian, consented to the vaccination. Department of Health verified with statistical records that the patients actual DOB is stated which made the vaccine a contraindication.  No known adverse reactions noted.
The patient had a hot rash at the site of injection, started 1 day after  having  mild fever, rash did not worsen
Sore throat; Runny nose; Coughing; Chills; Fatigue; Bad headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat), RHINORRHOEA (Runny nose), COUGH (Coughing), CHILLS (Chills) and FATIGUE (Fatigue) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat), RHINORRHOEA (Runny nose), COUGH (Coughing), CHILLS (Chills), FATIGUE (Fatigue) and HEADACHE (Bad headache). The patient was treated with PSEUDOEPHEDRINE HYDROCHLORIDE (SUDAFED [PSEUDOEPHEDRINE HYDROCHLORIDE]) for Runny nose, at a dose of 1 dosage form. At the time of the report, OROPHARYNGEAL PAIN (Sore throat), RHINORRHOEA (Runny nose), COUGH (Coughing), CHILLS (Chills), FATIGUE (Fatigue) and HEADACHE (Bad headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Blood test: (Negative) Didn't detect anything bacterial.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant detals was not provided  by the reporter. Treatment details included Sudafed. It was reported that the events could possibly be covid-19 related, and would get the result by next Tuesday. Patient has the second dose scheduled on 29Apr2021.
No adverse effect; patients who received improperly stored GARDASIL 9 since 8/13/2019; This spontaneous report as received from a phlebotomist refers to a 12-year-old patient of unknown gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions and allergies was provided.     On an unknown date in 2019 (reported as since 13-AUG-2019), the patient was vaccinated with incorrect stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, lot # 1602281, expiration date 21-JUL-2021 (dose and route of administration were not reported) for prophylaxis. The temperature excursion occurred on 13-AUG-2019. The vaccine was stored in temperature 30.60 degrees Fahrenheit for 41 minutes and in temperature 56.80 degrees Fahrenheit for 4 hours 30 minutes. There was no previous temperature excursion. The digital data logger was involved. No adverse effects were reported.; Sender's Comments:  US-009507513-1909USA004622:
Patient reported to prescribing MD on 7/13/23 that after receiving Gardasil-9 on 6/20/23 she had had immediate burning pain that lasted for weeks. She reported not being able to put on or her take off shirts easily since.
itching; redness; rash; body fatigue; aching in her left shoulder; sore throat; burning and watery eyes; burning and watery eyes; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat), EYE IRRITATION (burning and watery eyes), LACRIMATION INCREASED (burning and watery eyes), PRURITUS (itching) and ERYTHEMA (redness) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 037A21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 02-Apr-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat), EYE IRRITATION (burning and watery eyes) and LACRIMATION INCREASED (burning and watery eyes). On an unknown date, the patient experienced PRURITUS (itching), ERYTHEMA (redness), RASH (rash), FATIGUE (body fatigue) and ARTHRALGIA (aching in her left shoulder). At the time of the report, OROPHARYNGEAL PAIN (sore throat), EYE IRRITATION (burning and watery eyes), LACRIMATION INCREASED (burning and watery eyes), PRURITUS (itching), ERYTHEMA (redness), RASH (rash), FATIGUE (body fatigue) and ARTHRALGIA (aching in her left shoulder) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   treatment :aspirin, loratadine and  Cera Ve
One day after vaccine administration, pt began feeling nausea/vomiting/diarrhea.  Two days after vaccine administration, patient spiked a fever, swollen neck.  Went to her PCP on 4/6/11 and was diagnosed with the mumps.
@ DTP site developed white pimply spots around inject area: (3" range) low grade fever for 3 days; MD suspected allergic response to pertussis;
Patient was given Baby dose not (PEDS) dose of Pfizer. Mom was contacted and CDC was also contacted. Gave information about repeat ASAP. Parents would like to talk about it giving correct dose vs waiting for Omnicom.
Patient was experiencing no side effects when pharmacist called him back to check on him on 12/20. However, patient reports that on 12/21, he started experiencing stomach cramps and diarrhea, along with a low-grade (100 degrees) fever. He is not sure if it is related to the vaccine, as he said he also purchased some salad on 12/19. He did not start getting symptoms until after he had eaten some of the salad. He does not report any issues at the injection site to my knowledge.
fatigue; headache; muscle pain; joint pain; chills; nausea; vomiting; Injection site red; injection site swollen; injection site itching; This spontaneous case was reported by a nurse and describes the occurrence of FATIGUE (fatigue), HEADACHE (headache), MYALGIA (muscle pain), ARTHRALGIA (joint pain) and CHILLS (chills) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A.) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, the patient experienced FATIGUE (fatigue), HEADACHE (headache), MYALGIA (muscle pain), ARTHRALGIA (joint pain), CHILLS (chills), NAUSEA (nausea), VOMITING (vomiting), INJECTION SITE ERYTHEMA (Injection site red), INJECTION SITE SWELLING (injection site swollen) and INJECTION SITE PRURITUS (injection site itching). At the time of the report, FATIGUE (fatigue), HEADACHE (headache), MYALGIA (muscle pain), ARTHRALGIA (joint pain), CHILLS (chills), NAUSEA (nausea), VOMITING (vomiting), INJECTION SITE ERYTHEMA (Injection site red), INJECTION SITE SWELLING (injection site swollen) and INJECTION SITE PRURITUS (injection site itching) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 21-May-2021: Updated Patient demographic details and AE Onset date
2 days after COVID vaccine (Pfizer), difficulty and pain moving head forward and back. Unable to drive.
Pt c/o lightheadedness.  BP 129/67, HR 66, RR 18 -- > 115/75, 75, 18 -- > standing BP 115/78, HR 76  Pt given fluids.  Pt stable and released from the vaccination site with father.
Chest pain- Nose bleeds- Continuous itching all of the body-antihistamines, steriod creams Tinnitus-constant, loud, continuous ringing and buzzing Inner ear pain-
I?m running a 101 fever and I feel very weak. I?ve had fever since an hour after the shot and I?ve had it for 24 hours. I am continuing to feel weaker
My 15 yr old daughter fainted within minutes after receiving the HPV vaccination. no warning was given to us that she may faint. The nurse left the room immediately after shot, and my daughter fell off the dr table face first onto the tile floor and was unconscious. They called 911, and took her to clinic. She had 15 stitches in her forehead, her nose has a deviated septum and teeth were loose and sore. Concussion and bruising from fall on knees and shoulder.
Patient stated that he received 1st booster in October, but not present. Patient given 2nd booster 20 days early.
Within a couple of minutes of the shot I became light headed.   This subsided within 10 minutes.  I never have issues with needles or other injections.   I experienced mild myocarditis over the next several days but it eventually went away.    I noticed that I was dizzy and had a loss of coordination for at least a week after getting the Covid shot.   These symptoms did improve but lasted about 1 week.     5-6 days after the shot I noticed blurry vision in my right eye and the development of myodesopsia (floaters).   The blurry vision improved over the course of the month but the myodesopsia still persists.   I have never had vision problems and have always had 20/15 vision prior to the Pfizer covid vaccine.   My vison in my right eye has degraded to 20/20 and the floaters are still present 3 1/2 months after the vaccination.
Initial report received from non-healthcare professional (patient parent) on 10 January 2014. An 18-year-old male patient, who is allergic to tree nuts with no illness at the time of vaccination, had received 1st dose of YF VAX (batch number and route of administration were not reported) in right arm on 11 January 2014 and Hepatitis A vaccine of other manufacturer (batch number, dose number, route and anatomical site af administration were not reported) on 17 January 2014. It was reported that on 12 January 2014, after receiving YF vaccine, the patient experienced fever of 101F and headache. The corrective treatments and laboratory investigations were not reported. At the time of this report, the outcome was not recovered. Documents held by sender: none.
On approx 22APR92 pt recvd Engerix-B; on approx 23APR92 pt underwent routine PE & was found to have inc liver function tests;
body aches and fever reaching 100.8 - lasted 8 hours - came and went suddenly
stomach cramps; diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (stomach cramps) and DIARRHOEA (diarrhea) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0131720A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 11-Feb-2021, the patient experienced ABDOMINAL PAIN UPPER (stomach cramps) and DIARRHOEA (diarrhea). At the time of the report, ABDOMINAL PAIN UPPER (stomach cramps) and DIARRHOEA (diarrhea) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were given. No lab details were provided. No treatment information was given. Patient experienced stomach cramps during the night and woke up with diarrhea.
Patient was supposed to get Covid 2nd dose (Moderna), No adverse reactions, however the Rph administered a booster dose
Narrative: COVID infection following COVID vaccine series 01/08, Pfizer, dose#1 01/29, Pfizer, dose #2 11/02 COVID swab, result: detected 11/02 Pt admit ED cc: Generalized weakness and bodyaches dx: COVID 19 LOS: 1 day 11/02 CXR impression: No evidence of acute cardiopulmonary process. 11/01 pt cc: cough, fatigue, myalgias, loss of taste or smell, dyspnea, exposure: son/recent travel 11/15 clinically resolved
Moderate episode of recurrent major depressive disorder - admitted due to suicidal ideation with a plan of overdosing on pills. Behavioral health admission and treatment. Hospital admission within 6 weeks of receiving the COVID vaccine.
Heart palpitations began approximately 10 hours after first vaccine dose and lasted for 9 days off and on but continuous  every day. The patient called cardiologist office on 2/3/21.  PA called patient back and ordered home monitor to be shipped to patient at the time. Patient awaiting arrival of heart monitor to her residence. Patient instructed to wear monitor for 1-2 weeks then mail back.
having hot and cold flashes; Dizziness; he is throwing up, not keeping anything down, He's been vomiting; This spontaneous case was reported by a consumer and describes the occurrence of FEELING OF BODY TEMPERATURE CHANGE (having hot and cold flashes), DIZZINESS (Dizziness) and VOMITING (he is throwing up, not keeping anything down, He's been vomiting) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 vaccination.     Medical history was not provided.     On 26-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING OF BODY TEMPERATURE CHANGE (having hot and cold flashes), DIZZINESS (Dizziness) and VOMITING (he is throwing up, not keeping anything down, He's been vomiting). At the time of the report, FEELING OF BODY TEMPERATURE CHANGE (having hot and cold flashes), DIZZINESS (Dizziness) and VOMITING (he is throwing up, not keeping anything down, He's been vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were provided. No treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 27-Aug-2021: Non Significant Follow Up received on 27-AUG-2021 contains no significant information.