chrisvoncsefalvay/vaers-outcomes huggingface dataset:
flare up/possible osteoarthritis; Fibromyalgia; Itchiness; Pain flare up; Rash; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of OSTEOARTHRITIS (flare up/possible osteoarthritis), FIBROMYALGIA (Fibromyalgia), PRURITUS (Itchiness), PAIN (Pain flare up) and RASH (Rash) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. In March 2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On an unknown date, the patient experienced OSTEOARTHRITIS (flare up/possible osteoarthritis), FIBROMYALGIA (Fibromyalgia), PRURITUS (Itchiness), PAIN (Pain flare up) and RASH (Rash). At the time of the report, OSTEOARTHRITIS (flare up/possible osteoarthritis), FIBROMYALGIA (Fibromyalgia), PRURITUS (Itchiness), PAIN (Pain flare up) and RASH (Rash) had not resolved and PAIN IN EXTREMITY (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant Drugs Not Reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for the event(s) of flare up/possible osteoarthritis, fibromyalgia, sore arm and severe muscle pain with Humira(adalimumab) was no reasonable possibility. The reporter's causality for the event(s) of itchiness, pain flare up and rash with Humira(adalimumab) was a reasonable possibility.  Treatment Drugs Not Reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2021-624197 (Patient Link).
2 days after receiving flu vaccine, patient was hospitalized for seizures and a possible stroke. Note that she had taken flu vaccine in the past without reaction. The medical record received on 12/11/03 state tremulous, fatigue, and arm pain. The patient has returned to work and normal activities.
After vaccine given and Pt sitting for 15 min c/o blurred vision and foot pain and tingling. Pt laying down, Vitals monitored.  Pt given fruit snacks and water. Vision and tingling cleared after 35 min Foot pain continued. Pt was rechecked in office at 11:00 8/28/2013 for bilateral leg pain Pain worse in right leg. C/o pain in back, shoulders legs and feet. Right foot swelling in AM noted by pt/ mother. Treating with Advil or Aleve prn.
Reports indicate patient presented to the hospital for evaluation because of worsening difficulty in breathing with activity.  She did test positive for COVID-19 on 12/04. Patient reports at least a greater than 5 day history of nasal congestion, chest congestion associated a cough that is sometimes productive of clear, but sometime discolored phlegm. Symptoms are associated with chills, but no fever. Patient also reports nausea with dry heaving, but no vomiting. Patient reports chronic, but not acute or acute worsening diarrhea..  Reports indicate patient was found to be saturating down at 89% on arrival.   On arrival into the hospital, patient was noted to be normotensive with blood pressure 100/54, otherwise afebrile saturating 93% on 2 liters/minutes supplemental by then.  Initial temperature was 99°.  Further workup in the emergency room does include a CMP that shows a BUN and creatinine of 34 and 2.1 respectively with a glucose of 97.  Albumin and total protein 2.2 and 5.8.  CRP was elevated at 3.76.  Ferritin was 288.7.  LDH 285.  Procalcitonin 0.13.  Troponin was 33.3.  D-dimer is 218. Lactic acid 1.3.  CBC with differential shows shows a hemoglobin and hematocrit 9.5 and 31.4 respectively with a platelet count of 450 and a white count of 8.08 with 94% represents segmented neutrophils.. COVID-19 testing was positive.   Because the patient symptoms, patient did go on to receive a L of normal saline as a bolus, she was given a starter dose of dexamethasone     Doxycycline and Rocephin empirically started.  Decadron and Remdesivir started per covid Protocol.  O2 support continued from ER.   Dr spoke with another Dr regarding anti-rejection medications noting amylase, lipase and creatinine levels were increasing with concern of transplant rejections.  Dr spoke with another Dr transplant team.  There were no beds available for transfer to hospital.  They discussed medication adjustments including Tacrolimus and Cellcept adjustments.   Patient continued to decline and night of 12/18, "12/18 night shift patient sustained accidental fall night shift with no new injury.  Patient also required non-rebreather mask overnight.  Chest x-ray bilateral pulmonary infiltrate. Labs revealed white cell count increased to 24. But procalcitonin 0.06 CRP 1.67."   Bicarbonate started after drop in bicarb and diarrhea.  She had IV fluid adjustments.  Breathing continued to decline and  REACH call completed. Code status re-addressed and she was adament regarding DNR/DNI status.  With continued declined, patient stated she could not continue as such.  She endorses knowing she was dying and "was done."  She pulled off her Bipap which was quickly replaced with nasal cannula.  She subsequently removed nasal cannula.   She was transitioned to Comfort Measures.  Patient's sister was notified and came to hospital.  Patient's son was notified.  On December 12/21/2021 at 0526 pt died from complications of Covid 19 Sepsis and Pneumonia.
p/vax pt devel varicella w/pruritic red spots on abd, legs, arms & scalp that looked like mosquito bites;no information about the number of lesions was provided;pt sought medical attention;
Client received her second Pfizer vaccine a week early. She should have received the vaccine on 4/22 but client came in and received it at a walk in clinic on 4/13. Client was made aware that her vaccine was given a week early.
felt nauseous the first day; injection site hot, red, hard, swollen for 3 days; injection site hot, red, hard, swollen for 3 days; injection site hot, red, hard, swollen for 3 days; injection site hot, red, hard, swollen for 3 days; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 25Mar2021 11:00 (Lot number: EN6206) at the age of 64 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "AFib" (unspecified if ongoing); "elevated cholesterol" (unspecified if ongoing); "hashimotos disease" (unspecified if ongoing). Concomitant medication(s) included: ELIQUIS; SYNTHROID; ROSUVASTATIN. The following information was reported: NAUSEA (non-serious) with onset Mar2021, outcome "unknown", described as "felt nauseous the first day"; VACCINATION SITE WARMTH (non-serious), VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE INDURATION (non-serious), VACCINATION SITE SWELLING (non-serious) all with onset 2021, outcome "recovered" (2021) and all described as "injection site hot, red, hard, swollen for 3 days".  Additional information: The patient has no known allergies. The patient did not receive any other vaccine within 4 weeks prior to COVID-19 vaccine. Prior to vaccination, the patient was not been diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.
This spontaneous report as received from a Licensed Practical nurse refers to a patient of unknown age and gender. On 13-NOV-2012, the patient was vaccinated with a dose of GARDASIL (lot number was reported as 0636AE and expiry date was 09-JAN-2015, route and dose were not reported) that was exposed to 25 degree Fahrenheit for an unknown period of time. No concomitant medications were reported. No adverse symptoms reported. This is one of the several reports received from the same reporter (MARRS# 1212USA000913, 1212USA000914, 1212USA003709, 1212USA003710, 1212USA003711, 1212USA003712, 1212USA003713 and 1212USA004285) Additional information has been requested.
Flu immunization administered at 9 month well visit. Due to parent concern, was observed in office for period of 20 minutes after vaccine was administered. On the way home, approx. 45 minutes later, patient developed swollen lip and wheezing. Was taken to the Emergency Room. En route to the emergency room parents administered EPIPEN Junior. Symptoms largely improved administration. In ED was given dose of DECADRON and BENADRYL. He was observed in the ED for a couple of hours until discharged home.
Presented with 2 day history right axilla lymph node swelling and tenderness. Treat with heat and ibuprofen.
Redness, swelling, 12 1/2 cm x 14 cm. No treatment.
EYES HURT; DIZZINESS; FATIGUE; HEADACHE; ARM SORENESS; SEVERE CHILLS; This spontaneous report received from a patient concerned a 47 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced arm soreness. On 07-APR-2021, the subject experienced severe chills. On 07-APR-2021, the subject experienced headache. On 08-APR-2021, the subject experienced eyes hurt. On 08-APR-2021, the subject experienced dizziness. On 08-APR-2021, the subject experienced fatigue. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from arm soreness, and dizziness, and had not recovered from severe chills, headache, eyes hurt, and fatigue. This report was non-serious.
Approx 5 minutes post vaccination patient got up from chair and fell against wall. He was standing but did not verbally respond to us. Patient was moved to lying position on ground and immediately began verbally responding. Blood pressure and heart rate were normal. Patient reported having blurred visions and feeling dizzy. Ice pack was applied to patients neck and he remained lying until EMS arrived to take over. Patient was taken to hospital with EMS per his request.
had onset of sx on 17NOV 3 days p/vax;no fever;
Information has been received from a licensed visiting nurse concerning a patient in his/her 30's who at some point in his/her childhood was vaccinated with a dose of MMR II (lot number not reported). It was reported that the patient was an unconfirmed case of mumps in a local correctional facility but they were pretty confident that it was going to come back positive after the lab testing. The patient was not hospitalized. At the time of the report, the patient's outcome was unknown. It was unknown if the patient sought medical attention. All telephone call attempts to obtain follow-up information have been unsuccessful. This is one of several reports received from the same source. Additional information has been requested.
Blood clot in left calf.  (Previous COVID19 vaccines in April 2021 and booster in December 2021 were Moderna.)
Obstructive jaundice - ED visit and hospital admission. This visit was within 6 weeks of receiving the COVID vaccine.
Patient received high dose flu vaccination on 09/26/2023 at 10 AM in RD. Per patient, she went to pharmacy around 3 PM on 09/26/2023. She states that as she was shopping she started to experience numbness on the L side of her mouth. She states that she then preceded to experience L hand numbness and tingling. She states that the episode lasted less than 5 min. She states that she had never experienced this previously nor has experienced this since the first episode. She states that she has an appt with her PCP today (09/28/2023) to follow up after the episode. She states that no test or procedures have been done at this time.
This is a spontaneous report received from a contactable consumer or other non-HCP. A 43-year-old female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# EW0161), at the age of 43, in right arm, on Apr 18, 2021, single dose, for COVID-19 immunisation. Medical history included alcoholism (unspecified if ongoing). Concomitant medication: baclofen taken for alcoholism. The patient experienced vaccination site pain (soreness in the arm after the first dose), onset Apr 18, 2021, with outcome of recovered (Apr 2021). Additional information: Baclofen started 6-9 months ago (more towards 9 months) with dose change every other week. Patient did not visit the emergency room or physician office. Soreness in the arm after first dose started a few hours later on Apr 18, 2021; and lasted roughly 1 to 1 ½ day. No follow-up attempts possible. No further information expected.
Pain/achiness all over body; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain/achiness all over body) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriatic arthritis.    Previously administered products included for COVID-19 vaccination: PFIZER BIONTECH COVID-19 VACCINE (Dose 1 Route of administration was intramuscular) on 01-Feb-2022 and PFIZER BIONTECH COVID-19 VACCINE (Dose 2 Route of administration was intramuscular) on 22-Feb-2022. Past adverse reactions to the above products included General body pain with PFIZER BIONTECH COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE. Concurrent medical conditions included Psoriatic arthritis.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. In April 2022, the patient experienced PAIN (Pain/achiness all over body). At the time of the report, PAIN (Pain/achiness all over body) had not resolved.      No concomitant medications was provided by the reporter. No treatment medications was provided by the reporter.
a 11 year old female patient received Daptacel instead of Adacel vaccine, No AE; a 11 year old female patient received Daptacel, No AE; Initial information received on 04-Aug-2020 regarding an unsolicited valid non-serious case received from the other health care professional.   This case involves a 11-year-old female patient who vaccinated with DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] instead of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included MENINGOCOCCAL VACCINE A/C/Y/W CONJ (DIP TOX) (MENACTRA) and HPV VACCINE VLP RL1 4V (YEAST) (GARDASIL) for  prophylactic vaccination.  On 03-Aug-2020, the patient received a 0.5 ml sixth dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE  [DAPTACEL] (lot number: C5643CA and expiry date: 17-Jul-2021) via an intramuscular route the right deltoid for prophylactic vaccination instead of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  It was a case of an actual medication error due to wrong vaccine administered and inappropriate age at vaccine administration. It was also reported that therapy date was 04-AUG-2020.  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 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.
I started coughing the day before Christmas of 2022.  The cough got worse, I went to a fast-track clinic and they gave me cough medicine.  I went back two days later, and they did a x-ray Admitted for 2 days they treated the pneumonia.  On the 12th of January I started coughing again more regularly.  That night my wife noticed I stopped coughing, and I pasted out and my wife called the Emergency crew.  They admitted me for another 4 days.  After I was released, I went back to my doctor, and he advised for me to go back to the ER.  They admitted me again and they found I had Dysphagia.  One of my vocal cords was paralyzed due to old age.  I was admitted to same hospital all the times I was admitted.  They believe it has nothing to do with the vaccine. I am currently being treated for this.
same evening of administration vomiting occurred along w/heart palpitations & knee pain; treated w/ATB @ hosp overnoc & felt better next day & sent home;
Anthrax vaccine received right arm and Typhoid received in left arm. Within 72 hours began to note redness, pain and swelling of upper right arm. By day 5 had numbness of all right finger with possible loss of grip stength.
Pt recv vax on 8/19/98; on 8/20/98 pt exp injection site rx.
Initial misuse report received from a healthcare professional on 23 July 2013. A patient was administered TYPHIM VI vaccine 1 week ago and then was given another dose on 23 July 2013 by mistake. No information was provided regarding the patients. No adverse event was reported. List of documents held by sender: none.
Caller wanted to know if the muscle pain and joint pain side effects will affect her; Caller wanted to know if the muscle pain and joint pain side effects will affect her; This is a spontaneous report from a non-contactable consumer via Pfizer sponsored program COVAX US Support. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE Solution for injection Lot number was not reported) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. Medical history included bone problems she had a reaction to the medication she took for her bones, acid reflux, cirrhosis, all from an unknown date and unknown if ongoing. Concomitant medications were not reported. On an unspecified date, the caller wanted to know if the muscle pain and joint pain side effects will affect her and if the side effects to the second dose are worse than the first dose. Caller had a concern about getting the Pfizer COVID 19 vaccine because she had underlying conditions stating bone problems, acid reflux and cirrhosis. Caller wanted to know when the second dose is given, how people with a liver problem were affected by the vaccine and if the Pfizer COVID 19 vaccine is FDA approved and what is an EUA and if the amount of time the vaccine stays in the body has an effect on how long we have immunity. The clinical outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
chills, temp, fatigue inflammation of right arm with severe pain that radiates down the arm.  Has lasted over a week.  Medical treatment was sought. Doctor ordered Motrin and Ketorolac and also Tylenol with codeine ordered for pain.
Expired Havrix administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 44-year-old male patient who received HAV (Havrix) (batch number 2BA99, expiry date 16th December 2022) for prophylaxis.   On 19th December 2022, the patient received Havrix. On 19th December 2022, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 19-Dec-2022 Reporter's comment: The reporter consented to follow-up. Additional supportive information: The patient received an expired dose of Havrix, which led to expired vaccine used.
Approx. 0850 gave patient Hep A plus Hep B vaccine to (R) upper arm and after 2nd shot given noticed that patient's eyes began to roll to back of head and she began to fall to (L) out of chairs. I immediately grabbed her and called for help from other coworkers. B/P 8:57 AM 90/60. B/P 10 AM 112/72. 08 APR 2018 Approximately around 09:00 patient received Hep A vaccine AC9F4 (Lot) 12/14/19 (EX) to (R) upper arm and Hep B vaccine 77H3M (Lot) 7/13/19 (Ex) to (R) upper arm. Within 30-60 seconds after receiving vaccines, patient lost consciousness with bilateral lower leg stiffness, bilateral arm stiffness, jaw clinched, and decreased airway sounds "Snoring -gasping". This reporting nurse tilted patient's head back and stabilized to increase open airway. Episode lasted approximately 1 minute. Postictal period (1-3 minutes) patient was confused, unable to communicate, blank stare, with white color to face upon consciousness. After 3 minutes patient was oriented x 3, color returned, and back to her normal baseline. EOR.
Information has been received from a physician concerning a 48 year old male with no known allergies who on 5/7/02 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent. Concomitant therapy included Prevacid (30mg BID); morphine and  Librium. There were no other reported vaccinations that day. On 5/7/02, the pt developed a bad local reaction. It was reported that "by the evening of the day of administration", the pt developed redness (about 15cm in diameter), mild induration and soreness on the right arm, following the injection (slightly below the deltoid) and a fever of 103F. The reporter indicated that there may be other causes of the fever, but did not clarify. It was noted that the pt was unable to take any NSAIDS. On 5/9/02, it was reported that "at this time, the condition appears to be getting worse". The pt sought unspecified medical attention. Additional information has been requested.
Fever, pleural effusion, Eosinophils in fluid and marked Eosinophils in peripheral blood.
March 6th evening hours- joint pain in left elbow and left knee March 7th at approximately 3AM fever 102.6 March 7th severe headache/ shooting pulses in my head March 7th at approximately 9PM- mild nose bleed. fresh bright red blood March 7th at approximately 9:30 PM -vomiting with streaks of blood in my vomit March 7th, 8th, 9th, and 10th Dizziness/Unable to concentrate/Depression March 11th Symptom free/ I did not seek treatment.
Evening of and day after felt extreme soreness in left arm, 2-4 days after experienced slight twitching and discomfort. Soreness and tingling followed on/off. August 4, began worsening feelings of numbness and tingling sensations on left arm and side. Injection site felt very tense. Two days after, tingling/numbing sensation spread to left side of face. It felt like my arm and side of face were asleep. I was fully neurologically functional throughout, it was just a persistent feeling of tingling and numbness. I visited Urgent Care August 7th and followed up with a doctor telephone visit August 9th. Feeling of tingling/numbness in face has gone away. Left arm feels slightly weaker and injection site is still extremely tense. Doctor suggested needle may have struck a nerve. She submitted my symptoms to allergy specialists for further inquiry. Bloodwork was completed to check for thyroid, etc. All results returned back normal.
PT was Vaccinated with Pfizer that was only diluted with 0.8ML Sodium Chloride. The staff member was not fully trained on the task and was told not to submit a VAERS unless the PT went to the emergency room.