chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Feels like she has head cold; lack of drug effect; COVID-19; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 19-Apr-2021. The most recent information was received on 19-Apr-2021 and was forwarded to Moderna on an unknown date.    This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Feels like she has head cold), DRUG INEFFECTIVE (lack of drug effect) and COVID-19 (COVID-19) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 027A21A) for COVID-19 vaccination.     Concurrent medical conditions included Rheumatoid arthritis and Allergy to antibiotic.   On 15-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 15-Apr-2021, the patient experienced DRUG INEFFECTIVE (lack of drug effect) and COVID-19 (COVID-19). On an unknown date, the patient experienced NASOPHARYNGITIS (Feels like she has head cold). On 15-Apr-2021, DRUG INEFFECTIVE (lack of drug effect) outcome was unknown. At the time of the report, NASOPHARYNGITIS (Feels like she has head cold) had not resolved and COVID-19 (COVID-19) outcome was unknown. Not Provided          No concomitant medications provided. No treatment information provided. Based on the information provided, the natural history of COVID-19, and the established profile of mRNA-1273, a causal association between the event of COVID-19  and mRNA-1273 use is assessed as not applicable. The event of drug ineffective remains as possible.   Most recent FOLLOW-UP information incorporated above includes: On 19-Apr-2021: Upon internal review on 15 Jul 2021, an event (lack of efficacy) was added at Moderna's request.; Sender's Comments: Based on the information provided, the natural history of COVID-19, and the established profile of mRNA-1273, a causal association between the event of COVID-19  and mRNA-1273 use is assessed as not applicable. The event of drug ineffective remains as possible.
Woke up on 07Mar with bottom swollen lip. 08Mar woke up with bottom and top lip swollen; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EN6203 and expiration date: not reported), via an unspecified route of administration, administered in Arm Left, on 06Mar2021 09:00 (at the age of 72-year-old), as dose 2, single, for COVID-19 immunisation. Medical history included arthritis and NSAIDs allergy. Concomitant medication included ezetimibe 10mg. The patient previously took ibuprofen and experienced allergy. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EL9266 and expiration date: not reported), via an unspecified route of administration, administered in Arm Left, on 13Feb2021 09:00 (at the age of 72-year-old), as dose 1, single, for COVID-19 immunisation. Patient did not receive other vaccine in four weeks. Patient was not diagnosed with COVID prior vaccination and was not tested COVID post vaccination. On 07Mar2021, the patient woke up with bottom swollen lip. On 08Mar2021, the patient woke up with bottom and top lip swollen. Patient was treated with antihistamines due to the event. The outcome of the event was not recovered.  No follow-up attempts are possible. No further information is expected.
This is a spontaneous report from a contactable consumer. A male patient, of unknown age, received the third dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# unknown), via an unspecified route of administration, on Nov 11, 2021, single dose, for COVID-19 immunisation. Medical history and concomitant medications not reported. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. The patient previously received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# unknown), via an unspecified route of administration, on an unknown date; and received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# unknown), via an unspecified route of administration, on an unknown date; both single dose, for COVID-19 immunisation. On Nov 12, 2021, at 09:30, patient sent an email with the following description: He  got his booster shot on Nov 11, 2021 and was not feeling great. The event did not result in doctor or other healthcare professional office/clinic visit/emergency room/department or urgent care. It was unknown whether any therapeutic measures were taken as a result of the event. Since the vaccination, it was unknown whether the patient has tested for COVID-19. The outcome of 'he was not feeling great:' unknown (at the time of this report). The batch/lot number for BNT162B2 not provided and will be requested during follow-up.
Mom called 6 days after immunizations to say that child's face was swollen and that he had hives.  Started on Friday, Septmeber 11, 2009.  Instructed mom to see primary care physician.  Spoke with mom on on Tuesday September 15th.  Mom state physician did not think that the hives were vaccine related.   Child placed on clarinex and was doing better.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 65 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 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 "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received Paxlovid treatment from 15Jul2023 to 19Jul2023.  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.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300261988 Same patient, different drug, different event;
Presented with headache, fever, cough, congestion, nausea, memory problems. Was given dexamethasone, vitamin C, zinc, remdesivir, oxygen Patient improved and was discharged
24 hours after injection woke up with rash on neck 48 hours after injection woke up with rash on neck, chin and  under eye swelling and facial swelling. 72 hours after around eye area became very red, tender and swollen. Went to emergency clinic and they prescribed Prednisone 2 times daily for 3 day.
rash on legs, arms, trunk, on mouth, 1 place looks like fever blister, tiny bumps-prickley feeling noticed this AM, low grade fever; MD said had hand foot mouth sx;
SUSPECTED COVID-19 INFECTION; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced suspected covid-19 infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected covid-19 infection was not reported. This report was non-serious.; Sender's Comments: V0. Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Patient, who is 12 years of age, received the formulation intended for 5-11 years.  No adverse reaction or untoward outcome occurred; reporting to Agency given error in administration.
pt recvd vax;T 104.9 for 1 1/2;would not wake up,face was bright redd;called MD,MD said to put pt luke warm tub x 15 min until fever went down;gave advil also;
On 8/7/21, patient presented for a Covid 19 vaccine to Pharmacy. At approximately 3:30p the patient was administered the Pfizer Covid 19 vaccination in her left arm. The patient was seated. Immediately afterward the patient began to "wobble" and fell forward toward her left knee and on the left armrest. The pharmacist immediately lifted her back upward to observe her reaction, the patient's body began to tense. The pharmacist confirmed the patient was breathing. The pharmacy intern assisted in holding the patient up while the pharmacist called in the patient's father. During this time the patient began to regain consciousness and had urinated in her seat. The time lapse from fainting to regaining consciousness was about 20 to 30 seconds. The patient was verbal and speaking but stated she felt weak. The patient was instructed to stay seated, she was offered a cold bottle of water, and asked to remove her mask so she would have better airflow. The pharmacist checked on her every few minutes. The patient felt better after about 25-30 minutes and confirmed she was ok to leave. The pharmacist checked and patient left with her father.
pt recv vax 12NOV95 & pt devel inj site soreness, fever, chills, nausea & dizziness;had diff moving neck & devel a stiff, throbbing, heavy feeling in legs;pt diff swallowing d/t constricted feeling in throat & sensation of tightness/heavy
Pt recvd vax & felt terrible & had nausea & vomiting; did not receive treatment, all sx improved; pt has recovered;
swelling around collar bone that may or may not be due to vaccine; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BONE SWELLING (swelling around collar bone that may or may not be due to vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     No Medical History information was reported.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BONE SWELLING (swelling around collar bone that may or may not be due to vaccine). At the time of the report, BONE SWELLING (swelling around collar bone that may or may not be due to vaccine) had resolved.
Parents noted varicella like rash 05/16/02, noted nauseated falling unsteady gait. Has persisted to this date. Also irritable, sleep difficulty, vomiting. No treatment yet to be evaluated by ped. neurologist.
The evening that the patient received the injection of Fluzone HD, she developed swelling and pain in the shoulder that received the injection. The pain and swelling has remained constant until this was reported to us on 10/1/15 at approx. 415pm.  She is taking anti-inflammatories and is going to speak to her physician if necessary.
patient noticed that left arm started to itch and was becoming warm and light pink, woke up in morning on 9/14/19 and was darker and still warm to touch
(L) arm rash x2 days, tender at site of vaccine. Mild erythema surrounding (L) lower injection site measuring 1.5 cm. Circle of area affected yesterday approx 3cm x 7cm. No sign of cellulitis.
Redness and swelling x 10cm at site of injection on left thigh. Mild lethargy and low grade fever. Onset within several hours after injection given.
Informed by client's mother that the injection site has erythema, edema, and is "hard and hot."  There is no rash present.  Client has been afebrile.  Per client's mom, client was seen at an immediate care clinic and told that the site was infected and was prescribed antibiotics.  On 10/29/08 the physician marked the location and told the client that if the redness spread at all to return immediately.  As of 10/30/08, there have been changes to the site.
only the diluant was given; only the diluant was given; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 1-month-old patient who received DTPa (Reduced antigen) (Boostrix) (batch number 5BC7N, expiry date 11th July 2022) for prophylaxis.   On 27th August 2021, the patient received Boostrix. On 27th August 2021, unknown after receiving Boostrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional information was provided as follows: The reporter stated that only the diluant was given for a Boostrix vaccine to a child, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up. The health care professional office gave permission to contact them. This case was linked with US2021192895, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021192895:same reporter
A non-serious spontaneous report of inadvertently administered expired FLUMIST was received from a health professional concerning a 25-year-old male. Neither past medical history nor concomitant medications were reported for this patient. The product expired on 22-Dec-2010. On 28-Dec-2010, the patient received expired product. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
EMS brought pt to ED with sudden onset of SOB; had previous hospitalization with COVID, difficulty weaning from O2; Left lower lobe pulmonary embolus, started on heparin drip; transferred to ICU due to hypotension and worsening hypoxia; septic shock; not tolerating BiPAP; DNR/DNI; comfort measures; pt died in the hospital
TONGUE SWELLING ON RETURN TRIP HOME.  PATIENT TOOK BENADRYL.
Almost three weeks after I tested for positive for Covid. I tested at home test 11/10/2022 but it was negative. The next day on 11-12-2022 I tested positive the next day and I got tested again at work and it was positive. I took a flu shot the same day on 10/18/2022. My COVID-19 symptoms low grade temperature, loss of taste and smell, prolific sore throat and headache and a slight cough. I was given PAXLOVID medication. I have recovered from my COVID-19 symptoms.
After receiving my third dose, I felt a pinch of pain while urinating. I used to get those years ago (haven't had a UTI for 3-4 years), but I went to urgent care and was told that I had a UTI. There was frequency of urination and a little bit of urine. I was given cipro. I also felt lethargic, anxious and had headaches. I am still experiencing a bit of pain even though I have completed my medication.
Information has been received from a consumer concerning her 19 year old daughter who on 21-AUG-2009 was vaccinated with the first dose of GARDASIL in her buttocks and she was fine. On 18-SEP-2009 the patient received her second dose of GARDASIL and it was given above her thigh area (almost near the hip and this dose was painful). At the time of the report the patient had recovered. The patient did not seek medical attention. No laboratory tests were performed. No further information is available.
I received my 4th dose on 09/16/2022. My adverse event started on 10/10/2022 in the morning around 8:00AM. I had a worsening  of my preexisting  conditions. My Alopecia areata  had flared up.   I went to the doctor  regarding this issue on 11/03/2022. They injected  Kenalog in the area on Alopecia. I also applied  topical drug  Clobetasol 2 times a day and  used Peroneus in the weekends 2 times  per day. I am still under treatment.
Patient was admitted to hospital on 4/15 for leg pain, being too week to stand. He tested positive for SARS CoV-2 via point of care rapid test. He had COVID in 2020, testing positive on 7/13/2020. He did not present with symptoms typical of COVID, however he continues to have an elevated D-Dimer, procalcitonin, and ferritin. He is on 100% BiPAP as well.
12:20PM THROAT 'FEELS SWOLLEN'. DENIES ANY SOB, DYSPNEA OR DIFFICULTY SWALLOWING.  12:35PM BENADRYL 50MG GIVEN PO. A/O, W/D, RESP REG WITH EASE. COMFORT GIVEN. 12:44PM STATES 'FEELING BETTER NOW'. 1:10PM SON HERE TO DRIVE PT HOME. PT TO EXIT PER W/C. NO ACUTE/OBVIOUS DISTRESS NOTED. 3-5-21 3PM TC - 'FEELING BETTER TODAY. TOOK BENADYL X2 YESTERDAY AND X1 TODAY  TO BE SAFE'.
DTAP 0.5 cc IM right deltoid. With in 10 min after IM injection mother noted redness and bruise area 50 mm around top of shoulder.
Pt presented to clinic for routine cardiology follow-up with NP. Pt resides in a nursing facility and presented to the clinic with his daughter and spouse. On completion of visit with NP, pt family asked that pt receive his flu shot while in the clinic. RN informed family that "usually the facility gives the residents their vaccinations" family insists that pt did not receive his vaccination at the facility yet. Chart was reviewed, query of outside vaccinations was requested with no results. High dose flu vaccine was given to the patient and scanned into the chart. Vaccine lot number, date, time, and location given was printed on to the visit orders sheet to return to the nursing staff and patient facility. On return of the patient to the facility, his primary nurse called the clinic and inform this RN that vaccine was already given to patient at their facility with record of it on file.
Chest tightness, cough, shortness of breath, fatigue. Dr. prescribed albuterol, benzonatate, azithromycin.  After taking this medication, I contacted my pulmonologist and he prescribed prednisone. Just began taking today.
74 yo male with a hx of ILD/IPF on 7L O2 chronically, AF on xarelto, HTN, HLD, presented with shortness of breath and hypoxia. He reports a hx of pulmonary fibrosis that was onset in Oct 2020 after a severe pneumonia. Follows w/ Dr for pulmonology. He reports increase hypoxia and SOB w/ exertion for the last 5+ days. He typically wears between 7 and 10 liters of oxygen. Over the last week he has noticed more SOB w/ exertion, desaturates quickly with minimal exertion such as walking out to the garage. He does report a dry cough.  He decided to utilize EMS services for today's ER visit; typically he arrived by private vehicle.  Upon arrival EMS documented he was in marked respiratory distress with a pulse oximetry of 68% on 8 L.  He was given 2 DuoNeb's, Solu-Medrol 125 mg, and placed on CPAP in route.  Pulse oximetry and respiratory distress had improved on arrival to the emergency department. He was admitted to the hospital for further management. He was ultimately diagnosed with COVID pneumonia causing an ILD/IPF flair. He was started on decadron and remdesvir and able to complete both courses while in the hospital. His oxygen requirement was able to be weaned to 9L which is in his home range of 7-10 liters. While in the hospital, he was seen by pulmonology who started him on ppx bactrim given chronic steroid use (15 mg prednisone daily). Near the end of his hospitalization, there were many conversations regarding GOC and disposition including an LTACH for ongoing oxygen weaning. Ultimately, patient met with the hospice team and decided to pursue home hospice after discharge. He was hemodynamically stable and discharged home on 1/1 with an oxygen requirement of 9-10 liters. He plans to enroll in home hospice this coming Friday. A new script for his home prednisone was provided as was a script for Bactrim.    Discharge diagnosis   #Acute on chronic hypoxic respiratory failure  #Idiopathic pulmonary fibrosis #ILD flair #COVID-19 pneumonia #HFpEF #Hx AF  #Thrombocytopenia, resolved #Hypokalemia #HTN #HLD #Diarrhea, chronic
Severe chills, low fever and racing heart.  The heart rate almost got me to the hospital.  112 BPM.  Symptoms lasted until early morning but then went away.
C/O lightheaded, sweating Pt. escorted to medical screening, pt. passed out while attempting to lie down, pt A+OX4 row Seen by onsite EMTs. Pt. initially presented with pale, diaphoretic skin, CAOx3. V/S WNL (ortho) during extended observation time At time of departure pt.skin dry,warm,color WNL Final V/S : B.P=138/86; Pulse =64 Spo2=100% Patient discharged home at 11:35 A.M.
Hx of recurrent C-diff infection, DM2, CKD3b. Who presents to ED c/o diarrhea for the last few days. She has been treated in the last months for C-diff. Pt looks dry and with poor appetite. Pt was supposed to have a procedure but had a family member 2 weeks ago who was positive for Covid so the procedure was delayed. pt denies NV or fever. No CP or SOB. She is weak and tired of diarrhea. She has recent Covid exposure. She has two doses of Moderna vaccine last one was in May. COVID positive on 11/27/21 and was admitted. Her Covid back positive that might contribute to her diarrhea.  Pt seems to have limited Covid infection. Not hypoxic or any distress. Sat 97% in room air.  No indications for any treatment. No . Discharged on 11/29/21.
Patient seen 7/22/2019 c/o tenderness in R deltoid. Mass palpable 3 cm X 2cm.
Cervical cancer; second dose not given in dosing window; This spontaneous case was reported by a patient and describes the occurrence of CERVIX CARCINOMA (Cervical cancer) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 16-Jan-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 CERVIX CARCINOMA (Cervical cancer) (seriousness criterion medically significant) and INCOMPLETE COURSE OF VACCINATION (second dose not given in dosing window). The patient was treated with Surgery (surgery and four sessions of chemotherapy) for Cervix carcinoma. At the time of the report, CERVIX CARCINOMA (Cervical cancer) and INCOMPLETE COURSE OF VACCINATION (second dose not given in dosing window) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication not provided. Treatment not reported.  She has undergone surgery and four sessions of chemotherapy. At the time of her originally scheduled second dose, she was too sick to receive it.   Reporter did not allow further contact; Sender's Comments: Based on current available information and the temporal association between the produce and the start date of the event a causal relationship is unlikely.
tingling, nerve pain throughout entire body, Pain in the head, sharp shooting pain,  and a flushing feeling that comes and goes. Heart racing that comes and goes. She said she could taste it on her tongue and her tongue felt funny.  She did not report trouble breathing or swallowing. She said it did not feel like the anaphylactic reaction she had had before with Doxycycline.
general malaise, persistent weakness, some n/v & some orthostatic light-headedness;strongly hemoccult positive stools;hemoglobin 9.7;blood sugar 227;pt is diabetic;ultrasound revealed live-abscess;rt & lt shoulder pain;sx w/liver absc
Orange sized bruised arm Chest pains x6 lasting approx 6minutes over 7 days Very fatiqued