chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Chills; Nausea; Stomach aches; Vomit; cannot eat very well without feeling disgusted; cannot eat very well without feeling disgusted; Fatigue; just feel like a hazy dream.; This is a spontaneous report from a contactable consumer, the patient. A 22-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the left arm on 06May2021 at 02:30 (at the age of 22-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant past medical history. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included escitalopram oxalate (LEXAPRO), lurasidone hydrochloride (LATUDA) and amfetamine aspartate/amfetamine sulfate/dexamfetamine saccharate/dexamfetamine sulfate (ADDERALL); all taken for an unknown indication on an unknown date and unknown if ongoing. On 08Jan2021,the patient underwent lab test and procedures which included nasal swab test and the result was found to be negative. On 15Apr2021, the patient received unspecified "tinnitus shot" via an unspecified route of administration in the left arm within 4 weeks prior to the vaccination. On 07May2021 at 17:15, on the second day, the patient had chills, nausea, stomach aches and vomit until stomach acid was coming out. She could not eat very well without feeling disgusted but symptoms were kind of light now. She had nausea and fatigue for the past 5 days. On 11May2021 (day 6), the patient just felt like a hazy dream. The events did not result in doctor 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. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events chills, nausea, stomach aches, vomit, cannot eat very well without feeling disgusted, fatigue and hazy dreams was not recovered at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by patient's friend.  The age at vaccination was not reported. The reporter stated that the patient suffered with shingles after taking the Shingles vaccine, why there were class action lawsuits, but we did not want to talk about that part. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation shingles was not reported. The case has been linked with the case US2021AMR174882 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR174882:same reporter
Feels faint, dizzy, unable to stand about 1.5 hrs after vaccination. Vital signs taken, bed rest with foot of bed elevated. EMS called and transported to local ER after 1.5 hrs monitoring and continued faintness.
Significant reaction; patient's arm felt significantly injured around the joint/something was physically attacking area around joint; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Significant reaction) and JOINT INJURY (patient's arm felt significantly injured around the joint/something was physically attacking area around joint) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     Concurrent medical conditions included Osteoarthritis.    On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jan-2021, the patient experienced VACCINATION COMPLICATION (Significant reaction) and JOINT INJURY (patient's arm felt significantly injured around the joint/something was physically attacking area around joint). At the time of the report, VACCINATION COMPLICATION (Significant reaction) and JOINT INJURY (patient's arm felt significantly injured around the joint/something was physically attacking area around joint) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, X-ray: abnormal (abnormal) Osteoarthritis.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications was not provided by the reporter. Treatment information was not provided.    This case was linked to MOD-2021-293274 (Patient Link).
fever up to 104, swollen glands, severe rash trunk & lower ext mainly, general malaise; came down w/chicken pox 2 days p/mealse rash-disappeared;
Headache, Myalgia, Arthralgia, NauseaVomting, Exhaustion, decreased appetite, Left axillary tenderness and swelling Narrative:
Got Bronchitis; still haven't gotten my second dose; What if I get the second dose after 3 months; This spontaneous case was reported by a consumer and describes the occurrence of BRONCHITIS (Got Bronchitis), PRODUCT DOSE OMISSION ISSUE (still haven't gotten my second dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (What if I get the second dose after 3 months) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In May 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BRONCHITIS (Got Bronchitis), PRODUCT DOSE OMISSION ISSUE (still haven't gotten my second dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (What if I get the second dose after 3 months). At the time of the report, BRONCHITIS (Got Bronchitis), PRODUCT DOSE OMISSION ISSUE (still haven't gotten my second dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (What if I get the second dose after 3 months) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant information was reported. No Treatment information was reported. Patient has stated that patient had wait until the event bronchitis got resolved.
Within hours of injection, soreness in arm, fatigue and light headedness Beginning at 11:00 muscle aches throughout entire body, massive headache and fever. Fatigue.  Lasted through the night and started to fade later afternoon. By evening experiencing mild muscle aches and low fever and arm soreness. No food, lots of water and acetaminophen for pain and fever.
Started having general weakness in hands and feet. Weakness spread up my legs into my quads. Limbs felt tingly, almost like they were falling asleep, but I still had full sensation in them. Also had hot shocks all over body and face.  Intermittent itching all over body.  After the symptoms started they continued to worsen throughout the week. I went to the emergency room once the tingling had crossed my knees and reached my upper legs. Symptoms peaked roughly 10 days after initial onset, following this they slowly decreased in intensity. I still have symptoms but they are greatly reduced from the initial peak.
Information has been received from a registered nurse concerning a 13 year old male with asthma and allergies to amoxicillin and CEFZIL who on 23-OCT-2008 was vaccinated with a 0.5 ml dose of PNEUMOVAX 23 intramuscularly, which had expired on 04-OCT-2008, and a dose of VARIVAX (MSD) subcutaneously, both in the left arm. Concomitant therapy included albuterol and montelukast sodium (MSD). On 24-OCT-2008, one day after vaccination, the patient developed a fever of 102 F and "a sore left arm". On 26-OCT-2008 the patient recovered from the fever and soreness without requiring treatment. No lab tests were performed. Unspecified medical attention was sought. Follow-up information was received from the registered nurse which reported that patient also had allergy to dust mites and no illness at time of vaccination. It was reported that on 23-OCT-2008 the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # 655054/0749F) in the deltoid. The vaccine was expired on 04-OCT-2008. Because of only 10 days expiration, the Doctor of Medicine (MD) decided not to revaccinate. The patient was seen by the physician and mentioned that the arm was sore and had 102 fever for days. Additional information is not expected.
Caller and his wife used a Paxlovid prescription back in 19Sep; Caller and his wife used a Paxlovid prescription back in 19Sep; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Caller and his wife used a Paxlovid prescription back in 19Sep". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient and his wife used a Paxlovid prescription back in 19Sep and it worked perfectly with no problems and wanted to know how long to wait before getting the new Pfizer Vaccination for Covid-19.   The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300172107 same reporter/product/event, different patient;
Jynneos vaccine administered intradermally; Case reference number US-BN-2022-002033 is a spontaneous case report initially received on 23-Aug-2022 from a consumer via agency (reference number: USBAV22-1138) and concerns a male patient of unknown age.  The patient's medical history and concomitant medication details were not provided.  On 15-Aug-2022, the patient was vaccinated with the first dose of Jynneos vaccine (smallpox and monkeypox vaccine, live, nonreplicating; batch number: unknown) at unknown dose, administered intradermally and at unknown site, for an unknown indication (explicitly coded as 'inappropriate route of vaccination').  At the time of this report, it was unknown if the patient experienced any adverse event due to Jynneos.  Additional information received on 24-Aug-2022 included local BN case ID.; Reporter's Comments: A male patient of unknown age was vaccinated with the first dose of Jynneos vaccine administered intradermally and at unknown site, for an unknown indication, which is considered as inappropriate route of vaccination. No associated adverse events were reported. Inappropriate route of vaccination is listed per company convention. The patient's medical history and concomitant medication details were not provided. Inappropriate route of vaccination is not related to Jynneos, but to a human factor. The case is non-serious.; Sender's Comments: A male patient of unknown age was vaccinated with the first dose of Jynneos vaccine administered intradermally and at unknown site, for an unknown indication, which is considered as inappropriate route of vaccination. No associated adverse events were reported. Inappropriate route of vaccination is listed per company convention. The patient's medical history and concomitant medication details were not provided. Inappropriate route of vaccination is not related to Jynneos, but to a human factor. The case is non-serious.
I had my vaccination on 09/13/2022. On 01/09/2023 I had a very sudden onset of inner ear issue and was diagnosed with Benign Paroxysmal Positional Vertigo that resulted in severe dizziness. In 12/2021 to 02/2022 I did have an awful sinus infection which was prolonged and had a long time to recover. I could not do antibiotics due to reactions to medications. My sinuses have not been the same since that illness. I tested COVID negative during this whole duration. They gave me meclizine and referred to a Vestibular specialist. I am still presently dealing with the inner ear issue and I am being followed by an Ear Nose and Throat Specialist. I do have a follow up 04/2023.
intense pruritis accompanied by an urticarial rash and erythema multiforme over the trunk and extremities lasting 6 hours and treated with chlorpheniramine 4 mg  q4h and loratadine 10 mg tid and topical 0.8% lidocaine gel.  Afebrile. Duration of treatment approximately 12 hours. (Photos of rash are available with date and time stamp).
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 02-OCT-2015, the patient was vaccinated with improperly stored (Oka-Merck) PROQUAD with lot number: L026728, expiry date: 15-JAN-2017 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Morning after, slight achiness and dizziness. At 22 hours, liquid bowel and diarrhea with heavy intestinal cramping lasting at least 6 hours intermittently.
patient started developing a rash 4 days after vaccine. Rashes are located in different locations such as wrist, forearm, underarm, each leg near knne, one on chest. Patient does not report any SOB or issues breathing.
The pt said devel a sunburn-like rash on face & that noc was wheezing; the next day both of hands were numb; later felt tingly;
Patient was given a half dose (we were administering booster doses and the nurse didn't realize that this was the patient's first dose of the vaccine).  I caught the error later on in the day while reconciling the Covid-19 Vaccine Screening forms for that date of service.   We have called the patient numerous times since 5/23, reached him today, 5/26 and he asked if he can come in tomorrow, 5/27 for the additional 0.25 dose.  We said okay since the interim recommendation for this type of administration error is to: repeat dose immediately with no minimum interval.  Given patient's age, we will schedule his second dose of Moderna, 8 weeks from 5/23.
Itching, red and tenderness at injection site seven days after shot. Feeling extra tired and headaches.
Starting 11 hours after administration started having body aches which continued for 17 hours.; Developed fever with highest being 101.4 at 26 hours after vaccination.; Nausea & vomiting occurred at 26 hours post vaccination & lasted 8 hours.; myalgia; Nausea & vomiting occurred at 26 hours post vaccination & lasted 8 hours.; This is a spontaneous report from a contactable Nurse (patient's parent). A 16-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: ER8736, and Expiration date: Unknown), intramuscular, administered in left deltoid on 18May2021 17:35 (at the age of 18-year-old) as dose 2, single for COVID-19 immunization, at other facility. The patient medical history included Fever on 22Jan2021 (Seriousness criteria: Not Serious, Outcome: Recovered, Treatment: No), seasonal allergy, and headache. Concomitant medications included loratadine (CLARITIN [LORATADINE]) taken for seasonal allergy, cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) taken for seasonal allergy and ongoing, and ibuprofen (MOTRIN [IBUPROFEN]) taken for headache from 13May2021 and ongoing. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EW0169, and Expiration date: Unknown), intramuscular, administered in left deltoid on 27Apr2021 16:40 (at the age of 18-year-old) as dose 1, single for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. No relevant testes were done. It was reported that, on 19May2021 04:00, the patient experienced "Starting 11 hours after administration started having body aches which continued for 17 hours". On 19May2021, developed fever with highest being 101.4 at 26 hours after vaccination. "Nausea & vomiting occurred at 26 hours post vaccination & lasted 8 hours" and additionally experienced myalgia on the same day. The patient underwent lab tests and procedures which included body temperature: which showed 101.4 on 19May2021 (Developed fever with highest being 101.4 at 26 hours after vaccination). No treatment was received for the events. The reporter considered that the Pfizer product had a causal effect to the adverse event. The device date was reported as 24May2021. It was reported that the autopsy information was not applicable for this report. The outcome of event myalgia was reported as resolved on an unspecified date in 2021. The outcome of other events reported as resolved on an unspecified date in May2021.  Follow-up attempts are completed. No further information is expected.
bleeding; burning; itching; sores; raised patches; This is a spontaneous report received from a contactable consumer (patient).  A 53-year-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in arm left on 14May2021 12:30 PM (Batch/Lot Number: EW0177) as single dose for COVID-19 immunisation, administered at church.  Medical history included psoriasis on her scalp since childhood and ongoing, C-sections in 1997 and 2001, hypothyroidism from 2005 and ongoing, Lupus anticoagulant from 2012 and ongoing, hysterectomy from 2012 to Dec2020 (as reported), hernia repair from 2012 to Dec2020 (as reported), anxiety, gastrooesophageal reflux disease (GERD). Concomitant medication(s) included levothyroxine sodium (SYNTHROID) at 50 mcg taken for hypothyroidism from an unspecified start date and ongoing; rivaroxaban (XARELTO) at 10 mg taken for lupus anticoagulant from an unspecified start date and ongoing; pantoprazole (PANTOPRAZOLE) at 20 mg taken for gastrooesophageal reflux disease from an unspecified start date and ongoing; escitalopram (ESCITALOPRAM) at 10 mg taken for anxiety from an unspecified start date and ongoing. The patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in arm left on 16Apr2021 12:30 PM (Batch/Lot Number: EW0161) as single dose for COVID-19 immunisation, administered at church, and on 17Apr2021 her scalp started to itch significantly (no treatment received).  On 15May2021 the patient experienced bleeding (medically significant) with outcome of not recovered, burning (non-serious) with outcome of not recovered, itching (non-serious) with outcome of not recovered, sores (non-serious) with outcome of not recovered, raised patches (non-serious) with outcome of not recovered.  The course of events was as follows: The patient had psoriasis on her scalp since she was a child. It went into remission on her 20's and returned in mild form in her late 40's. After her first COVID vaccine her scalp started to itch significantly. After her second shot her scalp has gotten significantly worse with raised patches, bleeding, sores, and burning and itching. She saw a dermatologist and then prescribed clobetasol. The patient underwent lab tests and procedures which included chest X-ray: normal on 17Mar2021, echocardiogram: normal in Mar2021, electrocardiogram ambulatory: normal   on 25Mar2021, mammogram: normal on 17Mar2021.  New med clobetasol for scalp was given as treatment.
Swelling in her left arm; Cannot move her left elbow due to the swelling and severe pain; Severe pain in left arm; blisters on hand, neck; pustules on neck and left arm; A few blisters on her hand and neck, progressively gotten worse; A spontaneous report was received from a nurse reporting on behalf of herself, a 39 year old female patient who developed blisters on her hand and neck which then spread into larger pustules on her neck and at the injection site (on her left arm). She reported that the pustules itch however there is no fluid drainage. Additionally, she developed swelling and pain in left arm and is unable to move her arm due to the swelling and pain.   The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included baby aspirin and clopidogrel.   On 24-Dec-2020, approximately one day prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Lot #011j20a) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 25-Dec-2020, she developed blisters on her hand and neck. The blisters have spread and advanced to larger pustules on her neck and left arm at the injection site. She reported that the pustules itch but are not draining fluid. Additionally, she developed swelling in her left arm and cannot move her left elbow due to the swelling and severe pain. Treatment for the event included oral diphenhydramine.   Action taken with mRNA-1273 in response to the events was not provided.   The outcomes of the events were not reported.; Reporter's Comments: This case concerns a 39-year-old, female patient. The patient's medical history was not provided. The patient experienced an unexpected event of blisters, Pustular rash, injection site joint movement impairment and expected event of injection site pain and swelling of arm. The event occurred 1 day after the first dose of mRNA-1273 (Lot #011j20a) administration. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
the next day the left hand, where she got the shot, turned numb; This is a spontaneous report received from a sponsored program. A contactable consumer (patient) reported this female patient of unspecified age received dose 1 of BNT162B2 (PFIZER BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 02Mar2021 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On 03Mar2021, the left hand where she got the shot turned numb. The patient tried to loosen her arm to relieve it, then it happened again "yesterday." It did not last that long; it would only last for a few seconds. The outcome of left hand where she got the shot turned numb was recovered.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
12 month old female infant had delayed reaction to vaccines listed above. large local reactions to right thigh. reaction happened almost a hour after administration.