chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Balance issue; Double vision; Problem with nerve in the eyes; inside his upper lip was swollen; Tired; This spontaneous case was reported by a consumer and describes the occurrence of DIPLOPIA (Double vision), OPTIC NERVE DISORDER (Problem with nerve in the eyes), LIP SWELLING (inside his upper lip was swollen), BALANCE DISORDER (Balance issue) and FATIGUE (Tired) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     No Medical History information was reported.  On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced FATIGUE (Tired). On 10-May-2021, the patient experienced DIPLOPIA (Double vision), OPTIC NERVE DISORDER (Problem with nerve in the eyes) and LIP SWELLING (inside his upper lip was swollen). On an unknown date, the patient experienced BALANCE DISORDER (Balance issue). At the time of the report, DIPLOPIA (Double vision), OPTIC NERVE DISORDER (Problem with nerve in the eyes), LIP SWELLING (inside his upper lip was swollen) and FATIGUE (Tired) outcome was unknown and BALANCE DISORDER (Balance issue) was resolving.      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 product use was not provided by the reporter. No treatment information was provided.  Reporter stated that, he developed double vision- balance issues after 2 weeks of first vaccination. it was resolving slowing and depending on being rested or fatigued.   This case was linked to MOD-2021-255911 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: New event "balance disorder" was added. On 14-Jul-2021: Non-Significant follow-up appended, contains information about patient race.
Patient awoke morning after vaccination with hives from her ankles to her hips, bilaterally.  It was itchy.
horrible body pain all the way to my finger nails (not ache) sensitivity to light, extreme exhaustion. Headache.
Blood pressure just dropped, blood pressure went down to 60/95; This spontaneous case was reported by a consumer and describes the occurrence of HYPOTENSION (Blood pressure just dropped, blood pressure went down to 60/95) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088D21A) for COVID-19 vaccination.     Concomitant products included CLONIDINE, OLMESARTAN and AMLODIPINE for Blood pressure.    On 18-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Aug-2021, the patient experienced HYPOTENSION (Blood pressure just dropped, blood pressure went down to 60/95). At the time of the report, HYPOTENSION (Blood pressure just dropped, blood pressure went down to 60/95) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information does not provided.
Situation: Patient in for his 2nd dose of Covid 19 vaccine. Background: Patient had anxiety/vasovagal reaction with last dose. Assessment: The patient feels anxious today. Transported patient to a quite observation room on a gurney. He is resting in a supine position. 1400: Vital signs: 120/71, 69, 16, O2 Sat 99 % on RA. 1410: 111/66, 69, 14, O2 Sat 99 on RA. Informed Dr. Recommendation: Patient states he is feeling better. He is sitting on the side of the gurney. Per Dr., okay to discharge the patient.
Drug exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Drug exposure during pregnancy) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No medical history information provided by the reporter.  The patient's past medical history included No adverse event. Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for Prenatal care.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 06-Aug-2021. On 11-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY (Drug exposure during pregnancy). On 11-Mar-2021, EXPOSURE DURING PREGNANCY (Drug exposure during pregnancy) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information not provided by the reporter. Concomitant medication also include medication for nausea.
Pt vaccinated with DTP/OPV, about 40 hrs later became limp with rolling up of eyeballs, lethargic, lasted five min. Was afebrile at that time.
Patient with history of asthma, seizures, and HIV. He was brought to the ED by EMS on 12/9/22 for cough for the past 10 days, along with shortness of breath, fatigue and malaise for the past 2 days. EMS noted his O2 sats were at 88% so was placed on 2L O2 NC. He tested positive for COVID by PCR that same day. He was admitted 12/9/22 - 12/15/22 for further management of COVID-19 and superimposed bacterial pneumonia. Discharge diagnoses include acute hypoxic respiratory failure, COVID-19 pneumonia with superimposed bacterial pneumonia, severe sepsis at presentation due to bacterial pneumonia, COVID-19 infection, among other diagnoses.
2 shots, right arm red/bright/hot, right upper arm with 2 cm knot with eryth dark then 4cmx2cm up on lighter a/r
Within 30 minutes of vaccine administration she became very flushed, short of breath, tingling all over, she has some redness on her skin, no sensation of her lips or tongue swelling.  She states similar to her anaphylactic reactions in the past.
Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 54-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 13-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information were reported.  No concomitant medications were reported.  The vaccine was manufactured on 09 Mar 2021. Delivered at vaccination center on 30 Sep 2021. Patient did not experienced adverse event.
Principal Diagnoses:  Principal Problem:   Pressure injury of sacral region, unstageable Active Problems:   Long-term (current) use of anticoagulants   Expressive aphasia   Chronic atrial fibrillation   Sacral osteomyelitis   Essential hypertension   Type 2 diabetes mellitus with hyperglycemia, without long-term current use of insulin     Discharge Diagnosis:  Sacral wound with chronic osteomyelitis Paroxysmal atrial fibrillation Myasthenia gravis Weakness inability to care for self   Hospital Course:  82-year-old female who was admitted from the emergency room secondary to sacral wound and inability to care for self. Patient was admitted repeat CT scan was performed which showed similar to previous imaging. Patient refused any surgical intervention was seen by infectious disease initially placed on IV antibiotics but these were discontinued and changed back to oral form as patient has refused surgical intervention. Infectious disease did not want pursue long course of antibiotics as without surgical intervention this would not perform any significant benefit and also increased risk of C. difficile. Patient accepted this risk and did not want to pursue any surgical intervention. Patient unable to care for self and agreeable to rehab with social work consult
Patient developed chest pain after injection no clear fever and pain persisted until arrival at hospital ED Work up included elevated CPK CKMB and TNT blood work EKG revealed early repolirazation pattern  He underwent cardiac catheterization revealing normal angiography and Left ventriculagram and Normal Echocardiogram.
2 days after administration of vaccine into LUE, patient developed RUE symptoms of pain, swelling, tenderness to touch, bruising that appeared consistent with superficial thrombophlebitis
increased ferritin levels; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 04-Jun-2021 and was forwarded to Moderna on 04-Jun-2021.    This spontaneous case was reported by a consumer and describes the occurrence of SERUM FERRITIN INCREASED (increased ferritin levels) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No medical history was provided by the reporter.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SERUM FERRITIN INCREASED (increased ferritin levels). At the time of the report, SERUM FERRITIN INCREASED (increased ferritin levels) outcome was unknown.            Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable. Consent for follow up declined. can the covid 19 vaccine from moderna cause increased ferritin levels. No concomitant product has been reported.   No treatment information has provided.
Information was received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's medical history, concurrent conditions or concomitant medications. On 21-NOV-2015, the patient received ZOSTAVAX (lot number dosage and route of administration unknown) from his primary care physician, during an annual physical for the prevention of shingles. It was reported that less than five months after receiving the vaccine, the patient woke up and discovered he was unable to walk. The patient was hospitalized and subsequently diagnosed with acute transverse myelitis. As a direct and proximate result of the defective ZOSTAVAX, the patient's symptoms have resulted in physical limitations not present prior to using the product. The patient also experiences mental and emotional distress due to resulting physical limitations from, and seriousness of, his condition. Further, as a tragic consequence, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. Upon internal review, acute transverse myelitis was considered medically significant. The lawyer considered acute transverse myelitis to be disabling. Additional information has been requested.
Nurse did not reconstitute vial.  Patient was accidentally given entire contents of vial equaling 6 doses.  Patient was admitted as a precaution for observation on Saturday, 2-20-2021, due to complaint of chills. Patient was discharged on Sunday, 2-21-2021.  Patient currently reports no side effects.
have swelling on the underside of, right near my elbow, on the side that would not hit the sun,underneath it's like a lumpy swelling; This is a spontaneous report from a contactable consumer. A 85-year-old male patient received of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown, Expiry Date: Unknown) via unspecified route of administration on 21Feb2021 at 18:00 in arm right as dose number unknown, single for COVID-19 immunization. Medical history included little handicap (He was 85 years old and he was a little handicap). Concomitant medications were not reported. Patient had vaccine yesterday around 6 O'clock in the evening and read all risk of Pfizer vaccine and tells you all good things. On unspecified date patient had swelling but the swelling was on underside on right near elbow on that side that would not hit the sun, underneath it's a lumpy swelling and its not at injection site, it on left arm. The clinical outcome of the event was unknown.   Follow-up attempts are completed. No further information is expected.
My daughter received her 9 month hep B vaccine, the following day she woke up with a fever, which eventually lead to a seizure and transport to the local ER. Blood work/urine came back normal.
Patient was described as having a "Grand mal" seizure within 15 minutes of vaccination.  Patient was observed, refused transport to ER, and was released to home when she felt better.
Narrative: Headache Myalgia, Arthralgia Lump in right axilla, headache, fever body ached initially, then 2 days post vaccine, began to develop a softball size lump in her right axilla, has not gone away, has been very painful, but the lump is now lower, still the same size, not as uncomfortable and appears to be resolving, states she knows of another family member who had she same thing occur and resolved. Not taking anything over the counter for the pain/discomfort/swelling
Information has been received from a registered nurse regarding a patient of an unknown age and gender. On 12-OCT-2012 at 18:00, ZOSTAVAX lot # H012576 was exposed to -8 for an estimated total time out of range of 10 hours 20 min. On 09-NOV-2012, the patient was vaccinated with an out of temperature range dose of ZOSTAVAX (dose and route administration were not provided) (lot # H012576, exp date 28-SEP-2013) (dose number was not provided). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
Received Tdap from Employee Health. Developed itching 4 hours after drug given progressed to hives and treated in ER with decadron, benadryl and pepcid
Lt. arm did swelling-rash x 1 wk. tetanus. No reaction in the rt. arm were Zostavax was given.
Took one capsule of Vivotif every day instead of every other day; This spontaneous case was received on 27FEB2020.  A pharmacist reported that a consumer "took one capsule of Vivotif every day instead of every other day" (PT: Inappropriate schedule of product administered) for immunisation. The consumer took one capsule of Vivotif every day instead of every other day for the first two doses. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the event was unknown.  Company Comment: A consumer took one capsule of Vivotif every day instead of every other day for the first two doses (Inappropriate schedule of product administered). Considering the nature of the event, the causality of Inappropriate schedule of product administered is assessed as not applicable to Vivotif.; Sender's Comments: A consumer took one capsule of Vivotif every day instead of every other day for the first two doses (Inappropriate schedule of product administered). Considering the nature of the event, the causality of Inappropriate schedule of product administered is assessed as not applicable to Vivotif.
abdomen pain; gas pain; he feels "Pretty Lousy."; nausea; small fever; This spontaneous report as received from a 35 years old male patient refers to himself. The patient's concurrent conditions included Hashimoto's thyroiditis and irritable bowel syndrome (IBS). The patient was allergic to sulfur, gramicidin (+) neomycin sulfate (+) polymyxin sulfate (NEOSPORINE) and penicillin. The patient had used unspecified concomitant medications.     On 04-OCT-2021, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) injection (route, strength, dose, frequency, batch/lot # and expiration date were not reported) for prophylaxis (reported as human papillomavirus (HPV) prevention).         On 05-OCT-2021 (reported as this morning), the patient stated that he felt "pretty lousy." Caller stated that he was experiencing nausea, abdomen pain, gas pain and had a small fever. The outcome of all events was reported as not recovered. No treatment was given for the events. The patient had sought medical attention.   The causality was not reported.
This spontaneous report as received from a company representative refers to a female patient over 40 years of age. On an unknown date the patient was "allergedly" vaccinated with M-M-R II (subcutaneous injection). Dosing information and lot number were not provided. On 08-DEC-2013 the patient developed mumps, sore throat, fatigue, "extreme" malaise and swollen glands. The patient sought medical attention because of the adverse events, by going to the health department. A buccal test and blood test for mumps were performed on an unknown date. The results of the tests were unknown. The patient had not recovered from the events. A causality assessment was not provided. This report is linked with report 1312USA006048, 1312USA006064 and 1312USA008378, received from the same reporter, regarding five additional patients, who also allegedly underwent vaccination with M-M-R II, and then developed mumps. It was stated that all patients in the linked reports were in close contact to one another by being related or working together. Additional information has been requested.
the patient received two immunizations in the same arm which was the deltoid of the left arm...the IMZ was Fluzone HD and Prevnar 20...upon inspection of the arm it was red, swollen, hot to touch, itching, and painful...the patient received the IMZ on Friday and said symptoms started on Friday night the patient was told to take Pepcid 20mg, benadryl, nsaid, use steroid cream and apply ice
Headache; Shortness of breath that gets worst every week/ after he took a shower, he will experience shortness of breath immediately; Fatigue; Hands shake; Feet get numb at night/his feet go numb in the evening; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 66-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Nov2022 as dose 4 (booster), 0.3 ml single (Lot number: GJ9697) at the age of 65 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 Immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 Immunisation; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 Immunisation. The following information was reported: FATIGUE (non-serious) with onset 10Dec2022, outcome "not recovered"; HYPOAESTHESIA (non-serious) with onset 10Dec2022, outcome "not recovered", described as "Feet get numb at night/his feet go numb in the evening"; TREMOR (non-serious) with onset 10Dec2022, outcome "not recovered", described as "Hands shake"; DYSPNOEA EXERTIONAL (non-serious) with onset 10Dec2022, outcome "not recovered", described as "Shortness of breath that gets worst every week/ after he took a shower, he will experience shortness of breath immediately"; HEADACHE (non-serious) with onset 30Dec2022, outcome "not recovered". The events "shortness of breath that gets worst every week/ after he took a shower, he will experience shortness of breath immediately", "fatigue", "hands shake", "feet get numb at night/his feet go numb in the evening" and "headache" required physician office visit and emergency room visit. Therapeutic measures were not taken as a result of dyspnoea exertional, headache.  Additional information: Reporter was reporting side effects which he experienced with the Pfizer COVID Bivalent for 12 years and older. He had "shortness of breath that got worst every week, fatigue, his hands shake, feet got numb at night, got headache." Reporter needed to know if there was something he can do regarding these side effects to get taken care of. Reporter shared that he went to the doctor, and he was sent to the emergency room and that they could not find anything. He was referred to a cardiologist. As per Reporter it was the shortness of breath that bothers him, "it was almost that the patient could not function". He also gave an example that after he took a shower, he would experience shortness of breath immediately. There were no other investigations and other products. The events were really affecting the life adversely. Healthcare provider had no explanation every time he brings it up and said Covid they did not want to hear about it.
One hour after vaccinations child awakened from a nap. Mom noticed child developed rash and swelling of hands and feet. Also had puffy lips. Rash present on chest and abdomen. Also developed wheezing.
5 minutes after receiving vaccine patient fainted, pharmacist and Intern got him into where he was given water and crackers. sat with him for one hour talking and getting updates on symptoms. He continued gradually improving through out the hour. Patient called to come pick him up. informed the pharmacy that he has had fainting spells before with other vaccines and medical procedures. walked them to the car to ensure no fainting spells or other symptoms occurred. Advised patient to call 911 or go to the emergency room if other symptoms arose. Also told them pharmacy will follow up with them later in the evening.
Husband only experienced headaches as a side effect of the vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID:   A male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history included: "leukemia" (unspecified if ongoing), notes: She also mentioned that her husband has leukemia. The patient's concomitant medications were not reported.  The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "Husband only experienced headaches as a side effect of the vaccine".  Clinical course: Reporter also mentioned that her husband only experienced headaches as a side effect of the vaccine, and he has leukemia.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
WAS GIVEN EXPIRED VACCINE/PRODUCTS HAD REACHED THEIR LISTED EXPIRATION DATES; This spontaneous report received from a health care professional 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 not reported, batch number: 213D21A expiry: 08-SEP-2022) dose was not reported, administered on 24-OCT-2022 for covid-19 prophylaxis. The drug was associated with Drug taken beyond expiry date. On 24-OCT-2022, the patient experienced was given expired vaccine/products had reached their listed expiration dates. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of was given expired vaccine/products had reached their listed expiration dates was not reported. This report was non-serious. This case, from the same reporter is linked to 20230149982, 20230150340, 20230150255, 20230150600, 20230150157, 20230150588, 20230150716 and 20230150777.