chrisvoncsefalvay/vaers-outcomes huggingface dataset:
legs swollen and cramping; hot flashes; chills; fever; arm was swollen; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (arm was swollen), MUSCLE SPASMS (legs swollen and cramping), HOT FLUSH (hot flashes), CHILLS (chills) and PYREXIA (fever) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0L0M01A) for COVID-19 vaccination.     No medical history.  The patient's past medical history included No adverse event. Concurrent medical conditions included No adverse event and No adverse event. Concomitant products included GABAPENTIN, HYDROXYCHLOROQUINE, POTASSIUM, LOSARTAN, BENZONATATE, LEVOTHYROXINE, MONTELUKAST, VALACICLOVIR HYDROCHLORIDE (VALACYCLOVIR HCL), TIOTROPIUM BROMIDE MONOHYDRATE (SPIRIVA), DORZOLAMIDE, PREDNISOLONE, CICLOSPORIN (RESTASIS), BRINZOLAMIDE (AZOPT), BRIMONIDINE TARTRATE, BRINZOLAMIDE (SIMBRINZA), FLUTICASONE FUROATE, VILANTEROL TRIFENATATE (BREO ELLIPTA) and ALBUTEROL [SALBUTAMOL].   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Mar-2021, the patient experienced PERIPHERAL SWELLING (arm was swollen). On 26-Mar-2021, the patient experienced HOT FLUSH (hot flashes), CHILLS (chills) and PYREXIA (fever). On 29-Mar-2021, the patient experienced MUSCLE SPASMS (legs swollen and cramping). At the time of the report, PERIPHERAL SWELLING (arm was swollen), MUSCLE SPASMS (legs swollen and cramping), HOT FLUSH (hot flashes), CHILLS (chills) and PYREXIA (fever) outcome was unknown.            Treatment information were Tylenol.
at 3 PM patient developed a tactile fever with shaking, chills, rolling her eyes to the back of her head. the seizure lasted 1 minute and family called 911. Patient stopped breathing and turned cyanotic. CPR was performed (2 breaths and 3 chest compressions) prior to spontaneous breathing resumed. Patient was taken to emergency department and Tylenol was given. Patient was seen in the office by dr. on 09/18/19.
Received Hep B injection about 8:15 AM. Pt called clinic about 11:45 AM same day with complaints of shakey, weak, having hot flashes and vomiting 7 times after eating something, slightly increased temp.
MOM REPORTED PATIENT HAD ITCHING AND RASH 1 HR AFTER ADMINISTRATION LASTING LESS THAN 45 MINUTES; EXACERBATE BY HOT SHOWER; CLEARED WITH BENADRYL.
Soreness of arm, rapid hear beat, tenderness in lymph node under arm, numbness in left side of body(arm, leg and face), feels as if heart is swollen, chest pains, feeling of cough, feels as fluid is in chest, heart hurts as if sore muscle.
Fever (102 F); This is a spontaneous report from a non-contactable consumer, the patient. A 37-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration in the right arm on 03Apr2021 at 15:15 (at the age of 37-years-old), as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204) via an unspecified route of administration on 14Mar2021 at 13:15 (at the age of 37-years-old), as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 04Apr2021 at 04:00, the patient experienced fever (102 F). The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient did not receive any treatment for the event. The clinical outcome of the event fever (102 F) was resolved on 04Apr2021.   No follow-up attempts are possible. No further information is expected.
Information has been received from a physician concerning a 62 year old female with a medical history of chickenpox and no drug allergies who on 09-JUL-2008 was vaccinated subcutaneously with a 0.65 mL dose of ZOSTAVAX in her right upper arm (lot # 659406/0298X). There was no concomitant medication. On 14-JUL-2008, the patient developed cramps on her right side and a red, papular rash that ran from the right side of her waist down along L-1 and L-2 dermatomes. The rash went as far as the top of her right knee. There were no vesicles present, but there were groups of papules. There was no fever. The patient was sensitive to touch, burning itchy pain with no systemic symptoms. The patient was diagnosed with shingles and treated with VALTREX. The patient had no fever. The pain was starting across lower abdomen, moving to right upper leg and around to right hip. The area was swabbed and also crapped with slide to obtain an adequate sample. There was approximately 50 lesions 1 cm made up of confluent papules in each patch, starting above right knee and running up leg around up right buttock to waist. The patient was recovering. No product quality complaint was involved. The patient was enrolled in the Varicella Zoster Virus Identification Program to identify if VZV is present and if it is present to identify if it is associated with the wild-type (WT) VZV strain or with the OKA/Merck vaccine VZV strain. The sample of the lesion was collected on 23-JUL-2008. The sample was taken from a papular lesion. The results was inadequate specimen, negative for B-globin and no strain I.D. Follow up information was received concerning that a lot check was requested.  Follow up information was received which reported that on 09-JUL-2008, the white patient received vaccine. There was no illness at the time of vaccination. On 14-JUL-2008, the patient began to get pain in lower abdomen. On 15-JUL-2008, pain increased and moved to lower right abdomen and top of right leg. On 17-JUL-2008, the patient's family doctor sent her to the hospital for an ultrasound of her right leg ruling out a blood clot. On 19-JUL-2008, rash started 5 inches above right knee. 21-JUL-2008, rash running 5 inches above right knee, up leg around and up right buttock to waist. On 22-JUL-2008, the patient was diagnosed shingles and given VALTREX and prednisone. Real time sonography of the right lower extremity deep venous system obtained from the level of the common femoral vein to the calf. Unremarkable compressibility and flow noted throughout. No evidence of echogenic intraluminal filling defect. Impression: no sonographic evidence of right lower extremity deep venous thrombosis. This is one of several reports received from the same source. Additional information has been requested. 12/23/08 This is in follow-up to report(s) previously submitted on 9/24/2008. A standard lot check investigation was performed. All in- process quality checks for the lot number in question were satisfactory. The lot met the requirement of the Center for Biologics Evaluation and Research and was released. Additional information has been requested.
Systemic: Anaphylaxis-Severe, Systemic: Rash (other than injection site)-Medium, Systemic: chest/throat tightness-Medium
Client reports that after HPV vaccine given on 2/27/09 she went home, started feeling dizzy, had chest pain, rapid heart rate and vomiting for 3-4 days.  No medical treatment resulted.  Symptoms resolved on her own.
pt recv 3 doses of vax between 1991 & 1992;recently pt was told that had hep B;no further details available @ this time;
Severe rash across upper torso (lasted approx. 3 days), severe headache, muscle aches, flu-like nausea, chills, skin painful to the touch
p/vax pt had new onset sz >20min;adm to hosp & started on phenobarb;
Headache, Myalgia, Fever, SkinRash, chills, fatigue, injection site redness Narrative: Pt reported fever, chills, body aches, facial rash, headache, fatigue, injection site redness after 2nd dose of vaccine resolved.
Patient tolerated well no reaction, dose was given after vial has been in fridge longer than 30 days.
Accident; Injury; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENT (Accident) and INJURY (Injury) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. In June 2021, the patient experienced ACCIDENT (Accident) and INJURY (Injury). At the time of the report, ACCIDENT (Accident) was resolving and INJURY (Injury) outcome was unknown. Not Provided          Concomitant product use was not provided by the reporter.  In 2021, the patient had accident and had to learn to walk again from injuries. No treatment information was provided. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2022-623063, MOD-2022-631095 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 18-Jul-2022: Live Follow Up contains no new information.
The patient has experienced persistent pain in the left shoulder following the administration of this vaccine on 10/12/2023. The symptoms began immediately, and are still present as of 10/28/2023.
A dry cough started on July 7.  Tested positive for COVID. Called Doctor who prescribed PAXLOVID. Symptom disappeared in two days. However on 07/21 cough returned along with runny nose. Vitals remain stable and Oxygen level is normal. Appetite is good, but he seems to be more tired than usual. Tested today and was again positive for COVID. Symptoms have lessened, however.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Sep2022 as dose 4 (booster), single (Lot number: GJ2524) at the age of 64 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Penicillin allergy" (unspecified if ongoing), notes: Known allergies: Penicillin. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: She took Paxlovid (Batch/lot number: 661437) from 18May2023 to 22May2023 for treatment of COVID-19.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300198897 Same patient, different product/event;
Information has been received from a registered nurse concerning a "high-risk" female (age unknown) with an early history of a HPV positive pap smear, followed by a "cleared" HPV pap smear (dates of testing not provided) who was then vaccinated with an unknown number of doses of GARDASIL (Lot # unknown).  It was reported that the patient may have received 2 doses.  Post vaccination, on an unspecified date, the patient had a positive HPV result on pap smear.  The patient sought unspecified medical attention in the doctor's office.  The patient's outcome was reported as not recovered.  No product quality complaint was involved.  No further information is available.
it was sore to move my arm; could not fall asleep until 4:30am; my arm became sore; a little tired; woke up at midnight drenched in sweat but not feeling cold just extremely hot; woke up at midnight drenched in sweat but not feeling cold just extremely hot; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Physician). The reporter is the patient.  A 31 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 28May2021 12:30 (Lot number: EW0202) at the age of 31 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "known allergies: Penicillin" (unspecified if ongoing), notes: known allergies: Penicillin. Concomitant medication(s) included: OMEPRAZOLE; CARAFATE. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 28May2021 16:30, outcome "recovered" (2021), described as "my arm became sore"; FATIGUE (non-serious) with onset 28May2021 16:30, outcome "recovered" (2021), described as "a little tired"; HYPERHIDROSIS (non-serious), FEELING HOT (non-serious) all with onset 28May2021, outcome "recovered" (2021) and all described as "woke up at midnight drenched in sweat but not feeling cold just extremely hot"; SLEEP DISORDER (non-serious) with onset 29May2021, outcome "recovered" (29May2021 04:30), described as "could not fall asleep until 4:30am"; PAIN (non-serious) with onset 29May2021 13:00, outcome "recovered" (Jun2021), described as "it was sore to move my arm". Therapeutic measures were not taken as a result of pain in extremity, fatigue, hyperhidrosis, feeling hot, sleep disorder, pain.  Additional information: Patient did not take other vaccine in four weeks, did not test COVID prior vaccination and post vaccination.It was stated that He  was fine when he got his shot at 12:30pm 28May2021 around 4:30 his  arm became sore and a little tired, he went to bed around 10 woke up at midnight drenched in sweat but not feeling cold just extremely hot, could not fall asleep until 4:30am. Woke up around 1pm that afternoon with bo symptoms except for he felt like he fell down a flight of stairs (right arm) could not lift it for about 6 days it was sore to move his arm but not sore to the touch. Now he feel normal.  No follow-up attempts are possible. No further information is expected.
Positive COVID test on 2/1/2022 and expired on 2/28/2022.
arm sore at injection site for 2 days. lumpy feeling after about 6 days. Red area appeared more than a week after shot. area itchy.
Information has been received from a registered nurse (R.N.) concerning her 15 year old daughter with no pertinent medical history, drug reactions or allergies who "three months ago", on approximately 18-APR-2008 was vaccinated with a dose of GARDASIL.  There was no concomitant medication.  "Approximately two months ago", in approximately May 2008, the patient began to experience numbness and tingling in her hands.  On 16-JUL-2008 the patient experienced two episodes of syncope during which she lost consciousness and hit the floor.  On 17-JUL-2008 the patient noted that all of her muscles felt tired.  Allergy tests were performed (results not provided).  At the time of the report, the patient's event persisted.  The patient did not seek medical attention.  The reporter considered numbness and tingling in hands, syncope and muscles tired to be immediately life-threatening.  Additional information has been requested.
Pt was admitted for symptomatic anemia and acute decompensated heart failure with acute respiratory failure with hypoxia.  Pt was tested for COVID on day 2 of admission and positive.
Pt came into the immunization clinic to get his H1N1 immunization at 15:25. The patient was screened with the military H1N1 questionnaire and the questions were reviewed by the screener with the patient.  The patient was cleared for the immunization and the immunization was given at 15:28.  At 15:40 the patient started scratching around his neck, face became flushed, started a slight dry cough and bean clearing his throat. Patient then complained of some tightness in his throat, generalized itching, with a generalized no raised erythmic rash noted on his chest and back.  Anaphylaxis protocol started at 15:41 with Epinephrine 1:1000--.3 mgm--IM--LVT. MD notified and was at patient's side within 2 min.  MD examined patient and Benadryl 50 MG given IM LUOQ at 15:45. 15:50--patient given SoluMedrol 125 mg--IM--RUOQ per order.  15:55-patient given Epinepherin 1:100--.3 mgm--IM--RVT.  Patient remained alert, oriented X3. SAO2 remained between 96% to 98%.  Pt. was paced on oxygen via nasal cannula for the first 30 minutes. Pt color remained pink. Skin was warm and dry within 30 minutes.  Rash subsided and patient denied dysphagia, dyspnea after 15 min. of treatment.  Pt. was observed for aprroximately 2 hours and was sent home with a prescription for Predinsone and a return apppointment in 24 hours with Dr.
I did not have an adverse reaction to the vaccine but I contracted Covid 19. I tested positive on June 13.  I started to not feel well early morning on June 13. Nasal congestion, cough, fever and chills and extremely tired for two days.  Home test on June 13 which showed positive very quickly. I got the prescription Paxolovid from my provider and started to feel better. I retested on June 20 and it was negative.
no adverse event; Nurse reported VARIVAX  was administered after TE; see TE case 02487539. See full details below. No additional AE/no PQCs.    ?    Names of vaccines involved VARIVAX X000532 1/4/2025        ?    Temperature 8.1°F        ?    Time frame 3 hours; This spontaneous report was received from Other Health Professional and refers to a patient of unspecified age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 25-SEP-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 1 dose, lot #X000532, expiration date: 04-JAN-2025 (strength, route of administration, and indication were not provided).   The nurse reported varicella virus vaccine live (oka/merck) (VARIVAX) was administered after temperature excursion (TE) of  8.4 degrees F during a time frame of 3 hours. No Previous temperature excursion was reported. No additional adverse events (AE) were reported.    ?
Patient is a 68 year old female. She requested an MMR stating her community college requires the vaccine. Patient was inadvertently given an MMRV instead of MMR.
Migraine; This spontaneous case was reported by a patient and describes the occurrence of MIGRAINE (Migraine) 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 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced MIGRAINE (Migraine). At the time of the report, MIGRAINE (Migraine) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   The patient did not receive any treatment.
MODERNA COVID VACCINE #3 GIVEN 11/16/21, LOT #066F21A; pt is a resident at a facility; to ED with AMS, hypoxia; c/o intermittent chest congestion x 1 wk; today more altered, lethargic, notably cyanotic; O2 supplementation; hypotensive; mid-April she had a positive COVID test; CT showed left lower lobe collapse; AHRF; ICU; corticosteroids and ABX; guarded prognosis; critically ill; status changed to DNR and eventually comfort measures only; vasopressors and BiPAP removed; pt passed away in the hospital
1st Engerix-B vax given JAN90. 3-4 days p/ vax, experienced URI & sinusitis; sx resolved. p/2nd vax MARCH90 exp'd delayed hypersensitivity rxn incl extreme pruritus involving all extremities & scalp. Also exp'd arthralgias - still persists
Received first dose 1/10/21 and 2nd dose 1/26/21, only 16 days apart.
This case was reported by a consumer via call center representative and described the occurrence of sinus infection in a 76-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included sinus infection (recurring). Previously administered products included NUCALA with an associated reaction of alopecia (refer case US2019012862). In January 2019, the patient received the 1st dose of SHINGRIX. In January 2019, less than a month after receiving SHINGRIX, the patient experienced sinus infection, rhinitis, wheezing and difficulty breathing. On an unknown date, the outcome of the sinus infection, rhinitis, wheezing and difficulty breathing were not recovered/not resolved. It was unknown if the reporter considered the sinus infection, rhinitis, wheezing and difficulty breathing to be related to SHINGRIX. Additional details were reported as follows: This call was transferred. The patient stated she had recurring sinus infections and had a sinus infection at the time of reporting. The patient stated she got them all the time. In January 2019 this year, the patient received the SHINGRIX vaccination and was going to get the 2nd dose. The patient stated she saw a top doctor for sinusitis and rhinitis and for her there was no cure. The patient stated they were debilitating with difficult breathing and wheezing. The additional vaccine information was not provided. The reporter gave consent to follow-up. This case has been linked to the US2019012862, reported for the pharma suspect of the same patient.
was given the 2nd shot on September 7, 2021.  Woke up in a pool of vaginal blood, uncontrollable bleeding- went to ER- had vaginal exam no reason for this much bleeding- have never bled this much in my life- they gave me a type of progesterone pill to help slow the bleeding down- I was weak, faintish, and felt muscle weakness.  from then on my life has changed for the worst- I continued with horrible periods with large clotting and copious amounts of blood- never had a heavy period in my life like this.  Muscle weakness progressed, extreme headaches, migraines muscle tightness in neck and whole back developed in Feb 2022. In and out of ERs for months, tons of scans, blood work, tests.  weakness progressed mostly in legs- May 2022- noticed legs felt numb, tingly, burning- waiting to see neurologist quite scared.   Sept 2022- diagnoses with a small nerve neuropathy by biopsy in right calf and right thigh, both were positive.  Muscle weakness, tingling, burning, sharp jots lightning bolts in legs, muscle spasms, nerve pain, heaviness so severe I can't sleep.  I am still suffering to this day and it has only gotten worse.