chrisvoncsefalvay/vaers-outcomes huggingface dataset:
PATIENT BEGAN WITH FEELING HOT AND A HEADACHE. PATIENT WAS GIVEN A COOL RAG TO PLACE ON HIS HEAD AND NECK. PATIENT THEN CONTINUED TO HAVE SHORTNESS OF BREATH DESCRIBED AS A KNOT IN HIS CHEST. HE WAS GIVEN 10ML OF BENADRYL, THEN VOMITED A FEW MINUTES LATER. BENADRYL AND COLD WATER WAS ADMINISTERED AGAIN. THEN HE STARTED FEELING TINGLY IN HIS RIGHT ARM. THEN TIGHTNESS IN HIS ENTIRE CHEST. THIS LASTED OVER AN HOURS TIME FRAME. BEGAN AT 8 MINUTES AFTER ADMINISTRATION.
This spontaneous report was received from a register nurse referring to multiple unspecified patients of unknown genders and ages. The patient's medical history and concurrent conditions were not provided. On an unknown date in November 2015, the patients were vaccinated with an improperly stored doses of VAQTA, lot L002717, expiration date 02-JUN-2017 and Lot # K018181, expiration date 04-JUN-2017, (route, anatomical place and dose number were not provided). Concomitant therapies were not provided. At the time of the report, no adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Fatigue; fever; This is a spontaneous report from a contactable other healthcare professional, the patient. A 37-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on an unknown date in Apr2021 at 15:00 (at the age of 37-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient had no allergic to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 09Apr2021, the patient underwent nasal swab test and the result was negative. On 02Apr2021 at 16:00, the patient experienced fatigue and fever of 101F. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events fatigue and fever was resolved in Apr2021.  No follow-up attempts are needed. No further information is expected.
itchy and red spots; lip swelled up and it felt numb; This is a spontaneous report from a contactable Consumer (patient). An 81-year-old female patient received second dose of bnt162b2 (BNT162B2, Solution for injection, Lot number: EM9809), via an unspecified route of administration on 17Feb2021 (age at the vaccination 81-year-old) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medication were not reported. Historical vaccine included first dose of BNT162B2 Lot number: EL1283 on 27Jan2021 as DOSE 1, SINGLE for covid-19 immunisation. Patient and her husband and their got first COVID 19 shot 27Jan2021. Then, three weeks later they got their 2nd vaccine on 17Feb2021, Then, the 22Feb2021, she developed a side effect. The first shots were fine. The second shot they thought was fine. Then, Sunday evening, 22Feb2021, she developed itching and red spots. It was not very comfortable. The small spots were here and there. They were not all over her body. Then patient top right lip swelled up and felt numb on 22Feb2021. It was not painful. It was like waiting for Novocain to go away. By the morning it was way down, and then by afternoon, it was all gone. It has not returned. It felt like she had been to the dentist. At first, she thought it was just hives or something. She put some cortisone cream on it, and she was able to sleep a lot better. Therapeutic measures were taken as a result of both events. The outcome of the event lip swelling was recovered on 22Feb2021 and Itchy was recovering.  Follow-up (14May2021): Follow-up attempts are completed. No further information is expected.
Fever, chills, head aches, extreme fatigue, sore muscles, neck pain, diarrhea, sweating, dehydration.  Injection site swollen, red, hot, sore.  Hives on legs, itchy.   Came to clinic on 04-23-2010.  Given Tylenol. Returned to clinic on 04-24-2010.  Headaches remains, stiff neck, rash (hives), slight fever, Injection site remains swollen, red, hot, painful.  Ice to injection site, ibuprofen, Zyrtec.
Abdominal cramping and pain; This case was reported by a consumer via interactive digital media and described the occurrence of abdominal cramp in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of abdominal pain (1st dose received on an unknown date, refer case US2022AMR019699).   On 1st February 2022, the patient received the 2nd dose of Shingrix. In February 2022, less than a day after receiving Shingrix, the patient experienced abdominal cramp. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the abdominal cramp was unknown.   It was unknown if the reporter considered the abdominal cramp to be related to Shingrix.  Linked case(s) involving the same patient: US2022AMR019699  Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not reported. The patient received his/her second dose of Shingrix a day before reporting. The side effects this time seem to be more severe than the first vaccine.  The abdominal cramping and pain was the most notable side effect. The follow up would not possible as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR019699:same report, 1st dose
High fever of 103.0 and headache. Took Tylenol.  Fever seems to be gone, but headache is still present on day 2 after injection.
Apparently received H1N1 vaccine at school or just before school. 2 hr. later developed multiple sz at school, which continued in ER and on floor overnight requiring aggressive acute sz management, and which then gradually subsided within 24-36 hours of immunization.  11/24/09 ER records received for date 11/19/09.  DX: seizures Pt. presented w/ ER visit due to continuous seizures post 2hrs vax. Pt arrived in ER lethargic, sleepy later resolved. Assessment: pt. has now had 2 occurrences of seizure activity post flu vax admin. Upon preparing for dc, pt had another seizure episode, eyes gazing upward, lip smacking, shaking in arms. Pt admitted and observed overnight. I spoke with Chelsea's mother who said she and school nurse have already spoken to someone from VARES who has obtained necessary infromation. Rest of form previously completed.
3 days with rash all over body and 2 days with fever 101.5 F.
10/20/11 - Left upper arm started itching & was red. Area sore & painful to touch. Pt has not taken or applied any medication or lotion. (L) upper arm is warm, red (9cm x 7cm) area & tender.
Doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses were given after expiration date) in a 19-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses were given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses were given after expiration date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  Date the vial was initially stored in the refrigerator was 04-Oct-2021. There was no temperature excursion. The reporter reported that that there was a confusion between the expiration date printed in the carton and the expiration date when the QR code was scanned.  The patient did not experience any adverse event.  No treatment information was provided by the reporter.
Within one minute of receiving the vaccine, I started having tightness in my chest. I took two benedryl and alerted one of the volunteers who directed me to the nurse's station. After about 15 minutes and my husband getting out of the car to go get the person staffing the nurse's station, the EMTs were called over. At this point, I was having trouble swallowing but my vitals were ok so they told me to sit and wait. About five minutes later, my tongue had swollen enough that I was having trouble swallowing my saliva. My husband called the EMTs back over and they gave me a shot of epinephrine. I declined the ambulance but did go directly to the nearest urgent care/ER where I was very quickly hooked up to an IV and given a dose of Pepcid intravenously.  About 2 hours later I started having trouble breathing again and was given a dose of Benedryl through the IV and a breathing treatment.  I was 'ok' but not feeling like the tightness in my chest and throat were all gone 2 hours after that, so I was given a does of steroids through the IV and released with directions to take zyrtec and ranitidine 2x a day for a few days.
After administration of vaccine, we were notified by local Authority that the vaccine had experienced a temperature monitoring event outside of our facility.  Patient was notified of CDC guidelines that recommend revaccination.  Patient returned on 10/21/2022 for revaccination.
severe swelling and pain in arms high fever nausea headache grand mal seizure loss of consciussness head injury with broken nose hearing and vision problems dizziness mental confusion muscle weakness lethargy
Pt recvd vax & 2 wks later exp itchy rash, diffuse macular rash & fatigue; treated w/steroids & anti-pruritc (atrax); lab test were pos for EBV; pos EBV was felt to be assoc w/poss prior mononucleosis type inflammation;
Information has been received from a registered nurse concerning a 74 year old female patient with a penicillin allergy and a history of a negative titer who in 1995 was vaccinated with a 2 dose series of hepatitis A virus vaccine inactivated (lot # not reported).  There were no concomitant medications.  On 01/22/2003 the patient had a titer that was negative.  Unspecified medical attention was sought.  Additional information has been requested.
Did not feel good into sunday; Nauseous; Headache; Body ache; Woke up Saturday feeling sick; The patient did not sleep all night, It was like drank 20 cups of coffee, It was like brain was racing; This spontaneous case was reported by a non-health professional and describes the occurrence of INSOMNIA (The patient did not sleep all night, It was like drank 20 cups of coffee, It was like brain was racing), MALAISE (Woke up Saturday feeling sick), FEELING ABNORMAL (Did not feel good into sunday), NAUSEA (Nauseous) and HEADACHE (Headache) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 052C21A and 051C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 10-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INSOMNIA (The patient did not sleep all night, It was like drank 20 cups of coffee, It was like brain was racing). On 07-Aug-2021, the patient experienced MALAISE (Woke up Saturday feeling sick), NAUSEA (Nauseous), HEADACHE (Headache) and MYALGIA (Body ache). On 08-Aug-2021, the patient experienced FEELING ABNORMAL (Did not feel good into sunday). At the time of the report, INSOMNIA (The patient did not sleep all night, It was like drank 20 cups of coffee, It was like brain was racing), MALAISE (Woke up Saturday feeling sick), FEELING ABNORMAL (Did not feel good into sunday), NAUSEA (Nauseous), HEADACHE (Headache) and MYALGIA (Body ache) outcome was unknown.            No concomitant product use was provided by the reporter. No treatment medication was provided.   This case was linked to MOD-2021-405040 (Patient Link).
8 hours after my vaccine I started getting the chills. Chills persisted and then had nausea and vomiting for a couple of hours. Nausea and vomiting resolved by noon the day after my vaccine and then symptoms subsided for a couple of hours. Then had fatigue and chills for a couple of hours. Fatigue the next day. Symptoms resolved by 48 hours after vaccine.
The area around the patient's left arm where the vaccine was administered became swollen, red and warm to the touch.
high blood pressure peaking 5/1-5/3  with mini panic attacks resulting in blood pressure as high as 180/120  an hour or more;  during the 3 days my blood pressure typically was 150s-160s/100s-110s  (my normal blood pressure before the vaccine was 120s-130s/80s-90s) later I experienced a feeling of wanting to throw up (5/5-5/6)
Headache, shivering, muscle aches, fever, fatigue, diarrhea. These side effects were severe and lasted about 36 hours.
Child was only 11 when receiving the COVID19 vaccine. Under the current EUA it is only authorized for patients 12 and older. Child also received second dose. I spoke with mom and she has no concerns for child at this time.
Recurrence of an erythematous induration on right arm under the vaccine site on 01/25/21.  Right arm feels heavy, indurated site feels warm to touch, itchy, and is tender to palpation.  Also with sneezing and body malaise 01/25/21, now resolved.  Induration first occurred on the same site 1-2 days after receiving the vaccine, resolved on the 4th-5th day post vaccination.  Tx - Acetaminophen 500 mg 2 tabs po prn; Zyrtec 10 mg po prn
58 y/o man with severe obesity with BMI of 50, OSA on CPAP, history of T2DM ( a1c of 9.7 as of 12/29/21), diabetic CKD3 (baseline creatinine 1.3-1.6) , AFib (single episode, not on AC), who presents with fatigue, shortness of breath and diarrhea was found to have covid pneumonia with hypoxemic respiratory failure. His symptoms started on 1/3 or 1/4.  Lives at home with his mother, who has no symptoms. Completed 2nd Pfizer vaccine in May. No known sick contacts but regularly visits a local Bingo hall.    Hospital course:    COVID-19 Disease with acute hypoxemic respiratory failure: Pt s/p 2 Pfizer vaccine in May 2021. Symptoms started 1/3/22. COVID + 1/5/22. Hypoxic to high 80s with ambulation/exertion. Mild lung involvement on CXR and mildly elevated inflammatory markers. Risks for severe disease include obesity, poorly controlled DM2. He has completed 5 days of remdesivir on 1/10. He is on D5 of decadron, will prescribe on discharge to complete a 10 day course. Albuterol MDI PRN. Isolation 20 days from start of symptoms per ID, until 1/25. He requires 1L NC on ambulation to keep O2 sat above 88%. Referral sent to oxygen clinic.    Poorly controlled T2DM: A1c >9% recently. On insulin 70/30 at 62 units BID. Gabapentin for peripheral neuropathy. He required NPH 30-35 units here on steroids. Discharged on lower doses of insulin. Close follow up.    History of hypertension/HLP: on PTA lisinopril 20 mg daily, lasix 20 mg daily and Atorvastatin 40 mg daily. He was hypertensive so increased lisinopril to 20 mg bid. Please monitor blood pressure.    Diabetic CKD 3 ( creatinine 1.3-1.6): creatinine at baseline   Chronic papular/scaly rash neck/back: photos (HC) appear to be psoriasis per Dr. She review the photos and feels most likely psoriasis and chronic. Most likely does not need treatment but since patient has itchiness she recommended triamcinolone 0.1% bid for 2 weeks then bid only Sat/Sun chronically. I talked to patient, he wants the prescription.    Primary Procedures:  none   Secondary Procedures: None   Reason for Hospital Admission (Admitting Diagnosis):  Covid pneumonia and hypoxemic respiratory failure
Case number PHEH2012US007047 is an initial spontaneous report received from a consumer who was a nurse on 27 Mar 2012 with the follow-up received on 21 May 2012. This report refers to 84-months-old male patient whose medical history, past drugs, current conditions and concomitant medications was unspecified. He was vaccinated with MENVEO (batch number: M10135B) at dose of 0.5 ml, intramuscularly on to unspecified site on 23 Mar 2012. Within 24-hours after vaccination, on 24 Mar 2012, he experienced soreness, swelling and redness at the injection site. He was administered antibiotics and the swelling and pain have resided. The outcome was reported as condition improving for swelling and pain and for redness reported as completely recovered. No other information was provided. Follow-up received on 21 May 2012: Updated patient age (84-months), date of vaccination (23 Mar 2012), date of onset (24 Mar 2012), (dose (0.5 ml) and outcome (completely recovered for redness).
Real tired, hands hurt, fingers hurt, thighs hurt and comes and goes and been going on about a year.
Pt presented 2 days following Zostavax administration with pruritic, purpuric rash, rash extended after tx with Benadryl. 9/10/06 placed on Prednisone at which time rash resolved. Extension was generalized to body. CBC 6/11/06, Platelets 236, HCT 34.4. HBG 11.8.
The day I got the vaccine my arm was really sore. The next day I was exhausted and slightly disoriented and had a headache and just feeling like crap. My arm hurt for 3 weeks. After that, I can't seem to return to my normal level of energy. I would say it is at 85% prior to what it was before the booster. On Feb 26th, I was feeling crummy and I thought it was just because of work, but then I started to get stuffy, then at night I started coughing. Luckily, I didn't work for the next few days so I stayed in bed, and I had no motivation to move. It was hard to move and I had an upset stomach and a headache. On Tuesday morning I was so weak I couldn't get up to do anything, and I got up to give my granddaughter breakfast and I gave her a donut and I needed to lay down. I slept for the rest of the day, I could not function at all. The next day I felt a bit better but I stayed in bed, my stomach and my head still hurt. And then I started having mild chest pain. On Thursday, I was feeling better. I was still tired but not weak and I had a mild headache. I got up and went out. I went to get breakfast, and I was sitting at the restaurant that I got severe chest pains that sent me to the ER. No heart attack but I tested positive for COVID. I was sent home and I stayed in bed and stayed resting. I still have stomach cramping and still have headaches. And now this past Friday I had chest pain again and my legs feel week.
I experienced shivers, fever, headache, vomiting the first day, second and third day shivers and fever, headache.
Injection site erythema; injection site induration; injection site warmth. Information has been rec'd from a RN concerning a pt with allergies to nitrofurantolin and with migraines who on 4/27/00 was vaccinated at 13:00 with pneumococcal vaccine 23 polyvalent (lot 630096/0044J) IM in the L deltoid. Concomitant vaccines included tetanus toxoid vaccine (lot 467-047) administered IM in the L deltoid. Subsequently the pt experienced injection site redness, warmth and a knot. A visit to a phys was required. Subsequently, the pt recovered. Other pt's had a similar reactions following vaccination with pneumococcal vaccine 23 polyvalent (WAES00061196 and 00111855). No further information is available. The pneumococcal vaccine 23 polyvalent infection site was changed from IM left deltoid to SC right deltoid. The time of vaccination was changed from 13:00 to 13:30 and venue of vaccination was added. The county in which the vaccinee was administered was added. The narrative was edited.
stomach/gut cramps, similar to menstrual cycle. Bloated gut. Syntoms persisted after defecation.
Orange vial pulled up 0.2 mL for dose without dilution. Usually a pharmacist pulls up and we were short staffed with Pharmacy Director unavailable at the time of vaccine preparation. Pediatric nurse observed vaccine preparation by pharmacy technician.
palpitations 24 hours after injection lasting several hours. Today is day 3 days since injection. This morning I noticed paresthesia of lips and face and tingling of lips and tongue. Beginning at 9 am and has continued through afternoon
Patient comes in today concerned about a lump she found in her left axilla. She first noticed her left axilla was swollen and tender yesterday. She has gotten cysts and acne in armpit area before, but this feels different and nothing is seen externally like it normally would be with a cyst. Hasn't noticed any other lumps anywhere else. Got vaccine in left arm one week ago on 06/21.   Left axilla appeared mildly swollen/bulging over bra compared to right axilla. Some scarring from previous acne and cysts was noted in the left axilla, but no active lesions were seen. Two lymph nodes were enlarged and palpable. One was 1/2 cm in diameter, tender, and mobile. The second was just superior to it along the axillary chain and was ~3 mm in diameter, mobile, and tender.   Right axillary was unremarkable. No lymphadenopathy was noted in the right axilla or any of the lymph node chains on the right side of the neck.
Pt had headache and aches in jaw and cheek but only on right side of head. She started taking TYLENOL with codeine 300/30 that she had from her arthritic pain rx. She also started using heating pad. As of this report, pain starting to subside per phone call 5:45 pm 10/6/17.
Swelling in lymph nodes on left side of body. Armpit area. Painful.
Hospitalized (1.8.22); COVID-19 positive (1.8.22); fully vaccinated. Admission Date: 1/8/2022, Discharge Date: 01/12/2022. DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Lactic acidosis [E87.2], Hypomagnesemia [E83.42], Acute cystitis without hematuria [N30.00], COVID-19 [U07.1], Emphysematous cystitis [N30.80], Cystitis [N30.90]. HOSPITAL COURSE: Patient is a 56 year old female with recent admission for emphysematous cystitis, HTN, asthma, GERD and IBS who presented to the ED with lower abdominal pain radiating to her back on 1/6-1/7. Patient also c/o nausea, vomiting, urinary frequency, and dysuria. Patient was recently admitted 11/21/21-11/24/21 with similar symptoms and found to have emphysematous cystitis. She had a cystoscopy to r/o enterovesical fistula (ruled out) during that admission. Patient was given antibiotics while inpatient and sent home with 14 days of amoxicillin. Patient completed the 2 week course and developed recurrent symptoms. Patient was found to be COVID positive in the ED. She had been vaccinated, but had not received a booster. Patient continued to improve, unclear exact etiology of patient's emphysematous cholecystitis. Urology was contacted in ED and recommended treatment with Cipro for 4 weeks. Infectious Disease was consulted and it was unclear if she indeed relapsed however was possible, despite improved CT, and her symptoms suggested probable urinary tract infection. Previous urine culture grew E coli and it was possible she could have anaerobes that contribute infection that were not well covered by amoxicillin. Infectious Disease recommended changing antibiotics to Augmentin as this would cover previous identified the coli and provide anaerobic coverage. It was noted emphysematous cystitis is typically treated with 10-14 day course of antibiotics and does not require prolonged course as there was no evidence of upper tract/renal involvement. She clinically improved and was discharged on Augmentin to complete 14 day course.