chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I had extreme chills, body aches and pain at injection for about a week. My allergies got worse after the vaccine, and I developed headaches. I would take something for my headache and sometimes it would work and sometimes not. I would increase hydration and that would help. I did see my doctor and they started me on medicine that is helping. As of today, the headaches have not gotten better but they haven't got worse. I am dealing with them on a daily basis.
I had the Moderna uh needle and my arm is still sore; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (I had the Moderna uh needle and my arm is still sore) in a male patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. In 2021, the patient experienced PAIN IN EXTREMITY (I had the Moderna uh needle and my arm is still sore). At the time of the report, PAIN IN EXTREMITY (I had the Moderna uh needle and my arm is still sore) had not resolved.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.       No concomitant medication was reported. Suspect product dosage text was reported as unknown. No treatment information was provided.
Pt. denied having any known chronic health or medical problems. Pt. was asked specifically if he was being treated for HIV and stated "no". FLUMIST was given. Pt. later reported "I have HIV".
Feverish, chills, HA-- taking Advil. TMAX (10/20/14 @ 9:30AM): 102.2F, chills myalgias.
Client received flu shot 10/7/09 and the following days, he felt soreness, burning sensation on the L scapular area radiates to the back of neck. Also felt stiffness on the back of neck. On the 4th day got better.
Exactly 3 weeks post vaccination....with no vaccine side effects whatsoever until this event. Herpes Simplex Virus - type 1  ?outbreak? (?10+?)  on both lips with no forewarning (a tingling sensation is usual for me).   I am used to getting  ?one? , with a manipulative dental procedure, sun overexposure or a fever and always have an oral prescription on hand to prevent worsening.  They were in full bloom!
11 year old child received Adacel, 8 months later, received second immunization/ NO AE; Initial information received on 23-Sep-2019 regarding an unsolicited valid non-serious case received from a other health professional. Additional information was received on 24-Sep-2019   This case involves a 11 year old received DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL], 8 months later, received second immunization but not received previous DTAP.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose 1  dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot number not reported via intramuscular route. 1 other doses were administered on unknown dates for suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  It was a case of actual medication error due to extra dose administered.  It was not reported if any adverse event occurred.  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.
Resident with S/P COVID-19 vaccine side effects: general tiredness and episode of fever (101.2 F); resident had COVID-19 vaccine on 12/30/20.
Pain and burning after vaccine. Constant pain after vaccine. Elbow pain and fingertips tingling.  Hand colder on left. Abduction limited by pain.
This spontaneous report as received from a pharmacist refers to 3 patients of unknown ages and genders. On an unknown dates the patients were vaccinated with ZOSTAVAX (route, dosage, dose number and lot number unknown). The pharmacist reported that 3 patiens over the last 5 years had developed an injection site reaction following vaccination with ZOSTAVAX. The pharmacist reported the injection site reaction(s) following vaccination with ZOSTAVAX were a raised red area at the injection site, about 2 inches in diameter characterized as a localized rash and was similar for all three patients. The outcome of the events were reported as recovered (unknown date). Additional information is not expected.
Patient experienced weak, lethargic, tender, sore, red, hard at the left arm injection site.
Later that night I got a sever headache, and some chills. Lasted for about 4 -5 hours, and injection site sore for 2 days
Outbreaks of hives all over the body (I have photos), red, they burn and itch, I could not stand the burning, I felt that they burned me. I took ALLEGRA and I got better for about 5 hours, then they come out again.
Developed rashes on my legs which seemed to be spreading. Slight swelling on the left legs.
Cyst; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 60 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid left, administration date 22Dec2020 (Lot number: EH9889) at the age of 61 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hypertension", start date: 2018 (ongoing), notes: Onset date: 2018, Stop date: ongoing, Pertinent details: Stable on medications; "Menopause", start date: 1999 (ongoing), notes: Onset date: 1999, Stop date: ongoing, Pertinent details: Stable on ERT estrogen; "Prediabetes", start date: 2018 (ongoing), notes: Onset date: 2018, Stop date: ongoing, Pertinent details: Stable on Metformin only; "Herpes HSV1", start date: 2018 (ongoing), notes: Onset date: Since childhood, Stop date: ongoing. Family history included: "Stroke" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "diabetes mellitus" (unspecified if ongoing); "obesity" (unspecified if ongoing). Concomitant medication(s) included: ESTRADIOL taken for oestrogen replacement therapy (ongoing); METFORMIN taken for glucose tolerance impaired (ongoing); LOSARTIN taken for hypertension (ongoing). The following information was reported: CYST (non-serious), outcome "unknown", described as "Cyst". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information included: Patient received no prior vaccination prior four weeks. It was unclear if vaccination resulted in decrease immunity to otter infection pathogens. The cyst persecuted after the first shot of Pfizer vaccine.  No follow-up attempts are possible. No further information is expected.
NAUSEA; MUSCLE ACHES; FEVER; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 204A21A, and expiry: UNKNOWN) dose was not reported, administered on 08-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-MAY-2021, the subject experienced muscle aches. On 08-MAY-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 99.5 -100 F. On 13-MAY-2021, the subject experienced nausea. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from nausea, fever, and muscle aches. This report was non-serious.
The next day after the vaccine around 12n I began feeling really fatigued and developed a fever off and on through out the day which went as high as 101 causing me to take a tylenol.  I had chills, muscle aches and a cough started.  I had a headache on Sat and Sunday. Sunday I was still fatigued,  slight temp, winded and lightheaded more than dizzy.  The temp finally diminished by the Sunday evening but still winded and very fatigued to date.  I reached out to my PCP for the SOB I was experiencing who advised if it gets any worse to go to the ER for further assistance and the symptoms still persisted so on Tues I went to the Urgent Care but they referred me to a outside makeshaft to setup for COVID testing but nothing still was done.  So  I went back to ER who checked my O2 sats which was good but still nothing was done there either and I am still experiencing the SOB.   I developed a bruise on my left forearm which developed yesterday and today my lower legs has developed various light colored little greyish looking bruises and is very sensitive to the touch.
dose was expired; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 5-year-old male patient who received DTPa-IPV (Kinrix) (batch number D24G7, expiry date 4th June 2022) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 22nd July 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 22nd July 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 22-Jul-2022 Reporter's comment: The license practical nurse reported that a patient received a dose of Kinrix on the day of reporting and the dose was already expired. The vaccine administration facility was the same as primary reporter. The reporter did not consent to follow-up. Additional supportive information: The patient received an expired dose of Kinrix, which led to expired vaccine used.
Tight , itchy throat, trouble swallowing, elevated blood pressure, hives, face red, fingers white with dusky tips
administered past the 30 day refrigeration time; administered past the 30 day refrigeration time; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered past the 30 day refrigeration time) and PRODUCT STORAGE ERROR (administered past the 30 day refrigeration time) 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 15-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered past the 30 day refrigeration time) and PRODUCT STORAGE ERROR (administered past the 30 day refrigeration time). On 15-Jun-2021, EXPIRED PRODUCT ADMINISTERED (administered past the 30 day refrigeration time) and PRODUCT STORAGE ERROR (administered past the 30 day refrigeration time) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter. No treatment medications were provided by the reporter.   This case was linked to MOD-2021-316219 (Patient Link).
Patient developed chest tightness during soccer tournament the day after receiving first dose of COVID vaccine and then subsequently developed abdominal pain with several episodes of hematochezia which self resolved. Upon arrival to the ED pt had elevated troponin which downtrended. EKG and ECHO were normal and symptoms resolved without intervention.
Redness and Swelling at the injection sith with some itching.  Induration did not extend past shoulder or below elbow.  Consistent with a Robust Take.
Vertigo; Fatigue; Rash over arms/rash on arm; Hives; Dizziness; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (Vertigo), FATIGUE (Fatigue), RASH (Rash over arms/rash on arm), URTICARIA (Hives) and DIZZINESS (Dizziness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Ankylosing spondylitis and Psoriatic arthritis.    Concurrent medical conditions included Ankylosing spondylitis and Psoriatic arthritis.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Nov-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. On an unknown date, the patient experienced VERTIGO (Vertigo), FATIGUE (Fatigue), RASH (Rash over arms/rash on arm), URTICARIA (Hives) and DIZZINESS (Dizziness). At the time of the report, VERTIGO (Vertigo), FATIGUE (Fatigue), RASH (Rash over arms/rash on arm) and URTICARIA (Hives) had resolved and DIZZINESS (Dizziness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  The causality for humira (adalimumab) for the event(s) of fatigue and dizziness was not provided. the reporter's causality for the event(s) of rash on arm, hives and vertigo with humira(adalimumab) was a reasonable possibility.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Action taken with humira (adalimumab) with response to the event fatigue was Dose not changed.  No treatment details reported.  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.   Reporter did not allow further contact
Patient started complaining of being tired that evening, went to bed around 9:00 PM, stayed in bed til 2:00 PM the next day, 07/10/20012 and laid around watching movies most of the afternoon and evening. Noticed a raised red area three inches in diameter around the injection site on 07/11/2012.
arm swollen; arm red; painful arm; felt sick; Fatigue; Headache; Shivering; Gastrointestinal symptoms; Myalgia; This case was reported by a consumer via call center representative and described the occurrence of swelling arm in a 70-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu unspecified (Flu vaccine) for prophylaxis.   On 13th September 2019, the patient received the 1st dose of Shingrix and Flu vaccine. In September 2019, less than a week after receiving Shingrix and Flu vaccine, the patient experienced swelling arm, erythema of extremities, pain in arm, feeling unwell, fatigue, headache, shivering, gastrointestinal symptom nos and myalgia. On an unknown date, the outcome of the swelling arm, erythema of extremities, pain in arm, feeling unwell, fatigue, headache, shivering, gastrointestinal symptom nos and myalgia were unknown.   It was unknown if the reporter considered the swelling arm, erythema of extremities, pain in arm, feeling unwell, fatigue, headache, shivering, gastrointestinal symptom nos and myalgia to be related to Shingrix and Flu vaccine.  Additional case details were reported as follows: The patient received vaccines in unknown arm. The patient received the first shot of Shingrix on Friday, before day of reporting and felt sick a weekend and arm was still swollen, red and painful. The patient had flu shot in other arm on the same day. The patient did not have idea that the new Shingrix had possibility of more side effects. The patient enquired whether his/her arm feels better over a few days. Less than a week after vaccination, the patient had fatigue, headache, shivering and gastrointestinal symptoms, except fever and myalgia. The patient would not look forward to the 2nd dose. The reporter consented to follow up.
Painful swollen lymph nodes near collar bone on left side (injection side); Painful swollen lymph nodes near collar bone on left side (injection side); This is a spontaneous report from a contactable consumer, the patient. A 38-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Er8733) via an unspecified route of administration in the arm left on 01Apr2021 at 14:45 (at the age of 38-years-old) as a single dose for COVID-19 immunisation and the patient also received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0175) via an unspecified route of administration in the arm left on 04May2021 as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient did not have any allergies to medications, food, or other products. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) 20 milligrams two times a day and naproxen sodium (ALEVE); both since an unknown date and for unknown indications. 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 did not receive any other vaccines within four weeks prior to the COVID vaccine. On 02Apr2021 at 13:00, the patient experienced painful swollen lymph nodes near collar bone on left side (injection side). The event resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. On 18Jun2021, the patient underwent blood work and the result was unknown. On 18Jun2021, the patient underwent ultrasound and the result was unknown. No therapeutic measures were taken for the reported events. The clinical outcome of the event painful swollen lymph nodes near collar bone on left side (injection side) was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Anaphylaxis: sudden hives, redness of face, flushing, hoarse voice; near LOC.  Nurse follow up on 09/02/04 states: "Itching."
patient got COVID after getting the vaccine; loss of taste and smell; sore throat; body aches; headaches; fever of 102 F; fatigue; really really stuffy nose; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (patient got COVID after getting the vaccine), AGEUSIA (loss of taste and smell), OROPHARYNGEAL PAIN (sore throat), NASAL CONGESTION (really really stuffy nose) and PAIN (body aches) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Mar-2021, the patient experienced NASAL CONGESTION (really really stuffy nose) and FATIGUE (fatigue). On 14-Mar-2021, the patient experienced COVID-19 (patient got COVID after getting the vaccine), AGEUSIA (loss of taste and smell), OROPHARYNGEAL PAIN (sore throat), PAIN (body aches), HEADACHE (headaches) and PYREXIA (fever of 102 F). The patient was treated with DOXYCYCLINE at an unspecified dose and frequency; PARACETAMOL (TYLENOL) at a dose of 1 UNK; PSEUDOEPHEDRINE HYDROCHLORIDE (PSEUDAFED) at an unspecified dose and frequency; FIBRONECTIN at an unspecified dose and frequency; GUAIFENESIN (MUCINEX) at an unspecified dose and frequency; ASCORBIC ACID (VITAMINS C) at an unspecified dose and frequency; VITAMIN D [VITAMIN D NOS] at an unspecified dose and frequency and ZINC at an unspecified dose and frequency. At the time of the report, COVID-19 (patient got COVID after getting the vaccine), AGEUSIA (loss of taste and smell), OROPHARYNGEAL PAIN (sore throat), NASAL CONGESTION (really really stuffy nose), PAIN (body aches), HEADACHE (headaches), PYREXIA (fever of 102 F) and FATIGUE (fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Mar-2021, Body temperature: 102 (High) Fever of 102 F. On 14-Mar-2021, SARS-CoV-2 test: positive (Positive) COVID-19 Positive.         For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessment.  Concomitant information not provided. Treatment included nebulizer.  The action taken with mRNA-1273 in response to the event was not applicable.
Fatigue, muscle aches, fever, chills, headache, light sensitivity, pain at injection site.
Tenderness erythema (15cm x 15cm), induration (10cm x 10cm) on L arm. Treated as cellulitis with Cephalixin 25mg, 10 days.
10/10/21   Left arm from shoulder to elbow became red, swollen and itchy.   as of today, 10/21/21  Left arm is less swollen and red, but still itchy.  Have been on Cephalexin 500mg capsule  1 tab BID since 10/15/21
Pt states 3 day muscle soreness at injection site. Swelling, pain behind knees, ankles & feet. Pt took BENADRYL.
My throat felt swollen and so did my tongue.  I immediately had tingling in my arm and hand upon injection.  Pharmacist who gave me the shot was completely unprofessional and uninterested.
12/30/2021 :Event occurred after Janssen vaccine dose.  Patient presents with two days of worsening dyspnea, cough, and fever. She is actively receiving chemo and radiation for metastatic lung cancer and has recurrent pneumonia requiring ED trips and hospitalization most recently in october.  Patient denies: Diarrhea, urinary symptoms, blurred vision, sore throat, back pain, palpitations, dizziness, -Continue Decadron for total 10 days Complete the course of remdesivir.  Home O2
Malaise; SOME LOSS OF BLADDER CONTROL; Some loss of balance; FEVER; CHILLS; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Malaise), URINARY INCONTINENCE (SOME LOSS OF BLADDER CONTROL), BALANCE DISORDER (Some loss of balance), PYREXIA (FEVER) and CHILLS (CHILLS) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (Malaise), URINARY INCONTINENCE (SOME LOSS OF BLADDER CONTROL), BALANCE DISORDER (Some loss of balance), PYREXIA (FEVER) and CHILLS (CHILLS). At the time of the report, MALAISE (Malaise), URINARY INCONTINENCE (SOME LOSS OF BLADDER CONTROL), BALANCE DISORDER (Some loss of balance), PYREXIA (FEVER) and CHILLS (CHILLS) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication information not provided.  Treatment information not provided.