chrisvoncsefalvay/vaers-outcomes huggingface dataset:
lilac and bright red spots of 0.5 centimeters - 7 centimeters appeared in  the abdomen, under the arms, and between the legs; I began to feel unwell; dizziness; weakness; was diagnosed with Scleroderma; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64 year-old patient received bnt162b2 (BNT162B2), administration date 04Oct2021 (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 (Dose 1), administration date: 13Sep2021, for Covid-19 immunization, reaction(s): "didn't feel any negative reactions". The following information was reported: SCLERODERMA (medically significant) with onset 2021, outcome "unknown", described as "was diagnosed with Scleroderma"; RASH MACULAR (non-serious) with onset 18Oct2021, outcome "unknown", described as "lilac and bright red spots of 0.5 centimeters - 7 centimeters appeared in the abdomen, under the arms, and between the legs"; MALAISE (non-serious) with onset 18Oct2021, outcome "unknown", described as "I began to feel unwell"; DIZZINESS (non-serious) with onset 18Oct2021, outcome "unknown", described as "dizziness"; ASTHENIA (non-serious) with onset 18Oct2021, outcome "unknown", described as "weakness". The events "was diagnosed with scleroderma", "i began to feel unwell", "dizziness" and "weakness" were evaluated at the physician office visit.  The lot number for bnt162b2 was not provided and will be requested during follow up.
All over body aches - severe, fever over 100 degrees F, uncontrollable chills initially (approximately 8hrs after shot), then chills - all symptoms last about 24 hrs. - 36 hrs.
Pt became light headed. Blood pressure 70/40 but elevated to 90/60 within 15 minutes. No other adverse effects observed. Remained alert and oriented.
Approximately a week and a half after the first shot of Pfizer, experience heart palpitations, headaches, abdominal pain and nausea.   Elevated blood pressure that changes upon standing along with elevated heart rate.  Symptoms have staying constant for past 5 months and re-intensified after receiving a booster shot in late December.  Symptoms have not resolved fully at this time.
Bad Itchy rash on both Arms & Legs; Dizzy; A spontaneous report was received from a consumer concerning a 70-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events dizzy, bad itchy rash on both arms & legs.  The patient's medical history was not provided. He stopped Lipitor prior to vaccination and has not restarted it. Concomitant medications reported were esomeprazole magnesium.  On 17 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 038K20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 17 Feb 2021, the patient felt a little dizzy for one day. On 19 Feb 2021, he developed an itchy rash on both arms and legs. On 20 Feb 2021, he went to the Hospital. The Emergency Room (ER) doctor administered one diphenhydramine injection to him, and discharged him the same day to continue diphenhydramine per oral at home. The rash lasted for five days. On 24 Feb 2021, the patient had very little symptoms. He took another diphenhydramine pill and it went away.  Treatment details included diphenhydramine Injection, diphenhydramine capsules.  Action taken with mRNA-1273 in response to the events was unknown.  Outcome for the event of dizzy and bad itchy rash on both arms and legs was considered resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the events, a causal relationship cannot be excluded.
Fever of 99-99.5 body aches. Nausea. Lack of appetite. Next day swollen lymph nodes only left side.
Injection site pain, tiredness, headache, muscle & joint pain, chills, nausea, feeling unwell and cloudy.
Patient started experience syncope symptom after the vaccine administration and during the waiting period (15 minutes).  She started feeling light headedness on her chair and tipping over to the floor.  Her father who arrived with her to the vaccination had come to the rescue, and together with the pharmacist on duty, helped situating her on the floor.  Paramedic was also called to ensure the patient safety but left shortly after since the patient had recovered nicely.
A few days after the vaccination my right deltoid ached , especially the joint area. About 10-14 days later my shoulder was feeling better but my right wrist started to ache, approx a week later the wrist was feeling better but my right hand finger joints ached for about a week. Now, starting approx 9 May  and 2021 and ongoing, I am experiencing ringing in my ears. The ringing is still present but has subsided. I attribute all these problems as side effects from the covid vaccine.
Adverse effect of other vaccines and biological substances, initial encounter on 2022-08-27.
not all the solution was injected; A spontaneous report ) was received from a healthcare provider  concerning a 19-year-old patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the administration of less than 0.5mL of vaccine. The event was reported as: not all the solution was injected.   The patient's medical history was not reported. No relevant concomitant medications were reported.  On 20-Dec-2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch:041L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 27-Jan-2021, the patient received their second of two planned doses of mRNA-1273 (lot/batch:041L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. While receiving the vaccine, the patient stated that all the solution was not injected.  No treatment information was provided.    Action taken with mRNA-1273 in response to the events was not applicable.    The outcome of the event vaccine underdose is resolved/recovered.; Reporter's Comments: This report refers to a case of product administration error for mRNA-1273, lot # 041L20A with no associated AEs.
Pt noticed a rash measuring 100 mm x 110 mm across injection site area. Appears flushed and is warm to touch.  Pt also has noticed a nodule present in left tricep from first vax, approximately size id 3.0 mm x 2.2 mm in size.
This is a literature report for the following literature source Vulvar Aphthous Ulcers in an Adolescent After Coronavirus Disease 2019 (COVID-19) Vaccination, Obstetrics and Gynecology. A 15-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "COVID-19" (unspecified if ongoing); "menarche" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: APHTHOUS ULCER (medically significant), 1 day after the suspect product(s) administration, outcome "recovered", described as "vulvar aphthous ulcers". The event "vulvar aphthous ulcers" required emergency room visit. The patient underwent the following laboratory tests and procedures: Blood culture: Unknown result, notes: health care professional was concerned for a labial abscess and collected Neisseria gonorrhoeae and Chlamydia trachomatis polymerase chain reaction tests; Body temperature: afebrile; Heart rate: 101, notes: isolated; Herpes simplex: negative; Polymerase chain reaction: Unknown result, notes: health care professional was concerned for a labial abscess and collected Neisseria gonorrhoeae and Chlamydia trachomatis polymerase chain reaction tests; Pregnancy test: negative. Therapeutic measures were taken as a result of aphthous ulcer. Sender's Comments: As there is limited information in the case provided, the causal association between the reported events with 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.
This spontaneous report as received from the registered nurse (R.N) and refers to a 16 year old male patient. No complete demographics of the patient was reported. No medical history and concurrent conditions were reported. In 2002, the patient was vaccinated with PNEUMOVAX23 (lot number, strength, dose, frequency and route of administration was not reported). On an unknown date, the patient was scheduled to undergo a cochlear implant. The action taken of the suspect product was not reported. The outcome of cochlear implant was unknown. The causality was also not reported. No product quality complaint (PQC) was filed. No additional information was provided. Additional information has been requested.
Neck pain; rash in neck, upper back and chest; Headache; This case was reported by a nurse via call center representative and described the occurrence of headache in a 64-year-old male patient who received Herpes zoster (Shingrix) (batch number h7at2, expiry date 28th August 2023) for prophylaxis.   On 1st October 2022, the patient received the 1st dose of Shingrix. On 1st October 2022, less than a day after receiving Shingrix, the patient experienced headache. On 6th October 2022, the patient experienced neck pain and rash. On an unknown date, the outcome of the headache, neck pain and rash were not recovered/not resolved.   It was unknown if the reporter considered the headache, neck pain and rash to be related to Shingrix.  Additional Information: GSK Receipt Date: 20-OCT-2022 Reporter's Comment: The reporter who was reporting on behalf of a patient.  She stated that, the patient received Shingrix.  He started to experience a headache on the same day.  On 6th October 2022, the patient experienced neck pain followed by a rash on the left side of his neck which extended to his upper back and his chest.  The symptoms had not yet resolved.  The reporter consented to follow up.
Patient given shots on 6/2/06. On 6/4/06 mom called child had left arm red and swollen with few blisters not draining early cellulitis.
Sore arm; This is a spontaneous report from a non-contactable consumer (patient). A 66-year-old female patient received bnt162b2 (BNT162B2), dose 1 intramuscular on 03Feb2021 (Batch/Lot number was not reported) as dose 1, single for covid-19 vaccination,; ibrutinib (IMBRUVICA), oral from Feb2018 (Batch/Lot number was not reported) and ongoing, at 140 mg, 3 times per day for Chronic Lymphocytic Leuk Of B-Cell Type Not Achieve Remission. The patient's medical history and concomitant medications was not reported. The patient experienced sore arm on 03Feb2021. Outcome of the event was recovered on an unspecified date of 2021. The action taken in response to the event for ibrutinib was unknown.  Information on the lot/batch number has been requested. Follow-up attempts are completed. No further information is expected.
-Hair loss 2 weeks after 1 dose - vitiligo got way worse after 2 weeks after 1 dose
Patient reported to pharmacy 3 days after vaccine was administered on 04/08/2022 irritated because she had localized redness, but it was extended towards her elbow. Patient reported only the redness; said it was not warm to the touch or causing her any pain. She was encouraged to follow-up with PCP and then let us know. She called back today and said that her PCP told her to wait it out, that it was just a reaction from the vaccine.
Patient was admitted to Hospital  on 1/16/2022 for Hypoxia due to COVID-19. This is considered a breakthrough case.
This literature study report was received from the authors of the published abstract and refers to 22-year-old female subject. As part of a small pre-clinical study of stage-specific antibody responses to pneumococcal vaccination, the authors enrolled a 22-year-old female with a history of asthma. At recruitment she denied previous vaccination. On unspecified day she received PNEUMOVAX 23 and within seven days developed a large local reaction lasting seven days; she was unable to work for three days due to limited range of motion and pain. After the event, medical records from a hospitalization for severe asthma three months prior to study entry were obtained and, upon review, she had received PNEUMOVAX 23. Blood was collected on day 0 (prior to vaccination), and on day 7 and day 35 post vaccination. Flow cytometry was performed on PBMC, and IgG anti-pneumococcal capsule antibody levels and opsonophagocytosis titers were measured with serum. At day 7, the subject failed to produce a robust plasma blast response. IgM + CD27 + memory B cells, the ratio of ASC to PC, and the numbers of CD4 and CDS T cells were unchanged. At day 35, IgG anti-capsule antibody levels and pneumococcal opsonophagocytosis titers were unchanged. Additional information has been requested.
Nurse Practitioner wrote an order for Fluzone Quadrivalent and the Technician gave Flublok Quadrivalent in error to a 13 years old , No AE; 13 years old received Flublok Quadrivalent, no AE; Initial information received on 29-Oct-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 13 years old female patient who experienced 13 years old received flublok quadrivalent (product administered to patient of inappropriate age, wrong product administered), while she received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] instead of  INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 28-Oct-2019, the patient received a one dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot QFAA1939 via intramuscular route in the right arm instead of INFLUENZA QUADRIVAL A-B VACCINE.  It was a case of actual medication error due to product administered to patient of inappropriate age and wrong vaccine administered.  It was reported as Nurse Practitioner wrote an order for Fluzone Quadrivalent and the Technician gave Flublok Quadrivalent in error to a 13 years old.   It was not reported whether the patient had any adverse effect.  It was not reported if the patient received a corrective treatment.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's 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.  No further relevant information was reported.
Mother said he gradually put his head down after receiving vaccine, then his head moved abruptly backward and legs and arms stiffened. He complained of abdominal pain, headache, and diaphoresis. Episode lasted 10 seconds. No loss of consciousness. He was evaluated by EMTs at the clinic.
I have been spotting and bleeding every day since I think early may. May 22 is when I started documenting the bleeding. I have had an IUD in since August of 2019 and prior to this May haven?t experienced any bleeding since getting it put it.
SORE ITCHY THROAT, ACHY, TIRED, STUFFED AND RUNNY NOSE, COUGHING.
Shortness of breath; Wheezing; Heart palpitations; Fatigue; asthma-like symptoms; Condition aggravated; This case was reported by a pharmacist via call center representative and described the occurrence of shortness of breath in a 55-year-old female patient who received Herpes zoster (Shingrix) (batch number 477S3, expiry date 17th October 2021) for prophylaxis.   Concurrent medical conditions included asthma.   On 25th July 2019, the patient received the 1st dose of Shingrix. On 25th July 2019, 1 hr after receiving Shingrix, the patient experienced shortness of breath, wheezing, palpitation, fatigue, asthma-like condition and condition aggravated. On an unknown date, the outcome of the shortness of breath, wheezing, palpitation, fatigue and asthma-like condition were recovering/resolving and the outcome of the condition aggravated was unknown.   It was unknown if the reporter considered the shortness of breath, wheezing, palpitation, fatigue, asthma-like condition and condition aggravated to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and about an hour to an hour and a half later started to experience asthma like symptoms that included shortness of breath and wheezing. The patient but saw an increase in symptoms after receiving the vaccine. The patient also experienced heart palpitations and extreme fatigue. The reporter spoke to the patient the day after she received the vaccine and she stated that she was feeling better, but not 100 percent. The reporter gave consent to follow up.
Patient was administered the vaccine and went shopping in the store with his guardian. The guardian said that patient felt dizzy in the electronics section and fell. He was taken to the ER. I called and followed up with the patients mother, and she said he was given fluids in the ER and is doing fine now.
past the 42 day interval of the first dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (past the 42 day interval of the first dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-May-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (past the 42 day interval of the first dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (past the 42 day interval of the first dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported. no treatment medication was provided   Most recent FOLLOW-UP information incorporated above includes: On 16-Jul-2021: Follow up received on 16 Jul 2021 contains no significant information
This spontaneous report as received from a health care worker refers to a female patient of unknown age. In September 2012 the patient received her first dose of GARDASIL (lot # not reported) (strength and total daily dose not reported). In November 2012 the patient received the second dose of the vaccine (lot # not reported) (strength and total daily dose not reported). This patient had yet to receive the third dose of the vaccine and at the time of report it was way past the timing of the dosing schedule in the prescribing information. No side effects were reported. It was unspecified whether the patient sought for medical attention. The outcome was unknown. Additional information is not expected.
I have numbness and tingling in leg, walking on it feels weak/ I cant put pressure on my leg/bottom part of leg; Tingling in leg; Walking on it feels weak; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (I have numbness and tingling in leg, walking on it feels weak/ I cant put pressure on my leg/bottom part of leg), PARAESTHESIA (Tingling in leg) and ASTHENIA (Walking on it feels weak) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA (I have numbness and tingling in leg, walking on it feels weak/ I cant put pressure on my leg/bottom part of leg), PARAESTHESIA (Tingling in leg) and ASTHENIA (Walking on it feels weak). At the time of the report, HYPOAESTHESIA (I have numbness and tingling in leg, walking on it feels weak/ I cant put pressure on my leg/bottom part of leg), PARAESTHESIA (Tingling in leg) and ASTHENIA (Walking on it feels weak) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product information was not provided.  Treatment information was not provided.  The patient had numbness and tingling in her leg, along with weakness. The patient wanted to know if this was a normal side effect of the Moderna COVID-19 vaccine.
Pt. states that after the 3rd Booster of Moderna 11/05/2021, started experiencing symptoms that evening of muscle aches, chills, and fever (100.3). Uncontrollably shakes due to chills, extreme fatigue (11/07/2021). No noted Primary visit/communications.
Patient presented to local ED on 4/8 after having symptoms ~0400 with right sided numbness unable to move fingers on right hand. Patient also unable to use right leg properly to walk. Later ~0800 weakness, numbness progressed to left side and patient had worsening paralysis to all extremities, trunk, and to face. Patient was transferred to our facility for concern for guillain-barre syndrome. Once admitted, patient was intubated for airway protection and remains on ventilator receiving plasma exchange sessions for presumed diagnosis.
2:30 PM joint pain, aching, 3:00 AM swollen throat and neck, trouble breathing, chest and jaw pain. 5 AM all good but he joint pain remained.
Inappropriate schedule of vaccine / wanted to be administered with second dose / 1st dose was administered during 2018; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrx (in March 2018, received 1st dose).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows:  The age at vaccination was not applicable for this report. Pharmacy intern reported that the patient was overdue for dose two of Shinrgix series. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. Consent to follow up was given.  The healthcare professional did not provide lot number or expiration date of dose one. No additional information was provided. VAERS details were reported for 1st dose.   Follow up information was provided by pharmacist on 19th May 2021: The reporter stated that, a 55 years old patient wanted to be administered with 2nd dose of shingrix but the 1st dose was administered during 2018. The reporter was asking for data about Shingrix Schedule and how to operate in such scenario. The Healthcare professional did not administer the second dose of shingrix and the 2nd line agent provided him with the information about new schedule for Shingrix.
Pt throat started to swell after few hours along with trouble breathing. Pt too liquid benadryl and it went away after a few hours.
My stomach hurts a lot, i was already sleeping they gave me some medicine, and they did some lab test