chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a male patient of unknown age referring to himself. Information about medical history and concurrent conditions were unspecified. On an unknown date, the patient was vaccinated with ZOSTAVAX (lot number, dose and route were unknown). Concomitant medications were unspecified. On an unknown date the patient developed contracted shingles, the patient was reluctant to provide any additional information on his condition. The outcome of the event was unknown. The causality between the event and ZOSTAVAX was not provided. No PQC involved Additional information is not expected because there's no contact details.
Menstrual cycle ended after one day. Typical menstrual cycle last 5-7 days. The menstrual cycle has not resumed.; This is a spontaneous report from a contactable reporter (consumer or other non HCP). The reporter is the patient.  A female patient (not pregnant) received bnt162b2 (BNT162B2), administered in left arm, administration date 28Dec2021 at 09:30 (Lot number: FL3197) as dose 1, single for COVID-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: AMENORRHOEA (non-serious) with onset 29Dec2021, outcome "not recovered", described as "Menstrual cycle ended after one day. Typical menstrual cycle last 5-7 days. The menstrual cycle has not resumed". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of amenorrhoea.  Additional Information: The patient reported that there was no possibility of pregnancy. There were several negative pregnancy tests. Known allergies was reported as not available (N/a). The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.
As of 1/5/2021 i experienced itchiness at the injection site.  The next morning more itchiness and redness and swelling at the injection site.
The day after 2nd dose of vaccine, pt reported fever and rash/swelling on face, torso, arms. Pt came to pharmacy and reported this 2 days after vaccine dose and no longer had fever but still had rash and some swelling. Pt was taking cetirizine to self treat. Pt was recommended to instead take diphenhydramine and follow up with urgent care, especially if reaction does not get better or gets worse.
The patient presented on 10/10/19 with generalized weakness, dysphagia, worsening numbness and tingling in her fingertips, feet, and tongue. Symptoms were much ore severe in her legs compared to her upper extremities. In the ED she was found to have a BP of 208/92 and a pulse of  56 bpm. She was admitted to the ICU and started on a Cardene infusion. Neurology was consulted and saw the patient on 10/11. Gullain-Barre Syndrome was suspected. A lumbar puncture was performed and IVIG 25g every 18 hours (2grams/kg over 5 doses) was initiated.  The lumbar puncture was consistent with Guillain-Barre syndrome with albumino cytologic dissociation. The patients symptoms persisted through 10/13. On 10/14 the patient's numbness and tingling began to improve. By 10/17 the patient symptomatically improved and ready to be discharged, though still very weak and required rehabilitation after discharge.
Fever 101.4 on 11/04/2001. Rash started 11/05/2001. Macular rash, no symptoms of itching; rash generalized; palms and sides spared. 11/06/2001 Seen in office, generalized rash, markedly erythmatous. 11/07/2001 Rash began to fading and resolving.
Child had a brief (45 second) classic febrile seizure 14 hours after receiving the flu vaccine.
Received pneumococcal vaccine in afternoon. By the evening of sameday 02/28/2003, noticed swelling, redness, chills, fever, SOB. Seen in medical center 03/01/2003. Dx as possible cellulitus. Rx with Keflex 500mg qid x 10 day and Darvocat N 100 4-6 hours for pain. Seen in medical center 03/03/2003. Swelling decreased. Rx Predisone 20mg qd x 3 days with Keflex.
pt recv vax; exp fever of 103 & rash around neck; exp cold sore on lip;
Left arm became erythematous, swollen, and warm to touch approximately 24 hours after injection. No signs of anaphylaxis though
Td shot 11/17/05. 11/19/05 developed redness and warmth of arm 12cmx7cm.
After administration of the vaccine, she developed slight redness where the bandage was placed and felt slightly lightheaded/dizzy. She sat for a few minutes and felt well enough to leave. Follow up call was made that evening and she felt fine and nothing further to report. She came back to the pharmacy on 10/27/2018 with her husband for his vaccine and she had a slight bruise where the vaccine was administered.
After vaccine, patient became pale, diaphoretic and neauseated.  Weak radial pulses.
The patient has experienced persistent dull headaches, a sore neck (onset 3/30/03), swollen lymph nodes in the armpits and neck, chills and nightsweats (3/31/03-4/1/03; no fever), and considerable fatigue (at times, it has been difficult for the patient to stay awake for more that 2-3 hours).  She was evaluated by her primary care physician (4/10/03), and the physician determined that the patient did not have encephalitis.  Ultracet was prescribed for the patient's headaches, but the medication did not help.  The patient was seen again by her physician on 4/15/03 and naprosen was prescribed for the patient's sore neck.  As of 4/18/03 the patient's neck was feeling much better, but she was still experiencing dull headaches and fatigue.  She has been referred to a neurologist, but no appointment date has been set.  The patient has already missed 10 days of work due to this illness.  NOTE: The patient has a history of migraines, but she indicated that her current headaches do not feel like migraines.
FEVER, CHILLS, BODY ACHES, LOSS OF APPETITE, HEADACHE
Information has been received from a certified medical assistant concerning a female, approximately 12 years old, who was vaccinated with Gardasil. Subsequently, the patient experienced a delayed period of one month. The patient's menstrual cycle returned to normal on it's own and the patient was reported to be recovered. Additional information has been requested.
Chills for 1 hour,;  headache and severe fatigue for 18 hours
Upper left arm area where received vaccine broke out in a red itchy rash after a little over a week, lasted 3-4 days, red area about 2-3 inches in diameter.
pain in injection site.  I noticed today that my skin had peeled away at the injection site after my son pointed it out.  There is a large square and  of skin peeled away.  The skin is also discolored.
Pt. got reaction from VARIVAX 3 days after vaccination, on injection area redness, swelling and itching. Pt. reported to clinic 2 weeks after vaccination, stated getting better.
received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received dose from vials beyond 30-day use by date) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received dose from vials beyond 30-day use by date). On 22-Jul-2021, EXPIRED PRODUCT ADMINISTERED (received dose from vials beyond 30-day use by date) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment medication use was reported.
This spontaneous report as received from a pharmacist via a company representative concerning a 64-year-old female patient. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 02-JUL-2018, the patient was vaccinated with a dose of ZOSTAVAX lot # N026815, expiration date 25-DEC-2018 (exact dose and route of administration were not reported) for prophylaxis. The vaccine was reconstituted with sterile diluent (lot # and expiration date were not reported). On an unknown date after the vaccination, in July 2018, the patient experienced rash and itching at injection site. The patient sought medical attention by calling the pharmacist. The pharmacist recommended the patient to use ice, unspecified topical steroids and BENADRYL as treatment. On 07-JUL-2018, the patient called the pharmacy and reported that rash had resolved (reported as rash had cleared up, the exact date was not reported). The causality assessment between the events and suspect therapies was not provided.
Pt. rep called 2/23 reported rash - pt. was advised to cover rash, take BENADRYL, report to Dr. if condition worsened. 2/25/12 - Pt. rep called - pt. went to ER on 2/24/13 - with chest pain, rash and swelling of lips and ears.
rash all over body-diffuse welts all over body per ER nurse that cared for pt; Epi x 2 pt stayed approx 2 hrs;
Patient has history of ITP (Immune related thrombocytopenia) which recurred after receiving her 2nd dose
Patient called pharmacy on 10/31/19 stating that her arm was still painful and sore from flu shot she received on 9.30.2019. She also stated that at times, she had experienced numbness and tingling in her fingers.
This spontaneous report has been received from a licensed practical nurse referring to a 9 month old patient of unknown gender. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not reported. On 14-MAR-2018, the patient was vaccinated with VAQTA (strength, dose, route, anatomical location, lot number and expiration date were not provided) for prophylaxis. No adverse events were reported.
All over body rash, itchy, sweaty, hot, cool and clamy skin, pulse 110-120bpm,lasted about 1-1 1/2 hours. No treatment. Did deep breathing and took a shower. Symptoms resolved on their own. I did have a very sore arm for about three days after the administration of the vaccine. Redness to the injection site with a knot under the injection site for three days.
Patient presents to clinic with right deltoid soreness and shoulder pain at injection site after receiving the flu shot.  She received the flu shot on November 20th.  Symptoms have persisted since.  She denies other injury or trauma.  Patient reports pain when she lays on her right side to sleep.  Also pain when working out in the gym or raising her arm.  She has had the flu shot in the past without issues.
Patient experienced shortness of breath and anxiety within 15 minutes of vaccine administration. No indications of anaphylaxis. EMS assessed client and released to home.
Her arm (around injection site) got redness and swollen so her PCP gave her Prednisone 20 mg (1 po qd) x 7days.
Itching feet and hands, fever, nausea, diarrhea and aching in joints.
Onset fever day of vaccine, max temp (103.5 x 4 d), stomach pain, fatigue since shot given.
Moderna COVID Vaccine EUA   I have what is being called "covid arm".  I have a red rash, that is swollen and hot.  It also is itchy.   It is about a 6" by 6" spot.  I have taken ibuprofen and applied ice.  This is the third day of the rash.  It appears to be getting smaller.  The information I have read says it going to take 5-7 days to resolve itself
pregnancy; no additional AE; This spontaneous prospective pregnancy report was received from a healthcare business professional who was a practice manager referring to a 23-year old female patient. The patient's concomitant medication and historical condition were not provided.  On an unknown date, the patient who was 29 weeks pregnant was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, dose, route, lot# and expiration date were unknown) for prophylaxis (Vaccine exposure during pregnancy). No additional adverse event. The dates of last menstrual period (LMP)and estimated date of delivery (EDD) were not provided. The pregnancy outcome was outcome pending.
Vaccine was stored in refrigerator on 04-Jun-2022 and administered on 13-Jul-2022; No adverse event; Administered the vaccine to patient after the 30 day use by date; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to patient after the 30 day use by date), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered on 13-Jul-2022) and NO ADVERSE EVENT (No adverse event) in a 65-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milligram. On 13-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to patient after the 30 day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered on 13-Jul-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to patient after the 30 day use by date), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered on 13-Jul-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to patient after the 30 day use by date) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered on 13-Jul-2022).    No concomitant product use was reported.  Patient received half dose.  Vial did not undergone any temperature excursions.  No treatment information was provided.
On 11/07/2021 I started getting ear pain. On the 10th I went to the clinic I had an ear infection, lips numb, tongue numb. On 11/13/2021 I was diagnosed with Bell's Palsy. Left side of face is numb. I am now on 10 days of steroids.
Immunization at 2:50PM began high pitch screaming at 4PM screaming lasted over 3 hrs.
SUSPECTED GUILLAIN BARRE SYNDROME; This spontaneous report received from a patient via a company representative concerned a patient of an unspecified age, sex, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number and expiry date were not reported) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced suspected guillain barre syndrome. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected guillain barre syndrome was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20220410424-COVID-19 VACCINE AD26.COV2.S -Guillain-Barre syndrome.These event are labeled per RSI and are therefore considered potentially related.
Arm pain began on 1/2 at approximately 4 pm and gradually worsened. Was significantly improved by the next morning; however, lower back pain began around 4 pm on 1/3 and gradually worsened, peaking on 1/4 and 1/5. This is still slowly improving. Appears to be some sort of sacroiliac joint inflammation.
Loud sustained Tinnitus, fatigue, brain fog, numbness, headache started on April 18th following 2nd booster of Moderna. Previous 3 shots were Pfizer and was told it was ok to take Moderna for 2nd booster.   14 day course of prednisone was given with no sustained relief. Sumatriptan prescribed but no relief.  Required increase in anxiety medication which helps to cope with disability the symptoms have caused.
11/10/19 couldnt get out of chair or walk. Weakness of R lower extremity. Decreased sensation of R upper extremity.  11/11/19 Went to ER and admitted to hospital.  Receiving IVIG 0.4g/kgx 5 days, Sodium Choloride 0.9% 500ml iv, tylenol, Benadryl 50 mg.  11/14/19 intubated,  11/16/19 extubated, 11/17/19 intubated.
On 06/11/03 patient was hospitalized for a Strep Infection. Blood culture was found to be positive for Strep Pneumo. Patient Recovered.
Syncope approximately 5 minutes after vaccination given. Patient given fluids (water/apple juice), rested in office, blood pressure normal. Patient left office with father after 10 minutes without incident.
Headache, fever (102),  nausea, rash all over the body, swelling in the arm of the injection
Edema and pain in armpit - starting 5 days after receiving booster. Hard to put arm completely down to side. ADVIL & ALEVE for discomfort. Significant swelling from edge of bra around to back.
The patient has a history of CHF, brain tumor, and myocardial infarction. He was seen in the ED on 10/20/23 and reported that he tested positive the day before (10/19/23). He reported cold symptoms - cough, weakness, and fever of 102 F - as well as increased weakness. Ultimately the patient was admitted 10/20/23 - 10/25/23 with acute respiratory failure with hypoxia due to COVID-19 infection. He was found to have O2 sats at 88-90% on room air so was initiated on supplemental oxygen. Additionally, he was noted to have an elevated troponin in the ED. The ED provider discussed with cardiology who believed this represented nonischemic myocardial injury likely due to COVID-19 infection. 2D echocardiogram showed an EF of 49% with regional wall motion abnormality involving the mid to distal inferolateral walls that was present in November 2022 as well. During his admission, the patient was able to wean off oxygen.   Of note, the patient has received the Pfizer Monovalent COVID vaccine (administered 1/14/21; 2/4/21; 8/27/21) and the Pfizer Bivalent COVID vaccine (administered 9/18/22; 6/16/23).
Pt recv vax on unknown day; post vax pt exp granuloma at vax site x 1-4 wk; tx=warm packs, move legs a lot, massage
11Dec90 pt vax w/ hepta B; devel fever blister on mouth.  Went to clinic & was given tx.  Clinic felt that event was not related to vax.
Received vaccines 5/16/07. Received Pediarix LT deltoid on 5/16/07. Client returned to clinic 5/18/07 - Had swollen left upper arm, Warmth to touch, intact skin, had induration irregular oval 4 3/8" x 3 24". Circumference L upper arm 7 3/4". Slightly pinker then rest of skin. Child active and alert.
The patient  was given the Johnson and Johnson vaccine on 4/1/2021 and he had already received the first dose of the Moderna  vaccine on 3/17 /2021.
During early morning hours after vaccine given, client had fever of 102 degrees. Also had complaint of headache. Symptoms lasted about 24 hours. Given Ibuprofen by her mother for fever and headache.
Super light, barely-there period May 16 Missed period June 16 long period July 4 -July 19 and ongoing (16 days and counting).: heavy menorragia with large clots (quarter- silver dollar size) cramping.
Patient came back to the pharmacy today and said he thought he was having a reaction to the shingles vaccination. He showed me a rash on his right forearm that he described as extremely uncomfortable, itchy and said it had a strange tingling sensation that concentrated on his arm but would radiate around his body. He also said the same rash was starting to develop on his scalp.
Moderna Covid-19 vaccine expired on 01-Apr-2022 was initially stored in the refrigerator on 04-Mar-2022; Patient received expired Moderna COVID-19 Vccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna COVID-19 Vccine) and PRODUCT STORAGE ERROR (Moderna Covid-19 vaccine expired on 01-Apr-2022 was initially stored in the refrigerator on 04-Mar-2022) in a 61-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 16-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna COVID-19 Vccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Moderna Covid-19 vaccine expired on 01-Apr-2022 was initially stored in the refrigerator on 04-Mar-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna COVID-19 Vccine) and PRODUCT STORAGE ERROR (Moderna Covid-19 vaccine expired on 01-Apr-2022 was initially stored in the refrigerator on 04-Mar-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported.  It was reported that the pharmacist thought that the expiry date of the vaccine was Jun-2022, However the vaccine expired on 01-Apr-2022. On 04-Apr-2022, the vial was initially stored in the refrigerator. Reportedly, the vial didn't undergo any temperature excursions.  No treatment information was reported.
Mom states that 5 days ago (11/30), patient woke up with hives-like rash, gave Benadryl. The following day, rash remained persistent, patient also woke up with puffy eyes and appeared to have facial swelling. Took patient to the pediatrician and allergist, where she received epi x1 and prescribed prednisone (3 day course) and zyrtec. Patient was feeling well  on 12/2-12/3, but on 12/4, patient started to complain more of joint pain, mostly complaining of pain in her neck, back, thighs, and feet, and became less mobile (refusing to get off the couch). Mom notes steroids initially seemed to help with the rash (seemed more flat than previously), but then after the first day of steroids rash worsened again and patient had possibly worsening facial swelling. During hospitalization the rash subsided and a dry cough developed. Albuterol was used to alleviate the cough and was discharged (12/7) on flovent, nasonex, and albuterol.
Vasovagal syncope during blood draw immediately after injection; attempt to relocate so patient could lay down, vasovagal syncope again with loss of bowel control. Remained laying on floor for 45 mins until O2 Saturation and pulse increased. Felt tired and dizzy for the rest of the day.
This spontaneous report was received from a nurse referring to a 18 year old male patient. There was none drug reactions/allergies or medical history. On 12-JUL-2016, the patient was vaccinated with a dose of GARDASIL 9, intramuscularly (dose, lot Number and expiration date were not provided). Concomitant therapy included TRUMENBA. The nurse reported that on 12-JUL-2016, after received GARDASIL 9, the patient experienced a syncope reported as the patient "started to pass out" but he did not lose consciousness. The patient rested and "revived".  Approximately in July 2016, the patient recovered from syncope. There was none lab diagnostic studies performed and the patient did not seek medical attention due to the event. The nurse did not assess the causality between the syncope and GARDASIL 9. Additional information has been requested.
Patient reports she developed symptoms consistent with Raynaud's . Currently being treated for Raynaud's.