chrisvoncsefalvay/vaers-outcomes huggingface dataset:
PATIENT HAD REDNESS TO RIGHT ARM AND WARMTH TO TOUCH AFTER RECEIVING HEP A, HEP B, AND MMR ON THAT ARM. PATIENT HAD NOT HAD ANY SHOTS PRIOR TO VACCCINE ADMINISTRATION. NO SIGNS OF SEVERE REACTION TO VACCINES. CHILD RECEIVED PENTACEL, PCV13, AND VARICELLA ON LEFT ARM. TELEPHONED MOTHER THE NEXT DAY TO FOLLOW UP ON CHILD, MOTHER STATED CHILD WAS DOING FINE WITH NO COMPLICATIONS. THE REDNESS HAD GONE AWAY.
FLU LIKE: CHILLS ACHE ALL OVER; STRONG PAIN, WEAKNESS, TIRED, REDNESS AND SWELLING  AT INJECTION, UPPER ARM. FOR 3 DAYS, THEN TODAY, 4TH DAY, WOKE UP WITH SWELLING OF MY LIPS AND BLISTER LIKE  SORES ON MY LIPS AND ALL AROUND MOUTH AREA.
SOB, racing heart rate, heaviness in B/L legs, feeling of malaise and unwell x 2 days, not flu like sx, not cold sx.
Summary (details to follow): Irregular heart rhythm was causing sudden shortness of breath, coughing, and fluttering in my chest.  Followed up with a cardiologist I had recently seen and the Dr determined the event was benign.  Symptoms subsided after 3-4 days. Details: Saturday the 22nd, as I was doing light cleanup around the house, I began to cough as I was working.  I thought it was asthma and allergy related (heavy pollen time of the year).  As the day progressed I began to notice fluttering in my chest each time I would reach down to pick something off of the floor - especially if my head dipped lower than my waist or chest.  The symptoms worsened into Sunday morning: I would feel the flutter/cough every time I would stand up from lying down or sitting.  By Sunday night and into Monday morning I was feeling the flutter/cough every few minutes regardless of activity.  I began using my Apple Watch ECG functions to capture sequences displaying the irregularity. I was able to capture multiple sequences clearly displaying my heart pausing for 2-3 seconds and then rapidly beating for 1-2 seconds before settling back into a regular rhythm.  These sequences always accompanied the fluttering feeling and urge to cough.    Coincidentally, 6 weeks prior (April 7, 2021), I had an event where my heart began racing while at a relaxed dinner.  I went to the hospital and initial tests were clear.  I had a followup with a cardiologist and received a thorough heart evaluation (ECG, cardiogram, etc.) which took place just 1-2 weeks before the May 22nd event and all test results showed that my heart functions were normal and healthy.    On Monday, May 24th, as the symptoms were still worsening, I followed up with the same cardiologist by phone and described my symptoms, then submitted the charts of the ECG to the cardiologist. Based on the previous baseline, the submitted charts, and symptoms I described, the cardiologist determined the symptoms to be benign.  The irregularities subsided after 4-5 days, although I did have an increased cough for a few weeks.  No treatment was given.
Lethargic, clammy, t103, screaming for 3 nights;
Had big red blotches, like water blisters, all over back, arms & neck. Felt warm & flushed. Went to ER & was given IV Benadryl & was told to rest. Got blotches again the next day & was told to take po Benadryl. Saw MD, more meds given.
6 to 7 hours after vaccination in left arm an itchy rash started forming on right arm, then a small area on left arm. Chest started itching. No hives or difficulty breathing. Came to clinic to see nurse practitioner. Diphenhydramine and Methylprednisolone were prescribed to patient.  Triamcinolone 40mg injection done on site.  No other symptoms beyond itch so patient was released home.
Weakness; Fever; Nausea; Headache; Chills; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weakness), PYREXIA (Fever), NAUSEA (Nausea), HEADACHE (Headache) and CHILLS (Chills) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-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 ASTHENIA (Weakness), PYREXIA (Fever), NAUSEA (Nausea), HEADACHE (Headache) and CHILLS (Chills). At the time of the report, ASTHENIA (Weakness), PYREXIA (Fever), NAUSEA (Nausea), HEADACHE (Headache) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The reporter was calling on behalf of their friend who had COVID and then received the first dose of the vaccine on 31-Mar-2021. The patient experienced fever, nausea, headache, chills, and weakness.  No Concomitant product use was reported. No treatment information was provided.
(see above) Narrative: Staff reporting loose bowel movements/diarrhea day after injection for 24 hours (self-resolved) upon screening for 2nd dosage. No associated nausea, vomiting, cramping, etc. Also noted to have mild swelling at injection site that lasted for a few days. Swelling described as small, well circumscribed circular swelling around area of injection.
Face and scalp started itching around 9pm 12/4/21. Itching started to increase after a couple of hours all over body. I noticed hives starting to appear all over and increased when scratched or touched. Took Allegra 24 hr. to help. Woke up next morning with same itching and hives, but I also had a burning sensation as well wherever the itching was. I work for an allergist, so the following Monday I was able to discuss everything with him. Nothing has changed, except me getting the vaccine. Until this day, 12/21/21, I'm still getting hives and itching, even while taking Zyrtec 10mg BID daily. We've done research and found many others who are experiencing this same delayed reaction after taking the vaccine. Some experiencing it months after.
Patient fainted immediately after vaccine administration. States she had blurry vision and muffled hearing prior. She was alert and oriented within a minute, and able to transfer to wheelchair and table in treatment area. Vital signs were stable and patient was given water, juice and an ice pack.
he started feeling pressure sensation around his head; This spontaneous case was reported by a consumer and describes the occurrence of HEAD DISCOMFORT (he started feeling pressure sensation around his head) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 007M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In June 2021, the patient experienced HEAD DISCOMFORT (he started feeling pressure sensation around his head). At the time of the report, HEAD DISCOMFORT (he started feeling pressure sensation around his head) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In June 2021, Alpha 1 globulin (0.2-0.3): high (High) 0.4.         It was stated that patient visited a neurologist and test results were normal except for one abnormal factor.  No concomitant medications were reported by reporter Treatment information was not provided by reporter
Received FLUZONE 0.5 ml at 0930 on 9/21/2017. Patient reported on 9/22/2017 that on 9/21/2017 at 1400 she began to experience eye itching. At 1900 on 9/21/2017 she had urticaria on the left side of her neck. She woke up on 9/22/2017 with "swollen eyes". She took 25 mg of BENADRYL at 0900 on 9/22/2017. She was seen by Dr. at clinic. He did not prescribe additional treatments and released with instructions to follow up if condition changes.
On Wed May 19 at approx 11:45 am my son was given the Johnson and Johnson vaccine as he was due to go to work on June 1st however patient had a seizure as a reaction to vaccine he was taken to vaccine site ER by ambulance where he had a second seizure around 3:55 pm he was released from ER after several hours and was told to follow up with PC within 2-3 days. As a result of reaction my son was disqualified from going to work on 6/1, due to seizure -this changed his whole life plans. To add his drivers license was medically suspended as well. Which we are now working having to submit medical test results in order clear him of having medical conditions.
Patient stopped breathing about 5:50. Paramedics were called. Baby pronounces dead at medical center. Autopsy confirmed natural causes (SIDS). Discharge summary rec'd on 03/02/2005 states additional codes of heart arrest and stupor.
pt recv vax & exp burning localized rxn (sl erythematous warm rash);sx resolved w/in 24hr;
RED, RAISED AT SITE, HOT TO TOUCH. 10CM ERYTHEMA AROUND SITE OF INJECTION.
typical arm swelling; headache; tiredness; This is a spontaneous report from a contactable consumer. This consumer reported similar events for 17 patients. This is the eighth (8th) of the seventeen (17) reports.  A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection (lot number and expiry date were not provided) via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter stated that multiple friends (unspecified) had the regular side effect of soreness in the arm on an unknown date. They all got the vaccine shot in the village and all had the typical arm swelling, headache, and tiredness on an unspecified date. The outcome of the events was unknown.  Information on lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021018227 same reporter/drug/event, different patient
My friends tested positive and I started noticing that the roof of my mouth was very sore. I had more of that pain and I was very tired. Those were the only symptoms during my COVID-19 diagnosis. I didn't test negative until the 5/23. I noticed the fatigue the most. The shingles I noticed on Sunday, 7/17, morning I noticed I had swollen gland under my arm. That night I had a lot of pain and it felt like a pulled/sore muscle. By Monday afternoon the pain was worse and I had three tiny red dots in a row on my shoulder and that clued me in to it being shingles. That afternoon I called the doctor and they gave me an antiviral prescription. I had a small rash on my back near bra and front upper chest area. Its not spearing but the patches are conjoining into a bigger piece. I also ad a raging headache on Tuesday. Gabapentin is helping with the nerve pain.
Dizzy; This is a spontaneous report from contactable consumer (parent).  A 24-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot/batch number and expiration date not reported, via an unspecified route of administration from 22Dec2020 to 22Dec2020 as single dose for COVID-19 immunization.  Medical history included asthma and allergy.  Concomitant medication included cetirizine hydrochloride (ZYRTEC) for Allergy and budesonide, formoterol fumarate (SYMBICORT) for Asthma.  The patient's parent stated that the patient experienced dizzy on 25Dec2020. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Large raised red area, approximately the size of a dollar bill, the area is red and hot around the area of the Zostavax vaccination site.
experienced redness/soreness and intense heat in both arms, starting around 5pm. had difficulty sleeping due to inability to put any pressure on either arm. took acetaminophen 650mg around 8pm and symptoms started to improve. soreness persisted into the next day but much less severe than yesterday.
Booster dose given too soon/The patient had received the Pfizer vaccine as the primary series.; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Booster dose given too soon/The patient had received the Pfizer vaccine as the primary series.) in an 18-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034F21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer (First dose) on 20-May-2021 and Pfizer (Second dose) on 10-Jul-2021. Past adverse reactions to the above products included No adverse event with Pfizer and Pfizer.    On 30-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Nov-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Booster dose given too soon/The patient had received the Pfizer vaccine as the primary series.). On 30-Nov-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Booster dose given too soon/The patient had received the Pfizer vaccine as the primary series.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient was given the booster dose too soon. The patient had received the Pfizer vaccine as the primary series.  No Concomitant product use was reported. No treatment information was provided.   This case was linked to MOD-2021-406059 (Patient Link).
COVID breakthrough case. I received my 2nd initial dose on 02/20/2021 and my COVID symptoms started on 10/06/2021  my right ear was hurting a lot and I had sinus infections. I went to the walk in clinic for treatment and they tested me for COVID which turned out to be positive on 10/14/2021. The urgent care gave me antibiotics. It covered both.
feel tired; headache; fever; arm is sore; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (feel tired), HEADACHE (headache), PYREXIA (fever) and MYALGIA (arm is sore) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (feel tired), HEADACHE (headache), PYREXIA (fever) and MYALGIA (arm is sore). At the time of the report, FATIGUE (feel tired), HEADACHE (headache), PYREXIA (fever) and MYALGIA (arm is sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided  No treatment medications were reported
Contracted COVID-19; Contracted COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 13-year-old male patient received BNT162b2 (BNT162B2), on 24May2021 as dose 1, single (Lot number: EW0175), on 14Jun2021 as dose 2, single (Lot number: EW0187) and on 07Jan2022 as dose 3 (booster), single (Lot number: FJ5683) at the age of 13 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 18Jun2022, outcome "recovering" and all described as "Contracted COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (18Jun2022) Positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of drug ineffective, covid-19. Clinical course: Patient had no covid prior to vaccination.
"pins and needles" sensation, along with a burning sensation in her fingers and her toes; "pins and needles" sensation, along with a burning sensation in her fingers and her toes; pain in joints; This is a spontaneous report from a contactable consumer (patient). This 43-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: ER8733) in left arm on 05Apr2021 16:00 at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On 05Apr2021, the patient experienced "pins and needles" sensation, along with a burning sensation in her fingers and her toes. Pain in joints. She reported that the symptoms were worse in her toes, and had been getting worse over the last week and a half, her regular doctor told her to not get the second dose. No treatment received for the adverse events. Patient did not diagnosed with COVID-19 prior to vaccination, patient had not been tested for COVID-19 since the vaccination.  The outcome of events was not recovered.   No follow-up attempts are needed. No further information is expected.
Patient presented as a "walk in " to the Covid Vaccine clinic.  Patient was accompanied by mother who signed consent for vaccine.  I was discovered when reviewing patient for the day that this patient was only 15 years 5 months.  Patient received first dose of Pfizer Covid Vaccine .  Patient is not eligible for the vaccine until December 2021.
Patient received vaccine that was stored in the freezer for 19 days prior to moving to the refrigerator.
She did experience flu like symptoms with the 2nd shot; she got very sick after receiving the 2nd shot.; she couldn't eat anything after receiving the 2nd shot.; she felt dizzy after receiving the 2nd shot.; she was nauseous after receiving the 2nd shot.; This spontaneous case was reported by a patient and describes the occurrence of INFLUENZA LIKE ILLNESS (She did experience flu like symptoms with the 2nd shot), ILLNESS (she got very sick after receiving the 2nd shot.), FEEDING DISORDER (she couldn't eat anything after receiving the 2nd shot.), DIZZINESS (she felt dizzy after receiving the 2nd shot.) and NAUSEA (she was nauseous after receiving the 2nd shot.) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concurrent medical conditions included Penicillin allergy (Patient is allergic to penicillin and does receive a shot every month for allergies.).   On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced INFLUENZA LIKE ILLNESS (She did experience flu like symptoms with the 2nd shot), ILLNESS (she got very sick after receiving the 2nd shot.), FEEDING DISORDER (she couldn't eat anything after receiving the 2nd shot.), DIZZINESS (she felt dizzy after receiving the 2nd shot.) and NAUSEA (she was nauseous after receiving the 2nd shot.). At the time of the report, INFLUENZA LIKE ILLNESS (She did experience flu like symptoms with the 2nd shot), ILLNESS (she got very sick after receiving the 2nd shot.), FEEDING DISORDER (she couldn't eat anything after receiving the 2nd shot.), DIZZINESS (she felt dizzy after receiving the 2nd shot.) and NAUSEA (she was nauseous after receiving the 2nd shot.) had resolved.            No concomitant medication was reported.  Patient received all Moderna COVID-19 shots in the past and she did experience flu like symptoms with the 2nd shot. She states that she got very sick and couldn't eat anything, was nauseous and felt dizzy after receiving the 2nd shot. These symptoms lasted for half a day to one day. Patient reported that the side effects after the 2nd dose were the worst for her.   She did not have any side effects after the 1st or 3rd dose. However, later during the call, patient stated that she did feel dizzy 2-3 hours after receiving the 3rd dose of the Moderna COVID-19 vaccine.   She wants to know if this could be a side effect of the vaccine and wants advice on whether she called her doctor regarding this.   No treatment medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-749372 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-749372:Same reporter (SPIKEVAX 2023-2024)
NauseaVomitting, HYPERtension cold sweats and sob Narrative:
RARE SEVERE BLOOD CLOTS; This spontaneous report received from a consumer via a company representative concerned 12 adult female patients of unspecified age, race and ethnic origin. No past medical history or concurrent conditions were reported. The patients received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: Unknown and expiry: Unknown) dose, start therapy date were not reported, 1 total, administered for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patients had rare severe blood clots. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of rare severe blood clots was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20211010045 and 20211009808.; Sender's Comments: V0: 20211023372-Covid-19 vaccine ad26.cov2.s -Rare severe blood clots. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
This is a spontaneous report from a contactable nurse (patient). A 45-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, batch/lot#  EW0179), at the age of 45,  via an unspecified route of administration, in left arm, on Jul 13, 2021, single dose, for COVID-19 immunisation. Medical history included gastritis from unknown date and unknown if ongoing. Concomitant medication included Gasvenz for her gastritis. Patient did not have any vaccination four weeks prior to the COVID-19 vaccine. On Jul 14, 2021, patient experienced side effects such as tiredness, headache, muscle pain, chills, injection site pain, swelling, feeling unwell, joint pain, injection site swelling, not eating at all, increased  body temperature (99.5ºF), arm pain, weakness, nausea and heartbeat feels a little faster. Patient want to know how long these side effects will last (seeking treatment recommendations). The patient underwent lab tests and procedures, which included body temperature: 99.5ºF on Jul 14, 2021. No treatment received for the events. The outcome of the events: unknown (at the time of report). Follow-up attempts completed. No further information expected.
pt presents to hosp with myalgias, weakness, cough, SOB and chest pain; dementia; positive for COVID over the course of hospitalization her O2 demands increased, 30L/70% on Vapotherm; pt's condition declined and she died in the hospital
This spontaneous report as received from a physician refers to a female patient of unknown age. The patient was vaccinated with dose 1 GARDASIL (lot number unspecified) in June 2012. Route was not reported. On 15-JAN-2013 she would receive her 2nd dose of GARDASIL (lot number unspecified). Route was not reported. No adverse effect was reported. Additional information has been requested.