chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This female subject was enrolled in the study 112957 (HIB-097).  On 13 September 2010 and 17 November 2010 she received the 1st, 2nd dose of HIBERIX (IM R thigh), PEDIARIX (IM L thigh), PREVNAR 13 (IM L thigh or deltoid) and ROTARIX (po).  On 19 January 2011, she received a 3rd dose of HIBERIX, PEDIARIX and PREVNAR 13.  This subject received HIBERIX (lot AHIBVC292A and AD02VB365A).  On 19 January 2011, 63 days after the 2nd dose of ROTARIX, on the same day after the 3rd dose of PEDIARIX, on the same day after the 3rd dose of HIBERIX, on the same day after the 3rd dose of PREVNAR 13, this six-month-old subject developed Kawasaki disease.  The subject was hospitalised.  The subject was treated with paracetamol, intravenous fluid(s), normal immunoglobulin, diphenhydramine and aspirin.  The event improved on an unspecified date.  The investigator considered that there was a reasonable possibility that the Kawasaki disease may have been caused by ROTARIX, PEDIARIX, HIBERIX and PREVNAR 13 and that the event was possibly due to disease under study.  Investigator Comments : Subject with fever for 5 days (101-102 axillary), conjunctivitis, red lips, and body rash.  Admitted to rule out Kawasakis.  Received 6 month shots 19Jan2011- developed fever that day, rash started 22Jan2011- erythmatous, maculopapular blanching and discrete conjunctival injection developed night prior to admission.  Lips bright red but not cracked.  No hand/feet swelling or skin changes but small blanching red spots on palms and soles, no lymph adenopathy noted.  Patient started on IV fluids and acetaminophen for fever and pain.  24Jan2011 patient with swollen hands and feet, cracked lips.  Nasopharynx Swab - negative for Influenza A and B and RSV.  Patient had normal echocardiogram 26Jan2011.  Patient tolerated treatment IV immunoglobulin 24Jan2011 for Kawasakis Disease with dramatic responses with near complete resolution of rash, conjunctivitis, hand/foot changes and mucositis.  High dose Aspirin started on 25Jan2011 following negative swab for Influenza A, B and RSV.  Slight waxing/waning of rash/conjunctivial erythema/lip redness but not considered significant enough for second dose of IV immunoglobulin.  Patient afebrile for greater than 48 hours prior to discharge.  Patient discharged on 27Jan2011 on low dose Aspirin 40.5 mg a day and acetaminiophen 120 mg suppositories prn pain or fever.  28Jan2011 follow-up clinic visit exam / assessment - resolving Kawasakis, neg echo, improving appetite though weight down 7.5 ounces, resolving conjunctivitis no rash, normal extremities purulent nasal discharge and normal mouth and throat.  Repeat echocardiogram in 6 weeks.
Headaches; Feeling the need to vomit; This is a spontaneous report from a non-contactable consumer, the patient. A 48-year-old, non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date (at the age of 48-years-old) as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported.  Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On an unknown date, the patient experienced headaches and feeling the need to vomit. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of events. The clinical outcome of events headaches and feeling the need to vomit were 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.
I got Covid virus; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) dose 1 via an unspecified route of administration on 12Jan2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medication were not reported. Patient got the first dose of the Pfizer Covid vaccine on 12Jan2021 then got Covid virus on 20Jan2021. Patient never got the 2nd dose of the vaccine. Patient was inquired about the protocol for me getting the 2nd dose. Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
couple other things for a few days; she had felt some more achy; headache; non immunocompromised patient received full 3rd dose instead of half; This spontaneous case was reported by a nurse and describes the occurrence of IMMUNISATION REACTION (couple other things for a few days), PAIN (she had felt some more achy), HEADACHE (headache) and ACCIDENTAL OVERDOSE (non immunocompromised patient received full 3rd dose instead of half) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027C21A, 007M20A and 013A21A) for COVID-19 vaccination.     The patient's past medical history included Heart failure. Concurrent medical conditions included Atrial fibrillation, Flutter atrial, Mitral regurgitation and Sleep apnea.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Oct-2021, the patient experienced ACCIDENTAL OVERDOSE (non immunocompromised patient received full 3rd dose instead of half). On an unknown date, the patient experienced IMMUNISATION REACTION (couple other things for a few days), PAIN (she had felt some more achy) and HEADACHE (headache). At the time of the report, IMMUNISATION REACTION (couple other things for a few days), PAIN (she had felt some more achy) and HEADACHE (headache) had resolved and ACCIDENTAL OVERDOSE (non immunocompromised patient received full 3rd dose instead of half) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient wanted to know whether the patient was eligible for 2nd booster shot or not and was concerned  to get it since got the full dose as 1st booster shot.  The patient was not taking any medications or treatments.   Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2022: Follow-up document received includes significant information; patient demographics, suspect vaccine details and additional events were added.
DVT Blood clot left popliteal vein.  Pt is healthy adult male road cyclist.  No other risk factors for DVT blood clot.
Had pain in my arm; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingrix and had pain in arm still 4 days later.  The reporter asked was that ok or did not mean should not get second shot.
After I received the first dose, I went into A-fib. I was hospitalized for one night. After receiving the second dose, I was hospitalized for 6 days, for A-fib as well. I do have a history of A-fib, but I have not had an episode in over a year. After the first dose, a week later I went into A-fib. I ended up going into rapid A-fib, while waiting for my doctor and the insurance company. It made me feel weak, dizzy and a little nauseous. He took me in and they admitted me into the hospital. The outcome after the first dose, they did a cardio aversion. They monitored me for the night and discharged me the next day. The aversion worked and I went back into sinus rhythm. After my second dose, I went into A-fib again. I called Dr. and he took me off of multaq and changed me to amiodarone 400mg twice daily for 1-2 weeks. The day I went into the hospital, I started to have chest pain. The pain wasn't severe, but it made me stop what I was doing and stand still. I was seen by the cardiologist and I was admitted. The cardiologist wanted to keep me for monitoring. They did a cardio aversion, but it didn't work. I was receiving IV diltiazem treatment plus my amiodarone. They did a cardio aversion following the medical treatment and it worked. I went back into sinus rhythm.
FATIGUE, INJECTION SITE PAIN, JOINT/MUSCLE PAIN, STOMACH PAIN Narrative:
Two weeks after the vaccine, a itchy rash would start to circulate around my body. It would come and go, and show up in different spots regularly. We initially thought the reaction was due to a dose of Doxycycline that I took one week prior, but a coworker was having the exact same issue one week later. I decided to report when that same coworker saw a dermatologist that said they have been seeing an increase in patients who have received their third dose get rashes all over the skin. It seems to be subsided with prescribed Hydroxyzine and Cetirizine.
I95.9 HYPOTENSION 7/3/2021 ESRD (END STAGE RENAL DISEASE) I95.9 HYPOTENSION 7/3/2021 ABNL LABORATORY FINDING
I have had one pregnancy in 2016. I am reporting an ectopic pregnancy. My Fallopian tube burst. I was unaware of being pregnant at the time of the vaccine injection. I became extremely ill and was losing blood. I had undergone laparoscopic removal of the left Fallopian tube and lost 2ltrs. Of blood therefore receiving transfusions. I suffered anemia and left the hospital with a hemoglobin level of 8.1.
Swelling around the injections site, circumscribed, roughly 6cm.  Swelling did not go past the shoulder or mid upper arm; Family iced the location - swelling resolved over two days.
1 inch silver dolor size rash on the injection site; Rash on the injection site. It was itching; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (1 inch silver dolor size rash on the injection site) and VACCINATION SITE PRURITUS (Rash on the injection site. It was itching) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001M21A, 041J21A, 026B21A and 046A21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Feb-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Jun-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE RASH (1 inch silver color size rash on the injection site) and VACCINATION SITE PRURITUS (Rash on the injection site. It was itching). At the time of the report, VACCINATION SITE RASH (1 inch silver dolor size rash on the injection site) was resolving and VACCINATION SITE PRURITUS (Rash on the injection site. It was itching) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication was reported. No treatment information was provided.   This case was linked to MOD-2022-688233 (Patient Link).
Case number PHEH2015US020224, is an initial spontaneous report from a physician received on 08 Oct 2015. This report refers to a 60 years old female patient. The patient had no history of illness. Concomitant medications were not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer: Novartis, batch number: not reported) intramuscularly on 08 Oct 2015. On the same day after vaccination the patient showed signs of moderate to severe bronchitis like reaction (wheezing). The chest X-ray performed indicated negative result. The outcome of event was unknown. Seriousness and causality of the event was not reported. Seriousness assessment of wheezing was upgraded based on information in the source document.
Stomach felt sick. Developed skin reaction, small welps, went away after 2 days.
Syncope after standing outside in the sun for an hour (more than 18 hours post-vaccine dose). Lay down for 15 minutes, drank bottle of water, ate fruit bar. Still have headache 4 hours later.
pt recv vax & w/in 12hr pt exp diarrhea, sore throat & fever;sx resolved in less than 3 days;diarrhea lasted approx 24hr & the sore throat & fever lasted approx 72hr;
Erythematous papular, flat topped rash on face, neck, extremities, itchy. No target lesions. Mild hypopigmentation/whitening around red papules. Systemically well. Seen 9/14/03.
About 29 hours after, when I went to bed, I noticed my heart was racing. My Fitbit registered 155 bpm, normal is around 90. I used my husband?s Apple Watch to do an EKG and it was inconclusive due to rapid pulse. It would go down to 107 and then back up. The highest was 176. I was not lightheaded or feeling sick. I googled this and found it was a thing. I read about a teen who got myocarditis from the Pfizer vaccine  and was in ICU. Since that is inflammation, I decided to take a Tylenol and went to sleep. When I got up on the morning I felt fine, pulse was normal. I have not had any more symptoms except this. It was a bit scary.
3-4 days after receiving his MMR and Varivax patient broke out into a rash all over his body. There was no associated fever initially. Fever  showed after the rash appeared associated with cough and cold. Fever treated with Tylenol.
I received my 1st covid shot  on Friday, February 5th. My left upper arm was sore for a few days but no issues.   On Friday, February 12th (a week later), my left upper arm began hurting again.   On Saturday, February 13th my arm was sorer and itchy with 2 red spots at/near the site of the injection that were "hard" compared to the rest of my upper arm.   On Sunday morning, February 14th the area was still red, itchy, and by mid-afternoon both areas seemed to be merging.  Monday, February 15th, my upper arm was still a bit itchy, less red, and spreading (now 5" long compared to Sunday morning at 4")  Tuesday, February 16th, the area is less red/itchy. It seems to be fading.
Face, eyelids, tongue went numb / tingled.  Six (6) hours to resolve.  Monitored at home and gradually began resolving.
03/30/21 hard, warm to touch lump at injection site, large red itchy rash, 99 temp, body aches, tired 03/31/21 hard, warm to touch lump at injection site, large red itchy rash, body aches
Swollen lymph node in neck. MD said if it does not bother me not to worry about it. It is sore still. It has not gone away
18 y/o female complaining of lightheadedness after receiving vaccination. Pt states she "almost passed out". Pt vitals stable. Pt CAO x4, resolved w/o treatment.
Tachycardia, heart palpitations, clammy, chills & terrible headache
Information has been received from a physician concerning a female "a little over 1 year old" who on 20-JUL-2007 was vaccinated with a 0.5ml dose of varicella virus vaccine live (Oka/Merck). On 10-AUG-2007 the patient was seen for chickenpox. Unspecified medical attention was sought. Subsequently, the patient recovered. No product quality complaint was involved. Additional information has been requested.
Patient is fully vaccinated.  33-year-old male, denies any chronic medical problems presenting with chest tightness over the past several days.  Endorses a "pressure "in his substernal chest. Patient was diagnosed COVID-positive 1 week ago.  Denies any fever chills, no significant cough.  No shortness of breath.  No nausea vomiting or diarrhea.EKG reviewed and interpreted by myself, sinus rhythm, normal axis, left atrial enlargement.  Blood work ordered by triage, reviewed, unremarkable. Discharged home from ED.
This is a spontaneous report from a contactable nurse. A female patient of an unspecified age and ethnicity received single dose of PREVNAR 13 on 14Jun2017 at 0.5 ml for immunization. The patient medical history and concomitant medications were not reported. Patient experienced hives, rash, red throat, hard to breathe all on 14Jun2017 and sent to the ER following the vaccine. Nurse stated that patient was sent to the Emergency Room from the doctor's office but was unsure whether or not she was admitted to the hospital. Outcome of events was recovering.
Adverse events: Right side facial droop, onset of 3/5, worsened to the point of ED visit on 3/8. Patient reports numbness around her mouth, difficulty blinking her right eye, and noting right eyebrow droop when trying on some glasses.  Treatment: Gave Rx for valacyclovir and prednisone to treat Bell's Palsy
Menstruation irregularities: first no period at all for 1.5 months, then strong blood loss and irregular cycle
6pm same day severe body ache, diarrhia, feeling chills/warmth. didn't take temp took Tylenol/Motrin daily. s/s today left shoulder nerve pain (had injection on right side) 6/10. No body ache, diarrhea, chills today. COVID 1/8 test negative.
Pentacel powder was not mixed with fluid and was given to pt. It was later realized that patient was only given the fluid, not powder. No symptoms, signs, etc.
symptoms-immediate burning sensation in chest, throat , and ears.  heart racing.  difficulty swallowing. left arm numbness tx- given benadryl and taken by ambulance to emergency room... monitored in emergency room for 3 hours continued with swollen glands and chest discomfort and fatigue for several days tx -given steroid pack 5 days after shot was administered.
Chills and fever began at 3:45pm on 4/1/21. Took 1000mg Tylenol at approximately 6pm. Fever up to 104.3 at 6:15pm on 4/1/21. Fever went down to 100.2 at 11pm. Awoke on  4/2/21 with temperature normal at 99.2. Had fatigue and felt ?run down? throughout the day on 4/2/21. Awoke on 4/3/21 feeling back to normal.
Information has been received from an adult female who on approximately 01-OCT-2006 was vaccinated with a dose of zoster vaccine live (Oka/Merck). The patient was "a little stiff that same day." As of 19-OCT-2007 the patient "still had a black and blue mark at the injection site but no rash." The patient did not seek medical attention. The outcome was unknown. There was no product quality complaint. No further information is available.
instead of using the diluent packaged with ActHIB, a diluent that was meant for MMR or Varicella was used to mix with ActHIB, no AE; Initial information received on 04-Dec-2020 regarding an unsolicited valid non-serious case from a other health professional.  This case involves a 1 years old female patient who was vaccinated with 0.5 ml second dose of HIB (PRP/T) VACCINE [ACT-HIB] (lot UT7102MA and expiration date 30-Jun-2021) using instead of using the diluent packaged with acthib, a diluent that was meant for MMR (mumps, measles and rubella) or varicella was used to mix with acthib, via unknown route in unknown administration site for prophylactic vaccination on 02-Dec-2020 (product preparation issue).  Medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   It was a case of actual medication error due to inappropriate reconstitution technique (same day latency).  The patient had no adverse event after this.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
a rash of the form of an egg bomb; itchy rash; itchy; hot; hard; sore on the armpit too; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE RASH (a rash of the form of an egg bomb), RASH PRURITIC (itchy rash), PRURITUS (itchy), VACCINATION SITE WARMTH (hot) and VACCINATION SITE INDURATION (hard) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051F21A and 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE RASH (a rash of the form of an egg bomb), RASH PRURITIC (itchy rash), PRURITUS (itchy), VACCINATION SITE WARMTH (hot), VACCINATION SITE INDURATION (hard) and AXILLARY PAIN (sore on the armpit too). At the time of the report, VACCINATION SITE RASH (a rash of the form of an egg bomb), RASH PRURITIC (itchy rash), PRURITUS (itchy), VACCINATION SITE WARMTH (hot), VACCINATION SITE INDURATION (hard) and AXILLARY PAIN (sore on the armpit too) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Treatment information was not provided.
Stiffness all over my body; Fibromyalgia; Pain all over my body/muscle pain all over; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Stiffness all over my body), FIBROMYALGIA (Fibromyalgia) and MYALGIA (Pain all over my body/muscle pain all over) in a patient of an unknown age and gender 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MUSCULOSKELETAL STIFFNESS (Stiffness all over my body), FIBROMYALGIA (Fibromyalgia) and MYALGIA (Pain all over my body/muscle pain all over). At the time of the report, MUSCULOSKELETAL STIFFNESS (Stiffness all over my body), FIBROMYALGIA (Fibromyalgia) and MYALGIA (Pain all over my body/muscle pain all over) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided.  Treatment information was not provided.
Sore throat, Nasal congestion, Sinus pain, Extreme fatigue, Runny nose, feverish, swollen sore tongue w/ red streaks. Took Tylenol on day 3 of symptoms Began Zpac 5-day treatment of antibiotics on day 4 of symptoms Took one dose of guaifenesin and on dose of Flonase on day 4 of symptoms I was quite sick for about one week, then slowly recovered in the next week.