chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Tingling; Numbness; Wearing off effect; Lost weight; Pain/Generalized aching; Fatigue; Headache; COVID-19; This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (COVID-19), PARAESTHESIA (Tingling), HYPOAESTHESIA (Numbness), THERAPEUTIC RESPONSE SHORTENED (Wearing off effect) and WEIGHT DECREASED (Lost weight) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. On 26-Apr-2021, the patient experienced COVID-19 (COVID-19). On an unknown date, the patient experienced PARAESTHESIA (Tingling), HYPOAESTHESIA (Numbness), THERAPEUTIC RESPONSE SHORTENED (Wearing off effect), WEIGHT DECREASED (Lost weight), PAIN (Pain/Generalized aching), FATIGUE (Fatigue) and HEADACHE (Headache). At the time of the report, COVID-19 (COVID-19) and THERAPEUTIC RESPONSE SHORTENED (Wearing off effect) was resolving, PARAESTHESIA (Tingling), HYPOAESTHESIA (Numbness), WEIGHT DECREASED (Lost weight) and PAIN (Pain/Generalized aching) outcome was unknown and FATIGUE (Fatigue) and HEADACHE (Headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient lost 28 pounds, starting on an unknown date.  Very limited information regarding the events has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding the events has been provided at this time.  Further information has been requested.
On 1/7/98, 2/20/98, in 12/98, 8/3/00 and 8/7/01, the vaccinee received her 1st, 2nd, 3rd, 4th and 5th 0.5ml IM doses of Infanrix. Additionally, on 8/7/01, she received a 0.5cc SC right deltoid dose of IPOL and her 2nd 0.5cc SC left dose of MMR. Within 24 hours, post vax, on 8/8/01, the vaccinee experienced an 8cm X 9cm diameter erythema with induration at the injection site. The vaccinee was examined by a healthcare professional on 8/9/01 for the reaction. On 8/10/01, the vaccinee had a 9cm X 9cm erythematous and indurated area which was painful to palpation and was warm to touch. The induration was a palpable mass. On 8/14/01, the vaccinee had a 8mm X 9mm erythematous indurated area of the left upper arm which was warm compared to "other" skin. The vaccinee was treated with cefalexin monohydrate (Keflex) 250mg 2 teaspoons 3 times daily for 10 days for cellulitis and with hydroxyzine hydrochloride (Atarax) 15mg 3 times daily orally from 8/10/01 to 8/18/01 for the allergic reaction. The pt was offered an appointment on 8/17/01 unless symptoms subsided. The pt did not come for the appointment. The reporter stated that the cellulitis and allergic reaction were moderate in intensity, were related to Infanrix and resolved on 8/17/01. The reporter stated that the cellulitis and allergic reaction were related to Infanrix. As of 8/17/01, the symptoms had resolved.
Full body rash - urticarial with erythematous base. Head, neck, trunk, upper and lower extremities. Fever - Started diphenhydramine - continued TYLENOL for fever.
Rash on thighs, arms and ankles developed 12 days after 1st dose and subsided 1 week after presentation.
Severe headache/migraine and nausea 2 hours post vaccination. Took 1 dose of sumatripan (100mg) for what felt like a migraine approximately 4 hours post vaccination. Vomiting 7 hours post vaccination (do not ever have vomiting with migraines in previous history). Severe headache and nausea continued through the next day though no more vomiting. After consulting with doctors office approximately 20 hours post vaccination, took 1 dose of tylenol (500mg x2) to help with headache. Tylenol dulled headache but did not eliminate. Nausea continued throughout day. Approximately 48 hours post vaccination nausea ceased and headache was mostly gone.
Received 1st AVA 9 May 1998 then 3 days later developed a rash on his feet, ankles and legs. The rash started as red, then small blisters appeared with clear fluid which would burst with contact or irritation, and then the lesions dried and cleared. He stated that the rash was also associated with itching. He denied any new food, or other materials. He denied any other symptoms and stated that the rash looked like poison ivy. This rash lasted 1 wk and then it would clear. He had no rash when he went for his second AVA on 22 May 98 and stated that within 3-4 days he broke out again with the identical rash and this rash lasted approx 1 wk and was clear by the time of this third AVA on 5 Jun 98. He reported the rash to the medic and they told him that it was normal and then gave him the shot. Within 3-4 days he broke out again with the same type of rash. He stated that with subsequent AVA the rash would longer and he would have recurrent outbreaks between the shots. He has had a total of AVA X 8 and reported that with each shot the rash hot worse. He denies any problems with the injection site other than a little redness and slight swelling. He denied fever, chills or aches with his shots and stated the swelling was minimal, smaller than golf ball. Today he continues to experience intermitted flares and clearing. His current flare has persisted for past 6 months, with longest episode lasting 8 months and his longest rash free period being close to one month. In addition to his lower extremities he now has lesions on his lower back, across shoulder blades and middle of chest. He also gets lesions on his arms. He reports that although he spent hours in the sun as a life guard during his teens, he currently cannot spend more than 30 min in the sum without worsening of his rash. He stated that he can only wear 100% cotton uniforms and bedding. He does not use the drycleaners and notices worsening during PT. Has seen a civilian dermatologist and per Dr. he has chronic contact dermatitis and polymorphic light eruption. Lesions, Vesicle Start: 05/1998
10/25/12 Symptoms began as lightheaded feeling that progressed to dizziness and H.A. Fever and fatigue began the next day along with swelling of face and eyelids, tingling and numbness of lips, and metallic taste in mouth. No resp. distress, tx with MOTRIN, rest and cool compress to face. Symptoms lasted for approximately 3 days.
WORKER STATED SHE STARTED ITCHING IN THE SHOWER AND NOTICED SMALL PINK DOTS ON HER CHEST, UPPER BACK, AND ARMS. AS THE DAY PROGRESSED, THE RASH SPREAD TO HER ENTIRE BODY. THE FOLLOWING DAY SHE STATED THAT SHE DEVELOPED FLU LIKE FATIGUE AND JUST DIDN'T FEEL WELL. THIS REPORT WAS FILED ON DAY 2.
PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 17 year old of unspecified sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced product administered to patient of inappropriate age, and off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the product administered to patient of inappropriate age and off label use was not reported. This report was non-serious.
rt gluteal area 10cm x 6cm local rxn of erythema, edema, heat;
On January 20th, after 8 days site of injection was swelled the size of an orange, red and itching.  This lasted  about 4 days.  I used Cortizone cream and took Benedryl.    Five days later my wife had a reaction in her arm, but it did  not swell , only got pink the size of an  lemon.    I only wanted to know if this was just a delayed reaction when I called your number, but was informed I needed to fill this form out & call my doctor.  I never felt bad at any time.
Within 5 minutes of receiving the vaccine I started to experience hot and cold sensations throughout my body, it continued for about 20 minutes and then it subsided.  I was due to start menstruating the day I received the vaccine but it did not come. My cycle has been very regular and my period always comes on time but it still hasn?t come. I have all my typical PMS symptoms and multiple negative pregnancy tests.
Pt recvd vax 20AUG92 & w/in 12 hrs of vax exp an inject site react which included a large red bump, swelling & soreness; 21AUG sx improving;
blood pressure went up; cannot focus; crazy dreams; talking to people out loud when dreaming; headache all the time; knee aches started again continuous; back ache started again continuous; hard to focus due to his pain; cannot do his job due to unable to focus; vaccine give in his right arm has affected the actual act of writing; light sensitive feels like a migraine in whole body; after second dose joint pain still contiinuing; tired from pain; Slept 17 hours yesterday; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (after second dose joint pain still contiinuing), PAIN (tired from pain), SOMNOLENCE (Slept 17 hours yesterday), BLOOD PRESSURE INCREASED (blood pressure went up) and FEELING ABNORMAL (cannot focus) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011L20A and 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Diabetes, Overweight, Osteoarthritis (Knee, hip and back problems) and Hypertension.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Apr-2021, the patient experienced SOMNOLENCE (Slept 17 hours yesterday). On an unknown date, the patient experienced ARTHRALGIA (after second dose joint pain still contiinuing), PAIN (tired from pain), BLOOD PRESSURE INCREASED (blood pressure went up), FEELING ABNORMAL (cannot focus), ABNORMAL DREAMS (crazy dreams), SLEEP TALKING (talking to people out loud when dreaming), HEADACHE (headache all the time), ARTHRALGIA (knee aches started again continuous), BACK PAIN (back ache started again continuous), DISTURBANCE IN ATTENTION (hard to focus due to his pain), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (cannot do his job due to unable to focus), PAIN IN EXTREMITY (vaccine give in his right arm has affected the actual act of writing) and FEELING ABNORMAL (light sensitive feels like a migraine in whole body). At the time of the report, ARTHRALGIA (after second dose joint pain still contiinuing), PAIN (tired from pain), SOMNOLENCE (Slept 17 hours yesterday), BLOOD PRESSURE INCREASED (blood pressure went up), FEELING ABNORMAL (cannot focus), ABNORMAL DREAMS (crazy dreams), SLEEP TALKING (talking to people out loud when dreaming), HEADACHE (headache all the time), ARTHRALGIA (knee aches started again continuous), BACK PAIN (back ache started again continuous), DISTURBANCE IN ATTENTION (hard to focus due to his pain), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (cannot do his job due to unable to focus), PAIN IN EXTREMITY (vaccine give in his right arm has affected the actual act of writing) and FEELING ABNORMAL (light sensitive feels like a migraine in whole body) outcome was unknown.
Hives within secondary of vaccine. No SOB. Hives resolved with Benadryl PO-prn.
I started with low grade temp and fever 7 hrs after, then at 4 the next day I had a backache which began in my lower back and began moving up, and symptoms of a uti despite taking motrin and Tylenol. I had pressure in my lower region, pain and especially during urinating, and chills, with a temp in the evening. I called my dr the next day because I was feeling worse and the motrin and Tylenol weren't helping. I was prescribed ciproflxacin 250 mg and phenazopyridine 100 MG. Yesterday after 4 days on meds, I'm feeling better.
Narrative: 98yo male patient with CAD s/p CABG, CVA with left-sided weakness, expressive aphasia and seizure s/p recent hospitalization AKI and Staph Epidermis bacteremia with likely source Endocarditis +/- pacemaker lead infection. Died while in hospice, no additional report to cause of death. Patient received one dose of the covid vaccine over two weeks prior to passing.
Itchy, burning sensation in throat dizzy, 2 hrs after getting H1N1 shot. Pt has to go to emergency room for swelling.
This spontaneous report was received from a pharmacist and refers a 64 year old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, drug allergies or reactions and concomitant medication were not reported. It was stated that the pharmacy received the ZOSTAVAX on 15-JUL-2016. On 16-OCT-2016, the patient was vaccinated with an improperly stored dose of ZOSTAVAX 19400 plaque-forming unit (PFU) injection, subcutaneously, 0.65 ml, lot # M014310, expiry date 26-MAY-2017 (anatomical location was not specified) for prophylaxis. On 22-MAR-2017, the pharmacy was audited by The Board of Pharmacy. The freezer temperature where ZOSTAVAX was stored was registered by the pharmacy thermometer as 2 Fahrenheit degrees, however the auditor's thermometer registered the temperature as 9 Fahrenheit degrees which was considered as a temperature excursion. The Board of Pharmacy auditor determined that the pharmacy's freezer thermometer should have been calibrated. Seven of the 10 doses of ZOSTAVAX that had undergone the temperature excursion had been administered to 7 patients between July 2016 and January 2017 (also reported as "over an 11 months period"). The remaining 3 doses were sent back for disposal. There was no previous temperature excursion. No adverse effect were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information is not expected as all follow up information has been received.; Sender's Comments: US-009507513-1703USA010654: US-009507513-1705USA006383: US-009507513-1705USA006384: US-009507513-1705USA006385: US-009507513-1705USA006380: US-009507513-1705USA006381:
feels like a train ran over me; This case was reported by a consumer via  interactive digital media and described the occurrence of general body pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of no adverse event (received 1st dose on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced general body pain. On an unknown date, the outcome of the general body pain was unknown.   It was unknown if the reporter considered the general body pain to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient got 2nd shot and felt like train ran over him/her.
This case was reported by a physician via call center representative and described the occurrence of injection site reaction in a patient who received FLUARIX QUADRIVALENT. On an unknown date, the patient received FLUARIX QUADRIVALENT at an unknown dose. On an unknown date, less than a year after receiving FLUARIX QUADRIVALENT, the patient experienced injection site reaction. On an unknown date, the outcome of the injection site reaction was unknown. It was unknown if the reporter considered the injection site reaction to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The age at vaccination was not reported. The healthcare professional called to see if there was any difference between FLUARIX QUADRIVALENT 2015/2016 and 2016/2017 season vaccines. The healthcare professional stated his hospital staffs were saying they were seeing more local reactions from last year. The healthcare professional stated he did not want to forward that information because the information was third hand information. No product or patient information was provided.
A spontaneous, non-serious report of a cut on finger when the sprayer broke during administration of FLUMIST, concerning a 43-year-old male patient. Medical history and concomitant medications were not reported. The reporting nurse did not receive FLUMIST. On 27-Oct-2010, the patient sustained a laceration injury to his index finger when the glass flange of the base of the barrel snapped after fully depressing the plunger while administering the second half of the FLUMIST vaccine. The laceration needed to be sutured; however, he was working in a remote village so the cut was closed with medical "super glue". On 05-Nov-2010, the laceration had healed. The event resolved on 05-Nov-2010.
PATIENT CAME TO PHARMACY AND REPORTED EXPERIENCING EXTREME ARM PAIN AFTER GETTING SHINGRIX INJECTION ON 3/13/2019 FOR ABOUT 3 DAYS. SHE SAID SHE HAS CONTINUED TO HAVE TROUBLE LIFTING ARM AND HAS CONTINUED TO HAVE SHOOTING PAINS IN SHOULDER, ABOUT INJECTION SITE AND UNDER ARM FOR APPROXIMATELY 6 WEEKS. THERE WAS NO VISUAL REDNESS, SWELLING OR WARMTH TO TOUCH ABOUT THE INJECTION SITE. THE PATIENT REPORTED USING A SLING AT TIMES AND TROUBLE SLEEPING WITH THE PAIN THE PATIENT REPORTED USING IBUPROFEN AND HOT AND COLD PACKS. WE RECOMMENDED THAT THE PATIENT SEE A HEALTH CARE PROVIDER FOR FOLLOW UP AND RECOMMENDED OTC ACETAMINOPHEN AND LIDOCAINE PRODUCTS TO ASSIST WITH PAIN MANAGEMENT. WE ASKED THE PATIENT TO CONTACT THE PHARMACY FOR FOLLOW UP AFTER SEEING HER HEATHCARE PROVIDER
Headache, Myalgia, Fever, Rash & UrticariaPruritus Narrative:
The  expired vaccine from the day before was mixed with non expired vaccine mixed that day.  We are unsure if patient received expired vaccine
pt developed a rash on left arm almost immediately after vaccine was administer/   gave pt a 50mg dose of benadryl and  rash almost immediately disappeared
pain behind her right knee and the rest of the leg; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (pain behind her right knee and the rest of the leg) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced PAIN IN EXTREMITY (pain behind her right knee and the rest of the leg). On 17-Feb-2021, PAIN IN EXTREMITY (pain behind her right knee and the rest of the leg) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Reaction (L) deltoid to Tdap about 5 cm swelling, redness, induration. Firm and tenderness c/o itchy.
Patient had received DTaP on right deltoid on 07/01/2003.  Patient had 9 x 9 cm red, raised area on right deltoid.  Prescribed keflex (250m/5cc) 1 tsp per mouth every ibx 10 days.
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 68 years old male patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.  In 2012, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a physician for shingles. The outcome of the events shingles was not reported. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).   Additional information has been requested.
Dose was mixed at 1030 am with an expiration of 430pm. The dose of vaccine was given to the patient at 530 pm
This case was reported by a physician via sales rep and described the occurrence of nausea in a female patient who received BEXSERO. On 7th June 2016, the patient received BEXSERO (intramuscular). On 7th June 2016, less than an hour after receiving BEXSERO, the patient experienced nausea (serious criteria other: serious as per reporter) and diarrhea. In June 2016, the outcome of the nausea and diarrhea were recovered/resolved. The reporter considered the nausea and diarrhea to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. Within one hour after receiving BEXSERO, the patient required emergency room (ER) visit for nausea and diarrhea.
45 Minutes after shot=dizzy, drowsy, painful arm. Day after shot=no ADR. 1 week after shot=painful arm. Today=no ADR
Vaccination LUE with YF Vax 2:30pm 6/15/09 after screening. At approx. 2:35 pt c/o redness, swelling and itching at injection site- 25 mg BENADRYL po. given with 8-12 ounces of H2O. At 2:45 while under observation pt c/o chills, shaky and weakness- 911 called, squad transported to hospital where she was treated and released.
Felt nauseous within 5 minutes after receiving Moderna vaccine. Patient started feeling better after drinking some cold water and was stable approximately 10 minutes after. Patient was under pharmacist's observation for 30 minutes.
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended and/or prescribed the ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In November 2016, a pharmacist administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). In December 2016, the patient was treated by a healthcare provider for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of his injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Took second shot at 10 am at 3pm I started feeling a bad headache. Then at 4am the next day I started feeling nauseous lasted until 2pm then I started to feel body aches on hands and feet, fever, chills, and headache. The next day Saturday  morning woke up feeling nothing.
Pt vaccinated with Influenza rash on chest, SOB, fever 100.6F, swelling of rt shoulder and rt knee to calf, 1 day diarrhea.