chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a mother concerning her 4 year old daughter who on 5/16/103 was vaccinated with MMR (lot # 640790/1378L). On 5/24/03 the patient experienced a seizure that lasted for 1/2 hour. Subsequently, the patient was hospitalized overnight and was given valium to treat her seizure. She had a spinal tap done and a Cat Scan while hospitalized. The patient was scheduled to be given an MRI and EEG later that week. Subsequently, the patient recovered. Upon internal review, seizure was considered an other important medical event (OMIC). Additional information has been requested.
Initial information received on 10-Jan-2019 regarding an unsolicited valid non-serious case received from Other health care professional (Medical assistant). This case involves a 15 months old two patients (gender unknown) who received vaccine ACT-HIB with an expired diluent. The patient's past medical history and family history were not provided. Concomitant medications included PREVNAR and INFLUENZA VACCINE. On 10-Jan-2019, the patients received a 0.5ml dose of suspect HIB (PRP/T) VACCINE, Lot- diluent U5962AA expiry date- 05-Jan-2019; powder lot UI822AA, expiry date 02-Jun-2019 via unknown route in the left thigh. It was an actual medication error due to Expired product administered. It was reported that two 15 month old patients received ACTHIB with an expired diluent. It was unknown whether patients experienced any adverse reaction after the injection. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender- none.
her arm was hurting really bad; She just felt lousy; feeling bad/I feel terrible; She had unsteadiness with walking; upset stomach without vomiting/she woke up with an upset stomach; very sore arm at injection site; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team.  An 83-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 26Sep2023 at 12:00 as dose number unknown ,single (Batch/Lot number: unknown) at the age of 83 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: BALANCE DISORDER (non-serious) with onset 26Sep2023, outcome "not recovered", described as "She had unsteadiness with walking"; ABDOMINAL DISCOMFORT (non-serious) with onset 26Sep2023, outcome "not recovered", described as "upset stomach without vomiting/she woke up with an upset stomach"; INJECTION SITE PAIN (non-serious) with onset 26Sep2023, outcome "not recovered", described as "very sore arm at injection site"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "her arm was hurting really bad"; MALAISE (non-serious), outcome "unknown", described as "She just felt lousy"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "feeling bad/I feel terrible". Therapeutic measures were not taken as a result of balance disorder, abdominal discomfort, injection site pain. Additional information:Patient had unsteadiness with walking, upset stomach without vomiting, very sore arm at injection site and asking if these are common side effects and when they would go away. Upon further discussion, consumer confirmed his wife got the most recent 2023-2024 formula for adults yesterday (26Sep2023) at around 12 noon.  She is age=83 years old.  That evening, she woke up with an upset stomach and her arm was hurting really bad.  She was very unstable on her feet, I had to walk her to the bathroom 3 times last night.  She did not vomit and does not have a temperature. There is no swelling or redness at the site of injection. She just felt lousy.  She said she started feeling bad around 10pm when we went to bed.  She did go to sleep for a while and woke up and said 'I feel terrible' and that was around midnight.   The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
full body muscle aches; patient received first dose on 27Dec2020 and 2nd dose on 13Jan2021; arm muscle sore; Extreme fatigue; vomited 4 times; legs and arms are still store; This is a spontaneous report from a contactable other healthcare professional (patient). A 23-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3302 and Expiration date: May2021), intramuscular at the left arm on 13Jan2021 15:00 at a single dose for COVID-19 immunization. The patient medical history was not reported. The patient was not pregnant at the time of vaccination.  Concomitant medication included ethinylestradiol, norgestimate (TRI-SPRINTEC) and spironolactone. The patient previously received the 1st dose of bnt162b2 for COVID-19 immunization at the age of 23 years old on 27Dec2020 @ 2PM at the left arm, Lot number: ET1685 and Expiration date: Mar2021. On 13Jan2021, the patient experienced arm muscles sore. The next day on 14Jan2021, full body muscle aches slowly developed. Extreme fatigue two nights later (Jan2021) and vomited 4 times 6 days later (Jan2021). Legs and arms are still store from Jan2021, still fatigued. The patient received first dose on 27Dec2020 and 2nd dose on 13Jan2021. This was assessed as Inappropriate schedule of vaccine administered. Treatment was not received for the adverse events arm muscle sore, full body muscle aches, extreme fatigue, vomited 4 times and legs and arms are still store .The patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The outcome of the events arm muscle sore, full body muscle aches, extreme fatigue, vomited 4 times and legs and arms are still store was not recovered.
Sharp pain in my arm and shoulder. Couldn't sleep or get comfortable. It is a week later and it still hurts so bad that my arm has to be supported by a pillow when I am sitting or held up by the other arm. I can't sleep at night, I wake up with a sharp pain after the meds wear off.
Had shingles three times after vaccination/Suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had once before vaccination).   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Had shingles three times after vaccination/Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 04-JUL-2023 This case was reported by a patient via interactive digital media. The patient reported that based on his or her experience do not get vaccinated. He or she received Shingles vaccine and experienced Shingles three times, so the vaccine is not effective or maybe shingles was in love with him or her because he or she had it in the same place every time. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Developed right Bell's Palsy 3 days after the vaccinations. The patient had developed right viral conjunctivitis 2 days prior to the vaccines and had the braces for her teeth tightened the day after the vaccines.
Client presented at vaccination site on 11/28/21. The client reported she received her first dose Pfizer COIVD vaccine on 11/07/21. Client reported within 15 mins she had redness on her left side of her face with hotness and numbness on her left arm where she had her injection. Client didn?t report to the EMT in the observation station. Client told she had the headache off and on for one whole week after and lightheadedness for two days and fatigue for one week. She told she took acetaminophen 500 mg with help for headache for three days straight. Client told she didn?t follow-up with her PCP. Client told she doesn?t have any chronic illnesses or taking any medications. Client told she has no known allergy. At 1112, PHN took client?s vitals: BP 112/71, HR 64, R 20, O2 Sat. 98%. Client is requesting second dose Pfizer COVID vaccine today. PHN submitted a medical consult via text message to clinical project coordinator requesting to proceed with the second dose Pfizer COVID vaccine. Per the doctor, approval to proceed with the second dose Pfizer COVID vaccine was obtained from medical consult team via text message from clinical project coordinator. Client received the second dose Pfizer COVID vaccine, LOT#: FF8841 on 11/28/21 at 1145. The client did not report any symptoms during the 30-minute observation period. PHN educated client on possible adverse reactions and when to seek EMS. Client verbalized understanding. Client left vaccination site at 1215 unassisted and with a steady gait.
DEAD; COULD NOT BREATHE; This spontaneous report received from a consumer via social media via a company representative concerned a 67 year old female of unspecified race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) 1 total, dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported.  The reporter stated, "My 67 year old mother in law took the shot and 15 minutes later could not breathe, 5 days later she was dead, so git you some shot". The patient died from unknown cause of death. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of dead on an unspecified date, and the outcome of could not breathe was not reported. This report was serious (Death).  Version created to amend previously reported information on 10-FEB-2022. Upon review the following information was amended: Amendment Adverse Event (the case validity assessment was updated to valid from the previously incorrect assessment of non-valid).; Sender's Comments: V1: Version created to amend case validity assessment to valid from the previously incorrect assessment of non-valid. This does not alter previous causality assessment of the reported events. 20220227565-covid-19 vaccine ad26.cov2.s -Dead. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Blood Clot Left Lung; Has not received 2nd dose; ow 90's and high 50s oxygen levels; Feeling bad; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY EMBOLISM (Blood Clot Left Lung) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  The patient's past medical history included Chronic kidney disease, Thrombus and Cancer. Concomitant products included SODIUM BICARBONATE (SODIUM BICARB.PED), HYDRALAZINE, Folic Acid, SEVELAMER CARBONATE (RENVELA), AMLODIPINE BESILATE (AMLODIPINE (ALS BESILAAT) SANDOZ), FUROSEMIDE, POTASSIUM CHLORIDE (LASIX + K), PRAVASTATIN and MONTELUKAST for an unknown indication.    On 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, the patient experienced PULMONARY EMBOLISM (Blood Clot Left Lung) (seriousness criteria hospitalization and medically significant), OXYGEN SATURATION ABNORMAL (ow 90's and high 50s oxygen levels) and FEELING ABNORMAL (Feeling bad). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Has not received 2nd dose). At the time of the report, PULMONARY EMBOLISM (Blood Clot Left Lung), OXYGEN SATURATION ABNORMAL (ow 90's and high 50s oxygen levels), FEELING ABNORMAL (Feeling bad) and PRODUCT DOSE OMISSION ISSUE (Has not received 2nd dose) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment with warfarin to treat the blood clot as provided by the patient.  Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.   This case was linked to MOD21-087825, US-MODERNATX, INC.-MOD-2021-114702 (E2B Linked Report).; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded. US-MODERNATX, INC.-MOD-2021-114702:Case for husband
dizziness, fever, vomiting, achiness in back, neck & h/a; low grade fever 99; pt c/o pain in cheeks, swollen chin & side of cheek;
Initial onset Nausea, headache  progressing to fever, chills, severe  pain  throughout the body at approximately 3:am, lasting approx 30 hrs. Still experiencing moderate headache
caller is not feeling well; feeling dizzy; cough; a bladder infection; This is a spontaneous report from a contactable consumer (patient) received from a program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Mar2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 26Mar2021, patient was feeling not well, dizzy, and had cough. She hopes it would not be COIVD-19. For the last few days, she noticed that she had a bladder infection. It feels like it, though not sure and had not been confirmed by an health care proffessional. She had been drinking cranberry juice for bladder infection and at the time of report, she feels a lot better. Her second dose of the vaccine was scheduled on Monday (29Mar2021). She wanted to know that if she still doesn't feel good by Monday, should she still take the vaccine. The outcome of the event bladder infection was recovering and of other events was unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Face was red and had hives on both legs and feet. Hives looked like mosquitoes bites. Mother gave Benadryl.
On March 17, 2023, I had a real bad pain in the calf on my right leg, the pain eventually subsided after I walked for a while. I went to the basement and came back up; I was out of breath and felt that something must be wrong. I went to ENT appointment first, then went to an Urgent Care, they ran bloodwork, chest x-ray, EKG. Once the test came back, they sent me to the hospital. The hospital also ran bloodwork, chest x-ray, CT scan that showed I had pulmonary embolism in both lungs, EKG. I was admitted for an overnight stay where I was given blood thinner by IV to help break up the blood clots. In the morning before I left the hospital, I had an ultrasound that showed my right calf had a DVT. I am now on Eliquis to keep my blood thin.
I received the first dose on 1/15/2021 around 3 pm.  At around 8;30 PM, I felt an extreme shot of adrenaline starting in toe,s that then traveled to my chest.  I felt this wave come over my body and I knew something was wrong.    I have HIGH BP, so i know  what  symptoms indicate another high BP event.  . I measured my BP and it rocketed  to 180/150.   This event lasted less than five minutes. I ingested One Clonidine tablet and my pressure decreased.  Outside of that ONE incident I had very little adverse events.
Pt recvd 2nd dose of Hep B vax on 10MAR92 & on 11MAR92 & exp a h/a, stiff neck, pain in neck, arm & shoulder; tx APAP & recovered in approx 2 days; No further details were provided;
Patient presents to clinic today 4/9/19 with swelling in right upper extremity from shoulder to elbow, redness, skin hot to touch following vaccine injection on 4/8/19 treated with oral antibiotics
A rather large bruise/clot developed on the thigh of the patient, the day after receiving her second Moderna COVID vaccination; therefore, two days after receiving the second dose of the vaccine, went to the emergency room to get her platelet count checked.  The reporter of this form, and her son, was concerned after reading a article titled "A Few Covid Vaccine Recipients Developed a Rare Blood Disorder" and thought it may be ITP (immune thrombocytopenia).  While in the emergency room, we asked for a CBC and indeed her PLT Platelet Count was low at 24K.  A platelet transfusion or dexamethasone were the treatment options considered.  was given 12mg of the medicine and was ordered to take an additional 28mg after picking up the medicine from the pharmacy.  After speaking with her primary care doctor, Dr., we agreed to forgo the additional 28mg and wait to see what the results of the subsequent daily blood tests will yield.  For the next two days, we got her platelet count checked again and they returned to normal and were 286K and 310K respectively.
Swollen red face itching  skin is flaking.   Sore throat, slight aches and pains.  The swollen red face, and skin flaking  was more severe on the second shot.   The first shot I had just a sore throat , aches and pains.
Light ringing in ears starting about 10 hours after vaccine and slightly intensifying since then,   Sore arm starting about 2 hours after vaccine Body aches and light headache started around 9 hours after vaccine Low grade fever started at around 12 hours after vaccine and rose to 101 over night. Extreme fatigue upon waking up the following morning.
Narrative:  Headache, chills, myalgia, arthralgia, fever 101.7, nausea vomiting; taking tylenol
On Feb 3 woke up very dizzy, lightheaded, arm pain.  Feb 9th developed rash on both arms from elbows to hands, extremely itchy and also had a large blister develop on left arm.
c/o tingling in throat.  No resp. distress.  B/P 148/94, HR 76, O2Sat 96%
Generalized rash, urticaria, lip and facial swelling/tingling/numbness, shortness of breath, pruritus.
3 hours post vaccination, patient experienced major shortness of breath and hyperventilation. She also had bad diarrhea and heart burn. She visited the doctor the following day and has been dispensed albuterol HFA.
The patient completed the gardasil 9 series at 10 years old was known to have cervical intra-epithelial neoplasia; This spontaneous report has been received referring to a female patient of unknown age. The patient's concurrent conditions, medical history, and concomitant medications were not provided.   On an unknown date, the patient was vaccinated with the HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) series (strength, dose, frequency, route of administration, anatomical location, lot number, and expiration date were not reported) for prophylaxis.  On an unknown date, the patient experienced cervical intra-epithelial neoplasia (CIN).  The outcome of the event was not provided.  The causality assessment was not reported.
PT BEGAN HAVING ABDOMINAL PAIN AND DIARRHEA, THIS HAS BEEN ONGOING AND HAS NOT RESOLVED. ALSO COMPLAINS OF HEADACHES AND PERSISTANT FATIGUE
3 DAYS AFTER GETTING THE VACCINE I DEVELOPED A BAD SORE THROAT, BODY ACHES AND A LOW FEVER.  THESE SYMPTOMS LASTED FOR 2 DAYS.
(R) thigh HIB IM site 6 cm x 10 cm area of Redness, swelling with increased local temp.
PT COMPLAINED OF INTENSE PAIN IMMEDIATELY AFTER INJECTING, THEN NAUSOUSNESS, THEN WANTED TO STAND, AS I WAS PREVENTING HIM FROM STANDING HE BEGAN TO SHAKE AND THEN WENT LIMP,  I USED SMELLING SALTS AND HE CAME TO, HE WAITED IN PHARMACY  HIS BP WAS LOW, WE GAVE WATER  AND AFTER ABOUT AN HOUR HE WAS ABLE TO WALK OUT ON HIS OWN
Initial report received on 25 June 2008 and on 26 June 2008. The original reporter was a physician with a state department of public health. Follow-up information was received on 26 June 2008 from a physician with the state department of public health, and on 27 June 2008 from another physician with the state department of public health that was also added to this case. A female patient (demographics not provided), who is a wildlife worker had physical contact with a bat that landed on her head during the daytime hours. It was uncertain whether the patient was bitten or not. The bat was not tested. An unspecified amount of time later, the patient received one dose of IMOGAM RABIES-HT, and three doses of IMOVAX Rabies vaccine (Lot # A0485-2). The dates of vaccinations, lot number of the IMOGAM RABIES-HT, routes and sites of administration for both the IMOVAX and IMOGAM were not provided. At an unspecified amount of time after receiving the third dose of IMOVAX RABIES vaccine, the patient developed a rash, facial swelling to where she was hardly recognizable, swollen tongue, swollen groin area and genital swelling to the point she could no longer urinate. The patient sought medical evaluation at that time and was treated with oral BENADRYL which was not totally effective. There was no allergist in the patient's area and due to difficulty controlling the patient's adverse events the patient was subsequently taken to the hospital (date not reported) for treatment. Treatments received, and diagnostic tests/laboratory data performed were not provided. At the time of this report, further vaccinations with IMOVAX were being discussed, and other options were being considered. The recovery status of the patient was reported as "not recovered."