chrisvoncsefalvay/vaers-outcomes huggingface dataset:
was diagnosed with mono and other complications; the patient was diagnosed with ovarian failure; was diagnosed with mono and other complications; This spontaneous report as received from a physician via a company representative refers to a 14-year-old female patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) intramuscularly (dose, lot # and expiration date were not reported) for prevention of human papillomavirus (HPV).  On an unknown date, the patient was diagnosed with mononucleosis (reported as mono) and other complications. On an unknown date, the patient was diagnosed with ovarian failure. It was reported that the patient's parents felt that she was diagnosed with the ovarian failure because of the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9).  The outcome of the events was reported as not recovered/not resolved.  The relatedness between the events of mononucleosis, other complications and ovarian failure and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided by the physician.
Within 20 min child had cough, wheezing, difficulty breathing, pale Oxy 93-96% on room air then developed itchy rash all over the body. Got XOPENEX nebulization, prednisolone PO -ZYRTEC PO and Epinephrine. Patient referred to nearest Pediatric Emergency Room by EMS
PATIENT RECEIVED AN EXPIRED DOSE OF THE PFIZER VACCINE.  PER STORAGE INSTRUCTIONS, THE VACCINE SHOULD HAVE BEEN WASTED ON 01.21.22.
administered expired Fluzone Quad vaccination with no reported adverse event; Initial information regarding this unsolicited valid non-serious case from via Agency (Reference number- 00816412) was received from a via other health professional via consumer/non-hcp and transmitted to Sanofi on 18-Oct-2021.  This case involved a 70 years old male patient reported about administered expired fluzone quad vaccination with no reported adverse event (expired product administered) while receiving vaccine Influenza Quadrival A-B Intradermal Vaccine [Fluzone].  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.    On 15-Oct-2021, the patient received a dose  dose of suspect Influenza Quadrival A-B Intradermal Vaccine lot UJ567AB via intramuscular indication prophylactic vaccination(with unknon formulation, strength, dosage).  On 15-OCT-2021 the patient developed a non-serious event administered expired fluzone quad vaccination with no reported adverse event (expired product administered) following the administration of Influenza Quadrival A-B Intradermal Vaccine.  Action taken with Quadrivalent Influenza Vaccine (Fluzone) was not applicable.  It was not reported if the patient received a corrective treatment for the event (administered expired Fluzone Quad vaccination with no reported adverse event).  At time of reporting, the outcome was Unknown for the 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.  No further information was reported.
Pt reported pain in feet and legs initially, then weakness and inability to walk, this later spread to arms and hands, neuropathy. Pt was then seen by physician. Has improved slightly but still remains.
Red's 0.5 pre-filled quad flu shot at office clinic on 10-01-14. Afternoon of 10-02-13, LA at site with redness, edema, blotchiness; warmth. Afebrile 2-3 other small 'hive-like' spots also to (rt) upper arm, cheek and neck by 10-03-14. Seen for s/s 10-03-14. Tx with KEFLEX (250/5 (8 ml BID x 7d).
pt was fine the day of vax began crying a dull cry on Friday between 8-10AM (day p/) until 7-8PM; given APAP; not able to console; began temp up to 102; dx flu; edematous-didn't void for 12 hrs;
I had slight cold symptoms the week before Christmas. It started feeling worse with a headache and sinus pressure. It was not that bad, but on 12/21/2022. I had a raw throat, crackling ears, really bad headache, eye was watering and nose running. I could not sleep. It felt like a really bad sinus infection. I contacted to get a virtual visit. I was given Paxlovid, my symptoms were better about a day in half later, I was surprised how much better I felt. I did have the horrible taste in my mouth. I still have the scratchy throat and sniffles with a little cough. But it is not that serious. I am back to exercising. My head is still a little clogged, I am taking Claritin for the congestion.
This case was reported by a other health professional via call center representative and described the occurrence of injection site pain in a 18-year-old female patient who received MENVEO for prophylaxis. On 4th January 2019, the patient received MENVEO (intramuscular). In January 2019, less than a week after receiving MENVEO, the patient experienced injection site pain, injection site erythema, injection site swelling, numbness in fingers and pain in arm. On an unknown date, the outcome of the injection site pain, injection site erythema, injection site swelling, numbness in fingers and pain in arm were unknown. It was unknown if the reporter considered the injection site pain, injection site erythema, injection site swelling, numbness in fingers and pain in arm to be related to MENVEO. Additional details were reported as follows: The patient received MENVEO vaccine on right arm. The onset of symptoms was not known. The patient was given the injection at a different clinic. The patient reported that she was experiencing numbness in the right ring finger, and the injection site was still swollen. Pain was also present at the injection site and was noted as a 6 on the pain scale. The swelling was described as 3 cm by 2 and 3 by 4 cm in size. The patient's circulation was intact. The reporter consented to follow up.
Developed severe reaction to two separate insect bites resulting in need for steroid therapy.  The first bite/reaction was in my left arm and resulted in severe swelling ranging from my armpit down to my forearm, redness, and hot to the touch.  Very similar to cellulitis.  This was on 8/1,  occurred over a course of three days, and on 8/4 presented to primary care physician where I received steroid injection.  The second reaction in September occurred on my buttocks and resulted in swelling around into my groin, lymphadenopathy in my groin, and again, significant redness and hot to the touch.  This second reaction occurred within 24hours of the bite.  I was seen by Urgent Care clinic and received oral course of steroid therapy and antibiotics.  I have no known allergens to bites and have never developed reactions like this before.   I never saw the presumed insect that caused the bite but developed burning and itching sensation at initiation of both reactions.   Of note, after my second vaccine I did have axillary and clavicular lymphadenopathy on the 3rd day post vaccine that lasted for several days in addition to fever/chills 12h post vaccine, body aches, and fatigue.
SORE FROM THE DATE OF INJECTION BUT DEVELOPED HOT RED TENDER SWELLING 2X2 INCHES IN INJECTION AREA WITH TENDER LYMPH NODE UNDER RIGHT AXILLA
15 second apnea episode, followed by paleness and lethargy for several minutes. Occurred 11 hours, post vax. Temperature 100.3F (R). No further problems after event.
Medical assistant calling to report a temperature excursion that occurred 8/14/2020 which involved the following products: GARDASIL9, PEDVAXHIB, RECOMBIVAX, ROTATEQ. Per caller, "it would be possible that at least 100 patients have received vaccines; This spontaneous report was received from a medical assistant, concerning a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies or concomitant medications were not reported.  On 14-AUG-2020, the patient was vaccinated with an improperly stored doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 0.5 ml orally as prophylaxis (lot # 1660991 with expiration date 27-APR-2021) (strength and frequency were not reported) and with haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) as prophylaxis (lot # S036818 with expiration date 22-APR-2022) (strength, dose, frequency, route of administration and anatomical location were not reported).  The improperly stored doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) and haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) experienced a temperature excursion of 35.4 Fahrenheit degrees (°F) for the time frame of 20 minutes without previous temperature excursions. It was confirmed that a digital data logger was involved.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2009USA006106:
Extreme pain in my left arm. Woke up with extreme pain throughout my entire body.  Also extremely bad headache and shooting pains everywhere for about 18 hours.  Took two Tylenol during the course of the pain and discomfort.
feeling uneasy; Shakiness; Adolescent patient received shingrix; Cramping in forearm (injected arm) from the elbow down; This non-serious case was reported by a consumer via call center representative and described the occurrence of cramp of limb in a adolescent female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12-SEP-2023, the patient received Shingrix (unknown arm). On 12-SEP-2023, less than a day after receiving Shingrix, the patient experienced cramp of limb (Verbatim: Cramping in forearm (injected arm) from the elbow down) and inappropriate age at vaccine administration (Verbatim: Adolescent patient received shingrix). On 13-SEP-2023, the patient experienced feeling abnormal (Verbatim: feeling uneasy) and tremor (Verbatim: Shakiness).  The outcome of the cramp of limb was resolved and the outcome of the feeling abnormal, tremor and inappropriate age at vaccine administration were unknown.   It was unknown if the reporter considered the cramp of limb, feeling abnormal and tremor to be related to Shingrix.     It was unknown if the company considered the cramp of limb, feeling abnormal and tremor to be related to Shingrix.   Additional Information: GSK Receipt date: 13-SEP-2023 The patient self-reported this case. Later that evening of vaccination, the patient experienced cramping in the forearm (the injected arm), from the elbow down.  This cramping went away overnight.  This morning (on reporting day), the patient reported shakiness and feeling uneasy.   The reporter stated that according to the chart, she received Shingrix, however the patient though she was getting the Flu vaccine, and the patient was going to contact her doctor to clarify what she received.  The reporter did not provide further details as the patient wanted to check with doctors' office to confirm which vaccine the patient received. Adolescent patient received Shingrix which led to inappropriate age at vaccine administration. The reporter did not consent to follow up.
Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025J202A and 043L20A) for COVID-19 vaccination.     Concurrent medical conditions included Depression since 2015. Concomitant products included CETIRIZINE HYDROCHLORIDE (CETRIZINE) from 28-Apr-2021 to an unknown date for Allergy, ESCITALOPRAM for Depression, PARACETAMOL (TYLENOL) for Pain, FOLIC ACID and MULTIVITAMIN [ASCORBIC ACID;BIOTIN;CALCIUM PANTOTHENATE;CYANOCOBALAMIN;FOLIC ACID;NICOTINIC ACID;PYRIDOXINE HYDROCHLORIDE;RIBOFLAVIN;THIAMINE HYDROCHLORIDE;TOCOPHERYL ACETATE] for Prenatal care.   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 18-Aug-2020 and the estimated date of delivery was 29-Jun-2021. On 29-Dec-2020, the patient experienced EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  nineteenth week of the pregnancy.  At the time of the report, EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Nov-2020, Ultrasound scan vagina: normal (normal) Viable intrauterine pregnancy. normal first trimester. On 03-Feb-2021, Ultrasound foetal: normal (normal) consists of 19 weeks baby, normal anatomy, posterior  placenta. On 30-Mar-2021, Glucose tolerance test: normal normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: added  ethnicity concomitant medications, events ,medical history and  lab details  No treatment related information has been reported.
Patient received 12+ adult Pfizer COVID-19 monovalent vaccine as a dose in their primary series instead of the authorized 5-11 years Pfizer COVID-19 monovalent vaccine.  Parent notified via letter 3/15/2023.
experiencing feeling tired/tiredness; bad headache / felt like he got hit by a Mack truck; had severe muscle pain; assumes that he had a fever (he did not take his temperature); was shivering; had night sweats / said this that night sweats are not normal for him / he was drenched; drenching sweating; This case was reported by a consumer via call center representative and described the occurrence of tiredness in a 51-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown  date).   On 24th May 2021, the patient received the 2nd dose of Shingrix (intramuscular). On 24th May 2021, less than a day after receiving Shingrix, the patient experienced tiredness, headache, muscle pain, fever, shivering, night sweat and drenching sweats. The patient was treated with medication unknown (Migraine-A (Medication Unknown)). On an unknown date, the outcome of the tiredness, headache, muscle pain, fever, shivering, night sweat and drenching sweats were not recovered/not resolved.   The reporter considered the tiredness, headache, muscle pain, fever, shivering, night sweat and drenching sweats to be related to Shingrix.  Additional details were reported as follows: The reporter was the patient. He stated that he got his dose of Shingrix in left arm at his doctor's office around noon. He did not have the lot number or expiration date but gave permission for safety to contact his doctor's office. By evening the patient experiencing feeling tired/tiredness and a bad headache. He took unspecified  migraine medicine to help with the bad headache. He states he felt like he got hit by a Mack truck. He said that he had severe muscle pain. He also assumes that he had a fever (he did not take his temperature) because he was shivering and wrapped himself up in a heating pad. He also stated that he had sweating; he had night sweats last night. He said this that night sweats were not normal for him. He said he was drenched. He said that last night sucked, it was bad but he was better by comparison on 25th May2021. His symptoms have not fully resolved. He was calling GlaxoSmithKline to ask how long it would be before the side effects resolved completely. He said his side effects were not severe. The reporter consented to follow up.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Feb2021 at 11:00 as dose 1, single (Lot number: EV9267), in right arm, on 15Mar2021 at 11:00 as dose 2, single (Lot number: EN6205), in right arm, on 24Sep2021 at 14:00 as dose 3 (booster), single (Lot number: 30130BA), in right arm and on 09May2022 at 13:00 as dose 4 (booster), single (Lot number: FM9992) at the age of 69 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Breast cancer-mastectomy", start date: Feb2021 (unspecified if ongoing); "Breast cancer-mastectomy", start date: Feb2021 (unspecified if ongoing); "Knee replacement", start date: Apr2022 (unspecified if ongoing). Patient had no known allergies. Concomitant medication(s) included: RALOXIFENE, start date: 15Jun2022; THYROID T3, start date: 08Jan2001; THYROXINE, start date: 08Jan2001. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 29Aug2022 at 15:00, outcome "recovered" (Sep2022) and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (29Aug2022) Positive; (03Sep2022) Negative; (04Sep2022) Negative; (05Sep2022) Negative; (06Sep2022) Negative. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Patient took Paxlovid for 5 days. Tested negative for 4 days after completion.
***VACCINATION IS ACTUALLY THE PNEUMONIA  PREVNAR 23*** When I called down there on 10/26/23-one of the nurse told me to go to an urgent care and tell them to check it out and show them what was going on, and I did that and they end up telling me it was cellulitis from the injection. They told me that if I had to be billed, they would send the bill to the clinic. Starting on Tuesday night my arm started to ache and swelled up the size of  a baseball, my left arm, triceps area. The next day it was red and swelled on the upper part of my arm with redness down to my elbow. It appeared to have fluid there hanging from my arm in my skin. By Thursday it remained red and rash looking and aching. Medication was given for the symptoms of cellulitis. I went to (urgent care)
01/29/2021 Received dose 1. Adverse event started on 10/01/2021 in the afternoon on my left arm I started feeling hot, bumpy, itchy rash. It felt warm. I went to ER they suggested me to use ointment. It prevented me to stop itching and scratch. That happened 9 months after my first dose 1. On my second dose I started feeling the same symptoms back again for around 24 hours. I used the same ointment. I didn't go to any doctor because I knew it was the same thing.
had diarrhea right the evening  following the administration of the Shingrix. Patient wanted us to report.
Patient says has a lump that goes from site of injection up and across her shoulder to her clavicle.
Breakthrough menstrual spotting at end of  May between 5/26/2021 and 5/29/2021. No menstrual cycle since despite ceasing use of oral birth control at end of May.
Disruption to menstrual cycle. After vaccine, started experiencing very long cycles (periods 40 days apart or more). Trying to get pregnant and hasn't happened yet. Cycle still has not returned to normal. Last half of cycle each time always feels like I have menstrual cramps for 2-3 weeks straight before I actually get my period.
The day of vaccine, my left arm was very sore and had a hard time sleeping. I could not lift my arm. I started to chill and finally went to sleep and woke up in a sweat. I woke up the next morning not feeling well. Then I went back to bed and felt feverish. My body had aches and pains. This lasted strong for 24 hours. I developed diarrhea with nausea and felt bad for a week.  I still have nausea even to this day. Then on 2/12/2022 I got a positive COVID-19 test. I had a feeling of a head cold. My daughter-in-law had COVID-19 so I got tested.
pt recvd vax 13OCT93 9 days later had febrile sz;
The night of receiving 2 immunizations complained of headache, stuffy nose, body aches, and jaw hurt.  Reports feeling feverish but has no thermometer.  Symptoms continued for at least 12 hours so patient called to report symptoms.  No local reaction noted.
Nausea,  vomiting, constipation, abdominal pain, body aches, heart hurts, fever, chills, rash, feeling faint, headache, eyes hurt, extreme fatigue.
Became sick; Missed days at work; 2nd dose not received after 2 years; This case was reported by a consumer via call center representative and described the occurrence of illness in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient did not receive the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, not applicable after receiving Shingrix and unknown after receiving Shingrix, the patient experienced illness, activities of daily living impaired and incomplete course of vaccination. On an unknown date, the outcome of the illness, activities of daily living impaired and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the illness and activities of daily living impaired to be related to Shingrix.     Additional Information: GSK Receipt Date: 14-OCT-2022 Reporter's Comment: Reporter was an acquaintance of the patient. The reporter stated that the patient had not received the second dose of Shingrix even after 2 years since the first dose. The reporter stated that the patient became sick after the first dose and missed days at work because of it.  Reporter did not consent to follow up. Reporter provided limited information. Additional supportive information: As patient did not receive 2nd dose of Shingrix vaccine which led to incomplete course of vaccination. This case is linked to the case US2022148320, reported by the same reporter.; Sender's Comments:  US-GSK-US2022148320:Same reporter
Information has been received regarding a case in litigation from a lawyer, a female patient of unknown age, and her spouse. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On an unknown date in 2014, at approximately 61 years of age, the patient was administered the ZOSTAVAX vaccine at a physician's office (lot number, dosage and route of administration not provided). On an unknown date, the patient was treated at a physician's office for the following injury resulting from her ZOSTAVAX use: Shingles. The outcome of the shingles is unknown. The patient claimed damages as a result of: injury to themselves, loss of consortium, loss of services, and economic losses. Additional information has been requested.