chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Menveo reconstituted with sterile water; Menveo reconstituted with sterile water; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 18-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA721A, expiry date 31st August 2023) for prophylaxis.   On 8th November 2022, the patient received the 2nd dose of Menveo. On 8th November 2022, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.      Additional Information: GSK Receipt Date: 11 NOV 2022 Reporter's comment:  The reporter stated that Menveo reconstituted with sterile water. Additional supportive information: As Menveo was reconstituted with sterile water which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The vaccine administration facility was the same as primary reporter. Reporter consented to follow up.
patient fainted within minutes of getting the vaccine. they reported they were afraid of needles and was advised to take a seat in the waiting ares. patient fainted breifly, were sweating. emergency services was called immediately and they questioned the patient and determined it was just the result of anxiety from the fear of needles. patient was okayd to leave the facility by emt at around 3.50 pm. (within about 20 mins from starting of incidient) patient then left the facility without any other issues.  follow will be done by rph in a few days.  there were no signs of an allergic reaction or history of one
Redness and swelling on left arm of injection site. Experienced nausea later that day of injection. The next day experienced headache, chills, nausea and vomiting. Never reached a fever.
My daughter received the H1N1 vaccine on the 17th of this month. The next morning I found a rash on her thigh just below the injection site. She said that it hurt and it was itching, and it felt warm to the touch. I phoned the nurse who administered the vaccination to see if this was a known reaction. She stated that she was not aware of any localized rashes from the vaccine. She asked questions, and it was determined that neither one of us knew what had caused this reaction, but the nurse felt that it was possibly contact dermatitis. My daughter still has the rash on her thigh today, however it has spaced itself out more bumps are no longer really close together. This is the only area on her body that this occurred. I just wanted to make the organization aware of this reaction, as I believe it is due to the vaccination. My daughter is scheduled to have the next injection in a month, we will see if this rash appears again. I should also add that my other 2 daughters received the vaccine the same day in the arm without any rashing.
Started on back, wrists and arm and stomach; Sat. started to clear but same on inner thighs, hives, under arms; Sunday on face under eyes and cheeks today on face and arms. They are in clusters welts. They itch no fever and they come and go. Pt has had these before when fever arises. First when fever reduces. This is 2nd time that they have started this long school i shaving her see dermatologist tomorrow.
Patient reports that the area where she received her immunization is still sore over 2 months after she received it which is unusual compared to other influenza vaccines she has received in the past. She says initially there was a bruise but that went away but the soreness has persisted.
Throat became scratchy 10 minutes, post vax. Began feeling short of breath, wheezing, and then "blacked out". Wife found him blue, tongue swollen and not breathing. EMS came at 11:30 and took him to ER. He was given steroids, overnight, in the hospital. Had hives for 3 days with headache. Full recovery with no lasting effects. Review of hospital discharge summary confirms diagnoses of anaphylactic reaction and small, superficial facial laceration.
PT RECEIVED SECOND DOSE OF PFIZER VACCINE.  10 MINS S/P ADMINISTRATION PT REPORTED FEELING DIZZY, LIGHTHEADED. THIS RN ASSISTED PT TO SUPINE POSITION UNTIL DIZZINESS DISSIPATED.  PT POSITION IN BED, HIGH FOWLERS AND ASSISTED DRINKING WATER, APPLE JUICE AND GRANOLA BAR.  PT APPEARED MILDLY DIAPHORETIC, WITH PALLOR AND SHAKINESS.  PT'S FIANCE REPORTED THIS HAS HAPPENED TO PATIENT SEVERAL TIMES IN THE RECENT PAST.  THIS RN ADVISED PT TO ESTABLISH PCP AS SHE DOES NOT CURRENTLY HAVE A PROVIDER.  PT SPO2 WNL. TACHYCARDIC BPM 120BPM, ABLE TO REDUCE WITH CALMING TECHNIQUES.  NO SOB, CYANOSIS OR DYSPNEA.  AIRWAY APPEARS PATENT.  PT STATES "IT FEELS LIKE MY THROAT IS SWELLING SHUT BUT I THINK IT IS ANXIETY."  PT DID NOT APPEAR TO HAVE ANGIOEDMA, HIVES, CONSTRICTING OF AIRWAYS.  PT ABLE TO CONVERSE COHERENTLY AND IS AAOX4.  BP ELEVATED TO 188/90, HAS HAPPENED SITUATIONALLY BEFORE.  PT STAYED 45 MINS SP VAX AND WAS ABLE TO LEAVE WALKING, UNASSISTED.  SHE WAS ADVISED TO RETURN TO ER IF BREATHING BECAME DIFFICULT, HIVES APPEARED OR LOC CHANGED.  REFUSED BENADRYL R/T PRIOR ADVERSE REACTION. THIS RN ATTRIBUTES REACTION TO ANXIETY, LACK OF ADEQUATE CALORIC CONSUMPTION THIS DAY AS WELL AS FEAR OF NEEDLES.
Patient was given Proquad but only needed MMR. Error was injecting wrong vaccine.  No symptoms, no signs, no reaction to vaccine.
Contraction of Covid-19   Patient presents today for urgent care due to covid symptoms and positive home test. He has been fully immunized. He has fatigue, head and chest congestion, sore throat, some shortness of breath and body aches.  Review of Systems Constitutional: Positive for activity change, appetite change and fatigue. Negative for chills and fever. HENT: Positive for congestion, sinus pressure, sinus pain and sore throat.   Respiratory: Positive for cough, chest tightness and shortness of breath. Negative for wheezing.   Cardiovascular: Negative for chest pain. Gastrointestinal: Negative.   Musculoskeletal: Positive for myalgias. Neurological: Positive for headaches.    Pulse 84  | Temp 99.3 °F (37.4 °C) (Oral)  | SpO2 91%  Constitutional:      General: He is not in acute distress.    Appearance: He is obese. He is ill-appearing.  HENT:     Head: Normocephalic and atraumatic.  Eyes:     General: No scleral icterus.    Conjunctiva/sclera: Conjunctivae normal.     Pupils: Pupils are equal, round, and reactive to light.  Cardiovascular:     Rate and Rhythm: Normal rate and regular rhythm.  Pulmonary:     Effort: Pulmonary effort is normal. No respiratory distress.     Breath sounds: Normal breath sounds. No wheezing.  Musculoskeletal:     Cervical back: Neck supple.  Skin:    General: Skin is warm and dry.  Neurological:     General: No focal deficit present.     Mental Status: He is alert and oriented to person, place, and time.
Extreme bone pain, worse on my right collarbone. Nausea starting 1/9/2021 morning around 6am. Active vomiting starting at 4pm and was vomiting every 10 minutes until about 10pm. Unable to keep any fluids down. Migraine since about two hours after vaccine administration.  Woke up 1/10/2021 with body aches, headache, sore throat, nausea, injection site arm pain radiating up my neck.
Immediately after receiving his fifth vaccine shot in a row, patient became limp and was placed lying flat. He momentarily threw his arms up. He regained a drowsy consciousness in 5 seconds, was warm and diaphoretic with HR of 80. Patient or his father would not allow a BP or OX reading. He remained lying for 30 minutes then was able to walk well.
This spontaneous report as received from 2 healthcare workers refers to unspecified amounts of patients of unknown age and gender. On unspecified date between 10-MAY-2014 and 23-JUN-2014, the patients were vaccinated with RECOMBIVAX (lot # J004700, expiration date 26-NOV-2015) that underwent a temperature excursion, 0.5ml, intramuscularly. No adverse effect reported. This is one of several reports from the same source. Additional information has been requested.
Red, itchy rash, hot to touch, appeared around injection site, around 3 inches in diameter, 12 days after receiving injection. Rash increased in size the following day but had less clearly defined borders. Rash began to resolve within 24 hours after taking antihistamine.
This has been worsening symptoms of a preexisting health condition. I had food poisoning, since then I noticed things were getting worse after 02/05/2023. I've had long standing discomfort and constant pressure. I had some acute pain on lower left region of my abdomen. It feels like food poisoning. It has been lingering and I have been having more acid reflux. I was prescribed a medication to resolve it, if it was caused by a past infection. The medication is pantoprazole. Today I feel similar to before the food poisoning event. I have uncomfortable gut pressure nothing acute.
Patient developed swelling in upper extremities after vaccination with Pfizer in right arm. Got "much worse" after second shot on 05/09/2021- reported leg swelling as well. As of June 2021 legs are less swollen, but arms persist, particularly the right arm- swollen enough it is difficult to close his hand
This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 58-year-old male patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included mental disability and tremor. On 18th June 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 19th June 2018, 1 days after receiving SHINGRIX, the patient experienced injection site swelling. On an unknown date, the outcome of the injection site swelling was recovered/resolved. It was unknown if the reporter considered the injection site swelling to be related to SHINGRIX. Additional details were provided as follows: This case was reported by patient's brother. The next day after receiving SHINGRIX, the patient experienced swelling at the injection site. It was about 1.5 inch in diameter and bulged up like there was a ball under the skin and took 3 to 4 days to resolve.
This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 11-FEB-2014, the patient was vaccinated with an improperly stored dose of GARDASIL (lot # J006236, expiration date: 25-FEB-2016) dose and route were not reported. No adverse experiences were reported. This is one of several reports received from the same source. Additional information has been requested.
Pt awoke with pain and redness in upper arm in area where it was administered.  She states the area is hot to the touch.
Woke less than 12 hrs later to a wicked headache. Headache lasted 7 days.
This spontaneous report was received from a nurse referring to a multiple patients of unknown age and gender. On an unknown date, the patients were vaccinated with improperly stored doses of VARIVAX (Merck) (dose, frequency and indication were not reported) lot # K005426 with expiration date 15-APR-2016. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
She developed low grade fevers, chills, myalgia and fatigue in the first week following vaccination. Her fevers tapered off and she developed knee, hip and shoulder pain and stiffness that transitioned into symmetric, polyarthritis of the wrists, ankles, MTPs, MCPs and PIPs. She started Motrin OTC that has helped with the swelling of her hands and feet but she remains with pain, stiffness and difficulty typing  Symptoms: PAIN IN UNSPECIFIED JOINT(M2550), EDEMA, UNSPECIFIED(R609), FEVER, UNSPECIFIED(R509), OTHER FATIGUE(R5383), MYALGIA(M791).
Had injections at 11:00 AM - by 4 PM couldn't raise arms - felt like arms had been broken - still have limited mobility today.
devel vesicular rash 23DEC95 & sibling devel similar varicella rash 14 days later than index case
Shots were given at 10:30 am. At approximately 11:00 am, baby was sleeping and became very pale. She stayed pale for about 3 to 4 hours and began extreme fussiness (inconsolable crying) around 3:00 pm lasting for approximately 3-3 1/2 hours. Her thighs were sore from the shots, and she had little to no appetite for about 5 hours. Her temperature never reached above 100 degrees Fahrenheit but Tylenol was given approximately every 4 hours for the entire first 24 hour period to keep temperature under control. Tylenol was given as needed for the following 48 hours. No other treatment was administered. Patient recovered from paleness and fussiness by 6:30 pm on the same day she received the shots.
Severe headache, loss of balance, malaise, fever (between 101-103.2 for about 24 hours), nausea, chills, body pain
Red raised bumps on injected upper arm; less than previous reaction.  Did not seek immediate medical care, but brought to MD's attention at next visit.
It was reported that a female pt received a Rabies Imovax IM vaccination and a RIG injection on 8/23/00. Reportedly, on 8/25/00, the pt developed dizziness and general malaise. Further information requested.
Fever, myalgias, generalized weakness (fell a couple of times). Reports that evening - some discomfort shoulder and also generalized upper body achiness. Next morning - husband went to wake pt and found her on the floor, husband reports she was confused as well -had not even been able to call for help. Needed assistance to get her up off the floor - reportedly 'fainted' again later that morning when 'trying to exercise' (unwitnessed). She was admitted for IVF hydration and observation. Following day she felt improved, cleared by PT to go home as was ambulating independently. Pt and husband reports temp up to 101.Symptoms resolved as quickly as they came on.
warm feeling on chest, increase heart beat, pulse 125, going down to 60 up to 120s, was told i was nervous, i felt this 5-8 minutes after vaccine.
Allergic reaction, pt was taken to ER at hospital for hyperventilation on 12/09/03, pt never came into office.
Pt. was given vaccine while sitting on exam table, band aid applied. Was standing by mom and talking minutes later, fell to knees and forward syncope. Unresponsive app. 10 sec. then awake but scared. No injury. Older sibling then C/O not feeling well after that. Observed x 15 min.
pt recvd 2 doses of Engerix-B & devel urinary yeast infection;  1st yeast infect never entirely went away & p/2nd inject again exp full blown yeast infection;
burning sensation in vaginal area. thought UTI or yeast.  Primary care physician tested for both and negative. sent to gynecologist who said uterine lining was exceedingly thin as if advanced menopause. questioned me about my vaccination status.  her thoughts were caused by vaccine as menstruating women had other issues after second covid vaccination.  put me on estrogen cream to be applied nightly for a month.  returned for follow up and she thought lining area much improved.  I am applying the cream now twice weekly.
Information has been received from a physician concerning a female patient who was vaccinated with a dose of HPV vaccine (yeast). Subsequently, the patient fainted.  Her outcome was not reported.  Additional information has been requested.
Pt experienced no adverse reaction. This error was discovered during a routine inventory of our vaccines Pt given DTaP HIB and Comvax (also containing HIB) which made an extra dose of HIB
1st dose administered to a 17 year old patient; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (1st dose administered to a 17 year old patient) in a 17-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-May-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (1st dose administered to a 17 year old patient). On 31-May-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (1st dose administered to a 17 year old patient) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication were reported. No treatment information was reported
Patient woke up at 4:30 am and went to bathroom, noticed lips/face was swollen. Has a physician appointment this afternoon (1-11-2018). Shot was given on 1-10-2018 at 2:30 pm.
Severe swollen lymph node in left arm pit, red splotchy rash around lymph node and surrounding area. Very painful, feels like a walnut in my arm pit. Very uncomfortable to have arm hanging down or to wear a bra. Rash lasted 2 days. Pain and swelling of lymph node is still constant as I type this.
Heat, pain, imflamation and itching in the right superior limb,where one of the vaccines was administered.
ON THE 2ND DAY POST VACCINATION OF THE MODERNA COVID 19 VACCINE, I BEGAN TO EXPERIENCE CHEST TIGHTNESS.  IT FELT AS IF I WAS BEING SQUEEZED IN A VICE.  I DID NOT HAVE A COUGH.  IT ALMOST FELT LIKE I WAS HAVING A HEART ATTACK.  IT RADIATES TO MY NECK AND MAKES ME SWALLOW HARD TO IMPROVE THE SX NO FEVER NO COUGH   TODAY IS THE 2ND DAY POST VACCINE AND I STILL HAVE THE SENSATION THAT MY CHEST IS BEING SQUEEZED.
Immediate complaint of stomach pain. Patient was told to lie down, face looked pale, slightly fatigued and uncomfortable.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-May-2021 at 11:18 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 24-May-2021 at 11:18 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 23.33.  Concomitant products were not provided.  On 24-May-2021, Excursion time was 08 AM and 09 AM, temperature was 35, total doses given for the day was not reported, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 18-May-2021, vial was moved to clinic on 24-May-2021. 3 vials were sent to clinic. Vaccine BUD date was 17-Jun-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  Temperature recordings were taken using a Fisherbrand traceable temperature monitor at every hour. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  Treatment medications were not reported.
No adverse event; Expired vaccine administered; This spontaneous report was received from a certified medical assistant referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications.  On 25-JAN-2021, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # R005341  that expired on 06-DEC-2020 for prophylaxis (dose, route of administration were not reported). The reporter stated that this product did not have a temperature excursion. No additional adverse events were reported.
2.5 months after vaccine, right side of face is numb.  Numbness has persisted since 5/29/2021.   I responded to the vsafe check-in and received a phone call requesting information regarding this condition.  Appointment scheduled for 8/11/2021
Exactly one week after the second vaccine I developed a severe headache. It was a pulsing in my entire forehead and into my eyes. It started the morning of May 25 and I have woken up with the same headache since then. Advil sometimes works but it does not completely reduce the symptoms.
Pt vaccinated with DTP developed temp to 39.2, floppy, unresponsive for 45-90 min would not awaken, stopped breathing for 1 min started spontaneously taken by car to ER - when child stopped breathing called ambulance taken by ambulance.
Significant pain in left elbow joint, limiting my ability to use that arm, particularly for any movements that involve forearm rotation and extending the arm.
Immediate burning headache, 5 days later developed L side numbness to tongue and facial drooping, 3 weeks later developed pain to R leg and 4 days later difficulty breathing with chest pain. Hospitalized  with DVT in R leg and bilateral pulmonary embolism on 11/15/21
Scattered scabbed papules and vesicles on right abdomen with erythematous base, single vesicle papule, pain in right abdomen that started the week of 12/19/00. Pain increased and had a fever of 101F. On 12/25/00, MD stated he has vaccine associated shingles; now resolving. Pt to call if worse.
patient developed diffuse body aches and joint pains for 2 weeks immediately after immunization.
From initial information received on 09/21/04 from a physician regarding an adverse event occurring in the USA, it was reported that a female patient (age and date of birth not reported) received a dose of Menomune A/C/Y/W-135, lot number UE239aa, administered on 09/20/04. The route and site of administration were not reported. During routine blood work the following day, it was noted that the patient had elevated white blood cell count of 16.4. No other signs or symptoms were noted. It was not reported whether the patient recovered from this event.
This spontaneous report as received from a Medical Assistant refers to 4 months old infant, gender not reported. On 03-DEC-2014, the patient was vaccinated with ROTATEQ, Lot # K004620, orally. It was reported that the administered vaccine was subjected to temperature excursion during storage. No adverse event reported. This is one of the several reports from the same reporter. Additional information has been requested.