chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The pt developed vague, general foot discomfort/fatigue; pain at metatarsal heads with weight bearing; intermittent lancinating pains in toes; in warm conditions, feet/toes hot and blush; in cooler conditions toes feel "like they are freezing" and ache. Bending over (to vacuum) increases paresthesias/numbness in shins/dorsal feet. Prolonged standing increases fatigue, discomfort and swelling in feet up to ankles. Fasciculations in calves are still precipitated by exertion. Treatment: Foot discomfort and swelling is greatly relieved by foot exercises and leg elevation and swimming. Neurologist assessment: Acute inflammatory polyneuropathy (AIP) or Guillain-Barre  temporally associated with influenza and anthrax vaccines; numbness paresthesias and weakness in both feet in L5-S1 distribution bilaterally secondary to residual effects of AIP; autonomic neuropathy secondary to #1 with secondary dependent edema problems; cervical herniated nucleus pulposus (C5-6 HNP) and bilateral carpal tunnel syndrome. Due to the incompatibility of this service member's medical condition with the demands of operational/remote/overseas environment, it is recommended that she be found unsuitable for such assignment. No prolonged standing, walking, running or jogging. Pt workload should not exceed 10-11 hours per day in order to allow for medical care requirements. She may need time to maintain her swimming program. Continue physical therapy. Allow use of non-confining (soft) footwear as tolerated, continue silicone orthotics with metatarsal bars (Viscoped), avoid further vaccinations unless specifically reviewed by vaccine safety assessment expert. Administer oseltamivir for influenza prophylaxis as indicated. After a LP in 10/99, Lyme neuroborreliosis was considered and she was given a course of Ceftriaxone therapy (2gms IV qd X 30 days). She noted no immediate improvement in her neurologic symptoms. By 8/00, she noted significantly increased weakness and atrophy of the intrinsic muscles of the feet. A repeat MRI in 8/00 showed findings consistent with a diffuse axonal peripheral neuropathy. She now manifests a claw foot-like deformity of the left foot. Update letter: The sensation in the feet/distal lower extremities has improved slightly with improved sensory discrimination. The strength of the foot intrinsic muscle has improved with improved foot function, toe strength and toe coordination. The autonomic neuropathy findings are still evident with shiny skin in the feet/distal lower extremities, vascular hyperreativity and intermittent dysesthesias-but the foot edema no longer seems to be a problem. Pt feels that the improvement in motor strength/function, resolution of the edema problem and control of the dysethesias is a result of a regualar physical therapy program.
Patient was administered Pfizer BioNTech Covid Vaccine  that had been drawn up the previous day and was at room temperature for 24 hours.  Contacted Pfizer , there is no data regarding stability.  Contacted CDC, dose needs to be repeated, there is no time frame for dose.  Pt had been monitored for 15 minutes, no adverse reaction noted.  Contacted Pt after 4 hours, no adverse reaction reported.
had lower back after her second dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 50 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2, for COVID-19 immunization. The following information was reported: BACK PAIN (non-serious), outcome "unknown", described as "had lower back after her second dose".  Additional information : Reporter (55 years old female) disconnected while on hold with DSU agent (name withheld) ID reportum number. Caller stated she received both doses of the Pfizer covid vaccine. after the first dose she had sore arm and after the second dose on Apr2021 she experianced, cough/dry hives, flu like symptoms, could not get out of bed as she has severe lower backpain, took ibuprofen for it. caller stated backpain is affecting her daily activities. Her sister-in-law (almost 50 years old) had lower back after her second dose of the Pfizer covid vaccine also. Caller wanted to know if that has been reported.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Temp >102 for greater than 24 hours, unsteady gate which resulted in a fall & ER trip, Urinary incontinence, lethargic.
HARD KNOT UNDERNEATH INJECTION SITE; ARM FEELS HOT TO TOUCH; WHITE SPOTS ON ARM; LEFT ARM SWELLED UP THE SIZE OF AN ORANGE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included covid-19.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, expiry: UNKNOWN) dose was not reported, administered on 29-MAR-2021 for prophylactic vaccination to the Left Arm. No concomitant medications were reported. On 31-MAR-2021, the subject experienced hard knot underneath injection site. On 31-MAR-2021, the subject experienced arm feels hot to touch. On 31-MAR-2021, the subject experienced white spots on arm. On 31-MAR-2021, the subject experienced left arm swelled up the size of an orange. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from left arm swelled up the size of an orange, hard knot underneath injection site, arm feels hot to touch, and white spots on arm. This report was non-serious.
Pediatric vaccine was inadvertently given to adult patient (0.25 mL), patient was subsequently given second dose (0.25 mL) to equal an adult dose. Tolerated without issue as of 10/16/23 at 0905.
PT PRESENTED TODAY 3-21-2011 WITH 1.5 INCH MOVABLE LUMP IN RIGHT LOWER THIGH.  ACCORDING TO MOM THIS DEVELOPED SINCE LAST IMMUNIZATIONS AND HAS BEEN GETTING BIGGER.  PT RECEIVED PCV13 IN THE RT THIGH ON 12/13/2010.  ADVISED MOM TO HAVE CHILD ASSESSED BY A PEDIATRICIAN.  WITHHELD PCV13 TODAY UNTIL CLEARED BY CHILD'S PEDIATRICIAN.
suspected vaccination failure/received second Shingrix, has possibly shingles; has possibly shingles; non-itchy rash; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On 1st December 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 19th October 2021, more than a year after receiving Shingrix and 322 days after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and rash. On an unknown date, the outcome of the vaccination failure and shingles were unknown and the outcome of the rash was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and rash to be related to Shingrix and Shingrix.  Additional details provided were as follows: The case was reported by the patient herself. The age at vaccination was not reported for 1st dose of Shingrix. The patient received her 2nd dose in her right arm and at the time of reporting she had a non itchy rash on her left neck around to the mid point of her left back. The patient thought it might possibly be a case of shingles but she had not been to the health care professional to confirm yet. The reporter did not give permission to contact health care professional. This case was considered as suspected vaccination failure since the details regarding laboratory test confirming shingles were unknown at the time of reporting. The reporter did not consented to follow-up.
No adverse effect reported.; the patient was inadvertently administered a dose of VARIVAX that had been improperly stored; This spontaneous report was received from vaccine coordinator and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 24-SEP-2019, the patient was inadvertently administered an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) (exact dose and route of administration were not reported) (lot numbers involved: lot# S008692, expiry date 21-MAR-2021, lot# S019463, expiry date 24-JAN-2021, lot # R035222, expiry date 04-DEC-2020) for prophylaxis. All lot numbers of varicella virus vaccine live (oka/merck) (VARIVAX) were reconstituted with properly stored sterile diluent (STERILE DILUENT). The storage temperature was 27.1 Fahrenheit (F) during the time frame of 40 minutes. A digital data logger was involved. There was no previous temperature excursion. No adverse effects were reported. The outcome of product storage error and no adverse event was unknown.
This spontaneous report was received from a pharmacist refers to an approximately 62 year old female patient. The patient's concurrent conditions, medical history and concomitant medication were not reported. On 20-MAY-2015, the patient was vaccinated with a dose 0.65ml of ZOSTAVAX (lot # L006381, expiry date 25-MAY-2016) subcutaneously. On an unknown date in MAY 2015, the patient experienced localized injection site reaction that consisted of swelling and a red itchy rash following the administration of ZOSTAVAX. The outcome of the events was unknown. The reporter did not provide the relatedness of the event with ZOSTAVAX. Additional information has been requested.
Approx 3 hr after receiving flu shot pt developed itchy rash on neck & extremities. Went to urgent care -> prednisone.
I started with a running nose that lasted about a day or so. I woke up in middle of night with 101.7 for about 5 to 6 days, tylenol would help, whenever it wore off I would have a fever. my fever broke August 14, I was tired, really tired, loss of appetite.
PC to reporter: pt c/o back pain & scapular pain; no discomfort @ site; rather, upper back pain;
10-11 hours after receiving MMR vaccine patient states she had severe itching at bottom of feet and palms of her hands then moving into her legs and arms. No difficulty breathing, wheezing, no chest tightness, no swelling of tongue or throat, no dizziness or weakness, no fever, no rash.
sore muscle around my neck; when in bed last night, she could not turn her head without it been so painful; had discomfort in her shoulder and stiffness; had discomfort in her shoulder and stiffness/neck was so stiff that it hurt to turn her/can hardly turn her neck; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL9264), via an unspecified route of administration on 30Jan2021 at 16:10 (4:10 pm) at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 30Jan2021, the same night of vaccination, the patient had discomfort in her shoulder and stiffness. On Monday, 01Feb2021, patient reported that her "neck was so stiff that it hurt to turn her head". She can hardly turn her neck. She added when in an "upright" position "it is ok" but "when in bed last night, she could not turn her head without it been so painful" to the point where she felt like she "would cry out". On an unspecified date it was reported that patient had sore muscle around my neck. The patient mentioned she alleviates her pain with "Tylenol, hot compresses, took a towel and put hot water on it and then put it around my neck, and a cream for soreness". The patient took a Tylenol last night and put hot compress on it. And rubbed it with a muscle something for a sore muscle. But it still very painful. The patient doesn't know whether it's related to the vaccine or not. The outcome of the event sore muscle was not recovered while for the rest of the events was unknown.
Per patient- her arm is swollen, red, itchy and looks likes hives an inch below the injection site.
First 48 hours was fever, chills, headache and fatigue, what we expected.     Then the symptoms continued off and on for the next 3 weeks.   Headache everyday, fever up and down between 99.3 to 100.7 and chills randomly with fatigue constantly for the next 3 weeks.     He is in week 4 and the symptoms are starting to diminish.     No more headaches, some fatigue and some chills randomly.
Chest pain with new onset Afib. HR in the 140s that started when he was watching tv at around 7:30 pm on 10/05/2022
First night-vomitting,then severe chills-couldn't stop shaking-when that stopped woke up all sweaty,. Next day severe back pain has continued since.chiropractor no help,ER could care less-just tested me for covid. finally doctor-after 2 visits determined UTI!! Again!!! tried coticosteroids first-worked first few days-then didn't! Now on SMX/TMP-seems to be getting better slowly.Last symptom was left side extremely sore and chills came back! Wife got sick too at this point-she's on amox/clav-elderly and barely hanging on. Will not be receiving any more new fangled vaccines-onlu J&J!!!!!
I had my vaccination on 09/10/2022. I started to feel unwell on 03/26/2023 with symptoms to include a fever of 102.6. I tested COVID-19 Positive on 03/27/2023. I was prescribed Paxlovid on 03/27/2023.  I presently feel fatigued but no fever.
Bodyaches , painfull joints ( more the knees), Fever(102 farenh) and chills the first day  followed by swollen lymph nodes on both sides of my neck, super swollen tonsils , which were red with  white patches.  Then  there was a sharp pain on my chest that ran down my left arm but lasted less then a minute.
Fluid around the eye had really puffed up; started having chills; Body aches; Whole area around their eye was swollen; Fluid had gathered up around that area; Eyelids were swollen; Eyelid had inflammation; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN (Body aches), EYE SWELLING (Whole area around their eye was swollen), OCULAR DISCOMFORT (Fluid had gathered up around that area), SWELLING OF EYELID (Eyelids were swollen) and BLEPHARITIS (Eyelid had inflammation) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029A21A and 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Surgery (3 weeks ago) and Cancer surgery (Skin Cancer removed(right eye was not affected) had stitches both internal and external (internal were removed).Recovering fine.). Concurrent medical conditions included Penicillin allergy and Drug allergy (Levaquin). Concomitant products included CALCIUM, COLECALCIFEROL (VITAMIN D3 CALCIUM).   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Mar-2021, the patient experienced PAIN (Body aches), EYE SWELLING (Whole area around their eye was swollen), OCULAR DISCOMFORT (Fluid had gathered up around that area), SWELLING OF EYELID (Eyelids were swollen), BLEPHARITIS (Eyelid had inflammation) and CHILLS (started having chills). On an unknown date, the patient experienced PERIORBITAL SWELLING (Fluid around the eye had really puffed up). The patient was treated with PREDNISONE (ophthalmic) ongoing since an unknown date at an unspecified dose and frequency. On 07-Mar-2021, PAIN (Body aches) and CHILLS (started having chills) had resolved. On 12-Mar-2021, EYE SWELLING (Whole area around their eye was swollen), OCULAR DISCOMFORT (Fluid had gathered up around that area), SWELLING OF EYELID (Eyelids were swollen), BLEPHARITIS (Eyelid had inflammation) and PERIORBITAL SWELLING (Fluid around the eye had really puffed up) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment include prednisone eyedrop. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: Event outcome changed.
Fully vaccined, vaccine breakthrough 11/10/21, mild symptoms Admitted 11/14 to deliver a full term baby girl vaginally.     Baby girl 39 w gestation, 3.09 kg.   Not needing NICU care.
Scratchy throat, tachycardia 1125am Took 1- 25mg benadryl oral. 1145- throat improving. Felt lightheaded approx 1150am. Symptoms improved 1211 and patient left.
child was given the adult Havrix; child was given the adult Havrix; This case was reported by a physician via call center representative and described the occurrence of overdose in a 1-year-old patient who received HAV (Havrix adult) (batch number 3A22R, expiry date 24th May 2022) for prophylaxis.   On 27th May 2021, the patient received Havrix adult. On 27th May 2021, unknown after receiving Havrix adult, the patient experienced overdose and adult product administered to child. On an unknown date, the outcome of the overdose and adult product administered to child were unknown.  Additional details were provided as follows: The patient were given an adult dose of Havrix, which led to overdose and adult product administered to child. The reporter consented to follow up. This case was one of 9 linked reports which were reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021120523:same reporter US-GLAXOSMITHKLINE-US2021120525:same reporter US-GLAXOSMITHKLINE-US2021AMR121314:same reporter US-GLAXOSMITHKLINE-US2021120532:same reporter US-GLAXOSMITHKLINE-US2021120526:same reporter US-GLAXOSMITHKLINE-US2021120516:same reporter US-GLAXOSMITHKLINE-US2021120519:same reporter US-GLAXOSMITHKLINE-US2021120521:same reporter
Redness swelling burning itching about 2 inches from injection side. Swollen pocket of fluid on one side of the redness today is 4th day of the reaction
Severe pain in injection site for several days. Lethargic for 3 days.
Given vaccine Moderna age 12+ and child was 11 years old. Patient didn't have any major side effects in the office. Per Mom at home only had a fever.
Developed myoclonic jerks several times a week approximately 2 weeks after vaccine.  These symptoms continued and eventually patient was diagnosed with Juvenile Myoclonic Epilepsy after an EEG in February, 2023.
This is a spontaneous report from a contactable physician via a Pfizer sales representative. A 19-year-old male patient received TRUMENBA (lot number and expiration date unknown), via an unspecified route of administration from an unspecified date at single dose for immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced supraclavicular lymph node on an unspecified date. Outcome of the event was unknown. Information on the lot/batch number has been requested
Narrative: Patient's wife contacted telephone triage nurse today requesting advice. She is crying on telephone, "My husband had the Johnson & Johnson covid vaccine 3 weeks ago and something is seriously wrong with him." States right after vaccine was provided, patient developed fatigue, weakness & chills. States symptoms did not improve after 2 weeks, "So I took him to the emergency room." States ER physician did a CXR, lab work and discharged him home, told to f/u with PCP clinic. States since patient received the vaccine, he is also experiencing nausea, abdominal pain/bloating/intermittent confusion, "severe sore throat", difficulty breathing and "He just stares at the wall like a zombie sometimes - he is just not acting right, there is something seriously wrong - this confusion scares me and I can't keep him awake. He is just not getting better and I don't know what to do." States he has been sleeping 15 hours/day. Patient was put on telephone, states "I just haven't felt right since I got the vaccine, just feel very sick." Patient states he is not getting confused, but is getting episodes of severe shortness of breath, "I'll just be outside pick up sticks and if I bend over to get it, I notice my equilibrium is off, and I can't breathe - I just get these random episodes where I can't get a full breath - I get real lightheaded when that happens and just can't breath- my equilibrium gets way off like I'm going to fall over." (Wife is arguing, states "no, he gets confused - he's not being honest with you.. When he walks in the door from outside, he walks in staring like he doesn't know he even lives here") She is again crying - states, "this has happened at least 4-5 times where he's just been out in the yard and he's been very, very confused." Patient is also c/o "pain" in the back of his R thigh, "from the knee all the way up, just aches." No prior h/o PE or DVT. No RLE swelling. Recommended her return to local ER now. Wife states she will take him now. Please follow up, thank you.
rash began noc of 4AUg98 when immun given;came to office 5AUG98 dx w/urticaria;hives seen lt inner thigh (blotchy rash) rt arm;mom states rash was more red, confluent, spots were larger earlier;no wheeze noted;
This case was reported by a pharmacist via call center representative and described the occurrence of headache in an unspecified number of adult patients who received Shingrix for prophylaxis. On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than a year after receiving Shingrix, the patient experienced headache, feeling bad and general body pain. On an unknown date, the outcome of the headache, feeling bad and general body pain were unknown. It was unknown if the reporter considered the headache, feeling bad and general body pain to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not applicable for this report. The healthcare professional stated that 5 to 10 of his patients experienced headache and body ache after receiving Shingrix. No further details available from health care professional.
Severe dizziness! Room spinning like merry go round. Lasted almost 30 hours. Only med taken was Tylenol. Was unable to walk. Had to lie flat with eyes closed .After lightheaded for at least 2days.
This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. The reporter stated that the patient inadvertently received a third dose of (Oka/Merck) VARIVAX. Does 1 of (Oka/Merck) VARIVAX was administered 15-APR-2011, dose 2 was administered sometime in February 2014 and dose 3 of (Oka/Merck) VARIVAX subcutaneous, 0.5 ml was administered on 13-AUG-2014. No symptoms reported. The outcome of the patient inadvertently received a third dose of (Oka/Merck VARIVAX was unknown. Additional information has been requested.
About 5-10 min after vaccinations (HEP A #1, VARIVAX #2) child started vomiting and became increasingly lethargic, No total LOC. Non discrete urticaria (small lesions) noted on lower abdomen. BP dropped 80/50 (previously 90/56), HR 100/min shallow respirations, pale and mildly cyanotic. Epinephrine and SoluMedrol given to which she responded. Brought to ER by paramedics for further evaluation and abt.
Patient stated while sitting in the observation area being observed , "My chest feels tight." Nurse Manager who was present was notified.  Patient had been observed 15 minutes and an additional 10 minutes. Patient denied any pain , breathing difficulties, respirations  recorded at 20 , breathing even and unlabored, oriented x's 4,  Nurse re-assessed patient  after the 15 minutes and the additional 10 minutes and patient was stable.