chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Swelling; Soreness in the arm; Warmth in the arm; Rash on the arm; Headaches; Chills; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Swelling), PAIN IN EXTREMITY (Soreness in the arm), FEELING HOT (Warmth in the arm), RASH (Rash on the arm) and HEADACHE (Headaches) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045J21A and 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, the patient experienced SWELLING (Swelling), PAIN IN EXTREMITY (Soreness in the arm), FEELING HOT (Warmth in the arm), RASH (Rash on the arm), HEADACHE (Headaches) and CHILLS (Chills). In 2021, HEADACHE (Headaches) and CHILLS (Chills) had resolved. At the time of the report, SWELLING (Swelling), PAIN IN EXTREMITY (Soreness in the arm) and RASH (Rash on the arm) had not resolved and FEELING HOT (Warmth in the arm) outcome was unknown.            No concomitant medications were provided. No treatment medications were reported.   This case was linked to MOD-2021-407682 (Patient Link).
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information has been received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 24-JUL2007, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), at a medical facility/office, as recommended for routine adult health maintenance for the prevention of shingles. ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On or about 22-AUG-2016, the patient was treated at a medical facility/office, for a blistering vesicular outbreak, that was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX, and or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The reporter considered the events to be related to ZOSTAVAX. The outcome of the events is unknown. Additional information has been requested.
Next day after the 2nd dose of the COVID vaccine patient began feeling fatigued and nauseous.  Then at urgent care, patient experienced difficulty breathing, tachycardia, and chest tightness. Patient also had a seizure and brief LOC. Patient went to urgent care, rapid response called and then transported to EMS to nearby hospital.
Temp elevation to 104.2, increased pulse, drop in O2 sat., irregular reparations, disorientation, followed by diarrhea
Took flu shots 23OCT92; 3 days later started cold sx & then turned into severe chest cold; was congested for 4 to 6 wks; no fever; little if any aching joints;
Information has been received on 09-JUL-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 23-OCT-2007, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route at a community hospital as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 03-JUL-2016, the patient was treated by a physician's assistant for a blistering vesicular outbreak, which was diagnosed as herpes zoster. The patient has been prescribed prednisone, tramadol and ketoconazole for management of her painful symptoms and excruciating pain. As a direct and proximate result of the ZOSTAVAX and/or despite receiving the ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Additional information has been requested.
injection site: red, warm and swollen; Arm had difficulty to raise due to sore.  Body aches; headaches; heart feels someone squeeze it time to time.
Expired Havrix administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 8-year-old female patient who received HAV (Havrix) (batch number 95EJ7, expiry date 6th February 2023) for prophylaxis.   On 7th February 2023, the patient received Havrix. On 7th February 2023, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 08-FEB-2023 Reporter's Comment: The medical assistant called to ask for information regarding the administration of an expired dose of Havrix to a patient.  The Vaccine was administered on 7th Feb 2023. The reporter asked how to proceed with this patient. The reporter consent to follow up. Additional Supportive Information: The patient received an expired dose of Havrix, which led to expired vaccine used.
the patient developed a rash all over her body as well as swelling of the hands; the patient developed a rash all over her body as well as swelling of the hands; This spontaneous report was received from a medical assistant via company representative and refers to a 4-year-old female patient. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On an unknown date in 2020, the patient was vaccinated with the second dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (exact dose, vaccination site, route of administration, lot # and expiration date were not provided) for prophylaxis. On the same date, the patient was vaccinated with the fifth dose of diphtheria toxoid, pertussis acellular 5-component vaccine, poliovirus vaccine inactivated (mrc-5), tetanus toxoid (QUADRACEL).  On an unknown date in 2020, the patient developed a rash all over her body as well as swelling of the hands. The patient sought medical attention. It was reported that no hospitalization was needed.The outcome of the events was unknown.  The causal relationship between the events and the suspect therapies was not reported.
Numbness of tongue, welts on arms and stomach, blistering in mouth and throat, passing blood in urine, bladder shut down, kidney cystic blistering.  Kidney surgery, partial or full removal 5/15/2023
Information has been received from a certified medical assistant concerning three patients who were vaccinated with Gardasil. Subsequently, the patients were closed to fainting or fainted (patient outcomes not provided). Attempts are being made obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available. The same source provided information concerning the experienced of other patients (WAES#0703USA01200 and WAES#0703USA04318).
On 10/25/12 pt developed a raised, red, itchy rash with hives which continues on 10/30. Pt taking BENADRYL & Hydrocortisone cream. Rash persists.
The patient is immunosuppressed and received the second booster, received 0.5 ml instead of 0.25 ml
Morbilliform rash located to face, arms, hands, legs, abdomen, chest. symptoms started 1 hour after getting 2nd pfizer vaccine.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 72-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Apr2022 as dose 4 (booster), single (Lot number: FMO), in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 19Jan2021 as dose 1, single (Lot number: 011620A), in left arm, on 19Feb2021 as dose 2, single (Lot number: 024M20A), in left arm and on 27Oct2021 as dose 3 (booster), single (Lot number: 032FF21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Breast Ca Spleenectomy" (unspecified if ongoing), notes: Other medical history: Breast Ca Spleenectomy; "R knee replacement" (unspecified if ongoing), notes: Other medical history: R knee replacement; "laryngeal stenosis" (unspecified if ongoing), notes: Other medical history: laryngeal stenosis; "Known allergies: Sulfa" (unspecified if ongoing), notes: Known allergies: Sulfa; "Vaccine brand: Pfizer/BioNTech, vaccine dose number: 4/vaccine brand other: Moderna, vaccine dose number: 3" (unspecified if ongoing), notes: Pfizer/BioNTech, vaccine dose number: 4/vaccine brand other: Moderna, vaccine dose number: 3. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid from 26Jul2022 to 29Jul2022.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Drug ineffective depends on many factors including pharmacokinetics, severity of disease and patient general health condition. However on conservative basis, the possible causality cannot be excluded.
pt recv vax 26JUL96 & 8JUL97 pt devel chickenpox w/300 lesions;pt exp a fever of 102 on 8JUL97;pt recovered from sx by 15JUL97 or 16JUL97;
D ouble Vision. Required hospitalization. Diagnosis 3rd cranial nerve palsey.  Vaccine was also given wit RSV vaccine Abrysvo lot HF5018 IM in left arm
Given Moderna 1st dose on 6/1/21 at 17yrs old.  Moderna currently approved for 18 yrs and older.   Gave 2nd dose 6/30/21 to complete series per recommendations.
Achiness, chills, headache over several days, resolved in part by Tylenol 1000mg, q 4 hr p.o.  daily
Information has been received from a nurse referring to multiple patients of unknown age and gender. On unknown dates the patients were vaccinated with improperly stored dose of GARDASIL 9 (lot # M005714 with expiration date of 03-OCT-2017; strength, dosage, frequency and route unspecified). No adverse effects were reported. This is one of two reports received from the same reporter.
WARM, REDDENED AREA ON ARM OF INJECTION. THE REDDENED AREA MEASURES ABOUT 4X5 INCHES AND IS LOCATED APPROXIMATELY 2 INCHES BELOW THE VACCINATION INJECTION SITE. THE AREA BECAME RED AND WARM 9 DAYS AFTER VACCINATION. PREVIOUS TO THIS REACTION, I ONLY EXPERIENCED PAIN IN THE ARM OF INJECTION ON DAYS 2-3 POST VACCINATION.
Information received from a physician concerning a 7 year old pt who on 04/08/2002 was vaccinated with a dose of varicella virus vaccine, live. On 08/03/2002 the pt experienced breakthrough varicella.  There were less than 50 lesions. Unspecified medical tx was sought, but there was no treatment or hospitalization. The pt recovered. No product quality complaint was involved. This is one pt out of 40 reported. Thirty nine cases ( WAES 0407USA01446, 0409USA01885 and 0409USA01857 through 0409USA01893) experienced breakthrough varicella after vaccination with varicella virus vaccine live. Additional information is not expected.
flu-like symptoms began a few hours after the vaccination and lasted a day. Specifically, lethargy, low-grade fever, muscle soreness, and chills. Also, soreness at the injection site lasted four days.
This spontaneous report as received from a nurse refers to an 8 months 28 days old male patient. No concurrent condition, medical history of allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) LIQUID PEDVAXHIB injection, lot # K016965, exp. date: 20-JUL-2017 (dose, strength and route unspecified). No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
3am-pinpoint to slightly larger papules, reddened, itchy rash developed to back of thighs, progressing to back of calves, later to anticubital. Rash resolves with Benadryl/topical hydrocortisone, but returns randomly somewhere on an extremity only 4-6hrs later. No rash on face or torso.  No other symptoms. Referred to physician.
THIS WAS MY FIRST DOSE OF THE MODERNA VACCINE: 5 minutes after I had the vaccine, I started feeling off.  I felt completely out of it, I went pale, shaking.  The EMT's were with me and checked my pressure.  It was through the roof.  I'm otherwise a healthy person with BP regularly of 120/80. My BP at 3:20 PM -- 148/96   3:35 pm - took one 25 mg of Benadryl.  3.45 -  BP 139/92 3.52 -  BP 122/88 3.55 - Took a SECOND benadryl pill 25 mg.   (throat felt heavy when swallowing) 4.20 -  BP 120/82 EMT stated that it was an ALLERGIC REACTION cause VASO VAGAL SYMPTOMS.  My throat felt swollen (I have NEVER experienced this before).  I was sitting in the car for almost 2 hours before I felt somewhat comfortable to go home.  My husband drove me home.
Red rash, swelling, itching at injection site. Symptoms beginning to resolve, but not completely gone. Advised pt to take Benadryl by mouth and use hydrocortisone cream topically.
Pain; Sweat; Fever; Chills; Body aches; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain), HYPERHIDROSIS (Sweat), PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Body aches) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced PAIN (Pain), HYPERHIDROSIS (Sweat), PYREXIA (Fever), CHILLS (Chills), MYALGIA (Body aches) and FATIGUE (Tiredness). The patient was treated with PARACETAMOL (TYLENOL) for Myalgia, Chills, Fever, Pain, Sweaty and Tiredness, at an unspecified dose and frequency. At the time of the report, PAIN (Pain), HYPERHIDROSIS (Sweat), PYREXIA (Fever), CHILLS (Chills), MYALGIA (Body aches) and FATIGUE (Tiredness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.
Left arm swollen,bright  red, hot, itchy in wide strip3? below the injection. Redness and swelling goes 3/4 of the way around the arm. The  area is about 3-4? wide from top to bottom. Received the injection 10/26/2023. Today is 10/28/2023. Symptoms are slightly better less redness and itching.
ACUTE HYPOXEMIC RESPIRATORY FAILURE ACUTE PULMONARY EMBOLISM HYPOXEMIA
Erythema, Pain, Edema over Lt Deltoid and upper arm.  Dx of cellulitis.  Tx'd with Rifampin / Septra DS
One day after vaccine and again six days after vaccine experienced numbness of lips and tongue-no difficulty breathing-I took benadryl and the symptoms resolved by the next day
Customer received her first covid vaccine.  After about 10 minutes, she came up to the pharmacy counter stating that she did not feel right and that she was having difficulty breathing.  We could hear her wheezing.  I called 911.  They told us to have her lay down and not eat or drink anything.  They told us not to administer the epipen.  They ambulance came and they took her to the hospital.
Fever, of 100.2, chills, nausea, vomiting yellow thick mucus at 6 am 4,19,21.    This also happened on my first shot dated 3,27,21
Were administered improperly stored VARIVAX; No adverse effects; This spontaneous report has been received from a medical assistant referring to unspecified patients of unknown age and gender. The patients' pertinent concurrent conditions, medical history and drug reactions or allergies, if any, were not provided.   The medical assistant reported that, on an unknown date, the unspecified patients were vaccinated with unspecified doses of varicella virus vaccine live (Oka/Merck) (VARIVAX) (dose numbers, route of administration and anatomical locations of administration were not provided; lot number R030606 with expiry date on 23-OCT-2020; lot number reported as R030847 with expiry date on 22-OCT-2020; lot number R026715 with expiry date on 18-SEP-2020; lot number R023504 with expiry date on 16-AUG-2020; lot number R022117 with expiry date on 02-AUG-2020; and lot number R020650 with expiry date 18-JUL-2020) for prophylaxis; and with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) rHA (dose numbers, route of administration and anatomical locations of administration were not provided; lot number S000623 with expiry date on 06-JUL-2020; lot number R030794 with expiry date on 22-APR-2020; lot number R030801 with expiry date on 22-APR-2020; and lot number R021102 with expiry date on 20-JAN-2020) for prophylaxis.   Lot number R030847 is an invalid lot number for varicella virus vaccine live (Oka/Merck) (VARIVAX).   The doses of varicella virus vaccine live (Oka/Merck) (VARIVAX) and Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) were exposed to a temperature excursion of -14 Celsius degrees to -10 Celsius degrees (-11.5 Celsius degrees) for a time frame of 46 hours and 15 minutes, which was not detected by the Digital Data Logger. There was a previous temperature excursion of -14 Celsius degrees to -10 Celsius degrees (-10.6 Celsius degrees) for 2 hours. No adverse effects were reported.   This case has been considered to be non-valid, since patients' identifiers were not provided.  Follow-up information has been received from the medical assistant on 23-MAY-2019. It was confirmed by the reporter that unspecified 1-year-old patients of unknown gender were vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX).Also, additional lot numbers for varicella virus vaccine live (Oka/Merck) (VARIVAX) were provided: lot # R034394, which was verified to be a valid lot number, with expiration date reported as 27-NOV-2020, but upon internal validation established as 04-DEC-2020; lot #R035222 with expiration date 04-DEC-2020 and lot # R030487 with expiration date 22-OCT-2020. The reporter mentioned that there have been 113 doses of the vaccines administered, however it was not specified how many doses of each vaccination were administered. There have no reports of adverse events following the vaccinations.   Upon receipt of follow-up information it was determined that this case is now valid because patients' identifiers were provided. This is one of two reports received form the same reporter.; Sender's Comments:  US-009507513-1906USA002535:
Patient experienced dizziness shortly after injection. Patient laid down on the ground while pharmacy staff called 911. Medics arrived, took his vitals, patient remained conscious and was alert.  Medics determined patient was feeling better and was able to walk off by himself without any help.
Initial literature report received on 01 Nov 2010: This patient participated in a prospective cohort study to evaluate T cell responses as correlates of protection against influenza following vaccination in older adults. The patients were vaccinated with Influenza virus vaccine 2007/2008 (manufacturer unknown, batch number: unknown) during the fall of 2007. The influenza surveillance was initiated at two study sites at the start of the influenza season in Jan 2008. The mean age of the study subjects was 74 years (range 60-92). Patients started reporting influenza-like illness symptoms. When reported symptoms met the ILI criteria and were within 5 days of onset, a nasal swab for detection of influenza virus was obtained during a home visit or a clinic visit. A laboratory diagnosis of influenza illness was confirmed by the detection of influenza virus in a polymerase chain reaction assay of the nasal swabs or a 4-fold or greater rise in the antibody titer after the illness. Subjects that met both clinical and at least one of the laboratory criteria were identified as laboratory-confirmed influenza. This patient had an antibody titer value of 5, 20, 10, and 10 after 0 weeks, 4 weeks, 10 weeks and 20 weeks of vaccination respectively. The patient did not have 4-fold increase in titer value and tested negative for seroconversion of strain but PCR tested positive. Therefore this patient was considered as an case of Influenza A/H3N2. The outcome was not reported.
Seizure 5/17/08. 5/17/08 Sent to hospital. 5/18/08 Transfer to another hospital.  6/23/2008 MR received for DOS 5/18-20/2008 with DX: Seizures. Infant presented after an episode of unresponsiveness following what was thought to be a choking episode. Infant had been unually sleepy prior to incident. In ER, pt had another episode of flailing of arms and legs followed by unresponsiveness, which self resolved. Had a 3rd event lasting 15-20 minutes. Loaded with Phenobarb with gradual return to baseline.
Vaccinated patient with Moderna Booster, but instead of (0.25 ml) we gave patient full dose (0.5) we called patient to let them know , he is feeling fine.
Pt developed hives at home, was given Benadryl at home. Pt was doing better but hives came back when Benadryl wore off. Mom gave Benadryl again. No anaphylactic symptoms.
received Moderna COVID-19 vaccine dose #1 on 01/20/2021. On 4/28/2021 he inadvertently received Pfizer COVID-19 vaccine for dose #2.
Syncopal event immediately following vaccine administration. Patient was placed in a laying position with feet raised and given water for hydration. They were monitored closely and had 3 total syncopal events separated 3 to 5 minutes apart and lasting  10 to 15 seconds with loss of consciousness and no injuries. Patient declined further medical treatment and was monitored by pharmacist for 30 more minutes until they were able to walk away from pharmacy on their own.
Extended full body chills and convulsions, extended rapid heartbeat and pulse, full body muscular and joint pain, full body exhaustion
Redness and swelling at site one week post injection - had quarter size nodule 1 week after injection.