chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Typical soreness in the area of the shot, without radiating; Muscle soreness; This spontaneous case was received on 04-Oct-2023 from a pharmacist via Communications (reference number SEQW23-02973) and concerned an 84-year-old, female patient.   The patient's medical history and concomitant medications were not reported.    On 03-Oct-2023, reported as yesterday, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine inact sag 4v; dose: reported as 0.5, route of administration and anatomical location: not reported) for prevention of influenza disease. The batch number reported was 371626 and the expiry date reported was 30-Jun-2024.  On an unspecified day in Oct-2023, an unknown amount of time after receiving Fluad Quadrivalent, the patient experienced soreness in the area of the shot, without radiating and typical muscle soreness.   On 04-Oct-2023, one day after receiving Fluad Quadrivalent, the patient reported to the pharmacist typical soreness in the area of the shot, without radiating and typical muscle soreness. There was no treatment measures associated with the events.  The outcome of the events was unknown.  The reporter did not provide causality assessment.  The case was assessed as non-serious.  Company Comment: The events of vaccination site pain and muscle soreness are assessed as possibly related to Fluad Quadrivalent due to plausible temporal relationship.; Sender's Comments: The events of vaccination site pain and muscle soreness are assessed as possibly related to Fluad Quadrivalent due to plausible temporal relationship.
Child returned to waiting area in mom's arms, with mom stating "he is having another reaction with hives after a shot"-child crying, alert. Mom instructed to observe closely and to seek medical attention if symptoms worsen.
I started to have persistent ringing in my ears. It continues to this day. All the time, regardless of what I am doing or where I am. The only time I do not hear ringing in my ears is when I am sleeping. In addition, I had a couple of periods of dizziness, possibly related to this.
not doing well; redness like rash; itching; swelling; burning; horrible cough; arm pain; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (not doing well), PAIN IN EXTREMITY (arm pain), RASH ERYTHEMATOUS (redness like rash), INJECTION SITE PRURITUS (itching) and SWELLING (swelling) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Thyroid cancer and Thyroidectomy. Concomitant products included GABAPENTIN, CALCIUM and LEVOTHYROXINE SODIUM (LEVOXYL) for an unknown indication.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced PAIN IN EXTREMITY (arm pain). On 16-Jan-2021, the patient experienced COUGH (horrible cough). On 21-Jan-2021, the patient experienced RASH ERYTHEMATOUS (redness like rash), INJECTION SITE PRURITUS (itching), SWELLING (swelling) and BURNING SENSATION (burning). On 27-Jan-2021, the patient experienced MALAISE (not doing well). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE, IBUPROFEN (ADVIL COLD, COUGH & FLU NIGHTTIME) for Cough, at a dose of 200 mg. At the time of the report, MALAISE (not doing well), PAIN IN EXTREMITY (arm pain), RASH ERYTHEMATOUS (redness like rash), INJECTION SITE PRURITUS (itching), SWELLING (swelling), BURNING SENSATION (burning) and COUGH (horrible cough) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient informed that she has a rare nerve condition, complex regional pain syndrome which she got 24 years ago after her thyroid cancer surgery.   Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: NNI, follow-up declined by the patient.
About 4 hours after receiving vaccine the site around the injection began to swell to the size of half a tennis ball and was red in places and warm to the touch. 28 hours later it has not resolved.
Extreme Fatigue, dizziness, nausea, fainting, seizures, vomiting, hair loss, joint pain, tingling in toes and fingers, mood swings. Have seen pediatrician, neurologist, endocrinologist, psychiatrist, cardiologist. Have had blood tests, cat scans, upper and lower GI.
Today (day 3 after 2nd dose) I woke up with the upper/outer of vaccinated arm blotch red, swollen, and hot to the touch. I did not have this at any point until today. Not with first vaccination either.   A few years ago I had an allergic reaction to Clinomyacin that started like this and then spread to my entire body. I do not want that to happen with this! I thought about taking a Benadryl but then though it might interfere with the working of the vaccine. I need to know what, if anything I should do and at what point should I be concerned and what should I do if it gets worse.
Information has been received from a 25 year old female with no known drug reactions/allergies and with a history of caesarean section for first pregnancy who in approximately September 2009, "about six months ago" was vaccinated with the first dose of GARDASIL. Concomitant therapy included SUBOXONE. The patient reported that she received the third dose of GARDASIL the same day she had a positive pregnancy test. The patient reported to be about 1 month pregnant. The last menstrual period was estimated happened in January 2010 and the estimated delivery date is 08-OCT-2010. The patient sought medical attention visiting the physician. Follow up information has been received from a physician from a pregnancy questionnaire who reported that the patient had an elective termination of pregnancy on 19-APR-2010, 11 weeks from last menstrual period. It was unknown if the products of conception were examined. It was unknown if the fetus was normal. The patient's last menstrual period was on 01-JAN-2010. Upon internal review elective termination was considered to be an other important medical event. No further information is available.
pt called the pharmacy 10/5/2022 complaining of black and blue marks on both arms and now turning red and warm to the touch.  Since it has been one week since she received the vaccines, we recommended that she schedule a visit with primary care for analysis/follow-up.
2 hours after receiving these vaccinations the patient had started to feel disoriented.  By 9:30pm that night he felt aches in his muscles and experienced a flushed feeling.  The next morning, 10/2, he had pain in his joints and a droopy eye.  He was able to see the doctor on 10/2, but by the time he was in the office the symptoms had resolved.  I spoke with the patient on 10/3 midday and he said that his symptoms were all improving over today.
Awakened from sleep with a continuous ROARING tinnitus in left ear--(loud as an air-raid warning horn) that persisted for 1/2 hour and then recurred 12 hours later---lasting for 1 hour.
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) 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's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2023, outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included PAXLOVID from 18May2023 to 22May2023 The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
CHILLS FEVER 101 HEADACHE  BLD PRESSURE 90/40 PULSE 95 lasted all day starting 15 hours after shot. Feel better today with mild headache and pulse  95
Fever 100.8 at 10pm 10-1-20; weakness, dizziness, almost fainted 10-2-20 5pm; blood pressure at 6pm 98/55, temp 99.0.
Administered 10-4-12 (PNEUMOVAX) reaction of raised red patches quarter sized and smaller around injection site and under arm noted 10-5-12 given steroids.
Information has been received from a registered nurse concerning a 5 year old white female who on 10/5/99 was vaccinated with a dose of varicella virus vaccine live. On 3/29/04 the patient's mother called the physician's office and said that her child had a rash that looks like chicken pox. The rash began on 3/28/04 and the patient was expected to come into the office in the next few days for confirmation and follow up. There was no treatment outlined at the time of report. It was also noted that the patient was vaccinated at a different pediatrician's office so they did not have a lot number. Follow up information noted that the patient had unconfirmed chicken pox with about 30 lesions scattered over her entire body. She was placed on acyclovir cream. No diagnostic tests were performed. On 4/7/04 the patient recovered. No product quality complaint was involved. No further information is expected.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 62-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles. Previously administered products included ZOSTAVAX vaccine, SHINGRIX with an associated reaction of injection site pain (for tolerance refer the first dose US2019GSK060272), Hepatitis A (received the dose of Hepatitis A on October 2018 in the opposite arm) and flu shot (received the flu shot on October 2018 in the opposite arm). Concurrent medical conditions included shingles. Concomitant products included acyclovir. On 27th March 2019, the patient received the 2nd dose of SHINGRIX. In March 2019, less than a week after receiving SHINGRIX, the patient experienced injection site pain, tiredness and feeling unwell. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the injection site pain, tiredness and feeling unwell were not recovered/not resolved. It was unknown if the reporter considered the injection site pain, tiredness and feeling unwell to be related to SHINGRIX. Additional case details were provided as follows: The day before reporting, the patient received the dose of SHINGRIX in left arm and experienced some of the side effects since last night and on the day of reporting. The patient had no lot number information. The patient stated that her left arm, the site she had the vaccine in, was sorer than the first shot, fatigue and feels like she was getting a virus. Overall kind of virally feeling as expected but nothing was alarming, but enough to cause the patient to stop and lie down. The patient has been referred to her physician and provided the median duration of events from the prescribing information. The patient was wondering and enquiry that how long the side effects normally last was one or two days.
EE had positive exposure to father (household member), whom tested positive 12/18/21. EE, mother, and brother also became symptomatic and tested Positive 12/21/21.
lots of clots; Heavy menstrual-like bleeding; recurring urinary tract infection symptoms; intense lower back pain.; This is a spontaneous report from a contactable consumer (patient).   A 46-years-old non-pregnant female patient received first dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number: EP7534, age at vaccination 46-years-old) via an unspecified route of administration and administered in left arm on 18Mar2021 08:00 as first dose, single for COVID-19 immunization. The patient's medical history included thyroid cancer survivor and allergies to Ciprofloxacin. The patient concomitant medication included levothyroxine sodium (UNITHROID) prior 2 weeks 112mg. The patient had no covid prior to vaccination. The patient did not take no other vaccine in four weeks. The patient experienced heavy menstrual-like bleeding, lots of clots, recurring urinary tract infection symptoms and intense lower back pain on 28Apr2021. Events resulted in Doctor or other healthcare professional office/clinic visit. No treatment was received for events. Covid was not tested post vaccination. The patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EP7533), dose 2 via an unspecified route of administration and administered in left arm on 08May2021 10:00 am. The outcome of events was not resolved at the time of this report.  Follow-up(30Jun2021): Follow-up attempts completed. No further information expected.
pt devel urticarial lesions over the face & the body soon p/vax;IMP urticaria; done well
Patient received tetanus vaccination in RT arm on 07/18/2018. Has allergy to latex. Presents to center on 7/20/2018 with reddened area on RT arm about 1.75 x 1.5 in size, raised, warm to the touch with localized itching. Denies difficulty breathing, swelling of tongue, additional body itching, fever, pain, N/V, headache, dizziness. Verbal instructions given to take apply cool compresses to area intermittently.
sudden onset of heat through out body, sweating, blurred vision, tigngling sensation through out arms and legs, loss/minimum movement of right hand, fever 100.1, pale loss of color in face, faint. lasted 10 to 15 minutes.
The pt was acting fine, woke up with approx 2" swollen, red area around injection site on (Rt) deltoid- mother said it didn't seem to bother him.
Patient presented to office 3 hours after receiving flu vaccine with temp to 104, hypertension and tachycardia. He was examined, given tylenol and observed for 40 minutes. Blood pressure and heart rate improved but fever did not. He felt better and was discharged home. . He took ibuprofen at 8 pm and went to bed. He woke at 2 am and did not feel well, Mom felt he "looked funny". He then collapsed in her arms. She called 911 and he was evaluated in ED, He was found to have no concerning findings and was discharged home. He has been afebrile since returning home.
11-23-04 - developed weakness in leg and trouble with her balance; 12-04 - weakness in legs progressed until patient had to use cane to walk; 2-05 - now has to use a walker/cane and c/o severe joint pain; A. Received Flu vaccine 11-18-04; B. On 11-23-04 patient noticed weakness in left leg and had trouble with her balance. C. Weakness continued to increase for several weeks, patient had to start using a cane to assist with walking. D. Jan and Feb saw DR who suggested a diagnosis of neuropathy. E. April of 05 patient now c/o pain down both legs, can only walk with cane or walker and has constant joint pain especially in legs. 7/16/08-records received-Presented on 12/6/04 with C/O neck hurting several years ago. Lots of tension. Dragging left lower extremity, left arm hurts from flu shot. Cervical spine pain. PE: mild scoliosis. Assessment: cervical disc syndrome, lymbar disc syndrome, osteoarthritis left knee, possible torn medial meniscus. Complaints continued.
6 in wheal and flare around injection site - right thigh with redness. Given BENADRYL and was seen in office on day 3 of it. It was red and tender to touch. Also developed fever day after injection of 102. In office on day 3 reviewing pictures taken by parent the area of vaccine had improved.
pt died 24JUN98;death certificate lists haemophilus influenzae/interstitial pneumonia;pt asymptomatic noc a/death;found dead in AM;SIDS ruled out ?;
Patient received  Covid vaccine 12/31/2021  at Nursing facility by representatives from Pharmacy. on Jan 2nd patient started with bruising on  Left arm and Back, Patient noted as developing shingles. Jan 4th bruising noted buttock. Bruising continued to be seen Chin and Neck. Patient brought to Medical Center for evaluation1/8/2021 not admitted discharged back to NH. Patient  noted as  70.3 on 1/6 and 71.2 on 1/8/2020.    H/H noted as 9/28.4 decreased from 12/9/2020 when 11.2/35.9.  also in history patient did receive Prevnar 13 on 12-10-2020. Patient Primary Care asked for possibility of ADR vaccine leading to VAERS report
Recovering from a stroke he suffered 3 months ago. Post vax, the pt woke up the next morning with his right arm weak and right leg completely numb. The right side was affected by the stroke. Complained of stomach ache after eating 2 bites of a hamburger last night and stomach still hurts today, 11/29/99. Saw a psychiatrist and was put of Paxil. Also seen by a psychologist about 1 week ago and bumped head on right and made a complaint of left sided weakness. Seen in ER and CT Scan was nml. He still feels tired and bruising more on Plavix with nausea. Scattered ecchymosis in various stages of healing over arm and legs. Dx'd with mild epigastric pain and gastritis and probable constipation. Senokot prescribed X 1-2 days. Has been walking with a cane but had not needed it after rehabilitation until the morning of 11/3/99 because of weakness and numbness in left side. Right arm has purpura and less strength than usual same as stroke. Dx'd with possible TIA. Hospitalized for more tests. Had a fainting spell at school on 12/1/99 and was out for about 20 seconds. He was complaining of a headache and dizziness for 1 hour after the episode. He has increased bruises per dad but he is on blood thinners and aspirin. Called dad on 12/4/99 at 12:00, to check on pt per doctor's request and no more fainting or constipation in several days; seems to be doing ok per dad.
Initial case received from a physician on 17 February 2010. A 1-year-old female patient received the following vaccines in July 2009: a right arm injection of ACTHIB (lot number UF369AA); an injection of PEDIARIX (GSK, lot number AC21B127AA); an injection of influenza vaccine (manufacture and lot number not reported; reported as "not sanofi pasteur" product); and a right thigh injection of pneumococcal vaccine (manufacturer reported as Merck, lot number U2639AA; however, this lot corresponds to MENACTRA, and clarification has been requested). The patient had no known allergies or medical conditions, and was not ill at the time of vaccination. One month post-vaccination, in August 2009, the baby developed decreased grip strength in her left hand. In February 2010 she presented with loss of grip in her left hand and loss of some movement in her left leg. The event was ongoing at the time of the report. Documents held by sender: None.
Fever, body aches, head congestion- lasted until about 11 pm on 5/19/2021
p/vax pt exp rash rt side face w/swelling; also devel h/a
1) Pt fainted / or passed out after vaccination 2) Vomiting (x1) afterwards.
Information has been received from a pharmacist concerning an adult patient who received the first dose of VARIVAX (Oka/Merck). Subsequently the patient experienced mild chicken pox rash. No additional information. It was unknown whether the patient sought medical attention. No further information is available.
Injection site shaped like triangle, raised in a tennis ball shape; Injection site was red; injection site was warm; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE SWELLING (Injection site shaped like triangle, raised in a tennis ball shape), VACCINATION SITE ERYTHEMA (Injection site was red) and VACCINATION SITE WARMTH (injection site was warm) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No adverse event history). Concomitant products included IBUPROFEN (MOTRIN [IBUPROFEN]).    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE SWELLING (Injection site shaped like triangle, raised in a tennis ball shape), VACCINATION SITE ERYTHEMA (Injection site was red) and VACCINATION SITE WARMTH (injection site was warm). At the time of the report, VACCINATION SITE SWELLING (Injection site shaped like triangle, raised in a tennis ball shape), VACCINATION SITE ERYTHEMA (Injection site was red) and VACCINATION SITE WARMTH (injection site was warm) outcome was unknown.        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.   There was no treatment for these events.
20 Patients received Spikevax past the 30 day expiration date; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (20 Patients received Spikevax past the 30 day expiration date) 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)) (batch no. 023C22A) 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) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (20 Patients received Spikevax past the 30 day expiration date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (20 Patients received Spikevax past the 30 day expiration date) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      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 EXPIRED PRODUCT ADMINISTERED (20 Patients received Spikevax past the 30 day expiration date).    No concomitant medication information was reported. No treatment medication information was reported.   This case was linked to MODERNATX, INC.-MOD-2023-700683 (E2B Linked Report). Sender's Comments:  MODERNATX, INC.-MOD-2023-700683: Master case
Pt stated on 04/08/19 she began to have a massive headache that she has never had before, and on 04/09/2019, and large red rash developed in the area where the vaccine was administered. It is bright red, and hot to the touch. She stated she can feel the heat radiating through her arm.
2pm Tdap LD. 2:10 c/o arm hurting, acting giddy, 2:20 moody -> anger, didn't want to talk to father, ran off into forest. 4pm approx went to older sister's house, didn't want parents told. 7pm Mom arrived at daughter's house. Patient moody, angry and couldn't sit still. fidgeted with empty plastic water bottle, crushing, crackling it. Son stated felt weird, different. Mom lightly stroked (L) arm. Son stated at 5 minutes and 1/2 hour later could still feel where she stroked. Continued to feel strange. Went to bed 2 am, slept 12 hrs. Ate food night of vaccination stated it tasted different. Awakened feeling different but unable to explain how. Took shower - felt normal on skin. 4 pm 8/18/11 calm and doing normal activities but still felt different. Father stated did not receive VIS form prior to vaccination. Accidentally handed back to LVN who returned after the shot. Stated if had rec'd VIS form for adverse reactions probably would not have allowed the shot. Our error, not allowing time to read VIS.