chrisvoncsefalvay/vaers-outcomes huggingface dataset:
swelling in hands; warm feeling in his hand and knee joints,; right thumb locked open; has woken up twice from sleep; decreased strength in hands; This spontaneous case was reported by a patient and describes the occurrence of PERIPHERAL SWELLING (swelling in hands), FEELING HOT (warm feeling in his hand and knee joints,), TRIGGER FINGER (right thumb locked open), SLEEP DISORDER (has woken up twice from sleep) and ASTHENIA (decreased strength in hands) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043L20A) for COVID-19 vaccination.     No medical history information reported.  Concomitant products included FISH OIL, EZETIMIBE, LISINOPRIL, IBUPROFEN and NAPROXEN for an unknown indication.    On 04-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-May-2021, the patient experienced PERIPHERAL SWELLING (swelling in hands), FEELING HOT (warm feeling in his hand and knee joints,), TRIGGER FINGER (right thumb locked open), SLEEP DISORDER (has woken up twice from sleep) and ASTHENIA (decreased strength in hands). At the time of the report, PERIPHERAL SWELLING (swelling in hands), FEELING HOT (warm feeling in his hand and knee joints,), TRIGGER FINGER (right thumb locked open), SLEEP DISORDER (has woken up twice from sleep) and ASTHENIA (decreased strength in hands) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication was reported .
Temp of 104F, then in the night had sz; Admitted to hosp; Doing well as 14FEB90; No problem w/previous vaccines; Normal growth & development;
Information has been received from a pharmacist concerning a currently 86 year old female patient. On unspecified date "many years ago", the unknown aged patient was vaccinated with Pneumococcal Vaccine (manufacturer unknown) (dose, strength, lot # and route were not reported). Other suspect therapy included unspecified flu shot. On unspecified date, the patient experienced her lymph nodes swollen, which resulted in the removal of some lymph nodes. The outcome of the event was not reported. The reporter considered the vaccines caused the lymph nodes swollen. Upon our internal review, the removal of some lymph nodes was determined to be medical significant. This is one of several reports received from the same reporter. Additional information has been requested.
pt devel pain @ inj site @ time of vax;appeared to have much discomfort & described it as knives in arm;pt advised to use motrin for pain & to ice inj site;
Patient received #2 Moderna Covid vaccine in office. After patient waited the 15 min mom said that her lips looked like they were a little swollen. Brought Nurse in to look at patient, she determined that her lips were swollen and advised to give 2 ml's of benadryl, this was given and patient's mom instructed to wait an additional 15 min in office to see if swelling went down. Swelling was noted to be gone after the 15 minutes of waiting
Mastitis, diagnosed by an ER physician, two weeks after the vaccination. Antibiotics were given for treatment. The follow up states the onset date as 8/5/02 upon awakening.
Temperature excursion of 8.9,8.8, 8.4 °C; This case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in an unspecified number of patients who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2022-2023 season) (batch number 24GY7, expiry date 30th June 2023), (batch number 9XL7N, expiry date 30th June 2023) and (batch number AS5RM, expiry date 30th June 2023) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Fluarix Quadrivalent 2022-2023 season. On an unknown date, the dose was an unknown dose. On an unknown date, the dose was an unknown dose. On an unknown date, the patient started Fluarix Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving Fluarix Quadrivalent 2022-2023 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug 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 Information: GSK receipt date: 7-Dec-2022 Reporter's comment: The registered nurse reported that their Fluarix QIV were exposed to an above temperature excursion of 8.9 degree Celsius for 30 minutes for Fluarix QIV. The vaccine was exposed on 13th September 2022 8.4 degree Celsius for 30 minutes, 28th September 2022 8.8 degree Celsius for 30 minutes and 29th September 2022 8.9 degree Celsius for 30 minutes. The reporter also stated these doses were already given to patients (no details available when asked). The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up (email was provided). Additional supportive information: The patients received the Fluarix QIV after temperature excursion, which led to incorrect storage of drug.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 73-year-old female patient who received SHINGRIX (batch number 9779K, expiry date 11th October 2020) for prophylaxis. On 27th June 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 29th June 2018, 2 days after receiving SHINGRIX, the patient experienced injection site erythema, injection site itching and injection site warmth. On an unknown date, the outcome of the injection site erythema, injection site itching and injection site warmth were not recovered/not resolved. It was unknown if the reporter considered the injection site erythema, injection site itching and injection site warmth to be related to SHINGRIX. Additional details were provided as follows: At 11:58 hours, the patient received SHINGRIX on left arm. The patient's left arm at the injection site was red, itchy and hot to the touch. The area measures 4cc by 4cc.
Patient presented on 6/14/2021 for Rash that began a week prior. No new foods or meds introduced during this time frame. Only difference prior to rash family could think of was COVID vaccine. Patient being treated Cetirizine and hydrocortisone 1% OTC
Diaphoretic, dizzy. BPs 153/98 (pulse 83), 153/92 (pulse 76). O2 97%. Patient seated, improved.
Extreme fatigue; fever; headache; migraine; swollen lymph nodes; dizziness; weakness; nausea; high heart rate; inflammation in joints and spine; inflammation in joints and spine; high ESR; This is a spontaneous report from a contactable consumer (patient). A 39-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EP7533) via an unspecified route of administration into left arm on 09Apr2021 17:30 (at the age of 39-year-old) as 1st dose, single for COVID-19 immunisation. Medical history included autoimmune disorder, anemia and hypothyroidism. Patient was not pregnant. The patient's concomitant medications were not reported. The patient previously took cephalexine and experienced drug allergy. On 09Apr2021 21:00, patient experienced extreme fatigue, fever, headache, migraine, swollen lymph nodes, dizziness, weakness, nausea, high heart rate, inflammation in joints and spine and high ESR (erythrocyte sedimentation rate). The event extreme fatigue was reported as serious, medically significant. The events resulted in emergency room and physician office visit. It was also reported that the patient was treated with IV fluids, ondansetron (ZOFRAN) and ketorolac (TORADOL). The patient underwent lab tests and procedures which included SARS-CoV-2 test: negative on 24Apr2021. Outcome of events was recovering.   Additional information has been requested.
PATIENT CONTACTED THE PHARMACY 10/19/17 STATING THAT SHE HAS HAD A HEADACHE NOT RELIEVED BY ALEVE/IBUPROFEN AND THAT HER LEFT EYE WAS WATERY AND OCCASIONALLY BLURRING. SHE DID NOT STATE EXACTLY WHEN THE SYMPTOMS STARTED, BUT SAID THEY WERE PERSISTENT. LATER TODAY, THE HOSPITAL EMERGENCY ROOM CONTACTED THE PHARMACY TO SEE HER MEDS AND WHAT VACCINES SHE HAD BEEN GIVEN. NO FURTHER OUTCOME HAS BEEN REPORTED AT THIS TIME.
her voice changes; dizzy; weak; side of her neck between her ear down to neck bone/Collar bone feels tight; she would walk to the left as if someone if pulling her to the left/couldn't walk straight; just don't feel right; started getting cramps in her stomach; having the same pain in her back, in her mid-rift underneath her breast; memory is not very good these days; don't have much of an appetite; weighted 10 pounds less than her normal weight; throat gets tight when she talks; feels like it is puffy inside; t hurts so bad; This spontaneous case was reported by a consumer and describes the occurrence of DYSPHONIA (her voice changes), DIZZINESS (dizzy), ASTHENIA (weak), MUSCLE TIGHTNESS (side of her neck between her ear down to neck bone/Collar bone feels tight) and GAIT DISTURBANCE (she would walk to the left as if someone if pulling her to the left/couldn't walk straight) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022-M2DA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ATORVASTATIN, VENLAFAXINE, CYCLOBENZAPRINE and TOPIRAMATE for an unknown indication.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DYSPHONIA (her voice changes), DIZZINESS (dizzy), ASTHENIA (weak), MUSCLE TIGHTNESS (side of her neck between her ear down to neck bone/Collar bone feels tight), GAIT DISTURBANCE (she would walk to the left as if someone if pulling her to the left/couldn't walk straight), FEELING ABNORMAL (just don't feel right), ABDOMINAL PAIN UPPER (started getting cramps in her stomach), BACK PAIN (having the same pain in her back, in her mid-rift underneath her breast), MEMORY IMPAIRMENT (memory is not very good these days), DECREASED APPETITE (don't have much of an appetite), WEIGHT DECREASED (weighted 10 pounds less than her normal weight), THROAT TIGHTNESS (throat gets tight when she talks), SWELLING (feels like it is puffy inside) and PAIN (t hurts so bad). At the time of the report, DYSPHONIA (her voice changes), DIZZINESS (dizzy), ASTHENIA (weak), MUSCLE TIGHTNESS (side of her neck between her ear down to neck bone/Collar bone feels tight), GAIT DISTURBANCE (she would walk to the left as if someone if pulling her to the left/couldn't walk straight), FEELING ABNORMAL (just don't feel right), ABDOMINAL PAIN UPPER (started getting cramps in her stomach), BACK PAIN (having the same pain in her back, in her mid-rift underneath her breast), MEMORY IMPAIRMENT (memory is not very good these days), DECREASED APPETITE (don't have much of an appetite), WEIGHT DECREASED (weighted 10 pounds less than her normal weight), THROAT TIGHTNESS (throat gets tight when she talks), SWELLING (feels like it is puffy inside) and PAIN (t hurts so bad) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
11DEC93 Pm low back ache progressing to neck; 12DEC93 very stiff neck, h/a, dizziness, chills, sweats, aching, weak, dizzy, t102-103; pt very sleepy during this time;
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On an unknown date in 2015, the patient was inoculated with ZOSTAVAX as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster or shingles. On an unknown date in 2016, the patient was treated by a physician for a blistering vesicular outbreak which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient had suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of events was unknown. Causality assessment was related. Additional information has been requested.
I have not had a period in 6 years as I take continuous oral contraceptive and do not do period weeks. I skip to the next pack when finishing 3 weeks of birth control. Shortly after receiving my second vaccination I began spotting. light enough that I only needed to use  panty liner. I would then go a few days with out and spotting only for it start again. fast forward to August 27th. I am experiencing heavy bleeding for the last 12 days (today being Sept 7th) I am experiencing an unsettling amount of clots passing out of me my uterus/ vagina. I have been still taking my constant birth control this entire time. I have taken two pregnancy tests just to rule out that. I knew I wasn't pregnant but better safe than sorry. I t has almost been 4 months since my final shot and the bleeding has only gotten worse. Some clots are smaller while a good amount of them are amount half of my pinky finger in size. I am passing about 10 a day in addition to regular blood. The clots are very dark in color, almost black and the blood is normal bright red. I should note that A. I have not experience even any spotting since starting continuous birth control 6 years ago and B. I have never experience clotting before except a little bit when I was first getting my period around age 14 but nothing like this and how long it has gone on for.
9/19/21: Patient arrived at the ER due to complaints of shortness of breath and cough which has been worsening over the last 4 days. EMR reported he has had symptoms since 09/07 but came to the ED on 09/14 after his wife testing positive on 09/13.  He tested positive on 09/14 and initially was complaining of body aches and diarrhea and was sent home with O2 monitoring kit.  Apparently, patient has noted hypoxia at home with O2 saturations dropping as low as 88% so he decided to come back to the ED. Reported associated symptoms include shortness of breath/dyspnea on exertion, diarrhea, fatigue, body ache and cough.  Bedside RN reports patient started complaining of chest/rib pain from coughing.
Allergic to the vaccine; This spontaneous case was received on 07-Jan-2021 from pharmacist via Med Communications (reference number: SEQW21-00085) and concerned a female patient of an unreported age.  The patient's medical history and concomitant medications were not reported.  On 15-Sep-2010, the patient was vaccinated with Fluvirin (inactivated influenza virus surface antigen (subunit), egg-derived, influenza vaccine; dose, route of administration, anatomical location: not reported) for influenza prophylaxis. The batch number reported was 111798PI and expiry date was 31-Mar-2011.  On an unspecified date, unknown amount of time after receiving Fluvirin, the patient followed up with a skin test, on which she reacted. The patient was allergic to the vaccine.  On an unspecified date in 2011, the patient saw an allergist.  The outcome of the event was not reported.  The reporter assessed the event to be releted to Fluvirin. The reporter stated that the patient was allergic to the vaccine.  The case was assessed as non-serious.  This case is linked to 202100271 due the same patient.  Company Comment: The event is considered as related to Fluvirin.; Reporter's Comments: The reporter stated that the patient was allergic to the vaccine.; Sender's Comments: The event is considered as related to Fluvirin.
Patient had trouble breathing/had asthma attack at least 15 minutes after injection. Gave BENADRYL & 1 dose of EPIPEN 0.3, nurse in clinic also administered pt's albuterol inhaler to her & Dexamethasone 0.5 mg/ml - she gave her 20 ml. 911 was called & they took pt to hospital after breathing was stabilized.
This spontaneous report was received from a pharmacist via company representative refers to a patient of unknown demographics. On an unknown date the patient was vaccinated with ZOSTAVAX vial (dose, lot number and expiry date not provided) for vaccination. On an unknown date the patient experienced swelling and redness at the injection site after receiving the vaccine. The outcome of the events was unknown. Additional information has been requested.
8/26/11 Vaccine given at 10:30AM (Lt) arm, client noticed it itched right after he received injection, HA started 10pm, poor appetite at dinner 5pm, at 10pm TYLENOL 1 tab, BENADRYL 25mg PO, at 11pm vomiting started lasting approximately 30 mins, went to sleep, at 5-6AM 8/27/11 vomited, then slept until 9:45AM, at 11AM giving sips of warm Coke, then noticed fever welted & rash around the injection site down to his elbow on (Lt) arm only. By 5pm feeling better fever gone & rash and welts gone 8/27/11.
Immediate erythema, heat, swelling to 9 cm around injection site (R) deltoid. DECADRON 8 mg IM.
Passed Out; upset stomach; Dry heaving; Stomach Cramps; Chills; Fever; This is a spontaneous report from a non-contactable consumer (patient). A 24-year-old female patient (not pregnant) received bnt162b2 (lot number unknown), via an unspecified route of administration, at Left arm, on 05Feb2021 16:15 at SINGLE DOSE for COVID-19 immunisation. The patient medical history was not reported. There were no concomitant medications. No covid prior vaccination. No covid tested post vaccination. No other vaccine in four weeks. The patient experienced woke up out of her sleep, upset stomach. Dry heaving. Stomach Cramps. Chills. Fever. Passed Out. Adverse event started on 06Feb2021 12:00 AM. No treatment AE. The outcome of the event was recovered in Feb2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Vomiting, dehydration, intense headaches, joint pain felt locked up, fever, Covid arm, rash itching & burning. fatigue
Vaccine administration error- Moderna Vaccine given to Age 16 year old. 16 year old presented with physician instruction to administer the vaccine.
This spontaneous report has been received from a nurse and refers to a 16 year old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. In November 2016, in March 2017 and in May 2017 the patient was vaccinated with the first, second and third (respectively) doses of GARDASIL 9 lot # M041212, expiration date 21-JUN-2019 (doses and route of administration were not reported). The reporter stated that the second and third doses were separated by 10 weeks. No adverse effects were reported. No product quality complaint was involved.  Additional information has been requested.
warmth, redness, swelling (non-tender) on lateral aspect of lt arm/deltoid-site of DTAP;
Red, swollen, warm to touch. Painful at injection site . 2-3 inches in circ. Advised Motrin-cool compress.
Fever up to 101 started 7/10/03 in evening. Patient came to office 7/11/03; had temp of 102.2. While waiting to be seen, patient had a tonic-clonic seizure of about 1.5 minutes duration which resolved spontaneously.
Patient states injection site has become red and warm to the touch. She also says it has developed some swelling.
Patient developed fever, shortness of breath, back pain and tingling in left leg. Had to be carried to ER by his mother.
20 mo old male takent o ER and admitted to ICU. Admitting diagnosis: pneumonia. Culture positive for Strep. pneumo. The hospital discharge summary received on 3/23/04 states dehydration, hyponatremia, empyema w/o fistual, pleural effusion, pneumothrorax, influenza, diarrhea, and difficulty breathing.
experienced similar welts/hives; burning sensations a couple of weeks after the booster/still experiences burning; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (experienced similar welts/hives) and BURNING SENSATION (burning sensations a couple of weeks after the booster/still experiences burning) in a female patient of an unknown age 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced URTICARIA (experienced similar welts/hives) and BURNING SENSATION (burning sensations a couple of weeks after the booster/still experiences burning). At the time of the report, URTICARIA (experienced similar welts/hives) outcome was unknown and BURNING SENSATION (burning sensations a couple of weeks after the booster/still experiences burning) was resolving.            No relevant concomitant medications were reported. Treatment medication was not provided by the reporter.  Patient still experiences burning, but not as bad.
Information has been received from a physician's assistant concerning a female patient who on unspecified dates was vaccinated with the first, second and third doses of GARDASIL (dose, route and lot number not reported). The patient developed pharyngitis after she received the first, second and third doses of GARDASIL. The patient was seen by the physician. This is one of two reports from the same source. Additional information has been requested.
joint pain; weakness; chills; diarrhea; dizziness; minor difficulty breathing; headache; Injection site pain; malaise; muscle cramping; swollen lymph nodes; projectile vomiting; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient (not pregnant) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EN9581) via an unspecified route of administration in right arm on 03Feb2021 15:45 at single dose for covid-19 immunisation.  Medical history included diabetes, hypertension (HTN), and gastrooesophageal reflux disease (GERD). Known allergies included xylometazoline hydrochloride (SUDAFED). Concomitant medication included omeprazole (PROTONIX), metformin hydrochloride, sitagliptin (JANUMET), empagliflozin (JARDIANCE), insulin glargine (BASAGLAR), escitalopram oxalate (LEXAPRO).  There was no other vaccine in four weeks. The patient had no COVID prior vaccination. The patient had no COVID tested post vaccination. The patient experienced joint pain, weakness, chills, diarrhea, dizziness, minor difficulty breathing, headache, injection site pain, malaise, muscle cramping, swollen lymph nodes, projectile vomiting, all on 04Feb2021 09:15 with outcome of recovering. No treatment received for the events.
My lymph nodes in my left armpit we're very swollen little larger and then an egg for about 24 hours then the swelling went away but they were still tender.
Fire EMS brought the patient 1ml syringe w/ Hypodermic Safety Needle 25G x 1", lot# P920363X, to be used for Pfizer COVID-19 vaccine. RN  when injecting the needle into the client, while plunging the syringe noticed some vaccine leaked from the needle down the client's arm. The client ended up only receiving a partial dose, unable to determine the actually amt of vaccine that the ct received. Two additional nurses prior to this incident had noticed the needle became loose when the cap was removed prior to administration. Both of these nurse realized the needle was loose right before injecting the needle into ct's arm giving them the chance to tighten the needle before administering. Nurse Manager reported to W
Nauseated; lightheaded; pale; VS 110/62-BP P-48 R=16 Denies at 715 pm dizziness.