chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Underdose; syringe was not secured enough; This spontaneous case was reported by a nurse and describes the occurrence of UNDERDOSE (Underdose) and DEVICE CONNECTION ISSUE (syringe was not secured enough) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (Medical history was not reported).   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 02-Mar-2021, the patient experienced UNDERDOSE (Underdose) and DEVICE CONNECTION ISSUE (syringe was not secured enough). On 02-Mar-2021, UNDERDOSE (Underdose) and DEVICE CONNECTION ISSUE (syringe was not secured enough) had resolved.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. No treatment information was provided.
reported onset of sx @ 5PM on 6MAY97;localized swelling, redness, hard & warm w/rash & itching;returned to work site clinic to report above & indicated swelling had dec by half, otherwise all other sx persist;DPH, APAP given;
07/22- Patient is a very pleasant 78-year-old gentleman with a history of pancreatic cancer on chemotherapy who presents today for evaluation of fever and chills.  Patient states he began feeling unwell overnight last night.  He developed shaking and chills.  He contacted the clinic and was referred to the emergency department.  He states he has had a mild cough.  He has had no abdominal pain.  He has had diarrhea which is somewhat chronic.  He has had no urinary symptoms.
Twenty minutes after flu shot given patient returned complaining of severe headache, sick to her stomach, hot and clammy.  Patient taken to ER.
About 16 hours after second dose of the Pfizer COVID-19 vaccination: - Fever of 101-102F - Chills - Body aches - Joint aches - Headache  About 40 hours after time of vaccine: - Fainting spells x2 (shakiness, blurry vision, ringing in ears, loss of balance)
Around 2:00pm day of vaccinations, I started to experience chills, fatigue, and body aches. I took Tylenol before retiring for the night around 10:00pm.  By 3:00am, the RSV site of injection was sore enough to awaken me when I rolled over on it, and I was experiencing an unusual headache ( I rarely get headaches), as well joint and body aches.  Once again I took Tylenol.  This morning (20th of October) I had mild symptoms, but by 2;00pm, I was very achey and cold so took a nap with blankets on me (the house temp was 71 degrees).  I awakened at 3:45pm still having the body aches and chills and am takin Tylenol again. I am trying to drink lots of liquids and forcing myself to eat healthy foods.  Hope this dissipates today .
Pt given VZV on Friday, over the weekend, mother noted swelling of upper extremitiy from elbow to shoulder by Monday was nearly resolved with 1 cm diff. in circumference right vs left.
Arm Pain; Arm is Swollen; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm Pain) and PERIPHERAL SWELLING (Arm is Swollen) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 00124216) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 23-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm Pain) and PERIPHERAL SWELLING (Arm is Swollen). At the time of the report, PAIN IN EXTREMITY (Arm Pain) and PERIPHERAL SWELLING (Arm is Swollen) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Dx with cellulitis secondary to VARIVAX. Tx with SEPTRA 40/200 per 5ml 2 tsp BID x 10 days; Diphenhydramine 12.5/5ml 2 tsp Q6 hours PRN.
acute thrombocytopenia that is persistant now for 3 months; temporally related to Hep B vax inject on 12MAY93 & 11JUN93;
Patient called into primary care office to report possible reaction to the COVID booster (received at pharmacy, not at this doctor's office he is unsure the Lot number). He developed his typical reaction on 10/12- felt "sick",  nauseous, tired/weak. Thursday 10/13 developed left testicular tenderness, pain. Friday 10/14 in addition to the left testicular pain developed left lower abdominal aching. he had the abdominal aching and testicular pain through Monday 10/17. He also had temp up to 100F. by 10/17 started to notice improvement in symptoms and on 10/18 feeling much better. Patient states some online research showed other people having a similar reaction to COVID vaccine and/or COVID illness.
Moderna vaccine was administered at 7hr and 15min after recommended 12-hr BUD time after first needle puncture. Bottle was kept at room temperature during this time. Patient was contacted 6 hours after receiving the vaccine and did not report any side effects at the time. A subsequent follow-up with patient was attempted the following day (today) but we were unable to reach patient.
Vaccines given in error.  Vaccines that were ordered for patient were TdaP and Menactra. Nurse giving vaccines gave Kinrix and Bexsero in error.  No adverse reaction noted.
Fevers and shaking chills, nausea, and some dizziness  started about 7 hours after the vaccine.  I lost hearing in my left ear at about the same time.  The hearing came back a few hours later but was muffled and echoed in the left ear for about 48 hours following the vaccine.  I tried decongestant medications and tylenol without improvement in the hearing issue.  The left ear has mostly resolved at this time but the ear is popping at times with muffled hearing intermittently.   All other symptoms are resolved.
severral medical students recvd 3 doses of Hep B vax about 9-10 yrs ago & 1 pt became violently ill w/high fever;
Soreness at injection site on day one. Day two, dizziness, fever of 100.5, joint soreness in hips arms knees and neck, lethargy. Day 3, symptoms are improving. Still tired but not as much achiness and no fever
several pts who recvd Engerix-B exp a burning following inject; this was the 2nd or 3rd dose for these pts, not a first dose;
Heavy menstrual cycle with excessive bleeding, cramps that were more painful than normal, lower back pain that I normally don?t have during this time, and exhaustion, beginning Monday morning and ending Thursday night.
Pt in clinic for immunizations. NKDA. Denies any previous reactions to immunizations. Consent signed. Handouts given: State copy of 121 form and vaccination personal record sheet.  Varicella and  HPV administered using aseptic technique. Educated parents and pt on vaccines, s/sx of adverse reactions, and when to seek medical attention. Client started getting clammy and sweaty. Color turned pale. Ice packs applied to forehead and layed client down with legs up. BP 100/58 P 50. Client states is very "scared of needles". Did not administer Menactra or Hep A after this incident. 15 min later BP 110/62 P 68, color came back and client was ok. Monitored for 30 minutes before client left HD.
administer expired vaccine to patients, after the manufacture date of expiration.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration.) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. Date the vial was initially stored in the refrigerator reported as unknown and the vial did not undergo any temperature excursions. The treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Live Non Significant FU - Primary Reporter address updated
MISSED THE LAST DOSE; This spontaneous case (PVX2019-762) was received from a pharmacist on 29-Mar-2019. It describes a 51-year-old adult female consumer who "missed the last dose", while receiving oral Vivotif (one dose every other day) for typhoid prophylaxis.  Case report: The consumer missed the last dose. She took the first dose of Vivotif on 18-Mar-2019 but she forgot to take her last dose, which was due on 24-Mar-2019.  Action taken with Vivotif was not applicable.   The clinical outcome of the event "missed the last dose" was unknown.  Company's Comment: The causality of the event "missed the last dose" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "missed the last dose" was considered as not applicable.
left elbow pain 8 hours after vaccination. has been present for 2.5 months, worsening with radiation into upper arm and shoulder. pain with extension of elbow.  prescribed cyclobenzaprine and medrol dose pack on 6/28/2021, patient deferred imaging, orthopedic referral.
Immediately p/vax pt became fussy & lethargic until fell asleep @ 10AM; slept until 12noon then awoke w/high pitched scream lasting until 3PM; Seen by MD;
had 3rd dose of Engerix-B & had titers drawn & they were low (level unk);
Fatigue, body aches. May have come on sooner but I do not have a doctors record.
Information has been received from a licensed practical nurse and a healthcare worker referring to unspecified patients of unknown age and gender. In June 2015 (also reported as since 15-JUN-2015), the patients were vaccinated with doses of oral, ROTATEQ (lot # K017575, expiration date: 01-JUN-2016, oral, dose was unknown) which were exposed to temperatures outside of the recommended range. No adverse experience was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Moderna COVID-19 Vaccine EUA  Noticed an abscess on my left leg that appeared suddenly on 8/28 at night after receiving the shot 8/26 in the late afternoon. Visited urgent care on 8/29 where it was lanced and I was prescribed antibiotics. On September 20th noticed two more abscesses on my left leg and was prescribed antibiotics again.
Vaccination date 06-19-08.  On 06-20-08 at 07:30am patient's mother noticed a red spot (dime size) on right arm.  06-21-08 spot spread around upper arm (inch wide, 2 3/4 inches long).  Patient taken to clinic to be seen by a physician.  Patient diagnosed with an abscess.  Treated with cephalexin 125mg.
patch on her back; red welt the size of a quarter; A 74-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot Number: ENS318; Expiration Date: May2021), via an unspecified route of administration in Arm Left on 22jan2021 (11:00) as a DOSE 1, SINGLE for COVID-19 immunization. The patient medical history was Dry Skin and scratching her back were reported. Concomitant medications included: VITAMIN C [ASCORBIC ACID], Colecalciferol (VITAMIN C [ASCORBIC ACID]), MAGNESIUM, TURMERIC [CURCUMA LONGA RHIZOME], Calcium taken for an unspecified indication, start and stop date were not reported. The reporter stated after her first shot on 22jan2021, and the second dose February 12th, each injection was given in her left arm at about 11:00AM on those days. She got her first shot and then a couple days later on 23Jan2021 she had a patch on her back with a red welt the size of a quarter, which she thought could be from scratching her back during the winter due to dry skin. It was reported that her welts have stayed about the same, she hasn't gotten any more, it is the same basic ones. Patient said that the first one looks like it is going away, and the others are smaller that appeared after the second dose, they are the size of a dime. She was applied Aloe Vera Clear Gel on it since it is unscented and has no smell or nothing. She stated that this product is an old one, but is still clear and didn't turn colours or anything. Aloe Vera Clear Gel UPC # LOT/EXP: Unknown, caller stated this product doesn't have this information to provide. Patient said the bottle says healing therapy, apply liberally to sunburn or irritated skin as needed. The patient was concerned because her sister looked at the welts and asked her if she thought she got shingles from it, and she was like no, it doesn't burn, though once in a while it does, and sometimes it doesn't itch, it is not something that bothers her, it's just there. The clinical outcome of the events were unknown. Follow-up attempts are completed. No further information is expected.
This spontaneous report as received from a consumer via company representative refers to a 15 year old female patient (consumers daughter). On specified date, patient begin her series of GARDASIL injection (120 Y). Approximately on an unknown date in July 2014 (also reported as about 1 month ago), patient received her second injection of GARDASIL. Within 24 hours, patient developed swollen lymph nodes. This progressed to swollen side of face. Patient was seen by her physician and diagnosed with pink eye and tonsillitis (approximately on an unknown date in July 2014). She sought medical attention and received unspecified treatment and issue resolved (approximately on an unknown date in July 2014). No additional information was given by this reporter. There was no PQC. Outcome of the reported events was recovered. Causality of the event was unknown. Additional information is not expected.
Patient was given a Tdap when he was supposed to be given a Dtap.  No adverse effects or reactions.
Symptoms slowly developed after 2nd dose March 30, 2021, then significantly worsened within a week after 3rd dose 1/8/2022. Developed debilitating fatigue, rapid weight loss with no other changes, heightened anxiety and restlessness/inability to focus, disorientation, muscle weakness, chest pain and racing heart rate even while at rest. Profuse sweating and heat intolerance.
This case was reported by a physician via sales rep and described the occurrence of urticaria in a male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (For tolerance of 1st dose refer case US2018GSK084164). On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced urticaria and pruritus. On an unknown date, the outcome of the urticaria and pruritus were recovered/resolved. It was unknown if the reporter considered the urticaria and pruritus to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced urticaria and pruritus for 16 hours. The reporter did not agree to follow up.
Pt felt very sick,spent next day in bed with chills, fever, lower back pain on left side, headache that started about 15 minutes after the immunization and over all aching like the flu.
At 1234 am I developed fever, chills, severe night sweats and whole body aches. It lasted approx. 6-630 hours. I also have had increase in GERD/acid reflux since about 2 hours after the injection.
First dose Pfizer Lot# FA6780 given on 08/05/21.  Second dose Lot#FD8448 administered on 08/20/21 (day 15)
Fibromyalgia flare, sore muscles, sore knees, pain up and down spine, fatigue.
swelling at the injection site; his lung problems came back; cough,tickle and Increased phlegm; Increased phlegm; This spontaneous report was received from a pharmacist regarding a 79 year old male patient. The patient medical history included pneumonia and current condition included hypertension. Concomitant therapies included metoprolol 100 milligram, eliqius 5 milligram and furosemide 20 mg. On 13-NOV-2019, the patient was vaccinated with properly stored pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) via intramuscular, lot # S026366 with expiry date 17-SEP-2020, (strength, dose were not reported) for prophylaxis. This was first pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) vaccine that this pharmacy has administered to the patient. The reporter stated that on an unspecified date in November 2019, the patient developed swelling at the injection site which was recovered on an unspecified date in 2019(also reported lasted two weeks). The patient also complained on an unspecified date in 2019, that his lung problems came back (lung disorder), cough, tickle and increased phlegm (productive cough) which reminded him of when he has a pneumonia on an unspecified date in the past. The patient had no cancer, over dose, medical attention and product quality complaint. The outcome of productive cough, cough and lung disorder was reported as recovered on an unspecified date in 2019. The reporter considered injection site swelling, productive cough, cough and lung disorder to be related to Pneumococcal Vaccine, Polyvalent (23-valent)(PNEUMOVAX23).
No adverse effect - patient received 2 Boostrix vaccines - 1st Boostrix given 6-5-06 - 2nd Boostrix given 8-4-08.
Itchiness, Nausea and vomiting after injection.  Admission to hospital for IVF and treatment of elevated INR.
5 minutes after vaccination pt c/o left sided chest pain, shortness of breath, dizziness.  BP 231/139 P 97  F/U 215/110 P 105 EKG possible ST elevations.  Aspirin administered, transferred by EMS to ED
Redness in the injection site; Swelling in the injection site; Myalgia in the injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 64-year-old male patient who received Herpes zoster (Shingrix) (batch number E523B, expiry date 5th November 2021) for prophylaxis.   On 22nd January 2020, the patient received the 1st dose of Shingrix. On 24th January 2020, 2 days after receiving Shingrix, the patient experienced injection site erythema, injection site swelling and injection site muscle pain. On an unknown date, the outcome of the injection site erythema, injection site swelling and injection site muscle pain were unknown.   It was unknown if the reporter considered the injection site erythema, injection site swelling and injection site muscle pain to be related to Shingrix.  Additional details were provided as follows: The patient experienced injection site erythema, injection site swelling and injection site muscle pain after receiving 1st dose of Shingrix. Consented to follow up was provided.
injection site: left arm  Woke up 12/20 8:30 am,  fever, body aches, severe headache & noticed a lump in my left armpit area.  went to work, mild symptoms continued but the lump continued to get larger & increased in tenderness. I kept track of the size by drawing a circle around the lump as the day went along.  Went to sleep around 9:30 pm with a mild fever of 101.3 throughout the night the lump site was very painful, kept waking up from the pain.  woke up this morning at 9am and noticed the lump became firm and grew in size maybe now 5 inches with tenderness & swelling in the entire left chest and armpit area. it bulges when i rain my left arm  intense muscle tension in my neck, left shoulder & upper back. cold sweats, intermittent headache   no reported fever
Information has been received from a retired nurse who on 11-JUL-2007 was vaccinated with ZOSTAVAX. Concomitant therapy included PRAVACHOL, atenolol, nitroglycerin, LORTAB, DALMANE, ATIVAN and CELEXA. In August 2007, the patient experienced difficulty  hearing. Medical attention was sought. The patient's difficulty hearing persisted. No product quality complaint was involved. Additional information has been requested.
Decavac the new Diphtheria tetanus come in a lovely prefilled syringe with a rubber leurlock tip. This tip fits right over a clave or other type of needless IV system. The syringe and the clave adapter connect and can be connected to the IV tubing we use. Nowhere on the syringe is the warning not for IV use or for IM use only. This is another accident waiting to happen. Our temp fix for this is to put each syringe in a bag labeled IM use only. We are getting syringe labels printed that say IM use only and put them on individual syringes. Apparently these labels do not exist commercially so we are having a custom print job done.
Patient reports receiving Covid vaccine 10 days before seeking treatment for lymphadenopathy in neck.  Unable to find any record of Covid vaccine received in our records or in the State immunization information system
rash beginning 10 days p/vax started on trunk & arms & progressed to legs;erythema also;
three days post injections, visual changes in left eye inability to see and feeling of pressure behind eye. As time progressed vision became worse and worse. On Saturday after injection went to eye dr
Since the second vaccine my wife and I have noticed that our blood pressure has steadily been increasing. Our doctor has asked us to monitor our blood pressure every day so that we will know what it is and if it is increasing, staying steady or decreasing. I have noticed that my blood pressure stays consistent 140 to 150 but it has been spiking as high as in the 154 to the 180's.  My wife and I never had a problen with our blood pressure before the vaccines it was always 118 to 122, now it stays high.
Hives over hands, arms, legs, abdomen, and back. Ears became red, hot and very itchy. Hands and legs were also very itchy.
severe nose bleeds; Caller states that she was diagnosed with Factor 10 deficiency; bruising; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team. The reporter is the patient.  A 67-year-old female patient received BNT162b2 (COMIRNATY), in Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 67 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose), administration date: Dec2020, when the patient was 67 years old, for COVID-19 immunization, reaction(s): "minor nose bleed"; Bnt162b2 (2nd dose), when the patient was 67 years old, for COVID-19 immunization. The following information was reported: EPISTAXIS (hospitalization), outcome "unknown", described as "severe nose bleeds"; FACTOR X DEFICIENCY (non-serious), outcome "unknown", described as "Caller states that she was diagnosed with Factor 10 deficiency"; CONTUSION (non-serious), outcome "unknown", described as "bruising". The patient underwent the following laboratory tests and procedures: Prothrombin time: unreadable. Therapeutic measures were taken as a result of epistaxis.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events, Epistaxis, factor x deficiency, contusion cannot be completely ruled out. 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