chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a nurse concerning a 16 year old female with no pertinent medical history or drug reactions/allergies, who on unspecified dates was vaccinated with the first, second and third doses of Gardasil. There was no concomitant medication. On 01-JAN-2008 the patient experienced prolonged headache "after receiving the third dose of Gardasil." "As of 22-JAN-2008, the headache had not subsided". It was reported that the patient "did not receive the Gardasil at the office." No product quality complaint was involved. Medical attention was sought at the physician. Additional information has been requested. Follow-up received 04/16/2008. The patient complained of severe prolonged headache for 3 weeks following the third dose of Gardisil vaccine on 02-JAN-2008. On 22-JAN-2008 the patient was seen in the office. The patient's body temperature was 97.9 degrees C and the blood pressure measurement was 112/62. The headache was in the eye area and at the top of the head. The patient was not getting headaches in the AM but in themiddle of the day and last til the evening. The headache sometimes resolved with sleep. Acetaminophen hcl (TYLENOL) helps. The patient limits activity. Throbbing and squeezing. The patient has had n o tress, no nausea or vomiting, no visual changes. Hard to concentrate no clumsiness. No fever/URI/cough. Her menses is regular. Eyes hurt but not watery. There is no prior history of headaches.On 30-JAN-2008 the patient stated that her headaches have improved. No product quality complaint was involved. Additional information is not expected.
patient was home sick with the flu; Initial information received on 14-Oct-2020 regarding an unsolicited valid non-serious case received from a non-health care professional via digital media through social media.  This case is linked to cases 2020SA291094 (same reporter).  This case involves a patient (age and gender unknown) who had home sick with the flu (influenza), while the patient received vaccine Influenza vaccine.  The patient's medical history, past medical treatment(s), concomitant therapy, vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect Influenza Vaccine produced by unknown manufacturer (lot number and expiry date not reported) via unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, (latency: unknown) after starting the suspect vaccine therapy, within 2 days ,  the patient had home sick with the flu (influenza) .  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the event was unknown.   There will be no information available on batch number for this case.
The ActHIB vaccine had an expiration date of 3/16/2023 and was not promptly removed from the fridge at the end of the business day nor at the beginning of the next day. At around 11am on 03/17 a clinic nurse pulled the expired vaccine that their patient was due for, and did not check the expiration date. Around 3:30pm an immunization nurse realized the expired ActHIB vaccine had remained in the fridge and immediately removed the vaccine. The nurse checked the vaccine reconciliation form and noticed that a dose had been pulled for administration. The clinic nurse upon attempted to chart the dose noticed that it was not an option in the vaccination dropdown selection. The nurse alerted the primary immunization nurse, and after a brief discussion the conclusion was made that the patient received an expired dose, 0.5mL, of the ActHIB vaccine.   To this nurse's knowledge the patient did not experience serious complications.
Information has been received from a physician concerning a patient who was vaccinated with a dose of Rotateq. Subsequently the patient experienced hematochezia. Upon internal review, hematochezia was considered to be an other important medical event. Additional information has been requested.
got metallic taste in mouth that went straight to tongue; Chills; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (got metallic taste in mouth that went straight to tongue) and CHILLS (Chills) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     The patient's past medical history included Anaphylactic reaction (random anaphylactic reactions). Concurrent medical conditions included Asthma and Taste altered (tongue gets really funny when eats acidic things, and things like walnuts).    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced DYSGEUSIA (got metallic taste in mouth that went straight to tongue) and CHILLS (Chills). At the time of the report, DYSGEUSIA (got metallic taste in mouth that went straight to tongue) had resolved and CHILLS (Chills) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant and treatment were reported.   This case was linked to MOD-2021-101854 (Patient Link).
She got her vaccine, she started to get hives on her neck and on the back of her neck, and then her face started to swell up when she woke up on 6/7/21 , and every day it seems to get worse to a point that she cannot even see, and can barely talk.   Her throat is swelling.   She went to the ER and they gave her antibiotics and Hydrocortisone, which are not helping and is actually getting worse.  She has an appointment today with a dermatologist.  Yesterday she went online to see the side effects and saw that swollen face is one of them.  She informed them that she had the vaccine and they didn't listen to her when she informed them of that.
Information has been received from a registered nurse referring to patient of an unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or drug reactions/allergies. On 25-JAN-2019, the patient was vaccinated with one dose of improperly stored M-M-R II with lot number R001659 and expiration date on 17-JAN-2020, administered for prophylaxis (strength, dose, route of administration and anatomical injection site were not reported)  It was reported that on an unknown date, the vaccine was exposed to a temperature excursion above 47 Fahrenheit degrees for 1 hour and 27 minutes time frame. There were not previous temperature excursions. The call was placed because of a Digital Data logger report. No adverse effect was reported.
Has pain in arm and fever, fever subsided with TYLENOL and MOTRIN, still has pain in arm 2 days later, told patient it was probably the pneumonia shot causing pain in arm told patient if it doesn't go away in a few days, may need to see dr to be evaluated.
Moderna COVID-19 vaccine had a storage excursion and was kept in the fridge for 31 days instead of the recommended 30 days. Analysis by Moderna indicated the lot of vaccine maintained the activity necessary to protect against SARS-Cov2 at the time of administration. No adverse events reported beyond normal s/e from vaccine.
This spontaneous report was received from a licensed practical nurse and refers to a 13 year old patient of unknown gender. No information about the patient's pertinent medical history, concurrent conditions and concomitant medications was reported. On 24-MAR-2016, the patient was vaccinated with an improperly with an improperly stored dose of GARDASIL 9 lot # L044475, expiry date 12-MAY-2017 (dose, frequency, route of administration and anatomical location were not specified). It was not reported if it was first, second or third dose of GARDASIL 9. The administered dose underwent temperature excursion at 1.5 Celsius degrees for 15 minutes. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
stomach ache; trouble sleeping; severe fatigue; headache; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (stomach ache), INSOMNIA (trouble sleeping), FATIGUE (severe fatigue) and HEADACHE (headache) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included CITALOPRAM, COLECALCIFEROL (VIT D [COLECALCIFEROL]), FAMOTIDINE, LISINOPRIL, RISEDRONATE SODIUM (RISEDRONATE) and SIMVASTATIN for an unknown indication.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Feb-2021, the patient experienced ABDOMINAL PAIN UPPER (stomach ache), INSOMNIA (trouble sleeping), FATIGUE (severe fatigue) and HEADACHE (headache). The patient was treated with CALCIUM CARBONATE, FAMOTIDINE, MAGNESIUM HYDROXIDE (PEPCID COMPLETE) for Stomach ache, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency. At the time of the report, ABDOMINAL PAIN UPPER (stomach ache) had resolved and INSOMNIA (trouble sleeping), FATIGUE (severe fatigue) and HEADACHE (headache) outcome was unknown.
Temp 101.7  Headache   Body ache  Runny nose Chills on and off    No taste  Nauseated  Dizziness
Vaccine was stored on refrigerator on 29-Oct-2021 and then administered on 08-NOV-2021; 606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine was stored on refrigerator on 29-Oct-2021 and then administered on 08-NOV-2021) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored on refrigerator on 29-Oct-2021 and then administered on 08-NOV-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine was stored on refrigerator on 29-Oct-2021 and then administered on 08-NOV-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication reported. On 29 Oct 2021, the vial was placed in the refrigerator. The vial did not have any temperature excursion and the patient had no adverse event. No Treatment medication reported.
This case was reported by a consumer and described the occurrence of loss of urine in a 5-year-old male subject who was vaccinated with ENGERIX B (GlaxoSmithKline). A physician or other health care professional has not verified this report. On 29 July 2014, the subject received 3rd dose of ENGERIX B (left arm). On 29 July 2014, less than one day after vaccination with ENGERIX B, the subject experienced loss of urine, incontinence, loss of bowel control and emotional, mental and physical tiredness. Subject's mother reported that her son received other vaccines on the same day, however she did not want to report the names of those vaccines. She also reported that her son was on other medications, however she did not feel that that information was relevant. She did not know the expiration date of vaccine, and also did not know the exact address for the facility. At the time of reporting, the events were worse.
Lump in throat; Pressure in sinuses and head; Pressure in sinuses and head; clogged ears; pain under left rib cage; off balance; tinnitus; brain fog; severe depression; anorexia; hot flashes; left eye twitch on and off; sore arm; bad cold symptoms; a low grade fever; bronchitis symptoms; Phelgm; post nasal drip; indigestion; This is a spontaneous report received from a contactable consumer (patient). A 56-year-old female non-pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EN6208, Expiration date was not reported), via an unspecified route of administration in arm left on 10Mar2021 at 11:30 AM (at the age of 56-year-old) as a dose number unknown, single for COVID-19 immunization. The patient's medical history included chronic obstructive pulmonary disease and known allergies: penicillin. The patient's concomitant medications received within 2 weeks of vaccination was reported as yes. It was reported that, the patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, has the patient been tested for COVID-19 was reported as yes. On 10Mar2021 at 11:30 AM, the patient experienced lump in throat, pressure in sinuses and head, clogged ears, pain under left rib cage, off balance, tinnitus, brain fog, severe depression, anorexia, hot flashes, left eye twitch on and off, sore arm. Then, she had bad cold symptoms for 4 days and then a low-grade fever with bronchitis symptoms for going on 12 days and not cleared up yet. Stated that, phelgm has been clear though so she thinks that was a reaction to the vaccine. Stated that, four days after vaccine, the patient used a saline nasal spray and it caused postnasal drip and indigestion on an unspecified date in 2021 and she was on for over 24 hours because of having to clear her throat. The reporter considered the seriousness of the events as non-serious. The adverse events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events postnasal drip and indigestion while for the other events was unknown. On 17Mar2021, the patient underwent lab tests and procedures which included Nasal Swab/PCR (SARS-CoV-2 test), resulted as negative on 23Mar2021, Nasal Swab/PCR (SARS-CoV-2 test), resulted as negative, covid test name post vaccination was PCR. The outcome of the events was not recovered.
Per pts husband, pt had been ? normal,? coking and even mowing the grass prior to receiving the covid vaccine. She started to hallucinate and eventually was admitted to our facility and diagnosed with acute encephalopathy. The pt went home on hospice and has since passed  Husband reports no one will listen to him regarding the events that took place.
Within an hour after the booster was taken, she developed fever, chills, fatigue, blurry vision, painful eyes, sweating, excessive post nasal drip and worsening anxiety. She was weak and could not go to work for 3 days. She reported that to me on 12/8/2021.
Patient presented to the ED and was subsequently hospitalized for Closed fracture of multiple pubic rami and Concussion with loss of consciousness of 30 minutes or less within 6 weeks of receiving covid vaccination.
Adverse event:  Chills (@ 12:45 a.m.) Treatment:   took 3 aspirin Time course:   lasted 3 hours. Outcome:  no current symptoms
Pt started feeling short of breath about 20 minutes after vaccine was administered. Husband honked horn from parking lot as instructed if any adverse reactions. Initial assessment: pt SOB, flushed, able to communicate, calm. 911 called and paramedics on scence in 1 minutes (we were at Firehouse for vaccine clinic). BP 179/68, HR 88, RR 28, Ox 99%. After monitoring, paramedics cleared patient to go home. Patient started feeling better after a few minutes of paramedics arriving. Encouraged by them to take Benadryl/Tylenol for any effects and to call 911 if she started to feel SOB again or had any other concerning symptoms. Husband and pt both verbalized understanding.
Cough; itchy eyes; aches; fatigue; vomiting; restricted breathing.
G62.9 PERIPHERAL NEUROPATHY 1/31/2023 IRON DEFICIENCY ANEMIA
patient was administered with liquid portion, with no AE; Initial information regarding an unsolicited valid non-serious case was received from a other health care professional via Global Medical Information (Reference number- 00401074) and transmitted to Sanofi on 21-Dec-2020.  This case involves a 7 months old male patient who received only the liquid portion of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (Lot number UJ342AAA, expiration date 22-Jun-2021, second dose, strength-standard) via intramuscular route in the right thigh for prophylactic vaccination on 17-Dec-2020 (product preparation issue).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) and INFLUENZA VACCINE INACT SPLIT 4V (FLUARIX QUADRIVALENT) for prophylactic vaccination.  It was a case of actual medication error due to Inappropriate reconstitution technique (latency-same day).  At the time of report, no adverse event was reported.  Reporter stated that while training new medical assistant (MA), got box of Pentacel. New MA gave only vial containing liquid portion (IPOL and Daptacel) and reporter did not check Pentacel box for any other components and just injected patient. Reporter discovered this error while documenting the dose when noticed that ActHB component was in the box. Reporter asked if the dose was valid and if patient need to revaccinate and when.   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 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.
pt recv vax 20JUN95 & 6 hr p/vax pt exp flu-like sx & heaviness in leg;sx resolved w/in 36hr w/o tx;
FULL BODY HIVES STEROIDS XOLAR IMENO THERAPHY SHOCK EPHY PEN
Initial information received on 15-Nov-2018 regarding an unsolicited valid non-serious case received from a non-health care professional (Office Staff). This case involves a 11 years old female patient who received vaccine DAPTACEL instead of vaccine ADACEL. The patients past medical history, concomitant medication and family history were not provided. On 14-Nov-2018, the patient received a 0.5ml dose of suspect DAPTACEL lot C5254AB, expiry date 15-Sep-2019 via intramuscular route in the left deltoid instead of suspect ADACEL lot number not reported. It was an actual medication error due to wrong vaccine administered and inappropriate age at vaccine administration. It was reported that 11-year-old patient received an injection of DAPTACEL when they should have received ADACEL. It was unknown whether patient experienced any adverse reaction after the injection. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the 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. List of documents held by sender- none.
Information has been received from a medical assistant concerning a 15 month old male patient with no known drug allergies or pertinent medical history who on 12-APR-2010, was subcutaneously vaccinated in the left upper arm with a 0.5 mL dose of VARIVAX (Merck) (Lot # 666044/1428Y). Secondary suspect vaccination included hepatitis A vaccine  (inactivate) (MSD). Subsequently, on approximately 12-APR-2010, the patient experienced red, raised areas "the size of a silver dollar" at the injection site of the left upper arm. On 26-APR-2010, the patient had an office exam. There were no lab tests performed. It was unknown if the patient required medical treatment. At the time of the report, the patient outcome was unspecified. Additional information has been requested. This is one of several cases reported by the same source.
Initial report received from a health care professional (medical assistant) on 11 Aug 2010: On 10 Aug 2010, this patient was vaccinated with 0.5 ml intramuscular dose of MenA conjugate component of MENVEO (batch number: 028011) that was diluted with a diluent for MMR vaccine. No adverse events were reported following this administration. Follow up report received from a health care professional (medical assistant) on 27 Aug 2010: Added patient information. This patient with medical history of asthma was previously vaccinated with DTAP vaccine on 24 Aug 1997, 28 Oct 1997, 29 Dec 1997, 19 Oct 1998 and on 02 Aug 2011. The patient also vaccinated with polio vaccine on 24 Aug1997, 23 Oct 1997, 29 Dec 1997 and on 02 Aug 2001. The patient had MMR vaccine on 30 Jun 1998 and on 02 Aug 2001. The patient received vaccination with Hib vaccine on 24 Aug1997, 27 Oct 1997, 29 Dec 1997 and on 19 Oct 1998. The patient received hepatitis B vaccine on 26  Jun 1997, 24 Aug 1997 and on 29 Dec 1997. The patient vaccinated with varicella vaccine on 05 Jul 1999 and second dose (batch number: 0847U, subcutaneously) in right arm on 07 Aug 2007. On 18 Dec 2003, patient was vaccinated with influenza vaccine. The patient received concomitant therapy with GARDASIL and BOOSTRIX on 10 Aug 2010. The outcome of event was reported as completely recovered.
Narrative:  Pt is a 51 y/o female who received the Janssen Covid vaccine on 4/10/2021. Provider contacted patient for post vaccine f/u on 4/16/2021. Pt reported acute side effects including chills, headache, and malaise that lasted 1-2 days post vaccination which resolved completely. Pt also reported beginning on 4/14/2021, she noticed new pain in her right leg located behind the right knee and into the calf, no sxs noticed in left leg. Pt denied any chest pain, headache, visual changes, or other neurological sxs. Discussion of rare incidence of blood clots following Janssen Covid vaccine occurred and was recommended to go to ER for further evaluation. Per 4/16/2021 addendum, pt went to ER and received a negative doppler. Per chart review, no noted s/ sx related to COVID-19 vaccination.
PATIENT PASSED OUT FOR ABOUT 10 SECONDS AND THEN REGAINED CONSCIOUSNESS.