chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient is fully vaccinated and booster given on 10/27/2021.  Admitted on 12/2/2021 for SOB.  A 59-year-old female patient presented to the ED after testing positive for COVID-19 on 11/17.  She states that she has been checking her pulse ox at home and saturation went down to 88% while walking.  Her doctor then advised her to go to the hospital for evaluation.  The patient denies any fever, chest pain, abdominal pain, nausea, vomiting, or diarrhea, though she admits to having some shortness of breath and cough.  The patient does have a past medical history for GERD and overactive bladder.  Otherwise, no symptoms. Acute Hypoxic Respiratory Failure. CXR negative No indications for antiobiotics; anti-viral therapy or steroids  Currently on room air.  Discharged to home.
INJECTION SITE SWOLLEN, RED, ITCHY; SWELLING PERSISTED AS OF 1/25/21
vaccines given in the same arm and at the same time/the area itched; This is a spontaneous report from a contactable consumer (patient). This 67-year-old female patient received pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) via an unspecified route of administration administered in the arm on an unspecified date (Batch/Lot number was not reported) as a single dose for immunization and influenza vaccine (FLU), via an unspecified route of administration administered in the arm on an unspecified date (Batch/Lot number was not reported) at an unknown dose for an unspecified indication. The patient's medical history and concomitant medications were not reported. The vaccines were given in the same arm and at the same time. The area itched. Outcome of the event was unknown.  Pfizer is marketing authorization holder of pneumococcal 13-val conj vac (dipht crm197 protein) in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report in situations where another marketing authorization holder of pneumococcal 13-val conj vac (dipht crm197 protein) has submitted the same report to the regulatory authorities.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report as received from a Registered Nurse refers to a patient of unknown age and gender. On 07-NOV-2013 the patient was vaccinated an expired first dose of GARDASIL (lot# 1073AA, expiry date: 11-OCT-2013) intramuscularly (dose and location unspecified). No adverse effect reported. Additional information has been requested.
2 year old patient received dose of Tenivac vaccine/No AE; 2 year old patient received dose of Tenivac vaccine in the left thigh/No AE; Initial information was received on 28-Jan-2020 regarding an unsolicited valid non-serious case from a nurse.  This case involves a 2-year-old patient who received 0.5 mL dose of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] [lot U6021AA, expiry date: 27-JUL-2020] via an intramuscular route at the left thigh on 24-Jan-2020.  Medical history, medical treatment, vaccination and family history were not provided. At the time of the event, the patient had ongoing Head injury.   It was a case of actual medication error due to inappropriate age at vaccine administration and vaccine administered at inappropriate site.  At the time of report, no adverse event was reported.  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 and Module VI of the 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.
stomach cramping; Diarrhea; body aches throughout body but especially her back; nausea; Fever; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (stomach cramping), DIARRHOEA (Diarrhea), PAIN (body aches throughout body but especially her back), NAUSEA (nausea) and PYREXIA (Fever) in a 23-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.     Concomitant products included BIOTIN, VITAMINS NOS (MULTIVITAMINUM) and ORAL CONTRACEPTIVE NOS for an unknown indication.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Apr-2021 at 3:00 AM, the patient experienced ABDOMINAL PAIN UPPER (stomach cramping), DIARRHOEA (Diarrhea), PAIN (body aches throughout body but especially her back), NAUSEA (nausea), PYREXIA (Fever) and VOMITING (Vomiting). On 12-Apr-2021, PYREXIA (Fever) and VOMITING (Vomiting) had resolved. At the time of the report, ABDOMINAL PAIN UPPER (stomach cramping), DIARRHOEA (Diarrhea), PAIN (body aches throughout body but especially her back) and NAUSEA (nausea) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Other concomitant medication included unspecified topical face medicine. No treatment medication details was reported.
Nausea (3 days); Headache (four days); Upper respiratory infection; No appetite; Low grade fever; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER 8737) via an unspecified route of administration in the left arm on 01Apr2021 at 11:45 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. Medical history included hashimoto hypothyroidism, rheumatoid arthritis and raynaulds syndrome. The patient did not have any allergies to food, medications, or other products. The patient received other unspecified medications within 2 weeks of 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 did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 01Apr2021 at 16:00, the patient experienced nausea (3 days), headache (four days), upper respiratory infection, no appetite and low-grade fever. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of events and included treatment with unspecified antibiotics. The clinical outcome of the events nausea was recovered on 04Apr2021, headache was recovered on 05Apr2021. The clinical outcome of the event upper respiratory infection, no appetite and low grade were recovered on an unknown date in Apr2021.  No follow-up attempts are possible. No further information is expected.
Sore arm, Blood in Urine, Loss of senseation of touch  Pharmacy provided the vaccine, patient called me the pharmacist to report adverse reactions.  We referred her to the hosptial or her PCP.  She said she would go to see them.
Patient came today at 12:20pm.  She said she took the first dose of Moderna not experience any side effect.  However, after she took the 2nd shot on 7/23/21, she was ok initially.   On the evening of 7/25/21, her left side gland under her left arm pit was swollen, left side of face was in pain, left ear have throbbing pain, and a low grade fever.  She has been taking  Tylenol to alleviate the pain and fever.  Whenever the Tylenol wear off, she will feel the pain.  Patient had an appointment with her PCP at 2:45pm today to evaluate and see what is going on.
Patient hospitalized due to COVID-19.   tested positive for COVID (previously vaccinated) 8/31, received monoclonal Aby 9/2.  Hospitalized here 9/4-9/7/21 due to AKI on CKD4 felt due to side effects of covid (severe diarrhea, poor oral intake)  Initially was not on oxygen, so received cautious fluids, but then did develop mild hypoxia so was started on dexamethasone, which he took for 4 days.   No remdesivir given CKD.   procal was mildly elevated but improved during hospitalization, and was felt more likely due to renal dysfunction; did not receive abx.
reaction started with a facial rash at about 6hrs post vaccination.  Proceeded to develop into a full rash from shoulders up and onto left and right arm.  In addition, significant flushing of the face and swelling of the face including eyes, lips, neck and face.    Symptoms reduced with benadryl administration but continuing to have a mild rash on 11/11.  Swelling has now resolved after about 48hrs.   No difficulty breathing.
Hospitalized, COVID (+) sxs, not known, POA did not return Agency attempt to call
Patient received Menactra on 03/21/2006 and later that evening began to have swelling at the injection site which progressed over 2 days to encompass her entire upper arm and half of her forearm.
Felt a little chill; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Felt a little chill) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Feb-2021, the patient experienced CHILLS (Felt a little chill). At the time of the report, CHILLS (Felt a little chill) outcome was unknown.            No relevant concomitant medications were reported.  No treatment information was reported.  Patient had no any side effects at all after the second dose.
Slight alteration in smell. Smells are not as pungent and some smells are different then what they should be.
Patient requested the Pfizer covid vaccine, but was accidentally given the Moderna vaccine as their booster dose.  Patient was immediately notified of the mistake.  She was checked on 20-30 minutes later and had no obvious signs of an adverse reaction.   She also stated that she was doing fine during the second converstation.  The administering pharmacist repeatedly apologized, and offered to help in anyway or answer any questions she might have.  The patient was given the company product Fact Sheet published 1/7/22.    Both conversations were witnessed by an RN at the facility.  The pharmacist then called and left a voicemail at 6:30PM on 1/19/22 and 10:00AM on 1/20/22 on the patient's cell phone.  He then called again at 5:05 PM on 1/20/22, but did not leave a voicemail.  Patient has not called back.
Patient has high blood pressure and anxiety about shots. He received 2 shots. After the shots, he walked to his cart and fell/passed out. He was moaning on the ground. He said he couldn't see or hear when he was put in a chair and was very pale/sweating. His BP was low when taken. He was given a Coke and peanut butter crackers to eat. After he sat for awhile, he felt better after drinking the Coke and eating the crackers. He left the store with the person he came with on his own.
Left arm soreness for 3 days after the vaccine. This morning, 8 days after vaccination, my left deltoid is sore again and it's temperature is warmer than my right deltoid.
Took IM flu vaccine at approx, 1:30 pm. Employee is a counselor. Had client session from 2-3 pm. When came out of session at 3:00 PM, (L) eye was swollen shut, lower (L) side of face swelled later. No resp. problems. Psychiatrist said "looks like allergic reaction." Took CLARITIN at 3pm and BENADRYL PO at 6:30pm and 10 pm - Swelling resolved by 9/23 AM and no further problems.
improperly stored vaccine; This spontaneous report was received from a medical assistant concerning to a patient of unknown age and gender. No information was provided regarding the patients' medical history, concurrent conditions or concomitant medications.  On 25-APR-2019, the patient was vaccinated with improperly stored dose of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) one dose, lot number R021078 with expiration date on 12-JUN-2021; and Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) lot number R028189 with expiration date on 06-JUN-2020. Dosage schedule, route and anatomical location were not reported for non of the vaccines, and all of them were administered for prophylaxis.  The administered doses experienced temperature excursion up to 52.5 degrees Fahrenheit (F) for 4 hours and 40 minutes. There was no previous temperature excursion. Digital data logger was involved.
Patient received COVID vaccine (PFizer) on 7/7/2021 and 8/5/2021 respectively. She presents to hospital on 9/14, which is 41 days after second vaccination, suffering an ischemic stroke with an acute/subacute infarct involving the left basal ganglia and internal capsule without evidence of hemorrhagic conversion. Patient has hx of tobacco abuse. She demonstrates moderate degree of dysarthria, right facial weakness and mild weakness of her right upper and lower extremities. NIHSS of 4.
A few hours after these shots, my son started to complain that his legs hurt. In which case, as the night wore on he insisted that I carry him instead of him walking. If we tried to touch the shot areas he would scream and cry. The next day it continued to the point of him not walking on his own, and wanting to be held if he had to use his legs. Again he was crying and in alot of pain if we tried to get him to walk and/ or touch the shot areas. As of today, he is limping on one side more than the other (right side) and sitting down to play instead of standing up or jumping or running. It has gotten better over the last 24hours, but it has been slow going.
"Client reported feeling hot and wanted to have her vitals checked. EMS attended to her. EMS reported that her vitals were stable throughout. While waiting in EMS area, she reported dizzy and jittery. She decided to go to the hospital to get checked, via Ambulance." "Pt also stated that she is going through menopause and feeling hot is not unusual." Supervisor Report
Injection Site Pain (Wed Sep 29 ~ 1350 to present time of this report ~1000 Fri Oct 1, obviously due to the vaccine), took NSAIDs, did not help. Chills (Thur Sept 30 ~ 1230 to 1330, never happened with any other type of vaccine, nor any other time when I was not obviously sick). Fatigue (Thur Sept 30 ~ 1230 to 1330, never happened with any other type of vaccine, nor any other time when I was not obviously sick). Dizziness (Wed Sep 29 ~ 1150 to Fri Oct 1 ~ 0900, very unusual for me and nearly constant for almost two full days). Headache (various times from Wed Sep 29 evening to Thur Sep 30 night, unusual due to frequency, usually only get one headache every few weeks). Itchy eyes (Thur Sep 30 ~ 0900 to 1400, hard to say if this is due to vaccine, but it was unusually intense and brief compared to seasonal allergies) I take Claritin every day but it did not help with this bout of itchiness.
Left arm with peripheral edema, cellulitis measured 4 x 4 inches to upper left arm, mild myalgia which went away. Seen in our office on 5/11/18 at 8:15 AM.
I develop a bone injection in my finger tips.  I can not get rid of it.  These have been going on in October and is still continuing today.  I been to my doctor about this.  They did blood work and MRI on me. I had two surgeries and it has not helps resolve this.  I was diagnosed with osteomyelitis.
VACCINE EXPOSURE VIA BREAST MILK; This spontaneous report received from a parent concerned a 2 year old of unspecified sex. The patient's weight, height, and medical history were not reported. The patient's parent received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 205A21A expiry: UNKNOWN) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-APR-2021, the subject experienced vaccine exposure via breast milk. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from vaccine exposure via breast milk. This report was non-serious. This parent/child case is linked.
can't wake up; Blurry vision; ear ringing; feet hurt; Pain; redness; Hardness; tired; body aches; nausea; headache; Chills; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (can't wake up), VISION BLURRED (Blurry vision), TINNITUS (ear ringing), PAIN (feet hurt) and PAIN (Pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (can't wake up), VISION BLURRED (Blurry vision), TINNITUS (ear ringing), PAIN (feet hurt), PAIN (Pain), ERYTHEMA (redness), VACCINATION SITE INDURATION (Hardness), FATIGUE (tired), MYALGIA (body aches), NAUSEA (nausea), HEADACHE (headache) and CHILLS (Chills). At the time of the report, ASTHENIA (can't wake up), VISION BLURRED (Blurry vision), TINNITUS (ear ringing), PAIN (feet hurt), PAIN (Pain), ERYTHEMA (redness), VACCINATION SITE INDURATION (Hardness), FATIGUE (tired), MYALGIA (body aches), NAUSEA (nausea), HEADACHE (headache) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.  No treatment medications were provided.   This case was linked to MOD-2021-086085 (Patient Link).
Chills; Nausea; Muscle Weakness; Fatigue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48 year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administered in arm left, administration date 17Mar2021 11:00 (Lot number: EL3247) at the age of 48 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "Eczema" (unspecified if ongoing); "allergies to Brazil nuts" (unspecified if ongoing). Concomitant medication(s) included: GABAPENTIN; LANSOPRAZOLE; NORETHINDRONE [NORETHISTERONE]; SYMBICORT. Vaccination history included: Bnt162b2 (Dose 1, Lot number: EL3247, administration time: 01:00 AM, vaccine location: Left arm), administration date: 24Feb2021, when the patient was 48 years old, for COVID-19 Immunization. The following information was reported: CHILLS (non-serious) with onset 18Mar2021, outcome "recovering", described as "Chills"; NAUSEA (non-serious) with onset 18Mar2021, outcome "recovering", described as "Nausea"; MUSCULAR WEAKNESS (non-serious) with onset 18Mar2021, outcome "recovering", described as "Muscle Weakness"; FATIGUE (non-serious) with onset 18Mar2021, outcome "recovering", described as "Fatigue". Therapeutic measures were not taken as a result of chills, nausea, muscular weakness, fatigue. Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination nor was tested for COVID-19 since vaccination. The events were reported as non-serious; did not result in death, caused/prolonged hospitalization, were not disabling/incapacitating, nor lead to congenital anomaly/birth defect.  No follow-up attempts are possible. No further information is expected.
This spontaneous report as received from nurse refers to a 14 months old patient. On 04-AUG-2014 the patient was vaccinated with MMR II (0.5 ml, subcutaneous, lot# was not reported, exp 03-AUG-2014). The vaccine was expired. No adverse effect reported. This is one of two reports from same source. Additional information has been requested.
Difficulty breathing (shortness of breath), paleness, weakness, fast heart beat, dizziness, blood pressure went up to 150/75 when I'm always normal, soreness.
Inconsolable crying, shrieking scream, unable to be soothed, completely uncharacteristic (had never happened before). Happened again 2 days later 10/07/2013 in evening- same inconsolable cry. 10/8/2013 baby began staring, unresponsive, despondent. Personality changes lasted a week, less smiling, less interaction.
Shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of an unknown age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On 07-AUG-2016 , the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot #, expiration date, dose, dose # and route not specified) for the long-term prevention of singles and zoster-related conditions. Subsequently on an unknown date, the patient was treated for singles. As a direct and proximate result of the patient's receipt of zoster vaccine live (ZOSTAVAX), the patient continued suffer ongoing injuries including but not limited to mental and physical pain and suffering, medical care and treatment for these injuries; significant medical and related expenses as medical losses and costs included care for hospitalization, physical care, monitoring, treatment, medications and supplies, diminished capacity for the enjoyment of life, diminished quality of life, increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of singles was not recovered. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
This spontaneous report as received from a physician refers to a 57 year old female patient with rheumatoid arthritis, blood pressure, depression, hot flashes, anxiety and attention deficit/hyperactivity disorder. The patient's historical drug included ACTEMRA. On 03-AUG-2017, the patient was vaccinated with ZOSTAVAX, vial#10 (strength, dose, lot/batch# and expiration date were not reported) subcutaneously for prophylaxis. Concomitant therapies included methotrexate, prednisone (manufacturer unknown), diltiazem hydrochloride, venlafaxine hydrochloride, guanfacine hydrochloride, clonazepam, ergocalciferol and Rheumate (medical food prescription containing folic acid). On an unknown date in August 2017, the patient experienced severe injection site reaction. It was about 2 inches 'by' 6 inches and was taking antiviral VALTREX, 1gm tablet, as treatment. It was reported that the patient was prescribed ZOSTAVAX before start taking XELJANZ. It was confirmed by the patient that she did not start therapy with XELJANZ at the time of the report. There was no lab work reported. There was no product complaint to report. The outcome of the event severe injection site reaction was unknown. The causality assessment was not provided by the reporter.
On 3/16/11 started feeling pain (5/10) in joint of Rt/Lt big toe both feet. Now less pain (2/10). Saw chiropractor on 3/17 - had adjustment for upper back T.S. 3/21 - developed Rt. knee pain 8/10. Today 3/24 - pain less (6/10). 3/24 pain swelling Lt. thumb & five fingers soreness 3/10. Initially rash Lt deltoid (vaccine site) & malaise until now. Taking TYLENOL ES 1 tab 3/23 PM & this AM TYLENOL tablet.
The patient reported that he has never received a COVID-19 vaccine before so he was administered Pfizer on 06/19/21, however it was documented in the electronic record that he received Moderna on 01/27/21 and 02/24/21
Large, firm, red welt appeared one week after vaccination.  Skin was warm to the touch and itchy. Applied topical hydrocortisone cream 2-3 times daily; applied ice pack for 15 minute intervals as able. Swelling and irritation deceased after 3 days and disappeared completely after one week.
tinittus began around 3 weeks after the second short (received on 2/4/2021
Patient developed hives and swollen face several hours after receiving Tdap. Patient was given Solemodral IM and Benadryl.