chrisvoncsefalvay/vaers-outcomes huggingface dataset:
BODY ACHES; INABILITY TO TELL WHAT WAS REAL OR NOT; FEELING LIKE FREIGHT TRAIN; CHILLS; FEVER; This spontaneous report received from a patient concerned a 25 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, and batch number: 201A21A expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 13:00 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, Laboratory data included: Body temperature (NR: not provided) 100.4 F. On 08-APR-2021 21:00, the subject experienced body aches. On 08-APR-2021 21:00, the subject experienced inability to tell what was real or not. On 08-APR-2021 21:00, the subject experienced feeling like freight train. On 08-APR-2021 21:00, the subject experienced chills. On 08-APR-2021 21:00, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and fever on 09-APR-2021, was recovering from inability to tell what was real or not, and had not recovered from body aches, and feeling like freight train. This report was non-serious.
I was having a sore throat and it was happening deep down in my throat and then I was having more issues down in my chest. I was having a productive cough and coughing up a green mucus. I then began feeling it in my head as well with the runny nose and congestion and more coughing. I have coughing fits throughout the night or when I change positions. I did go to urgent care on January 4th, and I was tested for both COVID-19 and Influenza and they were both negative. By that time things had died down but then had come back and I had a trip coming up so I wanted to make sure I could travel.  I do have a little bit of a productive cough left but am able to make it through the night and not be woken up with a coughing fit.
This spontaneous report was received from a pharmacist via a company representative and refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. In 2014 (reported as "last year"), the patient was vaccinated with a dose of ZOSTAVAX (dose, route of administration, lot# and expiration date were not reported). In 2015 (reported as "this year") the patient was administered another dose of ZOSTAVAX (dose, route of administration, lot# and expiration date were not reported). No adverse effects were reported. Additional information has been requested.
Moderna COVID-19 Vaccine EUA My right arm was sore for about 2 days after the shot (April 12 and 13). Then 10 days after the shot on April 21, I had a red spot about the size of a ball where the shot was injected. It hurt and itched for about a few days.
Patient tested positive for COVID on 01/06/2021. Patient received out patient monoclonal antibody treatment on 01/09/2021.
Severe vomiting, headache, body aches, chills x 2 days. This resolved with hydration, ALEVE and time.
Dizziness, chills, fever, headache, lethargy.   started about 10:00 AM.  Slept for many hours.  no appetite. Felt better next day, but seems to have progressed into upper  respiratory infection.   Still having symptoms on November 7th.
Fever of 102.5 followed by a rash on stomach. Next day fever again and by night time the rash was also on his face.
PATIENT CALLED ME RETROSPECTIVELY TO INFORM ME SHE HAD EXPERIENCED TEMPATURES RANGING FROM 99 TO 101 DEGREES FAHRENHEIT FOR 6 DAYS CONSECUTIVELY STARTING WITHIN HOURS FOLLOWING THE MODERNA VACCINATION.  THIS WAS THE FIRST DOSE IN THE TWO DOSE SERIES.
Increase Eczema; Peanut allergy sensitivity. Skin; Peanut allergy sensitivity. Skin, mouth; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE: Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 13Apr2021 at 13:15 (at the age of 56-years-old), as a single dose for COVID-19 immunisation. Medical history included allergy to peanuts. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient did not take any concomitant medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE: Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on an unknown date as a single dose for COVID-19 immunisation. On 19Jul2021, the patient underwent SARS-CoV-2 test (nasal swab) and the result was negative. On 23Jul2021, the patient experienced increase eczema and peanut allergy sensitivity, skin, mouth.  The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event increase eczema and peanut allergy sensitivity, skin, mouth were not resolved at the time of this report.     The lot number for BNT162b2 was not provided and will be requested during follow up.
Mini Fevers,Fatigue Lightheadedness, Dizzy Spells, Sore Throat, Hoarse Voice, Malaise, Lump about the size of Tennis ball did not subside until Wednesday. Treated in Hospital Emergency room Monday 5 Apr 2004 and given 48 hours bed rest at home.
YF-VAX was reconstituted with sterile water and administered to a patient with no adverse event reported; Initial information received on 21-Mar-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an unknown age and gender patient, reporter reported that yellow fever vaccine [YF-VAX] was reconstituted with sterile water and administered to a patient with no adverse event reported.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.   On an unknown date, the patient received unknown dose of suspect yellow fever vaccine, solution for injection, (strength, lot number and expiry date: not reported) via unknown route in unknown administration site for immunisation.  On an unknown date, YF-VAX was reconstituted with sterile water and administered to a patient with no adverse event reported (product preparation error) (latency: same day) following the administration of yellow fever vaccine.  No lab data was reported.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.   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 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.
Client reports at clinic today for #2 MMR and #2 Hep B that swelling of hands and feet (left hand the worst) occurred 5 weeks after receiving first MMR.
Beginning 03/06 0900: 101 degree fever, unresponsive to tylenol or ibuprofen. Joint pain and intense headache persisted throughout entire day. Fever did not break. BP @ 1200p - 130/76 100bpm, @ 08:00p - 140/84 80bpm.   03/07 am: Awoke with 100 degree fever, came down to 99.6-99.8 for the remainder of the day with 2 tylenol. Persistent headache, unresponsive to tylenol.  Red vertical oblong patch surrounding injection site 3?x6?. Site painful and tender to the touch. Joint aches subsiding gradually but still present at 22:00. Unusual chest pain upper right.
Hospitalized for COVID-19 on 9/6/21.  Passed away on 9/18/21.
Pt. started experiencing  the following symptoms: Lightheaded, mouth tingling, and dizziness. Hives noted around chest radiating towards neck. Lip swelling and redness to the face also noted.  Lungs and throat clear.  Administered 20mL (50mg) of Benadryl orally at 1102. First set of vitals were taken at 1103 and were the following: BP - 112/64, HR - 68, RR - 14, SpO2, 100% on RA. Pt. stated she was feeling better. Hives, redness to face,  and swelling to face going away. Pt. left at 1125 with guidelines on secondary reactions.
19 days after MMR had swelling of Rt parotid and decreased hearing.  60 days lat swelling resolved, still c/o of muffled hearing but hearing screen L Refer
Pt. appears with small bump on (L) arm at injection site. C/O pain to site. No S/S of redness, or drainage or edema.
Vaccine 12/17/21 Frozen embryo transfer 1/7/22 with positive pregnancy test on 1/16/22 3/22 discovered at 12.5 weeks pregnant that baby has anencephaly with no known cause
s/p Shingrix IZ in 2019 she had fever, L arm pain, and her L arm has never felt the same, still has normal strength, no tingling/numbness, but feels she has to be more delicate with it and flexibility is less, demonstrates normal ROM of L shoulder as she discusses; she thinks she has an injury from her IZ
First felt very tired the next day started with cough and achy feeling waited a day before taking Covid test contacted Dr., prescribed MUCINEX and over the counter cough syrup called in prescription for PAXLOVID.
Nosebleeds from left nostril every morning for three weeks.  On evening of 15th day, severe nosebleed for one and a half hours. (Possibly from both nostrils, couldn't tell.) P.A. ordered blood tests on 17th day, my APTT was 34.1 sec. (Standard Range 23.1-34.3) Nosebleeds ended then, and have not happened since. Did not get my second shot of Moderna Covid Vaccine, as felt it was unsafe for me personally. Am disappointed to not be protected by getting both shots of the vaccine.
Immediate syncope episode consistent with breath holding secondary to pain from needle. 20-30 seconds syncope patient responded and was very withdrawn for 5 min.
1 day after TDAP developed stiff, painful, hot area at site of shot. Next day area became red 11 X 12cm. Afebrile. Treated with KEFLEX 500 mg TID X 10d.
patient was injected with TDAP on 9/15 and then seeing it had expired on 9/11 with no reported adverse event; Initial information received on 19-Sep-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 12 years old female patient who was injected with DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] on 9/15 and then seeing it had expired on 9/11 with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 15-Sep-2022, the patient received 0.5 mL dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (formulation and strength not reported: lot C5770AA and expiry date: 11-Sep-2022) via intramuscular route in the right arm for prophylactic immunization.  On 15-Sep-2022, (latency: same day) the patient was injected with tdap on 9/15 and then seeing it had expired on 9/11 with no reported adverse event (expired product administered) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.   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 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.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Severe, Additional Details: Patient lost color in her face and said that she could not see anymore...She was able to communicate and squeeze my hand for a bit before she stopped talking to me.  Her friend and I laid her on the ground to prevent fainting and in doing so she ended up passing out.  She was non responsive, but breathing.  911 was called. Pulse ox was placed on her finger and breathing checked.  She came to in about 30 seconds and we kept her on the floor flat until EMS came.  EMS arrived quickly and took over
Fever 100.3F for a couple of days; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever 100.3F for a couple of days) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Mar-2021, the patient experienced PYREXIA (Fever 100.3F for a couple of days). On 16-Mar-2021, PYREXIA (Fever 100.3F for a couple of days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported.  Treatment information was not provided.  Patient is healthy and does not have a history of thyroid problems.   This case was linked to MOD-2021-293023 (Patient Link).
About 4 months after the vaccination started to have sob, fatigue.  Later confirmed lab test for hyperthyroidism, Graves disease.
I developed a large red inflammed area on left arm (location of vaccine shot given on 1/26/21). Monitored for 13 days and the inflammed area continued to grow larger.  The area started out measuring 2" x 2" in diameter and grew by the 12th day to measure 4 1/2" x 4" in diameter.  It continued to be red and had a dark area in the middle of the inflammed area.  It has been warm to touch, swollen and itchy at times.  Registered with V-Safe; phoned CDC on 2/4/21 and was advised to go to emergency room.  On 2/4/21, I contacted my primary physician and visited Urgent Care.  Doctor described it as an allergic reaction, left arm swelling, vaccine reaction and I was given Solu-Medrol Steroid shot in buttocks. On 2/5/21, the area continued to spread in size.  I consulted with my primary physician and he was concerned and referred me to an Allergist who I have been unable to reach at this time.  My primary physician thinks I definitely am having an allergic reaction to the Moderna Vaccine.
took first dose while pregnant; Injection site pain,Muscle pain in the injection site; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (took first dose while pregnant) and VACCINATION SITE PAIN (Injection site pain,Muscle pain in the injection site) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     Previously administered products included for an unreported indication: TDAP (injection and left deltoid) on 17-Mar-2021. Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) from 19-Jul-2019 to an unknown date and FOLIC ACID, IRON (IRON & FOLIC ACID) from 17-Feb-2021 to an unknown date for an unknown indication.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient's last menstrual period was on 30-Aug-2020 and the estimated date of delivery was 06-Jun-2021. On 02-Apr-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (took first dose while pregnant) and VACCINATION SITE PAIN (Injection site pain,Muscle pain in the injection site). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirtieth week of the pregnancy.  On 03-Apr-2021, VACCINATION SITE PAIN (Injection site pain,Muscle pain in the injection site) had resolved. At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (took first dose while pregnant) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications provided by the reporter included :Prenatal vitamins with DHA (indication:Take it with breakfast) , Iron supplement(take it with orange juice)       Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: follow up were received on 03-JUN-2021 , patient details were updated, concomitant medication updated
Fever  and chills 100 F for 2 days, Body ache injection site pain for 2 days Injection site itching 2 days
injection site warmth; I slept longer then normally I do; soreness; Received 3rd dose being not immunocompromised; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (injection site warmth), SLEEP DISORDER (I slept longer then normally I do), INJECTION SITE PAIN (soreness) and EXTRA DOSE ADMINISTERED (Received 3rd dose being not immunocompromised) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 034C21A, 013M20A and 023M20A) for COVID-19 vaccination.     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 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXTRA DOSE ADMINISTERED (Received 3rd dose being not immunocompromised). On an unknown date, the patient experienced INJECTION SITE WARMTH (injection site warmth), SLEEP DISORDER (I slept longer then normally I do) and INJECTION SITE PAIN (soreness). On 25-Sep-2021, EXTRA DOSE ADMINISTERED (Received 3rd dose being not immunocompromised) had resolved. At the time of the report, INJECTION SITE WARMTH (injection site warmth), SLEEP DISORDER (I slept longer then normally I do) and INJECTION SITE PAIN (soreness) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment medication use was reported.   This case was linked to MOD-2021-333240 (Patient Link).
About 2 weeks after dose 1, whole body itchy skin, legs, arms upper/lower back, chest area.  Very painful.  Suspect hives.  Started course of Benadryl, anti itch otc products, colloidal oatmeal baths.  Symptoms of itchy skin, pain continues.  No previous knowledge of allergies other than seasonal alergy
RotaTeq was given on 11/20/2023 and upon medical assistant documenting the vaccine it was discovered that vaccine expired on 11/17/2023.
patient states after she received the vaccination (minutes after) her arm felt like a bee sting. She has a hard knot with redness and swelling at the injection site and on day 2 she states the redness is spreading on her arm
Flu-like symptoms; slept for an entire day; Bad Aches; throwing up; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu-like symptoms), HYPERSOMNIA (slept for an entire day), PAIN (Bad Aches) and VOMITING (throwing up) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No medical history was reported.     On 21-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like symptoms), HYPERSOMNIA (slept for an entire day), PAIN (Bad Aches) and VOMITING (throwing up). At the time of the report, INFLUENZA LIKE ILLNESS (Flu-like symptoms), HYPERSOMNIA (slept for an entire day), PAIN (Bad Aches) and VOMITING (throwing up) outcome was unknown.            No concomitant medications were provided by the reporter.   No treatment information was provided.
day after pt got Moderna bivalent booster , she had severd abdominal pain, went to ER and CT showed diverticulitis with microperforation
Bursitis and frozen shoulder in left arm where I received 2nd COVID vaccine shot. Unable to have full range of motion of left arm. Waited six months to see if it got better before going to Dr. in July and having an MRI. Received cortisone injections 8/19 and started physical therapy 8/30.
Patient reports severe right sided facial pain and twitching which started within the first 24 hours of the vaccine.  It lasted for a week. It has mostly resolved - but he occasionally gets mild pain and twitching
Very severe flu like symptoms - chills, night sweats, muscle aches, nausea, and vomiting.  Chest pain and shortness of breath.  Very large rash at injection site.
I have had a chronic dry cough that started 3 days after my second shot. I cough all the time.; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 53 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 25May2021 12:00 (Lot number: Ew0172) at the age of 52 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (product=COVID 19, brand=Pfizer, lot number=Er8730, lot unknown=False, administration date=04May2021, administration time=02:30 PM, dose number=1, vaccine location=Left arm), administration date: 04May2021, when the patient was 52 years old, for COVID-19 immunization. The following information was reported: COUGH (non-serious) with onset 29Jun2021 12:00, outcome "not recovered", described as "I have had a chronic dry cough that started 3 days after my second shot. I cough all the time.". The event "i have had a chronic dry cough that started 3 days after my second shot. i cough all the time." was evaluated at the physician office visit. Therapeutic measures were not taken as a result of cough. Additional information: No other vaccine in four weeks and no other medications in two weeks. No treatment. No covid prior vaccination and no covid tested post vaccination.  No follow-up attempts are possible. Follow-up attempts are completed. No further information is expected.
Vaccine was pulled from our fridge with a BUD date of 10/31 and administered. Later that day we received a notice from our corporate that the lot used was short-dated by the manufacturer and expired on 9/30 regardless of when it was placed in our fridge.
This case was reported by a other health professional via sales rep and described the occurrence of swelling arm in a patient who received FLUARIX QUADRIVALENT. On an unknown date, the patient received FLUARIX QUADRIVALENT at an unknown dose. On an unknown date, less than a year after receiving FLUARIX QUADRIVALENT, the patient experienced swelling arm and pain in arm. On an unknown date, the outcome of the swelling arm and pain in arm were unknown. It was unknown if the reporter considered the swelling arm and pain in arm to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced arm tender to touch. The sales representative did not have patient or product information. He had very limited details of adverse event. The sales representative stated that the healthcare professional might have called in to report the adverse event prior but was not absolutely sure. However, no duplicate case was found.