chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine related skin reaction/allergic reaction; Spreading and cellulitis-like near vaccination site upper L arm; Bump on injection site; Redness; Itching sometimes/itchiness/scratching injection site; This spontaneous case was reported by a health care professional and describes the occurrence of DERMATITIS ALLERGIC (Vaccine related skin reaction/allergic reaction), VACCINATION SITE CELLULITIS (Spreading and cellulitis-like near vaccination site upper L arm), VACCINATION SITE PRURITUS (Itching sometimes/itchiness/scratching injection site), VACCINATION SITE SWELLING (Bump on injection site) and VACCINATION SITE ERYTHEMA (Redness) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     The patient's past medical history included Blepharitis and Cataract. Concurrent medical conditions included Allergy (Allergy to cefaclor, sulfamethoxazole trimethoprim). Concomitant products included DINOPROSTONE, CALCIUM, CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) and VITAMIN B COMPLEX for an unknown indication, FISH OIL, OENOTHERA BIENNIS OIL, TOCOPHERYL ACETATE (OMEGA 3 & 6).   On 29-Jan-2021 at 3:19 AM, the patient received first 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 06-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Itching sometimes/itchiness/scratching injection site). On an unknown date, the patient experienced DERMATITIS ALLERGIC (Vaccine related skin reaction/allergic reaction), VACCINATION SITE CELLULITIS (Spreading and cellulitis-like near vaccination site upper L arm), VACCINATION SITE SWELLING (Bump on injection site) and VACCINATION SITE ERYTHEMA (Redness). The patient was treated with LORATADINE at a dose of 10 mg. At the time of the report, DERMATITIS ALLERGIC (Vaccine related skin reaction/allergic reaction), VACCINATION SITE CELLULITIS (Spreading and cellulitis-like near vaccination site upper L arm), VACCINATION SITE PRURITUS (Itching sometimes/itchiness/scratching injection site), VACCINATION SITE SWELLING (Bump on injection site) and VACCINATION SITE ERYTHEMA (Redness) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment also includes Azithromycin and sulfamethoxazole trimethoprim.  lab test also includes CBC w/diff, CMP, CRP drawn on 02/09/2021.
9-1-11 7:00 am c/o both hands itching , "red & white" . Blotchy noticed by mom. 8-31-11 playing in sandbox for 1hr.
I have had Tinnitus in both ears for over a year now.  A week and  a half after receiving the shot, my Tinnitus has gotten much worse.  It is a high pitch sound.  Over the last year it has subsided significantly; however, now it seems to be getting worse.  In addition, periodically the sound increases significantly.
Elevated blood sugar level at over 200/A1C Spike; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD GLUCOSE INCREASED (Elevated blood sugar level at over 200/A1C Spike) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 4031A21A and 4002A21A) for COVID-19 vaccination.     Concurrent medical conditions included Osteomyelitis (Both knees) since 01-Jan-2003, Diabetes (Managed by increased after injections) since 15-Sep-2018, Drug allergy (Allergic to Lisinopril) and Blood sugar abnormal since 01-Jan-2017. Concomitant products included LOSARTAN, EMPAGLIFLOZIN (JARDIANCE), METFORMIN and LIRAGLUTIDE (VICTOZA) 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 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced BLOOD GLUCOSE INCREASED (Elevated blood sugar level at over 200/A1C Spike). At the time of the report, BLOOD GLUCOSE INCREASED (Elevated blood sugar level at over 200/A1C Spike) had not resolved. Not Provided    For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Before the vaccine Patient had digestive distress due to Metformin.So that patient was using Empagliflozin and Glipizide .Blood Glucose was low 100's and A1C was 7.2 Other Concomitant medications includes NSAIDS, Zypon for  digestion and Mag R & R for leg cramps   It was reported that Patient was also taking Probiotics,Magnesium,Calcium-D Gluconate,Oregano oil,Digestive enzymes   Most recent FOLLOW-UP information incorporated above includes: On 11-Jun-2021: Additional information received and patient demographics details, medical history, second dose details, outcome of the events and treatment details were updated. On 22-Jul-2021: Follow-up information received on 22-JUL-2021, updated relevant history and concomitant medications.
pt. recvd 2nd dose of hepatitis B vac & exp. swelling of the eye,pruritic red face,hot flashes, & low grade fever.tx meds.
This spontaneous report was received from a physician via a company representative concerning a female patient of unknown age. No concurrent conditions or medical history was reported. On an unknown date, the patient was vaccinated with ZOSTAVAX one dose once (dose, route and anatomical location of administration were not reported). No concomitant therapy was provided. On an unknown date, the patient developed shingles (herpes zoster). No Product Quality Complaint (PQC) was involved. The outcome of herpes zoster was unknown. This is one of several reports received from the same source. Additional information has been requested.
Patient states that she was vaccinated on 1/4/2021. She is stating that she is in pain and went to get a MRI a few days ago. The doctors told her that she has fluid in the joints from post vaccination. The doctor also mentioned to her that she needs to see an orthopedic surgeon to remove the liquid.
on 2/8 developed cough  on 2/13 to Hospital Emergency Room, diagnosed viral pneumonia on  2/15 back to ER, admitted, diagnosed with pulmonary embolism  on 2/20 to ICU, intubated and put on ventilator on 3/3 died from pneumonia due to COVID-19 per death certificate
Pt received Pfizer both doses. Admitted to the hospital on 8/7/2021 d/t generalized weakness. Pt was COVID positive d/t exposure. Pt did not require oxygen throughout admission
Patient received COVID Moderna second dose of vaccine on 2/2.  Reports abdominal pain, body aches, fever, headache and congestion  that started several hours later that continues into 2/4 Per PCP, rest, hydration and Tylenol for treatment
Injection site inflammation. Injection site redness. Injection site swelling. Injection site warmth. From initial information received on 25/Nov/2003 from a registered nurse regarding an adverse event occurring in the USA, it was reported that a five year old female patient received her fifth dose of DAPTACEL, lot number C1606AA, administered intra-muscularly in the left arm, a fourth dose of IPOL, lot number W1582, administered subcutaneously in the left arm, a second dose of MMR, lot number 6244N/0608N, manufacturer Merck, administered subcutaneously in the right arm. Two days later, the patient developed redness, warmth and swelling of the left arm. Reportedly, the patient recovered from these events. The reporter of this case is the same reporter of cases 2003-03263, 2003-03264, 2003-03266, and 2003-0367.
Shingles after 1st shot; Rash; Pain; Discomfort; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In February 2023, the patient received the 1st dose of Shingles vaccine. In February 2023, 5 days after receiving Shingles vaccine, the patient experienced shingles, rash, pain and discomfort. The patient was treated with emollients and protectives (Moisturizing Cream). On an unknown date, the outcome of the shingles and rash were unknown and the outcome of the pain and discomfort were recovering/resolving.   It was unknown if the reporter considered the shingles, rash, pain and discomfort to be related to Shingles vaccine.     Linked case(s) involving the same patient:  US2023032782   Additional Information: GSK receipt date: 24-Feb-2023 Reporter's comment: This case was reported by a patient via interactive digital media. The patient stated that he/she got shingles outbreak after the 1st shot.  The patient asked his/her primary care physician that if 1st shot triggered the outbreak, as physician confirmed that he/she had Shingles 5 days after the shot. The physician replied that it was not a big deal and prescribed acyclovir and gabapentin, and recommended applying a moisturizing cream  to the rash.  The patient was in second week of the outbreak and he/she said that the pain and discomfort were manageable.  The patient was not discouraging anyone from getting vaccinated, but was just telling everyone what they need to know. Additional Supportive Information: The follow-up could not be possible as no contact details were available. As acyclovir and gabapentin were prescribed to the patient but was not whether the patient had started the prescribed drugs or not.; Sender's Comments:  US-GSK-US2023032782:Same reporter
patient has not received the second dose; Sickness the day after the shot; The patient also reports a low grade fever; arm soreness; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In November 2019, the patient received the 1st dose of Shingrix .5 ml. On an unknown date, the patient received the 2nd dose of Shingrix. In 2019, less than a year after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced pain in arm. In November 2019, the patient experienced sickness and low grade fever. On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the pain in arm, sickness and low grade fever were recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the pain in arm, sickness and low grade fever to be related to Shingrix.  Additional details were received as follows: The patient received his first dose of Shingrix in November last year.  Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination. The patient also reported a low grade fever, sickness the day after the shot, and arm  soreness with the first dose. The reporter consented o follow-up.
Employee noted erythema at the injection site for 7 days. She also has noted an intermittent Lt upper arm aching, especially when lifting heavy objects. It is getting better over time.  She is taking Aleve, which helps.
Case number PHEH2016US029301 is an initial spontaneous report received from a nurse on 07 Nov 2016. This report refers to a 41 year old male patient. Medical history and concomitant medication was not reported. The nurse stated that first temperature excursion of FLUCELVAX Quadrivalent on 18 Oct 2016 at 52 Fahrenheit (F) for 1 hour, second excursion of FLUCELVAX Quadrivalent on 23 Oct 2016 dropped low 6 times to 34 Fahrenheit (F) and lasted 30 minutes each time, it was unknown if vaccine was frozen. The patient was vaccinated with FLUCELVAX Quadrivalent (batch number: not reported) at a dose of 0.5 ml intramuscular on 24 Oct 2016. Third time excursion on 02 Nov 2016 down to 32 Fahrenheit (F) 3 times over the course of 12 hour. It was unknown if vaccine was frozen. Nurse did not know which lot was given to which patient. No adverse event was reported following this administration error.
Not received the second dose after 42 days; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Not received the second dose after 42 days) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 28-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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Not received the second dose after 42 days). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Not received the second dose after 42 days) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This report refers to a case of Inappropriate schedule of vaccine administered for mRNA-1273, lot # unknnown  with no associated AEs.; Sender's Comments: This report refers to a case of Inappropriate schedule of vaccine administeredfor mRNA-1273, lot # unknnown  with no associated AEs.
Except for mild soreness in arm, felt perfectly fine for f, s and sun.Then,  Awoke at 3 AM dizzy, difficulty balancing, severe vomiting and diarrhea. Felt like food poisoning with a horrible hangover. I felt like I wanted to die. For 90 min, My head was on the toilet seat or agsainst the floor. No one else in my house got sick snd we all ate the same meal. Couldn?t hold my head up. Felt terrible next day, vomiting had stopped, but diarrhea and dizziness/ lightheaded persisted. Missed  full day of work on mon, 1/2 day on tues. I?m 90%better, but still with residual lightheadness snd feel off balance  when I move my head or change position quickly.  Had covid back in March - no respiratory sxs, just HA, congestion, sore throat, snd no sense of taste or smell for 6 weeks
Got the vaccine and nothing for a week. On 01/18/2021 I woke up that morning and I had a red spot that itched really bad at the injection site. Round area about 3 inches in diameter. I have tried different things to control the itch, took a baking soda bath, what works the best has been wetting a bar of soap and rubbing it on the area until it leaves a white paste on the area and then leaving it to dry.   Has left a message for doctor and has not received a call back.
12 hours after my vaccine I had a fever, chills, headache and arm pain. This lasted 24 hours. After 48 hours my arm still hurts ans I have a large red circle on the arm of the injection site.
Swelling bump below the injection site; Bruise at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Swelling bump below the injection site) and VACCINATION SITE BRUISING (Bruise at injection site) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE MASS (Swelling bump below the injection site) and VACCINATION SITE BRUISING (Bruise at injection site). At the time of the report, VACCINATION SITE MASS (Swelling bump below the injection site) and VACCINATION SITE BRUISING (Bruise at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment information was reported.
pt sustained punchline wound to hand 10/29/07 received Tdap 10/30/07-swelling and erythema approx 3 cm x 2 1/2 cm at injection site. No lymphadenopathy
Patient received Pfizer Covid-19 >12yo  dose instead of pediatric (5-11yo) dose.
Breakthrough case admission after 2 vaccines Moderna 1/15/21 lot# 037K20A;  Moderna 2/12/21 lot# 037K20A
Patient went to the school to lift weights the next day after receiving the Tdap vaccine. His eye started swelling shut, his lips got swollen. He was wheezing and having difficulty breathing. His mother took him directly to the ER, which was 2 blocks away. He was treated with Subcutaneous epinephrine, IV Benadryl, IV Solumedrol, and received an albuterol neubulizer treatment.
caught every cold that came in the way; Initial information received on 12-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer or non-healthcare professional via social media.  This case involves patient (unknown demographics) who caught every cold that came in the way (nasopharyngitis), when received vaccine INFLUENZA VACCINE.  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer, lot number not reported) via an unknown route at an unknown administration site prophylactic vaccination.  On an unknown date, the patient caught every cold that came in the way (nasopharyngitis) (unknown latency) following the administration of INFLUENZA VACCINE.  Laboratory details were not reported.  It was not reported if the patient received a corrective treatment.  The event outcome was unknown for nasopharyngitis.  There will be no information available on the batch number for this case.
Fever; Age reported as 0.66 years; Literature report:   This literature marketed report was received from the authors in a published literature article titled as stated above, regarding an infant female patient, which age was reported as "0.66 years", from an initial group of 204 patients (84 female and 120 male patients; enrolled in a study, which aim  was to evaluate the safety of live virus vaccines and the characteristics of the recipient population that are associated with successful live virus vaccination (LVV) post liver transplant (LT).  On an unknown date, the patient received a LT, along with an immunosuppressive regimen of tacrolimus and Mycophenolate mofetil (MMF) (doses, routes and frequencies were not reported). It was reported that, pre-transplant, the patient was Negative for the IgG of the corresponding vaccine  On an unknown date, "3 years" after the LT (discrepant information),  the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) (lot #, expiration date, dose, route and frequency were not reported) along with varicella virus vaccine live (oka/merck)(manufacturer unknown) (lot #, expiration date, dose, route and frequency were not reported) for prophylaxis.    On an unknown date, the patient experienced fever that was considered a side effect from the 2 received vaccines.  At the reporting time, the outcome of fever was not reported. The authors considered the event to be related to measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) and varicella virus vaccine live (oka/merck)(manufacturer unknown)   A copy of the published article is attached as further documentation of the patient's experience.  This is one of several reports obtained from the same literature article.; Sender's Comments:  US-009507513-2201MEX008251: US-009507513-2202USA001022: US-009507513-2202USA001023:
10 min. after receiving shot; patient stated she was feeling "funny", then started stating her vision was blurry; then minute after onset began to complain of SOB, lightheadedness and nausea; then her eyes and face began to swell and cont. shortness of breath.
Headache on top of her head and vice-like pain 5/7/10. Pain sometimes alleviated with Tylenol - onset 2 days post Yellow Fever vaccine (Same as husband) but persists to this day.
Fever of 106.3 for 3 days. Sever chills, fatigue, breasts sore.
little bumps all over her body, on her back, stomach, back of knees, breasts and tops of thighs; This is a spontaneous report received from a contactable female consumer (patient). A 57-years-old female patient received a second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: Unknown) via unspecified route of administration on 23Apr2021 00:00, as a SINGLE DOSE for COVID-19 immunization. Patient has history with past dose of BNT162B2 on an unspecified date. Concomitant medication of the patient was not reported. Patient received second dose on 23Apr2021, then on Monday she developed little bumps all over her body, on her back, stomach, back of knees, breasts and tops of thighs. Her two sisters who live with her aged 56 (INT 227111) and 55 (INT 227113) also developed a similar rash after developing symptoms. Outcome of the event was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
pt recvd vax;day p/ vax crying constantly (shrill), shaking, head thrashing for approx 48 hrs; denires resp sxs; no fever noted;
On 9/25/04 patient reported mild fever (100) and sore throat.  On 9/26/04 patient developed an itchy, bumpy rash.  Rash disappears when patient takes Benadryl.
A few weeks after vaccine, patient began complaining of heart burn.  She was taken to doctor, but nothing was diagnosed.  It continues so she was taken to her cardiologist.  He has treated her for some time.  Except for a pacemaker, he had said her heart was very strong.  This time he said she was having little heart attacks and was prescribed nitroglycerin.   He subsequentially admitted her to hospital for procedure.  She did not do well after.  After a stay in rehab. she was sent home.  The problems continued.  She was hospitalized again in May.  After several days. she was released to assisted living on May 31.  I visited her that evening and she was still feeling ill, confused, and in pain.  I received a call around 1:00 a.m that she has was not breathing and taken to hospital.  Upon arrival at the hospital, I was told she passed away.  Later, I was informed that her heart wall had ruptured.  Up until this point patient was for her age very healthy and active.  Her doctor had said that she had good healthy heart except for the pacemaker.  Her rapid decline was I believe because of the vaccine.
This spontaneous report as received from a healthcare worker refers to a 4 year old patient of unknown gender. No information regarding the patient's medical history and concurrent conditions was provided. On 20-NOV-2015, the patient was vaccinated with improperly stored dose of VARIVAX lot # L024256, expiration date: 01-JUL-2017, (exact dose, route of administration and injection site were not reported). There were no concomitant medications reported. It was stated that the vaccine underwent a temperature excursion of 20.3 degrees Fahrenheit for 72 hours. Digital Data Logger (DDL) was used to capture the excursion. No previous temperature excursion was reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Initial misuse report received from a healthcare professional on 04 September 2013. A patient (No information was provided regarding the patient) had received an expired (expiry: 16 August 2013) ACTHIB vaccine on 03 September 2013. No adverse event was reported. List of documents held by sender: none.
Pt was given Td, Hepatitis AB and Influenza (TIV) vaccines around 8:30 am on 3/12/13. Pt experienced hives, itching on trunk, arms & legs, swelling in neck around 7:30pm on 3/12/13. Pt's wife stated the rash came & went away several times for 6 days. Pt was not examined by a health care provider.