chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Trouble breathing; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Trouble breathing) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriatic arthritis and Plaque psoriasis.    No Medical History information was reported.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced DYSPNOEA (Trouble breathing). In 2021, DYSPNOEA (Trouble breathing) had resolved.            Concomitant medication was not provided.  Treatment medication information was not provided by the reporter.  In 2021, the patient experienced trouble breathing. In 2021, the trouble  breathing resolved. It was unknown if patient was enrolled in a COVID-19 vaccine trial.  This case was identified as part of a retrospective clean-up activity where certain emails received in the moderna mailbox were missed to be booked-in.
heart racing and erratic; urinated 9 times in the next hour +; This is a spontaneous report from a contactable consumer reported for him/herself. A 76 Years old patient received 1st dose of BNT162B2 (lot number=EL1283) on 16Jan2021 at single dose on Left arm for covid-19 immunization. Medical history was Addison's Disease, 6 heart bypasses. Concomitant drugs were not reported. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19. Past drug was Allergies to Sulphur. 11 days later (27Jan2021), patient woke up at 02:30 am with heart racing and erratic. Patient also urinated 9 times in the next hour +. No treatment. Outcome of the event was recovered. Patient also received 2nd dose of BNT162B2 (Lot number=EL9261) on 06Feb2021 01:30 AM at single dose on Left arm for covid-19 immunization.  No follow-up attempts possible. No further information expected.
I had a sore throat, cough, fever, mild chills, body aches loss of smell, loss appetite. I treated myself with tylenol and mucinex, Urgent Care Dr. gave me albuterol. I also received the monoclonal antibodies , about 2 days after receiving that treatment my symptoms began to improve,
Arm was extremely sore; nausea; slight headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was extremely sore), NAUSEA (nausea) and HEADACHE (slight headache) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure abnormal, Blood cholesterol abnormal and Anxiety. Concomitant products included CLONAZEPAM for Anxiety, SIMVASTATIN for Blood cholesterol abnormal, BISOPROLOL FUMARATE, HYDROCHLOROTHIAZIDE (BISOPROLOL /HCTZ) and LISINOPRIL for Blood pressure abnormal, VITAMIN D3 and CALCIUM CARBONATE (CALTRATE [CALCIUM CARBONATE]) for an unknown indication.    On 15-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm was extremely sore), NAUSEA (nausea) and HEADACHE (slight headache). At the time of the report, PAIN IN EXTREMITY (Arm was extremely sore), NAUSEA (nausea) and HEADACHE (slight headache) had not resolved.            The patient did not receive any corrective treatment for all the events.  The patient's current symptoms were ongoing but had calm down a bit.   This case was linked to MOD-2021-365030, MOD-2021-365056 (Patient Link).
Within a few days of 2nd Vaccination patient began having eye irritation and sore and very red eye lids and skin under eye. Patient being treated for Blepharochalasis
The patient was given a vaccine on 06/05/2010 and on 06/25/2010, he was admitted with an acute encephalitis with sequela. He was evaluated by neurology associates and also treated by infectious disease. The patient had shingles one month prior to this incident. The patient had a three (3) day history of increasing weakness, somnolence, loss of balance and loss of bladder control. He was seen at one hospital and transferred to another hospital. By the time the patient was admitted, he had become non-responsive, comatose. Since then, he has developed a neurogenic bladder and has some mental impairment due to his encephalomyelitis. He is being followed by neurology associates.
Mom called at 11:30 am on 04/06/05, 2 days post vaccination, stating patient had redness, swelling and pain at left arm injection site. Also had increased crying. Taking Tylenol without effect. Discussed giving Ibuprofen 50 mg PO QID with food and apply ice pack 10 minutes on, 10 minutes off for 1 hr take a 30 minute break and repeat.
After my third Anthrax shot I started having extreme fatigue.  I continue to feel fatigued.  I am always tired and even wake up feeling tired.
Patient received 2nd dose of Pfizer Covid-19 vaccine and during post vaccination waiting period she reported feeling numbness on her lips, gums and left cheek. She reports taken a children's dose of Benadryl at around 10:55. Patient is able to talk and is breathing normally but has a small rash on her cheek. Patient indicates that she has an extensive list of allergies to medications and foods. Patient is not taking medications currently . Her BP is 169/113 p is 91. At 11:06 Patient had developed a rash on her face, ears ad her chin as well as a large area on her chest. EMT on site- evaluated Patient and administered Epi pen (lot DFM355 exp 11/21) on the left thigh at 11:10am. 911 was called and EMS transported Patient to the hospital. Patient's husband is by her side.
At site of injection (left arm sub-q) pt presents area of 4 inches height and 2 1/2 inches wide redness, swelling, heat and soreness that presented evening after received injection. As of 2 days after injection, pt is ok with no MD appointment required. Pt. reports flu-like symptoms the day after received vaccine and pt. feels still recovering. Sx of aches (muscle aches) weakness and fatigue.
low grade fever; rash that started on the forearms and progressed to entire body (not itchy); ActHib was administered with incorrect diluent; Initial information received on 12-Aug-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 20 months old male patient who experienced low grade fever and  rash that started on the forearms and progressed to entire body (not itchy), while he received vaccine HIB (PRP/T) VACCINE [ACT-HIB].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant vaccines  included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, TETANUS VACCINE TOXOID (INFANRIX); PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR); and HEPATITIS A VACCINE INACT (VAQTA) for Immunisation on 31-Jul-2019.  On 31-Jul-2019, the patient received a 0.5 ml fourth dose of suspect HIB (PRP/T) VACCINE via intramuscular route in the right thigh (Carton Lot: U1950AAB Exp. date: 24/01/2020 and Diluent Lot U6111AA Exp. date: 24/01/2020).  On an unknown date, the patient developed low grade fever (pyrexia) and rash that started on the forearms and progressed to entire body (not itchy) (rash generalised) following the administration of HIB (PRP/T) VACCINE.  Also It was an actual medication error case due to wrong solution used in drug reconstitution as ActHib was administered with incorrect diluent, nurse found an extra vial of ActHib diluent.  Details of lab data not reported.  Final diagnosis was rash that started on the forearms and progressed to entire body (not itchy) and low grade fever.  The patient went to urgent care on Saturday on August 3rd and followed up with PCP the week after.  On an unknown date, the patient had recovered from events.  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.  List of documents held by sender: none.
This report describes headache in a 57 year old female who received Hep-B vaccine. This report was received from the vaccinee and has not been verified by a physician or other health care professional. Reportedly, on 10/16/01, the pt received her 1st RA injection of Engerix-B. Reportedly, post vax on 12/16/01, the pt experienced a headache that "lasted about a week". As of 11/01/01, the headache reportedly had resolved.
Evening of vaccination and next day the left side only - there was swollen gland/neck. (Same side of vaccination flu). There was no pain or warmth just swollen gland. Pt saw MD to ask about it. Then it got better. No other problem.
Parents brought child to clinic for fever (102.1 on arrival) and "listless".  Fever since early this morning (about 10 hours).  had not given any remedy for fever.  Was seen by MD and given tylenol suppository for fever and parents advised of fever control.  no other symptoms voiced.  child received flu vaccine 2 days ago.
Vaccine administered at noon on 3/14/21.  Felt fine until 7;30 pm, suddenly became very tired, went to bed.  By 9pm, experienced severe chills,  by 1:00 am, had fever of 101.3, fever down to 99 by 8 am following morning.  On 3/15/21, temp stayed normal, had mild headache and was just tired most likely due to lack of sleep.
Acute onset of myalgia and fever- nausea- and subsequent marked erythema at site of injection.
tiredness; achiness; Initial information received on 04-Sep-2020 regarding an unsolicited valid non-serious case received from a non health care professional (patient).  This case involves a female patient (age not reported) who experienced tiredness (fatigue) and achiness (pain), while she received vaccine INFLUENZA VACCINE.  The patient's vaccination(s) included Fluzone High Dose. Medical history, concomitant therapy, medical treatment(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious tiredness (fatigue) and achiness (pain) (Unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the event was unknown.  There will be no information available on batch number for this case.
I have latent TB and am diagnosed with herpes 1 and 2; I have latent TB and am diagnosed with herpes 1 and 2; This is a spontaneous report from a contactable other health professional. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 11Jan2021 at single dose for covid-19 immunization. Patient had the first dose of the vaccine on 11Jan2021 and she/he had pre-existing conditions. A long time ago, she/he had 2 tachycardia episodes and was sensitive to epinephrine. Patient had latent TB and was diagnosed with herpes 1 and 2 in Jan2021. Outcome of events were unknown.  Information about lot/batch number has been requested.; Sender's Comments: The association between the events "latent PTB and Herpes 1 and 2" with BNT162b2 can not be completely excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Patient had syncopal episode with in 60 seconds of vaccination. Patient responded immediately to nurse when name was called. Patient was helped  down to the  floor vital signs taken BP low O2 sat 95%. Ambulance crew was in the parking lot of College came in to assess patient, FNP came from clinic at College to assess patient. Continuous monitoring of vital signs, patient BP came up, patient given orange juice to drink per FNP. Patient was very anxious about vaccination and had eaten since the previous day. Patient monitored about 45 minutes, vital signs improved, patient appearance improved and stated he felt better. Patient 's Mother reached on phone by ambulance crew, she did not want him transported. Patient left College accompanied by brother. Advised to be seen by provider or ER if symptoms worsen.
I developed pericardial effusion on Feb. 23 and had 750 ml of fluid removed from my heart. On April 27 another pericardial effusion developed and I had to have surgery to have a pericardial window created.
Impetigo surrounding inferior and superior border of vaccination site. 10-day course of Cephalexin 500mg twice per day.
No adverse event; Vaccine administered after the 30 day beyond use date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered after the 30 day beyond use date) and NO ADVERSE EVENT (No adverse event) in a 53-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7144B) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 21-Oct-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered after the 30 day beyond use date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered after the 30 day beyond use date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Vaccine administered after the 30 day beyond use date).    No concomitant medications were reported.  It was reported that patient received vaccine from opened individual vials of vial size 2.5 ml. The vial was initially stored in the refrigerator on 20-Sep-2022. The vial did not undergo any temperature excursions. Patient was administered the vaccine as Second booster dose.  No treatment details were reported.
patient was vaccinated on June 10,2003.  Has had persistent fevers since receiving the vaccine.  The day after the immunizations she experienced high fevers 104-105 degrees F.  She also experienced a brief febrile seizure.  Since that time she has had fevers around 101 F usually occurring at nigh.  Otherwise fussy and some nasal congestion.  She had a 2 day history of erythematous papular rash on the trunk which occurred approximately 10 days after the immunizations. No treatment given.
Severe Allergic Reactions; hives; swollen face; swollen eyes; difficulty in breathing; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced severe allergic reactions immediately after the administration of 1st dose of Pfizer/BioNTech Covid-19 vaccine which resulted in more than 24-hour hospitalization with symptoms of  hives, swollen face, swollen eyes and difficulty in breathing, all on an unknown date. It was unknown if the patient received treatment for the events. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
About 30 min after leaving the vaccination site I was driving home and felt face getting flush and tingly, on one side of my face. Felt slight swelling of my mouth and tongue. Those lasted about 45 min to an hour and they dissipated and then about a week later I started having a full body sensation, I started feeling like a burning sensation all through my body, like an internal sunburn all through my body and I have been feeling like that ever since. It also started oscillating between the burning sensation and a cold sensation. I also feel like pins and needles and most recently numbing of my hands and arms. It has been chronic since then. My PCP told me to take Zyrtec 30mg a day OTC and it did not help. I then met with a neurologist and allergist. Allergist did not believe it was an allergic reaction. The neurologist prescribed prednisone and it did not help. She also prescribed B12 (I have a history of B12 deficiency) and  she initially diagnosed me with sensory malfiber polyneuropathy. She has been running some auto immune tests and some have come back normal and she is trying to figure it out the next plan of care. It is not just a sensation, part of it is physiological because my ears for example sometimes get very red and hot to the touch and my hands get very cold.
Chest tightness and pain,  severe muscle back and hip pain, feels like I've been run over or used for a trampolin all into 2nd day after shot.  Horrific vivid continuous nightmares from first into 2nd night.  Fever 1st through2nd night, diarrhea 2nd day after shot.  I feel awful.
2/1/16 Mom called reporting staring spells; will stand motionless, unresponsive to voice almost daily (office visit HPI). He did not lose tone, no abnormal movements. 2/4/16 Evaluated: EEG and MRI normal. Neuro consult: Dx breath holding (doctors agreed with dx.) 4/12/16 Mom expressed concern about vaccine 11/2/15 triggered events above.
Left upper arm, reddened and swollen, warm to touch. Persisted until 3/22/03. Resolved without sequilae? No treatment.
Patient is currently "physically and mentally disabled"and has mental and or physical "capacity of an eight year old".; Patient is currently "physically and mentally disabled"and has mental and or physical "capacity of an eight year old".; On unspecified date three months after administration patient "went into a coma".; This spontaneous report was received from a nurse via company representative referring to an adolescent female patient. The patient didn't have pertinent medical history. Information about drug reaction or allergy and concomitant medication was not provided.      On an unknown date (reported as when patient was 16 years old), the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, vaccine dosage detail, route of administration, lot# and expiration date were unknown) for routine recommendation. The patient did not experience any symptoms when she received her first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). On an unknown date (reported as the patient was then 17 years old), the patient was administered her second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9).   On an unknown date, three months after her second dose administration, the patient went into a coma. On an unknown date, the patient was physically and mentally disabled and had mental and or physical capacity of an eight years old. The patient sought medical attention and received unknown treatment for the events. Information about lab diagnostics or studies was unknown by the reporter. The outcome of coma was recovered on an unknown date. The outcome of physically and mentally disabled was not recovered. The causality between the events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided.   The event of physically and mentally disabled was determined to be life-threatening by the reporter.   Upon internal review, the event of coma was determined to be medically significant.
I have Peripheral Artery disease and have had bypasses done on both legs.  It has been managed fairly well with a several minor "tune ups" by angio. I was able to walk pretty well with minimal pain.  About a week after my second dose I started noticing increased pain in both of my calves which has become considerably worse since then.  I cannot walk 1/10 of a mile without taking a break.  Also,  around July 1st, my fingers went numb in my right hand,  then I started getting pain in my right forearm and cramping in my hand. That pain has made it so the way up my arm.  I saw my vascular surgeon and an ultrasound revealed a clot in the bend of my elbow.  I was asked how I think I could have gotten the clot, the only thing I've done differently was get that vaccine. It's extremely obvious to me that the vaccine has caused a severe reaction in me.  I have a surgery scheduled on Wed. July 14 to have the clot removed.
Headache Narrative:  SIDE EFFECTS: Vax #1: none reported Vax 3@: localized: pain x 3 days, discomfort on day 4. Generalized: on day 2 - fever, chills, fatigue, myalgia, nausea, HA. Day 3: HA, fatigue
This case was reported by a other health professional via call center representative and described the occurrence of chills in a 52-year-old female patient who received SHINGRIX (batch number 4G5HX, expiry date 9th July 2021) for prophylaxis. On 5th March 2019, the patient received SHINGRIX. On 6th March 2019, 1 days after receiving SHINGRIX, the patient experienced chills. On an unknown date, the outcome of the chills was unknown. It was unknown if the reporter considered the chills to be related to SHINGRIX. Additional details were provided as follows: The health care professional called to report that the patient experienced chills.
sick; feeling like he had the flu and other symptoms; This is a spontaneous report from a contactable consumer. This consumer reported for a male patient (reporter's niece's brother in law).A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: Not Reported) via an unspecified route of administration on an unspecified date  as 2nd Dose, Single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The reporter stated My niece told me that her brother in law took the first shot and had some soreness and then took the 2nd shot and was so sick, feeling like he had the flu and other symptoms. After the 2nd shot the patient was sick and he has the flu and other symptoms. The outcome for the events was Unknown. Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
On 5/18/21 I woke up at 0300 with severe pain in right arm.   Took Ibuprofen and went back to bed.  Woke up around 0800 and had pain under my arm.  Saw that my lymph node is severely swollen and sticking out of my arm pit.  Its about the size of a baseball now on Day 3.  It progressively got bigger throughout day 2
Pt. loss consciousness within 10 sec's after IM injection. Pale, eyes rolled to back of head, tonic-clonic seizure activity x 5-10 secs. Postictal, cleared prior to oxygen. Transferred to hospital in stable condition via ambulance. Labwork drawn there.