chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient developed a few bumps on back of neck and face on 7/23 patients indicated bumps itched. MD diagnosed as a mild case of shingles and patient was treated with acyclovir 400mg five times daily x 7 days.
03/02/22 presents to Birth Center Triage for "contractions" "38w6d". PMHx of "anemia"
Pt was given Dtap-IPV left thigh, no issues. After giving MMR-V in right thigh, pt immediately got red and swollen at injection site. Started complaining of itching. We applied ice pack and told mom to give Benadryl and Tylenol when arriving at home.
J96.90 RESPIRATORY FAILURE, UNSPECIFIED ACUITY 12/17/2021 CARDIAC ARREST CAUSE UNSPECIFIED
May have been given only the diluent; May have been given only the diluent; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 17-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMXA585A, expiry date 1st April 2023) for prophylaxis.   On 14th October 2021, the patient received Menveo (intramuscular). On 14th October 2021, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The healthcare professional reported that the patient might have received only the diluent component of Menvo, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up.
pt recvd vax;approx 3 hrs later devel reverse L shaped red streaked at inject site;
Local reaction at the sites where he received Flu and Menveo vaccinations 3 x 4 inches wide total area of redness.  Flu was administered left upper deltoid, Menveo administered left lower deltoid.
rash devel w/in hr & lasted 3-5 days;erythematous, maculopapular, no hives or wheals;
Very painful ejection itself followed by immediate soreness and swelling.  Severe soreness and swelling over a couple of weeks.  Once it started to abate I am left with significant immobility in the shoulder.  I am unable to sleep on my left side, have weakness in my left arm, and numbness in my left arm and hand.  This persists 3 months after the initial injection.
Intussusception.   12 cm located in small bowel.   3 hour emergency surgery also removed 75 cm of intestines.   A mass was tested, there was no tumor or cancer .
This spontaneous report was received from a medical assistant refers to a 2 month old patient. The medical history, concurrent conditions and concomitant medications was not reported. On an unknown date, the patient was vaccinated with one dose of improperly stored VARIVAX (N009768, 24-MAR-2019) was administered. Temperature 9 to 8 degree centigrade(-7.3c) for 112 hours. There was no previous temperature excursion. There was data logger. Additional information has been requested.
Patient received her second covid dose (Moderna) 22 days from the first dose (Pfizer).
A report was received from a health care professional on 11/22/02, concerning a group of vaccinees less than 4 years old of unknown demography who inadvertently received Fluvirin from approximately 11/07/02 onwards. There were no reported adverse events. There was insufficient information to determine the reporter's causality assessment. Update (1) 12/10/02: A follow up report was received on 12/10/02, indicating that a 21 month old female vaccinee was inadvertently administered Fluvirin intramuscularly on 11/15/02. the vaccinee experienced no adverse reactions. Cross reference: PJP200200848, PJP200200849, PJP200200850, PJP200200851, PJP200200852, PJP200200853, PJP200200854, PJP200200855, PJP200200856, PJP200200857,PJP200200858, PJP20020859, PJP200200860, PJP200200861, PJP200200862, PJP200200863, PJP200200805, PJP200200865, PJP200200866, PJP200200867, PJP200200868, PJP200200869, PJP200200870, PJP200200871, PJP200200872, PJP200200873, PJP200200874, PJP200200875, PJP200200876 andPJP200200877.
pain started immed, tender to touch, sore achy & swollen upper arm 24hr later;painful axilla;in 24hr gen malaise;in 48hr red welts 3-4" from inj site (circular);tenderness cont;
My arm hurt really bad for two, so much so that it woke me up at night. The pain subsided to minimal and then became constant. Now I can't raise my elbow very high without pain, I have to ice my arm nightly before bed, it is stiff and very painful in the morning. My doctor told me to see a orthopedic doctor; have an appointment on 5/4/2021.
Narrative: Patient received his Moderna COVID vaccine #1 on 7/28/21 and his second vaccine on 8/25/21. No further notes or scanned records entered to indicate that he had issues with his vaccine or cause of death. A date of death was recorded as 9/15/21. There were 21 days from the second vaccine to his date of death.
A few days later after the 2nd shot, my left wrist felt like it was injured by a sprain, even thought I never injured it. Over the few weeks it got worse to a point where I was in a lot of pain trying to pick up anything that was heavier than 1lbs. About a month after the second shot, I also noticed my tinnitus in my ears started getting much worse, even though I was not exposed to loud noises. As of today, my left wrist is still in pain, some days better that others, I have been taking ibuprofen at 600mg with not relief of pain. I have also bought a Dynaflex ball to exercise my wrist which has helped some, but the pain comes back unexpectedly for no reason. My tinnitus has doubled in loudness, now I hear ringing all the time even in very loud environments, such as driving down freeway with windows open, loud restaurants, traffic, etc. The ringing has doubled in loudness for no reason but the Covid shots.
This spontaneous report was received from a physician, via company representative, and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant therapies, drug reactions or allergies were not reported. On 30-NOV-2015, the patient was vaccinated with an improperly stored PNEUMOVAX 23 10 PK, lot # L002310, expiration date 08-JUL-2016, at a dose of 0.5 ml, (route and anatomical location of administration were unspecified). The vaccine underwent a total temperature excursion, of 208 hours. The lowest recorded temperature was 34 Fahrenheit degrees (1.111111111 Celsius). The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator(R)". No adverse effects were reported. No Product Quality Complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Five minutes after receiving vaccine, it started with heat in my lower stomach and the heat kind of moved up a little bit and I  got real hot and then my noticed my heart rate increased. I knew my blood pressure was up. Normally, it's very controlled with meds. They took my blood pressure and it was high . Much higher than what I normally have. It started to subside but then I felt the heart rate increase again. And they took me to the hospital and by the time I got to the hospital my symptoms seemed to be gone - I felt okay. Doctor checked me and said that everything looks good. I walked out on my own. I was a little tired later on but I had no other symptoms.
Henoch-Schonlein purpura (small vessel vasculitis) (pt enrolling in college & had no proof of prior vax);
I was exposed to a positive case of COVID 04/20/2022. I started having a runny nose on 04/21/2022. I took three at-home tests on April 21-22-23 that were Negative. I took another on 04/24/2022 that was Positive and then took a PCR test on 04/25/2022 that did confirm Positive. I had chills, fatigue, congestion, post-nasal drip, cough, chest tightness, and shortness of breath. On 04/26/2022 I had a tele-health visit and she prescribed Paxlovid taking two 150mg (and a 100 mg  tablet by mouth two times a day for a total of 400mg two times daily. Since I have started it I am feeling better and now I just have congestion, cough, and post-nasal drip.
Small Cold Sore began to appear on bottom lip midday - 1/2pm  Fatigue hit hard - 4pm  Fever/chills - 7pm  Numbness and mild paralysis on left side of face - 11pm
COVID-19; COVID-19; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 21K-163-4034481-00.  A 64-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 64 years, all intramuscular for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; adalimumab (HUMIRA), on 07Oct2020 (ongoing) as unk (citrate free) (Batch/Lot number: unknown) subcutaneous for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2021, outcome "recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. The action taken for adalimumab was dosage not changed.  The reporter considered "covid-19" related to BNT162b2.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal association between the reported events and suspect drug BNT162B2 cannot be excluded.,Linked Report(s) : US-PFIZER INC-202200936734 same reporter/patient, different drug dose/event;US-PFIZER INC-202200936733 same reporter/patient, different drug dose/event;
pt recvd vax 7OCT94 & devel pain, swelling & warm feeling @ inj site;MD visit 10OCT-ecchymosis noted over a 2" x 4" area below inj site;also area warm to touch w/tenderness;treated w/heat
She received her 1st dose last 17MAR2021 and she tested positive with Covid-Virus last 19MAR2021; This is a Spontaneous report received from a contactable consumer (patient, self-reported). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, solution for injection, lot number and expiry dates were not provided), via an unspecified route of administration, on 17Mar2021, as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient wanted to cancel her second dose appointment because she had COVID-Virus. She was tested positive with COVID-Virus test on 19Mar2021. Outcome of the event was unknown.   No Follow-up attempts are needed. No further information is expected.
Pt received her Moderna vaccine and was advised to wait 30 minutes in observation due to history of allergies. Pt reports through out her time in observation she started to feel like her heart was pounding and sweaty.  EMS was called and pt was evaluated by the paramedic. Pt complained of mild shortness of breath, BP was elevated. Oxygen saturation was stable around 97%, HR was within normal limits. EMS checked pt's BS which was 120. Pt had not eaten since 12 pm. Pt reported to EMS she was starting to feel better. Pt signed a refusal with EMS as she did not want to go to the hospital. Pt was given strict instructions to call 911 if symptoms return to which the pt verbalized understanding. Pt's daughter came to clinic to drive her home.
woke up the morning after teh shot with a WICKED stiff neck and headache. i still have it 2 WEEKS LATER. will it go away?? and should i even get a second shot?  i have hypogammaglobulinemia, and my doc said that if my antibodies were tested and were corpulent that only one shot would suffice. please ADVISE - I NEED THIS TO GO AWAY.
Patient experienced severe pain at INJ. site nausea and dizziness - 4 hrs after INJ. Symptoms resolved (Right arm).
Evening of 4th when arm pain disappeared digestive upset and diarreha resulted and continued throughout the night.; Evening of 4th when arm pain disappeared digestive upset and diarreha resulted and continued throughout the night.; Arm pain for two days; This is a spontaneous report from a non-contactable consumer, the patient. A 35-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 03Mar2021 at 11:45 (at the age of 35-year-old), as a single dose for COVID-19 immunisation. Medical history included high blood pressure and pulmonary embolism [on blood thinners for pulmonary embolism (PE) in 2013]. The patient did not have any allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included lisinopril (MANUFACTURER UNKNOWN) and rivaroxaban (XARELTO); both for unknown indication from an unknown date and unknown if ongoing. On 03Mar2021 at 14:00, the patient experienced arm pain for two days and on 04Mar2021, in the evening, when arm pain disappeared digestive upset and diarrhea resulted and continued throughout the night. 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, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event arm pain for two days was recovered on 04Mar2021 and the events digestive upset and diarrhea resulted and continued throughout the night was recovering at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
mesothelioma; Initial information received on 18-Jul-2022 regarding an unsolicited valid Legal serious case received from a lawyer.  This case involves an 84 years old female patient who had mesothelioma while receiving vaccine influenza vaccine and while treated with dimeticone.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient started taking dimeticone (with an unknown batch number, expiry date, form, strength, dose, frequency, route and indication).  On an unknown date, the patient received a dose of suspect influenza vaccine produced by unknown manufacturer lot number and expiry date not reported.  On an unknown date the patient had mesothelioma (unknown latency) following the first dose intake of dimeticone and influenza vaccine.  There were no lab data reported.  Action taken with dimeticone was unknown, not applicable for influenza vaccine.  It was not reported if the patient received a corrective treatment for the event (mesothelioma).  At time of reporting, the outcome was Unknown for the event mesothelioma.  Seriousness criteria: mesothelioma event was assessed as medically significant. The patient was hospitalized for this event.; Sender's Comments: Sanofi Company Comment on 21-Jul-2022: This case involves an 84 years old female patient who had mesothelioma while receiving vaccine influenza vaccine and while treated with dimeticone.Causal relationship of the suspect drugs cannot be excluded however limited information provided regarding this case precludes comprehensive assessment of this case. Case would be re-evaluated post further update on the patient's underlying disease conditions, past medical and drug history, concurrent illnesses and concomitant medications.
Pre-exposure Rabies. October 1996. Three to six weeks later, very strong pain in legs. Dx: Arthritis.
12 minutes after vaccination onset of stomach upset followed by hives and bilateral upper extremity tingling. Denies SOB, wheeze, throat tightness.  PE: Urticaria right face, . neck, upper chest Rapid clearing of hives started under one minute after oral diphenhydramine
My child began with aggressive behavior the day following the flu vaccine, which is unlike him. He has expressed this same behavior when taking MIRALAX, both which contain Polyethylene Glycol which had a study done that showed it causing aggression in children. This behavior was also noted when receiving his flu shot last year. This behavior cleared after stopping the MIRALAX and about 2 weeks after the flu shot last year.
No additional adverse effect reported; Caller reported that VAQTA and ROTATEQ that underwent temperature excursions; This spontaneous report was received from a physician and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 20-NOV-2021, the patient was vaccinated with improperly stored dose of hepatitis A vaccine, inactivated (VAQTA) lot # U004366, expiration date 01-OCT-2022 (dose, route of administration and anatomical location were not reported) for prophylaxis. Administered dose of hepatitis A vaccine, inactivated (VAQTA) experienced temperature excursion of 0.7 degrees Celsius for 2 hours. There was no previous excursion reported. No additional adverse event was reported.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2112USA000819: US-009507513-2112USA000713: US-009507513-2112USA000817: US-009507513-2112USA000821: US-009507513-2112USA000820: US-009507513-2112USA000818: US-009507513-2112USA000823: US-009507513-2112USA000824: US-009507513-2112USA000825:
MOM NOTICED PT HAD RASH THAT STARTED ON TRUNK A FEW HOURS AFTER VACCINE ADMINISTRATION. THE NEXT MORNING THE RASH HAD SPREAD AND LOOKED LIKE HIVES.
This case involves adult and unknown gender patient who experienced flu (influenza) while receiving INFLUENZA VACCINE. The patient had no medical history, concomitant disease, or risk factor. The patient medical treatment(s), vaccination(s), concomitant medication, and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer [lot number and expiry date not reported] via an unknown route in unknown administration site for prophylactic vaccination. On an unknown date, the patient developed a non-serious flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE. Details of laboratory data not reported. It was not reported if the patient received any corrective treatment for the event. At time of reporting, the outcome was unknown for the event flu. There will be no information available on the batch number for this case.
5-10-11 Mother reported to pediatrician, that infant developed wheezing (heard by stethoscope by mother) mild resp. distress. These symptoms all cleared with one albuterol aerosol. Wheezing developed within 12 hrs of administration of DTaP on 1-10-11. Mother also reported Temp 101 - 101.5 also. Mother also reports that baby was fussy after first IPV at age 3 mo of age.
That evening you had sore arm injection site; muscle aches. I took Tylenol and that helped. Late Thursday is when I started feeling better. The symptoms went away completely after 36 hours.
Pt recvd 3 doses of Engerix-B vax 23AUG90, 23SEP90, & 23MAR91 & exp elevated liver enzymes; Reported indicated that outcome is pending;
sore throat coughing nasal mucous last 3 weeks from onset, diminishing in severity over time
Nausea; Body aches; Chills; Night sweats; Sore joints; Vomiting; This is a spontaneous report from a non-contactable consumer, the patient. A 18-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 22Jun2021 at 15:00 (at the age of 18-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included sertraline hydrochloride (ZOLOFT) from an unknown date and for an unknown indication. The patient had no known allergies. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 01Jun2021 at 11:00 (at the age of 18-year-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 23Jun2021 at 21:00, the patient experienced nausea, body aches, chills, night sweats, sore joints and vomiting. Therapeutic measures were not taken as a result of these events. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events nausea, body aches, chills, night sweats, sore joints and vomiting was recovering at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
ANXIETY; NOT ABLE TO EAT; BAD REACTION; SUFFERED FOR WEEKS BEING LEFT; DEATHLY SICK; ACHES; CHILLS; SEVERE HEADACHE; FEVER; DIARRHEA; VOMITING; HIGH PITCH RINGING IN MY LEFT EAR; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included: diabetes, and heart disease. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced deathly sick, anxiety, not able to eat, suffered for weeks being left, bad reaction, aches, chills, severe headache, fever, diarrhea, vomiting, and high pitch ringing in my left ear. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from anxiety, not able to eat, bad reaction, suffered for weeks being left, deathly sick, aches, chills, severe headache, fever, diarrhea, vomiting, and high pitch ringing in my left ear. This report was non-serious.
15OCT91 t106 ax w/in 1 hr of bathing in cool water & giving APAP went to 98.8; crying during temp w/general body sensitivity; Mom called ER;
patient experienced lips tingling after 5 min, then dry mouth.. Lip Tingling went away but still had dry mouth after 15min.
is still experiencing myalgia; some days feels really weak; This case was reported by a pharmacist via call center representative and described the occurrence of myalgia in a male patient who received Herpes zoster (Shingrix) (batch number 592EB, expiry date 20th May 2022) for prophylaxis.   On 1st October 2020, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 3 months after receiving Shingrix, the patient experienced myalgia and weakness. On an unknown date, the outcome of the myalgia and weakness were not recovered/not resolved.   It was unknown if the reporter considered the myalgia and weakness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported but could be 60 or 61 years. The patient was still experiencing myalgia till the date of reporting and the reporter said that it was known that it was a common reaction but wanted to know why it persisted this long.  Some days the patient felt okay and some days felt really weak.  The reporter did not consent to follow up.