chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Inability to sleep; Fatigue; Headache; brain fog; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 3248) via an unspecified route of administration in the right arm on 13Apr2021 at 11:30 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure. The patient had no known allergies. Concomitant medications included hydrochlorothiazide (MANUFACTURER UNKNOWN) and amlodipine besylate (MANUFACTURER UNKNOWN), both taken for unspecified indications from unknown dates. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 3248) via an unspecified route of administration in the right arm on 23Mar2021 at 11:00 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 14Apr2021 at 03:00, the patient experienced inability to sleep, fatigue, headache and brain fog. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events inability to sleep, fatigue, headache and brain fog were resolved on an unknown date in Apr2021.   No follow-up attempts are needed. No further information is expected.
Information has been received from a registered pharmacist concerning a newborn female who on 25-JUN-2010 was vaccinated with 0.5 mL of RECOMBIVAX HB IM (Lot # 666188/1491Y). On approximately 25-JUN-2010 the patient experienced apnea and seizures. On an unknown date, the patient recovered from apnea and seizures. The patient was in the hospital and sought medical attention. The pharmacist wanted to know with the lot check it will be tested if there was overfill or contaminates. Apnea and seizures were considered to be immediately life-threatening. This is one of 4 reports from the same reporter. It was noted that three of the four patients had seizures and one of the four had full arrest. It was unknown what patient had which of the reactions. A lot check has been initiated. Additional information has been requested.
Painful lumps in thighs 6 weeks after injection. Fevers after vaccination lasted 10 days.
arm was red size of my palm; hot arm; itchy arm; hard arm; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 04-Feb-2021 and was forwarded to Moderna on 05-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (arm was red size of my palm), FEELING HOT (hot arm), PRURITUS (itchy arm) and INDURATION (hard arm) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included METFORMIN, PRAVASTATIN, POTASSIUM (POTASIUM M), ACETYLSALICYLIC ACID (BABY ASPIRIN), LOSARTAN, METOPROLOL and LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 22-Jan-2021 at 12:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, the patient experienced ERYTHEMA (arm was red size of my palm), FEELING HOT (hot arm), PRURITUS (itchy arm) and INDURATION (hard arm). On 03-Feb-2021, FEELING HOT (hot arm), PRURITUS (itchy arm) and INDURATION (hard arm) had resolved. At the time of the report, ERYTHEMA (arm was red size of my palm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details included Benadryl when itching badly.
Felt dizzy immediately after vaccines and resolved within hours. Next day was lethargic / low grade fever 2 days after vaccines vomit x 1.
had to sleep a lot; didn't want to eat food; tired; headache; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (had to sleep a lot), DECREASED APPETITE (didn't want to eat food), FATIGUE (tired) and HEADACHE (headache) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 030M20A) 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. On an unknown date, the patient experienced SOMNOLENCE (had to sleep a lot), DECREASED APPETITE (didn't want to eat food), FATIGUE (tired) and HEADACHE (headache). At the time of the report, SOMNOLENCE (had to sleep a lot), DECREASED APPETITE (didn't want to eat food), FATIGUE (tired) and HEADACHE (headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment medication use was reported.   This case was linked to MOD-2022-439146, MOD-2022-439198 (Patient Link).
Information has been received from the registered nurse on 02-JAN-2014. It was reported that GARDASIL vaccines were stored in improper temperatures and were administered to overall number of 132 patients. This report refers to one of the patients involved: a patient of unspecified age and gender, who was administered dose of GARDASIL on 21-MAR-2013 (lot # H011350, Expiration Date: 21-FEB-2015). This is one of the report from the same source. Additional information is not expected.
I was very dizzy. I contacted my doctor, and they told me to go to the emergency room. Since I had recently had surgery, they thought I might have a Pulmonary Embolism, but it turned out that I did not. Then, I started doing physical therapy to try to solve my balance issues. I am still dealing with this at this time.
Swollen left eyelid day 2 after shot have taken benadryl after day 2
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), on 27Sep2022 at 16:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 71 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Fibromyalgia" (unspecified if ongoing); "Known allergies: batrim" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Treatment of COVID-19; (May2023) Positive, notes: tested positive again; (May2023) Positive, notes: testing positive; (May2023) negative, notes: I had tested negative at first when finishing Paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical Course: Patient took Paxlovid Treatment from 12May2023 to 17May2023.  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-202300204125 same reporter/patient, different drug/event;
pt presents to ED with increasing SOB, cough, congestion, decrease in appetite, and weakness; admitted for respiratory failure secondary to COVID infection (positive test on 8/21/21); course was complicated by sepsis and multiorgan failure; pt's condition worsened; O2 supplementation; DNR/DNI; pt experienced cardiac arrest and did not survive; death certificate and medical records sent per VAERS request
When the nurse was administering the dose she pulled out the syringe too early or too quickly and there was a leakage. She consulted with two other nurses and they all said it was ok. I did asked them how come I did not have a wheal like I had with the first dose, they said that sometimes people don't get a wheal. They let me go home. I did not develop anything, not even itchiness. Once home I read that if there is no wheal and there was a leakage the inoculation should be considered invalid and repeated right away. Now I am not sure what to do. I am not sure if I am covered or not or if I should repeat the dose.
seizure activity 11/10/2009 H&P for admission 10/29/2009. Patient with new onset seizure activity, also dry cough and nasal congestion. Tx not noted. no DC DX noted
Swelling and pain on (R) arm after DTaP-MOTRIN, ice advised.
No adverse effects reported; inproperly stored PROQUAD was administered to a patient; This spontaneous report was received from a nurse referring to a patient of unknown age and unknown gender. Information about pertinent medical history, drug reactions/allergies and concomitant medication was not reported.  On 18-OCT-2019, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # S013712 with expiration date 01-NOV-2020, dose detail and route were not reported) for prophylaxis. The vaccine experienced improperly stored and was stored at minus 13.75 degree Celsius for 68 hours. There was no previous temperature excursion. The call was because of a data logger involved. No adverse effects were reported.
Patient was treated in Emergency department for laceration to finger.  She received dose of TD toxoid in left deltoid. Patient complained of pain at the site of injection that increased in intensity over the next few days.  The upper arm became red and swollen. The patient complained of itching  and burning. Patient sought medical attention and family physician prescribed Augmentin and Naproxin. Parent requested Medwatch report.
within first half hour: 1) redness and itching on torso where clothes bind with skin, waistband, underwear 2)heart palpitations 3) prickling feeling all over chest, back and arms. Lasted about an hour, then dissipated over the course of another couple hours within first day: 1) facial puffiness 2) extreme weakness 3) sore throat 4) low temperature and pulse rate (approx 95.5 degrees) 5)normal arm tenderness at injection site 6) diarrhea 7) stomach upset 8) felt feverish, but was the opposite. Generally felt like someone had run over me with a bus. Symptoms lasted about 2 days.
This spontaneous report as received from a non-health professional reporter via a company representative refers to a patient of unknown age and gender. On 29-OCT-2015, the patient was in the office to receive influenza virus vaccine (unspecified) and received GARDASIL instead (lot # K010215) (dose and route not reported) instead. The reporter could not verify if the patient received GARDASIL or GARDASIL 9 however the lot number indicated that the patient received GARDASIL. This was outside the age indications for this vaccination as well. No adverse effects reported. Additional information has been requested.
6 days after shot I got a debilitating headache (the worst headache of my life 10/10 pain).  I went to the ER and they proceeded to do a CT scan and blood work.  Nothing abnormal was found.   The next day I went to Hospital ER due to the head pain, shortness of breath, chest pain and high blood pressure.  They put me on steriods and pain meds and I was referred to a Cardiologist and neurologist.  4 days later I was in the ER again for head pain, my BP was 220/125 due to pain when entering the hospital.  After about 2 weeks, I saw  a neurologist.  He prescribed various pain meds including anti- seizure meds and shots.  The cardiologist feels that it is not a heart issue.   I remain having  daily headaches 6 weeks later but the intensity is lower (5/10).  My BP is now back at a normal level.  I am awaiting 2 more tests.  MRV and spinal puncture test.
Cardiac arrest. I survived but had 3 months of recovery after the event to return to normal.
Fatigue, headache, and pain on injection site - 1 + 2 days after shot Red rash spot on the injection site - 10 days after shot
Left arm and neck pain. Feels like a deep bone pain, wakes her up at night. Can't sleep on her side because of the pain. Started after receiving the Johnson and Johnson vaccine.
Intense chills began about 9 pm.  Lasted till about 10:30 pm.  At about 9:30 pm, the aches kicked in in most joints in my body.  Back, shoulders, knees, elbows,
no adverse event --mixing error--multi diluent vial was used more than once to draw and mix with covid vaccine
tested positive for COVID; Disorientated; Difficulty breathing; Fever; cough; This is a spontaneous report from a contactable consumer (the patient's wife) received from a Pfizer-sponsored program. A 55-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number not provided), via an unspecified route of administration in the left arm on 02Apr2021 (also reported as 03Apr2021) around 16:00 (at the age of 55-years-old) as a single dose for COVID-19 immunization. There was no medical history or concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. There were no adverse events following prior vaccinations. The patient tested positive for COVID on 10Apr2021 and went to the hospital.  The patient also experienced fever, disorientated, and difficulty breathing.  The patient's wife clarified that the patient went to the emergency room and was hospitalized for four days, from 16Apr2021 to 20Apr2021, for all three symptoms of fever, disorientated, and difficulty breathing. The patient was hospitalized for COVID. It was also reported that fever was from 11Apr2021 to 18Apr2021, disorientated from 16Apr2021 to 17Apr2021, difficulty breathing from 14Apr2021 to 24Apr2021, cough from an unspecified date. On 10Apr2021, COVID test results were positive. On 24Apr21, COVID test results were negative. For treatment at home, the patient took acetaminophen (TYLENOL), ibuprofen (ADVIL), and an albuterol inhaler. When he was admitted to the hospital, he was given IV fluids, TYLENOL, dexamethasone, a blood thinner (did not know the name). He also took cough medicine called guaifenesin at the hospital. When the patient was released from the hospital, he was given 6 days of prednisone to take. The patient did not have an appointment yet for the second dose. All events were considered medically significant. The outcome of cough was unknown. The other events recovered on the following dates: tested positive for COVID- on 24Apr2021, fever- on 18Apr2021, disorientated- on 17Apr2021, difficulty breathing- on 24Apr2021.  Information on lot number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021498996 same drug/similar event, different patients;US-PFIZER INC-2021502035 same drug/similar event, different patients;US-PFIZER INC-2021502065 same drug/similar event, different patients
Information has been received from a nurse in physician's office, concerning an 88 year old female who in June 2007, was vaccinated with ZOSTER (Oka/Merck) in her left deltoid.  It was reported that the patient on 08-AUG-2008 experienced symptoms of herpes ZOSTER that began with tingling.  Nurse reported hat the patient on 21-AUG-2008 was diagnosed with shingles.  No lot number was provided.
Patient came into the hospital after falling at home 2nd time in one day. No previous mention of falls.  After labs and tests has elevated troponin, cardiomegaly noted on CXR, she has no history of this. only history is spinal stenosis and osteoporosis.
This spontaneous report was received on 08-MAY-2017 from a licensed practical nurse and refers to a 6 month infant (gender not reported). There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On 13-SEP-2016 the patient was vaccinated with an improperly stored dose of ROTATEQ (lot # L046319, expiration date: 28-SEP-2017, dose was not reported), orally. No symptoms were reported. The administered dose of ROTATEQ experienced the temperature excursion of 32 degrees Fahrenheit for 15 minutes and 31 degrees Fahrenheit for 15 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1608USA012908: US-009507513-1608USA012916: US-009507513-1705USA004981: Original Case : 1608USA012794 US-009507513-1705USA004982: Original Case : 1608USA012794 US-009507513-1705USA004983: Original Case : 1608USA012794 US-009507513-1705USA004984: Original Case : 1608USA012794 US-009507513-1705USA004985: Original Case : 1608USA012794 US-009507513-1705USA004944: Original Case : 1608USA012794 US-009507513-1705USA004952: Original Case : 1608USA012794 US-009507513-1608USA012794: Original Case : 1608USA012794 US-009507513-1705USA004954: Original Case : 1608USA012794 US-009507513-1705USA004955: Original Case : 1608USA012794 US-009507513-1705USA004956: Original Case : 1608USA012794 US-009507513-1705USA004957: Original Case : 1608USA012794 US-009507513-1705USA004958: Original Case : 1608USA012794 US-009507513-1705USA004959: Original Case : 1608USA012794 US-009507513-1705USA004960: Original Case : 1608USA012794 US-009507513-1705USA004961: Original Case : 1608USA012794 US-009507513-1705USA004962: Original Case : 1608USA012794 US-009507513-1705USA004963: Original Case : 1608USA012794 US-009507513-1705USA004964: Original Case : 1608USA012794 US-009507513-1705USA004966: Original Case : 1608USA012794 US-009507513-1705USA004967: Original Case : 1608USA012794 US-009507513-1705USA004968: Original Case : 1608USA012794 US-009507513-1705USA004973: Original Case : 1608USA012794 US-009507513-1705USA004972: Original Case : 1608USA012794 US-009507513-1705USA004969: Original Case : 1608USA012794 US-009507513-1705USA004970: Original Case : 1608USA012794 US-009507513-1705USA004971: Original Case : 1608USA012794 US-009507513-1705USA004951: Original Case : 1608USA012794 US-009507513-1705USA004950: Original Case : 1608USA012794 US-009507513-1705USA004974: Original Case : 1608USA012794 US-009507513-1705USA004942: Original Case : 1608USA012794 US-009507513-1705USA004945: Original Case : 1608USA012794 US-009507513-1705USA004946: Original Case : 1608USA012794 US-009507513-1705USA004947.
This case was reported by a pharmacist via patient support programs and described the occurrence of spaced out in a 74-year-old male patient who received SHINGRIX (batch number 77PL3, expiry date 18th April 2021) for prophylaxis. On 19th December 2018, the patient received SHINGRIX .5 ml. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced spaced out and activities of daily living impaired. On an unknown date, the outcome of the spaced out and activities of daily living impaired were unknown. It was unknown if the reporter considered the spaced out and activities of daily living impaired to be related to SHINGRIX. Additional details were provided as follows: The patient was felt out and could not get himself dressed and went to the emergency room where the medical team equated it to the vaccine.
After having her coronavirus booster vaccine dose 2 weeks ago, she had pain in her arm at the site of the injection about 15 minutes later.  She tells me today that she has had pain off and on in her right upper extremity, from the shoulder down to her hand, since the day that she got the shot 2 weeks ago.
Headache, Myalgia, Fever, Chills, fatigue Narrative:
Muscle aches, sore legs within 3 days sleepiness on day of event and next day and a rash with pain on upper back within 2 days  treated at home  sleepiness ended day 3 muscle aches and rash ongoing
PT Vaccinated on left arm with first dose of PEDI Pfizer (0.2ml) at 1436. Pt states immediately she started feeling dizzy, having ringing in her ears and loss of vision. Pt given Apple juice by RN and BP was taken. Initial BP was 56/25. At 1443 MD Stat was called for patient. Patient was transferred to gurney and was now laying down. MD STAT team arrived at 1447. MD  arrived and spoke to the patient and left. Glucose taken was 83 and another BP was taken 108/65. Patient vision restored but was still hearing ringing in her ears. MD called to come back. Dr.  arrived and assessed and interviewed the patient and spoke with mother. Patient expressed she has felt similar symptoms before but not as extreme.  Appointment placed to follow up with PCP on Tuesday.
temperature 101; vaccine was administered to 7-year-old son; This is a spontaneous report from a Pfizer sponsored program, received from a contactable nurse. This nurse reported similar events for two patients. This is the first of two reports.  A 7-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date were not provided) solution for injection, via an unspecified route of administration on 12Jan2021 at a single dose for Covid-19 immunization. Medical history included respiratory distress (at birth had persistent respiratory distress requiring oxygen for 10-12 days), Febrile seizure in Jan2017, and pneumonia in Jan2017. The patient's concomitant medications were not reported. A mother went to get vaccinated for Covid-19. She took her kids ages 7 and 15. The kids were also vaccinated. The vaccine was administered to the 7-year-old son on 12Jan2021. Her son (patient) had a temperature of 101 on 13Jan2021. The mother was concerned because the vaccine was not recommended for his age. She was wondering if he should be in the ER. The reporter does not know if the child still has a fever. She said that the vaccination providers went ahead and gave the vaccine to the children as well even if they were not scheduled to get them. Outcome of the event was unknown.  Information of lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021041926 Same reporter, product, and event, different patient
back pain, right shoulder pain 2 days after vaccine. right axillary numbness and pain 8 days following vaccine.
fever to 103.6 & febrile sz; seen in ofc when fussy & irritable & discharged; seen in ER p/sz w/t103.1; discharged p/sponging & observation
Thigh was red, warm + swollen, painful T99.5.  Doctor ordered Benadryl + Motrin. Area was cleared the next morning, but returned that evening so reported Motrin + Benadryl again - went away permanently then.
unrelenting screaming, high pitched-staring noc of vax;fevers to 104 reported by mom;no documented, t99.5;concurrent diarrhea;pt ate poorly until 20JUN96 when screaming also stopped;mom still says high fevers-MD strongly disbelieve;
Mild fever (100.7), chills, body aches, dizziness, mild sore throat all beginning 12 hours after vaccination and continuing until the following morning
Headache, muscle aches, muscle/arm soreness, swollen lymph nodes in armpit and around left arm/side, tiredness
11 hours after vaccine administration, rapid onset of fever (100.0F), full body muscle aches, chills, sweating, lack of appetite, and extremely sore arm. Symptoms lasted until the following morning, at which time 400mg ibuprofen were taken, mitigating most symptoms except fatigue.