chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Couldn't walk; Trouble with fine motor skills; Trouble with balance; chills; Increased Fatigue; Injection pain; fever; This spontaneous case was reported by a consumer and describes the occurrence of GAIT INABILITY (Couldn't walk), FINE MOTOR SKILL DYSFUNCTION (Trouble with fine motor skills), BALANCE DISORDER (Trouble with balance), CHILLS (chills) and FATIGUE (Increased Fatigue) in a 50-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.     Concurrent medical conditions included Multiple sclerosis, Fatigue, Headache, Spasticity, Depression, Heartburn and Sleep disorder NOS.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced GAIT INABILITY (Couldn't walk), FINE MOTOR SKILL DYSFUNCTION (Trouble with fine motor skills), BALANCE DISORDER (Trouble with balance), CHILLS (chills), FATIGUE (Increased Fatigue), VACCINATION SITE PAIN (Injection pain) and PYREXIA (fever). At the time of the report, GAIT INABILITY (Couldn't walk), FINE MOTOR SKILL DYSFUNCTION (Trouble with fine motor skills), BALANCE DISORDER (Trouble with balance), CHILLS (chills), FATIGUE (Increased Fatigue), VACCINATION SITE PAIN (Injection pain) and PYREXIA (fever) outcome was unknown.        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.   Patient had medical history of excess fluid. No relevant concomitant medications were reported. No treatment medication was reported.
Information has been received from a physician concerning a 4 year old female who on 23-AUG-2007 was vaccinated with her second measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (Lot#654984/1169F). On 23-AUG-2007, the patient experienced injection site red macular rash and trailing rash down to the elbow. Medical attention was sought through the reporting physician. Subsequently, the patient recovered in about 5 minutes. The recovery status was unknown for the rash at the injection site but was not as bad as the initial rash. The physician also reported that, "the patient had a very fair complexion and did not know if that had something to do with it potentially." There was no product quality complaint. Additional information has been requested.
Patient states the rash didn't truly present itself until Sunday (10.6.19) morning and that it started to spread from the injection site around down to her armpit. Patient does have an appointment to be evaluated by her PCP today (10.7.19).
Patient received FLUZONE and PNEUMOVAX 23 on Monday 12/4/17. Patient developed a rash on Wednesday 12/6/17 that spread from the injection site to the patient's elbow.
Chills; Fatigue; Difficulty in breathing; Heart racing; Muscle Pain; Headache; A spontaneous report was received from a consumer concerning a 73-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events chills, fatigue, difficulty in breathing, heart racing, muscle pain, headache.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 24 Mar 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 003B21A) via unknown route in the left arm for prophylaxis of COVID-19 infection.  On 24 Mar 2021, the patient experienced the event(s) chills, fatigue, difficulty in breathing, heart racing, muscle pain, headache.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), chills, fatigue, difficulty in breathing, heart racing, muscle pain, headache was unknown.
Patient hospitalized several times within 6 weeks of receiving COVID vaccination. DOS include 3/19/2021, 3/26/2021, 3/28/2021, 3/31/2021, 4/6/2021, 4/9/2021, 4/13/2021, 4/14/2021. Patient received second dose of covid vaccine 4/19/2021. On 4/20/2021 patient presented to the ED and was subsequently hospitalized. All of these visits were related to alcoholic cirrhosis of liver with ascites.
Information has been received from a physician concerning a 12 month old pt who on 1/3/01 was vaccinated with MMRII. On 1/6/01, the pt experienced severe angioedema with a serum sickness-like component. The pt was treated with prednisolone sodium phosphate (Pediapred) 10mg po bid for 2 weeks and recovered. The pt had a similar experience following exposure to MMRII (MSD) (WAES 01042108). Upon internal review the pt's experiences were considered to be "Other Medical Events". Additional information has been requested.
slightly less terrible reaction to the second shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (slightly less terrible reaction to the second shot) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (slightly less terrible reaction to the second shot). At the time of the report, VACCINATION COMPLICATION (slightly less terrible reaction to the second shot) outcome was unknown.            Patient stated she had a immunoglobulin deficiency, and that might have affected the way her body reacted to the vaccine.  Concomitant medication were not reported.  Treatment information was not provided.   This case was linked to MOD-2021-022457 (Patient Link).
This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) in a 68-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 00C21A2) for COVID-19 vaccination. No Medical History information was reported. On 29-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine). On 29-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were provided. No treatment medications were provided. The vaccines were stored in freezer, we took out one to two vials and placed in fridge each day as needed.
Heavy off cycle vaginal bleeding 1 week after normal period accompanied by breast swelling, severe weakness and bruising on the knee (not accompanied by any injury)...off cycle bleeding is not something that has ever occurred before so is highly unusual
Information has been received from a registered nurse concerning a 12 month old female, with no medical history and no known allergies, who on 15-JAN-2007, at 10:06 a.m. was vaccinated with a first subcutaneous dose in the right thigh of ProQuad (Lot# 655842/1330F). There was no illness at the time of vaccination and there were no adverse events following prior vaccination. It was reported that the patient woke up the following morning, on 16-JAN-2007, at 10:30 a.m., with a fever of 102.8. The patient was treated with TYLENOL and MOTRIN. It was reported that the patient also developed a large swelling and redness at the injection site. The fever lasted one day only and the patient was reported as recovery on 17-JAN-2007. Unspecified medical attention sought. No product quality complaint was involved. Additional information has been requested.
I had a severe case of Bell's Palsy  in 2014 and right side of face never fully returned to normal.   3 hours after my first vaccine (right side), I had numbness starting at my chin and going to my forehead.  This lasted about 3 hours.  I had no drooping or other symptoms on my face.  The numbness event left a deeper indentation  line of my chin. The other symptoms were chills and lower back ache that lasted a day.
Information has been received from a CMA concerning a female pt who was vaccinated in the left deltoid with a dose of pneumococcal 23v polysaccharide vaccine (Lot # 645853/0256N). One day post vaccination, the pt had a red, hot to touch, swollen left arm from the deltoid to the elbow, and she developed cellulitis.  The pt was treated with antibiotics and recovered.  Unspecified medical attention was sought. There was no product quality complaint. No other information was available. The records of testing prior to release of this lot have been checked by Quality Assurance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. The reporter also mentioned one other female who was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (Lot # 645853/0256N) and developed an adverse event (WAES # 0404USA02020).  The reporter expressed a concern regarding the lot #, requesting a lot check. Additional information has been requested.
Patient returned from outside at about 40 minutes after injection.  Symptoms included rash development on face and trunk, swelling of face and lips and slight shortness of breath.  One adult epipen was administered and EMS was called (9:15 am).  Fire Dept arrived approximately 10 minutes later and EMS followed.  Symptoms were subsiding and pt refused transit with EMS.  Patient received ride with parent to ER
Dizziness From initial information received on 10/28/2003 from a health care professional regarding an adverse event occurring in the U.S.A., it was reported that a 38 year old female patient received a dose of FLUZONE SV '2003-'2004 USP, lot number U1132AA, administered intra-muscularly in the left deltoid on 10/28/2003. Within three minutes of vaccination, the patient felt dizzy and light headed and fell to the floor. She was taken to the emergency room via wheelchair. The patient's recovery status is currently unknown.
suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional Information: GSK Receipt Date: 17-SEP-2023 This case was reported by a patient via interactive digital media. The patient stated that, he/she was stupid enough to take that vaccine (Shingles vaccine) and got shingles just like that. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
turned pale & blue around lips;eyes rolled up;body turned red waist down;redness & induration of lt thigh;referred to MD;
Mother returned to clinic 2 days after vaccination with child. Child had sever inflammation of R deltoid where DTaP was given.
02/26/20 itching the afternoon of vaccination, 02/27/20 hives and itching on head neck but not at injection site. 02/28/20 hives coming and going on back. No respiratory issues throughout. 03/01/20, petting her dog, hives on her hands.
Patient received PCV vaccine on 12/17/13 and 3/18/14. Patient had 2 inch wide red swollen spot at injection site after both. But, after 3/18/14 injection, swelling and "wheal" came back on 4/4/14, 4/10/14, and 4/18/14 (one month later). She also developed Pneumonia 4 days after vaccine, diagnosed 3/23/14 and was very sick for a month.
no adverse symptoms were reported; 1 patient was administered a dose of improperly stored VARIVAX on 04/20/2020; This spontaneous report was received from a licensed practical nurse concerning a currently 1 year old patient of an unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided.           On 20-APR-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) (strength, dose and route were not provided) lot# S002392 expiration date 23-JAN-2021 for prophylaxis.             On an unspecified date, digital data logger registered a temperature excursion between -14 Celsius degrees to -10 Celsius degrees (-10.7 Celsius degrees) for 20 hours and 20 minutes and another excursion between -9 Celsius degrees to 8 Celsius degrees (-0.7 Celsius degrees) for 16 hours.
Nauseated, feels extremely tired and sleepy, is sweating since one day after receiving vaccine. Has not taken any medicine for symptoms.States he had a flu shot at his private doctor on 10/18/06.
vial was initially stored in the refrigerator on 4Jun2022 and administration of vaccine on 14Jul2022; No adverse event; Administered the vaccine to 346 patients after the 30 day by used; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used), PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 4Jun2022 and administration of vaccine on 14Jul2022) and NO ADVERSE EVENT (No adverse event) in a 79-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 14-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 4Jun2022 and administration of vaccine on 14Jul2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used), PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 4Jun2022 and administration of vaccine on 14Jul2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used) and PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 4Jun2022 and administration of vaccine on 14Jul2022).    Concomitant medications were not reported.  They administered the vaccine to 346 patients after the 30 day by used and total Number of vials was 35. The vial did not undergo any temperature excursions. The vial was initially stored in the refrigerator on 4Jun2022.  Treatment medications were not reported.
3.5 days after vaccine i experienced chills, fever, fatigue, and vomiting/dry heaves, which lasted 2 days.  i did not seek medical attention.
He got the Johnson and Johnson shot. Soon after going to bed that night he vomited. The next day he felt tired and had little appetite.
Severe muscle aches; headache, major congestion and headache; Stomach pain; slight fever for about 4 hours; This is a spontaneous report from a contactable consumer, the patient. A 56-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 in the arm right on 08Apr2021 at 12:45 (at the age of 56-year-old) as a single dose for COVID-19 immunisation. Medical history included lupus, Sjogren's, migraine, and methicillin-resistant staphylococcus aureus infection (MRSA) and skin infection. The patient received unspecified medication within two weeks of vaccination. The patient had allergies to (unspecified) medications, food or other products. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 18Mar2021 at 12:30 (at the age of 56-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. The patient did not receive any other vaccines within four weeks prior to the vaccination.  On 08Apr2021 at 19:00, the patient experienced severe muscle aches, headache, stomach pain, major congestion and headache and a slight fever for about 4 hours. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of the events and included treatment with lidocaine and ibuprofen. The clinical outcome of the event slight fever was recovered on 08Apr2021 and of the severe muscle aches, stomach pain, headache, major congestion and headache was not recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
about 5 minutes after receiving injection, patient's BP dropped. She was sitting when it happened and we rushed over to put feet up. She was non-responsive for about a minute and then started to come back for syncope episode. Water was provided until ambulance arrived to check on patient.
received expired vaccine; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 73-year-old male patient who received HAV (Havrix) (batch number KM72C, expiry date 18th June 2022) for prophylaxis.   On 20th June 2022, the patient received Havrix. On 20th June 2022, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 21-Jun-2022 Reporter's Comments: The reporter stated that a patient received Havrix expired vaccine. The reporter consented to follow up via email. Additional Supportive Information: The patient received Havrix expired vaccine with expiration date: 18th June 2022, which led to expired vaccine used.
Mild allergic reaction; 6-inch long rash below the injection site; Mildly itchy (rash); This case was reported by a consumer via call center representative and described the occurrence of rash in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th July 2022, the patient received the 1st dose of Shingrix (intramuscular). On 15th July 2022, 4 days after receiving Shingrix, the patient experienced rash and itchy upper limbs. On an unknown date, the patient experienced allergic reaction. On 19th July 2022, the outcome of the rash and itchy upper limbs were recovered/resolved. On an unknown date, the outcome of the allergic reaction was unknown.   The reporter considered the rash to be related to Shingrix. It was unknown if the reporter considered the itchy upper limbs and allergic reaction to be related to Shingrix.     Additional Information: GSK Receipt Date: 22-SEP-2022 Reporter's comment: This case was self-reported by patient. The patient received the first dose of Shingrix intramuscularly on right deltoid. Less than 3 months after vaccination, the patient developed delayed mild allergic reaction to Shingrix.  After 4 days of the injection, the patient developed a 6-inch long rash below the injection site, located a couple inches below the right shoulder, which was mildly itchy and lasted a couple days. It was mostly gone by 18th July 2022 and it was completely gone by 19th July 2022.  The reporter consent to follow up.
Blood clots in her lungs; Respiratory arrest; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP), Program ID.  A female patient (not pregnant) received bnt162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1, single; lot number: unknown), for COVID-19 immunization. The following information was reported: The spouse reported that his wife (patient) died after receiving her second shot of Pfizer's vaccine. She spent weeks in the hospital for blood clots in her lungs. She died a few months later of respiratory arrest. Her reaction to the vaccine was reported to VAERS and they were told to report to CICP. Their time limit ran out waiting for all the doctors and hospital reports. So they have been left with no choice but to start legal action against Pfizer. The outcome of event "Respiratory arrest" was fatal while the outcome of event "Blood clots in her lungs" was unknown. The patient date of death was unknown. Reported cause of death: "Respiratory arrest". It was not reported if an autopsy was performed.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Reported Cause(s) of Death: Respiratory arrest
12 year old patient received Pfizer dose for 5-11 years at 4:32pm on 2.11.22. Patient was not revaccinated. Observed patient for 15 mins. Let patient's parent know for his 2nd dose he would receive Pfizer for 12+. apologized to patient and parent.
arm swollen; hardness; no hungry; felt not good; chills; little headache; nauseas; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (arm swollen), INDURATION (hardness), DECREASED APPETITE (no hungry), MALAISE (felt not good) and CHILLS (chills) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 on 13-Dec-2020. Concurrent medical conditions included Hypothyroidism. Concomitant products included LEVOTHYROXINE for Hypothyroidism.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, the patient experienced PERIPHERAL SWELLING (arm swollen), INDURATION (hardness), DECREASED APPETITE (no hungry), MALAISE (felt not good), CHILLS (chills), HEADACHE (little headache) and NAUSEA (nauseas). On 27-Mar-2021, HEADACHE (little headache) had resolved. At the time of the report, PERIPHERAL SWELLING (arm swollen), INDURATION (hardness), DECREASED APPETITE (no hungry), MALAISE (felt not good), CHILLS (chills) and NAUSEA (nauseas) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Dec-2020, SARS-CoV-2 test: positive Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Other Concomitant medication include medicine for blood clot, cholesterol statin, allergies, reflux and inhaler biold.  Treatment medication were not reported/unknown.   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Live follow up received on 10-May-2021: Updated Outcome of the Event chills, peripheral swelling, induration, decreased appetite, malaise, nausea from Unknown to Recovering. Patient declined for further followup.