chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  Clinical course: Antiviral treatment of Paxlovid for COVID 19 were started from 14May2022 to 19May2022. Adverse event: Terrible taste in mouth after eating or drinking that lasted hour.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
I received the H1N1 vaccine on 1/22/2010. Adverse events occured on 1/25/2010 to present. Red bumps appeared on my back and in the front of my torso, arms, stomach etc.  Red bumps became huge welts all over my body. Size of welts ranged from 3 inches in height to 6 inches in width and greater and vice versa.  The hives have been traveling up to my neck to the soles of my feet,arms, thighs, legs, and hands, etc.  Very, very, very, itchy.  Seems to worsen in the evening.   Treatment:  Soaked in tub with baking soda on first day.  On second day used Hydrocortisone and Benadryl. On the third day went to the doctors.  He said to continue with what I was doing.  Called doctor today and said that the hives were still bothering me. Doctor called in prescription for predisone today.  I will pick up prescription tomorrow. Hives are continuing up to today 1/28/2010
This case was reported by a healthcare professional and described the occurrence of pain in shoulder joint in a 30-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). On 30 October 2008 at 12:00 the subject received a dose of FLULAVAL (unknown). At an unspecified time after vaccination with FLULAVAL, the subject experienced extreme pain in the shoulder joint. The subject took ALEVE twice daily for the pain. The event was unresolved at the time of reporting.
exercise induced asthma during a night out; was wheezing the next day and had difficulty taking deep breaths; I emailed Dr. and she had me come in; discussed my hx with childhood asthma and she prescribed me Albuterol to keep on hand.
This spontaneous report as received from a nurse practitioner regarding a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On 10-FEB-2012, patient received improperly stored VARIVAX dose 2, from batch/lot # 669842/0931AA ( expiry date, dose units, route and anatomical location were not specified). No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there were insufficient data to provide 100 percent assurance on vaccine stability. This is one of the several reports received from the same reporter. Additional information has been requested.
Low grade fever, headaches and moderate joint pain are continuing 10 days after second dose.  Ibuprofen does not really help.  Moderate to severe swollen joints within 24 hours after BOTH first and second dose.  Each time lasted 72+ hours.  Fever, headaches, injection side arm pain were expected and experienced.
Extremely weak; Bone pain; Stomach pain; Severe reaction to second moderna vaccine; Throwing up; Head pain; Chills; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Extremely weak), BONE PAIN (Bone pain), ABDOMINAL PAIN UPPER (Stomach pain), VACCINATION COMPLICATION (Severe reaction to second moderna vaccine) and VOMITING (Throwing up) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, 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 ASTHENIA (Extremely weak), BONE PAIN (Bone pain), ABDOMINAL PAIN UPPER (Stomach pain), VACCINATION COMPLICATION (Severe reaction to second moderna vaccine), VOMITING (Throwing up), HEADACHE (Head pain) and CHILLS (Chills). At the time of the report, ASTHENIA (Extremely weak), BONE PAIN (Bone pain), ABDOMINAL PAIN UPPER (Stomach pain), VACCINATION COMPLICATION (Severe reaction to second moderna vaccine), VOMITING (Throwing up), HEADACHE (Head pain) and CHILLS (Chills) outcome was unknown.            No concomitant medication was reported.  The treatment information was not given.
The spontaneous information was received from a physician regarding 22 patients of unknown age and unknown gender. Pertinent medical history, drug reactions or allergies were not reported. This report refers to a patient who on 05-MAR-2014 was vaccinated with PROQUAD (merck) lot # J015595, expiration date 05-JUN-2015, that were exposed to highest temperature of 5 Celsius degree for 5 months (also reported as exposed to refrigerator temperatures not greater than 46F), (strength, dose and dose schedule were not reported). No concomitant therapies were reported. No adverse effects reported. The outcome was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
92 y.o. female with PMHx of CHF, CAD, HTN, hypothyroidism presented to the hospital with 3 days of worsening shortness of breath, fever/chills, myalgias, fatigue, and an intermitted cough. Had not been taking home Lasix since she started feeling sick. She was COVID positive on admission and started on Paxlovid. Shortness of breath improved with IV lasix. She was transitioned back to her home Lasix 40 mg qD. She was somewhat hypotensive during her admission and her carvedilol, lisinopril, spironolactone, IMDUR, prn Nitrostat were held. These will be discontinued at discharge and she will need to follow up with her PCP in 2-3 days to discuss resuming these.
Initial report received on 27 August 2010 from a health care professional.  A 12-year-old female patient had received a second dose of MENACTRA vaccine on 23 August 2010.  It was reported the patient had received the first dose of MENACTRA vaccine on 07 October 2005.  On 24 August 2010, i.e. the following day after receiving the MENACTRA vaccination, the patient started to experience headache and fever.  Two days later, the headaches were of a migraine type nature.  The patient was evaluated by her physician the following day, but it was not reported whether the patient required any treatment.  No relevant diagnostic tests or laboratory data were performed.  The patient had no concurrent illnesses at the time of the vaccination on 23 August 2010, and had no known allergies.  Per the mother of the patient, the patient had experienced headaches prior to receiving the MENACTRA vaccination on 23 August 2010.  The patient's recovery status was not reported.  Documents held by sender:  None.
The event started about 2 weeks ago, the last week in July. I noticed a rash under both arms, very painful and itchy. I have not ran a fever. This past Thursday I had a phone conversation with a doctor. I was advised to stop using the deodorant I've been using for 15 years. I was prescribed a corticosteroid 3 days ago (8/7/21) with no relief. I was told to wait 2 weeks to see if the symptoms get better.
Extreme body aches, chills, nausea, vomiting, headache, fatigue, joint pain
Got vaccine on 4/7 at 10-10:30 am approximately  By 1 pm I was sleepy and woke up at 3 By 4-5 pm I had chills, body ache, no fever, nausea, heart palpitations, feeling that my blood is on fire, mild sore arm By 6-8 pm I was vomiting a lot and also going to the bathroom loose no diarrhea  All night I felt sick and had raising thoughts in my mind. I have sensitivity to noises as well. On 4/8 I woke up very sick. Kept throwing up water and liquids. Couldn?t eat. By 1 pm I have thrown up some more The raising thoughts and things in my mind bother me 3 pm my veins in the back of my knees are hurting  I have the feeling that I can feel my kidneys, liver, intestines  Took Tylenol  9 pm and still feeling sick 4/9 still nauseous and with a pounding headache  Took Tylenol  By 8 pm I?m feeling a bit better
This spontaneous prospective pregnancy report as received from a nurse refers to a 26 year old female patient. Pertinent Medical History of the patient included prediabetic, gestational high blood pressure, high lipids and irregular menstrual cycle. The patient had none drug reaction/allergies. The nurse reported that a patient had a negative pregnancy test and on 08-JAN-2014 the patient was vaccinated with VARIVAX (Merck) (lot# reported as J002316, Exp date 22-FEB-2015), 0.5 ml, route unspecified. Other suspect therapies included M-M-R II 0.5 ml, route unspecified (lot# reported as J002316, Exp date 22-FEB-2015). Concomitant therapies included vitamins (unspecified), aspirin and metformin. On 13-JAN-2014, the pregnancy test returned results that the patient was pregnant. The Last Menstrual Period (LMP) and expected date of delivery (EDD) was not known. The pregnancy outcome was pending. Patient went to nurse's office for medical attention. No adverse effects reported. Additional information has been requested.
Had menstrual spotting from 3/24/21-4/18/2021 after receiving first dose of moderna vaccine.  Have had no spotting or period since 4-18-2021.
This spontaneous report was received from a other health professional (dentist) refers to a female patient of unknown age. Patient's pertinent medical history and drug allergies were not reported. On an unknown date the patient was vaccinated with GARDASIL (dose, frequency, therapy route, lot # and expiry date not reported). On an unknown date the patient experienced fainting on an unspecified date after receiving GARDASIL. Outcome of the event was not reported. Causality assessment was not provided. This is one of the several reports received from the same source (MARRS #1412USA001433). Additional information has been requested.
Patient reported she felt very sick with symptoms including fatigue headaches and a red swollen arm at the site of injection.
Giddiness, dizziness, "feeling drunk", failed finger-to-nose test, uncoordinated, and memory loss of events x 10 hours.  He was able to answer questions, but kept repeating same questions over.  Approximately 13 hours from onset of adverse event, he stated feeling "punched in the face", headaches, and ringing in one ear.  Also experienced numbness in fingertips.  Approximately 24 hours after vaccination, ringing in ears/numbness in fingertips resolved, but some dizziness.  Now with lethargy, and chills - which are some of the expected side effects.  He states, "I lost at least 8 hours of my life."
loss of appetitie, chills and fever, right-sided headache, chest pains and shortness of breath all of which resolved except for the headache now posterior, inspiratory chest pain and shortness of breath
This spontaneous report was received from a Licensed Practical Nurse refers to a female patient of unknown age and gender. No medical history was reported. On 19-MAR-2013, the patient was vaccinated with a dose of 0.5 ml PNEUMOVAX 23 (lot # h015780, expiry: 11-JUN-2014) intramuscularly. No concomitant medications were repotted. On 21-MAR-2013, the patient called the office because she had developed swelling and redness at injection site. No treatment was given. The outcome of swelling and redness at injection site was unknown. The relatedness of the events with PNEUMOVAX 23 was unknown. The nurse called because she is requesting to have a lot check done for PNEUMOVAX 23. This is 1 of 3 reports from the same source. Additional information has been requested.
Arm swelling; This spontaneous case was reported by a health care professional and describes the occurrence of PERIPHERAL SWELLING (Arm swelling) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jan-2021, the patient experienced PERIPHERAL SWELLING (Arm swelling). At the time of the report, PERIPHERAL SWELLING (Arm swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were provided. The patient  had exercised to get rid of arm swelling.   This case was linked to MOD-2021-215057 (Patient Link).
This ?event? occurred  4 months after receiving my booster.  I experienced runny nose, sinus pressure, frequent colorful nasal discharge including blood mucus.  I sinus pain and pressure.  Symptoms lasted a little over three weeks starting on February 6, 2022.  I participated in an exchange of emails (what calls an ?E-Visist? that resulted in a prescription for an antibiotic.  At the end of the  5 day course of antibiotics, my symptoms cleared up.
Tested positive for Covid 19; This is a spontaneous report from a contactable consumer (patient's wife) from a Pfizer-sponsored program. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not provided), via an unspecified route of administration on 06Mar2021 at 1st dose, single dose for COVID-19 immunization. Medical history included shingles from an unspecified date to Feb2021. The patient's concomitant medications were not reported. The reporter and the patient received their first doses of COVID-19 vaccine on 06Mar2021 and then the patient tested positive for COVID-19 on 17Mar2021, he felt symptoms and tiredness and then he was quarantined. After being quarantined, he got his second dose today, 01Apr2021. The patient just recovered from shingles a week before he had his first dose. The outcome of the event was unknown.   Information on the lot/batch number has been requested.
Extreme increase in anxiety a little less than a week after the first dose. Panic attacks, which I never experienced before. Waking up feeling flooded with adrenaline, restless legs, feeling in a daze. Started more therapy, but effects are still occurring
Throughout me feeling sick, the migraine and nausea kept more occupied so not sure how often the tight feeling in the upper left area and the heavy left arm was going on. On 8/16/18, I woke up feeling normal and have had no problems so far.
Approximately 5 mins after administration of GARDASIL-9 in right deltoid, patient complained of dizziness and lightheaded. Patient pale in color. Vomit x1 - clear emesis. Patient shaky. Pt. laid on exam table with feet elevated. Water and ice pop given. Monitored x 30 mins. - Symptoms improved. In follow-up that evening patient more tired than usual. Felt "normal" by next morning 6/23/16.
rash (nonurticarial, blanching, nonpruritic), lacy reticulated on extremities and face within 10 min of receiving shot. No vomiting/diarrhea/wheezing/face swelling. Provided Benadryl12.5mg/5ml, 8 ml dose x 1 with improvement but not resolution. Observed 30 min w/o worsening and sent home.
POSITIVE COVID TEST, ASTHMA, ALZHEIMERS, ACUTE HYPOXEMIC RESPIRATORY FAILURE
Patient had an adverse reaction to her first shot, unreported, mostly local to the injection.  For this 2nd dose, she was not feeling well the day after the shot, but was at work.  She did not show up for work on Friday and was found dead.  Time of death was undetermined.  She lived alone. An autopsy was not performed.
Received vaccines on 5/12/08. Came in 5/14/08 with swelling and redness where vaccines given. Placed on antibiotic treatment
Patient to the ED on 12/6/2021 for altered mental status from nursing home.  Patient with a fever here of 101.2.  Denies any other complaints.
A non-serious spontaneous report of "I gave a 7 month-old FluMist" was received from a nurse subsequent to FluMist. Neither relevant medical history have not been reported for this patient. On 26-Oct-2009, a nurse inadvertently administered FluMist to the 7 month-old patient. There was no adverse event associated with this vaccination error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months for FluMist. Required follow up attempts have been performed, requested information unable to be obtained.  23-Feb-2010.
No Lot #.  Tingling right cheek, fatigue, arm soreness. 2nd day, swelling numbness right side of face with drooling. Dr. told she to take Benadryl. Swelling was right side of face up to eye. Improving by Friday with Benadryl.  Last week the swelling returned. And travelled to back of head. 1/7/21 saw dentist, no problem reported. 1/11/21 started the prednisone prescribed by doctor.
Injection being administered, needle popped off of the syringe due to pressure, faulty connection with syringe. Contents of syringe spray out onto administrator, not full dose injected.
EVERY SYMPTOM OF MYOCARDITIS; This spontaneous report received from a consumer via a company representative via social media concerned a female of unspecified age, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number and expiry date were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced every symptom of myocarditis. As per reporter, "Johnson and Johnson my coworkers wife has virtually every symptom of myocarditis after her vaccine, and both her doctor, and cardiologist refuse to even entertain the thought that it could be vaccine related. They will most likely lose their jobs if they do. Big pharma has far too much power over our medical industry, our media, and our politicians" The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of every symptom of myocarditis was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20221138832- possible myocarditis. The event has an unknown/unclear temporal relationship, is unlabeled, and is scientifically plausible. There is no information on any other factors potentially associated with the event. Therefore, the Causality is considered indeterminate. The company causality is considered unassessable.
Per MOC puffy face no breathing problems. Tx: - ORAPRED 2tsp po every day x 3 days - BENADRYL 2tsp po every 6 hours x 24 hours then every 8 hours x 2 days - go to ER for any respiratory difficulty.
Patient is a 77 year old female who has completed a 45-minute observation period with the following signs and symptoms of an adverse reaction: other - itchiness no evidence of hives or skin rash upon assessment. Pt report no shortness of breath. Pt stated she feels fine otherwise. Moderna COVID-19 vaccine# 1 in series administered.  o Action(s) taken: Other - benadryl giver per pt request 25mg PO o Allergy to COVID-19 vaccine documented in Allergies activity: No,  o Patient advised to discuss second dose considerations with a clinician
Depression, Headache, Myalgia, Arthralgia & Fever Narrative:
Injection site pain,tiredness,headache,muscle pain,chills, joint pain,nausea,feeling unwell, temperature 99.6
No adverse effects reported; the patient was inadvertenly administered a dose of ROTATEQ that had been improperly stored; This spontaneous report was received from a medical assistant concerning to a patient of unknown age and gender.  The patient's concurrent conditions, pertinent medical history, drug reactions or allergies and concomitant medications were not reported.  On 21-AUG-2019, the patient received a unspecified number of doses of improperly stored Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) orally for prohpylaxis (dose not reported) (lot#: S000961, expiration date: 19-OCT-2020) (lot # R033255, expiration date: 26-JUN-2020). The total temperature was 48.5 degrees Fahrenheit for a total time frame of 15 minutes. There was a previous temperature excursion of 46.9 degrees Fahrenheit for 5 minutes. The call was due to a data logger. No adverse effects were reported.
Given Tdap (unsure which manufacture- documented by OB) while pregnant with second child on 7/25/2019. Received Tdap during first pregnancy on 5/10/2018 with no adverse reaction. Due date was 9/29/2019. Diagnosed with Guillian-Barre Syndrome 9/5. Emergent c-section at 36w4d. Birth weight 6lbs 13oz. Plasmapheresis started, and continued until mid october. Partial paralysis and decreased mobility and sensation. Pain, numbness, decreased sensation and tingling continues as of 10/28. Decreased mobility continues 10/28. Fatigue continues 10/28. Gabapentin prescribed for pain. Prednisone prescribed for inflammation. PT/OT and speech therapy multiple times per week.
Scattered confluent erythemic papules, wheals, 1 cm x 7 cm indurated erythemic plaque left anterolateral thigh.  Per MD.
client called 8/30/23 to report "I kind of broke out in a rash, I am taking Benadryl and applying itch cream". Client left this info on voicemail of this clinic nurse. Client called back 8/30/23 @ 12:00 pm to report welt-like rash started itching 8/28/23 after bedtime. Welts and itching (by next morning 8/29/23) then spread to both arms, front of chest and both armpits. Has not gotten worse since yesterday. Benadryl and itch cream are helping.
Patient was administered IMZ at approximately 1:55 pm. Within 2 minutes patient motioned she was in distress. Face turned red and patient exhibited signs of difficulty breathing. Patient could not talk. At approximately 2 PM 911 called and EPIPEN administered. Patient  was layed on floor with knees up. Cold compresses were applied. Paramedics arrived within 5 minutes she was transported to medical facility for treatment at approximately 2:05 PM.
Patient received FLULAVAL vaccine 10/23/18 right deltoid muscle. No adverse reaction after 15 minutes. 10/24/18 office visit for possible reaction to flu vaccine. Patient complains of stomachache, headache and rash to right upper arm. Right arm erythema 4.5in x 1.4in, mild induration.
I started vomiting about12 hours after the injection on Thursday. I also had a headache, weakness and dizziness. I went to the ER on Friday for the vomiting and headache. I had IV fluids, an injection for the nausea, blood and urine tests and a CXR. I was there about 6 hours. I was in bed from Saturday to Monday. I went out on Tuesday, but still felt queasy and weak.
Fever 101.8, sore throat, drowsy, severe malaise, achy joints, shivering, head ache, cold hands and feet
Hospitalization 8/14-8/22/2021 for acute respiratory failure/pneumonia due to COVID.  Treated with dexamethasone 6 mg IV daily; Remdesivir for 5 days. Expired 8/22/2021
Fever, body aches, arm and corresponding under arm very sore, thirsty by 1:00 11/1/22. Later, coughing, nausea