chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Only Menveo diluent portion used; Only received  diluent portion; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) (batch number AMXA660A, expiry date 31st March 2024) for prophylaxis.   On 6th February 2023, the patient received Menveo. On 6th February 2023, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt date: 07-FEB-2023 Reporter's Comment: The reporter from a doctor´s office reported that a patient received Menveo diluent portion (grey cap) alone. Inadvertent Administration of Only the MenCYW-135 Liquid Conjugate Component of the 2-vial Presentation of Menveo. The patient information was not available. The reporter consented to follow up via email. Additional Supportive Information: The patient received Menveo diluent portion (grey cap) alone, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
pt recv vax 7MAR95 & pt exp malaise;reporter felt that there was a possible problem w/the lot of vax;
Patient reported right arm throbbing from under armpit down to the wrist about 20 minutes after administration.  She said her right arm was basically not useable.
Patient rearrived in office x 20 minutes after vaccines - no reaction.  Approximately 20-40 minutes later complained of tingling in lips - tongue.  No breathing difficulty.  Lips became puffy x 24 hours.  Complained of pain in left arm at injection site with 4.5cm raised red area lasting 3-4 days.  Instructed by phone to administer Benadryl tablet every 4 hours for 24 hours.  Motrin PRN for pain and oral (Topical for swelling at site of injection).
Diarrhea and gas; upset stomach. Co-worker who got vaccine at same time had similar symptoms; both of us returned from a trip on 12/12/2009.
Received Pfizer vaccines on 3/6/21, 3/27/21 Positive for COVID 19 by PCR on 10/7/21 admitted to Hospital ICU on 10/7/21 with COVID-19 pneumonia. Underlying malignant endometrial cancer, type 2 DM
Left size  of my collarbone was big   (inflamed) (size of a grape); An awful feeling.; I felt really sick; My left arm was hurting a lot/Pain all over my body; I felt really tired; This spontaneous case was reported by a consumer and describes the occurrence of OSTEITIS (Left size  of my collarbone was big   (inflamed) (size of a grape)), FEELING ABNORMAL (An awful feeling.), MALAISE (I felt really sick), MYALGIA (My left arm was hurting a lot/Pain all over my body) and FATIGUE (I felt really tired) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 22-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced OSTEITIS (Left size  of my collarbone was big   (inflamed) (size of a grape)), FEELING ABNORMAL (An awful feeling.), MALAISE (I felt really sick), MYALGIA (My left arm was hurting a lot/Pain all over my body) and FATIGUE (I felt really tired). At the time of the report, OSTEITIS (Left size  of my collarbone was big   (inflamed) (size of a grape)), FEELING ABNORMAL (An awful feeling.), MALAISE (I felt really sick), MYALGIA (My left arm was hurting a lot/Pain all over my body) and FATIGUE (I felt really tired) outcome was unknown.            No Concomitant medication were reported. Treatment medication was not provided. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable.
I tested positive for COVID-19 on 05/03/2022. I had mild cold symptoms, headache, congestion, low grade fever, and a sore throat.
Pt was to receive their third COVID vaccine. Pt received the monovalent dose instead of the bivalent like they were supposed to.
Pfizer-BioNTech Covid 19 Vaccine EUA  Reaction: shooting pain in arm that was  injected,  tired and cold, unable to sleep on arm due to pain
Information has been received from a health professional concerning a 77 year old white female patient with sulfonamide allergy who on 1-MAR-2007 was vaccinated with the first dose of ZOSTAVAX (lot # 656412/1476F) subcutaneously in the right arm. Concomitant therapy included COUMADIN, SYNTHROID, calcium (unspecified) (+) vitamin D (unspecified), estrogens, PREMARIN and ACIPHEX. On 22-JAN-2009 the patient experienced a red rash area on left upper back that was itching, spreading and very painful and tender to touch. The patient was diagnosed with shingles. As of 03-FEB-2009 the outcome was unknown. Shingles was considered to be an other important medical event by the health professional. Additional information has been requested.
Initial unsolicited report received from a health care professional (daughter of patient and Physician's assistant) on 11-Aug-2016. This case involves a female patient (age not reported) who was vaccinated with a dose of ADACEL (batch number: unknown, expiry date, dose, route and site of administration was not reported) on an unspecified date. Patient's ongoing illness, medical history and concomitant medications were not reported. On an unspecified date following vaccination the reporter stated that the patient experienced reaction, swollen lymph nodes above the left clavicle with swelling upwards to face, redness of swollen area, headache, nausea and sweating. Lab test and corrective treatment were not reported. The outcome of the events was unknown. List of documents held by the sender: None.
This spontaneous report was received from a physician referring a 4 year old male patient. Current conditions included developmentally delayed, the patient's medical history was not reported. On 15-SEP-2016, the patient was vaccinated with (Oka-Merck)  PROQUAD (lot number, expiration date, concentration, dose, frequency and via were reported as unknown), other suspect therapies included (unspecified) Influenza virus vaccine (lot number, expiration date, concentration, dose, frequency and via were not reported) and DAPTACEL (lot number, expiration date, concentration, dose, frequency and via were not reported) that were administered simultaneously in the same date were indicated. No concomitant medications were reported. On 15-SEP-2106, during a visit to the physician's office, the patient experienced a brief episode of vomiting. No laboratories or studies were performed. At the time of the report, the outcome of vomiting was unknown. The causality between (Oka-Merck) PROQUAD and the adverse event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
1743/Vaccine administered , 1800 Pt's husband  reported that pt was having a reaction of a swollen tongue. Prior to vaccine administration, Pt and her husband communicated pt's medical history of Hereditary Angioedema and were well prepared for such reaction. Pt had an IV in her left hand, saline locked and was ready to administer CI Esterase Inhibitor which is the only medication that will help aside Plasma. Medical lead and EMT on the bus arrived to the scene. Pt's tongue was swollen, pt was alert and pushing the medication through the IV. V/S checked, BP 137/,87 HR 118, O2 93%, RR 18.  911 called since med was not helping. EMS arrived after 5 minutes. Pt transported to the ER via ambulance for Plasma infusion.
After receiving shingles vaccination developed prolonged burning sensation throughout body - genitals-extremities for 2 months. Diagnosed with dysesthesia and monoclonal gammopathy of undetermined significance.
Chest congestion began, following next morning by acute sore throat & swollen gland in throat, coughing & coughing.  After 2 wk had strep culture (negative) & developed Shingles. Low temp. at & below 97 most of time, continues 3 wk later. Improving very slowly, too tired to do anything except rest.
Pt. received Fluvirin vaccine on 9/4/12 and noticed reaction at 11:30, pain at site. On 9/6/12 Reported lymph node reaction - swollen, tender, sore and very painful. Sent to urgent care.
Immediately after receiving the vaccine the client learned forward in the chair, and was help to the floor.  He experienced a seizure that lasted for about 50 seconds.  Upon recovery his BP was found to be slightly elevated 138/90 and his heart rate was rapid. He fully recovered within 10 minutes and returned to the nurses office.  His parent was called and he went home.  The PCP was called by the parent and according to the school nurse, no additional action was taken.
This child had a fever of Tues 03/13/01, 2 hours after her shot at about 10 AM to present 03/15/01 at 1:30 PM. Lethargy on Tues at 03/13/01 at 10 AM, continues at this time 3:30 on 03/15/01.
Received Prizer Bivalent booster on 10/06/2022. Another dose of Pfizer Bivalent booster was administered on 12/28/2022 which is outside of current CDC guidelines.
PREVNAR 13 and flu vaccine administered 10/17/16. Patient presented to office on 11/7/16 c/o pain at injection site. She presented again on 12/16/16 c/o pain weakness (L) arm.
My face swelled up didn?t think much of it, then my throat started to tighten or swell I had a coughing fit, couldn?t breathe passed out, my boyfriend found me unconscious and took me to the hospital. They said I had a severe reaction (anaphylaxis) and got me on IVs.
under my arm, where I put on deodorant, is a little swollen.; injection site arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (under my arm, where I put on deodorant, is a little swollen.) and VACCINATION SITE PAIN (injection site arm was sore) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088D21A) for an unknown indication.     No Medical History information was reported.    On 09-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Aug-2021, the patient experienced VACCINATION SITE PAIN (injection site arm was sore). On 11-Aug-2021, the patient experienced PERIPHERAL SWELLING (under my arm, where I put on deodorant, is a little swollen.). The patient was treated with PARACETAMOL (TYLENOL) for Injection site pain, at a dose of 2. At the time of the report, PERIPHERAL SWELLING (under my arm, where I put on deodorant, is a little swollen.) and VACCINATION SITE PAIN (injection site arm was sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided by the reporter.
Vertigo the next two days, took bonine 08/10 and started to get better, mostly while lying down. Some sweating, hot flashes. Neck, shoulder tightness. Sore and itchy injection site on 08/11/19
Sore arm and slight nausea.  Developed itchy eyes, scalp, and ankles within 3 hours of injection, followed by rash on arms, upper back, and upper chest the next morning.  Treated with benadryl 25 mg po tid.  Symptoms improving.
Noticed pinpoint blood dots on the top of my feet.  By the next day they were on my ankles and going up my calves.  'Spots' began getting bigger. Saw doctor  Thought it was folliculitis and prescribed antibiotic-I did not take Rx as I didn't agree with the dx.  Ran bloods.  White and red counts were fine.  Saw specialist. She believed it it was leukocytoclastic vasculitis.  'Spots" began to get worse-very painful-some ruptured.  Right Ankle was swollen and painful-horrible burning sensation.  This lasted about 4-6 weeks.  During this time the spots started moving up my body onto thighs, tops of hands, forearms, stomach, and some on breasts.  It is now 3 months later and while the majority of the spots are gone-healing from the feet up, i still have a lot of discoloration.  I continue to get new spots on my forearms and tops of hands, occasionally on legs and stomach.
Patient was asked if she had eaten anything and answered that she had not.  With mom's permission, nurse gave patient lollipop which she begin to eat. Nurse also instructed patient to wait in chair after vaccinations for a few minutes before going to lobby to continue waiting 15 minutes.  At approximately 11:15 a.m, within a minute of receiving the last vaccination (HPV), patient put her head in her lap and appeared to be fainting.  Nurse supported patient so she would not fall on floor, mom got paper towels and wet them, nurse applied cold wet paper towels to patient's face, neck, arms, and hands.  After several minutes, patient begin to open her eyes and get color back in her face.  Chair was moved into place, and patient raised her legs onto chair.  Mom supported patient while nurse went and got cold water bottle and crackers.  Patient sipped slowly on cold water for several minutes.  Nurse continued to apply wet towels, cold pack (brought by other nurse), and assist patient with cold water bottle sips and lollipop. At no time did patient fall to floor or become injured.  At 11:45 a.m. mom determined that patient had recovered.  Nurse and mom assisted patient as she ambulated into lobby where she continued to wait, observed by front office staff.  At approximately 11:50 a.m. mom and patient walked from lobby after front office staff asked if patient was feeling better, and they stated she was o.k.---RN
Expired vaccine. No temperature excursions occurred. Moderna determined the vial "maintained the activity necessary to protect against the SARS CoV-2 virus at the time of administration."  No adverse reactions reported.
Three days post vax, this pt experienced swelling and tightness in the fingers. Swelling and pain also developed in the knees and wrists associated with morning stiffness. The pt was able to grasp, but with pain. No soreness developed in the are of the shot. Medical treatment was sought and the reaction was described as "serum sickness like." She was treated with acetaminophen and ibuprofen. Approximately 1 week post onset of symptoms, she recovered.
Allergic Inflammatory Response Distal to the injection site. Redness, swelling, tenderness, itching, and warmth.
pt's wife reported pt w/fever & chills, dry cough 2 days p/receiving flu vax; to MD on 12OCT92 4 days p/vax; told reaction to flu vax & had flu; was given Suprax & provental;
pt recv vax;appx 9:30,noted raised reddened areas on both arms & both legs;denies any itching;sx gone next am;
Large red spot, white around edge, warm to touch and tender to touch 2 inches below injection site
Fullness and tenderness in R axilla (vaccine given in LUE), tender sores on both sides of tongue; lasted almost 2 wks, resolved without treatment
symptoms began in late evening of 08/09 with chief complaint of pain, edema/swelling, warm to the tough, sensitive. pt also states he felt nauseous and had some form of twitching
Bell's Palsy; .A spontaneous report was received from a consumer who was also a 79 years-old male patient, who received Moderna's COVID-19 vaccine (mRNA-1273), and experienced Bell's palsy (facial paralysis).  The patient's medical history was not provided. Concomitant medication reported included metformin.  On 29 Jan 2021, prior to the onset of event, the patient received their first of two planned doses of mRNA-1273 (batch number: 012L20A), intramuscularly for the prophylaxis of COVID-19 infection.  On 29 Jan 2021, after the administration of vaccine, the patient developed Bell's palsy. The patient went to the emergency room (ER) for treatment but was unable to get the condition resolved. The patient was referred to a neurologist, but the side effects were still present up to this point.  Action taken with second dose of mRNA-1273 in response to the event was not reported.   The outcome of the event, Bell's palsy, was not recovered.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the event, a causal relationship cannot be excluded.
Dyphoretic; chest tightness; trouble swallowing within 15 minute waiting period  Administered epinephrine and benedryl  911 called-client refused transport
Head pain, high fever, weakness. Back right side of head still aches with bending over 13 days post 2nd Moderna shot.  Tylenol and fluids taken.
Given Moderna Spikevax and developed flushing and chest tightness within 2 minutes. Taken to ED for further evaluation and treatment.
Improperly stored VARIVAX administered after storage outside of PI.; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reaction or allergy and concomitant therapy was provided.   On 01-OCT-2020, the patient was administered improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot # S012037, expiration date 17-APR-2021, strength, dose and route were not reported) for prophylaxis.    Administered dose of varicella virus vaccine live (oka/merck) (VARIVAX) were stored -14 degree Celsius (C) to -10 C (-10.5 C) for 1 hour and 11 minutes. Previous temperature excursion included -10 C to 8 C (-3.9 C) for 2 hours and 23 minutes. The digital data logger was involved.
About 30 hours after the shot, I had SUCH sore lymph nodes in my armpit that I could not even move my arm to pull down my pants to urinate. I could not sleep that night because I was too uncomfortable.
When the health department and patients daughter arrived at nursing and rehab facility to administer the 2nd shot in the series, The nurses were told that she had gotten her shot already.  When the nurses from the health department and the daughter questioned the staff as to when the patient had gotten her shot, they stated that they skill nursing gave her a moderna vaccine on May 28th, 18 days after her first shot was given to her. At that time, the nurses immediately called the health department to get information on patient and at that time was advised to leave the facility and not administer the second shot.  I did talk with the Administrator about this situation. Advised her to report to Vaccine Adverse Event Reporting Systems, and that they also need to Call moderna and let them know that this patient was given her vaccine 18 days after her first shot, and it should of been 28 days, so she got it 10 days early.  also advised them that if she pt. had gotten the shot at the facility, it was not registered in state web site, which they had not reported in the state web site.  Advised them they had to place that within 24 hours which they had not.  Also reported to me was that the patient had the appearance of a stroke reported by the nurses at the health department, when questioned about the one sided droopy face of the patient,  the nurses stated on May 10 th when the first vaccine was given she did not have the droopy appearance.
Attendee complained about anxiety and being lightheaded. So was retained at the site.  1 hour after vaccination the attendee fainted, aroused within 5 seconds and was awake alert and oriented x 4.  Attendee was retained at the site for another 25 minutes.  She refused to have anyone come get her and she left the site independently.
Information has been received from a physician concerning a 7 year old female who on 04-FEB-2000 was vaccinated with a dose of Varivax. Subsequently on 05-APR-2006 the patient experienced breakthrough varicella rash. Unspecified medical attention was sought. No further information available. There was no product quality complaint involved. Additional information received indicated that there was no further information available. No additional information is expected.
Information has been received from a pediatric medical records and a physician concerning a 15 week old bottle fed female with no known drug allergies, colic and a history of diaper rash, head congestion, nasal congestion, runny nose, cough, bruise, generalized skin erythema, rhinitis, fever and weight loss (0802USA04707) who on 22-DEC-2008 was vaccinated with the first dose of RECOMBIVAX HB (manufacturer unknown). Vaccine received at the same day including the first dose of concomitant therapy included  PEDVAXHIB (manufacturer unknown), the first dose of DTAP (unspecified), the first dose of POLIO (unspecified) and the first dose of PNEUMO (unspecified). The patient's weight was 10.1 HC 38 cm HT 23.1. Decreased in colic symptoms were noted. Formula amount was to increase. On 21-JAN-2009, at the office visit, the patient had developed red eye for 2 days. The patient had clay colored stool. Treatment was to hold pedialyte increase formula 5-6 ounces and no treatment for red eye (not illness related). The baby's HC was 16 and temperature 97.8. On 10-FEB-2009, the patient visit the office, the patient experienced diarrhea, coughing and congestion for 5 days and noted yellow/green color diarrhea. The physician prescribed TYLENOL. The physician noted new cereal for 5 days (rice) formula (lipid). Plan was to hold cereal for few weeks. On 18-FEB-2009, at the office, the patient had developed bloody diaper rash for 1 week and had used vaseline. The physician prescribed Nystatin twice to three times daily until 48 hours after symptoms resolve and keep dry. On 25-FEB-2009 the patient was diagnosed with a birth mark/stork bite birth mark on forehead and deltoid at the physical exam. The rash was better. The patient's weight was 13.5 lbs, Ht was 26 and HC was 16.5. Formula type was Enfamil lipid. It was noted that the infant should receive the following vaccinations: the second dose of PEDVAXHIB (manufacturer unknown), DTAP (unspecified), POLIO (unspecified) and PNEUMO (unspecified) at the health department at 4 months, after 11-MAR-2009. Birthmark/Stork bite on the forehead and deltoid was considered a congenital anomaly. No further information is available. All available medical records will be provided upon request.
TDap 10-12-13. Returned 10-14-13 for re-eval site. 8 x 6 cm area of Erythema and warmth. No induration.
p/vax pt exp soreness underneath rt arm; then tender burning rt breast and now has tender burning sensation in both breasts; no treatment given; symptoms just about gone
Case number PHEH2014US015561 is an initial spontaneous report received from a healthcare professional (medical assistance) on 29 Jul 2014. This report refers to a 16 year old female patient. Her medical history and concomitant medication were not reported. She was vaccinated with MENVEO (batch number: M14023) intramuscularly on 25 Jul 2014. It was reported that the MenA powder component was reconstituted with a sterile diluent instead of CYW-135 liquid component. No adverse event was reported following this administration error (wrong solution used in drug reconstitution).
Had Hep B at 3:30 pm.  At 9:15pm tongue thick feeling, right side face numb feeling and throat felt like closing up. Went to ER and Dr. said didn't think allergic reaction but neuro or mini stroke.  Pt was given IV and 4 baby aspirin.  Another ER doctor said possible allergic reaction.
Developed Zoster outbreak one week after receiving Zoster vaccine.  Started on antiviral
Patient called our onsite registered nurse on 15APR21 to report a rash on her neck, chest and abdomen.