chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient said she woke up the next day and her arm hurt very bad and it was hurting even in her chest. It got worse throughout the day. She noted that her blood pressure was high as well. She tested it and it was over 180 sbp. She called me on the evening of 4/9/21 to let me know the chest and arm pain was getting worse. She told me her current systolic blood pressure was over 160 and she normally does not have elevated blood pressure. I advised her to go to the ER. She called the next day to let me know at the ER she found out that she had fluid around her lungs. They told her this was from her immune system's response from the vaccine.
1/26/2021 at about 1pm I began getting chills and was very cold. Later on the night I got a bad headache. This went on for 2 more days. The headache was so bad I couldn't eat, drink, or lift my head and I was so cold I had a heater, heating pad and several blankets.
This spontaneous report as received from registered nurse refers to an unknown number of patients of unknown age and gender. There were no pertinent medical history and concurrent conditions reported. On an unknown date the patient was vaccinated with ROTATEQ (dose, lot# not reported). No concomitant medications reported. On an unknown date an unknown number os patients were in advertently administered ROTATEQ that had been improperly stored and no adverse effects reported. This report is one of two linked reports from the same reporter. Additional information has been requested.
HPV given in error to a 7 mo. old infant. Poison Control/Toxicologist called. MD/PCP notified. Mother notified. IMMPACT called. VAERS report.
Fever of 101, body aches, chills, headache, nausea, loss of appetite, dry mouth and all symptoms came on quickly. All symptoms last until 9pm the following evening and dissipated as quickly as they came on.
PATIENT IS 3O WEEKS PREGNANT, DELIVERY DATE 12/27/21, HAS HAD  4 FULL TERM PREGNANCY. PATIENT COMPLAINIG OF REDNESS, SWELLING AND ITCHINESS ON INJECTION SITE .
Client presented to the vaccination site on 01/14/2022. The client notified RN that he received a first dose of Moderna on 04/14/2021 and is here for the first dose of Janssen. Per client, he develop hives all over body approximately 8 hours after administration. No other symptoms were reported, per client he was taken to the nearest hospital by family member and was given oral benadryl and oral prednisone. Client stated he never received second Moderna dose. Per client, he has heart conditions and is taking daily metoprolol and atrovastatin and allergic to Brazilian almonds. RN submitted a medical consult via text message to Vaccine Operations Leads, requesting to proceed with the COVID vaccine Janssen. Approval to administer COVID vaccine Janssen was obtained from medical consult team via text message from MD. Client received COVID vaccine Janssen Lot# 1855191 on 01/14/2022. The client did not report any symptoms during the 30 minute observation period. RN educated client on possible adverse reactions and when to seek medical care. The client left the vaccination site at 2:28pm with a steady gait. VAERS completed.
Weakness, pain left arm then later also right arm pain, sore, weakness both arms can't lift arms over shoulders.
WORST SEVERE HEADACHE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported. On an unspecified date, the patient experienced worst severe headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of worst severe headache was not reported. This report was non-serious.
No adverse event; Patient received the monovalent booster instead of the bivalent booster; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient received the monovalent booster instead of the bivalent booster) and NO ADVERSE EVENT (No adverse event) in an 18-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Oct-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Patient received the monovalent booster instead of the bivalent booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient received the monovalent booster instead of the bivalent booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Patient received the monovalent booster instead of the bivalent booster).    No concomitant medications were reported. It was that moment they did not have the bivalent vaccine. They received the bivalent vaccine 04 Oct 2022. No treatment medications were reported.  This case is for 1st patient out of 5 patients.   This case was linked to PR-MODERNATX, INC.-MOD-2022-656475, PR-MODERNATX, INC.-MOD-2022-656478, PR-MODERNATX, INC.-MOD-2022-656480, PR-MODERNATX, INC.-MOD-2022-656483 (E2B Linked Report).; Sender's Comments:  PR-MODERNATX, INC.-MOD-2022-656475:Patient 2 PR-MODERNATX, INC.-MOD-2022-656478:Patient 3 PR-MODERNATX, INC.-MOD-2022-656480:Patient 4 PR-MODERNATX, INC.-MOD-2022-656483:Patient 5
severe local (swelling, pain) & febrile (oral temp 103.5) react;
Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Hypertension-Mild, Systemic: Shakiness-Medium, Systemic: Tachycardia-Medium
2mo began high pitched inconsolable crying approx6hr p/vax w/some dec appetite;duration 48hr @ which time resolved;no fever, diarrhea, rash;neurological exam nl;
FEVER, CHILLS, HEADACHE, MUSCLE ACHE DIDN'T TAKE ANYTHING. MY ARM STILL HURTS.
It was a gradual number of symptoms that began with muscle pain and fatigue and loss of strength and overall just not feeling well. I had loss of appetite, weight loss, etc. and this all began around July 2021. I contacted my DR on August 2 2021 and I was referred to a specialist three days later. The outcome of that was diagnosis of polymyalgia rheumatica, and I was prescribed prednisone.
Dizziness, Myalgia, Soreness at injection site, bad taste in mouth, fatigue, dyspnea  Narrative:  Per nursing report: "2nd dose of Moderna yesterday [2/3]. C/o right arm soreness at site with redness and swelling noted. Last night c/o bodyaches, hot/cold, bad taste in mouth, fatigue. States got up this morning [2/4], became dizzy in shower. States sat on side of tub for a while until felt better. Came in to work and states became winded as walking up towards building. States feels so exhausted with fuzzy feeling and eyes hurting. States has general weakness."
Mother noted fine, pin point, pink rash on face, back of head, trunk- chest and back. Symptom noted 2 days after vaccines administered. No treatment. Baby active, smiling, breast feeding well.
Feeling hot; Tenderness and swelling of the lymph nodes; Tenderness and swelling of the lymph nodes; A spontaneous report was received from a consumer concerning a 76-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events tenderness/ vaccination site tenderness and swelling of the lymph nodes in the Same arm of the injection/ Vaccination site lymphadenopathy.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 1 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 012M20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 2 Feb 2021, the patient experienced the events tenderness and swelling of the lymph nodes in the Same arm of the injection.  No treatment details were provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events tenderness and swelling of the lymph nodes in the Same arm of the injection was unknown.  Based on MSA comment Feeling hot coded as Vaccination site warmth
Excessive ringing in the ears, intermittent Sinus headache and congestion,, dizziness, bouts of complete exhaustion. and a slight cognitive issue.
This is an instance of breakthrough COVID-19 after which death occurred. The individual was vaccinated with the Pfizer product on 01/11/2021 and 02/01/2021. They tested positive for COVID-19 on 10/27/2021 via antigen test at the assisted living facility at which they were a resident. They were admitted to hospital on 10/27/2021 with a primary complaint of anxiety. They experienced complications of COVID-19 pneumonia and respiratory failure. Due to lack of improvement, they were transitioned to comfort care only. They remained hospitalized until their death on 11/02/2021 (Some clinical notes say 11/03/2021).
Sweats; Neck pain ("shooting up my spine"); Headache; Body aches; Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Sweats), NECK PAIN (Neck pain ("shooting up my spine")), HEADACHE (Headache), MYALGIA (Body aches) and CHILLS (Chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 31-Mar-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, the patient experienced HYPERHIDROSIS (Sweats), NECK PAIN (Neck pain ("shooting up my spine")), HEADACHE (Headache), MYALGIA (Body aches), CHILLS (Chills) and PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, HYPERHIDROSIS (Sweats), NECK PAIN (Neck pain ("shooting up my spine")), HEADACHE (Headache), MYALGIA (Body aches), CHILLS (Chills) and PYREXIA (Fever) outcome was unknown.            No concomitant medications were reported.
Initial information received on 05-Dec-2018 regarding an unsolicited valid non-serious case received from other health professional and an additional information was received on 05-Dec-2018 by the same reporter. This case involves a 48 years old male patient who was vaccinated with a 0.5 ml dose of FLUZONE QUADRIVALENT, lot UJ046AB in the shoulder nos. on an unknown date at 07:42 AM (reported as yesterday) that was exposed to 11 F. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to product storage error and poor quality product administered. It was not reported whether the patient experienced any adverse events. 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.
C/o redness, swelling at site of injection went to E.D. given BENADRYL 6.25mg PO & sent home with follow up care instructions.
Within 30 minutes after receiving flu vaccine, employee returned to clinic with c/o fullness in throat, anxiety, difficulty swallowing, skin w/d to touch, color pale. Escorted to ED and report to triage nurse.
Severe swelling from elbow to shoulder, skin hot, tender and painful to touch, worsened throughout the day.
Myocarditis as evidence by elevated troponins. Normal EKG and Echo. Treated with NSAIDS and troponins downtrended.
First 24 hours dizziness, chills, weakness  Day 3 vomiting, lasting 20 hours.
Within the first couple of minutes she had a metallic taste in her mouth that went away quickly. After about 25 minutes the left side of her face began to swell and tingle and her cheeks were flushed. I called 911 and monitored her blood pressure. She never felt faint. She went to hospital via ambulance to get treated. She was released from hospital a couple of hours later and she stated that after steroids and pepcid the face swelling was completely gone.
Information has been received from a practice manager concerning a patient who in October 2007 was vaccinated with ZOSTAVAX (Oka/Merck) and developed shingles. Additional information has been requested.
Patient had large (whole area of upper arm), red rash at injection site. Patient states slightly tender to the touch but not itchy. Some swelling of injection site. Told patient to apply some hydrocortisone cream to skin and use Benadryl at night. Also told to take ibuprofen to help with swelling and if did not improve over the next few days or got worse to contact her MD
Received varicella vaccine 4-23-04. Two weeks later had nodule like areas on back of neck, areas on back, face, and head. Areas red, raised sore to touch. The areas itched and hurt. There were no blister areas. Also developed a sniffly nose during this time. Seen by doctor 4-28-04. Had deep papules on back & face. Few macules, tiny red on arms & thighs.
Loss of memory from 11 pm; not feeling right; severe seizure at 5:00 AM.
Pt. noticed this a.m. an irregular ecchymotic area distal and anterior on upper left arm approx. 7 cm. No redness or swelling noted at injection site. Encourage warms soaks QID.
HEART RATE DROPPED TO 36-37 BEATS/MINUTES; SWEATING PROFUSELY; DIZZINESS/ LIGHTHEADEDNESS; This spontaneous report received from a patient concerned a 51 year old male. The patient's height, and weight were not reported.  The patient's concurrent conditions included alcohol user, and non-smoker, and other pre-existing medical conditions included no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, and expiry: UNKNOWN) dose was not reported, 1 total administered on 12-APR-2021 at left arm for prophylactic vaccination. No concomitant medications were reported.  Patient reported that, he got the Janssen vaccine on Monday 12-April -2021.Right after vaccination patient started experiencing lightheadedness, sweating profusely, heart rate dropped to 36-37 beats/minutes.he did not see his MD and did not go to ED(emergency department) Patient was feeling much better right now. He was not on any chronic medications. Laboratory data included: Pulse rate (NR: not provided) 36-37 beats/minutes. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from heart rate dropped to 36-37 beats/minutes, sweating profusely, and dizziness/ lightheadedness. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210431941-covid-19 vaccine ad26.cov2. s-heart rate dropped. 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.
Rapid heart beat; Dizziness; Light-headedness; She felt nauseated; Sweating; Really Hot; Really Cold; Chills; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (Rapid heart beat), DIZZINESS (Dizziness), DIZZINESS (Light-headedness), NAUSEA (She felt nauseated) and HYPERHIDROSIS (Sweating) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced HEART RATE INCREASED (Rapid heart beat), DIZZINESS (Dizziness), DIZZINESS (Light-headedness), NAUSEA (She felt nauseated), HYPERHIDROSIS (Sweating), FEELING HOT (Really Hot), FEELING COLD (Really Cold) and CHILLS (Chills). At the time of the report, HEART RATE INCREASED (Rapid heart beat), DIZZINESS (Dizziness), DIZZINESS (Light-headedness), NAUSEA (She felt nauseated), HYPERHIDROSIS (Sweating), FEELING HOT (Really Hot), FEELING COLD (Really Cold) and CHILLS (Chills) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant information  provided. No Treatment information  provided
light hurting eyes, blurred vision, h/a, nausea, pale, vomit, diarrhea;
Pain, heavy feeling to deltoid, some radiation down to hand. No redness, swelling, fever.
Patient passed out about 5 minutes after receiving the Meningococcal B Vaccine. She was standing at the time and fell backward and hit her head. After coming out of it she had pain in her head and neck as well as dizziness. We stayed in the doctors office for approximately 2 hours while the doctor monitored her vitals. Patient has been dealing with a concussion since that time. Also, the day after the vaccine was given she had a reaction at the injection sight. She had a 3 inch diameter of swollen, hot to the touch and very painful to which she was unable to lift or use her left arm.
This spontaneous report was received from a registered nurse refers to unspecified number of patients of unknown age and gender. No medical history or concomitant medication were reported. On an unknown date the patients were vaccinated with improperly stored dose of LIQUID PEDVAXHIB (lot number-H022058, expiry date-10-Oct-2015, dosing regimen unknown) following multiple excursions, that started on an unspecified date in February 2014 and have persisted until an unspecified date during the last month. It was reported that the excursions were recently discovered during a Vaccines for Children audit and that no specified dates of administration was currently available. No doses were administered after their expiration date. PNEUMOVAX 23 and M-M-R II (K014833, exp: 14-SEP-2016) had appeared on the product list as temperature stability questions were asked about these products, but no doses of these products were administered to any patients. No adverse events were reported. No laboratory tests were reported. No product quality complaint (PQC) was involved. The outcome of the events was unknown. This is one of several reports received from the same reporter. Additional information has been requested
2nd day: chills for one day; sore injection site/arm for three days; resolved at present. Narrative:
Symptoms started with a severe back ache. Admitted to the hospital on 12/12/11 and experienced progressive weakness. Remained hospitalized 11 days.
Developed sensation of increased heart rate about 10 minutes after injection along with anxiety. BP 144/88, p-93, O2sats- 99% on RA.  Given water and symptoms resolved within 10 minutes. No chest pain, no shortness of breath, no sensation of tongue or lips swelling.  Vitals rechecked 130/78, p-83 and O2sats- 99%.  No further symptoms and patient expressed desire to leave.
Pediatric dose was given to adults mistakenly; Moderna COVID-19 vaccine administered to patients post temperature excursion; Poor quality vaccine administered; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patients post temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR5186C) for COVID-19 prophylaxis.     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 WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patients post temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patients post temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patients post temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered).    Concomitant product use was not provided by the reporter.  It was reported there was a temperature excursion between 26 May 2022 to 30 Sep 2022 and lot AR5186C was affected between 08 Sep 2022 to 27 Sep 2022. AR5186C was previously reported. Pediatric dose was given to adults mistakenly and were reported to CDPH, VAERS, CAIR and each patient that received the error dose, with instructions to re-vaccinate 2 months from the initial error dose. 051B22A was kept in the freezer upon receipt of shipment on 08-Jan-2022 and individual vials were put in the refrigerator on the day of use.  No treatment information was provided.  This case contains information for the 32nd of 104 adult patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-669791 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-669791:Master Case
Information has been received regarding a case in litigation concerning a male child who, on or about 7/21/99, 9/8/99 and 11/29/99, was vaccinated (route and site of administration not reported) with a first, second and third dose of hep B vaccine recombinant (lot numbers not reported). Concomitant therapy included a first, second and third dose of HIB conjugate vaccine (lot numbers not reported) on or about 9/8/99, 11/29/99 and 8/1/00 (route and site of administration not  reported). It is alleged that as a result of these vaccinations the pt was poisoned by the cumulative doses of mercury in Thimerasol. It is further alleged that as a result of the mercury in the injections that the pt now suffers and will continue to suffer from the toxic neurological effects of mercury poisoning. Upon internal review, toxic neurological effects and mercury poisoning were considered to be other important medical events (OMIC). Additional info has been requested.