chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a physician refers to a patient of unknown age and gender. On 21-OCt-2013 the patient was vaccinated with an expired dose of ZOSTAVAX 19400 PFU (lot # H012519, expiration date 09-OCT-2013) (dose and route were not reported). Concomitant medications were not reported. No adverse symptoms reported. This case is linked to case 1310USA009900 via same reporter link. Additional information has been requested.
This spontaneous report was received from a registered nurse and refers to an unspecified  number of patients of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date, the patients were vaccinated with improperly stored doses of PROQUAD (lot # M001152, expiry date 05-JUL-2017 (dose, route of administration and administration site were not specified). Administered doses of PROQUAD, underwent temperature excursion at 75 Fahrenheit degrees for 1 hour and 10 minutes. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Severe tinnitus in both ears. High pitch frequency constantly, 24/7  (both ears). Sounds like I've been to a heavy metal concert....except I HAVEN'T !!!!! Can't fall asleep at night because of it. Been 11 months since that second injection and I still have it!!! (THIS SUCKS!!!!!!!)
pt recv vax & w/in 24hr post vax pt exp tinnitus;no tx was given; sx persist;
not feeling good today at all; extreme fever reaching 100.4 F; This is a spontaneous report from a contactable consumer (friend). A 51-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient went and got the shot yesterday he was not feeling good today at all. He has a temperature of 100.4. He had an extreme fever reaching 100.4 F. He took ibuprofen instead of Tylenol. The reporter was told to take Tylenol and asking if him taking Ibuprofen did that to him. He just went to eat. He should not have taken ibuprofen and was supposed to take Tylenol. The report was considered as non-serious by reporter. The outcome of events was unknown.  Information on the batch/lot number has been requested.
lt arm swelled all the way to finger tips & broke out in huge welts approx 3 hrs p/inject this started; hives raised about 1/4" DPH cream was given as pt reacts to oral antihistamines;  medicine hurts worst first given;
Injection site pain; tiredness; muscle pain; chills; swollen lymph nodes. Symptoms started three hours after injection and lasted a day and a half, except swollen lymph nodes and injection site pain that lasted a couple of days longer. Patient took acetaminophen and symptoms resolved without further treatment.
SWEAT; FEVER; NAUSEA; HEADACHE; INJECTION SITE PAIN; TIRED; This spontaneous report received from a patient concerned a 36 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included sulfa medications allergy, tramadol allergy, alcohol user, and cigarette smoker, and other pre-existing medical conditions included no drug abuse or illicit drug usage. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 204A21A, expiry: 23/JUN/2021) dose was not reported, administered on 13-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-MAY-2021, the subject experienced sweat. On 14-MAY-2021, the subject experienced fever. On 14-MAY-2021, the subject experienced nausea. On 14-MAY-2021, the subject experienced headache. On 14-MAY-2021, the subject experienced injection site pain. On 14-MAY-2021, the subject experienced tired. Laboratory data included: Body temperature (NR: not provided) 100.9 F. The action taken with covid-19 vaccine  was not applicable. The patient recovered from nausea, and tired on 14-MAY-2021, was recovering from fever, and sweat, and had not recovered from headache, and injection site pain. This report was non-serious.
pt recvd vax & had fever of 104 1 hr p/ immun; lasted 12 hrs even w/ tx of apap then had t 100 next 4 hrs; denies oth sxs, called MD told to cont apap;
MOM AND CHILD DESCRIBE PROLONGED EXHAUSTION/FATIGUE FOR MONTHS FOLLOWING HE FIRST HPV VACCINE
Myalgia, Arthralgia, Fever, UrticariaPruritus, photophobia Narrative: Employee received second dose of Moderna vaccine on 08/30/2021 at 5pm and withing 2 hours, began to experience fever, chills, joint pain, body aches, hives, and sensitivity to light. Reports took Tylenol for symptoms. No other information provided in report.
Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after refrozen; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen). On 15-Apr-2021, EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) had resolved. At the time of the report, PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided  Treatment medication was not provided by the reporter
Primary ADR suspected medication (dose, route, frequency): Covid-19 Pfizer vaccine 0.3ml IM once ADR suspected medication indication: booster Additional medications contributing to ADR: none ADR reaction: The patient stated that his diarrhea started around 11/11/2021, after he received the 3rd shot of Pfizer COVID-19 vaccine.  His diarrhea is mainly watery, with about 5 episodes daily.  No blood or mucus seen in his stool, the patient denies fever or chills.  No abdominal pain.  No close contacts with similar symptoms .  No recent antibiotic use.  No history of recent travel.  No chest pain .  No respiratory symptoms.  No urinary frequency or dysuria .  No hematuria.  The patient reports episodes of nausea with poor oral intake over the past 3 weeks.  Associated with dizziness and lightheadedness, mainly when he wakes up in the morning.  No vomiting.  He wears a CPAP at home for obstructive sleep apnea. The patient was evaluated by his PCP, stool studies were ordered, however not done yet, outpatient labs reviewed, showed worsening of his chronic kidney failure stage IV.  His current serum creatinine is 3.24, his serum creatinine on June of 2021 was 2.14.  And his serum creatinine on December 2020 was 2.05.  His Lasix was recently placed on hold for 3 days because of his ongoing diarrhea and worsening kidney functions.  Diagnosed with severe dehydration leading to AKI on CKD. BUN/Cr on admission 129/3.24. from 42/2 at baseline. ADR managed: IV Hydration, furosemide held, probiotic started Patient outcomes (Select all that apply): Hospitalization and Supportive treatment provided
I experienced severe period after my first shot. I went to see my first doctor who refused to acknowledge the vaccine as a possible reason. I had an ultrasound done and fibroids were found. I was bleeding so bad to the point I was hemorrhaging. My normal doctor recommended me to see a specialist.  I went to see another doctor who recommended ablation. Once I got ablation done, it took three weeks for me to recover because my doctor cut through my uterus and had to open my stomach up to make sure he didn?t hit my intestines. I?ve been on my period consistently for three years straight. I bleed through ultra tampons in two days and am experiencing extreme pain. I now take progesterone three times a day to try to control the bleeding.
Patient went to the ED and presented with chief complaint of 3 days of rib/sternal pain. Patient stated that it began after twisting torso to squeeze between a palette and wall at work. Was moving heavy objects. Patient has been constant. Hard to sleep. Also has some epigastric abdominal pain, discomfort. Took TUMs, not helping much. Taking motrin for rib pain. No cough, shortness of breath, not exertional. Chest is tenderness to palpation.
Patient had felt nervous prior to getting her 2nd shot. I asked if she had every had any serious reactions from previous medicines or vaccines, she stated "no". I then asked how she did after her first shot and she said ok. While waiting her 15 min in the observation area she alerted us that she was feeling extremely hot. We brought her back into the IMZ booth and had her sit in the chair and turned a fan in her direction. I sat down with her an asked her questions and kept her talking to try to calm her down. She stated that she felt as if the chair was swaying a little. We laid out a yoga mat on the floor in the booth, had her lay down and elevate her feet in a chair. She began to get upset and I asked if she had anyone with her, she was able to open her phone and gave me permission to call her family member. Family member came in the store and was able to help calm her down. We gave her some water and had her rest. I monitored her pulse and face/lip color. She became a little flushed. She was able to leave on her own accord, I did walk out with her to ensure she made it safely. I called 2 hours later to check on her and she stated she was feeling better, less dizzy, but just a little tired.
Information has been received from a nurse referring to an unspecified number of patients with unknown age and gender. On unknown dates the patients were vaccinated with improper stored RECOMBIVAX HB (lot # K024552, expiration date 22-OCt-2016) (dose and route were not reported) by an unspecified physician. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
1122: SPC notified this RN about this pt's ADRs. Upon arrival, pt stated, "my tongue feels tingling, numb and back of my throat feels like I have phlegm. It feels weird when I swallow." Pt stated she has epi pen for bee sting, and the s/s she is having is similar as with Bee sting. Pt with her daughter in car, and her husband in another vehicle next to her.   1125: V/S obtained. BP 113/69, 98O2 RA, Resp: 18. Frequent throat clearing, c/o closing up airway at back of throat but no SOB. EPI pen administered over clothes immediately to left superior thigh region.   1130: BP 120/80,  98O2 RA, Resp 18. MAJ  informed, and at site.
Headache, Arm redness with 2inx3in lump, achy, chills Narrative:
24 hours after DTaP/VARIVAX developed large area of redness/warmth/itching and mild tenderness. Pt. took MOTRIN but no antihistamine (BENADRYL) prior to today's visit - still 7cmx7.5cm area of erythema/warmth/mild tenderness. --> BENADRYL 25mg PO given here. OMNICEF 250mg/5cc 1 1/2 tsp qd x 10d for possible cellulitis.
BLOOD CLOTS ALL OVER BRAIN; This spontaneous report received from a patient via a company representative concerned a male of unspecified age, race and ethnicity unknown. 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 not reported, batch number: Unknown) frequency one total, dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  It was reported on an unspecified date, that the patient experienced blood clots all over his brain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clots all over brain was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0- 20210758279 -covid-19 vaccine ad26.cov2. s Blood clots all over brain. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Swollen, itchy, red, burn and stinging, warm to touch. Back of throat-> uvula red also red.
low grade fever; After 2nd injection had symptoms as if was beginning of cold or flu only a couple 1-2 days; After 2nd injection had symptoms as if was beginning of cold or flu only a couple 1-2 days; This is a spontaneous report from a contactable female nurse (patient) via Pfizer-sponsored program. A female patient of unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on 14Mar2021 as dose 2, single for COVID-19 immunization. The patient medical history included pre-existing bruise. The patient concomitant medications were not reported. The patient historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on 23Feb2021 as dose 1, single for COVID-19 immunization and experienced arm soreness/sore arm/her arm was a moderate level of pain, around 4-5, she was exposed to a COVID positive, then a day after her 1st dose she was exposed again. Now the caller is COVID positive and experienced a cold, part of soreness of the injection site, temperature did get higher/temperature was 99.4/elevated temperature and feeling kind of punky and draggy and after first injection, pain in arm exacerbated possible by a pre-existing bruise. On an unspecified date in 2021, the patient experienced low grade fever, after 2nd injection had symptoms as if was beginning of cold or flu only a couple 1-2 days. Verbatim and event description: Patient said that she has been using an app through (Name) after her covid-19 vaccines and received paperwork from drug and safety to contact Pfizer, patient had her first dose of the vaccine on 23Feb2021 and noted that she had a sore arm, her second dose was 14Mar2021 and noted that she had a low-grade fever. After 1st injection, pain in arm exacerbated possible by a pre-existing bruise. After 2nd injection had symptoms as if was beginning of cold or flu only a couple 1-2 days. Patient was fine. Patient had never been COVID Positive and never had symptoms of covid. Patient had only ever had post vaccine symptoms common to a number of different vaccines (arm soreness, transient flu-like). Outcome of all the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Info has been received from a health professional concerning a child who was vaccinated with a dose of varicella virus vaccine live (date unspecified). Subsequently, the pt experienced breakthrough varicella. No further info was available at the time of the report. The RN also reported that the pt's siblings had adverse reactions post vaccination. Follow-up info has been received from the RN indicating that the pt's mother did not provide any additional info regarding the pt's breakthrough chickenpox. Additional info is not expected.
Immediate syncope. Dizziness. Headache. Lethargy. Drowsiness. Complaining of leg weakness and pain afterward and still currently to date.
Systemic: Dizziness / Lightheadness-Severe, Systemic: lost consciousness-Severe
Vaccines administered 5/18/16. Redness and swelling noted on (L) upper arm this afternoon. 7 x 7 cm area of erythema. No tenderness.
Have been having asthma type wheezing noises and limited lung capacity since having the vaccine. I haven't had anything like that since i was a kid 40 years ago or so
19 yr old female travelled to see boyfriend 3/30-03-4/3/03. Boyfriend vaccinated on 3/28/03. Pt had intermittent contact. According to LB, site covered entire time of contact but may have had contact with towels, clothes, etc. Presented to her physician on 4/10/03 with two-scabbed lesions on her chin and above her lip.  Her physician notified acute disease unit that day. After consultation, it was felt the pt had probable contact vaccinia. Viral cultures wee obtained from the chin lesion and were received by public health lab for procession on 4/11/03. Her symptoms started on 4/6/03 with fevers, chills, diffuse muscle aches, cough, congestion, groin lymph node swelling. She noted a pustule on her scalp on 4/6/03 that was pruritic and scabbed over. On 4/8/03 she noted a blister on her chin with a red base that has scabbed over. She also noted a new blister above her lip today. She states she has all sites now covered with dry gauze dressing. Additionally, she has also noted some irritation on her perineum and a possible new lesion that appeared today.
My father received the shot on Sunday May 23rd in the late afternoon, on Tuesday May 25th he had an artery embolism and passed away that morning.
Fever x 3 days (up to 103.2), Congestion, rhinorrhea, cough, malaise.  Developed rash 2/2/2015 - diffuse maculopapular - that lasted for 1 week.
On May 1, patient with a prior history of stroke reported immobility and pain starting April 30 with soreness in her left arm not mitigated by her current regimen of opioid medication for chronic pain. She reports no redness around injection site. Pt said she could not maintain a grip when trying to hold items. I advised patient to continue to monitor symptoms and seek medical attention with emerging redness or worsening soreness and to consult PCP when available. The following day (May 2) I called the patient and she reported lessening soreness and increasing mobility (she can now hold items). I advised her to continue to monitor for lessening symptoms.
covid arm was just starting to appear; induration; itching left hip / local itching; swelling left hip; redness left hip / local redness; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of PRURITUS (itching left hip / local itching), JOINT SWELLING (swelling left hip), ERYTHEMA (redness left hip / local redness), VACCINATION COMPLICATION (covid arm was just starting to appear) and INDURATION (induration) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L21A) for COVID-19 vaccination.     no medical history provided.  Concurrent medical conditions included Breast cancer since January 2008, Breast cancer in December 1995, Graves' disease since January 2004 and Insect bite allergy (20 cm of induration, urticari) since 07-Jun-2014. Concomitant products included ANASTROZOLE (ARIMIDEX) from 01-Jan-2009 to an unknown date for Breast cancer, LEVOTHYROXINE from 01-Jun-2005 to an unknown date for Graves' disease.    On 19-Jan-2021 at 1:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced PRURITUS (itching left hip / local itching), JOINT SWELLING (swelling left hip) and ERYTHEMA (redness left hip / local redness). On 28-Jan-2021, the patient experienced INDURATION (induration). On an unknown date, the patient experienced VACCINATION COMPLICATION (covid arm was just starting to appear). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (oral) for Induration, at a dose of 1 dosage form and PREDNISONE for Induration, at a dose of 1 dosage form. On 03-Feb-2021, INDURATION (induration) had resolved. At the time of the report, PRURITUS (itching left hip / local itching), JOINT SWELLING (swelling left hip), ERYTHEMA (redness left hip / local redness) and VACCINATION COMPLICATION (covid arm was just starting to appear) had resolved.        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.   Treatment medication antihistamines dose 25mg given per oral noted.   Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: Significant FU : patient medical history provided On 19-Jul-2021: Follow-up information received on 19 Jul 2021 contains significant information. added medical history insect bite, added vaccine facility information, added treatment medications prednisone and Benadryl added, added events vaccination adverse reaction and induration.
approx 5-530 started screaming/crying x 15 mins reawaken several times screaming/crying for short periods; fell asleep in mothers arms; pt felt hot but no temp taken;
facial pain radiating to eye, ear and Rsideof the face; Incomplete course of vaccination; This case was reported by a consumer via call center representative and described the occurrence of facial pain in a 76-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In February 2019, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced facial pain and incomplete course of vaccination. The patient was treated with antivirals nos, antivirals nos, antivirals nos, antivirals nos (Antiviral (Drug Name Unknown)). On an unknown date, the outcome of the facial pain and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the facial pain to be related to Shingrix.  Additional details were provided as follows: The patient had vaccine and experienced facial pain radiating to eye ear and right side of face. The patient took antiviral pill which alleviated the sx. At the time of reporting did not receive the 2nd dose, which led to incomplete course of vaccination. The patient asked whether it is safe to have the follow up vaccine suggested after 6 months.
severe hives-itching-malaise generally no fever reported by mom; 21MAR95 was dx w/Fifths disease by MD;
Patient became dizzy, cold and clammy,  Starring and not responsive for 1 minute.   Jaw was clamped down but upon asking the patient then spoke 2 minutes into episode.   Vitals were stable.   Rapid response was called.   Patient was observed, given fluids and sent home.
Systemic: Fainting / Unresponsive-Mild, Additional Details: patient did not report to the the rph on duty. but told me when getthing his secound shot. made sure it wasnt a allergic reactions.
For about 24 hours soreness in left arm near injection site, more swelling and a lump under left arm and burning sensation under left arm and chest area where I typically have swelling and numbness due to lymphedema post mastectomy. Resolved within 24 hours with no treatment.