chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Received influenza 4 strain Flucelvax flu shot on 10/7/17. Within 7 days, left knee began aching continuously as well as both shoulder joints and rotator cuff popping. Orthopedic doctor took x-rays stating knee required a full replacement and to temporarily relieve the pain administered a cortisone shot to the knee. Pain subsided in knee for 20 days, however the shoulder joints kept getting worse then all my joints in the body became inflamed. Dr ordered multiple blood tests to isolate issue, results indicated an auto immune disease however it is not Rheumatoid Arthritis, not Lupus, not Scleroderma but Sedimentary Rate was very high out of range. Dr prescribed 15mg Meloxicam to ease inflammation however it did not have any affect. Dr prescribed 800mg Dexius (ibuprofen with Pepcid) and this has reduced pain and inflammation 50% but returns to 100% after 8 hours drug wears off. On 12/7/17 Dr has diagnosed, symptom is vaccine induced arthropathy and will take several months to see any improvement.
Same day onset of shortness breath, next day onset of tachycardia.  Patient advised to go to the ED
Staphylococcus aureus infection; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team. The reporter is the parent.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: STAPHYLOCOCCAL INFECTION (non-serious), outcome "unknown", described as "Staphylococcus aureus infection".  Additional information: Reporter was calling to ask for medical information, reporter's daughter, she developed a reaction after the vaccine, she developed a staph infection, very serious staph infection after vaccine, like 4 days after the vaccine and reporter wanted to ask what do you have in your data, do you have (Incomplete sentence) Reporter wanted to search your database and let know if there is any history of that what we can expect reporter was trying to find if she can get second vaccine or not.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
foggy head; sleeping 12-14 hours; Circular Rash at injection site.; swollen, and hot to touch.; head ache; swollen, and hot to touch; lethargic; chills; fever; loss of appetite; This spontaneous case was reported by an other health care professional and describes the occurrence of LETHARGY (lethargic), CHILLS (chills) and PYREXIA (fever) in a 45-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 15-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) .5 milliliter. On 15-Nov-2023, the patient experienced LETHARGY (lethargic) (seriousness criterion life threatening), CHILLS (chills) (seriousness criterion life threatening), PYREXIA (fever) (seriousness criterion life threatening), DECREASED APPETITE (loss of appetite), VACCINATION SITE RASH (Circular Rash at injection site.), VACCINATION SITE SWELLING (swollen, and hot to touch.), HEADACHE (head ache) and VACCINATION SITE WARMTH (swollen, and hot to touch). On an unknown date, the patient experienced BRAIN FOG (foggy head) and HYPERSOMNIA (sleeping 12-14 hours). The patient was treated with PARACETAMOL (TYLENOL) in November 2023 at a dose of 600 milligram. At the time of the report, LETHARGY (lethargic), CHILLS (chills), PYREXIA (fever), DECREASED APPETITE (loss of appetite), VACCINATION SITE RASH (Circular Rash at injection site.), VACCINATION SITE SWELLING (swollen, and hot to touch.), HEADACHE (head ache) and VACCINATION SITE WARMTH (swollen, and hot to touch) had not resolved and BRAIN FOG (foggy head) and HYPERSOMNIA (sleeping 12-14 hours) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use), the reporter did not provide any causality assessments.   Concomitant medication was not reported. Company Comment: This is a case concerning a 45-year-old female patient with no medical history, who experienced the serious (due life-threatening) unexpected, events of lethargy, chills and pyrexia, together with other non-serious events, which occurred on the same day after a dose of mRNA-1273.815 (SPIKEVAX 2023-2024) vaccine. It was reported that the patient was treated with paracetamol. The outcome of the events was reported as not recovered. The benefit-risk relationship of mRNA-1273.815 (SPIKEVAX 2023-2024) vaccine is not affected by this report.
Patient is a 85 y.o. male patient of, CNP with history of atrial fibrillation, hypertension, CAD status post CABG, GERD presented to Hospital with acute respiratory failure with hypoxia. Problem based management in the hospital is as follows:   Acute metabolic encephalopathy, resolved Acute delirium, improved In setting of hypoxia, UTI, advanced age Treatment of UTI and COVID as mentioned below Continue delirium precautions   Acute respiratory failure with hypoxia Covid-19 Virus Infection Date of onset of symptoms: 2/19/23 Symptoms present on admission: Respiratory failure Date of covid positive test: 2/19/23 Vaccination status: Unknown Imaging: Chest x-ray?multifocal opacities throughout the right side, ill-defined prominent left perihilar interstitial lung markings Oxygen requirements on admission: Nonrebreather mask Patient currently on 4 L oxygen nasal cannula.  I spoke with the nurse to continue to wean oxygen with O2 saturation target around 92% given the COVID infection and also for comfort. Medical therapy: Decadron started 2/21, ordered a fast taper at discharge to be completed on 3/5 for Decadron. Remdesivir started 2/22, remdesivir therapy now completed. Consultants following: Infectious disease Anticipated special isolation end date: 3/3 completed cefepime course/23   Urinary tract infection?secondary to Pseudomonas Present on admission Currently on cefepime, will finish a 5 to 7-day course. ID following   Atrial fibrillation Supratherapeutic INR History of sick sinus syndrome-pacemaker in place Was on Coumadin, now discontinued since he is DNR CC INR 3.2 <7.6 <5.7<4.6<3.2<4.2<2.7 Given 1 dose of vitamin K 2.5 mg on 2/23 Will give another dose of vitamin K since hematuria has recurred Continue to monitor INR off Coumadin Echocardiogram July 2022-EF of 57%   Hematuria, resolved Secondary to coagulopathy from Coumadin and UTI Give vitamin K, hold Coumadin, continue antibiotics Since he has history of nephrolithiasis and stent placement, consulted urology, stent removed on 3/2   Hypothyroidism On Synthroid
She called pharmacy on 10/13/16. She spoke to pharmacist. She stated she had redness at injection site developed same day and now it is travelling down the arm. She was advised to see physician. She stated she was seeing dosctor in ER.
Bell's palsy diagnosed in ER. Onset 2/8 @ 2100.  Noticed right-sided numbness and facial weakness, including lack of motor control of tongue. Came promptly to ER. Reports family history of Bell's palsy - mother, 50+ years ago.
Nausea; vomiting; severe diarrhea; fever; tiredness; This is a spontaneous report from a contactable consumer, the patient. A 43-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: ER8732), via an unspecified route of administration in the arm right on 25Mar2021 15:30 as dose 2, single (at the age of 43-years-old) for covid-19 immunization. Medical history included copd, acid reflux, depression and allergies to medications, food and other products. Concomitant medication included omeprazole. The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: EN6199), via an unspecified route of administration in the arm right on 04Mar2021 15:45 as dose 1, single for covid-19 immunization. On 26Mar2021 21:00, the patient experienced nausea, vomiting, severe diarrhea, fever and tiredness. The patient did not receive any treatment for the events. The patient did not diagnose with COVID-19 prior to vaccination and since the vaccination, the patient did not test for COVID-19. The outcome of the events was not recovered.  No follow-up attempts were possible; information about lot/batch number could not be obtained.
Patient had a positive COVID PCR test on 10/06/2021 after receiving both vaccine doses
THE PATIENT CALLED THE PHARMACY ON 8/29/2018 AND STATED THAT HER RIGHT ARM HURT AT THE INJECTION SITE OF THE MENACTRA AND THAT HER THROAT FELT SWOLLEN . A SWOLLEN THROAT WAS LISTED AS A RARE SIDE EFFECT & REFERRAL TO PHYSICIAN WAS RECOMMENDED IN THE LITERATURE. THE PHARMACY RECOMMENDED SHE CONTACT HER PHYSICIAN ASAP. THE PHARMACY ALSO RECOMMENDED SHE TAKE 25 MG OF BENADRYL IF SHE FELT HER THROAT WAS STARTING TO CLOSE AND SHE WOULD NOT BE ABLE TO BREATHE ADEQUATELY. THE PATIENT ASKED IF SHE COULD USE A COLD PACK ON HER THROAT. THE PHARMACY SAID YES BUT IF SHE WAS STRUGGLING TO BREATHE SHE SHOULD TAKE THE BENADRYL AND DIAL 9-1-1. SHE STATED THAT SHE DID NOT FEEL HER LIFE WAS IN PERIL AT THIS TIME.
muscle stiffness 10/27/06 High fever and some slight jerking 10/28/06 High fever (101)
22DEC92 mom phoned pt eyes rolling backin head, lip & face turning blue, pt is getting stiff, unable to arouse; fever t108 R; EMS stated that sz activity R/T fever;
PATIENT CAME TO FLU/COVID SHOT CLINIC AND ASKED FOR VACCINE, AND PHARMACIST REVIEWED database AND CONSULTED ON POSSIBLE SIDE EFFECT OF COVID SHOT AND PATIENT SAID SHE IS AWARE OF THEM, AFTER PT RECEIVED MODERNA BOOSTER AND WHILE PHARMACIST WAS FILLING OUT NEW VACCINE RECORD CARD, PATIENT SAID SHE IS HERE AT THE CLINIC FOR FLU SHOT, NOT COVID SHOT, SHE ALREADY RECEIVED  PFIZER UPDATED BOOSTER ON 09/26/22 , TODAY'S SHOT WOULD BE HER 6 TH DOSE AND 2ND BIVALENT BOOSTER. FOLLOWED UP WITH PATIENT 6 HOURS AFTER DOSE AND PT DID NOT REPORT ANY SIDE EFFECTS.
dose was administered to a patient after 30 day use by date; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose was administered to a patient after 30 day use by date) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036C21A) for COVID-19 vaccination.     Concurrent medical conditions included Iodine allergy (iodine), Drug allergy (Doxycycline), Drug allergy (Prednisone), Drug allergy (Codeine), Latex allergy (Latex), Drug allergy (Sulfa) and Drug allergy (Nalbuphine). Concomitant products included CERTOLIZUMAB PEGOL (CIMZIA), COLECALCIFEROL (VITAMIN D3), MAGNESIUM, POTASSIUM and SODIUM BICARBONATE (SODIUM BICARB.PED) for an unknown indication.    On 22-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (dose was administered to a patient after 30 day use by date). On 22-Sep-2021, EXPIRED PRODUCT ADMINISTERED (dose was administered to a patient after 30 day use by date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Treatment Information were provided by the reporter   Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: Significant follow up received. Added patient demographics, relevant history (allergy) and concomitant medication
This case was reported by a healthcare professional and described the occurrence of a red circle around the injection site in a 50  year old female subject who was vaccinated with Flulaval (GlaxoSmithKline) for prophylaxis.  On 30 October 2007 the subject received a one time dose of Flulaval in the left arm.  On 30 October 2007, at an unspecified time after vaccination with Flulaval, the subject experienced an injection site reaction.  The subject developed a 1.5 inch circular, red, hot injection site reaction.  At the time of reporting the events were unresolved.
Rash is itching; Right arm swollen with rash; Right arm rash is red; Right arm rash under the wrist has like a mass; Abrasions on left wrist/Abrasions on right wrist; Sore arm after the vaccination; Rash on both arms/Rash on right forearm/Rash on right hand biceps; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Rash is itching), PERIPHERAL SWELLING (Right arm swollen with rash), RASH ERYTHEMATOUS (Right arm rash is red), MASS (Right arm rash under the wrist has like a mass) and SKIN ABRASION (Abrasions on left wrist/Abrasions on right wrist) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 04-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jun-2021, the patient experienced RASH (Rash on both arms/Rash on right forearm/Rash on right hand biceps). On an unknown date, the patient experienced RASH PRURITIC (Rash is itching), PERIPHERAL SWELLING (Right arm swollen with rash), RASH ERYTHEMATOUS (Right arm rash is red), MASS (Right arm rash under the wrist has like a mass), SKIN ABRASION (Abrasions on left wrist/Abrasions on right wrist) and MYALGIA (Sore arm after the vaccination). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of UNK dosage form. At the time of the report, RASH PRURITIC (Rash is itching), PERIPHERAL SWELLING (Right arm swollen with rash), RASH ERYTHEMATOUS (Right arm rash is red), MASS (Right arm rash under the wrist has like a mass), SKIN ABRASION (Abrasions on left wrist/Abrasions on right wrist), MYALGIA (Sore arm after the vaccination) and RASH (Rash on both arms/Rash on right forearm/Rash on right hand biceps) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported. The patient was prescribed steroid cream to put twice a day, not specified.
On the 8th day after the injection, where the injection was, it swelled and itched. The next day plus 2 more days it hurt. The swelling and all side effects were gone by end of 11th.
flu like symptoms; This case was reported by a physician via sales rep and described the occurrence of influenza-like symptoms in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was unknown.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported, however the patient's age group could be elderly. The patient received Shingrix and experienced flu like symptoms. The reporter agreed to be followed up. This case has been linked with case US2019AMR140071, for same reporter.~
She said on Saturday, 2/3/18, that her arm became hot and feverish with a hard lump at the injection site. Then her arm began to itch. However, when she woke up on Sunday morning, her face was also red and swollen with a burning sensation. In addition, she was having lots of chills. She went on to say that most of the above has subsided after taking benadryl. In addition she said today, Monday, 2/5/18, she was only experiencing some soreness and tenderness on the back side of her arm. The patient stated she was taking benadryl to help combat the reaction, and she was feeling much better since the swelling had subsided.
The reaction is a large, 2 " red and warm circle on the left arm where the vaccine was injected. it started the day after the vaccination and persists until now, ten days after. No other adverse symptoms.
Approx 30 minutes after receiving injection had tingling from "top of her head to bottom of her feet", and broke out in a rash and became itchy. 8mg chlorpheniramine PO given and v/s taken. Within 10-15 minutes symptoms decreased, only tingling remained in head.
Patient developed swelling, reddness and temperature at the site of the injection. Her mother called her Dr and placed ice packs and took motrine as instructed. Injection given on Tues. and on Fri. she came by the clinic the site was still red, swollen and warm to the touch. She was going to see the Dr after this clinic visit.
Patient fainted few minutes after administering VARIVAX shot. Immediately 911 was called. But recovered immediately in few seconds. He was stabilized Parents were there when vaccine was administered. Patient's father actually helped during the vaccine was being administered to keep patient calm and relaxed. Patient's father also helped during stabilizing child. No allergic reaction, no Shortness of breath, no itching/hives was reported during the event. Patient Fainted for few second and got back to normal in few seconds. 911 (Paramedic team) arrived in few minutes they asked few question to patient and his father. As patient was feeling normal patient's father denied help from Pharmacy team and as well as 911 team. Patient was asked to wait for at least 15 minutes. They waited for more than 15 minutes in our waiting area. Patient was continuously monitored by pharmacy team. Patient was completely stabilized and feeling normal before they left Facility. Patient was referred to his physician for further medical evaluation.
After the first dose I experienced normal immune reaction. After the second dose I experienced normal immune reaction but never really felt better. Beginning in mid-May I began experiencing extreme fatigue, increased symptoms of GERD, polyarthralgia (spine, hips, knees, ankles, feet), tinnitus, and vertigo. After ongoing symptoms for months I was referred to rheumatology and ultimately diagnosed with psoriatci arthritis  on Septemher 2021
Normal muscle aches, chills,  fever, and headache as explained as a possible side effect.  The widespread rash did not start until almost 48 hours after the vaccine.
Site: Bruising at Injection Site-Mild, Site: Redness at Injection Site-Mild, Additional Details: Patient's arm bruised and turned red after IM injection, applied cotton ball to stop bleeding, then ice, redness was relieved, left voicemail message for parents to follow up following day
Moderate loss of vision in left eye. Slight loss of vision in right eye. Started the day after receiving vaccination and is still present today. Have not seen Dr.
Localized pain/soreness; Light headedness; This is a spontaneous report from a non-contactable consumer, the patient. A 31-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration in the left arm on 06Mar2021 at 11:00 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. Medical history included chronic headaches and migraines. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included amitriptyline (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date and unknown if ongoing. On 06Mar2021 at 18:00, the patient experienced localized pain/soreness and light headedness. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Any therapeutic measures were not taken for the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events localized pain/soreness and light headedness was recovered on an unknown date in Mar2021.  No follow-up attempts are possible. No further information is expected.
Started having shooting pain in limbs for 1 week immediately after receiving vaccine. 10 days later, sudden double vision with severe migraines, constant eye tearing, severe near sightedness and far sightedness and pain in left side of face. Pain in limbs disappeared after 1 week. Double vision, tearing, near and far sightedness, migraines and face pain persist.
Swelling at site of injection and bruising.  Warm to the touch.  Treated with Ice.
Day after 2nd injection my blood pressure skyrockets to 200/104 with chest pressure.  Admitted to medical center. All heart tests EKG, Echo and Stress Test came back normal.
atrial fibrillation; This is a spontaneous report from a contactable consumer (patient) via Medical information team. An 83-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Lot number was not reported) as SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient wanted to know if she can delay her second dose of the Pfizer COVID-19 vaccine. She was scheduled to take the second dose of the Pfizer COVID-19 vaccine today (12Mar2021) but she is reluctant to get it because of her reaction with the first dose of the vaccine. She was hospitalized for atrial fibrillation after taking the first dose. The outcome of the event was unknown.  Information on about lot/batch number has been requested.
p/3rd dose of hep b vax pt had an autoimmune rxn described as mixed connective tissue disease;pt also exp short term memory loss;
Patient falsified DOB when registering for vaccination, stating the minor was  born on different date. Guardian, consented to the vaccination. Staff verified with statistical records what the patients actual DOB is which made the vaccine a contraindication.  No known adverse reactions noted.
Information has been received from a physician concerning a patient of unknown age and gender. The patient's medical history and current conditions were not reported. On 07-MAY-2015, the patient was vaccinated with an improperly stored dose of (Oka/Merck) VARIVAX (dose, frequency, route of administration, lot# and expiration date were not reported). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Child was immunized on 04/18/2005.  On 04/20/2005, mother reported that the child's left arm was red and very swollen, and that the child had had a low grade temperature on 04/19/2005.  Mother instructed that possibly was normal occurance with immunizations given, and refered to her VIS statements for further information regarding side effects of vaccination.  Mother told to take child to pediatrician for evaluation if she deemed it necessary.  Follow up phone call made to mother on 04/21/2005, mother stated that she did not take the child to the pediatrician, and that the child's swelling was gone, no redness was present, no further fever had occured, and the child was "back to her normal self".  Mother instructed again to refer to her VIS statements for further information, and to contact clinic if further problems occurred.  Follow- up call made to mother on 04/22/2005, no answer, message left on machine.