chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Body aches; Muscle pain; Joint pain; Fatigue; Injection site swelling; Redness at the injection site; Tenderness to the touch at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE SWELLING (Injection site swelling), INJECTION SITE ERYTHEMA (Redness at the injection site), INJECTION SITE PAIN (Tenderness to the touch at the injection site), PAIN (Body aches) and MYALGIA (Muscle pain) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension and Allergy.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced INJECTION SITE SWELLING (Injection site swelling), INJECTION SITE ERYTHEMA (Redness at the injection site) and INJECTION SITE PAIN (Tenderness to the touch at the injection site). On 22-Jan-2021, the patient experienced PAIN (Body aches), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain) and FATIGUE (Fatigue). The patient was treated with NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency. At the time of the report, INJECTION SITE SWELLING (Injection site swelling), INJECTION SITE ERYTHEMA (Redness at the injection site), INJECTION SITE PAIN (Tenderness to the touch at the injection site), PAIN (Body aches), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
After the MODERNA booster, my 3rd shot I had the normal mild side effects for 1 day, fever, chills. But after 2 days I started developing numbness in my toes and feet, specifically the bottoms and pads of my feet and toes. It has grown debilitatingly worse. I contacted my family physicians and due to being overweight, they set up a blood panel for me to test my sugar, glucose, thyroid, vitamin D/ B12 etc. All tests came back normal. It's now been more than a month and I cannot feel my toes. It's very bad in the morning, total numbness and changes a bit throughout the day. it's been excruciating. I've also started having some random joint pain, hips, shoulders, elbows etc.
Syncope episode after MENACTRA vaccine admin. Placed head between knees, gave cool compress, with immediate improvement. Color pale, skin moist. 10:33 B/P 81/49 P. 44 10:36 B/P 106/74 P. 53 10:45 B/P 111/77 P. 55 Color pink, skin dry - stated feeling "OK now".
Hurt, ache all over body - weakness, low energy to get around walking,  1st night threw up  arm hurt into back of shoulder 1.5" round pink at injection site - which seemed higher up on arm than usual...closer to shoulder Got booster on Thursday at 1:00 p.m...fine until early hours of next day with throwing up and painful aches....then sleep on and off all next 3 days with body aches all over. Little appetite or energy to make any food...but then mostly only wanted fruit. Today Tuesday, 4th day after feeling more like self...ache arm, some weakness.
This spontaneous report was received from a Licensed Practical Nurse concerning to a 20 year old female patient. Medical history, concomitant medication and concurrent conditions were not provided. On 27-NOV-2017, the patient was vaccinated with the first dose of VAQTA (adult dose) (dose, route, frequency, lot# and the expiration date were not reported) for prophylaxis. On 19-JUN-2018, the patient was inadvertently administered a second dose of VAQTA (pediatric dose) (underdose) lot # N026997, the expiration date: 10-NOV-2018 (dose and route were not reported). No adverse effects.
itching; more bumps as the days go on; headaches; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PRURITUS (itching), RASH (more bumps as the days go on) and HEADACHE (headaches) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     No historical conditions were reported.  Concomitant products included VITAMIN D [VITAMIN D NOS] for an unknown indication.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced HEADACHE (headaches). On 16-Feb-2021, the patient experienced PRURITUS (itching) and RASH (more bumps as the days go on). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency; HYDROXYZINE for Itching, at an unspecified dose and frequency and TRIAMCINOLONE (topical) for Rash, at an unspecified dose and frequency. At the time of the report, PRURITUS (itching), RASH (more bumps as the days go on) and HEADACHE (headaches) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant drugs include blood pressure medication and cholesterol medication.
adenopathy - swelling of nose, above the clavicle, near to shoulder; severe allergic reaction to food and drinks; A spontaneous report was received from a healthcare professional concerning  his wife, a 57-year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced swelling of nose (swelling), adenopathy-swelling above the clavicle, swelling near to shoulder(vaccination site lymphadenopathy) and severe allergic reaction to food and drinks(food allergy).  The patient's medical history was not provided. The relevant concomitant medications use was not reported.  On 29 Dec 2020, prior to the onset of the events, the patient received her first of the two planned vaccine doses of mRNA-1273 (Lot number: unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On unspecified date, after vaccination the patient experienced adenopathy-swelling of nose, swelling above the clavicle, swelling near to shoulder and had severe allergic reactions to food and drinks. The patient has been to the emergency room twice and has seen a local immunologist.  Treatment for the event was provided included prednisone.   Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events, swelling of nose (swelling), adenopathy-swelling above the clavicle, swelling near to shoulder(vaccination site lymphadenopathy) and severe allergic reaction to food and drinks(food allergy), were considered unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
multiple outbreaks of herpes, herpes zoster; postherpetic neuralgia; dysphonia; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown gender who was approximately 75-year-old at the time of this report. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 29-NOV-2012, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, lot # and expiration date were not specified) for the long-term prevention of shingles and zoster-related conditions at a pharmacy. On an unspecified date, the patient was treated by healthcare providers for multiple outbreaks of herpes, herpes zoster, postherpetic neuralgia, and dysphonia. The outcome of the events was not reported. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).
foot started hurting really bad; I just got rid of planter fasciitis and may be it came back; I noticed a spot on my foot that coincided with a sting ray bite I had last summer; tendered and it was itchy; foot was swollen; tendered and it was itchy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71 year-old patient received bnt162b2 (BNT162B2), administration date 23Aug2021 (Batch/Lot number: unknown) at the age of 71 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Blood pressure" (unspecified if ongoing); "Cholesterol" (unspecified if ongoing); "Allergy" (unspecified if ongoing); "planter fasciitis" (unspecified if ongoing), notes: I just got rid of planter fasciitis. The patient took concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 Immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "foot started hurting really bad"; PLANTAR FASCIITIS (non-serious), outcome "unknown", described as "I just got rid of planter fasciitis and may be it came back"; PIGMENTATION DISORDER (non-serious), outcome "unknown", described as "I noticed a spot on my foot that coincided with a sting ray bite I had last summer"; TENDERNESS (non-serious), PRURITUS (non-serious), outcome "unknown" and all described as "tendered and it was itchy"; PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "foot was swollen".  Additional information: The patient had shots like two Mondays ago/ couple of weeks ago. The patient also reported that the second dose was on 23rd\ 23Aug. The patient noticed a spot on foot that coincided with a sting ray bite that the patient had last summer, and everything towards the sting ray bite my foot was swollen, it was tendered and it was itchy and the patient wondered why that happened as that was a really old bite. Patient height: was reported as 5,10 or 11. The patient took allergy medication, blood pressure medicine and cholesterol medicine (medication name not clarified further).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Prolonged menstrual bleeding (24 days): stopped only after my PCP prescribed Provera  That said, would still get the vaccine if I had to do it over.
type 1 diabetes/ ended up in the ICU; Diabetic ketoacidosis; got very ill and he looked liked a skeleton; This is a spontaneous report from a contactable consumer. A 16-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 03Jun2021 (Batch/Lot Number: EW0180) as DOSE 1, SINGLE; and dose 2 via an unspecified route of administration, administered in Arm Right on 25Jun2021 (Batch/Lot Number: EW0196) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included Family history of diabetes. The patient's concomitant medications were not reported. Her son went into the ICU on 28Jul2021. It was stated that her son, got the Pfizer Covid vaccine in 03Jun2021 and on 25Jun2021 and a month later he ended up in the ICU and she highly suspects it was the vaccine that caused this. Calling so that she can report that now he has Type 1 Diabetes and has to be on insulin. He was a perfectly fine and healthy child. He had Diabetic ketoacidosis and ended up on insulin and ended (withheld)  hospital. They were at  and he got very ill and he looked liked a skeleton. They transferred him to Dr. (withheld) hospital and then was transferred to (withheld) ICU.  He was discharged on 30Jul2021. Went into diabetic ketoacidosis on the 28th and they did blood work and all that stuff. They started him on insulin on that same evening to bring down his blood sugar. It was at 688 and when he started on the insulin, little by little it brought the blood sugar down. Not sure what insulin was given in hospital in the IV and unable to provide NDC, Lot, or expiry, but thinks it's the same as what's given since he has been using at home, but not really sure. He now is taking Novolog for meals, fast release, and it's based on his carb input. It depends on how much he is eating right now, so he takes about 7 units in a pen. When it's very high he ends up getting up to 10 units. He uses Lantus for the evening/bedtime , a slow release, which he uses once daily. When he started on the insulins it started bringing the blood sugar down and the next day he saw the nurse practitioner and they were not sure that day about his diagnosis, which one he had. They fully diagnosed him with Type 1 diabetes on this past Tuesday, 03Aug2021. The event type 1 diabetes/ ended up in the ICU was assessed as life-threatening. The patient was hospitalized for the events from 28Jul2021 to 30Jul2021. The patient had lab data: blood sugar of 688 on 28Jul2021. The outcome of the event Type 1 diabetes was not recovered, while recovering for the other events. The patient received treatment for the events.
This spontaneous report was received from a Nurse refers to a 13-month-old patient of unknown gender. The patient concurrent conditions, medical history and concomitant medications were not reported. On an unknown date, the patient inadvertently administered together with PROQUAD lot # N029879 for prophylaxis and VARIVAX lot # M033907. No adverse effects reported. No product quality compliant (PQC) was reported.
Myalgia, Arthralgia, Fever, Diarrhea, CHILLS, SORE ARM, ARM PAIN Narrative:
This spontaneous report as received from a healthcare worker, refers to three patients of unknown ages and genders. No pertinent medical history, concurrent conditions or drug reactions/allergies were reported. On 22-MAR-2016, the patients were vaccinated with an improperly stored dose of GARDASIL 9, which had a lot # of L016428 and an expiration date of 30-AUG-2017 (dose, dosage number, route of administration and anatomical location were not reported). It was stated that the temperature excursion was 28.9 for a time frame of 7 hours. This excursion was found due to a data logger. Additionally, it was stated that no previous temperature excursions had occurred. This is one of the several reports received from the same reporter. Additional information has been requested.
pt reports ringing in his ears that has been occurring intermittently. This started two days after his vaccination (1st dose Moderna). He says that at times it goes away and then comes back. He said that last night the ringing was so bad he was not able to sleep.
Dizziness; Breastfeeding; Fever 103.5 F on Forehead and 105.7F in the Ear. (After Second Vaccine); Chills; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), EXPOSURE VIA BREAST MILK (Breastfeeding), PYREXIA (Fever 103.5 F on Forehead and 105.7F in the Ear. (After Second Vaccine)) and CHILLS (Chills) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-May-2021, the patient experienced DIZZINESS (Dizziness), EXPOSURE VIA BREAST MILK (Breastfeeding), PYREXIA (Fever 103.5 F on Forehead and 105.7F in the Ear. (After Second Vaccine)) and CHILLS (Chills). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, DIZZINESS (Dizziness), EXPOSURE VIA BREAST MILK (Breastfeeding), PYREXIA (Fever 103.5 F on Forehead and 105.7F in the Ear. (After Second Vaccine)) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-May-2021, Body temperature: 103.5f on forehead (abnormal) 103.5F on forehead. and 105.5f tympanic (abnormal) 105.5F tympanic.         No relevant concomitant medications were reported.  Action taken with mRNA-1273 in response to the events was not applicable.    This case was linked to MOD-2021-110294 (Parent-Child Link).   See case MOD-2021-110294 for details regarding the child case.
The infant initially had a fever and arthralgia for 2 days after immunization, progressing to bilateral otitis media, coryza, and anorexia. The patient had a rash on her face, GU region spreading to the trunk area with appearance of white spots on her oral mucosa, resolution of fever. Presently with fading rash and bilateral otitis media.
Fainting; This serious case was reported by a consumer via interactive digital media and described the occurrence of fainting in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced fainting (Verbatim: Fainting) (serious criteria GSK medically significant). The outcome of the fainting was not reported.   It was unknown if the reporter considered the fainting to be related to Arexvy.     It was unknown if the company considered the fainting to be related to Arexvy.  Additional Information: GSK Receipt Date: 09-OCT-2023 This case was reported via interactive digital media. The follow-up could not be possible as no contact details were available.
"flu like" symptoms; Body aches; fever; fatigue; nausea; Weird voice; Sensation that something is stuck on her back throat; Back throat felt warm/ burning; Constriction in throat; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of THROAT IRRITATION (Back throat felt warm/ burning), THROAT TIGHTNESS (Constriction in throat), PAIN (Body aches), INFLUENZA LIKE ILLNESS ("flu like" symptoms) and DYSPHONIA (Weird voice) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Addison's disease and Food allergy (several; unspecified). Concomitant products included HYDROCORTISONE for Addison's disease, LEVOTHYROXINE for Hypothyroidism, FLUDROCORTISONE for an unknown indication.    On 04-Jan-2021 at 12:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jan-2021, the patient experienced THROAT IRRITATION (Back throat felt warm/ burning), THROAT TIGHTNESS (Constriction in throat), DYSPHONIA (Weird voice), OROPHARYNGEAL DISCOMFORT (Sensation that something is stuck on her back throat) and NAUSEA (nausea). On 05-Jan-2021, the patient experienced PAIN (Body aches), INFLUENZA LIKE ILLNESS ("flu like" symptoms), PYREXIA (fever) and FATIGUE (fatigue). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 04-Jan-2021, THROAT TIGHTNESS (Constriction in throat) had resolved. On 08-Jan-2021, PAIN (Body aches), INFLUENZA LIKE ILLNESS ("flu like" symptoms), PYREXIA (fever) and NAUSEA (nausea) had resolved. On 11-Jan-2021, THROAT IRRITATION (Back throat felt warm/ burning), DYSPHONIA (Weird voice) and FATIGUE (fatigue) had resolved. At the time of the report, OROPHARYNGEAL DISCOMFORT (Sensation that something is stuck on her back throat) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Severe lower back pain. Went to ER almost two weeks later. MRI results showed two herniated discs in lumbar region. Lost sensation in left leg and foot. Could not get out of bed for one week. Needed aid of a walker and cane for three weeks. Prescribed prednisone, Flexeril, and 600 mg ibuprofen. Pain has subsided, but is still there. Top of the foot is still numb. Able to walk on his own now, but residual pain in lower pain limits physical activity.
This spontaneous report as received from a healthcare worker refers to a male patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported. The patient had completed both VAQTA, (dose, lot # and route not reported) and RECOMBIVAX HB (dose, lot # and route not reported) series on an unspecified date. On 08-APR-2015, the patient was inadvertently vaccinated with an extra dose of both VAQTA, (dose, lot#, expiration date, route and injection site were not reported) and RECOMBIVAX HB, (dose, lot#, expiration date, route and injection site were not reported). This is one of several reports received from the same reporter. No adverse effects were reported. Additional information has been requested.
This spontaneous case, initially received on 02-Nov-2016, was reported by a health professional and concerns a 43 year old patient. Weight: not provided; Height: not provided. Concomitant medication: Not reported. Administration of company suspect drug(s): On 16-Sep-2016 the patient received AFLURIA. Dose regimen: Not reported, Route of administration: Intramuscular. Batch number: WT54306. No additional suspect drugs. Adverse event description: On 23-Sep-2016, a nurse reported that a refrigerator went in and out of (temperature) range while there was flu vaccine in it. On 16-Sep-2016, doses were administered (special circumstances: drug administration error without adverse event, incorrect product storage without adverse event). Flu vaccine was first delivered to the vaccination facility on 15-Aug-2016. As the nurse reviewed the refrigerator temperature log, she stated that another excursion occurred on 15-Sep-2016. The doses arrived at 09:00 and were placed in a refrigerator that was at 10 degrees Celsius in the morning. Then the temperature remained at 9 degrees Celsius throughout the 15th and 51 doses were administered on the 16th at a flu clinic. The refrigerator was not back in range until 19-Sep-2016 at a temperature of 8 degrees Celsius. Temperature excursion identified: Log documentation reflected temperature excursions from 31-May-2016 to 23-Sep-2016 which ranged between 8 to 10 degrees Celsius. Vaccines had been given to patients between 31-May-2016 and 23-Sep-2016. On 04-Oct-2016, the remaining 42 doses of lot number WT54306 were discarded. The patients will be contacted for revaccination.
PAIN AFTER VACCINATION; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. 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 20-MAR-2021 to left elbow for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced pain after vaccination. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of pain after vaccination was not reported. This report was non-serious.
Received MMR on 6/4/21 approx 8 days later started having Joint pain  R base of r big toe r knee then left knee then hand bilateral .    Pain 1/10 scale_3-4/10 up to 5 _currently.  Was 8/10.    Now in b/l hands   Precipitating Factors___sleeping on the joints very stiff______very stiff in hands in the morning_exercise   Palliative Factors______Light exercising of hands Ice, motrin, needs to massage in the morning Self treating with Ibuprofen 600 mg bid  Is being referred to Rheumatologist through workers comp.