chrisvoncsefalvay/vaers-outcomes huggingface dataset:
she has a rash on her forehead, chest, back, lower back and stomach; hive-measley looking rash; hive; This is a spontaneous report from a contactable consumer (Patient's mother). A 25-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via intramuscular on an unknown date as a single dose for COVID-19 immunization. The patient medical history and concomitant medication were not reported. It was reported that patient had rash on her forehead, chest, back, lower back and stomach on an unknown date. It was reported that patient had no difficulty breathing. The patient also had hive measley looking rash on an unknown date. The patient received benadryl as a treatment medication for the events. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. .
I have been nauseous for a week; Ive been throwing up multiple times a day; I am not able to eat or sleep; I am not able to eat or sleep; This is a spontaneous report from a contactable consumer, the patient. A 17-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the left arm on 01May2021 at 01:00 (at the age of 17-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patent had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the vaccination. Concomitant medications were not reported. On 01May2021, the patient had been nauseous for a week. She had been throwing up multiple times a day. She was not able to eat or sleep. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. On 07May2021, the patient underwent nasal swab test for COVID-19 and the result was found to be negative. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had been tested for COVID-19. The clinical outcome of the event the patient had been nauseous for a week was resolved on 07May2021. The clinical outcome of the events she had been throwing up multiple times a day and she was not able to eat or sleep was not resolved at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Swollen lymph nodes left arm; Body aches; Chills; Shortness of breath; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of breath), LYMPHADENOPATHY (Swollen lymph nodes left arm), MYALGIA (Body aches) and CHILLS (Chills) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025B21A and 026A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Apr-2021, the patient experienced DYSPNOEA (Shortness of breath), MYALGIA (Body aches) and CHILLS (Chills). On 28-Apr-2021, the patient experienced LYMPHADENOPATHY (Swollen lymph nodes left arm). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 28-Apr-2021, DYSPNOEA (Shortness of breath), MYALGIA (Body aches) and CHILLS (Chills) had resolved. At the time of the report, LYMPHADENOPATHY (Swollen lymph nodes left arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported.   This case was linked to MOD-2021-094812 (Patient Link).
My right arm in and below the deltoid area became red, hot, swollen, and itchy 24 hours after my Moderna Vaccine # 2.    I also  developed body aches and temperature of 99.3. Reddened area on arm progressively worsened so I went to my PCP who prescribed cortisone ointment and antibiotics.  I have an allergy to steroids so she could not prescribe those
HYPOTENSION 2/21/2023 -- RECURRENCE OF SAME SYMPTOMS
21MAR96 starting vomiting, fever to 102, broke out in rash around neck, started screaming & jerking all about 1030PM;took to ER about 1AM;could not hold APAP down in ER;mom given rx but not filled because was told would not help pt any way;
This is a spontaneous report from a contactable consumer or other non health care professional. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Batch/Lot number: Not reported) via an unspecified route of administration, administered on an unspecified date in Jul2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient got the first dose exactly 3 weeks ago (an unspecified date in Jul2021), after the first dose, she got Covid and was quarantined for 2 weeks. The patient was due for the second dose tomorrow. They wanted to know if she can take vaccine or not. On an unspecified date the patient underwent lab tests and procedures which included sars-cov-2 test and resulted positive for covid-19. The outcome of the event covid-19 was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
no additional AE/PQC reported.; The patient was given the Children/Adolescents (12 months through 18 years of age) dose rather than the Adults (19 years of age and older); patient is 19 years old.; This spontaneous report was received from a Licensed Practical Nurse referring to a currenly 19 year old patient of unknown gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported.     In approximatly 2020 at 17 years old, the patient was vaccinated with their first dose of hepatitis a vaccine, inactivated(VAQTA) (strength, route, dose, frequency, anatomical location, lot # and expiration date were unknown) for prophylaxis.   Subsequently, on an unknown date in 2020, the patient was vaccinated with their second dose of hepatitis a vaccine, inactivated(VAQTA) 0.5 milliliter (strength, route,frequency, anatomical location,lot # and expiration date were unknown), the patient was given the Children/Adolescents (12 months through 18 years of age) dose rather than the Adults (19 years of age and older). No additional adverse events were reported.
administered IPOL after it exceeded the stability data documented in the local labelling  with no reported adverse event; administered IPOL after it exceeded the stability data documented in the local labelling  with no reported adverse event; Initial information received on 10-Aug-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 16 years old male patient who had administered IPV (VERO) [IPOL] after it exceeded the stability data documented in the local labelling  with no reported adverse event.   The patient's past medical history, medical treatment(s), concomitant medication, vaccination(s) and family history were not provided.   On an 19-Jul-2022, the patient received a 0.5ml dose of suspect IPV (VERO) (strength, formulation was unknown, lot U1C572M and expiry date: 17-Jun-2023)) via subcutaneous route in the right deltoid for Immunization.  On an 19-Jul-2022, the patient developed a non-serious administered ipol after it exceeded the stability data documented in the local labelling with no reported adverse event (poor quality product administered) (latency same day) following the administration of IPV (VERO).  On an unknown date, the patient developed a non-serious event of administered ipol after it exceeded the stability data documented in the local labelling with no reported adverse event (product temperature excursion issue)(latency unknown).  Action taken : not applicable.  Outcome: Unknown  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 the guidelines. 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.
pt recv vax 13SEP96 & on 23SEP96 pt devel full blown varicella w/greater than 50 lesions;
Initial unsolicited report received from nurse on 25-Oct-2017. This case was linked to 2017SA210269 and 2017SA210270 (same reporter, same vaccine). This case involves a six-year-old male patient who was vaccinated with 0.5 ml dose once of FLUZONE (Batch number: U5896CA, expiration date, dose was not reported) via intramuscular route in right deltoid on 21 Oct 2017. The patient's medical history and concomitant medications were not reported. On an unspecified date, following the vaccination, the patient experienced softball size bump from deltoid to elbow and around to bicep. Lab data was not reported. The patient received corrective treatment with Tylenol. The patient was not recovered from event. List of documents held by sender: none.
Injection site became red; Received a dose of Flulaval on 10/1/2020 subcutaneously; This case was reported by a nurse via call center representative and described the occurrence of injection site erythema in a 62-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2020-2021 season) for prophylaxis.   On 1st October 2020, the patient received FluLaval Tetra 2020-2021 season (subcutaneous) .5 ml. On 1st October 2020, less than a day after receiving FluLaval Tetra 2020-2021 season, the patient experienced injection site erythema and intramuscular formulation administered by other route. On an unknown date, the outcome of the injection site erythema was not recovered/not resolved and the outcome of the intramuscular formulation administered by other route was unknown.   It was unknown if the reporter considered the injection site erythema to be related to FluLaval Tetra 2020-2021 season.  Additional details were provided as follows: The age at vaccination was not reported. HCP was reporting her own experience with Flulaval.  The patient received a dose of Flulaval Quadrivalent 2020-2021 season on 1st October 2020 subcutaneously instead of the indicated intramuscular route which led to intramuscular formulation administered by other route.  The reporter stated that the injection site became red on 1st October 2020 and this continued. The reporter consented to follow up.
After 1st shot I had heart pain; After receiving my first Pfizer covid shot. I developed three very distinct mosquito like bites on my left arm. They were not going away, were very scratchy and developed a black dot within them; After receiving my first Pfizer covid shot. I developed three very distinct mosquito like bites on my left arm. They were not going away, were very scratchy and developed a black dot within them; Concurrently my gums swelled and were leaking blood/puss for unknown reasons; Concurrently my gums swelled and were leaking blood/puss for unknown reasons; This is a spontaneous report from a contactable consumer (patient). A 45-years-old female non-pregnant patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: FA6780), via an unspecified route of administration, administered in left arm on 19Jul2021 at 05:00 (at the age of 45-years-old) as single dose for COVID-19 immunisation. The patient's medical history included COVID-19 from an unknown date and unknown if ongoing. The patient had no known allergies. There were no concomitant medications. The patient after receiving first Pfizer COVID shot on an unspecified date developed heart pain, three very distinct mosquito like bites on left arm. They were not going away, were very scratchy and developed a black dot within them and concurrently the patient's gums swelled and were leaking blood/puss for unknown reasons. The patient had no other vaccine in four weeks; no other medications in two weeks. The patient received no treatment for the adverse events. The patient had COVID prior to vaccination and had not tested post vaccination. The clinical outcome for the events was unknown.  Follow-up (27Aug2021): This is a follow-up spontaneous report received in response to the mail trail sent regarding the confirmation below mentioned query. The response included:  Response: Dear Colleagues, please find translated form.  Follow-Up (03Sep2021): Follow-up attempts are completed. No further information is expected.
Pt exp a dec in ANA titers p/(?) second dose of Engerix-B;
he is near death; Some flu sickness; Could barely walk; Not eating; Soaked with his sweat; He just wants to sleep; Fever for 2 days; Bad headache; A spontaneous report was received from a consumer concerning a male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced some flu sickness, he is near death, could barely walk, fever for 2 days, not eating, soaked with his sweat, bad headache and he just wants to sleep.  The patient's medical history, as provided by the reporter, included positive nasal swab COVID test. No relevant concomitant medications were reported.   On 07 Dec 2020, the patient had a nasal swab that was positive for COVID at the emergency room and received hydrochloroquine.  On 30 Dec 2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. He experienced some flu sickness for a few days and then felt fine.  On 27 Jan 2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. It was reported that the side effects were really bad and he was near death. The patient could barely walk and was not eating. He had a fever for two days with temperatures of 103 Fahrenheit (F), 101F, 98F, 100F and 99F. It was also reported that the patient was soaked with his sweat and soaked through his bedding and mattress. He also had a bad headache that was described as being worse than when he had COVID. The patient just wanted to sleep and was difficult to wake up. Treatment for the events included two acetaminophen or ibuprofen, zinc, vitamin C, vitamin D, sports drink and water while he is awake. The patient refused a protein shake and wanted nothing. Consent given for Safety to follow up.  Action taken with mRNA-1273 in response to the events is not applicable since the patient received two doses as scheduled.   The event, some flu sickness, was resolved on unknown date. The events, he is near death, could barely walk, fever for 2 days, not eating, soaked with his sweat, bad headache and he just wants to sleep, were not resolved at the time of this report.; Reporter's Comments: This case concerns a male patient , age unknown, with medical history of positive nasal swab COVID test, who experienced a serious unexpected event of Critical illness and NS events of Influenza like illness, Gait disturbance, Decreased appetite, Hyperhidrosis, Hypersomnia, Pyrexia and Headache. The event occurred 29 days after first dose of the study medication administration and on the same day after the last dose administration. Treatment for the events included two acetaminophen or ibuprofen, zinc, vitamin C, vitamin D, sports drink.   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.
Purpuric rash on both legs below the knee, chills, malaise. Patient experienced same reaction 6 days after 2010 flu shot. No reaction previous to 2010.
Onset within two hours of injection site pain, followed by joint pain, fatigue, headache, increased & irregular heart rate (112 at rest), and noise sensitivity.
Gastro paresis is the term given me, however that is being researched.  I do have gastritis, pretty chronic and severe, yeast in my throat and stomach, being treated.  I don't think this is an adverse reaction but I was told to report anyway
11/8/21 - Booster shot - low grade fever, joint & muscle pain, swollen left arm, swollen left armpit, & fatigue.  11/22/21 - runny nose & coughing then sick with head cold symptoms with severe head congestion & coughing from 11/23/21 through 11/27/21.  11/29/21 - Negative COVID-19 Test 12/10/21 - telehealth doctors visit for sinus infection symptoms & bronchitis symptoms. Given Doxycycline (antibiotic), Predisone (steroid), and Albuterol Inhaler 3/1/21 2nd shot - severe headache, severe injection site arm pain into neck and shoulder. Pain in arm and shoulder lasted for 1 week after 2nd COVID shot on 3.1.21.
A report has been received from a Health Professional concerning a 1 year old, Male patient, who had been receiving Nasal FLUMIST (intranasal), 0.2 Millilitres, Unknown for INFLUENZA. FLUMIST (intranasal) started on an unknown date for INFLUENZA. The nurse reported that FLUMIST was inadvertently administered to a 22 month old infant male today which started on 28-Oct-2015 and also reported that FLUMIST to 22 months old infant male. The outcome of the event of ADMINISTRATION TO 22MO OLD and FLUMIST TO 22MO OLD was unknown. The report was considered to be non-serious.
60 yo obese who had an apparent anaphylactic respond to her first pfizer covid vaccination. She was treated in the ER for 5 hours with steroids, oxygen, IV fluids and epinephrine. Pt still having GI distress with abdominal pain and diarrhea. This is Day 3 s/p vacccine.
FLU LIKE SYMPTOMS; HEADACHE; FEVER; FATIGUE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, administered on 23-MAR-2021 for prophylactic vaccination.  The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers No concomitant medications were reported. On an unspecified date, the patient experienced flu like symptoms, headache, fever, and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, flu like symptoms, fever and fatigue was not reported. This report was non-serious.
looks like chicken pox; itching; pain in chest; pain in chest; scratches.; This case was reported by a consumer via call center representative and described the occurrence of varicella-like rash in a 76-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th April 2019, the patient received Shingrix (intramuscular) .5 ml. On 15th April 2019, 1 days after receiving Shingrix, the patient experienced varicella-like rash, itchy rash, painful rash, pain and scratch. The patient was treated with topical steroid nos (Steroid Cream). On an unknown date, the outcome of the varicella-like rash, itchy rash, painful rash, pain and scratch were not recovered/not resolved.   It was unknown if the reporter considered the varicella-like rash, itchy rash, painful rash, pain and scratch to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in his left arm.  The next day his right arm broke out in what looked like hives. The breakout no longer looks like hives, but looks like chicken pox and it had traveled to his back and chest. It was very itchy and on his chest it was painful as well. The rest was not painful unless he scratches. The breakout was continuing to get worse. He saw his internist for a regular appointment and showed him the breakout and was referred to a dermatologist.  The dermatologist took a scraping from his back and said it was not shingles. He had now gone to an allergist, who drew several vials of blood. He had taken steroids and steroid creams, but the breakout continues to get worse. The reporter had consented to follow up. Emergency room visit required.
moderate vertigo; depression severe enough/significant depression; depression severe enough to have daily suicidal thoughts; This is a spontaneous report from a contactable other healthcare professional (patient). A 56-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date unknown), via an unspecified route of administration on 16Apr2021 as dose 2, single for covid-19 immunization. Medical history included thyroid and; mild anxiety. There were no known allergies. Concomitant medication included bupropion hydrochloride (WELLBUTRIN) taken for thyroid, hormone replacement therapy (HRT), and mild anxiety from 2001. The patient was previously vaccinated with the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown) on an unspecified date 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. The patient was not pregnant at the time of vaccination and at the time of the events. The patient experienced moderate vertigo approx. 2 weeks after the second dose in 30Apr2021, which lasted for several hours. The patient took scopolamine for the vertigo. The patient informed that she has been taking Wellbutrin for 20 years for mild anxiety; and she has never had problems with depression, but for "about 6 weeks" on an unspecified date in 2021, she had depression severe enough to have daily suicidal thoughts which was very bizarre for her. The patient further stated that she experienced significant depression "approx. 4 months" after the second dose. No treatment was received for depression. The patient recovered from vertigo on 30Apr2021. The outcome of the other remaining events was recovering. Since the vaccination, the patient has not been tested for Covid-19.  The lot number for BNT162B2 was not provided and will be requested during follow up.; Sender's Comments: A causal relationship between BNT162B2 and the reported events cannot be excluded based on  temporal association. 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 RAs, Ethics Committees, and Investigators, as appropriate .
Covid19 breakthrough.  1st vaccine received on 01/22/2021.  91y/o PMH DM, HTN, COPD, OSA/CPAP, AFIB, CAD, Lung CA, Intracerebral hematoma presents to ED 1/11/2022 with Covid19 x5 days.  Pt with +Covid test and was given Regeneron without improvement of symptoms so referred to ED for management of Covid PNA.  Pt c/o increasing SOB and cough.  CXR with upper lobe consolidation and lower lobe atelectasis.  Requiring 2L NC.  O2sat 95%.  Started on IV ABX/Steroids.  Pt expired on 01/14/2022.
1/19/21 chills for a few hours starting 7pm. Put on a vest, turned up the heat, took a tylenol. 1/20/21 Feel fine today except slight itching at vaccine site.