chrisvoncsefalvay/vaers-outcomes huggingface dataset:
at night, hives started on thigh, neck and all over the abdomen; headache, progressively got worse for 3 days; Itching; could not sit up because of the pressure; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (at night, hives started on thigh, neck and all over the abdomen), PRURITUS (Itching), MOBILITY DECREASED (could not sit up because of the pressure) and HEADACHE (headache, progressively got worse for 3 days) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination.     The patient's past medical history included Anaphylaxis and Asthma. Concurrent medical conditions included Hypersensitivity, Hay fever and Hives. Concomitant products included PROGESTERONE, VITAMIN B [VITAMIN B NOS], VITAMIN D NOS, DHEA, MAGNESIUM and FISH OIL for an unknown indication.   On 26-May-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 28-Apr-2021, the patient experienced PRURITUS (Itching) and MOBILITY DECREASED (could not sit up because of the pressure). On 26-May-2021, the patient experienced URTICARIA (at night, hives started on thigh, neck and all over the abdomen) and HEADACHE (headache, progressively got worse for 3 days). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at a dose of 1 dosage form and LORATADINE (CLARITIN [LORATADINE]) from 28-May-2021 to 30-May-2021 for Hives, at a dose of 1 dosage form. On 24-May-2021, PRURITUS (Itching) had resolved. On 26-May-2021, MOBILITY DECREASED (could not sit up because of the pressure) outcome was unknown. On 29-May-2021, HEADACHE (headache, progressively got worse for 3 days) had resolved. At the time of the report, URTICARIA (at night, hives started on thigh, neck and all over the abdomen) outcome was unknown.            Treatment medication were not reported. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Not applicable) was Not applicable.   This case was linked to MOD-2021-268117, MOD-2021-268117 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: Significant follow up received on 27Jul2021 contains itching as an event , relevant history and concomitant drugs.
This spontaneous report as received from a Registered Nurse refers to an unspecified number of patients of unknown age and gender. The patient's medical histories and concurrent conditions were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of VAQTA (administration route, lot numbers and expiration dates were not provided). No concomitant therapies were reported, neither was any adverse effect. This is one of several reports from the same reporter. Additional information has been requested.
Severe Headache, Muscle pain, Weakness, Fever 101 Also reddishness about 2 inches diameter at the site of vaccine
Cellulitis NOT at the injection site. Started with minor red irritation at injection site. Over a period of a few days, the redness increased and moved about 2 inches below injection site.  At that time, there was no redness at injection site. Over the course of a few days, the area grew from the size of a golf ball to bigger than a dinner plate and wrapped around my  bicep, and ended at elbow . Crimson red, hot to touch, painful and extremely swollen.  We marked the area every day to track growth and every day it got bigger and grew down my arm.  Finally went to doctors and was diagnosed with cellulitis. Was prescribed 10 days of Bactrim , 2 doses a day. Was told to use ice and Motrin for discomfort.
Mild soreness on lower back the day after, missed period of 26 days on otherwise regular cycle patient, still no Menstruation at the time of completing this form.
Was given vaccine at 1:45PM T: 97.5. Began feeling wheezy/tight chest at 3PM. No SOB. Continued normal activities by 5PM eyes became extremely bloodshot itchy, painful and very mucous filled. When I pressed on top or bottom of eyes copious amounts of yellow mucous. Eyes continued to be painful, swollen and red. Nose became red and productive cough developed. Took 25mg BENADRYL. Symptoms became manageable. That night had 1 episode of n & vomiting and achy. Next day woke feeling better and no signs and symptoms. Was if it never happened.
Moderate headache; Muscle pain; Chills; General feeling unwell; This is a spontaneous report from a contactable consumer (Patient). A 58-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, lot number and Expiration date was not reported), via an unspecified route of administration on 20Apr2021 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient experienced moderate headache, muscle pain, chills and general feeling unwell. The patient had four side effects that started on the third day after the vaccine. The patient had taken tylenol 500mg for her headache and it gives her some relief. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained
That evening I had chills followed by night sweats.  My heart beat was racing over 130 beats per minute for over 8 hours.  Headache, 104 degree fever, severe fatigue, pain at injection site, cough developed
Pt was given influenza vaccine with preservative - the box was mislabeled by the manufacturer.
Information has been received from a registered nurse referring to unspecified numbers of patients of unknown age and gender. There was no information about the patients' medical history and concurrent condition. On an unknown date these patients were vaccinated with improperly stored RECOMBIVAX HB (lot # K018180, expiration date: 17-SEP-2016 or lot # K020216. expiration: 17-SEP-2016; strength, dose and route unknown)(incorrect product storage). There was no information about concomitant therapy. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
About a week after I had my 1st shot, I came down with a case of Shingles About a week after my 2nd shot, I was diagnosed with Atopic Dermatitis
shingles outbreak; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In June 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, 3 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional information received were as follows: The reporter reported that about 3 days after receiving a dose of Shingrix, the patient experienced a shingles outbreak on his back about 2 inch by 4 inches.  The patient was seen by his physician and diagnosed with shingles and stated that it cleared up and resolved about one week later without treatment. The reporter consented to follow up.
patient received expired Daptacel vaccine/ no AE; Initial information received on 22-May-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to cases 2019SA143977 and 2019SA143976, same reporter.  This case involves a 5 years old male patient who received vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  The patients past medical history, and family history were not provided.  Concomitant medications included IPOL and PROQUAD VACCINE.  On 21-May-2019, the patient received a 0.5ml dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot C5202AA, expiry date 16-May-2019,  via intramuscular route in the left thigh.  It was an actual medication error due to expired vaccine used.  It was reported that patient received expired Daptacel vaccine.  The patient did not experience any adverse reaction after the injection.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.
Vaccine was administered by the nursing student. Patient stated that when the needle was removed from arm she saw a bunch of liquid squirt out of the needle. She was concerned that she did not get enough of the vaccine. Called and spoke to patient and consulted with student and Dr. at care services. Patient did not have a sore arm or any reaction to indicate that she got any of the vaccine. As directed to call patient and have them come to the clinic tomorrow Saturday March 6th to receive the 1st dose again.
The Patient received a 0.5 mL expired dose of ActHib with no AE; Initial information regarding an unsolicited valid non-serious case was received from the other health professional via Agency (Reference number- 00653461) and transmitted to Sanofi on 23-Jun-2021.  This case involves a 2 month old male patient who received a 0.5 mL expired dose of suspect HIB (PRP/T) VACCINE [ACT-HIB] [lot number: UJ324AA, expiry date: 14-Jun-2021], via an unknown route at the left thigh on 22-Jun-2021, for prophylactic vaccination (expired product administered).  On the same day, patient received PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13), DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE RHBSAG (YEAST), PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (PEDIARIX) and ROTOVIRIS as a concomitant medications.   Medical history, medical treatment, vaccination and family history were not reported.  It was a case of actual medication error due to expired vaccine used. (Latency: on same day)  At the time of report, no adverse event was reported.  At time of reporting, the outcome was of event reported as unknown.  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 the 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.
Pt felt unwell on the way home. Woozy and imbalanced. Dizziness and weakness. No swelling or difficulty breathing. No pain. Used the right arm because the left arm was affected by previous stroke. Redness left behind. Did not see PCP - blood sugar elevated from shot. Eventually regulated. Still not feeling the same.
Interchange of vaccine products; I am having some issues with those like allergies; Chest pressure; Drug from Sep2022 is a Booster for 2023 and it said that it expired; I realized that it had an expiration date of a whole year ago; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 74-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Apr2023 as dose 6 (booster), single (Lot number: GL0087, Expiration Date: Sep2022) at the age of 74 years for covid-19 immunisation. The patient's relevant medical history included: "Blood clots" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "Allergy" (unspecified if ongoing). Concomitant medication(s) included: XARELTO taken for thrombosis; CARDIZEM CD taken for hypertension. Vaccination history included: moderna (DOSE 1, LOT#: 011J20A), administration date: 11Jan2021, when the patient was 72-year-old, for COVID-19 immunization; moderna (DOSE 2, LOT#: 029L20A), administration date: 08Feb2021, when the patient was 72-year-old, for COVID-19 immunization; BNT162b2 (DOSE 3, 1st Pfizer Covid-19 vaccine, LOT#: FF8839), administration date: 15Sep2021, when the patient was 73-year-old, for COVID-19 immunization; BNT162b2 (DOSE 4, 2nd Pfizer Covid-19 vaccine, LOT#: FJ8762), administration date: 19Apr2022, when the patient was 73-year-old, for COVID-19 immunization; BNT162b2 (DOSE 5, 3rd Pfizer Covid-19 vaccine, LOT#: GH9693), administration date: 08Oct2022, when the patient was 74-year-old, for COVID-19 immunization. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious), outcome "unknown"; HYPERSENSITIVITY (non-serious), outcome "unknown", described as "I am having some issues with those like allergies"; CHEST DISCOMFORT (non-serious), outcome "unknown", described as "Chest pressure"; EXPIRED PRODUCT ADMINISTERED (non-serious), outcome "unknown", described as "Drug from Sep2022 is a Booster for 2023 and it said that it expired; I realized that it had an expiration date of a whole year ago". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of hypersensitivity.  Additional information: The patient received Flonase 20 mcg manufacturer unspecified guessed it was made in PRIVACY with Lot H8X, expiry date: Aug 2024. She mentioned that the number said was A142281 and it was Flonase. The first 2 were Moderna, they were all the rest have been Pfizer all 4 have been Pfizer.  The drug from Sep2022 was a Booster for 2023 and it said that it expired; she realized that it had an expiration date of a whole year ago. The patient had some issues with those like allergies or whatever since she took it, but the point was, she wanted to make sure that was actually covered by a Booster that Pfizer as she was suggested to take Booster. She has had little bit of chest pressure but it happened. For investigation the reporter mentioned that "They had just taken blood test to make sure that her A1C was good."
This spontaneous report was received from a medical assistant, referring to a 12 month old patient of an unknown gender. The patient's medical history, concurrent conditions or concomitant medication were not reported. On 08-JUN-2018, the patient was vaccinated with improperly stored doses of Oka/Merck VARIVAX lot # N024568, expiration date 07-SEP-2019 or lot # N029631, expiration date 23-OCT-2019, for prophylaxis (dosage information and route of administration were not informed). Other suspect therapies included MERCK STERILE DILUENT lot # M029682, expiration date 12-JAN-2019. No adverse effects were reported. It was also reported that the temperature and time frame were -14°C to -10°C (-12.7°C) for 20 minutes. There was no previous temperature excursion. A "data logger" was involved. This is one of several cases from the same reporter. Sender's Comments:  US-009507513-1806USA005053: US-009507513-1806USA012317: US-009507513-1806USA012319: US-009507513-1806USA012316.
Within 12 hours (Monday am), nausea, vomit, diarrhea, delirium and long-term deep sleep and semi-unconsciousness, incoherence, lack of muscular control a d loss of bowel control, fever up to 102 degrees. Partial recovery by Tuesday, full by Wednesday. Spouse said she was close to calling for ambulance.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05Jan2023 as dose 5 (booster), single (Lot number: CNS16785) at the age of 67 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history included: "some arthritis" (unspecified if ongoing), notes: some arthritis. Concomitant medication(s) included: BUPROPION, start date: 01Mar2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2023) Positive, notes: regimen prescribed by doc day after testing positive; (2023) Negative, notes: tested negative at day 9 post; (2023) Positive, notes: on day 12 post initial positive test; (2023) Positive, notes: converted to positive again. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Known allergies no. Other medication in 2weeks Yes. Paxlovid, Treatment start date: 02Feb2023, Treatment stop date: 06Feb2023, Indication: Treatment of COVID-19. I went through regimen prescribed by doc day after testing positive. Included prednisone (decreasing dosage), Famotodine, baby aspirin, extra Vit C, Vit D, and Zinc. I recovered nicely, tested negative at day 9 post, no symptoms. Over weekend started feeling fatigued, and on day 12 post initial positive test, converted to positive again.
Gave clinic prescription from doctor for Menomune but Menactra was given at 2 different locations 2 days apart. Client had told staff she had not recieved it yet.
About the 18th of March (one week after vaccination) sore gums and sores inside my mouth began to appear. They gradually became worse until my whole mouth was sore (difficult to eat and swallow).  I rinsed often with mouthwash and by Tuesday the 21st it was improving and better by Wednesday the 22nd.
REPORTING DUE TO VACCINE ADMINISTRATION ERROR--GIVEN 14 DAYS TOO EARLY. NO ADVERSE EVENT NOTED IN PATIENT.
7 minutes after getting vaccine I had a sudden onset of rapid heart beat and near syncope. The rapid heart rate continued and I was seen at urgent care who then told me to report to the ER. Symptoms continued through today 12/29/20.
LPN administered Pfizer COVID-19 pediatric dose of 0.2 ml IM out of orange Pfizer vial for ages 5-11 year old patients. Patient's mother was immediately notified via telephone on the same day once it was discovered that patient received a lower dose than what was required. No reported adverse reactions of vaccine verbalized by patient's mother.
Fever to 103, headache, "flu-like", myalgia  7/11/08 Reviewed hospital medical records of 6/25-6/28/2008. FINAL DX: no d/c summary available.  Admitted for febrile illness. Records reveal patient experienced flu-like symptoms, left arm pain at injection site, myalgias, arthralgias, ached all over.  Symptoms worsened.  Developed rigors, SOB, nausea, loose stools, confused, disoriented, chest pain that resolved spontaneously, & HA.  In ER, temp was 103.  Exam revealed lower abdominal tenderness, injection sites were w/o problems.  Admitted & ID consult done.
CHILLS FOR 5 HOURS; Loss of sleep; This is a spontaneous report from a non-contactable consumer, the patient. A 29-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the left arm on 06Apr2021 at 13:00 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. The patient has not reported any other health issue. The patient had no known allergies to medications, food or other products. Concomitant medication was not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6203) via unspecified route of administration in the left arm on 07Mar2021 at 12:00 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 06Apr2021 at 23:00, ten hours after the vaccination, the patient experienced chills for 5 hours and loss of sleep. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events chills and loss of sleep. The clinical outcome of the event chills was resolved on 07Apr2021 at 04:00 and the clinical outcome of the event loss of sleep was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
By history, 1 day after receiving HPV vaccine he came back to the clinic for blood work, and in the process, he became cold and clammy and felt almost like passing out. Glucose fingerstick done was 100.
Muscle soreness; Maternal exposure during pregnancy; This spontaneous retrospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) and MYALGIA (Muscle soreness) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025L20A and 043L20A) for COVID-19 vaccination.     Previously administered products included for an unreported indication: PROGESTERONE (Progesterone suppository to prevent shortening of cervix and but was stopped at 32 weeks.). Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. The patient's last menstrual period was on 23-Apr-2020 and the estimated date of delivery was 26-Jan-2021. On 30-Dec-2020, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). On an unknown date, the patient experienced MYALGIA (Muscle soreness). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirty-sixth week of the pregnancy. The delivery occurred, which was reported as Normal Pregnancy Outcome. For neonate 1, The outcome was reported as Delivered NOS. There were no complications, except the baby was in NICU for 3 days for respiratory issue because he swallowed some fluid while he was coming out. On 30-Dec-2020, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved. At the time of the report, MYALGIA (Muscle soreness) outcome was unknown.            No treatment products reported   This case was linked to MOD-2021-202164 (Parent-Child Link). This case was linked to MOD-2021-200726 (Patient Link).   See case MOD-2021-202164 for details regarding the child case.
Cellulitis in right thigh-warm, red, indurated area. AUGMENTIN was prescribed which helped in resolution. Resolved within 7-10 days.
nausea and diarrhea after 1st dose. 100.6 fever, and reports feeling like intestines were twisting up.
This was the second shot.  I didn't expect to get sick since I had been sick after the first one.  Symptoms were for the first night uncontrollable shaking, vomiting & light fever  (100).  This is the second day and I feel tired although I slept about 20:00 hours yesterday and 12 today.   Expect to recover tomorrow!
arm was sore for 2 days p/receiving vax; it hurt when lifting up;
I was called by immunization nurse. She told me pt developed involuntary movements after rolled eye with HPV administration.