chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse effect; Was administered a third dose of PROQUAD; Information has been received from a licensed practitioner nurse concerning to an 11 year old female patient. No medical history, concurrent conditions nor concomitant medications were reported. On 14-JUL-2020, the patient was vaccinated with a third dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (Lot No. S008575, exp. date 16-SEP-2020) (route of administration not reported) for prophylaxis (extra dose administered). The vaccine was reconstituted with properly stored sterile diluent (Lot No. S002624, exp. date 05-NOV-2021).
Initial and follow up information has been received from a physician concerning a female 19 years old with no drug allergies, debilitating dysmenorrhea, acne, weight loss, and irregular break-through bleeding, and with a history of yeast infection, bacterial vaginois, varicella (1/90), cellulitis (5/06), urinary tract infectin, cramping, and abscess of legs  who, on 27-Jun-2007 at 12:30 (Lot # 657868/0523U) was vaccinated intramuscularly with a 0.5 mL dose of Gardasil. Concomitant therapy included TRI-CYCLEN LO. It was also noted that the patient received at least one other vaccine on the same date as when GARDASIL was administered. The patient sought unspecified medical attention. Subsequently, at approximately 12:31 the patient felt dizzy (previously reported that she fainted), complained of lightheadness, and was very pale. The patient was given water and animal crackers while she laid on the exam table. Within a few minutes the patient felt better and was able to sit up with return of good color. The patient sought unpecified medical attention.No laboratory diagnostic studies were performed. The patient recovered on the same day as when the injection was given. No product quality complaint was involved. This is one of several reports from the same source. Additional information has been requested. This is in follow-up to report (s) previously submited on 5/14/2007. Additional information is not expected.
Approximately 8 pm on January 5,2022, the day I received my first vaccine, I started chilling, took 2 , 200mg of Ibuprofen, temperature 102.  Headache most of the day.   Following morning, headache continues, neck pain, sore arm, no fever.  Approximately 4:30, chills begin. Not as bad, slept for 2 hours, felt better.  Back in bed by 8 pm, no temp taken, sometime during the night, fever broke with sweats, feeling much better.  Slight headache today, no other complaints.
8 pm- fatigue, beginning of headache.  11 pm chills and fever 1 pm body ached and crushing headache.  did not sleep.  fever went away after 3-4 hours, body aches dissipated over 2nd day,  headache lasted until 3rd morning. woke up Sunday feeling tired but headache all but gone. now 3 days later, still have fatigue and a little fogginess. much like when I get over the flu- just weak and tired.
Severe flu-like symptoms; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient's friend. The age at vaccination was not reported. The age group was not reported but was captured as an adult as per vaccine indication.  The patient experienced severe flu-like symptoms that lasted for a week. The reporter did not consent to follow-up.
Initial Encounter: Per patient, she has had allergic reaction to sulfa drugs. When she took sulfa medication, she developed hives and tongue swelling. She denies having any respiratory or anaphylactic reactions. patient denies wanting to speak to her provider about getting the vaccine and has consented to get the vaccine today. patient is aware that she will be monitored for 30 minutes.   16:22: Patient is currently complaining of tongue tingling and concerns for tongue swelling.  Patient escorted to room 11 with resource RN available.    1624: EE brought back to Obs room 11 for complaint of tingling to tongue. On assessment EE was alert and oriented, Sat probe placed and BP cuff, observed EE to have redness to chest and that continued to worsen as BP cuff placed. Clear to all lobes, no increased WOB. Per EE tongue felt tingley, no swelling observed to tongue, lips or face. VS obtained at 1624: HR 124, RR: 16, Pox: %99, BP: 159/102 tp Lt arm. Pt developed redness to Lt arm from elbow down to wrist. VS obtained again, HR: 114, RR: 16, Pox: %99, BP: unable to obtain as EE was moving arm. EE began complaining of increased itchiness in mouth and "lip swelling", writer and PCT both observed swelling to EE upper lip. Instructed to call 911, RN called back to Obs rm 11to assist. Epi pen administered to Rt quadricep at 1633, VS reassessed; HR: 116, RR: 16, Pox: %99, BP: 169/107 (126) Rt arm. Redness to Lt arm, chest and neck began to resolve and swelling to upper lip began to resolve, clear to all lobes. Dr. arrived to Obs rm 11 and was updated on events. EE remained alert throughout. EE's daughter notified via teams and was able to call and speak with her mom. EMS arrived and care transferred. Per EMS EE was to be transferred to Parkland. EE left on EMS stretcher with personal belongings. ~RN
Systemic: Lymph Node Swelling-Medium, Additional Details: Pt has experience some lymph node swelling 3 weeks after the first dose. She experience it in her left axillary.
JUST WANT TO SINK INTO SOMETHING AND NEVER GET UP; CHILLS; MUSCLE ACHES; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 11-JUN-2021 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 12-JUN-2021, the subject experienced just want to sink into something and never get up. On 12-JUN-2021, the subject experienced chills. On 12-JUN-2021, the subject experienced muscle aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills, and muscle aches, and the outcome of just want to sink into something and never get up was not reported. This report was non-serious.
Pt came in office with rash on left side x 3-4 days. Itching too. Pt has been prescribed Valacyclovir and Hydrocortisone. No pain at this time.
This is a spontaneous report received from a noncontactable consumer or other non-HCP (patient) for a Pfizer sponsored program (159558). A patient (no qualifiers provided) received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), Mar 2021, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. Vaccination history included the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), Feb 2021, for COVID-19 immunization. The patient experienced hot flush (4 weeks ever since getting hot flashes), onset 2021, with outcome of not recovered. Additional information: The patient reported that it's kind like go through just having a changed life. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Started with a low grade fever and on 7/30/2016 the spots appeared in his belly. Low grade fever continued until 8/4/2016. He slept 15hrs straight and woke up with a bright red rash all over his body, along with more spots.
5 days after receiving the first dose of the Pfizer Covid-19 vaccine my skin started having red patches of scaling dry skin with pimples and cysts. I was 2 months post partum at the time of vaccination and starting to wean my child from breastfeeding so I thought it was a hormonal reaction. However, after waiting a week to see if there was any improvement, I went to my OBGYN who thought it was a skin condition and they recommended I see a dermatologist to receive a diagnosis/treatment. I went to see Dr. who biopsied my skin and confirmed a diagnosis of psoriasis.
Patient's caregiver reported that the patient (wife) had swelling of the lips, and swelling of the ankles.
Red streak on inner side of left arm; Felt was going to die; General malaise; Weakness; Slight dizziness; Nausea; Vomited; Blood pressure fluctuation; Hives on inner arms; A spontaneous report was received from a consumer and physician concerning a 83-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced felt was going to die, general malaise, red streak on inner side of left arm, hives on inner arms, weakness, dizziness, blood pressure fluctuating, nausea and vomited.   The patient's medical history included breast cancer, breast cancer surgery and hives. Concomitant product use was not provided.   On 05 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot #: 039K20A) (route of administration not specified) in the right arm for prophylaxis of COVID-19 infection.   On 17 Jan 2021, 12 to 13 days after the vaccination, the patient developed hives on inner arms which would come and go, appearing in the morning and disappearing during daytime. Patient took Benadryl for it and applied cortisone cream.  On 26 Jan 2021, after taking a walk, the patient experienced weakness, slight dizziness, and nausea. Patient was taken to the emergency room (ER) and vomited. The patient was sent home the same day but the patient's blood pressure was noted to be fluctuating.  On 27 Jan 2021, the patient "felt that she was going to die" and had general malaise. The patient was brought to the ER of another hospital but again was sent home.  On 29 Jan 2021, with the symptoms still ongoing and a red streak noted on the inner side of the left arm, the patient was admitted for observation at the second hospital.  Laboratory details included Blood works and radiologic tests were done with normal results. The patient's blood pressure was stabilized but patient was still experiencing malaise and still had the on and off rash on both inner arms.    Treatment information included Benadryl and Cortisone Cream for the indication hives.   Action taken with mRNA-1273 in response to the events was not reported.  The event, blood pressure fluctuation, was considered resolved/recovered on 01 Feb 2021.  The outcome of the events, hives on inner arms, red streak on inner side of left arm, weakness, dizziness, nausea, vomited, felt was going to die and general malaise, was unknown.; 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, a causal relationship cannot be excluded. Further information has been requested.  This case concerns an 83-year-old female hospitalized with serious unexpected malaise, erythema, anxiety, and NS unexpected urticaria, asthenia, dizziness, BP fluctuation and NS expected nausea, vomiting. Event onset 23 days after the first dose of mRNA-1273. BP changes resolved, other events unknown. As above, a causal relationship cannot be excluded.
On 3/5/00-1 day post vax, pt experienced headaches until present. On 3/7/00 pt experienced nausea, vomiting. On 3/9/00 pt experiences a fever of 101.0.
c/o shaking and was pale, per assessment. VSS. RRT assessed. Narrative: pt. noted to be shaking and had labored breathing when brought to Observation area after vaccination. RRT called and recommended additional 30 min. monitoring. 121/76, P 72, R 20, O2 sat. 98% Discharged in stable condition at 4:15PM.
18 year old male patient administered dose of Menactra instead of Bexsero with no reported avderse event; Initial information received on 15-Jul-2021 regarding an unsolicited valid non-serious case received from a other health professional.   This case involves a 18 year old male patient who was by mistake given dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] instead of MENINGOCOCCAL VACCINE B RFHBP/NADA/NHBA OMV [BEXSERO].  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.   On 14-Jul-2021, the patient received a 0.5 ml third dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot U6921AB and expiry date: 17-Apr-2022) (Frequency: once) instead of BEXSERO not produced by Sanofi Pasteur via an intramuscular route at an unknown administration site for (Wrong product administered) prophylactic vaccination.  It was an actual medication error case due to Wrong vaccine administered (latency on same day).  It was reported that "Nurse Practitioner stated that a gave Menactra by mistake instead of Meningococcal B it was given to 3 triplets. Is there any harm done with them getting a third Menactra vaccine. Is is alight for them to come back in to get the Meningococcal B in a few days. Nurse practitioner states triplets were given an extra dose of Menactra instead of Meningococcal B dose of Bexsero. What should they look for and can they get the Bexsero so they can go to college. Patient Information Patient age greater than one year enter as 2 month, 4 month, etc. Many pediatric vaccines need month for age. Dose: 0.25 mL to 2 mL for vaccines or 0.1 mL for TB skin test-0.5ml, Strength: standard except for Fluzone HD-standard TB skin test-immunization. Event Information treatment- none at this time and they have spoken with the father who doesn't report any problems, dose if series-they had the first dose in childhood and one at 15-16 years and now this one by accident. They were in the clinic for school shots. Reporter relationship: HCP (health care professional) Product used: used First time product used: no still using product: no".  At the time of reporting, no adverse event was reported.  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.
From initial information received on 10/18/02, 7 female employees were vaccinated on 10/15/02 and 10/17/02 with Fluzone. They experienced local reactions of redness, swelling and itching 24 hours post vaccination. The facility physician prescribed Tylenol. From additional information received on 11/4/02 via fax from reporter, 4 of the 7 employees have been identified. Patient 1 is a 43 year old female who received a Fluzone vaccination, lot # U0968AA, administered IM in the left arm in October 2002, exact date not specified. Sometime after receipt of vaccination, exact date not specified, the patient developed a 5cm, raised, warm erythema at the injection site on her left arm. The patient also complained of an ache in her arm, and mild systemic itching all over her body. The patient's left arm is still stiff and achy. The patient has not yet recovered from this event.
pt recvd vax 27JAN93 10AM & 8PM same day pt exp a sz (5-10 mins p/receiving APAP); taken to ER temp 39C; given Pediaprofen in ER & sent home; 29JAN seen in office, t99 & doing well; pt recovered;
This case was reported by a healthcare professional (medical assistant) and described the occurrence of not responding to therapy in a 59-year-old male subject who was vaccinated with ENGERIX B (GlaxoSmithKline). Historic vaccination included hepatitis A vaccine inactivated; GlaxoSmithKline; unknown; unknown given on December 2011 and June 2012. In December 2011, June 2012 and 21 January 2013 the subject received 1st dose, 2nd dose and 3rd dose of ENGERIX B (unknown details). The dose administered on 21 January 2013 was 1ml administered into the left arm. In June 2012 and 21 January 2013 the subject experienced drug dose administration interval too long. In April 2013, 3 months after vaccination with ENGERIX B, the subject experienced not responding to therapy. Relevant test results included a hepatitis b surface antibody test in April 2013 and "the test was 'non-reactive'". At the time of reporting, the outcome of not responding to therapy was unknown.
After the first shot, I had a rash on my left arm at the elbow. It was like a bruise that turned into hives. On the second shot, the same rash popped up in the same spot on my elbow and then also appeared on my knees.
This spontaneous report as received from a licensed practical nurse refers to the unknown number of patients of unknown age and gender. No information on the patients' concomitant medications, concurrent conditions, pertinent medical history, drug reactions or allergies was reported. On 03-NOV-2016 and on 04-NOV-2016, the unspecified patients were vaccinated with improperly stored doses of GARDASIL 9 injection (lot # M009378 with expiry date on 23-APR-2018; lot # reported as M011840 with expiry date on 01-FEB-2018; lot # L036301 with expiry date on 20-DEC-2017; lot # M018810 with expiry date on 28-MAY-2018; dose, route of administration and anatomical location were not reported). Administered doses of vaccine experienced the temperature excursion of 35 degrees Fahrenheit for 6 hours. Data logger was involved. There were no previous excursions reported. No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
patient received expired Flublok Quadrivalent, no AE; Initial information received on 28-Oct-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked with 2019SA301057, 2019SA301296, 2019SA301298, 2019SA301297 (same reporter)  This case involves a 58 year old patient (gender not reported) who was inadvertently vaccinated with an expired dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (frequency once) lot QFAA1827 via intramuscular route in the left deltoid on 26-Oct-2019.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It is an actual medication error case due to expired vaccine used.  At the time of reporting, no adverse event was reported.  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 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 as received from a registered nurse refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with one dose of one of the following lot numbers for VARIVAX; lot# M024683, expiry date: 18-MAY-2018; lot# M025867 expiry date: 24-MAY-2018; lot# L050956, expiry date: 17-DEC-2017; or lot# M024675 expiry date: 18-MAY-2018, via subcutaneous route, following a supported temperature excursion. The nurse confirmed that the lot number involved was unknown. No adverse effects were reported. No product quality complaint involved. No further information available. Additional information has been requested.
Lungs got very tight 2 hrs after shot and had a hard time breathing. It lasted 2-3 hrs.
Starting at 2200 on 1/12/21, I began experiencing fever (101.9F), chills, body aches, and headache. The fever broke at around 0600 on 1/13/21, but the headache and body aches persisted until about 1200 on 1/13/21 when I took Ibuprofen.
Retaining water; Legs are swollen, feel heavy, ache.; Legs are swollen, feel heavy, ache.; Legs are swollen, feel heavy, ache.; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the arm left on 26Apr2021 at 12:15 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. The patient's medical history was reported as none. It was unknown whether the patient had any known allergies. Concomitant medications included multivitamin (MANUFACTURER UNKNOWN), glucosamine (MANUFACTURER UNKNOWN) and testosterone supplement (MANUFACTURER UNKNOWN), all were taken for unknown indication on an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 27Apr2021 at 00:00, the patient experienced retaining water, legs swollen, feel heavy and ache. It was unknown whether the adverse event resulted in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. It was unknown whether the patient had received any treatment for the reported events. The clinical outcome of the events retaining water, legs swollen, feel heavy and ache was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Patient experienced a rash on the arm that was about 1-2 inches from the injection site. This was noticed on 10/10/11 in the morning.
I noticed a rash on my back and the back of my scalp. It itched really bad, to the point where it would have to bleed to stop itching. I went to a Dermatologist and was given Prednisone and topical steroid creams. I used that and the rash and itching went away. Two days after stopping it came back with a vengeance. I went to an Allergist and he put me on an elimination diet and put me back on Prednisone for 3 months. I was also put on Hydroxyzine (two tablets daily, but now down to once daily) for the allergic reaction and Cimetidine and was on that four times per day, but I'm down to twice daily now. I also take Xyzal daily. The Prednisone started at 5mg 2x four times a day and I was weaned off of it over time. I still have moments where I feel that bugs are crawling on my back and scalp, but I deal with it until it goes away. During the elimination diet, I was able to slowly add items back to my diet one by one. There weren't any reactions when adding them back. Since June, I started experiencing arthritic pain on the top of my right foot. This pain lasted for about 2-3 weeks. Shortly after that, I started to have swelling and pain in my left hand. I noticed that my fingers were starting to cross over each other. I went to my Internist and he performed a rheumatoid test to rule out that type of arthritis. I do not have Rheumatoid Arthritis. I have noticed that I was starting to have body aches and joint pain. I am starting to feel a little better now after exercise.
Itching in fore arm of injection arm that evening Fatigue for day and a half Brain fog for about 4-5 hours 48 hours after injection
Immediate pain at the site of the injection. Pain has been ongoing since 10-05-22 without relief.  Sought treatment at clinic.   1. Motrin 400 mg PO BID for 5 days, then discontinue. Take with food. Stop medication for any GI distress, melena or hematochezia and proceed to ER. 2. Provided with written instructions for shoulder stretching and strengthening exercises. Apply heat prior and ice after with thermal barrier. Do not exceed 20 minutes in one sitting.