chrisvoncsefalvay/vaers-outcomes huggingface dataset:
presented with Dehydration sec to nausea, vomiting and diarrhea. She was started on IVF with resolution of her symptoms and it was felt these are related to a viral infection. She did hyponatremia and hypokalemia. The former has now resolved and the later is being replaced. She tested positive for covid but with no pulmonary symptoms and no evidence of pneumonia on CXR or chest CT.
He has no immunity to the vaccine, his immunity is less than 1 .4.; This spontaneous report was received from a physician and refers to a 13-year-old male patient. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On an unknown date in 2008 and an unknown date in 2011, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) injection (dose number, dose, route of administration, anatomical location, lot # and expiration date were not reported for any) for prophylaxis. Then, on 21-SEP-2018 and on 26-OCT-2018, he received his dose of varicella virus vaccine live (oka/merck)(VARIVAX) injection (dose number, dose, route of administration, anatomical location, lot # and expiration date were not reported for any) for prophylaxis.  On an unknown date, the patient had "no immunity to the vaccine", his immunity was less than 1.4 (units not provided) (antibody test negative). It was also reported, that his ELIZA was negative and Measles, Mumps and Rubella was positive. The physician could not find more sensitive test.  The outcome of no immunity was not reported.  The causality assessment between the event of no immunity and varicella virus vaccine live (oka/merck)(VARIVAX) was not provided.
The evening after the am booster, I began having joint pains in my legs.  I awoke during the night with a fever of 102 with my normal temperature running at 97.8 and aching all over with a severe headache.  This condition lasted for two days and began to gradually resolve with first the fever going down and then the headache resolving and the body aches were the last to subside at about 4 to 5 days.  While I am able to eat, I have not experienced hunger in a normal manner since this booster injection.  I also went into a rheumatoid joint and tendon flare right after this booster injection but that could also be because of the season change and/or because of caring for an ill parent.  The flare is lasting longer than it has in the past and has yet to subside.
LARGE HIVE that got bigger as the day progresses. I had a large hive that went down my arm near my elbow. The injection site was hot, ichi, and painful to touch. This lasted for about 3 weeks and when I was mandated to take the second dose I had inform about mu reaction and was told that I should be fine... well when I received the second some hours about 3 hours later I began to have pain in my check and felt like I had a heavy baby laying on my chest and I had pain in my chest, I also had pain in my back and... I was also experiencing odd heart beats... injection site was very painful and hot, but what was scary wa the amount of visit to the er I had because of this vaccine... I never had any heart problems and now I am dealing with this because of this shot
PATIENT REPORTS OF GENERAL BODY WEAKNESS, FATIGUE, SORE ARM,REDNESS IN ARM,HEADACHE,FEVER. SYMPTOMS WERE TREATED WITH TYLENOL,AND BENADRYL TABLETS WITH MILD IMPROVEMENTS.
Narrative:  COVID vaccinated x 2 presented to hospital with recurrent falls and upper respiratory symptoms found to be COVID positive. Patient did have hx of COVID infection back in July 2020.
Throat/tongue swelling initially.  Took benadryl.  Next day, I was very weak, in/off heachache. Mild temperature.  Today is day 6 and I'm still very weak,  get light headed at times
Nausea, headache, chills, fever--onset two days after vaccine, symptoms lasted two days. A couple of days after that I had a bad rash covering neck, chest, and both arms. Doctor prescribed a steroid to alleviate symptoms.
Information has been received from a pharmacist via a company representative referring to a male patient of unknown age. Information about concurrent condition, medical history and concomitant medication was not provided. On an unknown date the patient was vaccinated with ZOSTAVAX (0.65 ml one time, subcutaneous; lot# and dose# unknown). On an unknown date following the vaccination, the patient experienced ophthalmic zoster. The patient had sought unspecified medical attention. The outcome of the event was unknown. Upon internal review, the event ophthalmic zoster was considered to be medically significant. Additional information has been requested.
Blockage in artery around the neck; Dizzniess; Eyes Watered Profusely; Eyes dont feel right; This spontaneous case was reported by a consumer and describes the occurrence of ARTERIAL OCCLUSIVE DISEASE (Blockage in artery around the neck), DIZZINESS (Dizzniess), LACRIMATION INCREASED (Eyes Watered Profusely) and OCULAR DISCOMFORT (Eyes dont feel right) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024C21A and 030B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-May-2021, the patient experienced DIZZINESS (Dizzniess), LACRIMATION INCREASED (Eyes Watered Profusely) and OCULAR DISCOMFORT (Eyes dont feel right). On 10-Jun-2021, the patient experienced ARTERIAL OCCLUSIVE DISEASE (Blockage in artery around the neck). At the time of the report, ARTERIAL OCCLUSIVE DISEASE (Blockage in artery around the neck), DIZZINESS (Dizzniess), LACRIMATION INCREASED (Eyes Watered Profusely) and OCULAR DISCOMFORT (Eyes dont feel right) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Jun-2021, Computerised tomogram: abnormal (abnormal) Patient detected with blockages in arteries around the neck.         No concomitant medication reported.  No treatment information was provided.  Company Comment : 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.   This case was linked to MOD-2021-079223 (Patient Link).; Sender'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.
Information has been received from a physician referring to an 18 years old female patient. The patient's medical history and drug reactions/allergies were unknown. Concomitant therapy included MENACTRA. In approximately 2016, the patient received a dose of GARDASIL (lot#, expiration date, dose and route were unknown) and a dose of VAQTA (lot#, expiration date, dose and route were unknown). After the administration, the patient passed out. The event happened so quickly. Unspecified treatment was given for the event. It was unknown if the lab diagnosis was performed. The outcome of passed out was unknown. The causality assessment was not reported. Upon internal review, passed out was determined to be medically significant. This is one of several reports received from the same reporter. Additional information has been requested.
pt recv vax & devel fever & fussiness p/vax in early 1990's;
None- vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 011J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported by reporter No treatment medications provided by the reporter.     This case was linked to MOD-2021-395985 (Patient Link).
p/recv vax pt exp a react; on alendronate the pt exp bloating & pt stomach hurt rt below rib cage; addl information indicated pt inj site rxn consisted of tenderness & slight swelling of arm;
Swelling under armpit; This case was reported by a consumer via call center representative and described the occurrence of swelling arm in a 53-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced swelling arm. On an unknown date, the outcome of the swelling arm was unknown.   It was unknown if the reporter considered the swelling arm to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient received vaccine in unknown arm. The patient had swelling under armpit on the same arm where the injection was given. The patient enquired whether this was normal side effect. The reporter requesting consent to follow up.
Patient received Fluzone influenza vaccine on 11/12/08 at 10:15 am.  On 11/13/08 patient returned to office with a local reaction on right thigh.  5 cm deep, 5 cm deep , 7 3/4 cm wide.  Deep red color, some tenderness, itching, warm to the touch.
Both of arms from top to wrist got warm; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Both of arms from top to wrist got warm) 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 23-Mar-2021 at 9:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FEELING HOT (Both of arms from top to wrist got warm). At the time of the report, FEELING HOT (Both of arms from top to wrist got warm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided by the reporter. No treatment information was provided by the reporter.
Received the contents of a full vial instead of just one dose/Patient was inadvertently given 2ml (whole reconstituted vial) of the 0.3 ml recommended dose of this vaccine; sore injection site; Fatigue; Chills; fever less than 5 hours; This is a spontaneous report received from contactable reporter(s) (Other HCP) from medical information team.  A 52 year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 03Dec2021 12:55 (Lot number: FJ1620) at the age of 52 years as dose 3 (booster), 2 ml single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Manufacturer unknown, Dose number: Unknown), for COVID-19 immunisation. The following information was reported: OVERDOSE (non-serious) with onset 03Dec2021, outcome "unknown", described as "Received the contents of a full vial instead of just one dose/Patient was inadvertently given 2ml (whole reconstituted vial) of the 0.3 ml recommended dose of this vaccine"; VACCINATION SITE PAIN (non-serious) with onset Dec2021, outcome "unknown", described as "sore injection site"; FATIGUE (non-serious) with onset Dec2021, outcome "unknown", described as "Fatigue"; CHILLS (non-serious) with onset Dec2021, outcome "unknown", described as "Chills"; PYREXIA (non-serious) with onset Dec2021, outcome "recovered" (Dec2021), described as "fever less than 5 hours". Therapeutic measures were not taken as a result of vaccination site pain, fatigue, chills, pyrexia. Additional information: The patient did provide information regarding the reported adverse event (s) with the use of the product. Vaccination facility Type was Health clinic.  Follow-up attempts completed. No further information is expected.  Follow-up (07Jan2022): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.  Follow-up (07Jan2022): This is a spontaneous follow-up report from a contactable Nurse. This Nurse reported in response to HCP letter sent via telephonic follow-up activity that included: No new information was updated.  Follow-up (09Feb2022):  This is a spontaneous follow-up report from a contactable Nurse. This nurse reported in response to HCP letter sent that included: New reporter, Patient information, RMH, Dosing regimen, New event (Vaccination site pain, Fatigue, Chills, Fever) and Treatment received added.  Follow-up attempts are completed. No further information is expected.
1 hr p/vax started crying frequently for 27 hrs; fever 101.2-102.4;
Whole body Numbness and tingling, loss of feeling of lower right arm and lower right leg. Loss of control of lower right arm. Extreme fatigue unable to get up and move at times. Very light headed and on the verge of blacking out.. possibly Loss of consciousness.  Extreme tightness in chest. Increase work of breathing. Confusion. Unable to keep eyes open and maintain alertness. Extremely tired   Symptoms have gotten a little better throughout the day of april 8th with lots of rest and very little physical activity.  I still have slight tightness in chest. Increase work of breathing. Still have tingling throughout body and am lightheaded. When doing any physical activity I become fatigued and lightheaded very fast and must stop after 5-10 minutes. Tongue is still tingling and metallic taste in moutg
This spontaneous report was received from a nurse practitioner, via a company representative, regarding four women, whose ages ranged from about 65 to 82 years. On an unknown date the patients were vaccinated with ZOSTAVAX, (dose 0.65 ml). Concomitant medications were not specified. In approximately December 2014, (reported as last few weeks) the patients experienced shingles after receiving ZOSTAVAX. The women went to an urgent care facility where they were diagnosed with shingles. The nurse went on to explain that all women had shingles before being vaccinated with ZOSTAVAX and were recommended to still receive the vaccine according to CDC (Centre for Disease Control) guidelines. The nurse was concerned that the women were encouraged to get the vaccine despite having shingles before vaccination. However, it was also reported that it was unknown if the four women were experiencing a continuation of their previous shingles infection or if it was a newly developed case of shingles from the shot. There was no mention of the severity of the cases of shingles the women had. The outcome of shingles was unknown. Causality assessment was not provided. Additional information has been requested.
This case was reported by a healthcare professional and described the occurrence of influenza symptoms in a female subject aged between 30 and 39 years old who was vaccinated with Flu vaccine (manufacturer unspecified). Concurrent medications included SYNTHROID. On an unspecified date in September 2011 the subject received a dose of Flu vaccine (details unknown). Less than one week after vaccination with Flu vaccine, the subject experienced influenza symptoms, nausea, headache and pain. It was reported that the subject had "never felt that bad" after flu shot before. At the time of reporting the events were improved. The healthcare professional considered the events were possibly related to vaccination with Flu vaccine. The healthcare professional reported two subject's who experienced adverse events following vaccination with Flu vaccine. This is case 1 of 2 (see case ID A0945851A for details of the other reports).
Rash same day vaccine was administered, and affected area got bigger by t he end of the day. Patient went to ER and was diagnosed with cellulitis. ER prescribers did not confirm its vaccine related.
Chills, fever101 for greater than 36 hours, then low grade for 24.  Eyes burned, unable to have open, headache for 36-48 hours.  Localized reaction.  Arm with hard knot at site, baseball size, diffuse redness from upper arm to elbow and around to underarm and axilla area.  Started on oral antibiotics on day 7 for cellulitis to arm
hearing problems; vision problems; balance problems; Information has been received regarding a case in litigation from a lawyer referring to a currently 63 years old patient of unknown gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 07-DEC-2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date unknown) in a clinic for the long-term prevention of shingles and zoster-related conditions. Subsequently, the patient was treated by a provider for the following injuries resulting from the patient's zoster vaccine live (ZOSTAVAX) use: hearing, vision and balance problems. The outcome of the events was unknown.
A report has been received from a Heath Professional concerning, subject of unknown gender, who had been receiving Nasal FLUMIST. FLUMIST started on 05-Dec-2012. The patient experienced A FULL DOSE OF FLUMIST WAS ADMINISTERED TO ONE NOSTRIL which started on 05-Dec-2012. The outcome of the event of A FULL DOSE OF FLUMIST WAS ADMINISTERED TO ONE NOSTRIL is unknown. The report was considered to be non-serious.
From day 2-5 I had symptoms similar to a shoulder rotator cuff injury where I could not raise my arm on its own, had very restricted range of motion, sharp pain when moving the arm. Had two Tylenol (500 Mg) one on the afternoon and one at night day 2, then 1 in the morning,2 at night day 3 and found I got no relief. Then the arm slowly improved on its own. Back to normal after 8-10 days.   I believe the injection site may have been too high up on the arm close to the shoulder. The dose was administered.
Hospitalized 01/12/2022; COVID-19 positive 01/12/2022; fully vaccinated  Discharge Provider: MD  Primary Care Provider : MD DETAILS OF HOSPITAL STAY Hospital Course: Patient is a 86 y.o. female with PMH of Type 2 DM (diet controlled), HTN, HLD, CAD, GERD, OSA who presented with cough, hoarse voice and shortness of breath. The patient reported symptoms that started on 1/7.    At Hospital patient was found to be hypoxic to 88% and was placed on 3 L oxygen via nasal cannula.   Chest x-ray was obtained showing mild cardiomegaly but no evidence of pneumonia.  Initial laboratory workup showed slightly low chloride 97, baseline kidney function with creatinine of 1.12, BUN 28. CBC showed no leukocytosis, stable hemoglobin of 10.5, normal platelets.  BNP normal at 353. She received a dose of Decadron prior to transfer.  The patient was transferred here to another Hospital for admission.   During admission the patient had minimal oxygen requirements. She was treated with dexamethasone and remdesivir. Blood pressure was low-normal during admission so her home antihypertensives were held. The patient was weaned to room air on 1/14 and she reported improvement. She was discharged on dexamethasone to complete steroid course. Lisinopril and Spironolacton-HCTZ were discontinued due to normotensive blood pressures with Lasix and Metoprolol alone. Recommend follow-up with PCP for blood pressure check and re-evaluation of potassium.   Will replace the patient's CPAP. She uses nightly CPAP for OSA. Home CPAP machine is not working properly and therefore the patient requires a replacement
Patient received Pfizer 3rd dose instead of Moderna 3rd dose. No adverse symptoms reported.
RECEIVED ONLY 2.5ML OF THE JANSSEN COVID-19 VACCINE; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 53 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822809, and expiry: 07-MAR-2022) dose was not reported, administered on 21-NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On 21-NOV-2021, the patient experienced received only 2.5ml of the janssen covid-19 vaccine. On 21-NOV-2021, the patient experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the received only 2.5ml of the janssen covid-19 vaccine and off label use was not reported. This report was non-serious. This case, from the same reporter is linked to 20211219386, 20211219731 and 20211219807.
Moderna COVID-19 Vaccine EUA; severe rash on arm 1-week after vaccination near the vaccination site, extremely itchy, puffy and red, and hot to the touch
Patient stated she needed the Pfizer COVID shot for her 2nd dose, but she actually received the Moderna COVID shot for her 1st dose. Patient was given the Pfizer shot for her 2nd dose when she should have received the Moderna shot.
Pain at injection site increasing daily - inflammation & swelling on area - spreading deep into area & surrounding shoulder - unable to lift arm or sleep due to pain (prescribed MEDROL Dose Pak).
A few hours after receiving my vaccine, I developed a headache which was not so bad at first progressed into a very severe migraine.  More concerning for me was the facial numbness and tingling that occurred late that afternoon, it was felt in my cheeks a bit but predominantly in/ on my nose upper lip area then my lips themselves. My headache then proceeded to get worse overnight, The day after my vaccine, Tuesday, i woke up with a more extreme headache, had to receive intramuscular injections of promethazine and keteorlac,  mid morning, which did not help, Tuesday night i had vomiting which was not helped with anti nausea medication, and still severe pain. Increased my diamox because it also felt like my pressure increased the headache remained thought the week. Still have intermittent facial numbness and headaches.
Patient was a previously healthy child who was developing normally and was significantly advanced in many developmental areas especially speech and language. After MMR vaccination he developed progressive neurological regression including regression in language/autism, marked change in dietary habits, loose stools which have persisted. Per follow up report received on 07/19/2005:  Severe developmental regression/delay, autism, mental retardation. Per follow up report: Extremely high anti measles titer 4y post vaccination.