chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning a 5 year old male (also reported as female) who on 07/31/2000 was vaccinated SQ in the LL with a first dose of varicella virus vaccine live. Subsequently the pt experienced breakthrough chickenpox. It was reported that the child had a fever of 101 degrees F and few pustules, no crusting as of yet. The physician reported that there were 4-5 lesions on the trunk, 2-3 lesions on both arms and 2-3 lesions on the head. The lesions began approximately 08/03/2004. It  was reported that no prescription medications were ordered but the mother was told to use diphenhydramine hcl ( Benadryl) for itch, acetaminophen (Tylenol) for fever and calamine + camphor+ pramoxine hydrochloride (Aveeno) bath if necessary. The mother was unaware of any contact with another affected person. The pt is recovering. At the time of the report, the pt's experience was considered to be an other important medical event. (OMIC) No additonal information was available. Follow up confirmation was receieved from the nurse who indicated that the pt experienced a very mild case of chicken pox that was definatedly not  serious. The pt has 15-20 spots. She did confirm that the parent was instructed to use Benadryl for itch, Tylenol for fever and calamine + camphor + pramoxine hydrochloride (Aveeno) bath if necessary. Additonal information has been requested. Another pt (WAES 0408USA00632) developed breakthrough chickenpox after vacciantion with varicella virus vaccine live.
Passed out; Heart felt like it was shifting gears, Heart felt like it was skipping a beat; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out) and EXTRASYSTOLES (Heart felt like it was shifting gears, Heart felt like it was skipping a beat) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jun-2021, the patient experienced LOSS OF CONSCIOUSNESS (Passed out) (seriousness criteria hospitalization and medically significant) and EXTRASYSTOLES (Heart felt like it was shifting gears, Heart felt like it was skipping a beat) (seriousness criterion hospitalization). The patient was hospitalized from 14-Jun-2021 to 15-Jun-2021 due to EXTRASYSTOLES and LOSS OF CONSCIOUSNESS. On 15-Jun-2021, LOSS OF CONSCIOUSNESS (Passed out) and EXTRASYSTOLES (Heart felt like it was shifting gears, Heart felt like it was skipping a beat) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.  No treatment medication was reported.  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. Further information has been requested   Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2021: Upon internal review on 16-SEP-2022 non-significant correction was performed to update the case received from field.; Sender'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. Further information has been requested
Second vaccination on 3/30. At 11 pm developed qualitative fever (unable to quantify), lasted 24 hrs. On 4/3/21 woke up in AM with hives covering trunk.  This has persisted and caused significant discomfort and impacted ability to do daily activities.  Associated fatigue.
She got infected with covid july24; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (She got infected with covid july24) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Jul-2021, the patient experienced COVID-19 (She got infected with covid july24). At the time of the report, COVID-19 (She got infected with covid july24) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Jul-2021, SARS-CoV-2 test: positive (Positive) Patient got infected with COVID.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter said that patient's husband got infected with COVID. Concomitant product use was not provided. Treatment information was not provided.
Little fever; Fatigue; Muscle aches; Nausea; Headache; Diarrhea; Lost bit of taste; Pain in the arm; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), AGEUSIA (Lost bit of taste), PAIN IN EXTREMITY (Pain in the arm), PYREXIA (Little fever) and FATIGUE (Fatigue) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced PAIN IN EXTREMITY (Pain in the arm). On 11-Apr-2021, the patient experienced DIARRHOEA (Diarrhea), AGEUSIA (Lost bit of taste), PYREXIA (Little fever), FATIGUE (Fatigue), MYALGIA (Muscle aches), NAUSEA (Nausea) and HEADACHE (Headache). On 26-Mar-2021, PAIN IN EXTREMITY (Pain in the arm) had resolved. On 13-Apr-2021, DIARRHOEA (Diarrhea) had resolved. At the time of the report, AGEUSIA (Lost bit of taste), PYREXIA (Little fever), FATIGUE (Fatigue), MYALGIA (Muscle aches), NAUSEA (Nausea) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Apr-2021, Body temperature: increased (High) increased.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  No treatment information was provided.
Information has been received from an approximately 40 year old female consumer who has an allergic reaction to the Flu vaccine in 1976.  In 1988 she was vaccinated with an injection of RECOMBIVAX HB (manufacturer unknown) (dose and frequency unknown) (dose and frequency unknown) and she experienced an allergic reaction.  The consumer sought unspecified medical attention and her present status was not specified.  No further information is available.
The morning of the 18th, I had my blood drawn, and my absolute neutrophil count was low, very low. It dropped from 2.1 to .4, and the only thing that seems to account for it was the vaccine. My white bloodcell count went below normal to the number 3.4. My anc was extremely low 0.4. And my platelets were down 118 which is below normal.
Patient presented to the ED on 2/27/21. He was hospitalized on 3/3/21 and had another ED visit on 3/23/21. This was within 6 weeks of receiving COVID vaccination.
shingrix vaccine--1st dose--second day extreme joint pain throughout body, especially in hands and finger--wound site became infected, old wound sites became actively sore--itching all over--trigger finger in both index fingers and swelling in knuckle joints ,very painful
pt recv vax 5DEC97 & mom noticed pt being really hot;taken to ER 1PM & temp was 104.7;ER MD stated immun were the reason for ther fever;
Information has been received from a registered nurse concerning a 50 year old male with no allergies who on 14-NOV-2006 was vaccinated with a 0.5 mL dose of Pneumovax 23 (655289/0958F).  Concomitant therapy included METAMUCIL, simethicone, albuterol inhaler, ADVAIR, fosinopril sodium, SPIRIVA, NORVASC and ISORBID.  That evening, the patient developed a temperature and when she came in for follow-up she had redness, swelling and warmth from the inner portion of the arm to the elbow.  The patient was treated with KEFLEX.  No diagnostic laboratory studies were performed.  At the time of this report, the outcome was unknown.  No product quality complaint was involved.  Additional information has been requested.
The vaccine site was Community Center being done by Paramedics and Fire Fighters. I received the vaccine and sat down in the chairs to wait the required 15 minutes. Within 2-3 minutes my face got very hot. I could feel the heat under my mask. Another minute or two, just below my knees to my toes started tingling. Another two minutes or so, I felt like my eyes were swelling. I took my glasses off and looked at my husband and asked if my eyes are swelling, he said, they sure are and called over one of the paramedics that were there. They directed me to a more private are and put me on a monitor and monitored my vital signs. My blood pressure which is well controlled on my meds (which I did take that morning) climbed and climbed to 200s/100s. My chest was tight and uncomfortable and getting more difficult to breath. They put and 02 mask on and gave me Benadryl IM. By that time the squad was there and took me to the local hospital ER. In the squad my tongue started to swell. At the hospital they gave me Solumedrol IV which took care of it all. The swelling quickly went away in my tongue and face, the chest pressure went away, and all the other little annoyances like the tingling. The hospital did a chest x-ray and bloodwork. I went home after 3-4 hours with a prescription for Prednisone 50 mg daily for 5 days.  No further reactions after that.
Breakthrough case admission after 3 vaccines  Pfizer 3/12/21 loT# EN6199;  Pfizer 4/5/21 lot# ER8733;  Pfizer 12/5/21 lot# 330308D
"very sore arm for 2 days, difficulty lifting arm, pain woke me in the night.  Also developed fever and nausea which only lasted about 6 hours"
I got a blood cloth in my middle finger. Symptoms: swelling, pain, warm skin.  Treatment:ibuprofen and hot pack. It goes away after 3 days.
Severe migraine on the right side of my head; soreness around the injection point; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 30Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Like my first shot, I didn't get any serious side effects other than a soreness around the injection point, it went away the next day.), for COVID-19 IMMUNISATION, reaction(s): "Soreness around the injection point". The following information was reported: MIGRAINE (non-serious) with onset May2021, outcome "not recovered", described as "Severe migraine on the right side of my head"; VACCINATION SITE PAIN (non-serious) with onset 30Apr2021, outcome "recovered" (01May2021), described as "soreness around the injection point". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Additional information: Like patient first shot, patient didn't get any serious side effects other than a soreness around the injection point, it went away the next day. But there's been something patient never experienced before, 5-6 days after, anything that requires certain amount of physical strength, gave patient a severe migraine on the right side of head. The first time patient got very concerned, didn't think of the vaccine, and this, sharp, sudden pain, patient thought patient was having a stroke or something, but after patient did a little bit of a research, due to the nature and suddenness, it's a migraine. Patient didn't know what a migraine was before these episodes that started roughly a week ago, now it's a persistent thing that gets triggered by anything that it's stimulating or physically demanding, none of this was present pre-vaccine.
4 hours post vaccine - first symptoms noticed dissyness, hot flashes  14 hours post vaccine - fever (101.2), headache, body aches, heartburn, exhaustion  32 hours post vaccine - fever (99.5), headache, body aches, heartburn, exhaustion current time
pt recv vax & the next day exp loss of peripheral vision (visual disturbance); An ER or MD visit was required;sx subsided;
Approximately 12 hours after the shot fever spiked making me feel like I was freezing. Fever of 101. Chills. Sweating. Headache. Extreme fatigue. Muscle aches. No medical treatment needed. Fever lasted from 7:30 pm on the 21st to approximately 4am on the 22nd no medicine taken to relieve fever since temp never raised higher than 101. Muscle aches were gone by approximately 7am the 22nd no pain relieving medicine needed, used heating pads to ease pain. Fatigue and headache remained until approximately 7am the 23rd. Extreme fatigue that resulted in inability to stand for two minutes to brush my teeth without sitting. No shortness of breath just felt too physically tired to stand. No medical treatment needed for fatigue rested and drank fluids including meal replacement shakes due to lack of energy to make food. Rested and limited physical activity. Energy returned by evening of the 22nd. By the morning of the 23rd the only remaining symptom was headache. The headache ranged from dull to pounding but was constant since the first onset of fever on the 21st and remained on the morning of the 23rd. Took one dose of over the counter aspirin for the headache at approximately 9am on the morning of the 23rd. Headache came back. Another dose approximately  3pm. Headache did not return. No other symptoms remained on the morning of the 24th.
Rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jan-2021, the patient experienced RASH (Rash). At the time of the report, RASH (Rash) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  No treatment information was provided.
No additional AE; the vaccine was administered after a temperature excursion; This spontaneous report was received from a nurse concerning a patient of unknown age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, and previous drug reactions or allergies.  On 14-JAN-2022, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin) (PROQUAD), at a dose of 0.5 milliliter (ml) (lot number U016975, which was verified to be a valid lot number, expiration date reported and upon internal validation established as 24-NOV-2022), as prophylaxis (route of administration, anatomical location and vaccination scheme were not reported) (product storage error). The administered vaccine experienced a temperature excursion of -14.1C during a time frame of 12 minutes. There was no previous temperature excursion. No additional adverse events were reported.
Sore throat with coughing and swelling, fever chills muscle aches, headache
This case was reported by a consumer via other manufacturer and described the occurrence of musculoskeletal pain in a adult patient who received SHINGRIX for prophylaxis. On 29th March 2019, the patient received SHINGRIX. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced musculoskeletal pain. On an unknown date, the outcome of the musculoskeletal pain was unknown. It was unknown if the reporter considered the musculoskeletal pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not provided. Age group was captured as adult as per SHINGRIX vaccine indication. The patient received SHINGRIX during the normal course of business. No additional information was provided.
This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Insomnia), CONFUSIONAL STATE (Confusion), DISORIENTATION (Disorientated) and UNEVALUABLE EVENT (Facial expression was like a stare, strange look on her face and not normal for her) in a 97-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Talwin) and High cholesterol. Concomitant products included VITAMINS NOS for an unknown indication.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jan-2021, the patient experienced INSOMNIA (Insomnia), CONFUSIONAL STATE (Confusion), DISORIENTATION (Disorientated) and UNEVALUABLE EVENT (Facial expression was like a stare, strange look on her face and not normal for her). At the time of the report, INSOMNIA (Insomnia), CONFUSIONAL STATE (Confusion), DISORIENTATION (Disorientated) and UNEVALUABLE EVENT (Facial expression was like a stare, strange look on her face and not normal for her) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use included low dose blood pressure medication Treatment information was not provided.  The reporter confirmed that the events lasted only a few days.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: The outcome of the events were updated.
12/28/20 called to observation area at 12:05.  she had already waited 15 minutes after vaccine.  reports tingling top of tongue, tingling ums, back of mouth/throat scratchy.  12:10 states no change,  12:12 rapid response and supervisor arrived - talked with her.  decided to not go to ER unless worse, agreed will not go back to work or leave for home until sx resolved.  12:20 states gum tingling decreasing.  12:30 states sx resolved - left observation with instruction to return if sx. 12/29/20 came to vaccine area at 1045 to report injection site with 1" redness, firm to touch.  blanches, tender w/ pressing outer edge redness.  arm size unchanged, noted when got up this morning.  states sore, able to move arm.  1050 evaluated by rapid response and nursing supervisor.  states otherwise feeling ok, no sx.  supervisor drew circle around redness.  suggested ice/anti-histamine.  talked with her - to wait 30 minutes, to contact PCP if spreads.  1130 states no change, decided to RTW
Patient with 3 Moderna COVID vaccines who admitted with COVID PNA who subsequently died.  Receiving dialysis but had worsening neurological status including seizures and was unable to tolerate hemodialysis.  Family changes status to DNR and patient admitted to hospice status and died on 08/31/22.
Patient received COVID-19 Moderna vaccine series doses on 2/11/21 and 3/11/21. On 4/12/21, patient presented to the ED with chief complaint of left sternal border chest pain. Patient was evaluated by PCP and was found to have elevated D-dimer. Patient was sent to the ED for CTA and was found to have bilateral segmental and subsegmental emboli. Patient was discharged home on Xarelto to treatment of PE.
On 11/10/2021 started getting a bad headache, sore throat and I call called in sick for work. I was super fatigue and tired. I went to work the next day 10/11/2021- I did not have a fever. Friday afternoon I started feeling worse than Thursday. I developed a cough and congestion, no fever. On Saturday, 11/13/2021- I took a COVID-19 test- negative at 3:30. The symptoms continue and continue as of today, 11/17/2021. My primary physician thinks it might be a sinus infection. I have been treating it with Sudafed, Mucinex and Oscillococcinum. Today, 11/17/2021 I had a slight fever.
Bells palsy; This spontaneous case was reported by a pharmacist and describes the occurrence of BELL'S PALSY (Bells palsy) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Apr-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 BELL'S PALSY (Bells palsy) (seriousness criterion medically significant). At the time of the report, BELL'S PALSY (Bells palsy) 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 reported.   Pharmacist wanted to know if they should receive the second dose of the vaccine.  Treatment information was not provided.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Heavy menstrual bleeding with large clots. Menstrual cycle occurred per usual cycle time-frame but exceptionally heavy. Similar exceptionally heavy menstrual periods with large clots occurred after 1st and 2nd Pfizer vaccines as well. These heavier menstrual cycles lasted approximately 8-10 days, and my usual cycle lasts approximately 7 days.
Pt receiving multiple immunizations, prior to travel. Pt very nervous about needle, and immunizations. Answered all pt questions & explained process. Gave 1st immunization Japanese Encephalitis and pt was fine. Then administered 2nd yellow fever & pt became very nervous & breathing rapidly. Pt then had vasovagal/fainting reaction lasting < 5 min. Pt had water & orange and waited in waiting room for approximately 30 minutes. Felt better when parent picked her up to take home.
8/9/2021:came to ED with SOB, cough and weakness for 10 days 8/10/2021: pos for COVID - discharged 8/13/2021: admitted with worsening symptoms 8/19/21: discharged to home with home health care  and dexamethasone and told to return if worsens