chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Left arm sore.; Where injection made is red and swollen approximately 2 inch diameter.; Where injection made is red and swollen approximately 2 inch diameter.; Left arm pit lymph node is swollen.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 11Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 51 years for covid-19 immunisation. The patient's relevant medical history included: "Known Allergies: Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Amoxicillin, reaction(s): "Known Allergies". Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer Unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose 2, Manufacturer Unknown), for COVID-19 Immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), Manufacturer Unknown), for COVID-19 Immunization; Covid-19 vaccine (DOSE 4(BOOSTER), Manufacturer Unknown), for COVID-19 Immunization. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 13Oct2023 at 07:00, outcome "recovering", described as "Left arm pit lymph node is swollen."; AXILLARY PAIN (non-serious) with onset 13Oct2023 at 07:00, outcome "recovering", described as "Left arm sore."; INJECTION SITE ERYTHEMA (non-serious), INJECTION SITE SWELLING (non-serious) all with onset 13Oct2023 at 07:00, outcome "recovering" and all described as "Where injection made is red and swollen approximately 2 inch diameter.". Therapeutic measures were not taken as a result of axillary pain, injection site erythema, injection site swelling, lymphadenopathy.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
The vaccine was performed early Wednesday morning.  The rest of the day the left arm was very sore. On Thursday morning after the vaccine, had a severe headache, a little upset stomach and a temperature of close to 100 degrees. Took an Aleve and slept another 4 to 5 hours.  The headache was less severe and took my temperature and it was close to normal. Did not eat much that evening but felt better on Friday.
This spontaneous report as received from a pharmacist refers to an approximately 79 year old female patient. The concurrent condition and medical history was not reported. The patient had no known drug allergies. On 16-DEC-2008, the patient was vaccinated with ZOSTAVAX (dose, route and lot details unspecified). The concomitant medication was not reported. On an unknown date in July 2015 the patient developed shingles. The patient sought medical attention by contacting the pharmacist. The event was treated with VALTREX and NEURONTIN. The outcome of herpes zoster was reported as resolved on an unknown date. The 'VZVIP' pack was faxed. Additional information has been requested.
ACUTE STROKE, UNSPECIFIED TYPE AND ARTERY 4/19/2023 ABNL HEAD CT SCAN    CONGENITAL SCOLIOSIS
vaccine was leaking out with no AE; a Fluzone Quadrivalent immunization was being administered in the employee health clinic and it was noted that the vaccine was leaking out with no AE; Initial information received on 29-Oct-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an unknown age patient who reported vaccine was leaking out (Syringe issue) and a fluzone quadrivalent immunization was being administered in the employee health clinic and it was noted that the vaccine was leaking out (Underdose), while he/she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 22-Oct-2019, the patient received a dose of suspect vaccine INFLUENZA QUADRIVAL A-B VACCINE (lot: UJ285AB, Expiry date: 02-Jun-2020) via unknown route used for prophylactic vaccination.  On an 22-Oct-2019, on the same day at the administration of FLUBLOK QUADRIVALENT VACCINE, patient reported that vaccine was leaking out (Syringe issue) and a fluzone quadrivalent immunization was being administered in the employee health clinic and it was noted that the vaccine was leaking out (Underdose).   No laboratory data was reported.  It was not reported if the patient received a corrective treatment.  Events outcome was not applicable.  At the time of the report, no adverse event was reported.   Disclaimer: 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.
Arm really hurts; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm really hurts) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 07-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced PAIN IN EXTREMITY (Arm really hurts). At the time of the report, PAIN IN EXTREMITY (Arm really hurts) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient's medical history was not provided.  No relevant concomitant medications were reported. No treatment information was provided.
I gave patient the original second booster dose after the CDC had released information that the Bivalent vaccine would be available in the coming week.
An allergic reaction.  Plan: MEDROL dose pack, BENADRYL 25 mg PO QHS.  ZANTAC 150 mg PO BID for 5 days.  Hep B titres.
Arm soreness at the injection site, but it didn?t start until about 3 weeks after the shot
The patient did notice the sore arm and general malaise that is to be noticed the morning after the administration of the injection. The patient did have increase swelling and soreness at the injection site. The swelling and soreness has continued for 3 days now. Patient will start taking an NSAID to help with the pain and swelling and will alternate between warm and cool compress. Will follow up with the patient the next several days to see if symptoms improve.
Client reported feeling dizzy and with chest tightness. She does report she has anxiety and is not sure if this is a panic attack or a reaction.  Client looks very pale,  O2 99, BP 120/80, HR 96, RR20 Lung sounds clear. Had client sit down, she refused to lie down. Given juice box and crackers. Rested for more 10 minutes, Pallor improved , reported dizziness and tightness of the chest are gone. She is asking to leave, her husband is picking her up.
Hospitalization COVID pneumonia  COVID positive. Remdesivir, and dexamethesone initiated
On 02/02/01, this patient felt tenderness in her left arm. ON 02/03/01 , the patient's left upper arm was tender, swollen, with 1 quarter size spot (red) at the site of the injection. Another smaller red spot closer to the body. On 02/04/01, the spots got larger , area swollen, itching, and painful. She called the ER and was advised to use Benadryl, Ibuprofen and warm pads. On 02/04/01, the patient's sickness increased so the patient went in to the ER. The MD suspected an infection but he was not sure it wasn't a reaction to the vaccine. The patient received a prescription for Keflex, and she was advised to continue the Benadryl and Ibuprofen. On 02/06/01, the patient saw her own MD and she was advised to not have another TD vaccination and to continue the Keflex until gone. The swelling and inflammation are down but she can still feel a soreness in the upper arm.
Roughly 12 hours after the vaccination I started to have a fever reaching 101.5 at the highest, generalized body aches, chills, and headache. I did not experience SOB, cough, vomiting, nausea, or diarrhea. These symptoms lasted about 20 hours, and were at first not responsive to extra strength Tylenol, but after many hours the fever broke. I was not allowed to return to work until I was fever free for 24 hours and tested negative for COVID-19 infection. I was swabbed at my place of employment, Hospital and my NP sample was run.  I tested negative on 1/13/21. I then returned to work on 1/14/21.
Pt vaccinated with MMR developed swollen glands base of neck, swollen area under rt ear, tender nodes in groin area.
Brief syncope 2 hours after the event.  Patient has fully recovered and did not seek care.  Event was reported on 3/10/2021.
Patient had previously received a single dose of Janssen vaccine (on 5/4/21). Should have received a bivalent Moderna booster, but was given monovalent instead. Will be contacted to return in 2 months for bivalent booster.
BACK PAIN; PAIN IN BILATERAL ARM; PAIN AT RIGHT KNEE; CHILLS; HEADACHE; PAIN AT INJECTION SITE; FEVERISH FEELING; FATIGUE; This spontaneous report received from a parent concerned a 27 year old female. The patient's height, and weight were not reported. The patient's past medical history included premature at birth, and other pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, and expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced back pain. On 09-APR-2021, the subject experienced pain in bilateral arm. On 09-APR-2021, the subject experienced pain at right knee. On 09-APR-2021, the subject experienced chills. On 09-APR-2021, the subject experienced headache. On 09-APR-2021, the subject experienced pain at injection site. On 09-APR-2021, the subject experienced feverish feeling. On 09-APR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pain at right knee, chills, and feverish feeling on 10-APR-2021, was recovering from pain in bilateral arm, back pain, and fatigue, and had not recovered from headache, and pain at injection site. This report was non-serious.
Tachycardia, warmth and flushed body esp face, mucus production (throat), scratchy throat, tingling sensations in feet, pain in R arm and radiated to neck and L arm, weakness, lethargy, dizziness, nausea, and headache.
Diarrhea; This is a spontaneous report from a contactable consumer, the patient.  A non-pregnant 77-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: CO87750), via an unspecified route of administration, in the left arm on 20Jan2021 at 10:45 AM (at the age of 77-year-old) as a single dose for COVID-19 immunization. Medical history included ongoing arthritis, congestive heart failure, open heart surgery in 2010.  There were no concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 21Jan2021, the patient experienced diarrhea. The patient reported "this morning" she had diarrhea. She had it again within the hour. The clinical outcome of diarrhea was not recovered.
Hives, 4 or 5 on my chest. Later that day into the next day more hives on my face, neck, and the top of my head.
Red raised area and vesicle at site of injection.  worsened over next two days and two vesicles appeared on abdomen and back.  Reported to OHP on 4/4/17 and vesicles crusted over.
Reddish welt/hive appeared near injection site exactly seven days after vaccine was administered. Hive has continued to grow over the past four days. Hive is itchy and sore to the touch. Small bruise appeared directly beneath the hive. fatigue.
This non-serious spontaneous case, initially received from other non-health professional on 02-Nov-2018, concerns a 77-year-old, elderly patient of an unspecified gender. It was reported that, the FLUCELVAX QIVc vaccine underwent temperature excursion for the first time. The vaccine was out for around 48 hours and it reached 11.6-degree Celsius. On 10-Oct-2018, the patient was administered FLUCELVAX QIVc [route of administration: intramuscular, anatomical location: left deltoid, batch number: 252230, expiry date: 31-May-2019 and dose: not reported] which underwent temperature excursion. At the time of this report, no adverse event was reported. This case 201805501 was crossed linked to original cases 201804863 due to same reporter.
I experienced painful sores inside my mouth and cheeks, along with bleeding gums.  They began the day after the vaccine and continued for 5 or 6 days.   There were no other changes in my life, behavior, or personal products which would have caused the issue.
Starting from the night of the second day (i.e., June 10th), the patient feels chest pain. The pain also extends to neck and left shoulder. Deep breath aggravates the pain. The patient could not fall asleep. He had a light fever at the night of vaccination day but the fever was gone before the chest pain.  Single lead ECG with Watch has been measured and sent to a friend of the parents' who is a physian, and no abnormal sign was shown from ECG. 400 mg Advil (ibuprofen) was given in the coming morning around 7 AM and the patient was able to fall asleep and symptons were gradually relieved. Another two doses of 200 mg Advil were given with six hours apart on the same day. The pain was gone by the following morning (i.e., June 11th) and no ibuprofen has been given afterwards. We suspect that this is related to myocarditis or pericarditis.  This was the second dose of Pfizer COVID-19 vaccine. There was no symptons for adverse effect after the first dose.
After receiving the Moderna vaccine, the patient was sitting in a chair in the pharmacy waiting area. About 5 minutes afterwards, he fell out of his chair. Upon asking the patient if he was okay and what happened, he reported he felt dizzy with racing thoughts on his mind. Then he lost his balance, slipped out of his chair, and fell to the floor.  He stated he has dizziness after every vaccine he has received in the past. He sat back in the chair and rested, and also reported he felt better. The supervisor on duty provided the patient with water. About 15 minutes after falling, the patient stated he felt fine and wanted to leave. He was stable upon standing up from the chair. I informed him if he experiences any other symptoms, that he should call my pharmacy, or if he experiences anaphylaxis, he should call 911 and seek immediate medical attention.
Sunday night, 1/3/21, I noticed my left upper arm being itchy.  Monday morning, 1/4/21, after my shower I noticed the itching again and an erythematous area, about 7 x 9cm, where I had received the injection.  Today the area is much larger, 15 x 20cm, less red and still itchy. A localized allergic reaction 10 days after the vaccine was received seems unusual to me.
Chills; Low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) and PYREXIA (Low grade fever) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 12-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 CHILLS (Chills) and PYREXIA (Low grade fever). At the time of the report, CHILLS (Chills) and PYREXIA (Low grade fever) 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 provided.
Developed hives and itching on arms, legs and trunk starting 1 hour after vaccination.
Red, swollen area at injection site. Says it burns and itches. No sign of actual rash just swelling. Told patient to take some BENADRYL and PEPCID in case allergic reaction and to go to the doctor. Also told her not to touch or scratch it.
Information has been received from a registered nurse concerning a patient who on 9/4/97 was vaccinated with a dose of varicella virus vaccine live. Subsequently, the patient developed mild break through with less than 50 lesions. It was noted that the patient was part of 7 children reported, 4 male and 3 female, some of which were siblings who were vaccinated with varicella virus vaccine live. Unspecified medical attention was sought. There was no product quality complaint involved. The reporter also mentioned six other patients who were vaccinated with varicella virus vaccine live and experienced similar reactions. Additional information has been requested.
Case was vaccinated and boosted by September 2021, then was hospitalized for Covid in January 2022.  Hospitalized at: Hospital  Acute hypoxemic respiratory failure due to COVID-19  Assessment & Plan Acute COVID-19 infection in an immunocompromised patient with underlying lung and renal disease (from granulomatosis with polyangiitis) maintained on mycophenolate.   Complications include acute respiratory failure and severe encephalopathy.   Initiated on dexamethasone and remdesivir at time of presentation on 1/13.  On 1/14, he was found to be seronegative and was given a dose of sotrovimab.   He has done quite well since shortly after admission.  Care plan discussed with the patient and his wife.  Tentative plan was to discharge patient today.  However, his wife would be his ride and she is feeling acutely ill.  He does not really have another ride available.  Plan now is to discharge home in a.m. 1/18 while they work out alternative strategies.   Tentative plan will be to discharge to complete a 10-day course of dexamethasone.  Resume his home prednisone and mycophenolate the day after he completes his dexamethasone.    Discussed risk of deterioration.  He should monitor his oxygen levels at home if he feels short of breath.  He should seek care if he is have any problems.
Got administered both doses of vaccine while being pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Got administered both doses of vaccine while being pregnant) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J202A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 11-May-2021. On 25-Dec-2020, the patient experienced EXPOSURE DURING PREGNANCY (Got administered both doses of vaccine while being pregnant). On 22-Jan-2021, EXPOSURE DURING PREGNANCY (Got administered both doses of vaccine while being pregnant) had resolved. Not Provided          Concomitant medication not provided. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 15-Mar-2021: Follow up received patient's address, date of birth, vaccine dates updated; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 36-year-old female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
COVID-19 vaccine-associated Guillain-Barre syndrome; other demyelinating conditions affecting the peripheral nervous system; This is a literature report.  An adult male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "progressive numbness" (unspecified if ongoing); "weakness" (unspecified if ongoing); "areflexia" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: GUILLAIN-BARRE SYNDROME (medically significant), outcome "unknown", described as "COVID-19 vaccine-associated Guillain-Barre syndrome"; NEUROPATHY PERIPHERAL (medically significant), outcome "unknown", described as "other demyelinating conditions affecting the peripheral nervous system". The patient underwent the following laboratory tests and procedures: Cardiac electrophysiologic study: unknown results; CSF protein: unknown results; Neurological examination: unknown results.; Sender's Comments: As there is limited information in the case provided, the causal association between the events Guillain-Barre syndrome"; NEUROPATHY PERIPHERAL and the vaccine (BNT162B2) cannot be excluded "The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.",Linked Report(s) : NL-PFIZER INC-PV202200023878 Same article/drug/ event; different patient.;
2/4/21  Woke with bad headache continued all day 2/5,2/6 Bad headache continued-Tylanol no help 2/8 AM  Loss of conshance. Loss of ability to speak. Taken to hospital. Briefly gained conshanceness. Still unable to speak. 2/27   Died.
Red raised skin on left anterior thigh, vital signs stable.  Benadry 50mg given
Heart swelling (pericarditis) , abnormal EKG showing STEMI initially on Saturday approximately 3 days after 2nd vaccine dose administration.