chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient presents for acute hypoxic respiratory failure due to COVID-19 pneumonia.  Patient's symptoms were ongoing for approximately 10 days before presentation.  On presentation patient was hypotensive with a blood pressure of 80/51 tachypneic and SpO2 of 86% on 6 L by nasal cannula.  Patient received 2 L normal saline bolus in the ER placed on high-flow nasal cannula.  Patient's hypoxia advanced requiring BiPAP therapy.  Patient was started on vancomycin and cefepime secondary concern for superimposing pneumonia and accepted to critical care.  Chest x-ray was significant for diffuse patchy infiltrates bilaterally.  Patient was initiated on Baricitinib along with Decadron.  Decadron was increased to b.i.d. Dosing secondary to high oxygen requirements.  Following day patient's oxygen requirements began down trending in continued so.  Patient's blood pressure was elevated Critical Care started the patient on hydrochlorothiazide.  Patient was transferred to the medical floor.  Patient weaned to room air within 24 hr of transferred to the medical floor.  Continued on Baricitinib till discharge.  Patient was discharged home on January 11, 2022 in stable condition.
Fever; Chills; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) and CHILLS (Chills) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever) and CHILLS (Chills). At the time of the report, PYREXIA (Fever) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were reported. No treatment medications were reported.   Reporter did not allow further contact
First developed wheezing with severe ear infection within one week of 12/22/1999 vaccinations. Then began developing red irritation around neck (doctors told me it was eczema and that he would have it every winter and probably eventually develop asthma) and hives all over body within one month of 12/22/99 vaccinations--patient would be up all night trying to itch neck area. Treated neck area with hydrocortisone cream--worked initially but as soon as stopped would return even worse. Eventually treated neck area with Homeopathy with success--neck irritation never returned. Wheezing and hives progressively  worsened over the years with hospitalization on 1/19/01 and 3/23/02 with oxygen levels between 80-85 and pneumonia on 1/19/01 hospitalization. Treated in hospital with antibiotics, oral Prednisone, Albuterol/Atrovent, and Pulmicort. At home, treatments were with a nebulizer using saline or Albuterol. After 3/23/02 hospitalization, patient was tested for allergies and found to be allergic to eggs, brewer's yeast, wheat, spelt, cane sugar, weeds, trees, dust, cats, molds. Doctors wanted me to treat him daily with steroids, inhalers, nebulizer, etc. Because of his symptoms were only getting worse with conventional treatments that were requiring more and more drugs to keep him breathing normally, I eventually took patient to Homeopathic doctor for treatment and have found the greatest relief of his symptoms through her treatments--since seeing her in August 2002, he has completely weaned off of all conventional treatments and has not wheezed in 8 months. He still gets some skin reactions and sneezing with runny nose, but it is progressively lessening with continued Homeopathic treatments. The medical records state otitis media and dermatitis.  60-day Follow up on 11/13/2003: "Vaccine recipient did not recover from adverse events.  Continued skin problems, allergies, difficulty breathing (wheezing).  His symptoms are not as frequent since I took him off all conventional treatments (steroids, nebulizer, etc) and started homeopathy under the care of a homeopathic physician about a year ago.  He was only getting worse with required hospitalizations with allopathic medicine.  So grateful we found homeopathy!"
Right arm hurt shortly after vaccine was administered, 6 weeks later it is still hurting and I am unable to lift arm even half way up.
shaking & fever c/o of pain in leg 2-3hr p/vax;chronix hx of immunodeficiency;
Fever; muscle aches; chills; fatigue; rash on arms; This is a spontaneous report received from a contactable consumer, the patient. A 26-year-old non-pregnant female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via an unspecified route of administration in left arm on 17Mar2021 at 13:15 (at the age of 26-year-old) as a single dose, for COVID-19 immunisation. Medical history was not reported. The patient received birth control (MANUFACTURER UNKNOWN) within 2 weeks of vaccination. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown), via an unspecified route of administration in left arm on 24Feb2021 at 00:00 hours (at the age of 26-year-old), as a single dose for COVID-19 immunisation. Prior to vaccination the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Since the vaccination patient had not been tested for COVID-19. The patient had codeine allergies. On 18Mar2021, the patient experienced fever, muscle aches, chills, fatigue and rash on arms. The patient did not receive any treatment for events. The clinical outcome of the events fever, muscle aches, chills, fatigue and rash on arms were recovering.  No follow-up attempts are needed. No further information is expected
The pt developed a transverse myelitis, weakness, numbness of both legs, inability to urinate and difficulty with morning bowels. She has improved.  Patient is walking without a walker, feels like his strenght is not yet fully back to normal.
Patient was walking and observed on bilateral knees by staff, rapid response called and assistance provided.  Patient stated he feels dizzy, lightheaded, diaphoresis noted.  Patient stated he had needle anxiety. Nurse  and MD at site obtained BP 120/80, HR 96, no respiratory distress noted with SPO2 98% RA. nurse provided patient with water, staff remained with patient with Q10 vitals, normal vitals, MD sent patient home with no other interventions.
hives on arms, stomach, back 22MAY97 rt p/shots;throat felt full;skin on arms tender to touch;
Client rec'd 1 dose of  Johnson and Johnson vaccine that is not approved for her age.
Arm itchin; Arm is tender; Like a lump; Arm has a red spot of the size of a quarter  like a lump; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Arm itchin), TENDERNESS (Arm is tender), MASS (Like a lump) and ERYTHEMA (Arm has a red spot of the size of a quarter  like a lump) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to metals (Nickel allergy causes rashes).    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced PRURITUS (Arm itchin), TENDERNESS (Arm is tender), MASS (Like a lump) and ERYTHEMA (Arm has a red spot of the size of a quarter  like a lump). The patient was treated with CORTISONE at an unspecified dose and frequency. At the time of the report, PRURITUS (Arm itchin), TENDERNESS (Arm is tender), MASS (Like a lump) and ERYTHEMA (Arm has a red spot of the size of a quarter  like a lump) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
Pain in elbow, difficulty in sleeping B/C of pain was prescribed Ibuprofen.
Pt is under the age of one and was given Kinrix. No signs or symptoms of any reaction. Provider notified and mother.
(L) arm from shoulder to elbow very swollen, tight, red, hot to the touch, painful, tingling sensation at times.
The patient received the vaccine on 31Dec2020 and then tested positive a week later; The patient received the vaccine on 31Dec2020 and then tested positive a week later; This is a spontaneous report from a contactable other HCP (healthcare professional) via a Pfizer-Sponsored Program,. A 41 (units not provided) female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection) via an unspecified route of administration on 31Dec2020 (at an unspecified age) as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. It was reported that the patient received the vaccine on 31Dec2020 and then tested positive a week later. The patient stated that she was supposed to receive the vaccine this Thursday and she wanted to know if she could receive the vaccine. The clinical outcome of the event "the patient received the vaccine on 31Dec2020 and then tested positive a week later" was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on the information currently available, lack of efficacy of the suspected vaccine BNT162B2 cannot be completely excluded. However, individuals may not be protected until at least 7 days after their second dose of the vaccine. It is unlikely that the patient would have fully developed immunity due to the very short time lag between the first vaccine dose and the event onset.
SEVERE headache, severe nausea, muscle aches, chills, low grade fever, stomach pain with loose stools.  I had to take an Imedrix for my headache and Meclizine for the nausea.   My symptoms were so severe I almost had my husband take me to ER.  Once I got the headache and nausea under control I was able to sleep.  I was in bed all day and all night.  On day two (today) I am without symptoms, just listless.  I know these are all "side effects" and not necessarily "adverse events", but since my symptoms were so severe, I decided to report them anyway.
No wheel noted after 1st injection attempt. Dose repeated and wheel was noted - No further incident
infected twice with COVID; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (infected twice with COVID) in a 46-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     Concurrent medical conditions included RA and Ex-smoker.    On an unknown date, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 03-Dec-2022, the patient experienced COVID-19 (infected twice with COVID). At the time of the report, COVID-19 (infected twice with COVID) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2022, Influenza virus test: Positive. In December 2022, SARS-CoV-2 test: Positive. In January 2023, Influenza virus test: Positive. In January 2023, SARS-CoV-2 test: Positive. On an unknown date, SARS-CoV-2 test: Negative.         No concomitant medications were reported. It was reported that patient had received one booster dose. Patient had been infected twice with COVID in the last 6 weeks. Once on 03-Dec-2022 and again on 07-Jan-2023. And both times patient went to an urgent care to get diagnosed because the Bionox test was negative. Both times the flu/Covid Test came back positive. Both times patient was prescribed the antiviral medication. Patient told this did not seem normal. And this last one, patient actually still could not breathe properly. Patient was breathing like patient had COPD. Patient got COVID 2 times in 1 month, patient do not go anywhere and tested negative with another test.   This case was linked to US-MODERNATX, INC.-MOD-2021-068675 (E2B Linked Report). This case was linked to US-MODERNATX, INC.-MOD-2021-068687 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-068675:Husband case
vaccinated years back, revaccinated; This case was reported by a consumer via call center representative and described the occurrence of extra dose administered in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine  (received Shingles vaccine some years ago from reporting date).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were provided as follows: The patient was reporter's father. The age at vaccination was not reported. The reporter reported that his/her father in law was in a nursing home and they accidentally revaccinated him with Shingles vaccine, which led to extra dose administered. The reporter asked that would this hurt the patient. The follow-up could not be possible as no contact details were available. Note: The case was conservatively kept as valid one as there is no clarification regarding total number of doses and follow-up could not to follow as no contact details were there.
The pt experienced left thigh swelling, redness, raised area with a small rash radiating to groin area. The pt complained of the area itching. Mother gave the child Tylenol every 4-6 hours. Benadryl and compresses were also used.
Pt was administered varicella vaccine 8/9/02. On 8/17/02 pt developed a rash. Mother took pt to a healthcare provider who confirm rash was varicella. Pt was given an antiviral medication. Pt had a mild case most of body per mother no complaint.
Swelling, erythema and pain of arm approximately 10cm x 20 cm distribution.  Refusal to use arm for two days.
Cellulitis at site of injection. Hospitalized 2 days; IV antibiotics.
assuming I have RA; broke out in hives; struggled to walk in the mornings; joint pain; stiffness; slight swelling in (hips, ankles, feet, hands, wrists); pain grew worse over several months; couldn't put rings on my fingers; work shows elevated inflammation; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 01May2021 12:00 (Lot number: ER8736) at the age of 46 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: LIPTONORM, start date: 23Apr2021. Vaccination history included: Bnt162b2 (Prev dose product: COVID 19, Prev dose brand: Pfizer, Prev dose brand name unknown: False, Prev dose lot number: ER8733, Prev dose Lot unknown: False, Prev dose administration date: Mar2021, Prev dose administration time: 12:00 PM, Prev dose dose number: 1, Prev dose vaccine location: Left arm), administration date: Mar2021, for Covid-19 immunization. The following information was reported: RHEUMATOID ARTHRITIS (medically significant) with onset Jun2021, outcome "recovering", described as "assuming I have RA"; URTICARIA (non-serious) with onset Jun2021, outcome "recovering", described as "broke out in hives"; GAIT DISTURBANCE (non-serious) with onset Jun2021, outcome "recovering", described as "struggled to walk in the mornings"; ARTHRALGIA (non-serious) with onset Jun2021, outcome "recovering", described as "joint pain"; JOINT STIFFNESS (non-serious) with onset Jun2021, outcome "recovering", described as "stiffness"; JOINT SWELLING (non-serious) with onset Jun2021, outcome "recovering", described as "slight swelling in (hips, ankles, feet, hands, wrists)"; PAIN (non-serious) with onset Jun2021, outcome "recovering", described as "pain grew worse over several months"; PERIPHERAL SWELLING (non-serious) with onset Jun2021, outcome "recovering", described as "couldn't put rings on my fingers"; INFLAMMATION (non-serious) with onset Jun2021, outcome "recovering", described as "work shows elevated inflammation". The events "assuming i have ra", "broke out in hives", "struggled to walk in the mornings", "joint pain", "stiffness", "slight swelling in (hips, ankles, feet, hands, wrists)", "pain grew worse over several months", "couldn't put rings on my fingers" and "work shows elevated inflammation" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: blood test: elevated inflammation(crp marker). Therapeutic measures were not taken as a result of rheumatoid arthritis, urticaria, gait disturbance, arthralgia, joint stiffness, joint swelling, pain, peripheral swelling, inflammation.  No follow-up attempts are possible. No further information is expected.
This spontaneous report was received from a Consumer, refers to a male patient around 72/85 age range. On 18-OCT-2013, the patient was vaccinated with PNEUMOVAX23 (lot # J006242, expiration date 03-AUG-2014, dose not reported). Per the reporter, the patient was affected. On 19-OCT-2013, the patient complained the area being red/hot and swollen the next day after the vaccination. At the time of reporting, the outcome of the event was unknown. This is one of several reports received from the same source. Additional information has been requested.
I contracted COVID-19 with symptoms of body aches, cough, knee pain, joint pain, back pain, fatigue, and fever of 101. The knee pain progressed to the point that I could not walk. I was prescribed medications that I cannot recall the name of. My symptoms began to improve after 3 days of beginning medications. I am fully recovered with no lingering symptoms.
Intoxication; Rash in all over her Body; This spontaneous case was reported by a consumer and describes the occurrence of POISONING (Intoxication) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by reporter.  Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for an unknown indication.    On 25-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Aug-2021, the patient experienced RASH (Rash in all over her Body). On an unknown date, the patient experienced POISONING (Intoxication) (seriousness criterion medically significant). At the time of the report, POISONING (Intoxication) and RASH (Rash in all over her Body) outcome was unknown.            The patient used unidentified medicament to alleviate rash.  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. Follow up information received 29 August 2021 does not change company causality, however a new event of "intoxication" was reported and added to the case.   Most recent FOLLOW-UP information incorporated above includes: On 29-Aug-2021: Route of administration suspected product  and event added.; 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. Follow up information received 29 August 2021 does not change company causality, however a new event of "intoxication" was reported and added to the case.
The patient has not felt well since he had the 3rd mRNA booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1; Manufacturer: Unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose 2; Manufacturer: Unknown), for COVID-19 Immunization. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "The patient has not felt well since he had the 3rd mRNA booster".  Additional information: It was reported that a patient started treatment on an unspecified date, over a year ago, with Pfizer BioNTech COVID-19 vaccine (Tozinameran) as a third dose (booster). It was reported the patient has not felt well since he had the third mRNA booster, and he won't get another mRNA vaccine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
rash; hive like rash / patches of non-itchy hives all over my torso; rash raised; fatigue; sore throat; sneezing; This case was reported by a physician and described the occurrence of fatigue in a 53-year-old female patient who received Herpes zoster (Shingrix) (batch number ZY3X4, expiry date 28th April 2020) for prophylaxis.  On 2nd April 2018, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 3rd April 2018, 1 days after receiving Shingrix, the patient experienced fatigue, sore throat and sneezing. On 8th April 2018, the patient experienced generalized rash, rash urticaria-like and raised rash. On an unknown date, the outcome of the fatigue, sore throat, sneezing, generalized rash, rash urticaria-like and raised rash were unknown.   It was unknown if the reporter considered the fatigue, sore throat, sneezing, generalized rash, rash urticaria-like and raised rash to be related to Shingrix.  Additional details were reported as follows: Six days after vaccination, the patient experienced rash which was described as full-body, hive-like and raised.   Follow up information received from the consumer on 5th February 2021: The batch details were updated. Previously administered products included Tdap vaccine received in recent years and flu vaccines. In April 2018, the patient received and week later broke out in huge patches of non-itchy hives all over my torso and took several days for it to dissipate.  The patient contacted the Shingrix representative and reported my side effect and was advised not to take a 2nd injection of Shingrix. The patient was curious to find out the potential ingredient in the Shingrix vaccine that could had triggered this side effect and never had an adverse reaction to any other vaccine that could recall.  The patient was treated with cetirizine hydrochloride (Zyrtec). It would be helpful to know the specific ingredient in the Shingrix vaccine that might had caused this reaction and any insight could provide would be most helpful. The brief chart that primary doctor had written documenting that had reported this to pharmaceutical representative. The patient consulted and asked pharma representative whether should get 2nd dose.; Sender's Comments:  US-GLAXOSMITHKLINE-US2018064604:Same reporter
Injection site pain from booster shot; Booster; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received third (booster) dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: was not reported), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient previously received first dose and second dose of BNT162B2 vaccine, on an unspecified date as a single dose for COVID-19 immunization. On an unspecified date, the patient experienced Injection site pain from booster shot. The outcome of the event was unknown.  The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow-up.