chrisvoncsefalvay/vaers-outcomes huggingface dataset:
She experience the rashes after taking the 2nd dose; I had a small bumps around on my neck; it look like a sun burn, redness; I had a small bumps around on my neck; it look like a sun burn, redness; This is a spontaneous report from a contactable consumer (patient herself) reported that a female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EW0185) via an unspecified route of administration on 15May2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 27Apr2021 for COVID-19 immunization. It was reported as patient stated that on 20May2021 she experienced rashes after taking the 2nd dose on and "she took 2nd vaccine on Saturday on 15May2021 and yesterday she had a small bumps around on her neck, toady she noticed and it look like a sun burn, redness so she is saying that it might be the side effect of the vaccine or it might be something else and she is allergic too, but she haven't had been experience allergy before". The outcome of the events was unknown.  No Follow-up attempts completed. No further information is expected.
Patient had itching 15 minutes after dose, no visible rashes. No problems breathing. Vital signs were normal. She was given diphenhydramine 50 mg PO .  Itching resolved after 30 minutes of administering diphenhydramine. Vital signs remained stable throughout stay. Patient did not have hives or dizziness or nausea or problems breathing or problems swallowing. She was observed for a total of 60 minutes. She was discharged home and advised to observe and take diphenhydramine every 6 hours for 24 hours. Emergency precautions were discussed. Advised to call her primary provider
KINRIX administered 2/11/14, morning of 2/13/14 mother called clinic dad reported redness and swelling where shot was given. Reports client feels fine and is afebrile.
Adverse reaction to chicken pox (Varicella) vaccine. Chicken pox like rash.
Employee had varicella vaccination administered in her right upper arm on 1/23/18; on 1/24/18 her right medial bicep area started becoming red, warm to touch, itching, and a burning sensation over her NEXPLANON (implanted birth control). Her NEXPLANON is located on the right medial lateral side of the upper arm. The area of redness measured 55 x 70 mm; this area was marked with a pen in order to see if it starts spreading. Employee's temperature was 99.7 degrees Fahrenheit when she was here. Employee denies feeling feverish. Consulted provider; will be seen by provider to be evaluated.
Injection site swelling, injection site redness, injection site welts, fever 102, vomiting.
Pain in shot area, down arm. Dizzy, Fever, Nausea, Lethargic, Vomit, No appetite, Hard to focus, Very sleepy.
pt recv vax & devel elevated liver enzymes manifested by GGT of 65, SGOT of 112, SGPT of 130;no further details were provided;
Had swollen  inflamed are around injection site a day after injection, which the disappeared after a couple of days.  However, it reappeared 10 days later and I still have it.
Narrative: obese man with HTN, HLD, GFR=55 not on asa, uncontrolled BP had a CVA. received TPA. CT showed nothing, couldn't do MRI due to obesity
Red swollen L arm-reported by clinic seen by physician and started on antibiotics 3/28/03-no diagnosis.
chills; flu like symptoms; This case was reported by a consumer via call center representative and described the occurrence of chills in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced chills and influenza-like symptoms. On an unknown date, the outcome of the chills and influenza-like symptoms were not recovered/not resolved.   It was unknown if the reporter considered the chills and influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as an adult as per vaccine indication.  After receiving Shingrix vaccine the patient experienced chills and flu-like symptoms. The reporter wanted to know how long do side effects last from  the first shot.
on 6/19/21  Patient came to store for his 2nd Moderna shot. After the shot was given I had staff observe the patient.  In a few minutes the patient felt tired and dizzy.  His wife  said this did not happen with the first shot.    I then had staff call for a code white and I went to assist the patient.  Immunization cart was brought out and I took the patient's BP  167/122 HR  76.  I asked the patient did he have any problems breathing, he said no.  I did inform him that his blood pressure was high and that can contribute to him feeling dizzy.  I continued to ask the patient if he was breathing ok and he said yes.  There was no need for an epi-pen as the patient was conscious and responsive to all my questions.  Where his blood pressure was still high I continued to take his blood pressure.     Blood Pressure remained high at recorded times:  4:06 pm  176/114  hr 73  4:16 pm  151/110  hr 76  4:18 pm  153/102  hr  76  4:19 pm  patient said he tests his sugar twice a day and complains of a headache straight across his forehead  4:26 pm  153/104  HR  74  at this time I was wanting to see if the cuff size played a role in the high blood pressure.  Staff was able to find a meter with a larger cuff size  4:30 pm  159/103  HR  79  wife stated that his BP was on the lower end at home  4:34 pm  patient stated that he's feeling a bit better .  BP still elevated.  4:35 PM  147/103   HR  77  4;36 pm  patient said bottom # rarely goes over 100 but has saw top # the same or higher  4:37 pm patient said he's able to walk and go on about his day.  I was asking about him eating/drinking anything and this is when he mentioned that he drank 2 monsters and had 2 cups of coffee.  I told the patient that this can contribute to him having high blood pressure at this time and asked his wife to monitor his BP when he got home.  I will call them in the morning to make sure he is doing ok.  Note:  patient does not have a PCP verified by his wife.  However standing order doctor will be notified.
Patient left 20 minutes after vaccination. Mother of patient said it started with pt trying to clear throat. soon as they left office while going down in elevator. Pt started wheezing which lead to coughing. Then SOB with heart palpitation Then some chest pain. Visited ER, where he was given O2, Benadryl and inhaler. She was released to her mom and stayed home tired today. Mom called at 9:00 AM 5-11-04.
Chills, body aches, headache, fatigue, weakness, moaning, insomnia
he has had no side effects or problems from the vaccine; expired dose of PNEUMOVAX 23 was administered to a patient; This spontaneous report was received from a pharmacist referring to a 65-year-old patient of unknown gender.  The patient's concurrent conditions, medical history and concomitant medications were not reported.  On 23-JUN-2021, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot # S028601, expiration date S028601) 0.5 mL intramuscularly (IM) (frequency and anatomical location not reported) for prophylaxis. It was reported that the patient had no side effects or problem from the vaccine and that the vaccine had no temperature excursions and was always stored within the recommended temperature range.
Pt was admitted for respiratory distress due to covid 19 infection, pneumonia treated with respiratory protocol, ascorbic acid (VITAMIN C) tablet 250 mg, vitamin D3 (cholecalciferol) tablet 2,000 Units, zinc sulfate (ZINCATE) capsule 220 mg  benzonatate (TESSALON) capsule 100 mg, guaiFENesin (HUMIBID LA) LA tablet 600 mg, azithromycin (ZITHROMAX) tablet 500 mg      enoxaparin (LOVENOX) injection 40 mg, Tiotropium Bromide-Olodaterol (STIOLTO RESPIMAT) 2 Puff  dexamethasone (DECADRON) 4 MG/ML injection 6mg . Respiratory distress resolved, pneumonia improved. Pt was discharged home stable condition, script for abx given, follow up pcp.
Have a sore, reddened throat with significant uvula swelling.  Diminished sense of taste.
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Mar2021 at 15:00 as dose 1, single (Lot number: EN6202), in right arm, on 11Oct2021 at 12:00 as dose 2, single (Lot number: 330125BA), in left arm, on 05Mar2022 at 12:00 as dose 3 (booster), single (Lot number: EP7534), in right arm and on 14Jun2022 at 12:00 as dose 4 (booster), single (Lot number: Fp7135) at the age of 64 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: FLUOXETINE; JARDIANCE; METFORMIN HCL; METOPROLOL; MONTELUKAST SODIUM; OMEPRAZOLE; RAMIPRIL, stop date: 05Jul2022. The following information was reported: DRUG INEFFECTIVE (medically significant), 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: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Eye red; This spontaneous case was reported by a consumer and describes the occurrence of OCULAR HYPERAEMIA (Eye red) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Apr-2021, the patient experienced OCULAR HYPERAEMIA (Eye red). Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
Leg numbness/heating sensations that continued from foot to full leg to both legs and eventually both hands and arms. Constant for several days then on and off for weeks.
Patient received MMR and Varivax 11-7-08.  Developed body rash 11-15-08 pm and became generalized maculopapular and developed fever 11-17-08.
chills, aches, headache, dizziness for 24 hours; nausea, diarrhea, decreased urination for 5 days
Developed keratitis in L eye the following morning.  On steroid drops for three weeks beginning the day of the doctor's appointment.
Client fainted approximately a minute after receiving vaccine, regained consciousness fairly quickly, no injury occurred. No interventions needed other than propping of legs and monitoring for safety/return to baseline.
had 1st in July 2022, I am scheduled for my 2nd dose tomorrow; This case was reported by a consumer and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (1st dose received in early July 2022).   On an unknown date, the patient did not receive the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 23-FEB-2023 Reporter's Comment: The patient self-reported this case. The patient stated that he/she scheduled his/her booster dose on 24th February 2023. The patient reported that this was just 1 month over the 6 months window for the shingles booster. The patient wanted to know did he/she need to get another booster given due to the extra more than 30 days past the 2 to 6 months' time frame. Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose of Shingles vaccine, which led to incomplete course of vaccination.
I received the Covid vaccination on 03/01/2022 and nerve conduction testing on 03/09/2022.  A week later I began to experience severe migraines and Tinnitus along with painful muscle spasm along my right leg and right arm.  Days later, I was burdened with a painful right shoulder, painful right elbow, extreme tremors at my right leg, right foot, right arm, and right hand.
Patient developed red rash on both sides of body and on spine after second Shingrix dose.  Patient describes it just as red rash but it is not painful or itchy.  Patient told to contact primary care provider for further evaluation and that he can use Benadryl if needed.  As of March 17th at 8:30 pm patient had not taken anything or contacted his provider yet.
This spontaneous report as received from a pharmacist refers to a 56 year old female patient. Pertinent medical history and drug allergies were none. On 09-SEP-2015 the patient was vaccinated with ZOSTAVAX, 0.65 ml, subcutaneous (lot # 1011533; expiry: 03-APR-2016). Concmitant therapies included XANAX, ENDOCET, Lisinopril (manufacturer unknown), LASIX, BENICAR, clonidine, ZYRTEC, MOBIC and morphien sulfate (manufacturer unknown). The pharmacist reported that on 11-SEP-2015, the patient developed a slightly raised red area around the injection site "about 2 inches wide" after receiving ZOSTAVAX. No treatment given for events. No further information was provided. The outcome of injection site erythema and injection site swelling was reported as not resolved. Causality assessment was not reported. Additional informatino has been requested.
~1830 19Mar; 101.3 fever recorded, nausea - TX with 200mg Ibuprofen ~2130 19Mar; 100.5 fever, whole body muscular shivering, body sweat, disorientation ; TX with clear fluid hydration and rest ~1100 19Mar; 99.4 fever recorded -TX rest ~0210 20Mar; 102.6 fever recorded-TX 200mg Ibuprofen, clear fluid hydration ~0445 20Mar; 99.2 fever recorded - TX rest ~0940 20Mar; 98.5 temp recorded, fatigue; TX clear fluid hydration, rest ~2000 20Mar; 98.6 temp recorded, upper arm rash present below injection site, slight itch to the touch, rash present for 5 days  - TX none -Injection site muscular soreness persists throughout the week following the administration of vaccine consistent with previous PX vaccinations
Anaphylaxis Narrative: 12/22 received COVID-19 vaccine at 1209 and developed SOB at 12:15. Took her own albuterol inhaler without relief. Transported to ED. PE: red hands with swelling, throat and lip swelling with difficulty swallowing. Later developed headache and dizziness then tachypnea and stridor. Meds given - See section 5 PLUS epinephrine IM and infusion @ 0.05 mcg/kg/min, Alb and ipratropium negs, racemic epi nebs. Admitted to the hospital on 12/22 and still hospitalized at the time of this report on 12/23. She remains on an epinephrine drip and was given methylprednisolone 125 mg IV x 2. No previous history of anaphylaxis. History of Reye's syndrome as a child when given aspirin.
Client received vaccine approved for ages 18 and up. Client was 17 at the time of the injection.
pt recvd vax 7APR94, devel high fever @ approx 12MN t103, swelling of rt leg, edema of face & lips; edema of rt leg was 2 times size of lt leg; seen in ER; pt cries when rt leg touched, warm induration area around inject site rt thigh;
Vial had been removed from deep freezer and placed into cooler longer than prescribe timeline outlined by Pfizer. Administered into patient (employee) prior to issue being identified. Pfizer states unlikely to have harmful effect, however cannot guarantee effectiveness. ID physicians recommend offering 3rd dose ~3-4 weeks, which will be done
Severe hives, blisters, swelling over entire body. Took Benadryl but did not help. Saw doctor on Oct 21, prescribed 40 Mg prednisone P/Day over 7 day period, and antihistimines. Never had a allergic reaction before.
Discharge Provider: MD Primary Care Provider at Discharge: DO Admission Date: 9/29/2022 Discharge Date: 10/2/2022  PRESENTING PROBLEM: Acute respiratory failure with hypoxia  COVID-19 virus infection COVID-19    HOSPITAL COURSE:  Patient is a 28 y.o. female PMH asthma taking QVAR who presents today with shortness of breath.  Patient is vaccinated for COVID-19 with posterior.   Patient states that up until Tuesday 09/27/2022 she had been in her usual state of health.  She and her boyfriend went to the zoo on Tuesday.  Within several hours of returning home patient started to experience sore throat, body aches, decreased appetite and chills.  On 09/28/2022 she started to experience increased shortness of breath, wheezes, cough.  She required home nebulizer treatment 5 times on Wednesday.  She stated that on Wednesday body aches worsened.  Today, patient required 7 nebulizer treatments to improve shortness of breath.  She stated that this improved his shortness of breath for about an hour max.  Wheezing, shortness of breath, cough would reoccur within 15-30 minutes.  She also started to develop diarrhea.  She took a home COVID test which was positive.  The patient decided to seek further care in the ER.   Initial vitals in ER were reassuring.  Labs notable for bicarb 19, BUN 7, CRP 19.5, lactic 1.1, WBC 5.57.  D-dimer 340. Chest x-ray negative for acute process.  Patient had improved with albuterol treatments while in the ER.  However when obtaining a ambulatory pulse ox, patient's oxygen saturation decreased to 86% she was placed on 2 L nasal cannula oxygen saturating in the low 90s.  Additionally patient became afebrile with temp of 37.8.  While in the ER, patient received acetaminophen 1000 mg orally, methylprednisolone 125 mg IV.  Hospitalist asked to admit patient for management of asthma exacerbation and COVID-19.   Patient was treated with dexamethasone and remdesivir and respiratory treatments.  Her symptoms improved and she was weaned off oxygen.  She was able to tolerate a solid diet.  She did not qualify for home oxygen.   Patient was discharged home in good condition
cyst on lung; Bladder infection; rash on arm all way to elbow; This spontaneous case was reported by a consumer and describes the occurrence of LUNG CYST (cyst on lung), CYSTITIS (Bladder infection) and RASH (rash on arm all way to elbow) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 08-Mar-2021, 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced LUNG CYST (cyst on lung), CYSTITIS (Bladder infection) and RASH (rash on arm all way to elbow). At the time of the report, LUNG CYST (cyst on lung), CYSTITIS (Bladder infection) and RASH (rash on arm all way to elbow) outcome was unknown.            No treatment information was provided by the reporter. No concomitant information was provided by the reporter.    This case was linked to US-MODERNATX, INC.-MOD-2021-075066 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-075066:dose 1 case
administer expired vaccine to patients, after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration) in a 58-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 070H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 12-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information provided.  The vial did not undergone to any temperature excursions. No treatment medication information provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Live FU received with non significant information
Pain in left arm lasted for over 1 month feeling like shot was just given.  Then progressed to shooting pains in left arm, numbness and pins and needles in arm and face on left side. Wake at night with left upper arm pain and left hand asleep.  Now feeling some pins and needles in left lower leg also.  Shoulder is frozen decreased range of motion.  Dr. took x-ray and it looked normal.  Prescribed Gabapentin, 100 mg 3 x a day.  No relief from medication.  Have been referred to physical therapy for loss of range of motion.  Have not had first appointment yet.
inflammation; rashes all over her face/ rash is on both sides to the neck and chest, it itched; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A 50 year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administration date 14Oct2021 (Lot number: FF8841) at the age of 50 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Breast cancer" (ongoing). Concomitant medication(s) included: TAMOXIFEN taken for breast cancer (ongoing). The following information was reported: RASH PRURITIC (medically significant) with onset Oct2021, outcome "not recovered", described as "rashes all over her face/ rash is on both sides to the neck and chest, it itched"; INFLAMMATION (medically significant), outcome "unknown", described as "inflammation". Therapeutic measures were taken as a result of rash pruritic, inflammation which included steroid shot for inflammation, desonide cream, and hydroxyzine tablets (LOT-155909). Clinical course was described as follows: the rash started 2-3 days after the first dose, it was on both sides to the neck and chest, it itched. The rash is still visible. The patient got the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot: FJ1620) on 23Nov2021.  Follow-up (29Nov2021): Follow-up attempts are completed. No further information is expected.
received Trumenba and Bexsero at same time; This case was reported by a nurse via call center representative and described the occurrence of overdose in a patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis and MENINGOCOCCAL B VACCINE (TRUMENBA) for prophylaxis.   On an unknown date, the patient received Bexsero, Bexsero Pre-Filled Syringe Device and TRUMENBA. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced overdose. On an unknown date, the outcome of the overdose was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Trumenba and Bexsero at same time, which led to overdose. The reporter did not consent to follow up.
Very painful when needle injected. Gradually worsening as day progressed. By 2:30 very intense which continued in right deltoids. Could not forward flex or abduct right arm .  10 on pain scale. 10/23 gradually improving, decreased pain, increased range.