chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Slight rash in her arm; A spontaneous report was received from a consumer who is a 67-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced slight rash in her arm.  The patient's medical history included hypothyroidism. Concomitant medications reported were medication for hypothyroidism.  On 23-Jan-2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot batch: 042L20A) intramuscularly in her arm for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the slight rash. The reporter indicated other for seriousness but this is not consistent with the presentation of the event slight rash.  No lab data was provided.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was Unknown  On an unknown date the outcome of slight rash was considered to be recovered.; Reporter's Comments: 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. This event is not serious.
The initial case was missing the following minimal criteria: no identifiable patient. Upon receipt of follow up information on 06Oct2015, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable pharmacist via Pfizer sales representative. This pharmacist reported similar events for seven patients. This is the sixth of the seven reports. A patient of unspecified age, ethnicity and gender received a single dose of PREVNAR 13 via an unspecified route of administration on an unspecified date (between Nov2014-Sep2015). The patient medical history and concomitant medications were not reported. The patient experienced rashes, chills, pain and concern for cellulitis on an unspecified date. The outcome of the events was unknown.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Additional Details: pt had gotten her vaccine and started feeling light headed like she was going to pass out.  we got her a fan and a drink.  she said she may have had low blood sugar and was nervous about shot
Swelling of his arm at immunization site. Developed afternoon of morning injection. Red 2" circle surrounding site. Swelling subsided by the next day 24 hours later.
Same day of shot nausea, fever, chills, body aches, left humerous red, swollen and tender. Pt was seen 2 days after onset and treated with Septra DS. Pt was diagnosed with Cellulitis.
This spontaneous report as received from a other refers to a patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX for prophylaxis. On an unknown date the patient experienced herpes zoster. The outcome of herpes zoster is unknown.
Fever; Headache; A lot of pain in throat; Couldn't swallow; arm was hurting; This is a spontaneous report received from a contactable consumer (mother). A 15-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0168), via an unspecified route of administration, administered in arm (Unknown if right or left, but thinks right) on 24May2021 (age at vaccination: 15 years) as 1ST DOSE, SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. On an unknown date in May2021 (was unsure of date, either 25May2021 or 26May2021), the patient experienced arm was hurting from the second day; on 13Jun2021 16:00, fever, headache, a lot of pain in throat and couldn't swallow. As the patient got sick and due to fever, she was sent to emergency room yesterday and they sent her home. The patient was due for second dose on an unknown date (reported as Monday, yesterday). She couldn't receive the second dose because she was sick, so she took her to the doctor yesterday because from Sunday she had a fever and Monday still having the fever so yesterday in the middle of the day, she took her to the doctor. She wasn't having symptoms from first dose, just arm was hurting, no fever or nothing else. She did not have fever after first dose until 13Jun2021 Sunday. The patient did not require a physicians' office visit. On 14Jun2021, the patient underwent test for throat infection which was negative and gave no antibiotics. The patient received the following treatment for the adverse events: Tylenol and Motrin, dose unknown, 2 pills for sore arm. For the Fever, pain in throat, headache, trouble swallowing received Tylenol every 6 hours and her daughter was getting better, no fever and headache. For swallowing: gargling with hot water, lemon, and salt, and was getting better. She no longer has the sore arm she is better now. The outcome of the event oropharyngeal pain and dysphagia was recovering, and all the other events were recovered on an unknown date in 2021.  Information on Lot/Batch number was available. Additional information has been requested.
PATIENT STATED SHE GOT CELLULITIS AND WAS IN THE HOSPITAL FOR 3 DAYS.
Consistent elevated blood pressure (150/110); This is a spontaneous report from a contactable consumer (reported for himself). A 36-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: ER8731/Batch number was not reported), dose 2 via an unspecified route of administration, administered in arm left on 18Apr2021 at 15:30 (at the age of 36-years-old) as dose 2, single for covid-19 immunisation at other. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient previously received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: ER8727/Batch number was not reported), dose 1 via an unspecified route of administration, administered in arm left on 26Mar2021at 15:30 (at the age of 36-years-old) as dose 1, single for covid-19 immunisation at other. On 19Apr2021 at 07:00, the patient experienced consistent elevated blood pressure (150/110). The reporter stated the events result in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient underwent lab tests and procedures which included blood pressure measurement: 150/110 on 19Apr2021 (Consistent elevated blood pressure (150/110)). Therapeutic measures were taken as a result of event included treatment with lostartan. The outcome of the event was not resolved.  No follow up attempts are possible. No further information is expected.
pt devel hives starting in the forearms then cheeks, then legs the next morning following vax;
Information has been received from a physician concerning a female whose 82 year old husband was vaccinated SC with a dose of varicella zoster virus vaccine live on 7/28/06. the vaccinee did not have a post vaccination rash. On 8/4/06 the pt began having pain and on 8/5/06 the pts rash appeared and was considered to be herpes zoster. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested.
body aches; chills; fever; headache; fatigue; severe vomiting; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body aches), CHILLS (chills), PYREXIA (fever), HEADACHE (headache) and FATIGUE (fatigue) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Apr-2021, the patient experienced PAIN (body aches), CHILLS (chills), PYREXIA (fever), HEADACHE (headache), FATIGUE (fatigue) and VOMITING (severe vomiting). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency and DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, EPHEDRINE SULFATE, ETHANOL, PARACETAMOL (NYQUIL) for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN (body aches), CHILLS (chills), PYREXIA (fever), HEADACHE (headache), FATIGUE (fatigue) and VOMITING (severe vomiting) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient's medical history and relevant concomitant medications weren't reported.
pt recvd vax & on the same day devel a fever of 104 & passed out; No further details were provided
On 10/05/1999, this 5 year old pt received his 5th dose in the series. Two days later, 10/07, he experienced severe erythema, swelling, and harness at the injection site. The most recent information received on 10/12, reports the condition of the pt as unknown.
Injected into muscle and when pulling needle out some of the liquid trickled down his arm so he did not get the full dose.  Hard to know how much he got.  Will call Pfizer this week to see if dose needs to be repeated.  His dose is only 0.2 ml so I estimate at least half of the dose was lost.
10/25/05 Received flu shot in right deltoid. Soreness in deltoid after injection. 12/30/05 Notified supervisor of soreness in deltoid. "Hurting off and on in that deltoid muscle ever since that time." 1/4/05 Spoke with clinic. Denied redness, rash, inflammation, numbness, fever, loss of arm use in right upper arm.
Pt was seen by her own physician, 2 days, post vax. She was complaining of intense headaches, hives on her back and joint pain. Seen by another doctor on 9/15/00 and per his evaluation, she has had a hypersensitivity reaction to MMR vaccine that was given on 9/13/00. She should be considered fully immunized and should not be subjected to a 2nd dose of MMR vaccine. If there are further questions about this matter, please feel free to contact my office.
Patient came to pharmacy and said that he had a reaction to the FLUZONE HD when he had a temperature spike of 103 degrees F. He said that he had flu-like symptoms, a fever & shivering.
SARS-CoV-2 positive PCR test following full vaccination series against COVID-19
24 hours a very strong body ache began, accompanied by fever for approximately 8 hours, very tired. Just after 15 days the fatigued returned, fever, chest pain (feeling of pressure or knot) muscle pain, headache.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients who were vaccinated on unknown dates with unspecified MMR II that were improperly stored. No adverse effects reported. No further information provided. Additional information has been requested.
Severe leg pain, refusal to walk, increased CK in blood, hematuria. Summary: Previously healthy almost 4 yr old presented to pediatrician 3 days S/P Fluzone injection on 10/14/06 with c/o pain and refusal to walk.  Vomited the night before.  Admitted for observation to R/O Guillian-Barre vs. acute myositis.   Discharged 1 day later. No D/C summary was written.  F/U visit to PCP on 10/25/06 with  DX: "myositis following an influenza vaccine".  Energy and activity level now normal.  Urinating well.  Status: Resolved./pc
My arm has been constantly sore since I received the shot.  I get a sharp pain when I try to raise my arm. It hurts more, and in the shoulder, when I raise it to the side than if I raise in front of me.
Patient received flu vaccine and ~3 minutes later appeared to pass out in her chair and convulse. She came to fairly quick and was immediately nauseous and vomited. We observed for 20 minutes and no additional reaction- she felt OK. Left with mother, advised she get future vaccinations at the provider's office to be able to lay down.
Whole body maculopapular blanching rash no pruritic rash starting 3 hrs after vaccine.
Piercing Headache for 3 days, extreme body aches, chills and nausea
Patient received 1st dose Pfizer COVID vaccine on 2/5/2021 and second dose on 2/26/21.  She had no adverse reaction to either dose.  Around 3/2/2021, she saw her physician complaining of pain in her arm, which was attributed to gout.  At the time, she also had a nonproductive cough, generalized weakness and one episode of loose stool.  She presented to the emergency room on 3/7/21 with significant hypoxia.  She tested positive for COVID 19 by both rapid test and PCR.  A quantitative test for COVID antibodies was sent out to a reference lab on 3/7/2021 and resulted on 3/11/2021 as >250 U/mL.  Pt. required CPAP, BiPAP, High Flow Oxygen and ultimately intubation.  Was not oxygen dependent before hospitalization. Pt. treated with dexamethasone, 2 doses of Remdesivir (then held due to acute kidney injury), tocilizumab X 1 dose, 1 unit COVID-19 convalescent plasma.  Pt. expired on 3/19/2021.  Sample sent for genome sequencing to check for variants of interest in joint effort between pathology and infectious disease.  Report not yet available.
The second dose for rabies immunization was administered on day six; Imovax given as a second dose for rabies immunization after RabAvert which was given as a first dose; Case reference number BN-2022-000953, initially downloaded on 02-May-2022, is a spontaneous case received from a health care proffesional via health authority (Worldwide Unique Identifier: 2237998-1; Project number: USSA2022SA121275) and concerns a patient of unknown demographics.  The patient's medical history and concomitant medication details were not provided.  On an unspecified date, the patient was vaccinated with the first dose of RabAvert ((Chicken Embryo Cell) (rabies virus (Inactivated, Strain Flury LEP) (PCEC) batch number was not provided)), at an unknown dose or route of administration, for pre-exposure immunization.  On an unspecified date, six days after the first dose, the patient was vaccinated with IMOVAX as the second dose of rabies immunization(Rabies vaccine; batch number was not provided), at an unknown dose or route of administration, since RabAvert could not be ordered, as reported (explicitly coded as 'Inappropriate schedule of vaccine administered' and 'Interchange of vaccine products').  It was also reported that the patient did not experience any adverse reaction.  No further information was provided.; Reporter's Comments: A patient of unknown demographics was vaccinated with IMOVAX as the second dose of rabies immunization on the day 6 after the first dose of RabAvert for pre-exposure immunization, which is considered as inappropriate schedule of product administration and interchange of vaccine products. No associated adverse events have been reported with the reported medication error. Inappropriate schedule of product administration and interchange of vaccine products are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Inappropriate schedule of product administration and interchange of vaccine products have been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A patient of unknown demographics was vaccinated with IMOVAX as the second dose of rabies immunization on the day 6 after the first dose of RabAvert for pre-exposure immunization, which is considered as inappropriate schedule of product administration and interchange of vaccine products. No associated adverse events have been reported with the reported medication error. Inappropriate schedule of product administration and interchange of vaccine products are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Inappropriate schedule of product administration and interchange of vaccine products have been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
This spontaneous report as received from a registered nurse referring to an unknown gender patient of unknown age who was vaccinated with a 1 ml (Merck) VARIVAX (Route and lot # not reported) on 18-JUL-2012. No other co-suspects were reported. No concomitant medications were reported. The nurse stated that on 18-JUL-2012, the patient received a double dose of (Merck) VARIVAX, no medication confusion discovered. The nurse also reported that a medical assistant reconstituted two vials of (Merck) VARIVAX. No adverse event reported. No treatment was reported. The outcome of patient received a double dose of (Merck) VARIVAX and no adverse event was unknown. Patient received a double dose of (Merck) VARIVAX was not related to (Merck) VARIVAX. Additional information has been requested.
As per patient on off dizziness since receiving vaccine on 4/17/09. But complaining on weekend fever negative, vomiting negative shingle negative follow up for questions.
Headache, muscle ache, joint pain, nausea, fatigue, chills (no fever), reddened and itching area below injection site Started morning after and continue but decreasing at day 3 post. Except for red and itching, other symptoms are intermittent and helped with Motrin
It was reported that a 38 year old female patient received a Fluzone SV '01-'02 vaccination administered on 10/01/01.  On 10/06/01, the patient went to an Er with complaints of joints pain, body aches and a fever of 100.6 F patient was diagnosed with viral syndrome, nausea and vomiting, she was discharged from the HR with medications (specifies not provided). On 10/10/01, the patient returned to the ER with complaints of fever temp 97 F, headache, nausea, weakness, dizziness and nosebleed, she was diagnosed with serum sickness possible labyrinthitis. Patient was discharged from ER. Symptoms are unresolved and the patient is to follow up with her family physician.
12/4/2020. Received Vaccine on 12/30/2020. Feeling unwell with abdomen cramping on 12/31 and 1/1. Positive urine pregnancy test on 1/2/2021. Borderline blood HCG level by doctor's office. It was determined eventually to be chemical pregnancy by the doctor.
(R) arm - lot itchier and red bump. (L) arm just itched and not as much. Itching started approx 24 hours later itching stopped 8/7/14 - though has little bump. Hurt immediately and for 1 day - both arms, but more on (R) arm.
Patient monitored  for thirty minutes per protocol of having multiple drug allergies.  Patient had no history of anaphylaxis.  Patient left clinic and while in car ( being driven by sister in law)  experienced tingling in the roof of her mouth.  50 mg. of Benadryl was administered by mouth per standing orders.
Pain in right jaw - mimics a tooth ache but the jaw is not sore to the touch nor do I have pain chewing. Taking Aleve to minimize discomfort.
Information has been received from a physician concerning a female (age not reported) who on an unspecified date was vaccinated with Gardasil.  On 06-MAR-2008 after receiving Gardasil the patient was admitted to the hospital with an intestinal inflammation and (the length of the stay was unknown).  Further
Patient felt dizzy after vaccines, approximately 10 mins after administration. Trendelenburg position.  Gave orange juice and sips of water. Patient felt better after 15 mins after. Able to ambulate on own. Accompanied by mother.
A report has been received from a Health Professional concerning an 11 year old, Female subject, who had been receiving nasal FLUMIST Quadrivalent (intranasal), 0.2 Milliliters, Unknown for influenza. FLUMIST Quadrivalent (intranasal) started on 22-Feb-2016 for influenza. It was reported that expired FLUMIST was administered to patient on 22-Feb-2016. The outcome of the event of expired FLUMIST administered to patient is unknown. The report was considered to be non-serious.
Patient with known history of vasovagal response to needles received 1st dose of jynneous monkeypox vaccine @ 11:45 am on August 28, and was observed by paramedic to fall to the ground  @ 11:55 am while walking in observation area. Patient reported feeling lightheaded, but LOC was not confirmed. Patient was immediately responsive to paramedic. MD was called for assessment while patient laying on the ground.  Initial VS @ 11:55 am 124/84 HR 74 and repeated @ 12:15  118/80 HR 78 Patient was laying on ground, alert and oriented and able to speak appropriately with staff and with family by phone. Patient immediately reported feeling better and gave history of vasovagal response in past with no other medical issues. He reported having eaten no breakfast in the morning, but only having a cup of coffee.  Patient was observed, laying supine and on blanket, with pillow, taking deep breaths for 15 mins. Patient was moved to a chair,  and was offered ½ liter of water, and reported feeling much better. His vital signs were repeated, and were stable. O2 sat 97-98%. He called family to drive him home.  He was observed by staff until patient was cleared by MD @12:25pm, and he left the site accompanied by family.
Pt. received 0.5cc FLUZONE IM in (L) deltoid, approximately 10 minutes later she returned stating that her arm was red & itchy. She was advised to take P.O. BENADRYL & offered an IM injection - she returned to work and later to her primary care physician & local ER. "Pain in chest, jaws locked up, mouth watering and felt like a lump in my throat."
Disorder of Optic Nerve; Optic Chiasm  Disorder; loss of vision; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 42 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 03Oct2021 (Lot number: ee8839) at the age of 42 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications in two weeks. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: ej1685), administration date: 19Dec2020, when the patient was 41 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: ej0140), administration date: 12Jan2021, when the patient was 41 years old, for COVID-19 Immunization. The patient did not experienced covid prior vaccination. The following information was reported: OPTIC NERVE DISORDER (disability) with onset 14Oct2021, outcome "not recovered", described as "Disorder of Optic Nerve"; VISUAL PATHWAY DISORDER (disability) with onset 14Oct2021, outcome "not recovered", described as "Optic Chiasm Disorder"; BLINDNESS (disability) with onset 14Oct2021, outcome "not recovered", described as "loss of vision". The events "disorder of optic nerve", "optic chiasm disorder" and "loss of vision" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: Multiple tests: (unspecified date) unknown; sars-cov-2 test: (27Jan2022) negative, notes: Nasal Swab. Therapeutic measures Prednisone course were taken as a result of optic nerve disorder, visual pathway disorder, blindness.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events OPTIC NERVE DISORDER, VISUAL PATHWAY DISORDER, and BLINDNESS and BNT162B2.  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.
Headache, Myalgia, Fever, pain in injection site;chills Narrative:
p/vax pt arm had some redness, swelling & was sore;also felt feverish;informed by MD;pt instructed to take APAP & to apply heat or ice for comfort;