chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information regarding Flumist (2003-2004 Formula) (influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) was received from a consumer regarding a 8-year-old male patient who experienced fever 102 deg F., secondary sinus infection, headache and GI symptoms. At 8 years of age, the patient received the second dose on 18-Feb-2004. Medical History: the child had no relevant medical history. The child was reported as "fine" following receipt of her first dose of Flumist on 16-Dec-2003. Product Details: Indication for Flumist (2003-2004 Formula) was immunization. Product was administered on 18-Feb-2004. Dose regimen was 0.5 mL (intranasal). Concomitant Therapy: Patient was not taking concomitant therapy. Event Details: On 20-Feb-2004, he developed a fever of 102 deg F. (pyrexia) for 2 days followed by a secondary sinus infection (sinusitis). He was treated with Tylenol (acetaminophen) and recovered. In March 2004, he again developed a fever of 102 deg F. with headache (headache) and GI symptoms (gastrointestinal disorder). He was treated with Tylenol (acetaminophen) and recovered by 16-Mar-2004. The reported indicated that the physician was not notified of these events. No additional information was available at the time of this report. Follow up: follow up information received from the physician provided sibling immunization history and medically confirmed the event.
Enlarged(swollen) Lymph node at the lower left side of throat, pain at lymph node, sore throat
Raised rash that was warm to touch and painful that started about an hour after being vaccinated. Pt. used ice and benadryl and that helped.
Soreness getting worse day by day and month by month leading to pain in the entire arm to the point of being unable to move it without pain. Even simple movements caused pain.  Finally in July I went to an orthopedic MD and he diagnosed it as bursitis and/or possible frozen shoulder.  With a cortisone shot and PT, I have made much improvement....however, I still have some pain and limited mobility.  I am scared to get another flu shot and may not this year due to this experience.
Information has been received from a nurse concerning a patient who was vaccinated PO with a dose of Rotateq.  The patient experienced rotavirus infection 2 days after vaccination.  The patient was seen by a physician for medical attention.  The outcome was unknown.  There was no product quality complaint.  Additional information has been requested.  Follow-up information from a physician's office practice manager indicated that the office was not aware of this incident.  No further information is available.
Patient is a 32 y.o. male with no significant medical history who was admitted from the ED for chest pain.  Patient has minimal medical comorbidities.      Patient reported substernal chest pain that has awoke him from sleep. He reported that he had a viral type symptoms earlier this week including a sore throat, body aches, an intermittent headaches that lasted for a couple a days.  During this time he had a strep test on 10/28/2021 which was negative.  These symptom resolved.  Patient had his 1st COVID-19 vaccination (Pfiszer) on 10/19/2021.    In the ED, initial VS included:  Blood pressure 119/70, heart rate 68, respiratory rate 17, oxygen saturation 99% room air, and temperature 36.7° C.  The initial 12 lead ECG showed:  Sinus rhythm at 86 bpm with ST elevation consistent with early repolarization particularly predominant in his inferior and lateral leads.  Laboratory tests were notable for:  Hemoglobin 15.0, hematocrit 44.4, leukocytes 6.4, platelets 268, sodium 138, potassium 5.4, BUN 13, creatinine 0.81, glucose 91, and initial high sensitivity troponin markedly elevated at 574.  2 hour troponin increased to 707.  6 hour troponin was 841 and was trended daily.  Subsequent troponins were 661, 430. CRP was slightly elevated, down trended prior to discharge.  Sed rate was elevated at 27 at the time of admission. Daily EKG were obtained, ST elevation resolved.   Cardiac MRI was obtained on 11/01/2021.  MR findings are consistent with acute myocarditis with myocardial edema and corresponding scattered foci of sub pericardial delayed enhancement in the LV.  LV is of normal size with preserved systolic function, calculated LVEF 53%.  RV is normal size and systolic function, no delayed enhancement seen in the RV free or inferior walls.   Consultation to discuss vaccine recommendations in this setting.  At this time it is recommended that he not receive mRNA vaccinations.   His history, presentation, physical and diagnostic findings consistent with myocarditis were discussed with MD. He recommends no specific day-to-day restrictions.  Patient was advised to avoid competitive sports for 3 months and to follow up with a cardiac MRI in 3 months as well as a follow-up in a clinic. If symptoms of recurrent chest discomfort or dyspnea, he should be seen sooner.
It was fatigue, congestion that was pretty much it. I did get Paxlovid and I took some over the counter cough suppression medicine. I probably had some Motrin during that time as well. My symptoms lasted for maybe about four days.
No additional AE/No PQC; PROQUAD was administered to 3 patients after the most recent prior excursion on 4/11/2023 and before the current excursion on 5/4/2023. Date of administration was unknown at time of call.; This spontaneous report was received from the Medical Assistant and refers to a 4-year-old patient of unknown gender.  The patient's medical history, concurrent conditions, and concomitant therapies were not provided.  On an unknown date in 2023, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (recombinant Human albumin) injection, 0.5 milliliter, lot #W012728, expiration date: 16-OCT-2023, administered for prophylaxis (anatomical location, strength, and route of administration were not provided) after the "most recent prior" excursion on 11-APR-2023, and before the current excursion on 04-MAY-2023 (product storage error). No additional adverse events.  The causality between events and suspect therapy was not provided.  This is one of the three reports from the same reporter.; Sender's Comments:  US-009507513-2305USA003457:Merck US-009507513-2305USA003128:Merck
4/4/22 (3 days post vaccination) Patient developed induration in right thigh (where Proquad was administered) which was improving. 4/6/22 (5 days post vaccination) developed right thigh pain + overlying ecchymosis + edema. Patient reported pain with walking. 4/10/22 (9 days post-vaccination) Patient seen in office noted to have mild edema & ecchymosis right lateral thigh mildly tender to palpation but mom does report some improvement since onset.
Left arm injection site swelling up. Patient was adviced for cold compresses to the area with good relief also had returned on 4/9/03 treated with antibiotics (Cephalexin) by MD. Patient was seen in clinic for physical exam.
Morning after vaccine, woke up with severe hearing loss in my left ear. On 12/18/2019, I started on a course of Prednisone, and then on 12/20/2019 I had the first of 3 Intratympanic  Dexamethasone injections. On 12/24/2019 I had my 2nd injection and my word recognition went from 4% to 64% on hearing test. On 12/30/2019, I had my 3rd injection. My hearing gradually improved.  My hearing test on 01/06/2020 showed my hearing was back to where it had been before the vaccine.
Patient received the FLUARIX QUAD vaccination, administered by this reporter Rph, on 09/30/2016. At the time of administration, there were no issues or complications with the injection, patient felt fine before leaving the store. On 10/23/2016, patient returned to the pharmacy to report that on the day of receiving the vaccination, she felt fine afterwards but a few hours later started feeling soreness on her right shoulder (where she received the injection). She reported that she continued to feel soreness and pain and that because she usually sleeps on that side of her arm it was inconvenient. She thought that it would go away after a while, as soreness is common as a side effect of flu vaccinations, but even after a few weeks, she is still feeling the soreness and slight pain. On the day of reporting, she showed her shoulder to RPH: there were no visible signs of distress or damage on the shoulder. Patient agreed that her shoulder and arm looked normal, she only felt the discomfort. Patient was advised to take over-the-counter pain medicine and possibly a cold pack for the discomfort, and to report back if symptoms still do not resolve.
p/recv vax pt exp erythema; fever 104; systemic rash & cellulitis w/significant induration about 4'' across & sharply demarcated; pt seen by MD & treated w/lorabid; benadryl; pt recovered 10/9/98
Patient's daughter called clinic to report adverse reaction. Call transferred to nursing supervisor: LVN. Per nurse daughter stated patient complained of having : fever, chills, body aches, swollen area of injection site and it being tender and hard. Nurse supervisors: LVN and RN advised patient to go to the hospital to be examined as soon as possible.
nuerosweet syndrome; This spontaneous case was reported by a patient family member or friend and describes the occurrence of ACUTE FEBRILE NEUTROPHILIC DERMATOSIS (nuerosweet syndrome) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ACUTE FEBRILE NEUTROPHILIC DERMATOSIS (nuerosweet syndrome) (seriousness criterion hospitalization). The patient was hospitalized for 6 days due to ACUTE FEBRILE NEUTROPHILIC DERMATOSIS. At the time of the report, ACUTE FEBRILE NEUTROPHILIC DERMATOSIS (nuerosweet syndrome) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Very limited information regarding this event has been provided at this time.  Further information has been requested.   This case was linked to MOD-2021-080668 (Patient Link).; Sender's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
9 hrs post injection, fever 103 for day and half, sore eyes, cough & body ache.
This spontaneous report was received from a physician refers to an unknown umber of patients of unknown age and gender. No medical history was reported. On unknown dates, the patients probably were vaccinated with MMR II (lot #, expiry, dose, route not reported). No concomitant medications were reported. The physician reported that there have been outbreaks of mumps in unspecified colleges in his area, in patients that he stated probably had received MMR II. The outcome of mumps was unknown. This is 1 of 2 reports received from the same reporter. Additional information has been requested.
Difficulty walking the whole day; Right knee did not have visible swelling, but felt like it was swollen on the inside and was worse than normal; Could not walk due to extreme pain in left knee, felt like my left knee had been thrashed; Sore arms; Chills; Fatigue; Low grade fever; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 08-Mar-2021 and was forwarded to Moderna on 09-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arms), GAIT DISTURBANCE (Difficulty walking the whole day), JOINT SWELLING (Right knee did not have visible swelling, but felt like it was swollen on the inside and was worse than normal), CHILLS (Chills) and FATIGUE (Fatigue) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Cancer and Immunocompromised. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL), CLONAZEPAM and RISPERIDONE for an unknown indication.    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arms), CHILLS (Chills), FATIGUE (Fatigue) and PYREXIA (Low grade fever). On 05-Mar-2021, the patient experienced GAIT DISTURBANCE (Difficulty walking the whole day), JOINT SWELLING (Right knee did not have visible swelling, but felt like it was swollen on the inside and was worse than normal) and ARTHRALGIA (Could not walk due to extreme pain in left knee, felt like my left knee had been thrashed). The patient was treated with ACETAMINOPHEN ongoing since an unknown date for Arthralgia, Chills, Pyrexia, Pain in extremity, Gait disturbance, Joint swelling and Fatigue, at an unspecified dose and frequency and OXYCODONE HYDROCHLORIDE, OXYCODONE TEREPHTHALATE, PARACETAMOL (PERCOCET [OXYCODONE HYDROCHLORIDE;OXYCODONE TEREPHTHALATE;PARACETAMOL]) ongoing since an unknown date for Chills, Arthralgia, Gait disturbance, Fatigue, Pyrexia, Joint swelling and Pain in extremity, at an unspecified dose and frequency. On 22-Feb-2021, PAIN IN EXTREMITY (Sore arms) had resolved. On 06-Mar-2021, GAIT DISTURBANCE (Difficulty walking the whole day), JOINT SWELLING (Right knee did not have visible swelling, but felt like it was swollen on the inside and was worse than normal) and ARTHRALGIA (Could not walk due to extreme pain in left knee, felt like my left knee had been thrashed) had resolved. On 07-Mar-2021, CHILLS (Chills) and FATIGUE (Fatigue) had resolved. At the time of the report, PYREXIA (Low grade fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Patient under 18 years of age got vaccine administered; A spontaneous report was received from a nurse concerning a 17-year-old, patient, who received Moderna's COVID-19 vaccine (mRNA-1273).  The patient's medical history was not provided. No relevant concomitant medications were reported.   On an unspecified date, prior to the onset of the events, the patient received a dose of two planned dose of mRNA-1273 (Lot number: 043L20A) intramuscularly for prophylaxis of COVID-19 infection.   Action taken with mRNA-1273 in response to the events is not applicable.   The outcome of the event was considered as recovered.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age (17 year old) for mRNA-1273 (lot number 043L20A) with no associated AEs reported.
Information has been received from a pharmacy technician via agency (other company US15-041314), referring to a 53 year old female patient who was a smoker. The patient's concomitant medication and past drug history were unknown. On 02-SEP-2015 the patient was vaccinated with a dose of PNEUMOVAX 23, lot # K010016, expiration date 05-AUG-2015, Intramuscularly in the left deltoid, once, for prevention of pneumonia. After the vaccine was given it was discovered that the vaccine was expired. After the injection the patient was acting okay. It was unknown if there was any relevant laboratory data. As of 02-SEP-2015 it was unknown if she would receive another PNEUMOVAX 23. Additional information has been requested.
Oct. 1 experienced pain, reddness and swelling Oct. 2  pain in left side of neck Oct. 2. Using my left to pick up a solid item, I felt water drops on my left hand
Fever, chills, nausea, headache, body aches. Started around 10pm on 4/10 (day I received vaccine). Fever broke around 2pm on 4/11. The headache, nausea and body aches went away around 5-6pm on 4/11.
sore arm; This is a spontaneous report from a contactable consumer or other non hcp. A unspecified age of male patient received BNT162B2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced sore arm on an unspecified date. The outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.
Severe Headache; Light sensitivity; Nausea; Bilateral upper extremity tingling
Pt recvd series of 3 Recombivax vax in 1984; In 1989 had "accident" titer checked & was "below minimum level" (non-response); Recvd 1 Recombivax booster in 1989; In 1991 had "accident" titer checked & was below minimum level;
Tinging in left hand/arm, small tingling in left calf. Muscles on left side of body feel tight, along with general soreness at the injection site. Noticed when I woke up this morning around 8am on 8/16/2021 the tingling. It has been persistent through the morning so far.
First dose of vaccine received on 8/12/2021.  After a couple of days, I experienced arthritis-like symptoms in the 2 upper joints in both my left index and left middle fingers.  I also noticed an increase in the "normal pain" that I have in my left ankle and my left lower back/upper hip was also sore.  NSAIDs did not completely relieve the pain or resolve the issue (only had limited effect for left ankle).  No previous history of arthritis in any of those joints.  Received second dose of vaccine on 9/2/2021 with continuation of soreness in knuckles.
This case meets criteria for vaccine breakthrough review. SxS include SOB, coughing, fever, chills, diarrhea, loss of taste and smell.
Site of injection was red in a circle the size of a baseball. The red area was raised and warm to the touch.
Pt states she developed a rash a few hours after vaccine. Rash on face, neck, chest and back.
i got covid after first does; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (i got covid after first does) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (i got covid after first does). At the time of the report, COVID-19 (i got covid after first does) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.   No treatment information provided.  COMPANY COMMENT :  This is a regulatory case concerning a patient unknown age and gender with no medical history reported, who experienced the unexpected non serious AESI event of COVID-19 on unknown date after the first dose of mRNA-1273 vaccine. At the time of report event outcome is unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This is a regulatory case concerning a patient unknown age and gender with no medical history reported, who experienced the unexpected non serious AESI event of COVID-19 on unknown date after the first dose of mRNA-1273 vaccine. At the time of report event outcome is unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
4-6 Hours after immunizations were given, she became irritable, had an abnormal sleep pattern and twitching of one side of her face, according to her mother, lasting about 10 minutes. Her temperature was 100.5 and mother gave Tylenol. She was less irritable the next morning. She was seen by a neurologist, exam was normal and suggested pertussis should be omitted in the future.
MILD MALAISE; FEVER; HEADACHE; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown)) dose was not reported, administered on 20-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced mild malaise, fever, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, headache and mild malaise was not reported. This report was non-serious.
Patient mother was called and stated that she was fine and playing. I did advice her that I will be calling her the following day to check up on her. She was given VIS  information and was told to contact the clinic if she had any signs of symptoms.
Triggered onset of rheumatoid arthritis.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 24-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Oct2022 as dose 4 (booster), single (Lot number: GJ3277) at the age of 24 years, in right arm for covid-19 immunisation; influenza vaccine inact split 3v (FLUARIX), on 17Oct2022 as dose 1, single (Batch/Lot number: unknown), in left arm for influenza immunisation. The patient's relevant medical history included: "PCOS" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: ROSUVASTATIN CALCIUM; ESCITALOPRAM OXALATE; YAZ. Vaccination history included: BNT162b2 (Dose 3 (booster), Single, Batch/Lot No: FF2590, Anatomical Location: Arm Right), administration date: 19Nov2021, for COVID-19 immunization; BNT162b2 (Dose 2, Single, Batch/Lot No: EW0151, Anatomical Location: Arm Right), administration date: 01May2021, for COVID-19 immunization; BNT162b2 (Dose 1, Single, Batch/Lot No: ER8729, Anatomical Location: Arm Right), administration date: 09Apr2021, for COVID-19 immunization. The following information was reported: RHEUMATOID ARTHRITIS (medically significant) with onset 17Oct2022, outcome "not recovered", described as "Triggered onset of rheumatoid arthritis.". The event "triggered onset of rheumatoid arthritis." required physician office visit. Therapeutic measures were taken as a result of rheumatoid arthritis. Clinical Course: Extreme joint pain with increased rheumatoid factors. Triggered onset of rheumatoid arthritis. Treatment Included: NSAIDs, Levothyroxine. Patient was not tested positive  for COVID-19 post vaccination or had COVID-19 prior vaccination.
Pt. presents with soreness on affected site, redness and hot to the touch, that spread to most of upper left arm. Took ALEVE that night which help reduce discomfort.
Patient reports she received 2nd Moderna vaccine lot #013L20A on 1/25/2021. Patient reports by 11AM on 1/26, she felt achy, temperature 101.5, states "every joint hurt". Patient left work early 1/26 and stayed home on 1/27/2021. Today 01/28, Patient returned to work since fever resolved. While at work, patient was advised to contact Covid line who directed patient to get tested and quarantine at home. Patient adds injection site has grapefruit size redness, swelling, and feels itchy. Patient contacted her PCP and was advised to self monitor. Patient has intermittently applied ice. Patient takes Allegra daily. Manager suggested warm compress. Patient denies to see EHS. Patient will contact manager with update tomorrow 1/29. Will follow. VAERS.
Vomiting, diarrhea 2nd day post inject; pt in gen good hlth;
Increasing shortness of breath that gets worse when laying down. Pt came by ambulance to the ER.
Small red area on left lower thigh, temp up to 103 responded to TYLENOL but up and down today. Plan: TYLENOL/MOTRIN prn will f/u by phone tonight & tomorrow.