chrisvoncsefalvay/vaers-outcomes huggingface dataset:
1st dose just a sore arm 2nd dose pain, swelling and redness at injection site.  I have approximately a 2 1/2? x 2 1/2? red raised welt also very warm. I couldn?t raise my arm very high because of the pain This started about 24-36 hours after injection Fever chills body aches fatigue nausea no appetite about 36 hours after injection. Those side effects lasted about 24 hours.  Still have the pain redness and swelling in my arm
Missed her  second dose; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed her  second dose) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Breast cancer.    On 26-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 PRODUCT DOSE OMISSION ISSUE (Missed her  second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed her  second dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment information was not provided by the reporter.   This case was linked to MOD-2021-313839 (Patient Link).
Swollen nodule L axillary, fatigue, frontal lobe headache x 3 days, neck stiffness.
Erythemic maculopapular rash. 3 inch radius around vaccination site. PT states it itches slightly. Rash began 5 days ago. PT received vaccine 11 JUL 18. vitals B/P: 115/70, HR: 64, Temp: 99 Degrees Celsius, SP02: 98%.
Died since taking your COVID vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death, medically significant), outcome "fatal", described as "Died since taking your COVID vaccine". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed. Reporter also reported that he/she has countless sick friends thanks to it. Stated that the clock was ticking, the truth will prevail.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300020087 as same reporter/drug/event, different patient.;; Reported Cause(s) of Death: Died since taking your COVID vaccine
Pfizer-BioNTech COVID- 19 Vaccine EUA Moderna COVID- 19 Vaccine EUA  Patient received COVID-19 Vaccine dose #1 as Moderna on December 30, 2020 and dose #2 as Pfizer on January 23, 2021.
Infant had prolonged crying, irritability, low grade fever, vomiting x 10 hours, symptoms lasting several days, hypotonic, dullness, lack of responsiveness and irritability sx 7 days - mild encephalopathy per neurology.
My arm is swelling up; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received pneumococcal 13-val conj vac (dipht crm197 protein) (PNEUMOCOCCAL 13-VAL CONJ VAC (DIPHT CRM197 PROTEIN)) (Batch/Lot number: unknown) as dose number unknown, single for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1, lot unknown, single); Bnt162b2 (dose 2, lot unknown, single); Bnt162b2 (dose 3, lot unknown, single). The following information was reported: PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "My arm is swelling up".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Received vaccine on 12/28/2020 had some pain and some swelling as I expected, 3 days later I had a large swollen are hard to touch probably 5x3 in size on my left arm which was  larger than the day before. I started to place warm compresses alternating with cold due to the itch  and for redness and swelling. Two weeks later today 1/11/2021 I still have the reddened swollen itchy area that has spread. that. I am concerned for the second vaccine.
The day after the shot I felt achy and uncomfortable, as expected.  Very unexpectedly,  however, two days after my first vaccine I felt much better than I had in years!  I had energy, alertness, and my fatigue was gone.  It lasted approximately half a day; then my normal fatigue returned.  Given that I have suspected POTS/dysautonomia, I was told to mention this to you all.  I did tell my doctor, but it didn't lead us anywhere, practically speaking.  However, given that people who have had COVID have reported their POTS-like side effects get better after vaccination, but I *haven't* had COVID but my similar symptoms POTS symptoms improved, I wanted to mention it in case that's relevant.
Information has been received from a registered nurse (R.N.) concerning a 14 year old female with no pertinent medical history or allergies who on 23-JUL-2008 was vaccinated intramuscularly with 0.5ml Hp, rll , 6, 16, 18, VLP vaccine (yeast) (lot#660620/051X).Concomitant therapy included hepatitis A vaccine (inactive) (HAVRIX) and diphtheria toxoid (+) pertussis acelluar vaccine (unspecified) (+) tetanus toxoid. On 23-JUL-2008, 5 minutes after vaccination, the patient walked out the office's door, passed out. Fell backwards and hit her head. The patient was revived and taken into the office, where she almost passed out again. The patient had headache and studies were performed. After resting for 45-minutes, the patient recovered.
That evening about 9 pm I had a sudden sharp very severe pain in my left ear that lasted about 30 seconds, something I had never felt.  This was followed that night by loud buzzing/ringing in my ears. I had a slight Tinnitus before this, but it has faded and was barely noticeable and random. This new ringing/buzzing is loud, constant, and very disturbing. It has not stopped even for one minute.   I  did have a severe reaction after the 2nd Moderna shot. It began with a burning sensation in my stomach about 2 hours after the shot. It developed into a fever of 102.5 (may normal temp is usually between 96.5 and 97.5). Severe body aches, no appetite, could hardly get out of bed the next day. This lasted 3 days, and improved, but took a week to feel okay again.
21 people were vaxed w/a series of 3 Engerix-B injects; 21AUG91 blood test showed that five of 21 people (approx 25%) did not respond (no titers); the 5 nonresponders are EMT which make them "vulnerable to HBV; pts will be revaxed;
Admitted on account of fever chills shortness of breath cough and congestion for about a week. He had been diagnosed with COVID 4 days earlier and came to the hospital account of worsening of his symptoms.  Evaluation emergency room confirmed COVID pneumonia with hypoxemia. Tx w/ abx, steroids, O2, Vit C, zinc; dc'd home w/HHC & O2.
PARENTS NOTICED A RED BUMP AT INJECTION SITE WITHIN A DAY OF VACCINATION ADMINISTRATION. NEVER WENT AWAY THEN AROUND 09/22-23 THEY NOTICED IT WAS MUCH LARGER, REDDER. SEEN IN OFFICE AND IT WAS DETERMINED BY THE PROVIDER THAT PATIENT HAD AN INFECTION AT THE INJECTION SITE. HE WAS PUT ON A 10 DAY COURSE OF KEFLEX.
Metal taste in her mouth; Heart palpitations; Felt like she had the flu; Couldn't move left arm; Shortness of breath (gets more winded); Fatigue; Muscle aches; Fever; Headache; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (Metal taste in her mouth), PALPITATIONS (Heart palpitations), INFLUENZA (Felt like she had the flu), MOBILITY DECREASED (Couldn't move left arm) and DYSPNOEA (Shortness of breath (gets more winded)) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced DYSGEUSIA (Metal taste in her mouth), PALPITATIONS (Heart palpitations), INFLUENZA (Felt like she had the flu), MOBILITY DECREASED (Couldn't move left arm), DYSPNOEA (Shortness of breath (gets more winded)), FATIGUE (Fatigue), MYALGIA (Muscle aches), PYREXIA (Fever) and HEADACHE (Headache). At the time of the report, DYSGEUSIA (Metal taste in her mouth), PALPITATIONS (Heart palpitations), INFLUENZA (Felt like she had the flu), MOBILITY DECREASED (Couldn't move left arm), DYSPNOEA (Shortness of breath (gets more winded)), FATIGUE (Fatigue), MYALGIA (Muscle aches), PYREXIA (Fever) and HEADACHE (Headache) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant mediations were reported. No treatment medication was reported. Patient received second dose of Moderna COVID-19 Vaccine on 12-mar-2021 in left arm with unknown batch no. Patient called to Moderna Customer Care to ask whether Moderna vaccine offered protection against the Delta variance?
Fatigue; Shivers; Weakness, lack of energy; This case was reported by a consumer via call center representative and described the occurrence of shivers in a 89-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event (on 21st October 2021, received 1st dose).   On 26th March 2022, the patient received the 2nd dose of Shingrix. In March 2022, less than a day after receiving Shingrix, the patient experienced shivers and weakness. On 27th March 2022, the patient experienced fatigue. On an unknown date, the outcome of the shivers, weakness and fatigue were unknown.   The reporter considered the shivers, weakness and fatigue to be related to Shingrix.     Additional Information: GSK Receipt Date: 28-Mar-2022 Reporter's Comments: This case was reported by the is the patient's daughter.  The patient received Shingrix in the morning and felt fine during the day but at night he experienced shivers and weakness. One day after receiving Shingrix, the patient experienced fatigue or lack of energy or weakness. It was unknown how he was feeling on the date of reporting. The reporter did not live with her father and thus did not have any paperwork which would have the lot number of the Shingrix but she did provide the pharmacy's information who should have the lot number on file.
Miserable; Sleeping a lot; headache; fatigue; Nausea; Chills; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Miserable), HYPERSOMNIA (Sleeping a lot), HEADACHE (headache), FATIGUE (fatigue) and NAUSEA (Nausea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced FEELING ABNORMAL (Miserable), HYPERSOMNIA (Sleeping a lot), HEADACHE (headache), FATIGUE (fatigue), NAUSEA (Nausea) and CHILLS (Chills). At the time of the report, FEELING ABNORMAL (Miserable), HYPERSOMNIA (Sleeping a lot), HEADACHE (headache), FATIGUE (fatigue), NAUSEA (Nausea) and CHILLS (Chills) outcome was unknown.        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.   Reporter did not allow further contact
high BP over 130; rapid heart beat; arms burning, sore and swollen; arms burning, sore and swollen; arms burning, sore and swollen; rashes from her back and legs; no appetite; fatigued; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 70 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2 (booster), single for covid-19 immunisation. Relevant medical history included: "asthmatic" (unspecified if ongoing); "she's allergic to a lot of things" (unspecified if ongoing), notes: she's allergic to a lot of things. The patient's concomitant medications were not reported. Vaccination history included: Jansen vaccine (Dose 1, Jansen vaccine, she got allergy), for Covid-19 immunization, reaction(s): "she got allergy". The following information was reported: BLOOD PRESSURE INCREASED (non-serious) with onset Jan2022, outcome "not recovered", described as "high BP over 130"; HEART RATE INCREASED (non-serious) with onset Jan2022, outcome "not recovered", described as "rapid heart beat"; BURNING SENSATION (non-serious), PAIN IN EXTREMITY (non-serious), PERIPHERAL SWELLING (non-serious) all with onset Jan2022, outcome "not recovered" and all described as "arms burning, sore and swollen"; RASH (non-serious) with onset Jan2022, outcome "not recovered", described as "rashes from her back and legs"; DECREASED APPETITE (non-serious) with onset Jan2022, outcome "not recovered", described as "no appetite"; FATIGUE (non-serious) with onset Jan2022, outcome "not recovered", described as "fatigued". Relevant laboratory tests and procedures are available in the appropriate section. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Around 6:00 pm I began running a temperature of about 101 F.  I took two Tylenol and went to bed. Around 11:00 PM  I awoke freezing and took my temp. It had risen to 106.00 F.  I immediately took a cool shower for about 20 minutes. My temp decreased to 103.04 F. I took two more tylenol.  My temperature remained at 103 for the next few days.  I took the second shot and had a very similar reaction except to spiked to 105.6 F.
Headache, Myalgia, Fever & Diarrhea Narrative:  Other Relevant History:
A patient received 2 vaccinations within same pregnancy one month apart, no AE; Vaccine exposure during pregnancy; Initial information was received on 01-Mar-2021 regarding an unsolicited valid non-serious case from a pharmacist. This case involves a female patient (age not reported) who was received DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (Suspension for injection, batch number and expiry date not reported) via an unknown route in an unknown administration site for prophylactic vaccination within same pregnancy one month apart at weeks and 35 weeks while she was pregnant (extra dose administered and exposure during pregnancy).   The date of last menstrual period was not reported.  The estimated due date was not reported.  Medical history, past medical treatment, vaccination, concomitant medications and family history were not provided.  It was case of vaccine exposure during pregnancy.  Pregnancy outcome was unknown at the time of report.  This was a case of actual medication error case due to extra dose administered (latency unknown).  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.  There will be no information available on the batch number for this case.
itchy from top of chest and neck; it's warm but not rash; she had little bit soreness; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchy from top of chest and neck), FEELING HOT (it's warm but not rash) and MYALGIA (she had little bit soreness) 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 02-Mar-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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced MYALGIA (she had little bit soreness). On an unknown date, the patient experienced PRURITUS (itchy from top of chest and neck) and FEELING HOT (it's warm but not rash). On 04-Mar-2021, MYALGIA (she had little bit soreness) had resolved. At the time of the report, PRURITUS (itchy from top of chest and neck) and FEELING HOT (it's warm but not rash) outcome was unknown.            No concomitant medication was reported.Treatment medication was not provided.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was not applicable.
Narrative:  Patient received first dose of Pfizer COVID19 vaccine on 2/11/21. At PCP appointment 3/1/21, patient complains of rash on his B torso (noticed 1-2 days), that "itches like crazy" per pt, applied "cortisone" otc and took "sudafed allergy" (not found in medical reference thus clarified with pt, later pt says that he actually took sudafed congestion) with "seems to suppress it so I can get some rest". PCP prescribed diphenhydramine, loratadine, and triamcinolone 0.1% cream. Was discharged from clinic and received second dose of Pfizer vaccine 3/4/21. No adverse events to second dose reported at 3/31/21 follow-up appointment.
following feeding,pt exp syncope (eyes rolled back,circumoral cyanosis);awakened w/stimulation by mom;recurrence occurred 8AM same day & 27NOV & 28NOV x 2;
dizziness; leg heaviness; feeling hot; tremors; feeling hot with heavy feeling in chest; lost consciousness; This is spontaneous report from a contactable pharmacist. An adult female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 28Dec2020 at 11:45, at single dose, for COVID-19 immunization. Medical history and concomitant medications were not reported. On 28Dec2020, 20 minutes post vaccination, the patient reported dizziness. The patient was sitting in chair with head down with no improvement. When assisting patient to lie down, she lost consciousness. Patient's head and neck were supported so she did not hit head. The patient recovered consciousness and was alert and oriented with c/o leg heaviness and feeling hot. The patient denied difficulty breathing and chest heaviness. No rash noted. She lost consciousness a second time while lying flat. When she recovered consciousness, she was alert and oriented but had c/o leg heaviness, tremors and feeling hot with heavy feeling in chest. No rash noted. Blood pressure: 135/84, pulse: 70, O2 saturation: 99-100. Medical alert was called and the patient was transported to ED. Lost consciousness resolved on an unknown date. The other events outcome was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on the time association, the possible contribution of suspect BNT162B2 to the event loss of consciousness cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
pt recv vax; fever, local redness & swelling; onset approx 8 hr p/ dtp;
Breakthrough case admission after 2 vaccines Pfizer 2/10/21 lot# EL3249;  Pfizer 3/4/21 lot# EN6202
Pain. Had trouble lifting arm and started right away. Came back to pharmacy 2nd day of pain. Has not gone away.
Patient states since receiving flu vaccine has had pain in Lt shoulder with ROM. Ibuprofen does not help. Now is painful to lay on that side. No recollection of any injury. No swelling or redness. Moderate pain with motion.
It is now the next day, and I feel significantly better. I have pain at the injection site, some muscle fatigue, a little bit of a depleted appetite, tiredness in my eyes and head (likely due to lack of quality sleep), and a bit of sweating, but my pain has reduced to maybe a 2/10 or 1/10 (i.e., not even uncomfortable). I did end up getting decent sleep between 2 AM and 12 PM with only a few interruptions of family members checking on me. The only notable pain that is worrying me is abnormal soreness in my right wrist that is not the result of overuse, overextension, etc., although I was able to take care of that pain with another 3 Advil pills. I am considering scheduling a doctor's appointment, as I know the J&J vaccine got recalled today for blood clots. My assumption is that because I am a healthy 20-year-old, my immune system overreacted to the vaccine, but I want to check to make sure that it doesn't cause any additional health problems.
Information has been received from a physician concerning a 16 year old female patient who on unspecified date was vaccinated with a first dose of GARDASIL (dose, route and Lot# not reported). Concomitant therapy included YAZ, anakinra, folic acid and methotrexate. The physician stated that on unspecified date developed juvenile idiopathic arthritis after administration of her first dose of GARDASIL. At the time of the report the patient's outcome was unknown. The patient sought unspecified medical attention. Additional information has been requested.
Headaches, nausea, vomiting, diarrhea, cold sweats, tinnitus, nasal pressure, congested ear, fatigue, short of breath
Slept 14 hours; woke up dizzy; then complained of a stomachache.
DROPPED DEAD; This spontaneous report received from a consumer via social media via a company representative concerned a patient of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number and expiry were not reported) dose, 1 total, start therapy date were not reported for prophylactic vaccination (Dose number in series 1). The batch number was not reported. The company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported. On an unspecified date, the patient dropped dead from unknown cause. It was unspecified if an autopsy was performed. Reporter stated that, "It was more than my family who dropped dead. You got it wrong, people still dyeing fully vaccinated (contaminated) with the booster as well" The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death). This case is a duplicate of 20211263643. This case, from the same reporter is linked to 20211258139 and 20211256750.; Sender's Comments: V0-20211263721-COVID-19 VACCINE AD26.COV2.S-Dropped Dead . This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: DROPPED DEAD