chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Booster; First two injections were Moderna that was 08Mar21 and 09Mar21. The booster was Pfizer and that was 30Oct2021 of this year.; First two injections were Moderna that was 08Mar21 and 09Mar21. The booster was Pfizer and that was 30Oct2021 of this year.; headache literally right before she is due to have that next injection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from License Party. Other Case identifier(s): AGN279967 (Allergan).  A 51 year-old female patient (unknown if pregnant) received bnt162b2 (BNT162B2), administration date 30Oct2021 (Batch/Lot number: unknown) at the age of 51 years as dose 3 (booster), single for covid-19 immunisation; botulinum toxin type a (BOTOX) (Batch/Lot number: unknown) for migraine. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Moderna covid-19 vaccine, administration date: 08Mar2021, for covid-19 immunisation; Moderna covid-19 vaccine, administration date: 09Mar2021, for covid-19 immunisation. The following information was reported: IMMUNISATION (non-serious) with onset 30Oct2021, outcome "unknown", described as "Booster"; OFF LABEL USE (non-serious), INTERCHANGE OF VACCINE PRODUCTS (non-serious) all with onset 30Oct2021, outcome "unknown" and all described as "First two injections were Moderna that was 08Mar21 and 09Mar21. The booster was Pfizer and that was 30Oct2021 of this year."; HEADACHE (non-serious) with onset 2021, outcome "recovered" (2021), described as "headache literally right before she is due to have that next injection". The action taken for botulinum toxin type a was unknown.  Additional information: It was reported that patient was one of the (unlisted) Support Specialist and just calling to report do have a patient three years on Botox for chronic migraines reporting headaches literally right before she is due to get her next injection series, so right at that 12th week. She did give permission to reach out to her and/or her doctor. So, yes to reach out to her and or her doctor. No idea about the number a units she was receiving. Her last injection was on 30Nov2021 of this year. Her next injection series is on 08Mar2022. She has had two COVID shots and a booster. So, COVID information. First two injections were Moderna that was 08Mar2021 and 09Mar2021. The booster was Pfizer and that was 30Oct2021. And again. So, the patient does not have a headache today but she is having she stated it just stated within the last six months or so she will get a headache literally right before she is due to have that next injection." Headaches literally right before she is due to get her next injection series within the last 6 months.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
2nd dose had fatigue; mild fever; body ache; tension headache; This is a spontaneous report from a contactable nurse reported for himself. A 49-year-old male patient received second dose of bnt162b2 (BNT162B2, Lot#: EJ1686), via an unspecified route of administration on 11Jan2021 on Right Arm at single dose for covid-19 immunisation. Medical history included Ulcerative Colitis. No allergies to medications, food, or other products. Concomitant medications included the patient received within 2 weeks of vaccination: Mesalamine. The patient previously took first dose of bnt162b2 (Lot#: EH9899) via Intramuscular on 21Dec2020 09:30 AM on Left arm at single dose for covid-19 immunisation. Facility where the most recent COVID-19 vaccine was administered was hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced 2nd dose had fatigue, mild fever, body ache and tension headache from 12Jan2021 06:00 AM. The outcome of the events was recovered. No treatment was received for the adverse event. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Location of injection information is available for all vaccines received on the same date.
Wheezing, coughing, 4 weeks, Pain in left arm was ease. Had no pain in left arm or tingling pain after the first dose of vaccination. After treated by the doctor from urgent care and medical doctor i was hesitant to do the second dose of the vaccination.. I was inform by the ER doctor to wait  until i saw the Pulmonologist to do the second dose of the vaccination. I did the second dose on June 18th and my symptom  is coughing and same as before my pain is not healed but i am not having the pain as before. I can sleep at night, lift my arm and its much stronger than before i did the second vaccination. I went to physical therapy and my therapist was amaze to see the improvement in my left arm. I goes to therapy twice per week and was there June 18 before i got the vaccination.  I am very concern about my improvement of my left arm and wish this could be a breakthrough for a new medication for patients who are suffering from Neuropathy, frozen shoulder and other pain that we experience and there is no cure for it otherwise with just taking pills for the rest of our lives.
HE received his vaccine and was in the post vaccine area for approximately 10 min. The paramedic and I looked up and  noticed a sudden change in mental status- dropped his phone and started making slight grunting noises as well as turning pale. We rescued the patient, got the stretcher and he became  lucid. His activity was seizure like  (petit mal). I  called the ED charge nurse, provided report, and the patient was transported via paramedic X 2 to the ED for an evaluation.
2-3 hours after vaccination, patient developed red, swollen arm from vaccination site to elbow. By next morning swelling had extended to fingers. C/O joint stiffness and pain. By 1/29/14 swelling reducing, joint stiffness improved. ROM back to baseline took BENADRYL 25 mg PO Rx TID PRN.
Pt was given dose 1 at 14:35. Upon checking with pt at 14:45, pt head in hands, rocking, and shaking. Pt was helped to back room, at that point, unstable, held by staff, taken by wheel chair to exam room. Pt was given benadryl, zofran, solu medrol, and epi. 911 was called, and pt was taken to local hospital.
local swelling p/vax 14JAN97 on 22JAN97 arthurs type rxn;redness, pallor, pain;lacy, maculopapular rash @ local inj site;
Pregnancy; Fever 38.3C; soreness at injection site; burning watery eyes; burning watery eyes; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EYE IRRITATION (burning watery eyes), LACRIMATION INCREASED (burning watery eyes), EXPOSURE DURING PREGNANCY (Pregnancy), PYREXIA (Fever 38.3C) and VACCINATION SITE PAIN (soreness at injection site) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Feb-2021 at 8:30 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 04-Feb-2021, the patient experienced EYE IRRITATION (burning watery eyes), LACRIMATION INCREASED (burning watery eyes), PYREXIA (Fever 38.3C) and VACCINATION SITE PAIN (soreness at injection site). On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (Pregnancy). At the time of the report, EYE IRRITATION (burning watery eyes), LACRIMATION INCREASED (burning watery eyes), PYREXIA (Fever 38.3C) and VACCINATION SITE PAIN (soreness at injection site) had not resolved and EXPOSURE DURING PREGNANCY (Pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Body temperature: 38.3c (High) 38.3C.         Concomitant product use was not provided by the reporter.   No treatment information was provided.     Most recent FOLLOW-UP information incorporated above includes: On 23-Jul-2021: Pregnancy has been added.
Patient received a second Moderna Bivalent booster.  No adverse reactions during the 15 min observation period. She was made aware that she received an extra unauthorized booster. She was confused because they told her it was time for her to get another booster.
Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 09-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No  concomitant medication was provided.  No treatment medication was provided.  The vaccines had remained in freezer at -24 degrees F up until the day of the vaccination.
11/8/2018 1041 AM patient is at work today and is calling to report that she got her flu shot 2 days ago, and now has painful swelling and a "mass" under her armpit/ ? lymph gland. She will stop by Occ Health today for RN to view it. She was advised that will probably need to be seen by PCP to be certain that is the flu shot that caused the reaction. 1315 PM patient in office to be checked. She has a palm size painful lump under left armpit area that is tender when palpated 5/10 pain. It is not hot or red. IM site can be seen with band aide irritation noted to Left deltoid. She did not get vaccine 2 days ago, but got it yesterday between 10a-2p during flu clinic. She reported "good technique" by student who gave vaccine. She is afebrile, and has no other symptoms. Area is marked with sharpie and photo taken with her phone. She will report back here at 10am start of her shift in the morning, and use ice and ibuproifen Q 6-8 hours until seen again. Any changes, she is to go to urgent care this evening. She will have spouse check marked area again this evening. RN also present for assessment. 11/9/2018 1254p Called patient as she did not come to office at 10am as agreed. She reports "not better" She has been using ice and Ibuprofen and it is more tender now. Size as marked has not changed, but she says it woke her up last night when she was turning over in bed. She plans to call her PCP or GYN and be seen. She will report back to Occ Health Monday with verbal report of whether they think this is related to the flu shot or not. She verbalizes that "she has had trouble on this side prior and they have been watching that side before  this happened. She will plan to not take vaccines in this arm in the future.
Volunteer was 17 years 6 months. She had no adverse reaction . Associate was under 18 was notifying Moderna and seeking guidance.
m soreness from both doses of the vaccine which lasted only for a day after each shots were; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (m soreness from both doses of the vaccine which lasted only for a day after each shots were) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (m soreness from both doses of the vaccine which lasted only for a day after each shots were). At the time of the report, PAIN IN EXTREMITY (m soreness from both doses of the vaccine which lasted only for a day after each shots were) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was reported.    This case was linked to MOD21-087622 (E2B Linked Report). This case was linked to MOD-2021-114511 (Patient Link).; Sender's Comments:  MOD21-087622:Same reporter, different patient
patient waited 15 min  then left the facility with her husband while driving in the car patient felt " like my face was swelling" patient instructed her husband to return to the vaccination clinic were she presented to the Registered Nurses stating" my face is swollen"  patient brought to building for triage ER MD arrived at 1412 orders given to rn to give 50 mg Benadryl IM stat.  Patient medicated as ordered at 1442.   Patient then complained of throat tightness MD gave epi pen IM left buttock.  911 called report given by MD.  Patient avox4 regular even respirations . pt transported via gurney
Pain immediately at injection site, sore since injection, bruised within 1st couple of days from shoulder to elbow, approx. 2-3 inches wide.  Stated blood pressure was low.
difficulty breathing; Difficulty swallowing ( felt as if my throat was closing); rapid heart beat; severe headache; This is a spontaneous report from a contactable consumer (patient).   A 35-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: Ff8839, Expiry Date: Not Reported), via an unspecified route of administration, administered in Arm Left on 29Sep2021 (at the age of 35-year-old) at 16:30 as dose 2, single for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The medical history included seizure. There were no concomitant medications. The patient historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: Fc3182, Expiry Date: Not reported) via an unspecified route of administration, administered in Arm Left on 08Sep2021 (at the age of 35-year-old) at 16:15 as dose 1, single for covid-19 immunisation. No other vaccine in four weeks. No other medications in two weeks. No covid prior vaccination. No covid tested post vaccination. The patient did not have any known allergies. On 30Sep2021, the patient experienced, difficulty swallowing (felt as if my throat was closing), rapid heartbeat, severe headache, difficulty breathing. Lasted about 20 or 30 mins. The patient underwent lab tests and procedures which included heart rate: rapid on 30Sep2021. The AE resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for reported event. Outcome of the events was not recovered.
This spontaneous report as received from a nurse refers to an unspecified number of patients. The patient's medical histories were not reported. On an unknown date, the patients received improperly stored doses of RECOMBIVAX HB (dose, route, site of administration and lot # were not reported). No adverse events were reported. This one of several reports from the same reporter. Additional information has been requested.
Mother reports fever 9 days after vaccines 102 & rash. Concerned with behavior, banging head, biting, tantrums, "not acting like herself."
generalized confluent rash sparing protected areas; This case was reported by a physician via sales rep and described the occurrence of rash in a 17-year-old male patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 3rd October 2022, the patient received the 1st dose of Bexsero and Bexsero Pre-Filled Syringe Device. On 17th October 2022, 14 days after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   The reporter considered the rash to be unlikely related to Bexsero and Bexsero Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 17-OCT-2022 Reporters comment:The reporter reported that patient received first dose of bexsero and experienced generalized confluent rash sparing protected areas.
She aches like the flu - no apparent fever.  Injection in left forearm, below elbow has red dots - spread out.  If I rub arm it tingles.  For 3 days still feels bad.
first event 03/31/2021 patient reports having a seizure episode with migraine, hospitalized 5/28/21-5/30 and 7/1/21-7/3/21 and multiple er visits
Lower leg pain from the hit down headaches fatigue For the next day in a half and she got checked out at urgent care asprin -low dose (baby asprin ) Tylenoyl
#1 2/12/21 #2 3/12/21 - headache started noon 3/18/21, not much appetite, got worse throughout the day, went to ED, INR 16.7
1/29/08 Child received DTaP, IPV, and Varivax at 4 yr ckup. 3:30 pm. At 4 pm 1/29/08 mom noticed blotchy rash all over child and child was coughing and appeared to be having difficulty breathing. Returned to care. Received 25 mg Benadryl at 4:05 pm, child was wheezing. Neb with 25 mg Albuterol given. Epinephrine 0.15 given-child seemed to respond well to Rx in the office. Was transported to hospital. See discharge summary enclosed.
covid-19; covid-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient (not pregnant) received bnt162b2 (BNT162B2 NOS), on 13Jan2023 as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient had no relevant medical history. 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 "recovered" (2023) and all described as "covid-19". Therapeutic measures were taken as a result of drug ineffective, Covid-19 with Paxlovid from Oct2023 to Oct2023.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300335935 same patient, different drug/AE;
10pm started feeling cold. Then got the shakes for 2  1/2 hrs. Had fever.  Woke next morning (Wednesday), nauseous, fever. Foggy and tired Arm painful and couldn?t lift it past waist.  Had fever 100.2 Wednesday and Thursday. Still felt tired.  Friday morning woke up feeling back to normal
36 yo female received Pfizer Covid-19 vaccine #1  at Mass Vaccination Clinic , and shortly after in monitoring area, complained of wheezing (was diagnosed with bronchitis and wheezing the day before), itchiness of throat, subjective discomfort of throat (swelling) with swallowing within few minutes of vaccine.  Exam: VS: HR 73, RR 20, BP 132/84, O2 sat 93%. BG 132  RUL wheezing, no lip/tongue/oropharyngeal swelling Albuterol MDI 2 puffs was taken. Benadryl 50mg po was given. Monitored for 50 minutes after vaccine. RUL wheezing improved, throat itching/discomfort resolved.  Repeat VS: HR 70, RR 20, BP 116/72, O2 sat 93% (on RA). Pt discharged to home.
[Arm] hurt; Nauseous off and on; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY ([Arm] hurt) and NAUSEA (Nauseous off and on) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY ([Arm] hurt) and NAUSEA (Nauseous off and on). At the time of the report, PAIN IN EXTREMITY ([Arm] hurt) and NAUSEA (Nauseous off and on) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication reported Case is cross linked to MOD21-036255
Acute Right unilateral vestibular Hypofunction (Vestibular Neuritis)  Vertigo Nausea  Vomiting
Gave Dtap instead of Tdap on 8/7/06 for school entrance vaccination. 8/8/06 13:20 TC to father and client had more soreness at site left arm today. He gave her ibuprofen this AM and daycare hasn't called him.
L upper arm has hurt since receiving the influenza vaccine. (L) upper arm muscle is firm to touch; (L) arm movement is painful. Client referred to MD for further evaluation.
Not an adverse event, but I have had a 5 personal zoster outbreaks in people previously immunized persons and know of 2 others in our community who had the shingles vaccine and still got shingles. Does this shot really work? Is my experience unusual. I have a small practice and I would suspect the failure of the vaccine to prevent shingles in at least 10% and will surely rise as the years go on. I didn't know where to send this report. I hope I have not wasted time.
Rash over 50% of body  and getting worse    Stared around 11:00am. 50% covert by 10:00pm Went to ER Treated with Benedryl, Pepcid, Soul Medrol by I V
Headache,  nausea , retroorbital pain, cough, shortness of breath, vomited once
Received Shingrix vaccine (first of two) on 10/26/2020 Developed fatigue, loss of appetite and myalgias on 10/29-30. On 10/31/2020, in AM, went to walk up steps and had cardiac arrest and died Family declined Autopsy
patient receiving a dose of Fluzone that was administered after it took to long to receive, no AE; Initial information received on 06-Oct-2020 regarding an unsolicited valid non-serious case from a consumer/non-health care professional.  This case involves patient of unknown age who received a dose of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE] (lot number and expiration date not reported) via unknown route in unknown administration site for prophylactic vaccination on unspecified date. This vaccine was administered after it took to long to receive, as the shipment was to be received in two day, but it took three days and was reported that the product was not viable (PT: product storage error).  The patient's medical history and concomitant medications were not reported.  It was an actual medication error case due to incorrect product storage. As the patient received it after the vaccine underwent temperature excursion.  No adverse event reported at the time of reporting.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information on the batch number for this case.
I have had Covid19 March2020.  I had same symptoms as i did when i had covid.  I had fever of 103, shivers/chill, hallucinations, bad dreams.  This feeling lasted for 36 hours.  After that I was back to normal.
Violent cough x 3 weeks per patient complaint on 8/4/06.  per T.C. Smoon 8/4/06: advised to get medical diagnosis & treatment ASAP.