chrisvoncsefalvay/vaers-outcomes huggingface dataset:
2 year old was administered Kinrix; Administered Kinrix instead of Infanrix; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 2-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.   Previously administered products included Pentacel (dose received on 17th November 2020).   On 7th March 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 7th March 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong 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: The reporter reported that the 2 year patient received Kinrix vaccine instead of Infanrix. The reporter stated that she did not had lot number and expiration date of the vaccine. The vaccine facility administration was same as the primary reporter. The reporter did consent to follow up. Additional supportive information: The patient received Kinirix instead of Infanrix, who was younger than the indicated age which led to inappropriate age at vaccine administration and wrong vaccine administered. This case was one of 10 cases, reported by same reporter.; Sender's Comments:  US-GSK-US2022136455:Same reporter US-GSK-US2022136453:Same reporter US-GSK-US2022136454:Same reporter US-GSK-US2022136456:Same reporter US-GSK-US2022136446:Same reporter US-GSK-US2022136451:Same reporter US-GSK-US2022136463:Same reporter US-GSK-US2022136465:Same reporter US-GSK-US2022136466:Same reporter US-GSK-US2022136459:Same reporter
Information has been received from a physician and a nurse concerning an approximately 16 week female with a history of colostomy who on 12-FEB-2007 was the first dose of vaccinated with rotavirus vaccine (human-bovine) by mouth. There was no concomitant  medication. On approximately 26-MAR-2007 (two to three weeks ago), the patient was positive for rotavirus at a visit to the emergency room for diarrhea. It was reported that per labs in the emergency room the patient was positive for rotavirus. Subsequently, the patient recovered from positive for rotavirus. The physician mentioned that the patient's mother thought the child spit up the dose of rotavirus vaccine (human-bovine) at the time of administration. The nurse's notes did not indicate that the child spit up the doe. Additional information has been requested. This is in follow-up to reports previously submitted on 5/14/2007. Information has been received from a physician and a nurse concerning an approximately 15 week female who was born with imperforate anus and had a colostomy who on 12-FEB-2007 was vaccinated with the second dose of oral ROTATEQ (Lot #655485/1033F). There were no concomtitant medications. On approximately 26-MAR-2007 (two to three weeks ago) also rported as March 2007, the patient was positive for rotavirus  at a visit to the emergency room for diarrhea. The patient developed diarrhea about one month after receiving the first rotavirus vaccine. It was reported that pel labs in the emergency room the patient was positive for rotavirus. Subsequently, the patient recovered from positive for rotavirus after a few days. The physician mentioned that the patient's mother thought the child spit up the dose of ROTATEQ at the time of administration. The nurse's did not indicate that the child spit up the dose. Additional information has been requested.
Had shallow breathing; Very weak; Could not walk; Disoriented; Wanted to sleep; Incoherent; couldn't/wouldn't eat; Dehydrated; This is a spontaneous report from two contactable consumers (primary reporter was patient's husband). An 80-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. Medical history included ended up in the hospital for 2 weeks with pneumonia and COVID-19 at the end of last Summer. The patient's concomitant medications were not reported. The patient's husband reported that the patient received the first Covid shot about a week to two weeks ago. She went to the facility and got the shot and was fine afterwards until she came home. Later that afternoon, she started showing symptoms of problems, was weak and couldn't walk, disoriented, wanted to sleep, was incoherent, couldn't/wouldn't eat, was very, very much having trouble, shallow breathing. He tried to stay right her and eventually it got to be scary for him with her shallow breathing. He ended up calling an ambulance and she went to the hospital. They gave her tests and was there until about 4 or 5 in the morning before she started showing signs. She was dehydrated was a part of it. The tests were showing the symptoms were improving and she was beginning to come out of it fortunately with doctor's care because he didn't know what to do. He had been going through materials and she is coming up on another shot next Monday and does not want her to go through that if it can be helped. She was coming up for the second shot. Saw something on the tv that rattled him to his bones. It had been found that people who had Covid virus previously and then got the shot may not need a second shot. He is trying to flush that out to whether or not that is something or not that she should be considering. They have the card to go back to the same place for the second shot and they are trying to figure if they need to set up an appointment now. Hoping that this was the worse of it and it is hard for them to call back and his physician is not an expert on this and he got Pfizer's office contact number and decided to call. Outcome of the events was recovering.  Information on the batch/ lot number has been requested.
This spontaneous report as received from a physician refers to an approximately 58 year old female patient with depression, hypothyroidism, fibromyalgia, sulfa allergy and gastritis due to prednisone (manufacturer unknown) (MARRS#1410USA004118). On an unspecified date in 2005 the patient was vaccinated with PNEUMOVAX 23, intramuscular (dose and lot number were not reported). Concomitant therapies included CELEBREX, ZOLOFT, and ARMOUR THYROID TABLETS. In 2005, within 48 hours of receiving PNEUMOVAX 23 the patient developed pain, swelling and redness at the PNEUMOVAX 23 injection site. The patient took TYLENOL on unspecified dates. On an unspecified date about 2 weeks after PNEUMOVAX 23 injection, the patient recovered. No lab diagnostics studies were performed. The patient called the physician. This is one of two reports from the same patient. Additional information has been requested.
Flu vaccine given 11/23/10. Pt still complains of arm pain and limited ROM. No erythema, induration son also has same sx.
so sick now; developed a thrush inf; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (so sick now) and CANDIDA INFECTION (developed a thrush inf) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ILLNESS (so sick now) and CANDIDA INFECTION (developed a thrush inf). At the time of the report, ILLNESS (so sick now) and CANDIDA INFECTION (developed a thrush inf) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Negative) Negative.         No concomitant medication reported.  No treatment medication reported.   This case was linked to MOD-2021-317625 (Patient Link).
he developed transverse myelitis had to relearn to and could not urinated or deficate only issue remaining is urination issue
Shortness of breath, hot flashes, feeling hot from the inside, having to breath fast, tired, sleepy
I caught Covid. I did have a slight headache, I woke up with this and slight sore throat and 1 nostril was completely clogged. Next day I started coughing and it got worse. The next day did a home test because my husband had tested positive. I called the doctor and they gave me 2 inhalers. I feel pretty good but my lungs are pretty, I had to get 2 new inhalers.
Body aches; Chills; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Body aches) and CHILLS (Chills) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and 039K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Jan-2021, the patient experienced MYALGIA (Body aches) and CHILLS (Chills). At the time of the report, MYALGIA (Body aches) and CHILLS (Chills) outcome was unknown.            No concomitant medications were mentioned. No treatment details were reported.  the patient received the third dose on 21Aug2021   This case was linked to MOD-2021-336417 (Patient Link).
FEELING LIKE DYING EVERYDAY; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced feeling like dying everyday. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of feeling like dying everyday was not reported. This report was non-serious.
I started experiencing dizziness and lightheadedness about two weeks after my first shot. I had intense migraines for about a week as well. I also suddenly get intense stomach pains whenever I eat bananas or pineapples, two foods I used to previously enjoy without issue
Immediately c/o difficulty breathing, feeling hot, face flushed, back pain. IV of NS started, O2 on.
Feet hurt, hands hurt, legs hurt; Feet are cold; Fever; Joints hurt; chills; Headache; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Feet hurt, hands hurt, legs hurt), PERIPHERAL COLDNESS (Feet are cold), PYREXIA (Fever), HEADACHE (Headache) and MYALGIA (Body aches) in a 34-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.     The patient's past medical history included COVID-19 (Positive for COVID-19 Dec 2020) in December 2020.   On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Apr-2021, the patient experienced HEADACHE (Headache) and MYALGIA (Body aches). On 26-Apr-2021, the patient experienced PAIN IN EXTREMITY (Feet hurt, hands hurt, legs hurt), PERIPHERAL COLDNESS (Feet are cold), PYREXIA (Fever), ARTHRALGIA (Joints hurt) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Feet hurt, hands hurt, legs hurt), PERIPHERAL COLDNESS (Feet are cold), ARTHRALGIA (Joints hurt) and CHILLS (chills) had not resolved and PYREXIA (Fever), HEADACHE (Headache) and MYALGIA (Body aches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2020, SARS-CoV-2 test: (Positive) positive.         Reporter stated no concomitant products were used. Treatment medicine include Tylenol Action taken with mRNA-1273 in response to the event was not applicable.
Some of the newly trained staff is giving one vial (adjuvant) instead of reconstituting; Still feel a small bump at injection site; Injection site red; Injection heated; Felling tired; Had the chills; Feeling soreness at injection site; Some of the newly trained staff is giving one vial (adjuvant) instead of reconstituting; This case was reported by a consumer and described the occurrence of injection site pain in a 53-year-old female patient who received Herpes zoster (Shingrix) (batch number T7GA9, expiry date 11th November 2022) for prophylaxis.   On 1st June 2021, the patient received the 1st dose of Shingrix (intramuscular). On 1st June 2021, less than a day after receiving Shingrix, the patient experienced injection site pain, tiredness, chills and inappropriate reconstitution technique. On 2nd June 2021, the patient experienced injection site erythema, injection site warmth and injection site induration. On an unknown date, the patient experienced incorrect dose administered. On an unknown date, the outcome of the injection site pain, injection site erythema, injection site warmth, tiredness, chills and incorrect dose administered were unknown and the outcome of the injection site induration and inappropriate reconstitution technique were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, injection site erythema, injection site warmth, tiredness, chills and injection site induration to be related to Shingrix.   Additional details were reported as follows: This case was reported by the patient. The patient stated that she went to the pharmacy and was told to make sure she gets 2 vials of Shingrix. Pharmacist told patient that some of the newly tarinned staff was giving one vial (adjuvant) instead of reconstituting.  Inquired if Shingrix dose equal to two vials. Also inquired if Shingrix needs to be 2 doses only or if she may need another dose in the future. Patient was concerned but with further questioning, she feels she did get both because she saw the pharmacy reconstituting two vials with different colored caps. She will clarify with pharmacy and call GSK back if needed.  Patient received first dose of shingrix on 01-JUN-2021 in right arm. On same day patient experienced injection site pain, tired, chills. The next day patient experienced a small bump at injection site bump. Reffered her to HCP. Consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021120502:Same reporter
Fever of 106F, with vomiting, seizures, persistent crying lasing over 3 hours, loss of appetite.
Skin Lesion - Information has been received from a registered nurse concerning a 4 year old caucasian male patient with no allergies or medical history who on 19 Aug 1998 was vaccinated with a first dose of varicella virus vaccine live in the left arm.  On 07 May 2000 the patient developed round, fluid filled skin lesions erupting successively over a 3 day period from 07 May 2000 to 11 May 2000.  Most lesions had healed or disappeared by 14 May 2000.  The patient was treated with calamine (+) pramoxine (+) nine acetate (Caladryl) and one or two doors of diphendydramine HCL (Benadryl) was given for itching. on 14 may 2000, the patient recovered.
1 week after receiving the second dose of the Pfizer vaccine, started to feel short of breath with chest pain, a week later showed up to the hospital with extensive bilateral PEs and new onset A. fib. Physician can not determine the etiology behind the PEs, but cannot find any malignancy. Referred patient to pulmonology and hematology for further work-up. Physician feels that this could be an adverse reaction to the Pfizer vaccine Heparin drip for pulmonary emboli 4/8
This medically confirmed spontaneous report (initial receipt: 26-Feb-2016) concerns a 28 year-old female patient. On 25-Sep-2015, the patient received AFLURIA (batch number U55406; expiry date: 30-Jun 2016 yet reported as 12-Jun-2016) 0.5mL via the intramuscular route. The AFLURIA vaccine was stored at 0.6 to 1.1 degrees Celsius (reported as 33-34 degrees Fahrenheit) multiple times. The last excursion was 0 degrees Celsius (reported as 32 degrees Fahrenheit) for no more than 24 hours. The outcome was not reported.
On July 7, 2022 I noticed my vision was deteriorating in my left eye. I could see straight lines (straight surfaces) would curve down (concave). My peripheral vision was blurred in my left eye. I contacted my doctor and she did a physical exam and found a mass behind my left eye. Diagnosis was Histiocytic Aggregates. About 4 years ago I had an eye exam and the doctor found a spot on the back of my retina. I was diagnosed with Xanthogranuloma. This past episode in July 2022 was more severe because my vision was more deteriorated.
Developed large splotchy red spots (hive like) on inner aspect of upper left arm and on regiht wrist area. No rash noted on torso, face, or neck. No swelling or throat itching. No stridor. Clear lung sounds. Administered 25 mg PO Benedryl at 10:08 SPaO2 was 98, Resp. rate 14, BP 170/100. Pulse 54 and regular.  By 10:40 rash very faint.  Vital signs stable but BP still high 160/100. Daughter will drive home and call MD re: BP.
Neurological symtpoms. Diffuse whole-body paresthesias  that started approximately 3 to 4 weeks after getting second dose of Pfizer Covid vaccine. Numbness and tingling all over her body. " From the top of my head down to my toes". Feeling like pins and needles. Feels like she was going to trip and fall, stumbles sometimes when walking. Tongue and lips numbness.
Flu vaccine given 11/7/06 approx 3pm, next morning pink rash (with itching) over trunk and extremities.
On Dec. 3, 2021. 22 days after my Moderna booster shot on Nov. 11, I woke up with a feeling of blockage,  some hearing loss and tinnitus in left ear after a very short nap. My ENT put me on a 10-day course of Prednisone and a diuretic after which I had another hearing test with the hearing returning to near normal (for my age).  An MRI of the auditory canal showed nothing unusual. I still have the tinnitus and intermittent blockage sensation plus very mild hearing loss.  The ENT said it's now a Eustachian tube issue which I know can be caused by inflammation. I had never had any hearing or ear issues before this happened.  It could be coincidental but I heard Dr. talk about this very issue on the radio which is why I'm reporting it.
Bright orange colored fluid in bowel; Sore throat; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of FAECES DISCOLOURED (Bright orange colored fluid in bowel), OROPHARYNGEAL PAIN (Sore throat) and PAIN IN EXTREMITY (Sore arm) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     The patient's past medical history included Bladder cancer (low grade) since an unknown date, Atrial fibrillation, Knee replacement and Spinal cord operation (Bolts in back). Concomitant products included WARFARIN, SPIRONOLACTONE, TAMSULOSIN, PRAVASTATIN, OXYBUTYNIN, ATENOLOL, BENAZEPRIL, FUROSEMIDE, DIGOXIN, CLOPIDOGREL, GABAPENTIN, ZINC and MAGNESIUM for an unknown indication.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced FAECES DISCOLOURED (Bright orange colored fluid in bowel), OROPHARYNGEAL PAIN (Sore throat) and PAIN IN EXTREMITY (Sore arm). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, FAECES DISCOLOURED (Bright orange colored fluid in bowel), OROPHARYNGEAL PAIN (Sore throat) and PAIN IN EXTREMITY (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
This spontaneous report was received from a pharmacist and refers to a male patient of unknown age.  The patient's pertinent medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX 23 (dose, route, lot number and expiration date were not reported) for vaccination. The patient contacted the pharmacist and reported that on an recent date, the patient developed an area on the from of his bicep that was "red, swollen and puffy" (erythema and swelling). It was unknown if any treatment was used to alleviate the reaction. At the time of reporting, the patient had not recovered from the events.    The causal assessment between the events erythema and swelling and  suspect therapy PNEUMOVAX 23 was not provided.
Wrong dose 10mcg rather than 30mcg.  RN did not have brand new EUA for 5-11 year olds, understood EUA for 5-12 year olds.   No reported adverse reaction, parent notified of error
Fever, Chills, Tachycardia, Headache, Dehydration, Muscle aches, Sleeplessness. Onset approximately 8:00 pm evening of vaccination, 1-14-2021. Fever, tachycardia , dehydration relieved approx 10:00 am following morning, 1-15-2021. Headache and muscle soreness persist.
headache; fatigue; muscle aches; I also had pain at my left testicle; lymph node under my left arm (but not right arm) was noticeably swollen to the size larger then a golf ball but smaller; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 27-years-old male patient received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: ER8729), via an unspecified route of administration, administered in Arm Left on 21Apr2021 09:15 (at the age of 27-year-old) as dose 2, single, and dose 1 via an unspecified route of administration, administered in Arm Left on 31Mar2021 09:15 (Batch/Lot Number: EP7534) as dose 1, single for covid-19 immunisation. The patient medical history was not reported. There were no concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On an unspecified date in 2021, the patient experienced headache, fatigue, muscle aches, i also had pain at my left testicle, lymph node under my left arm (but not right arm) was noticeably swollen to the size larger then a golf ball but smaller. No treatment was taken as a result of events. The outcome of the events headache, fatigue, muscle aches was recovering whereas outcome of  i also had pain at my left testicle, lymph node under my left arm (but not right arm) was noticeably swollen to the size larger then a golf ball but smaller was recovered with sequelae and recovered on an unspecified date in 2021 respectively.  No follow-up attempts are possible. No further information is expected.
This spontaneous report as received from a registered nurse refers to a 66 year old female patient. On an unknown date the patient was vaccinated with PNEUMOVAX 23 (dosing regimen unspecified) lot # L029306, expiry date- 23-JUN-2016. On an unknown date the patient experienced redness and swelling localized at the injection site. No laboratory tests were reported. No product quality complaint (PQC) was involved. The outcome of the events was reported as recovering/resolving. The causality assessment was not provided. This is one of the several reports from the same reporter. Additional information has been requested.