chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a pharmacist via call center representative and described the occurrence of injected limb mobility decreased in a 28-year-old male patient who received BOOSTRIX (batch number K2D2T, expiry date 8th December 2018). Concurrent medical conditions included asthma (has had since childhood). Concomitant products included vitamins NOS (Multivitamin). On 26th October 2016, the patient received BOOSTRIX (intramuscular) 0.5 ml. In October 2016, less than a week after receiving BOOSTRIX, the patient experienced injected limb mobility decreased, wheezing, movement disorder, numbness of limbs, tingling and muscle weakness. On an unknown date, the patient experienced fatigue. On an unknown date, the outcome of the injected limb mobility decreased, movement disorder, numbness of limbs, tingling and muscle weakness were unknown and the outcome of the wheezing was recovering/resolving and the outcome of the fatigue was recovered/resolved. It was unknown if the reporter considered the injected limb mobility decreased, wheezing, movement disorder, numbness of limbs and tingling to be related to BOOSTRIX. The reporter considered the muscle weakness and fatigue to be related to BOOSTRIX. Additional details were provided as follows: Initially it was reported that, approximately within a day of getting the vaccination, the patient began to experience wheezing, and numbness and tingling in both arms and legs, which was almost to the point of feeling like pins and needles. The patient experienced difficulty in shifting the gears in his car due to the numbness and tingling. Also, the patient experienced difficulty during raising both of his arms. The reporter stated that the patient went to physician and was told that the wheezing was not related to the BOOSTRIX. The reporter was going to have the consumer contact to response center to provide further details. On 1st November 2016, the consumer was contacted and stated that, he did not talk initially about the numbness and tingling in his arms and legs, and the muscle weakness and only discussed wheezing and was told it was probably related to allergies. The patient stated that the symptoms of wheezing, muscle weakness, and numbness and tingling in his arms and legs started within 72 hours of receiving the vaccination. The patient went to the emergency room visit on 31st October 2016, because of the numbness and tingling, and muscle weakness. They were unable to find anything wrong with patient. It was reported that patient felt extremely fatigued after receiving the vaccination. The numbness and tingling in his arms was not constant but rather "on and off", and numbness in his legs was extremely pronounced when he was driving. He initially went to get the vaccination because he cut his pinky on a rusty plate that hold the battery in a car.
Tested positive on antigen test. Received Pfizer booster in Oct2021; Tested positive on antigen test. Received Pfizer booster in Oct2021; Experienced fever 102, chills and lethargic; Experienced fever 102, chills and lethargic; Experienced fever 102, chills and lethargic; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 46-year-old female patient received BNT162b2 (BNT162B2), in Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete;  unknown manufacturer), for Covid-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Tested positive on antigen test. Received Pfizer booster in Oct2021"; LETHARGY (non-serious), PYREXIA (non-serious), CHILLS (non-serious), outcome "unknown" and all described as "Experienced fever 102, chills and lethargic". The patient underwent the following laboratory tests and procedures: Body temperature: 102; SARS-CoV-2 test: positive.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
At Approximately 2:00 p.m on the day of injection, I Had extreme muscle and joint fatigue, migraine, body aches, and fever. I slept 10-12 hours.
Fever; Chills; Muscle pain; Diarrhea; Profuse sweating; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 08Apr2021 at 10:45(at the age of 47-year-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. Concomitant medications included sertraline (MANUFACTURER UNKNOWN) for unknown indication from an unknown date. The patient had no known allergies to medications, food or other products. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in right arm on 18March2021(at the age of 47-year-old) as a single dose for COVID-19 immunisation. 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 09April2021 at 02:00, the patient experienced fever, chills, muscle pain, diarrhea and profuse sweating. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. It was unknown whether therapeutic measures were taken as a result of the events. The clinical outcome of the events fever, chills, muscle pain, diarrhea and profuse sweating were recovering at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
devel chickenpox 8/17/99 1wk p/vax;seen 8/19/99 over 40 lesions w/blisters, papules typical of chickenpox;
Complaints of numbness to hands from knees down bilaterally after Covid vaccine. No shortness of breath. Itching left side of cheek- mild throat tightness. Received Benadryl P.O. 25 mg and Decadron 10 mg P.O.  Observed for 2 hours ? no reoccurrence of symptoms.
Anaphylaxis - throat closed, rash on face and upper body, swollen, red, and tender shot site, difficulty breathing.  Admitted to urgent care - Benadryl IV and cortisone IV.  Transferred to hospital for overnight care and observation at Medical Center.  Benadryl IV until 11/11/09.  12/01/09 MR records received for DOS 11/09/09-11/10/09. Pt admitted for a scheduled surgery for pelvic organ prolapse, dyspareunia, urinary incontinence. Pt recovered from surgery, eating regular diet, passing flatus, able to ambulate. Pt discharged home in stable condition.
Parent called 1/30/2020 to report child had a fever between 101-103 last night and reports Right leg pain at injection site. He pulls away when parents try to touch leg. Parents gave a fever reducer that brought the temp down to 101. Instructed to apply ice to injection site for inflammation/pain, and monitor. Report to us tomorrow.
Patient was given moderna vaccine and was only 17.  He should not have been scheduled into clinic.  Spoke with parents and they agreed that he should have it.
Soreness at injection site; nausea; headache; fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 17-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Dec2022 at 14:30 as dose 3 (booster), single (Lot number: GJ6742) at the age of 17 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "IBS" (unspecified if ongoing); "ADHD" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Peanuts" (unspecified if ongoing). Concomitant medication(s) included: SERTRALINE; VITAMIN D [COLECALCIFEROL]; STRATTERA. Vaccination history included: BNT162b2 (DOSE 2, SINGLE, Pfizer BioNTech, Batch/Lot No: FC3180, Location of injection: Arm Left, Vaccine Administration Time: 06:00 PM), administration date: 10Aug2021, when the patient was 15-year-old, for COVID-19 immunization, reaction(s): "COVID-19"; BNT162b2 (DOSE 1, SINGLE, Pfizer BioNTech, Batch/Lot No: FA6780, Location of injection: Arm Left, Vaccine Administration Time: 06:00 PM), administration date: 20Jul2021, when the patient was 15-year-old, for COVID-19 immunization, reaction(s): "COVID-19". The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 27Dec2022 at 18:00, outcome "recovering", described as "Soreness at injection site"; PYREXIA (non-serious) with onset 27Dec2022 at 18:00, outcome "recovering", described as "fever"; HEADACHE (non-serious) with onset 27Dec2022 at 18:00, outcome "recovering"; NAUSEA (non-serious) with onset 27Dec2022 at 18:00, outcome "recovering". Therapeutic measures were not taken as a result of vaccination site pain, nausea, headache, pyrexia.  Additional information: Location of injection for vaccine received same date: Influenza-Left arm. The most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient been had not tested for COVID-19, since the vaccination.
This spontaneous case reported by a consumer, describes the occurrence of COVID-19 (consumer also mentioned patient's daughter just tested positive for COVID-19) in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Jan 7, 2022, patient experienced COVID-19 (consumer also mentioned patient's daughter just tested positive for COVID-19). At the time of the report, COVID-19 (consumer also mentioned patient's daughter just tested positive for COVID-19) outcome: unknown. Diagnostic results: On Jan 7, 2022, SARS-CoV-2 test: Positive. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medication or treatment information reported. This case linked to MOD-2022-444983 (patient link). Sender's comments: This case concerns a female patient (with no reported medical history), who experienced unexpected SARS-CoV-2 test positive that occurred after the dose of the mRNA-1273. The re-challenge not applicable due to unspecified number of doses administered and nature of the event. The benefit-risk relationship of mRNA-1273 not affected by this report.
CHILLS AND BEING TIRED CONSISTENLY FOR 3 DAYS TOOK TYLENOL. STILL HAVE CHILLS AT TIMES AND TIRED
Numbness/tingling  in left arm from shoulder to finger tips.  Numbness/tingling/ pain in neck/ left ear lasting approximately 32 hours
A 20 year old, male patient (with no known allergies) complained of fatigue and headache, approximately 2-3 hours after receiving YF-VAX (lot number UE951AA) intramuscularly in the left deltoid; Imovax (lot number Z0943-11) intramuscularly in the right deltoid and Typhim Vi (lot number Z0664) intramuscularly in the left deltoid, on 06 April 2007. His temperature rose and he went to the hospital and was given O2 and blood work and sent home. He denied any illness at the time of the vaccinations. It was reported that he recovered. Follow-up information received on 08 May 2007. It was reported the patient subsequently received Imovax Rabies (lot number Z0943-1)-dose 2, intramuscularly in the right arm on 13 April 2007 and Imovax Rabies (lot number Z0943-1)-dose 3, intramuscularly in the left arm son 26 April 2007. The patient also had laboratory tests which showed yellow fever antibody IgG.
Weakness; My arm was swollen; Hard; My right chest felt hard and swollen, like when you are breastfeeding; headache; Body ache; shoulder pain; It is itchy where the vaccine was given; Mild arm pain; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weakness), PERIPHERAL SWELLING (My arm was swollen), INDURATION (Hard), CHEST DISCOMFORT (My right chest felt hard and swollen, like when you are breastfeeding) and VACCINATION SITE PRURITUS (It is itchy where the vaccine was given) in a 52-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.     No Medical History information was reported.   On 23-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 24-Apr-2021, the patient experienced VACCINATION SITE PAIN (Mild arm pain). On 23-May-2021, the patient experienced VACCINATION SITE PRURITUS (It is itchy where the vaccine was given). 23-May-2021, the patient experienced ARTHRALGIA (shoulder pain). On 28-May-2021, the patient experienced MYALGIA (Body ache). On an unknown date, the patient experienced ASTHENIA (Weakness), PERIPHERAL SWELLING (My arm was swollen), INDURATION (Hard), CHEST DISCOMFORT (My right chest felt hard and swollen, like when you are breastfeeding) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. On 25-Apr-2021, VACCINATION SITE PAIN (Mild arm pain) had resolved. At the time of the report, ASTHENIA (Weakness), PERIPHERAL SWELLING (My arm was swollen), INDURATION (Hard), CHEST DISCOMFORT (My right chest felt hard and swollen, like when you are breastfeeding), VACCINATION SITE PRURITUS (It is itchy where the vaccine was given), MYALGIA (Body ache), HEADACHE (headache) and ARTHRALGIA (shoulder pain) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication were reported.  The patient received both scheduled doses of mRNA-1273 prior to the events therefore, action taken with the drug in response to the event is not applicable.   This case was linked to MOD-2021-200825 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 30-Jun-2021: Follow-up received contains updated event outcome from unknown to recovered.
I thought I just had a sore throat and a stuffy nose. My ear and the left side of my temple by my left eye hurt. I was treating myself with cold medicine. I did not think I had Covid-19. I then noticed that the juice was burning the back of my throat. I got tested and I was positive for Covid-19. My symptoms really only lasted 2 days after taking the medication. I consulted my doctor and I was prescribed a Z-Pac, Albuterol, and some Prednisone. I was fully recovered within a week of the first symptoms.
Patient was fainted after his first Pediatric Pfizer dose.. Patient was feeling Dizzy and blurred vision 5-10 mins after the shot. I saw his head bended towards his mom suddenly, So I let patient lay down on his back and elevated his leg. Within 10 seconds he was feeling perfectly fine.
Hospitalization: 1/10/2023 - 1/11/2023 (30 hours) Presentation to the ED: SOB.  COVID + date: 1/10/23 Treatment: dexamethasone.  Discharge to: Home.   031L20A 2/3/2021 027A21A 3/8/2021 035C21A 10/25/2021
No adverse event; Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use date) and NO ADVERSE EVENT (No adverse event) in a 20-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 023H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 20-Dec-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 20-Dec-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use date) 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use date).    Concomitant Medication use information was not provided by reporter.   Pharmacist reported that more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 monovalent and 20 bivalent) which were beyond the 30 days beyond use date.   Patient received vaccine at Pharmacy.  The lot 023H22A beyond use date of the vaccine was reported as 13 December 2022.   NDC number was reported as 80777-282-05.   Treatment Medication use information was not provided by reporter.    This case was linked to US-MODERNATX, INC.-MOD-2023-704416 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 24-Jan-2023: Follow up received that contains significant information includes updated patient details, suspect product details and updated narrative. On 24-Jan-2023: Follow up received is NNI.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704416:Master Case
patient did not get a dose of FLUZONE HD after administration because the product leaked on the part where the needle meets the syringe when the administering staff injected the plunger with no adverse event; Initial information received on 12-Sep-2023 regarding an unsolicited valid  non-serious case received from a Nurse.  This case involves a 76 years old and unknown gender patient who did not get a dose of influenza quadrival A-B high dose HV vaccine [Fluzone High-Dose Quadrivalent] after administration because the product leaked on the part where the needle meets the syringe when the administering staff injected the plunger with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 08-Sep-2023 at 4:30 PM , the patient received a  dose 0.5 ml of suspect  influenza quadrival A-B high dose HV vaccine, injection, (lot UT8072DA; Expiration Date :30-Jun-2024: strength not reported) via intramuscular route in the deltoid nos (not otherwise specified) for Immunization and did not get a dose of Fluzone hd after administration because the product leaked on the part where the needle meets the syringe when the administering staff injected the plunger with no adverse event (incorrect dose administered) (latency: same day)  It was reported by nurse from their department injected a patient with FLUZONE HD but it leaked on the part where the needle meets the syringe and patient was not able get any of the vaccine.   Action taken : not applicable.  Outcome : Unknown.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Soreness in left arm from injection site (patient claims to be high) and any range of motion. This includes reaching up, scratching neck, reaching back, putting on clothes, turning/mopping, and general daily activities. Left arm  is compound fracture of humorous. Patient has titanium plate roughly 8 inches long. No issues in the past with any other immunizations. First time receiving a vaccine in left arm. This has been going for for roughly 5 months.
Fever and crankiness on Dec. 3rd - followed by 2 evenings of uncontrollable high pitched crying for about 7 hours each night. Very disoriented and unresponsive to consoling. In constant phone contact w regular physician.
This spontaneous report as received from a registered nurse refers to a 9 week old female infant. On an unknown date the 9 week old female infant was vaccinated with a dose of pediatric VAQTA 25/0.5 U/ML. Lot # was unspecified. No adverse effect reported. Additional information has been requested.
30 minutes after getting the vaccine I started having unbearable pain on my legs, hands and arms, my veins hurt and are swollen, some of my veins have erupted.  I can't even sleep because of the pain
Patient had swelling at injection site immediately after immunization. No systemic side effects reported. Iced injection site and monitored patients for 30 mins post vaccine
In March I was in my friend's house and the AC was blowing  at my back. Two days later, I had congested chest and hard to breath. My chest hurt . I spoke to pulmonologist' s nurse on the phone and was prescribed antibiotics Levaquin . After taking it for 3 to 4 days, there was no difference and they prescribed to another medication. I went to ER, I still want to see a doctor and did CAT scan to make sure I was better even if I was feeling better. They said that I may have had Pneumonia. I had it in the past and I know how it felt.
Patient returned 4 days early for second dose Pfizer COVID vaccine due to application sending him a text confirming his appointment on 4/30/2021. Client stated he assumed he was rescheduled from original return date of 05/04/2021 to 04/30/2021. Client was given his second dose early due to a communication error between the RN administering the dose and the ancillary staff.
No adverse effects; May have received smaller than recommended dose; unsuccessful attempt of the administration of GARDASIL 9; This spontaneous report was received from a nurse referring to a 13-year-old male patient. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported.      On 01-OCT-2021, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # T026323 with expiration date 22-FEB-2023, for prophylaxis (strength, dose, route of administration and anatomical location were not reported). It was stated that the patient might have received smaller than recommended dose due to unsuccessful attempt of the administration of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9). No additional adverse events were reported.
Temperature during 3 days. Sunday am severe chest pain. Shot went through arm pit extreme pain. Rash outlined like bulb, under arm pit and chest areas very tender
Information has been received from a physician concerning a 15 year old female who was vaccinated with a dose of Gardasil. Subsequently, the patient developed bad rash. The patient visited an urgent care center for unspecified treatment. The patient's outcome was unknown. Additional information has been requested. This is one of two reports received from the same source.
Stiff neck developed for few days after initial flu vaccine. Booster dose given, pt developed torticollis  worsening over 5 days.