chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Did (the vaccine) and now have had shingles for 2 months/Suspected vaccination failure; Have had shingles for 2 months; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 28-SEP-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The reporter reported that do not get the vaccine. The reporter reported that the patient received Shingles vaccine and now patient have had Shingles for 2 months. Additional supportive information: This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Patient's friend reported to pharmacy patient passed out as they walked out the store about 15 minutes after the shot, and someone already called 911.  Pharmacist walked out to check on patient, paramedics were already there checking on her.  Paramedics said patient is ok, and they will release her.    Patient came back to the pharmacy about 10-15min later to tell us she is ok.
10x8 cm Indurated, erythematous skin reaction at site of Moderna shot about 24 hours post injection.
pt recvd vax 11AUG95 & groaned & rolled out of the chair to the rt;hitting head on the floor; p/put in fetal position when hit the floor & rolled over, eyes were open & pt crying;pt monitored 30mins;
I had Covid back in January this year even after getting the Pfizer Vaccine; I had Covid back in January this year even after getting the Pfizer Vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A 66-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Low immune system" (unspecified if ongoing), notes: I have always had a low immune system; "surgery on my spine" (unspecified if ongoing), notes: I had had surgery on my spine. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "I had Covid back in January this year even after getting the Pfizer Vaccine".  Additional information: During inbound call: Patient stated, she had gone back to using the 5mg that she had left over from a year ago since she could not get the 11mg. She had Covid back in January this year even after getting the Pfizer Vaccine. She had had surgery on her spine and she have always had a low immune system. Patient was prescribed Xeljanz XR 11mg.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient developed erythematous papules on his low back (#12) and his face (#3) following the administration of VARICELLA vaccine
pt recv vax following exposure to a sibling w/chickenpox; pt exp severe rash; reporter was not able to provide any addtl info as was notified of the case by another MD:
For the last year, I have been lifting weights for about 15 min a day (COVID has been good for maintaining the routine).  I did not skip any days after getting the vaccine on 2-5-21 until skipping on 2-12-21.  When I did my routine on 2-13-21, my L arm said it was tougher (I expected it to be easier after a day off).  Later that day and for the next day, my L arm became weak and had mild pain when I tried to raise it up or reach out or pronate it (ie with deltoid functions).  If I wanted to brush my hair with my L hand, I had to use my R hand to lift my L hand up to my head.  Similarly, if I wanted to turn on a faucet with my L hand, I had to use my R hand to lift my L hand to the faucet,etc.  My L arm gradually returned to normal over the next 3 days.  I have not lifted weights since 2-13-21.  Bicep function was not affected.  I did not seek medical care (I am a doctor).  Only treated with rest.
I mistakenly diluted 0.2 into covid vaccine instead of 2.2. Then, administered to  patient.
Subsequent to receiving two doses of Lymerix, the pt was referred by his family physician to an orthopedist for a complaint of ulnar sided left wrist pain not precipitated by any traumatic events or episodes. At that time upon a physical exam the orthopedist diagnosed extensor carpi ulnaris tendinitis and prescribed a splint and anti-inflammatory treatment as needed (Vioxx). The pt received the third dose of Lymerix. The most recent information reports the outcome of the event as unknown.
c/o soreness of R arm, mild swelling near injection site, chills, sweats, body aches, nausea, mild erythema at injection site. Seen in clinic 7/9, vac administered R deltoid on 7/7. Rec. Tylenol or motrin, ice pack to arm, phenergan 25 mg po every 6 hrs prn nausea. Pt called back on 7/10, said feeling much better.
rash; swelling in hands; develop hives all over body (flare) on day 3; inflammation; This is a spontaneous report from a contactable consumer (patient herself). A 40-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 27Apr2021 14:00 (Batch/Lot number was not reported) at the age of 40 years, as dose 2, single for COVID-19 immunisation. Medical history included undifferentiated connective tissue disease (UCTD) from an unknown date and unknown if ongoing. There were no concomitant medications. The patient received no other medications within 2 weeks of vaccination. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 06Apr2021 (Batch/Lot number was not reported) as dose 1 for COVID-19 immunization and experienced rash and swelling in hands. The patient was not diagnosed with COVID-19 prior to vaccination. On 30Apr2021, the patient experienced rash and swelling in hands and developed hives all over body (flare) on day 3. The patient have been on steroid for 7 days to decrease inflammation but it was not going away. The events resulted in resulted in doctor or other healthcare professional office/clinic visit. Treatment included steroids (methylprednisolone)/ antihistamine. The outcome of the events was recovering. The patient had not been tested for COVID-19 since the vaccination.  The lot number for the vaccine BNT162B2 , was not provided and will be requested during follow-up.
Pneumonia; difficult time breathing; A spontaneous report was received from a health care professional concerning a 40-year-old male patient who was administered Moderna's COVID-19 vaccine and experienced having a difficult time breathing (dyspnea) and pneumonia.  The patient's medical history included autism and mental retardation.  Concomitant product use was not provided by the reporter.  On 18 Jan 2021, approximately 2 days prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) for prophylaxis of COVID-19 infection.  On 20 Jan 2021 early in the morning, the patient had a difficult time breathing.  Around 17:00 the patient was taken to the emergency room and was given 10 liters of oxygen.  The patient was admitted to the hospital.  On 22 Jan 2021 everything cleared suddenly, so the patient was able to leave the hospital.  The patient was diagnosed with pneumonia.  The reporter indicated the patient did not have a history of lung problems, so she was concerned and wanted more information on what happened. Treatment for the event included 10 liters of oxygen.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the events, having a difficult time breathing and pneumonia, were considered recovered/resolved on 22 Jan 2021.; Reporter's Comments: This case concerns a 40 year old male subject, who experienced a serious unexpected event of pneumonia after first dose of mRNA1273 (Lot# unknown). Very limited information has been provided at this time. Further information has been requested.
I always got flu when I got shot; Initial information regarding an unsolicited valid non-serious case received from a patient on 22-Nov-2020.  This case involves a patient of unknown demographics who had always got flu when he got shot (influenza), while patient received vaccine INFLUENZA VACCINE.  The patient's medical history included flu.  Information about past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medication was not reported.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer, lot number not reported) via an unknown route at an unknown administration site as a prophylactic vaccination.  On an unspecified date, (latency unknown) after the administration of vaccine, the patient reported of suffering from flu (influenza). The patient also reported that after each administration of INFUENZA VACCINE, the patient suffers from flu, hence have not got shot from past 12 years.  No relevant laboratory tests were reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting, outcome of the event was unknown.  There will be no information regarding the batch number of the case.
Pt started having rash around the injection site.  Over the next few days, the rash progressed, became slightly raised, itchy, and red. The symptoms continued up until August 3rd (when the pt visited our office). The measurement of rash was 7X9 cm.
On 04/05/1999 the patient developed a red rash on her arms, legs and stomach which was diagnosed as disseminated varicella virus infection. The patient was sent to a dermatologist on 05/10/1999. The dermatologist diagnosed acute aggravated psoriasis vulgaris treated till 07/15/1999. The patient recovered.
Patient was confused on the appropriate schedule for the COVID Pfizer vaccine. Patient came too early for 2nd dose and self scheduled an appointment 3 days after initial vaccine. (initial vaccination date was 03/29/21. Patient did not experience any adverse side effects during observation period.
pt recv ax & devel diarrhea, vomiting & T101;presented to ER;fluids encouraged;mom instructed to cont oral hydration;20MAR93 vomited 10 times & had diarrhea 3x;pt appeared dehydrated devel oral thrush & diaper rash;dx gastroenteritis
Headache, 102 degree fever, leg cramps, nausea, and fatigue. Fever has gone away, leg cramps are occasional now, and the nausea and fatigue are still occurring.
In March I had my period and then continued bleeding on most days through today's date of Aug. 10, 2021.  Not much bleeding, but enough that I need to wear protection and change it during the day. In May 2021 I noticed a large lump on my right breast.  It was a complicated Cyst.  I had a diagnostic ultrasound and mammogram done.  I also have 2 swollen lymph nodes noticed in my left breast.   In July 2021, I began to feel very fatigued.  Fatigue appears to be better now. on most days.
chills started about 4:00 pm  ABOUT HOUR LATER  EXTREME BODY ACHES MUCH MORE THAN NORMAL, TIRED AND SLEPT A LOT.  ARM WAS SORE FROM THE TIME OF THE SHOT AND KEPT GETTING WORST AS TIME, DAYS WENT ON  MY ARM WAS BRUISED WHERE THE SHOT WAS GIVEN AND JUST BELOW THAT IT WAS  SWOLLEN - RED - SORE. THE REDNESS WAS ABOUT THE SIZE OF A SMALL SAUCER, EXTENDING ALMOST TO MY ELBOW AREA. COULD NOT LAY ON MY RIGHT SIDE WHEN SLEEPING AND IF I DID IN MY SLEEP IT WOULD AWAKE ME RIGHT AWAY  ON SATURDAY MY ARM ITCHED IN THE RED AREA UP TILL ABOUT MONDAY -   MY ARM HURT EVERY TIME I MOVED IT OR USED IT - BUT EACH DAY IT WAS LESS   TODAY 2-9-21 MY ARM IS  NOT SWOLLEN OR RED ANYMORE BUT SLIGHTLY SORE TO THE TOUCH
This spontaneous case, initially received on 16-Dec-2016, was reported by a health professional and concerns a female patient. Weight: not provided; Height: not provided. Concomitant medication: not reported. Administration of company suspect drug(s): The patient received AFLURIA from 31-OCT-2016 to 31-OCT-2016. Dose regimen: 0.5 ml, Route of administration: Intramuscular, Batch number: WT56407, Site: Left arm. No additional suspect drugs. Adverse reactions/events and outcomes: On an unknown date, the patient developed arm pain a number of weeks after the event, the patient had symptoms right away and it continued to get worse. The patient experienced left arm pain and shoulder pain that has persisted since administration of the vaccine. Outcome for all events: unknown.
5 hours after vaccination (May 20 9am), starting having fever/headache symptoms, which increased in severity over the course of the first day. On the night of May 20, I started feeling chest pains, difficulty breathing, and an elevated heart rate (around 100 bpm) in bed. These symptoms remained and I went to the emergency room around midnight. I did a chest xray and electrocardiogram and waited to see a doctor over the next few hours; ultimately the symptoms decreased in severity on their own.
The vial was initially stored in the refrigerator on 10-jun-2022 and the doses were administered on 12-jul-2022; Dose administered after 30-day Use By Date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 10-jun-2022 and the doses were administered on 12-jul-2022) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001M21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 12-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 10-jun-2022 and the doses were administered on 12-jul-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 10-jun-2022 and the doses were administered on 12-jul-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.     No concomitant medications was provided by the reporter.  Dose administered past the 30 day storage on the refrigerator Number of doses or vials administered 15 doses. Date the vial was initially stored in the refrigerator 10-Jun-2022. The vial had not undergone any temperature excursion.  No adverse reaction was reported.  No treatment medications were reported.
pt found blue 2hr p/last feeding;brought to ER pt cold, blue w/rigor present;pt intubated given med but remained asystolic;
L facial paresthesia - started with itching on L chin the day after receiving the vaccine - then paresthesia began 3 days after receipt of vaccine. Paresthesia spread from chin to L face and involved tongue.
pt presented to ER on 26MAY w/finger laceration;pt recv tetanus shot upper arm;1JUN98 returned w/large red, hot painful cellulitis @ area of tetanus shot;pt states redness started 2 days ago;
Mild cold symptoms, runny nose, some nausea. Presented to ED with blackened toe, pt has Diabetes. Tested positive for covid on 5/4/22
fever; Chills; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PYREXIA (fever) and CHILLS (Chills) in a male patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine in March 2021. Past adverse reactions to the above products included No adverse event with Moderna COVID-19 Vaccine.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever) and CHILLS (Chills). At the time of the report, PYREXIA (fever) and CHILLS (Chills) outcome was unknown.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.   For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   The concomitant medication was not reported by reporter. On 28-OCT-2023 patient had hip replacement surgery.  The treatment medication was not reported by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-749212, US-MODERNATX, INC.-MOD-2023-749212 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-749212:Husband case
Redness upper left arm, swelling up in shoulder and neck, temp 103.4.
When I left the vaccine site, I felt normal with a sore arm. Throughout the day, the pain in my arm began to increase. In the night when I was sleeping, I woke up around 2am in extreme amount of body pain and aches, a huge headache, a high fever or 101.9 and my whole body was chilled even though I had a fever and was burning hot.
This case was reported by a pharmacist via call center representative and described the occurrence of erythema of extremities in a 70-year-old female patient who received SHINGRIX (batch number 9NJ59, expiry date unknown) for prophylaxis. On 16th July 2018, the patient received the 1st dose of SHINGRIX. On 16th July 2018, less than a day after receiving SHINGRIX, the patient experienced erythema of extremities, pain in arm and upset stomach. On an unknown date, the outcome of the erythema of extremities, pain in arm and upset stomach were unknown. It was unknown if the reporter considered the erythema of extremities, pain in arm and upset stomach to be related to SHINGRIX. Additional details were provided as follows: The patient received the dose of SHINGRIX in the left arm and experienced pain, redness with red streaks down the arm and upset stomach that all began on the day of vaccination. The reporting pharmacist was unsure of the duration of the patient's symptoms. The reporting pharmacist consented to be followed up. The expiration date of the SHINGRIX was not available.
Child had received FLUZONE last year so one dose of vaccine was required for this year.  Received .5cc dose instead of correct dose of .25cc.  No adverse reaction reported.
pt recvd vax & devel headache & vomiting w/ diff to arouse according to mom; pt was sleepy, pale; pt rechecked at clinic, PE was nl;
The injection site is hard, red, & inflamed. Patient experienced itching. She tired to treat with a hot compress. I suggested BENADRYL.
Patient started coughing approximately 10 minutes after vaccination, stating that her throat felt like she had something in it.  She then started retching, with minimal vomiting.  At approximatedly 4pm, epinephrine 0.3mg was administered by intramuscular route via auto-injector.  Emergency medical services were contacted, and patient was transported to local hospital, where she was admitted overnight.  She states she received intravenous dexamethasone while in the hospital.  She was released 10/23/21 and reports improvement in her breathing but reports diffuse itching throughout her body.  Patient was prescribed a 12 day course of 5mg prednisone taper.
Headache, chills, weakness, severe dizziness, watery mouth and heavy perspiration.
Starting at 3am I started feeling symptoms of Fatigue, headache, muscle and joint pain, chills, fever of 100.7
Patient had a really severe reaction to VARIVAX that went on for several weeks; He was screaming in pain, and said the pain was all over his body; The vaccine changed his personality; This spontaneous report was received from the mother of a 23 year old male patient. The patient had none pertinent medical history, concomitant medications, drug reactions or allergies.  On an unspecified date in August 1999, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) subcutaneously (dose, lot #, expiration date and anatomical location were not provided) to prevent chickenpox. The patient's mother said that her son had a really severe reaction to varicella virus vaccine live (oka/merck)(VARIVAX) (vaccination complication) that went on for several weeks, described as that patient was screaming in pain which was all over his body. On an unspecified date in 1999, the patient's personality changed. His mother reported that before the vaccine he was more expressive and emotional, but since vaccination he was definitely more reserved and loner. Patient sought for medical attention and the physician advised against a second shot of the vaccine. Physician discovered that the reaction ocurred "in less than 0.5% of the population". Patient's mother did not remember if any specific treatment was received for the events. On an unspecified date in 1999 (reported as a few weeks after vaccination), the patient recovered from the pain. The outcome of the severe reaction to the vaccine was unknown. At the reporting time, the patient had not recovered from personality change.   The reporter considered vaccination complication to be related to varicella virus vaccine live (oka/merck)(VARIVAX). The causality between the events of pain and personality change was not reported.
Had 3 incidents of local redness, tenderness, swelling pt's receiving Td vax; Occurred w/in 1 wk; 1 individual returned to clinic w/fever 101.1, dizziness & swelling @ inject site;
injection site began to itch.  The next day, 10/15/2009, developed a 4cm x 4cm warm area of redness and induration.
The patient "broke out in hives the day after he was administered PNEUMOVAX 23"; This spontaneous report was received from a physician, via company representative, regarding a male patient of unknown age. Information about his pertinent medical history, drug reactions or allergies, and concomitant medications were unknown by the reporter.   On an unspecified date, the patient was vaccinated with 1 dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), injection for prophylaxis (strength was not provided; route, lot number and expiration date were unknown by the reporter).   On an unspecified date (reported as the day after he was administered pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23)), the patient broke out in hives. The patient did not seek medical attention nor diagnostic laboratories, or studies were performed. It was unknown by the reporter if he received treatment for the event. It was reported that the event of hives was no a cancer or an overdose event. On an unspecified date (reported as within 24 hours), the patient recovered from hives.  The reporter did not provide causality assessment between the aforementioned event and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23).
Patient became dyspneic 30 minutes post immunization. He was seen in the ER where questionable wheezing was noted. He was given prednisone and albuterol with rapid relief.
Three (3) HPV, lot # (J013324) had been exposed to the out of range temperature and need to be returned. These three vaccines were mistakenly and in administered to three (3) patients. Whoever the staff person was who administered 3 doses of the HPV that should not have been used, clicked on the new lot number (J012212) instead of the old lot # (J013324). We have been unable to identify the three patients who received the vaccines exposed to the out of range temp. I have been indentify the 12 patients who administered HPV vaccine between the dates of 2/12 - 12/18/14 under lot number (J012212).