chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 03-MAY-2016 the patient was vaccinated with an improperly stored dose of GARDASIL 9 0.5ml (lot# L024993, expiration date 17-OCT-2017). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree/ Celsius) and the type of excursion (R/F) for each time were 88, 32 and R; 48, 9 and R. The storage criteria was refrigerator (R). This is one of several reports received from the same source. Additional information has been requested.
24 hours after: some dizziness/ nausea Mild cold like symptoms for 1 and a half days after the dizziness (of course sore arm but expected that) 5 days after: sore throat / earache (could be unrelated) 1 WEEK LATER: SUDDEN EXTREME ITCHINESS AND WELT LIKE REDNESS AROUND VACCINE SITE 1 week and 1 day after vaccine: continued itchiness and blotchy rash on upper arm where received vaccine This itchy reaction on arm to vaccine did not appear until a week after!
patient states they had severe arm and joint pain starting two weeks following second dose of Moderna vaccination. Pain intensity each day differs but is impacting quality of life. Patient has tried NSAID's, ice and heat and has seen a healthcare provider but nothing has helped.it is now 2 months post injection and severe joint and muscle pain in the vaccinated arm still exists.
Patient was in advertently given FLUZONE 0.25mL IM by intranasal route. PCP/Health Dept have been notified, response in process. Patient's mother notified.
49 yo WF was given IM Pneumovax in left detoid on 3/2/09 at clinic visit for cough and sore throat. RN reported using one inch 25 gauge needle and proper technique. Pt voiced no concerns at the time the injection was given but developed fever and redness, swelling, and pain in the left arm on 3/3/09. Pt treated self with Tylenol alternating with Motrin every 4 hours. Returned to clinic 3/5 f/u. On assessment, pt's L upper arm from a couple of inches above the elbow up to the shoulder was red, swollen, warm to touch and painful. Temp 98.8. Augmentin 875/125 PO bid for 10 days prescribed. Pt will f/u in clinic in 6 days.
morning after vaccine woke up with the worse headache and left are soreness. The following morning  headache and body aches from the hips and both legs. In the following days pain got progressively worse until it was very difficult to walk. After a week of this the pain settled into my left hip. On the 9th day of pain and difficulty walking went to see my PCP. Treated me for bursitis of the left hip with a steroid injection to the left hip joint. Pain has gotten better but still painful. The vaccine was given at Urgent Care. Post vaccine visit was with PCP
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, pertinent medical history, concomitant medications, drug reactions, or allergies was provided. On 05-NOV-2016, the patient was vaccinated with improperly stored dose of PNEUMOVAX 23, injection (intramuscularly, lot # M020521, expiration date: 17-NOV-2017; dose was not provided). There was no adverse effect reported. The dose of administered vaccine was exposed to the temperature excursion of 0.8 degrees Celsius for 14 minutes. There were no previous temperature excursion. Digital Data Logger was involved. Additional information has been requested.
Pfizer-BioNTech COVID-19 Vaccine EUA: Vaccine recipient reported that they had shortness of breath and felt that their throat was closing. EMS administered diphenhydramine, solumedrol, and was transported to the emergency room.
Patient received her first dose as Moderna in January did not complete the series.  States she was told by registration that she would need to start a series over and we were giving Pfizer.  Error was realized when we put in the reporting system.   Patient was observed for appropriate amount of time and educated that she had completed her series of vaccine.
Patient became faint and pale after blood was drawn from her arm and the Gardasil injection was given. I put her feet up on a chair and applied cool cloth to her forehead. Her BP was low prior to the injection and went up to a normal range after a few minutes. Pulse ox remained in the high 90's. Patient was given juice and cookies as she hadn't eaten much that day.
Within the next couple days of receiving her second Pfozer COVID vaccination (first dose given in April, 2021), the patient experienced unusual vaginal bleeding and syncope, and was found to be having internal bleeding after presenting to the Emergency Room.  There she was diagnosed with a low platelet reaction believed to have been triggered by the COVID vaccination. Patient was hospitalized and is now stable.  Patient had reported that after her first dose she had experienced unusual bruising, predominantly along much of her vaccinated arm and also on her legs. At that time, she did not seek medical attention and it was not confirmed whether there was a true thrombocytopenic reaction, but based on the outcome of her second vaccine it is likely that thrombocytopenia did occur.
Moderate chills, body aches, slight nausea and headache which developed approximately 48 hours after receiving the vaccine and lasted for approximately 4-6 hours during the middle of the night and then completely resolved.
This spontaneous case, initially received on 20-Jan-2017, was reported by a health professional and concerns a 46-year-old female patient. Weight: not provided; Height: not provided. Concomitant medication: not reported. Administration of company suspect drug(s): The patient received AFLURIA from 19-JAN-2017 to 19-JAN-2017. Dose regimen: Not reported, Route of administration: Intramuscular. Batch number: WT53706. No additional suspect drugs. Adverse reactions/events and outcomes: On 19-JAN-2017, the patient experienced swelling (medically significant, outcome: not recovered / not resolved), swelling around her eyes (medically significant, outcome: not recovered / not resolved), swelling around her lips (medically significant, outcome: not recovered / not resolved), swelling around her tongue (medically significant, outcome: not recovered / not resolved). Patient took an antihistamine for the reaction and the swelling has reduced. Patient is still taking the antihistamine until the swelling completely subsides. Reporter comments: The healthcare professional considered all events as serious and related to AFLURIA vaccination. Follow-up received from 26-Jan-2017: The overall outcome was reported as recovered on 23-Jan-2017. Intervention was required to prevent permanent impairment/damage. Reporter comments: The healthcare professional considered all events as related (probable) to the administration of AFLURIA.
pt began having sl fever, erythema & edema @ inj site approx 1PM 10/26/99;pt phoned 10/28/99 AM area approx 3"x2" red & hot inj site rt upper arm;advised pt to take DPH & call if worsens;10/29/99 AM redness/edema rt arm down to elbow;
in their shipment of 2021-2022 product they received vials of 2020-2021, with no reported adverse event; 20-staff members and 7-Residents received expired doses, with no reported adverse event; Initial information received on 04-Nov-2021 regarding an unsolicited valid non-serious case received from a other health professional, physician and non health care professional via Agency number: 00842649.  This case is linked to cases 2021SA371630, 2021SA369738, US-SA-2021SA370183, US-SA-2021SA371632, US-SA-2021SA369738, US-SA-2021SA370183, US-SA-2021SA371632, 2021SA370209 and 2021SA369789 (CLUSTER).  This case involves a 95 years old female patient who experienced in their shipment of 2021-2022 product they received vials of 2020-2021, with no reported adverse event administered an expired dose of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE QUADRIVALENT MULTIDOSE] (expired product administered).  The patient's medical history, past medical treatments, vaccinations, concomitant medications and family history were not provided.  On 03-Nov-2021, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED lot number: UJ507AC and expiry date: 30-JUN-2021via unknown route in unknown administration site for prophylactic vaccination.  It was case of an actual medication error due to expired vaccine used (latency: same day).  At the time of reporting, no adverse event was reported.  It was reported 'The Nurse reported that the doses came shipped to their central supply; that then the vaccines were distributed and placed in the vaccine refrigerators through the facility; that she is not the person that receives the vaccines from shipping and that she does not have the packaging slips or boxes due to it is handled with central supply; that when their staff is administering a vaccine the expiration date is not noted prior to administration; that the expiration date is not documented but just the LOT number; that the staff is not looking at the expiration date when administering; and that a nurse, yesterday, saw the expiration date to be expired after vaccinating residents."  At time of reporting, the outcome of the event was reported as unknown  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 the 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.; Sender's Comments:  US-SA-2021SA369738:
A week later a very itchy rash on both feet. The rash is red and occurs mostly on the tendons and heels. Occasionally a fleeting itch on the index finger of each hand, but not scratching it the itch on both fingers disappears.
This is in follow-up to report(s) previously submitted on 05/28/2004. Information has been received from a health department RN concerning a 25 year old female pt with no allergies who on 01/09/04 was vaccinated with a dose of MMRII (Lot # 645520/0296N). The pt had a positive home pregnancy test on 03/01/04.  The pt had spotting and cramps one week before taking the pregnancy test. On 03/04/04 it was reported that the LMP and gestation were unknown. Unspecified medical attention was sought.  On 08-Dec-2004 the reporter noted that they were unable to contact the patient. She had "come in" for an immunization only and they have no other records for her. Additional information is not expected.
Information has been received from a physician concerning a 75 year old female who on 28-MAY-2008 was vaccinated with ZOSTAVAX (Merck) (lot #659325/1823U) via IM into her right deltoid.  On 09-SEP-2008 the patient experienced prodromal pain followed by a shingles rash on her lower abdomen.  An ultrasound was performed (results not provided).  As of the reporting date, the patient was recovering.
After the second dose I felt nausea, fatigue and had enlarged tonsils and a sore throat. After 24 hours I felt better but with a lingering earache and tonsil pain, mostly on right tonsil. Then, about 48 hours later, the lymph node in my lower right cheek, close to the ear, had an "event." It felt like an "explosion" in my cheek. It was visibly swollen and I was then unable to eat for the next 24 hours. Severe pain in lymph node and an ear ache. I also felt like I had a "raisin" stuck in my throat. Symptoms have improved but there is still a visible bump on one tonsil with some lingering ear and throat pain. It's concerning to me.
Moderate to severe headache, minor but continuous nausea, minor swelling of lips/face, odd tingling sensation (primarily of the head/face),   Resolved after administration of 24 hour dose of naproxen sodium, and Tylenol PM (acetaminophen + diphenhydramine). Patient still combated lethargy until 6:00-7:00 PM, though it could have been a side effect of the dose of diphenhydramine. Felt fine after.
Pt seen by MD 7MAY91 for abnormal crying screaming; When seen by MD sx had subsided;
p/vax pt exp transient numbness from the rt shoulder down to the foot, & lasted ten minutes a/resolving;
Extreme itchiness and redness, started in my legs and moved to my arms (in the morning). By noon, it was full body. Called and set a telehealth appointment, and was advised to visit urgent care. At urgent care, I was examined and diagnosed with hives. I was given a dose of prednisone and a short prescription for hydroxyzine to help with the itching. I'm still extremely itchy. I've never had seasonal allergies, there have been no med, food or product changes, and the prednisone helped briefly but did not eliminate the itchiness. I was told to try an over-the-counter relief products, which I will be trying tomorrow.
Child administered vaccines on 9/14/15 - mom states the following day she noticed her right leg was red and at daycare/ Today (9/16/15) mom reports the leg (right) was very swollen, red, and warm to the touch. She sought medical attention at the child's pediatrician.
This spontaneous report was received from a nurse refers to an unspecified number of patients of unknown age and gender. There was no information about concurrent condition, medical history or concomitant medication. On an unknown date, the patients were vaccinated with improperly stored dose of PROQUAD (Merck) (lot# L037968 and expiry date 29-MAR-2017) (dosing details unspecified). No adverse effects were reported. No Product Quality Complaint (PQC) was involved. Details of temperature excursion: Temperature: 6.7 F, Time frame: 42 minutes, Data logger: Yes, Previous temperature excursion: No. This is one of the two reports received from the same reporter. Additional information has been requested.
pt recvd vax & 24JUN94;JUL94 devel elevated transaminases which have not yet resolved;further details have been requested;
Symptoms started on 7/19/2021, and tested positive on 7/23/2021. Patient admitted to hospital on 7/26/2021.
Arthritis magnified 200%.  Severe limp and excruciating pain in my left leg, him, groin and knee. I am unable to walk any distance  or perform any tasks which require walking , bending, squatting along with carrying anything more than 5 pounds.
Patient attended COVID19 vaccine clinic in community, hosted by County Public Health, where both pediatric and adult doses of Pfizer were being administered. After administering the vaccine to the patient listed above, vaccinator realized that she administered an adult dose and formulation of Pfizer (0.3ml) rather than the recommended pediatric dose and formulation of Pfizer (0.2ml). Patient was monitored for 15 minutes after receiving the vaccine with no adverse reaction. Mother was notified and provided contact information for On-Site Medical lead (this reporter). Medical lead followed up with mother, via text, on 11/15 who confirmed that patient, "was good most of the day yesterday [Sunday 11/14], but got hit last evening. He slept well and awoke today much better."  Medical lead enocouraged mother to reach out by phone, text, or email should any other symptoms develop in the patient. All side effects sound to be within expected side effect profile after COVID19 mRNA vaccine receipt.  After-midday break, vaccine tables and vaccinators were separated by vaccine type. No additional mix-ups reported, supported by all matching number of vaccine expected for each age group and number up vaccines drawn from vials.
This spontaneous report as received from a Nurse refers to five patients of unknown age. On an unknown date the patients were vaccinated with GARDASIL (lot# was not reported) which were improperly stored. No adverse events was reported. Additional information has been requested.
He had a second Covid shot 8 days ago.  Yesterday he noticed the onset of a painful red swelling in his left medial calf.  Left calf shows varicose veins.  There is marked erythema and tender swelling along the vein of the medial calf.  There is no palpable clot.  Negative Homans sign.
Client verbalized feeling lightheaded after receiving the vaccine.  Client was then evaluated by Paramedic onsite.  Client was released to go home at 9:13 am by paramedic after symptom was resolved.
Muscle spasms only on left side, in left toes, upper arm, lower arm and shoulder
Patient reported an allergic reaction: redness, itchiness and warm to the touch on her left arm below injection site- not including injection site.
This spontaneous report as received from an administrator refers to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On unknown dates, the patient's were vaccinated with improperly stored doses of GARDASIL 9 (dose, route, lot # and expiry date were not reported). The reporter stated that maximum time out of range for the vaccines was minutes only when door was being opened and closed. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Rash under both arm pits snd now rash across chest and under arm pits.
The patient developed swollen lips, a rash on his forehead and on both lower lids and both lower lids were swollen. The skin had a scaly appearance. The family has been treating symptomatically with 1% steroid cream.
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. In 2013, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster also knows as shingles. During 2014, the patient was treated by for a blistering vesicular outbreak which was diagnosed as severe herpes zoster, or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Has 2-3 mm firm, mobile mass in left thigh, present since 2 mo vaccines. Now with overlying hyperpigmentation. No pain. On chart reviewed, he received the Pediatrix and Hib vaccines in that thigh on 7/9/19.
all symptoms lasted less than 24 hours, I went to the ER because I thought it was my gallbladder, RUQ pain CT scan ordered and shows intestines were inflamed, they thought I was constipated. I went home and took tylenol for management. I had 4 sessions of severe projectile vomitting and felt relief right after. I never felt ill I only had pain and vomitting.
A 32 year old female patient received an intramuscular left deltoid infection of ADACEL (lot number C3067) left deltoid injection of TYPHIM Vi (lot number B11472), and a right deltoid injection of HAVRIX (manufacturer GSK, lot number AHAVB244AD) on 10 June 2009 at 2:00 PM. At 8:00 PM that evening that patient was unable to move her left arm. The following day, the patient was able to move her arm 4 inches. However, the patient recovery status was reported as unknown. The patient did not experienced any other symptoms. Follow up information received on 17 August 2009 from a health care professional. The patient received ADACEL in the left lower deltoid, TYPHIM Vi in the left upper deltoid, and HAVRIX in the right deltoid. The patient recovered. No other information was provided. List of Documents held by Sender: none.
1 hr 35 minutes after shot, pt came back to pharmacy stating her legs were "tingling" - denied any itch - gave 50 mg Diphenhydramine at 12:50 pm - at 1:15 pm had tingling in fingers but not in legs - at 3:15 pm had itch - sent to Urgent Care.
Patient is a 67 y.o. male patient of DO with history of pulmonary hypertension, COPD with chronic respiratory failure ( on home o2 at 2L), bronchiectasis, hypertension, IgA deficiency, chronic kidney disease presented with worsening shortness of breath admitted for further evaluation and treatment   Acute on chronic hypoxic respiratory failure Bronchiectasis COPD exacerbation - Continue IV decadron, supportive O2, bronchodilator - Appreciate pulmonary assistance - Discharged home on baseline O2 and 10 days of decadron 6mg daily   Positive COVID-19 - Up to date with vaccination including boosters x2 - Continue IV steroids, O2 support, deferring on IV remdesivir given length of illness   Acute on chronic anemia - Suspect due to underlying CKD - Transfuse 1 unit of PRBC for Hb 6.6 - Hb on discharge day was 7.7 - Repeat CBC in 1 week   Chronic kidney disease stage IV - Baseline creatinine is 2.4, presented with a creatinine of 2.6 - Continue bumex - Repeat labs in a week  - Follows up with nephrology as an outpatient (Dr.)   IgA deficiency - On weekly Hizentra   Hypertension Home regimen; Coreg 25 twice daily, Cardura 8 mg nightly    Histoplasmosis High titers noted with high fungitell Per ID planning for 12-week course of itraconazole Arranged 12/1/22 follow up with Dr. - may repeat CT at the end of 3 month course of itraconazole Discontinue cefepime after discussion with ID given sputum culture
1 week post injection redness, itching, swelling, began. Felt like a day-old wasp sting. Day 8 post injection and itching less but larger red are. Arm sore and achey from  shoulder to wrist.  Will wait to see if gets worse before going for doctor visit.
No adverse effects reported for the patient; administration of one dose of an improperly stored vaccine, VAQTA, to one patient on 11/6/2019; This spontaneous report was received from  a office manager referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant medication were unknown. On 06-NOV-2019, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated(VAQTA) injection at a dose of 0.5 milliliter, one dose of lot # S009943 with expiry date 26-JUL-2020 (frequency and route of administration were unknown) for prophylaxis (product storage error). On an unknown date, the vaccine was exposed to 58.6 Fahrenheit temperature for 10 minutes. There was no previous temperature excursion. Digital data logger was involved. The office manager also reported a possible malfunction of the data logger, but does not know if the data logger malfunctioned or not. No adverse effects reported.
Headache, Myalgia, Fever, Diarrhea, chills, fatigue, arm soreness Narrative:  Fever, myalgia, diarrhea, headache, chills,  fatigue, sore arm. Took ibuprofen; resolved.