chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The patient received a dose of the vaccine following temperature excursions on unknown dates; No adverse event; This spontaneous report as received from a medical assistant refers to a current 3-month-old patient of unknown gender.  The patient's concurrent conditions, medical history and concomitant medications were not provided.   On an unknown date, the rotavirus vaccine, live, oral, pentavalent (ROTATEQ)  (lot # S013439 with expiration date 03-MAR-2021, lot # S013436 with expiration date 30-JAN-2021, and lot # S006050 with expiration date 12-DEC-2020) underwent a temperature excursion.   Temperature Total Time and LOWEST Temperature BELOW 36°F/2°C (0C) Time frame 7 hours 30 minutes Previous temperature excursion? yes, Total Time and LOWEST Temperature BELOW 36°F/2°C (0C) for 8 hours 30 minutes Was call because of a "data logger"? yes  On an unknown date, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) at a dose of 2 ml (route not provided) as prophylaxis. No adverse events were reported.  This is one of several reports received from the same reporter  This spontaneous report as received from a other health professional refers to a patient of unknown age.    On an unknown date the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # S006050, 2 milliliter for prophylaxis.       On an unknown date the patient experienced product storage error and no adverse event.    The outcome of product storage error and no adverse event is unknown.   The reporter considered product storage error and no adverse event to be not assessed to Rotavirus Vaccine, Live, Oral, Pentavalent(ROTATEQ).     {Additional information has been requested. / Additional information is not expected.}; Sender's Comments:  US-009507513-2005USA003382: US-009507513-2005USA004545: US-009507513-2005USA004950: US-009507513-2005USA004951: US-009507513-2005USA004952: US-009507513-2005USA004953: US-009507513-2005USA004954: US-009507513-2005USA004955: US-009507513-2005USA004956: US-009507513-2005USA004957: US-009507513-2005USA004958: US-009507513-2005USA004959: US-009507513-2005USA004960: US-009507513-2005USA004961: US-009507513-2005USA004962: US-009507513-2005USA004963: US-009507513-2005USA004964: US-009507513-2005USA004965: US-009507513-2005USA004966: US-009507513-2005USA004967: US-009507513-2005USA004968: US-009507513-2005USA004970: US-009507513-2005USA004971: US-009507513-2005USA004972: US-009507513-2005USA004973: US-009507513-2005USA004974: US-009507513-2005USA004975: US-009507513-2005USA004976: US-009507513-2005USA004977: US-009507513-2005USA004978: US-009507513-2005USA004979: US-009507513-2005USA004980: US-009507513-2005USA004981: US-009507513-2005USA004982: US-009507513-2005USA004983: US-009507513-2005USA004984: US-009507513-2005USA004985: US-009507513-2005USA004986: US-009507513-2005USA004987: US-009507513-2005USA004988: US-009507513-2005USA004989: US-009507513-2005USA004990: US-009507513-2005USA004991: US-009507513-2005USA004992: US-009507513-2005USA004993:
0905 experienced hypotension 97/54  BP rechecked by RN 104/78 Patient had no further symptoms and was ok to go home
Herpes Zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 67 year old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In November 2016, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced herpes zoster. On an unspecified date, the patient was treated by a physician for herpes zoster. The outcome of the event was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).   Additional information has been requested.
Transverse Myelitis; This spontaneous case was reported by a consumer and describes the occurrence of MYELITIS TRANSVERSE (Transverse Myelitis) 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 information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYELITIS TRANSVERSE (Transverse Myelitis) (seriousness criterion medically significant). At the time of the report, MYELITIS TRANSVERSE (Transverse Myelitis) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant or treatment medications were reported.  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.  Further information is  expected.; 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.  Further information is  expected.
COVID Breakthrough  Pfizer Dose 1 4/15/21 (Er8732) Pfizer Dose 2 5/21/21 (EW0168) COVID Positive 8/25/21  8/25/21: Patient is a 55 year old female with a history of COPD, pulmonary embolism on anticoagulation, HTN, tobacco abuse, sickle-cell anemia who presents for evaluation of shortness of breath.   Patient notes that she started feeling sick on Monday. She initially presented to clinic on Monday for evaluation. Patient's primary symptom is shortness of breath.  She notes that going upstairs she has more difficulty than normal.  Patient has also had increased cough productive of white/yellow sputum.  Patient notes that she has had some right sided rib pain, but is currently denying chest pain. She denied recent sick contacts or exposure to COVID. Patient is not vaccinated for COVID.  No hemoptysis, recent travel or calf tenderness.  Patient notes she had a left rotator cuff surgery recently.  No other concerns today. In the emergency department patient's vitals showed tachycardia to 111.   Patient's initial oxygen saturation was 82% on room air, but improved into the mid 90s on 4 L. labs were obtained and showed mild transaminitis, lactic acid 4.0, troponin 0.01.  ABG showed pH 7.36, pCO2 34, HC03 19. Blood cultures X 2 ordered.  COVID rapid antigen positive.  Chest x-ray showed evidence heart failure with small bilateral pleural effusions and moderate pulmonary vascular congestion as well as airspace disease in the bilateral lower lobes. Patient received breathing treatments, Solu-Medrol and gentle hydration.  She was subsequently admitted to inpatient.   Social history:  Patient admits to drinking approximately 0.5 gallons of vodka per week.  She denies ever having issues withdrawing from alcohol.  Patient smokes half pack per day since the age of 12.  Other past medical history reviewed and updated in the chart.  8/30/21: Brief hospital course: Patient is a pleasant 55 yo F who presented on 8/25/21 with SOB x 3-4 days. She had exposure to husband who was COVID+ and patient was subsequently found to be COVID+. In the ER, O2 sat was 82%, which improved after supplemental oxygen. Afebrile, no CP, no EKG changes, troponin negative. CXR did reveal findings concerning for possible heart failure. Echo during hospital course showed moderate mitral regurgitation with EF 52%. Given Solu-Medrol, Levaquin in ER. CRP was elevated, thus oral prednisone was added along with Mucinex and albuterol inhaler. Patient's hospital course notable for pain in lower back that patient attributed to sickle cell crisis which she endorsed that she has not had for approximately a decade. Her pain regimen was modified to be a PCA. Patient was on CIWA protocol due to alcohol use history. Of note, patient was found to have alcohol in the hospital that was confiscated. On 8/30, patient was deemed stable for discharge with close follow-up on outpatient basis. Patient placed back on home oral pain regimen (MS Contin and Dilaudid). Patient on room air and breathing comfortably, able to move all extremities and ambulate. ER precautions were thoroughly discussed, patient verbalized understanding.
Pt squirted MMR II vax into right eye on 13AUG90 & exp redness & burning in the eye which persisted for 2 hrs.
pt did not seroconvert following vax w/measles & rubella vax; no further details were provided;
Patient had redness and her arm was swollen. She didn't say that she was in pain, nor did she realize it was swollen until she was at the doctors office and the nurse was looking and told her.
Patient was seen by provider and told to take NSAIDs and BENADRYL OTC. Urticaria pruritus and red, hot area where vaccine was given.
Patient vaccinated on 2/26/07 for smallpox, onset of sx. on 03/07/07. Patient presented with malaise, low grade temp. and expanding area of erythema around inoculation site on left deltoid (approximately 20cm x 7cm), thought to be c/w cellulitis. Tx: Keflex 500mg PO TID x 10 days.
This is a spontaneous report from a contactable consumer. A 70-year-old female patient received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (unknown trade name) lot number and expiration date unknown at a single dose and influenza vaccine (FLU VACCINE), at an unknown dose, both administered on patient's arm via unspecified routes of administration on an unspecified date for immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient's bad cold started last week (date unspecified) and it has been 10 days now since she had a pneumonia shot and a flu shot. It was reported that right after she got that the pharmacist told her that the flu shot was fine, but the pneumonia shot will be uncomfortable for a few days. Her arm on the side where she got the shot makes her feel drained out and then after that she got the cold and she has been taking paracetamol (TYLENOL). Outcome of the events was unknown. Information on the batch number has been requested.
hives; weird nightmares; feeling hot; confused; itchiness; a lot of pain; weak; extreme headaches; body aches; tired; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives), FEELING ABNORMAL (weird nightmares), FEELING HOT (feeling hot), CONFUSIONAL STATE (confused) and PRURITUS (itchiness) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 12-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Jul-2021, the patient experienced URTICARIA (hives), FEELING ABNORMAL (weird nightmares), FEELING HOT (feeling hot), CONFUSIONAL STATE (confused), PRURITUS (itchiness), PAIN (a lot of pain), ASTHENIA (weak), HEADACHE (extreme headaches), MYALGIA (body aches) and FATIGUE (tired). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, URTICARIA (hives), FEELING ABNORMAL (weird nightmares), FEELING HOT (feeling hot), CONFUSIONAL STATE (confused), PRURITUS (itchiness), PAIN (a lot of pain), ASTHENIA (weak), HEADACHE (extreme headaches), MYALGIA (body aches) and FATIGUE (tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.
A call was received from a medical examiner stating the child had died of SIDS on 1/12/01. Autopsy states pulmonary congestion and edema. Final cause of death given as sudden death associated with bronchopulmonary dysplasia.
Information has been received from an unknown reporter regarding patients of unknown age and gender who had enrolled in a Market Research program. The patient's concurrent condition, medical history and concomitant medication was unknown. On an unknown date the patient was vaccinated with PNEUMOVAX 23 (dose, frequency and route were not reported). It was reported that, the reporter or his/her hospital had decided to administer PREVNAR 13 at least some adult patients. The key reasons for the decision was the patients were allergic to PNEUMOVAX 23. Action taken with the suspect vaccine was unknown. The outcome of the event allergic to PNEUMOVAX 23 was unknown. The reporter did not provide any causal relationship between the event and PNEUMOVAX 23. This is one of several reports received from the same reporter. Additional information has been requested.
patient's father requested for medical staff to assist his 18yo daughter. Patient c/o light headedness without any accompanying symptoms. per patient she "passed out", according to father, patient did not completely lose consciousness, but became weak and minimally responsive. per pt and father, patient has a significant history of "passing out' associated with medical procedures and the sight of blood.  Upon initial assessment, no acute distress noted, patient was slightly pale, AOx4, verbal, able to make needs know, and answers questions appropriately. Respiration even and unlabored, lung sound clear to auscultation. after approx 1 minute, noted patient's skin pink, dry warm, & intact. Respiration remained even and unlabored, lung sound clear to auscultation. no sx/sx of allergic reaction. Patient?s father reported that patient has a history of anxiety. Denies any significant past medical history, or allergies. Patient was assessed while seated in chair, with bilateral lower extremities elevated,  in observation area. physical examination and past medical history obtained simultaneously. initial vital signs 124/80 hr 106 O2sat 99% rr20. Continued to observe patient for an additional 30 minutes. No acute distress noted throughout that time. Respiration remained even and unlabored, lung sound clear to auscultation. denies dizziness, light headedness or  other symptoms. Skin warm, dry and appropriate for ethnicity. v/s @ 1640 122/84 hr 74 O2sat 98% rr20 , AOx4, no acute distress noted. Educated patient and her father on on sx/sx of allergic reactions, and anaphylaxis. Instructed patient's father not to leave patient unattended for remainder of day. instructed to call 911 if experiencing difficulty breathing or loss of consciousness. encouraged patient to follow up with her PCP. patient and her father expressed understanding of all instructions and education. . Patient left home with father @ 1645.
Patient started to feel light headedness after about 15 minutes after the injection.  Patient did no complain of any other discomforts nor were any other s/s noted by the staff who observed her.  First set of vital were 140/90, hr 67, resp 19 and 99% on rm air.  Patient remained lighted head for about 20 min.  Vitals were taken in between and her latest being 115/65, hr 75, resp 19 and 99% rm air.  She was released and discharged at 12:25 with no further escalation in symptoms not and feeling better.
Within 20 minute of receiving the shot my face was very flushed and hot; Within 20 minute of receiving the shot my face was very flushed and hot; lips slightly swollen; Mild itching on face continues 20 hours later; This is a spontaneous report from a contactable consumer reporting for herself. A 72-years-old non-pregnant female patient received BNT162B2 lot number unknown, via an unspecified route of administration on 22Jan2021 15:45 (at the age of 72-years-old) as a SINGLE DOSE  in the right arm for covid-19 immunisation. Medical history was none.  It was unknown if the patient had allergies to medications, food, or other products. Concomitant medications were none. The facility where the most recent COVID-19 vaccine was administered was provided as other. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19.  Within 20 minutes of receiving the shot, the patient's face was very flushed and hot, lips slightly swollen on 22Jan2021 16:00. Mild itching on face from unspecified date in Jan2021 continues 20 hours later. No treatment was received for the events. The clinical outcome of within 20 minute of receiving the shot my face was very flushed and hot was not recovered It was also reported that since the vaccination, the patient had not been tested for COVID-19.  Information on the lot/batch number has been requested.
Fever of 101.2 for 3 days, headache for 3 days and joint aches for 3 days.
extreme fatigue; unsteady on feet; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 27-Jun-2021. The most recent information was received on 12-Jul-2021 and was forwarded to Moderna on 12-Jul-2021.    This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (extreme fatigue) and GAIT DISTURBANCE (unsteady on feet) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Jun-2021, the patient experienced FATIGUE (extreme fatigue) and GAIT DISTURBANCE (unsteady on feet). On 05-Jun-2021, FATIGUE (extreme fatigue) and GAIT DISTURBANCE (unsteady on feet) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product information was not provided.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 12-Jul-2021: Significant follow up. Information regarding events from first dose updated to reflect follow-up information.
approx 12noon 24 hrs p/vax mom noted reddened area on thigh where immun given; observed approx 1PM 5APR94 had area approx 3" of erythema @ site of inject; area sl edematous & warm to touch; didn't wont to walk, firm are was noted @ site;
No additional AE reported; Nurse reported two temperature excursions on multiple refrigerated vaccines.  There was a prior excursion on 5/3/2022 and a recent excursion on 5/26/2022.  She said it was very likely all vaccines had been administered since the excursions occurred.; This spontaneous report has been received from a nurse, concerning a 12-months-old male patient. No information was provided regarding the patient's pertinent medical history, concomitant medications, concurrent conditions, and previous drug reactions or allergies.  On 03-MAY-2022, the measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) lot # U014656 experienced a temperature excursion of 47.3 Fahrenheit degrees (F) for 5 minutes, if a digital data logger was involved was not reported (product storage error).   Consequently, on 23-MAY-2022, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) (lot number reported as U014656 confirmed as valid, expiration date reported and stablished as 07-MAY-2023) administered as prophylaxis (formulation, strength, dose, vaccination scheme, route of administration and anatomical location were not provided) (product storage error). No additional adverse events (AE) reported (no adverse event).  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2206USA001103:
HPV vaccine was adm. 1st, immediately after vaccine was adm. pt. held (R) side of her head & went limb. Her body then became rigid while in the chair. I held her head & instructed her to take deep breaths, she followed command. Rigidness lasted approx. 20 - 30 sec. she then came to. When asked what she felt she replied she did not recall anything. Monitored pt. for extra 30 min. after vaccine c/o sleepiness only on exit.
When I got the vaccine, an itching started in my body and intense pain in the neck and head; I felt weird, I thought it was similar to the 1st dose and I waited. This time I was shaking a lot and I started to stutter, I couldn't speak, I didn't have you. I went to the emergency room and they told me that I had had a pre-stroke (pre-attack). They did all the tests like it was a stroke and I was in the hospital for a week (yellow) and half of my body was paralyzed, I had no strength. The doctor told me it was a reaction to the vaccine. I am still in treatment with psychiatrists and a psychologist and counselor for the emotional damage I have had. I didn't want to live because I felt emotionally exhausted.
Rash and nausea, vomiting. Methylprednisolone 125 mg once, diphenhydramine 1 tab PRN.
Pt recvd 3 doses of Engerix-B & was found t have a neg titer;
Soon (1-2 minutes) after last vaccine given, pt had a strong menstrual cramps (which she was having prior to visit) and became nauseous. She vomited x2 and felt weak. She recovered in 20-30 minutes and went home.
I had left side pain and could barely walk. I had difficulty walking because it was so painful on the left side. I took a muscle relaxer and went to bed. Later in the night the pain had become more severe. 2 days later it was gone and it returned again yesterday March 24, 2023 on the same side in the same area. I saw a nurse practitioner who had me do several movements and discussed what I was doing when the pain came on. She completed a urinalysis and a urine culture. She diagnosed me with having a muscle sprain and prescribed ibuprofen and cyclobenzaprine for the pain. I have not yet taken the medication. My symptoms are not as bad today. They have eased up some. I can still feel it. It's like a nagging ache. My doctor advised that it would likely take a few weeks to recover from it.
received vaccines after a temperature excursion; This non-serious case was reported by a other health professional and described the occurrence of incorrect storage of drug in a 57-year-old patient who received Herpes zoster (Shingles vaccine) (batch number 7KG39) for prophylaxis.   On 27-JAN-2023, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced incorrect storage of drug (Verbatim: received vaccines after a temperature excursion). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK receipt date: 14-Apr-2023 The reporter consented to follow-up. This case is for one of 119 patients, reported by same reporter. The patient received unstable vaccine after a temperature excursion, which led to incorrect storage of drug; Sender's Comments:  US-GSK-US2023054677:same reporter US-GSK-US2023AMR055743:same reporter
Pt. stopped by 5/11/2006 with complaint of recurrent pain in left arm/shoulder.  She described the change in pain from the initial day following her Tdap/Adacel IM injection until this visit.  She described it as hurting for approximately 3-4 days (improved when she took Advil), then the pain subsided for approximately 3 days and then it began hurting severely again the past few days.  When questioned about the pain, she said the pain was a sharp pain from her shoulder to her collar bone & that was most painful when lifting something up, pushing & pulling with a bent elbow or when she was swimming laps.  Questioned further regarding swimming & this is her routine form of exercise, regular exercise is 80 laps/day.  She "gradually" worked back to her routine by one day of 40 laps and one day of 80 laps, between the 40 & the 80 is when her pain soared from mild to severe.    We developed a plan of 40 laps/one week, then 60 times one week, then return to 80 laps in the third week.  Shoulder therapy: Warm up in the morning with heat as need and ice at the end of the work out.  Medicate: Motrin/Advil 400-600 twice daily for 1 week.  Mantoux Skin Test given at the same time using 0.1 mm dose (TB syringe/needle).  Given in left forearm, no reaction noted after 48 hours.