chrisvoncsefalvay/vaers-outcomes huggingface dataset:
scab on arm; redness on arm; This spontaneous case was reported by a consumer and describes the occurrence of SCAB (scab on arm) and VACCINATION SITE ERYTHEMA (redness on arm) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced SCAB (scab on arm) and VACCINATION SITE ERYTHEMA (redness on arm). The patient was treated with GRAMICIDIN, NEOMYCIN SULFATE, POLYMYXIN B SULFATE (NEOSPORIN [GRAMICIDIN;NEOMYCIN SULFATE;POLYMYXIN B SULFATE]) at an unspecified dose and frequency. At the time of the report, SCAB (scab on arm) and VACCINATION SITE ERYTHEMA (redness on arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Headache, brain fog - cloudiness Narrative: Employee recieved 2nd dose of Moderna this morning and has slight HA 2/10 and cloudiness
Pt received 1st dose J&J COVID vaccine right deltoid @ 1413.   Around 1428, pt c/o chest tightness, lips feeling numb, tachypneic, and dizziness post vaccination. V/S: 102/85, HR 108, SPO2 95% RA, RR 26. EKG done in clinic. SPO2 93% noted, started on 2 LPM via nasal cannula.   RRT notified. RN-to-MD report given to Dr. Pt transferred to UC via wheelchair via 2-person assist @ 1453.
Had prior pain from shoulder blade up to neck and ear.  Lasted 3-4 days. Had been increasingly Itchy. On 4/23/2021, rash on shoulder neck.  Went to dr rash not there.   Treated for shingles. Rash reappeared later that evening.  Husband received vaccine same date/time. Being Treated for shingles.  He reported his event
Chronic fatigue, on and off flu like symptoms, swollen glands body muscle nerve pain migraine 75 % worse
Patient has not reported any adverse event. Patient received the vaccination while using Humira, which weakens the immune system.
Injection site red, a little swollen and warm (very) to touch, itchy. Taking Benadryl and ibuprofen.
FEVER, CHILLS, MUSCLE ACHES, NAUSEA, ARM PAIN AT INJECTION SITE, SWEATING
Discharge summary "Patient is a 57 YO female with a PMHx of chronic respiratory failure on 2 L O2 at baseline, COPD, MDD, anxiety, metabolic stone disease, neurogenic bladder, multiple urinary tract infections (follows with Urology as noted below), chronic foley, HLD, MS (bed-bound at baseline, only has use of left arm/hand), chronic constipation, GERD, and insomnia who presented to the ED on 3/15/23 with fever, shortness of breath, weakness and nonproductive cough for one day. She tested positive for COVID-19 on 3/14/23.      Patient was brought to the ED on 3L O2. Her oxygen saturation dropped to 88% and she was titrated up to 5L. She had a fever of 102.5 F and was tachycardic up to 135. Rapid COVID test was positive. Patient did not have a leukocytosis. Lactic Acid was not elevated. Procalcitonin was elevated to 0.4. D-dimer was elevated to 650. Chest X-ray demonstrated chronic left lower lobe atelectasis or pneumonic scarring. CTA pulm was negative for embolism or definite pneumonia. Left greater than right posterior airspace disease favoring atelectasis. Pneumonia, such as aspiration pneumonia possible. EKG demonstrated sinus tachycardia with ST and T wave inversion in the inferior leads. Patient was administered Ofirmev, fluid bolus and Unasyn. Patient was accepted for admission to the hospitalist team.    Patient was treated with Decadon, DuoNebs, and Mucinex, and she was weaned off of supplemental oxygen as tolerated.  IV Unasyn was continued. UA results were indicative of UTI and culture grew gram negative rods. Blood cultures had no growth. Patient had no further fevers during her hospital stay. She was weaned off of oxygen completely and was saturating 98% on room air. On evaluation on the morning of 3/16/23 patient admitted to being back to her baseline. She was feeling well and requesting to go back home. As vitals and labs were stable patient was discharged home with 5 days of Augmentin to treat her UTI. "
feverish; pain,/body ache; This case was reported by a physician via sales rep and described the occurrence of fever in a 17-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 23rd August 2021, the patient received the 1st dose of Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, less than 3 months after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced fever and general body pain. On an unknown date, the outcome of the fever and general body pain were unknown.   It was unknown if the reporter considered the fever and general body pain to be related to Bexsero and Bexsero Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided are as follows: The patient experienced feverish pain, body ache and no rash. For tolerance of 2nd dose of Bexsero, refer case US2021AMR225328, reported by same reporter. The reporter consented to follow-up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR225328:same reporter
very sick like both if they had COVID-19; very sick like both if they had COVID-19/ deathly ill; This is a spontaneous report from a contactable consumer (patient's wife) via a Pfizer-sponsored program. This consumer reported similar events for two patients. This is the second of two reports.  An 85-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date unknown) on 02Mar2021 (85-year-old at time of vaccination), at single dose, for COVID-19 immunization. The patient medical history included COVID-19 from Dec2020. Concomitant medications were not reported. Patient's wife stated both she and the patient got the COVID-19 back in December (Dec2020). They were told that it was safe for them to receive the vaccine. They received the first dose of BNT162B2 on 02Mar2021. The next day (03Mar2020) they got very sick like both if they had COVID-19, this symptoms went as fast as they came, 05:00 for the patient; both she and the patient were deathly ill; they got up very sick on 03Mar2020. Stated that they are scheduled to the get the second shot and has wondered if it they should get the second shot. The outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) :  same reporter/drug/event, different patient (wife)
Two days post vax, pt returned to clinic. Complained of left arm hurting, arm red starting at mid upper arm down to below the elbow. Evident swelling right above and below the elbow. Referred to private physician.
A report was received from a health care professional on 10/11/02, concerning a vaccinee of unknown demography who experienced a medication error after receiving Fluvirin on an unreported date. On an unreported date, a vaccinee was inadvertently administered Fluvirin subcutaneously. No adverse reactions were noted.
pt recv vax 21JAN96 & 5FEB96 pt exp fluid surrounding heart, swollen liver, high fever, sever abd pain, rash red in color like little pin pricks & serious dry skin & was hosp;sx include red swollen lips, t;conjunctivitis;mac pap rash;
arm is sore was reported as worsened; arm is keeping her up at night; it hurts, it's like a muscle pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 74 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 17Feb2021 14:00 (Lot number: EN6201) at the age of 74 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "high blood pressure" (unspecified if ongoing); "cholesterol" (unspecified if ongoing); "thyroid" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 17Feb2021, outcome "not recovered", described as "arm is sore was reported as worsened"; INSOMNIA (non-serious) with onset 17Feb2021, outcome "unknown", described as "arm is keeping her up at night"; MYALGIA (non-serious) with onset 17Feb2021, outcome "unknown", described as "it hurts, it's like a muscle pain". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pain in extremity, insomnia, myalgia.  Additional information: It was reported that patient administered flu shot every year, her arm might be sore for a day or two at the most, but patient did not remember it being sore hardly at all. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations were not available were none. Vaccination Facility Type at Pharmacy and Grocery Store. There were no relevant test. The patient did not received any vaccine within 4 weeks prior vaccinations. Patient did not administered vaccines on same date with the Pfizer vaccine considered as suspect. Concomitant Medications, History and Investigations: Caller has, and takes medicine for high blood pressure, cholesterol and her thyroid medicine. She took all those medicines. She's had her normal yearly Blood test. She did not feel they are relevant to this report.  No follow-up attempts are possible. No further information is expected.
Rash on chest; it was kind of warm to the touch; it was a little itchya and kind of felt itchy all over; This is a spontaneous report from a contactable consumer (patient) reporting for self. A 55-year-old female patient received BNT162B2 (BNT162B2, Solution for injection, Lot Number: ER2613; Expiration Date: 31Jul2021, PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in Arm Right on 19Mar2021 as dose 1, single (at the age of 55 year) for covid-19 immunisation (CDC). Medical history included ongoing seizure, ongoing cholesterol and ongoing allergy, Heart stent and epilepsy. Concomitant medications included acetylsalicylic acid (ASPIRIN (E.C.)) at 81 mg; escitalopram oxalate (LEXAPRO) at 10 mg; ezetimibe (ZETIA) taken for cholesterol, at 10 mg; montelukast sodium (SINGULAIR) taken for allergy, at 10 mg; omeprazole (PROTONIX) taken stomach, start and stop date were not reported; alirocumab (PRALUENT) at 75 mg, zonisamide (ZONEGRAN) taken for seizure; cyclobenzaprine hydrochloride (FLEXERIL) taken as muscle relaxant, at 10 mg. The patient experienced rash on chest, it was kind of warm to the touch and it was a little itchy and kind of felt itchy all over on 20Mar2021 with outcome of unknown. Patient underwent laboratory test and procedures reported as popped up today and now have noticed one in leg on 20Mar2021. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Information has been received from a registered nurse concerning a 68 year old male who in 2006 was vaccinated with a dose of the PNEUMOVAX 23. Subsequently, the patient experienced swelling in his arm from the shoulder to the elbow, fever and shortness of breath. Unspecified medical attention was sought. Laboratory tests performed included pulse oximetry, 92-94 percent. Two days after vaccination, his symptoms were gone. Additional information is not expected.
This spontaneous report was received from a medical assistant referring to a multiple patients of unknown age and gender. These patients' concomitant medication, pertinent medical history and drug reactions were not reported. On unspecified dates since 21-JUL-2017, these patients were administered improperly stored GARDASIL 9 (lot# N001533 with expiration date 16-OCT-2019, lot# N004799 with expiration date 15-NOV-2019, lot# M034437 with expiration date 03-FEB-2019, dose and route not reported) for prophylaxis. The vaccine was exposed to temperature excursion of 47 to 77 Fahrenheit (F) for 43 minutes. There was no previous temperature excursion. The data logger was involved. No adverse effect was reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA004620: US-009507513-1709USA004622: US-009507513-1709USA004623: US-009507513-1709USA004619: US-009507513-1709USA004621.
Fatigue; Headache; Muscle aches; Runny nose; Nasal congestion; Low fever; This is a spontaneous report from a contactable consumer (patient). A 25-year-old female patient received the first dose of bnt162b2 (Lot number: E13247), via an unspecified route of administration in left arm on 21Jan2021 16:30 at single dose for covid-19 immunization. The patient medical history was not reported. Concomitant medication included fluoxetine hydrochloride (PROZAC). The patient experienced fatigue, headache, muscle aches, runny nose, nasal congestion and wondering if its a sinus infection, low fever (highest temp recorded was 99.9 F) on 24Jan2021 06:00. It was unknown if treatment received for the adverse event. The events resulted in Doctor or other healthcare professional office/clinic visit. The patient was no pregnant. The outcome of events was not recovered.
Patients caretaker reported he was hospitalized the day after with pneumonia and a stroke. Not sure if they are related as history shows pt. tolerated flu shot in the past.
2-3 weeks post vax the pt experienced 10 vesicles. The pt was afebrile.
Immediately after injection patient started seizing. I sat with patient until it passed as he advised it had happened previously and just had to "get through it".
tasted salty; coughing; runny nose; noticed welts of the size of a fingernail in her legs; Bumps; itchy/ itching around the neck line/ it started itching a little bit more; This spontaneous case was reported by a patient and describes the occurrence of SKIN MASS (Bumps), PRURITUS (itchy/ itching around the neck line/ it started itching a little bit more), DYSGEUSIA (tasted salty), URTICARIA (noticed welts of the size of a fingernail in her legs) and COUGH (coughing) in an 88-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 024H22A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient had not received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  The patient's past medical history included Leg injury. Previously administered products included for Product used for unknown indication: Johnson & Johnson (1st dose) on 08-Apr-2021. Past adverse reactions to the above products included No adverse event with Johnson & Johnson. Concurrent medical conditions included Asthma. Concomitant products included SALBUTAMOL (ALBUTEROL HFA), FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (WIXELA INHUB) and MONTELUKAST for Asthma.    On 12-Dec-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 12-Dec-2022, the patient experienced SKIN MASS (Bumps). 12-Dec-2022, the patient experienced PRURITUS (itchy/ itching around the neck line/ it started itching a little bit more). On 14-Dec-2022, the patient experienced URTICARIA (noticed welts of the size of a fingernail in her legs). On 15-Dec-2022, the patient experienced DYSGEUSIA (tasted salty). 15-Dec-2022, the patient experienced COUGH (coughing) and RHINORRHOEA (runny nose). The patient was treated with PARACETAMOL (TYLENOL) on 13-Dec-2022 for Itching, at an unspecified dose and frequency. At the time of the report, SKIN MASS (Bumps) and PRURITUS (itchy/ itching around the neck line/ it started itching a little bit more) had not resolved, DYSGEUSIA (tasted salty) outcome was unknown and URTICARIA (noticed welts of the size of a fingernail in her legs), COUGH (coughing) and RHINORRHOEA (runny nose) was resolving.            It was reported that after the Moderna bivalent booster during the evening patient started itching around the neck line, next day patient took Tylenol and itch was not so bad, but on the next day before patient went to bed it started itching a little bit more and patient noticed welts of the size of a fingernail in the legs, next day around 12:30 patient started coughing and needed to drink water and then by 2 o clock patient had runny nose and tasted salty. Currently patient still had bumps and itchiness.   This case was linked to MOD-2022-689496 (Patient Link).
Total 48 hrs started with severe headache, progressed to chilling nausea. Overall aching with painful joints. Excruciating headache and very stiff neck. Fever 100.4 degrees F. Considered ER for meningitis symptoms. Resulted in loss of work.
S/Sx began after H1N1 administration. Itchy/scratchy throat, mild cough, HA, ear pain with subjective fever/chills.
injecting the vaccine too high/ the side effect that she is experiencing may not be directly contributed to the vaccine itself but to incorrect vaccine administration technique.; shoulder pain and elbow pain; Experienced aching in the arm; This is a spontaneous report from a contactable Nurse (patient). This 63-year-old female nurse received the first dose of BNT162B2 (Lot number ER8734) intramuscular at single dose for COVID-19 immunisation on 07Apr2021. Relevant history included Hyperthyroidism and Pott's disease. Relevant concomitant drug included carvedilol, ivabradine hydrochloride (CORLANOR) and levothyroxine sodium (SYNTHROID). The patient and her husband had their first dose of Covid 19 vaccine on 07Apr2021, both of them had experienced aching in the arm for a week and one of the main reason why was calling now was because of a lady who helped them she said that she was not sure if that's a nurse or a doctor it's just a pharmacist that person did not know what she was doing because that person was like injecting the vaccine too high and it's like so much into the shoulder and told to that person if you are going to vaccinatedus too high it might cause shoulder injury she was asking if she was okay to take it in legs because it is also an intramuscular injection so it doesn't matter it's in arms or legs the person the pharmacist said to her is like this. The patient said that after the shot she experienced severe pain on her shoulder (back side of the humerus). Also, the caller said that she was afraid that this might affect Pfizer on another note as the side effect that she is experiencing may not be directly contributed to the vaccine itself but to incorrect vaccine administration technique. She also mentioned that the administrator of the vaccine have to massage her arm very furiously post vaccination. The patient also experienced aching in the arm and Elbow pain. She was still having some shoulder pain and elbow pain and she thought it had nothing to do with the vaccine she thought it had to do with poor administration too high up on the shoulder instead of down in the muscle. No treatment was received, she just been trying to rest her arm and hope it will go away. The patient was resolving (improved).    No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021423506 same reporter, same drug, similar event, different patient
rash at injection site occurred 8 days after vaccine, not resolved yet (today is day 10);  some itchiness on neck and upper back
Severe swelling of back of left arm from shoulder to elbow. Slight itching. No fever occurred day after yellow fever vaccine. Lasting about 3 days.
This case involves an unknown age male patient who experienced "got very sick" (illness), after receiving INFLUENZA VACCINE. The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination. On an unknown date, the patient developed non-serious "got very sick" (illness) (unknown latency) following the administration of INFLUENZA VACCINE. Details of laboratory data not reported. It was not reported if the patient received any corrective treatment for the event. It was reported "The only one who ever got the flu shot was my mother and she was the only one to get severely sick with the flu. My son did it one time and he got very sick. Nope I will rely on my immune system." At time of reporting, the outcome was unknown for the event. There will be no information available on the batch number for this case.; Sender's Comments: SanofiPVPortal20211122000939:
After second, very ill with fever, body aches, headache, debilitating lassitude headache.  Lasted 36 hours.
Headache began on 1/13 and has not gone away in spite of agressive treatment at emergency department on Friday night (1/15).  Some nausea and major nose bleed on Thursday night (1/16). At emergency dept did neurological exam, oxygen and sequential treatment with Zofran, Toridal, Adivan, Dilauded. Gave Rx for Anaprax - started on 1/17.
About 1/2 hour after injection my fingers were tingling, then about 45 minutes after injection my heart started beating fast and felt like it was going to burst out of my chest. My blood pressure went up to 170/95. I was at work (dental practice) so continued t monitor the  blood pressure. The symptoms slowly subsided but continued through the afternoon till 5pm. My blood pressure returned to normal the next morning.
Very sick; Flu like symptoms; fast heartbeat; aching whole body; Slight headache; Strange (no pain) swirling sensation 1/2 hr after shot; fatigue; Slight sore arm; fever; malaise; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number EP7534 and expiry date was not reported), via an unspecified route of administration, administered in Arm Right, on 21Mar2021 12:30 (at the age of 62-year-old), as dose 1, single, for COVID-19 immunisation. Patient was not pregnant at the time of vaccination. Medical history included obesity, BPPV, mild colitis, high BP, high lipids, prediabetes, congestion and COVID in Mar2020. Concomitant medications included bisoprolol (5 mg); atorvastatin (40mg); calcium (600mg); atorvastatin (LIPITOR [ATORVASTATIN]); paracetamol (TYLENOL) taken for nasal congestion.  The patient previously took codeine and experienced itching (sensitivity). Patient was not tested for Covid post vaccination. On 21Mar2021 13:00, the patient experienced strange (no pain) swirling sensation 1/2 hr after shot followed by fatigue. An hour later, the patient experienced flu like symptoms beginning with fast heartbeat and aching whole body, slight headache. The patient also experienced slight sore arm, body aches, fever, malaise and very sick. It was reported that, the patient felt like 50% of original covid 19 symptoms, but was very short lived, (only a few hours). No treatment received for the events.  The patient recovered from slight sore arm, body aches, fever and malaise after 2 days and the outcome for other events was recovering.  No follow-up attempts are possible. No further information is expected.