chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Floaters in eye; he still has obstruction in his vision; he had a black dot in his vision that changed to more like a hair over the next day or two; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 12Mar2021 (Lot number: EN6207) at the age of 66 years as dose number unknown, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VITREOUS FLOATERS (non-serious) with onset 12Mar2021, outcome "not recovered", described as "Floaters in eye"; VISUAL ACUITY REDUCED (non-serious) with onset 12Mar2021, outcome "not recovered", described as "he still has obstruction in his vision"; VISUAL IMPAIRMENT (non-serious) with onset 12Mar2021, outcome "not recovered", described as "he had a black dot in his vision that changed to more like a hair over the next day or two". The events "floaters in eye", "he still has obstruction in his vision" and "he had a black dot in his vision that changed to more like a hair over the next day or two" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of vitreous floaters, visual acuity reduced, visual impairment. Additional information: The patient saw an eye doctor and stated that he has done no treatment. The eye clinic said that there is no treatment for the patient.    No follow-up attempts are possible. No further information is expected.
Patient complained of fatigue and weakness beginning the evening after receiving the dose, the morning after dose the patient was unable to stand/walk on her own.  Patient was taken to hospital via ambulance and currently in hospital.
pt recv vax 27JUL97 & pt devel upper resp tract infect;14JUN97 pt devel varicella-like lesions;pt recovered;
Abdominal pain, ribs down to abdomen full of air, very painful, about an hour later, then moved up to my chest. I was very concerned. My husband took me to the hospital, there for 13 hours. I missed work for two days. This fall, I had trouble with shortness of breath.
Red, hot, raised area measuring 3.5 inches across by 2 inches tall. Compresses and BENADRYL.
REDNESS IN THE AREAS OF THE HANDS; BLOOD LINE UNDER THE SKIN OF ALL OVER BOTH HANDS THAT LOOKS LIKE BROKEN BLOOD VESSELS; This spontaneous report received from a patient concerned a 51 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included hypertension, thyroid problems, anxiety, latex allergy, and sulfonamide allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802070, expiry: UNKNOWN) dose was not reported, administered on 16-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-APR-2021, the subject experienced blood line under the skin of all over both hands that looks like broken blood vessels. On 16-APR-2021, the subject experienced redness in the areas of the hands. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from blood line under the skin of all over both hands that looks like broken blood vessels on 04-APR-2021, and was recovering from redness in the areas of the hands. This report was non-serious.
COLD & FLU LIKE SYMPTOMS WITH FEVER REDNESS, SWELLING AND PAIN AT INJECTION SITE NO TREATMENT
Patient presented to the ED and was admitted on 2/21/2023. Patient had been experiencing symptoms of back pain on her right side, feeling lethargic, on and off fevers, and fatigue since 2/19/2023. When presented to the ED, patient was afebrile. Urine culture positive for E. coli infection, UTI. Urine color was amber. Patient was treated with IV Rocephin. Leukocytosis-elevated at 12.77. Hypokalemia-low at 3.2. Hyperglycemia noted, likely in reaction to infection. Ultrasound of her kidneys was obtained and did demonstrate bilateral cysts on her native kidneys, normal transplant kidney, no evidence of pyelonephritis, no evidence of stranding, no evidence of hydronephrosis. Patient believed she heard a renal cyst pop, and reported she usually gets a UTI. Patient reported a history of cysts on her native kidneys and have had cysts rupture in the past. Patient reported the main concern of her admission was due to a rupture of a cyst on one of her native kidneys. She has been completely afebrile for the duration of her admission. Patient was given Keflex for treatment when discharged. During the course of her admission, patient had an outbreak of Herpes Labialis and was given acyclovir orally to treat for 10 days. Patient received the Janssen Ad26.CoV2.S vaccine on 9/7/2022. Patient is approximately 180 days post-vaccination at time of the report. Per research study PI, this adverse event is not related to the Janssen Ad26.CoV2.S vaccination on 9/7/2022.
Pt. states that after receiving the 1st dose of Pfizer 05/06/2021, started experiencing symptoms within a couple weeks hives developing in the chest area lasting 2 weeks at a time. No noted Primary visit/communications. Still continuing to experience symptoms.
Bad headache continuosly; This is a spontaneous report from a contactable consumer (patient, self-reporting). A 61-year-old male received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: EN6202 and expiration date was not reported), via an unspecified route of administration in left arm on 09Mar2021 at 16:30 (at the age of 61-year-old) as first dose, single for COVID-19 immunization. Patient had no known allergies and other medical history. The concomitant medication included fenofibrate, daily multivitamin administered on an unspecified date for an unspecified indication. Patient did not have any other vaccine in four weeks. Patient did not have COVID prior vaccination and was not test for COVID post vaccination. On 10Mar2021 at 01:30, nine hours after receiving vaccination, patient experienced bad headache continuously. Patient did not receive any treatment for the adverse event. Outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.
3 days after smallpox, fever and cold symptoms-note-this fever/cold symptoms was going around 4 days after smallpox vac hive like rash covering entire body with exception of hands and feet
Does not have her period; Felt awful; Aches down her entire spine; Aches down her hip flexor; Aches down her knee; Aches down her elbow; Aches down her shoulders; Laid in bed at 7.30pm because of dizziness; Pain behind both eyes; Feeling tired; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Laid in bed at 7.30pm because of dizziness), EYE PAIN (Pain behind both eyes), SPINAL PAIN (Aches down her entire spine), FEELING ABNORMAL (Felt awful) and OLIGOMENORRHOEA (Does not have her period) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 14-Apr-2021 at 9:45 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021 at 5:00 PM, the patient experienced FATIGUE (Feeling tired). On 14-Apr-2021 at 7:30 PM, the patient experienced DIZZINESS (Laid in bed at 7.30pm because of dizziness) and EYE PAIN (Pain behind both eyes). On 15-Apr-2021 at 3:00 AM, the patient experienced SPINAL PAIN (Aches down her entire spine). 15-Apr-2021 at 3:00 AM, the patient experienced ARTHRALGIA (Aches down her hip flexor), ARTHRALGIA (Aches down her knee), ARTHRALGIA (Aches down her elbow) and ARTHRALGIA (Aches down her shoulders). On 15-Apr-2021 at 7:30 AM, the patient experienced FEELING ABNORMAL (Felt awful). On 18-Apr-2021, the patient experienced OLIGOMENORRHOEA (Does not have her period). At the time of the report, DIZZINESS (Laid in bed at 7.30pm because of dizziness), SPINAL PAIN (Aches down her entire spine), FEELING ABNORMAL (Felt awful), FATIGUE (Feeling tired), ARTHRALGIA (Aches down her knee), ARTHRALGIA (Aches down her elbow) and ARTHRALGIA (Aches down her shoulders) outcome was unknown and EYE PAIN (Pain behind both eyes), OLIGOMENORRHOEA (Does not have her period) and ARTHRALGIA (Aches down her hip flexor) had not resolved.            She took pregnancy test and was negative. No concomitant medications reported. Treatment information was not provided.
Round delineated hive 2.5 inches in diameter appearing 1 week after the injection and remains to date.  Was itchy upon appearing but lessened over time.  It is not at the injection site but is 2 inches to the left and down from the actual injection site.
Administered 0.25 ml from vial that was punctured more than 24hrs prior.
late for 2nd dose,  1st dose administrated on  2019; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 18th December 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The patient was late for the second dose of Shingrix and till the reporting time did not receive it, which led to incomplete course of vaccination. The first dose was administrated and no adverse event was reported . No patient's identifiers provided and no lot number and expiration date provided. The reporter did not consent to follow-up.
presented to hospital with complaints of increased weakness, dyspnea, and weight loss; immunosuppressed due to heart transplant; intubated, condition worsened and patient passed away in the hospital; COVID pneumonia ARDS
headache nonstop; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache nonstop) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jul-2021, the patient experienced HEADACHE (headache nonstop). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) for Headache, at an unspecified dose and frequency. At the time of the report, HEADACHE (headache nonstop) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medication information was reported.
Headache, Myalgia, Fever, pain at injection site, fatigue Narrative:
Client arrived back to the clinic location an hour after her vaccination and c/o chest tightness. She verbalized feeling fine after waiting 15 mins at our observation area outside and felt her adverse effect while at home. She used her Albuterol inhaler at home and verbalized some congestion as well as feeling unwell since last Thursday.  V/S taken and are as follows: BP 132/84, HR 85, R 20, O2 99%. Lungs were clear upon auscultation and no SOB noted. Client has HX of chest tightness and allergic reactions to certain foods. Client was advised to go to the ER for evaluation in which she stated that she would like to stay at our clinic site until she felt some relief. After 15 mins, the client stated the chest tightness was subsiding and she was ready to go home. Client was again advised to get evaluated at the ER  (the client verbalized that she would do so if her chest tightness recurred)and to have a companion accompany her in which her daughter was able to do so. The client and her daughter left the clinic site approximately at 1645.
Dose 1: 24 hours of fever, chills, rigors, nausea, and fatigue starting day of vaccination. Treatment was supportive care. Resolved in 48 hours. Dose 2: >48 hours of fever, chills, rigors, nausea, dizziness and fatigue starting day of vaccination.  Treatment includes supportive care and cefdinir for possible vaccine site cellulitis. Symptoms have not yet resolved.
Developed swelling and itching and redness and heat circumferentially around the arm where she got the shot.
Within about 45 seconds of getting the shot, I became lightheaded, dizzy, woozy feeling, un-steady on my feet, difficulty concentrating, felt like I was going to faint. I told the staff and she said to tell the nurse in the waiting area. I walked over to the nurse and told her my symptoms. She had me lay in a reclining chair, relax, drank juice. She took my blood pressure (144/78 and pulse was 100). I sat in the reclining chair for 30 minutes then walked around to see if I felt safe to leave. By then my pulse was down to 70bpm.
After the 1st shot, I had the usual sore arm and swelling. In the next few days, there was a large amount of swelling on the right side. Pain at the injection site, lymph swelling. It stayed pretty constant and I did my best to move my arm and use ice to combat the pain. For my second shot, I was still experiencing pain on the right side so I asked to have it in the left. I reacted with the typical low-grade fever and aches. I had some slight swelling on the left side but it went away in about 24 hours. Within that week the right side axillary area swelled up and pain got worse. My breast became very swollen too.
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 54-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 29-Dec-2020, 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 product use was reported. No treatment information was provided.   This case was linked to MOD-2021-395985 (Patient Link).
started feeling weird like flu like symptoms; chills; fever 102.3; This is a spontaneous report from a Pfizer-sponsored program support received via a contactable consumer (patient).   A female patient of an unspecified age received BNT162B2(PFIZER-BIONTECH COVID-19 MRNA VACCINE, Batch/Lot number was not reported),  via an unspecified route of administration on 18Mar2021 as dose 2, single for covid-19 immunization.  The patient medical history and concomitant medications were not reported.  The patient started feeling weird like flu like symptoms with chills and fever 102.3 F. The patient underwent lab tests and procedures which included body temperature: 102.3 fahrenheit on an unspecified date. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
h/o developmental delay, DM type 2, HTN, HLD, anemia, past h/o provoked PE (2000) with a h/o lower extremity numbness and weakness. She is experiencing difficulty walking, having difficulty with urination (has urge but difficulty voiding) for the past 3 days. She has no recent fever, diarrhea, respiratory illness. She had a flu shot a month ago.
14 yr old passed out after Td administered. Fell to floor face forward, landed on abd and face, turned slightly cyanotic, had slight jerking once, rigid, responded after 1-2 mins. O2 at 6 later, feet slanted, pt taken to ER for evaluation accompanied by mom and brother and 2 ambulance personnel. Pt stated after rec'd TD felt tingle sensation to left arm.
Per HCW, approximately 30 -45 minutes after receiving vaccine, she developed severe chest pain radiating to left arm, left breast.   HCW reported she sought treatment at  Emergency Room.  Per HCW, she was evaluated for a myocardial  infarction  and troponins were negative.  HCW reports Chest pain have subsided; however, left arm heaviness, left chest/breast  area is tender to touch.
About one week after vaccination I experienced tingling and loss of feeling in my fingers in both hands simultaneously. I was unable to pick up my children, unable to open bottles or jars.  This peripheral neuropathy did go away and then came back after the 2nd dose of the Pfizer BioNTech Covid 19 vaccine.
Early period, migraines. Know three others who got their second period of the month from their vaccines.
pt recv vax 16SEP97 & 17SEP97 pt blacked out, was lightheaded & white as chalk & exp diarrhea, vomiting & dry heaves;
Day four, after 2nd dose of moderna vaccine, arm is still red, burning and swollen
Fever, back pains, swelling of arm, and blood in vomit and stool
Left arm  was red and warm to the touch, flu type symptoms, dizziness, and tightness in chest that started today.
Information has been received from a female patient who in November 2006, was vaccinated with the second dose of Gardasil (yeast). It was reported that the patient received the first vaccination in September 2006. On 21-Dec-2006, the patient underwent an "HPV DNA" test. The results indicated that the patient tested positive for HPV type 16. The patient sought unspecified medical attention. The patient's outcome was not reported. Additional information has been requested.
No adverse effects reported.; Improperly stored 68 F / administered vaccine; This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.   On 17-NOV-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) lot # T006347 was confirmed to be valid, expiration date 20-FEB-2022 (exact dose, route and site of administration were not provided) for prophylaxis. On 08-NOV-2020, the administered dose of vaccine was exposed to the temperature of 68 degrees Fahrenheit for 20 hours. There was no previous temperature excursion. The call was because of a digital data logger. No adverse effects were reported.
All my joints and muscles hurt. No relief with anything I tried. I had fever, chills, all flu-like symptoms, blood pressure was low, pulse was high, equilibrium was off.  All happened on 11/03/2021. By the third day I had a hard time breathing . I had a big red knot the size of a baseball that's red and hot to the touch. I went to urgent care and diagnosed with cellulitis on my arm he gave me medication. The baseball like rash moved to back of my arm to elbow. By Monday it was moving up to my shoulder. Went back to Urgent Care, which sent me to ER.
High fever (103), intense headache that required narcotics to ease the pain, body aches, chills, Covid toe
Pt's husband was vaccinated on the same date and reported redness and tenderness to back of arm following. He further stated his wife experienced the same. Per pt's husband, her symptoms were improving since the initial observation, no further issues or concerns.
Pt received the orange cap pediatric  undiluted 0.3 ml  covid vaccine instead of the gray cap
Dry patches of skin in several places which constantly itch. Even after scratching, the itch continues. Have scratched to a point where there is a hole in arm and itching sensation is still there.
This spontaneous report was received from a 35 year old female patient, who was reporting on herself. The patient's pertinent medical history was not reported. The patient's concurrent conditions included asthma. The patient's allergies included allergy to gluten. The patient's concomitant medications included MICROGESTIN and DULERA. On 06-JAN-2017, the patient was vaccinated with one dose of PNEUMOVAX 23 for prophylaxis (reported as "advice to receive vaccine"; route, lot # and expiration date were not reported). It was reported that after receiving the PNEUMOVAX 23 the patient experienced redness in the arm on the same date. Then, on 07-JAN-2017, the patient went to the emergency room because she was not feeling well where she was told that her white blood count was "high", so she was given unspecified medications and was sent to home. After that, the patient returned to the same hospital's emergency room  (adverse event) and was later admitted on 08-JAN-2017 to the emergency room and was hospitalized the same day. During hospitalization, it was stated that the patient was diagnosed with a blood infection and cellulitis. The patient was released from hospital on 11-JAN-2017. At the time of reporting the outcome of the events was reported as recovering. The causality assessment between the events and PNEUMOVAX 23 was not provided. Upon internal review blood infection and cellulitis were determined to be medically significant events. Additional information is not expected because the reporter refused consent for follow up.
Initial unsolicited report received from a consumer on 03 November 2014. A patient (age and gender not reported), whose medical history and concomitant medication were not reported, had received a dose of FLU VACCINE, (batch number, dose, cycle in series, route and site of vaccination not reported, on 27-Oct-2014. On an unspecified date, patient experienced hurting "all over", barely able to move, inability to sleep and hair thinning out. Corrective treatment and laboratory investigations were not reported. At the time of this report, the outcome of the event was reported as unknown. Documents held by sender: none. Follow-up information received from a consumer on 02 March 2015: The patient was 63 years of age. The patient did not receive any concomitant vaccine. The patient's illness at the time of vaccination includes multiple sclerosis and was allergic to iodine and macrodantin. The patient did not experience any adverse event following prior vaccination. Documents held by sender: none.
pt recv vax; T 104 2 wk later, broke out in rash; to er; dph given; recovered 2-3 days later;
Information has been received from a physician concerning a female patient (age unknown), who, on an unspecified date, was vaccinated with a dose of Gardasil. Subsequently, approximately five days after the vaccination the patient broke out in hives and her throat swelled up. The patient had to go to the emergency room and was treated as an anaphylactic reaction. At the time of the report, the patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Patient reported having reaction to vaccine starting on same day as vaccination 10/13/21. Patient reports hives, itching started behind both ears and then on neck and spread to back. It has not gone away and now patient sees redness and itches on body, especially where clothes touches skin at waist. Patient says they did not have any trouble breathing or closing of the throat. Patient says they have taken flu shots in the past with no issues. Patient has not taken anything OTC.
Redness, soreness, swelling, fever at the shot injection sight, headache, difficulty breathing, weakness, hoarseness, fast heart beat, irregular heartbeat, high blood pressure, skipping heart beat