chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A report has been received from a Health Professional concerning an 8 year old, Female subject, who had been receiving nasal FLUMIST Quadrivalent. FLUMIST Quadrivalent started on 06-JAN-2015. The patient had administered of expired vaccine product which started on 06-JAN-2015. The outcome of the event of administration of expired product is unknown. The report was considered to be non-serious.
a little fever; feel a little sore in the arm; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, 15 ug single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "he has coeliac disease" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "a little fever"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "feel a little sore in the arm".  Additional information: Dose/Dosage Form: Gray cap, Original/Omicron BA.4/BA.5 (Bivalent), less or equal 12 years - 15/15 mcg per dos. Reporter reports that he has coeliac disease so he cannot consume gluten, he asks if the new Pfizer Covid19 Bivalent vaccine contains gluten. He mentions that he may feel a little sore in the arm and may be a little fever but that the vaccine won't probably have any effect on his gastrointestinal.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
gen rash p/inj required oral DPH to control; 2 pts were treated for rash p/mass vax of 400 employees;rash was reported hrs p/vax on 27NOV95;
Vaccine expired on 20May2022 ,stored in refrigerator on 7Jun2022 and administered on 8Jun2022; No adverse event; patient received Moderna Covid-19 vaccine that was expired and past the Manufacturers; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received Moderna Covid-19 vaccine that was expired and past the Manufacturers), PRODUCT STORAGE ERROR (Vaccine expired on 20May2022 ,stored in refrigerator on 7Jun2022 and administered on 8Jun2022) and NO ADVERSE EVENT (No adverse event) in an 88-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033K21-2A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Jun-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Jun-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received Moderna Covid-19 vaccine that was expired and past the Manufacturers). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 20May2022 ,stored in refrigerator on 7Jun2022 and administered on 8Jun2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient received Moderna Covid-19 vaccine that was expired and past the Manufacturers), PRODUCT STORAGE ERROR (Vaccine expired on 20May2022 ,stored in refrigerator on 7Jun2022 and administered on 8Jun2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (patient received Moderna Covid-19 vaccine that was expired and past the Manufacturers) and PRODUCT STORAGE ERROR (Vaccine expired on 20May2022 ,stored in refrigerator on 7Jun2022 and administered on 8Jun2022).    No concomitant drug information was provided. Vial was initially stored in refrigerator on 7Jun2022. Vial had not undergone any temperature excursion issue.  It was unknown if the patient had allergies to any food, medication, or other products. It was also unknown if the patient had received any other vaccine 1 month prior to Moderna vaccine and had any COVID-19 positive test or diagnosis previously. It was also unknown if the adverse event caused the patient to seek medical care (office visit, Urgent care, ER, hospitalized).  No adverse event was reported.  No treatment drug information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 01-Sep-2022: Follow-up received, updated suspect drug information and I narrative. On 02-Sep-2022: Follow-up received contains no new information.
Rash developed five hours later. Treatment: BENADRYL OTC and ZYRTEC.
This non serious case was received on 06 February 2009 from a non health care professional.  A 5 year old female patient received DAPTACEL (lot number C3083AA) in the left arm and IPOL (lot number B0009) in the right arm on 04 February 2009.  On approximately 05 February 2009 the patient developed swelling at the injection site (right arm), arm swelling (arm not specified), vomiting, diarrhea, loss of appetite, jerkiness, shaking, swelling of face, and pallor.  The patient's mother called the doctor's office to report that the diarrhea and vomiting resolved.  The date the symptoms resolved and date of phone call was not provided.  Follow-up information received from a health care professional on 04 May 2009.  The patient's symptoms included swelling at IPV injection site, vomiting, diarrhea, lethargy, pallor, jerkiness, shaking, swelling of the face and hives.  The patient's mother was instructed to observe and call the office if symptoms increased or did not subside.  A follow-up call was made on 06 February 2009 and the mother reported no further vomiting or diarrhea but the patient had no appetite at that time and still showed swelling at the injection site.  At that time, the patient's mother expressed that she wanted no further vaccinations.  Information received on 04 May 2009 indicated that the patient had recovered.  Follow-up information received on 21 May 2009 from a health care professional who clarified that the patient experienced swelling at the injection site only and did not experience swelling throughout the entire arm.  Therefore, the event of arm swelling was removed from the adverse event screen.  The reporter did not have additional information to provide at the time of the report.  List of Documents held by Sender:  Vaccination History, Medical Records.
2ND DAY TYPICAL FATIGUE AND ACHES, AFTER RECURRENING SHOULDER PAINS- DESCRIBED AS SHOOTING PAINS- FROM INJECTION SITE THAT  EXTEND DOWN ARM TO ELBOW. AT TIME OF REPORT TO PHARMACY 9/21/2023 PT STATED THE SHOOTING PAIN CONTINUES TO HAPPEN WHEN PATIENT RAISES HIS ARM AT A CERTAIN ANGLE, THE SHOOTING PAIN IS LIMITING FULL MOBILITY OF LEFT SHOULDER
Redness, minor swelling, fever, soreness vaccines given in same arm. Patient waited 3 days to report.
48 hours of vaccination began having an anxiety attack, emotional lability, menstrual cycle was longer and 15 days apart, lymph node swelling to left axillae and breast, severe nipple tenderness.   Warm soaks to axillae and breast decreased lymph node involvement, menstrual cycles are still abnormal, still experiencing episodes of anxiety. It should be noted, episodes of anxiety were not experienced before and nor have they  been experienced due to or during the COVID-19 pandemic.
Sore arm at site of injection, headache, fatigue, general malaise, runny nose and sore throat
This spontaneous report as received from a physician via company representative refers to a 17 year old male patient. He has no medical history, past drug history, and no concomitant medications. On 25-MAY-2017 the patient was vaccinated with GARDASIL 9 injection (route and lot # unknown) in his arm one time, dose unknown for immunization. Other suspect therapies included TRUMENBA received at the same time in unspecified separate arm. After receiving the vaccines he experienced "massive swelling in his arm". The chief complaint was reported as "soreness in both arms". The patient complained of shortness of breath and chest tightness after the immunization. The patient was taken to emergency room due to shortness of breath and chest tightness. However patient was not treated due to long wait. The family called doctor and patient was instructed to take MOTRIN for pain in his arms. His breathing was fine at the time but he was still having shortness of breath. He no longer receives GARDASIL 9. On unknown date the symptoms of "massive swelling in his arms", soreness in both arms, shortness of breath, chest tightness, and pain in his arms have been resolved and patient is better now. Additional information has been requested.
Tdap and MENVEO vaccines were administered IM on left deltoid muscle on 5/22/12. Child developed adverse reaction on 5/23/12. Symptoms included pain, swelling, erythema of left deltoid muscle.
9/16/02 pt presented to clinic with complaints of soreness and swelling at LTH area; had become symptomatic 9/13 day of immunization with redness at site plus swelling and same discomfort. Mom gave Motrin and used ice packs.
Patient called the pharmacy and reported that her left arm has swollen severely.  Patient said that the swelling started the evening of the same day after receiving the vaccine.  She called back the next day to let us know that her arm is still swollen.  The swelling was near the vaccination site and surrounding areas - even under the arm.
Severe nerve-like stabbing/poking pains throughout body and ache; Chills; Nausea; This is spontaneous report from contactable consumer, the patient. A 65-years-old non pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch number: EN6198), via an unspecified route of administration in arm left on 17Mar2021, at 0930, (at the age of 65 years) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Medical history included sulfonamide allergy. Concomitant medications included (ZOLOFT), Vitamin-D (MANUFACTURER UNKNOWN), Calcium (MANUFACTURER UNKNOWN), and Baby aspirin (MANUFACTURER UNKNOWN), all for an unspecified indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch number: EN6198), via an unspecified route of administration in arm left on 24Feb2021, at 0900, (at the age of 65 years) as a single dose for COVID-19 immunisation. On an 18Mar2021, the patient experienced severe nerve-like stabbing/poking pains throughout body, aches, chills, nausea. The patient did not receive treatment for the event. The clinical outcome of events body pains, chills and nausea were recovering at the time of report. No follow-up attempts are needed. No further information is expected.
Pt experienced mild non-painful left eye blurring 10 minutes after vaccination. Pt recommended to stay 30 minutes instead of 15 minutes. At 30 minutes blurring continued, but did not advance. Pt advised that if symptom persists till evening or next day, pt should contact health care provider
My lower heart was start like giving me a sort of pain; that is 21Aug and 09Dec21, dates for the first and second dose; it is hard to fall asleep; My chest was hurting; my chest and my heart bothered me; my heart bothered me; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 09Dec2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (first dose), administration date: 21Aug2021, for COVID-19 Immunization. The following information was reported: ANGINA PECTORIS (medically significant) with onset 09Dec2021, outcome "unknown", described as "My lower heart was start like giving me a sort of pain"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 09Dec2021, outcome "unknown", described as "that is 21Aug and 09Dec21, dates for the first and second dose"; INSOMNIA (non-serious) with onset 09Dec2021, outcome "unknown", described as "it is hard to fall asleep"; CHEST PAIN (non-serious) with onset 09Dec2021, outcome "unknown", described as "My chest was hurting; my chest and my heart bothered me"; CARDIAC DISORDER (non-serious) with onset 09Dec2021, outcome "unknown", described as "my heart bothered me". Patient took second dose on Thursday and same night, when the side effects were kicking in chest, it was hurting and lower heart was start like giving a sort of pain, it was hard to fall asleep and patient tried to sleep it all and going to wait for the next day which was Friday and then had to contact as early because my chest and my heart bothered me. And so patient also had this number down street because it said, when first got first shot, the number given as it says to call the number if you are experiencing any kind of side effects thats concerning you and I call this number. (voice not clear) If patient should call on today or Sunday.   The lot number for bnt162b2 was not provided and will be requested during follow up.
This spontaneous report was received from a health care worker and refers to a 11 year old female patient. The patient did not have any concurrent condition and had history of drug reaction/allergy to amoxicillin. The reporter stated that a patient received her first dose of GARDASIL 90.5 ml, intramuscular, lot # J007354 exp. date. 20-FEB-2016) for immunization. The GARDASIL with this lot # was recalled. Soon after vaccination with GARDASIL, on 04-OCT-2013, the patient displayed emotional liability. The patient's mother called the physician's office and reported that the patient was laughing and crying and that her behavior was not right. The physician recommended that the patient should be seen in an Emergency Room (ER), but the patient did not go to the ER. None lab diagnostics studies were performed. The reporter called back the patient's mother the next day and reported that the patient's behavior had returned to normal. The patient recovered on 05-OCT-2013. The relatedness between GARDASIL, and events was not reported. Additional information has been requested.
Dizziness, Headache, Myalgia, NauseaVomiting, Angina, EAR PAIN OFF BALANCE Narrative: PT WAS OUT OF WORK FOR OVER 4 MONTHS. PER THE PT: CHILLS,FATIGUE,HA,EAR ACHE, NAUSEA,DIZZINESS AND OFF BALANCE DAY 2 THROUGH WEEK 18. CHEST PAIN AND LEFT LEG PAIN SENT HER TO THE ER. EKG AND U/S WERE COMPLETED. EKG WAS ABNORMAL BUT U/S NEGATIVE FOR DVT.
Pain, burning, hot leg, throbbing in the calf and fingertips, red areas (spots like accumulated blood) all this on the left leg. Possible thrombosis for which they sent me to to a study. They gave me anticoagulant and pain medication. It did not ease the pain.
Hearing loss; Tinnitus; Aural fullness; This is a literature report.  A 58 year-old female patient (unknown if pregnant) received bnt162b2 (COMIRNATY) (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: DEAFNESS (medically significant), outcome "unknown", described as "Hearing loss"; TINNITUS (non-serious), outcome "unknown", described as "Tinnitus"; EAR DISORDER (non-serious), outcome "unknown", described as "Aural fullness". The events "hearing loss", "tinnitus" and "aural fullness" were evaluated at the physician office visit.  No follow-up attempts are required. No further information is expected; Sender's Comments: As there is limited information in the case provided, the causal association between the event Deafness and the suspect drug bnt162b2 cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
He was tested positive for Covid after 1 week; 5 days after receiving 1st dose, Patient found out that someone at the office was positive for covid; This spontaneous case was reported by a consumer and describes the occurrence of EXPOSURE TO SARS-COV-2 (5 days after receiving 1st dose, Patient found out that someone at the office was positive for covid) and COVID-19 (He was tested positive for Covid after 1 week) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced EXPOSURE TO SARS-COV-2 (5 days after receiving 1st dose, Patient found out that someone at the office was positive for covid). On 12-Mar-2021, the patient experienced COVID-19 (He was tested positive for Covid after 1 week). The patient was treated with IBUPROFEN at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, EXPOSURE TO SARS-COV-2 (5 days after receiving 1st dose, Patient found out that someone at the office was positive for covid) and COVID-19 (He was tested positive for Covid after 1 week) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.
Patient reported joint pain affecting all limbs persisting from 10-25-23 to 10-30-23
injection site pain; sore arm; chills; headache; light fever/slight fever; dry cough; tiredness; he had swelling at the injection; just irritating; This is a spontaneous report from a contactable consumer or other non hcp. A 64-years-old male patient received bnt162b2 (BNT162B2), Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 21Sep2021 (at the age of 64-years-old) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history included pneumonia (he has a history of pneumonia and will be getting his shot in 24November2021), covid-19 from 2020 to an unknown date (he tested positive for COVID last year, it was mild and resolved after 2-3 weeks). The patient's concomitant medications were not reported. It was reported that on an unspecified, the patient experienced injection site pain, sore arm, chills, headache, light fever/slight fever, dry cough, tiredness, he had swelling at the injection, just irritating. It was reported that, patient got his flu shot last month. his HCP emphasized the importance of getting the flu shot and ever since he has been getting flu and pneumonia shot and hasn't been getting sick every year. After the second shot, he had a sore arm, and a few other symptoms like, chills, bad headache, slight fever, and dry cough, similar to getting a flu shot. The outcome of event was unknown.  The lot number for [BNT162B2], was not provided and will be requested during follow up.
headache,nausea. patient received 2nd moderna COVID vaccine 2 days ago. Presents with headache and nausea.  CHIEF COMPLAINT & HPI:  40 yo F had her 2nd covid vaccine 2 days ago. Yesterday night or this morning, she started developing body aches, chills, nausea, and headache.  No rash.  No neck stiffness.  no CP/SOB.  no abd pain.  no dysuria/hematuria.
Hives, intense itching, hours later developing into redness and fluid-filled red rash on buttocks, torso, arms, hands and thumb on left hand. Tuesday evening Oct. 27, I had shock like sensations (off and on) in both left arm and right arm resulting from left arm swelling. Also inability to lift arm over head from swelling of left arm. The shocks were very painful and I was unable to sleep. I spoke with nurse who prescribed Kenalog cream for the blisters. Ibuprofen and Extra Strength Tylenol (maximum doses) for pain. I remained on the meds the rest of the week until Oct. 29th.  I still have numbness and tingling in my fingers and left thumb. I also have some weakness in my arms and hands.
Patient presented to urgent care center with headache and nausea, and few skin lesions on face, chest, and back.  No fever, no CP, or other sxms.  She was subsequently admitted for supportive care overnight, and did well.  DHA Immunization team consulted and concurred with dx of probable NVP.
Not that painful; A spontaneous report was received from a consumer, who was a 42-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and it was painful.   The patient's medical history was not provided. Relevant concomitant medications were reported included sildenafil.  On 30 Dec 2020, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 31 Dec 2020, the pain began the same day of injection. The patient's pain was not that painful. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event, not that painful, was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Information has been received from a consumer concerning his/her son, a 12 month old male patient with penicillin allergy and bronchiolitis and a history of ear infection who on 12-MAY-2012 was vaccinated with a dose of VARIVAX (Merck) (dose, route and lot # not reported). Concomitant therapy included albuterol. It was reported that on 15-MAY-2012 the patient developed a virus with blisters all over his body and he got a fever after he had the VARIVAX (Merck). The patient sought unspecified medical attention. The patient was given BENADRYL and Calamine Lotion. Lab tests were not performed. AE did not improve. Outcome was reported as not recovered. Follow up information has been received from the patient's mother concerning her a 12 months old male son with latex allergy and none illness at time of vaccination. On 12-MAY-2012, the patient was vaccinated with dose 2 of VARIVAX (Merck) subcutaneously in right thigh (lot # 671163/1208AA) (dose not reported). Other suspect therapies included M-M-R II given subcutaneously in left thigh, second dose (lot number 1001AA) on 12-MAY-2012. Concomitant medications included PENTACEL (IM, left thigh) and PREVNAR (IM, right thigh). On an unknown date the patient was seen in ER for rash. No treatment information was reported. The outcome of developed virus with blisters all over his body and got a fever after he had VARIVAX (Merck) was reported as not recovered/not resolved. The outcome of rash was reported as recovered/resolved. Additional information has been requested.
Patient presented to ED for c/o SOB 4/17/21. He was diagnosed with PE. Also for completion, patient did have shoulder surgery 6 weeks ago without complication.
Patient was feeling dizzy and then fainted. The patient was unconscious for a few seconds and then regained consciousness. We kept the patient hydrated and he felt much better.