chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Very very tired/still wiped; Weak; Chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 14Mar2021 15:00 (Lot number: ER753H) at the age of 63 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "COPD" (ongoing), notes: Diagnosed about 2 years ago; "Bipolar" (ongoing); "smokes" (ongoing). Concomitant medication(s) included: SEROQUEL taken for bipolar disorder (ongoing). The following information was reported: FATIGUE (non-serious) with onset 16Mar2021, outcome "recovering", described as "Very very tired/still wiped"; ASTHENIA (non-serious) with onset 16Mar2021, outcome "recovering", described as "Weak"; CHILLS (non-serious) with onset 16Mar2021, outcome "recovering", described as "Chills". Therapeutic measures were not taken as a result of fatigue, asthenia, chills.  Additional information: There were no additional vaccines administered and the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient also stated that she can't take penicillin. It was reported that patient still feel so tired and wiped. When she was asked to clarify what still wiped meant, she stated that she was very very tired, she felt weak, and that she had chills. She reported that the chills and weakness were really bad yesterday. She then stated she was feeling better today but was still a little tired, a little weak and had a little chills. Events did not result to emergency room and physician office visit.  No follow-up attempts are possible. No further information is expected.
Had no memory of what transpired during the episode; extremely weak; almost catatonic; lost control of bowel and bladder; lost control of bowel and bladder; couldn't write; slept for almost 24hrs/ Very sleep; This is a spontaneous report received from a contactable consumer (patient) and contactable nurse. A 95-year-old female non-pregnant patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: EL3302), via an unspecified route of administration on Arm Left on 09Feb2021 17:30 as single dose for COVID-19 immunisation. Medical history included chronic anemia and AFIB (atrial fibrillation. The patient known allergies was reported as none. Concomitant medications included levothyroxine sodium (L-THYROXINE); omeprazole; acetylsalicylic acid (ASPIRIN) at 81 mg; calcium carbonate, magnesium carbonate (TUMS) and iron; all are received within two weeks of vaccination. The patient was not received other vaccines within four weeks. The patient had no COVID prior to vaccination. The patient was not tested COVID post vaccination. The patient historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL9261) on 19Jan2021 17:30 on left arm for COVID-19 immunization. On 10Feb2021, after 20+ hours, the patient became extremely weak, almost catatonic, lost control of bowel and bladder, couldn't write, slept for almost 24 hrs. Improved next day and restored almost 90% by 2nd day. Had no memory of what transpired during the episode. The nurse further stated that, 20hrs after each shot, she become very sleep, weak, lost bladder control, and didn't want to communicate. The patient was not received any treatment for the events. The outcome of the events was reported as recovered on Feb2021. The Nurse considered the Pfizer product had a casual effect to the adverse event.
Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient felt that he was about to pass out and almost fell from the chair. He then lied down on the floor. He was awake and alert, was able to breathe normally. EMS arrived and checked on him saying his heart rate and blood pressure were normal. He wanted to be taken to the hospital to get checked up.
RHD beneficiary who developed right upper arm pain within 24 hours following receipt of Tdap (right arm) and PNEUMOVAX (left arm) vaccines on 18 APR 2012. Previous Td vaccine received on 3/19/2007. Patient denies anything unusual about vaccine administration technique, and dose not recall unusual pain during vaccine administration. Patient denies any unusual or persistent bruising, redness, swelling, or warmth at vaccination site. On day of vaccine receipt, noted "usual" aching pain in right deltoid area. Patient often experiences that type of pain after vaccinations and tries to "work it out". The day following vaccinations her right shoulder became more painful with a "constant throbbing" pain reaching a pain intensity of about 8/10. The pain sometimes is triggered by palpation to the right pectoral area and sometimes is noted in her right scapula and up into her neck. Sometimes it feels like a "vise" and other times it is so intense that it is like an "electric shock". She denies any numbness/tingling or weakness or her right upper extremity. Her pain increases with any movement - writing, opening a jar, turning door handle and when she used her left arm to cover a sneeze, she experienced pain in her right upper extremity. Pain leading to limitations with ADLs and interfering with sleep. Patient has not self treated as she is already taking a number of medications for arthritis/symmetric polyarticular inflammation, including ibuprofen 400 mg three times per day. Patient sought evaluation last p.m.; she said the evaluating provider was not sure what was causing the pain, but prescribed PERCOCETS as needed until patient could be evaluated by her Rheumatologist. Patient denies similar pain affecting her right upper extremity and shoulder. She denies recent trauma, except she recently fell in the garden and hit her right knee; does not think she caught herself using her upper extremities. Patient was feeling well on the day of vaccine receipt. She denies any previous vaccine reactions except short-lived aching at vaccination site. Patient denies any angioedema, rashes, cardiorespiratory, or GI symptoms. She has noted a "dry mouth" over the past 2 days (onset prior to initiation of PERCOCET.), otherwise no other new symptoms. Patient reports allergies to Sulfa, AUGMENTIN, ACTONEL and FOSAMAX (itching, rashes or both). She does not tolerate NAPROSYN. EXAM per Rheumatologist on 23 APR: Musculoskeletal system: General/bilateral - Musculoskeletal system: Skin overlying bilateral shoulder and chest without erythema or warmth. No notable swelling of bilateral shoulders or anterior chest wall. However, fullness and TTP of (R) trapezius, (R) deltoid and (R) pectoralis muscle. Pain limiting (R) shoulder abduction, flexion, internal and external rotation. Positive liftoff, Neer's Hawkins, Jobe's.
devel a rash on head & chest, & had a fever of 102 for 2 days;
My arm is hurting very bad; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (My arm is hurting very bad) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced VACCINATION SITE PAIN (My arm is hurting very bad). At the time of the report, VACCINATION SITE PAIN (My arm is hurting very bad) outcome was unknown.            No concomitant product was provided. No treatment medication was provided.  The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable.       Most recent FOLLOW-UP information incorporated above includes: On 01-Jun-2021: Contact details updated
Patient seated in observation area reported itchiness & burning at right shoulder 4:24 patient self ambulated to private observation area, accompanied by RN and EMT 4:26 VS 124\97 | HR 86 | PO2 98% ice bag provided to help with itchiness\ redness noted at left neckline | no redness noted on back 4:31 husband arrived in private observation (he is a cardiologist MD) 4:33 Benadryl 25mg given with water | 50 mg declined recommended that patient premedicate w/Bendryl prior to 2nd vaccine dose, also recommended she bring her epipen & husband 4:35 itchiness improved | additional redness noted  at chest husband and patient took baseline pictures & RN shared medication time | family confirmed that Benadryl available at home 4: VS38 132\98 | HR 83 | PO2 99% family declined transport \ need for emergency care | husband MD signed VAERS form patient discharged and self ambulated with husband to car
I used to be able to run machines and the coolant didn't bother my hands but now it seems that after I had my Moderna vaccinations I have to wear gloves because my skin is now sensitive to the coolants the machine uses and my hands don't like having rubber gloves on all day so I have to use Desitin lotion and bandages for rashes
1 Year  Received Hepatitis A and Varicella in right thigh and developed redness, red bumps Approximately  10 days. Vaccine also has diffuse  Red Papular  rash
UNDERAGED CHILD. DOB ON CONSENT REPORTED AS DATE. CHILD DOB IN SYSTEM IS OTHER DATE.  UNKNOWN IF CHILD RECEIVED SECOND PFIZER DOSE.
Pt's parents did not provide DOB or ID for pt and stated  that the pt was 12 when he was not.
Severe hair loss starting a month or so after receiving the Hepatitis B and A vaccinations. Hair loss lasted for a fun 6 weeks.  Mental discombobulation, anxiety, and panic- tingling in head, hands, and arms. - four day fever.   The Epstein Barr viris also surfaced after the vaccine complete with extreme tiredness and  weakness.  The mainstream western doctors did not believe me until I went to a homeopath.  She gave me homeopathic remedies to releve the panic and worked at detoxing me to rid me of the adverse affects of the vaccine -- it took a month or so but now I'm finally doing better -- I also am juicing all organic fruits and vegetables in order to clease out the toxic effects of the vacinations.   The juicing seem to help the best.
This spontaneous report as received from a pharmacist refers to a 64 year old patient of unknown gender. On 14-OCT-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot # J005721, expiry date: 29-AUG-2014 as reproted) (dose, location unspecified). In October 2013 the patient experienced a dermatological reaction with redness and swelling (had injection site reactions, size of swelling around injection site and redness, the redness was approximately 3 inches in diameter). At the time of report, the outcome of the events was not provided. This is one of several reports received from the same reporter. Additional information has been requested.
Information has been received from a pharmacist concerning 1500 patients of unknown age and gender. There was no information about concurrent condition, medical history or concomitant medication. In 1996 (reported as occurred approximately 20 years ago), 1900 patients were vaccinated with RECOMBIVAX HB (strength, dose, route and lot # not provided) in an immunization program where the pharmacist was working in. The patients' titers were tested later at an unspecified time. Only 400 patients had positive titers. At the time of reporting, the outcome of hepatitis B surface antibody negative was unknown. The causality was not provided. Additional information is not expected as the reporter did not wish further contact.
ACUTE KIDNEY FAILURE; This spontaneous report received from a consumer concerned a male patient of an 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, and batch number was not reported and has been requested) dose, start therapy date were not reported 1 total administered for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced acute kidney failure (severe side effects including vomiting, stomachache, headache) and he was hospitalized in ICU for two days (date unspecified). Doctors refused to report that events as vaccine-related issue.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of acute kidney failure was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0: 20210444537-covid-19 vaccine ad26.cov2.s-Acute kidney failure. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Shot was given today, about 20 minutes after recieving #1 of covid19 vaccination patient experienced shaking and rigors and feeling "warm" and then chills, he denied chest pain sob muscle aches or pains or headaches or lightheadedness. Vitals were taken HR 105 pulse ox 99% normal S1S2 tachycardian lungs were clear  We gave IM 25mg benadryl in right arm and 1000mg tylenol once we will monitor condition closely and re-assess, Dr was present for this assesssment and plan
Started pregnancy with fetal size similar between last menstrual period dating and ultrasound estimation of gestational age. Received first dose of COVID-19 vaccine at 15 weeks and by 19 weeks had severe early onset fetal growth restriction.  Had second COVID-19 dose in the series at 19 weeks. At 20 weeks started having bleeding from placenta previa. At 25 weeks the fetus was found to have echogenic foci in the liver and cardiac right ventricle hypertrophy. The estimated due date is Feb 19, 2022 and the patient is still pregnant.
Temp. Tremors. Confusion.   Slowly coming to awareness  30 hours later Keeping hydrated and taking temp
very high fever 40.5 C,  fatigue, weakness, whole body pain, muscle pain , nausea, vomiting x2 , headache, blurry vision  in the morning  on 08/31/21.  I received second dose of covid Pfizer  vaccine on 08/30/21 and developed this significant side effects . Even by taking advil every 7 hours, drinking  fluids when I can still I have  this symptoms .    It should be further investigation  and evaluation. And who is responsible  for forcing this vaccine in healthy adults ?
Severe flu-like symptoms, shaking, sweating then chills. Joint and muscle pain.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient medical history and drug reactions or allergies were not provided. On an unknown date, the patient was vaccinated with PROQUAD (Merck) (route, lot # and expiration date were not provided). Concomitant medication information was not provided. On an unknown date, the patient received PROQUAD (Merck) that was improperly stored. No adverse effects were reported. It was unknown if the patient sought medical attention. At the time of the report, the patient status was unknown. This is one of several reports received from the same source. Additional information has been requested.
Information has been received from the physician's assistant concerning a college aged female who an unspecified date who vaccinated with the first dose GARDASIL.  After receiving her first dose. The patient developed headaches. The patient sought medical attention, office visit. On an unspecified date,a magnetic resonance imaging(MRI), a computed tomography (CT) scan of head and blood test were performed.  All test and studies were within normal limits. At the time of reporting, the patient had not recovered. Additional information has been requested. Follow up information was received from the patient's pediatrician's office manager concerning the dates at which the 17 year old female received the three doses of GARDASIL. The first dose was administered on 30-MAY-2007, the second dose of GARDASIL was received on 09-AUG-2007 and the third dose of GARDASIL was adminstered on 26-DEC-2007. On 24-MAR-2008 the patient was seen at the office for complaints of headaches but was never hosiptalized. The patient felt the headaches were related to the GARDASIL, but was not the opinion of the medical assistant. As of 23-DEC-2008, the patient was still complaining of chronic headaches. Additional information is not expected.  1/14/09 Reviewed Neuro medical records of 3/24-8/25/2008. FINAL DX: chronic migraine HA; chronic neck pain. Records reveal patient experienced chronic HA x 1 year w/phonophobia, photophobia, dizziness, fatigue, visual lights flashing/bright spots, blurry vision, neck pain.  Had 2 episodes of numbness & tinling of toes/fingers w/hot flashes.  Tx w/multiple med trials & PT w/some improvement.  Seen in Er 8/08 for intense HA & tx w/flexeril & chiropractor which relieved HA.  HA, nausea & blurred vision returned when flexeril d/c.
Initial information received on 09-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 34 years old female pregnant patient who was exposed to vaccine ADACEL which was given subcutaneously instead of intramuscularly. The reported Vaccine exposure during pregnancy occurred at unknown gestation period and the patient was exposed to DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE at 25 weeks of pregnancy, during second pregnancy trimester for DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. The date of last menstrual period was reported as 21-Mar-2018. The estimated due date is 26-Dec-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was not reported. It was not reported that No other vaccines given at the time. On 05-Sep-2018, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot C5577AA expiry date: Feb-2021 via subcutaneous route in the left deltoid while she was pregnant. It was also reported that patient did not have one before. It was an actual medication error case due to Wrong route of administration. No adverse event was experienced. (Other relevant tests included No lab data). Final diagnosis was vaccine exposure during pregnancy. It was not reported if the patient received a corrective treatment. Additionally, at time of reporting, the pregnancy is still ongoing. 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.
Wrong vaccine administered; Interchange of Vaccine; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate schedule of vaccine administered in a 53-year-old female patient who received HAB (Twinrix) (batch number 3597P, expiry date 12th March 2022) for prophylaxis.   Co-suspect products included Hepatitis A vaccine for prophylaxis and Hepatitis B vaccine for prophylaxis.   On 19th July 2019, the patient received Twinrix. On an unknown date, the patient received Hepatitis A vaccine at an unknown dose and Hepatitis B vaccine at an unknown dose. On 19th July 2019, unknown after receiving Twinrix and not applicable after receiving Hepatitis A vaccine and Hepatitis B vaccine, the patient experienced inappropriate schedule of vaccine administered. On an unknown date, the patient experienced wrong vaccine administered. On an unknown date, the outcome of the inappropriate schedule of vaccine administered and wrong vaccine administered were unknown.  Additional information received were as follows: The patient received Twinrix to start the series, received Hepatitis A and Hepatitis B monovalent as the second doses in the series, which led to wrong vaccine administered. The patient received Twinrix as the third dose in the series, which led to inappropriate schedule of vaccine administered.
Pain began the day of vaccination. Currently 4 weeks from administration of vaccination and symptoms continue to include arm and shoulder pain requiring ibuprofen for some relief. Very limited range of motion without increased pain.
pt recvd vax;pt told mom "I do not feel well" then became pale,slumped to floor,stopped breathing,unconscious;to hosp;T 101.4 per amb personnel;adm to hosp for observation x 5 hrs;MD attributed sz to vax;on amoxicillin,apap;slept well @ noc
Rash appeared at injection site 7 days after receiving vaccine. The next morning the rash turned into a large, pink spot surrounding the injection site.  Mildly warm to the touch and mildly itchy.  Took oral Benadryl before bed on day 2 of rash.  Day 3 the rash was a bit larger in size, but faded in color; still a little itchy.  Took oral Benadryl before bed on day 3 of rash.  Day 4 and 5 rash continued to fade.  Day 6 rash is almost gone, but now there is a new pink ring around the former rash.
Rash bilateral lower extremities and groin, face swollen (but not throat) and red, fatigue
Altered Consciousness event about 24 hours after vaccines.  This event was self-limited, lasted 10-30 seconds.  Child was unresponsive, eyes closed, rhythmic jerking of body, cried and then appeared fine.  She was evaluated in the office about an hour later and required no treatment.
2nd Dose administered beyond 30-day use; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (2nd Dose administered beyond 30-day use) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (2nd Dose administered beyond 30-day use). On 22-Oct-2021, EXPIRED PRODUCT ADMINISTERED (2nd Dose administered beyond 30-day use) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant information was reported. No treatment information was reported. Reporter stated that the date taken out of freezer: 08-SEP-2021
Information has been received from a registered nurse concerning a 5 year old female pt with no past medical history and no known drug allergies who on 08/07/1998 was vaccinated with a dose of varicella vaccine. There was no concomitant medication. On 11/25/2001, the pt was seen in the doctor's office with 50-100 lesions, afebrile, and was diagnosed with varicella. The ptw as treated with Aveeno and Benadryl prn. It was noted that the pt's sister had a similar experience. No further info is available.
Patient is an adult and received the MMRV vaccine. No treatment needed and no adverse reaction occurred.