chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Kinrix administered as 1st dose in DTaP series; Kinrix administered as 1st dose in DTaP series; This case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 4-year-old patient who received DTPa-IPV (Kinrix) 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 wrong vaccine administered and inappropriate schedule of vaccine administered. On an unknown date, the outcome of the wrong vaccine administered and inappropriate schedule of vaccine administered were 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: 22-SEP-2022 Reporter's comment: Nurse reported that a 4 year old patient was administered Kinrix as the first dose in the DTaP series. At the time of call, the nurse did not have the patient details, date of administration, lot number and expiration date. The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up. Additional Supportive Information: The 4 year old patient was administered Kinrix as the first dose in the DTaP series, which led to Wrong vaccine administered and Inappropriate schedule of vaccine administered. This was one of the five cases reported by the same reporter.; Sender's Comments:  US-GSK-US2022136456:Same reporter US-GSK-US2022136446:Same reporter US-GSK-US2022136459:Same reporter US-GSK-US2022136453:Same reporter US-GSK-US2022136454:Same reporter US-GSK-US2022136455:Same reporter US-GSK-US2022136461:Same reporter US-GSK-US2022136451:Same reporter US-GSK-US2022136466:Same reporter US-GSK-US2022136465:Same reporter
pt recv vax & exp erythema & induration @ the inj site;pt also devel a facial, cervical, thoracic & lt brachial rash (diffuse);pt sought unspecified med attention;exp reported as allerg rxn;
Patient complained of heaviness in head, pain in back of head. BP 161/64 (pulse 75). Given 2 small bottles of water, and was encouraged to engage in deep breathing.
This spontaneous report was received from a nurse and refers to a 14 years old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On 21-OCT-2017, the patient was vaccinated with improperly stored VAQTA lot # N017094 with expiration date on 31-AUG-2018 for prophylaxis (strength, dose and route were not reported). On an unknown date, the VAQTA was stored in temperature of 48.9 Fahrenheit degrees for 6 minutes. Previous temperature excursions were reported as 48.9 Fahrenheit degrees 24 minutes and 47.4 Fahrenheit degrees for 15 minutes. No adverse effect was provided. Data logger was involved. No product quality complaint was reported. This is the one of several case reports received from the same reporter.; Sender's Comments: US-009507513-1711USA004812:  US-009507513-1710USA013033: US-009507513-1711USA004811:
headache; aching; fatigue; low grade fever; felt like the flu; aching in her joints; This case was reported by a consumer via call center representative and described the occurrence of headache in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2019-2020 season) for an unknown indication.   Previously administered products included Zostavax. Concurrent medical conditions included methylenetetrahydrofolate reductase gene mutation (had methylenetetrahydrofolate reductase mutation, not able to break down folic acid or folate).   In October 2019, the patient received the 1st dose of Shingrix (intramuscular) and Influenza vaccine Quadrivalent 2019-2020 season (intramuscular). In October 2019, 3 hrs after receiving Shingrix and Influenza vaccine Quadrivalent 2019-2020 season, the patient experienced headache, bone pain, fatigue, low grade fever, influenza like illness and joint pain. The patient was treated with ibuprofen (Advil). On an unknown date, the outcome of the headache, bone pain, fatigue, low grade fever, influenza like illness and joint pain were recovered/resolved.   Additional details were provided as follows: The patient received dose of shingrix in an unknown arm and flu vaccine(manufacturer unknown) in an unknown opposite arm at the same time. Approximately 3 to 4 hours after receiving the vaccines, the patient had eadache, aching in her bones and joints, low grade fever, fatigue and felt like had the flu. The patient received high dose of Advil as a treatment medication and stayed in bed. The reporter stated that, the symptoms were lasted for 2 to 3 days. The reporter consented to follow up.  It was unknown if the reporter considered the headache, bone pain, fatigue, low grade fever, influenza like illness and joint pain to be related to Shingrix and Influenza vaccine Quadrivalent 2019-2020 season.
Narrative: pt received first dose of Moderna COVID vaccine on1/14/2021. Symptoms reports starting on 1/23/2021 including rash (currently on left flank and abdoment, but reported to move around on body) and angioedema x 1 day (starting on 1/25), no tongue or throat swelling, no difficulty breathing or shortness of breath. Pt seen in ED on 1/26. Assessed by ED provider and sent to dermatology for same day consult. Diagnosed with acute idiopathic urticaria with angioedema; trigger unknown. Discharged with cetirizine 20 mg BID, PRN diphenydramine for itching, and epi pen for possible allergic reaction/angio edema in future.
A few days after the vaccination, the patient reportedly developed a local reaction at the injection site and then developed Pityriais-Rosea. No further information is anticipated. This case is closed.
4x4 cm induration and redness at site of Hib. Rx: Ibuprofen; Diphenhydramine.
pt recvd vax; devel fever, dizziness & malaise; 1 wk later, exp four papules on arm, trunk & wrist;f/u:md stated event not reported to him therefore could not provide any further details;
Patient complained of feeling nauseated immediately after receiving the vaccine, stated she could taste the vaccine in her mouth over a period of about 10 minutes and stated she did feel nauseated but had no emesis, spit up a small amount of saliva, verbalized she was feeling better; she was observed for 30 minutes following vaccination.
Hives several hours after vaccine, arm and muscle swelling, took BENADRYL oral and cream, better now 11/7/14.
I broke out in hives on my neck.  Shingle blisters and pox marks starting on my left knee spreading to my right knee and then various places on my legs and arms.  Itching and tingly feelings for almost 3 weeks now. I applied Witch Hazel  to the sites which alleviated the itch and I applied baking soda/water to my neck to alleviate the hives.
In the beginning I didn't have any issues, I was fine. I went to bed and woke up at 2am and started vomiting like I never before and had diarrhea , a fever of 101.3.  My fever dropped in three hours  back to normal which was weird.  It was strange.  The  diarrhea lasted for days, it was uncontrollable . The vomiting  lasted for three days, it was non-stop. I had this headache that was unbelievable . Since having Covid I get headaches daily. I had Covid in March 2020. I lost 4lbs in three days and I called my Dr. He said  You need to go the ER right now.  I went to the ER and had to wait three hours, I had aches and pain like the flu, I was totally out of it. They did a Cat scan, and blood work was normal. They gave me IV fluids, IV Tylenol and Tramadol. They did a Covid and flu test, both were negative. Then they gave me a shot of Fetanal , that took away my headache for 30 minutes. At this point I didn't have any more vomiting or diarrhea . I stayed about 8 hours in the ER and went home. I was told by my Dr. not to get the next shot.
Headache; Fever; Scary shivering; This case was reported by a consumer via call center representative and described the occurrence of headache in a 51-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st March 2022, the patient received the 1st dose of Shingrix. In March 2022, less than a week after receiving Shingrix, the patient experienced headache, fever and shivering. On an unknown date, the outcome of the headache, fever and shivering were unknown.   It was unknown if the reporter considered the headache, fever and shivering to be related to Shingrix.  Additional details were reported as follows: The case was self reported by the patient. The patient received first dose of Shingrix vaccine and experienced headache, fever and scary shivering. The patient hoped that his/her fever did not stay too long.  The patient was asking if the second shot could present more severe side effect. The patient was worried about second shot of Shingrix vaccine. The patient did not want to disclose his/her contact information and asked to contact via email.
Shortness of breath, heavy legs, immediate swelling, wheelchair bound paralyzed. Hospitalization totaling 79 days. Treatment consisted of medication and physical therapy. To present it will be two years in Dec.
ANEMIA; LOW PLATELET COUNT; This spontaneous report received from a consumer concerned a 79 year old female of unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: cll (Chronic lymphocytic leukaemia), and other pre-existing medical conditions included: The patient had no known allergies, and no relevant medical history reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, 1 total administered on APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included ibrutinib for cll (Chronic lymphocytic leukaemia).  On an unspecified date, the patient experienced anemia, and low platelet count, and was hospitalized (dates and duration unspecified). Laboratory data (dates unspecified) included: Platelet count (NR: not provided) low. On 02-NOV-2021, Laboratory data included: Bone marrow biopsy (NR: not provided) not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from low platelet count, and the outcome of anemia was not reported. This report was serious (Hospitalization Caused / Prolonged). This case, involving the same patient is linked to 20211123439.; Sender's Comments: V0: 20211130491-COVID-19 VACCINE AD26.COV2.S-low platelet count, anemia. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: CONMEDS-OTHER SUSPECT DRUGS
Shortness of breath for 6 hours after vaccine, severe headache, muscle aches, nausea
Information has been received from a patient's father concerning his son who was an approximately 2 year old male patient. The patient's medical history included ear infection. The patient had no known drug allergies. In approximately 2012 (reported as "when patient was approximately 2 years old") the patient was vaccinated with the first dose (0.5 ml) of M-M-R II (route, lot # and expiration date not reported). There was no concomitant medication reported. Twenty minutes after receiving the vaccine, during the car ride home from the unspecified physician's office, the patient experienced lethargy and his tongue was sticking out the side of his mouth. The father called the unspecified physician's office and was told that could have been a mini seizure. The father was advised to keep his son under observation. The father did not seek any additional medical attention for his son. No treatment was given for the event. No lab diagnostics studies performed. On an unspecified date, the outcome of the event was reported as fully recovered. Upon internal review, the event of a mini seizure was considered to be medically significant. Additional information is not expected because no reporter contact detail provided.
Pt vaccinated with DTP/OPV/Measles developed temp of 103 x 2 days and sore right arm for 3 days.
ACHE.; HIDRADENITIS SUPPURATIVA FLARE; HIDRADENITIS SUPPURATIVA FLARE; FEVER; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (ACHE.), HIDRADENITIS (HIDRADENITIS SUPPURATIVA FLARE), CONDITION AGGRAVATED (HIDRADENITIS SUPPURATIVA FLARE) and PYREXIA (FEVER) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Hidradenitis suppurativa.    No Medical History information was reported.   On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Jan-2022, 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) Solution for injection in pre-filled pen, CF. On an unknown date, the patient experienced PAIN (ACHE.), HIDRADENITIS (HIDRADENITIS SUPPURATIVA FLARE), CONDITION AGGRAVATED (HIDRADENITIS SUPPURATIVA FLARE) and PYREXIA (FEVER). At the time of the report, PAIN (ACHE.) and PYREXIA (FEVER) outcome was unknown and HIDRADENITIS (HIDRADENITIS SUPPURATIVA FLARE) and CONDITION AGGRAVATED (HIDRADENITIS SUPPURATIVA FLARE) was resolving. Concomitant product use was not provided by the reporter. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter causality for the event of hidradenitis suppurativa flare, fever and ache with co suspect Humira was not reported.  Treatment information was not provided.
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 75-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: "High blood pressure", start date: 2022 (ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 24Nov2022, outcome "unknown" and all described as "Treatment of COVID-19". The event "treatment of covid-19" required emergency room visit. The patient underwent the following laboratory tests and procedures: Chest X-ray: (28Nov2022) Negative, notes: Result: Negative; Unit: Not Provided; Computerised tomogram: (28Nov2022) Negative, notes: Result: Negative; Unit: Not Provided; Electrocardiogram: (28Nov2022) Negative, notes: Result: Negative; Unit: Not Provided; SARS-CoV-2 test: (24Nov2022) positive, notes: Treatment of COVID-19; Scan brain: (28Nov2022) Negative, notes: Result: Negative; Unit: Not Provided. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: She took the Pfizer Vaccine and was diagnosed with COVID on 24Nov2022 and was then prescribed Paxlovid. Pfizer Vaccine: Clarification of product name/Lot/NDC/Expiry: Not provided, caller chose to end the call abruptly. When she went to emergency room at (Hospital name withheld) on 28Nov2022 they did an EKG, Chest X-Ray, CAT Scan and Brain scan because they thought she was having a heart attack, but all of those test results were negative.  The information on the batch/lot number for [BNT162B2], has been requested and will be submitted if and when received.
Pain in top of the hand; Patient has a numb feeling; Difficulty concentrating; Felt foggy; Patient has joint pain in her pinky, ring finger; Fatigue; This is a spontaneous case, initially received from other health professional via Agency (reference number: SEQ19-06370) on 07-Nov-2019, concerning a 38-year-old female patient.   The patient medical history include allergy to Percocet, codeine, aspirin in high dosage (gets hives and rash). The patient does not use any concomitant medications.  On 07-Nov-2019, at 11 AM, the patient was administered Flucelcax QIV [influenza vaccine, subunit influenza virus, vaccine polyvalent, dose: 0.5 mL, route of administration: intramuscular, anatomical location: deltoid, batch number: 263334, expiration date: 30-Jun-2020] for influenza prophylaxis.  On the same day, after receiving the vaccine, the patient had joint pain in her pinky, ring finger and top of the hand, she has a numb feeling, she also felt foggy, fatigued, and had difficulty concentrating. The patient took a Tylenol (paracetamol) 5 minutes before speking to Seqirus.  On 10-Dec-2019, the reporter saw the patient's sister who stated that the patient was fine and had no adverse event.  On an unspecified date, the outcome of all the events was resolved.  The events were assessed as non-serious. The reporter did not provide causality assessment.  Significant follow-up received from other health professional (reference number: SEQ19-06774) on 10-Dec-2019: The outcome for all events was changed from not resolving to resolved. The narrative was amendment accordingly.   Company comment: The patient experienced pain in extremity, hypoaesthesia, disturbance in attention, feeling abnormal, arthralgia and fatigue on the same day, after vaccination with the suspect product Flucelcax QIV. Chronology is plausible. Reportedly, the patient did not use any concomitant medications. Considering all the above mentioned, causality between suspect product and the events is assessed as possibly related.; Sender's Comments: The patient experienced pain in extremity, hypoaesthesia, disturbance in attention, feeling abnormal, arthralgia and fatigue on the same day, after vaccination with the suspect product Flucelcax QIV. Chronology is plausible. Reportedly, the patient did not use any concomitant medications. Considering all the above mentioned, causality between suspect product and the events is assessed as possibly related.
No adverse event; an employee received Moderna Covid Vaccine, Bivalent, instead of Moderna Covid-19 Vaccine Monovalent for the 2nd dose of the primary series.; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (an employee received Moderna Covid Vaccine, Bivalent, instead of Moderna Covid-19 Vaccine Monovalent for the 2nd dose of the primary series.) and NO ADVERSE EVENT (No adverse event) in a 25-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 02-Dec-2022, the patient received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 02-Dec-2022, the patient experienced WRONG PRODUCT ADMINISTERED (an employee received Moderna Covid Vaccine, Bivalent, instead of Moderna Covid-19 Vaccine Monovalent for the 2nd dose of the primary series.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (an employee received Moderna Covid Vaccine, Bivalent, instead of Moderna Covid-19 Vaccine Monovalent for the 2nd dose of the primary series.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (an employee received Moderna Covid Vaccine, Bivalent, instead of Moderna Covid-19 Vaccine Monovalent for the 2nd dose of the primary series.).    No concomitant medications was reported. No treatment medications was reported.
Found out I was pregnant on the 21st.  Went to the doctors on November 30th.  I was suppose to be 7 weeks according to my LMP.  They did an ultrasound and discovered the baby had not developed properly.  I eventually had a miscarriage.
Unexpected menstrual bleeding (Mirena IUD in place). Bleeding occurred for a total of 3 cycles.
Approximately 4-5 hours post injection, significant fatigue and difficulty concentrating.  By 9-10 hours could not stay awake. By 15 hours, onset fever to 101,  significant myalgias and joint pain. Dizziness by 24 hours. Fever waned by 36 hours and ibuprofen taken at 26 hours relieved myalgias. Dizziness and intermittent vertigo has persisted to present, currently 78 hours.
Patient received a 3rd dose of Moderna. 1st dose on 1/18/21, 2nd dose of 2/15/21, 3rd dose on 8/2/21.
Mother relates patient began with swelling, redness on left upper arm after DTAP vaccination on 7/24. Since that time, redness/swelling has increased, having pain, and subjective fever. Taking acetaminophen regularly, last dose 10AM on 7/26. Afebrile during visit on 7/26. Mother relates pt. has decreased appetite, denies SOB/difficulty swallowing.  Mother denies similar reaction to any vaccinations in the past.  Referred to urgent care for evaluation due to no PCP.
Patients physician calls about confusion with cognition and memory issues. She is also still having balance issues with extreme fatigue.
On 6/20. Wore a mask for 90% for a fligth. developed a cough on 6/23.  had symptoms and tested negtaive on rapid tests from 6/24 and 6/25, flew on 6/27  because I had tested negative and was told it was a sinus infection at the urgent care. tested positive on a rapid test for COVID on 6/27, Tested negative again on 7/6. Have had a very bad cough that started on 6/23 and has not stopped as of 7/19. I am currently(as of 7/19) 36 weeks pregnant, est due date 8/16
Pt. experienced stiffness in the arm that I gave her the flu shot in and wasn't able to move it freely.
Patient received 2 doses of Shingrix (13 July 2018 and 05 October 2018) within our health care system. Patient's primary care recommended patient receive the High Dose Influenza vaccine at off-site community pharmacy since it was not in stock within clinic. When patient brings in proof of immunization, paperwork show patient received High Dose influenza AND Shingrix, which would be her 3rd dose. No adverse effects reported.