chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, and expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 13:04 on left arm for prophylactic vaccination. No concomitant medications were reported.  On MAR-2021, the subject experienced itching. On MAR-2021, the subject experienced red. On 12-MAR-2021, the subject experienced pain in chest. On 12-MAR-2021, the subject experienced trouble in breathing. On 12-MAR-2021, the subject experienced body shacking. On 12-MAR-2021, the subject experienced body aching. On 12-MAR-2021, the subject experienced could not really eat. On 12-MAR-2021, the subject experienced chills. On 12-MAR-2021, the subject experienced hot spots, rash on lower back, hip, front thighs, side of ankles, belly and white bumps. Treatment medications included: paracetamol. On 13-MAR-2021, the subject experienced minor pain in joint. Additional treatment medications (dates unspecified) included: hydrocortisone, and diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pain in chest, trouble in breathing, body shacking, body aching, could not really eat, and chills on 14-MAR-2021, was recovering from hot spots, rash on lower back, hip, front thighs, side of ankles, belly and white bumps, and itching, and the outcome of minor pain in joint and red was not reported. This report was non-serious.
Tetanus shot was given SubQ instead of IM.  Patient developed a knot of fluid under dermis.  Injection site red, irritated, swollen.
shortness of breath, throat tightening, rash, itching  Pt was seen in the ER and was given Epi IM , benadryl and solumedrol
C/O  BEING CLAMMY, SYNCOPE EPISODE HEADACHE.     MOTHER CAME TO THE SCENE AND TOOK THE CHILD HOME
Breakthrough COVID case: My husband and I received our boosters on the same day, May 11th. He tested negative twice after that. I started feeling a scratchy throat one week after my shot. I tested that day and it was negative. I assumed it was a cold like my husband had. Two days later, on Friday, we were expecting a guest. I tested again and it was positive. My husband tested again and, this time, he was positive, too. I called the doctor's office and spoke with the nurse. Because of the high cholesterol, she prescribed PAXLOVID for me. I had an appointment already scheduled to see my doctor on May 25th so we spoke about COVID then, but, by then, I was pretty much getting better. That was Dr. that I saw that day.  I was feeling, not feverish, but pretty run down for the first couple of days. The Paxlovid seemed to help a lot pretty quickly. My symptoms didn't get as severe as my husband's and it's usually the other way around. My symptoms were mostly stuffy and congested with a cough, sore throat, and fatigue. Once I started taking Paxlovid, it all started alleviating pretty quickly.
having covid; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 29-Jan-2022 and was forwarded to Moderna on 29-Jan-2022.    This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (having covid) 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 COVID-19 (having covid). At the time of the report, COVID-19 (having covid) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.     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.   Patient is enquiring how long should be waited to receive booster shot after contracting COVID-19. No concomitant medications were provided by the reporter. No treatment medications were provided by the reporter.; Sender's Comments: This spontaneous case concerns a patient of unknown age/sex with no medical history, experience the unexpected AESI event Covid-19 in association with mRNA-1273. The event occurred on an unknown date after the first dose of mRNA-1273. The patient was tested positive for SARS-Cov-2. The patient had only first dose and the dates of dose and events were not reported. The treatment details were not reported. At the time of reporting the outcome was not known. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Patient requested to received vaccine in the "left gluteal area". Spoke to patient via telephone and she states "I would rather it there than anywhere else. I highly recommend it for women. I can actually move my arm." She report side affects " as to be expected" swollen, tender and muscle aches with chills" Patient states " I would not have gotten the vaccine if i could not get it there".
Information has been received from a registered nurse concerning a 43 month old white male with Down's Syndrome, hydronephrosis, and an unspecified congenital anomaly who on 3/20/02 was vaccinated with his first dose of varicella virus vaccine live. There was no illness at the time of vaccination. On 10/19/04, the patient experienced rash on trunk for one day with approximately 40 lesions; the patient did not have a fever. The patient was seen at the pediatrician's office, no laboratory/diagnostic tests were done. It was reported that the patient recovered with no problems. Additional information is not expected.
Patient complain of tongue tingling and itchy throat, on assessment noted small raised bumps on tongue, redness of face, patient denies any shortness of breath, Benadryl 25mg po given, tolerated well . Was reassessed after 20 minutes, denies any discomfort in throat, no raised bumps noted, member was notified to pick up patient for home,  Left at 9:28 accompanied by staff to car with family, no shortness of breath noted.
10/20/12 - Pt develops fever 101 for 2 days. 10/23/12 - Develops rash et taken to doctor et diagnosed with chicken pox. Spot/rash on face, trunk, arms & legs. <50 spots noted, no itching.
He started coughing on Tuesday and Wednesday. Around 06:45PM he said he was having trouble breathing. I asked if he could walk to the health care unit he said no, please call them. Once they got there, they put him on oxygen and got him to the unit. They found that he had a fever. They intubated him took x-rays found out that he had pneumonia and was in septic shock. They tested both of us for COVID-19, we both tested negative. He was transferred to the hospital and there they retested and that is when he tested positive for COVID-19, he has been in ICU and should be moved to a regular room tomorrow.
She completed the series of COVID vaccines on 3/16/2021. She started having a fever home on 9/19/21 after possible family exposure, and her family conducted a home COVID test, which was positive. She was given Regeneron on 9/22/21. She developed diarrhea and confusion, so she was admitted on 9/26/21. She was given one dose of remdesivir and is still on steroid therapy as of hospital day 5. She is not febrile and on room air.
Red face and neck, itching on certain parts of body, lip swelling and right lower jaw pain.  I took 50mg benadryl 1 hour prior to appointment. My itching and redness were better this time than first vaccine, but jaw pain and lip swelling was new. They were mild, took 50 mg of benadryl 5 hours later and again 6 hours after that. Lip swelling and jaw pain were mild, but continued until the next morning. The next day I had body aches, headache and fatigue for 12 hours. Still get headaches on and off.
Severe ear popping beginning 10 hours after vaccination. Nonstop 12 hours. Intermittent but several occurrences daily for 3 weeks. Week 4 mostly gone. (Right ear)
After receiving the BEXSERO vaccine, pt had syncopal event, fell and hit head, and required further medical treatment. The nurse administering the vaccine was in the room with the patient for the first 1-2 minutes post vaccination and then had left the room.
Nausea; stomach cramps; headaches/ Painful in head to have eyes open.; achiness; Had to take work off and slept off and on throughout day; Debilitating immune response.; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0167) via an unspecified route of administration in the arm left on 04May2021 at 10:30 (at the age of 29-years-old) as dose 2, single for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in the left arm on 13Apr2021 at 10:30 (at the age of 29-years-old) as dose 1, single for COVID-19 immunization. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 04May2021 at 22:00, the patient experienced debilitating immune response, onset at night. Nausea, stomach cramps, headaches, achiness. Painful in head to have eyes open. Patient had to take work off, and slept off and on throughout day. Patient also reported that he did workout much harder than he usually does in the afternoon. The patient did not receive any treatment for the events. The clinical outcome of events was not recovered at the time of reporting.  No follow-up attempts are needed. No further information is expected.  Follow up (02Aug2021): This follow-up report is being submitted to amend previously reported information: Events tab and narrative were amended.
patient had administered a dose of the Moderna COVID-19 vaccine after the 30 day beyond use date; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient had administered a dose of the Moderna COVID-19 vaccine after the 30 day beyond use date) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002M21A) for COVID-19 vaccination.     No Medical History information was reported.    In May 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. In May 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient had administered a dose of the Moderna COVID-19 vaccine after the 30 day beyond use date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient had administered a dose of the Moderna COVID-19 vaccine after the 30 day beyond use date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported.  It was reported that dates of administration were 03 MAY 2022,04 MAY 2022, 09 MAY 2022, 11MAY2022, 17MAY2022, and 20MAY2022.  No treatment medication were reported.
Patient reports on 8/27/21 itching to the right upper arm and warm to touch. 9/4/21 Patient noticed arm itching, erythema and redness.  Patient denies any fever or any other symptoms. Patient denies taking any new medication or any other medication in the right arm.
This spontaneous report as received from a other health professional refers to a patient of unknown age. On 25-MAR-2019 the patient was vaccinated with VARIVAX lot # R023501 for prophylaxis.       On 25-MAR-2019, 1 day after onset of therapy the patient experienced product storage error. On an unknown date the patient experienced no adverse event.
1-2 minutes after receiving vaccine patient was sitting in chair and asked for water.  Upon evaluation, patient's head fell forward and he passed out.  Once Paramedic and NP responded, patient became responsive, was transferred to wheelchair.  VS 122/72, 98%, 82 HR.  Client was discharge after 30 min monitoring.
This spontaneous report was received from a certified medical assistant and refers to multiple unspecified patients of unknown age and gender. No information about the patients' pertinent medical history, concomitant medications and drug reactions or allergies were reported. On an unknown dates, the patients might have been vaccinated with improperly stored doses of GARDASIL 9 injection (dose, route of administration, anatomical location, lot # and expiry date were not specified). The administered doses of GARDASIL 9 underwent a temperature excursion at 30 Fahrenheit degrees for 14 days. There were no previous temperature excursions reported. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several cases received from the same reporter. Additional information has been requested.
Severe ringing/buzzing in my ears within two hours of the vaccine.  I contacted my ENT on April 9th, April 15th and May 5th.  I was scheduled for testing with an audiologist.
pt c/o severe arm soreness associated w/bilat ankle swelling starting the day p/inj;
Two days after the shot, my mouth developed sores inside both lips, the lower lip was swollen. Inside lower lip blisters erupted.  From then the soreness spread into the floor of my mouth and under my tongue. It was difficult to eat as the food  would scrape the sore parts. I have been washing my mouth with Oragel  two or three times a day, and am now rinsing with salt water.  My lips are so dry I have to keep lip balm on them continuously.  Today feels a little better but still have soreness in parts of the mouth, and roof of mouth.  Am worried regarding the second shot due on the 26th.
ADVERSE EVENTS: INJECTION SITE PAIN, TIREDNESS,  HEADACHE, MUSCLE PAIN, CHILLS, JOINT PAIN, FEVER (101.9 DEGREE F @ 2 AM 3/11/21 & BETWEEN 100.6 - 99.6 THROUGH THE EVENING 3/11/21), NAUSEA, FEELING UNWELL, SWOLLEN LYMPH NODE.  TREATMENT: TYLENOL EVERY 4 HOURS STARTING AT 8 AM 3/11/21. SYMPTOMS SUBSIDED THROUGH THE LATE NIGHT OF 3/11/21 EXCEPT SWOLLEN LYMPH NODE & INJECTION SITE PAIN STILL PERSISTS 3/12/21.
SOB, chest pain, chest tightness, muscle aches, couldn't speak, elevated blood pressure (203/150) - symptoms started Saturday afternoon and by Sunday evening they were bad enough that she went to the hospital. Patient went to the ER Sunday evening for 4 hours - they gave her NTG and did an X-ray and EKG - said she had no cardiac issues.
Presented to emergency room for symptoms of urinary tract infection and was found to be positive for COVID19 during screening for hospital admission on 2/4/21. Patient did not experience any symptoms relating to COVID during hospitalization. An additional COVID test was ordered on 2/7/21 as patient did not have symptoms and was also positive. Patient was hospitalized from 2/3/21 to 2/15/21 for urinary tract infection.
Information has been received from a nurse concerning an approximately 19 month old patient who in approximately September 2010, was vaccinated with a dose of PROQUAD (Merck) (Lot# unknown). In approximately September 2010, the patient experienced swelling at injection site, fever, vomiting, crying, screaming and fussiness. At the time of the report, the patient had recovered. It was unknown if the patient sought medical attention. The nurse said that the office no longer gave the first dose of PROQUAD in the younger patients, they only gave it to 4-6 year old patients now. This is one of several reports from the same source. Additional information is not expected.
Information has been received from a consumer concerning her son with gelatin allergy who on 17-NOV-2009 was vaccinated with a dose of MMR II (lot # not reported). On 20-NOV-2009 3 days after receiving the vaccine the patient developed a fever and rash. The patient sought unspecified medical attention. On an unspecified date, the patient recovered from fever and rash. No further information is available.
Stomach flu lasting 72 hours. The family has had the stomach flu 47 times since. We have had blood drawn, carbon monoxide testing, stool samples, and natural gas testing done.
no adverse reaction to the vaccine, but who presented to the ED on 9/1/23 with a chief complaint of generalized weakness.  He also noticed a little swellling in left lower extremity.  He was admitted to the Adult Care Unit for further evaluation due to patient not feeling comfortable returning to home (~50 miles away), and due to hypoxia on exertion (down to sat on room air of 89%), weakness, and inability to ambulate as he normally does.
two of the three patients were administered the liquid component only (DTaP-IPV) and not the lyophylized componet (Hib); Initial information received on 23-Jul-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves two patients who received vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] and reported that two of the three patients were administered the liquid component only (Dtap-IPV) and not the lyophylized componet (HIB).  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On 16-Jul-2019, the patient received a dose of suspect 0.5 ml DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot C5544AA and expiry date: 06-Oct-2019 via unknown route in unknown administration site.  It was a case of actual medication error due to inappropriate reconstitution technique.  It was not reported if any 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.  List of documents held by sender: none.
a red looking rash that's itchy; a red looking rash that's itchy; This is a spontaneous report from a contactable consumer (patient).  A 31-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EL0140 and expiry date: Mar2021, via an unspecified route of administration in left arm from 23Dec2020 to 23Dec2020 as single dose (first dose) for COVID-19 immunisation.  Medical history was reported as none.  There were no concomitant medications. The patient stated she noticed the day after getting the COVID vaccine, 24Dec2020 that morning when she woke up between 9am to 10am that she had this red looking rash that it is itchy. The person who gave her the shot placed a band-aid on the site of injection. At first caller thought the person who gave her the injection missed the site where it was injected where placing the band-aid. However, this was a big red circle. The circle was bigger than a quarter. It is still itchy. This is located on her left arm. She stated she was hoping it would just go away on its own. No additional details provided. She is due to receive the second dose on 13Jan2021 or 14Jan2021 depending on when there is availability. The patient is about 130 pounds give or take. The outcome of the event was not recovered.
covid 19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (covid 19) in a 60-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On 09-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 10-Nov-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced COVID-19 (covid 19). At the time of the report, COVID-19 (covid 19) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Nov-2023, SARS-CoV-2 test: Positive.     The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   The concomitant medication was not reported by reporter. Patient never had covid and never thought she would get covid because exposure was minimal. The treatment medication was not reported by reporter.   Reporter did not allow further contact
stability is confirmed till october 19 but initial expiration was sept 30 for this lot number pediatric pfizer
Patient came to pharmacy on 9/11/11, 3 days after receiving flu shot complained that he has pain in his left arm since 9/9/11 after getting flu shot on 9/8/11. Patient came to the pharmacy on 9/11/11 complaining that he has muscle pain on his left arm since 9/9/11 after receiving his high dose flu shot on 9/8/11. He noted that it hurts more and it felt like a needle is poking him when he moves or lifts his left arm. He thinks that a piece of needle from the flu shot might of have broke and remained in his deltoid muscle. He said he did take TYLENOL/MOTRIN, but it doesn't seem to help. He said he never have any pain from flu shot before. Pharmacist working on 9/11/11 and also the one gave him his flu shot inspected the site, no redness, tenderness or swollen observed. Pharmacist reassured him that he got the high dose flu shot, and one of the side effects he might experience is more pain at injection site. Also, the needle was not a retractable needle; she pulled the needle out completely then recapped with safety device, so it is very unlikely the needle is broke and still in him. She recommended him to take MOTRIN around the clock to help with the pain and she will follow-up with him the next day. Pharmacist called the patient the next day on 9/12/11, he said that the pain is not getting better, it still bothering him that caused him to woke up last night. Pharmacist recommended the next step for him to do would be to see his doctor and possibly get an x-ray to assure him that there is no needle piece in his arm. The patient said he will wait 1-2 more days before he decide if he wants to do that. Another pharmacist called the patient and follow-up with the patient on 9/15/2011. He said he went to his doctor, got an x-ray. X-ray result is negative and his doctor said everything looked normal. He said he is on pain medication now to help with the pain; pharmacist didn't take note of name of pain medication. The patient asked the pharmacist to go ahead and fill out VAERS form regarding his adverse event. The pharmacist asked him to contact us with any new information regarding his side effect and he said he will do that.
Difficulty Breathing with wheezing started 3 hours after immunizations tx - prelone, nebulizer tx
Patient stated that she woke up with soreness and stiffness to right arm, the injection site. She denied any redness or swelling to the area, and denied any itching around site. She also stated she had limited movement to her right arm.
Patient got an odd red blotch on 'bicep' area, was inflamed, went to MD, thought it was just a reaction to vaccine, cleared up in 48 degrees.
This spontaneous report was received from a physician via office manager refers to a patient of unknown age. On 30-APR-2013, the patient was vaccinated with a dose of VAQTA, (lot # H010659, expiry date MAR-2015), which was exposed to 31 degree Fahrenheit. Concomitant medications were not reported. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
"swollen left arm,  red and itchy one big raised hive / topical steroid cream and Benadryl