chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient was given yellow fever vaccine on 6/4/18. Pt states that site of injection started to feel hot and itchy and rash on face on 6/5/18. Patient started taking CLARITIN and BENADRYL. Patient came in clinic on 6/7/18 to have site looked at. Local reaction looked within normal limits but rash on face was not. Referred to nurse and provider for further evaluation.
Moderate lower back pain started on day 5 in the afternoon (2/17/2021) that lasted 12 days.  Pain not noticeable unless pressure is applied to the lower back.  Took extra strength Tylenol on day 13 (2/25/2021).  Left armpit lymph nodes pain on day 13 (2/25/2021) that lasted two days.
Patient received Moderna  on 10/13/2021 after having Pfizer on 09/13/2021. Patient was notified. No c/o side effects reported by patient when this nurse spoke to her on 10/14/2021. Patient was notified on 10/14/2021 that she is considered fully vaccinated per CDC response via e mail.
PT STARTED FEELING  DIZZINESS AND LAID ON THE FLOOR AT HOME.  PT STATES SHE FEELS MUCH BETTER AFTER LAYING ON THE FLOOR. PT HOME WITH MOTHER WITH STABLE CONDITION
I had the pneumonia vaccine 23 at the same time I had the Pfizer dose 3. I did have chills, and aching the next day, and night. I started those symptoms on Saturday late afternoon. By Sunday morning everything was perfect, within 36 hours it was gone. That could have been either one of the vaccines. The arm I received the pneumonia vaccine got sore. The other one did not bother me. Around 10/2021 it felt like my ears were stopped up.  I went to the ENT Doctor, and I found out I had lost some hearing in my left ear, some high pitches. Unexplained hearing loss in my left ear.
Associate began feeling numbness in left arm and chest pain later in the day after vaccine. Sought care at the ER for cardiac workup.
Vaccination while pregnant; sore arm; slight headache; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Vaccination while pregnant), MYALGIA (sore arm) and HEADACHE (slight headache) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 010M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. The patient's last menstrual period was on 23-Sep-2020 and the estimated date of delivery was 30-Jun-2021. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (Vaccination while pregnant), MYALGIA (sore arm) and HEADACHE (slight headache). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-third week of the pregnancy.  At the time of the report, EXPOSURE DURING PREGNANCY (Vaccination while pregnant) and MYALGIA (sore arm) had resolved and HEADACHE (slight headache) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pregnancy test: positive (Positive) positive.         Action taken with mRNA-1273 in response to the event was not applicable.
On 03/23/2021 I had the second dose and I had a little bit of sore arm and a little bit lethargic for about 7-8 hours. On 05/04/2021 I woke up at 6:30 am and I felt just fine so I went back to sleep and woke up again at 8:30 and right away I knew something was wrong, I felt really weird. I could not hear, I lost hearing on my right ear for about 24 hours. I started to get vertigo and started to throw up and I vomited for about an hour. My wife decided to take me to the ER and they did an MRI and determined the stroke was in my cerebellum and that would explained the vertigo but that do not explained the hearing of loss. They gave me a blood thinner and diuretic. They thought is was Ménière's disease because of the hearing loss but after doing the MRI and CAT scan they determined it was a stroke. I was in the hospital for 3 days. I still have some balance problems and dizziness but I am getting better gradually.
lung issues; heart issues; random heart rate spike; This is a spontaneous report from a non-contactable consumer. A 30-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration in left arm on an unspecified date in May2021 as dose 1, single for COVID-19 immunization. The patient's medical history was not reported. It was unknown if the patient received any concomitant medications. Prior to vaccination, the patient was not diagnosed with COVID-19, did not receive any vaccines within four weeks and was not pregnant. The patient experienced lung issues, heart issues and random heart rate spike on an unspecified date in May2021. It was reported that the patient feels iffy about the vaccine. Patient was hospitalized 2 times due to reaction to vaccine. She also stated the vaccine gave her heart and lung issues but they're finally going down some but still having random heart rate spike. Since the vaccination, patient has not been tested for COVID-19 and it was unknown if any treatment was received for the event. Outcome of events was resolving.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
left under arm tenderness, pain, and swelling; left under arm tenderness, pain, and swelling; Swollen under arm lymph nodes; soreness of injection site & bruising; soreness of injection site & bruising; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 25 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 04Oct2021 12:00 (Lot number: 30135BA) at the age of 25 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "Allergic to shellfish" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose number=1, dose product=COVID 19, dose brand=Pfizer, dose lot number=EK5730, dose administration date=21Dec2020, dose vaccine location=Left arm), administration date: 21Dec2020, when the patient was 24 years old, for Covid-19 immunization; Bnt162b2 (dose number=2, dose product=COVID 19, dose brand=Pfizer, dose lot number=EK9231, dose administration date=11Jan2021, dose vaccine location=Left arm), administration date: 11Jan2021, when the patient was 24 years old, for Covid-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), PERIPHERAL SWELLING (non-serious) all with onset 05Oct2021, outcome "not recovered" and all described as "left under arm tenderness, pain, and swelling"; LYMPHADENOPATHY (non-serious) with onset 05Oct2021, outcome "not recovered", described as "Swollen under arm lymph nodes"; VACCINATION SITE PAIN (non-serious), VACCINATION SITE BRUISING (non-serious) all with onset 05Oct2021, outcome "not recovered" and all described as "soreness of injection site & bruising". Therapeutic measures were taken as a result of pain in extremity, peripheral swelling, lymphadenopathy, vaccination site pain, vaccination site bruising.  Additional information: 24 hours after receiving 3rd dose of COVID vaccine (booster) in left arm, left under arm tenderness, pain, and swelling. Swollen under arm lymph nodes. 48 hours after vaccine, continuing to experience significant pain in arm pit with swelling & tenderness (Also experienced side effects of soreness of injection site & bruising) What treatment received for the adverse event? Comfort measure treatments (meds &heat/ice). Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID- 19. Since the vaccination, the patient has not been tested for COVID-19. No other vaccine was administered in four weeks.  Follow-up attempts are completed. No further information is expected.
Pt describes that she started to have a delayed reaction on 12/1/2021 to the Moderna vaccine 2nd dose administered on 10/16/2021.  Person states she has a burning sensations in my body but specifically in my legs. As well as on 10/16/2021 she had soreness of the left arm at the injection site, which she took pain medication to help. She also took pain medication to help with the burning sensation in her legs have helped a little but not all the way gone
Urinary tract pain and a little bleeding; feeling puncture pain on my right flank and bladder; Urinary tract pain and a little bleeding; feeling puncture pain on my right flank and bladder; Off label use; 1st dose Janssen on 09Apr2021 and 2nd dose Pfizer on 12Nov2021; This is a spontaneous report from a contactable consumer (patient). A 34-year-old non-pregnant female patient received dose of BNT162b2 (Pfizer BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number: FF2593 and Expiration date was not reported), via an unspecified route of administration, administered in left arm on 12Nov2021 at 12:15 hours as dose 2 (booster), single (at the age of 34-years-old) for COVID-19 immunization. Patient had no medical history. It was unknown if patient had any known allergies. The patient concomitant medications were not reported. Historical vaccine included patient received COVID-19 Vaccine (Janssen COVID-19 Vaccine, Batch/Lot number: FF2593 and Expiration date was not reported), via an unspecified route of administration, administered in right arm on 09Apr2021 at 00:00 hours as dose 1, single (at the age of 34-years-old) for COVID-19 immunization. Patient had no other vaccine in four weeks. Patient was not diagnosed with COVID-19, prior to vaccination and had not been tested for COVID-19, since the vaccination. On 13Nov2021 at 08:00 hours, patient experienced urinary tract pain and a little bleeding and about 55 hours after the vaccine, patient started feeling puncture pain on right flank and bladder. Patient received no treatment for urinary tract pain and a little bleeding and feeling puncture pain on my right flank and bladder. The outcome of urinary tract pain and a little bleeding and feeling puncture pain on my right flank and bladder was not recovered.   Follow-up attempts are completed. No further information is expected.
Information has been received from a 72 year old female registered nurse who was also the patient, with allergy to erythromycin, emphysema and hypertension who on 08-OCT-2007 (also reported as given four years ago) was vaccinated with a dose of ZOSTAVAX (Merck) (route, site, dose and lot number not reported). Concomitant therapy included calcium (unspecified), hypertensive medication and anti-depressant. On 23-FEB-2012 the patient presented with shingles. The patient was seen on 23-FEB-2012 with a rash on her neck on the left side and on the back of the neck on the hairline. There was also a blotch on her jaw and that was when she was diagnosed with shingles. It was prescribed pain medication and two week later prescribed gabapentin, as treatment for the adverse event. The patient did not know of lab diagnostic studies performed. The patient said that she was getting better, she still had pain but it was less than before. At the time of the report, the patient was recovering. Shingles was considered to be disabling by the registered nurse since the pain was pretty incapacitating. Additional information has been requested.
headache; Tiredness; slept all day; really draggy; This is a spontaneous report received from a consumer (patient) via other company. A patient of an unspecified age and gender received (Pfizer Covid 19 Vaccine, Solution for injection) via an unspecified route of administration on an unspecified date as single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that, "after the Covid vaccine, patient had headache and tiredness was really draggy, and slept all day Pfizer Covid 19 vaccine". Reported of ADRS where the initial reporter identified the suspected drug as one marketed by another applicant, should be forwarded to that applicant. Outcome of the events was unknown.  Information on lot/batch number has been requested.
arm was very sore all night; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was very sore all night) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced PAIN IN EXTREMITY (arm was very sore all night). At the time of the report, PAIN IN EXTREMITY (arm was very sore all night) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details were provided. No treatment information was mentioned.   This case was linked to MOD-2021-297345.
Pt recvd 3 doses of Recombivax & was determined to be a non-responder; pt recvd 4th dose booster of Engerix-B;
When administering the immunization -the plunger would not inject-  I pushed as hard as i could-  After disposing of the faulty shot-  I administered one that worked.  Patient recieved no vaccine from first syringe
30X30mm Area of redness, swollen and hard  around the site where injection was given.  Started as a little lump she said then grew.  She has not sought medical attention.
At 1320 pt. c/o light headedness and dizziness, vital signs included 106/90, 80bpm, RR=18, T=98.1, @98% RA. Pt. was helped to a supine position with legs elevated and deep breaths were encouraged. At  1331 Bp=150/85, RR=18, HR=82, T=98.2 @97% RA.  PT. reported symptoms subsiding . At 1343, pt. reported symptoms had fully subsided and felt stable in all positions. pt. was d/c home shortly after. pt. incurred no falls or traumas while at the clinic.
Got 3 dose of the Pfizer vaccine. With each vaccine, had violet episodes of projectile vomiting of bile (bout a pint each). Without warning. No nausea.
Extreme itchiness and rash/redness around injection point. The itchiness started about one week after the injection was administered.
Fever. Chills/real bad. Muscle aches and pains all over. Fatigue.
Symptoms: Very sore arm where the shot got administered - hard to even lift it. Also: fever, malaise, great tiredness, body aches. All except the sore arm went away within 24 hours. The arm remained sore for about 2 days.
Pt complained of upset stomach and feeling faint. Fainted, laid down and elevated feet. Pt awoke asking what happened. Mother stated that pt had not eaten and was very nervous before receiving the shot.
TOOK UNREFRIGERATED DOSES; This spontaneous case report was received from a pharmacist (PVX2019-300) on 31-Jan-2019. The report describes an adult male consumer who "took unrefrigerated doses". The consumer was receiving Vivotif for an unknown indication.  It was reported that the consumer took the first dose of Vivotif on 23-Jan-2019 and the last dose on 29-Jan-2019. All the doses were unrefrigerated.  The action taken with Vivotif with respect to the event "took unrefrigerated doses" was not applicable.  The clinical outcome of the event "took unrefrigerated doses" was unknown.  Company's Comment: The causality of the event "took unrefrigerated doses" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took unrefrigerated doses" was considered as not applicable.
Fever of 105 last night.  Temp 102 today.  Using MOTRIN/TYLENOL.  Instructed: Sleeping since he got home from school.  Instructed to take to ER for evaluation.
Week after vaccine developed shortness of breath and pain breathing.  Trip to ER and admitted to hospital.   Diagnosed with Pulmonary Embolism.  Blood clots both lungs.
Began having abdominal pain and nausea evening of 5/25, worsening at intervals. Went to Emergency Room on 5/27. Surgery on 5/29 to remove gall bladder.  Additionally I had food poisoning or a stomach "bug" on Feb. 9 - 12 - forceful diarrhea, vomiting, nausea, some stomach cramps. No medical treatment sought, resolved on its own.
pt recvd vax;w/in a few min p/ dose 2,exp stiffness,pain,urticaria;low grade t;lab tests done;
This spontaneous report as received from a nurse practitioner via company representative, refers to a female patient of unknown age. On an unknown date in June 2007, the patient was vaccinated with a dose of ZOSTAVAX (dose, route and lot number were not reported). One week later (in 2007), the patient experienced shingles on her forehead. The patient sought medical attention via the doctor's office visit. The outcome of shingles on her forehead was reported as recovered. Relatedness between the therapy and the event was not provided. Additional information has been requested.
5 year old with mild urticaria at wrists, thorax and back after receiving COVID vaccine approximately 5 minutes prior to onset of symptoms. No lip or tongue swelling. No wheezing or emesis. Benadryl 1.25 mg/kg given by mouth once in the office. Pt assessed by Doctors. Patient was observed for an hour. Pulse oximeter read 99%  on room air.
after the first dose she had body aches; fatigue; fever; through up for two day; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (after the first dose she had body aches), FATIGUE (fatigue), PYREXIA (fever) and VOMITING (through up for two day) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21a) for COVID-19 vaccination.     Patient has never been diagnosed/tested positive for Covid-19. Patient did not receive other vaccines within 1 month prior to Moderna COVID-19 vaccine. Patient did not have any acute illnesses or chronic conditions at time of vaccination.  Previously administered products included for Product used for unknown indication: Flu shot (bit more dramatic). Past adverse reactions to the above products included Vaccination adverse reaction with Flu shot. Concurrent medical conditions included Penicillin allergy.    On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced PAIN (after the first dose she had body aches), FATIGUE (fatigue), PYREXIA (fever) and VOMITING (through up for two day). In 2021, VOMITING (through up for two day) had resolved. At the time of the report, PAIN (after the first dose she had body aches), FATIGUE (fatigue) and PYREXIA (fever) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medication information was provided. Patient did not receive medical care. No treatment medication were provided. The patient stated that she did not got covid, because of the Moderna covid19 vaccine, and everything that happened with her was all broadly publicated online.   This case was linked to MOD-2022-543456, MOD-2022-543457 (Patient Link).
I had chills, severe headache, muscle ache, injection site pain, nausea, vomiting and fatigue.  After approximately 12 hours I took a Tylenol PM to sleep. By the next morning all symptoms were gone.
Pt recv vax on unknown day;  on 12/11/98 pt exp sore bones & joints, tired, chills, flushing, nausea, itching & rash, diarrhea, headache, sore jaws; tx=Dapro
local erythema diffuse large blotchy areas over entire body; resolved w/DPH;
Large, red, swollen, itchy spot at the injection site.  It has not gone away as of today, 4/24/20
Dizziness, HYPERtension, Syncope, Tachycardia, DIZZINESS AND LIGHTHEADED NESS AFTER VACCINE THIS AM AROUND 8:30. AT 12:30, WAS VERY PALE, WARM, DRY AND FEELING FAINT. 165/87, 104, 96.2, 98%, BLOOD GLUCOSE 158. NO SOB, RASH, OR ITHCING. AFTER 30 MINUTES WAS 112/69, 73, 18, 98%. Narrative:
Headache, Myalgia, Fever, Right arm lymph node swollen Narrative:
I had a flu shot 9/24/12. My arm has been sore since then. It hurts when I use my arm.
Profound pain and weekness in both shoulders not related to injection site   All injections only in left arm
Doctor observed a "silver looking tatooing about period size" at visit on 3/31/10. Mom took child to doc after noticing dark spot @ 2 injection sites wasn't going away after receiving imms. on 3/10/10. Area was not red, tender, or swollen and no foreign body under skin. One spot on (L) leg and one spot on (R) Leg.
Quite sick; COVID; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Quite sick) and COVID-19 (COVID) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (Quite sick) and COVID-19 (COVID). At the time of the report, ILLNESS (Quite sick) and COVID-19 (COVID) outcome was unknown.            No concomitant products and treatment information were reported. It was reported that his booster is due beginning of Feb.  Company Comment: This is a spontaneous case concerning a male subject of unknown age, with unknown medical history, who experienced the non-serious unexpected events of Illness and COVID-19 (AESI). The events occurred unknown number of days after the second dose of mRNA-1273 vaccine. There is no available information regarding clinical course and treatment medication. There is also no information regarding the first dose and vaccination schedule. Rechallenge was not applicable as there was no information regarding an additional dose. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2021-286573 (Patient Link). Sender's Comments: This is a spontaneous case concerning a male subject of unknown age, with unknown medical history, who experienced the non-serious unexpected events of Illness and COVID-19 (AESI). The events occurred unknown number of days after the second dose of mRNA-1273 vaccine. There is no available information regarding clinical course and treatment medication. There is also no information regarding the first dose and vaccination schedule. Rechallenge was not applicable as there was no information regarding an additional dose. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Experienced intense chills, inability to maintain body temperature, headache, body ache. These symptoms intensified over a course of 3-4 days. Symptoms were most severe on the 3rd night -- in addition to chills and aches, experienced difficulty breathing, tightness in chest, vomiting. Treated with bed rest and Tylenol. Consulted family physician on the 4th day.
Pt exposed to brother (WAES97111693). Pt recv 1 dose vax 20Nov97. 08Dec97 Pt exp chickenpox.
Pericarditis, Treating with NSAIDS, treatment ongoing Blood clot, Treating with Eliquis, treatment ongoing
Unexplained blood clot. It has been a year since my vaccine but thought it might be relevant for long term effects data.
pt recv vax 1030AM & 1PM pt began high pitched scream that lasted intermittently until 1AM;t99.8;no redness @ inj site;