chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case, initially received on 14-APR-2017, was reported by other health professional (physician) and concerns a 82-years-old female elderly patient. Administration of Company suspect drug: On an unspecified date, the patient received INN Flu Vaccine Seasonal (dose, batch number, expiry date: not reported, batch number: 1515901, anatomical location: left arm and route of administration: intramuscular route). Non-company suspect drug: On 21-Dec-2015, the patient received PREVNAR (dose number: 1, dosage: 0.5 ml, batch number: M27767, expiry date: illegible, anatomical location: right arm and route of administration: intramuscular route). Adverse reactions/events and outcomes: On 21-Dec-2015, after administration of suspect vaccine, the patient still had a constant pain at the injection site, immobile right arm with associated symptoms, no used of her right arm, losing function in her arm, she could not use her right arm and could not move her arm past her head, spasms, swollen arm, muscle contraction. She did not have any feeling in her right arm and muscle was constantly hurting. Action taken with the vaccine was not reported. Outcome of the events was not recovered/not resolved. Reporter's Assessment: The reporter did not provide the causality between influenza vaccine and events. The reporter assessed the causality of the events considered to be related to the pneumococcal vaccine. This report was not serious.
Dizziness; Sweaty; Ringing in ears; Head pressure; Shaky; Headache; Tired; right arm hurting; pain has shifted to the elbow; felt nauseas; This spontaneous case was reported by a patient and describes the occurrence of DIZZINESS (Dizziness), HYPERHIDROSIS (Sweaty), TINNITUS (Ringing in ears), HEAD DISCOMFORT (Head pressure) and TREMOR (Shaky) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    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 DIZZINESS (Dizziness), HYPERHIDROSIS (Sweaty), TINNITUS (Ringing in ears), HEAD DISCOMFORT (Head pressure), TREMOR (Shaky), HEADACHE (Headache), FATIGUE (Tired), MYALGIA (right arm hurting), ARTHRALGIA (pain has shifted to the elbow) and NAUSEA (felt nauseas). At the time of the report, DIZZINESS (Dizziness), HYPERHIDROSIS (Sweaty), TINNITUS (Ringing in ears), HEAD DISCOMFORT (Head pressure), TREMOR (Shaky), HEADACHE (Headache), FATIGUE (Tired), MYALGIA (right arm hurting), ARTHRALGIA (pain has shifted to the elbow) and NAUSEA (felt nauseas) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided. Treatment information was not provided Action taken with mRNA-1273 in response to the event was unknown.   Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: Non significant follow up accepted on 28-05-21
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a adult male patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included solitary kidney. On 4th August 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional information was received as follows: The age at vaccination was not reported. No further information was reported. This case was linked to the case US2018GSK167259, reported by the same reporter for the same patient.
This infant had a rash to his torso and shoulders, 12 days after his vaccinations.
This case was reported by a consumer via call center representative and described the occurrence of pain in a 59-year-old female patient who received SHINGRIX. On 20th March 2018, the patient received SHINGRIX. In March 2018, less than a month after receiving SHINGRIX, the patient experienced pain, joint range of motion decreased and movement disorder. On an unknown date, the outcome of the pain, joint range of motion decreased and movement disorder were not recovered/not resolved. It was unknown if the reporter considered the pain, joint range of motion decreased and movement disorder to be related to SHINGRIX. Additional details were provided as follows: After receiving the SHINGRIX vaccine, the patient had lots of pain with it. On the 8th day, the patient developed decreased range of motion in her arm. She had difficulty reaching up. The patient already saw her doctor who told her to give it more time. The patient wanted information from GSK as to whether this side effect was seen or not.
ED Discharged 10/18/2021 - 10/19/2021 (10 hours)  ED  Treatment team  Providers COVID-19   Fever, unspecified fever cause  & Generalized weakness & Fatigue Chief Complaint Patient presents with ? Fatigue         History of Present Illness   Patient is a 56 y.o. year old female with a past medical history of DVT, HTN presenting to the ED with shortness of breath, fever, cough, generalized body aches and diarrhea.  Patient states that her daughter tested positive for Covid about a week ago, called her tonight, and recommended that she get tested as well.  She states that her cough has been ongoing for several weeks, but yesterday, she started getting a fever, generalized body aches, shortness of breath and diarrhea.  She states that her shortness of breath feels different than her prior PE, and states that when she had a PE in the past, she also had right lower extremity pain and swelling, and was noted to have a DVT.  She states that she completed her course of Xarelto, and then was taken off due to absence of recurrence.  Review of records, does appear that her prior PE was provoked during a long car ride when she was moving.  She denies chest pain, abdominal pain, nausea, vomiting, hemoptysis, hematemesis, hematochezia or melena.  Office Visit  10/29/2021 Internal Medicine Sinus congestion +   Right sided abdominal pain, Chronic nonintractable headache, unspecified headache type, History of pulmonary embolism,  Thick nasal mucus, Dysphagia, unspecified type, Benign essential HTN  Plan: o Rt side abd pain- CMP normal last few times. i suggested checking RUQ u/s and kidney u/s but she wants  CT scan abd/pelvis. Recommend calling ob/gyn for evalution of her ovaries. Concerned that when she gets upset this causes lots of pain. If no findings o Chronic Sinus issues-recommend flonase, saline nasal spray. ENT referral 2/2 chronic mucus issues o HA/migraine: possibly from COVID vs migraines with squiggly vision changes today.  no focal deficits. Continue with tylenol as it does control sx. Continue to monitor, o dyspahgia- follows with GI o Elevated blood pressure-patient is not taking her medications currently as she feels she does not have blood pressure issues at this time.  I reck advised her to take the blood pressure medications as uncontrolled blood pressure can cause damage to her heart and kidneys. o hx of PE-asymptomatic currently.
The shoot hurt right away, had golf ball size lump, warm to the touch and really bad night sweets for about a week. Arm still hurts to this day at injection site. (21 years later) Lost 50% strength in my left arm.
Rash on neck; This is a spontaneous report from a contactable other healthcare professional (patient). A 29-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3248), via an unspecified route of administration on 21Jan2021 at a single dose on right arm for COVID-19 immunization. The patient's medical history was not reported. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. No allergies to medications, food, or other products. There were no concomitant medications. The patient previously received first dose of BNT162B2 on 29Dec2020 for COVID-19 immunization (brand: Pfizer, lot number: EL1284, administration time: 02:45 PM, route: intramuscular, vaccine location: left arm, dose number: 1). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced rash on neck on 23Jan2021 09:00. The event was reported as non-serious. The patient has not been tested for COVID since the vaccination. No treatment was received for the adverse event. The patient has not recovered from the event.
hoarse, wheezy, felt like bronchitis & asthma, tightness in chest;
COVID breakthrough; COVID breakthrough; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  An 18-year-old male patient received BNT162b2 (BNT162B2), in Apr2021 as dose 1, single (Lot number: ER2613), in Apr2021 as dose 2, single (Lot number: ER2613) and on 15Dec2021 as dose 3 (booster), single (Lot number: 330308D) at the age of 18 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 05Jan2022, outcome "recovered" (2022) and all described as "COVID breakthrough". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (05Jan2022) Unknown results, notes: COVID breakthrough. Therapeutic measures were not taken as a result of drug ineffective, covid-19. Clinical course: The patient did not receive any other vaccine in four weeks.  No follow-up attempts are possible. No further information is expected.
Chills Narrative:  Per SHIFT note 12/16/20: Patient received COVID vaccine Pfizer at approximately 1300. Patient reported chills and no further symptoms, vital signs are stable. Patient believes that it could be a part of his tendency to run cold. Extra blankets were provided to patient and room temperature has been increased to 70 degrees. Patient stated that he no longer felt chills after interventions were performed. Per 12/17/20 Inpt attending note, "No acute events overnight. Some chills last night but feels fine now."
Patient administered 0.25mL of the 6 to 11-year-old Moderna vaccine. This resulted in the patient receiving less than the intended dose.
This spontaneous report was received from a nurse practitioner via company representative refers to unspecified number patients of unknown age and gender. The nurse reported that the physician's office had unspecified number patients who were administered GARDASIL (lot# 0459AE, expiration date unknown) route dose and location unspecified on an unspecified date and experienced syncope. The physician inquired "is there increased risk of syncope associated with GARDASIL lot # 0458AE". At the time of report, the outcome of syncope was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Mouth began to quiver/drool; was able to walk inside from outdoors; had been happening about 2 =3 minutes before I realized what was happening.  Was standing so had him continue to do so while I held onto him to let the event pass.  Recovered within 5 minutes with no adverse affects.  Has been 1.5 years since any previous seizures so wanted to report this for fyi.
Eczema rash on scalp, took him to the doctors and they said it was cradle cap. Went back another month and still had it on his scalp and doctor said it was a fungus infection. Then he got patches of eczema on his cheeks, went to a chiropractor who determined that he was probably allergic to wheat/gluten and dairy. We still have outbreaks of eczema on his cheeks and other body parts (arms, legs, stomach and buttocks) from dairy and wheat products.
pt states 2hr p/vax had throat constriction, tongue swelling, nose running, light headed;took DPH tablet & had relief in 30min or less;did not notify MD;
Fever to 102.1. Tempra administered. Fever resolved. Then on 7/17/15 develop rash that started on face & spread to trunk.
Broke out in a rash. Had one small bump prior to shots. In the evening broke out in a rash that progressed to hives by the next morning. Had tactile temp this morning as well.
Information has been received from a healthcare worker concerning a 1 year old female who, on 06-JUL-2008, was vaccinated with MMR II (lot number: 660207/0453X). Patient's mother stated that after receiving the vaccination the patient seemed "different" and was doing things that seemed odd. The mother did not provide anymore details or examples of what she meant by the odd and different behavior. The physician has requested a lot check. A lot check has been requested. Lot check result for 660207/0453X: A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the center and was released. Additional information has been requested.
Swollen lymph nodes on same side of injection next day, slight swelling of face on left side, night sweats, chills.
the patient received improperly stored vaccine at an unspecified date; This spontaneous report was received from a physician and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not provided.  On an unknown date, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (PROQUAD) (lot # S007075 and expiry date 06-SEP-2020; albumin status was unknown; injection site, route of administration and exact dose were not reported) for prophylaxis. The vaccine was exposed to temperature of 32.5 degrees Fahrenheit (F) for 8 hours. There was no previous temperature excursion. Digital data logger was involved.
Patient received both vaccines at the pharmacy around 10:30am on 10/2/14 and indicated that she has not had her pneumonia vaccine in the past. Patient came back in around 2:30pm the same day to pick up a prescription unrelated to the vaccines. She did not complain of any adverse events at this time.  Patient's daughter came in on 10/4/14 reporting the patient became dizzy around 7pm on 10/2/14 while walking to the bathroom, fell down, hit her head and became unconscious. The patient's daughter reported that the doctors at the hospital said the patient had a small amount of "water on the brain" and they gave her a presciption for meclizine which her daughter picked up for her on 10/4/14. Her daughter said the patient spent 1 night in the hospital and the doctors were not sure if the vaccines could have caused her dizziness.
Per patient, she had an arm rash that radiated to her breast area and was similar to what she experienced when she got the covid vaccination.  She did not experience shortness of breath or flu like symptoms.  Her arm had typical soreness.  She saw her PCP for her rash but it was concluded that the rash was due to the vaccination.  The rash & soreness resolved in a few days.
Were given doses of the Moderna COVID-19 Vaccine on 1Sep2021 from vials that expired 31Aug2021; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Were given doses of the Moderna COVID-19 Vaccine on 1Sep2021 from vials that expired 31Aug2021) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Were given doses of the Moderna Covid-19 Vaccine on 1Sep2021 from vials that expired 31Aug2021). On 01-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Were given doses of the Moderna COVID-19 Vaccine on 1Sep2021 from vials that expired 31Aug2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Relevant concomitant medications were not provided by the reporter. Treatment medication was  not reported.    Most recent FOLLOW-UP information incorporated above includes: On 07-Sep-2021: Follow-up received includes no new information.
Pain , redness, itchiness at site immediately. Next day larger area of redness and significant swelling.  Chills, malaise, tiredness, stomach distress (mild), brief fever. Next day dizziness.  Fifth day, raised rash at injection site.
Approx 3 hrs after receiving Hep B #1 and Tdap, and PPD, pt returned to clinic (where she is working with c/o a cold coming on. Stated no problems with breathing. Had been taking allergy medication. Sent to urgent care for symptoms. Dr stated pt had reaction to vaccines and gave pt epinephrine and Benadryl S/S subsided after 1/2 hr.
immed c/o pain;w/in 5min c/o dizziness, weakness, diaphoretic, SOB, numbness in rt side of face;transferred to acute care clinic-inc AP while sitting c/o n, dizziness, dec BP if supine;IV NS KVO, EKG, transferred to another hosp;
Pain and aches all over; 1st dose March2022, 2nd never; This case was reported by a consumer via call center representative and described the occurrence of general body pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In March 2022, the patient received the 1st dose of Shingrix. On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, less than 9 months after receiving Shingrix, the patient experienced general body pain and incomplete course of vaccination. On an unknown date, the outcome of the general body pain was recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the general body pain to be related to Shingrix.     Additional Information: GSK receipt date: 21-Nov-2022 and 24-Nov-2022 Reporter's comment: The patient had the first shot almost a year ago and had the side effects- pain, aches etc lasted a couple of days so, the patient never got the second shot.   The vaccine was Shingrix, and the patient believed the first dose was March 2022.   When asked the location of the pain and aches, the patient stated all over.  Reporter did not had the dose lot number information. The reporter did not consent to follow-up. Additional supportive information: Till the time of reporting, the patient did not receive second shot of Shingrix, which led to incomplete course of vaccination.
A report has been received from a Health Professional concerning a 6 year old, Male subject, who had been receiving FLUMIST quadrivalent (intranasal). FLUMIST (intranasal) started on 03-Dec-2013. The registered nurse reported that they inadvertently gave a dose of expired FLUMIST on 03-Dec-2013. The patient has not reported any symptoms. The outcome of the event of inadvertently gave a dose of expired FLUMIST is unknown. The report was considered to be non-serious.
This spontaneous report was received from a pharmacy technician regarding a female patient of unknown age. The patient's current condition, medical history and concomitant medications were not reported. The patient's drug reaction/allergies were unknown by the reporter. On 02-JUN-2017, the patient was vaccinated with ZOSTAVAX (strength and dose were not reported) (lot/batch # M037656, Expiry date: 29-NOV-2017) (strength and dose were not reported) after reconstituting with sterile water diluent (MERCK STERILE DILUENT) (expiration date and lot/batch # were not reported), subcutaneously in her right upper extremity for vaccination. On 03-JUN-2017, the patient's reported that her arm hurt. The patient was directed by pharmacy to put ice on the area and to take ADVIL. On 04-JUN-2017, the patient was advised by different pharmacy who directed her to take BENADRYL. It was reported that on 06-MAY-2017, the patient saw her family physician and the physician told her that "she had a really bad infection and if she hadn't come in then she would have lost her arm". Patient was then prescribed an unspecified antibiotic and unspecified steroid. On 08-JUN-2017, the patient reported that the patient's right upper extremity appeared "swollen". Information regarding lab diagnostics studies performed were unknown by the reporter. There was no product quality issue (PQC) involved. The outcome of the events were reported as not recovered. The causality assessment was not provided by the reporter. Upon internal review the event bad infection was considered medically significant. Additional information has been requested.
Pain and stiffness in hips, knees, and ankles. Fatigue. Legs feel like they have lead weights in them
Patient started within 12 hours of receiving the vaccine with a mild case of shingles in the location she usually gets them. She had been counseled prior to receiving the vaccine that this was a possibility due to live vaccine. She stated they were itching and uncomfortable. When she called originally I advised she call her doctor or go to urgent care ASAP to begin antiviral treatment to prevent worsening of the symptoms. I called her again this evening and she had not done that. She stated that as of now, 7:25PM on 7/7, the shingles had not worsened and were starting to feel a little more comfortable. She had been applying DESITIN to the site.
patient called the pharmacy several hours after receiving vaccination and complained of numbness in the arm. patient was asked if there was any swelling of lips, tongue, throat, or facial features; which there was not. patient was asked if the numbness was extended to whole arm or just the injection site. patient said near injection site and the surrounding area.  patient had us double check that the correct and in date vaccine was administered, which it was. patient was advised to monitor for any discoloration/darkening of the area surrounding the vaccine, radiating numbness to any other portions of the arm/body or any darkening of the urine along with severe muscle pain or weakness (and also signs of anaphylaxis). if any of these should happen patient was advised to call for emergency services and seek medical care. patient was advised of common side effects from vaccines, which can include transient soreness and discomfort at administration site, and how to seperate them from previously mentioned severe adverse reactions.
Patient is currently hospitalized in Hospital with Covid. His Wife reported admission with O2 Sat at 48.  He has Pneumonia, Ketones of 4, borderline ketoacidosis, and Fluid on his lungs,.
The patient seemed tired, was breast fed  around 6pm, then suddenly started staring off to the side. The patient went limp and unresponsive 2 - 3 minutes, then eyes rolled back.  He came to but repeatedly sucked on his bottom lip several minutes before he fully regained normal state.
Employee calling to report a reaction after receiving a COVID-19 vaccine.    Vaccine Name - Pfizer  Vaccine Lot # - EJ1685  Vaccine Date and time  - ? 12/18/2020 @ 8:30am  Is this your first or second dose? First  Date and time of symptom onset - ?12/21/2020 @ 06:30am  Symptoms - ? Fatigue, body ache, shortness of breath but resolved after taking albuterol breathing treatment (hx of COPD)  Last day of work and shift - ? today, never missed work  Home remedies? -    Tylenol & Ibuprofen  Any improvement? -  yes  Recommendation?  Continue to monitor symptoms and take Tylenol as needed   Employee voiced understanding Employee of information ? yes  Employee voiced any concerns ? no, her manager told her to report her symptoms to vaccine support line    Employee?s questions answered to employee?s satisfaction - yes
Received First dose 8/2/21 then Received second dose 8/16/21   Less than 2 8 days