chrisvoncsefalvay/vaers-outcomes huggingface dataset:
INFECTIVE HEART VALVE; CALCIFIED HEART VALVE; HEART WAS POUNDING; SUSPECTED COVID-19 INFECTION; VESSELS SWELLED UP ALL OVER BODY; LOT OF PAIN IN HER ARM AND IT WAS BURNING AS SOON AS SHE RECEIVED IT; This spontaneous report received from a patient concerned a 71 year old female. Initial information was processed along with the additional information received on 14-NOV-2023. The patient's height, and weight were not reported. The patient's concurrent conditions included: ulcerative colitis, unspecified drug allergy, latex allergy, non alcohol user, and non smoker, and other pre-existing medical conditions included: The patient had not done any drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, expiry: UNKNOWN) dose was not reported, 1 total administered at left arm on 06-MAY-2021 for covid-19 prophylaxis. Age at time of vaccination 71 years old. Concomitant medications included metoprolol. On 06-MAY-2021, the patient experienced lot of pain in her arm and it was burning as soon as she received it, patient had a very bad reaction. On an unspecified date, the patient experienced infective heart valve, heart was pounding, vessels swelled up all over body, calcified heart valve, and suspected covid-19 infection. It was reported that patient got sick after getting it and felt weaker. On unspecified date AUG-2022, the patient received open heart surgery. She probably will need to get 2 more valves replaced. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the heart was pounding, calcified heart valve, infective heart valve, suspected covid-19 infection, lot of pain in her arm and it was burning as soon as she received it and vessels swelled up all over body was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint 90000303556. The suspected product quality complaint has been confirmed to be the reported event was not associated with a product defect or product performance issue. this customer preference case has been assessed and did not represent a product quality complaint based on the PQC evaluation/investigation performed.; Sender's Comments: V0: 20231135023- Infective heart valve, Calcified heart valve. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.
Nausea, Headache, Fever - 101.2°F, Chills, Lethargy, extremely painful arm - Started approximately 10 hours after vaccination. Stayed home from work following day. Fever broke at 1:00 AM on Wednesday. Returned to work on Wednesday with headache and painful arm. By the end of Wednesday the headache declined and energy began to return.
Headache, back ache, chest pain, hurt all over, chills, felt like the first day I had Covid 19
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2021 at 10:46 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 07-Jan-2021 at 10:46 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 72.22.  No concomitant medications were reported.  Batch number 025L20A administered on 07-Jan-2021 underwent temperature excursion with temperature range 34 degrees Fahrenheit from  09:00 AM to 10:00 AM. This vial was moved to fridge on 05-Jan-2021 and beyond use date for the vial was reported as 27-Jan-2021. Product moved to clinic on 07-Jan-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).
Severe headache with light sensitivity.  Nausea and vomiting and severe diarrhea
Within 5 minutes-chest pressure and tongue tingling lasted about an hour. Had already taken over the counter pain reliever for sore wrist. Body aches and severe headache started approximately 7 hours after shot. Attempted to take Tylenol or Motrin around the clock. Body aches lasted two days after shot. Severe headache day of shot and day after somewhat relieved with over the counter pain relievers. Day 3 and 4 after shot still with moderate headache. Still using over the counter pain relievers.  Day after shot ankle joints painful relieved with over the counter pain relievers only lasted one day.  Day after shot noticed redness, tenderness and hard lump, the diameter of a clementine at injection site. Two days after shot lump larger size of a tennis ball in diameter,  harder still with redness and itchy. Three days after shot lump diameter still size of tennis ball, redness improving, still hard and still itchy. Day is three days post-injection.
Spotting  started 4 days after vaccine and lasted for 2 days.  Localized pain on areas of the head/forehead, left elbow, left armpit, groin crease area on both sides started 3 days after the vaccine Inflammed cyst formed under right armpit 4 days after the vaccine and one week later the swelling has decreased, but it is still there.
Headache, body ache low abdominal pain, chill to shivering 36 hours, weakness
This spontaneous report was received from a registered nurse and refers to a patient of an unknown age and gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 11-OCT-2018, the patient was inadvertently vaccinated with an expired dose of PNEUMOVAX 23, lot# reported as M047619 (lot# was not valid for PNEUMOVAX 23, expiration date: 04-AUG-2018 (exact dose, site and route of administration were not reported). No adverse effects were reported.
In about 5 minutes after getting FLUZONE HD and PNEUMOVAX, patient returned to the pharmacy and complained of extreme dizziness and almost fainted. Her face and neck were very red in color. The patient sat down in the pharmacy waiting room to rest and while sitting, she was complaining of chest pain and almost extreme lower back pain. Patient did not have any facial swelling, throat constriction, or hives/rashes. An ambulance was called due to the chest pain complaint. Once the paramedics came, patient's symptoms subsided and she returned to normal. Upon further check up by the paramedics, blood pressure and vitals were normal/stable. Patient was fine the rest of the day and haven't had any further events due to the vaccines.
4/24/04  0035 Reports skin rash and itching. No respiratory involvement. Sent to ER. Prednisone 40mg daily x 5 days. 4-28-04 noted big blotchy rash seen by MD. Solu-corter 100 mg IM given. Tricortison 0.1010 cream, Zyrtec 10mg qd. 4/30/04 came back.
No adverse reactions within first hour after vaccination administered. Notified of client's death on 01/15/2010.
Parent phoned facility on 03/12/2008 at approximately 11am. Parent reported that child had been "crabby" but did not have a fever on 03/11/2008 in the morning but by 12 noon on that same day began having trouble breathing, sounding "congested", and was breathing faster. Parent reported this happened within 12 hours and stated that the child had previously had a slight cold. The child was taken into an Urgent Care center "last night" (03/11/2008). The parent stated that the child has a "fast moving pneumonia" and later stated clinician speculation of a "superbug". The parent stated that the child was "almost admitted" and is now on steroids.
pt recv vax 11/14/97 & became pregnant;pregnancy was confirmed by hcg titers;4/3/98 amniocentesis revealed nl results, 46xy;ultrasounds 16, 22, 26, 28 & 30 wk revealed placenta previa;ultrasounds 32, 34 & 39 wk revealed polyhydramnios
A report was received from a health care professional on 10 November 2003 concerning a 3 year old female vaccinee who inadvertently received Fluvirin on 10 November 2003. On 10 November 2003 the vaccinee inadvertently received 0.5 ml Fluvirin. It was not reported whether or not an adverse event had occurred. There was insufficient information to determine the reporter's causality assessment. Follow up pending. Cross reference with: PJP200301039. Update 1, 06 January 2004. A follow up report was received from a health care professional indicating that no adverse effects were experienced by the vaccinee at the time of the follow up report. No follow up pending.
This spontaneous report as received from a registered nurse (R.N.) and refers to a female patient of unknown age. No medical history and concurrent conditions were reported. In 2012, the patient was vaccinated with first dose of GARDASIL injection (lot number, dose, frequency, route and indication not reported) and in 2013, second dose of GARDASIL (lot number, dose, frequency, route and indication not reported) was administered (inappropriate schedule of drug administration). The outcome of inappropriate schedule of drug administration was unknown. No further information was provided. No product quality complaint (PQC) was filed. Additional information has been requested.
Pt felt mild itchiness on both cheeks on her face. Pt came into the medical room. Pt?a vs were taken and normal. Pt itching went to her arms and back. Small rash was noticed on her back and shoulders and chest. Pt was given 50 mg of oral benadryl. Pt has he of allergies to many substances. Pt denies sob pt rested for 25 mins on stretcher and her car were monitored and normal. Pt felt better and rash was gone.  Pt was released back to observation area and pt checked out.
This spontaneous report as received from a pharmacist refers to a 60 year old female non-pregnant patient. The patient's concurrent conditions and medical history were not reported. On 28-FEB-2015, the patient was vaccinated with a dose of ZOSTAVAX, dose and route were not reported (lot # K015310, expiration date: 17-DEC-2015). On 10-MAR-2015, the patient experienced 2 inch red, swollen ring at the injection site. The patient did not seek medical attention. No treatment was given for the event. The outcome of the event was reported as not recovered/not resolved. The relatedness between the event and ZOSTAVAX was not provided. Additional information has been requested.
Headache; profound fatigue/tired; not feeling well; sick; This is a spontaneous report from a contactable consumer. A 72-Year-old female patient received first dose of BNT162B2 (PFIZER BIONTECH COVID VACCINE, lot number unknown, expiration date unknown), via intramuscular on the left upper arm, on 21Jan2021 at 16:30 at the age of 72 years old at a single dose for COVID-19 immunisation at senior residence. The patient medical history was none. Concomitant medications were not reported. The patient previously took Shingrix for shingles vaccine (immunisation) and both times she took it she was in bed for 3 days and then she was fine. Patient was calling about the Pfizer BioNtech covid vaccine. Since she had the vaccine and this is the 8th day since she had it. On 21Jan2021, patient had a headache and profound fatigue, she was not feeling well since she got the vaccine. She was still sick on an unspecified date in 2021. Her headache started about 30 minute s after getting the vaccine. That same night she felt really tired and when she woke up she was really fatigued. The patient occasionally takes Advil as treatment. The patient did not visit emergency room and physician office. No additional vaccines administered on same date of the Pfizer suspect. The patient was not recovered from the event sick, while patient was recovering from all other events.  Information on lot/batch number has been requested.
I felt like a slight case of flu for just one day after 1st and 2nd shot; This case was reported by a consumer via interactive digital media and described the occurrence of flu in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of influenza (1st dose received on an unknown date, for tolerance refer case US2022AMR098889).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced flu. On an unknown date, the outcome of the flu was recovered/resolved.   It was unknown if the reporter considered the flu to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 26-Jun-2022 Reporters comment: This case was reported by the patient via interactive digital media The patient received a dose of shingles vaccine and experienced slight case of flu for 1 day. The patient thought it was worth it, not to get shingles. Follow up was not possible as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR098889:Same Reporter
Temp. excursion lasted 13h-35.7°F, Vx administered; This case was reported by a other health professional via other manufacturer and described the occurrence of incorrect storage of drug in a 5-month-old male patient who received Rota (Rotarix lyophilized formulation) (batch number 7L2D7, expiry date 24th February 2024) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) (batch number FN5555, expiry date unknown) for prophylaxis.   Additional patient notes included None.   On 4th January 2023, the patient received Rotarix lyophilized formulation (oral), Rotarix Oral Applicator Device and the 2nd dose of PREVNAR 13 (intramuscular) .5 ml. On 4th January 2023, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug 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: 06-JAN-2023 Reporter's comment: The reporter was certified MA (Medical assistant) called on behalf of facility. The reporter weight was 17 pounds, 14 ounces. The patient had no family medical history relevant to adverse event. The patient was not vaccinated with prior vaccinations (within 4 weeks). The reporter was reporting that they had given Rotarix and Prevnar 13 to patient after temperature excursion. The patient was administered with Prevnar 13 at appropriate age to get second dose. The temperature excursion lasted 13 hours and lowest temperature reached was 35.7 degrees Fahrenheit. The reporter clarified that 2 patients received the vaccines involved in the temperature excursion. Additional Vaccine administered on the same date of the Pfizer suspect. The patient was not required emergency room visit. The was not visited to physician office. Additional Supportive Information: The reporter was reporting that they had given Rotarix and Prevnar 13 to patient after temperature excursion, which led to incorrect storage of drug. The case had been linked to US2023AMR002404, reported by the same reporter, for a different patient. As clarification was raised to confirm the vaccination date and event onset date, the vaccination date and event onset date were captured 4th January 2023 from the narrative conservatively.; Sender's Comments:  US-GSK-US2023AMR002404:Same reporter
Child received first dose ROTATEQ on 5-9-08. Child received 2nd dose ROTATEQ on 7-10-08. Child started with vomiting/colic on 7/14/08 - dx with intussusception which was reduced with an enema on 7/16/08 at hospital. 9/8/08-records received for DOS 7/16-7/17/08. DC DX: Intussusception. Dehydration. Received from another facility after day stay 7/14-7/16/08 presentation C/O vomiting and abdominal pain and bilious vomiting. Lethargic, feeding poorly, decreased abdominal sounds and tenderness to palpation in lower quadrants of abdomen.  Post reduction experienced bout of excess gas in intestine with passage of gas per rectum. Bowel movement next day normal.
On 11/4 patient presented in pharmacy complaining of redness and swelling several inches below injection site over the past 2 days. Mentioned some numbness in fingers the day of injection.
Heart Murmur discovered during April 26. 2021 routine physical.  Previous pre-op physical  conducted January 21, 2021 noted no heart murmur.
very high temperature; needed help going to the bathroom; feels a little fussy headed; slept till the next evening; felt very miserably; couldn't get out of bed; COVID-19 Test positive; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BODY TEMPERATURE INCREASED (very high temperature), GAIT INABILITY (needed help going to the bathroom), HEAD DISCOMFORT (feels a little fussy headed), SOMNOLENCE (slept till the next evening) and FEELING ABNORMAL (felt very miserably) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (had COVID19 last December.) in December 2020. Concurrent medical conditions included COPD. Concomitant products included CITALOPRAM, FAMOTIDINE, IRON, LOSARTAN, METOPROLOL, ALENDRONATE SODIUM (FOSAMAX), SIMVASTATIN, PREDNISONE and ALBUTEROL [SALBUTAMOL] for an unknown indication.    On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, the patient experienced BODY TEMPERATURE INCREASED (very high temperature), GAIT INABILITY (needed help going to the bathroom), HEAD DISCOMFORT (feels a little fussy headed), SOMNOLENCE (slept till the next evening), FEELING ABNORMAL (felt very miserably), DYSSTASIA (couldn't get out of bed) and SARS-COV-2 TEST POSITIVE (COVID-19 Test positive). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of 1 dosage form. On 18-Apr-2021, BODY TEMPERATURE INCREASED (very high temperature), GAIT INABILITY (needed help going to the bathroom), SOMNOLENCE (slept till the next evening), FEELING ABNORMAL (felt very miserably), DYSSTASIA (couldn't get out of bed) and SARS-COV-2 TEST POSITIVE (COVID-19 Test positive) had resolved. At the time of the report, HEAD DISCOMFORT (feels a little fussy headed) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: TCR received on 26-May-2021 contains significant information. Reporter informed that the patient is improving. Also stated that the patient may not receive the second dose of vaccine due to adverse event.
Chills, Nausea, Headache, Body Ache, Skin Hurt, Left hand pain base of middle finger back of hand Lasted about 5 hours, Headache remained into the next morning. Took Benadryl and Ibuprofen
Patient developed joint aches (especially elbows) and chronic fatigue approximately 30 days after vaccine.
Patient received vaccine due to nail puncture. Within 1-day lump at vaccination site started and it was more prominent by day 2. The vaccination site was red and warm to touch. Patient went to doctor on 2/15 doctor and they recommended the use of an ice pack and to take it easy. Patient still has lump at vaccination site but since then has also developed muscle wasting. Patient had another doctor visit on 3/4, a sonogram was performed and it was determined that it was a granuloma. Doctor recommended to continue use of ice pack and prescribed Diclofenac 1mg topical cream 4 times a day; the cream did not help. On 3/8  sent to ultrasound and determined it was granuloma; per doctor, surgery is not an option because of VWD. On 3/29, patient has appointment with orthopedic doctor (Dr) and for a CT scan. Patient scheduled to start physical therapy at Rehabilitation the week of 4/3. Patient has received the Tdap vaccination before with no problem.
The first dose was administered on 04/06/2021 at 6:45pm. The next day I was lethargic, moderate pain at the injection site, swollen lymph nodes in the neck, and about a week late developed a slight pain behind the knee on the right leg. 2nd dose was administered on 05/04/2021 at 6:15pm. Developed pain 2-3 hours in the right arm (injection site). Today 05/05/2021, woke up around 8am with pain behind my knee in the right leg. I have felt lethargic all day so far.
body aches fever chills headaches 1/29/21  dizziness swollen hands headaches sore @ site nauseated
C/o facial heat/redness.  Vital signs stable.  Given water and chair.  Twenty minutes later, flushing fading.  Fifteen minutes later, left clinic without complaint.
1 yr after pt vax w/ hepta B pt devel urticarial eruption in combination w/ erythema multiforme.
This spontaneous report as received from a pharmacist refers to two patients of unknown ages and genders. The patients' medical history and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with improperly stored dose of ZOSTAVAX (lot # M027348, expiry date: 27-JUL-2017) (route: subcutaneous) (incorrect product storage). The vaccine was stored at a temperature of 9.4 F for 50 minutes. There was no previous temperature excursion. Digital data logger was involved. No adverse effects reported. The outcome of the events was unknown. Additional information has been requested.
pt recv vax 12DEC96 & devel varicella 16OCT98;
Increased pain, redness and induration 10 cm diameter in localized area around injection site Rt deltoid.