chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient received Menveo with an unapproved diluent; patient received Menveo with an unapproved diluent; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: patient received Menveo with an unapproved diluent) and inappropriate dose of vaccine administered (Verbatim: patient received Menveo with an unapproved diluent). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 25-JUL-2023 The reporter consented to follow up. The patient received Menveo with an unapproved diluent, which led to which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
pt recv vax 4DEC95 & 10DEC95 pt exp fatigue, nausea & fever which resolved on 10JAN96;28DEC95 pt WBC was 19.5, RBC 2.8, hematocrit 24.8, hemoglobin 8.3 & iron 4.0;10JAN96 pt fever recurred;BUN 61 & creatinine clearance of 3.9;
10 days after the first shot I got ?Covid arm?  at injection site. By Day 16 the redness had doubled in size, approximately 11 mm by 15 mm. The area is hot to touch versus the non impacted skin.
Pain, swelling, inflammation started at injection site. Low Grade fever, aches, headache, nausea, diarreaha, fatigue, dizziness began 24 hrs post 2nd vaccine. Lots of hydrating of water, Motrin 3 times a day, rest. Fatigue, Major headaches. I'm now 8 days post vaccine and hoping to turn the corner.
Narrative: 70 year old male patient reports headache lasting one week following his second COVID-19 Pfizer dose on 02/19/2021. No symptoms were reported following his first dose on 01/29/2021.
pt recvd vax & rt deltoid was swollen 2 1/2 inches x 1 3/4 inches, reddened; c/o chest pain & nausea & HA;
In 1/11/23 clinic, a vaccinate candidate presented COVID19 card and consent form with last dose recorded as 4/17/22 on both of the documents.  And so the the candidate was given the bivalent Pfizer booster dose per guidelines.  However, upon database submission it was noticed that this individual had received a dose on 09/21/22 from another facility which is not noted on either of the doucments provided at the time.   As the error was noticed with the administration of extra dose, both facility director and candidate were made aware.
lip swelling and itchy; lip swelling and itchy; Injection site hot to the touch; Injection site itchy; Injection site hard like a baseball; Cellulitis; A spontaneous report was received from a consumer who was also a 40-years-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and who experienced cellulitis, injection site hot to the touch, injection site itchy, and injection site hard like a baseball, lip swelling and lip itchy.  The patient's medical history was not provided.  Concomitant product use was not provided by the reporter.   On 28 Jan 2021, approximately 19 days prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 010M20A) in the left arm for prophylaxis of COVID-19 infection.  On 09 Feb 2021, the patient's injection site was hot to the touch, itchy, and hard like a baseball. On the same day patient went to the doctor diagnosed the symptoms as cellulitis. On 15 Feb 2021, the patient had lip swelling which was itchy. The patient also stated that patient took almonds but does not think patient had nut allergy. Treatment for the event included antibiotics, Trimethoprim at eight hundred mg and Sulfamethoxazole for injection site hotness, itchiness, and hardness which was stopped on 13 Feb 2021 and had Zyrtec for itchy lip swelling.  Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the events was unknown.; Reporter's Comments: This case concerns a 40 Y/O F female with a medically significant and serious unexpected event of Cellulitis and NS unexpected lip swelling and lip pruritus, with injection site warm, itchy, and hard. The events occurred 13 days after the first dose of mRNA-1273. Treated with antibiotics. Event outcomes unknown. Based on 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.
I, patient was vaccinated on March 30, 2021 at the time mentioned above in the form with the Janssen COVID-19 vaccine at a Medical Center hospital, for 24 hours after the vaccination, I am unwell general: (headache, body ache, diarrhea, stomach ache, chills, fever and discouragement), at the hospital they recommended taking tylenol, after 24 hours all symptoms started to improve, then I was able to go back to my work. As the days passed, I began to present discomfort in my legs: (extreme fatigue, pain, swelling, redness and a lot of itching) being the symptoms more severe in the right leg, I also had a headache, chest pain and back. By April 15, 2021, I could no longer bear the By April 15, 2021, I could no longer bear the discomfort and pain so strong and decided to go for emergencies to the Bergen New Bridge Medical Center hospital, where I was hospitalized for two days, on April 15 and 16, 2021, there too. . I was diagnosed with venous thrombosis in my right leg due to the Janssen COVID-19 vaccine. After leaving the hospital, I was prescribed a medicine of (Xarelto) 20 milligrams, for 3 months and 10 days of disability, being able to return to work on April 28, 2021. After 3 months and I finished my medication on July 9, 2021, after 7 days I returned to present the same symptoms that I had presented on April 15, 2021, seeing myself in the obligation to return to the emergency center of the Medical Center hospital, there they gave me medications until July 21, 2021 where I had my follow-up appointment with my general practitioner MD, that day my doctor told me that I had not had any improvement and would have to send me medications again for another month until next month where I will have a follow-up appointment for my illness. Personally I feel that I am not evolving for the better, I feel more and more tired in my legs and the pains and swelling are getting stronger. In advance, I thank you very much for your attention.
general arm soreness and warmth in the injection sight for ~48 hours, bodily chills + fever for 12 hours (beginning ~5 hours after vaccination administered).   8 days later: redness, itchiness, swelling and warmth at injection site,  flushed face and fatigue (dissipated by morning).
Patient called to report that apx. 2 hrs after receiving vaccination she began to develop significant swelling of arm, limiting mobility of arm, pain and redness that covered an area spanning from the shoulder to elbow. Pt. refused to have this evaluated.
have leg pain in my calve and thigh; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 22Nov2021 09:30 (Batch/Lot number: unknown) at the age of 38 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: PROZAC. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 27Nov2021, outcome "not recovered", described as "have leg pain in my calve and thigh". Therapeutic measures were not taken as a result of pain in extremity.  Additional information: No other vaccine in four weeks. No COVID prior vaccination. No COVID tested post vaccination. No known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
No known adverse reaction at this time (9/8/2021 @1535) after an  offsite Covid  vaccine clinic while  documenting in system our office found that patient has already received two doses of Pfizer Covid vaccine in February 2021. Patient had filled out the covid vaccine registration form prior to the Moderna vaccine given 9/8/2021. Patient did not mention he had any other Covid vaccines in the past. I did try to call the patient to update him that a report would be filled out and to gather anymore information that he may have, patient did not answer. A voicemail was left to call our office.
Information has been received from a licensed practical nurse concerning a 5 year old male student with no known drug allergies who on 9/29/99 was vaccinated SC on the left side with the first dose of varicella virus vaccine live (lot # 631176/0718J). It was reported that on 3/7/04, the patient developed scattered vesicles on his body. The patient was seen in a physician's office. On 3/8/04, the patient recovered. The reporter also mentioned the patient's sibling (WAES0404USA00508) who was also vaccinated with varicella virus vaccine live and experienced a similar reaction. Additional information is not expected.
Soreness that does not resolve.  Stiffness and inability to use full range of motion.  After a month my arm still aches and makes routine movement difficult.
Offender was given the 2nds dose 22 days after 1st dose.  Offender denies adverse reactions.
p/vax pt devel body rash 3/14/99;seen by MD 3/15/99;MD stated rash related to MMR to mother;
Long lasting myalgia; Neck pain; Flu like symptoms; This case was reported by a other health professional via sales rep and described the occurrence of myalgia in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced myalgia, neck pain and influenza-like symptoms. On an unknown date, the outcome of the myalgia, neck pain and influenza-like symptoms were recovered/resolved.   It was unknown if the reporter considered the myalgia, neck pain and influenza-like symptoms to be related to Shingrix.     Additional Information: GSK Receipt Date: 08-SEP-2022  Reporter's Comment: Reported stated that patient had long lasting myalgia, neck pain and flu like symptoms for multiple weeks. Reported did not consented to follow up. Additional supportive information: This case has been linked with the case US2022AMR129917 reported by same reporter.; Sender's Comments:  US-GSK-US2022AMR129917:Same reporter
2-27-21 same day about 6:00pm severe throwing up and diaherra  until Monday 2-29-21 and ran a low grade fever 100.7 . Continued to not feel well, very weak by Wednesday 03-03-21 unable to pee good, just a very small amount and severe pain. 3-3-21 went to health clinic. Tests results indicated kidney and bladder infection took antibiotic SULFAMETHOXAZOLE-TMP DS TABLET on 3-3-21. Pain still server when peeing so on 3-5-2021 Dr. gave me TAMSULOSIN HCL 0.4 MG CAPSULE. Still having trouble peeing went back to  on 3-22-2021 still had infection so given another antibotic CIPROFLOXACIN HCL 500 MG TAB TABLET. Referred to Urologist with no real findings, continued with flomax
This case was reported by a pharmacist and described the occurrence of urinary frequency in a adult male patient who received FLULAVAL (batch number MJ7A9, expiry date June 2015). Co-suspects products included BOOSTRIX (batch number 95L3P, expiry date 11th April 2016). On an unknown date, the patient received FLULAVAL and BOOSTRIX. On 28th January 2015, an unknown time after receiving FLULAVAL and BOOSTRIX, the patient experienced urinary frequency, blood pressure high, runny nose and sneezing. On an unknown date, the outcome of the urinary frequency, blood pressure high, runny nose and sneezing were unknown. It was unkonwn if the reporter considered the urinary frequency, blood pressure high, runny nose and sneezing to be related to FLULAVAL and BOOSTRIX. Additional information was provided: This case was reported by a pharmacist via a claim from the consumer who experienced the adverse events.
Headache, fatigue, flushing initially. Weak muscles in legs (started in thighs). Went to hospital 10/19/18 after experiencing thick tongue and throat (stopped eating lunch). After blood work, low platelets, increased creatinine, increased sedimentation rate at hospital; pt received IV fluids...muscles resolved...MD said pt was dehydrated. As time went on, pt started to feel better and was discharged and is still slowly recovering at home.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Oct2021 as dose 3 (booster), single (Lot number: 301458A), in left arm and on 24Jul2022 as dose 4 (booster), single (Lot number: FP7137) at the age of 63 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's relevant medical history included: "Hypothyroidism" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXIN, start date: Jan2010; CALCIUM, start date: Jan2000; GLUCOSAMINE CHONDROITIN [CHONDROITIN SULFATE;GLUCOSAMINE], start date: Oct2021; COLLAGEN, start date: Nov2017; VITAMIN D [COLECALCIFEROL], start date: Aug2021. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: Patient's concomitant medication also included VitreousHealth.  Follow-up attempts are completed. No further information is expected.
Patient presented on 5/12/21 to  Hospital ED with severe headache, photophobia, neck stiffness that began on 5/10/21. Lumbar puncture done and confirmed meningitis with Varicella Zoster Virus isolated from CSF.  Patient remains hospitalized at this time receiving two weeks of IV Acyclovir treatment. Infectious Disease physician consulted and felt that there could be a correlation to her recent COVID vaccination and a reactivation of VZV.
Onset of fever & sweats, culminating with a maximum temperature of 102 degree on 9/26. Also had episodes of vomiting and diarrhea. Her temperature was also elevated on 9/27 & 9/28 (99.9 on 9/28), and she missed work on both of those dates.
Patient felt dizzy after administration and then fainted as she got up from chair and then was taken to emergency room.
Pt had a syncopal or near syncopal episode after vaccine, which he stated was normal after any  needle.  But this time he had chest pain with the syncopal episode which he stated has never happened.  Pt was assessed by ems cew and transport via ambulance
Had fever-went to ER Had vomiting and diarrhea & cold symptoms 3/1/02 Diagnosis with Otitis Media. Unlikely due to vaccine per nurse practioner but diagnosis as immunization reaction @ hospital
pt recvd 1st dose of vax w/no noted problem; Pt recvd 2nd dose of Hep B vax on 18AUG92 & w/in an hr following vax pt exp sore arm w/pain @ the inject site; sx resolved w/in 24 hrs;
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 65-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 64 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Crohn's" (unspecified if ongoing); "Known allergies: Dairy" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Ceftin, reaction(s): "Known allergies: Ceftin"; Celexa, reaction(s): "Known allergies: Celexa". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient received Paxlovid for the treatment of COVID-19 on 04May2023 and stop on 09May2023.  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.; Sender's Comments: Based on the information available, the events Drug ineffective and COVID-19 are assessed as related to BNT162B2 administration.
fever 101, arm soreness, body aches, fatigue, nausea, congestion and dry cough
Pt vaccinated with Hepatitis B Vaccine developed onset of herpes zoster 9 days after received hepatitis B Vaccine.
Immediate nausea, mild pain/warmth at site of injection. Onset of headache approx 1 hr after inoculation. Muscle aches same evening of injection. Woke up with neck stiffness -?d moderate/severe joint pain (7/10 pain scale) in hips, wrists, and knees. Headache and nausea continuing throughout day today, along with severe joint pain and moderate muscle aches.
This spontaneous report as received from a pharmacist via a Poison and Drug Center, refers to a 72 year old female patient. She had no relevant medical history and is not allergic to neomycin or gelatin, concomitant medications and past drug use are unknown. On 30-AUG-2013 the patient was vaccinated with ZOSTAVAX (lot # J003796 exp date: 28-JUN-2014; 1 subcutaneous injection in the left arm) for prevention and PNEUMOVAX 23 (lot # H013581; exp date: 03-MAR-2014; 1 intramuscular injection in the left arm) for prevention. On 31-AUG-2013 the patient started to notice swelling in her left arm. On 01-SEP-2013 her left upper arm is red, and swelling from the site of the, 2 days after onset of the ZOSTAVAX around the arm to the outside, and states it is sore. It is unknown if there is any relevant laboratory data. As of 01-SEP-2013 it is unknown if she will have another ZOSTAVAX or PNEUMOVAX 23 and she continues to have redness, swelling and a sore upper left arm. Additional information has been requested.
bronchospasm; shortness of breath; brain fog; difficulty sleeping at night; extreme exhaustion; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 52-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Dec2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; pneumococcal 20-valent conjugate vaccine (diphtheria CRM197 protein) (PREVNAR 20), in Dec2022 as single dose (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BRONCHOSPASM (non-serious), 10 days after the suspect product(s) administration, outcome "recovering"; DYSPNOEA (non-serious), 10 days after the suspect product(s) administration, outcome "recovering", described as "shortness of breath"; FEELING ABNORMAL (non-serious), 10 days after the suspect product(s) administration, outcome "recovering", described as "brain fog"; INSOMNIA (non-serious), 10 days after the suspect product(s) administration, outcome "recovering", described as "difficulty sleeping at night"; FATIGUE (non-serious), 10 days after the suspect product(s) administration, outcome "recovering", described as "extreme exhaustion". Additional information: The patient reported being very sick after receiving the 4th COVID 19 Booster vaccine Pfizer with variant and Prevnar 20 vaccine in Dec2022. After 10 days receiving the vaccine patient reported she begun experiencing the same symptoms as she did after receiving the COVID booster injection last time (unknown date.) These symptoms include "bronchospasm, shortness of breath, brain fog, difficulty sleeping at night, and extreme exhaustion," but they are improving. Per the doctor and patient indicated that the symptoms were reaction's to the "COVID booster". Therapy was currently on hold. The last dose of Lenvima 18mg capsules once a day was on Feb2023 (unknown exact date). Unknown when to resume therapy. No hospitalization. MD is aware.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, pneumococcal 20-valent conjugate vaccine (diphtheria CRM197 protein) has been requested and will be submitted if and when received.
Pt comes in with concerns about possible Pfizer vaccine reaction. Initially had hives- which resolved now with some mild tenderness and prominence of existing varicosity.  Sx c/w mild thrombophlebitis- which is unlikely to be a SE of the vaccine will get US to r/o DVT, advise elevation, compression and NSAIDS  rash of LLE looks ecchymotic, she denies fall. Has had bruising in the past which she states was associated with trauma Again- difficult to say whether this is a vaccine-related event will get labs - including CBC VWF, ESR and CRP the rash has already begun to improve .
Child received DTaP #5 to left deltoid on 4/21/03. Mother brought child today 4/23/03 at 11:30AM. Left deltoid moderately swollen, hard, and warm to touch and slightly red. Cold compress applied by mother on 4/22/03 when swelling was first noted. No other adverse reactions noted. Advised mother to continue with cold compress and bring child to a doctor if symptoms worsens. Child alert, conscious, and responsive.
upper rt arm pain-20min post vax arm swelled doubling in size w/rash, painful to touch, limited motion;
Severe pain upper arm, pain when moving arm. Developed day of injection. Pt seen 12/13/2011 and had focal pain at injection site and with abduction of left arm. Prescribed tapering course of prednisone, and cold packs.  MRI of left upper arm ordered, done 12/16/2011. Was normal. Pt. seen again 12/27/2011 still with left arm pain and now complains of "funny feeling "in left arm when raising arm. Patient referred to orthopedic dr. and neurology.  Pt. wanted to see orthopedic first.  Was treated with cortisone shot left arm.  Pt. had no relief, then had physical therapy  Pt. states no relief and she had appt. with neurologist 1/27/2012.  I also tried treating patient with Ultram for pain and Mobic 15 mg. a day.  Pt refused appt. with me this week, wanted to see the neurologist and would contact my office.
Pt experienced flu-like symptoms (body aches, low grade fever, chills), sore arm with injection site warmth, decreased joint mobility.