chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No PQC or additional AEs reported; vaccine administered after temperature excursion; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender.  The patient's concurrent conditions, medical history and concomitant medications were not reported.  On 07-JUL-2021, the patient was vaccinated with an improperly stored dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot # T039322, expiration date 09-SEP-2022) 0.5 mL, intramuscularly (IM) for prophylaxis. The vaccine was stored at a temperature of -1 degrees Celsius (C) for 3 hours and 3 minutes. No previous temperature excursions were reported, and a digital data logger was involved. The patient did not experience any adverse event (AE) with the vaccine. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T039322; expirationdate: 09-SEP-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Began with severe left groin pain and I couldn't lift leg. Pain then travelled down to left knee and around hip into left lower back. Pain in between left shoulder and elbow.  All of the pain is the same side as vaccine was given, Pain and disability have not subsided.  Physical therapy did not help.
Received Vaccine 1/20/21 1/21/2021 Morning: Nursing staff noted decreased O2 Saturation and put her on an oxygen mask 1/21/2021 Night: Patient found unresponsive, not breathing. DNR. Pronounced Expired
redness is quite large beyond the injection site; extremely painful; lump is large; This non-serious case was reported by a consumer and described the occurrence of erythema in a 76-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Concurrent medical conditions included hypothyroidism and allergy. Concomitant products included levothyroxine, liothyronine (Armour Thyroid).   On 18-SEP-2023, the patient received Arexvy. On 18-SEP-2023, less than a day after receiving Arexvy, the patient experienced erythema (Verbatim: redness is quite large beyond the injection site), pain (Verbatim: extremely painful) and mass (Verbatim: lump is large).The outcome of the erythema, pain and mass were not resolved.   It was unknown if the reporter considered the erythema, pain and mass to be related to Arexvy.     It was unknown if the company considered the erythema, pain and mass to be related to Arexvy.   Additional Information: GSK Receipt Date: 21-SEP-2023 This report was submitted via the online direct entry reporting system.  The reporter wanted to know what the ingredients were in Arexvy.  The information said that a person should not take the vaccine if they were allergic to any of the ingredients. Since they were not listed how would she knew that if she were allergic to it. The redness was quite large beyond the injection site.  It was extremely painful and the lump was large. The reporter also wanted to know how long this was going to last.  This was the third day.
patient has been busy and traveling a lot and inadvertently received flu shot fluzone high dose twice in one flu season. no adverse reactions reported by patient. first shot received 9/2/21 and second flu shot received 10/18/21
Dizziness, Headache, Had sore arm and "felt like hell, thought I was going to pass out" Very weak and fatigued. Had headache. Slept from 5:30pm on Tues till 14:30pm on 12/30. Fells fine on 12/31/20. Narrative:
This spontaneous report was received from a 18 year old female patient's mother. Patient had no pertinent medical history. Patient has possible sulfa antibiotic allergies. Sometime in August 2013, patient was vaccinated with GARDASIL dose 1 (intramuscular). On 25-NOV-2013 the patient received GARDASIL dose 2, intramuscularly. Concomitant therapy included ethinyl estradiol, ferrous fumarate, JUNEL FE. On 25-NOV-2013 after the patient received the second dose, she had trouble breathing. Reporter stated that the physician advised the patient to use ADVIL (unspecified dose/frequency and manufacturer), because he thought the patient was hyperventilating. The outcome of the event was not recovered. No lab diagnostics were performed. Patient sought medical attention by visiting office on 26-NOV-2013. No PQC involved. Additional information has been requested.
Have been having excruciating headaches since the morning after vaccines.   They will dullen with Tylenol but will not go away.  I have been sick to my stomach/nauseous since the morning after vaccines.   Being a woman in menopause, I have now started having a period again since the morning after the vaccine.
pt recv vax & 2wk later pt devel a fever & purpura;w/in 2-3mo pt recovered;it was reported that there were no urine changes or gastrointestinal involvement & the pt has had persistent arthralgia since then;
I am 35 and was 33 weeks pregnant at the time of my vaccination on Monday morning, 10/18/21. The night of Wednesday, 10/21/21, I woke up with severe stomach pain and eventually started vomiting. I proceeded to experience the pain and vomiting through the next day (10/22/21) and it was so severe, I couldn't even keep water down. The pain changed from my entire abdomen to just the right side sometime Thursday afternoon. I decided to go to the hospital to get checked out at their Labor and Delivery department. They gave me an IV for hydration because I was very dehydrated at this point and ran blood work. My white blood cell count came back high so they proceeded to do an MRI to check for appendicitis. They found early appendicitis on the MRI and decided to treat me with antibiotics instead of surgery until I get a little further along in pregnancy. While in the hospital, I developed a reaction to one of the antibiotics, which I have never had reactions to medications before, and I am still experiencing the pain from appendicitis as well as severe itching from the antibiotics.
I started coughing and it immediately went deep - hacking and wheezing and coughing up phlegm. Headache, other mucous symptoms including watery and swollen eyes. Heartrate was around 150 bpm. Went to Urgent Care center where they checked vitals. BP 147/83 HR 87. They suggested that symptoms were subsiding but could worsen. Prescribed an epi-pen and sent me home with instructions to use it and call 911 if symptoms worsened.
Headache & Tachycardia Narrative: treated with OTC ibuprofen
Patient felt dizzy 10 minutes post vaccination and temporarily fainted.  Pt shows sign of enlarged pupil, pale, and blue-ish lips.  EMSA treated patient. Patient declined to go to the hospital for further treatment.
16 year old female came to the triage to utilize the cot to lay down to get vaccinated. Patient had no chief complaint at the time of arrival to the triage area. Patient lay down to get the vaccine due prior history of seizure after vaccine in 2018. Patient vaccinated at 4:50pm, at 5:12 pm patient wanted to stand up to see how she feels, prior to standing patient denies reporting any complaint. at 05:12 Per EMS, as soon as she stood up she went into Tonic-clonic seizure that last for one minute. Patient Stumped into EMS COT. Blood sugar 130.  Bp at 17:10 136/96 Pulse 78, RR 24, )2 sat 100, PERLA, Normal sinus Rhythm. BP at 17:30 136/88  pulse 76 RR 20, O2sat at 100 %, PERLA, Normal sinus Rhythm. Patient has history of asthma, seizure after shot, NKDA. patient was postictal after seizure.no sob or any acute distress. This Nurse Practitioner was radio at 05:14 pm, i arrived at 05:17pm, Patient mental status was assessed, patient was awake and alert x 4, patient report history of seizure after shot and Asthma. Patient did not appear to be in any acute distress. Patient mother was present at bedside. Patient and patient mother was informed that patient will be transported to the hospital to be further evaluated, patient mother agree to the plan of care.
Petechial rash started 7 days after flu shot.  Dx with ITP.  12/17/2008 MR received for DOS 11/17-18/2008 with DX:  ITP. Pt presented several day hx of rash and bleeding lesions.  Petechial rash and bruising noted on lower extremities, small sclera bleed, and lip bleeding on PE.  Treated with WinRho and developed vomiting H/A and chills which resolved.  D/C to f/u as outpt.
Patient fainted in aisle. He hit his forehead on wall when he fainted.  Was very pale laying in the aisle in store.  pharmacist went to help wake him and make sure he was okay and breathing. We called 911 and watched him to make sure he was okay. He came to and was able to talk and sit up. He got up and sat in chair in waiting room while waiting for EMT's to arrive. He was able to talk with them and explain what happened. He was able to walk around and did not need gurney. They offered to bring him to ER just in case but he declined - no insurance and did not feel it was needed.
Client was in for update of immunizations. Clerk checked 11-14-07 GRITS and failed to see that client had received MCV4 and Tdap 1-9-07. When the billing clerk was inputting data into the computer and checking to be sure data had transferred to GRITS she found that these immunizations were replicated.
Patient received dose 1 of the pediatric Pfizer COVID vaccine (lot FK5127) at approximately 1710. At 1713, the patient lost consciousness, slumped forward and fell on the ground, hitting her head. PHN and RN responded, assisting the patient supine. The patient was alert and oriented to person, place, and event. At 1715, vital signs: blood pressure 154/88, pulse 124, O2 98%, respirations 20. Patient reported she had felt lightheaded and had a headache before she fell. The patient's father reported that she had no medical conditions, took no medications, and had no allergies. The patient reported she ate prior to arrival. The father reported the patient had no prior history of syncope. RN provided ice pack for head, PHN noted no visible deformity, blood, or skin tear. PHN assessed neurologic function: pupils even and reactive to light accommodation, hand grip strength equal and strong bilaterally, foot strength equal and strong bilaterally. PHN offered to call EMS but patient's father declined. PHN offered Benadryl but patient's father declined. PHN educated on remaining for 30min monitoring from time of syncope, to follow up with provider, and when to call 911 for allergic reaction or concussion symptoms. At 1725, vital signs: blood pressure 146/82, pulse 104, O2 99%, respirations 16. Patient reported all symptoms had resolved but she felt anxious and her extremities are were Patient reported fear of needles. At 1730, patient sat up slowly, continuing to report no symptoms besides anxiety and cold extremities. At 1735, vital signs: blood pressure 142/82, pulse 96, O2 97%, respirations 16. Patient stood up, monitored closely by PHN and RN, and continued to report no symptoms besides anxiety. Patient was tearful. PHN completed concussion protocol and handed to father of patient after explaining. At 1744, vital signs: blood pressure 142/82, O2 100%, pulse 87, respirations 18. Patient reported she still felt anxious after the syncope. At 1745, patient left walking with steady gait, accompanied by father who would drive her home.
Case number PHEH2015US015227 is an initial spontaneous report from a nurse received on 03 Aug 2015. This report refers of unspecified age and gender. Medical history and concomitant medications were not reported. The patient was vaccinated with BEXSERO, (batch number: unknown) on an unknown date. On an unknown date after the vaccination the patient had vomiting, pain and headache. The outcome, seriousness and causality assessment of the events was unknown.
Onset of low-grade fever (100.2 orally) that night, then thigh pain the next day, then rash and swelling the day after that. I examined him 8/12/09 and noted a 6 cm round area of erythema, induration, and edema over the site of IPV vaccination, but nothing around the DTaP, MMR, and Varivax sites.
eyes swollen shut, hives head to toe (even on palms of hands) - still currently having this reaction
SEVERE LEFT UNDER ARM/ARMPIT PAIN UNABLE TO LIFT ARM, SWOLLEN ARMPIT SEVERE LEFT GROIN SWOLLEN PAIN BRUISES ON BREASTS APPEARED AFTER BOOSTER SHOT
Got the shot and still got/suspected vaccination failure; got in leg, terrible; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Got the shot and still got/suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: got in leg, terrible). The outcome of the vaccination failure and shingles were unknown.   It was not reported if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was not reported if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: The case  was received from the patient via interactive digital media. The patient got the Shingles shot and still got shingles in one leg and it was terrible. The follow-up could not be possible as no contact details were available.
INJECTION SITE RED 1 INCH DIAMETER, NEXT DAY RED, SWOLLEN HARD TENNIS BALL SIZE. RESOLVED IN ABOUT 5 DAYSSIZE Narrative:
Arm began to ache, and then I began to ache all over, around 5-5:30 I began to get chills and felt very cold. I didn't take my temp. but my skin was very hot. My heart felt like it was racing, and this continued most of the night. The next day I didn't feel well at all, with no appetite. I was very weak, and still am. I have many flu shots before, and never had a reaction.
Pt. states that after receiving the 1st dose of Phizer 08/26/2021, started experiencing symptoms 09/02/2021 of headaches, fatigue, and weakness. Neurologist appt. scheduled 11/12/2021. Still continuing to experience symptoms.
COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report from a contactable consumer (patient). This male patient of unspecified age received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unknown date, for COVID-19 immunisation. Relevant medical history and concomitant medications were not reported. On an unspecified date, the patient tested positive for COVID19 after getting the first shot and wanted to know if doctor will proceed with his second dose. Event outcome was unknown. Information on the lot/batch number has been requested.
The patient called with a 102 degree fever at 1:30pm and was really weak. I checked back with her at 3pm and she had vomited 3 times. I checked back at 5:30pm and the nausea had stopped and fever had gone back down to 100 degrees. I followed up with her today and she still has a fever 101 degrees, has now developed a soar throat.
Myalgia, Fever, PAIN AT THE INSERTION SITE. MISS WORK D/T TO SX. Narrative:
itchy; Leg and hip pain; Rash with blisters; Leg and hip pain; This spontaneous case was reported by a consumer and describes the occurrence of RASH VESICULAR (Rash with blisters), PAIN IN EXTREMITY (Leg and hip pain), PRURITUS (itchy) and ARTHRALGIA (Leg and hip pain) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 010M20A) for COVID-19 vaccination.     Concurrent medical conditions included Rheumatoid arthritis. Concomitant products included METHOTREXATE SODIUM (METHOTREXATE INJECTION BP), ESCITALOPRAM OXALATE (LEXAPRO), SIMVASTATIN, MONTELUKAST SODIUM (SINGULAIR), VITAMIN C [ASCORBIC ACID], MAGNESIUM CITRATE, VITAMIN D3, FOLIC ACID and BIOTIN for an unknown indication.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Mar-2021, the patient experienced RASH VESICULAR (Rash with blisters), PAIN IN EXTREMITY (Leg and hip pain) and ARTHRALGIA (Leg and hip pain). On an unknown date, the patient experienced PRURITUS (itchy). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency; TRIAMCINOLONE ACETONIDE at an unspecified dose and frequency and GRAMICIDIN, NEOMYCIN SULFATE, POLYMYXIN B SULFATE (NEOSPORINE) at an unspecified dose and frequency. At the time of the report, RASH VESICULAR (Rash with blisters), PAIN IN EXTREMITY (Leg and hip pain), PRURITUS (itchy) and ARTHRALGIA (Leg and hip pain) had not resolved.            The action taken with mRNA-1273 in response to the event was not applicable.
Information has been received from a nurse practitioner concerning a 72 year old female homemaker with no history of HSV I or II and allergy to aspirin, osteoporosis, irritable bowel syndrome and gastrooesophageal reflux disease who on 01-FEB-2008 at 15:30, was vaccinated with a dose of ZOSTAVAX (Oka/Merck) (lot # 658210/1079U) 0.5 mL, subcutaneously into her left upper arm.  Concomitant therapy included ACTONEL, HYOSCYAMINE and OMEPRAZOLE (MSD).  The nurse reported that within 48 hours of vaccine, on 03-FEB-2008, the patient described a few small blister like lesions on her left arm at the injection site and had 4x4 inch patches of these blisters on each buttocks.  The nurse reported that the patient described as burning and tingling, then scab over and go away.  Had had frequently since injection.  The patient had 3 noted on right buttock.  The nurse stated that there were "3 blister like herpetic like lesions" at visit on 12-FEB-2009.  At time of reporting, the patient had not recovered.  There were no lab and diagnostic tests.  There was no illness at time of vaccination.  Additional information has been requested.
muscle spasms in different parts of my body all over.Every day since the 16th of february 2022 they come and go everyday
anaphylaxis - throat tightness, hoarseness, coughing, trouble swallowing, nausea, dizziness, pallor, watery eyes, urinary incontinence, sense of impending doom
Big red circular below the injection mark; It was like 3 inches in diameter; I was very dizzy I couldn't even get out of bed; I had been feeling nauseous and I was throwing up; I had been feeling nauseous and I was throwing up; My eyeballs hurt and I had joint pain; My eyeballs hurt and I had joint pain; I had a stomach ache; This is a spontaneous report from a contactable consumer. A 71-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number: EN6206; Expiration Date: 30Jun2021, NDC number, UPC number was not reported), via an unspecified route of administration, administered in Arm Left on 09Mar2021(Age at vaccination 71-years-old) as dose 2, 0.3 ml single for covid-19 immunisation. Medical history included ongoing cholesterol, ongoing cancer, ongoing restless legs,  ongoing for the back area (back disorder), ongoing for sleeping. Concomitant medication included lovastatin taken for cholesterol gabapentin taken for back disorder, exemestane taken for neoplasm malignant, start; trazodone taken for sleep disorder, ropinirole taken for restless legs syndrome. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number, Expiry date was not reported), via an unspecified route of administration, administered on an unspecified date as dose 1, single for covid-19 immunisation. Consumer stated, I would just like to go over the Pfizer vaccine second shot that I had on Tuesday at. I did received a side effect yesterday which was concerning which was a big red circular below the injection mark on 13Mar2021. It was like 3 inches in diameter and I still have it today and I woke up yesterday where I was very dizzy on 13Mar2021, I couldn't even get out of bed, I woke up very dizzy and I still don't know what it was. I couldn't get out of bed for couple of hours and then I realized when I went into the shower that this is what got on my arm yesterday that it came out about and I had been feeling nauseous on 13Mar2021 and I was throwing up everything else that I had like. My eyeballs hurt and I had joint pain both on 13Mar2021 and I had a stomach-ache for like 3 days on 09Mar2021. So, I just want to go over the side effects. Consumer stated Yes, 3 days but the rash didn't start until yesterday. Product details Consumer stated, I don't see it. Consumer stated, for the nauseous and everything else I was taking a Tylenol for the joint pain trying to get rid of that. It was just like a stomach-ache and finally I did throw up couple of times, but I was trying to get rid of the joint pain so was taking Tylenol. Consumer further stated no, is this redness going to go away, is this common, because I was trying to look on the internet because I saw on the listed under the list and was trying to find out. Therapeutic measures were taken for event nauseous, Joint pain. The outcome of events was not recovered.   No follow-up attempts are possible. No further information is expected.
Patient left waiting area and was waiting outdoor in the sun.  She felt dizzy, nausea, light headed.  We brought the patient inside in the AC room and did her vitals.  Vitals were BP 98/53 and pulse of 51 and repeated again BP 101/54 Pulse 56.  Patient stated she is a active runner as well.  We had patient wait for 45 mins.  Provided her with a snack and water as well.  Vitals were BP 99/59 Pulse 76.   Patient was not longer dizzy and felt good enough to drive home.  Did not want us to call family to pick her up initially, but ended up calling parents for a ride home.  Pharmacist followed up with patient around 4pm and she said she was doing ok with nothing new to report.
ALLERGIC REACTION COUGH NAUSEA HIVES ANAPHYLAXIS CHEST PAIN J18.9 - Pneumonia, unspecified organism
Patient c/o mild  throat tightness within 20 minutes of getting vaccine. She also c/o itchy ears which resolved in 30 minutes.