chrisvoncsefalvay/vaers-outcomes huggingface dataset:
4 month old received the Kinrix; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 4-month-old male patient who received DTPa-IPV (Kinrix) (batch number 24T2N, expiry date 7th May 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration 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: 25-Jul-2022 Reporter's comment: The health care professional reported that a 4 month old patient received the Kinrix. The patient was due for their 2nd dose of Dtap and IPV.  The Vaccine Administration Facility was the same as Primary Reporter. No reactions were reported. The reporter consented to follow up via email.  Additional supportive information: The patient received a dose of Kinrix at inappropriate age, which led to inappropriate age at vaccine administration.
pinpoint urticaria & facial swelling;urticaria involved upper torso, upper extremities, face;tx atarax;
Information has been received from a physician concerning a 6 month old patient (weight 20 pounds 10 ounces) with no illness at time of vaccination or pre-existing allergies, birth defects, medical conditions who on 04-DEC-2008 was vaccinated with the first dose of ROTATEQ (lot # 662876/1169X) oral administration. Concomitant therapy included DAPTACEL (Lot # C3082AA) and ACTHIB (lot # UF579AA). On 06-DEC-2008 the patient experienced severe diarrhea, 5 times a day. Subsequently, 24 hours after the patient recovered. On 04-FEB-2009 the patient received her second dose of ROTATEQ (lot # 662953/1169X), and her second dose of DAPTACEL and ACTHIB. On 06-FEB-2009 the patient experienced severe diarrhea, 5 times a day. Subsequently, 24 hours after the patient recovered. Additional information is not expected.
can´t move arm; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of mobility decreased in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 09-MAR-2023, the patient received Shingles vaccine. In MAR-2023, an unknown time after receiving Shingles vaccine, the patient experienced mobility decreased (Verbatim: can´t move arm). The outcome of the mobility decreased was not reported.   It was unknown if the reporter considered the mobility decreased to be related to Shingles vaccine.   It was unknown if the company considered the mobility decreased to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 12-MAR-2023 This case was reported by a patient via  interactive digital media. The patient just received his/her shingles shot on Thursday.  The patient could not move his/her arm. The follow up would not possible as no contact details were available.
Fever-over 100 degrees/chills/severe headache and face pain/extreme fatigue/slept from 1:30 p.m. Thurs. until 6:30 p.m. Friday/went to bathroom in between and drank water only/took one pill Friday a.m. and vomited.
rash; pruritis; This is a spontaneous report from a contactable consumer (patient). A adult female (Age not reported) patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced rash, pruritis. Therapeutic measures were taken as a result of rash, pruritis with steroids and continued Benadryl. After completing 5-day course of steroids her rash and pruritis recurred. Completed an additional 6 days of steroids. Patient was a part of clinical trial. 3 days later developed rash and pruritis after the first dose. This reaction was already reported to the study investigator according to the patient. The outcomes of events were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 57-year-old female patient who received SHINGRIX (batch number 95LX9, expiry date 22nd February 2021) for prophylaxis. On 7th August 2018, the patient received SHINGRIX. On 7th August 2018, less than a day after receiving SHINGRIX, the patient experienced injection site erythema, headache, fever and injection site warmth. SHINGRIX was continued with no change. On an unknown date, the outcome of the injection site erythema, headache, fever and injection site warmth were recovering/resolving. It was unknown if the reporter considered the injection site erythema, headache, fever and injection site warmth to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on right deltoid. The patient experienced redness at the injection site, described as an 8 X 7 cm circle at the injection site. The patient noted the site was hot to the touch. The patient also experienced headache and fever. At the time of reporting, the symptoms were improving.
Per patient and his wife: Exhaustion to the point of falling asleep mid-sentence. Could not keep eyes open. Once seated, did not have the strength to stand again. Wet the bed because he could not get up to use the restroom due to muscle fatigue. Total loss of appetite for 4 days. After 4 days, extreme muscle pain in legs and back. Confusion and memory loss.
About 24 hours after the vaccine i started to develop aggressive  hives all over my body. They started at my vaccine site and grew quickly. Everyday they were more and more aggressive. 3 days later i called 911 because i was starting to go into anaphylaxis.  I was given 50mg of benadryl in the ambulance, a shot of epinephrin at the ER followed by a liter of allergy meds and sent home. My hives would come and go for another week or so but did not get worse or unmanageable.
Moderna COVID-19 Vaccine EUA Chills, joint pain, muscle pain, fatigue, headache, nausea Pain so bad at night, I could not sleep until around 4 am after taking ibuprofen. Woke back up to pain (chills, joint and muscle pain, headache) at 6am. Uncomfortable throughout today (1/14/21).  Not so bad as to go to hospital, but wanted to share side effects give them the limited data on this new vaccine.
she felt very ill; vomiting; severe headache; severe joint muscle ache; fatigue; severe joint muscle ache; This is a spontaneous report from a contactable consumer (patient).   A female patient of an unspecified age received BNT162B2(PFIZER-BIONTECH COVID-19 MRNA VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on 02Mar2021 16:00 as dose 1, single for covid-19 immunization.  The patient medical history and concomitant medications were not reported. The day after vaccination patient  felt very ill, vomiting, severe headache, severe joint muscle ache, fatigue and went to the emergency room. Patient reported it took her 2 weeks to get rid of these symptoms. She said that she cancelled her schedule of second dose and wanted to know if she is still protected with only getting the first dose. Patient wanted to know whether it was safe for her to get the second dose of the vaccine as she recovered with the side effects 2 weeks after getting the first dose. The outcome of the events was recovered on an unspecified date.   No follow-up attempts are possible. No further information is expected.
Patient called pharmacy complaining of tight throat, hives, and itching. All occurred about 36 hours after vaccination. Advised patient to take 50mg of Benadryl 4 hours apart then 25mg every 4 to 6 hours. Patient described a close form of anaphylaxis. Advised patient to proceed to ER if difficulty breathing or symptoms progress. Also advised patient to follow up with PCP if symptoms continue for another 24-48 hours.
pt recvd vax; adm to hosp for lethargy & fever; outcome: resolved;
Lower back hurt giving a concern 4th and 5th vertebrae; Neck hurts; Right knee hurting; Lower back hurting; Flu like; Arm sore; This spontaneous case was reported by a consumer and describes the occurrence of INTERVERTEBRAL DISC DISORDER (Lower back hurt giving a concern 4th and 5th vertebrae), VACCINATION SITE PAIN (Arm sore), NECK PAIN (Neck hurts), ARTHRALGIA (Right knee hurting) and INFLUENZA LIKE ILLNESS (Flu like) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced VACCINATION SITE PAIN (Arm sore) and INFLUENZA LIKE ILLNESS (Flu like). On an unknown date, the patient experienced INTERVERTEBRAL DISC DISORDER (Lower back hurt giving a concern 4th and 5th vertebrae), NECK PAIN (Neck hurts), ARTHRALGIA (Right knee hurting) and BACK PAIN (Lower back hurting). The patient was treated with MENTHOL (FLEXALL) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, INTERVERTEBRAL DISC DISORDER (Lower back hurt giving a concern 4th and 5th vertebrae), VACCINATION SITE PAIN (Arm sore), NECK PAIN (Neck hurts), ARTHRALGIA (Right knee hurting), INFLUENZA LIKE ILLNESS (Flu like) and BACK PAIN (Lower back hurting) had not resolved.            No concomitant medication provided.  On an unknown date patient experienced lower back hurting, with concerns to 4th and 5th vertebrae. Neck and right knee hurt as well. In 2021, patient experienced arm sore, felt congestion and flu like symptoms after the booster shot.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in
This case was reported by a nurse via sales rep and described the occurrence of vomiting in a 17-year-old female patient who received MENVEO. Concomitant products included TRUMENBA. On an unknown date, the patient received MENVEO at an unknown dose. On an unknown date, unknown after receiving MENVEO, the patient experienced vomiting, fever and muscle weakness. On an unknown date, the outcome of the vomiting, fever and muscle weakness were unknown. It was unknown if the reporter considered the vomiting, fever and muscle weakness to be related to MENVEO. Additional details were provided as follows: The age at vaccination was not reported. The patient went to the emergency room, but it was unknown if the patient was hospitalized.
My arm was numb and tingly at first, at times painful, and then it turned into burning. It goes from my chest/shoulders/back all the way down to my fingers on my left arm.
achy, chills, red, swollen, itchy, injection site very sore-sx started the day after injection and each day got a bit worse
I was diagnosed with Belles Palsy. My left side of my face went numb and I was unable to shut left eye for about 3 mths.My right eye sagged or drooped and felt much heavier than left eye. Almost felt like I had 2 faces.
Facial edema, oropharyngeal edema; Lip swelling; Throat itching; Tachycardia; A spontaneous report was received from a healthcare professional concerning a 28-year-old female, patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed lips swelling, throat itching, facial edema, and oropharyngeal edema.    The patient's medical history was not provided. Concomitant product use was not reported.  On 15 Jan 2021, approximately five minutes prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the arm for prophylaxis of COVID-19 infection.   On 15 Jan 2021, five minutes after the vaccine was administered, at 11:15am, the patient complained of lip swelling and throat itching. A healthcare provider assessed the patient and vital signs included, pressure 132/103 mmHg, heart rate 95 beats per minute, and 100 percent oxygen saturation. At 11:22am, the patient had facial edema, oropharyngeal edema and attempted to clear her throat. Vital signs reported at that time included, blood pressure 143/106 mmHg, heart rate 121 beats per minute, and oxygen saturation 99 percent. Treatment for the event included diphenhydramine 50mg and epinephrine by injection twice. Emergency services were called to transport the patient, however, the patient declined transport.    Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, lip swelling, throat itching, facial edema, and oropharyngeal edema, was unknown.; Reporter's Comments: This case concerns a 28 year-old, female patient, who experienced events of lips swelling, throat itching, facial edema, and oropharyngeal edema. The events occurred within minutes after the first and last dose of mRNA-1273 vaccine administration. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded and the events are assessed as possibly related.
Thrombocytopenia occurring within one day of receipt of Hep B vaccine and HBIG. The discharge summary states, "supraventricular tachycardia."
suspected vaccination failure; shingles; This case was reported by a consumer via other manufacturer and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included disability.   On an unknown date, the patient received Shingrix. On an unknown date, less than 2 years after receiving Shingrix, 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 Shingrix.  Additional details were provided as follows: The patient received the Shingrix, about a year ago from the date of reporting. The age at vaccination not reported. She mentioned that, it did not work it was a total placebo. After receiving Shingrix, the patient had the shingles for about a year and she described it as the worst shingles that she had ever had. The patient had gotten the shingles vaccinations since they became available and they had always worked on her.  She spent on the vaccine and did not cover it, she paid for it and it did not work at all.  She would keep receiving a replacement, another inoculation at no charge since the one she got did not work.  The patient was given PMI phone number, reporter also said she had a vocal disability. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation of shingles were not provided.
This is a spontaneous report from a contactable physician regarding her daughter, received via a sales representative. A female patient of an unspecified age and ethnicity received the 1st dose of TRUMENBA, via an unspecified route of administration on an unspecified date in 2016 (about one year before reporting) at single dose for immunisation. The patient medical and concomitant medications were not reported. The patient experienced headache, malaise (she was down for 4 days), and injection site on an unspecified date with outcome of unknown. Also was reported that at the time of the report the patient did not yet received the 2nd dose.
Redness at injection site after first vaccine; Pain at injection site with first vaccine/ Soreness to arm after first vaccine; This is a spontaneous report from a contactable consumer (patient). This 32-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 09Mar2021 Arm Right single dose (Lot EN6206) for covid-19 immunisation. Medical history included ongoing Eczema for her whole life. Concomitant therapy was none. She states that with her first vaccine on 09Mar2021 she had Redness at injection site after first vaccine, pain and soreness at the injection site/ Soreness to arm after first vaccine that lasted for about 24-48 hours then it was gone. She denies any medical conditions, medications, labs, testing, or treatment relevant to these events.  Outcome of the events was recovered in Mar2021.  No follow-up attempts are needed. No further information is expected.
pt recvd vax;2 days later,devel a large,round,red,hot,hard,sl swollen wheal (5cm) at inject site; tx w/ warm compresses;
Received MMR shot 08/05/2006, noted skin reaction 08/06/2006, blistering, peeling skin left 5 digits, right 3 digits, diagnosis: dermatitis.
Information has been received from a licensed vocational nurse (LVN) referring to an unspecified number of patients of unknown age and gender. On unknown dates the patients were vaccinated with doses of improperly stored ROTATEQ (lot # K020181, exp. date: 24-JUN-2016; K024700, exp. 30-JUL-2016; L013192, exp. 19-JAN-2017; strength,, dosage and frequency unspecified) orally. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
the 91yo frail homebound individual received the Moderna bivalent Covid booster (left arm) and High Dose flu vaccine (right arm) at the same time. Approximately 20hrs after the injections she reported not being able to use both arms and both legs. She was monitored by her concerned family members at home during this time. After two days' time, she reports that she was able to again use her arms and legs. She reports recovering completely.
Psoriasis Reaction; hives; rash/ Rash that is bright red and bump from elbow to wrist, and lower back; itch; red blotches; tired; felt foggy; agitated; This spontaneous case was reported by a health care professional and describes the occurrence of FEELING ABNORMAL (felt foggy), AGITATION (agitated), DERMATITIS PSORIASIFORM (Psoriasis Reaction), RASH MACULAR (red blotches) and FATIGUE (tired) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038K20A and 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included BPH. Concurrent medical conditions included Hypertension. Concomitant products included AMLODIPINE for Blood pressure, TADALAFIL, BETAMETHASONE from 05-Mar-2021 to an unknown date, METHYLPREDNISOLONE SODIUM SUCCINATE (SOLUMEDROL) from 16-Apr-2021 to 22-Apr-2021 and TRIAMCINOLONE from 27-Apr-2021 to an unknown date for an unknown indication, CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) from 03-Mar-2021 to an unknown date and BETAMETHASONE.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced FEELING ABNORMAL (felt foggy), AGITATION (agitated), RASH MACULAR (red blotches) and FATIGUE (tired). On an unknown date, the patient experienced DERMATITIS PSORIASIFORM (Psoriasis Reaction), VACCINATION SITE URTICARIA (hives), VACCINATION SITE RASH (rash/ Rash that is bright red and bump from elbow to wrist, and lower back) and VACCINATION SITE PRURITUS (itch). On 03-Mar-2021, FEELING ABNORMAL (felt foggy), AGITATION (agitated), RASH MACULAR (red blotches) and FATIGUE (tired) had resolved. At the time of the report, DERMATITIS PSORIASIFORM (Psoriasis Reaction), VACCINATION SITE URTICARIA (hives), VACCINATION SITE RASH (rash/ Rash that is bright red and bump from elbow to wrist, and lower back) and VACCINATION SITE PRURITUS (itch) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment drug not reported.   This case was linked to MOD-2021-033582 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Lower level term updated from Injection site itching to Vaccination site pruritus, Injection site hives to Vaccination site urticaria.
Pt received her varicella vaccine and Tripedia DTaP/HIB combo at 1330 9/17/02 at approx 1600 pt's mother brought pt back with rash from head to toe. No respiratory problems. Tx with Benadryl.
On 4/18/18, developed a large raised bump the size of a lime under the injection site surrounded with erythema and discomfort. Examined by physician on 4/26 and area had decreased to dime size wheel with mild erythema and tenderness to the site. No reaction with previous 2 injections.
In AM of 9/23/10 itchy lesions appeared on chest. Seen at clinic approx 3:30pm. 4-5 lesions of oval shape, slightly raised (1-1.5cm). BENADRYL 25 mg 1 PO.
Rash on left and right arm. Rash on upper chest. Significant itching on arms
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 22-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Feb2021 as dose 1, single (Lot number: EN6200), in left arm, on 12Mar2021 as dose 2, single (Lot number: EN6206), in left arm and on 17Dec2021 as dose 3 (booster), single (Lot number: FL31017) at the age of 21 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Lupus" (unspecified if ongoing), notes: Other medical History: Lupus; "IBS" (unspecified if ongoing), notes: Other medical History: IBS; "Sjögren's Syndrome" (unspecified if ongoing), notes: Other medical History: Sjogren's Syndrome. Concomitant medication(s) included: PLAQUENIL, start date: 31Oct2019; SPIRONOLACTONE, start date: 31Oct2021. Past drug history included: Amoxicillin, reaction(s): "Allergy:Amoxicillin", notes: Known allergies: Amoxicillin. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive; (Jun2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.
presents with c/o abdominal pain, nausea and vomiting, generalized weakness, and fatigue; pt hyperkalemic and small SBO; + covid; did not require any supplemental oxygen and chest x-ray did not show any infiltrates. He was continued on supportive care; creatinine and other electrolytes normalized and d/c with HH