chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Received Engerix-B for Second Injection; Initial Report Received on 31-Dec-2020  A registered nurse, reported that that a 60-year-old female, received HEPLISAV-B for hepatitis B immunization.  The patient has a medical history significant for allergies to Demerol (meperidine), scopolamine patches, sulfa, contrast dye, cats, dogs, dust mites, mold, ragweed trees, weeds and sunflower seeds.  On 11-Nov-2020, the patient received dose 1 of HEPLISAV-B in the left deltoid (Lot #934598, expiration date 25-Feb-2022, serial number not available).  On 30-Dec-2020, the patient received dose 2 of a hepatitis B vaccine but was administered Engerix-B (Lot # and expiration date not available).    The patient reported no adverse reactions to either injection.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Patient was given covid-19 dose #2 on 8/3/22. When entering the vaccine into the electronic health record, it was noted on a consent form on 6/1/22 that the patient received a booster dose. There was a note on the consent form that the patient received two covid-19 doses in another state but no documentation of proof was available. There was only one vaccine documented. Patient monitored for 20 minutes without any problems.
Immediately after vaccination the site bruised. Site was painful, and swollen for 5 days. Considerable fatigue and aches for 5 days. Two weeks after vaccination a raised, red rash 3" wide by 1.5" high appeared about 2" below the injection site (Moderna Arm).
Head ache, high fever, nausea, fatigue, chills, whole body pain.
I felt soreness in my arm 15 minutes after receiving vaccine. Started feeling fatigue and nauseous as well.
After receiving immunizations, patient became dizzy and light headed. BP 88/52 after a few minutes of laying down BP back to 121/71, but patient c/o headache and tiredness. Was able to walk out ok.
irritable; very tired; soreness around the inoculation area; Chills; This spontaneous case was reported by a consumer and describes the occurrence of IRRITABILITY (irritable), CHILLS (Chills), FATIGUE (very tired) and VACCINATION SITE PAIN (soreness around the inoculation area) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011D21A, 010M20A and 027A21A) 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) (unknown route) 1 dosage form. On 07-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced IRRITABILITY (irritable), CHILLS (Chills), FATIGUE (very tired) and VACCINATION SITE PAIN (soreness around the inoculation area). At the time of the report, IRRITABILITY (irritable), FATIGUE (very tired) and VACCINATION SITE PAIN (soreness around the inoculation area) outcome was unknown and CHILLS (Chills) had resolved.            No concomitant medications reported by reporter No treatment medications provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 20-Dec-2021: No New Information.
Patient received monovalent Moderna 0.5ml blue cap purple label. Patient was intended to receive bivalent Moderna 0.5ml blue cap grey label.
Difficulty swallowing, difficulty breathing, tongue swelling, rash to neck and arms-symptoms appeared 13 minutes after the vaccine given during the 15 minute observation.
Pt. received Hep A & flu shot on 1/11/13; states on 1/12/13 started breaking out on arms & hands.
Edema & erythema on site of injection 30 x 40 mm in diameter.
This spontaneous report was received from a registered nurse refers to 12 years old patient of unknown gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not provided. On 02-SEP-2016, the patient was vaccinated with improperly stored GARDASIL 9 (lot/batch number: M009378, dose, frequency, expiry date were not reported) for prophylaxis. The vaccine was purchased with private funds/Insurance. The temporary temperature excursion was occurred in the fridge on 01-SEP-2016 however, it was not discovered till 26-SEP-2016. No adverse effects were reported. Product quality complaint (PQC) was not involved. Additional information has been requested. Sender's Comments: US-009507513-1612USA003706.
fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever). At the time of the report, PYREXIA (fever) outcome was unknown. Not Provided          This case was linked to US-MODERNATX, INC.-MOD-2021-109798 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-109798:
1202- pt was moved to the post-vac area.  Pt c/o headache, dizziness, and diaphoresis with anxiety as well.  Pt states her mom drove her here and she believes she is just anxious because her mom stated "you know you are going to pass out."  BP: 122/62 P: 64 R:16 99% Sp02 RA.  1207-  Pt states she is feeling bettr and the dizziness has "almost gone away"  Pt drinking water A&O x4, anxiety has decreased.  VS retaken BP: 108/68 P: 76 R: 18 99% Sp02.  Pt ambulated, denied any dizziness.  Pt monitored 15 more minutes, mother driving pt home
Vomiting, fever , sent false readings to blood sugar meeting, coughing up mucous.
POST VACCINES AND BICILLIN C/O n/v, felt light headed, shortest of breath, throat tightness, periobital redness/swelling and blotching to face and neck. tx; Epipen, Benadryl 50 mg, 125 mg Solumedrol.
chest was tight; wheezy /wheezing; headache; exhaustion; chills; lung being foggy; woke up sweating; mild fever; This is a spontaneous report from a contactable consumer (patient herself). A 53-years-old female patient received bnt162b2 (BNT162B2; Lot number was not reported, Expiry date: Unknown), via an unspecified route of administration, as dose 1 single on 30Aug2021(at the age of 53 years) for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 31Aug2021, the patient experienced chest was tight, wheezy like a mild allergic reaction, but had no trouble breathing. This was the same reaction she has when she eats certain types of avocado. On an unspecified date in 2021, other symptoms she experienced included headache, exhaustion and chills. The patient described what she experienced post-vaccine as wheezing, lung being foggy, no pain but just mild wheezing and it did go away. She had to miss work yesterday and today. She woke up sweating and reported mild fever last night. Patient would like to know if her symptoms will be worse with the second dose of the Pfizer COVID-19 vaccine. The outcome of the events were reported as unknown.  The lot number/Batch number has been requested.
Patient reports that her arm was sore after vaccine administration about 2 hours later. She had trouble lifting something with the arm. She saw a medical provider shortly after who referred her to sports medicine and they informed her to follow-up with them in 3 months if not improved. She recently did so but didn't receive any treatment for it.
Information has been received from a registered nurse referring to an unspecified patient of unknown gender and age. Information about concurrent condition, drug reactions/allergies and medical history was unknown. Concomitant therapies included sterile diluent (manufacturer unknown). On 09-AUG-2017, the patient was vaccinated with improperly stored doses of VARIVAX (Lot # M042857, expiration date 21-OCT-2018, strength, dose and route unknown) for prophylaxis, the sterile diluent (manufacturer unknown) (lot# and expiration date unknown) used to reconstitute the vaccine above was properly stored. No adverse effects were reported. The vaccines were exposure at the temperature of 12.4 Fahrenheit (6 to 14 Fahrenheit) for 15 hours and 45 minutes. There was no previous temperature excursion. A data logger was involved. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1708USA008578: US-009507513-1709USA007601: US-009507513-1709USA007603: US-009507513-1709USA007604: US-009507513-1709USA007605: US-009507513-1708USA007019.
c/o pain, swelling & redness of arm where vax given;pneumovax given in other deltoid w/no problems; c/o t102;
Patient on ocrelizumab, fully vaccinated with Pfizer COVID-19 vaccine. Developed COVID-19 requiring ICU admission and mechanical ventilation. This is second patient in two weeks with identical story.
every sympotom listed except breathing problems; all the common side effects; weakness; nausea; fatigue; chills; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (every sympotom listed except breathing problems), ADVERSE EVENT (all the common side effects), ASTHENIA (weakness), CHILLS (chills) and NAUSEA (nausea) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported.).    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced CHILLS (chills). On 10-Apr-2021, the patient experienced ASTHENIA (weakness), NAUSEA (nausea) and FATIGUE (fatigue). On an unknown date, the patient experienced ADVERSE EVENT (every sympotom listed except breathing problems) and ADVERSE EVENT (all the common side effects). At the time of the report, ADVERSE EVENT (every sympotom listed except breathing problems), ADVERSE EVENT (all the common side effects), ASTHENIA (weakness), CHILLS (chills), NAUSEA (nausea) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment reported: acetaminophen. No concomitant medications reported.
This spontaneous report was received from a registered nurse and refers to an 83 year old male patient. The patient's concurrent conditions, medical history and drug allergies were not reported. The stock of vaccine was received in April 2016. On 16-NOV-2016, the patient was vaccinated with an improperly stored ZOSTAVAX lot # L046899 with expiration date of 28-FEB-2017 (dose, route and frequency were not reported) reconstituted with properly stored sterile diluent (MRK) for prophylaxis. No adverse effects were reported. It was stated that the vaccine underwent a temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 19 days. It was reported that there was no need to repeat vaccine. No previous temperature excursion. The call was not because of a "data logger". There was no Product Quality Complaint (PQC) involved. No further information was provided. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1705USA014052.
Employee received vaccine prior to end of shift. Upon follow up by staff, employee denied symptoms of any form. Employee went home and began experiencing episodes of facial flushing, extreme warmth and extreme cold, as well as a headache. Employee states they laid down and after resting  for an estimated 2 hours, symptoms had resolved. Employee denies any known changes in environment or routine with the exception of vaccine. Employee denies seeking medical care for complications following  initial outcome.
Patient reported symptoms of tachycardia and dizziness around 10 minutes after receiving the dose. She also reported blurry vision. An ambulance was called to the scene and EMS took her blood pressure, pulse, and blood sugar. All came back within normal limits. Patient was given water and EMS offered to take her to the hospital. Patient refused to be taken to the hospital. She was advised to stay for at least another 15 minutes. When she left the pharmacy she said she was feeling better. I called her at 2:30 pm to check on her and she stated she was feeling fine and "back to normal". I advised her to call the pharmacy if she has any questions and to seek medical help if symptoms come back.
Initial report was received from a health care professional on 14 June 2011 who is also the patient's husband. A 58 year-old female patient with a history of MS (multiple sclerosis) had received in November 2009 a first dose intramuscular injection of Influenza Vaccine (lot number, site and exact date of administration not reported). In February of 2010 the patient received a "four tier injection for spinal pain" and four days later experienced a collapse and exacerbation of MS. The patient was hospitalized (dates were not reported). No further information was available at the time of the report. The patient's outcome was not reported. The reporter for this case is the as for case 2011-03450. Documents held by sender: none.
11 month old patient rec'd Fluzone High Dose, no treatment necessary, no adverse reaction.
Pain at the injection site; Myalgia; Shivering; Fever; Upset stomach; Fatigue; 1st dose in 2019, 2nd dose on 2023; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in 2019 as 0.5 mg/ml dose in unknown deltoid via intramuscular route).   On 25-APR-2023, the patient received the 2nd dose of Shingrix (intramuscular, unknown deltoid) .5 ml. On 25-APR-2023, less than a day after receiving Shingrix, the patient experienced injection site pain (Verbatim: Pain at the injection site), myalgia (Verbatim: Myalgia), shivering (Verbatim: Shivering), fever (Verbatim: Fever), upset stomach (Verbatim: Upset stomach), fatigue (Verbatim: Fatigue) and drug dose administration interval too long (Verbatim: 1st dose in 2019, 2nd dose on 2023). The outcome of the injection site pain, myalgia, shivering, fever, upset stomach and fatigue were not resolved and the outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the injection site pain, myalgia, shivering, fever, upset stomach and fatigue to be related to Shingrix.     It was unknown if the company considered the injection site pain, myalgia, shivering, fever, upset stomach and fatigue to be related to Shingrix.   Additional Information: GSK Receipt date: 26-APR-2023 This case was reported by patient's wife. The patient's wife reported that her husband received his first Shingrix vaccine four years ago.  The patient received his second Shingrix vaccine one day before reporting and started symptoms last night which included pain at the injection site, myalgia, shivering, fever, upset stomach, and fatigue. The reporter stated that symptoms had not resolved this morning. The reporter was not willing to share mailing address, but did gave email. The reporter did not consent to follow-up. The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccination schedule.
fever; chills; fatigue; injection site soreness; Body aches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 20Oct2021 15:00 (Lot number: FF8841) at the age of 52 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing). Concomitant medication(s) included: AMBIEN taken for sleep disorder (ongoing); TYLENOL. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EN6199, Location of injection: Arm Left, Vaccine Administration Time: 03:00 PM), administration date: 30Mar2021, when the patient was 52 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3248, Location of injection: Arm Left, Vaccine Administration Time: 02:00 PM), administration date: 09Mar2021, for Covid-19 immunization. The following information was reported: PYREXIA (non-serious) with onset 21Oct2021 11:00, outcome "recovered" (22Oct2021), described as "fever"; CHILLS (non-serious) with onset 21Oct2021 11:00, outcome "recovered" (22Oct2021), described as "chills"; FATIGUE (non-serious) with onset 21Oct2021 11:00, outcome "recovered" (Oct2021), described as "fatigue"; VACCINATION SITE PAIN (non-serious) with onset 21Oct2021 11:00, outcome "recovered" (Oct2021), described as "injection site soreness"; PAIN (non-serious) with onset 21Oct2021 11:00, outcome "recovered" (22Oct2021), described as "Body aches". Therapeutic measures were taken as a result of pyrexia, chills, pain. Therapeutic measures were not taken as a result of fatigue, vaccination site pain.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination.Facility where the most recent COVID-19 vaccine was administered: Workplace clinic.  No follow-up attempts are possible. No further information is expected.
pt recv vax 21DEC95 & 28JUN96 pt lab results revealed the presence of meningitis;
Edema to left arm and hand- resident stated that the swelling was noted overnight, CRNP notified-
My 16 month old was crying in pain shortly after we returned home.  He then began limping and suddenly couldn't walk and resorted to crawling.  He doesn't have control of his gait and has been falling down for 5 days.
One day post vax, pt complained of hives, redness and warmth 2 X 1.5 inches at injection site.
Patient came to Pharmacy to show me she had a black and blue bruise where the vaccine was adminstired. She did not have any pain assoicated with the brusing. She felt completely fine.
ACUTE HYPOXEMIC RESPIRATORY FAILURE 11/15/2022  &   1/19/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
I had a sore arm right after vaccine but it was severe and didn't last long.  On the 13th, I had some unusual vaginal discharge. Went to the hospital to be evaluated for pre-term labor. I was having early contractions. I spent a week in the hospital. There were enough contractions last night that I came back in to be evaluated to do. Today I'm getting observed at the hospital - not sure if they will admit me or not. Pregnancy history - 2nd pregnancy; 1st - live birth at 34 weeks - she spent a week at NICU but is doing great now. Projected due date is July 13, 2021 for this pregnancy.
PHN administered Pfizer Biontech vaccine for 5-11years of age on 7/20/22 at 1545 in her Right deltoid. Patient observed in clinic for 15 minutes after injection. Mother of patient reported to PHN that patient states she is feeling dizzy at 1559. PHN attended to patient, patient able to hold a gaze, was able to stand and walk without difficulty. PHN brought patient to a private area checked vital signs. Blood pressure 115/73, Heart rate 83, O2 sats 99% temperature 97F, Respirations 20. PHN applied a cool rag to patients back of neck, patient took some sips of water. Patient reports she last ate pancakes at 0700, mom states she ate at 1030. Only thing patient has had t drink today was tang, unsure how much.  Patient declined any other symptoms, no Shortness of breath, no swelling in face or throat, no rash, no nausea, upset stomach, headache, or any other feeling of being unwell. Patient stated she no longer felt dizzy at 1614. Vital signs at that time 114/74, HR 86, O2 sats 99%, 97.2F, and RR 19. PHN continued to observe patient for 15 more minutes, but patient doing well, and no longer complaining of dizziness. Instructed parent on emergency numbers for clinic and care after hours needed. Informed CHAP and NP in clinic of patient's status after vaccination. No further interventions at this time.
This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's relevant medical history, concurrent condition and concomitant medication were not reported. On 23-OCT-2017 the patient was vaccinated with an expired dose of M-M-R II one vial, once subcutaneously (strength was not reported), for prophylaxis (lot number: L041456, expiration date: 22-OCT-2017) reconstituted with sterile diluent (lot number: M009799 and expiration date on 11-SEP-2018). There were not prior temperature excursions for M-M-R II or sterile diluent. None any other vaccinations were administered within the previous 4 weeks. Additionally, it was also reported that the pharmacist was informed about the potency of the vaccine which was still good. There were no injury or adverse effects reported from the patient.
No additional AE reported; Expired Recombivax HB was administered to a patient; Prior excursion of 49.2 F for 1 hour; This spontaneous report as received from a nurse referring to a 6-weel-old female patient. Information regarding patient's concurrent conditions, concomitant medications, drug allergies or reactions was not provided. Patient previous vaccinations include hepatitis B virus vaccine first dose.      On 12-NOV-2020, the patient was vaccinated with an expired and improperly stored second dose of hepatitis b vaccine (recombinant)(RECOMBIVAX HB) 0.5 milliliter, intramuscularly in the left leg thigh (LLT) lot # R012001 and expiration date 06-NOV-2020 for prophylaxis.      The vaccine had a excursion of 49.2 Fahrenheit degrees for 1 hour, no digital data logger was involved, no adverse effects were reported.
Information has been received from a physician concerning a 73 year old female with liver disease (unspecified) who was vaccinated IM with a dose of 0.5 ml PNEUMOVAX 23 vaccine in the left or right deltoid "within the last 2 months." The physician reported that the patient experienced a severe injection site reaction which impaired the use of the injection site arm (could not lift for 3 to 4 days) and had a fever over "103 degrees" and was in bed for 3 days. The patient sought medical attention and contacted the physician. At the time of the report, the patient recovered. The reporting physician considered injection site reaction, impaired use of injection site arm, (could not lift) and fever over "103" to be disabling. This is one of several reports received from the same source. Additional information has been requested.
Patient reports waking up around 3 AM on 3/5/2021 with fever, aches, headache, and chills. Reports taking Tylenol and feeling better around 10 or 11 AM. Then around 1:30 PM (24 hours later) patient reports being in kitchen preparing a sandwich and started to not feel well. Patient sat in chair to take blood pressure, while taking blood pressure patient passed out. Patient reports waking to grand-daughter rubbing back and she stated, "I passed out didn't I". Patient letting health care provider know. Patient reports having A-FIB 9/2/2021 was feeling sick, headache, and chest discomfort. Reports going to ER Monday September 7, 2020 after being tested for COVID-19. Reports Negative results for COVID-19. Reports passing out and having a 5 day stay in the hospital.
Swelling, redness. hot to the touch left arm. Pt was told to give Tylenol Q 4 hours. Warm packs to arm 3-4 x Q D x 10 minutes.