chrisvoncsefalvay/vaers-outcomes huggingface dataset:
FLUBLOK being administered to pediatric patients with no reported adverse event; Initial information was received on 27-Sep-2022 regarding an unsolicited valid non-serious case received from a healthcare professional.  This case is linked to cases 2022SA402396(CLUSTER), 2022SA402443(CLUSTER), 2022SA402505(CLUSTER), 2022SA402514(CLUSTER), 2022SA402525(CLUSTER), 2022SA402530(CLUSTER), 2022SA402619(CLUSTER), 2022SA402662(CLUSTER), 2022SA402704(CLUSTER), 2022SA402707(CLUSTER), 2022SA402964(CLUSTER), 2022SA402510(CLUSTER), 2022SA402530(CLUSTER) and 2022SA402436(CLUSTER).  This case involves a 5 years old male patient who was administered Influenza Quadrivalent Recombinant Vaccine [Flublok] at inappropriate age with no reported adverse event.  The patient's past medical history, medical treatment(s) and family history were not provided.  Concomitant vaccinations included: Diphtheria vaccine toxoid, HIB vaccine CONJ (TET TOX), Pertussis vaccine acellular 5-component, polio vaccine INACT 3V (MRC 5), Tetanus vaccine toxoid (Pentacel) for Prophylactic vaccination; Measles vaccine live (ENDERS-Edmonston), Mumps vaccine live (JERYL LYNN), Rubella vaccine live (WISTAR RA 27/3) (MMRVAXPRO) for Prophylactic vaccination; and Varicella zoster vaccine live (OKA/MERCK) (Proquad) for Prophylactic vaccination.  On 13-Sep-2022, the patient received suspect Influenza Quadrivalent Recombinant Vaccine at dose of 0.5 ml, once (formulation, strength: unknown) (lot UJ887AA, expiration date: 09-Jun-2023) via intramuscular route in the left deltoid for Immunization at 5 years of age with no reported adverse event (product administered to patient of inappropriate age).  Action taken: Not applicable.  Outcome: Unknown.  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.
large sterile abscess w/myonecrosis of entire lt thigh muscle anteriorly;no pain or fever
I thought I was having allergies. I had lots of congestion and was more tired than normal. I had some nasal drainage and a throat tickle and a small cough. My son had tested positive on the day that I got my second booster which was the 24th. I have not been around him much and he has been able to stay away from the family. Through the weekend I got a stuffed-up head and I was even more tired and ended up napping because of being tired. The scratchy throat continued and has been bothering me still. Monday night I took a home test and it was positive and then I went to urgent care the next day and they did a COVID-19 PCR test which was positive. They gave me PAXLOVID if I wanted to use it but I have not taken it as this point because my symptoms have really been more like bad allergies. At this point my symptoms have not worsened and really stayed the same this far.
This spontaneous report was received from a physician regarding an unspecified number of patients of unknown ages and gender. The patients medical history, drug reactions or allergies were not provided. Between 09-OCT-2015 and 16-OCT-2015, an unspecified number of patients received unspecified doses in Oral, ROTATEQ (dose and route were not provided, Lot number L000425, expiration date 21-JUN-2016 and Lot number K023159, expiration date 26-JUL-2016). Concomitant medications were not provided. There was no adverse effects reported. This is one of three reports from the same source (MARRS #1510USA008696 and 1510USA013291). Additional information has been requested.
Choking; Cough; Agitation; emotional state, Facial edema, nasal congestion, unusual crying, urticaria, vomiting - Information has been received from a physician concerning a 4 year old male, with no drug allergies and no known allergies to eggs, who on 29 Nov 2000 was vaccinated with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live second generation 636398/0828k.  In the initial report, the physician stated that within 4 minutes, patient became very upset worked up began to cough, choke, scream and vomit and also had a rash and swollen lips.  In follow up the physician reported that the patient cried when the injection was given, then seemed fine.  The patient went to the waiting room, seemed congested, then got upset and vomited.  Within 30 minutes, the patient developed swollen lips and hive like rash that persisted for about 6 hours.  The rash was relieve and faded with diphenhydramine hydrochloride Benadryl.  The physician reported that during the vomiting and swollen lip event, the patient was crying uncontrollably.  The physician was uncertain as to whether the patient's  reaction was a result of the measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation) vaccine or from the child's own adrenaline.  The physician reported that the patient recovered from his experiences on 30 Nov 2000.  No further information is available.
Patient had large red area clearly defined around shoulder and arm where shot was administered. Recommended patient to call their physician, or go to ER if worse. Patient said it was better than yesterday.
I was unable to eat or drink because everything smelled and tasted rotten. The sight and smell of food or drink besides water made me gag or vomit. It took me more than three days to transition to liquids besides water, and five for solid foods. I still cannot eat or drink foods with strong smell without feeling nauseous, is had been at least eight days.
She reported her injection site became red, hot to touch, and swollen, she also said she felt body aches all over and had a temperature of 99.6 for several days after the vaccine. Today is the first day she didn't have a temperature and she feels good.
Approximately 48 hours after vaccination, onset of pain was noted at injection site. Four hours after onset of pain, induration about 4 inches in diameter was noted at injection site, along with other smaller indurations, redness, swelling and pain down to elbow. Area warm to touch. Symptoms started to subside about 24 hours after onset.
fever 101.5 at peak coughing lasting a week sweating chills fatigue loss of appetite
This spontaneous report was received from a Nurse Practitioner and refers to a 4 year old male patient. The patient's medical history, concomitant medications and drug allergies/reaction were not reported. On 04-DEC-2018,  the patient was vaccinated with VARIVAX injectable, 0.5 ml Vaccine National Drug Code (NDC) 0006-4827-01) administrated intramuscular instead of subcutaneous in the left thigh as routine immunization (lot # R017635 with expiration date on 20-JUN-2020) with sterile diluent (MERCK STERILE DILUENT). She also reported that the patient was there for an extra 30 minutes and she did not notice any events from the injection.
Moderna Bivalent 051D22A on October 21, 2022 at 4:30 p.m. in left arm. Patient experienced a lot of pain on right side by rib cage.  Never had that pain before. She took one Extra-StrengthTylenol afternoon of Oct. 24; took two Extra-StrengthTylenol morning of Oct. 25.
Patient bled immediately from vaccine, and a hard bump/bruise appeared within seconds of vaccine administration on the patient's upper arm/deltoid region. Patient reported sore arm the following morning, as well as a sore neck, which she was positive occurred before the vaccination.
low grade fever (not ck'd), generalized aching, weak, dec appetite, sinus problems, did not miss work, sx lasted 4 days;
6/14/04: Walk-in with mother. Reports that child began, within the hour after receiving Pediarix injection, with symptoms of possible reaction to vaccine. Says he has run "high fever", cried continually, leg became swollen, with redness extending approximately 2.5-3 inches above and below site of injection as well as completely around the leg- says Tylenol brought fever down, but goes right back up. Observed site and noted symptoms. Mother described-leg warm to touch, swollen, redness above and below and around leg: slightly raised rash on outer perimeter of swollen, hard area extending from site of injection. Mother to get medical consult with doctor and to ask doctor to give note, specifying what vaccine child should have, i.e., "Pediatrics DT" if not to have pertussis vaccine. To continue warm compresses to leg/obtain instructions from doctor for care and medical assessment of reaction. Left with child to go directly to doctor's office. Will call back with report from doctor. 6/15/04: phone call to client's mother. reports seen doctor on 6/14/04. RE: response to immunization given on 6/11/04. Mother states no infection "definitely a vaccine reaction" . Mother reports continued temp of 102 degrees. Increase in ER following immunizations all weekend and up to 6/14/04. Placed on antibiotic. 6/16/04: phone call to mother. She reports child doing better. Without increase in temp. Resolved 6/14/04 . Left leg remained inflamed, but improved.
Shortly after Tdap shot, started with localized pain in arm and neck - then radiated to severe chest pain. Which when diagnosed with CIDP, the treatment is IVIG. Bilateral paralyzed diaphragm.
Sore arm, intermittent fevers 100-101, facial rash, swollen lymph nodes in neck, groin and 3 at rear base of skull, loss of appetite and weight loss, fatigue, hyperactive with mood swings, night sweats and exacerbation of pectus excavatum. 11/99, nighttime chronic cough w/"whoop", muscous congestion and drainage for 2 weeks.
After 30 minutes of receiving both the Tdap and flu vaccine, I started shaking, felt numb in my arms and legs, and very tired. I fell asleep immediately upon my arrival home, waking up the next day around 7am. Since I receive the flu shot annually, I did not suspect it being the catalyst. Also, I had not had a reaction to the Tdap vaccine as a baby/small child, so not sure if the combination caused the adverse reactions or there was a preservative in the Tdap vaccine. I did report it to my doctor (no longer in practice), but it was a foggy recollection. Since then, I have not received the Tdap vaccine, even when pregnant (2017-2018 and 2020) in fear of a similar reaction. Due to the COVID vaccine mandates and autoimmune diseases that have rectified during my pregnancies, I was motivated to figure out what caused my severe reaction/allergy. After speaking to my current primary doctor and a pharmacist, they both suspect a filler or preservative like polysorbate-80 had caused it, which is also found in the COVID vaccines. I did not seek treatment after the reaction because I did not recall more than the above-mentioned symptoms and didn't seem to be affected thereafter.
nasal congestion; Fatigue; tired; A spontaneous report was received from a consumer concerning herself, a female patient of 69-years-old who received Moderna (mRNA-1273) vaccine and experienced tiredness, fatigue and nasal congestion.  The patient's medical history was not provided. No relevant concomitant medications was reported.  The patient received their first of two planned doses of mRNA-1273 (Batch no: unknown) on 18-FEB-2021 intramuscularly in an unspecified site for the prophylaxis of COVID-19 infection.  On 19-FEB-2021, the patient experienced feeling of tired, fatigue and nasal congestion.  Laboratory details was not provided. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the events, tiredness, fatigue, nasal congestion was not recovered/ resolved.
Site: Pain at Injection Site-Mild, Additional Details: Patient stated they have had random bouts of pain/achiness where they received the shot (received 3 weeks ago). They said it hurt a lot the next day, but now randomly throughout the day it will be painful for a couple minutes at a time.
This spontaneous case was reported by an other and describes the occurrence of ADVERSE REACTION (Patient said yes when asked if had experienced a side effect but did not provide further information.) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE REACTION (Patient said yes when asked if had experienced a side effect but did not provide further information.). At the time of the report, ADVERSE REACTION (Patient said yes when asked if had experienced a side effect but did not provide further information.) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Moderna vaccine was inadvertently administered past the 30 day use by date. No signs or symptoms reported at this time.
Within 24 hours, patient noticed increased redness, swelling, and pain in the area of the injection.  She presented to the clinic for follow up approximately 36 hours after the injection.  Her upper arm has extensive erythema, edema, and pain to palpation.  She also complained of some genralized fatigue and malaise. She was scheduled for an upper extremity ultrasound. She was instructed on warm compresses.  She was given follow up appointment to monitor for resolution.
After receiving vaccines, the pt would not walk, had persistent crying, fell asleep. The child had chills and cold skin, the child laid down, fever started at 106. The pt was given cool bath, temp reduced to 103. ER visit and was instructed to give Tylenol, and Motrin alternating for the next 48 hours. The next day at 1:30 PM the child was screaming, found seizing, laying on his back, arms up, eyes fluttering, verbal repetitive gasping cry, child seized for about 3 minutes. Ambulance called, the pt was taken to the ER. No neurological findings, released at 10:03PM. Instructed to give Tylenol and Motrin alternating.
Throbbing pain at injection site and entire arm. Unable to move up without assistance. Pain grew more and more intense. Went to urgent care on unspecified date. NP examined me and discovered a lump in my arm. Both the lump and the vaccination site hurt when she pressed on them. She prescribed presdone and gave me a work order for a vascular ultrasound to be performed on my left arm. I went on unspecified date for the scan. It was discovered that a DVT blood clot had formed in my brachial vein in the left arm. I was then prescribed eliquis, 20 mg a day for 7 days and told not to take the predesone. NP called my pcp, his office immediately called me and asked me to come in as they are concerned about the high dosage of the eliquis.
Information has been received from a pharmacist and the patient's mother concerning a 12 year old female who on 29-JAN-2007 was vaccinated with the first dose of Gardasil. On 30-MAR-2007 the patient received a second dose of Gardasil. On 04-APR-2007 the patient was diagnosed with genital warts. The patient had no other symptoms. Additional information has been requested.
Patient experienced large, elevated rash on left arm. Initially expanded to approximately 6 inches wide for 3 days and currently stable. Itchy, painful.
pt rcvd vax; lab test taken & pt was anti HBs neg & anti HBc pos;
SEIZURE IMMEDIATELY AFTER TRUMENBA WITH DIZZINESS, ARCHING OF THE BACK, ROLLING OF THE EYES, FOAMING AT THE MOUTH,RIGIDITY IN THE UPPER EXT B/L, NO INCONTINENCE, LASTING 5 MINS .  GLUCOSE 96(POST VACCINE). BP 101/64(PRE VACCINE), HEART RATE 65/MIN(PRE-VACCINE), PULSE OX 99 % ON 2 LITERS OF OXYGEN(POST VACCINE)
Headache; Soreness; This is a spontaneous report from a non-contactable consumer, the patient. A 17-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 08Apr2021 at 16:15 (at the age of 17-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 08Apr2021, the patient experienced headache and soreness. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the events headache and soreness was resolved on an unknown date in Apr2021.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
achy arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (achy arm) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 029A21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Mar-2021, the patient experienced PAIN IN EXTREMITY (achy arm). At the time of the report, PAIN IN EXTREMITY (achy arm) had resolved.            Concomitant product included high blood pressure medication. Treatment information included Tylenol.
stiff neck; Muscle pain across the back; muscle pain spreading; Patient is feeling worst; This case was reported by a pharmacist via call center representative and described the occurrence of stiff neck in a 80-year-old female patient who received Herpes zoster (Shingrix) (batch number 9974P, expiry date 9th May 2022) for prophylaxis.   Previously administered products included Shingrix (1st dose received on unknwon date.).   On 24th October 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 25th October 2020, 1 days after receiving Shingrix, the patient experienced stiff neck, muscular back pain, muscle pain and feeling unwell. On an unknown date, the outcome of the stiff neck, muscular back pain, muscle pain and feeling unwell were unknown.   It was unknown if the reporter considered the stiff neck, muscular back pain, muscle pain and feeling unwell to be related to Shingrix.  Additional details were as follows: The age at vaccination was not reported. On 28th October,2020 pharamcist reported that patient received the 2nd dose of Shingrix on sunday 24th October,2020 and on monday morning patient woke up with with a stiff neck and muscle pain across the back. It was also reported that symptoms were spreading and patient was feeling worst. The reporter consented to follow up.
Woke with severe pain in right cervical  spine muscles, right upper shoulder. Sharp burning radiating pain progression to right deltoid. Treatment, tried Aleve,  Tylenol, massage without relief.  Emergency room visit 1/27 8am due to worsening Symptoms. Dx of muscle spasms, prescribed Valium a 8 hours, lidocaine patch and Tylenol, heat. No relief to of pain. TeleHeath with pcp on 1/28, who again dx muscle spasm. Changes script to flexeril. No relief in pain and now  new onset of numbness right . uncertain if this is related to covid but occurred  less than 24 hours after vaccine and have never experienced this issue before and no other mitigating cause known
Information has been received from a registered nurse concerning her approximately 42 months old son who in 1997 was vaccinated with varicella vaccine. In approximately 1999 the child developed a mild case of chicken pox. The registered nurse also reported that her other son developed mood disorder, blisters and insomnia after being vaccinated with varicella vaccine (WAES 0112USA01518). Additional info has been requested.
Myalgia & Arthralgia  Narrative:  dose 2-day 1-4- fatigue; chills; bodyache; joint pain
There was a nickel-size rEd rash, pimply in tExturE and itchy hivE-likE bumps below that.
Information has been received from a physician concerning a pt who on an unspecified date was vaccinated with HPV rL1 6 11 16 18 VLP vaccine yeast. Subsequently the pt experienced hives. No further details were provided, and at the time of this report, the outcome of the event was unknown. Additional information has been requested.
Treatment of COVID-19; Treatment of COVID-19; Vaccine brand=Pfizer / BioNTech, Vaccine administration date=12Oct2021, Vaccine dose number=3 / Vaccine brand other=Moderna Booster, Vaccine administration date=04Aug2022, Vaccine dose number=4; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Feb2021 as dose 1, single (Lot number: EN6201), in left arm, on 10Mar2021 as dose 2, single (Lot number: EN6204), in left arm and on 12Oct2021 as dose 3 (booster), single (Lot number: 30145BA) at the age of 68 years, in left arm for covid-19 immunisation; elasomeran (COVID-19 VACCINE MODERNA), on 04Aug2022 as dose 4 (booster), single (Lot number: AR4504B), in left arm for covid-19 immunisation; davesomeran, elasomeran (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), on 19Jan2023 as dose 5 (booster), single (Lot number: 023H224), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Ciprofloxacin, reaction(s): "Known allergies: ciprofloxacin". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 04Aug2022, outcome "unknown", described as "Vaccine brand=Pfizer / BioNTech, Vaccine administration date=12Oct2021, Vaccine dose number=3 / Vaccine brand other=Moderna Booster, Vaccine administration date=04Aug2022, Vaccine dose number=4"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Mar2023, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment; Positive, notes: I continued to test positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received paxlovid treatment from 23Mar2023 to 28Mar2023.
COVID-19; Loss of Taste; Loss of Smell; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue), AGEUSIA (Loss of Taste), ANOSMIA (Loss of Smell) and COVID-19 (COVID-19) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced FATIGUE (Fatigue). On 10-Jan-2021, the patient experienced AGEUSIA (Loss of Taste) and ANOSMIA (Loss of Smell). On 13-Jan-2021, the patient experienced COVID-19 (COVID-19). At the time of the report, FATIGUE (Fatigue), AGEUSIA (Loss of Taste), ANOSMIA (Loss of Smell) and COVID-19 (COVID-19) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported.  Treatment of the events were not reported.; Sender's Comments: Although a temporal association exists, based on the current available information, mechanism of action of mRNA-1237 vaccine and the pathogenesis process of Covid-19 infection, the events are assessed as unlikely related.
pt stopped breathing & went limp; was shook by father & taken to ER: CPR done; put on respirator; declared brain dead 1-2 days later & machine turned off; not sure what if any relationship exist between vax & following events;