chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vomiting; Got the second dose 21 days after the first one; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Got the second dose 21 days after the first one) and VOMITING (Vomiting) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027C21A and 001C21A) for COVID-19 vaccination.     Concomitant products included IBUPROFEN, TROMETHAMINE, LOSARTAN POTASSIUM, OXYBUTYNIN HYDROCHLORIDE (OXYBUTYNIN [OXYBUTYNIN HYDROCHLORIDE]), OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]) and ATORVASTATIN CALCIUM for an unknown indication.   On 22-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Aug-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Got the second dose 21 days after the first one). On an unknown date, the patient experienced VOMITING (Vomiting). On 12-Aug-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Got the second dose 21 days after the first one) had resolved. At the time of the report, VOMITING (Vomiting) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications also included ointment plebanate propionate.  Treatment information was not provided.  HCP called to find out if the second dose administered to patient after 21 days of getting the first dose is a valid dose or if needed to repeat it.
Arm red/ swollen began at injection site then traveled down arm warm to touch. Hx: Surgery , no lymph nodes. T 98.2. No fever. Dx: Inflammation instructed to use anti-inflammatory BID x 3 days. Elevated arm to decrease edema and see MD again if worsens.
The patient felt shaky and flushed. She also felt dizzy. We treated pt with 25 mg of BENADRYL.
Patient began exhibiting peculiar motor activity such as rapid tilting of the head to one side and generalized tremors following first set of immunizations.
First vaccination was received on 3Mar: Typical adverse events associated with the vaccine occurred on the day of first vaccination administration: neck/head pain immediately afterwards, followed by headache for 8 hours. At day 12 after first vaccination, a red painless rash occurred in the same arm as vaccine administration, though not in the same spot.   At 22 days after the first shot,  I began to experience stomach pain associated with acid reflux and a hollow, bloated feeling in the stomach; these two symptoms do not occur simultaneously, but trade off, occurring  for 4-12 hours per day every day, unresolved even with continued use of lansoprazole for acid reflux management.  Second vaccination was received on 31Mar; common reactions occurred: pain/redness/swelling at injection site, mild diarrhea, chills, mild fever, fatigue.   Current side effects as of 13Apr2021: stomach pain associated with acid reflux mixed with hollow, bloated feeling in stomach, ongoing for 23 days; swollen supraclavicular lymph node on same side as second vaccination.
Patient is a 89 y.o. male patient of MD with history of COPD, morbid obesity, PAF, prostate cancer, OSA on CPAP presented to Hospital with shortness of breath . Assessment and Plan   Acute respiratory failure with hypoxia Due to COVID-19/ Pneumonia and acute COPD exacerbation Management as mentioned below Required 2 L of oxygen on exertion on home o2 eval    Acute Exacerbation of COPD Pneumonia/ Bronchitis Previous PFTs: 12/9/2019 moderate severe obstruction with mild restriction Chest x-ray-atelectasis in the left lung base, normal procalcitonin but sputum cultures grew MRSA and Strep Started on antibiotics Omnicef and Doxy and cont at dc Cont Duoneb, Symbicort. Decadron to complete the course Incentive spirometry every 4, Mucinex twice daily, Tessalon 100 mg as needed Cont home CPAP    Covid-19 Virus Infection Date of onset of symptoms: 1/25/2023 Symptoms present on admission: Cough, Dyspnea, fatigue Date of covid positive test: 1/25/2023, rapid test at facility.  Requested copy of the test Vaccination status: vaccinated Imaging: Mild atelectasis/infiltrate with fluid suggested in the left lung base.  Oxygen requirements on admission: 2 L NC Current oxygen requirements: 2 L NC Medical therapy: steroids complete total of 7 days Ok to complete home paxlovid Consultants following: None at this time Anticipated special isolation end date: TBD  Lasix 20 mg x 1 given for dry lung strategy      BPH Abnormal urinalysis History of prostate cancer Complaining of burning, frequency and urgency in urination UA was sent after ceftriaxone, noted microscopic blood in the urine possibly due to UTI Complete antibiotics as mentioned above  History of PAF Not on rate controlling medicines, continue Eliquis  OSA Continue CPAP
Chest pain above right breast when turning; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Chest pain above right breast when turning) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ATORVASTATIN for Cholesterol, PARACETAMOL (TYLENOL) for an unknown indication.    On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, the patient experienced CHEST PAIN (Chest pain above right breast when turning). At the time of the report, CHEST PAIN (Chest pain above right breast when turning) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Red, swollen, hard, itchy lump that is warm to the touch  at injection site. Started 1 day after vaccine but got progressively worse
Patient reports he has noticed over the past week increased shortness of breath on exertion--at baseline able to exercise with walking 45-60 minutes without dyspnea, however noticed over the last week getting some shortness of breath even walking to the garage. No chest pain, no fevers, chills, cough. He saw his PCP for these symptoms who ordered EKG and CXR 1 day PTA which per patient were normal--plan was for referral to cardiologist. However on the morning on presentation around 6:45 AM after taking an elevator for work he began feeling lightheaded and lost consciousness, awakening on the floor. He went home as he was not feeling well however proceeded to have another 2-3 episodes of loss of consciousness at home witnessed by his girlfriend--the later 2 occurred while lying down and were not clearly associated with any presyncopal symptoms.
Minor Cellulitis Reaction to ZOSTAVAX vaccine. Patient came to the pharmacy and showed pharmacist the injection site which was red, slightly inflamed, and itching. The diameter covered approximately 5-6 inches from the injection site. The patient was counseled to apply cool compress/ice to the area to help with inflammation and BENADRYL to help with the itching. She was further counseled to report any worsening symptoms to MD. After review, there was no reason to believe that the vaccine was administered improperly, so we are deciding the patient is simply having a minor cellulitis reaction because of it.
COVID-19 treatment; COVID-19 treatment; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4488813-00 (AbbVie).  A 69-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; adalimumab (HUMIRA), as citrate free (Batch/Lot number: unknown) subcutaneous for psoriasis. 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) all with onset 2022, outcome "recovering" and all described as "COVID-19 treatment". The action taken for adalimumab was unknown. Clinical course: It was unknown if patient was enrolled in a Covid-19 Vaccine Trial.   The reporter considered "covid-19 treatment" related to BNT162b2.  The reporters causality for the event of Covid with Adalimumab was not provided.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on available information, a possible contributory role of Comirnaty vaccine cannot be excluded for the reported events.
Urinary tract infection. Pain in bladder area and burning sensation while urinating. Frequent urge to urinate. Contacted telehealth for treatment.
Fever, achiness, nausea, and then vomiting 5 times, unrelated to food. Most of it was bile. At 12:30 AM Feb 21 I woke up with violent chills and took an tylenol to break the fever. At 3:00AM I threw up for the first time, then again at 5:00AM, then again at 6AM, 7AM, and the last one was at 7:30AM.
1st night (9/27/21): Pain in right side of neck & headache; pressure in back of eyeballs; aches & pain throughout body much like flu symptoms 2nd day/night (9/28/21): same symptoms throughout the day; tylenol helped relieve pain; no appetite; only consumed water and stayed in bed; vomited at 11pm in evening 3rd day/night (9/29/21): symptoms somewhat diminished; diarrhea mid-day; con't to rest & drink water; ate some soup; took a tylenol 4th day/night (9/30/21): awoke and felt quite well except for a continued neck ache
Systemic: Allergic: Rash (specify: facial area, extremeties)-Severe, Systemic: Allergic: Rash Generalized-Severe, Systemic: Body Aches Generalized-Severe, Additional Details: Pts Husband said his wife has develoved severe rash all over the body, begging Jan 2nd post COVID booster. Says wife is in alot of pain as rash is severe and wide spread over all areas of the body. Husband says the rash is in teh form of blisters throughout the body.
Entire upper arm swollen, red, sore, fever and red throat. Last year had a similar reaction but much less severe. The spot where the shot was given was only about the size of an orange. This year my entire upper arm was affected. 2 doctors have told me not to get the flu shot next year. The reaction lasted about 5 days. I had the senior dose.
Husband called our clinic on Saturday, March 6th at approximately 10:15 to report that on 3-5-21,  this patient seemed confused, was not responsive to questions he asked her, and did not make any meals.  He does report that she was oriented to person, place and time, but did not eat any food, would not shower and could not use the phone. Her temperature at bedtime was 101 degrees.   The husband was offered an office visit for evaluation of symptoms, but he declined stating that she seemed to be coming around on Saturday 3-6-21.  The husband was advised that pt. could take Tylenol for fever.  Husband was advised that if symptoms worsened over the weekend that she should be evaluated by the nearest ER.
CHILLS; FEVER 99F TO 102.7F; BAD HEADACHE; This spontaneous report received from a patient concerned a 55 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included COPD, type-2 diabetes, smoker, and non alcohol user, and other pre-existing medical conditions included the patient had no known drug allergies. the patient did not have any drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, and batch number: 205A21A expiry: 23-JUN-2021) dose was not reported, administered on 04-MAY-2021 10:30 for prophylactic vaccination. No concomitant medications were reported. On 05-MAY-2021, the subject experienced chills. On 05-MAY-2021, the subject experienced fever 99F to 102.7F. On 05-MAY-2021, the subject experienced bad headache. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 99F to 102.7F. Treatment medications (dates unspecified) included: acetylsalicylic acid, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever 99F to 102.7F, chills, and bad headache. This report was non-serious.
No additional AE or PQC reported.; a patient only received half a dose of PROQUAD due to moving around when the vaccine was injected; This spontaneous report was received from an administrator and refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported.  On 16-MAR-2022, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin (rHA)) (PROQUAD) subcutaneous injection, 0.5 milliliter, lot #U029321, expiration date: 19-MAR-2023, administered for prophylaxis (strength, side and route of administration were not provided). Administered vaccine was diluted in a 0.5 ml sterile diluent (lot# U002746, expiration date: 25-JUN-2023). The patient received only half a dose of the vaccine due to moving around when the vaccine was being injected (accidental underdose). No additional adverse event was reported.
I received 2 dose of vaccine and a booster and I still got the covid virus.; I received 2 dose of vaccine and a booster and I still got the covid virus.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SUSPECTED COVID-19 (medically significant), VACCINATION FAILURE (medically significant), outcome "unknown" and all described as "I received 2 dose of vaccine and a booster and I still got the covid virus.".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Flat red rash developed next morning on neck, chest, both arms; Hive developing on right hand; No increased SOB; only itching on right hand at time of exam
Forehead lips numb; Aches in neck; Aches in  shoulders; Forehead lips numb; This is a spontaneous report received from a contactable consumer, the patient. A 61 years-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8732) via an unspecified route administration in the left arm on 25Mar2021 at 14:00 (at the age of 61-year-old) as a single dose, for COVID-19 immunisation. Medical history was not reported. The patient was allergic to naproxen. The concomitant medications included unspecified blood pressure medication, zinc (MANUFACTURER UNKNOWN) and colecalciferol (VITAMIN D3) all taken unknown indication from unknown date. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 26Mar2021 at 05:30, the patient experienced forehead lips numb, aches in neck and shoulders. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for events. The clinical outcome of events forehead lips numb, aches in neck and shoulders were not recovered.   No follow-up attempts are possible. No further information is expected.
Patient returned to office approx 45 min after immunization with red flushed face & large whelp like rash. BENADRYL 3 ml given PO. Rash resolved. Pt observed for 45 min.
This spontaneous report was received from a physician refers to a patient of unknown age and gender. On 29-JUN-2015, the patient was vaccinated with improperly stored PROQUAD (Merck) lot # K025766, expiry date 08-JUN-2015. This is one of the several reports received from the same reporter. Additional information has been requested.
8 x 9 cm swelling with induration at vaccine site no drainage. (+) cluster of vesicles in center of site. (R) lateral upper arm.
Dizziness after Menactra injection. State that objects and people seemed far to him. He was observed.
First shot: (02/03/2021) very sore arm, tired for two days, headache and dizziness.  Second shot: (03/04/2021) Arm very sore, nausea, headache, neck pain, chills, warmth, skin hurts,  more aware of body parts, more pain in joints, unable to sleep well.
None- vaccine given 16 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (None- vaccine given 16 days post expiry) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 011J20A) for an unknown indication.     No Medical History information was reported.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (None- vaccine given 16 days post expiry). On 22-Nov-2021, EXPIRED PRODUCT ADMINISTERED (None- vaccine given 16 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided by the reporter.  No treatment information was provided by the reporter.
blood sugar crowding to the 130 mg/dL upper limit/numbers have been higher than normal; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect. A contactable consumer (patient) reported that an 81-year-old male patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number requested), via an unspecified route of administration on 19Jan2021 at a single dose for COVID-19 immunization. Medical history included being diagnosed as pre-diabetic from an unknown date. The patient's concomitant medications were not reported. The patient reported that he noticed in the last 2 days his blood sugar crowding to the 130 mg/dL upper limit on 19Jan2021. He stated that after getting vaccine, numbers have been higher than normal. The patient wants to know if that's from vaccine or something else. The outcome of the event was unknown.  Information on the batch number/lot number  has been requested
Information has been received from a physician concerning a female patient who completed her full course of GARDASIL. Subsequently the patient had an "abnormal PAP smear". The patient was believed to be HPV naive at the time of vaccination. The patient had sought unknown medical attention. At the time of report the patient's status was unknown. Additional information has been requested.
I had a side effect; I have soreness under my arm, the left arm where I had the shot; My arm is red; Nausea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "I had a side effect; I have soreness under my arm, the left arm where I had the shot"; VACCINATION SITE ERYTHEMA (non-serious), outcome "unknown", described as "My arm is red"; NAUSEA (non-serious), outcome "unknown".  Additional Information: Concern: Consumer (patient) stated, had a side effect from this Prevnar 20 vaccine and patient wanted, was there any kind of medication patient could take. Patient did have soreness under arm, the left arm where patient had this shot and arm was red. So, was there any kind of medication that kind of like get me calm back that or not. Paraphrase concern: Consumer stated, "Yes." Consumer was informed about the role of Pfizer Drug Safety Department. Consumer was informed about the Pfizer Medical Information Department and provided with the number, timings as 8 am to 9 pm on Monday to Friday. In response to file safety report: Consumer stated, "was it concerned a medication because you know, to help patient with this nausea that patient had (Appropriate response was provided). Okay, go ahead." When probed for mailing address consumer hung up the call abruptly. Further probing could not be done as consumer hung up the call abruptly. Hence, product details (lot, expiration date, NDC, UPC), purchase details and other details were unknown and limited information was available over the call. Reporter type was not available over the call hence, reporter type captured as consumer or other non health professional in tab by default.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pt recv vax 27FEB96 & 29FEB96 pt exp a chickenpox-like rash w/about 20 lesions;the rash was described as full-blown chickenpox;nurse & pediatrician felt the pt sx were not related to therapy w/vax
The day after receiving the vaccination I experienced sharp lower back on my left side. Over the next several days the pain continued to move to my left hip then across my leg to the groin. As the days passed, it traveled to the outside of my knee and then under it.  On Dec 12, as I stepped up I felt something in the outside of my left knee pop and I was having difficulty walking. After a week it move to the inside of my left knee where it is still present. An addition pain is present in my left shin. As it continued to move down my left side I kept hoping it would disappear. With Christmas and New Years  during this period, I decide to try to treat it myself with rest, icing, compression and elevation. I also did I also did some stretching exercises. I think I have done all that I can by myself. I called vaccination hotline on Jan 2 and followed this up with a call to my doctor who is seeing me tomorrow, Jan 3, 2020.
T,SCREAMING X 4 HOURS-TWELVE HOURS AFTER IMMUNIZATION.  NO REDNESS, NO TENDERNESS, NO SWELLING.
COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown), in right 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) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "COVID 19"; COVID-19 (medically significant), outcome "unknown", described as "COVID 19 ". Therapeutic measures were taken as a result of drug ineffective, covid-19 which includes Paxlovid.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Approximately 24 hours post vax, the pt developed left thigh/knee swelling with associated erythema approximately 2 inches below injection site.