chrisvoncsefalvay/vaers-outcomes huggingface dataset:
received Menveo / mixed with saline diluent and not the liquid conjugate component.; received Menveo / mixed with saline diluent and not the liquid conjugate component.; This case was reported by a nurse via sales rep and described the occurrence of inappropriate dose of vaccine administered in a 12-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA439A, expiry date 28th February 2022) for prophylaxis.   On 10th March 2021, the patient received Menveo. On 10th March 2021, unknown after receiving Menveo, the patient experienced inappropriate dose of vaccine administered and inappropriate preparation of medication. On an unknown date, the outcome of the inappropriate dose of vaccine administered and inappropriate preparation of medication were unknown.  Additional information was provided as follows: The patient received Menveo on 10th March 2021 which had been mixed incorrectly; it was mixed with saline diluent and not the liquid conjugate component, which led to inappropriate dose of vaccine administered and inappropriate preparation of medication. The mistake was discovered and patient returned for a complete/correct dose of Menveo on 24th March 2021. The reporter did not consent to follow up.
Ten days after receiving shot, I noticed my arm felt warmer in the area of the shot than the rest of my arm.  The next morning I noticed a red triangle shape in the same area.  No pain, but do feel a lump in the area.
Information has been received from a 73 year old female patient with sulfa allergy who in July 2008, was vaccinated with a dose of ZOSTAVAX (Merck). Concomitant therapy included FUROSE and lisinopril (unspecified). On 25-APR-2009 the patient developed shingles. At the time of reporting the patient was recovering. No further information is available.
Information has been received from a registered pharmacist concerning a female who on an unspecified date was vaccinated with 0.65 ml ZOSTAVAX (Merck) (lot# not reported). Subsequently the patient came to the pharmacy with an injection site reaction that resembled a mosquito bite and it was red and swollen. The pharmacist reported that the patient was instructed to take BENADRYL or BENADRYL cream to put on the injection site. The patient sought unspecified medical attention. There was no laboratory test performed. At the time of the report, the outcome of the event was unknown. Additional information has been requested.
Sunday, I woke with chills and sore throat symptoms. I went to the doctor and took two test that came back negative.  I then developed a sinus infection and decided to take another COVID test and it came back positive.
CC: burning in mouth( at 4:05pm) Treatment: no medication was given. patient was under observation.  Water improved symptoms Outcome: symptoms resolved and patient was sent to POV/Home.
1120 AM MMR vax recvd; 1130AM sleepy, when asked to ambulate felt dizzy; 1135AM orange juice PO; 1140AM hives lt anticubital area & rt acromion; 1142AM DPH given;
This spontaneous report as received from a nurse practitioner via company representative refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with ZOSTAVAX (dose, route and lot number were not reported). Concomitant medications were not reported. On an unknown date the patient experienced shingles "2 weeks after" having received ZOSTAVAX. The outcome of shingles was not reported. The relationship between ZOSTAVAX and the events was not reported. Additional information is not expected.
shingles - like rash / Rash is painful; shingles - like rash; This case was reported by a other health professional via interactive and described the occurrence of painful rash in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced painful rash and vesicular rash. The patient was treated with valaciclovir hydrochloride (Valacyclovir). On an unknown date, the outcome of the painful rash and vesicular rash were unknown.   It was unknown if the reporter considered the painful rash and vesicular rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingrix and had shingles like rash. The rash was painful and patient received valacyclovir 1 g BID was helpful.  The reporter asked was it possible to get shingles from the vaccine.
Pt apparently attributes recent URI (Cough, laryngitis) to flu vax; also w/post nasal drainage; yellow geen sputum & sinus pressure; MD did not feel vax & illness necessarily related;
pt recvd vax 8NOV93; later in evening devel genl urticaria; seen by MD; treated w/DPh; pt recovered;
Pt experienced fainting sensation shortly after receiving vaccine. Pt was sweating and reported temporary loss of vision after getting up after the vaccine.  Pt informed pharmacist of 2 previous incidents of vasovagal syncope and was instructed to receive the vaccine while sitting on a cot. Pt was instructed to lie down flat on the cot for 30 minutes to be observed by pharmacists. Blood pressure and pulse monitored (normal range 126/66mmHg and 76BPM). Pt fully recovered after 5 minutes. Pt was instructed to seek emergency help if any new symptoms develop or worsen.
Hives, swollen face, rash, itching, racing heart--Benadryl and steroids.
Case developed nausea, hot/cold flashes, lightheaded.  Case vomited and felt better.
Pt developed fever of 104 and was in a hyporesponsive state. She was very lethargic and could not lift her head up.
Pt. states that after receiving the 2nd dose of Moderna 06/21/2021, started experiencing flu-like symptoms 06/22/2021 continuing for a week. Little bumps appear around the elbows, swollen in the area (elbow) hive-like symptoms continuing 3 weeks. Red spots appearing around the toes (nail area).  Worse when downtime (bedtime).
Blood clot in right calf.   Took about 5 weeks to go away.   I did not go to doctor first time.    Second time in calf in left leg November 1st.   Doctor put me on warrfrin.   They did a sonagram on leg and showed a clot.   Took about 5 weeks to go away.  Still on warrfrin
Chest pain, fluttering and heart has been racing. Doctor referred me to cardiologist (this was 2 weeks ago). They heard about this and having all the symptoms.
Significant cellulitis on his left shin and foot; Anorexia/lack of appetite; Abdominal pain; Diarrhea; Fever; Chills; Fatigue/frequently had to lay in bed; A spontaneous report was received from a physician concerning a 50-year-old, White, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced fever, chills, abdominal pain, anorexia/lack of appetite, diarrhea, fatigue/frequently had to lay in bed, and cellulitis on his left shin and foot.  The patient's medical history was not provided. No concomitant medications were reported.  On 31 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On an unspecified date, the patient experienced fever, chills, abdominal pain, anorexia/lack of appetite, diarrhea, fatigue/frequently had to lay in bed, and cellulitis on his left shin and foot. The patient took paracetamol and naproxen for the events, which somewhat helped.  Action taken with mRNA-1273 in response to the events was not provided.  The events, fever, chills, abdominal pain, anorexia/lack of appetite, diarrhea, fatigue/frequently had to lay in bed, were considered resolved on an unknown date. The outcome for the event, cellulitis on his left shin and foot, was reported as not resolved.; Reporter's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested. Cellulitis of shin and foot is unlikely related to mRNA-1273.
Information has been received from a nurse concerning a 3 year old patient who on 19-JAN-2009 was vaccinated with a dose of ZOSTAVAX instead of a dose of VARIVAX by a human error. No adverse effect reported. Follow-up information was received from the RN. It was reported that "the person giving the vaccine to the patient was new to immunizations and they grabbed the wrong vaccine". The physician has talked to the patient's mother and the patient is doing fine. Additional information has been requested.
Diarrhea 10 days post first vaccine. Have had Irritable Bowel Syndrome since 2/24/2021
Hypertensive, tachycardic into the 130's and RRT ECG revealed PVCs approximately 40 minutes following first dose of Pfizer-BioNTech COVID-19 vaccine 0.3 mL IM in right deltoid.  On duty paramedic examined patient. Pt. has no significant past medical history, not currently taking any meds, and has allergies to albuterol which give her hives. Paramedic performed ECG. Called RRT and transported to ED. Placed on 2 L oxygen via nasal cannula while being monitored. Oxygen saturation up to 99% on room air after monitoring. Symptoms resolved and patient discharged in care of spouse.
leg pain; Back pain; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (leg pain) and BACK PAIN (Back pain) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 27-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, the patient experienced PAIN IN EXTREMITY (leg pain) and BACK PAIN (Back pain). The patient was treated with TIZANIDINE at a dose of UNK dosage form. At the time of the report, PAIN IN EXTREMITY (leg pain) and BACK PAIN (Back pain) outcome was unknown. Not Provided          Action taken with mRNA-1273 in response to the event was not applicable. Many concomitant drugs were used which was not reported. Treatment for the event included prednisone which was substituted by Tizanidine.
Patient was given an expired COVID VACCINE BOOSTER. Date of expiration 10/9/21.
Arm sore, swollen and red at injection site. Advised Advil, ice pack
Pain at injection site, erythema, swelling from injection site dow to elbow, very warm to the touch.
The pharmacy technician stated that they were able to inject the vaccine but when the syringe was pulled out, the patient bled profusely from the site of the injection.; This spontaneous case was reported by a pharmacist and describes the occurrence of INJECTION SITE HAEMORRHAGE (The pharmacy technician stated that they were able to inject the vaccine but when the syringe was pulled out, the patient bled profusely from the site of the injection.) in a 68-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. AU3835E) for COVID-19 prophylaxis.     Concurrent medical conditions included Osteoporosis. Concomitant products included INFLUENZA VACCINE for an unknown indication.    On 12-Oct-2023, the patient received fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) .5 milliliter. On 12-Oct-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced INJECTION SITE HAEMORRHAGE (The pharmacy technician stated that they were able to inject the vaccine but when the syringe was pulled out, the patient bled profusely from the site of the injection.). At the time of the report, INJECTION SITE HAEMORRHAGE (The pharmacy technician stated that they were able to inject the vaccine but when the syringe was pulled out, the patient bled profusely from the site of the injection.) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use), the reporter did not provide any causality assessments.   Treatment medications were not reported.
69 y.o. 11/21/1952   Admit Date:  8/3/2022   Discharge Date: 8/6/22   Principal Dx/ Final Dx: Acute respiratory failure with hypoxia   Relevant Inpt Dx: Principal Problem:   Acute respiratory failure with hypoxia Active Problems:   Tobacco abuse   COPD (chronic obstructive pulmonary disease)       HPI:   Hospital Course:   This 69 year old woman with copd was admitted with copd exacerbation and covid.  She was treated with steroids and nebs and remdesivir and is improved.  Today her lungs show improved air movement and her pulse ox on room air at rest was 97%.  She will go home later today.  She will complete steroids.  She will be assessed for home oxygen.  Follow up with pcp.          Consults:   IP CONSULT TO SOCIAL WORK       Disposition:  home   Discharge Condition:  fair
There were on adverse events. However, he was administered with the BOOSTER shot and he did not have the PRIMARY SERIES yet. The pharmacy had administered him with wrong vaccine shot.
Information has been received from an office manager through a manufacturer pregnancy registry concerning a 22-year old female who on 13-Jan-2003 was vaccinated with a dose of varicella virus vaccine live. The reported indicated that the patient may have been pregnant at the time of vaccination. No medical attention was sought. Additional information has been requested.
no additional AE; expired dose of GARDASIL 9  was administered to an adolescent patient; This spontaneous report was received from a physician via a company representative and referred to an adolescent patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 21-SEP-2022, the patient was vaccinated with an expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, quantity: 1, to prevent human papilloma virus infection (lot #1659422, expiration date: 04-SEP-2022, strength, dose, and route of administration were not provided) (expired product administered). No additional adverse event was reported (no adverse event).
Developed Bells Paulsy on 14th June 2021, Could not shut left eye at all, Droop in left mouth area. Went to urgent care as thought I was haveing a stroke. They performed ekg & catscan with neg results of stroke. Put me on prednisone & Valacyclovir. Its week three and I can force my eye shut but still can not close normally, still have numbness in left cheek and lip droop.
Ringing in ear, headache, fever (101.6) muscle aches (entire body). All within 6 hrs. of injection. Lasted approximately 24 hrs. An additional 24 hrs. of fatigue, loss of appetite. Only meds taken - IBUPROFEN.
The daughter-in-law stated that the patient has a 3x 5 red, raised area where the vaccine was given.  Stated that she circled the reddened area and will keep an eye on the area for worsening.  The patient sees her PCP tomorrow for another reason but will ask PCP to look at the site.
After the first shot he felt sick with flu symptoms for several days.; After the first shot he felt sick with flu symptoms for several days.; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INFLUENZA (non-serious), ILLNESS (non-serious), outcome "unknown" and all described as "After the first shot he felt sick with flu symptoms for several days.". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
RED SWOLLEN "KNOT" @ INJECTION SITE, SIZE OF QUARTER; FUSSY,
swelling, stiffness, pain in rt arm above aid below the elbow x 1 day;
Pain at injection site; Adverse events; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Adverse events) and VACCINATION SITE PAIN (Pain at injection site) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History was provided by the reporter.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 05-Feb-2021, the patient experienced VACCINATION COMPLICATION (Adverse events). On 06-Feb-2021, the patient experienced VACCINATION SITE PAIN (Pain at injection site).  On 07-Feb-2021, VACCINATION COMPLICATION (Adverse events) and VACCINATION SITE PAIN (Pain at injection site) had resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter. No treatment information was provided.
POPPED/BURST CAPPILLARIES IN CHEEKS; MIGRAINE; INJECTION SITE REDNESS; INJECTION SITE SORENESS; INJECTION SITE SWELLING; HOT TEMPERATURE; PETECHIAE ON HER CHEEKS AND ARMS; CHILLS; URINE OUTPUT DECREASED; VOMITING, LOSS OF APPETITE/NAUSEA, DEHYDRATION, LOWER ABDOMINAL PAIN, SWELLING IN ABDOMEN; ORAL INTAKE REDUCED; This spontaneous report received from a patient concerned a 45 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included immunocompromised, nausea, vomiting, migraine, lupus, drug allergy to tegretol, ritalin, adderall , sporanox, latex contact long term and thyroid. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029 and  expiry: UNKNOWN) dose was not reported, administered on 14-MAR-2021 for prophylactic vaccination. Concomitant medications included ondansetron for vomiting, and nausea, and promethazine for vomiting, and nausea. On 28-MAR-2021, the subject experienced vomiting, loss of appetite/nausea, dehydration, lower abdominal pain, swelling in abdomen. On 28-MAR-2021, the subject experienced oral intake reduced. On 28-MAR-2021, the subject experienced urine output decreased. On 28-MAR-2021, the subject experienced petechiae on her cheeks and arms. On 28-MAR-2021, the subject experienced chills. On 28-MAR-2021, the subject experienced hot temperature. On an unspecified date, the subject experienced popped/burst capillaries in cheeks, migraine, injection site redness, injection site soreness, and injection site swelling. Laboratory data (dates unspecified) included: Blood test (NR: not provided) NORMAL. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from oral intake reduced, and hot temperature, and injection site redness, injection site soreness, and injection site swelling on 21-MAR-2021, was recovering from vomiting, loss of appetite/nausea, dehydration, lower abdominal pain, swelling in abdomen, chills, urine output decreased, popped/burst capillaries in cheeks, and petechiae on her cheeks and arms, and the outcome of migraine was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Initially with localized reaction with redness, swelling, tenderness, low grade fever.  She was treated with a course of oral antibiotics for possible cellulitis without improvement.  She continued to have redness around the injection site and discomfort.  She was then treated with a topical steroid without benefit.  She then took a 5 day course of oral steroids after which the redness resolved.  She continues to have thigh pain now 2 months later.
looks like shingles; red rash; itching; red at injection site; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (looks like shingles), RASH ERYTHEMATOUS (red rash), PRURITUS (itching) and VACCINATION SITE ERYTHEMA (red at injection site) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HERPES ZOSTER (looks like shingles), RASH ERYTHEMATOUS (red rash), PRURITUS (itching) and VACCINATION SITE ERYTHEMA (red at injection site). At the time of the report, HERPES ZOSTER (looks like shingles), RASH ERYTHEMATOUS (red rash), PRURITUS (itching) and VACCINATION SITE ERYTHEMA (red at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was unknown by the reporter. Treatment information was not provided.    Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: NNI
pt recv vax 26OCT95 & 25MAR96 pt broke out w/17 lesions which were generalized;pt exp fever during the first to third day, & the exp of lesions lasted 6 days;pt sibling devel chicken pox 2wk prior;pt recovered;
Right anterior thigh with 6 1/2 cm by 6 cm erythematous swelling.  No drainage notes.
bad reaction; Initial information was received on 16-Jul-2021 regarding an unsolicited valid non-serious case from a consumer/non-hcp (healthcare professional).  This case involves a male patient who experienced bad reaction (adverse event) after receiving vaccine INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE QUADRIVALENT MULTIDOSE].  The patient's medical history, past medical treatments, past vaccinations, concomitant medication and family history were not provided.   In 2014, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED (lot UI196AB and expiry date: 30-Jun-2015) via unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious bad reaction (adverse reaction) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED.  It was reported that "reporter would like to know the ingredients in FLULAVAL 2014 MDV? Please see Event Field for additional information. Additional Description of event Adverse events : Caller would like to know the ingredients in FLULAVAL 2014 MDV? Caller would like to know what went into his body. Advised caller to visit website which is a institute of health website."  Laboratory data was not reported.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was unknown for the event.
This spontaneous report was received from a physician and a support services director via company representatives and refers to a patient of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. On 20-JAN-2016, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 0.5 ml (lot# L038522, expiry date 11-AUG-2017; strength and route of administration were not reported). There were no concomitant therapies reported. The dose of the vaccine was exposed to temperature excursion (dates unspecified). The vaccine was stored in a refrigerator in the lowest temperature recorded of 31 degrees (-0.56 degrees Celsius) for 80 hours and 32 degrees Fahrenheit (0 degrees Celsius) for 40 hours (exact dates and sequence were not reported). No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Information has been received from a registered nurse concerning an approximately 16 week old patient who on approximately 11-JAN-2010 ("last week"), was vaccinated with dose of ROTATEQ. Concomitant therapy included globulin, immune. The patient did not experience any known symptoms. It is unknown if the patient sought medical attention. Additional information has been requested.
Severe sweating starting about one hour after receiving the influenza vaccination (Fluvirin -Novartis 5 mL PFS Lot #9712165P) and continuing for several hours.
Severe body aches, Nausea, Headache, Fever up to 102.4. All lasted 24-30 hours