chrisvoncsefalvay/vaers-outcomes huggingface dataset:
puffy; itchiness; big, red circle/redness/red spot; arm sore; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SKIN SWELLING (puffy), INJECTION SITE PRURITUS (itchiness), MYALGIA (arm sore) and INJECTION SITE ERYTHEMA (big, red circle/redness/red spot) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), ASCORBIC ACID (VITAMIN C ACID) and ZINC for an unknown indication.    On 17-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, the patient experienced MYALGIA (arm sore). On 24-Feb-2021, the patient experienced SKIN SWELLING (puffy), INJECTION SITE PRURITUS (itchiness) and INJECTION SITE ERYTHEMA (big, red circle/redness/red spot). The patient was treated with HYDROCORTISONE (HYDROCORTISONE 1% IN ABSORBASE) (topical) on 25-Feb-2021 at a dose of twice a day to four times a day and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of UNK UNK, bid. At the time of the report, SKIN SWELLING (puffy), INJECTION SITE PRURITUS (itchiness), MYALGIA (arm sore) and INJECTION SITE ERYTHEMA (big, red circle/redness/red spot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
AS PER MOM STARTED TO DEVELOP STATTERING AT THE END OF WORDS WITH ABNORMAL FACE GESTURES AS BLINKING,CLENCHING ON  HER TEETH, MOVE HEAD TO SIDE DURING TALKING, TALKING A LOT AND LOOK FATIGUED WHEN SPEAK
Rash, itching and whelps across arm at injection site.  Within 2 hours bilateral upper extremity and chest.  Within 6 hours across abodomen, back, chest and arms. Within 12 hours across all as listed above, onto hips, neck and face.
No adverse effects reported.; an unspecified "9 month old male patient" received one dose of GARDASIL 9.; an unspecified "9 month old male patient" received one dose of GARDASIL 9.; This spontaneous report was received from a registered nurse regarding a 9 months old patient. There was no information reported about the patient's concomitant medication, pertinent medical history and drug reactions/allergies.   On 25-JUL-2018, the patient received a dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (dose, anatomical site, lot number N022583 and expiration date 20-JUN-2020) intramuscularly for prophylaxis. No adverse events were reported.
Patient felt dizzy, lite headed with chills, tingly-spicy throat, shaking, spacy, tight upper chest, denied SOB, hives or rash...transported to urgent care.
dry mouth 3 days after second dose; This spontaneous case was reported by a consumer and describes the occurrence of DRY MOUTH (dry mouth 3 days after second dose) in a male patient of an unknown age who received mRNA-1273 for COVID-19 vaccination.     No Medical History information was reported.   In February 2021, the patient received second dose of mRNA-1273 (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form. In February 2021, the patient experienced DRY MOUTH (dry mouth 3 days after second dose). At the time of the report, DRY MOUTH (dry mouth 3 days after second dose) outcome was unknown.            Concomitant medications and treatment information was not provided by the reporter.
The week following- uncontrollable severe shaking to the point I could not text for help, aches, 103 fever, swollen arm, headache, nausea. Longterm- heart palpitations. Now documented right bundle branch block.
This case was reported by a consumer via call center representative and described the occurrence of adverse event in a 58-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (no adverse events). On 2nd January 2019, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was unknown. It was unknown if the reporter considered the adverse event to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. In January 2019, after receiving the vaccine, the patient seem to be having all the symptoms on website (not specified). The reporter asking how long would the side effects last. The patient received the vaccine from local pharmacy and no prescriber.
Sick; Cough; Losing my voice; Going to break down; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2019-2020 season) for prophylaxis.   Co-suspect products included PERTUSSIS TOXOID (WHOOPING COUGH VACCINE) for prophylaxis.   In August 2019, the patient received Influenza vaccine Quadrivalent 2019-2020 season and WHOOPING COUGH VACCINE. On an unknown date, less than 4 months after receiving Influenza vaccine Quadrivalent 2019-2020 season, the patient experienced sickness, cough, loss of voice and nervous breakdown. On an unknown date, the outcome of the sickness was not recovered/not resolved and the outcome of the cough, loss of voice and nervous breakdown were unknown.   It was unknown if the reporter considered the sickness, cough, loss of voice and nervous breakdown to be related to Influenza vaccine Quadrivalent 2019-2020 season.  Additional case details were reported as follows: The age at vaccination was not reported. The patient was sick with cough and losing his or her voice.  The patient was going to break down and seek doctor advice because it has been long time since the patient was sick. It was unknown if the reporter considered the sickness, cough, loss of voice and nervous breakdown to be related to whooping cough vaccine.
The first shot on 09/02/2021  Lot number 058E21A  - I Had no side effects, The second shot number 061E21A on  09/30/2021,  Headache started 30 minutes after injection, Headaches continues thru today 10/07/2021 along with nausea and tiredness. I did have chest pain on the second thru fifth  day 10/01/2021 thru 10/05/2021.
Information has been received from a nurse concerning her friend's approximately 19 year old son who on an unspecified date in approximately 1991 (18 years ago) was vaccinated with a dose of MMR II (Wistar RA 27/3) (HSA, lot#, route and site of administration not reported). Subsequently, the patient was autistic after vaccination. At the time of this report, the patient's outcome was unknown. Upon internal review, being autistic was considered to be an other important medical event. This is one of several reports from the same source. No further information is available.
Child is 10 years old and received the Covid 23/24 Pfizer vaccine for ages 6 months to 4 years instead of the correct dose of Covid 5-11 years
was vaccinated / with Pediarix / on that same day, by confusion / was also vaccinated with Engerix-B / and with Polio vaccine; This case was reported by a nurse via call center representative and described the occurrence of accidental overdose in a 2-month-old female patient who received HBV (Engerix B pediatric) (batch number 7574E, expiry date 29th December 2022) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa-HBV-IPV (Pediarix) (batch number 9X3T5, expiry date 5th March 2023) for prophylaxis, dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis and POLIOMYELITIS VACCINE (POLIO VACCINE) for prophylaxis.   On 3rd June 2021, the patient received Engerix B pediatric, Engerix B Pre-Filled Syringe Device, Pediarix and Pediarix Pre-Filled Syringe Device. On an unknown date, the patient received POLIO VACCINE. On 3rd June 2021, unknown after receiving Engerix B pediatric, Engerix B Pre-Filled Syringe Device, Pediarix, Pediarix Pre-Filled Syringe Device and POLIO VACCINE, the patient experienced accidental overdose. On an unknown date, the outcome of the accidental overdose was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The nurse called to report that the patient was vaccinated with Pediarix afterwards on that same day, by confusion was also vaccinated with Engerix-B and with Polio vaccine from Sanofi Pasteur, which led to accidental overdose. The Healthcare professional did not know the brand name of the vaccine at the time of the call.  No further events were reported at the time of the phone call. The reporter did not consent to follow up. The Healthcare professional did not consent nor decline follow up and wanted to know on how to proceed. No further details were provided at the time of the phone call.
Pt. called to report a localized raised area around injection site. Pt. denied shortness of breath, fever, loss of feeling.  Area is warm to touch, but the rest of the arm shows no signs of swelling, warm to touch, or discoloration.  Pt. instructed to seek medical attention if symptoms worsen.  Pt. verbalized understanding.
Vaccine headache did not go way after 4 days.  Treated with 1000mg tylenol and 2 Aleve.   Daily persistent headaches ensued.   Vestibular issues started, tinnitus, throbbing headaches, etc.  Contacted neurologist.  Medrol pak 5 weeks after vaccine.  limited to no impact.  MRI.  No sign of active lesions.  Migraine symptoms started to be less frequent at 8 week mark.
Bruising/ Entire leg turning black and blue; Could not bend/ could not put pressure on leg; swollen leg; Trouble walking; knee issues and leg pain/rt leg started to ache/ache got worse and pain intensified/ tender to touch; Arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (knee issues and leg pain/rt leg started to ache/ache got worse and pain intensified/ tender to touch), MOBILITY DECREASED (Could not bend/ could not put pressure on leg), GAIT DISTURBANCE (Trouble walking), PERIPHERAL SWELLING (swollen leg) and CONTUSION (Bruising/ Entire leg turning black and blue) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031B21A and 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Stroke on 27-Jun-2017. Concurrent medical conditions included Latex allergy and Drug allergy (Lipitor). Concomitant products included WARFARIN SODIUM (COUMADIN) from 29-Jun-2017 to an unknown date and ROSUVASTATIN from 29-Jun-2017 to an unknown date for Stroke, ROSUVASTATIN CALCIUM (CRESTOR), VITAMINS NOS (DAILY MULTIVITAMIN), GLUCOSAMINE and ZINC for an unknown indication.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In March 2021, the patient experienced PAIN IN EXTREMITY (knee issues and leg pain/rt leg started to ache/ache got worse and pain intensified/ tender to touch) and PAIN IN EXTREMITY (Arm soreness). In April 2021, the patient experienced GAIT DISTURBANCE (Trouble walking). On 16-Apr-2021, the patient experienced MOBILITY DECREASED (Could not bend/ could not put pressure on leg) and PERIPHERAL SWELLING (swollen leg). On 22-Apr-2021, the patient experienced CONTUSION (Bruising/ Entire leg turning black and blue). At the time of the report, PAIN IN EXTREMITY (knee issues and leg pain/rt leg started to ache/ache got worse and pain intensified/ tender to touch), PERIPHERAL SWELLING (swollen leg) and CONTUSION (Bruising/ Entire leg turning black and blue) was resolving and MOBILITY DECREASED (Could not bend/ could not put pressure on leg), GAIT DISTURBANCE (Trouble walking) and PAIN IN EXTREMITY (Arm soreness) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Mar-2021, International normalised ratio: 3.1 (High) shoots up. On 21-Apr-2021, International normalised ratio: 3.23 (High) high.         No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: Significant follow-up: Patient demographics ,concomitant mediation, relevant history ,allergies were added.
Injection site reaction pain swelling and redness; Injection site reaction pain swelling and redness; Injection site reaction pain swelling and redness; Fever over 100; Dizziness; Nausea; Severe Headache; Neck pain; Trouble speaking; This non-serious case was reported by a physician via sales rep and described the occurrence of injection site pain in a 62-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced injection site pain (Verbatim: Injection site reaction pain swelling and redness), injection site swelling (Verbatim: Injection site reaction pain swelling and redness), injection site erythema (Verbatim: Injection site reaction pain swelling and redness), fever (Verbatim: Fever over 100), dizziness (Verbatim: Dizziness), nausea (Verbatim: Nausea), headache (Verbatim: Severe Headache), neck pain (Verbatim: Neck pain) and speech disorder (Verbatim: Trouble speaking). The outcome of the injection site pain, injection site swelling, injection site erythema, fever, dizziness, nausea, headache, neck pain and speech disorder were resolved (duration 96 hrs).   It was unknown if the reporter considered the injection site pain, injection site swelling, injection site erythema, fever, dizziness, nausea, headache, neck pain and speech disorder to be related to Arexvy.     It was unknown if the company considered the injection site pain, injection site swelling, injection site erythema, fever, dizziness, nausea, headache, neck pain and speech disorder to be related to Arexvy.   Additional Information: GSK Receipt Date: 07-SEP-2023 Reporter stated after the administration of Arexvy vaccine patient suffered for 96 hours of reported symptoms (injection site pain, injection site swelling, injection site erythema, fever, dizziness, nausea, headache, neck pain and speech disorder). The reporter consented to follow up.
This case was reported by a nurse via call center representative and described the occurrence of allergic reaction in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced allergic reaction. On an unknown date, the outcome of the allergic reaction was unknown. It was unknown if the reporter considered the allergic reaction to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as per the vaccine indication. The health care professional reported via chat that patient might had an allergic reaction from the SHINGRIX. The health care professional would not provide additional information. The health care professional just wanted a copy of the package insert.
Covid breakthrough. I started out with low grade fever that wouldn't break for three or four days. I used over the counter Motrin. It never got higher than 101 degrees. Day five I started feeling bronchitis symptoms, I ended up going to the doctor an got an inhaler and antibiotics. That lasted for about a week. I had weakness and shortness of breath for two months. The last 30 days I feel like I am back to normal.
Fever, Chills, Fatigue, Headache and slight numbness in fingers and toes.
Lymph nodes on right side armpit and side of breast swelled and were painful for about 24 hours. I took advil and used a heating pad to ease the pain.
flu-like symptoms; temperature 101; body aches; tiredness; nausea; a really bad headache; a bruise of 5 inches diameter; it stayed there for a long time; she also got bruises in her legs; big; unexplained; one of 6-7 inches diameter; took a long time to resolve; A spontaneous report was received from a healthcare professional concerning a 49-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events nausea, a really bad headache, a bruise of 5 inches diameter, it stayed there for a long time, she also got bruises in her legs, big, unexplained, one of 6-7 inches diameter, took a long time to resolve, flu-like symptoms, temperature 101, body aches, tiredness.  The patient's medical history was not provided. Concomitant medications reported were Multivitamins for drug use for unknown indication.  On 30 Dec 2020, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 037K20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 13 Feb 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: 007M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event(s) nausea, a really bad headache, a bruise of 5 inches diameter, it stayed there for a long time, she also got bruises in her legs, big, unexplained. One of 6-7 inches diameter, took a long time to resolve, flu-like symptoms, temperature 101, body aches, tiredness.  Treatment details included Ibuprofen.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), nausea, a really bad headache, a bruise of 5 inches diameter, it stayed there for a long time, she also got bruises in her legs, big, unexplained, one of 6-7 inches diameter, took a long time to resolve, flu-like symptoms, temperature 101, body aches, tiredness was unknown.
The patient stated that she had joint pain that began the day after she received the first dose of the COVID-19 Moderna vaccine and that she particularly had weak knees. She also stated that she had insomnia and was up all night. She also stated that she had a low-grade fever 02/02/21-02/03/2021.  By 02/04/2021 she stated that she was feeling better and that her symptoms were more mild. Today (02/10/2021) she states that she feels better but that she has had some increased pain and insomnia; she estimates, though, that these symtoms that she mentioned today are due to recent medication changes.
Adult dose of Influenza Vaccination administered, onset of nausea, abdominal pain, headaches, myalgia started the following day. Abdominal sx  continued, patient lost 15 lbs in six weeks and was hospitalized. Gastrointestinal symptoms later diagnosed as gastrointestinal dysmotility secondary to a clinical diagnosis of mitochondrial disease (diagnosed in 2002).  The initiation of the influenza vaccination was the "trigger" for the start of the mitochondrial symptoms. 8/13/08-records received-office visit 10/5/92-presented with C/O persistent sore throat present for approximately 1 week. Developed white spots on tonsils and felt unwell, always tired. Retin-A for acne. Assessment viral pharyngitis, acne, 10/7/02 continues with C/O sore throat. 10/19/02 seen for persistent symptoms and after flu shot C/O fatigue, chronic headaches, anorexia and constant nausea with  7lb weight loss. Low grade temps. Assessment probably viral syndrome. 11/2/92 C/O continued nausea and additional weight loss. 11/9/02-heart murmur detected, systolic murmur. 7/7/94-receiving TPN via jejunostomy feedings for intestinal pseudo-obstruction. 3/30/98-orthostatic intolerance may be contributing to symptoms of abdominal pain particularly when it is provoked by exercise.  4/3/01-C/O increased weakness with ambulation and stumbling gait. Assessment extreme muscle fatigue. 4/25/03-symptoms suggestive of an underlying mitochondrial disease. 6/30/03-chronic pseudo-obstruction associated with abdominal pain, diarrhea presumably from bacterial overgrowth, chronic/recurrent pancreatitis, autonomic dysfunction, muscle fatigue with reduced endurance, muscle cramping post exercise, chronic thrombocytopenia, retinal pigmentation,  pancreatitis, GERD, SVT..
pt recv vax 18JUN97 & exp itching on upper chest;a few hr later, pt exp raised, red rash on upper chest & upper back w/itching;pt tx w/DPH;
Tingling in hands and fingers.  Extreme pain in muscles and joints.  Back pain was so severe that I could not sleep on my back.  Fatigue.  Muscle weakness to the point where I could not do daily tasks.  Headaches.  It took two months to get into a Rheumatologist.  I told him it felt like my body was destroying itself.  He prescribed Diclofenac for pain.  It has helped with pain but I am still suffering  with weakness.
CoughWheeze, COVID-19 PCR positive, fully vaccinated, fatigue, congestion Narrative:
COVID-19 case: On 05/13/2022 started with sore throat in the morning and felt very fatigued by the evening. The following day by the afternoon felt pain in my calves, hands and experienced a terrible headache. Then I had nasal congestion and allergies and low grade fever. On 05/16/2022 I took a covid test, I also contacted my doctor and had lab work. My covid test resulted positive. If I walk long distances I feel very fatigue and sore throat and have congestion.
The patient was given three doses / 1. 12/12/2019 / 2. 12/19/2020 / 3. 4/9/2021; first Shingrix vaccine / on December 12, 2019; the second / on December 19, 2020.; This case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too long in a 64-year-old female patient who received Herpes zoster (Shingrix) (batch number 95JR5, expiry date 5th November 2022) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 12th December 2019).   On 9th April 2021, the patient received the 3rd dose of Shingrix (intramuscular). On 19th December 2020, the patient received the 2nd dose of Shingrix. On 19th December 2020, not applicable after receiving Shingrix and unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On 9th April 2021, the patient experienced extra dose administered. On an unknown date, the outcome of the drug dose administration interval too long and extra dose administered were unknown.  Additional details were provided as follows: The patient received 2nd dose of Shingrix, more than the recommended interval, which led to lengthening of vaccination schedule. The patient received 3rd dose of Shingrix, which led to extra dose administered. All information was not available. The reporter consented to follow up.
Information has been received from a registered nurse concerning a "14 or 15" year old female who was vaccinated with a dose of Gardasil.  Subsequently the patient developed pain at the injection site and headache.  Unspecified medical attention was sought.  Subsequently, the patient recovered.  Additional information has been requested.
Adverse reaction to TriHibit given IM in right thigh. Pt had a 9cm X 7cm red localized area that was swollen and hot to the touch. Dad stated child had a decreased appetite, was non-active, listless and somewhat "lethargic." Appeared to be very sleepy.
HA, achiness, chills, fever, pain and swelling at sight of injection deltoid R arm, no redness at injection sight. Later that day developed pain and swelling in R axillae.
Patient with progressive ascending weakness over 2 weeks. Diagnosed with Guillain-Barre Syndrome.
ITCHY RASH, DISCRETE RED PAPULAR LESIONS, LYMPHANGITIS EXTENDED FROM SITE.  NO VESICLES OR PAPULES.