chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Customer states that she has "tingling and twitching" on the right side of philtrum of nose. Some pain involved as if cold sore coming. She does have history of cold sores, but not with the twitching that is happening. She requested this be sent in. She was just diagnosed with recurrence of cancer and that may be stress causing this.
12 yr old female was given Pfizer COVID vaccined that was formulated for a 5-11 yr old instead of the Pfizer COVID vaccine formulated for a 12 yr old and older. No signs or sysmtoms  after vaccine was given.
Patient presented on 5-6-13 with swelling and pain in right arm. The area of the injection was warm to touch. Patient noticed arm was hurting after someone else touched the area on 5-5-13. There was no pain or swelling in left arm.
This spontaneous report has been received from a pharmacist, concerning a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant medications were not provided. On an unknown date in December 2016, the patient was vaccinated with a dose of ZOSTAVAX (dose, frequency, route of administration and expiration date were not provided) and then was vaccinated again with a second dose of ZOSTAVAX Lot number M041087  and expiration date 30-JAN-2018 which were reconstitued with an unspecified sterile diluent (manufacturer unknown). No adverse effects reported.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old male patient received BNT162b2 (BNT162B2), on 21Sep2021 as dose 3 (booster), single (Lot number: 301358A), in left arm and on 30Apr2022 as dose 4 (booster), single (Lot number: Fk9894) at the age of 47 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Crohns" (unspecified if ongoing); "primary sclerosis cholangitis" (unspecified if ongoing), notes: Other medical history: primary sclerosis cholangitis; "known allergies: Sulpha" (unspecified if ongoing). Concomitant medication(s) included: DOXYCYCLINE, start date: 16May2022, stop date: 25May2022; AZITHROMYCIN, start date: 07May2022, stop date: 11May2022; HUMIRA, start date: 22May2022; MERCAPTOPURINE, start date: 01Mar2022; FLOVENT, start date: 12May2022. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results, notes: Indication: Treatment of COVID-19; Negative, notes: after Paxlovid treatment I tested negative and this week I am positive again; Positive, notes: after Paxlovid treatment I tested negative and this week I am positive again. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information:-Covid rebound after paxlovid treatment and patient tested negative and after a week patient got positive again.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old male patient received BNT162b2 (BNT162B2), on 20May2022 at 12:00 as dose 4 (booster), single (Lot number: FM7553) at the age of 58 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.   Clinical information: Patient had no other medication in 2 weeks.
This spontaneous report as received from an other health professional refers to patients of unknown age and gender. In August 2017, the patients were vaccinated with improperly stored doses of VAQTA lot # N005274 and N008823 for prophylaxis. No adverse effects were reported. Data logger was involved. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1709USA001288: US-009507513-1709USA001289: US-009507513-1709USA001290: US-009507513-1709USA001287:
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 or about 29-DEC-2009, the patient was inoculated with ZOSTAVAX at a facility 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 of herpes zoster, also known as shingles, and other complications. In 2016, the patient was treated by a Dermatologist for a blistering vesicular outbreak that was diagnosed as severe herpes zoster with ophthalmic complications. 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 has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Upon internal review, ophthalmic herpes zoster was considered to be medically significant. Additional information has been requested.
Vaccine administered on 3/12/19. Patient developed shingles rash on 3/16/19 on chest. Quickly spread across right side of chest around right side of neck and back and now appearing on right eye.
I was under evaluation for cardiac issues with a Holter monitor and they determined I had 17.6% of PACs.
At around 9:00 pm on 05/26/2021, I started having paralysis in my arms/hands, and legs/feet. I also had shortness of breath when I walked around my home. In the morning I still had the symptoms but by evening they were gone.
chest pain, crying, rapid heartbeat 170 BPM, spots all over body, itching, chest swelling;
Information has been received on 15-JAN-2019 regarding a case in litigation from a lawyer concerning a female patient of unknown age. There was no information provided regarding the patient's concurrent conditions, medical history or concomitant medications. The patient was prescribed the ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 29-OCT-2009, the patient was administered the ZOSTAVAX (lot number, expiration, dose and route unknown) by a healthcare provider at a medical clinic. In 2010, the patient was treated by a healthcare provider at a medical clinic for the following injuries resulting from the patient's ZOSTAVAX use: shingles. The patient claims damages as a result of injury to herself and economic losses. The outcome of the event is unknown. The causality of the event is related. Additional information has been requested.
On April 12, shortly after I got my second Pfizer shot, I started my period. It was very early by several weeks, and only a week since my previous period ended, which is why I made note of it and have kept a record.  For the first week it was fairly light and mostly spotting. After a week, it progressed and became more like a normal period in terms of the amount of blood I was seeing. By April 23rd I started noticing a lot more blood clots in my period than usual--ordinarily I'll see one or two each time I get my period, but there were about five days in a row when I noticed multiple blood clots. The clots stopped around April 28th, but as of today (May 3rd) my period is still ongoing, making it exactly three weeks long, and more unless it suddenly stops today.  For the most part the blood has been red and I haven't noticed any other unusual discharge. I have noticed the past few days that the blood is more brown, like old blood.  I have not experienced bad cramps or stomach upset during this very long period--I had the same level of menstrual cramping/stomach upset that I am accustomed to over the first couple of days, but nothing since then. I have felt bloated and tired the entire time, however. I have also experienced a really low mood for these few weeks, though I can't be certain if this is worse than I usually experience on my period, because it may just be because it's lasting so long that it feels worse.
Soreness to injection site that persisted, causing increased pain & loss of range of motion. Saw doctor on 12/18/2012. Placed on steroids & VICODIN for pain. Pain persisted-seen by orthopod. Placed on NSAIDS & physical therapy. Diagnosis of severe capsulitis. Still in physical therapy.
pt recv vax 14MAR97 & w/in 4hr pt exp itchy palms, & hand were red;17MAR97 pt devel welts on neck;
Had second CoviD shot. Waited 15 minutes and felt fine. One my driving home, I suddenly felt nausous, hot flash, moth tingling and felt like tounge/throat was swelling. I was on the highway and closer to city I lived. By time I was there was dizzy, heart ponding and trouble breathing. - Gave me EpiShot and called Ambulance -Unsure what I was given in the ambulance by IV -Went to ER  and given Benadryl, Pecid and Solu-Medrol for swollen throat/mouth. -Sent home later with EpiPen and steriods. --Mouth now gets "tingaly" when I took steriod with minor swelling. (so stopped) Also now with some foods and drinks now.  (Such as coffee, peanuts- taste is off)
Vaccine given after the adjusted use-by date but before the official expiration date. There was no adverse event per local health dept instructed us to file this report anyway.
Patient reports chest and upper abdominal discomfort, fatigue and difficulty taking a deep breath since receiving 2nd dose of Pfizer Covid vaccine.
Fever of 102 degrees and chills. Low blood pressure, 80/50. Elevated heart rate, 105 BPM at rest. Body aches all over. Nausea, fatigue; symptoms lasted appx. 72 hours.
R axillary pain secondary to R axillary lymphadenopathy since 3/1/21 morning (x2days). the night before that, her R shoulder was hurting but that resolved with onset of R axillary pain.
tested positive for COVID-19 more than a week after receiving our COVID-19 vaccine; tested positive for COVID-19 more than a week after receiving our COVID-19 vaccine; This is a spontaneous report from a non-contactable consumer. A 45-years-old patient of an unspecified gender started received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date not reported), via an unspecified route of administration from an unspecified date at a single dose for Covid-19 immunization. The patient medical history and concomitant medications were not reported.  The patient tested positive for COVID-19 more than a week after receiving COVID-19 vaccine. Outcome of the event was unknown.  No follow up attempts are possible. Information on lot/batch number cannot be obtained.; Sender's Comments: Based on the information available, a possible contributory role of the suspect products cannot be excluded for the reported event of positive for corona virus infection for the lack of efficacy of the vaccine. However, based on the mechanism of action of the vaccine, it is unlikely the patient would have fully developed immunity for the vaccine to be effective, due to the number of days passed since the vaccine is given. Case will be reevaluated based on follow-up information
pain in the back of neck; pain in left shoulder blade, 1 day later pain also in right shoulder blade; This is a spontaneous report from a contactable consumer, the patient. A 79-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: En6208) via an unspecified route of administration in the left arm on 16Mar2021 at 13:30 (at the age of 79-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 18Mar2021, 2 days after injection, the patient experienced pain in left shoulder blade and 1 day later pain also occurred in right shoulder blade. On 19Mar2021, 3 days later, the patient experienced pain in the back of neck. It was reported that the pain in shoulders subsided. It was unknown if the patient received treatment for the reported events. The clinical outcome of the event pain in left shoulder blade and also in right shoulder blade was recovered on an unknown date in Mar2021. The clinical outcome of the event pain in the back of neck was not recovered.   No follow-up attempts are needed. No further information is expected.
I recieved the guardisil vaccine three shot series. I was also administered one hepatitis A vaccine shot and the heptatis B series at the same time. Since the administration of the guardisil vaccine. I have had an increase in pain levels throughout the body. I have total body aches that are extremely sensitive to touch and hot water. I have trouble closing my hands and weakness in the left and right arms. I have also had severe calf muscle cramping that came on with sudden onset. I also had episodes of depression and directly after the shots were given I had severe stomach cramping and diarrhea. The bowel movements were extreme and very painful my family had to lift me off the toilet. I had dizziness and redness at the injection site. My genital area began chafing and a layer skin peeled off the scrotum and penis. This happened rapidly after the second shot in the series. I continue to have weakness and arthritic type pain my whole body aches since the vaccine. I've had pain in the neck area with no MRI findings. My moods immediately changed after the guardisil series. The loss of a friend seemed to make it worse. I felt fatigued and my pain started increasing. I was prescribed a medication for the painful diarrhea. I've had numerous neurological problems and uncontrollable leg and hand shaking since administration of the vaccine. I have night sweats with an unknown cause.  8/18/2008 MR received from PCP dated 11/7/2006 to 6/30/2008. Pt received HPV4 #1 on 3/8/07 and #2 on 4/30/07. Seen multiple times for multiple sx (see PMH). Seen 7/5/07 for numbness in feet and L leg weakness and knee pain. On PE absent knee reflexes and ankles 1+. Assessment: bilateral knee pain, probably patellofemoral syndrome. Seen 8/7/07 for new skin lesion- a light brown papule on dorsum of L hand-appears benign. Seen 9/7/07 for increasing back pain, shaking, spasms and numbness of legs attributed to PMH of DDD. 3rd HPV4 given. Seen 10/4/07 for new papule on R flank, swollen, tender and draining pus, possible furuncle. Tx with abx. Seen 11/26 with 3 day hx of ankle swelling. Assessment:  Bilateral ankle swelling of uncertain cause- probable side effect of medication. Resolved by Jan 2008.
This case was reported by a nurse via call center representative and described the occurrence of erythema of extremities in a 73-year-old female patient who received SHINGRIX (batch number 7X3EJ, expiry date 13th October 2020) for prophylaxis. On 27th July 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced erythema of extremities. On an unknown date, the outcome of the erythema of extremities was resolved with sequelae. It was unknown if the reporter considered the erythema of extremities to be related to SHINGRIX. Additional details were provided as follows: This case was reported by registered nurse (RN) supervisor. The patient received SHINGRIX on an unknown arm. The patient experienced redness in her whole injected arm. The reporter was uncertain of onset or duration of redness, but stated that it had resolved. The reporter gave consent to follow up.
Pharmacist reported that "we had a couple patients that received 10mcg dosage from the Dark Pink Cap and a Label with a Yellow Box; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Pharmacist reported that "we had a couple patients that received 10mcg dosage from the Dark Pink Cap and a Label with a Yellow Box) and NO ADVERSE EVENT (No adverse event) in a child patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 216K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Pharmacist reported that "we had a couple patients that received 10mcg dosage from the Dark Pink Cap and a Label with a Yellow Box) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Pharmacist reported that "we had a couple patients that received 10mcg dosage from the Dark Pink Cap and a Label with a Yellow Box) 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 WRONG PRODUCT ADMINISTERED (Pharmacist reported that "we had a couple patients that received 10mcg dosage from the Dark Pink Cap and a Label with a Yellow Box).    No concomitant medications was reported. No treatment drug details was reported. This case contains information of 9th out of 18 patients (12 patients initial dose) as described by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-723715, US-MODERNATX, INC.-MOD-2023-723704, US-MODERNATX, INC.-MOD-2023-723715 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-723715:9 Out of 18(12 Patients-Initial Dose) US-MODERNATX, INC.-MOD-2023-723704:Patient 1(Master Case) US-MODERNATX, INC.-MOD-2023-723715:9 Out of 18(12 Patients-Initial Dose)
Patient stated she received the smallpox vaccine on 30 July 2018 at the Center and while at home she experienced swelling, pain and infection at the injection site that affected her upper right arm down to the elbow. She was seen at the hospital diagnosed as reaction to the smallpox vaccine and prescribe clindamycin. Upon returning she followed up with her Care Provider and steroids.
2/4/2021 migraine  3/22/2021 migraine   Enlarged axillary lymph nodes both times
Shot hurt; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.  Additional Information: GSK Receipt Date: 13-JUN-2022 Reporter's Comment: This case was reported by a consumer via interactive digital media. The patient got the shingles shot and it hurt for a few but better than that mess. The patient stated that, he/she had seen people suffered bad and seen some die. The reporter further stated that, got the shingles shot peeps and love, love and dance. Additional Supportive information: The follow up would not possible as no contact details were available.
Erythema, edema & pruritus left arm (inject site). Tx with Motrin and ice.
Vertigo started 10/31 and lasted approximately 4 hours, subsided for 48 hrs, returned for 48 hours, then subsided for 4 days, then returned for over six weeks.  Nausea, vomiting, extreme dizziness. Unable to stand or walk without aid for 3 weeks.  Unable to return to work for 4 weeks.  Visual cues intensified symptoms.
Flu vaccine -  Arm pain/felt inflamed (afternoon) Headache (overnight) Nausea (next day) and throwing up
Caused "horrible pain" in knee joints affecting her gait. Had to have knee sockets drained. Also "aching pain" in eyes and eye sockets (flu like feeling) and sinuses have been affected with an increase in mucous and drainage.
Right flank pain, nausea, body aches. Urinary tract infection/pyelonephritis diagnosed.
received at 13 years and 2 months; No other AEs; This spontaneous report was received from a nurse prescriber and refers to a 13-year-old patient of an unspecified gender. The patient's medical history, concurrent conditions, concomitant medications, previous drug reactions or allergies were not reported.      On an unknown date, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (strength, route of administration, anatomical location were not reported, dose, lot # and expiration date were unknown) for prophylaxis, at age of 13-year and 2 months old (inappropriate age at vaccine administration). No adverse event (AE) reported (no adverse event). No other information was available.
sore left arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore left arm) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore left arm). At the time of the report, PAIN IN EXTREMITY (sore left arm) outcome was unknown.            Patient is immunocompromised with no  known drug or food allergies.  No concomitant and treatment information were reported by the reporter   This case was linked to MOD-2021-409869 (Patient Link).