chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021 at 9:34 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 15-Apr-2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 40.77   Concomitant products were not provided.  On 15-Apr-2021, Excursion time was 09 AM, temperature was 34, total doses given for the day was 188, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 06-Apr-2021, vial was moved to clinic on 15-Apr-2021. 18  vials were sent to clinic. Vaccine BUD date was 09-May-2021.  On 15-Apr-2021, vials were stored in cooler 1, at following time and temperature respectively, 8 AM: 00, 9 AM: 34, 10 AM: 36, 11 AM: 38, 12 AM: 39, 1PM: 43, 2 PM: 44, 3 PM: 44, 4 PM: 42 and 5 PM: 42.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a brand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
This case was reported by a consumer via call center representative and described the occurrence of tremor aggravated in a adult male patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included tremor. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced tremor aggravated. On an unknown date, the outcome of the tremor aggravated was recovered/resolved. It was unknown if the reporter considered the tremor aggravated to be related to SHINGRIX. Additional information received as follows: The reporter was an advocate for the Agency, a nonprofit that supports people with central tremor condition. The age at vaccination was not reported. The patient had a history of central tremor and reported that the condition worsened after he received the shot. The tremor eventually subsided. The reporter had no additional information to provide. The reporter was going to tell the patient to call GlaxoSmithKline response center for follow up.
Initially it was typical soreness at injection site but the pain has become progressively worse and has impacted range of motion in left shoulder currently 3 weeks post immunization.
Extreme chills where my body would not stop shaking, sweats, muscle aches, nausea, bad headache, tired. Took 2 Tylenol every 4-6 hours to help the headache. It lasted until Sunday morning. My nose felt stuffy when I woke up Sunday morning at which time there was blood in my nose. The rest of the day it was clear but a small amount appeared Monday morning as well. Both sides of my temples are sore to the touch as if they were bruised. Other than that and being weak the other symptoms are gone.
Information has been received from a registered nurse concerning 4 children, male and female, 10 to 13 years of age, who were inadvertently vaccinated with Zostavax (Oka/Merck) (lot #657559/0462U) instead of Varivax (Oka/Merck) (MSD).  The nurse stated this was a staff error only, and there was no product quality complaint.  Attempts are being made to obtain identifying information to distinguish the individual patients mentioned in this report.  Additional information will be provided if available.
Fever of 100.8 F., chills, headache, shivers, eye ache, left arm muscle pain
In May, 1999, the pt received the 1st dose of Lymerix, with no untoward effects. In June, 1999, he received the 2nd dose of Lymerix and during June, he reported experiencing pinpoint injection site pain which spread to his entire arm. He reported the pain sometimes feels like an "electrical shock" which settled in his shoulder. He reported decreased range of motion and decreased strength in the affected arm and shoulder. No treatment was given. The most recent information received on 6/14/00, reported the symptoms were ongoing.  Received on 09/21/2000: "Follow up from his physician reported "patient has bursitis of the shoulder.  No correlation with Lymerix."  The most recent information received on 09/19/2000 did not provide an outcome.  The events bursitis, shock-like feeling in arm, and decreased range of motion do not meet ICM serious criteria, but are being submitted expeditiously per FDA request.
Tingling in legs, felt like skin was crawling Left side pain in joints...shoulder, elbow, hip, knee, and ankle  Hot and cold flashes
Body ache; Fever; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Body ache) and PYREXIA (Fever) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    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 MYALGIA (Body ache) and PYREXIA (Fever). At the time of the report, MYALGIA (Body ache) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant information provided. No treatment information provided.
Fever greater than 101 - 48 hours Body chills - 48 hours Body aches - 48 hours Severe headache - 48 hours Chest pain - 48 hours Redness/soreness at injection site - 48 hours
warm to the touch; inflammed; itches really bad just like a mosquito bite; swollen again in the area of the shot; bright red; swollen; pain in the shot area; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (warm to the touch), VACCINATION SITE INFLAMMATION (inflammed), SWELLING (swollen), VACCINATION SITE PRURITUS (itches really bad just like a mosquito bite) and VACCINATION SITE PAIN (pain in the shot area) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0211321A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Heart attack in 2017. Concurrent medical conditions included Hypertension and High cholesterol. Concomitant products included METOPROLOL, ATORVASTATIN, CLOPIDOGREL and RANOLAZINE for an unknown indication.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, the patient experienced VACCINATION SITE PAIN (pain in the shot area). On 07-Apr-2021, the patient experienced SWELLING (swollen). On 13-Apr-2021, the patient experienced VACCINATION SITE WARMTH (warm to the touch), VACCINATION SITE INFLAMMATION (inflammed), VACCINATION SITE PRURITUS (itches really bad just like a mosquito bite), VACCINATION SITE SWELLING (swollen again in the area of the shot) and VACCINATION SITE ERYTHEMA (bright red). At the time of the report, VACCINATION SITE WARMTH (warm to the touch), VACCINATION SITE INFLAMMATION (inflammed), VACCINATION SITE PRURITUS (itches really bad just like a mosquito bite), VACCINATION SITE PAIN (pain in the shot area), VACCINATION SITE SWELLING (swollen again in the area of the shot) and VACCINATION SITE ERYTHEMA (bright red) outcome was unknown and SWELLING (swollen) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
7 cm x 9 cm red area noted at injection site along with small blister like areas. Started out as small red dot getting larger with each day.
first dose of covid vaccine 3/19/2021.  Also reports slowing down of her thinking process and frequent word searching when talking.  She had covid disease in 9/2020. It took her 6 weeks to recover partially. She continued to have headache, nausea and muscle weakness. Fatigue, dizziness/spinny sensation, headache, muscle weakness and tremors and nausea.  Has history of obstructive sleep apnea diagnosed in 2010. Has not used CPAP device in 9 years.  No vomiting or diarrhea no abdominal pain at present. No chest pain, no shortness of breath no fever no chills. No loss of sense of smell or taste.  Last week she developed some numbness in 1 side of her face associated with the headache.  She was evaluated at Hospital and was believed to have migraine headache as her CT scan of the head was unremarkable.
I started off with a runny nose. I had been exposed at work on Monday and Tuesday. When I got home from work on Thursday I contacted my insurance provider. They did not answer so I tested myself at home and it tested positive. I also tested with a PCR and it was positive as well. I only had the runny nose. I had very little soreness. Thursday I blew my nose a couple of times but I did not have anything else, so I think I was asymptomatic. I took Zinc, Vitamin C, Ginger, and Tylenol one day. I still feel kind of tired.
I have swollen arm and pain on the day of vaccination. Pained continued to be focused on the injection site for about 3 days after which my whole arm started to feel painful. The pain was not specific to the injection site after almost a week on the shot. The pain was not specific to one area. My whole arm was painful and it did not feel specific to the muscle. Even with extensive rest the pain won't go away.  using my arm for daily activities (washing dishes, writing/typing) was causing a little more pain. Wearing Backpack was causing more pain. My arm also felt numb, and heavy. I still feel the same pain, numbness and heaviness. Numbess is not continuous (i.e not all the time). I do not sleep on my arm and it still is painful. Sleeping on it will cause more pain. There  are times when I feel burning sensation that almost feels that it is within my veins. The pain and heaviness are still persistent at the same level. These symptoms are intefereing with my daily activities since my right arm is the dominant one.
Acute shoulder pain at site of shot, has spread underneath into armpit.  Fever and acute tiredness for 12+ hrs the day after, low fever and tiredness second day after.
Rash to abdomen and back; edema to injection site.  Complaints of itching 04/21/04.  Keflex 250mg three times a day.  Benadryl syrup 125cc every 6-8 hours.  Motrin syrup 200mg 6-8 as needed.
Developed chronic idiopathic urticaria that presents itself as full body dermatographia on 01/15/22. 12 days post 3rd Moderna Covid vaccine. Condition is chronic and has not changed over time. Treatment consists of 10mg Loratadine 20 mg Famotidine  (AM), 10mg Cetirizine 20mg Famotidine (PM), and 25mg hydroxyzine p.r.n when symptoms surpass the usual regimen.
On 3/20/2006. Pt came to office c/o swelling at site of injection and redness.
c/o pain in side, upset stomach, aches, pains, flu-like sx, severe h/a; states had been seeing a sinus specialist a/getting vax & was on Antihistamine;
Information has been received from a health professional concerning an adult female who on 11/1/05 was vaccinated in the deltoid with a 0.5ml dose of Pneumococcal 23v polysaccharide vaccine (lot 650302/1039P). ON 11/1/05, post vaccination, the pt called the office complaining of arm soreness, redness, swelling, and arm was warm to tough. The physician ordered diphenhydramine HCL Benadryl and told the pt to call back. She subsequently called back and said she was fine. At the time of this report, the pts outcome was unknown. Additional information has been requested.
This case was reported by a nurse and described a 55 yr old female pt who had a decreased response to the hep B vaccine recombinant (Engerix B) immunization series. On unspecified dates, the pt received three doses of Engerix B. Approx six weeks following the third dose of Engerix B, on 14Nov03, a hep B surface antibody titer was 2 mIU/mL. The nurse did not have the lot number for Engerix B available, but she did mention that five other pts received Engerix B from the same lot number and expiration date and all had a high titer of hep b surface antibody.
Hives discovered on upper trunk and appendages later in the evening when showering.  Patient stated mild itching throughout the day, but did not think hives were occurring. Patient stated he took Diphenhydramine 25 mg and slept in which the reaction resolved the morning after when he woke up.
Patient presented to the pharmacy today 3/23/23 stating that he was still experiencing pain in his right arm from the injections on 8/18/2022. He says he cannot sleep on his arm because of the pain, and that he cannot lift it high or work out due to lingering pain. I advised patient to seek medical care from his doctor.
11/19/2022 1:03pm patient was administered a pfizer bivalent pediatric 5-11 covid-19 vaccine in the left deltoid and a Flucelvax flu vaccine in the right deltoid. Promptly after removing the flu vaccine needle the patient leaned forward and lost consciousness in her chair. After leaning the patient back in the chair and repeating her name she regained consciousness and was fully responsive. Patient also showed pallor, sweating and anxiety. Lapse of consciousness was between 3 and 10 seconds long. Patient was given water and then blood pressure, heart rate and oxygen saturation were taken. Blood pressure read 90/55 mmHg O2 sat was 98% and HR 55 bpm. After 10 minutes she was allowed to be moved to another chair to be watched by her caregiver. Caregiver and patient left at 1:28 after no further incident.
Information has been received from a physician concerning a female with a history of 3 knee operations, who on 11-MAR-2007 was vaccinated with her first dose of Gardasil vaccine, IM (Lot# 654389/0961F). On approximately 14-MAY-2007, the patient was vaccinated with her second dose of Gardasil vaccine, IM (Lot# 65503/0012U). On 08-OCT-2007, the patient was vaccinated with her third dose of Gardasil vaccine, IM (Lot# 658650/1062U). Concomitant therapy included Ortho Tri-Cyclen. Shortly after 14-MAY-2007, the patient experienced headaches, extreme fatigue, light headed, shaky and weak "with a feeling of almost fainting". The patient continued to have those symptoms, but still received the third dose. The patient's headaches, extreme fatigue, light headed, shaky and weak "with a feeling of almost fainting", persisted with the patient having at least one symptom "just about everyday". The patient had blood work, CT of the head and CMP, which were all normal. The patient did not have any adverse experience after the first dose. Additional information has been requested.
Information has been received from a health professional concerning a 5 year old white male with no past medical history and no known drug allergies who on 03/25/1999 was vaccinated SC in the left arm with a first dose of varicella virus vaccine live (Lot # 928526/1673H). There was no illness at the time of vaccination. On 09/22/03 the pt developed approximately 20 pox. No fever was noted. Some itching was noted. Subsequently, the pt recovered on 09/27/03.  No relevant diagnostic tests or lab data were reported. There were no adverse events following prior vaccinations of the pt or his siblings. Additional information has been requested.
FIRST DOSE ONLY: Within 24hrs, developed fever 101.2, severe body aches, headache. Treated with OTC ibuprofen, On day 4, developed rash on torso (petechie, not itchy, lasted 2hrs). On day 7, developed cold sore (long history of cold sores).
Severe joint pain. Elbows, knees, toes, fingers, spine, shoulders. Menstrual cycle was late and different than usual. Less bleeding. Delayed start.
Patient was very anxious about receiving vaccines, said she was afraid of the medicine in the vaccine and not the needles. Cried before receiving the vaccine and during. Said she felt fine after. Left the booth then felt faint in the parking lot and sat down.
Information has been received from a physician via a company representative, concerning a female patient who was vaccinated with either a first dose or second dose of GARDASILl. Subsequently the patient experienced nausea after vaccination. The patient recovered within a day. The patient sought unspecified medical attention. Additional information has been requested. Follow up information confirmed thst no known person was identified or involved with the event.  Therefore, VAERS # 0702USA03636 is being deleted from our files.
Vaccine Administered Error.  Bivalent Booster should of been given.  No reaction reported.
Moderna COVID-19 Vaccine EUA.  Approximately 16 hours after the injection, I felt tired. As the day progressed (within 2-3 hours), I experienced a feeling of malaise and body aches and no appetite and a slight runny nose.  I took two (2) OTC Tylenol to relieve the pain (worked very well!) and consumed two (2) 12 oz cans of ginger ale over the next 8 hours.  Upon waking up (about 40 hours after the injection), I felt rested, alert and about 95% of great. No symptoms or other side effects whatsoever since.
My appetite is messed, not good; I am never gonna have appetite.; taste is sweet; throwing up; Diarrhea; A bad taste in my mouth; Headache; Chills; I get hot for a while then I get down cold.; that night my blood sugar was high; This is a spontaneous report from a contactable consumer (patient herself). A 72-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. Medical history included hypertension (Verbatim: Hypertension) and Blood sugar was high (Verbatim: Blood sugar was high) The patient's concomitant medications were not reported. The patient experienced her appetite is messed, not good; she never gonna have appetite, taste is sweet, throwing up, diarrhea, a bad taste in her mouth, headache, chills, she get hot for a while then she get down cold and that night my blood sugar was high on an unspecified date. Patient reported that she received a treatment. The outcome of events was unknown.  Information on Lot/Batch number has been requested.
Adacel dose was given subcutaneously instead of IM to a pregnant patient/ no symptoms; Adacel dose was given subcutaneously instead of IM to a pregnant patient/ no symptoms; Initial information received on 03-Jul-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 30 years old female patient who was exposed to vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] while she was pregnant.  Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known.   The gestation period at onset was 28 weeks. The date of last menstrual period was not reported. The estimated due date was not reported. The patients past medical history, concomitant medication and family history were not provided. The patient had unknown previous pregnancy/ies.  On 02-Jul-2019, the patient received a 0.5ml dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot number not reported via subcutaneous route in the left arm.  It was also a case of an actual medication error due to inappropriate route of vaccination as adacel dose was given subcutaneously instead of IM to a pregnant patient.  Lab data and prenatal testing was not provided.  Final diagnosis was adacel dose was given subcutaneously instead of IM to a pregnant patient.   It was unknown whether patient experienced any adverse reaction after the injection.   The patient outcome is reported as Not Applicable.  Additionally, at time of reporting, the outcome of the pregnancy is unknown.  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. Information on batch number was requested for this case.
Patient received vaccine Kinrix (combination of Dtap and Polio) and a separate IPOL (Polio) vaccine.  Staff thought Kinrix vaccine only contained vaccine for Dtap.  Patient received 2 doses of Polio.  No reaction was observed or reported.
Hot flashes; loss of period; menopausal symptoms within hours after injection and since then; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 46-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 46 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: HOT FLUSH (non-serious) with onset 12Oct2022, outcome "not recovered", described as "Hot flashes"; AMENORRHOEA (non-serious) with onset 12Oct2022, outcome "not recovered", described as "loss of period"; MENOPAUSAL SYMPTOMS (non-serious) with onset 12Oct2022, outcome "not recovered", described as "menopausal symptoms within hours after injection and since then".  Additional information: It was unknown if the patient receive any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown if the patient diagnosed with COVID-19 prior to vaccination. It was unknown the patient had been tested for COVID-19 since the vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Fever to 101; tx w/APAP; mom called both MD & cardiologist advised of nl rxn to vax; mom uncomfortable w/heart rate above 200 beats took pt to hosp;
21 X 25 CM swelling on L arm localized. warm to touch. No pus, no problems with breathing.