chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pneumonia; urinary tract infection; Shortness of breath; Currently critically ill; This is a spontaneous report from a contactable consumer reporting for himself. A 92-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EN6203/expiration date: not provided), via an unspecified route of administration, on 03Mar2021 at 10:00 (at the age of 92 years old) as a single dose in the right arm for COVID-19 IMMUNIZATION. Relevant medical history included congestive heart failure, pace-maker to treat congestive heart failure, ongoing and consistent treatment for high cholesterol, high blood pressure, and shell fish allergy. Concomitant medication included levotyroxine, atrovastatine, amniodarone, and wafarin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 06Mar2021 at 04:15, the patient experienced shortness of breath and needed to be hospitalized with pneumonia and urinary tract infection. The patient was currently critically ill. The events required an emergency room visit and hospitalization. It was unknown if any treatment was received. The outcome of the events shortness of breath, pneumonia, urinary tract infection, and ill was unknown. Since the vaccination, the patient had been tested for COVID-19 on 06Mar2021, with a negative result.
-Pharmacist administed vaccine (wiped area with alcohol, preped syringe & needle, administered) -Just as finishing pushing the plunger, pt began to pass out (head back and eye rolled back) - Pharmacist & mother worked to awake patient. Pharmacist went to grab ice pack, Epipen, & CPR mask, when returned, pt was semi-alter responding to mother - both pharmacist & mother continued to awaken patient using cool ice pack. Pt began to responed. Stated could breathe without issue and answered questions - pharmacist called 911 for assistance - Pt never showed signs of issues breathing and continued to remain responsive.
This solicited report has been received from a 27 year old female patient regarding herself, while she was part of a Market Research. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unspecified date, the patient was vaccinated with PNEUMOVAX 23. Other suspect therapies included influenza virus vaccine (unspecified). The patient reported that when she was "younger", she would get very sick after vaccination with PNEUMOVAX 23 and influenza virus vaccine (unspecified). The outcome of the event is unknown. Causality of the event with the suspect therapies was unknown. Additional information has been requested.
I had the vaccine on Friday and that following Thursday, I started to have a very heavy menstruation. I was soaked in blood all of the way down to my shoes. I had to wrap a towel around myself before I went into the ER. A doctor checked me out. I've never seen that amount of blood or clots come out before. I mentioned that I had the vaccine the week earlier and the doctor thought that since I've had a history of fibroids, that it could have been related to the fibroids. They gave me a hormone, at the ER to take. I had a tele-appointment with my GYN, and he put me on a birth control pill now. I have not had any problems since. The heavy bleeding stopped around midnight that night. They feel that it's related to my fibroids. I was expecting my period at that time, but it came heavier than it ever has before.
Anaphylaxis- was riding bike home and had to stop and jump off bike legs went numb couldn't breath and I couldn't ask for help because I was too confused. This came in waves of 5 minutes or so until yesterday.  Very scary.
Per our records, patient was given an expired vaccination. This was several years ago. The only symptom mother of patient recalls following vaccination was a high fever. It is possible that the lot number that was entered was incorrect. Unfortunately our EMR does auto populate previously entered vaccines.
anaphylaxis & a rash reported in pt receiving vax; reporter stated that pt devel a severe anaphylactic react w/in 5 hrs p/vax of fluogen; pt reaction consisted of dyspnea & diffuse erythematic rash; pt was treated w/unk steroids;
Episodes of disorientation, twitching, muttering- occurred apprx. 11 hours after her shots. Mothersaid axillary temp 99 degrees, but she did not feel hot.
Fever of 102 for about 10 hours.  Over next several weeks experienced periods when I felt a buzzing in my head and became immediately  dizzy and my vision was blurry.  It only lasted a few seconds.  This happened several times a week for a few weeks and went away.    I did not contact my doctor.
Received Tdap 9.29.14, called on 10-6 to say that she had slight pain for a day. Then on 10-2-14 woke with severe shoulder pain. Better but still present. Has tried heat/cold/TYLENOL. Was 30+ wk preg.
Sustained fever of 101+, nausea, severe headache, trouble moving arms and legs. It lasted until the morning of 11/19/2021
The patient's temperature was 99.9F; Patient has a loss of appetite; The lesion is warm and tender; The lesion is warm and tender; The patient has a large red lesion on the right thigh at the site of the injection; This spontaneous report has been received from a physician concerning a 4-year-old female patient.      The patient's concurrent conditions, medical history, concomitant therapies, and allergy/drug reactions were not reported.  On an unknown date, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (strength, vaccination scheme, dose/route/frequency of administration, lot number, and expiration date were not reported), as immunization against measles, mumps, rubella and varicella.  Over the past week (approximately on 18-JUL-2023), the patient started to experience adverse effects as a large red lesion on the right thigh at the site of the injection (injection site erythema). The patient's lesion was 7 cm in diameter, a bright red circle and it has been getting bigger over the past week (18-JUL-2023). Also, the patient had a loss of appetite (decreased appetite) and had no other systemic symptoms. The physician reported that the lesion was warm (injection site warmth) and tender (injection site pain). The physician also reported that the patient's temperature was 99.9-degree Fahrenheit (body temperature abnormal). It was reported that medical attention was sought for the patient. The outcome of the events was not reported.  The physician did not report a causality assessment between the events of injection site erythema, body temperature abnormal, injection site warmth, injection site pain, and decreased appetite and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD).
Chills and shaking from chills. Pounding headache that has not gone away.  Sweating and body aches
Information has been received from a registered nurse concerning a nine year old male who on 15-JUL-1998 was vaccinated with Varivax. There was no concomitant medication. On 15-NOV-2006 the patient was seen in the doctor's office and diagnosed with varicella. The patient recovered from the varicella on an undisclosed date. No further information is available.
Developed headache 10/18/06 worsened 10/19/06. Developed achy joints and low back discomfort felt tired for 1 week.
I began to notice that I was short of breath. I began to notice that my stamina greatly decreased. I noticed weakness in my legs and had a headache for a while and that diminished. I noticed my right arm, if I have that extended over a length of time over my head, when I bring my arm down, it hurts fiercely. I can stretch it to the right and bring it down, but I can't bring my arm straight down in front of me in the upper muscle area of the right arm. My doctor has checked and have done lung x-rays, EKGs, stress tests, CAT scan and we haven't found anything. Still ongoing.
LMP 8/3/2021 patients states bleeding and cramping consistent with miscarriage  starting on 10/8/2021 negative fetal heart tone on ultrasound
Shortness of breath; Loss of taste; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of breath), AGEUSIA (Loss of taste) and FATIGUE (Fatigue) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. p26C21A) for COVID-19 vaccination.     Ty2 2 diabetic controlled, CAD, CKD stage 3b, psoriatic arthritis, rehumatoid arthritis, hypothyroidism, high blood pressure.   Allergic to Cimziai, Remicade,Methrotexate, Psudephrine, latex.  Concurrent medical conditions included Diabetes (Type 2 diabetes, controlled), Coronary artery disease, Chronic kidney disease (Stage 3B), Psoriatic arthritis, Rheumatoid arthritis, Hypothyroidism, Hypertension, Drug allergy (Allergic to Cimziai, Remicade, Methrotexate, Psudephrine) and Latex allergy.    On 25-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Aug-2021, the patient experienced DYSPNOEA (Shortness of breath), AGEUSIA (Loss of taste) and FATIGUE (Fatigue). On 07-Sep-2021, DYSPNOEA (Shortness of breath), AGEUSIA (Loss of taste) and FATIGUE (Fatigue) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered DYSPNOEA (Shortness of breath), AGEUSIA (Loss of taste) and FATIGUE (Fatigue) to be possibly related.    Sender's (Case) Safety Report Unique Identifier- -2021-001245 No concomitant medication information provided by reporter. No treatment information provided by reporter.   Most recent FOLLOW-UP information incorporated above includes: On 08-Sep-2021: Follow up received contains non significant information.
Palpitations; Headache; This spontaneous case was reported by a patient and describes the occurrence of PALPITATIONS (Palpitations) and HEADACHE (Headache) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma, Hypertension and Sulfonamide allergy. Concomitant products included HYDROCHLOROTHIAZIDE and LISINOPRIL for Hypertension, SERTRALINE for an unknown indication.    On 28-Dec-2020 at 6:15 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Dec-2020 at 6:45 AM, the patient experienced PALPITATIONS (Palpitations) and HEADACHE (Headache). At the time of the report, PALPITATIONS (Palpitations) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Based on the current available information and temporal association between the use of the product and the start date of the events within 30 minutes after vaccination, a causal relationship cannot be excluded. Further information has been requested; 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 within 30 minutes after vaccination, a causal relationship cannot be excluded. Further information has been requested
Reaction to injecton site; swollen; redness body aches/headache. Patient took BENADRYL at onset.
This spontaneous report as received from a Registered Nurse refers to a unspecified number of patients of unknown gender and unknown age. It was reported that on an unknown date, the unspecified number of patients received unspecified doses of GARDASIL, (dose number, lot/batch number, expiration date, route of administration not reported) that were improperly stored from 20-MAR-2014 to 07-MAY-2014. Nurse stated that vaccines were exposed to 10.5C for 56.05 hours cumulatively through 07-MAY-2014. It was reported that also M-M-R II, PNEUMOVAX, ROTATEQ and PEDVAX were improperly stored (event captured in MARRS# 1405USA012894, 1406USA000956, 1406USA000957 and 1406USA000958 respectively). No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
My heart was racing, I was light headed and dizzy with 6 episodes for about an hour.
Patient received influenza vaccine at 1105 AM 10/15/2007 and was found asystolic and unresponsive in the parking lot at 1138 AM.  Resuscitative efforts were unsuccessful.
about 2 mins p/vax pt sat on floor then lay down on floor; uncoordiated movement of arms & legs was observed; exam revealed pt was unconscious; pt revived p/10 seconds of NH inhalant; pulse was 108; BP 100/60, resp 22;
p/vax pt devel an inj site rxn characterized by swelling & redness;pt was seen by MD 4/23/99; runny nose also noted;MD prescribed DPH & applications of ice;
No adverse event; Temperature excursion; This spontaneous report was received from an office manger referring to a patient of unknown age and gender. Patient's concurrent conditions, medical history and concomitant medications were not provided.     On 12-AUG-2021, the measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) with lot # U026795, expiration date: 26-FEB-2023 (dose, frequency, route of administration were not provided) and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) with lot # 1742463, expiration date: 20-SEP-2022 (dose, frequency, route of administration were not provided) for prophylaxis had temperature excursions. Temperature for measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was -14 degree C to -10 degree C (-10.1 degree C) for 0 hours 46 minutes and 0 seconds. Temperature for rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was above 9 degree C (9.79 degree C) for 0 hours 45 minutes and 0 seconds. The caller could not confirm if measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) were administered.  No Additional AE, NO PQC and no additional information was provided.
sick; Broke out in shingles; Headache; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left at the age of 65-years-old on 31Mar2021 (Batch/Lot Number: EW0150) as 2nd dose, single for COVID-19 immunization. Medical history included ongoing osteoporosis and "thyroid". The patient previously took the first dose of BNT162B2 on 10Mar2021 (lot number: EN6208) in the left arm. Concomitant medication included levothyroxine sodium (SYNTHROID) taken for thyroid therapy from 1977 to an unspecified stop date. After the first vaccine she broke out in a rash, and after the second vaccine she broke out in another rash which was worse. She still has it in the neck area. She put Cortisone lotion on it and it goes away and comes back. She usually uses the size of a dime or a quarter. She also broke out in Shingles. It's clear across her back. She was still itchy. After the second injection she was itching all over her head, hands, arms, legs, and feet. She was reading about the side effects of a rash, but her whole body was itching. She broke out in shingles and she never had that before. She needs to get Temlos injections for her osteoporosis, she was supposed to start, but she refrained from doing so because she was afraid it might affect the COVID vaccine or the COVID vaccine will affect these injections. The second injection made the 2-inch slough on her arm from the first dose worse, but it went away faster. She also got a 2-inch slough on her neck and she still have it. That was what she was concerned about. The one on her neck came back in a flurry after the second injection, and that was when she broke out in shingles, it blew up like fire on back and neck. Its drying up. The one neck was flaring, red, itching and dry. She put Cortisone lotion on it. Her lower back still has the rash. The rash lasted for about 3 days to a week after the second injection. It came back worse, the second injection did a number on her skin, from top to bottom, but the worst area was the neck, and right where the back attaches to the butt, in that area, in the lower back. The itch was there like phantom itch, there are no bumps or rash on her upper legs and lower legs, her head, back my arms, all night long she was itching. The second vaccine was when she got sick. She also had a major headache for 2 days. 2 days of major headache, and the rest of week if she bent over too fast, she would feel remnants of the headache, especially on the right side over her eye and temple area, went on for about a week. The patient had no previous immunization on the day of vaccination and within 4 weeks. The events did not require a visit to the ER or physician office. The events shingles and headache started on 01Apr2021 while sick on an unknown date. The patient used Cortisone and Benadryl lotion for a rash and itch and it didn't go away. The outcome of the event headache was recovered on Apr2021 while for shingles and sick was unknown.
Ten minutes after I got my vaccine myarm burned, I felt warm, flushed, and my heart rate went into the 90s.  Normal resting is 62.   The feeling calmed a little and then came in waves.  After about 20 minutes after the vaccine my blood pressure was 154/110., usually it?s normal or low. We tried an ice pack on my neck and then went outside to cool off.  The nurse called my doctor and he said to take Benadryl. The cool air and Benadryl calmed down my symptoms and  after about an hour my blood pressure was closer to normal and was feeling more like myself.  About 6pm all of a sudden I had aches all over, felt nauseous, extremely tired, and felt ill.  That lasted about 36 hours.
none.  I was alerted that because the child was 14 days shy of being 6, it was considered an adverse event to have given him the Moderna for age 6-11.  He is fine, no problems whatsoever.
pt recvd vax & exp tiredness & loss of strength in lt arm 2-3 days p/vax; loss of strength in lt arm, numbness in lt arm, heavy sensation in chest & weak sensation, fatigued; MD stated poss post vax synd; poss GBS; pt cont to have paresthes
Urticaria over body that was 1st noticed on 3/6/03. Benadryl elixir given but continues with hives on 3/7/03. Allergic Reaction.
Pt presented to the emergency room with complaints of severe epigastric abdominal pain, nausea, and vomiting.  He was diagnosed with acute kidney injury likely secondary to dehydration, creatinine peaked at 3.5 and trended down with IV fluids..  Fraction excretion of sodium was 0.2% consistent with prerenal azotemia. Creatinine improved to 1.1 at the time of discharge. Encouraged oral hydration.  He was found to be COVID positive but was asymptomatic.
FEELING DIZZY AND LIGHT HEADED; This spontaneous report received from a consumer concerned a female of unspecified age (local case ID# 2021270545). 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 administration, and batch number were not reported) frequency 1 total, dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced feeling dizzy and light headed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of feeling dizzy and light headed was not reported. This report was non-serious.; Sender's Comments: V0:  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Bad rash over whole body (pityriasis rosea) - steroids for 7 days.
The next morning after receiving the seasonal flu vaccine that is required by office as an employee, I developed severe left deltoid / supraspinatus soreness with inability to reach above shoulder level, reach behind back, and difficulty with functional tasks involving my left upper extremity. The severe soreness and weakness persisted for 4 days. It remained at a moderate level for 2.5 weeks, and I now still have mild soreness. The current soreness and some mild pain and weakness occur with shoulder external rotation especially in 90 / 90 position. This has prevented me from completing resistance training using my left shoulder.
Itching at first, later in the day got a fever, and then nausea and vomiting for 2 days straight.
Flu-like symptoms; chills; sore arm - "it was bad"; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of INFLUENZA LIKE ILLNESS (flulike symptoms), CHILLS (chills) and MYALGIA (sore arm - "it was bad") in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     Medical history was not provided by the reporter.  Concomitant products included CARIPRAZINE HYDROCHLORIDE (VRAYLAR) for Antidepressant therapy, VILAZODONE HYDROCHLORIDE (VIIBRYD) and VITAMIN D [VITAMIN D NOS] for an unknown indication.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flulike symptoms), CHILLS (chills) and MYALGIA (sore arm - "it was bad"). At the time of the report, INFLUENZA LIKE ILLNESS (flulike symptoms), CHILLS (chills) and MYALGIA (sore arm - "it was bad") had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       The patient reported that she was still experiencing the same side effects about 138 days later after her first and second dose. She saw her physician but they didn't know what to do for her. Treatment was reported as none taken.   This case was linked to MOD-2021-238895 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: Event outcomes were updated.
Information has been received from a nurse practitioner for GARDASIL concerning a 22 year old female patient with no medical history who on 26-AUG-2011, received her first dose of GARDASIL (Lot # not reported). On 16-SEP-2011, she tested positive for pregnancy. (It was also reported that the laboratory studies performed included pregnancy test on 03-AUG-2011 with no result). Her last menstrual period was on 03-AUG-2011. Estimate delivery date was 09-MAY-2012. The outcome of pregnancy was unknown. The patient sought medical attention by visiting office. Additional information is not expected.
Patient developed a bell's palsy, off balance, weakness, shortness of breath. He was seen in the emergency room, ruled out for stroke, and given steroid treatment for his bell's palsy. Upon reviewing his nerve conduction studies, pt had a demyelinating neuropathy. This in conjuntion with his clinical history was very concerning for guillian barre. Pt was given IVIG, benadryl, acetaminophen and gabapentin.  12/18/09 Discharge summary, hospital records, outpatient notes received. Service dates 11/10/2009 to 12/14/2009. Assessment: Guillain-Barre syndrome. Patient noticed recent weakness in both legs. Face asymmetic. Several ER visits. Bell's palsy. Tingling, numbness, headache. Agitation. Chest tightness, lower back, neck, and shoulder pain. Outpatient NCS demonstrated demyelination. Told to return to ER for admission. Facial paralysis. Lower extremity muscle weakness. Decreased sensation (R) hemibody and bilateral lower extremities. Areflexic upper and lower extremities. Slow, cautious gate. IVIG administration. Gingival abcess (R) lower 3rd molar.
Patient broke out in hives presented on, face, abdomen, back, and R/L legs. Local Allergy Doctor contacted and alerted of situation. Parent told to administer children's zyrtec. Parent educated on s/sx of anaphylaxis/when to seek medical attention. Local Allergist office will call and schedule appointment for child.