chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; Bivalent doses administered after the BUD to patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Bivalent doses administered after the BUD to patients) and NO ADVERSE EVENT (No adverse event) in a 42-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 11-Oct-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Bivalent doses administered after the BUD to patients). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Bivalent doses administered after the BUD to patients) 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 (Bivalent doses administered after the BUD to patients).    Concomitant medications were not reported.  Total 51 doses from Lot AS7140C Bivalent doses were administered after the BUD to patients. Treatment medications were not reported.
Pain in the left neck started on Aug 27th 2021 after the 1st shot. Pain increased in a few days, so started taking Ibuprofen, Tylenol but no change in pain. Slowly pain became severe covering the entire area from upper left neck to mid left shoulder. Unable to rotate head and bend neck and shoulder.   So started applying Bengey and Salonpas Pain relief patches and pain became worse. Since the pain didnt reduce and unable to sleep in the nights, finally went to urgent care and the doc gave Cyclobenzoprine 10 mg tablet (every 8 hours as needed) and Naproxen 500 mg (twice a day as needed). Pain slightly reduced but still exists and cannot move my head and shoulder freely impacting my daily works!
booster; Increased energy; increase effective extreme concentration; decreased anxiety/increased productivity; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33-years-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Known allergies: SULFA" (unspecified if ongoing), notes: Known allergies: SULFA. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Location of injection: Arm Right), for COVID-19 Immunization, reaction(s): "Increased energy", "had very positive side effects from each vaccine / increase effective extreme concentration, decreased anxiety, increased productivity"; Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Location of injection: Arm Right), for COVID-19 Immunization, reaction(s): "Increased energy", "had very positive side effects from each vaccine / increase effective extreme concentration, decreased anxiety, increased productivity". The following information was reported: IMMUNISATION (non-serious) with onset 2021, outcome "unknown", described as "booster"; ENERGY INCREASED (non-serious) with onset 2021, outcome "recovered" (2021), described as "Increased energy"; DISTURBANCE IN ATTENTION (non-serious) with onset 2021, outcome "recovered" (2021), described as "increase effective extreme concentration"; THERAPEUTIC RESPONSE UNEXPECTED (non-serious) with onset 2021, outcome "recovered" (2021), described as "decreased anxiety/increased productivity". Therapeutic measures were not taken as a result of energy increased, disturbance in attention, therapeutic response unexpected.  Additional Information: The patient did not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. No other medications were received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination was not tested for COVID-19.  The lot number for bnt162b2 was not provided and will be requested during follow up.
right vocal cord paralysis--severe, immediately after vaccine. treated with oral steroids, vocal cord injection (with prolaryn gel).
Vaccines given approx 10:30am 9-9-09 baby slept until 12:30pm started crying uncontrollably - took to MD office approx 4:15 pm- 9-9-09 MD instructed to alternate Tylenol and Ibuprofen. Temp 99.1 at MD office cried hysterically until 7pm 9-9-09. No problems after 7:00pm MD called the am 9-10-09 - states baby was hysterical -nothing made him calm down. Saw baby today and is back to normal.
09:22: complained of throat and roof of mouth feel warm and itchy  A: no difficulty talking, swallowing, breathing; clear speech, concise sentences  09:33 Per patient, her "throat feels better, it's almost gone". She left with her mom. Patient instructed to seek medical attention if any breathing difficulties.
IIV4 received 11/6/2017. UTD 2016-2017 flu season Client vaccinated on 3/17/17 with IIV4 dose #2 non-valid dose received.
Sore shoulder; Pain at injection site; This is a spontaneous report from a contactable consumer (patient). This consumer reported 2 reports for same patient and different dose, this is the second of 2 reports. A 43-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via intramuscular, administered in right arm (reported as right shoulder) on 26Jan2021 15:30 (Batch/Lot Number: EN5318; Expiration Date: 31May2021) as SINGLE DOSE for covid-19 immunisation at Workplace clinical. Patient's medical history reported as none. No prior vaccinations. No concomitant drugs. There were no concomitant medications. The patient experienced pain at injection site (seriousness criteria: not serious) on 26Jan2021 15:30 with outcome of recovered on an unspecified date, this event did not require the initiation of new medication/ other treatment/ procedure, sore shoulder on an unspecified date with outcome of unknown. No relevant test. First Dose resulted in a sore shoulder.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021169816 Same patient, same product, different dose, similar events.
Loss of apatite,  when the time for diaper change arrived, patient was found without vital signs.
I ended up with intense upper stomach pain and the taste of bile at the top of my throat. I had the pain for about 2 days and then started vomiting. Upon doing an ultrasound, they determined I had gallstones and one was stuck in bile duct. I met with the surgeon and had an MRCP test and ultrasound and I was scheduled for surgery. The bile like taste lasted for about a month and a half. I had surgery to remove my gallbladder on January 04, 2022. I have completely recovered.
No additional AEs reported; GARDASIL 9 was administered following a temperature excursion; This spontaneous report was received from an office manager referring to a 12-year-old male patient.  The patient's concurrent conditions, medical history, and concomitant therapies were not reported.  On 03-NOV-2022, the patient was vaccinated with one dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) pre-filled syringe injection, administered as prophylaxis (there were five possible lot # of the vaccine administered: lot #1775811, expiration date: 07-DEC-2023; lot #1775827, expiration date: 27-JUN-2024; lot #W009829, expiration date: 19-OCT-2024; lot #U032681, expiration date: 26-OCT-2023; and lot #1780876, expiration date: 09-NOV-2023; however, it was not specified which one was received by the patient) (strength, dose, route of administration, anatomical location, and vaccination scheme were not provided). It was reported that the vaccines suffered from three temperature excursions with a total of 25 minutes (on 09-SEP-2022 for 8 minutes; on 16-SEP-2022 for 5 minutes; and on 03-JAN-2023 for 12 minutes). The excursions were not noted until it was noticed that an employee mistakenly cleaned the data logger more than once a day (product storage error). There were no additional adverse events (AEs) reported in the patient (no adverse event).  This is one of several reports received from the same reporter.
This spontaneous report was received from a pharmacist via company representative refers to a patient of unknown age. On an unknown date in 2012, the patient was vaccinated with a dose of ZOSTAVAX, (lot number, expiry date and route was not reported). Concomitant medication was not reported. On an unknown date in 2012 (reported as next day), the patient developed hives on the face and neck. The outcome of the event was unknown. Additional information is not expected.
IgA nephropathy; Acute kidney injury; gross hematuria; This is a literature report from Kidney International, 2021, Vol 100, Pgs 944-945, entitled "Acute kidney injury with gross hematuria and IgA nephropathy after COVID-19 vaccination". This reporter reported 2 reports; this is the 1 of 2 reports. The full publication has been requested.  We also cared for 2 patients who had prior biopsy-proven IgAN, who developed gross hematuria after their second dose of the Pfizer vaccine, without a preceding COVID-19 infection. Table 1 outlines the clinical data. Our first patient presented 5 days after his second dose, with nonspecific myalgias, chills, headache, dysuria, and gross hematuria within 24 hours of initial symptoms. Previous IgAN flares in this patient were precipitated by upper respiratory infections and were limited to gross hematuria with no AKIs and no requirement for steroids in the past. His postvaccine workup was notable for AKI, with a serum creatinine level of 3.53 mg/dl and a urine protein-creatinine ratio of 3.0. He was empirically started on steroids with recovery to baseline renal function at 1 month and recovery to baseline proteinuria within 2 months. Our second patient developed gross hematuria within 24 hours of receiving his second dose. His hematuria resolved after 3 days with supportive therapy only. To our knowledge, we are the first to report an IgAN flare that has led to an AKI that resolved with steroid therapy. We agree that it is not clear how a nonmucosal immune challenge led to an IgAN; Sender's Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and IgA nephropathy, Acute kidney injury, Hematuria  cannot be completely excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) US-PFIZER INC-202101461686 Same article/drug/event, different patient.
Patient up to date on vaccines who admitted to hospital with positive COVID test.  Minimal respiratory symptoms (cough).  Provider discharge note below:  "88 YO male who was admitted for Presyncope which was thought to be from dehydration and orthostatic hypotension associated with electrolyte abnormalities. Patient worked with PT/OT and recommended home with assist. His dizziness got better, home antiHTNsives were held. TED HOSE were applied. Patient also was found to have COVID on 2/7, he did not have much symptoms while admitted other than cough. He was encouraged to continue quarantine until cough improves. Patient was discharged home with family to transport, he already has home care established."
Severe abdominal cramping, nausea (9:00 am, 2/19/21); nausea, vomiting (3:00 pm, 2/19/21)
(1) Fever 102.0, chills, body aches < 3 hrs after shot, pain into shoulder. (2) Within 2 days after developed a large whelp, then hives around upper arm, pain into back next to spine.
The patient didn't have any medical conditions or medications that she is taking. It was reported that I am experiencing chest pains, is this normal? When I breath in it hurts in the left side of my chest. The event started on an Apr2021 with outcome of unknown. The event was reported as non-serious.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Intussusseption on 5/21/7-reduced by air contrast enema.   8/31/07 Received vax record from pcp which confirmed RO dose & lot as reported.  9/28/07 Vax records faxed to CDC.  10/2/07 Reviewed hospital medical records which reveal patient experienced reduced oral intake, decreased urine output, irritability, bloody stool x 1.  Admitted 5/21-5/22/2007 for overnight observation s/p IS reduction.  Progressed well & d/c to home. FINAL DX: Intussusception, enema reduced.
Fever 102, HA and fatigue. After fever broke after 9 hours the patient experienced chills. HA lasted 3 days.
Client c/o tightness in chest, dry mouth and shortness of breath 20 min. after vaccination.  Care initiated by onsite EMS.  Client placed on stretcher.  O2 applied.  EMS transported client to ambulance for transport to hospital.  Client's son and niece declined transport.  EMS monitored client in the ambulance for 10-15 min.  Client stated that she felt "okay".  Declined transport to hospital.  Client signed papers provided by Fire Rescue.  Client exited ambulance, ambulating with assist by son and niece.  Stated that she was "okay".  Encouraged client to follow up with Emergency Services and PCP as needed.  Verbalized understanding.  Driven off site by son.
Patient stated that she was having muscle aches and soreness on both shoulders and her neck.  She then called me again 11/8/15 to say that she was still sore in her neck, but that she was improving.  She isn't sure if she slept wrong or hurt herself in another way.
Severe chills, bodyache,joints ache Quarter size red area injection site. Swelling  warm to touch.
Left arm swollen, sore armpit and upper back near arm.  Swollen and painful left armpit, lymph node.
mild hive like rash started approx a few hours and increased over the next 24 hours with hives on arms ,chest itchy,red  bumps
1) Pt developed shingles in (R) T9 dermatome 9/5/2012. He has pain & redness.
38 year old white female developed rapid onset of symptoms: redness with itching and feeling "hot": hands, feet, neck, ears, lips slightly swollen with tingling.  Resoved with 1. 50 mg oral diphenhydramine 2. cool compresses 3. iced water symptoms relieved no sequele with approx 30-25 min. (2:25 p.m. to 3:15 p.m.)  Flu vaccine given 5 hours prior to symptoms.  VS 159/105 102 n difficulty breathing.
Fatigue, aches, flu-like symptoms, fever. Lasted 3 days.
This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose administered 12 hours post puncture.) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 07F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (dose administered 12 hours post puncture.). On 01-Dec-2021, EXPIRED PRODUCT ADMINISTERED (dose administered 12 hours post puncture.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by the reporter. No treatment was reported by the reporter.
p/vax pt devel inj site rxn of redness; warmth & pain; pt seen by MD; tx APAP
38 y/o M with syncope 3-4 minutes after receiving Janssen vaccine at 12:54pm. Patient with loss of consciousness for 1-2 minutes with some rigidity to body. Patient placed in supine position with legs raised. RN administered smelling salts at 1:00 pm  and patient regained consciousness slowly.  4 sets of vital signs taken between 1:07pm and 1;18pm. Emergency Medical Services called at 1:12pm.  Patient denies prior history of allergies, denies current medication or medical conditions. Patient reports not eating or drinking  prior to vaccine administration time. Last set of vital signs taken at 1:18pm showed blood pressure and heart rate within normal range. Paramedics took over assessment at 1:19pm, patient refused to go to hospital for further evaluation and left facility on his own. Patient with steady gait and ambulated on his own. Recommend follow up with Primary care physician.
Lethargy initially, Irritability, clinginess, loss of appetite, constant whining/crying, regression of skills (was sitting but prefers to lie down now).
Anxiety; Rash increasing from 1' to 3" left arm; Fatigue; Stronger pain at injection site (LEFT); Pain at injection site (LEFT); Taste metal; Tongue ulcers; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DYSGEUSIA (Taste metal), TONGUE ULCERATION (Tongue ulcers), ANXIETY (Anxiety), FATIGUE (Fatigue) and VACCINATION SITE RASH (Rash increasing from 1' to 3" left arm) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history reported.     On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced DYSGEUSIA (Taste metal), TONGUE ULCERATION (Tongue ulcers) and VACCINATION SITE PAIN (Pain at injection site (LEFT)). On 07-Mar-2021, the patient experienced VACCINATION SITE PAIN (Stronger pain at injection site (LEFT)). On 08-Mar-2021, the patient experienced FATIGUE (Fatigue). On 09-Mar-2021, the patient experienced VACCINATION SITE RASH (Rash increasing from 1' to 3" left arm). On an unknown date, the patient experienced ANXIETY (Anxiety). On 10-Mar-2021, DYSGEUSIA (Taste metal), VACCINATION SITE PAIN (Pain at injection site (LEFT)) and VACCINATION SITE PAIN (Stronger pain at injection site (LEFT)) had resolved. At the time of the report, TONGUE ULCERATION (Tongue ulcers), ANXIETY (Anxiety), FATIGUE (Fatigue) and VACCINATION SITE RASH (Rash increasing from 1' to 3" left arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment information was provided.
LITTLE SORENESS; This spontaneous report received from a patient 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 is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced little soreness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of little soreness was not reported. This report was non-serious. This case, involving the same patient is linked to 20211220462.
Patient came in for a 2nd dose vaccination and did not have his vaccination card.  He was given Pfizer for his 2nd dose and after receiving the vaccine indicated he had received Moderna for his first dose.
pt was in 21NOV94 for 2nd dose of DTP/HIB/OPV-no illness, no complaint & neg exam, develop nl, pt recvd vax 11AM & < 30 mins later exp crying & cont to cry-stopped crying about 11-12 hrs later;
Incorrect dose  of 1mL of Hepatitis B vaccine given to a 19 year old.
Confusion, Dizziness, NauseaVomiting, altered cognition, memory loss, burning sensation Narrative: treated with IV fluids
PATIENT WAS ADMINISTERED 0.8 ML OF THE PFIZER COVID VACINE INSTEAD OF 0.3ML  NO ADVERSE EVENT NOTED PATIENT WAS MONITORED FOR OVER AN HOUR.  HE WAS ADVISED TO HYDRATE .  FOLLOWED UP ON PATIENT OVER THE NEXT FEW DAYS - NO ADVERSE REACTIONS REPORTED
pt stated approx 4hr p/vax had swelling, redness & warmth lt deltoid to elbow & lt deltoid to neck nodes;
generalized sz, low grade fever 100.7;probable familial sz-many family members w/sz;
This case was reported by a physician via sales rep and described the occurrence of injection site erythema in an unspecified number of patients who received BEXSERO. On an unknown date, the patient received BEXSERO. On an unknown date, unknown after receiving BEXSERO, the patient experienced injection site erythema and injection site pain. On an unknown date, the outcome of the injection site erythema and injection site pain were unknown. It was unknown if the reporter considered the injection site erythema and injection site pain to be related to BEXSERO. Additional details were provided as follows: As per reporter, she was seeing more pain, redness at the injection than any other vaccine. This case has been linked with cases US2018GSK075115 and US2018GSK070534, reported by same reporter.
I experienced tingling and numbness which started next  to my left eye, and then it proceeded down my face and neck and shoulder. About 40 minutes later, it started going away in my shoulder then my neck and most of my face. The tingling and numbness remained next to my eye for over one hour.
Headache on right side; feels increased heart beat; dizziness, feeling of blacking out, stuffiness, cold sweat. BP118/80.   Improved over time but still some right headache & eyes "tired" @1:10pm @pick-up by husband. Transported to car via wheelchair.
1 of 2 pts vaxed from the same vial who exp inj site rxn;pt vaxed in AM by afternoon same day pt's arm was swollen, red, painful & warm extending from deltoid to forearm;no fever reported;recovered;
Within weeks my face broke out in painful sores. Was diagnosed and seen twice for Perioral Dermatitis, still on going. within 12 weeks I have had Hives covering my body most days. I've been prescribed a topical cream and taking a daily antihistamine. Have not had any luck getting it to go away. VERY UNCOMFORTABLE the past 6 months - I have never had skin issues in my life.
Parent reported the baby became less animated, no smiling or cooing, less eye contact the day of vaccine administration. Mother then reports infant developed some myoclonic movement (head turning, eyes now looking directly at parent) Seen in ED x 2 no interventions except exam and counseling seen by pedi neuro 8/2/2016 EEG reported normal. Baby has returned to baseline.
Patient seen 05/03/19 for right arm swelling, redness and warmth. Dx with cellulitis and given amoxicillin.
Blood in stool after receiving ROTATEQ vaccine (+) occult blood also. Blood in stool started 3 days after receiving vaccine. Still (+) occult blood on 09/26/16.