chrisvoncsefalvay/vaers-outcomes huggingface dataset:
bilateral great toe skin change - less than 1cm area of blue discoloration with skin peeling. - day 4 initially 24 h after shot had body aches, felt like had a fever,  pain at injection site
The area around the injection got red and swollen, hard to the touch. Had pain in arm through the night, wasn't able to sleep. The next day it was larger in size, more swollen and painful, took a BENADRYL that night, but the next day the redness was all around the arm and swollen and painful. Went to the doctor and she diagnosed it as allergic reaction to vaccine.
On September 21, 2017 I got a TD, after getting my allergy shots on 9/20/17. Then on the 9/22/17 my forearm began swelling and hurting. As of 10/11/17 it still swelling and hurt. No am on prednisone and on prednisone until 10/20. As of 10/10/17 no allergy shot. On September 20, 2017 at 3:45 PM I went and got my allergy shot in both arms from Dr. Then on September 21, 2017, I went to clinic and got a TD, because mine had expired. After the shot, my right arm began swelling and hurting in my forearm. I am unable to bend it all the way down. I received a check-up on October 10, 2017 by Dr. and was started on prednisone due to me now being unable to take my allergy shots until my check up on October 20, 2017.
Information has been received from a consumer concerning her 7 year old daughter with no known medical history who on 7/17/96 was vaccinated with a 0.5ml dose of varicella virus vaccine live. There was no concomitant medication. On 4/12/03 the patient developed chicken pox described as 60 lesions that were all over her body by yesterday. Medical attention was not sought. Follow up information from a registered nurse indicated that the patient's records were transferred from this office on 7/23/99 and the office had not seen the patient since 12/11/98. They have no information on this adverse experience. Additional information has been requested.
This spontaneous report was received from a nurse referring to an unspecified number of patients of unknown age and gender. Medical history and drug reactions or allergies for the patients involved were not reported. The nurse reported that on unspecified dates an unspecified number of patients received an improperly stored dose of ROTATEQ lot number: M038744 (expiration date: 26-APR-2018), lot number: M046000 (expiration date: 27-JUN-2018), lot number: M046006 (expiration date: 28-JUN-2018), lot number: N005618 (expiration date: 04-OCT-2018) for prophylaxis (strength, route, dose or units were not provided). There was digital data logger involved. The administrated doses underwent temperature excursion between 0 Celsius degrees to 1 Celsius degrees (also reported as "0.4 Celsius degrees") for 35 hours and 29 minutes and between 2 Celsius degrees to 8 Celsius degrees (1.6 Celsius degrees) for 6 hours and 7 minutes. There was no previous temperature excursion. No adverse events were reported. Follow up information has been received from the reporting nurse concerning a 5-month-old male patient. At the time of the vaccination the patient had no illness according to 4 month child exam. On 26-SEP-2017, the patient was vaccinated with the first dose of ROTATEQ orally, lot # N005618, expiry date 04-OCT-2018 (dose was not reported) for prophylaxis. Concomitant therapies included PENTACEL and PREVNAR. It was reported that medication error occurred during storage in clinical Practice. No treatment was given due to the event. The patient was vaccinated at public health or hospital and the vaccine was purchased with public funds. No symptoms or adverse effects were reported.
Patient had "frozen arm" from shot and arm was very painful.  Unable to move arm properly or without pain until received a Cortisol shot.  After Cortisol shot, arm did return back to normal.  This info was reported to our pharmacy in May 2019.
shoulder a little sore; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 22-year-old male patient received BNT162b2 (BNT162B2), on 18Apr2022 as dose 2, single (Lot number: FK9894) at the age of 22 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (First Dose, Lot Number / Expiry Date: FJ6369/unknown, Route, Anatomical Location: left arm, left upper shoulder), administration date: 14Mar2022, when the patient was 22-year-old, for Covid-19 immunization. The following information was reported: ARTHRALGIA (non-serious) with onset 18Apr2022, outcome "unknown", described as "shoulder a little sore".
This case was reported by a nurse and described the occurrence of abnormal menstrual cycle in a 33 year old female subject who was vaccinated with Twinrix plus a separate injection of tetanus and diphtheria toxoids adsorbed. Medical history included hypothyroidism and rosacea. Concurrent medications included Birth control pills. On 10 February 2006 the subject received 1st dose of Twinrix (lot AHABB026AC) plus a separate injection of Tetanus and diphtheria toxoids (lot U13408A). On 11 February 2006, one day after receipt of the vaccinations, the subject "received her menstrual cycle." The subject was seen at a physician's office. The event resolved on 16 February 2006. The nurse considered the event to possibly be related to vaccination with Twinrix tetanus and diphtheria toxoids adsorbed. Case A595775A and A595774A are duplicates of A0595765A. All further information will be entered into A0595765A.
Baby awoke at 0600 on 11/21 and was well. At 0900 had fever of 104 and was not moving any extremities and head lagged on picking her up. However once up and in mom's arms, moved her arms well and legs and head-seen in ER with temp 103.6-Normal CBC, CXR, BC and UC.
Information has been received from a physician and the husband of a 70 year old female with no allergies, blood pressure increased, a history of chickenpox as a child and hysterectomy on 11-APR-2008 was vaccinated with 0.5 cc zoster vaccine live (Oka/Merck) in the left shoulder. Concomitant therapy included unspecified high blood pressure medication, LIPITOR, amlodipine, and ALLEGRA. On 14-APR-2007, the patient experienced severe pains in her head. Lumps and spots developed on the left side of her head. On 17-APR-2008, the patient was seen by the physician. Blister formations were noted on the left head. She was diagnosed with shingles/herpes zoster in the occipital division of the 5th nerve on left side of the head with a 3-4 out of 10 level of pain and malaise. The number of lesions were not counted by the physician. It was noted she had no recent exposure to chickenpox. No fluorescent antibody or PCR was collected. Subsequently, the patient recovered. The reporting physician advised that the hospital pharmacy who dispensed the zoster vaccine be contacted for the vaccine's lot#. The hospital pharmacy provided lot # of 658861/1822U. However, the hospital pharmacy was unable to verify that this (lot#) was what the patient received, as the physician was responsible for lot # documentation. Additional information has been requested. This is in follow-up to report(s) previously submitted on 6/24/2008. Follow up information was received from the physician concerning a 70 year old female with no known allergies and a history of chicken pox as a child, who on 11-APR-2008, in the morning, was vaccinated with a second dose of ZOSTAVAX (Merck) subcutaneously in the left shoulder. Concomitant medications included LIPITOR, NORVASC, ALLEGRA and LOXOL. On 17-APR-2008, the patient experienced a rash. Distribution of Herpes zoster lesions were found in the occipital division of V cranial nerve (left). At the time of reporting the patient had recovered. There was no recent exposure to chicken pox. There was no illness at the time of vaccination. The patient was enrolled in the Varicella Zoster Virus Identification Program to identify if VZV is present and if is associated with the wild-type (WT) VZV strain with the Oka/merck vaccine VZV strain. The sample of the lesion was collected on an unspecified date. The sample was taken from vesicle and papule lesions on the left occipital divisions of V cranial nerve. No further information is available.
Since i got the vaccine 2 weeks ago, almost every night since I have had significant dreams, much more so than I would normally. Normally I would have vivid dreams a couple times a month. This isn't a problem as I like the fact I'm getting deep sleep but I just wanted to report it. Thanks.
started 5 mins admin w/ dry cough w/  itching in throat and ears; given 25mg po benadryl; pt then started experiencing hives, coughing episodes, red rash, purities, tachycardia (135 at it's highest), chest tightness and SOB.   Epi pen was delievered to pt.  Pt transported to local ER
Started with 1st Moderna shot in January 9 and then continued to 2nd Moderna shot in February 6th and continued until Booster Moderna shot listed about. It is a severe muscle ache in glutes and hamstrings at a level 8 when I get out of bed in the morning.
pt recv vax & exp transverse myelitis p'/vax;pt has not yet recovered, sx still persits;vax given 29SEP94;pt still exp transverse myelitis on 13OCT94;EMG performed on 12OCT96;3JUL97 related that became paralyzed p/vax;
Pt received Pfizer x2.  Pt tested COVID + on 8/16/21 and admitted to hospital for COVID on 8/27/2021. Pt received remdesivir x3 doses and dexamethasone.
03/23/2021: Patient presented and was admitted through ED for right lower extremity pain after a recent fall. CT of the pelvis which showed to have Comminuted subtrochanteric proximal right femoral shaft fracture with angulation. She had difficulty walking, and difficulty with activities of daily living skills. Patient had PMH of arthritis.  Per the EUA, hospitalizations are to be reported irrespective of attribution to vaccine.
Patient reports today for second dose of Moderna vaccination. No known reaction to first dose of vaccine.  During observation patient lost consciousness 5 minutes post injection, tipping over backwards and hitting head on the floor.  Patient was unresponsive with strong pulse.  Emergency response was activated and smelling salts were administered.  Patient came to after smelling salts were given.  While patient was coming to, mild seizing was noted.  Patient noted headache after coming to.  Emergency services arrived for extended assistance prior to releasing patient.
Site of injection erythema, & swelling which resolved over period of 3-4 days without any therapy.
Dad called complaining of pain in left arm the day after administration. No fever, swelling. Recommended ice and Motrin as needed.
feeling faint and stomach pains after COVID booster; Chills; hot flashes; dizziness/feeling faint after COVID booster; headache; fatigue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete, Manufacturer: Unknown), for COVID-19 immunization. The following information was reported: ABDOMINAL PAIN UPPER (non-serious), outcome "unknown", described as "feeling faint and stomach pains after COVID booster"; CHILLS (non-serious), outcome "unknown"; HOT FLUSH (non-serious), outcome "unknown", described as "hot flashes"; DIZZINESS (non-serious), outcome "unknown", described as "dizziness/feeling faint after COVID booster"; HEADACHE (non-serious), outcome "unknown"; FATIGUE (non-serious), outcome "unknown".  Additional information: Event took place after use of product.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Chest pains with cough, lasted a few days. No treatment, thought was normal until heard it was not.
10JUN91 pt reports since DT inject c/o joint pain of armpits, elbow, & all joints; inc temp first 2 days p/inject of 101-102; Called MD;
7 days after shot, swelling, redness, itching surrounding the injection site.  Firm lump under skin about 2 inches in diameter.
Initial and follow up information has been received from a registered nurse and a physician concerning a 16 year old white female student with a cefaclor (Ceclor) allergy, asthma and allergic rhinitis who on Oct 15 2004, at 1:15pm, was vaccinated IM in the left deltoid with a second dose of pneumococcal 23v polysaccharide vaccine (lot 649696/0490P). Concomitant vaccination, at the same time, on Oct 15 2004 included a dose of influenza virus split virion 3v vaccine inactivated (Fluzone) (lot U1496AA), also administered IM in the left deltoid. Additional concomitant therapies include desloratadine (Clarinex), drospirenone (+) ethinyl estradiol (Yasmin), escitalopram oxalate (Lexa pro), trazodone hydrochloride, fluticasone propionate (Flonase), and fluticasone propionate (+) salmeterol xinafoate (Advair)(250/50 mcg). On Oct 17 2004 the patient called the office to report a red and tender reaction at the injection site with was 3 x 6 inches. The patient was treated with ice packs and ibuprofen (Motrin) for the pain, The patient called again on Oct 18 2004 and reported a 104 degree fever and swelling and redness at the injection site of 7 x 4 inches (also reported as 10x20 centimeters). It was also reported that it was very painful and she was unable to move her arm, symptoms were not relieved by ibuprofen and ice. The patient came to the office ans was given acetaminophen (+) hydrocodone bitartrate (Vicodin) and ice packs for the pain. As of Oct 19 2004 the inject site was still painful and red, but it was reported that she was recovering. She was given naproxen (Naprosyn) for the pain, It was also reported that th patient was prescribed cephalexin (Keflex) for suspected cellulitis and referred to the emergency room for evaluation of suspected myoglobinuria, which was ruled out. The patient was seen in the hospital emergency room on Oct 22 2004 and had a left upper extremity ultrasound, which indicated subcutaneous edema and no abscess. The following diagnostic laboratory tests were performed on Oct 22 2004 and reported below normal: blood hemoglobin test 11.7 g/dl, blood lymphocyte count 24.6%, serum creatin Kinase test 27 u/l, whole blood hematocrit 34.1%, urin specific gravity measurement 1.000, serum sodium test 135 mEg/L, and red blood cell count 3.88m/mm3. Both white blood cell count and blood platelet count were reported above normal at 12.9 K/mm3 and 463 T/mm3, respectively. The physician reported that the patient had one previous dose of pneumococcal 23v polysaccharide vaccine (date not reported) and more than 10 previous vaccinations with influenza virus split virion 3v vaccine inactivated. It was also reported that at the time of vaccination, the patient has generalized aches and pains with subjective fevers and sore throat, no corroborative physical findings or specific etiology. the patient recovered on Oct 31 2004. There was no product quality complaint involved. Additional information is not expected.
Prolonged abdominal pain, nausea, diarrhea, chest / heart pain, chest tightness, elevated heart rate.
About two months after the COVID-19 vaccine, I started to have chest pain and shortness of breath with exercise. It was intermitted with exercise. I went to see my primary physician who referred me to have an exercise stress test, which indicated I had arrythmias, V tachycardia. When I received the cardiac catheterization, it showed normal coronary arteries and normal heart function. My doctors think my arrythmias is due to myocarditis. I'm currently having a Holter monitor done.
After first JANSSEN vaccine had ongoing vertigo and dizziness for 5 five months.  Was not able to drive, etc. Received the JANSSEN booster shot on 11/11/2021 and 3 days later had a debilitating migraine that lasted for two weeks.  Multiple visits to my primary physician as well as an ENT, emergency care visit resulted in a diagnosis of vestibular migraines.  No history of migraines previously or health issues.  Still having chronic migraines and vestibular issues.
Pt received vaccines on 8/10/01 and 8/16/01. On 8/24/01, the pt stated she had experienced a 30 second LOC with "shaking leg and "gurgling" as described by her husband, who witnessed the event. This was preceded only by "extreme fatigue", which the pt said lasted for 1 hour, before event. She had no headache or dizziness or other signs or symptoms and stated she felt "terrific" after the event. She did not seek medical attention elsewhere. (Pt alerted me on 9/18/01 of the event which occurred on 8/24/01).
Severe headache woke me up in the night after vaccine -resolved after putting ice pack on neck and head, night 2 woke again in the night with severe headache repeated ice pack felt better but I felt like something was wrong so made apt with my PCP that morning.  BP was very high, was shaky and had low grade pain in back neck/ spine.  BP slowly came down.  Day 3 had 2 episodes of chest pain in am  had an ekg later that day and it came out ok. No events detected.  Going into week after vaccine (days 5-8) ongoing pain mid back/ spine and developed a cold sore ( had not had one in over a year) 4/12 woke with   Head and neck pain but not as severe as first couple days. Still don?t feel ?quite right? but functioning ok.
This case was reported by a consumer via out of hour services and described the occurrence of injection site swelling in a female patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced injection site swelling, injection site erythema, injection site pain, injection site rash and discomfort. The patient was treated with hydrocortisone and medication unknown (ice pack (NOS)). On an unknown date, the outcome of the injection site swelling, injection site erythema, injection site pain, injection site rash and discomfort were not recovered/not resolved. It was unknown if the reporter considered the injection site swelling, injection site erythema, injection site pain, injection site rash and discomfort to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX vaccine on an unknown arm. The patient's arm swelled and was very red to the extent that 4 days later she still had a 3 inch by 2.5 inch diameter circle in her arm where the injection was placed. The pharmacist told her to use ice packs and hydrocortisone ointment. The patient felt that she should be compensated for this soreness, rash, burning, and inconvenience to her and wanted to be called back.
13 year old was administered Moderna instead of Pfizer; This spontaneous case was reported by a non-health professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (13 year old was administered Moderna instead of Pfizer) in a 13-year-old patient of an unknown gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (13 year old was administered Moderna instead of Pfizer). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (13 year old was administered Moderna instead of Pfizer) had resolved. Not Provided          No concomitant medication was reported No treatment medication was reported
Developed  a DVT in right calf on 03/17/2021.   Doctor told me it was a significant clot that had developed , after review of ultrasound exam
Became feverish 103. 1, heart racing  111, pulse oxygenation 93 ,very fatigued , heart rate 176/ 93  called 911 ran EKG advise to take Tylenol for fever and to relax, drink plenty of fluid was this way for two days then was extremely tired and weak , no appetite for about 5 days
I95.89 CHRONIC HYPOTENSION 10/12/2022 HX OF TRANSIENT ISCHEMIA ATTACK I95.9 HYPOTENSION 9/25/2022 HX OF TRANSIENT ISCHEMIA ATTACK
Fever, chills, headache/migraine, diarrhea, body aches, pain on the arm of shot
Hives and welts appeared on my body and continue 5 days later.  My face started to swell badly and I ended up on the ER.  I have been advised to not get the second shot.  This has been very bad, and showing no signs of letting up.
Patient states they received vaccine and starting soon after had "excruciating" pain in the injection arm, underneath the arm in the armpit area. Patient states they were barely able to move the arm for about three days. After this pain began to resolve a large area of bruising in the same area around the armpit area, extending down to the side of the breast, about the size of the palm of her hand, which is still present to day 11/7/23. Patient also received a FLUAD vaccine in the other arm at the same time and has had no complaints with that vaccine.
Within a minute or two of receiving the vaccine patient felt flush and was having trouble breathing. Adult epipen 0.3mg was administered in patient's right thigh. Also 50mg of diphenhydramine was administed in patient's left deltoid. Ten minutes later the patient was again having breathing problems. Second injection of adult epipen 0.3mg was administered in patient's right thigh. Patient was also given Lorazepam 2mg. Patient was taken to the Emergency room via ambulance. At the emergency room patient was given Prednisone and an additional 1mg Lorazepam. After observation, patient was sent home.
Pt. called to report she received a shingles vaccine (L) SQ and Flu vaccine (L) IM on 10/15/12 at HD. Now has redness about 3 inch x 3 inch area, with sm. amt of swelling and erythema at site of shingles injection. Also, sl. tenderness to touch. No skin breakdown, drainage or fever. Advised to watch area for s/s of worsening and use ice and Ibuprofen for comfort.
Patient went to bed with a knot and mild erythema over injection site. Woke in the morning with the site 3x bigger, warm to the touch, and favoring that leg. Came to the office and was diagnosed with adverse reaction/cellulitis and placed on Cephalexin. Called the office 4 hours after starting treatment, noting that she now had a fever and the redness was larger. Told family to give second dose of meds as well as ibuprofen, outline the second area now (had already outlined the first), and if it continued to spread in the next few hours, to take her to the ER. Unsure at this time if family ended up FU in the ER or not.
PATIENT DESCRIBES INJECTION SITE WAS HARD AND SWOLLEN.  SWELLING SPREAD TO UNDER THE ARMS.  PATIENT ALSO STATED WAS HARD TO BREATHE.
This spontaneous report was received from a Nurse refers to a 13 year old patient. On 20-MAR-2014, the patient was vaccinated with improperly stored VARIVAX (Merck) Lot # H014074 (dose, route and frequency were not reported). The nurse reported that on 24-OCT-2013, VARIVAX (Merck) was stored for -13.9 C for 8 hours. On 29-OCT-2013, the VARIVAX (Merck) was stored for -12.8 C for 4 hours. On 14-NOV-2013, the VARIVAX (Merck) was stored for -11.4 C for 1.5 hours. On 26-MAR-2014, the VARIVAX (Merck) was stored for -14.7 C for 1.5 hours. On 14-MAY-2014, the VARIVAX (Merck) was stored for -13.8 C for a total of 5 hours. Since the overall average for VARIVAX (Merck) was below -15 C, these cumulative excursions of -11.4C for 20 hours is supported. No adverse effect has been reported. No further information was provided. This case is linked to the case 1405USA015833, 1405USA015834, 1405USA015835, 1405USA015836, 1405USA015837, 1405USA015838, 1405USA015839, 1405USA015840, 1405USA015841 and 1405USA008798 (same reporter link). Additional information has been requested.
pt recv vax; er reports states sz 4mar95 at approx 6:30pm; tx w/ dilantin;