chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. The patient's pertinent medical history was not reported. On 23-APR-2015 the patient was vaccinated with improperly stored VAQTA (lot # K010579 and expiry date: 12-FEB-2017) (dose, frequency and route were not reported). The patient did not experience any adverse events. No product quality complaint (PQC) was reported for a hepatitis a vaccine, inactivated. This is one of the several reports from the same reporter. Additional information has been requested.
pt recv vax 22JAN97 & 4FEB97 pt devel a mild rash consisting of approx 15 pox expanding over body;
Shortness of breath and flushing reported at time of vaccination. 1231: HR 9, BP 135/80 and pulse ox 97%.  Patient felt like it was her asthma and did not have inhaler along. Offered benadryl, refused.  1239 pulse ox 96%, 1249 pulse ox 97%.  Continued to report tightness in chest but no worse.  Offered patient to go to ED. Patient refused.  1257: bp 126/62, HR 89 and pulse ox 97%. Patient stated they would go to the ED if their inhaler did not work. released home.
Flu shot admin at 07:45 am. Employee self admin "Loratadine" 20 mg at 10:30 am. At 11:30 am employee c/o "feeling like throat was going to close". EE transported to ER via paramedics. ER diagnosis: allergic reaction - mild-moderate. Undetermined what caused reaction. Discharged home from Emergency Department same day.
Patient received three Moderna COVID-19 vaccines per registry, on 2/26/2021, 3/26/2021 and 12/6/2021; was subsequently tested positive for COVID-19
her arm hurt so bad that woke her up; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (her arm hurt so bad that woke her up) 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 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced PAIN IN EXTREMITY (her arm hurt so bad that woke her up). At the time of the report, PAIN IN EXTREMITY (her arm hurt so bad that woke her up) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
pt recvd vax & 3-4 wks p/vax c/o chronic pain lt upper arm biceps & deltoid area; inc w/adduction of arm; no c/o infection;
1-25 Left was cold and Body started hurting 1-26 arm swelled up 27-28 could not lift arm. Red swollen bigger than my hand including fingers body hurt in the bones, cried dreamed I was dying. 29 arm started going down but as it went down I was getting sick hurting again. Took 3 months for the knot to go away. While I was sick stomach starting feeling swollen, now I just seem like I can't get my energy back. Really took a toll on me I am just sending this because one thing or another keeps happening to me. I just want to get well.
PAIN AT THE INJECTION SITE FOR 3 DAYS. AURAL FULLNESS. TINNITTIS.
Patient came in for a second dose of Pfizer monovalent, and monovalent had been pulled due to fda recommendation, new recommendations hadn't come out yet, pharmacist administered the Bivalent booster in place of the Pfizer monovalent second dose.
Intense lower back pain; Upset stomach; Muscle tightness; Very thirsty for first day; Total body soreness; Soreness at injection site; Soreness through upper left arm; Exhaustion; Brief tingling in hands and feet.; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via intramuscular route of administration in the left arm on 28Apr2021 at 12:30 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. Medical history included eczema, GERD, allergic to paw paws, onions, sensitive to soy, tomatoes, and seasonal allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included cetirizine hydrochloride (ZYRTEC), pseudoephedrine hydrochloride (SUDAFED) and omeprazole (MANUFACTURER UNKNOWN) and collagen supplements; all since an unknown date for unknown indication and unknown if ongoing. The patient previously took BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EW0150) via intramuscular route of administration in the left arm on 31Mar2021 at 12:30 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 28Apr2021 at 16:30, the patient experienced soreness at injection site and through upper left arm, total body soreness and muscle tightness followed. The patient experienced exhaustion and was very thirsty for the first day, had brief tingling in hands and feet, intense lower back pain at end of day 2 of symptoms, and an upset stomach. The patient reported the symptoms started at 16:30 on the day of injection, lasted through next day and the symptoms were worse on day 2. 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, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the reported adverse events. The clinical outcome of the events intense lower back pain, upset stomach, muscle tightness, very thirsty for first day, total body soreness, soreness at injection site, soreness through upper left arm and exhaustion and brief tingling in hands and feet was recovered on an unknown date in Apr2021.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
3 days following 3rd dose of Moderna, woke at 4 am on 10/31/21 with heart palpitations and elevated blood pressure. Went to ER.  EKG, bloodwork and chest xray performed.  Admitted for monitoring.  Discharged at 12pm on 11/1/21 and advised to followup with electrophysiologist on 11/2/21 who put me on 12.5mg of Metoprolol and a 48 hr Holter Monitor.  Further followup on 11/15/21.  Could be SVT or VT.  Symptoms have subsided but are not eliminated at this time.
Patient called stating that that her right arm hurt so badly that she could barely lift it up. The right arm was swollen on the back of the arm (on the tricep area) and swollen down to the elbow. I recommended that she visit urgent care. She did see the doctor and they gave her a prescription for an antibiotic and a steroid. I spoke with the patient 24 hours later, she said the swelling had gone down and that she was taking the medications that were prescribed.
c/o fever, chills, dyspnea x 1 day. Had first COVID 19 vaccine(Moderna) on 4/21. EMS noted sats 87% on RA. Improved to 95% on 2L NC. Also had nausea, vomiting and diarrhea on 4/22 which is now resolved as per patient.  States never had pills in his vomiting.  Always vomited food as per him.  Diarrhea was only a few episodes and was nonbloody and had no mucus.  Feeling very weak and having diffuse myalgias also as per patient.  In ER chest x-ray showed pulmonary edema and also had accelerated hypertension.  He is admitted for further management.
Immediately (no delay) after injection,  tingling in arm followed by flushing of face and subjective SOB, no wheezing noted, face and anterior chest with uniform erythema, no hives.  Epinephrine administered immediately by vaccinating nurse.  No further development of symptoms.  Developed some palpitations and chest discomfort - normal EKG.  Discharge home after 6 hour observation, no recurrence of symptoms.
pt recv vax;devel swelling about size of quarter at inject site but resolved x/ mild erythema;7-10 days later sx recurred;to MD,2 small areas of induration approx 1cm each were noted;MD felt rxn to vax;f/u MD stated no more contact w/ pt;
She said she experienced headache, dizziness, and body aches. She could not get out of bed
Haemophilus influenzae, type B meningitis & sepsis.  Complications; seizures, cerebral edema, intracerebral bleed, DIC & ARDS.
Fever, vomitting, nausea. Unable to hold down water, body aches, no appetite, overall feeling awful, pain and swelling at injection site
p/vax pt became fussy, constipated not easily consoled & mom gave dilute prune juice;passed soft stool;irritable;T102.6R;pallor, dehydration, shallow breathing & eye deviation;to hosp;focal sz;EEG some spikes not hx of HSV;sepsis;
A week after shot started to get pains in chest and  feeling  very tired and very hard breathing
Patient inadvertently received  a 1ml dose of influenza vaccine instead of correct 0.5 ml dose. Patient reported her arm was sore a few days but has resolved.
headache; lots of congestion; This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION (lots of congestion) and HEADACHE (headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced NASAL CONGESTION (lots of congestion) and HEADACHE (headache). At the time of the report, NASAL CONGESTION (lots of congestion) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Day 7 -  itching at injections site.  Day 8 -  area is sore, itchy, red and swollen.
Temperature 101, tenderness, edema, erythema left arm. Seen in ER.  Treatment Augmentin x 10 days.
Brain fog; headache; Muscle spasm at injection site; Severe fatigue; joint pain; Driving difficult; Swelling; This is a spontaneous report from a contactable nurse (patient). A 62-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249, expiry date not reported), via an unspecified route of administration in the left arm on 08Jan2021 16:00 at single dose for COVID-19 immunisation. Medical history included latex allergy. Concomitant medications included ibuprofen and paracetamol (TYLENOL). The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19.  The patient previously took first dose of bnt162b2 (lot number: Ek5730, expiry date not reported) in the right arm on 18Dec2020 15:00 at single dose for COVID-19 immunisation. On 08Jan2021 at 18:00, the patient experienced brain fog, headache, muscle spasm at injection site, severe fatigue, joint pain, driving difficult and swelling. It was unknown if treatment was received for the adverse events. Clinical outcome of the events was not recovered.
Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Hypotension-Mild, Additional Details: 1st Dose given at 6:05 PM, lightheaded within 5 minutes. also developed chills. BP read 115/60, 5 mins later 108/67 and sat for 30 minutes. patient had improved since then and was able to leave.
Awoke crying & irritable w/ 101 ax temp, poor appetite, pulling lt ear-soft waxy drainage onset 48 hrs p/vax; On 17OCT fever 100.4 ax ear red & retracted; tx APAP & Amoxicillin; Fever broke 20OCT Amoxicillin stopped due to onset of rash;
Very sore arm, tiredness, sudden vaginal bleeding during menopause; Very sore arm, tiredness, sudden vaginal bleeding during menopause; Very sore arm, tiredness, sudden vaginal bleeding during menopause; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 55-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 01Apr2021 (Lot Number: EW 0150) at single dose for covid-19 immunization. Medical history included chronic pain from old injury. No known allergies. The patient didn't have Covid prior vaccination. Concomitant medications included paracetamol (TYLENOL) taken for an unspecified indication, start and stop date were not reported; hydromorphone 2 mg taken for an unspecified indication, start and stop date were not reported; tramadol ER 200 mg taken for an unspecified indication, start and stop date were not reported. No other vaccines in four weeks. The patient previously received the first dose of bnt162b2 (Lot number: EN6207) in left arm on 12Mar2021 at 55 years old for covid-19 immunization. The patient experienced very sore arm, tiredness, sudden vaginal bleeding during menopause on 01Apr2021 05:00 PM. No treatment was received for the events. Covid was not tested post vaccination. The outcome of the events was unknown.
Fever and myalgias started approximately 36hrs after administration. Fever, myalgias, headache, drenching night sweats continued for over 24hrs until approximately 72hrs post administration.
She states she felt like sleeping and didn't want to eat and really made her sick; She states she felt like sleeping and didn't want to eat and really made her sick; She states she felt like sleeping and didn't want to eat and really made her sick; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An elderly female patient received BNT162b2 (BNT162B2), on 14May2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 3), administration date: 01Oct2021, for COVID-19 immunization, reaction(s): "real sick"; Covid-19 vaccine (dose 1, Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (dose 2, Manufacturer unknown), for COVID-19 immunization. The following information was reported: ILLNESS (non-serious) with onset May2022, outcome "recovered" (May2022), SOMNOLENCE (non-serious), DECREASED APPETITE (non-serious) all with onset May2022, outcome "unknown" and all described as "She states she felt like sleeping and didn't want to eat and really made her sick".  Additional information: She states she had her 3rd dose of the Pfizer COVID-19 vaccine on 01Oct2021 and wants to mention that she is almost 88 years old. She states number 3 made her real sick but nothing like this. Caller states the information was probably in the report as she did report this after her 3rd dose of the COVID-19 Vaccine in Oct. She states only one day and then this was 2 days. She states 2 days ago she got the 4th dose of the Pfizer COVID-19 vaccine. She states she felt like sleeping and didn't want to eat and really made her sick. She states yesterday she was very sick and today she is fine.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Four hours post vaccine I had muscle and joint pain throughout my entire body and I took 600 mg Advil.  Four hours after that I repeated the 600 mg dose of Advil and went to bed.  I felt feverish and my pain did not diminish despite the medication.  At approximately 2 am I got up to try and cool myself off.  I fainted in my bathroom and fell, hitting my head on the tub, although I did not know this at the time.  I thought I just laid down.  I was unable to get up.  For the next 2 hours I slowly inched myself from the bathroom into the hallway and towards my bed.  I was very cold and in severe pain.  When I reached my bed I finally warmed up and fell asleep.  I was unable to get up out of the bed, except to raise myself on my right elbow to drink a mouthful of water, until approximately 4 pm the following day.   This was 28 hours after the vaccine.  No medications helped my pain, it just slowly subsided on it's own.      For the next 24 hours I was able to get up and use the bathroom and drink some water and juice but I could not eat or perform any function. I could not even sit up in bed.  When I was able to start eating again I had diarrhea for 24 hours.  It has been 5 complete days since the vaccine.  I am still winded while performing simple cleaning tasks.  I need about 2 hours of rest in bed (twice yesterday) just to get through a day with nothing in it.   I did not expect the level of immobility/illness, unalleviated pain or the seriousness of my second vaccine reaction.
12/28/21: Comes to the emergency room with a 2-day history of having chest pain that progressively is getting worse.  Also, it is associated with shortness of breath.  As per patient, she was tested for COVID that was positive, and she decided to come to the emergency room for evaluation. Chest x-ray with opacity consistent with atelectasis versus pneumonia. Assessment- see below: Please note: Patient received first dose Pfizer vaccine on 1/4/2021 Lot # EL0140 and the second dose on 1/25/2021 Lot # EL3248    Additional information for Item 18:  Assessment: COVID positive  Viral pneumonia POA 2/2 above  Sirs criteria not met  Acute hypoxic respiratory failure POA 2/2 pneumonia Chest pain-ACS ruled  Pericardial effusion-no tamponade CKD-creatinine around baseline  Normocytic anemia-hemodynamically stable  Hyperkalemia POA  Insulin-dependent diabetes  Anxiety  Morbidly obese-BMI 40  Hypertension Anxiety  Decreased mobility  History of falls  Headaches  Plan : COVID unit  Labs, vitals, imaging, notes reviewed  Continue current medication regimen Dex/Lovenox/REM Monitor/obtain CRP  Monitor metabolic panel Monitor started while on REM  O2  Maintain O2 saturation greater than 92%  Cardiology on board  Further recommendations pending hospital course Will need therapy evaluations prior to discharge
Patient was weak, no/little appittite, chills, feverish, tenderness to surrounding immunization area. Tenderness and aching to left armpit. Treated for local cellalitis reacton and immunization site at civilian ER.
Systemic: Numbness (specify: facial area, extremities)-Medium, Additional Details: Patient's wife called the pharmacy on 06/27/21 to say that the patient has been complaining  of tingling in both arms that started 4 days after the second dose of pfizer covid 19 vaccine. She also said will contact his phisician tomorrow, we gave her the vaers toll-free n umber and also the phone number for pfizer safety reporting.
Fever and Chills for 24hrs. Nausea for 32hrs. Headache for 48hrs.Rightside body ache from head to toe for 12hrs. Cold sore appears 3 days after.
Heart pulse racing and pounding for no apparent reason. Extreme shortness of breath, blood pressure instability.
MODERNA COVID VACCINE DOSE #3 GIVEN 10/29/21, LOT #011F21A; pt in SNF; DNR and comfort measures; pt tested positive for COVID on 7/7/22; placed in isolation; O2 saturation 63% on RA; O2 supplementation; pt's condition worsened and she passed away the next day in the facility
PATIENT SAYS SHE HAD SWELLING, REDNESS, AND ITCHING AT THE INJECTION SITE LATER IN THE DAY AFTER RECEIVING THE PNEUMONIA VACCINE. SHE SAYS THE SWELLING WENT AWAY THE NEXT MORNING, BUT IT MOVED DOWN HER ARM TO CLOSE TO HER ELBOW.
29Dec97 pt recv 1 dose vax. 29Jan98 pt exp vesicular rash on trunk,face & abdomen w/ some scattered dry vesicles.No fever.
(Lt) lateral thigh with about 4 x 4 cm induration & about 6-7 cm x 6 cm redness surrounding inject. site. Positive swelling began 9-22-11. Tx includes: BENADRYL  x 1-2 d; ibuprofen PRN; warm packs/baths to area. To call PRN if increases.
Patient came into the pharmacy on 11/8/18 at 9:08am and stated that after she go the flu shot she has been coughing up blood and in her left ear there was blood in it. She stated that the phlegm is green to dark red in color. I advised the patient to go to urgent care to get it checked and she agreed. Pt states she is feeling otherwise fine.
chills and tingling leg pain 12 hours after the shot, and fever of 100.5 by the following day.  Fever lasted all day.  Overall body aches and tiredness, lack of appetite. injection site pain
improperly stored vaccines; This spontaneous report was received from an office manager and refers to a patient of unknown age and gender. No information was given regarding the patient's concurrent conditions, concomitant medication or medical history.  On 22-FEB-2021, the patient was vaccinated with improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) lot # S018595 with expiration date on 17-JUN-2021, 0.5 milliliter for prophylaxis and varicella virus vaccine live (oka/merck)(VARIVAX) with lot# T021824 with expiration date on 25-JUN-2022, 0.5 milliliter for prophylaxis.     The vaccines experienced a temperature excursion of 54F  for 43 hours. There was no previous temperature excursion and the call was due to a data logger.
Patient presented with a large red area around the injection site on right arm.   "Rash at site of influenza vaccine: Consistent with large local reaction.  Area essentially nontender so cellulitis unlikely.  Dose of benadryl given in clinic.  No systematic symptoms.  Family to give ibuprofen and benedryl for the next few days.  Ink line drawn around the erythema to better track increase/decrease in size."
No tinnitus ever before Pfizer Covid shot. The day after receiving Covid vaccine, tinnitus developed.. Approximately six months later, tinnitus remains, albeit a lower "decibel"
Patient describes a tingling feeling all over the body, especially in the hands in face and it came in 2 waves lasting not more than a few seconds. She no longer is having these symptoms
Unable to sleep; fever; Headache; Body pain; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), HEADACHE (Headache), PAIN (Body pain) and INSOMNIA (Unable to sleep) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 06-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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. On 06-Apr-2021, the patient experienced PYREXIA (fever), HEADACHE (Headache) and PAIN (Body pain). On an unknown date, the patient experienced INSOMNIA (Unable to sleep). At the time of the report, PYREXIA (fever), HEADACHE (Headache), PAIN (Body pain) and INSOMNIA (Unable to sleep) outcome was unknown. Not Provided          Concomitant drugs were not provided and Treatment none
Pt said the day after she got BOOSTRIX vaccination she felt like she slept on her arm. She feels a tingling sensation when she moves her arm and numbness. Recommend pt to see MD.
Developed a cellulitis on right thigh after immunization 3/25/04. Received DTaP #5 & MMR #2 that day. Area swollen to size of small grapefruit with increase warmth.
It's been more than a month since he received the first dose (>42 days); This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTRATION INTERRUPTED (It's been more than a month since he received the first dose (>42 days)) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced PRODUCT ADMINISTRATION INTERRUPTED (It's been more than a month since he received the first dose (>42 days)). At the time of the report, PRODUCT ADMINISTRATION INTERRUPTED (It's been more than a month since he received the first dose (>42 days)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.