chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Congestion in lungs - coughed up blood , brown, green and yellow mucus; stopped up; Loss sense of taste and smell; Loss sense of taste and smell; Headache; Fever; Very tired; Chills; A spontaneous report was received from a consumer, who is a 63-year old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced congestion in lungs- coughed up blood , brown, green and yellow mucus/ pulmonary congestion, stopped up/ nasal cavity packing, headache, fever/ pyrexia, very tired/ fatigue, chills, loss sense of taste/ ageusia and smell/ anosmia.  The patient's medical history included injuries in right arm. Concomitant medications included clonazepam, potassium, magnesium, fluticasone propionate, salmeterol xinafoate, dexamethasone, metformin, sumatriptan, bupropion and cyclobenzaprine.  On 03 Mar 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 023M20A) intramuscularly in left arm for prophylaxis of COVID-19 infection. On 07 Mar 2021, approximately 4 days after receiving vaccine, the patient experienced congestion in lungs- coughed up blood , brown, green and yellow mucus (medically significant), stopped up, headache, fever, very tired, chills, loss sense of taste and smell. Treatment medication was reported as paracetamol.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, congestion in lungs- coughed up blood , brown, green and yellow mucus stopped up, headache, fever, very tired, chills, loss sense of taste and smell was considered as resolved on 10 Mar 2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Information has been received from a medical assistant for the pregnancy registry for GARDASIL concerning a 15 year old female patient with type 1 diabetes mellitus and sulfonamide allergy who on 04-MAR-2008 was vaccinated IM in the right arm with the first 0.5 ml dose of GARDASIL (659182/1757U). Concomitant therapy included MENACTRA and insulin. The patient received her first dose of vaccine when she was pregnant. The physician did a vaginal exam (unspecified date) which found that the patient had a 16-18 week uterus size with a LMP of 07-DEC-2007, and an estimated delivery date of 12-SEP-2008. Unknown medical attention was sought in the office. Patient outcome was unknown. No product quality complaint was involved. Follow up information has been received from a certified medical assistant on 09-MAR-2009. It was reported that the patient delivered a healthy, normal male, a "few weeks early". The patient had an induction of labor secondary to her history of preexisting insulin-dependent diabetes. The induction failed and she had a cesarean section. The baby weighed a little over 7 lbs. The reporter said the mother recovered "fine" and the baby was released for adoption, so they have no further information on the baby beyond this. Upon internal review, induction of labor that failed was determined to be an other important medical event. Additional information is not expected.
1st dose Pfizer 12/26/2020 Lot# EL0140, 2nd dose 01/20/2021 Lot# EL3247 Sever coughing, pericarditis, high blood pressure medication on now 50mg Metoprolol twice daily
On 1-5-15 @ 9:30 PM client developed raised red rash on chest area with burning sensation. She  took 50mg Benadryl PO, went to bed and rash was gone next morning. Approx. 9:30 PM on 1/06/15, client's face became red, swollen, & blistered.  Neck & chest had red rash. Went to ER, was given IV fluids, Solu-medrol, and Benadryl IV. Client discharged with diagnosis of allergic reaction.  Client reports face became red @ 9:30 PM on 1/7/15, took 50 mg Benadryl, went to bed & was gone next morning.
Fever, chills, severe muscle aches, severe headache, dizziness, weakness, loss of appetite  12 hours post vaccine Chest pain/heaviness which led to some shortness of breath 32 hours post vaccine following temperature returning to normal  Treated severe headache with Tylenol without relief
Initial report was received 19 October 2010 from a health care professional. A 46-year-old male dialysis patient had received an injection of FLUZONE HIGH-DOSE No Preservative 2010-2011, lot number U3566FA (lot number invalid for FLUZONE HIGH DOSE, but consistent for FLUZONE SV No Preservative 2010-2011) at 12:35 hours (date not reported) and at 15:00 hours (also reported as 3-4 hours after injection), the patient developed an allergic reaction with symptoms of shortness of breath (SOB), increase respirations, chest tight, tightness in throat and a sensation of throat swelling (with no physical swelling). The event did not require a doctor's visit or an emergency room visit. The event duration was not reported; however, the patient's outcome was recovered (date not reported). The reporter for this case is the same as for case number 2010-06035. Documents held by sender: None.
Information has been received from a medical assistant referring to a patient of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On 25-NOV-2013 the patient was vaccinated with GARDASIL(confirmed not GARDASIL 9) for prophylaxis.  On 13-SEP-2016, the patient received GARDASIL 9 (confirmed not GARDASIL quadrivalent). Information of treatment was not provided. At the time of this report, no adverse symptoms was reported. Additional information has been requested.
Swelling in face , eye lids felt tight, numbness in nose, ear fluid and confusion starting 20 or more minutes after shot and lasting for 4 hours after shot .took allergy med 10mg and 2 baby asprin .  Next day pain with eye movement, sinus pain , popping in ears, aches and chills , heart palpitations , shortness of breath like after sprinting  , loss of appetite , weeping for no reason , body agitation ., vision change as if I needed stronger prescription to read . Took naproxen and symptoms lessened by 30 hours after shot . Lots of joint popping after pain and discomfort subsided.
Information has been received from a healthcare worker concerning a 66 year old female with Diabetes Type 2 and "Balerian allergy", who in October 2008, was vaccinated with her first dose of PNEUMOVAX (0.5ml, IM left deltoid, lot # unspecified), and a second dose (0.5ml, IM left deltoid, lot # unspecified) on 27-AUG-2009.  Concomitant medication included "other medications for diabetes".  On 28-AUG-2009 the patient had swollen area at the injection site of left arm.  The reporter stated this was an overdose due to the fact that the first dose of PNEUMOVAX was administered in October 2008, and the second dose was administered on 27-AUG-2009.  The patient sought unspecified medical attention.  At the time of the report, the patient was not recovered.  Follow up information has been received from a registered nurse indicating that the patient with no illness at time of vaccination, was vaccinated with her second dose of PNEUMOVAX (lot # 662687/0983X) in the left arm.  The patient had pain, redness and swelling at injection site, and complained of headache.  The reactions occurred after vaccine error.  At the time of the report, the patient was recovered.  No further information is available.
tested positive for covid 11/17/21- asymptomatic, tested r/t known exposure
Vacciane received on Dose 1 07-Jan-2021 and Dose 2 02-Apr-2021 85 days apart; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Vacciane received on Dose 1 07-Jan-2021 and Dose 2 02-Apr-2021 85 days apart) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for an unknown indication.    No Medical History information was reported.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On 02-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Vacciane received on Dose 1 07-Jan-2021 and Dose 2 02-Apr-2021 85 days apart). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Vacciane received on Dose 1 07-Jan-2021 and Dose 2 02-Apr-2021 85 days apart) outcome was unknown.            No concomitant medications were reported. No Known allergy. There was no reported medical history.  It was unknown if patient was enrolled in covid-19 vaccine trail.   This case was linked to MOD-2022-580249 (Patient Link).
Pt had shot on 9/30/9 - immediately said arm hurt and left. Called few days later said arm still hurt, told her to go to MD.
swelling x 3 days and pain/tenderness of the L axilla with no palpable lymphadenopathy x 6 days. No treatments given. Outcome: continue to have mild tenderness, swelling has decreased.
administered one dose to a patient that was expired on 29Oct2021; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered one dose to a patient that was expired on 29Oct2021) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034C21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Fluzone (Lot number- UT356JA, Route of administration- Intramuscular, Body site - Left deltoid) on 17-Nov-2021 and pfizer (The patient had Pfizer as a primary series). Past adverse reactions to the above products included No adverse event with Fluzone and pfizer. Concurrent medical conditions included Depression, GERD and Seasonal allergy. Concomitant products included OXYMETAZOLINE HYDROCHLORIDE (CLARITIN ALLERGIC) from 2017 to an unknown date for Allergic reaction NOS, SERTRALINE from 2019 to an unknown date for Depression, FAMOTIDINE from 2021 to an unknown date for GERD, MELATONIN from 2020 to an unknown date for Sleep disorder NOS.    On 18-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered one dose to a patient that was expired on 29Oct2021). On 18-Nov-2021, EXPIRED PRODUCT ADMINISTERED (administered one dose to a patient that was expired on 29Oct2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided. After administration of vaccine patient was closely monitored for 30 minutes, no adverse events occurred.   Most recent FOLLOW-UP information incorporated above includes: On 22-Nov-2021: Follow up received On 22-Nov-2021 contains Significant information. Patient demographics, medical history and Concomitant medications were added. Route of administration and anatomical location of Suspect product added.
Information has been received from a physician, via a company representative, concerning an 18 year old female patient, who was vaccinated with the first dose of Gardasil (date, dosing details and lot # not reported), and subsequently "came down with genital warts."  The patient completed the second and third dose of the vaccination series.  At the time of this report, the outcome of the event was unknown.  The reporting physician did not feel that the genital warts were related to therapy with Gardasil.  Additional information has been requested.
Mild ringing in the ears; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Mild ringing in the ears) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and 018821A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No recorded medical history.).   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Mar-2021, the patient experienced TINNITUS (Mild ringing in the ears). At the time of the report, TINNITUS (Mild ringing in the ears) outcome was unknown.            No relevant concomitant medications were reported. The patient reported that the event mild ringing in the ears would come and go but was minimal and the patient wasn't  sure if it ever went away completely or if it was just less noticeable because she was busy with other work. No treatment information was provided. The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-061186 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-061186:
The patient was inadvertently given Pfizer Bivalent 5-11 y/o undiluted.  Patients mother was contacted and informed of the error, she reported the patient was having a headache and sore arm. Patient scheduled to be seen in the clinic.
02/13/22 presents to ED for "cough, congestion, nausea, vomiting, diarrhea" "progressive weakness" "diagnosed COVID on 2/9/22". PMHx of "HTN, asthma, BPH, morbid obesity"
chills and achiness 3 days after vaccine. New fevers starting 4/28/21 along with fatigue and malaise. Symptoms of fever and malaise lasted about 2 weeks. Oral cold sores developed after fever.
Initial report received from a healthcare professional on 16 October 2013. A male patient (age was not reported), whose medical history and concomitant medications were not reported, had received a dose of FLUZONE INTRADERMAL (batch number not reported, route of administration: Intradermal and anatomical site of administration was not reported) on an unspecified date. On unspecified date, the patient had "serious reaction" after the intradermal shot of vaccine. Complementary investigations and laboratory data were not reported. As of 16 October 2013, the outcome was not reported. Documents held by sender: none.
This a a very pleasant 60 years old female with a past medical history significant for rheumatoid arthritis on methotrexate, and hypothyroidism.Admitted to the health care facility on with c/o shortness of breath and weakness.Patient has a recent past medical history of COVID-19 infection approximately 21 days ago (Aprox Aug 6/2021).She did not receive any antiviral treatment she was not with shortness of breath.Now she is presenting with above-mentioned chief complaint, shortness of breath and weakness that has been getting worse for the last 4-5 days.oxygen saturation at 88% on room air,connected to oxygen supplementation.c/o fatigue,n/v and diarrhea.
Administered Moderna first dose of vaccine around 5:04 pm, at 5:12 patient started to "feel out of it", lethargic and having a difficult time breathing. An epipen was administered at 5:13 with patient consent and due to little relief I called 911 to have paramedics arrive. Paramedics arrived around 5:28 and began speaking with the patient. They took her to the hospital due to feeling of throat swelling and difficulty breathing after the vaccine that was not resolved by an epipen. We will be following up and calling the patient tomorrow.
Redness/warmth to (L) deltoid. No fever. No drainage. Seen in ED. Dx with local allergic Rx/vs cellulitis. Rx with ABX.
muscles are sore; nausea; Been sick; This case was reported by a consumer and described the occurrence of muscle soreness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced muscle soreness, nausea and sickness. On an unknown date, the outcome of the muscle soreness and nausea were unknown and the outcome of the sickness was recovered/resolved.   It was unknown if the reporter considered the muscle soreness, nausea and sickness to be related to Shingles vaccine.  Additional details were provided as follows: The patient self reported this case. The age at vaccination was not reported. The patient got the 1st shingle shots and had a lot side effects, all muscles was sore, nausea and been sick for two days so far, this was awful.  The patient still need to get the second vaccine
Started feeling really strange, started shaking uncontrollably to the point of almost having seizures , had a high fever from 100-103.6 after receiving vaccine , had severe headache and nausea , started having a cough reflex like throat was swelling . Insides were shaking so bad and couldn?t get it to stop . Went on like this for Thursday night , all day Friday , then Saturday so far . Shaking is better but still having headaches and fever and feeling like something just isn?t right in body .
Immediate sweating, cold, stomach ache, very pale. Gave juice at clinic. 15 minutes later still cold but feeling better.
Fever 103 Chills Nausea Sever headaches and light sensitivity Joint and muscle pain over whole body
x2 ER visits 2/7/21, 2/8/21 c/o n/v/d; X2 inpatient admissions for small bowel obstruction 2/8/21, 2/16/21; admitted 3/18 swg bed for physical deconditioniong. 3/18/21 Swg Bed admission HPI:  82 y.o. female presents for direct admission to swing bed.  Back in the middle of February the patient had a high-grade small-bowel obstruction ended up with laparotomy and lysis of adhesions.  She was extremely deconditioned.  She came to swing bed here and states here for about 2 weeks.  She thought she was ready to go home and be successful at that time.  Unfortunately, she has gotten home and found that she can barely take care of herself.  She is extremely deconditioned.  She thinks she just needs to be built up for another week or 2 and then could be very successful at home.  She does have a friend that is helping her, but is worried about getting so weak that she end up hurting herself.  I saw her yesterday in the office and thought that another swing bed stay a might be in order.
Localized chest pain; palpitations; This is a spontaneous report from a non-contactable consumer (Patient). This report was received via a sales representative. A 40-year-old female patient received Second dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection Batch/Lot number: Not reported), dose 2 via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was unknown whether patient was pregnant at the time of vaccination. On 27Apr2021, the patient experienced localized chest pain, palpitations lasted 24 hours. The outcome of event was recovered on an unspecified date in Apr2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Client reports that for his first vaccine he felt dizziness and heaviness in his head. Client reports it lasted 30 minutes and he felt better after eating since he did not eat that day.
Red raised sandpaper appearance to rash. Itch to site of KINRIX (DTAP/IVP) right deltoid.
Patient reports that her blood pressure and blood sugar became elevated about 2 hours after receiving her vaccine.  They have since returned to baseline, but were elevated for about 12 hours.  She did not seek medical attention, but reported to the pharmacy approximately 48 hours post vaccine administration.
Easy severe bruising throughout the body, from ankle to injection site. (Bruises that were dark and lasted for almost two weeks, that usually would not be there, or didn't really have an explanation as to how they occurred.) Injection site sting pain continued for 3 weeks, ie; a sting feeling, each time it was rubbed. From Injection site muscle to bottom of neck, entire strap of muscle was very tense, like a constant charley horse pain. Muscle ache pain was felt into spine near neck. Really Really Really weird dreams when muscle was aching during sleep.
The patient reported that her right arm was swollen to the size of a silver dollar shortly after receiving the vaccination. Patient recalls the flu shot being given to her in her right arm rather than the PREVNAR, though I have recorded the vaccinations as our records reflect. Patient told us that her right arm has not only was swollen and painful, but that she has not been able to lift her arm for the past month, as it has been 23 days since receiving the shot. She told us she took BENADRYL after going to the urgent care where they told us she was having a reaction to the flu shot and sent her on her way. After 2 weeks of taking BENADRYL she stopped taking it and the swelling has went down the but her arm is still heavy and there is tingling from the injection site up to her neck.
Information has been received from a certified medical assistant referring to unspecified number of patients of unknown age. On an unknown date the patients were vaccinated with doses of improperly stored VAQTA (dose, route, lot# were not reported). No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
MOTHER REPORTED c/o Head ACHE, DIZZINESS  And NAUSEA IN THE Morning  LATE AFTERNOON fever 101.3  HEAD- ACHE, DIZZINESS- TYLENOL 500mg Administered per Mother
Red, slightly swollen, warm area on anterior left thigh measuring 10x11cm. Area was slightly itchy, no systemic symptoms.
full blown COVID side effects; This spontaneous case was reported by a consumer and describes the occurrence of SUSPECTED COVID-19 (full blown COVID side effects) 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.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SUSPECTED COVID-19 (full blown COVID side effects). At the time of the report, SUSPECTED COVID-19 (full blown COVID side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown demographics. No concurrent conditions or medical history were provided. The medical assistant reported that those patients were administered with a doses of PNEUMOVAX23 (doses, routes of administration, indications, lot#, expiry dates unspecified) between 13-OCT-2013 and 13-NOV-2013 that had been improperly stored. No concomitant medications were reported. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Reported that since receiving 3rd booster  10/26/2021,  began having intractable nausea, vomiting, generalized body aches, flu-like symptoms and dehydration.  Progressed to extreme weakness.  Led to intubation and mechanical ventilation; sepsis; AKI; shock liver. Transferred to the Medical Center for higher level of care on 11/3/2022.  Despite maximum therapy, patient expired 11/4/2021.