chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient came in today stating that he received a flu shot a few days ago and has had a red and swollen arm with the swelling and redness spreading down to his elbow, the symptoms started yesterday. He pointed to a spot on his arm that he states he received the vaccination in. It seemed a little lower than usual (but seemed to be near the tail end of the deltoid muscle). I advised him to take a picture of the swollen arm and send it to his MD. I advised him to apply hydrocortisone and ice as needed and to take tylenol for pain as he can not take NSAIDS due to other meds. I told him I would check in on him in the evening. I spoke with the administering Pharmacist who stated she always gives in the upper arm.
This spontaneous report has been received from a pharmacist referring to a currently 21 year old female patient. The patient's medical history, drug reactions, allergies, concurrent conditions and concomitant therapies were unknown by the reporter. On an unknown date, the patient was vaccinated with a dose of M-M-R II, (dose, frequency, route of administration, lot#, and indication were unknown by the reporter) for prophylaxis. On an unspecified date, after the vaccination, the patient had MMR titers drawn which showed no seroconversion after vaccination. It was unknown by the reporter if the patient received treatment, sought medical attention or required hospitalization. A product quality complaint was not involved. At the time of reporting, the outcome of events were unknown. The relatedness between adverse events and M-M-R II, was not reported. Additional information has been requested.
On day 1 post-vaccine, patient called the office complaining of swelling from his shoulder to his elbow and pain that's limiting this range of motion in his right arm where the Pneumovax vaccine was given. He took acetaminophen, which only provided relief for about an hour. He reported a fever through the night of 104 F and took ibuprofen, which he states did not help with his pain. At the time he called the office, he checked his temperature, and he was afebrile. Patient was advised to continue to alternate acetaminophen and ibuprofen every 4 hours for pain management and encouraged to keep his arm moving.   On day 3 post-vaccine, patient said his swelling has gone down some and his pain is less compared to the day before. He agreed that it seemed to be doing better except he developed a red rash between his should and the crease of his elbow. Patient was advised to continue with the same treatment plan and allow more time for resolution of his symptoms.
Menstrual cycle is only 2 days long and heavy,my normal menstrual cycle is normally 7 days long and heavy,its a good adverse affect,I just wanted to make you aware because other women are having changes in menstruation as well,and there seems to be a correlation between the vaccine and menstrual cycle changes
Was afflicted with Severe poison Ivy on back of left leg from below glute down to mid calf. I had numerous smaller and less severe patches. Before getting the covid shot, I had had poision ivy for about 10 days. On the second day after receiving second shot of pfizer, I had a secondary rash occur that surrounded the poison ivy rash. There was a noticeable difference in that the covid rash appeared to come from within the body rather than the poison ivy rash that looked and felt as a more external rash.   The symptoms aside from additional rash was when I would move around and generated any type of body heat the "covid rash" would begin to severely itch and irritate. Additionally, If I would go for walks, the area on my leg that still had the poison ivy rash along with the covid rash would not only itch but burn. It created the sensation that a lighter was being held to my skin. It was quite painful.  The other small areas that had the mix of poison ivy and covid rash were not as painful when I was moving around/ walking like the bigger afflicted area.
Initial misuse report received from a healthcare professional on 05 FEBRUARY 2014. A 2-year-old patient (gender was not reported) had received fifth dose of ADACEL on an unspecified date. No adverse event was reported. Documents held by sender: none
Vaccine expired on 13-Oct-2021 and then stored in refrigerator on 29-Oct-2021; expired dose was given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired dose was given after expiration date) and PRODUCT STORAGE ERROR (Vaccine expired on 13-Oct-2021 and then stored in refrigerator on 29-Oct-2021) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired dose was given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 13-Oct-2021 and then stored in refrigerator on 29-Oct-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired dose was given after expiration date) and PRODUCT STORAGE ERROR (Vaccine expired on 13-Oct-2021 and then stored in refrigerator on 29-Oct-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment information was provided. The patient received the booster dose of the vaccine. No adverse event was reported. The vial had not undergone any temperature excursion issue. The vial was initially placed in the refrigerator on 29-Oct-2021. Many doses were administered from expired lots due to confusion with the expiration date printed in the carton.
Received VARIVAX #2 to Rt posterior upper arm on 10/21/11. Started having redness, swelling, pain on 10/23/11. In treatment for cellulitis with KEFLEX 500 TID x10 days (started 10/24/11).
Rebound covid infection 07Jul2022, cold like symptoms. Positive covid home test on 09Jul2022, negative test on 13Jul2022.; Rebound covid infection 07Jul2022, cold like symptoms. Positive covid home test on 09Jul2022, negative test on 13Jul2022.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76-year-old male patient received BNT162b2 (BNT162B2), in Jan2021 as dose 1, single (Lot number: EL3249), in left arm, in Feb2021 as dose 2, single (Lot number: EL9265), in left arm and in Sep2021 as dose 3 (booster), single (Lot number: 301358A) at the age of 75 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "overweight" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 07Jul2022, outcome "recovering" and all described as "Rebound covid infection 07Jul2022, cold like symptoms. Positive covid home test on 09Jul2022, negative test on 13Jul2022.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (09Jul2022) Positive; (13Jul2022) Negative. Therapeutic measures were not taken as a result of drug ineffective, covid-19.  Clinical course: Paxlovid treatment started from 27Jun2022 to 02Jul2022 as covid-19 treatment, lot number GE1498. It was reported that the patient previously receive a COVID-19 Vaccine. No known allergies.  No follow-up attempts are possible. No further information is expected.
Used unapproved diluent (sterile water); Used unapproved diluent (sterile water); This case was reported by a physician and described the occurrence of wrong solution used in drug reconstitution in an unspecified number of patients who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patients received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 12-Jan-2023  Reporter's Comments: This report was submitted via the online direct entry reporting system GSK employee reporting ref.  Please process using the related SOP.  Initially the reporter consent to contact given. The physician consent to contact. There was no reporter seriousness for used unapproved diluent (sterile water) and administered only the lyophilized A vial and did not reconstitute with CWY vial or ad-minister CWY. Not Serious Menveo manufacturer unspecified expiry date of Menveo was unknown  The additional context of Menveo which dose of the vaccine was this. I reporter did not know (used unapproved diluent (sterile water) and administered only the lyophilized A vial and did not reconstitute with CWY vial or administer CWY. The reporter was asking for any additional information about the adverse event. The provider who reached out to me stated that this happened with more than one patient.  A nurse had been accidentally reconstituting the lyophilized vial that contains sero-type A with sterile water and only administering that portion of Menveo.  The second liquid/CWY vial was not administered.  No harm to the patient but patients would need revaccinated patient's age. The age group was not related to an existing case. Additional supportive information: Menveo reconstituted with sterile water and administered only the lyophilized A vial and did not reconstitute with CWY vial or administer CWY, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.; Sender's Comments:  US-GSK-US2023004489:Same reporter
Red rash on (L) arm 24 hrs after injection 14 x 6 cm distal to TDAP.
Flu vac given at 11:15 AM. Pt stated since 12 PM she had numbness and tingling on Rt hand fingers, tongue and lips. Came to med room at 1:35 and stated she is feeling worse. BP 150/78 Puls 94 Puls ox 100%. Dr in attendance BENADRYL 50 mg I/M Rt deltoid 1:45 PM. She is being monitored by RN 2:30 PM BP 142/77 Puls 82 Puls ox 100% states she is feeling better.
Approximately 10 days post vax the pt developed a fever and fussiness, then experienced a red macular-papular rash, blanching, trunk and neck extremities. Possibly be roseola.
patient received expired dose of MENACTRA/ NO AE; Initial information regarding an unsolicited valid serious case was received from a Nurse via Medical Information (Reference number- 00580513) and transmitted to Sanofi on 28-Apr-2021.  This case involves a 11-years-old female patient to whom medical assistant from the office gave 0.5 mL first dose MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (batch number: U6585AB and expiry date: 11-Apr-2021 via intramuscular route in gluteus maximus) (expired product administered) on 27-Apr-2021 for prophylactic vaccination.  The patient's past medical history, medical treatment, vaccination, concomitant medication and family history were not provided.  Concomitant medications included HPV VACCINE VLP RL1 4V (YEAST) (GARDASIL) and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (TDAP) for prophylactic vaccination.  It was an actual medication error case due to expired vaccine used (latency: same day).  No adverse events or symptoms reported, she was fine, after 15 minutes.  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 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.
This spontaneous report was received from a Registered Nurse concerning a patient of unknown age and gender. On 09-OCT-2013, the patient was inadvertently vaccinated with an intramuscularly 0.5 ml dose of PNEUMOVAX23 (route and dose not reported) (Lot # 671680/1489AA) that had expired on 12-MAY-2013. No adverse effects reported. this is one of five reports concerning the same source. Additional information has been requested.
No additional ae reported; undergone temperature excursion; This spontaneous report was received from a registered nurse referring to a 15 year old female patient. The patient's pertinent medical history, concurrent conditions, previous drug allergies or reactions, and concomitant medications were not reported.  On 02-FEB-2022, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) for prophylaxis (lot# U008180 with an expiration date on 12-MAR-2023)(strength, dose, anatomical location, and route of administration were not reported) that had undergone temperature excursion (product storage error).         No additional adverse events were reported.
Body aches Hives on arms, chest, neck Chills Low grade fever Nausea
9 pt recv vax & 7 had no detectable humoral response, while the remaining two pt produced low titers (1.2 and 1.8) of the two patients over age 13 both had low titers (1.2 and 1.8) p/vax of 2 doses;
My son received 4 vaccines 3-6-13. He received 2 vaccines in his (R) thigh. Later, within weeks, his right thigh swelled up so much, it looked like there was a golf ball under the skin. Red, swollen and very tender. I took him in to see the doctor said he has rarely seen this. The Dr. was going to lance it later when it would come to a head, but it never did. Within time, it just became "spongy" and absorbed from the inside, and went away.
Patient received Moderna Covid 19 vaccine on 02/04/21. Patient reported experiencing twitching in right eye the night of 02/04. Patient had swollen face and little difficulty in swallowing upon awakening today (02/05/21). MD treated patient with steroid injection and Benadryl and recommended not to get second dose.
7 hours of shot was given throat felt closing sore, hurting. Multiple symptoms headache back of neck hurting, left arm was hurting and burning w/bruising. Had an upset stomach, severe shakes, with fever, painful joints. Both eyes became blood shot red, they were hard and dry (white of eyes).
his son developing transient synovitis-fluid on left hip joint 3 inches from his injection site, which was still red and swollen- after the second dose of the varicella vaccine; This spontaneous report was received from the patient's father and refers to a 5 year old male patient. No information about the patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions or allergies was provided.  On an unknown date, the patient was vaccinated with the second dose of varicella virus vaccine live (oka/merck) (VARIVAX), reported as "the varicella vaccine from Merck," for prophylaxis (strength, dose, route of administration, frequency, lot/batch # and expiration date were not reported).      The reporter referred his concern due to his son developing transient synovitis-fluid on left hip joint 3 inches from his injection site, which was still red and swollen- after the second dose of the varicella virus vaccine live (oka/merck) (VARIVAX) when he was 5 years old.     The outcome of synovitis was unknown.        The causal relationship between the event and varicella virus vaccine live (oka/merck) (VARIVAX) was not provided.
Vaccine administered 10/25/03 L deltoid region arm. No symptoms x 1 month, approx. 2 weeks from 12/26/03 noticed a somewhat painful no palpation 3/4cms cystic area at vaccination site. No fever. No redness. No neurologic symptoms. Skin normal appearance. Plan is to observe to ER if it appears or needs incision.
Aches: joints and muscles, Aches: whole body, Agitation, Nocturnal myoclonus, Mood: anxiety, High cholesterol, Concentration trouble, respiratory rpoblems, etc.  12/8/06 Received medical records from MC which reveal patient with marital disagreements & seeking divorce since increased irritability upon returning from deployment.  Patient gained 40 lbs since return in 2004 from 1 year deployment. Additional medical problems listed as peptic ulcer dx, sleep apnea, obesity, disc disease, hypercholestreolemia, non allergic rhinitis & sinusitis, elevated LFTs dermatophytosis of nail & costochondritis.  Left hand & elbow surgery in 2001.  Patient being treated by private psychiatrist for depression, violence & PTSD.
Sore throat, swelling,  redness, tingling, burning, rash x1 week post vaccine
shortness of breath; asthma; This is a spontaneous report from a contactable other HCP. This 32-year-old female other HCP (patient) reported for herself that she received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number, Expiry Date: not reported), via an unspecified route of administration, administered in right arm on 31Oct2021 at 11:15 (at the age of 32 years) as dose 1, single for covid-19 immunisation. Patient's was not pregnant at the time of vaccination. Medical history included known allergies. Patient had other medications in two weeks. Patient had other vaccine in four weeks. Concomitant medication(s) included influenza vaccine (Influenza Quadrivalent Preservative Free) via intramuscular (IM) at left arm taken for an unspecified indication from 29Oct2021 at 12:00 PM. No covid prior and post vaccination. The patient experienced shortness of breath with asthma on 31Oct2021 at 12:00. Shortness of breath-trigger asthma reaction which was not resolving. AE resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The seriousness of events was non-serious. Therapeutic measures were taken as a result of events included Ventokin HFA inhaler prescriber. The outcome of events was not recovered.  The lot number for the vaccine, [bnt162b2], was not provided and will be requested during follow up.
On my arm I would touch my arm and it was itching and red and swelling, the more I scratched the worst it got. I seen my provider and she had me try Claritin and Alegra and did not work. Then they put me on Prednisone, and it did help with symptoms. My next appointment will be for medication Xolair injection is going to be my next treatment.
feeling fatigue; dry mouth; dry mouth and throat.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 74 year-old female patient received bnt162b2 (BNT162B2), administration date 05May2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "seasonal allergies" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1), for COVID-19 Immunization. The following information was reported: FATIGUE (non-serious) with onset 07May2021, outcome "unknown", described as "feeling fatigue"; DRY MOUTH (non-serious) with onset 07May2021, outcome "unknown", described as "dry mouth"; DRY THROAT (non-serious) with onset 07May2021, outcome "unknown", described as "dry mouth and throat.".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Started with injection site Hurting, Developed tiredness, light headache, hurting all over, had chills for 3 nights fever range from 100 degrees up to 103.8, had nauseau and vomited one day, my face- looked a little swollen and cheeks were pink, was in bed mostly for 13 days.  Called My Doctor after about 4 days , he prescribed MethyIIPredisolone 4 mg tablets, seems to bring fever down and stop chills, still feeling really bad, went to Urgent Care and they did Covid Test which was Negative, had virtual call with their doctor , and they prescribed a "Z Pak"  Did not stated feeling better until 13 day.  When taking Predisone, I started having chest pains, when I only had 4 more pills to take.  Had to take 2 Nitro and discontinued Predisone. Still weak and tired.
patient received booster dose of Pfizer around 6:50PM.  Around 7:00PM he starting having chest pain and nausea. This dissipated a few minutes later. EMS was called.
Tinnitus, continues to this day. Had to see my physician to get an appointment with Audiologist. Had appointment yesterday and he told me to report this to the CDC.  Next appointment is in February 2022 and will test hearing.
Raised rash around injection site and across hips at lower back.  Not red, no swelling, nor itching other than the skin stretched over the raised area. Came on within 4 days of vaccine.  Never have had this symptom before.  Only telling CDC for info gathering.  No real issue.
Had rash on left arm, she had FLUVIRIN and PNEUMOVAX both on left arm. PNEUMOVAX was first time. Rash was noticed after 72 hours, resolved by BENADRYL.
Break through menstruation bleeding and cramping.  I have been Port-Menopausal for 11 years!
quite itchy and just on the site of the injection; started to have itchiness on different parts of her body, like her toe, waist, stomach; headache; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (started to have itchiness on different parts of her body, like her toe, waist, stomach), INJECTION SITE PRURITUS (quite itchy and just on the site of the injection), HEADACHE (headache) and FATIGUE (fatigue) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     The patient's past medical history included Open heart surgery (5 years ago). Concurrent medical conditions included Drug allergy (once in last 10 years and patient required an injection from her allergist and one 25 years ago.). Concomitant products included AMLODIPINE and METOPROLOL for an unknown indication.   On 03-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced HEADACHE (headache) and FATIGUE (fatigue). On 05-Mar-2021, the patient experienced PRURITUS (started to have itchiness on different parts of her body, like her toe, waist, stomach). On 08-Mar-2021, the patient experienced INJECTION SITE PRURITUS (quite itchy and just on the site of the injection). On 07-Mar-2021, PRURITUS (started to have itchiness on different parts of her body, like her toe, waist, stomach) had resolved. At the time of the report, INJECTION SITE PRURITUS (quite itchy and just on the site of the injection), HEADACHE (headache) and FATIGUE (fatigue) had resolved.            Concomitant medication included heart medication Treatment for the events, included ice. Action taken with mRNA-1273 in response to events was not applicable.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Additional information received captured event outcome.
Tingling and numbing around neck throat and under jaw. Breathing and swallowing were not affected but Benadryl was given multiple times. Sensation did not go away and steroid shot, steroid pills, and allergy medication were given. Sensation still comes back in intervals.
Pt received HPV 9 vaccine at 3:20 pm. pt began to feel shaky in arms and legs, weak and faint. Pt BP 80/52 did not lose consciousness. Recovered and BP WNL after lying down, juice and crackers.Pt received HPV 9 vaccine at 3:20 pm. pt began to feel shaky in arms and legs, weak and faint. Pt BP 80/52 did not lose consciousness. Recovered and BP WNL after lying down, juice and crackers.