chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Excursion from the freezer/administered to 118 patients(01Nov2021- 53 given); This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Excursion from the freezer/administered to 118 patients(01Nov2021- 53 given)) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Nov-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Excursion from the freezer/administered to 118 patients(01Nov2021- 53 given)). On 01-Nov-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (Excursion from the freezer/administered to 118 patients(01Nov2021- 53 given)) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was given.  No treatment medication was given. There was an excursion from their freezer on 01Oct2021.   This case was linked to MOD-2021-383439 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-Nov-2021: Follow up received Added patient demography and vaccination information.
Skin start to have rash and very itchy, and then have open wound over the rash and that would not heal for over 8 months already.; Skin start to have rash and very itchy, and then have open wound over the rash and that would not heal for over 8 months already.; Skin start to have rash and very itchy, and then have open wound over the rash and that would not heal for over 8 months already.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46 year-old male patient received bnt162b2 (BNT162B2), administration date 30Mar2021 (Lot number: ER8732) as dose 1, single and administration date 20Apr2021 (Lot number: EW0161) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PRURITUS (non-serious), RASH (non-serious), WOUND (non-serious) all with onset 2021, outcome "not recovered" and all described as "Skin start to have rash and very itchy, and then have open wound over the rash and that would not heal for over 8 months already.". The event "skin start to have rash and very itchy, and then have open wound over the rash and that would not heal for over 8 months already.", "skin start to have rash and very itchy, and then have open wound over the rash and that would not heal for over 8 months already." and "skin start to have rash and very itchy, and then have open wound over the rash and that would not heal for over 8 months already." was evaluated at the physician office visit. Therapeutic measures were taken as a result of pruritus, rash, wound.  Additional information:The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient diagnosed with COVID-19. Since the vaccination, the patient been tested for COVID-19. The patient was treated with Medicine and skin cream for the adverse event.   No follow-up attempts are possible. No further information is expected.
Fussy x 1 wk after vaccines (8/5/08), blood in stool x 1 on 8/11/08, "runny stools" x few days.
Sore arm; This spontaneous case was reported by a non-health professional and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008BZIA) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The concomitant medications were not provided.  The treatment information was not provided.   This case was linked to MOD-2021-059904 (Patient Link).
This spontaneous report received from a patient concerned a 61 year old male. The patient's weight was 188 pounds, and height was 174 centimeters. The patient's concurrent conditions included non-alcoholic, and non-smoker, and other pre-existing medical conditions included no allergies, no history of drug abuse, no any other medical history or relevant pre-existing conditions, no any other medication at the time of adverse event started, no past history of similar event, no history of allergy to vaccine, drug, or food, no adverse event after any previous vaccination(s), no pre-existing acute illness 30 days prior to vaccination, no history of hospitalization in last 30 days, with cause, no family history of any disease (relevant to vaccination) or allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 09-MAR-2021 on muscle for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced very sick. On 14-MAR-2021, the subject experienced runny nose. On 14-MAR-2021, the subject experienced sore throat. On 14-MAR-2021, the subject experienced cough. On 14-MAR-2021, the subject experienced weakness. On 14-MAR-2021, the subject experienced mild nausea. On 17-MAR-2021, Laboratory data included: PCR (NR: not provided) Negative, and SARS-CoV-2 test (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from very sick, runny nose, sore throat, weakness, and mild nausea on 19-MAR-2021, and was recovering from cough. This report was non-serious.  Additional information was received from the patient on 22-Mar-2021. The following information was updated and incorporated into the case narrative: Reporter's details (first, middle and last name, address, city, zip code, state and phone number), patient's details (date of birth, gender, disease tab, age at the time vaccination, height and weight), social history, events added (cough), details for all events (outcomes, start and end date), site of vaccination, therapy start date and end date and lab data were added.
A chronic headache, tiredness and sleepiness for 12 days after vaccination. In ER, after MRI and CTI and blood tests, i was diagnosed with Migraine and sinusitis was prescribed
mom stated pt became purple from the waist down the evening p/the last vax; called PMD who thought a poss rxn to pertussis or sz was cause; rx for ped DT given;
has a temperature; Initial information received on 05-May-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 6 months old male patient who experienced has a temperature while receiving vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].   The patient's past medical treatment included HEPATITIS B VACCINE.  The patient's past medical history, vaccination(s) and family history were not provided.    On an unknown date, the patient received a  dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot number and expiry date was unknown not reported via unknown route in unknown administration site for Tetanus.  On an unknown date the patient developed a non-serious has a temperature (pyrexia) (unknown latency) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE.  Action taken with DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE (PENTACEL) was not applicable.  It was not reported if the patient received a corrective treatment for the event (has a temperature).  At time of reporting, the outcome was Not Recovered / Not Resolved for the event has a temperature.
Myalgia, Arthralgia, NauseaVomiting, Pain/Redness/Rash @ injection site Narrative:
Day following vaccination had low-grade fever the last 2 days.  Patient is most concerned with left ear pain, tinnitus, subjective difficulty hearing, axilla pain that occurred 3 days after and resolved within 1 week.
Pt come to VNA office 1/12 or 1/13 and said he still had soreness in right arm from pneumonia shot. He had been to see his doctor. His DR told him to get an x-ray first. Rx was dated 11/22/05. He still had not done so.
Soreness of upper arm left; Internittent headaches for 48 hours; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Soreness of upper arm left) and HEADACHE (Internittent headaches for 48 hours) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Soreness of upper arm left) and HEADACHE (Internittent headaches for 48 hours). At the time of the report, PAIN IN EXTREMITY (Soreness of upper arm left) and HEADACHE (Internittent headaches for 48 hours) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medication included Acetaminophen and light activity. No concomitant medication was provided
Mom brought baby in 6/26/13 with rash on legs. Previously received vaccines on 6/24/13. Dr Rx calamine lotion and TYLENOL if worse will come back 6/27 if not 6/28.
This spontaneous report as received from a registered nurse refers to multiple unspecified patients of unknown ages and genders. The patients' medical history and concurrent conditions were not reported. On unspecified dates, the patients were vaccinated with GARDASIL (lot #: K006960, expiry date: 19-FEB-2017) (route of administration: intramuscular) that had been improperly stored at a temperature of 47 F for a time frame of 74 hours (incorrect product storage). No adverse effects reported. The outcome of the events was unknown. Additional information has been requested.
headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 06Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset 06Apr2021, outcome "unknown", described as "headache".  Additional information: Callback to a consumer who stated "I just wanted to know if I can take Tylenol or Advil for a headache?".  Reporter stated that she received her first dose of Pfizer-Biontech Covid19 vaccine today. PQC was not present. AE present was reported as yes.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
The patient is breast-feeding her 10 month old son, and the child developed a persistent fever of 100 - 103 F. starting 12-24 hours after vaccination and still persisting on day #4 after vaccination.
I was perfectly fine after I got my shot (yay)! But then, I started around 9:30 PM when I was talking to my husband getting severe shaking/chills to the point where everything was shaking uncontrollably. I am also very weak, feel very cold, and have a headache. Pulse according to watch is 104 bpm. It is 11:00 pm now and I still have these symptoms. Warm blankets help.
Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Severe, Systemic: Allergic: Rash Generalized-Severe, Systemic: Body Aches Generalized-Severe, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Joint Pain-Severe, Systemic: Numbness (specify: facial area, extremities)-Severe, Systemic: Tingling (specify: facial area, extemities)-Severe, Systemic: Unable to Sleep-Medium, Systemic: Weakness-Severe
I had a severe prostate infection and the actual diagnoses inflammatory disease of prostate, I went to the emergency room because of high fever. I was given IV and that worked to get the white blood count and fever down. I was on antibiotic.
Pfizer covid vaccine given to 11 year old - when it was suppose to be 12 and older
This spontaneous report was received from a healthcare worker concerning an unspecified number of patients of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with a dose of RECOMBIVAX HB (dose, frequency, strength and route were not reported). Co-suspect and concomitant therapies were not reported. The healthcare worker reported that an unspecified number of patients (no patient information was known) was administered RECOMBIVAX HB, which was improperly stored outside the temperature storage range listed in the product inserts, on an unknown date. No adverse effects reported. Additional information has been requested.
4/11-4/17 Stiff neck and shoulders. Could hear whooshing sounds of my blood circulating at times squeaking sounds 3 different occasions. Thought I might have an ear infection and called Teladoc was prescribed Oxi Clav 825 mg . 2x day. 4/25-4/26 significant temporary loss of control of left arm and left  leg felt wobbly but intensity subsided to minor loss of mobile control.4/27 Left leg went totally numb from the knee down with no control couldn't wiggle toes , Left should went numb 2x left face went numb 1x Stroke, total blockage of left corroded artery
eyes became so dry; irritation on both corneas; welts on my right lower jaw; s first appeared as a rash, then a couple of big lumps that were very itchy; This spontaneous case was reported by a consumer and describes the occurrence of DRY EYE (eyes became so dry), CORNEAL IRRITATION (irritation on both corneas), URTICARIA (welts on my right lower jaw) and RASH PRURITIC (s first appeared as a rash, then a couple of big lumps that were very itchy) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     The patient's past medical history included Thyroid infection in 1985, Hypertension in 1990, Gout in 2019, Bone density abnormal, Pelvic pain in 2020 and Anxiety in 2019. Concomitant products included ASCORBIC ACID, BETACAROTENE, CUPRIC OXIDE, TOCOPHERYL ACETATE, ZINC OXIDE (PRESERVISION), VITAMIN B [VITAMIN B NOS], VITAMIN C [ASCORBIC ACID], VITAMIN D3, CALCIUM, MAGNESIUM and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced DRY EYE (eyes became so dry), CORNEAL IRRITATION (irritation on both corneas), URTICARIA (welts on my right lower jaw) and RASH PRURITIC (s first appeared as a rash, then a couple of big lumps that were very itchy). The patient was treated with DOXYCYCLINE ongoing since an unknown date for Rash, at a dose of 100 mg twice a day and METRONIDAZOLE ongoing since an unknown date for Rash, at an unspecified dose and frequency. At the time of the report, DRY EYE (eyes became so dry), CORNEAL IRRITATION (irritation on both corneas), URTICARIA (welts on my right lower jaw) and RASH PRURITIC (s first appeared as a rash, then a couple of big lumps that were very itchy) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, COVID-19: positive (Positive) did get tested and did get COVID.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       Con. med: Turmeric/ginger Treatment: ointment and artificial tears   Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2021: Follow up received on 21-Apr-2021 patient medical history and concomitant medications included.
I have been sick with Diarrhea; I have been sick with Diarrhea; Nausea; Fever; Have a bump; This is a spontaneous report from a contactable consumer. This consumer (patient) reported that:  A female patient of unspecified age had received dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch no/ Lot number: unknown), via an unspecified route of administration 20Aug2021, at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient had experienced I have been sick with diarrhea, nausea, fever and have a bump. At the time of reporting, the outcome of the events were unknown.  Information on the lot batch number has been requested.
This spontaneous case reported by a consumer, describes the occurrence of pyrexia (fever) in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced pyrexia (fever). At the time of the report, pyrexia (fever) outcome: unknown. No concomitant medication or treatment information reported. Reporter did not allow further contact.
patient received 3 doses; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date) and Shingrix (2nd dose received on an unknown date).   On 28th June 2021, the patient received the 3rd dose of Shingrix. On 28th June 2021, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacist stated that, the patient received 3 doses of Shingrix, which led to extra dose administered. No further details were provided at the time of the call. The health care professional was in a hurry and did not provide any patient demographics, vaccine information or consent. The reporter did not consent to follow up.
Vaccine dilution error.  The Pfizer vaccine was diluted with 1.5ml of the diluent NaCl 0.9% instead of the recommended 1.8ml.  The 0.3ml dose was given with this slightly higher concentration of vaccine.  Patient was contacted later the same day and he stated that he felt fine.
Redness & slight swelling on right arm. Using cool packs, ADVIL/TYLENOL.
Severe Body aches, muscle and joint pain, fever 102.5, daily migraines and fatigue . Took 800 mg Ibuprofen every 4-6 hours for 48 hours for pain and excedrin migraine 2 tabs every 12-24 for 48 hours for migraine. S
patient is experiencing soreness at the injection site; his daughter completed a three dose GARD A SIL vaccination series, two to three years ago. patient received a dose of GARDASIL 9, on 6/18/2020,; his daughter completed a three dose GARD A SIL vaccination series, two to three years ago. patient received a dose of GARDASIL 9, on 6/18/2020,; This spontaneous report was received from a pharmacist referring to his daughter, a 15-year-old female patient with coeliac disease and raynaud's phenomenon. The patient was not pregnant. The patient had no concomitant medication or drug reactions/ allergies.        In approximately 2017 (reported as two to three years ago), the patient completed a three dose quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) vaccination series (dose detail, frequency, route, lot# and expiration date were not reported) for prophylaxis. On 18-JUN-2020, the patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (0.5 mL, once, lot# 1637642 with expiration date unknown but upon internal validation established as 28-MAY-2022) intramuscularly for prophylaxis when it was believed that she had not completed the initial series with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) (inappropriate schedule of product administration and interchange of vaccine products). On the same day, the patient experienced soreness at the injection site.   The patient did not seek medical attention. No treatment was given for the event. The outcome of the event was not recovered. The causality assessment between two suspect vaccines and the event was not provided. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: 1637642; expirationdate: 28-MAY-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Pt. states that after receiving the 3rd Booster of Moderna 11/29/2021, started experiencing symptoms that evening of Chills, injection site higher than recommended, pain throughout the arm, and difficultly lifting arm (Left). No noted Primary visit/communications.
Gave powder reconstituted with sterile water; Gave powder reconstituted with sterile water; This case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 14-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA587A, expiry date 31st August 2022) for prophylaxis.   On 25th January 2022, the patient received Menveo. On 25th January 2022, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The patient received Menveo dose in left deltoid. The patient inadvertently administered the Menveo lyophilized powder reconstituted with sterile water, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter did not consent to follow up.
After about 10 minutes my left arm was sore, but my thumb on my left had got ?stuck/couldn?t move it for about 2 minutes? and after about 20 minutes my left ankle hurt and my upper right arm?which about 2 months ago I had an injection (NSAID )....I also got a headache in the hours to follow, took a regular Tylenol, a slight fever, chills....then by Monday(the shot was on Friday) the headache?which was left side, left eye, was dull and barely there?but my upper right arm then lower right arm was sore, my left thigh at the hip was sore.....
Followed Dr. orders of requested Rotavirus vaccination. Rotavirus vaccine administered at initial clinic well baby visit as 3rd dose. Mom informed day 1 post vaccine administration of unscheduled well visit vaccine per Dr. No reported adverse symptoms per Dr.
Pt. returned to office approximately 1 1/2 hr after receiving adtp & hib vaccine due to stiffening and flexing motion to body - especially in arms & neck that started 45 minutes after vaccine given.
Head ache with sharp pains Neck and shoulder pain Swollen and soreness left underarm Fatigue  Light headed  Nausea