chrisvoncsefalvay/vaers-outcomes huggingface dataset:
the liquid starts leaking where the needle is attached and onto the patient's shoulder as they try to push down the plunger with no reported adverse event; Initial information received on 21-Sep-2023 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves an unknown age and unknown gender patient for whom reporter reported, the liquid starts leaking where the needle is attached and onto the patient's shoulder as they try to push down the plunger with no reported adverse event while receiving influenza quadrival A-B high dose HV vaccine [Fluzone High-Dose Quadrivalent].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 21-Sep-2023, the patient received a dose of suspect influenza quadrival A-B high dose HV vaccine (lot UT8072AA, expiry date- 30-JUN-2024) (with an unknown strength, formulation, dosage)  via unknown route in unknown administration site for Immunization.  On 21-SEP-2023 the reporter reported that the liquid starts leaking where the needle is attached and onto the patient's shoulder as they try to push down the plunger with no reported adverse event (accidental exposure to product) (latency- same day) following the administration of influenza quadrival A-B high dose HV vaccine.  Reportedly, Pharmacist is reporting a recurring issue with FLUZONE HD QIV administration. They report that after the needle is attached to the pen tip, it doesn't seem to have a good seal and the liquid starts leaking where the needle is attached and onto the patient's shoulder as they try to push down the plunger.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.   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.
pt recv vax & devel a 3-inch area of redness @ the site of vax;
Previously frozen Flublok Quad 22-23 PFS vaccine was inadvertently administered to the patient.   No reaction has been reported
pt recv vax 8JAN98 & same day devel a 50 cent size local rxn @ the inj site which was described as being itchy, pimply, warm, puffy & sl tender;9JAN98 also exp bump size of hand w/50cent size reddened area @ inj site;arm sore;nausea;
Facial edema, redness, and headache. Started about 16 hours after injection no specific treatment indicated.
Mouth tingling and tongue "heaviness", itchy lips.    We have seen this reaction before, treated with 25mg benedryl.  Symptoms improved after about 20 minutes.
have been throwing up for 6 hours non-stop and that is just horrible.; This is a spontaneous report from a non-contactable consumer or other non hcp. A patient of unspecified age and gender received bnt162b2 (BNT162B2, Formulation: Solution for injection), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient has been throwing up for 6 hours non-stop and that was just horrible on an unspecified date. Outcome of the event was unknown.  No follow-up attempts are possible; Information about lot/batch number cannot been obtained.
This morning around 6am. I started experience intense chills that lasted approximately over an hour. Once I couldn?t continue to sleep I slowly started developing an intense headache, I took some advil but the headache had only gone down slightly. All while this is happening I?m also experiencing a fever, moving around can be very challenging. Its currently 9:30am. 1/23/21. And I?m still feeling the discomfort.
Information has been received from a Healthcare worker, a nurse practitioner and a clinical assistant concerning a 22 year old female with no pertinent medical history and no known drug reactions/allergies who on 03-NOV-2011 was vaccinated IM with the second 0.5mL GARDASIL (Lot#668554/0306AA). There was no concomitant medication. The nurse practitioner stated that on 03-NOV-2011, following the administration of the second dose of GARDASIL, the patient almost fainted, lost vision and hearing for a short period of time. The clinical assistant provided adverse event details and stated that following the administration of vaccination "today", the patient on check out, told her that she thought she was going to faint, was sweating, nauseous, and her vision was blurry and dark. There were no lab diagnostics studies performed. Treatments for AE included placing a cool rag on the patient's forehead, giving her apple juice, and laying her down in the back room. Patient was monitored and her eye sight returned. On 03-NOV-2011, the patient fully recovered before leaving the office. Upon internal review, lost hearing was considered to be an other important medical event. Additional information has been requested.
Patient reported headache, nausea, vomiting, diarrhea starting Tuesday, 8/22/07 in the afternoon. Wednesday, 8/23/07 awoke w/ petechial rash on palms, arms, soles of feet and legs and increasing severe headache. Seen in our office at 8:40am. Referred to hospital for admission and evaluation w/ diagnosis of probable meningitis. Lumbar Puncture done - spinal fluid showed gram negative diplococci on gram stain. At 12:00pm started Rocephin 2grams IV. Decreased mental status throughout the am. Last coherent verbal communication from patient was at 12:00pm. Due to worsening status pt. was admitted to ICU after LP. As of today pt. is still non-verbal. EEG was WNL. Continues w/ IV antibiotic therapy. Currently prognosis is guarded. 11/19/07-records received for DOS 8/22-9/4/07-DC DX: Acute meningococcal meningitis. Seizures. Headaches. Debility. Encephalopathy. Elevated liver function tests. Presented with acute febrile illness associated with rash, nuasea, vomiting, diarrhea, fever and was not feeling well. Recent travel. PE: Skin warm dry with flat pinpoint petechial and purpuric rash on palms of hands. Agitated. Focal seizures. Opted not to talk to anyone in the middle of her hospitalization. Positive pain sensation with any neck motion. Back Pain. Positive straight leg raising test. Per 60 day follow up: See attached note from neurologist.
Information has been received on 09-FEB-2018 from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On an unknown date, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route 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. On or about 26-JAN-2017, the patient was treated by a physician for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster or shingles. 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, pain and suffering, and other damages. Additional information has been requested.
Cannot keep sugar from dropping about 5 hours after the shot - cannot keep blood sugar levels up in a normal range - it keeps dropping into the 40s and should be around 100.   Insulin was not administered and has not been administered since the vaccination due to low blood sugar levels.  Ate dinner around 6 pm, no insulin administered and sugar dropped into the 40s around 11 pm and again in early morning.  He drinks juice to bring the levels back up but they quickly drop.  Trying to get blood sugar up and stable.  There is a risk of death if his sugar cannot be brought back up to the correct levels and stabilized.
A month later after taking vaccine felt heaviness on her left side and kinda felt like she was drunk she was taking to the ER and x-rays was done found out she had 2 smalls strokes on her lower right quadrant
rapid heart rate; A spontaneous report was received from a consumer concerning a 65-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events rapid heart rate.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 20 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 030L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 20 Jan 2021, the patient experienced the event rapid heart rate.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event, rapid heart rate was unknown.
I had 2 weeks of debilitating cramps and stomach pain. Could not get out of bed for the first 10 days
Hot at injection site; Double Vision; Itching at injection site; Headache; Very dry mouth, not a drop of spit; Chills; Soar arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soar arm), INJECTION SITE WARMTH (Hot at injection site), DRY MOUTH (Very dry mouth, not a drop of spit), DIPLOPIA (Double Vision) and HEADACHE (Headache) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced PAIN IN EXTREMITY (Soar arm) and CHILLS (Chills). On 26-Feb-2021, the patient experienced DRY MOUTH (Very dry mouth, not a drop of spit) and HEADACHE (Headache). On 28-Feb-2021, the patient experienced INJECTION SITE WARMTH (Hot at injection site), DIPLOPIA (Double Vision) and INJECTION SITE PRURITUS (Itching at injection site). On 26-Feb-2021, DRY MOUTH (Very dry mouth, not a drop of spit) and CHILLS (Chills) had resolved. On 28-Feb-2021, DIPLOPIA (Double Vision) had resolved. On 01-Mar-2021, HEADACHE (Headache) had resolved. At the time of the report, PAIN IN EXTREMITY (Soar arm), INJECTION SITE WARMTH (Hot at injection site) and INJECTION SITE PRURITUS (Itching at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not reported  Treatment information was not provided   Reporter did not allow further contact
Emergency visit to Medical Center on 6/6/2021 at 1659. Reason for visit was fever. Active administrations include sodium chloride 0.9 % injection 2 mL EVERY 12 HOURS SCHEDULED, Intracatheter, first dose on 6/6/21 at 2100 and PRN flush of sodium chloride 0.9% to flush tubing. Inactive administrations include acetaminophen (TYLENOL) tablet 1,000 mg ONCE PRN, Oral, Fever, Starting Sun 6/6/21 at 1716, For 1 dose; Cefepime (MAXIPIME) 1,000 mg in sodium chloride 0.9 % 100 mL IVPB, 1,000 mg ONCE, Intravenous, Administer over 30 Minutes, Sun 6/6/21 at 1752, For 1 dose, * MINIBAG PLUS - Mixed before hanging;  sodium chloride (NORMAL SALINE) 0.9 % bolus 1,000 mL ONCE, Intravenous, Administer over 15 Minutes, Sun 6/6/21 at 1718, For 1 dose, Administer for Sepsis Fluid Challenge.
lt thigh pain. Lt thigh pain x 4 days; became raised and tender yesterday, reports some drainage yesterday, increased pain today  Reports fevers at home. 23 yo F w/ no known chronic medical conditions, p/w several days gradually worsening "boil" to L inner thigh. Initially thought it was an ingrown hair, so she pulled the hair out. A boil formed yesterday, which she attempted to "pop." The area drained a little bit of pus at the time, but since then area has grown since. Woke up and the lesion had doubled in size; now raised, red, warm, very tender. Hurts to walk; couldn't even put on her underwear this morning because it hurts so much to touch the area. Denies fevers/chills, n/v/d, lesions/rash elsewhere. No h/o si23 yo F w/ no known chronic medical conditions, p/w several days gradually worsening "boil" to L inner thigh. Initially thought it was an ingrown hair, so she pulled the hair out. A boil formed yesterday, which she attempted to "pop." The area drained a little bit of pus at the time, but since then area has grown since. Woke up and the lesion had doubled in size; now raised, red, warm, very tender. Hurts to walk; couldn't even put on her underwear this morning because it hurts so much to touch the area. Denies fevers/chills, n/v/d, lesions/rash elsewhere. No h/o similar sx.
rash appeared in both upper arms/the rash had extended to the rest of the arms/ both legs also displayed the rash; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9262), via an unspecified route of administration in left arm on 25Jan2021 14:30 at a single dose for COVID-19 immunisation. The patient has no medical history. No allergies to medications, food, or other products. Patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. On 25Jan2021 21:00, a few hours after receiving the vaccine, a rash appeared in both upper arms. By the end of the day, the rash had extended to the rest of the arms. After 36 hours of receiving the vaccine, both legs also displayed the rash. The event was reported as non-serious. Since the vaccination, the patient has not been tested for COVID-19. No treatment was received for the adverse event. The outcome of the event was not recovered.
Passed out and fell to the floor before daylight; Passed out and fell to the floor before daylight; Dizziness; This is a spontaneous report from a contactable consumer (patient's spouse).   A 74-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9265) on 01Feb2021 at 13:15 at single dose intramuscular COVID-19 immunization. Relevant medical history included Alzheimer's disease diagnosed about 5-6 years ago, seizure (diagnosed 40 years ago) and ongoing high blood pressure. Concomitant medications were not reported. On 02Feb2021 patient passed out and fell before daylight morning, it may be around 06:00-07:00 (as reported). Patient's spouse informed that  got up early and was already up when she called him to tell him she had fallen. She sleeps a lot anyway, so she was  just put back to bed. Reporter didn't known exactly when she was up again. It was also informed that several of the medications that she took have side effects like dizziness (as reported).  At the time of the reporting event outcome was unknown.
red erythematous rash with fine macules at the site of injection about 2" long, lasted for 10-12 days.
Wheezy cough 9pm hives on face, stomach and chest dark purple dots on palms of hands purple fingernails
Dose given approximately at 1405. around 1409 she reported having tingling in her mouth and lips and a lump in her throat. pt did not have any increased WOB. pt speaking in full sentences but visibly upset. no lip, tongue, or facial swelling. she denied itchiness. no hives found. O2 sat 100%, HR 130s, pulse was not thready. pt reported very bad headache, denied having headache prior to vaccine. reported dizziness and tunnel vision. denied nausea, abdominal pain. BP 156/80. Epi 0.3mg given IM to right thigh at 1422. supplemental O2 provided. ambulance was called, husband of patient was called. within 2 minutes pt reported globus sensation had resolved. tongue tingling resolved. she still had lip tingling. within 4 minutes of epi her HA had resolved, tunnel vision and dizziness also resolved. still no hives, no lip or facial swelling. lip tingling resolving. held on second dose of epi. BP at 1429 was 176/87. pt reported complete resolution of all symptoms upon ambulance arrival except for shakiness which was noted on exam. report given to ambulance services. systolic BP upon transport was 168.
This spontaneous report as received from a medical assistant and refers to unspecified patients of unknown ages and genders. No pertinent medical history, drug reactions/ allergies or concurrent conditions were reported. Since 26-JAN-2017, the patients were vaccinated with a dose of improperly stored PROQUAD which had a lot # of M022403 with expiration date of 01-NOV-2017 and  M007964 with expiration date: 15-AUG-2017, however, dosage number and route of administration were not reported), for prophylaxis. Nevertheless, no adverse effects were reported. The vaccines experienced the following temperature excursions: on 26-JAN-2017 more than -15 degree centigrades (C), but less than 10 degree C (-12.7 degree C) during 1 hour and 4 minutes of; on 14-FEB-2017, more than -15 degree centigrades (C), but less than 10 degree C  (-11.1 degree C) for 6 hours and 4 minutes, and on 15-FEB-2017, more than -15 degree centigrades (C), but less than 8 degree C (-6.2 degree C) for 10 hours and 24 minutes. There had been no previous temperature excursions and the aforementioned ones were identified due to a data logger. Furthermore, no product quality complaint was involved. Additional information has been requested.; Sender's Comments: US-009507513-1703USA000468:
Child was given shots at 2:05 p.m. per protocol, child was up talking and playing, then stated he didn't feel good, child fainted,  noticed child was very pale, emergency cart obtained, O2sat/74, B/P 98/60, P)92, R)16, lips turning blue, no s/s of SOB, Rash, or seizures, Oxygen applied at 2/LM via face mask, 2:30 p.m. B/P)100/70, P)100, o2sat/85%, R)14, child talking and laughing, fainted again.  Epinephrine 0.15 prepared, ambulance called, oxygen increased to 4/LM, EMA arrives, child talking at this time, faints again and EMT increase oxygen to 6/LM via blow by method, child still groggy and in/out of conversations, child taken to Center via ambulance with Mother/Father/Brother following.  Epinephrine 0.15 wasted, d/t EMA in building, and not needed. PC to mother at 4:30, reported just left ER, child doing fine, color back to normal, lips pink, and playing with dad/brother. Mom encouraged to follow up with child PMD/Dr. On Monday Morning 04/01/2019; has not made appointment as of today 04/01/2019, encouraged to do so.
Patient states he had very bad back pain that felt like he had kidney stones.  This started a few hours after his shot and lasted the rest of the day.  It was gone the next morning. Patient reported this reaction from his first dose when he came in for his booster today.
Patient was given a vaccine that was expired.  It should have been removed from refrigeration and wasted on 01.20.22 due to temperature requirements (28-31 days in the refrigerator)
Information has been received from a nurse concerning a 2 year old patient of unknown gender. Information about concurrent condition, concomitant medication and medical history was not provided. On an unknown date the patient was vaccinated with one dose of VARIVAX lot # N008077, expiry date 09-MAR-2019, subcutaneously for prophylaxis, following temperature excursions of -12.3 Celsius degree for 30 minutes and -9.8 Celsius degree for 3 hours 30 minutes (product storage error). A data logger was involved. No adverse effect was report. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1711USA010721: US-009507513-1711USA010722: US-009507513-1711USA010723: US-009507513-1711USA000697: US-009507513-1711USA010725: US-009507513-1711USA010726: US-009507513-1711USA010727: US-009507513-1711USA010728: US-009507513-1711USA010729: US-009507513-1711USA010730:
Rash on shot site the following day after shot with tiny red bumps, then swollen red area size of golf ball. Patient was advised to take BENADRYL (48 hrs) later.
This spontaneous report was received from an unspecified healthcare professional, referring to multiple unspecified patients of unknown age and gender. Information about patients' medical history, concurrent conditions and concomitant medication were not reported. On unspecified dates, the patients were administered doses of improperly stored VAQTA that were exposed to a fridge excursion on 21-JUL-2017 (lot # M003011, expiration date 15-NOV-2017, lot # L009445 expiration date 01-JUN-2017, L009521 expiration date28-APR-2017, lot # K012456 expiration date 28-APR-2017, lot# L023936 expiration date 15-MAR-2017, lot# L045713 expiration date 14-JAN-2017). This is one of the several reports received from the same reporter. Additional information has been requested.
Information has been received from a nurse practitioner concerning a 25 year old female with a history of caesarean section (about 3 years ago) and with no reactions/allergies who was vaccinated intramuscularly with three doses of GARDASIL (therapy start date was reported as July 2009 and third dose on in the middle of June). Concomitant therapy included PROVERA. After being administered GARDASIL in all three of her dosages, in July 2009 the patient experienced flu-like symptoms. She experienced pain in her body, back and had lingering headaches. She also bled profusely during her menstrual after being administered her third shot on approximately 15-JUN-2010. The patient went to emergency room (ER) on several occasions and had blood work done in the ER after being administered her first shot. The patient was hospitalized on an unspecified date. At the time of the report the patient had not recovered. Additional information has been requested.
Patient experienced a vasovagal response 10 min after receiving the vaccine. He was placed on a cot and his vital signs monitored. 88/53; pulse 47. After 5 min 102/67; pulse 58. After 15 min 110/72; pulse 58. He felt fine and discharged in stable condition. The entire event was about 25 min. He was given water to drink.
Second dose given 25 days after dose 1; This non-serious case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short (Verbatim: Second dose given 25 days after dose 1). The outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt Date: 11-SEP-2022 The reporter reported that the patient over 50 years of age inadvertently received second dose of Shingrix vaccine 25 days after received first dose. The reporter did not provided consent to capture his contact details and declined permission for follow up.  The reporter did not had exact dates of administration available, and did not had patient date of birth or age, stating that the patient was over 50 but no further details were available at the time of the reporting. The patient received 2nd dose of Shingrix, early than the recommended interval, which led to shortening of vaccination schedule. The reporter did not consent to follow up.