chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Heart racing; Anxiety; Trouble sleeping; Panic attacks; Thought process is not clear; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid left, administration date 22Oct2021 11:00 (Lot number: FD0809) at the age of 51 years as dose 3 (booster), single for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), intramuscular, administered in deltoid right, administration date 21Oct2021 (Batch/Lot number: unknown) as dose number unknown, single. Relevant medical history included: "known allergies: Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1,single, Lot number:EP6955, Dose administration time:12:00, Vaccine location:Left arm (Left deltoid), Route of administration: Intramuscular), administration date: 24Mar2021, when the patient was 50 years old, for Covid-19 immunization; Bnt162b2 (Dose 2,single, Lot number:EW015D, Dose administration time:10:00, Vaccine location:Right arm (Right deltoid), Route of administration: Intramuscular), administration date: 14Apr2021, when the patient was 50 years old, for Covid-19 immunization. The following information was reported: PALPITATIONS (non-serious) with onset 23Oct2021, outcome "not recovered", described as "Heart racing"; ANXIETY (non-serious) with onset 23Oct2021, outcome "not recovered", described as "Anxiety"; INSOMNIA (non-serious) with onset 23Oct2021, outcome "not recovered", described as "Trouble sleeping"; PANIC ATTACK (non-serious) with onset 23Oct2021, outcome "not recovered", described as "Panic attacks"; THINKING ABNORMAL (non-serious) with onset 23Oct2021, outcome "not recovered", described as "Thought process is not clear". Therapeutic measures were not taken as a result of palpitations, anxiety, insomnia, panic attack, thinking abnormal.  Additional Information: If covid prior vaccination was reported as no. if covid tested post vaccination was reported as no. Concomitant drugs was reported as none. Patient's Medical History (including any illness at time of vaccination) was reported none. Relevant Tests was reported was none. Specific Relevant Test For Thromboembolic Events With Thrombocytopenia was reported as None.  No follow-up attempts are possible. No further information is expected.
Trigiminal Neuralgia , pain on left side of face.  Nerves shooting and sharp pain.
On 20Jan2021, Right sided Bell's palsy was developed; After Bell's palsy, right-sided cervical radiculopathy started; Now, right-sided trigeminal neuralgia was started.; This is a spontaneous report from a contactable other healthcare professional. A 54 year old non pregnant female patient received bnt162b2 (BNT162B2), dose 1 intramuscular, administered in Arm Left on 19Jan2021 16:00 (Batch/Lot Number: EL3246) as DOSE 1, SINGLE for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient did not have COVID prior vaccination. The patient was tested for COVID post vaccination. On 20Jan2021, the patient experienced Right sided Bell's palsy was developed, After Bell's palsy, right-sided cervical radiculopathy started, Now, right-sided trigeminal neuralgia was started. The patient underwent lab tests and procedures which included sars-cov-2 antibody test negative on 21Feb2021 with nasal swab, sars-cov-2 antibody test: negative on 24Feb2021 with nasal swab, sars-cov-2 antibody test negative on 12Jul2021 with nasal swab and sars-cov-2 antibody test negative on 11Aug2021 with nasal swab. Therapeutic measures were taken as a result of this with Tegetol for trigeminal neuralgia. The outcome of events was unknown.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the events Bell's palsy cannot be excluded   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
Patient reported a headache on the same day of injection about 2 hours later. Next morning, she has a 3-4 cm red circle that is warm to touch around her injection site. She complains of extreme soreness on the area.
Sore arm which got worse later in the day and at night. On date of vaccination. Arm hurt from shoulder down to wrist. On the next day only site of vaccination hurt and today 2 days later the vaccination area hurt less but still noticeable.
palpitations, tachycardia, mild dyspnea which lasted several minutes; recurred several hours later then resolved
inappropriate schedule of vaccine administration (First dose on 17Mar2021/Second dose on 23Mar2021); lack of appetite; Fever; chill; weakness; headache; This is a spontaneous report from a contactable consumer or other HCP (Patient, reported for self). A 42-year-old (non-pregnant) female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot number: EL3247) via an unspecified route of administration, administered on left arm on 17Mar2021 (at the age of 42-year-old) as dose 1, single. Patient also received second dose via an unspecified route of administration, administered on left arm on 23Mar2021 as dose 2, single (at the age of 42-year-old) for COVID-19 immunization. The Relevant medical history included High blood pressure from an unknown date unknown if it was ongoing. Concomitant medication was not reported. Patient had no known allergies. Patient was not pregnant at the time of vaccination. Patient did not receive any other medications within two weeks and no other vaccine with four weeks. Prior to vaccination, patient was not diagnosed with covid. It was reported that on 17Mar2021 patient experienced Fever, chill, weakness, headache, lack of appetite and inappropriate schedule of vaccine administration (23Mar2021). Patient did not receive any treatment for the events. Since the vaccination, the patient has not been tested for COVID-19. Outcome of the reported events was recovering.  No follow up attempts are possible. No further information is expected.
Covid arm; Swollen arms; Problems to move; She had some minor knee pain that she attributed to age; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION COMPLICATION (Covid arm), PERIPHERAL SWELLING (Swollen arms), MOBILITY DECREASED (Problems to move) and ARTHRALGIA (She had some minor knee pain that she attributed to age) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included COPD and Atrial fibrillation.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Covid arm), PERIPHERAL SWELLING (Swollen arms), MOBILITY DECREASED (Problems to move) and ARTHRALGIA (She had some minor knee pain that she attributed to age). At the time of the report, VACCINATION COMPLICATION (Covid arm), PERIPHERAL SWELLING (Swollen arms), MOBILITY DECREASED (Problems to move) and ARTHRALGIA (She had some minor knee pain that she attributed to age) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2022-439753, MOD-2021-018093 (Patient Link).
worst asthma attack he had ever had; unable to breathe; passed out/unconscious; cannot walk; lost weight; has no muscle left; teeth chattering; shaking; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ASTHMA (worst asthma attack he had ever had), DYSPNOEA (unable to breathe) and LOSS OF CONSCIOUSNESS (passed out/unconscious) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Intubation (The doctor told him that he would have died if they had not intubated him.) from 14-May-2021 to 21-May-2021. Concurrent medical conditions included Asthma (The patient had asthma since childhood.). Concomitant products included FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) and ALBUTEROL [SALBUTAMOL] for Asthma.    On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 14-May-2021, the patient experienced ASTHMA (worst asthma attack he had ever had) (seriousness criteria hospitalization prolonged and life threatening), DYSPNOEA (unable to breathe) (seriousness criteria hospitalization prolonged and life threatening), LOSS OF CONSCIOUSNESS (passed out/unconscious) (seriousness criteria hospitalization prolonged, medically significant and life threatening), TREMOR (shaking) and CHILLS (teeth chattering). On an unknown date, the patient experienced GAIT DISTURBANCE (cannot walk), WEIGHT DECREASED (lost weight) and MUSCULAR WEAKNESS (has no muscle left). The patient was hospitalized from 14-May-2021 to 31-May-2021 due to ASTHMA, DYSPNOEA and LOSS OF CONSCIOUSNESS. The patient was treated with Physical therapy for Gait disturbance. On 21-May-2021, LOSS OF CONSCIOUSNESS (passed out/unconscious) had resolved. At the time of the report, ASTHMA (worst asthma attack he had ever had), DYSPNOEA (unable to breathe), GAIT DISTURBANCE (cannot walk), TREMOR (shaking), WEIGHT DECREASED (lost weight), MUSCULAR WEAKNESS (has no muscle left) and CHILLS (teeth chattering) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The treatment information included many medications and physical therapy.   Company Comment  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded
My COVID-19 infection started on 02/19/2023 at night around 10:00PM. I had a post nasal drip. I started feeling congestions. I took the home COVID-19 test on 02/21/2023 which was positive. I had cough was dry, fever of 99.08-99.09, body aches, lymph nodes were swollen, fatigue, headaches and shortness of breath. The same day I did a telehealth with clinic where they prescribed PAXLOVID for 5 days and inhaler. I took the complete course of the medication but I stopped using the inhaler immediately. I wasn't feeling well with the inhaler. I test negative for COVID-19 on 02/25/2023. On 02/28/2023 I had severe congestions in the morning along with post nasal drip, fatigue, and sore throat. On 03/02/2023 I took another COVID-19 which was positive. I did another telehealth on the same day they prescribe me with antibiotics and cough syrup. On 03/08/2023 I tested negative for COVID-19 infection. I was quarantined for at least 5 days or so. I do have sinus infection so am not sure if it's from COVID-19 infection.
Twelve hours after vaccine- nausea, vertigo, weakness, severe pain at injection site.
Tongue numb and tingling, after first vaccine; Feels like days are blurred together, after first vaccine; Tongue numb and tingling, after first vaccine; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration on an unspecified date as single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. She stated she had an odd side effect, and she feels like all of her days have blurred together. She stated that everyday since she got her first vaccine, throughout the day, her tongue goes numb and it tingles. She stated that she was able to taste. She has not called previously, because she thought this was a weird effect. She stated the effect was not that annoying to her now, but she was unsure if the second dose will make it worse. She stated that today, she was supposed to go get her second vaccine. Reclarified, she was not sure if she should get her vaccine today, or not. She wanted to report her event first, in case Pfizer recommended that she see her doctor before getting the second vaccine. She has her vaccine appointment in the next half hour at a walk in clinic. She has contacted her doctor and left them a message but they have not called her back. She stated that her husband was at the doctor yesterday, and he asked the doctor about her effects. The doctor stated that those effects are some that have been reported. She asks the DSU agent if she should hold off on the second dose? She stated she can speak to a provider in the clinic where she got her first vaccine, about her effect, if she can't reach her doctor. The outcome of events was unknown.  Information on the Lot/Batch number has been requested.
received the covid vaccine 12/30/2020 that night I had a very bad sore arm lasted 3 days that night at around 6pm I experience tiredness, cold chills and body aches and a low grade fever a temperature was 99.8 I took a nap I typically never nap. My symptoms since the vaccine I have been feeling very tired id say more sleeping and eyes feeling heavy throughout the day  and on and off headache I have had a cough which I have had lingering for the past month.  These are my symptoms currently fatigue, tired and on and off headaches.
This case was reported by a nurse via sales rep and described the occurrence of pneumonia in a 59-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pain (1st dose received on an unknown date, refer case US2018GSK173665). On 17th August 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. In August 2018, less than a week after receiving SHINGRIX, the patient experienced pain, head pressure, headache and balance disorder. On 30th August 2018, the patient experienced pneumonia (serious criteria GSK medically significant) and mucous membrane disorder. Rechallenge with SHINGRIX was positive. In August 2018, the outcome of the pain, head pressure, headache and balance disorder were recovered/resolved. On an unknown date, the outcome of the pneumonia and mucous membrane disorder were not reported.  The reporter considered the pneumonia and mucous membrane disorder to be unrelated to SHINGRIX. It was unknown if the reporter considered the pain, head pressure, headache and balance disorder to be related to SHINGRIX. Additional information received as follows: The case was reported by the registered nurse. The patient experienced more pain with the second dose of SHINGRIX compared to the first dose of SHINGRIX. The patient experienced pain to the point where the patient felt off balance while walking. The reporter did not clarify where was the pain was located. The patient also complained about a pressure sensation with his forehead and headaches. The pain radiated to the back to his head. The symptoms slowly resolved over 2 weeks. On 30th August 2018, the patient was feeling better. On 30th August 2018, the patient was developing mucus build up. No clarification was provided on location of mucus build up.  The patient was diagnosed with pneumonia on 30th September 2018.
Redness, swelling, warmth at site of injection accompanied by nausea, headache, and irregular breathing pattern (possibly due to anxiety per father) 05/01/11 at approx. 10:00 am soreness at injection site 04/30/11 at approx. 3 hrs after injection.
Developed swelling at injection site within 1 day; appeared as hematoma-persisted to > 2 wks post shot.
soreness on the arm which is on the injection site; soreness on the arm which is underneath the arm; This is a spontaneous report from a contactable consumer (patient) via a Pfizer sponsored program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm on 28Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. Patient received the first dose of vaccine on 07Mar2021 for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced soreness on the arm which is on the injection site and underneath the arm after the second dose on an unspecified date with outcome of unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
We had a temperature excursion today 6/6/2022.; The patient was administered booster after excursion; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (We had a temperature excursion today 6/6/2022.) and POOR QUALITY PRODUCT ADMINISTERED (The patient was administered booster after excursion) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 059A22A, 039A21A and 045A21A) for COVID-19 prophylaxis.     The patient had no known allergy and had no acute illness at the time of vaccination and up to one month before. The patient had no chronic or long standing health conditions. It was unknown if any prescriptions, over-the-counter-medications, dietary supplements, or herbal remedies had been taken by the patient at the time of vaccination and/or at the time of the adverse event.  The patient's past medical history included COVID-19.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Jun-2022 at 10:49 AM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 06-Jun-2022 at 10:49 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (The patient was administered booster after excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (We had a temperature excursion today 6/6/2022.). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (We had a temperature excursion today 6/6/2022.) and POOR QUALITY PRODUCT ADMINISTERED (The patient was administered booster after excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  The reporter mentioned that they had a temperature excursion today on 06-Jun-2022. The vaccine was thawed at the time of excursion. The Lowest reading was 35.6 for a total time of 30 minutes. The vaccines remained in travel cooler. No visible changes to vial were noted. At 11:18am vaccines were placed in refrigerator.  It was reported that there was no adverse reaction with the administration of this vaccine. On 06-Jun-2022 the reporter noticed that the datalogger from the travel cooler was out of range, and they tool the necessary actions to bring the cooler back within range. It took approximately 6 mins for the temperature to be regulated. The datalogger failed to alert the reporter of the excursion of approximately 36 minutes.   The patient was administered booster after excursion. The manufacturer was advised of the excursion and of the administration of the booster, The response from the manufacture was that the vaccine was not affected, therefore being a viable booster dose.  No Treatment medication was reported.
seven patients were given Flublok with ages ranging from 2 years and 5 months to 15 years old,no AE; Initial information received on 11-Nov-2019 regarding an unsolicited valid non-serious case received from a physician.  This case involves seven patients (gender unknown) with ages ranging from 2 years and 5 months to 15 years old, which were given INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot number, expiry and dosage not reported) via unknown route in unknown administration site on an unknown date.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error due to inappropriate age at vaccine administration.  At the time of reporting no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.
Patient reported having heaviness in her throat and upper eyelids. She was complaining of chest palpitations and fast heartbeat. Patient conveyed to nurse her symptoms 20 mins after sitting when she was about to leave facility. She presents alert and orientated times three. Handoff to EMT team. Vital signs are stable. POC 81. She began scratching her right arm marks noted but she states they are old bites. She reports her eyes feel heavy and her vision is cloudy. Advised to rest on stretcher. She declines to go to the ER. She was observed for 45 mins. Snack provided. She states she will return to work she states she feels much.
patient presented w/ urticaria, seeming to stem from the right tricep area; no fever; felt ok except for pruritis; the rash has resolved and patient had no respiratory sx; rash covered scalp to waist, ant & post
Reporting administration error as per Agency. We contacted Pfizer for expiration dates, Pfizer vaccine specialist advised expiration dates and deemed  vaccine viable at the time of vaccine administration. Pfizer vaccine vials only incude manufactuarer dates on the box and vials. Therefore, we contacted Pfizer to attain expiration dates directly from them.  No adverse reaction reported from the patietn at the time of the vaccination and no adverse reaction  reported since given vaccine.
Macular rash on neck, on 6/15 spreading to shoulders, back, chest and abdomen, sparing thighs and arms, reportedly starting 6/21, evaluated 6/23.
Patient stated he saw a bruise at the site of injection after removing bandage. The bruise starts at site of injection to his elbow. Pt stated no pain and no swelling.
Approx 5 minutes post vaccine, patient lost consciousness but remained in chair.   Patient was immediately given a cold compress to apply to back of neck and wrists.  Patient regained consciousness but was very pale and was sweating profusely.  Patient was able to hold a conversation but reported feeling very warm and sweating.  After approx 5 minutes, patient began to feel normal.  Patient's color returned to normal, stopped sweating and reported feeling normal. Patient was monitored for an additional 15 minutes before leaving.