chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Painful eyes; golf ball sized lump under injection site with swelling and itchiness; golf ball sized lump under injection site with swelling and itchiness; golf ball sized lump under injection site with swelling and itchiness; This is a spontaneous report from a contactable consumer (patient). A 23-year-old female non-pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number and expiration date was not reported), via an unspecified route of administration in left arm on 05Sep2021 14:30 as dose 1, single for COVID-19 immunization (at the age of 23-year-old, non-pregnant). The most recent COVID-19 vaccine was administered at Pharmacy or Drug Store. Medical history included depression and anxiety, known allergies to Penicillin, black beans, agave, everything bagel seasoning and patient had covid prior vaccination from an unknown date and unknown if ongoing. Covid was not tested post vaccination. Concomitant medication(s) (within 2 weeks of vaccination) included sertraline hydrochloride (ZOLOFT). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced painful eyes, golf ball sized lump under injection site with swelling and itchiness on 05Sep2021 15:45. Reported seriousness for the events was non-serious. The patient did not receive treatment for the event. The outcome of the events was not recovered.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Information has been received from a physician a female patient who was vaccinated IM with a first dose of GARDASIL. Subsequently the patient fainted. The patient recovered. Patient received her second injection on an unknown day and had no complications. Additional information has been requested.
A nurse called stating that a patient received an extra dose of VARIVAX. No additional AE's and no PQC's were reported.; A nurse called stating that a patient received an extra dose of VARIVAX. No additional AE's and no PQC's were reported.; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 22-SEP-2022, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, quantity: 1, use as directed to prevent varicella infection, administered for prophylaxis (dose, anatomical location, and route of administration were not provided), lot# U010744 is not valid for varicella virus vaccine live (oka/merck) (VARIVAX), expiration date reported as: 03-OCT-2022. The reporter stated that the patient received an extra dose of varicella virus vaccine live (oka/merck) (VARIVAX) (extra dose administered).  There were no adverse events reported (no adverse event).
81 YOM with hx of RA, PUD and HLD presents to GVH ED with 3 days of LUQ abdominal pain. He states pain stared after he received his 2nd mederma covid vaccination. He stats 1-2 days after 2nd shot on 1/28 he had expected fever and chills but then developed LUQ pain worse with inspiration. Pain is minimal at rest and no other associated sx, denies CP, SOB (only hurts with deep breath) adn no N/V.   CT abd/pel with contrast showed multiple peripheral wedge-shaped hypoenhancing dense regions consistent with splenic infarcts . Pt was placed in observation for starting AC and monitoring on tele.
Information has been received from a physician concerning an approximately 2 month old patient who was vaccinated po with a first dose of Rotateq. Subsequently the patient developed rotavirus and was admitted to the hospital. The patient was still in the hospital and it was unknown for how long . Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
Small somewhat superficial  slightly less than quarter sized palpable firm tissue overlying the right deltoid at the site of vaccine injection.  No erythema, no tenderness, no swelling. Improving but not fully recovered yet.
Blisters / appeared near the injection site on her upper left arm / Still has a few on her stomach today / "chicken-poc" like blisters appear each day; Blisters that scab over; This case was reported by a consumer via call center representative and described the occurrence of blister in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th February 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 1st March 2021, 2 days after receiving Shingrix, the patient experienced blister and scab. On 8th March 2021, the outcome of the scab was recovered/resolved. On an unknown date, the outcome of the blister was not recovered/not resolved.   It was unknown if the reporter considered the blister and scab to be related to Shingrix.  Additional information provided as follows: Several days later vaccination, patient developed blisters that scab over appeared near the injection site on her upper left arm. The patient still had a few on her stomach on day of reporting. A few chickenpox like blisters appeared each day and scab over. The reporter consented to follow up.
Extremely irritable the evening and following day of vaccines; seemed to improve 2 days after receiving vaccines.
Presented w/ weakness and diarrhea, lethargy. Tested Codvid
Myself and husband came down with flu after 6 yr old twins got H1N1 Flumist (48 hr after). He tested positive for Influenza A and H1N1 is being sent off.
Pt describes a "tire track" mark appx 2-3 inches wide across upper arm, not itchy, red or swollen. Pt states that the appearance looked "blotchy".
Subsequent to receiving one dose of varicella virus vaccine live the pt experienced a rash on the upper shoulder area with no vesicular outbreak. No further information is available.
RASH ALL OVER HEAD, FACE AND NECK - PRICKLY, PIMPLY LIKE RASH WITH WHITE HEADS - VERY ITCHY
Information has been received from a lawyer regarding a case in litigation concerning a female 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 vaccine to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On 10-MAY-2013, a healthcare provider at a pharmacy administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On 21-FEB-2014 and 18-APR-2016, the patient was treated by healthcare providers for shingles and herpes zoster keratitis, respectively. 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 the patient's 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 (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Upon internal review, herpes zoster keratitis was determined to be medically significant. Additional information has been requested.
Rash boils hives on neck chest arms belt line genitals legs buttocks started 3-4 days after 1st Modern?s shot
3-23-21 1PM PT STATES RT DELTOID IS PAINFUL X 2-3 DAYS - PAIN RELIEVED WITH ADVIL; 'NOT AS PAINFUL TODAY'. GOOD MOTOR, NEURO AND SENSORY NOTED. GOOD CAP REFILL.  NO ACUTE DISTRESS. 3-24-21 9AM : PT STATES RT DELTIOD 'FEELS BETTER TODAY-STILL A LITTLE SORE'. DENIES ANY TROUBLE MOVING ARM.
Pt returned to vaccine site today on 4/16/2021 for her second dose but wanted to speak with a provider prior to her second dose. Pt reports after her first dose of Moderna on 3/16/21 she went home after waiting for 30 minutes and noticed red lines by her nose when she got into her car but thought it was nothing and did not mention it to any staff members/providers. Per the patient, went to bed that night and her throat got tight and her tongue swelled up so she called her PCP and he advised her to take 'medication' and she said symptoms improved. Pt notes for a few days she had to take these 'medications' because her throat was still a bit tight. Pt denies ever going to the ER. Pt reports symptoms have resolved completely.   *I did not vaccinate this patient. This pt did not report any reactions while being monitored for 30 minutes by a provider on 3/16/21.   I am currently seeing regular office visits today and the patient asked to speak with a provider prior to her second dose she was scheduled to come have done today. This patient is brand new to me and new to clinic and has has never been seen before aside from getting her first Moderna vaccine here. I advised she cannot get her second dose of Moderna and she agreed. I also advised that she report the adverse reaction herself and she agreed. STRICT ER precautions were advised and pt was recommended to follow up with her PCP.  Pt verbalized understanding and agreed and her second dose of her Moderna COVID vaccine was cancelled and I wrote on her vaccine card she cannot receive her second dose due to anaphylaxis.
Headache, Myalgia, right axilla tender mass (adenopathy); bruising Narrative: 1/19 received 2nd vaccine 1/20 - onset of headache, myalgias. Slept for 2 hours and all symptoms resolved around 1830 1/21 - noticed tennis ball sized tender mass in the right axilla. pain is mild. No other symptoms. 1/25 - reports complete resolution of the swelling in both axillae. Over the weekend he developed cramping in both calves and anterior shin pain. On his right shin he noticed a large painful red area. It has improved over the 3 days. E -right anterior mid shin with 10 cm dark red macule. No other skin lesions noted. He was seen in employee health and evaluated for possible coagulopathy with PT/PTT/INR all of which were normal. CBC (including platelet count) and comprehensive metabolic panel were also normal.
Patient came into Health Department reporting redness, itching, and bruising to right arm that started the evening after receiving PREVNAR 13 on 10-30-15. She stated she was unable to raise her arm above her head the evening of 10-30-15 but has since had no trouble with range of motion. She had a bruise approximately 2 cm in diameter at injection site with redness and hardness extending to the elbow. She stated it was itching. No warmth or drainage noted. She reported this on 11-3-15. Since client has stated the redness has gone down and is doing better.
This spontaneous report as received from a nurse refers to a patient of unknown age. On 29-MAY-2013 the patient was vaccinated with an expired dose of GARDASIL lot # 668261/1397AA, expiry date 09-APR-2013. Dosing information and route of administration were not provided. No symptoms were reported. Additional information has been requested.
I received the shot at 11:30 am and at 4:30 pm on the same day while sitting on my couch, I felt fluttering in my left inner thigh by my knee and then a tightness of the muscle, and around the same time my right calf muscle started cramping like a charley horse that didn't go away; the different areas feel like a warmth to them and after the initial cramp or flutter then almost like an itch-hard to describe. Throughout the rest of the evening I continued to have similar feelings in my legs and the bottom of my feet. The next morning when I woke up my skin on my legs and neck looked like I had a mild sunburn. I did not have any noticeable swelling; I had intermittent headaches, dizziness and felt like my reaction time with mobility was slightly off. I continued to have the same feelings in my legs for 13 consecutive days since the vaccine and had not ever had these symptoms previous to the vaccine. After the initial 13 consecutive days, I have had soreness in the previously active areas, i.e. left thigh near knee, right calf, etc. On 9/18 my legs started bothering me again and yesterday, 9/19/2021, I felt like a sort of flareup like when these leg issues first started on 8/11, cramping and heat (internal heat-don't feel from the outside), but no swelling.
facial tick, Muscle or nerve spasms in 1 side of my face; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of FACIAL SPASM (facial tick, Muscle or nerve spasms in 1 side of my face) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 20-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FACIAL SPASM (facial tick, Muscle or nerve spasms in 1 side of my face). At the time of the report, FACIAL SPASM (facial tick, Muscle or nerve spasms in 1 side of my face) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
Information has been received from a registered nurse concerning a female who "between the beginning of the September and now" (date not specified) was vaccinated IM with 0.5 ml dose of Gardasil vaccine (yeast). Subsequently on an unspecified date, the patient experienced a "definite stinging " at the injection site. Unspecified medical attention was sought. At the time of this report, the patients outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Lesion left deltoid region. Erythematous and developed central blister before crusting over about 5 days. Multiple new lesions (>30)over subsequent 4 days (mainly on Day 3 of symptoms). Also mild fever (100.5 degrees F rectal). Seen by MD on Sep 7 with no treatment or investigations recommended other than acetaminophen prn for fever.
Patient's wife described her husband's symptoms at her vaccination:  Quite tender to touch and very red at and around the injection site.
Initially soreness around injection site later  followed by vertigo, nausea and vomiting. which resolved after 48 hours.  Dizziness continued and on fourth  day I developed body aches, low grade fever (100.9) and nausea. which lasted for three days.
Flush feeling through entire body within 10 min with dizziness associated. Numbness of bilateral hands and feet as well as lips. Rise in Bp up to 150/100. Red, blotchy neck. Within hour, dizziness subsided, but numbness of extremities and lips lasted approximately 10 hours.
Right arm swelled about 2 inches below injection site, which was 2 inches below shoulder.  It swelled down to within 2 inches of the wrist.  My right arm was swelled, red rash and hot to touch.  The swelling continue to grow for 3 days until I took 2 benadryl every 6 hours as directed by the urgent care doctor, on November 22 at 5:00 pm.
I started hearing ringing in my ears. Not sure of real date just noticed it and finally acknowledged that THIS was different.   Sometimes the ringing is louder than at other times. Finally, I called my physician and was able to get appointment on 4/22/2021.
Swelling, redness, and warm to touch below immunization site. No c/o's pain.
the patient missed his dose on day 3/ no AE; Initial information was received on 13-Dec-2021 regarding an unsolicited valid non-serious case received from a Pharmacist via Agency (Reference number- 00895881).  This case involves a 11-year-old male patient who missed his dose on day 3 with no adverse event (Product dose omission issue) while receiving RABIES (HDC) VACCINE [IMOVAX RABIES].  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On 06-Dec-2021, the patient received a dose (once) of suspect RABIES (HDC) VACCINE [lot number not reported, and expiry date not reported] via unknown route in unknown administration site for prophylactic vaccination, Post exposure immunization and Product used for unknown indication.  It was reported "Caller reporting the patient received his first dose of IMOVAX on day zero on 06Dec2021 and missed his dose on day 3. Caller reporting that the patient is coming in today, on day 7, to receive second dose. Caller with question on whether he needed to restart series or just continue the schedule".  It was a case of actual medication error case due to Missed dose (latency was on the same day).  At the time of report, no adverse event reported.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on batch number for this case.
Patient was due for second flu shot to complete first FLUZONE Quadrivalent series. Patient received 0.5 ml was to receive 0.25 ml.
I had a severe allergic reaction, my entire body from head to toe was red. It also became bumpy and my body felt warm to the touch. I also felt hot like my body was burnt. I went to the emergency room and was given a shot of steroid.  After getting the shot it made it better but the next day it came back . So the doctor prescribed me ointment cream that eventually helped it go away.
Approximately nine hours after receiving my 1st dose, I had an anaphylactic attack. I immediately took 50 mg of Benadryl and adverted a full blown attack. I have had two attacks in the past for reasons unknown. One was approximately 21 years ago and the other was approximately eight years ago.  Should I receive a second dose?
- Occasional fatigue ranging from mild to moderate.   - Occasional "drained" feeling like I pulled man G's. - Mild brief dizziness (1-2 times a day),   - Constant soreness in hands with mild sensation of having held something that vibrates (e.g., power tool)  - Occasional arthritis-like pain in joints (fingers and knees).    A few notes: - All of the above sensations have increased noticeably in intensity/frequency since 5/5/21.   - I tested negative for Covid-19 on 5/8/21 (PCR).   - I have been diagnosed with arthritis in my pinkies. - I am under doctor's care/monitoring for kidney stones which may give rise to some common symptoms such as the fatigue.
Patient received 0.25mL of Moderna Covid-19 Vaccine, Bivalent; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of UNDERDOSE (Patient received 0.25mL of Moderna Covid-19 Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced UNDERDOSE (Patient received 0.25mL of Moderna Covid-19 Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (Patient received 0.25mL of Moderna Covid-19 Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for UNDERDOSE (Patient received 0.25mL of Moderna Covid-19 Vaccine, Bivalent).    No concomitant medications were reported.  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 27-Dec-2022: Follow-up information included patient's age group updated.
I received both doses of the vaccine and two days after each dose I started my period. I was not due for a period until 2 1/2 weeks later and started again after the vaccine. The first dose was on 2/27/21 and I started on 3/1/21. My second dose was on 3/24/21 and I started on 3//27/21. Neither time was I scheduled to start my period.  And both were very heavy bleeding.
Patient had slightly larger than a localized reaction on his upper right arm- very red, firm, swollen
This spontaneous report was received from a physician via company representatives and from a support services director concerning to a patient of unknown age and gender. Information about the patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications was not reported. On 17-DEC-2014, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23, "10PK-0.5ml SD-PFS LLok wTip" which had the lot # K009874 with expiration date 19-MAR-2016 (dosage number and route of administration were not reported). On unspecified dates, the vaccine had two temperature excursions; one for 48 hours in which the lowest recorded temperature was 34 degrees Fahrenheit (1.111111111 degrees Celsius) and another one for 40 hours in which the highest recorded temperature was 47 degrees Fahrenheit (8.333333333 degrees Celsius). The vaccine status was reported as "in excursion". The vaccine storage criteria and type were reported as "refrigerator(R)". No adverse effects were reported and no product quality complaint was involved. This is one of the several reports received from the same reporter. Additional information has been requested.
SEVERE SWELLING AT INJECTION SITE IN THIGH. RED RING AROUND INJECTION SITE APPROX 3 IN IN DIAMETER. HOT TO TOUCH. PAINFUL FOR CHILD TO WALK X5 DAYS.
Narrative:  Patient presented to urgent care due to "severe itching to entire body" after receiving COVID-19 vaccine. Patient prescribed "steroids" for several days (specific steroid given is unknown).
Warmness near the injection site; Redness near the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Warmness near the injection site) and VACCINATION SITE ERYTHEMA (Redness near the injection site) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027l20a) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included CIPROFLOXACIN and LOSARTAN for an unknown indication.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Warmness near the injection site) and VACCINATION SITE ERYTHEMA (Redness near the injection site). At the time of the report, VACCINATION SITE WARMTH (Warmness near the injection site) and VACCINATION SITE ERYTHEMA (Redness near the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.