chrisvoncsefalvay/vaers-outcomes huggingface dataset:
cant get out of bed; fever blisters in ear, nose, lip; loss of appetite; has to stay in bed most of the day/Feels so sick; chills; sore lymph nodes; headache; nauseas; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (cant get out of bed), BLISTER (fever blisters in ear, nose, lip), DECREASED APPETITE (loss of appetite), ILLNESS (has to stay in bed most of the day/Feels so sick) and CHILLS (chills) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced NAUSEA (nauseas). On 14-Feb-2021, the patient experienced MALAISE (cant get out of bed), BLISTER (fever blisters in ear, nose, lip), DECREASED APPETITE (loss of appetite), ILLNESS (has to stay in bed most of the day/Feels so sick), CHILLS (chills), LYMPHADENOPATHY (sore lymph nodes) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. On 06-Feb-2021, NAUSEA (nauseas) had resolved. At the time of the report, MALAISE (cant get out of bed), BLISTER (fever blisters in ear, nose, lip), DECREASED APPETITE (loss of appetite), ILLNESS (has to stay in bed most of the day/Feels so sick), CHILLS (chills), LYMPHADENOPATHY (sore lymph nodes) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: Follow up document received via TCR on 13-JUL-2021 contains no information: ; 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.
That day the pt started experiencing and has since, brain scramble/fog. Having trouble driving, can only stay in the lane while staring at the lines. Zero engery. Lays in bed everyday. Having hard time sitting up.
From the recipient's phone log. Dr.'s practice manager, Dr., Pt = Patient 7/31/08 Pt called c/o pain & swelling near sight of Td left arm that began today.  Records show Td given 7/25/08.  Pt had left arm pain for 2 days following the shot that resolved.  Discussed with Dr.  Appt planned for tomorrow.  7/31/08 17:00 I spoke with Pt.  Pt now states that her left arm pain and swelling has been continuous since receiving the shot, worsened on the 29th, and even wakes her up from sleep.  I told her this is a VAERS-reportable incident and she should report it (I will also) and that she definitely should see a doctor for this.  She decided that she will keep her appt with me tomorrow.   8/1/08 I called Pt to confirm today's appt and left message.    8/1/08 Pt called back and cancelled today's appt noting that she was "too busy" to keep it.  Was advised to reschedule for early next week and to go to urgent care or ER in the interim if Pt feels that cannot wait.  Dr. aware.   Postscript:  Recipient never rescheduled her appointment to have her arm examined by Dr.
Fever on and off for over 1 week. Fast heart rate, 1 night on the next day, post vax. Nauseous, personality change and weak. Did not eat well if at all for over 1 week.
Shot received Friday 9/22 pain at injection site, pain in left axilla,  swollen lymph nodes in left axilla area,  chills Friday and Saturday vomiting and shortness of breath Saturday night into Sunday (worse with stairs/exertion).  Reports having some chest tightness.  Treatment - Prednisone 10mg 4 tablets daily x 3 days, 3 tablets daily x 3 days, 2 tablets daily x 3 days, 1 tablet daily x 3 days
Received the J & J vaccine 10/31/21 in left deltoid, increased pain, noted into shoulder x 3 weeks and radiating into elbow with occasional numbness extending into ring and pinky finger. Redness, heat, and swelling noted in upper arm. 11/22/21 initial visit in the occupational health department, Keflex 500 mg QID x 5 days prescribed. A referral is given to  Orthopaedics. 11/30/21, occupational health department follow-up, continues with swelling, discomfort, and heat, Keflex 500 mg TID prescribed. 12/3/21, occupational health visit follow-up. 12/7/21 Orthopaedic, Dr. consult, determined rotator cuff inflammation recommended exercises. 12/10/21 occupational health follow-up, D/C from service. Continues with aching in the upper arm. Prior Hx of Covid-19 infection 12/20, + antibody test 04/21.
No adverse event; Patient received dose of the Moderna covid-19 vaccine after the published expiration date.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received dose of the Moderna covid-19 vaccine after the published expiration date.) and NO ADVERSE EVENT (No adverse event) in a 9-month-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR9236B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Feb-2023, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Feb-2023,  after starting , the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received dose of the Moderna covid-19 vaccine after the published expiration date.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received dose of the Moderna covid-19 vaccine after the published expiration date.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient received dose of the Moderna covid-19 vaccine after the published expiration date.).    Concomitant products were not reported.  It was reported that patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.   Treatment medications were not reported.
Infant would not eat, vomited, was exhausted and would not stay awake, seemed as though in a lot of pain and would scream, body temp cycled between hot and cold and clammy.  Treatment was enema.  1/27/09 Reviewed hospital medical records of 12/11-12/12/2008. FINAL DX: Intussusception, enema reduced Records reveal patient experienced sleepiness, diet refusal, irritability, vomiting. Had URI x 2 weeks.  Admitted for observation overnight s/p enema reduction.  Progressed well &  d/c to home.  12/31/08 Reviewed PCP office records of 12/5/2008.  No vaccine lot #s provided. Records reveal patient experienced stuffy nose & cough on day of vaccination.  Otherwise in good general health./ss  1/12/09 Reviewed PCP office records of 12/9/08.  Patient experienced nasal congestion x 1 mo occasionally labored breathing which was worse at night.  Older sibling w/runny nose.  Dx w/acute URI.  RTC on 12/30 w/fever, congestion & cough.  Bilat ears w/congealed pus.  Tx w/antibiotics.  Record reveals patient had recent IS.
Fever two nights following the vaccination. Sweating and mild nausea the second night following the vaccination. Slowly fading pain at the injection site for three days following the vaccination.
she gave ADACEL instead of DTaP to a 3 year old with no reported adverse event; she gave ADACEL instead of DTaP to a 3 year old with no reported adverse event; Initial information received on 14-Oct-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 3 years old female patient and it was reported that she was given adacel instead of dtap to a 3 year old with no reported adverse event while receiving vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A) for Immunisation.  On 13-Oct-2022, the patient received a dose of 0.5 ml of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (formulation, strength: unknown) lot U7276AA, expiration date: 21-Jan-2024 via intramuscular route in the right thigh as immunization .  On 13-OCT-2022 the patient was given adacel instead of dtap to a 3 year old with no reported adverse event (wrong product administered) (product administered to patient of inappropriate age) same day following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was Unknown for all.    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Shingles; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received bnt162b2 (Formulation: Solution for injection; Batch/Lot Number: Unknown), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date patient experienced shingles. Reporter stated, I have caller on the other line. She is calling from a medical institute and she said that they receive questionnaire from Pfizer regarding the patient that they need to fill up this questionnaire because the patient received, I mean had shingles. I think it's in between the vaccine the Pfizer COVID 19 vaccine. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
a skin disorder; I am also having heart anxiety problems; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (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), for Covid-19 immunization; Covid-19 vaccine (Dose 2), for Covid-19 immunization; Covid-19 vaccine (Dose 3), for Covid-19 immunization. The following information was reported: SKIN DISORDER (non-serious), outcome "unknown", described as "a skin disorder"; CARDIAC DISORDER (non-serious), outcome "unknown", described as "I am also having heart anxiety problems". The events "a skin disorder" and "i am also having heart anxiety problems" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: the patient now had a skin disorder that was a mystery to four doctors: urgent care, dermatologist (including a biopsy), autoimmune specialist, primary care physician, and patient was being referred to a hematologist. The patient was also having heart anxiety problems.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Patient states that about 1 week after receiving the vaccines, she started feeling sick with an increased temperature, and pustules started breaking out all over her body and in orifices. Her temp went up to 104 F, and it became bad enough that she went to the ER and was hospitalized from March 19-22. She stated they told her it was chickenpox from the vaccine. When she contacted us on March 26, she said she was feeling better- no longer feverish, and she was scabbing and healing over.
No adverse event; Dose administered after manufacturer date of expiry; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry) and NO ADVERSE EVENT (No adverse event) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M21A) for COVID-19 prophylaxis.     It was unknown if patient had any allergies to medications, food and other products. It was unknown if patient was ever been diagnosed or tested positive for COVID-19. It was unknown if patient had any acute illness at the time of vaccination or a month before vaccination. Not known if patient had any chronic or long standing health conditions.     On 20-Sep-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 20-Sep-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry).    No concomitant medication were reported.  Patient received Monovalent vaccine. Individual vials of size 5.5 ml. The vial was initially stored in the refrigerator on 20Sep2022. The vial did not undergo any temperature excursions.  No treatment information was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 23-Sep-2022: Live Non-significant follow up received contains: reporter details updated.
Client woke up on Dec. 18, 2009 with a pimple-like, itchy rash on the left side of her chest from her breast to her navel. No other symptoms. No history of allergies or problems with vaccines.
Fever (101.6) Headache, light sensitivity, mild neck "soreness", chills, myalgias received lumbar puncture to r/o meningitis.
Mother refers the child had an allergic reaction to vaccine the following day. Referred inflamation in the thighs, genital area and face. The mother did not inform the vaccine provider the child was sick with bronchitis when he was vaccinated.
Menstrual cycle came two weeks early, no cramping at all (which is abnormal) thicker/ clotty, lasted a normal amount of time. I have had hx of abnormal menstrual cycles in the past, but not that come this early.
After booster, Itching got worst; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (After booster, Itching got worst) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041J21A) for COVID-19 vaccination. No Medical History information was reported. On 21-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Dec-2021, the patient experienced PRURITUS (After booster, Itching got worst). The patient was treated with DOXYCYCLINE for Itching, at an unspecified dose and frequency and HYDROXYZINE for Itching, at an unspecified dose and frequency. At the time of the report, PRURITUS (After booster, Itching got worst) had not resolved.  mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. Patient was not sure if itching was caused by the vaccine. Other Treatment medications include Antihistamines and an unknown injection. Patient's dermatologist prescribed several unknown creams as treatment. This case was linked to MOD-2022-488823 (Patient Link).
I had really bad diarrhea that is still ongoing, bad headache, laryngitis, really bad upper respiratory stuff, sneezing blowing my nose a lot, nausea, coughing. I went to the doctor and he prescribed antibodies but never got it so he asked me to take nasal spray. I tested for COVID-19 almost everyday and it was negative.
On 12/19/2000 the patient experienced chicken pox with 5 to 100 insect like bite like lesions, pink with different sizes, an itchy rash and no fever. Subsequently, the patient's symptoms had resolved. Unspecified medical attention was sought. No further information is expected.
This spontaneous case, initially received from a pharmacist on 25-Sep-2018, concerning a 68-year-old, elderly female patient. The patient's medical history and concomitant medications were not reported. On 24-Sep-2018, the vaccine was left in cooler and the temperature reached 34.4F, which was out of the recommended temperature range for 45 minutes and the average temperature was 35.4F. It was the first excursion. On 24-Sep-2018, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number 252657 and expiry date: 31-May-2019) which underwent temperature excursion. The patient did not experience any adverse event after the vaccination. The reporter assessed the case as non-serious. This case 201804056 was cross-linked to source case 201804054 due to the same reporter. Follow-up report received from the reporter on 25-Oct-2018: The reporter confirmed the date of temperature excursion and vaccine administration (24-Sep-2018). The narrative was amended accordingly.
runny nose, persistent cough, nausea, vomiting, unable to eat. joint pain.
Severe Headache; LT arm numbness and shaking; LT arm numbness and shaking/Involuntary muscle jerks in LT arm and shoulder; Nausea; Vomitting; Fatigue; Insomnia; This is a spontaneous report from a contactable other health care professional (patient).   A 31-year-old non-pregnant female patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EW0183) via an unspecified route of administration, administered in left arm on 27Aug2021 at 01:45 (at the age of 31-year-old) as single dose for COVID-19 immunization. Patient had known allergies to penicillins, Ibuprofen. The patient's concomitant medications were not reported. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown if the patient diagnosed with COVID-19 prior to the vaccination. The patient had been not tested for COVID-19 since the vaccination. The patient received within 2 weeks of vaccination naproxen sodium (ALEVE, batch/lot number not reported), route of administration, start and stop date, dose not reported. The patient previously took ibuprofen and experienced drug hypersensitivity. On 27Aug2021 at 14:00 the patient experienced severe headache, arm numbness and shaking, involuntary muscle jerks in lt arm and shoulder, nausea, vomiting, fatigue, insomnia. Treatment received with OTC medications for the event headache. No treatment received for other events. Device Date: 29Aug2021. Outcome of the events were not resolved.  Follow-up attempts are completed. No further information is expected.
This spontaneous report as received from a nurse refers to unspecified number of patients of unknown age and gender. Pertinent medical history was unknown. On an unknown date an unspecified number of patients were vaccinated with ROTATEQ (route of administration, dose and anatomical location was unknown) that underwent another temperature excursion. Concomitant medications were unspecified by reporter. No adverse effects reported. The outcome of the events was unknown. No further information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
T of 104 F.Local rxn /w redness & swelling. 3rd DTP. No problems, no past hx of allergy or seizure
Clinical Summary Patient is a 91 y.o. male with a history of HTN, HFpEF, HTN and PE who presented to hospital 11/6/2022 with abdominal pain n/v shortness of breath and weakness for about 4 days found to be septic with CT ABD pelvis concerning for acute cholecystitis.    1. Acute cholecystitis: Present on admit, complicated by sepsis. CT AP 11/6/22 with dilated diffusely thickened GB and mild ileus.  Continued Zosyn 11/12/2022..  S/p PCT?11/8/2022.  OR cultures showed Clostridium perfringens and viridans.  IV Zosyn transitioned to Augmentin until 11/17/2022.  Surgery and infectious disease followed.  2. COVID-19: + 11/9/2022.  Was also positive in February 2022.  Vaccinated and boosted.  Unclear if he is having respiratory distress secondary to COVID or if this is a new infection versus old.  Inflammatory markers elevated.  D-dimer also elevated.  CTA did not show PE.  Continued steroids until 11/15/2022.  S/p monoclonal antibody infusion 11/11/2022.  Also procalcitonin elevated no further need of antibiotics per ID?followed..   3. Acute hypoxic respiratory failure: Likely combination of heart failure exacerbation versus pneumonia as below.  Weaned to room air. 4. Acute on chronic diastolic congestive heart failure: BNP significantly elevated 1645.  Mostly euvolemic on exam.  Chest x-ray also does not show signs of fluid overload.  Echocardiogram 7/2019 with ejection fraction of 60 to 65% with diastolic heart failure.  Repeat echo 11/10/2022 with ejection fraction of 65%..  Continued home Lasix?BP dose decreased as  BP allows.  Cardiology followed 5. SinusTachycardia: Prior history.  Now exacerbated due to sepsis.  Improved after increasing to prior dose of 50 mg.  Dose decreased back to 25 mg as per cardiology.   6. Dysuria: Complains of burning urination with hesitancy.  UA negative?11/9 /2022.  Symptoms improved.   7. Thrombocytopenia: Baseline 122 130- ?90 11/7/2022.  No signs of active bleeding.  Monitored.   8. PE: Hx 2012, no longer on any anticoagulation.  9. HTN: Held amlodipine due to low blood pressure.
Excruciating right lower abdomen (ovary) area; blacked out from pain. Went to ER
Headache all day; arm red, hard and swollen "larger than baseball size" local reaction lasted one week.
Hives over majority of body,  over the counter benadryl taken.  Started 6/7, the morning after the 2nd shot.  Started small on elbows and gradually moved to the legs, face, arms, fingers, hips, torso throughout 6/7.  6/8 still present over most of body.  I would like to note that I have had hive outbreaks in the past through about age 20 while living in state.  No cause was determined if allergy vs viral.  This could just be my body's way of fighting viruses and not an actual cause of the vaccine itself.  However, I still wanted to report as the hives occurred the day after the 2nd vaccine dose.
In January I got COVID-19. I was feeling nausea and vomiting I was sick from January 13th to the 17th. I did lose my sense of taste and smell. On the third day I had crippling nausea and I could not keep any food down. I contacted my doctor, and they prescribed me medicine called ondansetron ODT for the nausea. I think by the Monday afternoon the nausea calmed down. I still cannot smell things like cloves and cinnamon. It came back a few weeks ago. But I feel fine now otherwise, but the loss of smell bothers me.
pt recvd vax & devel hives, burning of ears, hands, lips, tingling in lips & face;devel aches & pains involving multiple joints & all limbs;lo grade fever/no temp taken;pt also devel stiffness & pain in wrists & neck,tingling in both hands
Patient experienced itching on her skin and in her throat.  She was given 25mg of diphenhydramine IM.  Symptoms resolved after diphenhydramine administration.
the nerves in my Teeth and Jaw are hurting. The pain comes in waves. It is keeping me up at night. I average about 3 hours of sleep every night.