chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Per pt. 2-3 days after receiving H1N1 vaccine (IM) 0.5 ml, she noticed changes in balance, lock of hip mobility (Lt>Rt), and exacerbation of multiple sclerosis. Pt received H1N1 on 10/20/09. Also reports flu sxs a couple of days after H1N1 inj.  11/19/09:  PCP record received for date of service 11/9/09. Assessment:  Pt. reports change in balance, lack of hip mobility and exacerbation of MS Symptoms as well as being sick with flu symptoms a couple of days after receiving the H1N1 vaccine.  11/24/09:  ED Record received for date of service 11/20/09.  Dx:  MS Flare. Assessment: Presents to ED with pain level of 10/10, ambulated via wheelchair,  needed 2 people to assist into gown, sick with HA and weakness.  Pt. incontinent of urine. Medicated Solumedrol, IV fluids, discharged with Medrol Dosepack.
12/3/07 Redness of upper arm, just above elbow, not at site of injection.  Some areas of excoriation.  12/4/07 Recheck Rt upper extremity, redness decreased, ecchymotic areas, bruising at injection site.  Dx. 682.3.  Rx Cipro 500 BID #14.
This spontaneous report was received from a consumer (patient's mother) regarding her 16 year old daughter. The patient's medical history included sensitive stomach. The patient had no drug reactions or allergies. Concurrent conditions were not reported. On 31-DEC-2015, the patient was vaccinated with first dose of GARDASIL 9 (lot # L025737, expiry date 28-JUL-2017) in the left deltoid, dosage regimen unknown. Concomitant therapies included cetirizine hydrochloride. On an unknown date in 2016, after patient received vaccine she began to feel unwell. On an unknown date in January 2016, 3 weeks after vaccination, the patient began to feel run down and felt like she was outside of her body. The patient was walking from the kitchen to the living room and she dropped to her knees with pain near her diaphragm. On an unspecified date in 2016, the patient was taken to the Emergency Room where a computerized tomogram (CT) scan was performed. The CT scan showed ovarian cysts on the left side. The patient was experiencing excruciating pain on her right side. The CT test also showed the patient's appendix was not enlarged. She was discharged from the Emergency Room but the pain did not diminish. The patient went back to the Emergency Room and the doctor told her that she would need to see a gastroenterologist. After a third trip to the emergency room, the patient was referred to a specialist. All the tests which patient had undergone, came back normal but it was reported that the patient was still in a lot of pain. A colonoscopy, ultrasound, biopsy and endoscopy have been performed on the patient on unspecified dates in 2016 and for unspecified reasons. The results showed the patient did not have an autoimmune disease and confirmed that it was an allergen. It was reported that the pain was located in the patient's pancreas and she was currently unable to eat due to the pain (unspecified if she is physically unable to eat or if she finds food unappealing at this time). Furthermore, the has been home schooled since early February 2016 and her walking was limited. It was also reported that the patient was not able to sit in chairs because of the pain she is experiencing (Activities of daily living impaired). It was reported that the treatment was given for the events and the treatment medication included NAUZENE. It was reported that the therapy with GARDASIL 9 was discontinued. The outcome of events were reported to be not recovered. The causality assessment for the events were unknown. The event home schooled, walking was limited and not able to sit in chairs was considered to be serious as disabling. Additional information has been requested.
Ear was hurting; Throat was hurting; Had a cough; Had swollen glands; This spontaneous case was reported by a consumer and describes the occurrence of EAR PAIN, OROPHARYNGEAL PAIN, COUGH, and LYMPHADENOPATHY in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EAR PAIN, OROPHARYNGEAL PAIN, COUGH, and LYMPHADENOPATHY. The patient was treated with AZITHROMYCIN at an unspecified dose and frequency. At the time of the report, EAR PAIN, OROPHARYNGEAL PAIN, COUGH, and LYMPHADENOPATHY outcome was unknown. Not Provided.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  Patient swab test results for COVID was pending.   Most recent FOLLOW-UP information incorporated above includes  On 08-Jul-2021: Follow-up information received contains no new significant information.
At 0430, woke up with full body shivering and severe headache. Covered with heavy blanket and shivering resolved.  At 1149, checked temporal temperature and found to be 101.2F. Removed heavy blanket and treated with 200mg ibuprofen. Temperature dropped to approx. 99F for several hours.  Around 2200, temperature returned to approx. 101F. Treated again with 200mg ibuprofen.  By the following morning, fever had resolved and temperature returned to approx. 98F.
patient stated that her arm was sore monday morning, but by monday evening the area about 2 inches below the injection site was warm to the touch and started swelling.  She state she had a fever which started late that evening.  The area continued to be red and warm to touch. She called and spoke to the other pharmacist this morning and he suggested she have her doctor to look at the area since she had an already scheduled appt today with said physician.  Dr prescribed an antibiotic for the patient and stated he felt like it was cellulitis in the arm nut did not think it was due to the injection since it was lower than where the injection site was.
On wk. post administration of FLUVIRIN in (L) arm (10/16/09) client experienced discomfort (R scapular area. A few days later - stiffness (R) neck. Today experiencing discomfort on collar bones - notices when reaching forward. No fever, no HA; no cough, lungs sound clear. T. 97, BP 136/88 APHR 72, reg.
Hib vaccine given instead of Meningococcal. Pt will have to come in to get another meningococcal vaccine. no s/s of adverse event
Shot administered at 3 pm 2/25. Woke up at 4:30 am 2/26 with fever chills nausea and muscle pain.  I was initially diagnosed with Covid 12/12/2020.  The reaction was worse than my symptoms when I had the virus
headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, the patient experienced HEADACHE (headache). At the time of the report, HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment medications were reported.
Patient got FLUZONE HD 11/15/2016. Patient called pharmacy 11/16/16 to report she had diarrhea, dizziness and headache. Patient wanted the egg free vaccine, but instead got FLUZONE HD.
This case was reported by a consumer via call center representative and described the occurrence of injection site discomfort in a 62-year-old female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced injection site discomfort. On an unknown date, the outcome of the injection site discomfort was recovered/resolved. It was unknown if the reporter considered the injection site discomfort to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced discomfort at the injection site that went away quickly. The reporter did not consent to follow-up. For tolerance to the 2nd of SHINGRIX refer case US2019GSK033744, reported by same reporter.
Tinnitus, distinct tone, right ear. Tinnitus would disappear when I turn head to right, to left or up. Chin down would attenuate the tinnitus nut not eliminate. Overnight sleep the tinnitus declined to to a constant hissing in right ear.
Patient developed heavy vaginal bleeding approximately 30 hours after 2nd dose of COVID-19 vaccine.
Developed three ulcerative lesions-one inside lip, two on tongue. Scab had separated two days earlier.
Narrative:  EMS was called to transport pt to the ER. BP elevated, however SPO2 was 99-100%. At this time do not know if pt was admitted or will just be treated and released in ER.
Janssen COVID-19 Vaccine EUA About 1-1/2 hours after injection I became very light headed. I sat down for a couple of hours and it went away. That night I could not sleep. I only had about 3 hours of on-and-off sleep through the night. One time I woke up with severe chills The following day (Saturday) I had a lack of energy and in the afternoon I was running a low grade fever (99.8). Went to bed around 8:30 Saturday night, slept all night and felt fine Sunday morning.
I got a headache, sour stomach, some neck stiffness about 6 h. after the injection. Headache and stomach upset were worse the following morning (about 18 h. post-injection), also felt slightly chilled.  The headache and stomach upset began to improve around late morning (about 22 h. post-injection) but by then I felt very fatigued.  I dozed for perhaps an hour on the lawn, then went to bed and slept solidly for an hour and a half.  I woke feeling very groggy, but the headache and upset stomach were mild (26 h. post-injection).  By the following morning I felt well.
Syncopal episode, treated with raised feet and cold compresses, checked  blood pressure :100/70  called ambulance for assessment, blood sugars normal, blood pressure 95/67, o2 levels 100%, patient released to mother's care
Client reported to that he developed a "feeling in his jaw" and felt that his heart was beating fast about 20 minutes after receiving the first dose COVID vaccine Pfizer. These symptoms lasted about 5 seconds. The client stated he was unable to describe the feeling in his jaw, but denied it being painful. The client described the feeling in his chest as palpitations. The client stated he has previously experiences this same feeling when he's been alone and had racing thoughts. The client denied SOB or dizziness after the first COVID vaccine Pfizer. The client did not seek treatment for the his symptoms at the time, did not follow up with a PCP, and did not take any medication for his symptoms. The client has a history of hypertension. He currently takes Tenormin 50mg daily in the morning. The client did take his Tenormin this morning. The client states he has consumed water and food prior to arriving at the vaccination site today. Vitals obtained around 5:50PM were as follows: automatic BP 159/94, HR 86. The client states that he is nervous around needles and feels nervous currently. Repeat vitals obtained around 5:55PM were as follows: automatic BP 171/93, HR 83. The client was provided water and began drinking it. Repeat vitals obtained at 06:15PM were as follows: automatic BP 165/94 and HR 86.
Eye pulling, blurry vision, extreme pressure in head, tingling in check, nose, tongue within hours of 2nd dose. Progressed to tingling and muscle twitching in right side of body, electric shocks in finger tips and toes. Internal tremors. Hand tremors. Lip twitching.  Random heart racing. Trouble swallowing. Hallucinations. Short term memory loss, random words running through head. Forgetting names and words.  Muscle twitching, numbness, stiffness and extreme weakness progressed to both arms and both legs. Pain all over.
pt recv vax & devel an inj site rxn characterized by swelling, redness, warmth, & pain as well as a fever;
On  05/15/2021  at around 4:30 pm I experienced  heart palpitations with light dizziness the heart palpitations lasted for about 4 hours. On 05/16/2021 I'm still experiencing the light headed and dizziness from the previous day.
This all may have been caused from a sinus issue I developed on 4/15/21, the day before I had the vaccine.  4/16/21-4/18/21 fever 99-100, cough, hot & cold chills, hot & cold flashes, weak, general not feeling well.  4/18/21 one time cough with yellow phlegm from right lung, rest of time regular cough.
Soreness of injection. Has not been pain free since injection. Much trouble sleeping on affected side and doing ADLS such as lifting. Firmness at injection site. Seen at occupational health clinic 4 months post injection. Orders for Prednisone, TYLENOL, cyclobenzaprine, and physical therapy.
Itch, burning rash under both arms (5" x 12" area), 5 days after vaccine, with heavy sticky sweat in days 19 and 22 after vaccine, lasted 8 hrs and 12 hrs respectively; skin peeling Day 21,  rash started receding on Day 20 and continuing today (Day 23), rash now 75% gone.  Severe pain on left kneecap with  bump and swelling on Day 6-8. Now gone. ; Unknown cause of bruise on lower inside of left arm,  Day 17.
Information has been received from a healthcare professional (HCP), concerning a female patient (age unspecified) with no known drug allergies, who on 30-JUL-2007 was vaccinated IM, with a dose, 0.5ml, of Gardasil (Lot #658490/0802U). There was no concomitant medication. On 30-JUL-2007, following the vaccination, the patient fainted (time duration to onset not specified), but did not have any other symptoms. She recovered on the same day. The patient sought unspecified medical attention. Additional information has been requested.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Pertinent medical history and drug reactions/allergies were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX 19,400 unit 1 standard package vial of 1 (lot number, dose and route were not reported). Co-suspect therapy was not reported. Concomitant therapy was not reported. On an unknown date, most of ZOSTAVAX injection came out of a patient's arm. The outcome of the events was unknown. Additional information has been requested.
Information was received on 23-MAR-2017 from a nurse reporting from a physician's office via a company employee concerning an 80 year old female. No medical history or concomitant medications were reported. It was reported that the patient received "PCB13 one year ago". On 21-MAR-2017 the patient received a dose of PNEUMOVAX 23 (lot N003997, expires 20-OCT-2018) (dose and injection site not reported) within the last 2 weeks. The patient called back within 1 day of receiving the PNEUMOVAX 23 and complained of "arms that are red, painful to touch, feverish and diarrhea." The patient had called the physician office. Treatment was given for the adverse events (not specified). The outcome of the events is unknown. No other information was provided. Additional information has been requested.
Pregnancy related outcome. EDD 9/12/21. Single umbilical artery found at 20 week US. IUFD at 35w 2d on 8/10/21. Delivered 8/11/21. weight 5 lbs 6.7 oz.
Pt was found with a decreased level of consciousness in which his blood sugar was 33, on one touch.
Redness, itching starting 2/22 & developed large rash & swelling local to upper arm.
With  both vaccines I came down with cold sores ( herpes simplex 1) first time 2 days after injection appeared in my nose. 2/3/21 1st shot     2 Nd  shot 3/2/21   It appeared @8 days later on the left side of my neck area- very small but I?ve had them since I was 14 and know what they are by now. I have prescription for Valtrex but did not take any either time.   Just thought this may be of importance .
This spontaneous report was received from an office worker and refers to a 17-year-old female patient with a tree nut allergy. The patient had no pertinent medical history and did not receive any concomitant medications. On 17-JAN-2017, the patient was vaccinated with a dose of GARDASIL 9, intramuscularly (lot# M030380, expiration date: 01-FEB-2019) (dose and anatomical location were not provided) for prophylaxis. On an unspecified date in 2017, the patient developed rash over body, blood-filled taste buds on tongue and petechiae in mouth. The patient sought medical attention by seeing a physician, on 08-MAR-2017 and was admitted to the hospital, on the same day, where she was diagnosed with immune thrombocytopenia (ITP). The patient received unspecified studies and received platelets and prednisone (manufacturer unknown) on an unknown date in 2017. The patient was discharged on 13-MAR-2017. On an unknown date in March 2017, the patient had low platelet count and a new hemolysis and was readmitted to the same hospital on 16-MAR-2017. The patient received an unspecified treatment and was discharged on 21-MAR-2017. No Product Quality Complaint (PQC) was involved. The outcome of reported adverse events was unknown. The relatedness between reported adverse events and GARDASIL 9 was not reported. Upon internal review, the events of hemolysis and immune thrombocytopenia were considered to be medically significant. Additional information has been requested.
Patient stated on 4/17/12 when she came in for anther PPD injection she had a rash on (L) arm, forearm, and (L) side of chest. Patient did not call anyone and just took BENADRYL and TYLENOL for the weekend.
Patient received Moderna dose 2 on 02/09/21 10:00, noticed that the LCP who administered the vaccine failed to identify landmarks to properly administer IM injection, injected high in the deltoid I received Moderna dose 2 on 02/09/21 and noticed that the LCP who injected me improperly landmarked the injection site. Note from the attached photo that I was injected high in the deltoid, approximately 1 cm below the acromion process. I'm now approaching 72 hours post vaccination and am still experiencing achiness in my upper left arm and limited ROM. No fever, swelling, redness, bruising or allergic reaction. I have been taking Tylenol 500 mg 2 tabs PRN, which has helped with the pain at night. approximately 1 cm below the acromion process. Patient noted gradually increasing achiness and feeling of heaviness in left arm 4-8 hours post vaccine, was unable to sleep due to pain. On 02/10/21, patient took Tylenol 500 mg 2 tab at 05:00 and 14:00, still had difficulty raising arm. On 02/11/21, patient woke up at 02:00 with 7/10 pain in left shoulder, took Tylenol and was able to fall asleep. Patient went to work but was unable to raise left arm no more than 30 degrees from body and continued to complain of achiness. On 02/12/21, patient woke up at 04:30 with 7/10 pain in left shoulder and took Tylenol 500 mg 2 tab. At 06:20, pain is 0/10 and patient is able to raise arm 90 degrees from body but notes stiffness and heaviness. Patient sent message to primary care provider to determine possible shoulder injury related to vaccine administration (SIRVA), awaiting MD response.
pt recvd vax 18nov94; mom stated on phone call, pt cranky & had bouts of crying in pm 18nov; fever & unable to eat/drink; pt to er & dx w/ otitis media R ear; meds given
Fever of 104° F starting 12h from injection. Fever broken 24 h after injection after taking 1000mg acetaminophen & 500mg NSAID. 72h after injection, onset of cervical joint stiffness and swelling on left side (injection side) locking neck in place & preventing head rotation to the right.
General malaise Tuesay evening. Wednesday morning fever, chills, weakness, fatigue. Wednesday evening - High fever 103 degrees. Wheezing, heavy cough with congestion, shortness of breath, extreme dizziness, unsteady on feet.
pt recvd vax; broke out in fine rash over entire body; T 103; to PMD who at 1st dx roseola but p/ learning of vax previous day, decided vax rxn;
the arm where he had the injection resulted to a sore and swollen armpit (lymph nodes).; the arm where he had the injection resulted to a sore and swollen armpit (lymph nodes).; his affected armpit feels slightly warmer; This is a spontaneous report from a contactable consumer or other non hcp (patient). A male patient of an unspecified age received first dose of bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: Not reported) via an unspecified route of administration on 31Mar2021 as dose 1, single for COVID-19 immunization. Medical history included COVID-19 from 2020 to an unknown date (Positive during Christmas (2020)). The patient's concomitant medications were not reported. It was reported that caller got his first dose on 31Mar2021. He mentioned that he and his wife tested positive during Christmas (2020) and did the quarantine deal. Before he got his first dose, he had an antibody test and he developed both types of antibodies. After receiving the first dose, on 05Apr2021 the arm where he had the injection resulted to a sore and swollen armpit (lymph nodes). He wants to know how come this happened and added if he need to be concerned about this matter. He was worried to get the second dose because of this. Although the swelling under his armpit was beginning to go down. He added his affected armpit feels slightly warmer on 05Apr2021. The outcome of the event the arm where he had the injection resulted to a sore and swollen armpit (lymph nodes) was recovering and other events it was unknown.  Information about lot/batch number cannot be obtained.No follow-up attempts are needed. No further information is expected.
headache,fever of 100.7,rapid pulse, pounding heart, feeling unwell, chills, join pain, arm pain,tiredness, muscle pain,dizziness weekness,shaking.
initial shot on 2/26/2021....rash developed by 3/6/2021 by 3/9/2021 had painful lump in left breast... rash comes and goes... second shot on 3/18/2021... rash comes and goes... 0n 4/24/2021 had an ischemic stroke...
slept for 2hr p/vax (usual nap time) awoke w/repetitive vomiting, pale, listless, almost bluish lips @ one point;vomited on & off x 2hr;BP nl @ MD office;perked up & regained nl activity by 3-4hr later;
Is stomach pain a side effect of the vaccine; This spontaneous case was reported by a patient and describes the occurrence of ABDOMINAL PAIN UPPER (Is stomach pain a side effect of the vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL PAIN UPPER (Is stomach pain a side effect of the vaccine). At the time of the report, ABDOMINAL PAIN UPPER (Is stomach pain a side effect of the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient asked whether stomach pain was a side effect of the vaccine.
08/22/22 presents to EC ED for "syncope, respiratory failure". PMHx of "diagnosed with COvid about 1 week ago" "HLD, HTN, DM2"
Immediate pain at injection site (L deltoid) progressing to left shoulder and neck pains. Pain such that L shoulder movement was impossible. After about 7 wks pain is subsiding and full motor function has returned. Still recovering.