chrisvoncsefalvay/vaers-outcomes huggingface dataset:
upper respiratory infection; This spontaneous case was reported by a consumer and describes the occurrence of UPPER RESPIRATORY TRACT INFECTION (upper respiratory infection) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced UPPER RESPIRATORY TRACT INFECTION (upper respiratory infection). The patient was treated with CODEINE (oral) on 19-Aug-2021 for Cough, at an unspecified dose and frequency; HYDROCORTISONE at an unspecified dose and frequency and AZITHROMYCIN (Z-PAK) for Product used for unknown indication, at an unspecified dose and frequency. At the time of the report, UPPER RESPIRATORY TRACT INFECTION (upper respiratory infection) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant product use was not provided by the reporter.   Treatment information also included Z-pack for upper respiratory tract infection started on 21-august-2021, last dose was on 27-august-2021.
Increased indirect bili 9; nl LFTs, nl haptoglobin, (-) sx except mild nausea after vaccine.  (-) pnh, (-) known dydbilirubinemias
10mm induration around inject site, 10cm erythema/warmth of skin around inject; tx APAP/Ibuprofen, apply heat/ice locally; No joint involvement
p/vax pt to MD for high fever;mom states broke out all over w/rash on entire body;
Left hand numbness approximately 15 min after vaccine on thr left deltoid. Pt was really anxious however the hand numbness improved after 20 mins of rest and relaxation. Initially pt was hypertensive however after resting BP improved
pt recvd vax & c/o soreness & tenderness on palpation at visit 7oct94;
after their first and second dose, their injection arm was warm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (after their first and second dose, their injection arm was warm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     The patient's past medical history included Thyroidectomy. Concurrent medical conditions included Diabetes.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Jan-2021, the patient experienced VACCINATION SITE WARMTH (after their first and second dose, their injection arm was warm). At the time of the report, VACCINATION SITE WARMTH (after their first and second dose, their injection arm was warm) had resolved.      mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   Concomitant drug was not reported.  Treatment medication was not reported.  It was reported that patient is not immunocompromised and received dose 2 and dose 3.   This case was linked to MOD-2021-318414, MOD-2021-318415 (Patient Link).
Approximately 36 hours after influenza vaccination, patient called complaining of itchy raised areas over body - right. Doctor advised temporarily Ketoconazole. Patient took Benadryl and rash subsided.
Syncopal episode without injury. Patient briefly lost consciousness, and was placed on the floor on his back with legs elevated, at which point the patient quickly regained consciousness. Patient was advised to remain on the floor and attempt to stand only under supervision of the pharmacist. After approximately twenty minutes the patient was able to stand and walk with no difficulty and was allowed to leave. No signs of injury or trauma were noted.
Day 8 post vaccination, I woke up with redness and swelling at the injection site. Today, (day 9) it is now warm to touch, red, swollen and painful to move the arm. I had very minor arm pain the first day after being vaccinated and now the pain is back.
Site: Itching at Injection Site-Mild, Site: Redness at Injection Site-Mild, Systemic: Allergic: Itch Generalized-Mild, Systemic: Allergic: Rash Generalized-Mild
Vaccination administered 1/16/08, despite argument with PA and LPN about not getting it (and being told I "may already have the virus," so I should get the vaccination; they obviously believed it was a cure instead of preventative) Severe itching appeared a few weeks after the initial vaccine. Injection site itched slightly after the vaccine was administered, and continued to spread to legs, hips, and buttocks). Itching felt as if it were coming from the inside (subcutaneous). Noticed lumps along collarbone (left side) and went to physician. After a number of physicians, received chest x-ray and needle biopsy, followed by an excisional biopsy, which diagnosed me with Hodgkin's Lymphoma, stage 2A. Treatment: Six months of ABVD chemotherapy (treatment occurred Thursdays, every other week from 06/24/08 to 12/04/08). Patient has been free of symptoms since December 2008.
chills, fever, body aches, headache - exact symptoms experienced at onset of COVID 19
Localized right arm pain, loss of voice (for one day), swollen/tender right clavicular lymph node. All symptoms resolved within one week. Lymph node swelling/tenderness resolved within two weeks.
Suspected vaccination failure; Sister in law has shingles after vaccination; This case was reported by a consumer via  media and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included COVID-19 VACCINE for prophylaxis.   On an unknown date, the patient received Shingles vaccine and COVID-19 VACCINE. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by the patient's relative. The age at vaccination was not reported. The patient received doses of shingles vaccine and Covid vaccines and experienced shingles. On an unknown date, unknown after receiving Covid vaccine, the patient experienced vaccination failure and shingles. It was unknown if the reporter considered the suspected vaccination failure and shingles to be related to COVID-19 vaccine. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up would not possible as no contact details were available. This case had been linked with case US2022AMR047516, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR047516:Same Reporter
In ordering vaccines, I selected PNEUMOVAX from the list instead of VARIVAX. The nurse administered PREVNAR (Pneumococcal 13) and then called it to my attention when she could not enter it into the electronic record.
Pfizer-BioNT COVID-19 vaccine EUA  All over slightly itchy rash.  I took a 10 MG tablet of Loratadine and that helped with the itch but did not clear up the rash.
Patient complained of throat feeling "thick." Also complained of mild nausea and shaking. Began approx 15 mins after vaccine was administered. Patient was treated with Epi and Benadryl, 911 was called. Patient left clinic alert and oriented with EMT.
Very cold; Very dizzy; Nauseous; Chills/Shivering; Arm is tight; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Very cold), DIZZINESS (Very dizzy), VACCINATION SITE INDURATION (Arm is tight), NAUSEA (Nauseous) and CHILLS (Chills/Shivering) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939904, 011A21A and 029K20A) for COVID-19 vaccination.     Concurrent medical conditions included Fibromyalgia. Concomitant products included VITAMINS NOS and CALCIUM for an unknown indication.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In October 2021, the patient experienced VACCINATION SITE INDURATION (Arm is tight). On 31-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced NASOPHARYNGITIS (Very cold), DIZZINESS (Very dizzy), NAUSEA (Nauseous) and CHILLS (Chills/Shivering). At the time of the report, NASOPHARYNGITIS (Very cold), DIZZINESS (Very dizzy), VACCINATION SITE INDURATION (Arm is tight), NAUSEA (Nauseous) and CHILLS (Chills/Shivering) outcome was unknown.            No treatment medications were reported.   This case was linked to MOD-2021-369498, MOD-2021-369499 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 31-Oct-2021: Follow up received contains start date of the Events.
Started with chills, I shook so bad, that I couldn't hold anything.  Began to run a fever 102.3. Morning of 9/17/2014 fever is gone, but I'm feeling very tired.  This is my fourth flu shot.  This is the first time I ever had any reaction.
Rebound nonproductive cough; chest tightness; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Rebound nonproductive cough) and CHEST DISCOMFORT (chest tightness) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    The patient's past medical history included Reactive airways disease. Previously administered products included for Product used for unknown indication: Aspirin, SULFA [SULFANILAMIDE], NSAIDS and OXYCODONE. Past adverse reactions to the above products included Allergy with Aspirin, NSAIDS, OXYCODONE and SULFA [SULFANILAMIDE]. Concurrent medical conditions included Hypertension, Anxiety, Obesity, Obstructive sleep apnea syndrome, Irritable bowel syndrome, Lung disease and GERD.   On 27-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (Oral) at an unspecified dose. On 18-May-2022, the patient experienced COUGH (Rebound nonproductive cough) and CHEST DISCOMFORT (chest tightness). At the time of the report, COUGH (Rebound nonproductive cough) and CHEST DISCOMFORT (chest tightness) was resolving.            No concomitant medication was provided by the reporter  Patient had history of reactive airway disease. Patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment. Device date was reported as 19-May-2022.  No treatment medication was provided by the reporter.
chills, chatter teeth,flu like symptoms, joint pain, low grade fever, sorenes redness of arm
developed bleeding spot on hand and fingers same side as injection/ Left side hand and fingers had several spots, 3 or 4 of the fingers and on the palm. Several spots. All together like 8 spots; positive D- dimer; This is a spontaneous report from a contactable physician.   A 75-years-old male patient received bnt162b2 (BNT162B2, PFIZER BIONTECH COVID 19 VACCINE, formulation: solution for injection, lot number was not reported), via an unspecified route of administration, in arm left on an unspecified date as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced strange reaction after getting the second dose of the Pfizer covid vaccine. The patient asked if he can get the third dose or not. He described the reaction as within 24 hours after the second dose, he developed what looked like a bleeding spot on his hand, on the palm of the hand and fingers, on the same side he received the injection/ left side hand and fingers had several spots, 3 or 4 of the fingers and on the palm. several spots. all together like 8 spots. It was not painful or raised. He had bloodwork done that showed a positive d dimer and he had no other symptoms. The bleeding spot disappeared within 24 hours. The patient received first dose of bnt162b2 (BNT162B2, PFIZER BIONTECH COVID 19 VACCINE, formulation: solution for injection, lot number was not reported), via an unspecified route of administration, on an unspecified date as dose 1, single for covid-19 immunisation. The patient's lab data included positive D- dimer. The outcome of the event bleeding spot on his hand, on the palm of the hand and fingers was recovered on an unknown date and of the event showed a positive d dimer was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: As there is limited information in the case provided, the causal association between the event Haemorrhage subcutaneous and the suspect vaccine BNT162B2 cannot be excluded. The case will be reassessed once new information is available. 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.
3/4/04 listless with low grade fever started with chickenpox lesions, 2, on neck and then more on trunk few on legs, less than 100, used Aveeno baths.
Patient received COVID-19 (Pfizer) vaccine while still under the age of 12. Currently not recommended for her age group.   Patient's guardian gave false information (wrong date of birth) when filling out immunization consent form. Correct date of birth was verified by primary care provider and insurance.
TATTOO ON INJECTION SITE DISAPPEARED; SORE ARM; TENDERNESS; This spontaneous report received from a patient concerned a 54-year-old adult female. The patient's height, and weight were not reported. The patient's concurrent conditions included: the patient was hypersensitive, drug allergy (narcotics), and other pre-existing medical conditions included the patient had Chest pain and was sick with Narcotics. The patient was previously received with covid-19 vaccine ad26. cov2. s (unspecified manufacturer) (suspension for injection, route of admin, and batch number: unknown, Expiry: unknown) dose not reported, frequency 1 total, start therapy date were not reported for prophylactic vaccination (Dose number in series 1). It was unknown whether patient had any adverse event following vaccination with covid-19 vaccine ad26.cov2.s.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211D21A, and expiry: Unknown) dose was not reported, 1 total, administered at right arm on 03-DEC-2021 for prophylactic vaccination (Dose number in series 2).  No concomitant medications were reported.  On 05-DEC-2021, the patient experienced tenderness.  On 06-DEC-2021, the patient experienced sore arm and tattoo on injection site disappeared. It was reported that, the patient had tattoo of about 2 by 2 inches and noticed tattoo was dissolving. Treatment medications (dates unspecified) included Motrin (Naproxen) for the sore arm and tenderness.(Dose number in series 2).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from tattoo on injection site disappeared, sore arm, and tenderness. This report was non-serious.
09/10/2008 Pain in injection area, increasing left shoulder pain 09/17/2008, left shoulder/chest pain. 9/26/2008 Anaphactic reaction all over body pain, weakness. 10/08 all over body pain/weakness, chest pain. 11/08 all over body pain/weakness and still has chest pain.
pt recvd vax; 14mar redness at site; inc redness 16 mar95 w/ pain;
Participant began feeling dizzy and lightheaded almost immediately. Sweaty. Blood pressure 126/72, HR -77, pulse ox 99%. Given water and walked outside with staff to get some cool air.  Followed up with participant at 1pm and stated that she felt fine.
Body aches, chills, sore throat, headache, low grade fever, fatigue-approximate 12 hours Alternate TYL and IBU
12 hours after receiving the vaccine intense leg pain. Also 12 hour after receiving the second vaccine 12 hours later the same leg pain came back and has not gone away.
04/10/2022 Initially I thought I had indigestion, I had pressure in my chest, pain under both arms down to my elbow, nauseated and tightness in my throat, front and back. I went to the hospital, and they hooked me up to an EKG. They saw a stemi and I went straight to the Cath Lab. I had 100% blockage in my right coronary artery which has been stented. I spent 2 days in ICU and 1 day in step down, then came home. I have no muscle damage to my heart. I had a waterfall CT scan on my lower body and they found a blocked artery in my right leg.
a 12 months old patient recieved expired dose of Daptacel in error, no AE; Initial information received on 04-Feb-2020 regarding an unsolicited valid non-serious case from an other health professional.  This case involves a 18 months old female patient who received a 0.5 ml fourth dose expired dose of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] in error (Preferred term: expired product administered, (lot C5367AA) (expiry date- 30-Jan-2020) on 04-Feb-2020 via intramuscular route in the left vastus lateralis for prophylactic vaccination.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Fluzone Quadrivalent for Immunisation.  It was an actual medication error case due to expired product administered.  No adverse event reported at the time of reporting.  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.
4 weeks after her second shot in the COVID-19 series, the patient developed asymptomatic thrombocytopenia to 64k found during the workup for iron deficiency anemia related to heavy menses. The following week, her platelets were down to 28k with an elevated immature platelet fraction consistent with idiopathic thrombocytopenia purpura. At this visit, her anemia was improving with iron supplementation.
Headache post vaccine, swollen posterior chain lymph node, resolved after 2 days.
Vaccine Td and Twinrix administered to left deltoid 8/16/2002. Pt returned 8/19/2002 with redness, warmth, and swelling measuring 3in x 6in distal to IM site.
My arm got a lump and got back and blue, I also had the chills and a slight fever and I was achy. Lump came that night the 19th and the black and blue was the next day and then the chills started in the morning of the 20th and I was cold but I was also in the car because I'm having medical treatment for my reconstruction and It was a rainy day so I didn't think anything of it. When I came back home from that I got the chills and goosebumps. I went to my room immediately after that. Then I started getting the aches and fever and it was really just overnight and then the next day I was a little tired and a little achy but I felt much better and was up and moving around.
Patient is past day 36 since the first dose and has not received the second; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient is past day 36 since the first dose and has not received the second) in a 34-year-old female patient 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient is past day 36 since the first dose and has not received the second). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient is past day 36 since the first dose and has not received the second) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant drug was not reported. Treatment medication was not reported.  It was reported that due to vaccine unavailability patient didn't receive dose 2. Her daughter had the first dose of the Moderna COVID-19 vaccine either in Jan2021 or Feb2021.   Most recent FOLLOW-UP information incorporated above includes: On 10-Aug-2021: Non-significant TCR attached. email added. On 10-Aug-2021: Follow up received on 17-Aug-2021 contained no new information.
About a day after getting the vaccine, I felt a strange sensation of moving up and across the left side of my face.  It stopped about half way across my face, with a tingle sensation .  My face was then numb for the rest of the day.  It only affected half of my face, the left side (I got the vaccine in left arm).   The same sensation occurred with the second vaccine dose, but it happened earlier on the day of the vaccine about 5 hours after getting the shot.  The same tingle and numbing sensation filled half of my face.
On 4/20/00, pt started with headaches, body aches, diarrhea, large area of redness, swelling, hard, and painful of forearm.
Patient was given a 0.25 mL of Moderna Bivalent Booster dose on 9/15/2022.The information was presented to medical staff on 9/27/22. The patient was called on 9/28/22 and 9/29/22. Unable to reach patient. Will make an additional attempt to contact patient on 9/28/22.
01/11/22 presents to ED for "worsening BL upper and lower extremity and scrotal swelling". PMHx of "afib on eliuis s/p cardioversion, restrictive cardiomyopathy 2/2 amyloid, HFpEF, CKD IIIB, HTN, DM2, HLD, hypothyroid, asthma, gout"
shortly after receiving these 2 vaccines the patient began having balance issues, these balance issues progressed and he has been hospitalized 4 different times, diagnosed with acute flaccid myelitis, GBS, acute cerebellar ataxia, and seizure activity. everything has been ruled out as to what is causing this except that it was an adverse reaction to one of his vaccines given 12/28/2020. he is still having episodes of ataxia and is on seizure medication
It was reported that a 36 year old female pt received a TD Adult vaccination, intradermal on 01/26/2001 at 9am. Reportedly on 01/28/2001 at 10am, the pt developed redness and itching. the pt reportedly recovered from this experience. From follow up #1 correspondence received on 03 Apr 2001, additional pt information was provided. See reports U2001-00435, U2001-00436, U2001-00438, U2001-00447, through U2001-00453, U2001-00454 and U2001-00456 through U2001-00461, same reporter.
This case was reported by a pharmacist and described the occurrence of possible aseptic meningitis in a subject of unspecified age and gender who was vaccinated with influenza virus vaccine for prophylaxis. On an unspecified date the subject received unspecified dose of influenza vaccine. At an unspecified time after vaccination with influenza vaccine, the subject experienced possible aseptic meningitis and was hospitalized. At the time of reporting, the outcome of the event was unspecified.