chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient was administrated with an expired dose of Kinirx on September 26 2022. The vaccine expired on August 26 2022; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a patient who received DTPa-IPV (Kinrix) (batch number yz97n, expiry date 26th August 2022) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 6th September 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 6th September 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used 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-SEP-2022 Reporters comment:  The medical assistant reported that the patient was administrated with an expired dose of Kinirx on 26th September 2022. The vaccine expired on 26th August 2022. No adverse event was reported  The reporter consent to follow-up. No patient's identifiers were provided Additional Supportive information: The patient was administrated with an expired dose of Kinirx on 26th September 2022 which was already expired in 26th August 2022.  which led to Expired vaccine used.
severe sinus infection; This spontaneous case was reported by a consumer and describes the occurrence of SINUSITIS (severe sinus infection) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SINUSITIS (severe sinus infection). At the time of the report, SINUSITIS (severe sinus infection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       concomitant medications were  not reported. No treatment information was provided.
"normal pain" at injection site for week after vaccine.  On 1-8-2021, began to notice knot, pain and swelling in left arm.  The morning of 1-13-2021; pain more significant and interfered with sleep and limits range of motion.  Bruise, some swelling and knot the size of half of a fist to left arm at site of injection. No redness or streaks coming from site.  Site appx 2-3 inches below proper site for IM deltoid injection.
This spontaneous report as received from a registered nurse refers to an unspecified number patients of unknown age and gender. Pertinent medical history, drug reactions or allergies were not reported. Since 15-SEP-2014, unspecified number of patients have been administered improperly stored doses of (Merck) VARIVAX (dose, dose number, route, anatomical location, lot number and expiration date were unspecified). No adverse events were reported. No concomitant therapies were reported. This outcome of the events was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
became extremely dizzy; when I came home and passed out.; Hit my head on floor; received a concussion; cut on scalp; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration administered in left arm on 15Mar2021 13:45 (at the age of 77-year-old) (Batch/Lot Number: en6205) as 2ND DOSE, SINGLE for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. The patient had no other vaccine in four weeks. The patient had no COVID prior to vaccination. The patient had no relevant medical history. The patient had no known allergies. Concomitant medications included atorvastatin; furosemide; and calcium. Historical vaccine includes first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: el9265), administered in left arm on 22Feb2021 at 02:30 PM (at the age of 77-year-old) for COVID-19 immunisation. On 15Mar2021, the patient became extremely dizzy when she came home and passed out. She hit her head on floor and received a concussion and cut on scalp. The events caused hospitalization for 2 days. The patient was tested for COVID post vaccination via nasal swab on 22Apr2021 which was negative. Therapeutic measures were taken as a result of all events which includes computed tomography (CAT) scan and electrocardiogram (EKG) with unknown results. The patient recovered from the events on an unspecified date.
Patient reported hives forming about 24 hours after administration of the vaccination. Started on face then spread to rest of his body.
Pt c/o of pain in arm, and fever, given tylenol. Red area the size of quarters to start then progressing to the size of half dollar. At school, redness was 6.5 x 7.7 cm and child was crying with pain. Area is red with welts.
This spontaneous report as received from a physician via company representative refers to a female patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX, vial (lot# and expiration date not provided) (dose not reported). The reporter stated that a patient experienced a red rash while using ZOSTAVAX. The physician did not administer the ZOSTAVAX, but a pharmacist that the physician wished not to name. The patient was not seen by the time of this reporting. The outcome of "red rash while using ZOSTAVAX" was unknown. The relatedness between the event and ZOSTAVAX was not reported. Additional information is not expected, because the reporter did not wish to be contacted.
Redness; Itchiness; This is a spontaneous report received from non-contactable reporter(s).  A female patient received pneumococcal 20-val conjugated vaccine (diphtheria CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown), in arm for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ERYTHEMA (non-serious), outcome "unknown", described as "Redness"; PRURITUS (non-serious), outcome "unknown", described as "Itchiness".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient c/o swelling of face and bilateral hands, HA, dizziness, mild pruritus at injection site, and rash on bilateral arms, legs, and thorax.  All symptoms resolved without sequelae after 3 days.  Patient denied fever.
Fridge door opened for long Max/Low temperature reached: 46.6F Duration of 2 minutes with no reported adverse event; ipol given after the temperature excursion with no reported adverse event; Initial information received on 31-Jul-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to cases 2023SA235015, 2023SA235023, 2023SA235694, 2023SA235058, 2023SA236046 and 2023SA234814.  This case involves a 17 years old male patient to whom Ipol was given after the temperature excursion with no reported adverse event and the fridge door opened for long max/low temperature reached: 46.6f duration of 2 minutes with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Hepatitis B Vaccine for Prophylactic vaccination; HPV vaccine for Prophylactic vaccination; Hepatitis A Vaccine (Hepatitis A) for Prophylactic vaccination; Meningococcal Vaccine B RFHBP/NADA/NHBA OMV (Bexsero) for Immunisation; and meningococcal vaccine A/C/Y/W CONJ (CRM197) (Menveo) for Immunisation.  On 12-Jul-2023, the patient received 0.5 ml (dose 3) of suspect IPV (VERO), Suspension for injection lot W1A191M, expiry date:16-Feb-2025 via subcutaneous route in the left arm for immunization (strength: unknown), was given after the temperature excursion with no reported adverse event (poor quality product administered) (latency same day).  On an unknown date the fridge door opened for long max/low temperature reached: 46.6f duration of 2 minutes with no reported adverse event (product storage error) (unknown latency).  This situation is due to human error.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the events poor quality product administered and product storage error.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
1.5 days after injection fever 100-102, 3rd or 4th day post injection, red rash over neck, arms, back and legs. Given steroid shot and cortico steroids by MD on 4th day after injection. Fever did not go away until 8 days after vaccine. Blisters on tongue, gums and oral cavity.
I had the following side effects within 24 hours from my second dose of Shingrix: HA, Nausea, strong shaking-more than shivering, tiredness, muscle pain and redness, I was unable to hold a glass of water for about 2 hours. After 48 hours, my side effects lessened to nausea only. After 72 hours, I no longer experienced any side effects.
This spontaneous report was received from a medical assistant referring to an unspecified number of patients of unspecified demographics. Information regarding the patients' pertinent medical history, drug reactions or allergies and concomitant therapies was not provided. On unknown dates, the unspecified number of improperly stored doses of GARDASIL 9 lot # M036059 with an expiration date of 03-JUN-2019, or N002720 with an expiration date of 12-MAY-2019 (single dose, route of administration and anatomical location were not reported) were inadvertently administered to the unspecified number of patients. No adverse effects were reported. The vaccines were exposed to temperature of 47 degrees Fahrenheit for 30 minutes before administration to the patients. There was a previous temperature excursion reported, with a temperature of 56 degrees Fahrenheit for 5 hours. The digital data logger was involved. The product quality complaint was not involved. This is one of several reports received from the same reporter. Is not expected, as there was no consent for further contact. Sender's Comments: US-009507513-1706USA009733: US-009507513-1706USA009734.
AFTER 5 MINS PT GOT VERY SWEATY AND THEN NAUSEOUS AND NOT FEELING WELL ALSO DIZZY AND WEAK. THEN PT GOT SUPER COLD AND CHILLS AND PT WAS STILL SWEATING  PARAMEDICS CAME AND CHECKED HER OUT AND AFTER ABOUT 30 MINS PT STARTING FEELING BETTER
Headache, Sedation, Arthralgia, Fever, Diarrhea & Syncope Narrative:
soreness in teeth, jaw and tongue;  left side only; location varied;  lasted 7 days, stopped for 1 day, resumed for 4 days
In October of 2014, depression suiciadal talk, OCD, severe anxiety, unprovoked anger. Lasted daily through March 2015 when I researched and learned to detox through diet and added holistic neurotransmitter supplements.
Starting 02/02/2022, I developed a rash on my left torso. It wasn't until 02/09/2022 that I saw my doctor via a telehealth visit who said it was shingles. There were medicines I could take, but due to it being a week after starting, I decided to let it run its course. It went away within a couple of weeks.
Information has been received from a medical assistant referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medication were not reported. On 24-AUG-2016, the patient was inadvertently vaccinated an expired dose of PROQUAD (dose and route unknown, lot # L005294, expiration date 17-AUG-2016). No adverse effect was reported. Additional informati0on has been requested.
vaccine leaked out; vaccine leaked out on patient's arm; vaccine leaked out on patient's arm; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a 53-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number B32NG, expiry date 13-JUN-2025) for prophylaxis.   On 19-APR-2023, the patient received the 1st dose of Boostrix. On 19-APR-2023, an unknown time after receiving Boostrix, the patient experienced incomplete dose administered (Verbatim: vaccine leaked out), exposure via skin contact (Verbatim: vaccine leaked out on patient's arm) and inadvertent exposure to vaccine (Verbatim: vaccine leaked out on patient's arm). The outcome of the incomplete dose administered, exposure via skin contact and inadvertent exposure to vaccine were unknown.   Additional Information: GSK receipt date: 19-Apr-2023 The pharmacist was wondering if they need to revaccinate the patient. The reporter consented to follow-up. The patient was recently injected with Boostrix but the vaccine leaked out on the patient's arm which led to incomplete dose administered, exposure via skin contact and inadvertent exposure to vaccine.
Vaccination adverse reaction; This spontaneous case was reported by an other health care professional and describes the occurrence of IMMUNISATION REACTION (Vaccination adverse reaction) in a 46-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS5051C) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 15-Jan-2023, the patient experienced IMMUNISATION REACTION (Vaccination adverse reaction). At the time of the report, IMMUNISATION REACTION (Vaccination adverse reaction) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medication was reported.   Reporter did not allow further contact
Commonly called "COVID Arm".  Raised welt approx 4 inches in diameter. Site is hot, flushed, slightly itchy. Very sore (enough to wake me up from sleep).
At midnight It felt like my brain was going to explode  like a had a brick being dropped on my head MUCH different than my typical migraines. I had so much muscle and nerve tension in my jaw and neck radiating down into my spine and body aches everywhere!  Called my family dr and they recommended me going to the ER. At the ER one liter of IV fluid , IV Benadryl, IV toradol, IV raglan , Tylenol , ibuprofen ,
Client is observed in the Observation area at the POD, showing lightheadedness, nausea, vomiting, anxiety, dizziness after getting 1st dose of Pfizer.  VS taken: @ 1406, HR 60, SpO2 99%; @1408, BP93/69, BS 107; @1413 BP 72/46, with no symptom, using adult cuff; @1422 BP 86/59 with pediatric cuff; @1429: BP 62, SpO2 99%, BP 87/56. Client is accompanied by parent, and was sent home with mother at 1447.
Patient complained of dry mouth, lips tingling, being hot/light headed.  Patient mentioned it could be low blood sugar.  She had her mother pick her up and take her to get lunch. We offered her a cold water since she was complaining of dry mouth and being hot after confirming there was no tightness of the throat and no difficulty breathing.
Had Varivax 4/6/2000; dx with chicken pox on 05/20/2005.
pt recvd vax was found dead w/ face against mattress & head against foot board; died of asphyxia;
The patient came back to the pharmacy where she recieved the vaccine and showed us a rash that had developed on the back of her arm at the site of the vaccination.  It was red and swollen a little and about the size of a silver dollar but elongated.  She also complained of a little soreness and itching.  She did not have any treatment for this adverse event.
p/vax pt exp a lack of seroconversion;pt sought unspecified medical treatment;
Patient had redness and swelling along left arm and left side of body 2 days after shot - told by Dr is not infection but AE.
This spontaneous report was received from a healthcare worker refers to a patient of unknown age. On 31-MAY-2007, the patient was vaccinated with first dose of M-M-R II, (lot number, expiry date and route was not reported). On 25-JAN-2008, the patient was vaccinated with second dose of M-M-R II, (lot number, expiry date and route was not reported) less than 12 months after the first dose and no adverse effect was reported. Additional information has been requested.
Varicella given IM vs Subcut in left thigh.  Supervisor, Mom and Medical Director notified.   Mom instructed on increased reaction due to IM vs subcut. Need for Tylenol and cool compress needed and to notify office if reactions outside of original directions given.  Mom verbalized good understanding and will monitor child.  Mom is an RN.
Arrhythmia and tachycardia on 2 occasions that both required hospitalization and cardioversion.
I gave the patient the immunization. She seemed fine after getting the shot. I asked her to go outside the immunization room and wait 15 minutes for observation.  Immediately upon leaving the room, she felt dizzy and made it to the chair to sit down, when she said she briefly blacked out. By that time, her father arrived, and gave her some orange juice to drink. She said she was starting to feel better, but that her stomach felt queasy. After15 minutes, the patient was feeling better and walked out with her father with no other reports of problems.
15 minutes after the vaccine she started getting dizzy. lasted about 5 minutes and resolved on it's on. She was given a bottle of water, O2 sat 98% HR-72 no other issues noted. Instructed to follow up with MD as needed.
No adverse event; Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 09-Jul-2022; Administered the vaccine to 346 patients after the 30 day by used; This spontaneous case was reported by an other health care professional and describes the occurrence of NO ADVERSE EVENT (No adverse event), EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 09-Jul-2022) in a 36-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 09-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 09-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 09-Jul-2022). At the time of the report, NO ADVERSE EVENT (No adverse event), EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 09-Jul-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 09-Jul-2022).    No concomitant medication information was provided.  The reporter administered the vaccine to the patient after the 30 day by used.  Patient received half dose.  The vial was initially stored in refrigerator on 04-Jun-2022.  The vial did not undergo any temperature excursions.  No treatment drug details was reported.
2 days after vaccination, began to have back pain - enough to seek emergency care. CT was neg. Rash consistent with zoster began several days later. Moderate redness and tenderness at inj. site too.
Immediately after the shot... Felt like passing out, red rash developed around her neck and was red all over neck - front and back.  Rash was also on chest and a few places on her stomach. Redness from her left shoulder down arm to elbow.  The next day she felt itchiness under her skin in muscles and joints and this lasted for 7 days.  It gradually got better until it ended after 7 days.
Recombinanat vaccine--Itching, and burning over entire body, hives (on both arms), swollen lips
got sick and two months later she was gone; Initial information received on 13-Jan-2022 regarding an unsolicited valid serious case was received from a consumer via social media.  This case involves a 96 years old female patient who got sick and two months later she was gone while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Respiratory disorder.   On an unknown date the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (strength, form, dosage, lot number not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient got sick and two months later she was gone (sickness) (unknown latency) following the administration of INFLUENZA VACCINE.  "It was reported that the patient got respiratory problems, they talked her into getting it anyways , we both got sick and two months later she was gone."  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (got sick and two months later she was gone).  At time of reporting, the outcome was Unknown for the event "got sick and two months later she was gone ".; Sender's Comments: Sanofi Company Comment dated 19-Jan-2022:  This case involves a 96 years old female patient who got sick and two months later she died. Further information regarding previous vaccination, concomitant medication and tolerance, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of a vaccine cannot be assessed.; Reported Cause(s) of Death: got sick and two months later she was gone