chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial report received on 18 May 2012 from the Investigator participating in a post-marketing observational surveillance study under the reference number M5A16. A case of pertussis disease in a nine-month-old male subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received 3 doses of PENTACEL; lot number C4026AA received on 22 September 2011, lot number C3999AA received on 23 November 2011 and lot number C4047AA received on 08 February 2012 (routes and sites of administration not reported). The subject developed cold-like symptoms and cough on 15 April 2012 approximately 2 months after the last dose. On 26 April 2012, the subject developed a paroxysmal cough with a whoop. The subject also experienced posttusstive vomiting, sleep disturbance and apnea. Laboratory testing included positive PCR  on 29 April 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 29 April 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 15 May 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 30 days. Investigator causality assessment is not required as per protocol. Company Medical Assessment: No vaccine protects 100% of individuals against infection and it is not unexpected to find cases of pertussis after only 3 doses of PENTACEL. Because this case was solicited from an electronic database, medical records are not available so it is unknown if the child had an underlying medical condition or was taking concomitant medications that could have increased vulnerability to infection or inhibited immune response to vaccination. This is one case out of a cumulative total of 67 cases solicited from the EDSS database during the surveillance period from 01 January 2010 to 18 May 2012. These 67 cases represent children who received 3 or more doses of sanofi pasteur vaccine; cases of pertussis disease in children who received DTaP combination vaccine from other manufacturers are not reported as per study protocol. Documents held by sender: None.
5 adults exp local rxn @ inj site, including redness, swelling, tenderness to touch lasting @ least 3 days p/vax;
Site: Pain at Injection Site-Medium, Additional Details: Pt. visited her doctor for pain after receiving shingrix. the doctor said she suffered a hematoma but that the injection site looked ok. There wasn't any overt bruising and it seemed the immunizer gave the shot in the appropriate area. he said for her to take advil or tylenol and use warm compresses. shes suffering for some pain radiating down her arm and tingling in her hand. she also has a history of shoulder issues. She's seeing an orthopedist also thinking it might be her shoulder
Patient presented to pharmacy for flu and COVID vaccines.  COVID BV booster was administered in left arm; Flu vaccine was administered in right arm.  Immediately following flu vaccine, patient fainted, fell onto the ground, and remained unconscious for ~10 seconds.  Patient hit his knee resulting  in a bump,  his face resulting in a small scratch below his left eye, and bit his tongue.  Patient remained seated at pharmacy for 20 minutes following event.  Pharmacist provided ice pack, water, crackers, and lollipop.
some sore in her arm; felt a tingling heat sensation and then it felt like a sucker punch in the arm; felt a tingling heat sensation and then it felt like a sucker punch in the arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP) from medical information team for a Pfizer sponsored program Support. The reporter is the patient.  A 51 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 31Mar2021 (Lot number: ER8730) at the age of 51 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "COVID-19", start date: Jan2021 (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Flu shot (Sore Arm with Flu Shot), reaction(s): "sore arm".  The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 31Mar2021, outcome "not recovered", described as "some sore in her arm"; PARAESTHESIA (non-serious), FEELING HOT (non-serious) all with onset 31Mar2021, outcome "not recovered" and all described as "felt a tingling heat sensation and then it felt like a sucker punch in the arm". Therapeutic measures were taken as a result of pain in extremity, paraesthesia, feeling hot.  Additional information: Time of vaccination was between 19:30-19:40. The events were treated with Tylenol. Consumer states that patient's first dose was 31Mar2021 and she was scheduled 28Apr2021 for her second dose. She was scheduled later than the normal 21 days. He states her main concern for medical information is for her first dose, she asked the nurse how long have the vaccines been stored and they said they can store it up to 6 days in the fridge. He stated what (name provided) knew was those vaccines can only be stored 5 days in the fridge. He states she was wondering if they vaccinated her with a 6th day stored vaccine and she wanted to know about the lot numbers of the vaccine to know when it has been delivered at facility and for how long.  Caller clarifies when she went there and asked the pharmacist who was distributing the shot, because she knows Pfizer needs to be kept at lower temperature stored, they said they can store in the fridge for up to 6 days, and when she went home it said 5 days. States she is asking if there is a chance that the shot was stored for 6 days in the fridge. Stated maybe they are thinking it can be for 6 days when it is actually 5. Stated she only had arm pain and she had the Covid virus back in January and she heard that if you had Covid you will feel a doozy on the first shot. States she was also wondering if they can trace how long the vaccine was at the (provided). There was no prior Vaccinations (within 4 weeks). There was no family Medical History Relevant to AE(s).  No follow-up attempts are possible. No further information is expected.
Headache, muscle aches for 2 days, feeling tired for 3 days, swelling and pain still present on the 3rd day.
fever; muscle aches; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever) and MYALGIA (muscle aches) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     Concurrent medical conditions included Cholesterol and Hypertension. Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN) for Anticoagulant therapy, ATORVASTATIN for Cholesterol, ATENOLOL for Hypertension, ASCORBIC ACID (VITAMIN-C), VITAMIN D [VITAMIN D NOS] and ZINC for Supplementation therapy.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced PYREXIA (fever) and MYALGIA (muscle aches). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, PYREXIA (fever) and MYALGIA (muscle aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-026699 (E2B Linked Report).; Sender's Comments:  MOD-2021-026699:different patient
Arm is extremely red and swollen, patient stated feeling sick with fever like symptoms... redness and swelling are very hot and area is growing over entire top half of arm.... we referred her to a doctor for symptomatic management.
Child developed high fever, nausea and vomiting 2 days after immunization. Seen by doctor at clinic who told parents the child's symptoms were a "reaction to shot".
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On or about 15-JAN-2016, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance and for the long-term prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. Later in 2016, the patient was treated at an Urgent Care for the onset of a vesicular rash which was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Initial information regarding a clinical sponsored solicited case was received on 19-May-2016 from the patient via the Patient Support Program. This case concerns a 63 years old female patient who experienced cold 19 days after receiving treatment with PRALUENT and unknown duration after receiving influenza vaccine. No information on any concomitant drugs, past medications or concurrent conditions was reported. Medical history: atherosclerosis of arteries and extremities. On an unknown date, the patient commenced treatment with influenza vaccine (dose, form, route, frequency, lot/batch number and expiry date: unknown) for an unknown indication. On 27-Apr-2016, patient commenced alirocumab injection at a dose of 75 mg every other week subcutaneously (lot/batch number and expiry date: unspecified) for Mixed hyperlipidemia delivered via alirocumab prefilled pen. Patient reported that she was sick right now; she caught a cold on 16-May-2016. She did take the flu shot. Her whole body was hurting and she had no appetite. All this started about Monday, 16-May-2016. Reportedly, her throat started hurting. On Tuesday she felt lightheaded and stopped up. She took her last injection on 11-May-2016. Action taken: Drug Withdrawn NOS. the therapy was withdrawn on 11-May-2016. Corrective treatment: Not reported. Outcome: Unknown. Reporter causality: Not reported with influenza vaccine and unknown with alirocumab. Company causality: Not associated.
has been experiencing arm pain since administration from injection site all the way down to her fingers; This is a spontaneous report from a Pfizer-sponsored program via contactable other healthcare professional (patient).   A female patient of an unspecified age received the first dose of bnt162b2 (BNT162B2, lot/batch number and expiry date were not reported), via an unspecified route of administration in arm on an unspecified date at SINGLE DOSE for Covid-19 vaccination. The patient's medical history and concomitant medications were not reported. The patient had been experiencing arm pain since administration from injection site all the way down to her fingers on an unspecified date. She had tried everything she can think of to subside the pain but nothing has been working. The outcome of event was not recovered.  Information on Lot/ Batch number has been requested.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), on 30Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 30 years, in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient has no known allergies. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 including Paxlovid from 27Sep2023 to 01Oct2023.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
I awoke with severs chills, fever at 5 am.  I have muscle/joint pain, very fatigued, slight headache, fever of 101.2, arm soreness on first day.  Today (2nd day) temp of 100, body fatigue/weakness, slight headache, arm soreness, but overall feeling better.
Dizziness, Headache, Fever, body aches (unspecified) Narrative:
I only had a significant reaction to Dose 2. Not as bad for Dose 1 or Booster.
Found patient on floor, awake but drowsy.  Patient was able to speak, appeared to have had a vagal response.  Patient was laid flat on back, legs raised,  given glucose, apple sauce and water.  Vital Signs stable.  Patient denied having a seizure, also later denied EMS service
allowed me to have a mild case; allowed me to have a mild case; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "allowed me to have a mild case".  Clinical course: Patients age was reported as 72. Patient thought the visuals were interesting. Music For her was difficult to understand the words kind of like when you sing the wrong lyrics and don't find it out for ages or until someone tells you. As for Pfizer she was grateful and feel positive towards it for if nothing else being the developer of the Covid vaccine [Comirnaty] which she used and allowed me to have a mild case.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
12 hours after receiving the ZOSTAVAX, noted a swelling in her fingers and ankles and a red, bumpy rash on face and chest. After 24 hours, the symptoms and signs resolved. (Was not seen by physician for these).
approx 3hr p/vax awoke from nap while on changing table, turned blue (cyanotic), dazed look, not responsive;looked scared;episode lasted approx 5min p/color returned;became more responsive, mom fed pt & seemed to be OK @ that time;
Body/ joint aches, fatigue, rash on chest and groin area for 24 hours.  Rash on chest and groin persisted beyond 24 hours.   No treatment required.
chills; fever; fatigue; very bad headache; This is a spontaneous report from a non-contactable consumer, the patient. A 33-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration on 29Mar2021 (at the age of 33-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medication were not reported. The patient had unspecified allergies to food, medications, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 30Mar2021 at 08:00, the patient experienced chills, fever, fatigue and very bad headache. The patient did not receive any treatment for the events. The events did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event chills, fever, fatigue and very bad headache were recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Left thigh with a 8cm red, indurated area shot reaction vs. cellulitis. Treatment- KEFLEX.
Information has been received from a pharmacist referring to 2 patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant therapy were unknown. On approximately 15-SEP-2016 (reported as about a week ago), the patients were administered ZOSTAVAX 19400PFU (lot # L046896, expiration date 23-FEB-2017; dose and route were unknown at physician's office. On approximately 17-SEP-2016 (reported as approximately 2 to 3 days after administration), the patients had pretty severe reactions including redness and swelling down to their elbows. No rash was reported. Both patients made a phone call to the physician to report the reactions, but it was unknown if any treatment was recommended. The outcome of the events was unknown. The causality assessment between the events and ZOSTAVAX was not reported. Additional information has been requested.
Patient developed fever on 5/13 after starting typ. pills, hep. A, yellow fever on 5/11. Fever over wknd 102.6 5/14. 5/15 100.6 and sore throat.
Information has been received from a healthcare worker concerning a patient who "last week" was vaccinated with pneumococcal 23v polysaccharide vaccine (lot#651321/1036P).  Subsequently, the patient experienced swelling of the injection arm, edema, redness, heat, and itching.  Ice packs, ibuprofen (ADVIL) and acetaminophen (TYLENOL) were the recommended treatments.  Subsequently, the patient recovered.  Additional information has been requested.
Information has been received from a nurse practitioner concerning a female patient who was vaccinated with the first dose of GARDASIL (Lot number not reported).  Subsequently the patient developed redness on the injection site.  The patient sought medical attention by speaking with the nurse practitioner.  Additional information has been requested. This is in follow-up to report (s) previously submitted on 5/14/2008. Initial and follow-up information has been received from a nurse practitioner concerning a female patient who on 12-Mar-2008 was vaccinated with the first dose of GARDASIL vaccine (Lot number 654539/0890F).  Subsequently the patient developed redness, swelling, hives, and warm to the touch at the injection site. The nurse practitioner was unsure if she would be giving the patient a second dose since the patient developed hives. The nurse pratitioner may pre medicate the patient with BENADRYL prior to second dose. The patient sought medical attention by speaking with the nurse practitioner. Additional information has been requested.
Friday night: headache, fatigue Saturday: Fever 101.5, headache, extreme fatigue, joint pain, muscle pain, dizziness, chills, sweating, difficulty concentrating Sunday: headache, fatigue, joint pain, muscle pain, painful red blister on left side of torso Monday: headache, fatigue
Treatment of COVID-19; Treatment of COVID-19; Light burning and redness at the rectal sight with inflammation; tan in color loose bowl movements; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Nov2021 as dose 2, single (Lot number: FG3527) at the age of 57 years, in right arm for covid-19 immunisation; janssen coviD-19 vaccine (JANSSEN COVID-19 VACCINE), on 05Mar2021 as dose 1, single (Lot number: 1802068), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthama" (unspecified if ongoing), notes: energy induced asthma. Concomitant medication(s) (other medications in 2 weeks) included: SINGULAIR; VITAMIN D3; VITAMIN B12 & FOLIC ACID; ZINC CHLORIDE; CITALOPRAM; VITAMIN C [ASCORBIC ACID]. The following information was reported: ANORECTAL DISORDER (non-serious) with onset 14Apr2022, outcome "recovered" (Apr2022), described as "Light burning and redness at the rectal sight with inflammation"; GASTROINTESTINAL MOTILITY DISORDER (non-serious) with onset 14Apr2022, outcome "recovered" (Apr2022), described as "tan in color loose bowl movements"; SUSPECTED COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were not taken as a result of anorectal disorder, gastrointestinal motility disorder. Clinical course includes tan in color loose bowl movements, light burning and redness at the rectal sight with inflammation. Patient had no known allergies.  Follow up attempts are completed. No further information is expected.
On 5/29/01 the pt developed a headache following the receipt of the meningococcal vaccine 4 days prior. The pt complained of not being able to hear, or see, was dizzy. She then was sent to the ER. Told was reaction to "shot".
I was absolutely fine & healthy prior to the early A.M. of Nov. 10, 2012. I suffered enormous pain, and paralysis and have endured major medical treatments and huge medical bills due to this illness from the flu shot.
Patient was taken to ER on 10/30/08 with temp of 103.4 F, nausea, vomiting and shakes.  States MD says she had localized redness and tenderness related to immumizations in Left arm.
doses of possibly frozen FLUZONE QUDRIVALENT HIGH-DOSE were administered on accidently with no reported adverse event; Initial information was regarding an unsolicited valid non-serious case was received from a consumer/non-health care professional via Medical Information (Reference number- 00814928) and transmitted to Sanofi on 29-Sep-2021.  This case is linked to case 2021SA345065, 2021SA345205, 2021SA345076, 2021SA344823 and 2021SA344344 (CLUSTER).  This case involves a 93-year-old female patient who accidently received frozen dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALEN (product storage error).  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medication and family history were not provided.  On 15-Sep-2021, the patient received a 0.7 mL dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (once, lot UJ716AA, expiry date: 30-Jun-2022) via intramuscular route in the left deltoid for prophylactic vaccination.  It was an actual medication error due to product storage error. (latency: same day). It was reported "doses of possibly frozen FLUZONE QUDRIVALENT HIGH-DOSE and FLUZONE QUADRIVALENT were administered on accident after a shipment of FLUZONE HIGH-DOSE and FLUZONE QUADRIVALENT arrived frozen. The doses were accidently used before realizing the shipment was frozen".  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 holder's compliance with the requirements set out in the 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.
1:00 in the morning, I started vomiting and having severe chills and throughout the course of that day - extremely tired; severe headache and my arm was sore. Wednesday I was back to normal.