chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Suffered from bloody diarrhea and again the morning of the 30Oct2021; That evening started cramping, and hurting and after a while; That evening started cramping, and hurting and after a while; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA HAEMORRHAGIC (Suffered from bloody diarrhea and again the morning of the 30Oct2021) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Colostomy (He is in three different blood thinners after a full colonostomy the previous month.) in September 2021.   On 29-Oct-2021 at 2:00 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, the patient experienced DIARRHOEA HAEMORRHAGIC (Suffered from bloody diarrhea and again the morning of the 30Oct2021) (seriousness criterion medically significant), MUSCLE SPASMS (That evening started cramping, and hurting and after a while) and PAIN (That evening started cramping, and hurting and after a while). At the time of the report, DIARRHOEA HAEMORRHAGIC (Suffered from bloody diarrhea and again the morning of the 30Oct2021), MUSCLE SPASMS (That evening started cramping, and hurting and after a while) and PAIN (That evening started cramping, and hurting and after a while) outcome was unknown.            No exact concomitant medications were mentioned.  No treatment details were reported.  The patient suffered from bloody diarrhea again the morning of the 30-Oct 2021.  Company comment: This case concerns a  77-year-old, male patient with relevant medical history of full colostomy and different administration of blood thinner, who experienced the unexpected event of Diarrhea Hemorrhagic. The event occurred approximately same day (few hours) after the third dose (booster) of mRNA-1273 (Moderna Covid-19 vaccine). The rechallenge was not applicable as event occurred after third dose. This patient's medical history and administration of blood thinner remains a confounder. The benefit-risk relationship of mRNA-1273 (Moderna Covid-19 vaccine) is not affected by this report.; Sender's Comments: This case concerns a  77-year-old, male patient with relevant medical history of full colostomy and different administration of blood thinner, who experienced the unexpected event of Diarrhea Hemorrhagic. The event occurred approximately same day (few hours) after the third dose (booster) of mRNA-1273 (Moderna Covid-19 vaccine). The rechallenge was not applicable as event occurred after third dose. This patient's medical history and administration of blood thinner remains a confounder. The benefit-risk relationship of mRNA-1273 (Moderna Covid-19 vaccine) is not affected by this report.
Left upper extremity red & warm to touch 16 1/2cm x 10cm around injection site.
had persistent, inconsolable crying that lasted from time of shot @ 10AM till about 330PM that afternoon; temp remained consistent @ 98.6 ax; APAP given w/warm & cool compressess to sl swollen lt thigh;
8/25 felt symptoms similar to a heart attack and then palpitations and flutters consistently after with chills.  Symptoms of heart attack went away but flutters and smaller chest pains persisted through the week.  9/8 the severe chest pain returned and I checked into the ER at  Hospital as left arm was knumb and tingly with severe chest pain.  Pain and a cramping feeling persists as well as abnormal feeling in heart and at random times of the day/night.
Itching; Delayed cutaneous hypersensitivity; Swell up; Up to 3 in with light reddish mark; severe itching; Feeling an intense cold stream going through my arm immediately after the shot was given; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE COLDNESS (Feeling an intense cold stream going through my arm immediately after the shot was given), VACCINATION SITE PRURITUS (Itching), VACCINATION SITE HYPERSENSITIVITY (Delayed cutaneous hypersensitivity), VACCINATION SITE SWELLING (Swell up) and VACCINATION SITE ERYTHEMA (Up to 3 in with light reddish mark) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced VACCINATION SITE COLDNESS (Feeling an intense cold stream going through my arm immediately after the shot was given) and PRURITUS (severe itching). On 15-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Itching), VACCINATION SITE HYPERSENSITIVITY (Delayed cutaneous hypersensitivity), VACCINATION SITE SWELLING (Swell up) and VACCINATION SITE ERYTHEMA (Up to 3 in with light reddish mark). On 10-Feb-2021, PRURITUS (severe itching) was resolving. At the time of the report, VACCINATION SITE COLDNESS (Feeling an intense cold stream going through my arm immediately after the shot was given), VACCINATION SITE PRURITUS (Itching), VACCINATION SITE HYPERSENSITIVITY (Delayed cutaneous hypersensitivity), VACCINATION SITE SWELLING (Swell up) and VACCINATION SITE ERYTHEMA (Up to 3 in with light reddish mark) was resolving.        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.   Concomitant product use was not provided by the reporter.  Treatment information was not provided.    Most recent FOLLOW-UP information incorporated above includes: On 18-Feb-2021: New events added On 01-Apr-2021: FUP received on this date included no new information. On 26-Apr-2021: FUP received on this date included no new information.; Reporter's Comments: Based on the information provided which includes a temporal association and the established safety profile of mRNA-1273 vaccine, a causal association between the event of headache and the product use cannot be excluded. Vaccination site redness, itching and swelling are consistent with the known safety profile of the vaccine.
No adverse events identified. Patient was given IPV that was involved in excursion on 10/01/15. 10/5/15- Vaccine temp was too cold. Vaccine was not discarded.
Pt complained of not feeling well about 10 minutes after the  Moderna vaccination.  He complained of heart issues.  I asked him if he wanted me to call an ambulance. He wanted to wait. A few minutes later he asked me to call an ambulance. The Pharmacy associate called the ambulance. During the wait for t he ambulance, I monitored him and he drank a little water. Pt called his partner.  The ambulance arrived about 15 minutes later.   He was calmer and felt better. He was evaluated and they left. Pt  left soon after the emergency care workers. I have been unable to contact Pt for a follow-up.
Information has been received from a lawyer and a consumer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. In or around May of 2012, the patient was inoculated with ZOSTAVAX, (lot# and route unknown) for routine health maintenance and for its intended purpose: the prevention of shingles. In or around April 2017, the patient was diagnosed with shingles by her primary care physician. The shingles lasted for approximately two months. In October of 2017, the patient passed out and was subsequently diagnosed as having a transient ischemic attack. Finally, in or around May of 2018 and August of 2018, the patient was again diagnosed with shingles by her primary care physician. As a direct and proximate result of ZOSTAVAX vaccine, the patient's symptoms have resulted in physical limitations not present prior to using ZOSTAVAX. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of the patient's condition. As a result, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the patient has incurred and will continue to incur medical expenses and other economic harm as a direct result of ZOSTAVAX. Three events of shingles and transient ischemic attack were reported as disabling. Upon internal review transient ischemic attack was considered medically significant. Additional information has been requested.
Syringe malfunction.  Vaccine squirted out of the hub and it was indeterminable how much vaccine the patient received.
Symptoms - ? EE reports she waited for 30-minute observation period with no adverse reaction.  EE left work to drive home after vaccine and reports approximately 45 minutes later felt ?hot and cold? all over her body and felt ?panicky.?  EE reports she pulled over and called her husband.  At time of call (approx. 13:33), EE reports still feeling a little ?tingly? on her entire body and ?odd.?  EE reports mild shaking to bilateral hands. EE reports last time she ate was at approximately 06:45 this am.    Home remedies? -   EE was in Starbucks parking lot at time of call and was going to be getting lunch after call.  Recommendation? EE educated to eat and drink something, EE verbalized back understanding.  EE educated to call vaccine support line for worsening symptoms, EE verbalized back understanding and denied further questions at this time.
Low grade fever 99-102 x 2 weeks post vaccine eased with Tylenol. Reports three episodes of seizure-like activity 8-19-07, 8-23-07 and 8-30-07. Advised to seek medical care. MD visit 8-31-07 Referred to Neurologist- Lab work ordered Amoxicillin Rx given
Cellulitis (L) arm inferior to area of vaccination - giving Keflex 500 mg T cap 2xd for 7 days. (10/2/20)
RN received covax 26Jan and the second covax on 09Feb 14 days after the first one.; burning sensation to skin and feet; This is a spontaneous report from a contactable nurse (patient) via a Pfizer-sponsored program. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 09Feb2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), on 26Jan2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient received Covax on 26jan and the second covax on 09feb 14 days after the first one. She also experienced burning sensation to skin and feet on an unspecified date of 2021. The outcome of events was unknown.  Follow-up attempts completed. No further information expected.
Broken nose; Fungal infection on the back of her tongue; This is a spontaneous report from a Pfizer sponsored program COVAX US Support from a contactable consumer.   A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number was not reported), dose 1 via an unspecified route of administration on 16Mar2021 as single dose for covid-19 immunization.  The patient's medical history and concomitant medications were not reported.  The patient experienced broken nose and fungal infection on the back of her tongue in Mar2021.  Details were as follows: the patient needed to visit her ENT doctor because of a broken nose and fungal infection on the back of her tongue; she was not taking any medications for the events yet. The outcome of broken nose and fungal infection on the back of her tongue was unknown.   The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
red mark on arm that itches after 8 days; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (red mark on arm that itches after 8 days) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A.) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 10-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2021, the patient experienced ERYTHEMA (red mark on arm that itches after 8 days). At the time of the report, ERYTHEMA (red mark on arm that itches after 8 days) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Breakthrough case of COVID-19; Symptoms began with a runny nose and a very mild sore throat, and within six hours of those symptoms, I started running a low grade fever of about 100.5, and I ran a fever not more than that for about two days. I was fatigue and that lasted for about two weeks, and was followed by insomnia issues for about another week.
over 42 days, 1st dose 05/27/21, 2nd dose 08/31/21
Given Td 9/25/04. Developed redness and warmth at right deltoid area (injection site) noted 9/26/04. Seen 9/27/04. Right arm (site of injection) swollen, red, and warm to touch. Advised to take Tylenol and cold compresses.
Since receiving the vaccine experience chronic muscle pain in my back and neck and shoulders along with frequent headaches. When I go to the gym I can only lift have to wait so I normally do
abd pain that began on 1/15/2021,  1/19/2021 admitted to hospital with Acute appendicitis with perforation
Serious malaise within 24 hrs. of vaccination,  visual disturbance, e.g.  large multicolored kaleidoscope  with visual distortion lower left of center.  Disturbance is in the same location when covering  either  eye, and is also present with eyes closed.  It dissipates within about 15 minutes, and this has happened twice, the reported time, and once again at 2:00 PM 14 Mar.
Moderate headache with fatigue approximately 16 hours after flu shot. Duration was approx. 24 hrs. I rarely have a headache.
Called answering service on 7/31/03 at 18:15 complained of rash spreading up leg and rash around injection site. 8/1/03 called pt at 8:45, mother stated, "It has become bumpy and swollen with redness on the right leg. Advised pt's mother to bring him to be checked. 4 cm x 3 cm hot, red with induration.
Bleeding at left arm injection site; Flu like symptoms; feeling unwell; fatigue; mild headache; injection site pain; injection site pain, increased soreness in 24 hrs; This is a spontaneous report from a contactable nurse.  A 51-year-old female received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EJ1685), intramuscular into the left arm on 17Dec2020 at 02:45 PM at single dose for COVID-19 immunization. Medical history included Childhood asthma, NIDDM and known allergies to Latex. Concomitant drugs included Metformin, Glyburide, Lisinopril, Jardiance, Januvia, Atorvastatin, Proventil, Advair, Tylenol, MVI, D3, Diosmin, Niacin, Flonase, Vit C. On 17Dec2020 after first dose administered, at 03:00 PM, the patient experienced injection site pain, increased soreness in 24 hrs, bleeding at left arm injection site; flu like symptoms at the 12th hour of vaccination despite of tylenol and ibuprofen alternate medication. Generalized feeling unwell, fatigue, mild headache. At the time of reporting, the patient was recovered.
Underdose; Adult patient was administered a pediatric dose of Engerix; This non-serious case was reported by a nurse via call center representative and described the occurrence of underdose in a 51-year-old female patient who received HBV (Engerix B pediatric) (batch number DD7K7, expiry date 31-MAR-2024) for prophylaxis.   On 09-AUG-2023, the patient received Engerix B pediatric (left deltoid). On 09-AUG-2023, an unknown time after receiving Engerix B pediatric, the patient experienced underdose (Verbatim: Underdose) and adult use of a child product (Verbatim: Adult patient was administered a pediatric dose of Engerix). The outcome of the underdose and adult use of a child product were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 10-AUG-2023 Nurse Practitioner called to inquire the way to proceed. NP reported an adult patient was administered a pediatric dose of Engerix instead of the full adult dose which led to underdose and adult use of a child product. The reporter did not consent to follow up from safety. Call Notes:HCP declined follow-up from safety.
Hip and legs bone, muscle, muscle insertion extreme pain, increased heart rate, increased blood pressure, one episode of leg weakness, bright red lupus looking (malar) rash on face.  It was hot to touch and burning.  ER gave me toradol, steroids, and fluids.  Facial rash and pain resolved that night.  Bright red malar rash came back Saturday, Sunday, Monday.....comes back now when hot or out in the sun just on face.
During 15 observation period I had a tightness in my throat, nausea, shortness of breath, abdominal and lower back cramping. By 7 pm on the same day the cramping and back pain was substantially worst and it progressed through the week. I was unable to move, walk, sit or take a deep breath on Wednesday March 10th due to the pain. On Monday March 8th and Tuesday the 9th, I awoke and my insides hurt.  Today that pain from my insides hurting returned as well as the back pain  and the abdominal cramping.    I have contacted my primary and have yet to hear back.
This medically confirmed spontaneous report (initial receipt 13-JAN-2011) concerns a 29 year old female patient. On 10-JAN-2011, the patient received AFLURIA Inj 0.5ml via intramuscular route for vaccination. A few hours after receiving the vaccination, the patient complained of her throat swelling and trouble breathing. About 15 minutes later, EMS (emergency medical services) was called to the patient's house. The event outcome was unknown.
Swollen around eyes, especially under eyes, duration three days, left under one eye slightly yellowish like a healing bruise
7 days after vaccines delayed onset rash with a few itchy raised red papular lesions on arms.
Health Department administered a Varicella and a MMR to client on 2/19/10.  On 3/2/2010 Health Department received phone call from Dr. regarding client. Dr. reported client had a temperature of 102.3, was acting more tired than usual, but had been eating and drinking fine. Doctor also reported a blanchable, raised rash on the face, hands and trunk, but no blisters were visible.
Patient received first dose of Moderna COVID-19 vaccine. Vaccine given 1511. Patient complained of SOB and sweating. Patient had syncope, urinary incontinence, and nonbloody vomiting. Patient was seen by Dr. and EMS. Patient refused to be transported to ED. Patient's wife drove their car but within 20 yards, car stopped and patient vomited again. Patient re-encouraged to go to ED and got into EMS vehicle but then demanded to be let out and go home. Patient's wife then drove patient home.
The patient developed a rash on the face last night. Then the rash spread down to the trunk and extremities. No fever. No conjunctivitis.
Redness with some swelling noted at injection site of the Varivax. 5.1 cm x 6.2 cm redness, 4.2 cm x 4.2 cm knot, warm to touch. Doesn't itch or bother her. Mom to call if knot and redness persist. Right upper thigh.
Slept all day; warmness at injection site; tension headache; fever; very tired; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSOMNIA (Slept all day), VACCINATION SITE WARMTH (warmness at injection site), TENSION HEADACHE (tension headache), PYREXIA (fever) and FATIGUE (very tired) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     The patient's past medical history included Diabetes since an unknown date.   On 26-Feb-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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 27-Feb-2021, the patient experienced HYPERSOMNIA (Slept all day), VACCINATION SITE WARMTH (warmness at injection site), TENSION HEADACHE (tension headache), PYREXIA (fever) and FATIGUE (very tired). At the time of the report, HYPERSOMNIA (Slept all day), VACCINATION SITE WARMTH (warmness at injection site), TENSION HEADACHE (tension headache), PYREXIA (fever) and FATIGUE (very tired) outcome was unknown.            No concomitant medications was reported Treatment information was not provided
Pt recvd vax 19OCT, 23OCT, 30OCT; On Pred daily x4-6 mos for rash; stopped & tapered over a few days; 19OCT90 incident provoked bite by cat; chief c/o h/a, fever, n/v & fatigue; 2NOV90 h/a cont w/fatigue, t102.4; pred restarted feels better
was a little fussy over the weekend but seemed to have no other symptoms post administration; received MENQUADFI at 4 months old instead of the recommended age; Initial information received on 11-Jul-2022 regarding an unsolicited valid  non-serious case received from a patient's mother calling on behalf of her son.  This case involves a 4 months old male patient who received meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi] instead of the recommended age and was a little fussy over the weekend but seemed to have no other symptoms post administration of vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant Medications Included Rotavirus Vaccine , Hepatitis B Vaccine, Hib Vaccine (Hib) and Polio Vaccine Inact (Ipv) all for Immunisation.  On 08-Jul-2022, the patient of 4 months old received a  dose of suspect meningococcal A-C-Y-W135 (T CONJ) vaccine, solution for injection (dose, strength, lot number and expiry date not reported) via intramuscular route in the left thigh for immunization instead of the recommended age (product administered to patient of inappropriate age) (latency same day). On an unknown date the patient was a little fussy over the weekend but seemed to have no other symptoms post administration (irritability) (unknown latency). It was asked that if there is any additional information available for the administration of MENQUADFI to patient's less than 2 years old.   Action taken : not applicable.  It was not reported if the patient received a corrective treatment for the events (was a little fussy over the weekend but seemed to have no other symptoms post administration).  Outcome : Unknown.   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.
Day One: Dry, red patch on R hand. Day Two: " " and small bumps started to form Day Three: " " and more small bumps spreading on R hand Day Four: " " and red patch over top of chest. Day Five: " " red patch on top of chest had small bumps forming and bumps forming on L hand. Day Six (today): " " and red patch and bumps forming on R arm and upper back, neck, and starting on chin and face.