chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Arm soreness; Lower back pain; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 19Feb2021 (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: PAIN IN EXTREMITY (non-serious) with onset Feb2021, outcome "recovered" (Feb2021), described as "Arm soreness"; BACK PAIN (non-serious) with onset Feb2021, outcome "recovered" (Feb2021), described as "Lower back pain".  Additional information: Reported by: Other HCP. Reporter Contact Information: Reported by Pfizer Colleague whose family member contacted me to notify me of the reaction. Description of Event: Dose 1 on 19Feb2021 experienced arm soreness 24 hours later that resolved in a day and then experienced lower back pain starting 48 hours later lasting one week. Name of Product: BNT162b2. Awareness Date: 31Mar2021. Country of Occurrence: United States. Event took place after use of product. [Query]: Please kindly help to confirm who is the reporter reported these events to you (Name) and pls help to provide his/her contact information if available. Besides, help confirm your awareness date of these events, I captured 21Mar2021 as PRD conservatively in case (withheld); (withheld); (withheld). [Response]: Yes, I am the reporter and reported immediately upon awareness. Asked if it was DSU reporting convention to have 3 AERs for a single report. [Query]: Could you please help to confirm the relationship between the patient (Initials) and yourself? Besides, is the patient your family member, who reported those adverse events to you, I created 3 cases for AER (withheld) (BNT162B2, 1st dose), AER (withheld) (BNT162B2, 2ND dose), AER (withheld) (Advil). [Response]: Yes, VA is an extended family member.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021314729 Same patient/ product, different dose/ event
Tachycardia for 15 minutes; PA states she's due for the second dose this Friday, 2Apr2021; This spontaneous case was reported by an other health care professional and describes the occurrence of TACHYCARDIA (Tachycardia for 15 minutes) and PRODUCT DOSE OMISSION ISSUE (PA states she's due for the second dose this Friday, 2Apr2021) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Thyroid disorder (PA also informed us as FYI that patient has thyroid problems.).    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 TACHYCARDIA (Tachycardia for 15 minutes) and PRODUCT DOSE OMISSION ISSUE (PA states she's due for the second dose this Friday, 2Apr2021). At the time of the report, TACHYCARDIA (Tachycardia for 15 minutes) and PRODUCT DOSE OMISSION ISSUE (PA states she's due for the second dose this Friday, 2Apr2021) 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 has valves issues and they came back for Lab work and EKG.  No relevant concomitant medications were reported.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 09-Aug-2021: Follow up information received contains significant information. Added Events, Added Medical history.
The patient developed erythema 4 to 6 inches below the injection site of PNEUMOVAX 23; This spontaneous report was received from a pharmacist concerning a 67-year-old male patient. Pertinent medical history and concomitant therapy was unknown. There were no drug reactions/ allergies.  On 20-OCT-2021, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (lot # U010533, expiration date reported and confirm upon internal validation; strength was unknown) 0.5 mL, once, intramuscularly for vaccination.    On 21-OCT-2021, the patient developed erythema 4 to 6 inches below the injection site of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23). The patient saw the pharmacist. The treatment was not given for the events. No lab diagnostics/studies was performed. The outcome of erythema was reported as recovering/resolving. The causality assessment was not provided.
Discoloring where vaccination occurred skin felt hard and warm to touch. Bad bruising start 12-15 hours after immunization. Soreness within arm.  Bruising still present on 10-31-2014.
Sore arm; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Sore arm".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient stated next day arms was sore to touch and then was bruised for over 3 plus inches going down his arm.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old male patient received BNT162b2 (BNT162B2), on 04Jun2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 74 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 was not reported. Concomitant medication(s) included: FLOMAX [MORNIFLUMATE], stop date: 21Aug2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Other medication in 2 weeks: Yes.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
38 days after the vaccine I had a stroke from two blood clots in the brain.  EMTs took me to ER then admitted to Hospital. I was there 4 days. I had been under regular preventive care by cardiologists for years and never had any issues
approx 2 days p/vax pt mom stated arm was reddened; pt lt arm was reddened, tender & hot; swollen from shoulder to 1/3 of upper arm;
Neurodermatitis; Seasonal allergy; This case (DE-PEI-PEI2019005917) was received from a consumer via health authority (EMA) on 09-Sep-2019. It described a 19-year-old male consumer who developed neurodermatitis (PT: neurodermatitis) and pollinosis (PT: seasonal allergy) after administration of Typhoral L, Pocken and Telanol for prophylactic vaccination.  Case report: The consumer took a dose of Typhoral-L on 14-Jul-1976, along with Pocken on 18-Aug-1976 and Tetanol on 02-Jul-1976. Subsequently, he developed pollinosis and neurodermitis in 1976 & 1977, respectively. The consumer showed disabling/incapacitating.  Action taken with Typhoral L with respect to the event pollinosis was unknown, while with respect to the event neurodermatitis was not applicable while that with Pocken, and Tetanol with respect to the events pollinosis. The consumer had recovered with sequelae from the reported events.  Company's Comment: In this case, it was reported that a 19-year-old adult male consumer developed neurodermatitis and pollinosis after the administration of Typhoral L, Pocken, and Tetanol. There is lack of information regarding start date of events, course of events, medical history and concomitant medications. Hence, the causality is assessed as not assessable for the reported events with respect to intake of Typhoral-L.; Sender's Comments: Company's Comment: In this case, it was reported that a 19-year-old adult male consumer developed neurodermatitis and pollinosis after the administration of Typhoral L, Pocken, and Tetanol. There is lack of information regarding start date of events, course of events, medical history and concomitant medications. Hence, the causality is assessed as not assessable for the reported events with respect to intake of Typhoral-L.
This case was reported by a consumer via call center representative and described the occurrence of cold symptoms in a 67-year-old male patient who received Shingrix for prophylaxis. On 17th August 2018, the patient received the 1st dose of Shingrix. On 19th August 2018, 2 days after receiving Shingrix, the patient experienced cold symptoms, runny nose, sneezing and headache. On an unknown date, the outcome of the cold symptoms, runny nose, sneezing and headache were recovering/resolving. It was unknown if the reporter considered the cold symptoms, runny nose, sneezing and headache to be related to Shingrix. Additional details were provided as follows: This case was reported by the GlaxoSmithKline employee on behalf of father (patient). This case was previously not reported to any one. The reporter stated that, the patient received Shingrix on Friday at his primary care provider office. The patient complaining of cold like symptoms which started on Sunday. The symptoms included runny nose, sneezing and headache. The symptoms were ongoing but got better as of a day before the reporting. The caller was unable to provide more details but provided contact information for father (patient) and healthcare professional office.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No pertinent medical history, drug reactions or allergies and concomitant medications were reported. On 14-JUL-2015 (reported as "today"), the patient was vaccinated with an expired dose of RECOMBIVAX HB (lot # H015537, expiration date 09-JUL-2015) for an unknown indication (dose and route of administration were not reported). No adverse effects were reported. Additional information has been requested.
Patient had a swollen tissue at upper arm pit towards breast side. It was a walnut-size. Initially patient had arm soreness but got a little better. But swelling/lump like is still there. She got shot on 8/25/17, on 8/27/17 morning she noticed the swelling.
I rec'd the vaccine on 10/8. Later in the week I noticed that my hands were swelling and painful. As the week went on my feet were swelling in addition to my hands. Eventually I was noticing generalized swelling in my arms, hands, legs, feet, etc. I was having trouble getting me feet into my shoes and couldn't close my hands due to the swelling. I never had any difficulty with breathing or laryngeal edema. I didn't initially equate the swelling to the vaccine. I called my Rheumatologist because the swelling was preventing me from being able to do things and it was very painful. We spoke on the phone and she asked me if there was anything different that had happened. The only new thing was the flu vaccine. She did some research and questioned whether the vaccine may have caused the edema and started me on prednisone.
AFTER VACCINE WAS ADMINISTERED SHE STOOD AND I GAVE A SHOT TO HER PARTNER AND WHEN I LOOKED UP SHE WAS LOOKING FAINT, AS I STOOD UP SHE STARTED TO FALL OVER AND SHE HIT HER HEAD ON THE WALL, I CAUGHT HER AND HELPED HER TO THE FLOOR AND HAD HER PARTNER USE HIS LEGS AS A PILLOW. AFTER 5 MINUTES OF LAYING DOWN SHE WAS ASSISTED TO A CHAIR, I TOOK HER BLOOD PRESSURE AT THE ONSET OF SYMPTOMS AND IT WAS 181/70 PULSE 78. AFTER 15 MINUTES IN THE CHAIR HER BLOOD PRESSURE WAS 117/71 PULSE 65. SHE DID NOT KNOW HER REGULAR BLOOD PRESSURE,   AFTER WAITING A TOTAL OF 30 MINUTES SHE LEFT THE STORE.
HCP to return call with actual number of recipients vaccinated post expiry.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP to return call with actual number of recipients vaccinated post expiry.) in a 44-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 15-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (HCP to return call with actual number of recipients vaccinated post expiry.). On 15-Nov-2021, EXPIRED PRODUCT ADMINISTERED (HCP to return call with actual number of recipients vaccinated post expiry.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  The box of vials were received on 14-Oct-2021. The vial was frozen when received and was immediately placed in the clinic vaccine freezer. The vials remained frozen until the date of use and were thawed in the vaccine refrigerator prior to use. The vials remained in the refrigerator between uses and each vial was discarded after the final appointment of the day. Only 1 vial was used per day between the hours of 8:00 hours to 4:00 hours. The 4 vials had been used/administered to the patient, 1 open/punctured and about half used. 5 vials remained unpunctured.  Treatment information was not reported.
Information has been received from a Medical Assistant referring to unspecified amount of patients of unknown age and gender. The patients' medical history, concomitant therapy and drug reactions were not reported. On 26-OCT-2016, the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot # M026306 with expiration date 30-APR-2018, lot # M007728 with expiration date 21-MAR-2018, lot # M021407 with expiration date 30-APR-2018, lot # M023169 with expiration date 13-JUN-2018; dose and route were not provided) for prophylaxis, which were exposed to 49.1 Fahrenheit (F) for 55 minutes. No adverse effects were reported. The data logger was involved. Additional information was received on 11-NOV-2016: Lot number M021407 and M026306 have been verified to be valid for GARDASIL 9. Follow up information was received on 05-JAN-2017. All telephone attempts to obtain follow-up information have been unsuccessful. This is one of several reports received from the same reporter. Additional information has been requested. Narrative were updated. Sender's Comments: US-009507513-1611USA000084: US-009507513-1611USA001748: US-009507513-1611USA001779: US-009507513-1611USA001825: MERCK 1611USA001731:Mfr number.
Skin rash / all over body rash; This non-serious case was reported by a nurse via sales rep and described the occurrence of generalized rash in a 86-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 274P2) and (batch number 574P2) for prophylaxis.   On 03-OCT-2023, the patient received Arexvy (left deltoid). On 04-OCT-2023, 1 days after receiving Arexvy, the patient experienced generalized rash (Verbatim: Skin rash / all over body rash).  The patient was treated with benadryl (nos) (Benadryl). The outcome of the generalized rash was resolved.   It was unknown if the reporter considered the generalized rash to be related to Arexvy.     It was unknown if the company considered the generalized rash to be related to Arexvy.   Additional Information: GSK Receipt Date: 06-OCT-2023 The reporter was a nurse at a long-term care facility. Following day of vaccination, the patient developed a skin rash on the left arm and the peri area, next day the rash spread to his head and feet.  First day it was just a general rash around the injection site but the next day it was a head-to-toe rash. According to the reporter the rash appears to be improving today. Treating physician was aware of this event. The patient was given Benadryl by mouth and the rash resolved. Lot number from antigen vial 574P2. No other lots provided. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.
My arm was sore after the injection; fever; nausia; headache; aches; ill with flu-like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (aches), INFLUENZA LIKE ILLNESS (ill with flu-like symptoms), PAIN IN EXTREMITY (My arm was sore after the injection), PYREXIA (fever) and NAUSEA (nausia) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019BZ1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hives (HIVES/URTICARIA) and Hay fever. Concurrent medical conditions included Contrast media allergy (injected die for venagram, developed rash/hives over entire body) since 1985.   On 01-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 01-Apr-2021, the patient experienced PAIN (aches), PAIN IN EXTREMITY (My arm was sore after the injection), PYREXIA (fever), NAUSEA (nausia) and HEADACHE (headache). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (ill with flu-like symptoms). At the time of the report, PAIN (aches), INFLUENZA LIKE ILLNESS (ill with flu-like symptoms), PAIN IN EXTREMITY (My arm was sore after the injection), PYREXIA (fever), NAUSEA (nausia) and HEADACHE (headache) had resolved.            No concomitant medications were reported. No treatment information was provided.   This case was linked to MOD-2021-040954 (Patient Link).
fever of 99.1 F; feeling tired/tiredness; headache; This is a spontaneous report from a consumer (patient) via a regulatory uthority. A female patient of an unspecified age received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 24Mar2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On 25Mar2021, 1 day after vaccination the patient experienced headache, tiredness, fever. She was wondering if she can take a pain reliever. The outcome of event was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Tight chest, shortness of breath, welts, red rash, swollen tongue, swollen bottom lip, itchy body, itchy mouth and throat, fatigue, tingling on legs, arms and hands
Had her Shingles Vaccine on Tuesday November 8th, 2011, she said yesterday the injection site Under her left arm was a little bit swollen, she noticed it because it was hot and itching, patient felt chest tightness and took her albuterol and some antihistamine (Claritin) this was last night, she measure the spot and she said it is 3.5 inches long and 2 inches across, no fever, no chest tightness and no SOB today, no numbness, and no new tingling in her arms and feet. She knows the achiness is normal but would like advise. I also told her if she develops chest tightness and becomes SOB she should go to the ER.
sore arm; pins and needles in half side of right brain every time she would eat; jawline and right side of thyroid of neck had water blisters; dizziness; ear soreness; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (sore arm), PARAESTHESIA (pins and needles in half side of right brain every time she would eat), BLISTER (jawline and right side of thyroid of neck had water blisters), DIZZINESS (dizziness) and EAR PAIN (ear soreness) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm), PARAESTHESIA (pins and needles in half side of right brain every time she would eat), BLISTER (jawline and right side of thyroid of neck had water blisters), DIZZINESS (dizziness) and EAR PAIN (ear soreness). At the time of the report, PAIN IN EXTREMITY (sore arm), PARAESTHESIA (pins and needles in half side of right brain every time she would eat), BLISTER (jawline and right side of thyroid of neck had water blisters), DIZZINESS (dizziness) and EAR PAIN (ear soreness) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       .   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: No specific follow-up information recorded.
Woke up at 3 am, temperature of 99.6,  body aches, joint pain, brain fog and fatigue. Starting taking Advil and Tylenol every six hours. No respiratory issues.
Patient was scheduled for catch up vaccination as a nurse visit. Float MA was unaware of need to notify physician of patient's arrival. MA chose vaccine product to give to patient, gave the immunization and patient left the clinic. Afterward, physician noted that the incorrect formulation of the vaccine had been given. Patient needed Tdap and IPV. Kinrix (DTaP-IPV) was given. Kinrix is only approved for use in patients between the ages of 4-6 years and this patient is 7 years old.
throat tightness, elevated HR, difficulty swallowing, chest pressure. Evaluated by EMS-Cleared
no adverse effect; multiple patients were vaccinated with improperly stored VAQTA on multiple dates; This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 08-MAY-2019, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated(VAQTA) lot # R027431, expiry date 08-SEP-2019 for prophylaxis.  No adverse event was reported. Previous temperature excursion was reported. Data logger was involved.
Patient received Pfizer COVID vaccine on 5/4/21 and 5/31/21. On 1/29/22, patient admitted to our inpatient facility with acute toxic respiratory failure and COVID19 pneumonia. Patient is chronic immunosuppressed due to treatment for myasthenia gravis. As of today (2/1/22), patient is still admitted in the med/surg unit.
2 days after vaccine administration patient presented to pharmacy with a round, raised, red area (about 4-5 inches in diameter) around area of administer. Reported to be itchy. Patient taking diphenhydramine.
I95.9 HYPOTENSION 8/31/2021 CANCER METASTATIC TO INTRATHORACIC LN J96.21 ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 8/31/2021 CANCER METASTATIC TO INTRATHORACIC LN I95.9 HYPOTENSION 8/31/2021 ATRIAL FLUTTER, UNSPECIFIED J96.21 ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 8/31/2021 ATRIAL FLUTTER, UNSPECIFIED I95.9 HYPOTENSION 8/31/2021 SQUAMOUS CELL CARCINOMA, MIDDLE THIRD OF ESOPHAGUS J96.21 ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 8/31/2021 SQUAMOUS CELL CARCINOMA, MIDDLE THIRD OF ESOPHAGUS I95.9 HYPOTENSION 8/31/2021 ATHEROSCLEROSIS OF AORTA J96.21 ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 8/31/2021 ATHEROSCLEROSIS OF AORTA