chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A patient was administered an expired dose of the Moderna COVID-19 vaccine; Booster dose was administered before 6 months after completing the primary series; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A patient was administered an expired dose of the Moderna COVID-19 vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Booster dose was administered before 6 months after completing the primary series) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004C21A) for COVID-19 vaccination.     Previously administered products included for an unreported indication: PFIZER BIONTECH COVID-19 VACCINE on 17-May-2021 and PFIZER BIONTECH COVID-19 VACCINE on 03-Jun-2021.    On 17-Nov-2021 at 10:00 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Nov-2021 at 10:00 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (A patient was administered an expired dose of the Moderna COVID-19 vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Booster dose was administered before 6 months after completing the primary series). On 17-Nov-2021 at 10:00 AM, EXPIRED PRODUCT ADMINISTERED (A patient was administered an expired dose of the Moderna COVID-19 vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Booster dose was administered before 6 months after completing the primary series) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment information was not provided. Patient was administered by an expired booster dose (more than 12 hours post puncture) of the Moderna COVID-19 vaccine. On 12- Nov-2021, the vial was initially stored in the Refrigerator. On 16-Nov-2021, at 8:00 am  the vail was first punctured. Vial was kept in the  refrigerator post puncture.
Burning out; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (Burning out) in a 66-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.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced BURNING SENSATION (Burning out). At the time of the report, BURNING SENSATION (Burning out) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       The patient received their first vaccine dose and experienced burning out post receiving the vaccine.   On 21-May-2021, the patient reported that they were feeling fine. Reportedly, the patient tool the second dose of vaccine and experienced no side effects.  No Concomitant product use was reported. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 21-May-2021: TCR report was received on 21-May-2021and additional details were added. Updated the outcome of the event. Updated the action taken for the suspect drug. Included the liner for the second dose in I-narrative supplement.
I have pain in my fingers/hands, elbows, neck, lower back, hips, knees and feet. My feet are numb and they hurt as I walk a distance. It hurts to sit. Once I am sitting, it is impossible to stand; it's extremely painful to get moving again. I have to keep moving, bending and massaging my hands. They hurt continuously. The pain wakes me from my sleep. Most days I feel as if I've run a marathon. The pain and fatigue is overwhelming.
STOMACH PAIN; COUGH; DIARRHEA; BODY ACHES; LOSS OF APPETITE; LOW FEVER; This spontaneous report received from a patient concerned a 74 year old female. 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: 1805018, and batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on left deltoid muscle on 15-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced stomach pain. On MAR-2021, the subject experienced cough. On MAR-2021, the subject experienced diarrhea. On MAR-2021, the subject experienced body aches. On MAR-2021, the subject experienced loss of appetite. On MAR-2021, the subject experienced low fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the stomach pain, cough, diarrhea, low fever, body aches and loss of appetite was not reported. This report was non-serious.
Pt reported the adverse events on 3/4/19 to me. Pt stated that her shoulder "was like paralyzed". She was in so much pain she had to take Ibuprofen. The ibuprofen didn't help but the symptoms didn't last more than a day.
I received the first dose on 8/11/21. I then began losing large clumps of hair on 8/17/21 that continued and escalated after the second dose on 9/1/21.
pt recvd vax & 33 days later devel a temp of 101, vomiting & other flu-like sxs;nurse subsequently reported that the pts illness turned out to not be related to vax
Individual woke up the next morning after receiving the H1N1 immunization with itching and a rash in posterior of neck and a little on her face. NO SOB, NO N/V. Individual did not miss any work. Self medicated with BENADRYL and ice compresses to area-Rash resolved after BENADRYL tx.
Maculopapular rash anterior and posterior chest/torso, most involved on left, which is vaccine side.
This spontaneous report was received from a registered nurse concerning unspecified number of patients of unknown age and gender. No concurrent conditions or medical history were reported. On an unknown dates, unspecified patients were vaccinated with improperly stored doses of GARDASIL (lot # K016966, 10-MAY-2017 and Lot # K023432, expiration date: 18-JUN-2016) (dose, route, and anatomical location of administration were not reported). No concomitant therapy was provided. No adverse effects were reported. It was unknown if the patients sought medical attention. This is one of several reports received from the same reporter. On 23-JUL-2015, the healthcare worker called to report a temperature excursion. The original caller, did not have relevant information regarding the excursion. The nurse who was called back with additional information on the same day and reported the lots # and expiration dates and the use of improperly stored vaccines. Additional information has been requested.
temp excursion on ipol (open and not open) for 1 hour and 30 mins. 1.8 to 1.9 C. Happened on June 11th; Initial information received on 02-Jul-2019 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional with live follow-up on 03-Jul-2019.  This case involves a patient of unknown demography who received vaccine IPV (VERO) [IPOL] and reported that temperature excursion on Ipol (open and not open) for 1 hour and 30 mins. 1.8 to 1.9 c. happened on June 11th.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect IPV (VERO) lot number not reported via unknown route in unknown administration site.  It was a case of actual medication error due to incorrect product storage.  It was unknown if the patient had any adverse event.  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.  Information on the batch number was requested.  List of documents held by sender: none.
Influenza vaccine received on 2-25-20 Injection site was red and tender, the area was 3 in diameter, on 2-26-20 This morning the area is 6-7 in across and red, hot & painful
I had problems over the years with my prostate. After the vaccine I had been urinating every hour with little output. I had to be catharize because of urinary obstruction, which means my bladder was not releasing urine. Extreme pressure in my abdomen because the is no urine output. The condition has persists, I now have to self catharize daily. Which has prompted me to have prostate surgery this coming Friday 06/11/2021.
About 7 minutes after receiving my vaccine, my tongue started tingling.  It felt slightly swollen.  About 20 minutes after the vaccination, my lips started tingling and felt slightly swollen as well.  This tingling was severe for about 4-5 hours and was gone within about 12 hours.  The next day I had headache and fatigue as anticipated, but the tingling was gone.
I was having a runny nose, and was sick with a temperature of 101 for three days. I took at COVID-19 Home test and it was positive. I had the fever for about a week as well. Then it moved to my chest and had the a bad cough. I could not take the antiviral medication because of having seizures but I took Mucinex and that helped. I finally tested negative after three weeks.
Child developed mutism, deafness, developmental delay and diluted cardiomyopathy possibly following vaccination several years before death.  10/3/08 Autopsy states COD as idiopathic dilated cardiomyopathy & contributing condition of chronic sequelae of encephalomyelitis. 9/26/08 Reviewed hospital medical records of 11/20-12/05/2008. FINAL DX: dilated cardiomyopathy, pulmonary edema, cardiac arrest. Records reveal patient experienced cough, DOE, weakness, extreme fatigue, excessive sleeping, rhinorrhea, sore throat & 1 day of diarrhea x 1 week w/newly dx cardiomegaly on CXR at outlying hospital. Weight loss over 1 month noted by family.  Exam showed holosystolic heart murmur.  Felt to have had dilated cardiomyopathy worsened by or caused by myocarditis.  Tx w/IVIG empiracally for viral myocarditis.  During intubation attempt in cardiac cath lab, had cardiac arrest & expired despite attempted resuscitation.
This spontaneous report as received from nurse refers to unspecified number patients of unknown age. On an unknown date the patients were vaccinated with RECOMBIVAX HB (lot# was not reported). Nurse reported the vaccine administered were improperly stored. No adverse events were reported. This is one of the reports from the same reporter. Additional information has been requested.
Information has been received from a pharmacist which was reported by an RN concerning an adult pt who was vaccinated with a 1st, 2nd and 3rd dose of Hep-B vaccine recombinant (yeast) in approx. 8/00, 9/00 and 10/00. "The vaccine was then delayed because the pt had a stem cell transplant". Unspecified medical attention was sought. Upon internal review, the stem cell transplant was considered an "Other Important Medical Event". Additional information has been requested.
pt recv vax 15JUL95 & 15OCT95 pt exp burning sensation over rt knee progressing to bilat knee, elbow, hip paint @ ligaments & tendons, myalgia & periarthritis;lab eval revealed lyme titer positive & western blot negative;
Patient stated he had no symptoms. Was advised to monitor self for symptoms and call clinic if symptoms occurred.
Tightness in throat and chest. Itching on arms. No rash. Provided prescription for Prednisone. Released from ED. No follow-up necessary.
Patient reported to ED complaining of chest pressure. Has a previous hx. of abnormal EKG's and chest pain.  Patient also had PVCs and Hypokalemia at the ED visit.
Patient received SHINGRIX vaccine date she reported of  3/20/2019 and 3/28/2019 started to experience myalgias and arthralgias and severe pain in all her joints of the body and muscles to the extent that she was unable to turn herself and her husband had to lift her and which point she went to urgent care with a fever of 102 and they told her to report to the Emergency department at which time she was admitted, treated with IV toradol, experienced improvement and was dc home on ibuprofen with Prilosec and instructed not to take the booster dose. She was admitted in the hospital x 4 days.
4/18/21 through Present - headaches, heart palpitations, shortness of breath, joint pain, muscle spasms, numbness/tingling throughout head/body, shooting pains on breasts and arm, blurry vision.
This is a spontaneous report obtained from a contactable pharmacist. A 67 year old female patient received, on 29Sep2016, PREVNAR 13, (Lot. N16562, Expiration date: Oct2017, NDC number: 00005197105, UPC number: 30005197105) 0,5 ml, single dose, route of administration unspecified, in the upper arm (deltoid) for immunization. Relevant medical history was none. Concomitant medication included FLUZONE, (Lot. UI666AA, manufacturer: Sanofi Pasteur), received on 29Sep2016, for immunization.  On 07Oct2016, the patient experienced swelling and redness in the arm. Clinical outcome of the event was unknown at time of this report. The events were considered related to pneumococcal 13-val conj vac (dipht crm197 protein).
not being able to sleep last night/couldn't sleep very well; Dry and tired eyes; Dry and tired eyes; Pain around the neck/tight and tired in neck; Feels like her legs are tight/tired and painful in legs; Feet are hot; Trouble walking/hard to walk; Not breathing well/Short of breath; Her heart feels fast; Stomach and head "feel like there is a bump on them''; Stomach and head "feel like there is a bump on them''; Fibromyalgia worsened; Feeling tired; Feels nervous; She has anxiety; Wants to throw up; very weird the way she feels; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- unknown) via an unspecified route of administration on 10Feb2021 as dose 2 single for COVID-19 immunization. Medical history included fibromyalgia. Concomitant medications included atenolol, alprazolam (XANAX). The patient reported feeling worse after the second injection compared to after the first. After the second injection, the patient reported experiencing not being able to sleep last night, dry and tired eyes, pain around the neck, feels like her legs are tight, bottom of feet are hot, trouble walking, not breathing well, and like someone is pinching her hands with a nail. The patient reported her stomach and head feel like there is a bump on them and her heart feels fast, feeling tired, feels nervous, she has anxiety. The patient was worried her blood pressure might be high but it had not been measured. Patient was calling because she had her second vaccine yesterday. The first one, she had a little bit of side effects, but after the second one she felt terrible. She was wondering how long this will last in her body. What can she do when she feels like this. Clinical course included she had been feeling tired. She had fibromyalgia, and she thinks this had been worse for her. She felt tight and tired in her neck. Her legs were tired and painful. She feels like tired. She had to call out of work. She also felt very nervous. Last night she could not sleep very well. Her heart was beating very fast. Her head. She had anxiety. She is a custodian at school. She was working this morning, and felt short of breath. She had to stop working. She almost felt like if her blood pressure was up or something like that. It was like when someone feels nervous. It made her uncomfortable. It was very weird the way she feels. She needs to know does she need to do something or take something.  She had a prescription from the doctor for Atenolol. She mentioned her stomach and her heart, and so she took an Atenolol. She also took a half of a Xanax, and she is feeling a little better now. She just wanted to know if this is normal. Should she go to the ER. The outcome of the events was unknown.   Follow-up attempts are completed. No further information is expected.
patients administered Moderna vaccine while temperature excursion assessment was ongoing; patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion"; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients administered Moderna vaccine while temperature excursion assessment was ongoing) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion") in a 46-year-old male patient 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) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients administered Moderna vaccine while temperature excursion assessment was ongoing) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion"). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients administered Moderna vaccine while temperature excursion assessment was ongoing) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion") outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. There had been no power outages that would have impacted the Moderna vaccine. She stated that because their facility had not been able to download the digital data logger for the months of Dec2021, Jan2022, and Feb2022. Thus, they considered to treat this issue as a temperature excursion. No adverse event was reported. No treatment medication was reported.
Hives(gone later that day),  Throat Swelling, Pain, Itching Nose Blockage, Itching(better than before as of 4/12/21)
High blood pressure, constant ringing in the ears much worse in the morning, nausea, lightheadedness, dizziness, a sick feeling all of the time. He doesn't feel right.
Within 24 hours of vaccine pt developed 3 cm x 4 cm erythematous mildly swollen area below varicella vaccine site. Pt states today 6/18/15 that has egg allergy but pt. answered no to this on vaccine questionnaire yesterday. Treatment - oral ZYRTEC and hydrocortisone.
@ 11:25 felt lips go numb, called for help.  Talking.  Became hoarse, "felt funny".  Benadryl 25 mg PO given @ 11:25 a.m.  BP 150/92.  Pulse 106.  Resp 20  Pt remained for total of 30 minutes.  Symptoms resolved
This is a spontaneous report from a non-contactable pharmacist via a Pfizer sales representative. A female patient of unknown age and ethnicity received PREVNAR 13 at 0.5 ml single dose. Medical history and concomitant medications were not reported. The patient experienced pain on an unspecified ate. The shot was more painful than her other immunizations. Outcome was not reported. No follow-up attempts are possible. No further information is expected.
Systemic: Headache-Medium, Systemic: Hypertension-Medium, Systemic: Nausea-Mild, Systemic: Vomiting-Mild
Patient tested positive for Covid-19 on July 10, 2021. Patient was complaining of being confused, had a fever, muscle aches, and headache. Patient also complained about nausea and abdominal pain. Patient was admitted to Medical Center on 07/24/2021 for confusion, SOB, nausea, and abdominal pain. Patient expired before they could be moved from ED to ICU.
Customer came to the window and said she received PPSV 23 yesterday and had a reaction.  Almost one-half of her upper arm was red and she had a small amount of swelling.  Pt stated she has been using ice on her arm and has also taken Tylenol.
Information has been received from a registered nurse concerning a 10 year old male who on 02/19/2002 was vaccinated with a second dose of Hepatitis B virus vaccine rHBsAg (yeast). Subsequently the patient developed hives. Unspecified medical attention was sought.  The patient recovered from the hives. It was reported that the patient did not complete the series with a third dose. There was no product quality complaint involved. Additional information has been requested. This is in follow-up to report (s) previously submitted on 3/7/2005.  Information has been received from a registered nurse concerning a 10 year old male with no known medical history or allergies who on 14-DEC-2000 was vaccinated in his left arm with a first dose of RECOMBIVAX HB (lot # 637850/1577K).  There was no illness at the time of vaccination.  Subsequently, "within 15-30 minutes after", the patient developed hives.  Unspecified medical attention was sought.  No laboratory diagnostic tests were done.  The patient recovered from the hives.  There was no product quality complaint involved.  Follow-up information from the registered nurse indicated that on 19-FEB-2002 the patient was vaccinated with a dose of ENGERIX-B (lot # KN65272A5) "without reaction".  Additional information is not expected.
11-year-old vaccinated with both on time vaccines tested positive for covid; 11-year-old vaccinated with both on time vaccines tested positive for covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 11 year-old female patient (not pregnant) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2 (tris), single and (Batch/Lot number: unknown) as dose 1 (tris), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 31Dec2021, outcome "recovered" and all described as "11-year-old vaccinated with both on time vaccines tested positive for covid". The event "11-year-old vaccinated with both on time vaccines tested positive for covid" and "11-year-old vaccinated with both on time vaccines tested positive for covid" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (31Dec2021) positive, notes: post vaccination. It was unknown if therapeutic measures were taken as a result of drug ineffective, covid-19. The patient had no known allergies. The patient had no other vaccine in four weeks. The patient had no COVID prior vaccination.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient called pharmacy at about 10:30 am inquiring about which flu vaccine he got to my technician.  He then was transferred to me to discuss an adverse reaction he was having. He also had a PNEUMOVAX 23 vaccination at same time as flu shot. He reported that he was having shallow breathing, joint pain, pain and swelling at the injection sight and upset stomach. He said the symptoms started at about 7pm on 10/16/17. Patient had called his primary care physician prior to calling the pharmacy and they suggested he come in for an appointment on 10/19 or go to the emergency room.  I also suggested based on the breathing concerns he should go to the emergency department. Patient reported he did not want to go to emergency room and was hoping symptoms would resolve. I followed up with patient at about 3:45pm and he reported that the breathing issues had resolved and he was feeling a little better. I advised him to follow up with his primary care physician on 10/19 if he was still not feeling better in the morning.