chrisvoncsefalvay/vaers-outcomes huggingface dataset:
injection site was warm; injection site was warm and hard; hives on her neck and chest; This case was reported by a nurse via sales rep and described the occurrence of injection site warmth in a 17-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis and MENACTRA for prophylaxis.   Previously administered products included Menactra (received 1st dose on an unknown date).   On an unknown date, the patient received the 1st dose of Bexsero, Bexsero Pre-Filled Syringe Device and the 2nd dose of MENACTRA. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced injection site warmth, injection site induration and hives. The patient was treated with benadryl (nos) (Benadryl). Bexsero was interrupted. On an unknown date, the outcome of the injection site warmth, injection site induration and hives were recovered/resolved.   It was unknown if the reporter considered the injection site warmth, injection site induration and hives to be related to Bexsero and Bexsero Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. After receiving Bexsero and Menactra vaccine, the patient had hives on her neck and chest that lasted for several days.  Also, the patient also had injection site was warm and hard.  The patient's mother gave her Benadryl and the hives resolved and the patient was ok.  The nurse said that, had decided not to give the second shot of Bexsero to the patient. The reporter consented to follow up.
Severe body aches migraine low grade fever nausea  diarrhea joint pain skin pain general maliase
Initial report received from a healthcare professional on 10 August 2011. A 17-year-old male patient, with no reported medical history and no illness at the time of vaccination, collapsed after receiving an intramuscular left deltoid injection of ADACEL (lot number U3973BA/ C3914). Per the reporter, the patient "gasped" when he saw the needle. After vaccination he was leaving the facility when he leaned on a shelf and collapsed. He did not lose consciousness, and after evaluation by a paramedic he was able to walk out of the facility. The event was considered to be resolved. Documents held by sender: None.
Patient requested and received a 2nd FLUAD immunization  2 months apart. Patient did not have any adverse reactions.
I had  Blood clot in my armpit; Vaccine administered Intravenously; 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 male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 57 years intravenous, in left arm for covid-19 immunisation; influenza vaccine (INFLUENZA VACCIN), in Oct2023 as dose number unknown, single (Batch/Lot number: unknown) for influenza immunisation. The patient's relevant medical history included: "Heart disease" (ongoing). The patient's concomitant medications were not reported. The following information was reported: THROMBOSIS (medically significant) with onset Oct2023, 4 days after the suspect product(s) administration, outcome "unknown", described as "I had  Blood clot in my armpit"; INCORRECT ROUTE OF PRODUCT ADMINISTRATION (non-serious) with onset Oct2023, outcome "unknown", described as "Vaccine administered Intravenously". The event "i had  blood clot in my armpit" required emergency room visit. The patient underwent the following laboratory tests and procedures: Lab test: (Oct2023) Unknown result. Therapeutic measures were not taken as a result of thrombosis. Clinical course: Patient got the Pfizer Vaccine (Pfizer COVID-19 Vaccine) on Friday and now on Monday four days later he had Blood clot in her armpit. Before that he had the flu shot (Unspecified Flu shot) on Monday. Patient stated that the flu shot was not  the issue it was COVID. He just found out today and was still waiting to see the doctor in the emergency room now. He had Heart disease, that was why he had the COVID Vaccine shot to protect her from getting sick. He just went today for lab test. They did not know yet. He just had done.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
606 doses were given after expiration date; Vaccine expired on 13-OCT-2021 and placed in refrigerator on 14-OCT-2021; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine expired on 13-OCT-2021 and placed in refrigerator on 14-OCT-2021) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine expired on 13-OCT-2021 and placed in refrigerator on 14-OCT-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine expired on 13-OCT-2021 and placed in refrigerator on 14-OCT-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported. Treatment medications were not reported.
I have Epstein barre and it feels like it has been reactivated.; waves of dizziness; fatigue; nausea; diarrhea; headache; I have been having vivid nightmares during this time as well; metallic taste; This is a spontaneous report from a contactable consumer (patient).  The 44-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Right on 24Feb2021 09:45 AM (Batch/Lot Number: EN6203) as SINGLE DOSE for covid-19 immunisation. Medical history included Chronic fatigue syndrome, Epstein barre. The patient was not pregnant. No other vaccine in four week. No covid prior vaccination. The patient did receive other medications in two weeks. The patient experienced i have epstein barre and it feels like it has been reactivated, waves of dizziness, fatigue, nausea, diarrhea, headache, i have been having vivid nightmares during this time as well, metallic taste on 24Feb2021 14:00.  Reported as: I have Epstein barre and it feels like it has been reactivated. I have waves of dizziness , fatigue, nausea, diarrhea, headache and metallic taste. I have been having vivid nightmares during this time as well. I developed a metallic taste in my mouth. AE resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care.The patient had covid tested post vaccination via Nasal Swab on 03Mar2021 and was negative. It's unknown if the patient received treatment. The outcome of the events was not recovered.  No follow-up attempts possible. No further information expected.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 2016, the patient's healthcare provider administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 30-OCT-2016 and 11-NOV-2016, the patient was treated by healthcare providers for shingles and neuropathic pain. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the her injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
This spontaneous report as received from a nurse refers to a 16 year old patient of unknown gender. Medical history and concurrent conditions were not reported. On 17-FEB-2015, the patient was vaccinated with an improperly stored GARDASIL dose 1, lot # K005881, expiration date 14-JAN-2017 (dose and route were not reported). No adverse event reported. No co-suspect and concomitant therapies were reported. This is one of several reports from the same source. Additional information is not expected. All follow up requested to complete the case were received.
1 day p/vax pt w/a hx of latex allergy devel a rash both arms for 3 days;treated self w/oral DPH;
Redness, itching, tingling, numbness, headache. Had a visible red bump at injection site with surrounding redness.
mom states pt had fever fo 103-104 times 2-3day; no relief when given APAP x 2 days; MD saw pt w/neg exam; mom states MD feels this was vax related;
Received MMR, varicella, PREVNAR with Hep A 6/8/09. Began with erythematous rash that night that became a generalized urticarial RXN the next day. No SOB wheezing or difficulty swallowing.
I noticed tingling in my fingers and feet from October 28, 2015, I took to my bed on November 14, and was unable to walk more than 2-3 steps on November 19th. I was hospitalized, diagnosed with Guillain Barre Syndrome and treated with intravenous immunoglobulin treatment. Heart rate rose to 160 beats per minute. Had loss of movement, sensation most of December, went to rehabilitation until end of January 2016 with weakness, balance issues (also ongoing, but improved). Fatigue continues.
Approx 5 minutes after COVID vaccine she started complaining of swelling tongue and dizziness. Anxiety along with tingling in hands and feet. Per protocol Epinephrine IM given along with Benadryl IM. EMS activated. She remained stable while on site, and left at approx 10:45 via ambulance in stable condition.
4 yr old male received DTAP, MMR, VAR, IPV, HEP A 3/27/09 no history of recent illness! h/o febrile seizures 3/28/09: pt sleeping, woke up @ 1AM screaming & out of bed Dad went to pt put him in bed & pt started jerking arms/legs, eye rolled back drooling felt warm. Lasted 8 minutes. To ER - OUl febrile seizures.
The patient felt lightheaded and hot and nauseated.  She said she felt nervous about the shot before hand, so we think this is a result of that.  I stayed with her until she felt better (more than 30 minutes).  She had someone with her to keep a check on her, but she said she felt back to normal before she left.
Within 48 hours of the second dose of the Pfizer Covid 19 vaccine, I developed a red rash on my whole torso and back. After 72 hours, the rash continued to spread up my neck and completely cover my torso and back
One of her friends died (67 years old) after getting the vaccine; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A 67 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death, medically significant), outcome "fatal", described as "One of her friends died (67 years old) after getting the vaccine". The patient date of death was unknown. The reported cause of death was "One of her friends died (67 years old) after getting the vaccine". It was not reported if an autopsy was performed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: One of her friends died (67 years old) after getting the vaccine
This spontaneous report as received from a pharmacist via a company representative refers to an elderly female patient. On an unknown date the patient was vaccinated with a dose of PNEUMOVAX23 (lot number, route and dose were not reported). Other suspect therapies included unspecified flu vaccine (manufacturer unknown) (lot number, route and dose were not reported) vaccinated on the same day. The patient had an injection site reaction soon after receiving PNEUMOVAX23. The site covered a large, swollen area on her whole upper arm. The patient had called pharmacy to seek medical attention. No treatment was given. At the time of the report, outcome of the event was unknown. Additional information has been requested.
10/16/2022 reported left shoulder arm pain 8/10 and burning. Denied blisters, swelling, redness. Practitioner advised ER care.  11/03/2022 patient walked into clinic with same complaints without change.  Provider prescribed   Valacyclovir 1 gm Q8h x7 days.  Gabapentin offered and declined.
Macular papular rash on entire body except palms & soles. Began 3/20/13.
Woke up the morning of 11/9/17 with a severe outbreak of hives. I have had this type of outbreak in the past, but it usually builds to this level of severity. I did have a couple of hives earlier in the week, so I started taking the over-the counter antihistamine to help, and it seemed to be working. On the morning of the 9th, I woke up to find myself covered in hives. (But mainly on my extremities.) There were none on my face and I had no swelling of my eyes or mouth; I also did not experience a problem breathing or feel my airway was swollen in any way. Since this did not appear to be an emergency, I took a couple of Atarax pills that I had from the last time I had such a reaction. They have been helping with the.
Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen). At the time of the report, PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) had resolved.        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.   Concomitant products were not provided. Treatment medication were not reported.
Admission diagnoses: Acute onset of word salad and altered mental status concerning for stroke; tongue mass noted concerning for squamous cell carcinoma and heavy alcoholic; alcoholism daily with risk factors for delirium tremens. 62-year-old with history of heavy alcoholism who presented on 1/14/2022 for change of mental status with word finding and inability to speak.  He was seen by emergency room Medicine and Neurology and given tPA for possible left hemisphere stroke. It was difficult for me to get an NIH stroke score scale on him as he would not cooperate with the examination. CT perfusion did not show evidence of large vessel occlusion with no core and no penumbra. The brother stated that he drinks alcohol every day from sun up to sun down and falls frequently at home. There has been some cough. The patient has received a 3 vaccination series with his brother taken him for a booster 5 days ago. His brother is a helper or primary caregiver. The brother noticed acute change in mental status and speech 1/14/2022. The brother also states he has had hip replacement. ICU admission is now undertaken per status post tPA protocol for probable stroke. After receiving tPA patient underwent a repeat head CT on 1/15/2022 which was revealing for hemorrhagic transformation of an acute right occipital infarct with adjacent vasogenic edema with acute blood product measuring 2.9 x 1.9 x 2.4 cm. No mass effect or midline shift was noted. Subsequent head CTs were relatively stable. Neurosurgery evaluated the patient and no neuro surgical intervention was required. Of note, the patient did require Precedex for 3 days due to agitation. This agitation was believed to be secondary to alcohol withdrawal. He was subsequently started on a phenobarbital taper and CIWA protocol. His agitation progressively improved. After coming off of his Precedex drip he was stable for discharge out of the ICU. Of note, tongue lesion was noted on CT. After resolution of patient's agitation, no tongue mass was noted on physical exam performed by Dr. He will be discharged to constant care. He was transferred to the floor 1/19. He improved neurologically though had prolonged encephalopathy due to stroke, alcohol withdrawal, and bacteremia. He had a prolonged stay due to needing to complete isolation for Covid-19 prior to transition to rehab. Once rehab was arranged he was transferred in stable condition. Fever: Covid related, patient tested positive 1/14 and hasn't had any other symptoms. Last fever 2/3. Chest x-ray 2/3 with no infilatrate. Patient did not require oxygen. CVA -MRI BATT-Acute right PCA infarct  -status post tPA with hemorrhagic transformation and vasogenic edema -evaluated by Neurosurgery while in the ICU -repeat CT head-1/17-stable with no mass effect or midline shift mild hydrocephalus -continue aspirin, Lipitor-cleared by Neurosurgery -Repeat CT Head post ASA/LMWH-Unchanged right parieto-occipital intraparenchymal hemorrhage and infarct with no evidence for new or increasing hemorrhage. Near complete resolution of the intraventricular hemorrhage -Echo EF 65 70% negative bubble -continue PT/OT -continue aspirin, statin.
Left arm with erythema, induration of 4x4 are, no tenderness with palpation of site, dery scaly skin at site
VACCINE MISADMINISTRATION - CLIENT SHOULD NOT HAVE RECEIVED NASAL H1N1 DUE TO AGE
8/7/21- 6:00 PM - Not feeling well overall, just not feeling normal; 8:00 PM - Blurred vision and restlessness in entire body; 9:00 PM - Asked to leave work and drive home due to more intense blurred vision and body fatigue. 11:00 PM - Home resting with increased body uncontrollable muscle spasms/convulsion; 12:00 PM - On phone with nurse advice line, but one hour wait too long, so I take 1500mg of Tylenol to sleep by 1:30 am; 8/8/21 Suffered from entire body uncontrollable shaking in my hand, feet, toes, arms, legs, seems like my muscles were all twitching without me being able to stop it. This lasted about a week. I also emailed my Dr. and she wrote me off work for MYALGIA.   As of today 10/5/21 I am experiencing uncontrollable muscle spasms all over my body daily, as well as tingling.
In order in which they occurred: Fatigue, chills, fever, body aches, headache, and vomiting. Treatment included cooling packs and ibuprofen, and when I was finally able to sleep I woke up with just exhaustion the next day.
This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with a dose of GARDASIL (dose, lot# and expiration date not reported) that was exposed to 20 F for an unspecified period of time, which was excursion that was unsupported by in-house stability data. No adverse symptoms were reported. Follow up information has been received on 24-APR-2014 from a nurse. The reporter mentioned that "30 patients or less" received improperly stored GARDASIL that was exposed to 20F for 11 days. Administration dates, lot # and expiration dates were not reported. Follow up information was received a health center manager. The patients' identifiers were obtained. This report concerns one of the patients. On 10-MAR-2014 at 10:00, the 23 year old female patient was vaccinated with the first dose of GARDASIL (lot # J005661, exp. 26-SEP-2014) into right deltoid (dose, route not reported). The medication refrigerator was out of range on the following dates: Jan 07, temperature (Degrees Fahrenheit) 44/26; Jan 09, 36/22; Jan 11, 26/40; Jan 14, 22/26; Jan 16, 26; Jan 20, 28/32; Jan 25, 22; Jan 27, 24/26; Jan 28, 20/20; Feb 17, 26/20. This is one of several reports received from the same source. Additional information is not expected.
Delayed onset swelling and itching at vaccination site on day 8 post vaccine, 3-4 cm area induration, warmth, redness and swelling upper deltoid
I start to itch within an hour  I started to break out in small patches that some were spread all over my body my back,arms legs stomach,neck, vaginal, every where. Around 8:00pm in the evening it starts to itch. I went to ER. I received a steroid shot and a benadryl shot they prescribed Prednisone 20mg for 5 days and hydroxyzine HCL 25MG for itching
Headache, then chills/fever; bouts of nausea; pain at the sight; joint pain and pain in R side. Symptoms seemed to peak @ 8:00 AM 12/29/2009, with fever slightly in excess of 102.  Treated somewhat effectively with ibuprofen.
patient presented to ED post covid vaccination with anaphylactic symptoms. Elevated BP, upper lip swelling, mild edema of all four extremities, tachycardia.  Patient received epi, Benadryl, famotidine, dexamethasone.  Patient was admitted for four days due to edema in all four limbs and difficulty ambulating. Patient has been out of work and subsequently readmitted for cardiac, BP and Edema issues
Pt.'s Daughter states that after the 2nd dose of Moderna 05/11/2021, started experiencing symptoms 05/18/2021 of Irritability, headaches, chills, and fatigue. Blood Clots causing Bi-Lateral Stroke 10/22/2021, Hospitalized for 7 Days. Currently in Skilled Nursing Facility.