chrisvoncsefalvay/vaers-outcomes huggingface dataset:
discomfort; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of DISCOMFORT (discomfort) and FATIGUE (Tiredness) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In June 2021, the patient experienced DISCOMFORT (discomfort) and FATIGUE (Tiredness). At the time of the report, DISCOMFORT (discomfort) and FATIGUE (Tiredness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant and Treatment was not specified.   This case was linked to MOD-2021-303237 (Patient Link).
I felt these symptoms after my first shot as well, but since they occured nearly 48 hours after my shot I didn't think they were associated with the vaccine. Now having experienced them after my second dose and reading that many other people are having these issues, I felt compelled to file a report so that this can be studied or investigated.  After both doses, 48 hours later I begin to experience what I can only describe as an intense brain fog and this feeling like something is wrong or off. I experience bouts of nausea and dizziness. I become unfocused, cannot concentrate and my eyes hurt. I also experience intense headaches. Finally, and most debilitating, I experienced a horrible anxiety attack after each shot. This most recent one was this morning. There has to be a reason for these symptoms after each of my doses, and reading online I am one of many who has experienced this. I pray this goes away soon.
totally disoriented mentally and physically. Stayed in hospital 5 days and is undergoing rehab at a local HCF
This spontaneous report was received from a registered nurse refers to an unspecified number of patients who on an unknown date, could have either been administered with a doses of GARDASIL (doses, routes and lot numbers not reported) that were exposed to temperature conditions that we could not support. No adverse reactions were reported. Attempts are being made to obtain additional information identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available. This is one of several reports from the same source. Additional information has been requested.
Elevated fever, as measured by a digital ear thermometer, above 100°F starting the evening after receiving the vaccine. The fever was consistently over 100°F and spiked to over 102°F on multiple occasions, over a week after the vaccine.
Blood in stool.  Had another streak of blood in stool on 12/22/14.
headaches, stiffness, dizzyness, fatigue, loss of appetite pnuemonia including a stay in hospital- antibiotics x 3 types, oxygen, steroids
Immediate pain at the time of injection.  I received the flu and the PS23 injections at the same time, both in my right arm.  Within 24 hours I suffered from low grade fever, all over body aches,   Removed band-aid the next day and there was a noticeable redness of the skin about the size of a quarter.  The redness from Wednesday to now it is Sunday night, has grown to the size of my open hand.  Feels like a gunshot wound in the area through the armpit.  Low grade fever broke on Saturday.  Muscle aches continues, swelling continues still noticeably red.  Have not been able to sleep on my right side due to extreme pain.  Burning sensation immediately, long-lasting from injection site down the length of arm.
pt recvd vax & 27 days p/vax pt devel urticaria & angioneurotic edema; sx resolved 2 wk p/seen by MD; no further details were provided;
COVID-19  Vaccine was given to a patient that did not meet the age requirement at that specific time in 2021.
Case number PHEH2016US023359, is an initial spontaneous report received from a nurse on 13 Sep 2016. This report refers to a 32 years old patient of unknown gender. Medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1515701) at a dose of 0.5 ml intramuscularly in the right arm on 01 Dec 2015. On 01 Dec 2015, FLUVIRIN MDV that had been exposed to 8 to 10 temperature excursions was administered to patient. The nurse stated that, no adverse event was reported following this administration error (incorrect product storage).
They have the flu; can barely walk after having booster yesterday; are sore; This spontaneous case was reported by an other health care professional and describes the occurrence of INFLUENZA (They have the flu), GAIT DISTURBANCE (can barely walk after having booster yesterday) and PAIN (are sore) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2022, the patient experienced INFLUENZA (They have the flu), GAIT DISTURBANCE (can barely walk after having booster yesterday) and PAIN (are sore). At the time of the report, INFLUENZA (They have the flu), GAIT DISTURBANCE (can barely walk after having booster yesterday) and PAIN (are sore) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment information was not provided.   This case was linked to MOD-2022-466436 (Patient Link).
Approximately 5 hours after receiving the injection I developed a fever of 101 degrees, had chills and shivering, redness and pain at the injection site. 24 hours after the injection the initial reactions subsided with the injection site pain and swelling remaining.  36 Hours after the injection, joint pain and fatigue were experienced and that lasted 7 days with the redness and swelling at the injection site increasing to about 3 inches in diameter around the actual injection site. After about 14 days the redness and swelling gave way to a bruise. Bruising is still slightly noticeable at 34 days since the injection.
Patient 16 years old and received Moderna vaccine.  I did not review the DOB when administering.  Talked to patients Mom, she was actually happy he received Moderna, she feels it better.  PER CDC guidelines he will receive the 2nd Moderna dose in 28 days on June 15th. No adverse events as of 10:45 (1 hr and 15 min after vaccine)
The patient received first dose of Menactra in early 2019 and never received the second dose, no AE; Initial information received on 18-Aug-2020 regarding an unsolicited valid non-serious case from a pharmacist .  This case involves a patient who received first dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot number not reported) via an unknown route at an unknown administration site, in early 2019 as prophylactic vaccination and never received the second dose of the same.  The patient's past medical history included Splenectomy. The patient's past medical treatment, vaccination and family history were not provided.   It was an actual medication error due to missed dose. (latency unknown)  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's 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.  There will be no information available on batch number for this case.
On April 24, 9 days after my vaccination, my left arm got very hot, red and swollen at the vaccination site. There was about a 5 inch diameter circle around the injection area. It was very visibly swollen and slightly itchy. I talked to a few medical professionals and they said this could happen and it is okay.  I took tylinol at 11 PM and went to bed. In the next two days, the red circle area grew larger and now covers about a 8-9 inch area of my arm. It is no longer hot, but there is a red ring and it is now painful to lift my arm. My lymph nodes under my armpit also became painful on the night of the 24th. I had a virtual visit with a doctor, and the doctor told me to ice it, take antihistamines, and observe for more growth and streaks down my arm.  Because of the handwriting, I cannot tell if the lot number of this vaccination is 043B21A, 043BZ1A, O43B21A, or O43BZ1A.
ACTHIB that was diluted with a different diluent aside from the diluent associated with the vaccine with no reported adverse event; Initial information received on 10-Jun-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 6 months old male patient to whom given HIB (PRP/T) VACCINE [ACT-HIB]  that was diluted with a different diluent aside from the diluent associated with the vaccine with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE RHBSAG (YEAST), PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (PEDIARIX) for Immunisation; PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for Immunisation; and ROTAVIRUS VACCINE LIVE ORAL 1V (ROTARIX) for Immunisation.  On 10-Jun-2022, the patient received a  dose of suspect HIB (PRP/T) VACCINE (lot UJ604AA) via intramuscular route in the left thigh vaccine  was diluted with a different diluent aside from the diluent associated with the vaccine with no reported adverse event (product preparation error).  Action taken : not applicable.  At time of reporting, the outcome was Unknown for the event acthib that was diluted with a different diluent aside from the diluent associated with the vaccine with no reported adverse event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. 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.
This is a spontaneous report from a contactable pharmacist. A 70-year-old female patient received PREVNAR 13 (Lot # M03211, Expiry Date Mar 2017, NDC number 0005-1971-01), via an unspecified route of administration at 0.5 ml, single in the right deltoid, FLUZONE (Lot UI703AA, expiration date 08May2017), intramuscular in left arm, ZOSTAVAX (Lot M024698, expiration date 27Jun2017), subcutaneous in left arm, all on 04Oct2016 for immunization. The patient medical history and concomitant medications were not reported. The patient previously took Fluzone for immunisation. On 05Oct2016 at 09.00, the patient experienced headache, nausea, a little dizzy, sweating, shivers, blister in mouth, fever. On an unspecified date in Oct2016 it hurts when she lifts her right arm, swollen right jaw, hurts when opens mouth. On 09Oct2016 she developed rash. The outcome of the events was not recovered.
Pt has a red swollen left arm. Red from injection site down to the inside elbow. There is swelling from bicep down to elbow with a red line at the edge of the swelling.
Information has been received from a nurse and a medical assistant concerning a female patient who was vaccinated IM with a dose of Gardasil. Concomitant therapy included antimicrobial (unspecified). The reporter reported that patient received Gardasil and her period stopped for 2 months, the patient only had a little bit of spotting for the 2 months. As of this report day patient has not recovered. Additional information has been requested.
I95.9 HYPOTENSION 12/9/2022 MATERNAL DELIVERY OUTCOME, SINGLETON BIRTH, LIVEBORN
Information has been received from a health care worker concerning a 77 year old male with procaine hydrochloride (NOVOCAIN) allergy and hay allergy and a history of basal cell carcinoma on the forehead and hyperlipidaemia who on 16-APR-2007 was vaccinated subcutaneously with a second 0.5 mL dose of Pneumovax 23 (Lot #651330/1048P). Concomitant therapy included atorvastatin calcium (LIPITOR), aspirin, linsinopril (MSD), carvedilol (COREG), vitamins (unspecified), niacin, finasteride (MSD) and morniflumate (FLOMAX (morniflumate)). On 16-APR-2007 the patient developed left upper arm injection reaction. The day after the injection, the patient called the office and stated that he was experiencing "flu-like symptoms". By the end of the day, the patient's left arm was very sore and he was having trouble using the arm. The patient was seen by the physician on 18-APR-2007 and that time the left arm had redness and edema around the upper arm and extending down the arm to about an inch into the elbow area. The arm was not to touch and painful to touch and movement. The patient continued to have difficulty using the arm. The nurse stated that the patient had pain just getting his coat off. The patient was placed on cephalexin (KEFLEX) 500 mg orally four times a day. Laboratory diagnostic tests were performed on 16-APR-2007 prior to the injection but was pending. It was noted that the patient had been vaccinated with first dose of Pneumovax 23 in 2000 and did not experience any problems at that time. At the time of this report, the patient was recovering. No product quality complaint was involved. Left upper arm injection reaction, flu-like symptoms, having trouble using the arm, redness and edema around the upper arm and extending down the arm to about an inch into the elbow area, arm hot to touch and arm painful to touch and movement (left are very sore) were considered to be disabling. Additional information has been requested.
48hr  Headache which  evolved into a migraine with vomiting,lethargy  and pain  at injection  site 12 hour after the injection, fever 99.1
Irritable crying, temp 101.4 post injection cried x 3 days. Seen 4/8/03 otitis media/cold-congestion seen 4/3/03 vaccine reaction.
Initial unsolicited report received from a consumer via other company (Pfizer) (Manufacturer Report Number: 2016470221) on 24-Oct-2016. This case invloves a patient (age, gender unknown) who was vaccinated with a dose of Influenza Vaccine (batch number, expiry date, dose, route and site of administration were not reported) on an unspecified date (date was reported as seventys). The patients medical history and concomitant medications were not reported. On an unknown date, unknown timeframe post vaccination, the patient experienced seizures. Laboratory investigations and corrective medications were not reported. The outcome of the event was not reported. Upon internal review, the company decided to consider the event serious because of important medical event: seizures. List of documents held by sender: none. Sender's Comments: This case concerns a patient who had received INFLUENZA VACCINE and developed seizures many years ago. The time to onset is unknown. Further information on the patient's previous immunization history and tolerance, concurrent conditions, medical history, lab data to confirm alternative etiology/diagnosis, latency, etc. would be helpful to completely assess this case.
The pt came to the clinic with his father to received MMR, DTAP and IPV. No problems noted at time of injection. On 4/24/02, clinic received phone call from doctor's nurse requesting information on vaccines child received due to possible adverse reaction. The doctor's office did not provide any other information. Information given to doctor's office from routing slip. No call received from parents. On 4/29/02, an RN placed a call to the child's mother to follow-up on possible reaction. Mother states the child woke up about 02:00 on 4/12/02, after receiving immunizations on 4/11/02 PM. The child complained of arm hurting, had a fever and lump on right arm. Mother states that they took him to the doctor the next day and had tests done, then ended up in the hospital for 2 1/2 days due to cellulitis. The child was treated with IV antibiotics. Mother states child appears fine now. Has full use of right arm and only complains of tenderness on upper right arm. Mother then states she had contacted an attorney and wants to know who is going to pay the hospital bills. Informed mother that the clinic was a state program and that I would get back with her with information on who to call for follow-up after speaking to the doctor. On 4/30/02, the RN placed a call to doctor's office and was told that the child was seen by the MD who is out of the office today. Able to check and see that child was seen on 4/13/02 in the office with fever, arm swelling and arm red and painful. Blood tests done. On 5/1/02, RN called to MD's office and received information that the child was admitted on 4/13/02 to the hospital with cellulitis and treated with antibiotics. MD did no fill out VAERS form.
pt w/sz disorder had sz @ 6AM 29JUL p/vax 28JUL;
Bad reaction; Not feeling well; Bad headache; A spontaneous report was received from a consumer, concerning herself, a 74-years-old patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced bad reaction, was not feeling well and had a bad headache.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On an unspecified date, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) via unknown route for prophylaxis of COVID-19 infection. On 22 Feb 2021, prior to the onset of the events the patient received second of two planned doses of mRNA-1273 (lot/batch: unknown) via unknown route for prophylaxis of COVID-19 infection.  On 22 Feb 2021, after second dose of vaccination, all day Monday, the patient experienced bad reaction, bad headache and was not feeling well. Patient also had other health issues; no specifics were provided. No treatment information was provided.  Action taken with mRNA-1273 in response to the events were not reported.   The outcome of event bad reaction, bad headache and not feeling well were resolved on 24 Feb 2021.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested
Had a fever of 102 degrees for 2 days then on the 3rd day July 11 broke out in a rash.  On July 12th rash was all over torso & speckles on arms, legs and face.  Doesn't seem to itch.
Allergic reaction of hives throughout body a week after vaccination period. Also occurred the same as first Moderna vaccination dose.
2pm: 50 year old B/F presented with complaints of losing feeling in legs, and hands, legs and knees hurt a lot, weak. T 99.6, 2:30 Ex Tylenol. PO Pulse 0 x 96; 125 mg. Solumedrol given in (R +) OQ.
Admit 6/27. Vaccine 4/19, 5/18 PRIMARY CAUSE OF DEATH:Cardio respiratory Arrest secondary to Covid 19 pneumonia
multiple sclerosis; Transverse Myelitis; seizures; This is a literature report.  A 34-year-old female patient received BNT162b2 (BNT162B2), on 06Jan2021 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SEIZURE (medically significant) with onset 25Jan2021, outcome "unknown", described as "seizures"; MYELITIS TRANSVERSE (medically significant) with onset 05Feb2021, outcome "unknown", described as "Transverse Myelitis"; MULTIPLE SCLEROSIS (medically significant), outcome "unknown".  Adverse event summary: new onset seizures starting 25Jan2021. Dx transverse myelitis on 05Feb2021 and, later, multiple sclerosis with an atypical presentation. Diagnosis was reported as multiple sclerosis. The patient underwent the following laboratory tests and procedures: Blood test: Unknown result; Lumbar puncture: Unknown result, notes: twice; Magnetic resonance imaging: Unknown result.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on available information and temporal relationship, a possible causal relationship cannot be excluded between the suspect vaccine bnt162b2 and all events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-PV202300065338 Same article/ drug/event and different patient;
pt recv vax 11MAR97 & started high pitched cont cry x 3 days, pthat pt was fussy & not self x 8 days;would not accept anyone but mom;took 2-3 wk to be laughing-happy baby;t99 underarm;
Ischemic stroke of the right corona radiata and right thalamus demonstrated on MRI after his symptoms started. Symptoms started the morning of the day after the injection.
Arm very itchy,  big red circle warm to touch. It started a couple days after the injection and has been persistent and never went away and has gotten bigger. I notified the contact person from the paperwork and they advised I make a report.
pt recvd vax 23AUG94 & 24AUG94 pt devel sizeable local erythema, swelling & mild induration @ inj site;pt recovered in 48hrs;
I had the vaccine and I still get them; I still get them, not wide spread/ they'e always around the scar and buttocks; Sharp electric like pain from tailbone to buttocks; Always when there's stress, get very sharp electric like pain; This 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 surgery (4 back surgery).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pain and stress. On an unknown date, the outcome of the vaccination failure, shingles, pain and stress were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, pain and stress to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 30-Aug-2022 Reporter's Comments: The reporter reported the case via interactive digital media. The patient had the vaccine and he/she still got them just not as widespread.  Always when there was stress, or he/she got very sharp electric like pain from tailbone to buttocks.  The patient had 4 back surgeries and they were always around the scar and buttocks. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
Tachycardia Narrative: Pt. received the Moderna COVID-19 vaccination at 1030. At 1040 pt. altered staff and stated that she felt like her heart was beating too fast. and that the back of her tongue felt tingly. Vitals were taken and found HR 130 bpm and SpO2 100% on RA, temp 99.1, BP 117/90. On site provider was notified and prescribed Benadry 50mg PO. Pt. was monitored for an additional 30 minutes. VS at 1100 were BP 116/85, HR 112, SpO2 99%. Sent to ED for observation until symptoms resolve.