chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Menveo powder with non-GSK sterile diluent; reconstituted Menveo powder with non-GSK sterile diluent; 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 16-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA702A, expiry date 28th February 2023) for prophylaxis.   On 1st August 2022, the patient received Menveo. On 1st August 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: 02-AUG-2022. Reporter's Comments: The clinical supervisor called in to inquire that should they revaccinate and if so, how long to wait. The clinical supervisor reported that they reconstituted Menveo lyophilized powder with a non-GlaxoSmithKline sterile diluent and inadvertently administered to a patient. No other additional details were provided. The consent to follow up was not granted. Additional Supportive Information: As patient reconstituted Menveo lyophilized powder with a non- GlaxoSmithKline sterile diluent, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.
This spontaneous report was received from a nurse refers to an approximately 11 year old female patient. No concurrent condition or medical history was reported. The nurse reported that the mother of the patient called physician to report that on 10-AUG-2015 the patient was vaccinated with GARDASIL 9 (lot # L004014, dose 2, intramuscular, dose not provided). No concomitant therapy was reported. On 11-AUG-2015, the patient had an unspecified fever. The therapy was not discontinued. The outcome of the event was reported as not recovered. The causality assessment was not reported. No product quality issue was involved. Additional information has been requested.
In October my arm started hurting and aching, it woke me up. I did not have mobility in my arm, I could not get dressed, use my arm to do simple task. I let it go for a month thinking it was related to my fibromyalgia. I woke up one morning and decided I needed to go in and see my doctor about this pain. She referred me Orthopedic doctor, he took x-rays to determine that it was not my roto cup but I did give me a steroid shot to help with the inflammation. It took a week for the shot and exercises to help. I do still have some pain if I move a certain way, sleep on it accidentally.
Information has been received from a physician concerning her 14 year old daughter with a history of cystinuria who in 1997 was vaccinated with three 0.5ml doses series of RECOMBIVAX HB (route and lot # not reported). The physician reported that in 2010 ("within the past year") she noted that her daughter did not develop antibodies to her three-dose series of RECOMBIVAX HB (manufacturer unknown). No treatment was given for the adverse event. In 2010 ("in the past year") lab diagnostics studies revealed her daughter had elevated liver function test results. At the time of reporting, the patient's status was unknown. This is one of several reports received from the same source. Additional information has been requested.
Diffuse redness in the armpit and around arm. Swelling and painful. Pt is following up w/local MD.
diarrhea; throwing up; sore throat; This is a spontaneous report from a contactable consumer (patient) via the Pfizer-sponsored program. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration, on 26Jan2021, at a single dose, for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the 1st dose of Covid vaccine on Tuesday, 26Jan2021. She called in to report that last night on 29Jan2021 she had diarrhea, was throwing up and, has a sore throat. The outcome of the events was unknown.  Information about the lot/batch number has been requested.
Swollen lymph nodes; stinging pain in neck, breasts, groin, abdomen; stinging pain in neck, breasts, groin, abdomen; stinging pain in neck, breasts, groin, abdomen; stinging pain in neck, breasts, groin, abdomen; Dose Number: 3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 57-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 20Aug2021 14:30 (Lot number: FD8448) at the age of 57 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Hashimoto" (unspecified if ongoing); "Sjogrens" (unspecified if ongoing); "Rheumatoid Arthritis" (unspecified if ongoing); "Fibromyalgia" (unspecified if ongoing); "Known allergies: sulfa medications" (unspecified if ongoing), notes: Known allergies: sulfa medications; "Known allergies: Antibiotics" (unspecified if ongoing), notes: Known allergies: Antibiotics. Concomitant medication(s) included: LEVOTHYROXINE; GABAPENTIN; FOLIC ACID; METHOTREXATE. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EL882, Location of injection: Left arm), administration date: 04Feb2021, when the patient was 57 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EJ1686, Location of injection: Left arm), administration date: 14Jan2021, when the patient was 57 years old, for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 20Aug2021 14:30, outcome "unknown", described as "Dose Number: 3"; LYMPHADENOPATHY (non-serious) with onset 23Aug2021, outcome "not recovered", described as "Swollen lymph nodes"; NECK PAIN (non-serious), BREAST PAIN (non-serious), GROIN PAIN (non-serious), ABDOMINAL PAIN (non-serious) all with onset 23Aug2021, outcome "not recovered" and all described as "stinging pain in neck, breasts, groin, abdomen". The events "swollen lymph nodes", "stinging pain in neck, breasts, groin, abdomen", "stinging pain in neck, breasts, groin, abdomen", "stinging pain in neck, breasts, groin, abdomen" and "stinging pain in neck, breasts, groin, abdomen" were evaluated at the physician office visit.  Additional information: This case assessed as non-serious by the reporter. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient not diagnosed with covid-19 prior to vaccination and since vaccination patient not tested for covid-19.  No follow-up attempts are possible. No further information is expected.
pt recv vax 26SEP96 & 3JUN97 pt devel a rash consisting of less than 50 lesions;pt also exp a mild cough, fussiness & had some nasal discharge;
Vomiting, diarehea, severe chills and body pains throughout the night. Still ill today
significant vertigo; fever of 100.8 F; Headache; Initial information received on 26-Aug-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a female patient (age not reported) who experienced fever of 100.8 F (Fahrenheit) (pyrexia), significant vertigo (vertigo) and headache, while she received INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's medical history, past medical treatment, past vaccination, family history and concomitant medication were not provided.  On 24-Aug-2020, the patient received a 0.5 mL dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (dosage form: prefilled syringe) (lot UJ432AB and expiry date was not reported) via an intramuscular route in the left deltoid for prophylactic vaccination.  On an unknown date, the patient developed a non-serious fever of 100.8 F (pyrexia), significant vertigo (vertigo) and headache (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Relevant laboratory test results included: Body temperature - On an unknown date: 100.8 F  Details of laboratory data was not reported.  The patient was treated with PARACETAMOL (TYLENOL) and IBUPROFEN (ADVIL [IBUPROFEN]).  At the time of this report, outcome of the event was not reported (unknown).
fever; body aches; had 2nd dose of COVID-19 vaccine yesterday at 17 days from 1st dose; This is a spontaneous report from a contactable consumer via a Pfizer Sponsored Program. A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient has historical COVID-19 vaccine BNT162B2 as first dose on unspecified date. The patient had 2nd dose of COVID vaccine yesterday at 17 days from 1st dose. The patient was experiencing fever and body aches and is wondering if taking the 2nd dose at 17 days was alright. The outcome of the events was unknown.
Information has been received from a nurse concerning a 22 year old female, who on an unspecified date was vaccinated with the first 0.5ml dose of GARDASIL (Lot # unknown) and at the end of March was vaccinated with the second 0.5 ml dose. The nurse reported that the patient developed a rash at the injection side as well as a high fever. She reported that the symptoms resolved on their own with no immediate medical attention. The patient did not seek medical attention. No further information is available.
My arm started hurting a bit in the evening, but had no issues going to bed.  I woke up in the middle of the night around 1am, shivering, with chills and my teeth clattering.  I was so cold, I had to put on socks and was using two blankets.  I went to the bathroom and was very dizzy that I almost fell twice.  I also noticed my lips were blue/purple and my temperature was 99.9.  I struggled to go back to sleep because I was still very cold, but also very tired and felt my body drained of energy and had the most intense headache ever.  I felt my head throbbing and like it was about to explode.  I was still cold, dizzy and with a headache the next day.  Two days later, I still had a headache but lighter.  Took Tylenol since Friday night, but I did not feel a difference.  I missed two days of work because of my symptoms.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date, patients were vaccinated with improperly stored GARDASIL (dose, frequency, route of administration and indication were not provided. No concomitants were reported. No adverse events were reported. The outcome of events was unknown. No further information was provided. There is one of several reports received from the same reporter. Additional information has been requested.
tenderness and pain in her left breast; tenderness and pain in her left breast; This spontaneous case was reported by a consumer and describes the occurrence of BREAST PAIN (tenderness and pain in her left breast) and BREAST TENDERNESS (tenderness and pain in her left breast) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 00721a and 012l20a) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high. Concomitant products included DILTIAZEM HYDROCHLORIDE (CARTIA XT) and ALPRAZOLAM (XANAX) for an unknown indication.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Apr-2021, the patient experienced BREAST PAIN (tenderness and pain in her left breast) and BREAST TENDERNESS (tenderness and pain in her left breast). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, BREAST PAIN (tenderness and pain in her left breast) and BREAST TENDERNESS (tenderness and pain in her left breast) was resolving. Not Provided          Patient was also taking an unspecified blood pressure medication as a concomitant mediation.   This case was linked to MOD-2021-074995 (Patient Link).
Infant was awoke from sleep, then while laying her down to change diaper, she became limp and cyanotic. Father stimulated her vigorously, then she awoke but remained sluggish. She was admitted for observation. Negative EEG/UGI series/Chemistry panel/CBC/DSV/CXR. No further event occurred in 48 hours, so she was discharged.
Site of injection (right deltoid) 4 cm area was red, hard, raised, and warm and patient had a low grade fever of 99.2 temporal. Pt treated with KEFLEX 500mg one po qid X 7 days for possible cellulitis.
Diarrhea, chills ,aches, really bad head aches, tightness in my chest, shooting Bain in my left breast,  Last 3 days Headaches remain
pt recv vax 11MAR96 & w/in 48hr pt exp a cutaneous rash over body (from head to foot);
1/20/23  0840 Patient said did not feel well and told me about  severe congestion the nights of 1/18 and 19 but was able to clear it. Nite of 1/18 accompanied by right arm pain. AM of 1/20 his breathing was gurgling and raspy. 0910 While I researched ERs he went to bathroom. 0925 When he was gone too long I checked to find him collapsed against bath door. 0930 called 911 and forced way into bathrm. He was lying on left side, had vomited, was conscious, moaning, not talking, kept reaching up with right arm. 0935 Ambulance arrived and 0940 took him to Hospital Emergency Room arriving approximately 0950.  Admitted to ER and ICU. He was conscious, able to talk with slight slur, intubated.  He asked for a Kleenex but could not wipe his nose so I did and told him it was difficult bek he had a device in his nose to which he responded "canula." They were his last words to me since 2 Dr's (one Emergency Dept, other Dr from Neuroscience ICU) pulled me out to get consent for TPA and interventional radiology (thrombectomy) because they thought he had an ischemic stroke with large thrombus on right side in middle cerebral artery. They asked history questions and I told them of  Covid booster, prostate aqua ablation, hernia surgery and Covid episode dated in item 19. While I was out they sedated patient and gave him TPA about 1030. 11:30 Dr  began interventional radiology. I was told it got the highest possible score for clot removal. 1:30 Moved to Neuroscience ICU 2:30 BP low. Maybe internal bleeding from groin insertion aggravated by TPA. Angioseal not work so used pressure disk which did. Heart beating weakly. Started lots of meds for bleeding and/or heart? Dr said maybe Covid, maybe TPA. Do formal echo and scan to make sure not bleeding. Central X trial lines and then ECG. Dr asked me re BP meds  told him well-controlled with Enalpril. They sent me away about 3:30 4:45  aortic line to precisely monitor BP. BP better but have to keep jacking up meds. Dr brought in cardiac team. 5:20  catheter to get rid of fluid, but could not get in bek of aqua ablation but later a guy from Urology was able to. 5:45  taken to scan 6:15  brought back up with scan incomplete bek went unstable. Gave lots meds for BP. Dr -  Heart not functioning, not pumping. Can do some kind of shock. Need to: 1. Id cause and reverse; 2.do what can to allow heart to rest.  3. Talked to cardio specialists  transcardiogenic shock. Do cardiac catheterization to examine vessels. If blocked, link heart to attachment and maybe insert mechanical device. Myocarditis  maybe covid. Need to act or won't survive. 7:04  Interventional cardiologists , Dr and colleague. TPA makes catheterization risky. Will only do right bek left too risky for bleeding. Dr wanted both sides. Max RX  more too much. Is unstable bek of stroke Dr thinks long-standing heart disease.( Nonsense) They asked me about CPR and I said yes. The other cardiologist recommended against bek he didn't think it would help and it is very painful for the family to watch. He was right. After the O on the monitor did not change for much too long, I stopped it.
5 days p/vax #3 pt c/o blurred vision, tunnel vision, lightheadedness, h/a (pinpointed in back of head);local rxn inj site erythema 1-5cm (diameter);
Pt got very light headed and dizzy, did not pass out. She was also feeling very hot.  This happened after first dose but not as severe . Pt laid down with and ice pack for 30?minutes and then was feeling much better
pt recv vax 26AUG98 & devel rash on 13SEP98;
About 5 minutes after vaccine administration, pt began crying and complaining about being unable to see. Shortly after she began vomiting which she said made her feel better. EMS arrive and took vitals, BP was on the lower end of normal. Pt regained color and was able to walk out on her own.
I started coughing up blood, called my internist who asked where I was at the time. I was actually at the hospital as my wife was there for a blood test. He told me stay where I was, he came to me and checked me out. He ordered a CAT Scan that showed multiple blood clots. I was then moved to the emergency room for treatments. They brought in a Pulmonologist who specialized in blood clots. I now have another specialist who specializes in genetic blood clots. At this moment I am only talking Aspirin 81mg for the blood clots.
Within five minutes of vaccine administration the patient developed upper respiratory congestion and sneezing.  Over the next five to ten minutes he developed a subjective feeling of tightness in the back of his throat and in his chest.  He also had mild facial edema, watery eyes, and pallor.  Exam at this time showed a normal blood pressure (98/62), a pulse of 88, and a respiratory rate of 24 per minute.  No stridor or wheezing was heard.  The patient was given 37.5mg of Benadryl p.o.  Oxygen Saturation was 97-99%.  Over the next several minutes the patient's throat and chest symptoms began resolving.  He was observed in the office for approximately 75 minutes.  After this period of time he had no respiratory complaints except for a stuffy nose.  He was discharged to home with instructions to take Benadryl 25gm every 6 hours.  On phone follow-up the following day there were no symptoms of respiratory distress.
Red sunburn type rash developed about 24 hours after GARDASIL injection. Patient seen by Dr on 9/22/14 Triamcinolone acetonide 40 mg IM given. Instructed to return to clinic if not improved within 2 days.
Chills, sweats, fatigue ("horrible"), headache, body aches, slightly dizzy, could not get up and do anything.  still with body aches and fatigue 3 days post vax.
Arm hurts so much; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE PAIN (Arm hurts so much) 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 an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Arm hurts so much). At the time of the report, VACCINATION SITE PAIN (Arm hurts so much) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No concomitant medication reported. No treatment information was provided.
This case was reported by a physician via call center representative and described the occurrence of guillain barre syndrome in a adult patient who received SHINGRIX for prophylaxis. In March 2019, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced guillain barre syndrome (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the guillain barre syndrome was unknown.  It was unknown if the reporter considered the guillain barre syndrome to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the clinician, who was just contacted by another physician's friend. The age at vaccination was not reported. The age group was not reported, but was selected as adult as per vaccine indication. A week prior to the reporting, the patient received a dose of SHINGRIX. Few days before the time of reporting, the patient was hospitalized. The reported inquired about specific data related to this condition if it was seen as a complication in the clinical trials related to SHINGRIX. The reporter wanted to know, it was possible even from a vaccine mechanism point of view or had there been any patients reported in the literature with this complication as an association. The reporter wanted to speak to someone medical.
cold; runny nose; cough; This is a spontaneous report from a contactable consumer (patient) via Pfizer-sponsored program. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: Not reported), via an unspecified route of administration on an unspecified date as 1st dose, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date (a week after the vaccination), the patient experienced cold, runny nose and cough. The outcome of the events was unknown.  Information on the lot/batch number has been requested.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
I have had severe migranes since getting the second dose.  I also spiked a fever of 102 with whole body weakness and flu like symptoms, but the migraines have not gone away.
on 1/31/2021 she had a small stroke and she is still getting therepy.
One day after second COVID-19 vaccination, patient reported a sore throat, rhinorrhea, and diarrhea. Patient was tested for COVID-19 and influenza, both tests were negative. There was no further escalation of care.
Information has been received from a physician concerning a female patient between 65 to 70 years old, who in approximately January 2007, was vaccinated with a dose of Zostavax. Subsequently within two weeks of vaccination, the patient experienced red blisters throughout her body. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested.
Injection site is very painful, also feeling pain on the left arm, and left side of the neck. Feeling groggy and drowsy and slow.
PATIENT RECEIVED FLUCELVAX. SHE WAS CHECKING OUT OF FLU CLINIC AND SHE PASSED OUT, CUT HER LOWER LIP WITH HER FRONT TEETH AND CHIPPED HER UPPER FRONT RIGHT TOOTH.  SHE QUICKLY REGAINED CONSCIOUSNESS BUT CONTINUED TO FEEL FAINT.  SHE WAS TRANSPORTED TO THE HOSPITAL FOR FOLLOW UP.
Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Additional Details: Facial rash under chin from spanning jawline accompanied with itch
Information has been received from a registered nurse regarding a patient of an unknown age and gender. On 12-OCT-2012 at 18:00, ZOSTAVAX lot # H012576 was exposed to -8 for an estimated total time out of range of 10 hours 20 min. On 05-NOV-2012, the patient was vaccinated with an out of temperature range dose of ZOSTAVAX (dose and route administration were not provided) (lot # H012576, exp date 28-SEP-2013) (dose number was not provided). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.