chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a health professional concerning a 14 year old female patient with "none" pertinent medical history and "none" drug allergies or reactions, who was vaccinated intramuscularly with the first and second 0.5 ml dose of GARDASIL, on 19-JAN-2011 and 18-MAR-2011 (lot #666948/0886Z expiration date: 21-NOV-2012) respectively. There was no concomitant medication. Nurse reported that after receiving the second dose of GARDASIL, "that evening" (on 18-MAR-2011), the patient developed a swelling in her left hip that was 2 inches long, 1 inch wide and 1/3 inch thick, and a rash on her left hip and her left leg. The nurse reported that the patient's rash was very itchy. Nurse reported that on 19-MAR-2011, the patient also developed swelling in her right hip and an itchy rash on her right hip and her right leg. Patient was treated with BENADRYL and topical hydrocortisone cream. No lab diagnostic studies were performed. It was reported that the patient woke up on 19-MAR-2011, and the swelling had disappeared on the patient's left hip, but the itchiness and rash remained on the patient's left hip and the patient's left leg. The nurse reported that "today" (21-MAR-2011) the patient's mother called the office and reported that the patient still had an itchy rash on both legs and both hips, but the rash was improving. Additional information has been requested.
Began with  about  1 by 2 inch red  area and rash centered on injection point on Sat. By Tuesday rash is gone but injection point still there and red area grown to about 2 by 4 inch down arm and toward body.  Less sore by Tuesday but still sore.
No adverse event; 113 Bivalent doses administered after the BUD to patients 12 and up.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up.) and NO ADVERSE EVENT (No adverse event) in a 42-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7148B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Dec-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 15-Dec-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up.).    No concomitant medication was reported. 60 doses were received with Lot AS7148B.  No treatment medication was reported.
No adverse symptoms reported; the patient received an improperly stored dose of PROQUAD; This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions, or allergies were not reported.  On 26-JUN-2020, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) injection (strength, vaccination scheme, anatomical location, route of administration were not reported; from lot number S030208, expiration date: 25-MAR-2021 or from lot number S031704, expiration date: 06-APR-2021) as prophylaxis (product storage error). Also, the use of a sterile diluent (MERCK STERILE DILUENT) (lot number and expiration date were unknown by the reporter) was reported. No adverse symptoms reported.  The vaccines experienced a temperature excursion between 6 degrees Fahrenheit (F) to 14F (9.9F) for 1 hour and 12 minutes, as recorded by data logger. There was no previous temperature excursion.
More than normal vaginal discharge after the first dose of the vaccine. Bleeding from vagina (possible period) 2 days after the second dose on 2/12.
Narrative: POSITIVE COVID TEST AFTER COMPLETION OF COVID VACCINE SERIES 01/20 COVID vaccine dose #1 02/09 COVID vaccine dose #2 04/28 pt reports cough and fatigue, requesting covid test 04/30 pt reports 1 week of bad cough and fatigue, had one episode of vertigo, but chronic issue for him; COVID test positive 05/01 reports cough, fatigue, mild nausea, reports 3  weeks of painful oral lesions, treated with viscous lidocaine
This case was reported by a other health professional via sales rep and described the occurrence of fever in a male patient who received SHINGRIX for prophylaxis. On 31st May 2018, the patient received SHINGRIX (intramuscular) .5 ml. On 31st May 2018, less than a day after receiving SHINGRIX, the patient experienced fever, chills, nausea, fatigue and headache. On an unknown date, the outcome of the fever, chills, nausea, fatigue and headache were unknown. It was unknown if the reporter considered the fever, chills, nausea, fatigue and headache to be related to SHINGRIX. Additional details were provided as follows: This case was reported by physician's assistant. The age at vaccination was not reported. The patient received SHINGRIX on Thursday. The patient experienced fever of 100.9 associated with chills, nausea, fatigue and headache within the first 24 hours after administration. This caused him to miss work the following day. The reporter agree to follow up from GSK.
Initial report was received from a health care professional on 22 November 2011. A 31-year-old pregnant female patient had received an intramuscular (IM) injection of ADACEL; sanofi pasteur Inc. lot number U3958BA (sanofi pasteur Ltd. lot number C3903) on 19 September 2011. The patient Medical History and Last Menstrual Period were not reported. Estimated Date of Delivery was reported as 13 May 2012. The patient did not experience an adverse event. The outcome was unknown. Follow-up information was received from a healthcare professional on 24 February 2012 reported that the patient and the father of the pregnancy, who was 30-years-old, were in good health. The patient had no past obstetric history, no risk factors and no treatment for infertility. Her Date of Last Menstrual Period was 06 August 2011 and her estimated date of delivery was 13 May 2012. She did not receive any drug during pregnancy or prior to fertilization that could remain present at the time of fertilization. There was no family history of congenital abnormalities. The patient had zero genetic test results, an unremarkable ultrasound (U/S) and normal prenatal labs. The outcome remained unknown. Follow-up Pregnancy Report Form information was received from a healthcare professional on 03 August 2012. Based upon the new information provided, this case has been upgraded to serious due to premature rupture of membranes (PROM). According to the reporter, the patient had an uneventful pregnancy until she developed PROM at 35 weeks, 5 days (date not specified). The patient delivered a single uterine pregnancy via vaginal delivery on 13 April 2012 at 35 weeks gestation, with no serious complications of labor and delivery, per report. The outcome was a male infant live birth, weighing 2.571 kilograms, with Apgar scores of nine at one minute and nine at five minutes, and no congenital abnormalities. The patient's event of PROM outcome remained unknown, with delivery date of 13 April 2012. Documents held by sender: None.
Red and swollen from above elbow all the way to shoulder. All around the arm not tender.
Sore right arm; Hot to touch; Could not lift up; Swelling; Hives on my abdomen; Temperature of 102; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Sore right arm), FEELING HOT (Hot to touch), LIMB DISCOMFORT (Could not lift up), PERIPHERAL SWELLING (Swelling) and URTICARIA (Hives on my abdomen) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011J20A and 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Essential tremor, Eczema, Vitiligo, Undifferentiated connective tissue disease, Rosacea, Allergy to antibiotic (Ciprofloxacin), Lactose intolerance (Lactose), Adhesive tape allergy (Adhesive) and Drug allergy (Hibiclens). Concomitant products included AZELAIC ACID for Rosacea, WOMEN MULTI and KETOCONAZOLE for an unknown indication.   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore right arm), FEELING HOT (Hot to touch), LIMB DISCOMFORT (Could not lift up), PERIPHERAL SWELLING (Swelling), URTICARIA (Hives on my abdomen) and PYREXIA (Temperature of 102). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and CLARITHROMYCIN (CLARITIN [CLARITHROMYCIN]) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Sore right arm), FEELING HOT (Hot to touch), LIMB DISCOMFORT (Could not lift up), PERIPHERAL SWELLING (Swelling), URTICARIA (Hives on my abdomen) and PYREXIA (Temperature of 102) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Feb-2021, Body temperature: 102 (High) High.
This spontaneous report as received from a registered nurse refers to 11 patients of unknown age and sex. The registered nurse reported that VAQTA, RECOMBIVAX HB and GARDASIL were exposed to 31 F degrees on 01-OCT-2012 and GARDASIL (Lot Number: H013977, exp: 19-MAR-2015 and Lot Number: 0459AE, exp: 13-DEC-2014) was then, administered to 11 patients over a period of eight weeks. No other co-suspects were reported. No concomitant medications were reported. No adverse effects reported. Patient's outcome were unknown. Additional information has been requested. This is one of several reports from the same source.
Fall on an already injured knee; This spontaneous case was reported by a consumer and describes the occurrence of FALL (Fall on an already injured knee) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Knee injury.    On 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced FALL (Fall on an already injured knee). At the time of the report, FALL (Fall on an already injured knee) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported. No treatment information was provided.
developed a fever that went away eventually; A spontaneous report (United States) was received from a healthcare professional concerning a 59-years-old  female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events developed a fever that went away eventually.  The patient's medical history included COVID 19. Concomitant medications reported were Gabapentin for drug use for unknown indication.  On 10 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 031L20A) Intramuscularly for prophylaxis of COVID-19 infection.  On 10 Feb 2021, the patient experienced the event(s) developed a fever that went away eventually.  Treatment details included Acetaminophen.  Action taken with mRNA-1273 in response to the events was not reported.  On 11 Feb 2021 the outcome of event(s), developed a fever that went away eventually was resolved.
My upper left arm hurts, every day & night, is hard to make certain movements. I try ointment, heating pads & cold packs. I even try acupuncture, is not getting better. I am going for therapy that my insurance will not cover, it is very expensive.
Product=COVID 19 Treatment, brand=Paxlovid/vaccine brand=Pfizer; Product=COVID 19 Treatment, brand=Paxlovid/vaccine brand=Pfizer; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Mar2021 as dose 2, single (Lot number: EN6204), in right arm and on 02Nov2021 as dose 3 (booster), single (Lot number: 320308D) at the age of 67 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: penicillin" (unspecified if ongoing), notes: Known allergies: penicillin; "Known allergies: tree nuts" (unspecified if ongoing), notes: Known allergies: tree nuts; "Known allergies: peanuts" (unspecified if ongoing), notes: Known allergies: peanuts; "Known allergies: coconut" (unspecified if ongoing), notes: Known allergies: coconut. Concomitant medication(s) included: AMITRIPTYLINE; ARMOUR THYROID; ROSUVASTATIN. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Product=COVID 19 Treatment, brand=Paxlovid/vaccine brand=Pfizer". Therapeutic measures were taken as a result of covid-19.  No follow-up attempts are possible. No further information is expected.
Information has been received from a registered nurse (RN) concerning her son who was vaccinated with a dose of Varivax. The RN reported that her son subsequently developed breakthrough chickenpox. Unspecified medical attention was sought. At the time of this report, the outcome was unknown. Additional information is not expected.
FLU VACCINE WAS ADMINISTERED ON 9/25/18. Patient STARTED HAVING A SEIZURE AT 2:00 AM ON 9/28/18. HE WENT TO THE HOSPITAL, WHERE HE STAYED UNTIL 9/29/18 AT 8:00 PM. HE DOES NOT HAVE MEMORY OF THE EVENT OR THE FOLLOWING DAYS.
General malaise, weakness of extremities, muscle pain, chills, foggy-headed feeling, perhaps slight fever which began at approximately 2:00 p.m. the following day after shot and lasted through the evening.  Lingering foggy-headed feeling and stomach upset lasted 48 hours beyond that. Rested and slept as treatment.  No medication taken for side effects.
1 week later she has chills, stiff neck - however she went to dentist next day & said she got a shot & experienced sweating & chills at that time - advised call MD for review.
4 hours after huge lump in my arm and red circle around it. Horrible headache and jaw pain. Instill have jaw pain 4 days after and a smaller bump on my arm that is itchy.  By the evening I had a fever and it got up to 102 by the next day. Severe aching especially.in my hands. Sweats and chills and the headache worsened.   This lasted 48 hours and then I felt 80% better. I still don't feel 100%, but it gets better every day.
Developed red spots and swelling at vaccination site; swollen lymph nodes under arm ; neck and liver ache
Severe pain 7 on 1-10 scale in entire L arm. Lack of strengh, numbness, aching & tingling down through fingers & in palm of hand.   Aleve, Tylenol & local massage to arm helped but still have weakness & tingling, especially L hand hours later.
This case was reported by a physician via sales rep and described the occurrence of seizure in a 16-year-old male patient who received MENVEO. Co-suspect products included GARDASIL. On 16th September 2017, the patient received MENVEO and GARDASIL. On 16th September 2017, 10 min after receiving MENVEO, the patient experienced seizure (serious criteria GSK medically significant). On an unknown date, the outcome of the seizure was unknown. It was unknown if the reporter considered the seizure to be related to MENVEO. Additional details were provided as follows: The age at vaccination was not reported. The patient received MENVEO and the GARDASIL at the same time. The patient went to school the next day. No additional information was provided.
Pt had vasovagal response with vomiting. Pt sat with head in between legs/knees. Color returned to normal within 10 minutes.
Pt. had a swollen an puffy arm for 2-3 weeks. A 3" diameter red rash for 4-5 days. Went to MD and received antibiotics (unknown type).
On March 11, 2009, I went in for a check-up, and referral for neurological evaluation and saw Dr. I had been previously ill since April 2005, and had begun to recover. Did describe to her my previous illnesses, and that seem to have a lot of issues with my immune system, and still tend to have reoccurring issues. She asked when my last tetanus shot was and I told her it had to been more than 15 years. And said it was time, and I told her that I was very sensitive to what seems to everything. She said given my immune system problem that is more reason to have one. Minutes later her nurse came in to give me the injection, and I still questioned it and had reservation, and she insisted on giving it to me because Dr. said so; I asked about giving half the dose, and replied could not. About three days later I started to experience my same old symptoms very fluish, and 3 days after that I broke out in unbearable itchy hives, starting from my feet all the way up my body ending at my neck, and then my feet blew up. Once this happened I called Dr's office and explained this to them, and spoke to an On Call Doctor, and delivered a message to Dr's office what had happened, and from thereafter received a returned call from nurse, this was not possible, and etc, and did nothing to help me. The hives were very hard to get rid of. I was rid of the hives in about 2 weeks, but was still feeling very ill once again, where I started to exhibit extreme fatigue, once again fluish symptoms, serious visual disturbances and hearing problems, my hearing felt like it was fading in and out; and the scariest part was heart symptoms, high blood pressure, abnormal ekg, & rapid heartbeat. Later on, did have an interruptions with my heart, I felt different and my heart started to beat. Went to immediate care, and wouldn't treat me because my heart symptoms were too serious, sent me to the hospital. I immediately put in the Cardiac Wing over the weekend; I was given medicine for my heart; And they just didn't understand my condition and wanted me to stay and could not. To this date, my blood pressure still fluctuates and my rapid heartbeat still remains a problem. At this time was working, and was doing my best to stay at my job, I have to say this itself caused the biggest disruption anyone should have to go through. I did finally recover somewhat; the fatigue I still have to fight, blood pressure, and rapid heartbeat, vision; it took approximately 1 year for me to recover to feeling somewhat normal, all because my reservations were not taken under consideration.. 6/4/09-records received for DOS 4/5/08-presented with substernal chest pain sharp in nature mild shortness of breath and mild abdominal pain and presented to urgent care center treated with nitro patch-similar episode several months prior with similar onset and resolution. Possibilty ischemia is related to gastritis.
Pt. has due for HIB vaccine, she was given a HEP B vaccine. Pt. mother was notified immediately after. Pt. is still due for HIB. No adverse affects reported from mother.
Shoulder paid in left shoulder: -8/28/17 Mon night bf school started around 9pm I got flu shot in upper left arm from pharmacy; it hurt the muscle upon injection and that night I had lots of pain in my arm that woke me up while sleeping -8/29/17 I had limited range of motion from my left shoulder (couldn't really lift my arm from the shoulder (elbow down fine)) and had similar sleeping pain, cannot dress myself with anything over head and barely with button down shirt -8/30/17-9/3/17 had pain and range of motion issues but range of motion slowly was getting better (like down to 20-30% issue) -9/4/17 went for a short 20 mins run of stairs at stadium and range of motion from shoulder worsened significantly over next 24 hours and had similar night pain so called for doc apt -9/7/17 went to clinic for appt, doc 'heard of this ailment, nurse had once for woman who had lifted weights after flu shot, was told not to exercise, to get a heating pad, and to take low dose med that's like ALEVE for 5-7 days -9/8/17-9/14/17 took all medicine and getting better but still not right (pain while dressing, showering washing hair, etc) -9/15/17 came back from store and carried 4 bags from street to dorm and shoulder got a bit worse -9/19/17 saw physician again and he said range of motion improved from first time but still clearly something wrong so prescribed PT -9/20/17 called PT but first available appt not until 10/11 -9/24/17 today: still hurts when raise arm to shave, while washing hair sometimes, while taking off shirt, and when putting on backpack; friend found article which corresponds extremely closely with what I'm experiencing! Also, regarding where I got the vaccine: pharmacy. Received: FLUARIX QUAD 2017-108 Syringe, GlaxoSmithKline NDC: 58160-0907-52 Qty 0.5 ML Exp Date: 03/2018.
lump on left arm; arm sore and puffy; top left side of head feels funny; pink rash; mild headache; arm started hurting right away after shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (lump on left arm), PAIN IN EXTREMITY (arm sore and puffy), FEELING ABNORMAL (top left side of head feels funny), RASH (pink rash) and VACCINATION SITE PAIN (arm started hurting right away after shot) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031B21A and 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Apr-2021, the patient experienced VACCINATION SITE PAIN (arm started hurting right away after shot). On 09-Apr-2021, the patient experienced VACCINATION SITE MASS (lump on left arm), PAIN IN EXTREMITY (arm sore and puffy), FEELING ABNORMAL (top left side of head feels funny), RASH (pink rash) and HEADACHE (mild headache). At the time of the report, VACCINATION SITE MASS (lump on left arm), PAIN IN EXTREMITY (arm sore and puffy), FEELING ABNORMAL (top left side of head feels funny), RASH (pink rash), VACCINATION SITE PAIN (arm started hurting right away after shot) and HEADACHE (mild headache) outcome was unknown.            No relevant Concomitant Medications were reported. No Treatment Information Provided.    This case was linked to US-MODERNATX, INC.-MOD-2021-057714 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-057714:1st dose
I developed blood clots 1 on each leg, don't know if the vaccine had anything to do with it.  Dr prescribed Eliquis 2.5 MG. So far the one on the left leg is gone,  I will be tested again in October.