chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a pharmacist and described the occurrence of injection site hemorrhage in a 12-year-old female patient who received HAVRIX 1440. On an unknown date, the patient received HAVRIX 1440 1 ml. On an unknown date, unknown after receiving HAVRIX 1440, the patient experienced injection site hemorrhage, injection site erythema, inappropriate age at vaccine administration and accidental overdose. On an unknown date, the outcome of the injection site hemorrhage, injection site erythema, inappropriate age at vaccine administration and accidental overdose were unknown. It was unknown if the reporter considered the injection site hemorrhage and injection site erythema to be related to HAVRIX 1440. Additional details were provided as follows: A 12 year-old patient experienced slight bleeding and redness at the injection site after receiving by mistake an adult dose of HAVRIX and led to inappropriate age at vaccine administration and accidental overdose.
This spontaneous report was received from a physician regarding a male patient of unknown age. On 14-DEC-2011, the patient was vaccinated with a dose of ZOSTAVAX (lot # 671451/1193AA, expiry: 25-OCT-2012). No concomitant medications were reported. The ZOSTAVAX was not kept at the required temperature as it was exposed to 28 degrees Fahrenheit from 17-NOV-2011 to 14-DEC-2011. The physician had confirmed that the ZOSTAVAX was stored improperly. No adverse reactions was reported. It was unspecified if the patient had sought medical attention. Additional information has been requested.
pt recvd vax; moderate local rxn, erythema; edema fr shoulder to elbow rt arm; tx: apap, cold compress off & on;
A report has been received from a physician concerning a 6 year old, male patient. No medical history, concurrent diseases and concomitant medications were provided. On 17-Sep-2012 the patient received nasal FLUMIST. The patient developed hives which started on 19-Sep-2012. Action taken with FLUMIST was unknown. The outcome of the event of hives was unknown. The report was considered to be non-serious by the reporter.
Information was received on 20-APR-2017 from a lawyer regarding a case in litigation concerning a female patient of unknown age. It is being complained and alleged that the patient was inoculated with a dose of ZOSTAVAX on or about 23-MAR-2014 at a pharmacy as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended but rather caused the patient to contract a persistent strain of herpes zoster. On or about 11-MAY-2015, the patient was treated by a physician at a physician's office for a painful rash that was diagnosed as herpes zoster or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering and other damages. Additional information has been requested.
React occurred 15 hours after receiving the vaccine.  Arm swollen red hot.  THROAT & FACE SWOLLEN. Throbbing headache  Fever. RAPID HEART RATE.
This case was reported by a nurse and described the occurrence of inappropriate preparation of medication in a 2-month-old male patient who received ROTARIX (batch number A41FB422A, expiry date 3rd September 2015). On an unknown date, the patient received ROTARIX. On an unknown date, an unknown time after receiving ROTARIX, the patient experienced inappropriate preparation of medication. On an unknown date, the outcome of the inappropriate preparation of medication was unknown. It was unknown if the reporter considered the inappropriate preparation of medication to be related to ROTARIX. Additional information received: A nurse gave 2 male twin patients just the diluent of ROTARIX. The lot number and expiration date are the same for both doses. No AEs have been reported. The HCP already discarded the pairing lyophilized portion of the vaccine. The HCP planned to re-vaccinate these patients.
Pt recv vax on 11/18/98; on same day pt exp tender, red vax site
she tested positive for COVID yesterday at work; she tested positive for COVID yesterday at work/started to have a fever last night/now she has loss of sense of smell; This is a spontaneous report from a contactable nurse (patient). A 65 (age units: unknown) female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 16Jan2021 at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient reported that she received first dose of vaccine on Saturday approx. 9 days ago. The patient reported that she tested positive for COVID yesterday (on 24Jan2021) at work. The patient reported that she has started to have a fever last night (on 24Jan2021) and now she has loss of sense of smell (in Jan2021). The patient would like to know the efficacy of vaccine after first dose. The patient would like to know if she should get second dose after testing positive post first dose. Second dose scheduled for 10Feb. The events were reported as non-serious. The outcome of events was unknown.   Information about lot/batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. However, full immunity is only expected 2 weeks after the second dose. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Patient started having fever 2 days after second dose of Pfizer mrna vaccine. First dose occurred January 19, 2021 and was uncomplicated. Fevers continued and she started to have delirium and increased neurologic symptoms that mimicked stroke 6 days after vaccination. She was admitted 6 days after vaccination with fever 102, delirium.
"Atrial Fibrillation with tachycardic ventricular rate" Awoke in the middle of the night to a rapid (150BPM+ rate), highly irregular heartbeat. Never had any issue with irregular heartbeat before. Never had any concerning heart rhythm disorder noted prior. Went to bed the night before with no symptoms.
angio-edema to eyes, face lips; trouble breathing; closed throat; This is a spontaneous report from a contactable consumer (patient reported for herself). A 63-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EW0182) via an unspecified route of administration, administered in left arm, on 09Jun2021 at 13:30 (at the age of 63 years old) as dose 2, single for COVID-19 immunisation. Medical history included hypothyroid. The patient has known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and no any other medications received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19 and has not been tested for COVID-19 since the vaccination. The patient's concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EW0182) on 19May2021 at 10:30 AM, left arm, for COVID-19 immunisation and the patient experienced hives, rash and itching  which was not related to vaccine at the time. On 09Jun2021 at 16:30, it was reported that the patient experienced angio-edema to eyes, face lips, closed throat and trouble breathing. The patient received steroid, diphenhydramine (BENADRYL) and famotidine (PEPCID). The outcome of the events was recovering.  Information on Lot/Batch number was available. Additional information has been requested.
Typhoid vaccination admin IM at 07:45, preceded directly by dose 1 of anthrax series and dose 1 of JEV vaccination. Pt had anaphylactic rxn w/foaming at mouth, flushing, wheezing and urinary incontinence. Tx: 0.3 mg EPI IM at 07:45 and 25 mg BENADRYL IM.
This spontaneous report as received from a medical assistant refers to multiple patients of unknown age and gender. The patients' medical history, current conditions and concomitant medications were not reported. On an unknown date the patients were vaccinated with improperly stored GARDASIL 9 (route and dose were not reported) lot # L016428 and expiry date:30-JUL-2017 for prophylaxis. The vaccine was exposed to 47.85 F for 8 hours. A data logger was not used to log temperatures, and there were no prior excursions. No adverse were reported. There was no product quality complaint involved. Additional information has been requested.
(L) upper arm swollen red and very tense with small amt yellow exudate weeping, 1/4 of upper arm extending to area just behind shoulder, no hives, no tenderness.
Fever initially, then generalized seizure about 1:30 am; went to ER, evaluated.
Sore arm; This is a spontaneous report from a contactable consumer (patient). A 39-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: En6205), via an unspecified route of administration, administered in left arm on an unspecified date (at the age of 39-year-old) as single dose for COVID-19 immunization. The patient is not pregnant. The patient's medical history and concomitant medications were not reported. No other vaccine in four weeks. No Covid prior vaccination. Not tested with Coved post vaccination. The patient experienced sore arm on 04Mar2021 20:00. No treatment for the event. The outcome of the event was unknown.    No follow-up attempts are possible. No further information is expected.
extreme fatigue, shortness of breath,  lungs feel like they're going to burst.  Unable to do simple chores without lungs bursting.  Unable to  walk daily. Since receiving the 1st vaccine I have been experiencing fatigue and it hasn't gotten any better after receiving the 2nd vaccine.  Prior to receiving the Pfizer vaccine, I was very active.  I walked 5 miles daily and had an abundance of energy.  I'm having a hard time walking 2 miles and my breathing is very labored when I walk.  My lungs feel like they're going to burst. I'm out of breath just doing simple chores at home.  These symptoms are not getting any better and I'm beginning to get a little nervous.  Let me say I was blessed not to have contracted  COVID.
Dad phoned localized reaction to right arm with swelling. Denies drainage. Varicella vaccine given at this site.
patient was so sick; Initial information was received on 04-Nov-2020 regarding an unsolicited valid non-serious case from a social media via consumer or non-health care professional (patient).    This case involves patient (age and gender unspecified) who was so sick (illness), while patient received vaccine INFLUENZA VACCINE [flu shot].  Medical history, medical treatment, vaccination, 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 at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient was so sick (illness) (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.  At the time of reporting, the event outcome reported as unknown for event.  There will be no information available on the batch number for this case
Approximately 15 minutes post injection child developed facial flushing distal to left earlobe and began tugging at left ear. At that point mother and child moved from immunization to walk in clinic to be evaluated.
Pt came in today 1/25/08 with a bright red rash all over body - had received MMR on 1/14/08.
At about 2:30 started feeling funny. Thought I was possibly hypoglycemic but my blood sugars were 123. Then about 3:00 tasted feeling tingling in my arm and finger tips and legs.  3:30 my legs felt like they were swollen but the weren't. Noticed I was coughing more to clear my throat.  And felt a little itchy on different parts of my body. Around 4:30 my husband noticed I had something on my face. Turned out to be hives.  My throat area velt wierd a little numb but not completely. I felt big lumps on both sides of my neck.    I then started to feel tingling on my nose and left side of my tongue.  I noticed it felt a little uncomfortable to swallow almost like a sore throat but without pain. I did not feel short of breath at any time.  I took 50mg of benadryl at 6pm. The symptoms started to subside.  Still had occasional itching.  By the morning I felt better.  Throat felt better and itching was gone. I did end up taking more benadryl at about 8pm because I noticed my throat feeling swollen again.  By the morning I was back to normal again.
Patient reports of lymph node swelling under the armpit on the same side as the YF vaccine and slight pain at the injection site approximately one week after receiving the YF vaccine.
Fever/aches pains/SOB/chest pressure/sore throat/laryngitis. Symptoms started in evening - vaccine administered at approx 5pm. Pt took APAP then Ibuprofen. Fever broke about 5:30 am.
I had a rash at the injection site for about 5 days. I also have swollen neck lymph nodes for about 6 weeks. I went to the doctor about this. She thought it was caused by the vaccine.
Irregular menses/amenorrhea - Expected period was to begin on 01/25/2021 (after 1st vaccine dose). I never had any menstrual bleeding in the days to follow. My period has always been regular. Expected period was to begin on 02/22/2021 (after 2nd vaccine dose)  and bleeding did not occur.
Information has been received from a registered nurse referring to an unspecified number of unspecified patients of unknown age and gender. On unknown dates these patients were vaccinated with GARDASIL (dose, route and lot# were not reported). On unknown dates these patients experienced injection site pain after receiving GARDASIL. The reporter felt this because GARDASIL was "irritating to the muscle." The reporter also reported that all of these unspecified patients cried after receiving GARDASIL because the injections were so "uncomfortable." No treatment was given for these adverse events. No lab diagnostics studies were performed. The outcome of these events was reported as recovered/resolved. The reporter considered injection site pain, injection site discomfort and injection site irritation were related to GARDASIL and the relationship between other events and GARDASIL was not reported. This is one of several cases reported by the same reporter. Additional information has been requested.
fever; chills; This spontaneous case was reported by an other health care professional and describes the occurrence of PYREXIA (fever) and CHILLS (chills) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced PYREXIA (fever) and CHILLS (chills). At the time of the report, PYREXIA (fever) and CHILLS (chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Mar-2021, Body temperature: 105 f (High) 105 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   no concomitant and treatment medication was reported   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: NNI
Allergic reactions to the vaccine; Heart inflammation; Anxiety; Needles in her heart at the bottom part; This is a spontaneous report from a contactable consumer or other non-HCP (patient herself) via Medical Information Team. A female patient of an unspecified age received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number-UNKNOWN) via an unspecified route of administration on an unspecified date in Mar2021 as dose 1, single for COVID-19 immunization. Patient medical history and concomitant medications were not reported. The patient experienced allergic reactions to the vaccine, heart inflammation, anxiety, needles in her heart at the bottom part on an unspecified date in Mar2021. Patient had the Pfizer-BioNTech COVID-19 Vaccine back in Mar2021 and said she cannot take the second dose. She already consulted an allergist, and the other allergist did not have an appointment right away and they had to go on a trip and had to postpone it. She was asking what type of doctor should she saw since time has passed already. She did not know if she should go to a primary health care provider, allergist, general care provider or internals. She was in a bad situation for 7 weeks and had been requested to get the vaccine again and she has this conflict. She had allergic reactions to the vaccine, heart inflammation, anxiety, needles in her heart at the bottom part that had cleared now. The reported seriousness of the case was non-serious. The outcome of events was resolved in 2021.    The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Vaccinations of DTaP, IPV & MMR around 0830.  Returned to health dept @ 1030.  Child with rash (raised & pink) on trunk of body & around neck.  1 episode of vomiting.  Sent straight to ER at hospital.  Benadryl and steroids in ER.
Most excruciating pain in his life in his back right side.; Back right thigh was so painful, he couldn't step down on the leg/back right thigh now a very lite pain; back right thigh was so painful, he couldn't step down on the leg; tissue pain  pain across chest area that feels like his is sore from a work out that comes and goes/ It doesn't feel like heart pain; body pains have come and gone since the 2nd shot; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Most excruciating pain in his life in his back right side.), PAIN IN EXTREMITY (Back right thigh was so painful, he couldn't step down on the leg/back right thigh now a very lite pain), GAIT DISTURBANCE (back right thigh was so painful, he couldn't step down on the leg), CHEST PAIN (tissue pain  pain across chest area that feels like his is sore from a work out that comes and goes/ It doesn't feel like heart pain) and MYALGIA (body pains have come and gone since the 2nd shot) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018B21A and 042B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-May-2021, the patient experienced BACK PAIN (Most excruciating pain in his life in his back right side.), PAIN IN EXTREMITY (Back right thigh was so painful, he couldn't step down on the leg/back right thigh now a very lite pain), GAIT DISTURBANCE (back right thigh was so painful, he couldn't step down on the leg), CHEST PAIN (tissue pain  pain across chest area that feels like his is sore from a work out that comes and goes/ It doesn't feel like heart pain) and MYALGIA (body pains have come and gone since the 2nd shot). At the time of the report, BACK PAIN (Most excruciating pain in his life in his back right side.), PAIN IN EXTREMITY (Back right thigh was so painful, he couldn't step down on the leg/back right thigh now a very lite pain), GAIT DISTURBANCE (back right thigh was so painful, he couldn't step down on the leg) and CHEST PAIN (tissue pain  pain across chest area that feels like his is sore from a work out that comes and goes/ It doesn't feel like heart pain) outcome was unknown and MYALGIA (body pains have come and gone since the 2nd shot) had resolved.            No concomitant medications reported. After the second shot, the next day he had the most excruciating pain in his back right side. The next day, his back right thigh was so painful, he couldn't step down on the leg. Also he had tissue pain across chest area.  It was not like heart pain. All of the body pains have come and went since the 2nd shot.  No treatment information was provided.   This case was linked to MOD-2021-309998 (Patient Link).
Nausea; head rush; headache; fatigue; chills; This is a spontaneous report from a non-contactable consumer or other non hcp. A 20-years-old non-pregnant adult female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6205 ),via an unspecified route of administration, administered in left Arm on 06Mar2021 at 5:00PM as First Dose, Single Dose for COVID-19 immunization. The patient's Medical history were not reported. The patient did not suffer from COVID-19 prior vaccination. The patient did not take any other vaccine within 4 weeks of vaccination. Concomitant medications in two weeks included Loryna birth control, minocycline 100mg.The patient did not test for COVID post vaccination. On 06Mar2021,at 10:30 PM, the patient experienced Nausea, head rush, headache, fatigue, chills. No treatment was received with regards to the events. The outcome for the events was note recovered/not resolved. No follow-up attempts are possible. No further information is expected.
Sweats, chilling, muscle aches, injection site reaction, fatigue. Pt was bedridden for about 14 hours and couldn't fall asleep; had to miss work.
Contracted Covid-19 infection; Pain; Felt achy; Fever; but she did not get her second dose; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Contracted Covid-19 infection), PAIN (Pain), MYALGIA (Felt achy), PYREXIA (Fever) and PRODUCT DOSE OMISSION ISSUE (but she did not get her second dose) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Contracted Covid-19 infection), PAIN (Pain), MYALGIA (Felt achy), PYREXIA (Fever) and PRODUCT DOSE OMISSION ISSUE (but she did not get her second dose). At the time of the report, COVID-19 (Contracted Covid-19 infection), PAIN (Pain), MYALGIA (Felt achy), PYREXIA (Fever) and PRODUCT DOSE OMISSION ISSUE (but she did not get her second dose) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date.       Concomitant product use was not provided by the reporter. Treatment information was not provided.
Light-headed, lethargic, warm, flushing, nausea, abdominal pain, lasted about 30 minutes and was fine after that