chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pt recv vax 7FEB97 & 28JAN97 pt underwent a hearing screening & it was determined to be nl;3MAR97 hearing deficit found p/a screening;6MAR97 hearing screening repeated & on 7MAR97 an extensive hearing test showed significant rt hearing loss. This is in follow-up to report (s) previously submitted on 03/08/1998. Information has been received from a pharmacist concerning a 5-year-old female relative who on 07FEB97 was vaccinated with the first dose of RECOMBIVAX HB vaccine. On 18JAN97 the patient underwent a hearing screening and it was determined to be deaf.
This spontaneous report was received from a certificated medical assistant referring to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB (lot # M025194 with expiration date of 22-MAR-2019, lot # M036057 with expiration date of 18-MAY-2019 and lot # L014427 with expiration date of 09-MAR-2018; strength, dose, route and anatomical location were not provided), for prophylaxis. It was also reported that the administered doses with the lot # M025194 and expiration date of 22-MAR-2019, lot # M036057 and expiration date of 18-MAY-2019 and lot # L014427 with expiration date of 09-MAR-2018, experienced a temperature excursion during 119 hours 30 minutes at a temperature between 32 degrees Fahrenheit and 35 degrees Fahrenheit (0 degrees Celsius and 1 degrees Celsius) (# cycles: 30) from 15-DEC-2016 to 13-JAN-2017, and a temperature excursion during 04 hours at a temperature between 32 degrees Fahrenheit and 35 degrees Fahrenheit (0 degrees Celsius and 1 degrees Celsius) (# cycles: 30) from 23-FEB-2017 to 24-MAR-2017. A data logger issue was involved. No previous temperature excursion and no adverse effects were reported. Additional information has been requested.; Sender's Comments: US-009507513-1704USA008691: US-009507513-1704USA002259:
Pt recvd MMR vax on 18DEC87 & approx 8FEB91 seen for wheezing, croupy cough & congestion; 1MAR91 the pt was seen again for a rash, cough, temp time 5 days, red eyes, congestion & loss of appetite; dx strep vx rubeola;
pt recvd vax 1JUN94 & pt devel altered mental status on 19JUN94, & subsequently dx w/infantile spasms (seizure disorder);
a 15 months old male patient was administered Pentacel instead of Daptacel/No AE; Initial information received on 06-Nov-2019 regarding an unsolicited non-valid non-serious case received from a consumer.  This case involves a 15 months old male patient who was vaccinated with DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/I PV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] instead of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  The patient's past vaccination(s) included IPOL POLIO VACCINE, ACT-HIB and PENTACEL three doses was received.  The patient's past medical history, medical treatment(s) and family history were not provided.  Concomitant medications included INFLUENZA VACCINE INACT SPLIT VIRION 4V (FLUZONE QUADRIVALENT) and HEPATITIS A VACCINE (HEPATITIS A).  On 05-Nov-2019, the patient received a 0.5 ml fourth dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot number: UJ123AA and Expiry date: 20-Sep-2019) in the left vastus lateralis instead of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  It was an actual medication error due to wrong vaccine administered.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.
Severe shoulder pain, for 8 hours, lessened with Advil. Still sore and limited movement 2 1/2 weeks later. Also, strange auditory effect in right ear. Sounds heard almost like an echo, especially when I talked. Lasted about 5 days.
Fatigue; Dizziness; Nausea; Soreness at injection site lasting over 24 hours so far; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the left arm on 14Apr2021 at 13:30 (at the age of 45-years-old) as a single dose for COVID-19 immunization. Medical history included anxiety, depression, COVID-19 infection. The patient had no known allergies to medications, food or other products. Concomitant medications included EFFEXOR (MANUFACTURER UNKNOWN) extended release for unknown indication, on an unknown date and unknown if ongoing. 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 COVID vaccine. On 14Apr2021 at 13:45, the patient experienced nausea, dizziness, fatigue and soreness at the injection site. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of reported events. The clinical outcome of the events nausea, dizziness, fatigue and soreness at the injection site was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Dose 1, Dose 2, Dose 3: BNT162B2; Dose 4: MODERNA COVID-19 VACCINE; COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Mar2021 as dose 1, single (Lot number: EN6205), on 01Apr2021 as dose 2, single (Lot number: ER8734) and on 02Oct2021 as dose 3 (booster), single (Lot number: Ff8839) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 06Apr2022 as dose 4 (booster), single (Lot number: 002M214) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "Psoriasis" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "Dose 1, Dose 2, Dose 3: BNT162B2; Dose 4: MODERNA COVID-19 VACCINE"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID-19 Treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19 included Paxlovid.  Additional information: The patient has no known allergies.
Mother reports child woke up "Sunday night at 1:30" (April 12) with c/o not feeling well, sore throat and swollen glands on side of neck.  Reports c/o headache and aching "all over".  Reports child was seen by Dr 4/13/09 and diagnosed with "allergies".  On 4/14/09 was seen at ED with diagnosis of "virus".
Body aches. Headache. Extreme fatigue. Shot site pain. Fever 100.4  All continued overnight. In a.m. next day all continued except fever, down to 98 - 99. Pain in my arm is worse, not able to use arm much.
HEP A 06/20/2013; Information has been received from a Physician regarding a case in litigation referring to a 5-year-old female patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 08-JAN-2009, the patient started therapy with hepatitis a vaccine, inactivated (manufacturer unknown) for prophylaxis (strength, lot #, expiry date, and route of administration were not provided). On 21-JUL-2009, the patient received the second dose and on 20-JUN-2013, a third dose was administered (extra dose administered). No further details provided.  The patient subsequently experienced several adverse events in the context of a litigation process for  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9).; Sender's Comments:  US-009507513-2203USA007241:
Arm weakness, swelling Advil, 11/01/06 lips, eyes swollen, arm pain, Advil, 11/01/06 went to emergency dept.
I had the normal initial reaction, sore arm, muscle fatigue. Those went away. On the 21st,  I started cramping in my left leg, then on the 22nd I had swollen bilateral ankles and other joints. I went to PT and they sent me to the ER because I also had shortness of breath starting on the 24th. On the 25th I went to the ER and was diagnosed me with DVT and PE. I went back to the hospital on the 26th because I was still having shortness of breath and pain in my calf. I'm currently on blood thinners.
This spontaneous report as received from a physician via company representative refers to a 26 year old female patient. On an unknown date the patient was vaccinated with PNEUMOVAX23 INJ (single dose injection; route and dosage unknown; lot number J010332 EXP 14-JAN-2015). Other suspect therapies included influenza virus vaccine (manufacturer unknown) (route, dosage, dose no unknown). It was reported that the patient suffered from "Rett" syndrome and was wheelchair bound. It was also mentioned that the patient had an injection site reaction, swelling to the arm the size of a "ball". The patient sought medical attention (saw the doctor). The relatedness for the adverse event was unknown for PNEUMOVAX23 and influenza virus vaccine (manufacturer unknown). Upon internal review wheelchair bound was considered as disabling. The outcome of injection site reaction and swelling to the arm the size of a "ball" was unknown. Additional information has been requested.
Fever, aches that were horrible, all I wanted to do is sleep, nauseated, no appetite for days
Initially after the vaccine, I was sick for about 48 hours. My menstrual cycle was affected very severely - a lot of cramping and pain. I also had irregular timing with my menstrual cycle. I also experienced numbness and tingling in wrists and legs, thighs - shooting down - for two months post vaccine. I work out regularly usually but I was unable to workout at my normal pace for at least a month. And still to this day, I feel like I can't reach the same cardiovascular level that I use to in my workouts. I have had Eczema over the last five years or so - little patches now and then. But since then, it has been exacerbated and I am in a flare - and sometimes I can't work because the palm on my right hand, lesions on inside of nose - bilateral and my earlobes (bilateral) - are bleeding or agitated. Never has it been in this severity before. Steroid cream for the eczema symptoms - that hasn't been helpful so we've stopped that. For numbness and tingling - I was doing ibuprofen to reduce inflammation and I upped my Omega 3's to help with overall body inflammation and I'm still taking that three times a day. My timing of my menstrual cycle is back to normal now. The numbness and tingling stopped after a couple of months. Mainly the skin condition has continued. And I do still feel like I have to stop and catch my breath sometimes and I never had that problem before. I do still have a bit of numbness and tingling in my temple region - that is very subtle and is intermittent. That may have started a bit later than the other tingling and numbness symptoms started but not sure when it did. Have had Primary care visits and have an upcoming dermatology appt - they may do a biopsy.
Myalgia Itchy throat, Achy back, Right ear "feels hot both inside and outside" Narrative:
Full body Urticaria, dermatographia with associated priorities. Occurs daily, still occurring at present. Responds partially to Zyrtec 10 mg four times daily.
Got measles shot last week in April (28th). About a week later broke out in a rash chest and head. A few on top of head were itchy, otherwise non itchy/not painful. Denies fever or URI symptoms. Seemed better after couple of weeks, but noticed rash right chest again about 1 week ago. When blowing nose in the morning will blow out bloody scabs x  2 weeks. Pain right temple/forehead when coughing x 1 week. "Was a little bluish initially" No pain this morning. Bruise easily since getting shot. Exam noted petechial/vascular rash right chest area and several bruises as well as irritated/bloody nose. Labwork revealed platelet count of 1. Sent to ER for treatment. Was hospitalized.
pt recvd vax & p/dose 2 exp fatigue, fever, & joint pain;
Pt presented 3 days after vaccination with a rash over the upper arm.  No visible redness at injection site.  Pt indicated that rash resembled previous shingles outbreaks on opposite arm.  Pt was advised to be evaluated by M.D. to determine if treatment was necessary.  Pt's wife indicated to me that rash is resolving after medication was prescribed but pt himself did not return my phone calls, so I do not know diagnosis.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with ZOSTAVAX (dose, indication, route and lot number were not reported) instead of VARIVAX (Merck). No concomitant medications were reported. No symptoms reported. The outcome of the patient at the moment of the report was not reported. Additional information has been reported.
Severe swelling at injection site approx. 10 hours post injection, soreness, warm to touch. Swelling extended to elbow in AM. A 1 inch wide ribbon towards wrist developed (redness and swelling). No fever.
pt recvd vax; was pregnant 1st trimester; baby boy was born deaf due to inner ear deformity which is known as a developmental problem;
Pin to bean size lump at right thigh injection site. No redness, no pain, no fever
The pt developed knee pain and stiffness in 12/06/2001. On 12/08/01 he developed some weakness in hand and had difficulty in coordination.
By evening I was stiff and shivering all night could not get warm or stop shivering.  Terrible headache.  Lasted until 5/23/2019.  Just a slight headache this morning and my stem is still sore but not as bad as the last two days.  Was not functional on the second day.  My urine was dark and red like a period last night and dark this morning.  Seems to be lightening up.
10 Days post Moderna Covid-19 booster shot, patient presented with severe itching and hives on hands, forearms, palms, armpits, back, scalp, front of neck, and back of neck. No other lifestyle changes took place, only the addition of the 3rd dose of the vaccine. This vaccination has definite side effects and should not be required to be or simply administered knowing it will have adverse outcomes for patients. Symptoms were attempted to be managed by over the counter anti-allergy medication, but the symptoms still persist without relief.
Pharmacist stated that pt had "flu-like symptoms"; This is a spontaneous report received from contactable reporter(s) (Pharmacist) from a sales representative.  A male patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Batch/Lot number: unknown) for immunisation; for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "Pharmacist stated that pt had "flu-like symptoms"". Additional information: The pharmacist stated that the patient had flu-like symptoms.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
- SEVERE SWELLING, RED, BLOTCHY, SEVERE PAIN FOR MORE THAN 1 MONTH
Approx 3:00 PM on day of Immunization-child was happing-began thrashing, eyes rolling back, pale, lethargic, limp-taken to medical center ER by mother
Patient received first dose of vaccine on 1/7/21 at a community Public Health clinic.  On 1/29/21 he received a second dose at the community Public Health clinic.  On 2/5/21, the patient presented to the ED with complaints of shortness of breath worsening over the last 2 weeks.  Patient reported that he had decreased exercise capacity and increased coughing with sputum production intermittently.  Patient reported that he had been feeling chilled, but no fevers. Patient was admitted and treated with Decadron and Remdesivir.  Patient experienced increased oxygen requirement.  Patient was a DNI and did not want to be on life support.  After discussion with the patient and family, patient was moved to comfort care. passed away on 2/11/21.
Red, painful lump at injection site. Mild erythematous popular rash - diffuse.
Patient with no known prior history of coronary artery disease,  woke up early morning between 4 and 5 with severe substernal chest discomfort, associated with some dyspnea. He had the 2nd COVID Moderna shot 2 days prior and has been experiencing mild fever, and chills. He did not get relief with ASA and antacid, and elected to come in . ECG at presentation showed left bundle branch block which was not present on previous ECG done in the hospital and stress test 2 years ago. His initial high sensitivity troponin was markedly elevated around 2500 ng/ml, and second set withint next 60 minutes rose to over 4000 ng/ml, consistent with acute coronary syndrome. Urgent coronary angiography was performed which did not reveal any culprit lesion. A stat echocardiogram showed normal EF and valve function. He was observed for 24 hours and discharged without incident on medical therapy.
Red spot left thigh; approximately 10cm diameter pinkish inflammation in left thigh positive mild edema ---> see notes.
Continuous migraine with  severe nausea, vomiting,  imbalance, vertigo, unable to bend over, ear fullness, pressure in head and ears, jaw pain, ringing in ears, constipation & diarrhea (chronic), weakness, photophobia, increased neck/shoulder pain, perception, ocular migraines,  dizziness, insomnia, unretractable pain, anxiety, increased depression, brain fog, inability to work, inability to concentrate
2days p/vax pt exp local pain/redness spreading to 12cm; positive edema noted to elbow & c/o coldness to lt hand
After shot: +0 minutes: Felt completely fine and normal +5 minutes: Dizziness, nausea, feeling of dread +6 minutes: Tongue began to swell and tingle +10 minutes: Lip tingling, some difficulty swallowing +30 minutes: Severe nausea, increased difficulty swallowing, lips swelling, swelling around cheeks and jaw +1 hour: Took Benedryl for symptoms +3 hours: Swelling mostly receded, most initial symptoms completely gone +4 hours - present: Chills, severe soreness in arm injection sight
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown demographics. No concurrent conditions or medical history were provided. On an unknown date, those patients were vaccinated with single doses of PNEUMOVAX 23 injection (strength, dose, route of administration, lot# and expiry date unspecified), post both supported and not supported temperature excursions. No concomitant medications were reported. No patient had reported experiencing an adverse effect due to receipt of vaccination post temperature excursion. This is one of several reports from the same source. Additional information has been requested.
Indigestion; Chills; Vomiting; A spontaneous report was received from a consumer concerning an 84-year-old female who experienced indigestion, chills and vomiting.  The patient's medical history was not provided.  Concomitant product use was not provided.  On 16-Jan-2021, approximately 1 day prior to onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 070821) intramuscularly for prophylaxis of COVID-19 infection.  On 17-Jan-2021 patient experienced indigestion, chills, and vomiting.  Treatment for indigestion included self-administered bismuth subsalicylate. Treatment for chills and vomiting was unknown.  Action taken with mRNA-1273 in response to the event was unknown.  The events, chills and vomiting were considered recovered/resolved.  The outcome of the event of indigestion was unknown.
Chills, body aches, diarrhea, blood in urine, cramps, kidney pain
Within 24 hrs of injection, diffuse erythema, edema, warmth of entire anterior thigh, tender with increasing indurated area which over next 24 hrs, included entire anterior muscle mass.
less than 12 hours my whole right side went limp, i woke up to get ready for work the day after the shot and my whole right side was limp and numb, as i was trying to get dressed  the use of my arm and leg came back around slowly, the whole right side was tingley all day. and it made me sick
Almost complete paralysis of right arm. Upper arm muscle tightness.  Brusing of right hand.  Cramping in feet as well.
Herpes Zoster Information has been received from a nurse practitioner concerning a 17 month old female who on 14-MAR-2005 was vaccinated SC with a 0.5ml dose of varicella virus vaccine live (Oka/Merck) (lot#649483/0766P). The nurse reported that the patient broke out in shingles and was seen at the physician's office on 25-AUG-2005. The patient was treated with acyclovir. Subsequently, the patient recovered. A product quality complaint was not involved. Additional information has been requested.
7 days after receiving vaccine I?ve been having nausea without vomiting and headaches. It started on Dec 25 and has continued and is present as of today Dec 28th. I will make an appointment to be Covid tested as soon as possible. On the Vaccination record card it stated to report any possible adverse reaction.  I?m unsure if this is related but felt I should report it.
Pt recvd vax 1DEC92 & devel aching of rt wrist & fingers as discomfort & cramping of the hand when writing; dull discomfort of the upper arm persisted overnoc & the next day;