chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A report has been received from a pharmacist concerning a 2 years 2 weeks 4 days old female patient, height: 35.0 inches; weight: 25.0 pounds. Patient relevant history, concurrent diseases and concomitant drugs were not provided. Patient received FLUMIST Quadrivalent (intranasal), 0.2 milliliters, years for guidelines practice, started on an unknown date. The PSS reported 2 days after the FLUMIST, 27-Sep-2015, her daughter had a runny nose, puffy eyes, sneezing, and a temperature of 99.3. FLUMIST Quadrivalent was continued. The patient recovered from the event of sneezing, temperature 99.3, runny nose and puffy eyes on 28-Sep-2015. The report was considered to be non-serious by company physician.
Fever; Chills; Temporary paralysis of upper arm; This case was reported by a nurse via sales rep and described the occurrence of arm paralysis in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced arm paralysis (serious criteria GSK medically significant), fever and chills. On an unknown date, the outcome of the arm paralysis was recovered/resolved and the outcome of the fever and chills were unknown.   It was unknown if the reporter considered the arm paralysis, fever and chills to be related to Shingrix.  Additional details were provided are as follows: The age at vaccination was not reported but patient was in 70s. The patient received a dose of Shingrix and experienced temporary paralysis of upper arm for approximately 24 hours, fever and chills. The reporter did not agreed for follow up. Note: There is discrepancy regarding patient's date of birth as it was approx. 1950 was reported therefore conservatively age group and age decades was capture in the case.
Covid 19 vaccination found to have been injected into left subacromial bursa instead of deltoid muscle causing a severe acute subacromial bursitis characterized by pain and limited range of motion of the shoulder.
Left thigh red, hot local reaction. 3 inches in diameter. Firm, but nonindurated, nontender.  Benadryl given every 6 hours for 48 hours.
Initial information received on 29-Oct-2018 regarding an unsolicited valid non-serious case received from a consumer/non-HCP. This case involves female patient who experienced dizzy and vertigo, while she received vaccine FLUBLOK QIV. The patient's past vaccination(s) included Flu vaccine. The patient's past medical history, medical treatment(s) and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot number not reported via unknown route. The patient developed a non-serious dizzy following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE. The patient developed a non-serious vertigo following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE. (Other relevant tests included No lab test). Final diagnosis was vertigo and dizzy. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for dizzy and as Unknown for vertigo.
Adverse events fatigue, body aches, fever 99.5 normally 96.6. Treatment: sleep 12 hours then acetaminophen 500 mg. At 3 PM the day after the injection fever and body aches are gone, fatigue remains.
Became extremely disoriented about 10 hours after vaccine. Could not "find"words,  speaking complete nonsense. Felt very, very out of it and confused. Fell asleep  and felt still confused but not as badly and could talk. Arm and mouth felt tingling / numb. Went to work but left as felt similar symptoms  to mini-stroke 15 years previous. Went to urgent care and then ER. ER stated EKG was abnormal indicating heart attack at some point.
very sore arm for 2 weeks around injection site.  Use of arm was severely limited, she could move it but Not use it for around 2 full weeks.
I had vaccination on 09/10/2022. I started to have COVID-19 symptoms on 11/28/2022 sore throat and fatigue. This progressed into cold like symptoms. I tested COVID-19 positive on 11/29/2022 with a PCR test. I was COVID-19 negative on 12/06/2022. I turned down PAXLOVID. I am doing ok on 12/13/2022 with a residual cough and it is getting better.
left arm is very very sore; laryngitis; very very fatigue; nauseated; throw up several times; slight headache; This spontaneous case was reported by a consumer and describes the occurrence of LARYNGITIS (laryngitis), PAIN IN EXTREMITY (left arm is very very sore), FATIGUE (very very fatigue), NAUSEA (nauseated) and VOMITING (throw up several times) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Type 2 diabetes mellitus. Concomitant products included METFORMIN, ESCITALOPRAM OXALATE (LEXAPRO), SIMVASTATIN, LISINOPRIL, ACETYLSALICYLIC ACID (ASPIRIN 81), FISH OIL and VITAMIN D [VITAMIN D NOS] for an unknown indication.    On 20-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Aug-2021, the patient experienced FATIGUE (very very fatigue), NAUSEA (nauseated), VOMITING (throw up several times) and HEADACHE (slight headache). On 23-Aug-2021, the patient experienced LARYNGITIS (laryngitis). On an unknown date, the patient experienced PAIN IN EXTREMITY (left arm is very very sore). At the time of the report, LARYNGITIS (laryngitis), PAIN IN EXTREMITY (left arm is very very sore), FATIGUE (very very fatigue), NAUSEA (nauseated), VOMITING (throw up several times) and HEADACHE (slight headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Aug-2021, Blood glucose: high (High) very High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Relevant concomitant medications also includes unspecified Vitamins. Treatment information was not provided.
N/V/D, numbness in all extremities, itchy throat and ears, dizziness
administer the Moderna vaccine, to one patient, after 31 days in the refrigerator; administer the Moderna vaccine, to one patient, after 31 days in the refrigerator; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administer the Moderna vaccine, to one patient, after 31 days in the refrigerator) and PRODUCT STORAGE ERROR (administer the Moderna vaccine, to one patient, after 31 days in the refrigerator) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Feb-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administer the Moderna vaccine, to one patient, after 31 days in the refrigerator). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (administer the Moderna vaccine, to one patient, after 31 days in the refrigerator). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administer the Moderna vaccine, to one patient, after 31 days in the refrigerator) and PRODUCT STORAGE ERROR (administer the Moderna vaccine, to one patient, after 31 days in the refrigerator) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not provided. The vial was initially stored in the refrigerator on 13Jan2022 Treatment medication was not provided.
No ADR, timing ERROR, 2nd dose given 58 days after 1st Narrative: Timing ERROR only
upper thigh, where vax w/secondary scarring, hypopigmentation of site & retraction to possibly include underlying muscle; Per follow-up dated 9/27/00, the pt's scar secondary to injection was markedly improved.
patient mother describes redness, heat and a hard knot at the injection site. Reports fever of 100 degrees F.
eyes seemed to move quickly back and forth; felt weak and had no energy; heart began to beat fast like it was going to beat out of chest; shake all over her body; vision came back blurry; blood pressure and heart beat were high; vision went in and out while driving down the freeway; This is a spontaneous report from a contactable consumer (patient). A 28-year-old female patient received bnt162b2 (Pfizer product), dose 2 via an unspecified route of administration, administered in arm left on 06May2021 11:45 (Lot Number: Ew0175) as single dose for covid-19 immunisation. Medical history and concomitant medications were none. No any other medications the patient received within 2 weeks of vaccination. The patient was not pregnant. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient previously received first dose of bnt162b2 (lot number: Ew0161) in left arm on 15Apr2021 at 11:30 for covid-19 immunisation. The patient previously took amoxicillin and experienced allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient stayed for 20 minutes after getting the second vaccine and was fine so she headed to work. A total of 40 minutes after vaccine (06May2021 12:25), her vision went in and out while driving down the freeway. At 12: 45, she started to shake all over her body and heart began to beat fast like it was going to beat out of chest. Her vision came back blurry and was able to pull over on the side of the freeway and call 911. They took her blood pressure and heart beat, both were high. After 30 minutes her heart beat and blood pressure returned to normal. For the remainder of that day the episodes happened 3 times, but only lasted 2-3 minutes at a time. Two days after (08May2021), her vision was blurry and eyes seemed to move quickly back and forth and she felt weak and had no energy. The adverse events result in Emergency room/department or urgent care. Unknown if treatment received. The outcome of events was recovered with lasting effects.
Onset 10/20/00, in the afternoon with sore throat, dry cough, increasingly severe headache, flush. Awoke approx. 06:30 on 10/21/00, with elevated temperature, facial rash along with red facial flush, lymphadenopathy (especially suboccipital, cervical and post auricular), severe arthralgia/myalgia. By the time I arrived at ER, rash had spread over chest, back, abdomen and extremities and accompanied by chills and malaise. Rash persisted X 5 1/2 days. Persistent lymphadenopathy and arthritis.
received expired doses of the Moderna COVID19 vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received expired doses of the Moderna COVID19 vaccine) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059h21a) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (received expired doses of the Moderna COVID19 vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received expired doses of the Moderna COVID19 vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant products were reported.  8 patients received expired doses of the Moderna COVID-19 vaccine.  Upon follow up, reporter provided the patient information for all patients, hence case became valid.  No treatment drugs were reported.   Most recent FOLLOW-UP information incorporated above includes: On 06-Apr-2022: Follow up received includes significant information, case became valid as patient details added with along with dose no. of suspect and product coding was updated.
Head ache with pressure/pain on top of head on 01/8/2021, woke 01/09/21 with nausea, progressed to headache and nausea so bad that I couldn't take migraine meds for fear of vomiting. Went to bed with chills. Woke with pain and  stiffness in right shoulder joint. Nausea subsided and I took 50 mg immitrex. Could no longer lay  down due to head pain, so slept sitting up two hours. Chills continued. Meds finally worked and headache subsided. Chills subsided. Mild nausea persists this evening.
In upper left arm in area of injection, soreness, heat, redness, swelling. Took some benedryl and tylenol. Some improvement a day later.
Headache, nausea, indigestion, fever. No respiratory issues.  Also stopped my period within 48hrs- when I had almost a week left. Adversity of that is questionable.
Extreme fatigue, soreness in all joints, pain in both arms, migraine, nausea.
FACE GOING NUMB STARTING WITH TONGUE AND JAW, TIGHT CHEST, ITCHING ALL OVER
Severe muscle aches and weakness in both legs within 24 hrs. after flu shot. After 1 week, right leg is better, but continues in left leg. Left leg flare up of osteoarthritis in knee.
ACT-HIB has been reconstituted with sterile dilute instead of the appropriate one with no advese event; Initial information received on 04-Feb-2022 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves an unknown age and unknown gender patient who reported act-hib has been reconstituted with sterile dilute instead of the appropriate one with no advese event while receiving vaccine HIB (PRP/T) VACCINE [ACT-HIB].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect HIB (PRP/T) VACCINE (lot-UJ611AAB,30-Nov-2022) via unknown route in unknown administration site for immunization.  On an unknown date the patient developed a non-serious event "act-hib has been reconstituted with sterile dilute instead of the appropriate one with no advese event" (product preparation error) (unknown latency) following the administration of HIB (PRP/T) VACCINE.  It was reported "She thinks there may be three patients but she is not sure who they are as she is still investigating who gave the product".  Action taken with HAEMOPHILUS TYPE B (HIB) VACCINE (ACT-HIB) was not applicable.  At time of reporting, the outcome was Unknown for the event act-hib has been reconstituted with sterile dilute instead of the appropriate one with no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
This spontaneous report concerning a 52 years old female patient with drug hypersensitivity to FLAGYL and hot flush was received from the patient herself and a pharmacist. At the time of reporting, the patient had no pertinent medical history. On 27-JUN-2016, the patient was vaccinated with ZOSTAVAX (strength, dose, frequency, lot and expiration date were not provided), in her arm. Concomitant therapies included an unknown medication for hot flashes, ascorbic acid (reported as vitamin C), CLARITIN and vitamins (unspecified) (reported as multivitamin). On 28-JUN-2016, the patient noticed that she had a large, warm, red area which was approximately 2.5 inches by 2.5 inches on the back of her arm at the injection site. In addition, the patient stated that the area felt "bubbly or texture". Furthermore, it was reported that the patient received an unspecified treatment for the adverse events and that no laboratory diagnostic studies were performed. No product quality complain was involved. At the time of reporting, the outcome of the events of injection site warmth, injection site reaction and injection site erythema was not recovered. The causality between the events of injection site warmth, injection site reaction and injection site erythema and ZOSTAVAX was not assessed. Additional information has been requested.
8 Days following first Phizer Covid 19 shot,  experienced a sharp pain in center of chest lasting about 30 seconds to 1 minute.  There after, chest pressure, and chest tightness continued for about 3 weeks.  At times felt pain  pressure in back region also.  Pain level went up and down from 2 to a  4 or 5 on a scale of 10.
Patient was given 1 dose 0.5 ml of Janssen COVID 19 vaccine and shortly thereafter became lightheaded and nauseous. She was given cold compresses and asked questions to assess her status. She recovered from the symptoms within 15 minutes.
C/O abdominal fullness and unable to burp.  C/O soreness in bilateral lymph nodes.  EMS review, VSS, Patient burped and reported improvement in symptoms
This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. On 20-JUL-2017, the patient was administered an improperly stored M-M-R II (lot # reported as M045402, exp date: 14-NOV-2018), that was reconstituted with sterile diluent (MERCK STERILE DILUENT) (lot# M015993, exp. date: 03-DEC-2018) for prophylaxis. The improperly stored information for M-M-R II this time was reported: temperature of 12.2 Celsius degrees with time frame of 53 hours. A digital data logger was involved. There was no previous temperature excursion for M-M-R II. It was also verified that diluent (MERCK STERILE DILUENT) did not undergo an excursion. No adverse effects were reported.
Really tired after second shot; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Really tired after second shot) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 006M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FATIGUE (Really tired after second shot). At the time of the report, FATIGUE (Really tired after second shot) outcome was unknown.            No Concomitant medication was reported.     No treatment medications were reported.   This case was linked to MOD-2021-385830 (Patient Link).
starting at 4:30a I felt weak, dizzy, like I was on a boat. I couldn't stand up straight, I kept falling over and into the wall. Within an hour I couldn't form words, I couldn't remember how to do the simplest of tasks at work.  I felt like I was going to be sick. My face and tongue were swollen, felt really weak. I couldn't focus on anything. Had multiple panic attacks, felt like I was going to pass out multiple times.   Got to the ER at 9am, and the panic attacks got worse, the speech was more slurred, less ability to focus, lights were too bright. Felt more weak. Face was more swollen, limited strength.   Got blood work back the next week, liver enzymes are were double the normal numbers, (AST and ALT's)
I first began to notice that when I typed a URL on a screen, I did not see all the characters, although I could see the entire screen.  My wife asked me to visit my optometrist.  She said there was no change in my eyesight since my last visit.  She recommended that I ask my primary care physician to have him order an MRI of my carotid arteries.  He refused and sent me to an Ophthalmologist.  He said there was nothing wrong with my eyesight and informed my primary care physician to order an MRI of my carotid arteries.  He did and they found no blockage.  I was light headed when I was standing at this time and when I stood for some time or began walking, I felt as if I was going to faint.  I asked my primary care
PT PRESENTS WITH REDNESS, PAIN, AND SWELLING.  SWELLING WITH INDURATION APPROX 35X20MM. SWELLING WITHOUT INDURATION CONTINUES TO ELBOW OF LEFT ARM.  PT RECEIVED BOTH VACCINES IN SAME ARM ON 11/16/2004.
Initial misuse report received from a healthcare professional on 10 April 2014. A patient (age and gender not reported) had received an unstable dose (exposed to -8 degree Celsius) of TYPHIM VIA on an unspecified date. No adverse event was reported. Documents held by sender: None.
I seriously thought I was dying. Extreme fatigue, chest pain, nerve pain all over my body (chest, head, legs), hallucinations and confusion. No treatment. Lasted a few days.
On 6th day after vaccination pt felt burning on his toes, later developed blisters on feet, went to MD on Tues => MD suspects shingles.
Certified Medical Assistant administered vaccines during patients 12 month wellness exam. Parents stayed after administration for observation due to patient being introduced to new immunizations. Immediately after administration, injection site began to turn red, and swell, and hives appeared. Provider was informed and went in to check on the patient. Symptoms were treated c Benadryl, given po, and patient remained in office for another 10 minutes. (Mom refused to stay any longer) Symptoms began to show improvement and parents were advised to take patient to ER if she began to show signs of distress or anaphylaxis. Mom verbalized understanding.
Hospitalization cough, vomiting, diarrhea, headache, and chills tested positive for COVID at HCF on 9/18.
Initial reaction day of vaccine: tenderness to injection site and swelling the size of half dollar. On day 2, patient experienced shills, diarrhea, headache, weakness that lasted 3.5 days. Reports follow-up with primary physician.
pharmacy was at facility to vaccinate community/  staff neglected to record previous bivalent vaccination given to patient 2 months earlier/  patient received 2 bivalent vaccines in a 2 month window
Janssen Covid-19 Vaccine EUA Had severe headache for 24 hrs, light headed for 24 hrs in which started about 3 hrs after shot
Patient Received double the required dose, she got 1 ml instead of 0.5ml
RASH, VOMITING, DROWSINESS, PERIORAL CYANOSIS.
Chills/ slight headache for two days after - still able to work, just didn't feel "normal".  Developed hives/welts on chest up neck and onto chin on 1/6/21 in the evening along with a slight headache.  Had a virtual visit with Urgent care and was prescribed Prednisone and zyrtec for the next 5 days and told to report.