chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Leg swelling, "It's different this time"; Sensitivity dorsally from knee to calf; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Leg swelling, "It's different this time") and HYPERAESTHESIA (Sensitivity dorsally from knee to calf) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 011M20A) for COVID-19 vaccination.     The patient's past medical history included DVT (groin to ankle left leg), Benign essential tremor and Factor II deficiency. Concurrent medical conditions included Shellfish allergy, Sulfonamide allergy, Iodine allergy, Gluten sensitivity, Dairy intolerance and Drug allergy. Concomitant products included APIXABAN (ELIQUIS), PROPRANOLOL, LEVOTHYROXINE SODIUM (SYNTHROID), NORTRIPTYLINE, RABEPRAZOLE SODIUM (ACIPHEX), FEXOFENADINE HYDROCHLORIDE (ALLEGRA), FUROSEMIDE and BETAMETHASONE for an unknown indication.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced PERIPHERAL SWELLING (Leg swelling, "It's different this time") and HYPERAESTHESIA (Sensitivity dorsally from knee to calf). At the time of the report, PERIPHERAL SWELLING (Leg swelling, "It's different this time") and HYPERAESTHESIA (Sensitivity dorsally from knee to calf) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Ultrasound scan: (Negative) Negative.         The concomitant medication included singular used for an unknown indication.  The treatment medications were not provided.  The action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-049437 (Patient Link).
Accidentally gave patient a 2nd dose of PREVNAR 13 (1st dose was given on 9/30/17). As of 10/8/18, the patient was not experiencing any side effects other than sore arm at site of injection.
dx w/GBS; seen beginning 27OCT92 w/stable angina, on 5NOV92 w/Hep B f/u; dx 2NOV92; on 16NOV92 for ETOH abuse;
Patient returned to office aprox 24 hours after vaccine administration. He presented with tense, pink, puffy left arm from shoulder to right above elbow, He was able to move arm and fingers. Mild tenderness noted with touch. He was afebrile and had no other symptoms. Treated with ibuprofen 200 mg and Benadryl 25 mg every 6 hours or when needed.
1st dose on 28-Jul-2020, 2nd not received; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a 80-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 28th July 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.       Additional Information: GSK Receipt Date: 24-OCT-2022 Reporter's Comments: The office staff reported that a patient received 1st dose of Shingrix and had not received 2nd dose. The reporter consent to follow up. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of shingrix, which led to incomplete course of vaccination.
Due to confusing way in which the expiration date is listed on box and vial 25 July 22 the patient received an expired dose of vaccine.  There was no adverse effect and the vaccine was scheduled to be regiven.
Upper arm, shoulder is hot to the touch, redness in arm and some swelling started shortly after vaccine. By 10/22/15 pm redness and swelling still there and in moving down her arm toward elbow area.
Patient received Jansen vaccination on 4/8/21 at another clinic, then received Pfizer dose 1 at this pharmacy on 9/11/21, and dose 2 at another pharmacy on 10/2/21.  Patient did not disclose at either visit that she had Jansen previously.
Patient felt dizzy, was sweating, and then fainted and lost consciousness a few minutes after receiving her first covid shot. She was sitting in front of the pharmacy in our post vaccination chairs. We noticed that she moved herself to the floor. I went out there to see if she was ok. She said she felt dizzy and faint. I started to fan her to cool her off. Then her eyes rolled back and she started to lose consciousness. We used the ammonia inhalant salts to try to arouse consciousness. We took her blood pressure and did call 911. After a few minutes, she regained consciousness. By the time the paramedics came, she was ok. We had her stay in the pharmacy post vaccination area for 30 minutes before she left with her husband.
Hives starting 36 hours after injection, lasting 3 days, used antihistamines with modest improvement
11:00pm woke with headache, heart racing, chills, and shaking so hard I couldn't get out of bed. Grabbed more covers and tried to get warm. Had vivid, swirling dreams. 12:30am Did not realize that much time had passed. Still had all the above symptoms. Woke husband to get 2 extra strength Tylenol. 1:00 am Shaking stopped. Still had vivid dreams and headache. 2:00 am Got up. Temp 102F. very thirsty. 8:00am Temp 101F. Took 400mg  Ibuprofen. Headache gone 4:00pm Temp 99F 9:00pm took Advil, no temp, just tired. Next day just tired Next day fine
4/23/21 Severe headache began within 2 hours of receiving the vaccine.  Body ache, chills and low grade fever into the evening and overnight. Sore right arm.   4/24/21 In the morning headache and body ache.  Late afternoon severe body ache, chills, 101 degree fever.  800mgs of ibuprofen and 1000mgs of Tylenol every 6-8 hours did not bring the fever down.  Sore right arm.   4/25/21 Headache and body ache all day. Late afternoon headache continued but with severe body ache, chills, 100 degree fever, swollen lymph nodes in right arm pit,  red, hot and swollen rash between right shoulder and neck,  sore arm.  We called the emergency department  and they stated it could take up to 3 weeks before the painful swollen lymph nodes in the arm pit would dissipate.  They left it up to us whether to come in. We chose not to because we didn't feel there was anything more they could do for us.
Narrative: Medical Center. J&J vaccine 3/10/21. Cough, malaise, syncopal episode, pneumonia, symptoms x 8 days. Discharged to home.
tested positive for COVID-19; tested positive for COVID-19; felt like a bad cold; This is a serious spontaneous report from a non-contactable consumer. This consumer reported similar events for herself and 1 patient. A 83-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: Unknown), via an unspecified route of administration on 10Feb2021 as a 1st dose, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient received their first dose of the Pfizer COVID-19 vaccine on 10Feb2021, and he was scheduled to receive second dose on 03Mar2021, however, he was exposed to COVID-19. Tested positive for COVID-19 and he had very mild symptoms and reporter stated that "he has been over it for at least a week." reporter said, "it will be 10 days ago tomorrow" [tested positive 9 days ago]. Patient had been in quarantine since they were exposed and that their required isolation time will be finished tomorrow (on an unspecified date). Patient had an appointment at his doctor's office tomorrow (date unknown). She was inquiring about receiving the second dose of the Pfizer COVID-19 vaccine after testing positive for COVID-19 and wanted to know if Pfizer can reschedule patient's appointment to receive his second dose of the Pfizer COVID-19 vaccine. It was reported that, he was exposed to COVID-19 along with quite a few people and everyone else was considerably younger than him. Patient's symptoms were very mild and stated that it "felt like a bad cold" and he attribute that to having had the first dose of the Pfizer COVID-19 vaccine in his system. Reporter wanted to know if the first dose could have helped his symptoms be milder than their friend's symptoms since their friends had not yet received any of the COVID-19 vaccines yet. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021289665 Same reporter,event, product/ different patient
I had a headache for a couple of days and than it went away; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 16 year-old female patient received bnt162b2 (BNT162B2), administration date 19Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset 2021, outcome "recovered", described as "I had a headache for a couple of days and than it went away".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021304214 Same reporter/same drug, different patient/ event(split)
Redness and mild swelling with few indurated wheals on bilateral lower extremities and redness at injection sites 5 minutes after vaccinations. Diphenhydramine given and redness, swelling and wheals resolved 15 minutes later. 2 petechial spots on left lower leg appeared.
COUGH, CHEST TIGHTNESS, ARM IS SORE AND SWOLLEN A LITTLE.  CHEST TIGHTNESS IS WORSE WHEN COUGHING.
After receiving the rotavirus vaccine, on 4-28-2011 the patient experienced diarrhea for 7 days.
Racing heartbeat, thready pulse, extreme redness to eyes, chills, hoarseness, deep cough. Elevated blood pressure, slight fever.
Information has been received from a physician and registered nurse concerning a patient who on an unspecified date was vaccinated with a dose of Zostavax (Oka/Merck) instead of Varivax (Oka/Merck) (MSD).  There were no known symptoms reported.  The incident was "due to human error".  There was no further information provided.  There was no product quality complaint involved.  This is one of several reports from the same source.  Additional information is not expected.
Information has been received from a health professional concerning a 61 year old female physician who on 9/30/00 was vaccinated with pneumococcal vaccine 23 polyvalent (lot 633102/1217J). Subsequently, the pt experienced injection site redness, inflammation, swelling and a rash. The rash has also spread since 9/30/00. Unspecified medical attention was sought. No further information is available.
Blurry vision on 09/29/2013, then on 09/30/2013, rash on torso, low grade fever, feeling sluggish, then on 10/01/2013, rash spread to entire body and itchy, patient sought medical attention.
A few hours after receiving the vaccine on 6/2/2021, patient developed a low-grade temp. Then through the night he started having nausea, vomiting, and diarrhea which worsened on 6/3/2021. He had very poor appetite and very poor oral intake.  Within 24 hours of receiving vaccine,  he developed hypoxia and required 4L via NC to maintain an oxygen saturation in the low 90s. Stat CXR was obtained on 6/3/2021 with no acute findings. Patient received phenergan 12.5mg IM injection X 1 which did improve nausea and vomiting. Diarrhea continued. Patient has poor urine output. Tachycardia with pulse of 122, BP 118/62.   Patient was seen for an acute visit by this NP on 6/4/2021.  Patient is lethargic but does awaken to tactile stimuli. He tolerates PO fluids. He is lethargic. Stat labs obtained for concerns of dehydration.  Will plan to order IV fluids for hydration after reviewing lab results.
Patient had Pneumovax and Flu shots at another facility on 10/20.  She had shooting pains in her legs and arms and weakness and lethargy later that evening and continuing through today.
is it safe to get 2nd Moderna shot after 6 weeks?; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (is it safe to get 2nd Moderna shot after 6 weeks?) in a patient of an unknown age and 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 23-Jun-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (is it safe to get 2nd Moderna shot after 6 weeks?). On 23-Jun-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (is it safe to get 2nd Moderna shot after 6 weeks?) had resolved.            No concomitant medication was reported. No treatment drug details was reported.   Reporter did not allow further contact
This was a booster shot, and the third shot from Pfizer for the Covid Vaccine.  I had the same reactions to all three shots.  The first day after shot, severe body aches,  chills, and headache.  I am also perimenopausal, I hadn't had menstrual periods for 6 months, but  weeks after getting the first shot, I got severe PMS symptoms including  migraines, bloating, etc, that I normally got before menstrual period. The day of second shot, I got a menstrual period with severe cramping, along with the body aches, chills in the reaction.  After that cycle, I stopped having PMS symptoms and menstrual periods again.  After third shot,  2 weeks later I'm experiencing severe PMS symptoms again, with migraines, bloating, etc.
I woke up noticing a slight headache, but I figured it was from poor sleep the night prior. I noticed after breakfast that I felt really cold and felt an internal shiver, especially in my chest. My fingers and toes were ice cold even with a sweater, blanket, and a warm tea. I noticed my skin starting to feel tender and I felt very fatigued. I wanted knew I needed to eat so that I could take ibuprofen, but I experienced a loss of appetite. I had a mild cough, but I felt too tired to even cough. I rocked in a chair in the sunlight outside for about 15 minutes and still felt cold. When I took my oral temperature after coming inside, I was reading 99.9. I took 400mg of Ibuprofen by 1130 and layed down to rest. Bundled in 3 layers, I felt the shivering couldn't stop. My headache got worse and my skin was tender to the touch. I was able to sleep for approximately 3 hours and I woke up drenched in sweat. I took my oral temperature again and was at 101.1. I drank some more water and tried to sleep some more. When I woke up around 4:30 pm, I felt a lot better. My temperature went down to 97.8 and I had a boost in energy and appetite. I no longer had a headache and I had only mild muscle aches. By the next morning, I felt completely normal again.
Pt received HIGH DOSE flu within 8 hrs had fever of 101 degrees and was vomiting. Has resolved pt feels "weak".
Received COVID booster on 1 DEC.  Noticed left sided facial droop , loss of muscular control on left side of  face, inability to close left eye.  Transported self to ER at the Medical Center ..  ER doctor diagnosed me with Bell's Palsy on 4 DEC.  Followed up with PCM on 8 DEC at the Clinic.
Red rash appeared on Left upper arm. It was raised and itchy and mild wheezing accompanied the rash and itchiness. Oral Benadryl 50 mg taken twice approximately 10 hours apart. Rash was present 24 hours. Mild wheezing and allergy symptoms present approximately 18 hours.
Patient complained of Left hand tremors and issues with motor skills two days after second dose of the Pfizer vaccine.
Woke up at 2AM the next day with a temp of 101.0 F, pain all over my body-joints, muscles and injection site was red, swollen and hot. I took acetaminophen and ibuprofen. I noticed a slight improvement but when these meds wore off I was back to the adverse reactions. In the following days I stayed the same except I started profusely sweating. Now is day 8 and my arm of the injection site continues to hurt. I cannot reach or hold anything. I read all the info about the Fluad 65+ vaccine. I should never have ANY VACCINE with SQUALENE!
pt recv vax 930AM; MOC called clinic 230PM reporting that pt had been crying continuously since inj; denied any swelling, redness @ inj sites; no fever; advised cool compress to site & APAP; 430PM infant sleeping;
Soreness at injection site Fever102.3 , fatigue headache muscle and joint aches, abdominal pain, nauseous lasted approximately 36 hours. My symptoms were worse than when I had actually had COVID in November 2020 and I was not hospitalized in November. Injection  was on Friday and symptoms improve by Sunday morning!
Information has been received from a female physician consumer (age not reported) with environmental allergies, penicillin allergy and allergy to lidocaine and clindamycin who a long time ago was vaccinated with first and only dose of Pneumovax 23 (lot # not reported).  One half hour post-vaccination, the patient developed hypotension and felt like she was going to pass out.  The outcome was not reported.  No further information is available.
pt recvd vax 27AUG93 20SEP93 fever 104 few days seen by MD; 23SEP93 rash for 24 hrs; & cold sweats;
Patient's injection site from varicella vaccine (upper right arm) swollen and red. <24 hours later, red blisters on chest, face, and scalp.
Pt recvd vax 09April97 & 08April97 exp inj site pain,redness & SC induration (3.5 cm), poss cellulitis & abscess.Date of last TD unknown. Pt seen 21April97 & no change in pt status.
Pt. Had 1st dose of Moderna COVID-19 vaccine on 3/22/21 at 7:45am. Pt. States she stayed at the vaccine location for approx. 15 minutes after receiving the vaccine and felt no symptoms. Once pt. Got in her car to go home she developed a feeling of pressure building up in the right side of her face and head. Pt. States she ended up going to the ED and had a BP of 204 upon arrival. Pt. States she was give Clonidine and prior to discharge her BP was 146/54. Pt. Also reports having memory problems for 24 hours after receiving the vaccine. Pt. States she would try to say "Super center store name" and end up saying "another name" Pt. States she is not having any symptoms to be triaged for at this time - but ultimately wanted to make sure this adverse reaction was noted. Pt. States her PCP is aware and she has the correct follow-up at this time.         From ED visit: CHIEF COMPLAINT:  OTHER (got covid shot. has head pressure. did feel like throat was swollen for a few minutes, but that resolved. ) Assessment/Plan  DIAGNOSIS at time of disposition: 1. Essential hypertension    MEDICAL DECISION MAKING 75-year-old female presents today to the emergency department for evaluation of symptoms after receiving her 1st COVID-19 shot.  Upon arrival to emergency depart patient is well-appearing and nontoxic.  Vital signs reviewed.  Patient is fairly hypertensive.  She describes the symptoms coming on immediately after shot.  Her neurologic examination is strong.  I do not appreciate any evidence of allergic reaction at this time.  Because of her hypertension here in the emergency department did assess basic labs.  She is given 0.1 mg of oral clonidine.  Blood pressure show significant improvement.  Patient is feeling much better at this time.  Certainly may have been a component of blood pressure here so I am unsure if this was related to her COVID-19 shot.  I did discussed follow-up with primary care physician as well as return criteria.  Patient is discharged in stable and improved condition.   BLOOD PRESSURE SCREENING: Based on last blood pressure taken in the ED of 146/54, active Diagnosis of HTN, patient excluded from screening.    Medications cloNIDine (CATAPRES) tablet 0.1 mg (0.1 mg Oral Given 3/22/21 2031)
This spontaneous report as received from a registered nurse refers to a 17 month old patient of unknown gender. The patient's concurrent conditions, medical history and drug allergies were not reported. On 17-OCT-2016, the patient was vaccinated with improperly stored PEDVAXHIB (dose and route not reported) from lot # M020102, expiry date: 08-MAR-2019, for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous temperature excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1610USA014705: US-009507513-1610USA014706.
Acute disseminated encephalomyelitis (ADEM): leg weakness; left face, arm, and leg sensory symptoms; no fever or other viral illness symptoms; increased DTRs, sustained B/L ankle clonus; MRI brain and spine showed multiple enhancing white matter lesions; CSF showed 40 wbcs, 2 rbc, prot 41; treated with high dose steroids and improved. 8/27/09 Additional correspondence rec'd from parent and PCP from date of vax until admission to hospital for ADEM. Immediately after receiving vaccines pt became pale and diaphoretic-dx with Vagal Rxn by PCP and recovered. 1 week later pt developed back pain, numbness in the arms and legs, vomiting and collapse, abdominal pain, H/A and L sided facial numbness.  Several ER and office visits.  Later developed constipation and difficulty and pain emptying the bladder and worsening numbness causing inability to walk and falls.  Finally admitted with dx:  ADEM  9/14/09 Neurology Consultant records received DOS 8/5/09. Assessment: Acute disseminated encephalomyelitis (ADEM type). Felt sick to stomach, became dizzy and collapsed. Back pain one week later, collapsed and threw up. Abdominal pain backache, headache, left-sided facial numbness. Numbness of left leg, problems urinating constipation. CNS examination reveals small area of numbness Left V2 V3 distribution.10/16/2009 received hospital records from dates 7/18-7/22/2009. Presented with sx of lt facial numbness, bilateral arm/leg numbness, and back pain. PE noted bilateral ankle clonus, abnormal gait. MRI noted white matter lesions with longitudinally extense T4-T7. CSF abnormal. TX: IV Steroids x 5 days, DC DX: ADEM 10/19/09 DC summary and hospital records received for dates 7/18/09 to 7/22/09.  DC DX: Disseminated Encephalomyelitis. Presenting SX: backache, facial numbness, difficulty walking/standing, constipation. Pt.admitted for eval.  Assessment: Tender over lower thoracic region, loss of sensation over left side face, unsteady gait, ankle clonus, sluggish BS. Pt had tx and PT then DC with improved status.
Mom reports fever up to 100, vomiting and leg soreness. Fever of one day followed by leg soreness and vomiting x 3 days. Legs were tender to the touch and appears red/purple per mom. No difficulty breathing or other rash noted.
7-hour duration of general lethargy, joint pain, chills, temperature of 101.2                         Went to bed that evening and woke up just fine following morning........