chrisvoncsefalvay/vaers-outcomes huggingface dataset:
trouble breathing; This is a spontaneous report from a non-contactable consumer from a Pfizer-sponsored program. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration on an unspecified date at a SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient stated, "I need to ask about, I need to ask about shortness of breath, I'm having a hard time breathing. I had the vaccine last night and having trouble breathing" on an unspecified date. The outcome of the event was unknown.  No follow up attempts are possible; information about lot/batch number cannot be obtained.
SEVERE RASH, SWOLLEN INJECTION SITE, HEADACHE, FEVER, CHILLS, BODY ACHE, LOUD RINGING IN THE EARS FOR ABOUT 3 DAYS.
Patient reports developing rash on torso, arms, and legs on 4/4. Was seen in an urgent care facility and reports that the provider at that facility questioned if the patient had ever had the measles.  The patient reported receiving the MMR vaccine on 3/3. Patient reports taking BENADRYL for itch with relief. Reports rash still present on 4/10 but not spreading.
A report has been received from a Health Professional concerning an 8 year old, male subject, who had been receiving FLUMIST. FLUMIST started on an unknown date. Reporter mentioned that patient was received multiple flu vaccines/we have a FLUMIST on 20-Nov-2013 to a child who received a dose on 06-Sep-2013 patient was inadvertently given FLUMIST twice. The outcome of the event of received multiple flu vaccines/we gave FLUMIST on Nov-20-2013 to a child who received a dose on Sept 6, 2013/patient was inadvertently given FLUMIST twice is unknown. The report was considered to be non-serious. Summary of significant follow-up information received on 03-Dec-2013 from a health professional. Product lot number and expiry date added. Event start date added. Patient details added.
The COVID-19 vaccine administered through PT vaccine administrator, CLINIC, between June 25 and July 30 came from the lot number 039K20A.  It was discovered that this particular lot was beyond its frozen expiration date by five (5) up to forty (40) days.  A case was opened with Moderna (Case #: MOD21-126790).  Please refer to this case number if you would like to contact Moderna directly.  Moderna confirmed that the vaccine doses administered maintained the activity necessary to protect against the COVID-19 virus.  Moderna also confirmed there is no danger to anyone's health from receiving a vaccine past its frozen expiration date.  No adverse reactions were identified.
Soreness, no swelling no redness,at injection site next day after injection. Then fine.  on day 9 after injection had itching at the injection site and noticed 1 large hive at the injection site, present for 1-2 hours, then resolved.  every day thereafter had noticed 1-4 small hives in various locations on arms and face that come and go
This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender who on unspecified date was vaccinated with the third dose of GARDASIL (dose, route, and lot # not reported) after the second dose had been given approximately in December 2010 (two years ago) (dose, route and lot # not reported). No other co-suspects were reported. No concomitant medications were reported. No adverse effect reported. Additional information has been requested.
Muscle aches around the neck area dizziness starting the next morning after shot administered. Muscle aches gone 4 days later but dizziness persists. I have not goe in for any treatment.
Initial misuse report received from a healthcare professional on 23 October 2013. The case were received 21 March 2014 at GPV. A pregnant female patient had received 0.5 ml of FLUZONE on 9 October 2013 and again on 23 October 2013 both doses were from an MDV. It's was a vaccine exposure during pregnancy and extra dose administered. No adverse event was reported. List of documens held by sender: none.
Pt recvd Td vax 18AUG92 & 3 months later devel abscess; also tenderness & induration;
Fever that reached 101.5 for about 12 hours, muscle spasms.
Not feeling well; Extra dose; This case was reported by a consumer via call center representative and described the occurrence of feeling unwell in a 14-year-old female patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On an unknown date, the patient received Boostrix at an unknown dose. On an unknown date, unknown after receiving Boostrix, the patient experienced feeling unwell and extra dose administered. On an unknown date, the outcome of the feeling unwell and extra dose administered were unknown.   It was unknown if the reporter considered the feeling unwell to be related to Boostrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter consented to follow up.
This case was reported by a physician via call center representative and described the occurrence of erythematous rash in a 79-year-old male patient who received SHINGRIX. Concomitant products included LIPITOR, SINEMET and verapamil. On 15th February 2018, the patient received SHINGRIX. On 19th February 2018, 4 days after receiving SHINGRIX, the patient experienced erythematous rash, pustular skin eruption and skin lesion. On an unknown date, the outcome of the erythematous rash, pustular skin eruption and skin lesion were unknown. The reporter considered the erythematous rash to be probably related to SHINGRIX. It was unknown if the reporter considered the pustular skin eruption and skin lesion to be related to SHINGRIX. Additional details were provided as follows: The reporter was the patient's partner who was also a retired physician. On 22nd February 2018, the reporter noticed the rash on the patient but believes it might have started on 19th February 2018 and was full blown by 22nd February 2018. The rash was described as red with pustular lesions appearing mostly on both arms. A few lesions also presented on his back and legs. The rash has mostly resolved but there were a few lesions still present. The vaccine was administered at a doctor's office but the reporter did not want the doctor contacted because they had not told the doctor till the time of reporting.
couldnt hear tv even though volume was high, trouble understanding what people talking to him were saying,despite yelling, injection site hot/moist,
Full body hives and swelling immediately after giving vaccine - gave BENADRYL and observed in the office for 2 hours.
Patient called pharmacy with 1" -2" rash on injection site. Patient called pharmacy on 7/5/12 and received vaccine on 7/3/12. Dr wants to see patient in the morning.
Extreme body aches, muscle and joint pain, headache, nausea, chills, fever. Most side effects lasted 28 hours. Headache and nausea lasted 3 days.
Very red/hot cheeks, very red/hot kneees, very red/hot palms of hands. Reported to Doctors on Duty. MD prescribed prednisone. Symptoms lasted a few days.
Symptoms manifested approximately 12 hours after injection and lasted 30-36 hours.  Started with rather severe chills, fever of 102 for next 24 hours, extreme fatigue, body aches, head ache, loss of appetite.  NOTE that I was tested Covid positive on November 2, 2020. I was tested for Covid antibodies in December 2020.
Total body urticarial rash, pruritic, starting 3 days p/inject w/swelling @ inject site;
Patient received above dose of Fluzone but had previously received influenza vaccine on 11/1/2022, so two doses given in the same flu season.  First dose of influenza vaccine was lot number 942386, but other details unknown
Superficial infection Left deltoid within 2-3 days and lasting 4-5 days.  Generalized malais, joint tenderness, body aches, ad weakness since vaccination.  Right shoulder severe pain, mild warmth and decreased range of motion from 10/16/07 and continued through this reporting date.
high blood pressure; headache; body aches; joint pain; fatigue; lack of appetite; This is a spontaneous report from a contactable consumer (patient).  A 70-year-old male patient receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: e79263), via an unspecified route of administration on 24Jan2021 at single dose for COVID-19 immunization. The patient medical history included high cholesterol and high blood pressure (controlled with medication), both from an unknown date and unknown if ongoing. The patient's concomitant medication included varicella zoster vaccine rge (cho) (SHINGRIX) on 30Dec2020 at single dose for immunization, paracetamol (TYLENOL), atorvastatin and olmesartan medoxomil (BENICAR). On 25Jan2021, the patient experienced high blood pressure, headache, body aches, joint pain, fatigue and lack of appetite. No therapeutic measures were taken in response to the events. The patient outcome of the events was not recovered.
Shot was given very high in my arm and hurt worse than any previous shot given. After shot my shoulder hurt and ached, and has continued to hurt. It has been almost 4 weeks and I have pain and aching through my neck and shoulder and down my arm. Feels like the pain is in my bone.
1/19/22 pt admitted from a residential facility to a local Medical Center for periumbilical hernia with vomiting and nausea; no surgery needed per consult; pt tolerating oral intake and ready to be dc'd to a residential facility; 1/20/22 pt had a positive COVID test; asymptomatic; dc'd to another Health Care Center where she passed away of cardiac arrhythmia and COVID  19.
I have not had my period since I got fully vaccinated in April 2021. And I had one trip to the emergency room because I was unable to urinate for many hours and I didn?t have a UTI
pt c/o itchy throat, throat closing & itchy all over 5min p/vax  prior BP 122/90 BP p//vax 160/100;given DPH & epi;
4 y/o patient was administrated Hiberix; Dose reconstituted with a steril diluent; Dose reconstituted with a steril diluent; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 4-year-old male patient who received Hib (Hiberix) (batch number ft775, expiry date 25th June 2022) for prophylaxis.   On 9th December 2021, the patient received Hiberix. On 9th December 2021, unknown after receiving Hiberix, the patient experienced inappropriate age at vaccine administration, wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration, wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The 4 year old patient was administrated a dose of Hiberix reconstituted with a sterile diluent and not the accompanying and recommended one, which led to inappropriate age at vaccine administration, wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. No further events were reported. The reporter agreed to be contacted for follow-up. The reporter consented to follow up.
COVID PCR (+) result 1/4/2022, admitted to same hosp on 1/4; sxs include cough, congestion, fatigue, runny nose
BILATERAL ANKLE SWELLING WITH PURPLISH DISCOLORATION AND TENDERNESS. EXTENDS MIDCALF TO MIDFOOT. SATELLITE PATCHES. 3+ PITTING EDEMA AND BOGGINESS. ELEVATED WBC. NO CALF TENDERNESS. NO HISTORY OF VASCULITIS, DVT, OTHER. OTHERWISE HEALTHY AND ATHLETIC.  MAJOR TAKE AT VACCINE SITE. HE REPORTS 7 JABS FOR PRIMARY VACCINATION: SHOULD HAVE BEEN 3, UNLESS HIS RECALL IS INCORRECT.
pt. received 2nd pfizer shot , about 15 minutes after vaccine pt. became dizzy, she leaned up against her car and was excorted to the gound, she lost consciousness for about 15 seconds, was still breathing and still had pulse, she was aroused with sternal rub and sniffing salts, EMS was called, was taken to local hopsital  where she was found to have alcohol intoxication  bac level of 0.26
Body aches and fatigue/these are the same symptoms that she had with her previous doses of the Pfizer Covid Vaccines; Body aches and fatigue/these are the same symptoms that she had with her previous doses of the Pfizer Covid Vaccines; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 59-year-old female patient received BNT162b2 (COMIRNATY), on 27May2021 as dose 1, single (Lot number: EW0183) at the age of 59 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Breast cancer", start date: 09Sep2009 (unspecified if ongoing). There were no concomitant medications. The following information was reported: PAIN (non-serious), FATIGUE (non-serious), outcome "unknown" and all described as "Body aches and fatigue/these are the same symptoms that she had with her previous doses of the Pfizer Covid Vaccines".
5 inch round indurated area tender with erythema at injection site. Accompanying malaise and generalized myalgias.
Syncopal episode, light headed,  chest pain, initial vs bp 86/54 and hr 85, bg 128 O2 85
1) Bilateral acute appearing pulmonary embolism right greater than left, clot burden moderately large. 2) . Probable portal vein thrombosis with partial superior mesenteric vein thrombosis.  3)  Changes of mild diffuse colitis are suspect. Potential etiologies for colitis includes infectious processes, inflammatory processes, as well as ischemic etiologies.  4) Splenomegaly. 5) Thrombocytopenia. Platelets of 39000
This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX (the dosage regimen information was not reported) lot # R012531 (expiration date: 01-MAY-2020) for prophylaxis, reconstituted with properly stored sterile diluent. No adverse effects were reported. The VARIVAX vaccine was exposed to a temperature excursion of 15-46 Celsius degrees (19.9 Fahrenheit degrees) for 21 hours and 32 minutes. There were no previous excursions and it was found because of a digital data logger.
Swollen around the injection site; Red around the injection site; Soar around the injection site; A spontaneous report  was received from a consumer, concerning herself, a female patient of an unspecified age who received Moderna's Covid-19 Vaccine (mRNA-1273) and experienced delayed allergy reaction at the injection site, swollen around the injection site, red around the injection site and sore around the injection site.  The patient's medical history reported included allergies. Concomitant medications were not reported.   On 31 Dec 2020, 8 days prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (Batch number: unknown) via unknown route for prophylaxis of COVID-19 infection.  On 07 Jan 2021, after vaccination, the patient experienced a delayed allergy reaction at the injection site, which was about the size of a decode card and had the shape of a plane care. Patient also experienced swollen, red and soar around the injection site. Treatment for the events included diphenhydramine.~  Action taken with mRNA-1273 in response to the events were not reported.  The outcome of the events delayed allergy reaction at the injection site, swollen around the injection site, red around the injection site and soar around the injection site were considered not resolved at the time of this report.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
On thurs. Nov. 25 I discovered a tick in my shoulder.  The hotel where I was staying helped rmove it, and the ite was very red and irritated.  I texted. Dr. andspoke with him on fri. Nov 26.  He sent a prescription for 100 mg tabs of Doxycycline Hyclate which I began taking that day., to be taken 2x day on empty stomach.  The medicine made me nauseous and caused vomiting.  I kept trying to take it, but it kept making me sick.  By Sunday eve. it caused vomiting again, and I called Dr. to prescribe a different antibiotic.  I have never reacted to an antibiotic this way before.
Injection site reaction which include redness, swelling, and pain.  Reaction spread from point of injection all the way down the arm to the elbow.  Patient reports significantly more pain than when she normally gets vaccinated.
About 45 minutes after injection, funny feeling in face (can?t explain, maybe tingly, puffy),  muscles in throat tightening.  Both of these were fleeting.  Following two mornings had no voice (laryngitis) first thing in the morning.  Voice came back as day went on.  No further issues
5th dose; 5th dose; lost 50% of strength while trying to lift things; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received BNT162b2, BNT162b2 OMI ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown) for Covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose: 1, Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose: 2, Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose: 3 (Booster), Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose: 4 (Booster), Manufacturer unknown), for COVID-19 immunization. The following information was reported: OFF LABEL USE (non-serious), IMMUNISATION (non-serious), outcome "unknown" and all described as "5th dose"; ASTHENIA (non-serious), outcome "unknown", described as "lost 50% of strength while trying to lift things".  Additional information: The case was reported as non-serious. It was reported that the patient received his 5th dose of the COVID vaccine and in his vaccination card it's written as "BIB" (later confirmed it was for the Pfizer-BioNTech COVID 19 Vaccine bivalent formulation). According to the agent, the questions of the patient were several, he started to have an antibody reaction and wanted to know if the side effects were permanent, he wanted a prognosis with this, some advice on how to resolve this and wanted to contact some qualified professionals with experience in antibody reactions. During the transfer, the caller said he has lost 50% of strength while trying to lift things. The patient mentioned that he started to experience his side effects 5 after receiving the vaccine and confirmed that he wanted a medical advice for his adverse events.  The information on the batch/lot number for BNT162b2, BNT162b2 Omi BA.4-5 has been requested and will be submitted if and when received.
During medical check for life insurance discovered that I had very high blood pressure. Made an appointment to follow up with my PCP. Was put on blood pressure medicine and began exercising. Medicine and exercise have decreased my blood pressure to normal limits.
tiredness; This case was reported by a pharmacist via call center representative and described the occurrence of tiredness in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain (for the tolerability of 1st dose, refer case US2020201575 reported for same patient).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced tiredness. On an unknown date, the outcome of the tiredness was recovered/resolved.   It was unknown if the reporter considered the tiredness to be related to Shingrix.  Additional details were provided as follows:  The age at vaccination was not reported. The patient experienced tiredness after the second dose of Shingrix. The reporter consented to follow up. This case has been linked with US2020201572, US2020201576, US2020201578 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020201572:same reporter US-GLAXOSMITHKLINE-US2020201576:same reporter US-GLAXOSMITHKLINE-US2020201578:same reporter US-GLAXOSMITHKLINE-US2020201572:same reporter US-GLAXOSMITHKLINE-US2020201576:same reporter US-GLAXOSMITHKLINE-US2020201578:same reporter US-GLAXOSMITHKLINE-US2020201575:same reporter
This spontaneous report was received from a 62 year old female Licensed Practical Nurse (who is also the patient) regarding herself. The patient's current condition included seasonal allergies, high cholesterol and hypertension. On 14-NOV-2012, the patient was vaccinated with a dose of ZOSTAVAX, (lot number, expiration date and route not reported). No concomitant medications were reported. On 14-NOV-2012, the patient experienced red lump at the injection site. She did not develop rash. No treatment was provided. Approximately on 18-NOV-2012 (reported as which lasted 3-4 days), the patient recovered from the event of red lump at the injection site. The nurse did not seek medical attention. The nurse also stated that on 19-NOV-2012, she cared for a 12 year old patient who had spinal muscular atrophy and was on a medical ventilator. On 25-NOV-2012, the 12 year old patient developed a red, itchy and raised rash on her right arm and left lower leg. Additional information has been requested.
Three days after second dose of vaccination patient presented to ED with pleuritic chest pain and dyspnea.  Patient found to have acute myopericarditis.  Patient treated with IV toradol and acetaminophen with resolution of symptoms.  Treated with metoprolol and colchicine.  Patient was hospitalized for 48 hours then discharged in stable condition.
Right shoulder joint pain and limitation in range of motion worsened over a week and has been persistent. Evaluated by PCP, Rheumatology, and Orthopedics.  Patient was 35 weeks pregnant at the time of the event.
This spontaneous report as received from a registered nurse refers to a 9 week old patient. The patient's concurrent conditions, medical history and drug allergies were not reported. On 07-DEC-2016, the patient was vaccinated with improperly stored ROTATEQ, oral, (dose not reported) from lot # M007311 (expiry date: unspecified) for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information is not expected as all correspondence has been received. Follow-up information indicated that suspect product with the lot# M007311 had not actually involved in the previously reported temperature excursion. Therefore, case # 1612USA012726 is being deleted from our files on generic rotavirus vaccine, live, oral, pentavalent. This is an amended report, as corrected. The reference type for the number US-009507513-1610USA014706 has been changed from Company Number to Linked Report. Sender's Comments: US-009507513-1610USA008140: US-009507513-1610USA014705: US-009507513-1610USA014706.