chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Within a few hours arm was sore but into the evening swollen and warm to the touch. Experienced headaches,chills, sweats,nauseated and achy everywhere.  These continued and stopped by the pharmacy to make sure everything was normal. Which the pharmacist said that it's stronger than the first one and it was normal. It's now Saturday, 7/9 and still not feeling great.  Was told it could be a week.
Patient received her first dose of the Pfizer vaccine today.  She had developed chest tightness and wheezing yesterday, she has a history of asthma. The chest tightness and wheezing increased after her vaccine. She also noted tingling to her lips and dizziness.  She had no shortness of breath, cough, palpitations or chest pain. No angioedema, rash or pruritis. She was in no acute distress. She was talking in complete sentences and drinking water without any issues. Her lungs were clear through out with no bronchospasm, her heart rate was regular.  BP 160/100, HR 66, RR 22, O2 99% on room air.  I spoke with the RN at ICC who accepted patient to be seen at the ICC for further evaluation and monitoring. Patient declined ambulance transfer and felt comfortable enough to drive her self to the ICC. She was monitored at the vaccine clinic for 35 minutes after receiving her vaccine and left in stable condition.  Her sister was notified.
felt like my heart stopped for a second or two, then it was normal; had to take more naps; felt fatigued; This spontaneous case was reported by a patient and describes the occurrence of EXTRASYSTOLES (felt like my heart stopped for a second or two, then it was normal), SOMNOLENCE (had to take more naps) and FATIGUE (felt fatigued) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0358214) for COVID-19 vaccination.     The patient's past medical history included Depression, Anxiety and Sleep disorder. Concomitant products included LISINOPRIL and CRATAEGUS SPP. FRUIT (HAWTHORNE BERRY) for Blood pressure, OLEA EUROPAEA LEAF (OLIVE LEAF EXTRACT) and ZINC for Cold, OLIVE OIL for Inflammation, ECHINACEA PURPUREA ROOT, OLEA EUROPAEA LEAF, SAMBUCUS NIGRA FRUIT (ELDERBERRY ECHINACEA & OLIVE LEAF) for Pain and Inflammation, CLONAZEPAM for Panic attack, HONEY for Viral infection NOS, COCONUT OIL for an unknown indication.    On 21-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jun-2021, the patient experienced EXTRASYSTOLES (felt like my heart stopped for a second or two, then it was normal), SOMNOLENCE (had to take more naps) and FATIGUE (felt fatigued). On 22-Jun-2021, EXTRASYSTOLES (felt like my heart stopped for a second or two, then it was normal) had resolved. On 25-Jun-2021, SOMNOLENCE (had to take more naps) and FATIGUE (felt fatigued) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Other concomitant medication information provided was Hemp oil with menthol, Alphalpha max in the morning and evening, Seaweed Kelp twice a day. Reporter stated that he wanted to know more about the pericarditis and enlarged heart after the second dose.  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   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: Follow-up information received on29-JUN-2021 contains non-significant information.; Reporter's Comments: Expiration date of the Moderna Vaccine Vial was reported as 31-Jun-2021; 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
The day I got the shot, I developed a headache, and felt kind of lethargic. The injection site was warm, swollen, and sore. Then, the next day, I developed a rash on my arms, all the way into the palm of my hands, and it itched really bad. That night the rash had spread around my waist, around my legs, down to my ankles, and on my stomach. It was very itchy. My doctor prescribed a cortisone cream to help with the itching. I am doing much better now. I used the cream until it was gone, and the rash slowly cleared up, but the injection site is still very sore.
For the Second and Forth shot of the vaccine, I did have mild flu like symptoms for a day or so but they went away.  Breakthrough Case of COVID- I had a sore throat, a cough, Mucus, very bad headache, and fatigued.
tested positive for COVID-19; A spontaneous report was received from a consumer concerning himself, who is a 39-years-old male patient received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events tested positive for covid-19.  The patient's medical history was not provided. Concomitant medications reported were vitamins for drug use for unknown indication.  On 15 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: not provided) via unknown route for prophylaxis of COVID-19 infection.  On 22 Jan 2021, the patient experienced the event tested positive for covid-19.  No treatment details were provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event tested positive for covid-19 was unknown.
High heart rate, normal resting rate is 65, Fitbit states 87. Feels like I move my eyes quick but my brain is a little slow to react.
Pt recv vax on 11/9/98; on 11/11/98 pt exp nausea, chills & sweats x 4 day; fatigue & body aches x 1 wk
Crankier today. At the injection site, 1 inch red, raised area. He has red welts around his arms, torso, legs. Raised and red, circular, warm to the touch, no itching or respiratory problems. ZYRTEC has not helped, suggested trying BENADRYL.
body aches; Fatigue; severe left arm pain; This is a spontaneous report from a contactable other health care professional. A 23-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation solution for injection; Batch/Lot Number and Expiration date was unknown) via an intramuscular route of administration in Left Arm on 17Mar2021 at 14:00 (at the age of 23-year-old) as dose 1, single for COVID-19 immunization. The patient medical history included COVID-19 (Prior to vaccination, was the patient diagnosed with COVID-19: Yes), food allergy (Allergies to medications, food, or other products:FOODS- SPICES), gluten sensitivity (NON-CELIAC GLUTEN INTOLERANCE) from an unknown date and unknown if ongoing. The patient concomitant medication included ethinylestradiol;ferrous fumarate;norethisterone acetate taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested positive for COVID-19. The facility where the most recent COVID-19 vaccine was administered was at a military base. On 17Mar2021, the patient had experienced severe left arm pain and fatigue at 16:00. On 18Mar2021, the patient experienced body aches. It was reported that the patient had severe left arm pain on the day and day after the vaccination, experienced fatigue 2 hours after injection and body aches only occurred day after, the patient felt better after taking NSAIDS. The clinical outcome of the events was recovered on an unspecified date.  No follow-up attempts are possible; information about lot number cannot be obtained.  Amendment: This follow-up report is being submitted to amend previously reported information: Updated the relevant history for COVID-19, FOODS- SPICES allergy, NON-CELIAC GLUTEN INTOLERANCE; added information in Best Doctor / Health Care Professional Information; Treatment Received ticked No for event severe left arm pain and Fatigue; Recoded concomitant drug LO LO ESTRIN; Ticked Vaccine Administered at Military Facility as Yes.
nausea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NAUSEA (non-serious), outcome "unknown", described as "nausea".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient started with fussiness and rash on Saturday morning 7/8/2017 per mother. The rash increased from his stomach to his entire body over the course of 2 days. The rash is classic maculopapular, red and covering his entire head to toe. There is no Koplik spots noted in his oral mucosa. He was fever free at the time of examination. He was alert and calm when with his mother and grandmother.
This spontaneous report as received from a Licensed Nurse Practitioner refers to an unspecified number of patients of unknown age and gender. On an unknown date the unspecified number of patients were vaccinated with LIQUID PEDVAXHIB (dose, strength, route and site of administration was not reported). The reporter stated that those doses of LIQUID PEDVAXHIB were exposed to temperatures outside of the proper storage range. No adverse effect reported. This is one of several reports from the same source. Additional information has been requested.
Immediately after vaccine was administered, patient reported she might have to pass out and felt nauseated. She had to breathe through her mouth and was warm to the touch. She reported not eaten anything in all day. Patient was given water, some sugar sources, and cold paper towels placed on the back of her back. After 10 minutes of staying seated, patient was fine and left the pharmacy with her family member. Patient knows the pharmacy's phone number and was encouraged to contact with any issues and/or questions.
left arm with pain, redness, hot to touch, swelling near injection site, fevers, body aches lasting 3-4 days
Info has been received from a male physician who on 10/25/2002 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (lot 642719/0376M). On 10/25/2002, the pt was concomitantly vaccinated with a dose of influenza virus vaccine in the opposite arm. Approx 24 hours post vaccination on approx 10/26/2002, the physician reported that his arm was sore and tender. At 36 hours post vaccination, he had a red, triangular, raised area at the site of the injection. He also developed chills and malaise. On 10/28/2002, he was beginning to feel more normal. He took acetaminophen for the symptoms. Additional info is not expected.
Rash, itching, blisters. MD visit:  05/03/2010.
Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  The patient's past medical history included No adverse event (no medical history reported). Concomitant products included LEVOTHYROXINE for an unknown indication.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced HEADACHE (Headache). On 26-Mar-2021, HEADACHE (Headache) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.    This case was linked to US-MODERNATX, INC.-MOD-2021-089050, US-MODERNATX, INC.-MOD-2021-089217 (E2B Linked Report). This case was linked to MOD-2021-089063 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-089050:Husband's case US-MODERNATX, INC.-MOD-2021-089217:Son case
like he had a "brain fog; couldn't remember her name / doesn't know what happened; Talking like a baby; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (like he had a "brain fog), DAYDREAMING (couldn't remember her name / doesn't know what happened) and SPEECH DISORDER (Talking like a baby) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     The patient's past medical history included Heart attack in 2015.   On 25-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, the patient experienced FEELING ABNORMAL (like he had a "brain fog), DAYDREAMING (couldn't remember her name / doesn't know what happened) and SPEECH DISORDER (Talking like a baby). At the time of the report, FEELING ABNORMAL (like he had a "brain fog), DAYDREAMING (couldn't remember her name / doesn't know what happened) and SPEECH DISORDER (Talking like a baby) had resolved.            Concomitant product use was not provided by the reporter.   Treatment information was not provided. Action taken in response to mRNA-1273 was not applicable.
PHARMACIST REPORTED ON BEHALF OF PT LIFTING BLOCKS 5/12/21 24 HOURS POST FIRST MODERNA SHOT FOR THE FIRST "FEW" HOURS PT REPORTED HE WAS FINE. PT REPORTED SHARP STABING PAIN AND FEELING OF NUMBNESS.PT DESCRIBED 'ARM WENT DEAD"PT DID NOT SEEK MEDICAL HELP. PT LEFT WORK AND WENT HOME. PT CLAIMED UNRESOLVED AND DID NOT TAKE ANY MEDICATION. +
Left arm bruising 1st 24 hours. Persistent erythema x3 weeks. Fever x48hr>.
I told nurse shot very painful and she said it would be fine. It began to hurt more than a normal flu shot. Within days I could hardly move my arm. I saw doctor after two months and have torn rotator cuff and ganglion cyst. Pain began with shot and intensified daily.
***********************COVID BREKTHROUGH CASE******************* I have allergies so I got tested just because the symptoms are similar and I got tested (positive) I had a headache. Video visit given Paxlovid.
Headache, Muscle aches, Nausea, Dizziness over a 10-12 hour period
12 weeks pregnant, last meal was 4 hours prior to vaccination. Patient started panting, says to have lost eyesight for a couple of minutes, eyes rolling in back of head.
physician administered a 4th dose of ActHIB too early; Initial information received on 02-Aug-2019 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 15-month old female patient who was vaccinated with a fourth dose of HIB (PRP/T) VACCINE [ACT-HIB] lot UJ079AA (expiry date: 26-Oct-2020) via unknown route in the left thigh on 02-Aug-2019.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  It was an actual medication error due to Inappropriate schedule of vaccine administered. It was reported that the physician administered a 4th dose of Act-HIB too early, the interval between the third and present dose was of two weeks only.  It was not known whether the patient had any adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
8 x 14 cm hive like lesion in area of injection - left deltoid.
Approximately 26 week gestation pregnant patient was unaware she was pregnant, had a negative urine pregnancy test that day, then was subsequently administered 1 dose of injectable anthrax vaccine and initiated a 7-day, 4-dose course of oral typhoid vaccination.
Severe arm pain, redness, swelling; severe headache present upon awakening 6:30 am 4/10/2021. No OTC medication taken. Improvement 4/11/2021. Pain, inflammation persisting 4/12/2021.
Severe chills/uncontrollable shaking  for 4 hours beginning 10 hours after the shot After chills ended - headache for 1 hour, body fatigue for 6 hours
Received Pfizer COVID vaccines per report on 12/26/20 and 1/16/21. Tested positive for COVID-19 by PCR on 5/24/20.  Unknown symptom onset date; had anosmia, dysgeusia.
On 4/26/02, right thigh: 2cm X 3cm nodule on anterior thigh with a less than 1/2cm in diameter erythematous, circular lesion. Not warm to touch.
Pt. states he had severe arm pain.  Arm that received in injection.  He was not sure if it was because of work, heavy lifting or vaccine given on 11/9/16.
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 62-year-old female patient received BNT162b2 (BNT162B2), on 10Dec2021 as dose 3 (booster), single (Lot number: FJ8757, Expiration Date: 30Dec2021) at the age of 61 years for covid-19 immunization. The patient's relevant medical history included: "Stage 3 renal failure" (unspecified if ongoing); "Super sick in the fall" (unspecified if ongoing); "Fatigue" (unspecified if ongoing); "Intestinal issue" (unspecified if ongoing); "COVID-19", start date: Sep2021 (unspecified if ongoing), notes: The end of September last year. There were no concomitant medications. Past drug history included: Oxycodone for hand surgery, reaction(s): "Raised liver levels"; Tylenol for Hand surgery, reaction(s): "raised liver levels", notes: Lot number: P144565, Expiry date: Sep 2023. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot number: EN6198), administration date: 19Feb2021, when the patient was 61-year-old, for Covid-19 immunization; BNT162b2 (DOSE 2, SINGLE; Lot number: EN0207), administration date: 11Mar2021, when the patient was 61-year-old, for Covid-19 immunization. The following information was reported: HERPES ZOSTER (non-serious) with onset Jan2022, outcome "unknown", described as "shingles"; ILLNESS (non-serious), outcome "unknown", described as "sick". Therapeutic measures were taken as a result of herpes zoster. Additional Information: Caller said all of the vaccine doses made her very sick, and then she had shingles a month after she had the booster. The reporter said that the treatment for shingles was Valacyclovir, which she also got sores in her mouth from her lupus so she had her Valacyclovir refilled so many times for the sores in her mouth, and she had also got something for the blisters on her back. Reporter stated she did not have medication with her at that time to provide NDC, Lot number and expiry date.
swollen; hard; tender to touch; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (swollen), INDURATION (hard) and TENDERNESS (tender to touch) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included LISINOPRIL and CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) for an unknown indication.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced SWELLING (swollen), INDURATION (hard) and TENDERNESS (tender to touch). At the time of the report, SWELLING (swollen), INDURATION (hard) and TENDERNESS (tender to touch) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Rash on torso; Third/booster dose of BNT162b2; Initial immunisation with COVID-19 vaccine moderna and booster dose with BNT162b2; This is a spontaneous report received from a contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 39-year-old female patient (not pregnant) received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administered in left arm, administration date 01Dec2021 at 09:30 (Lot number: FG3527) at the age of 39 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "None". There were no concomitant medications. Vaccination history included: Moderna covid-19 vaccine (DOSE 1, SINGLE, Lot number: 009021A, Anatomical location: left arm, Administration time: 09:00), administration date: 24Apr2021, when the patient was 38 years old, for COVID-19 immunisation and Moderna covid-19 vaccine (DOSE 2, SINGLE, Lot number: HRSA0421A, Anatomical location: left arm, Administration time: 09:00), administration date: 22May2021, when the patient was 38 years old, for COVID-19 immunisation. The following information was reported: IMMUNISATION (non-serious) with onset 01Dec2021 at 09:30, outcome "unknown", described as "Third/booster dose of BNT162b2"; INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 01Dec2021 at 09:30, outcome "unknown", described as "Initial immunisation with COVID-19 vaccine moderna and booster dose with BNT162b2"; RASH (non-serious) with onset 02Dec2021 at 21:30, outcome "not recovered", described as "Rash on torso". Therapeutic measures were not taken as a result of rash. Additional information: The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.
Pfizer BioNTech COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccines on 3/27/2021 and 4/17/2021. Presented to the ED with altered mental status.Admitted for acute hypoxic resp failure 2/2 Covid PNA and COPD exacerbation. Received: vitamin C, budesonide, methylprednisolone, zinc, redesivir, tocilizumab, and antibiotics. Mentation initially improved but 2/1/2022 transferred back to ICU due respiratory decompensation. On 2/2/2022 had a brief cardiac arrest following mechanical intubation. CRRT was initiated in the evening and patient subsequently had another PEA arrest. Patient expired at 2139.
I started bleeding vaginally about four days after the shot, plus was fairly dizzy for the first week.  I haven't bled vaginally for nearly 13yrs and am very healthy.  Tests were run and all came back normal.  Medication solved the problem, but I bled for nearly two weeks.
The patient was treated for shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation referring to a female patient of unknown age. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On an unspecified date in 2008, the patient was vaccinated with zoster vaccine live(ZOSTAVAX) (lot#, expiration date, dosage and route of administration were not provided) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, subsequent to inoculation, the pt was treated for shingles. The pt had and would continue suffering ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. At the time of the report, the outcome of shingles was unknown. The reporter considered shingles to be related to Zoster Vaccine Live(ZOSTAVAX).
throat tightness, lower lip swelling, mild chest tightness. Mild Angioedema