chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 05-SEP-2017, the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot # N019923 and expiration date of 28-APR-2019 0.5 ml, intramuscularly for prophylaxis. No adverse effects were reported. The vaccine was exposed to a temperature excursion of  -1°C or colder for a time frame of 1 day 13 hours 30 minutes. There was previous temperature excursion of 9°C to 25°C for 7 hours 20 minutes. A "data logger" was involved. Sender's Comments: US-009507513-1709USA004386.
Feeling sick/"About to get sick/body not feel very well; Feeling badly/ Not ok; Hot very hot; Sweaty; I'm about to throw up/Nausea; Headache; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Feeling sick/"About to get sick/body not feel very well), FEELING ABNORMAL (Feeling badly/ Not ok), FEELING HOT (Hot very hot), HYPERHIDROSIS (Sweaty) and NAUSEA (I'm about to throw up/Nausea) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013F218, 022D20A and 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MALAISE (Feeling sick/"About to get sick/body not feel very well), FEELING ABNORMAL (Feeling badly/ Not ok), FEELING HOT (Hot very hot), HYPERHIDROSIS (Sweaty), NAUSEA (I'm about to throw up/Nausea) and HEADACHE (Headache). At the time of the report, MALAISE (Feeling sick/"About to get sick/body not feel very well), FEELING ABNORMAL (Feeling badly/ Not ok), FEELING HOT (Hot very hot), HYPERHIDROSIS (Sweaty), NAUSEA (I'm about to throw up/Nausea) and HEADACHE (Headache) outcome was unknown.            No concomitant product use was provided by the reporter.  The patient wanted to know that how long will take the symptoms to go away and if she could take Tylenol or not.
NO ADVERSE REACTION PT GOT EXPIRED VACCINE. WAS LEFT OUT ROOM TEMP SINCE 10AM THE DAY BEFORE
High Fever (above 103 degrees), swollen face, upset stomach and diarrhea
lower extremity cellulitis; swelling of extremity; shortness of breath; generalized fatigue/fogginess; difficulty concentrating; Chronic Inflammatory Demyelinating Polyneuritis/ ascending numbness into his extremities which eventually moved into his shoulders and hips; generalized fatigue/fogginess; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   In or around 10-SEP-2013, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX) vaccine, the patient initially suffered and developed lower extremity cellulitis, swelling of extremity, shortness of breath and generalized fatigue/fogginess and difficulty concentrating. Immediately following these injuries and in relation to the above, he experienced ascending numbness into his extremities which eventually moved into his shoulders and hips. The patient was further diagnosed with chronic inflammatory demyelinating polyneuritis. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the patient's symptoms had resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of all events was considered to be not recovered and causal relationship was assessed as related.   The lawyer considered all events to be disability.   Upon internal review, the events of cellulitis and chronic inflammatory demyelinating polyradiculoneuropathy were determined to be medically significant.
It was reported in a Letter to the Editor, a 31 year old female patient with systemic lupus erythematosus, common variable immune deficiency and sinopulmonary infection. The patient's medical  history included decreased igg and decreased igm. On an unknown date the patient was vaccinated with PNEUMOVAX 23 (dose, route and lot # not reported). Past drug therapy included: hydroxychloroquinem prednisone (manufacturer unknown), mycophenolate mofetil, pulse-dose methylprednisolone and cyclophosphamide for systemic lupus erythematous. In April 2009, based on a history of recurrent sinopulmonary infection and decreased serum IgG and IgM levels, she was diagnosed with CIVD and began receiving monthly IVIG. In February 2010, she developed debilitating watery diarrhea causing dehydration. She had no evidence of parasitic or bacterial infections, did not respond to a strict gluten-free diet, and her antitissue transglutaminase IgA titer was negative. In September 2010, biopsies of the duodenum showed patchy mild villous blunting and increased numbers of intraepithelial lymphocytes (35 lymphocytes/100 enterocytes) with no viral cytopathic effect. In November 2010, her diagnosis of CVID was confirmed with undetectable titers to tetanus toxoid and pneumococcal vaccines. On the same date, the patient experienced antibody test negative. The outcome of antibody test negative was unknown. The reporter considered antibody test negative to be related to PNEUMOVAX 23. Additional information has been requested.
Daughter of patient called to state vaccination was given erroneously above the deltoid causing loss of movement in arm and pain.
Stomach pain/cramping - severe pain in left arm & shoulder (positional pain). This is his second shot. The first shot was given 7/19/2011. Patient saw his MD on 8/24/11 where it was determined that it was reaction to immunization.
mixing error--used more than once to draw diluent from multi dose vial to mix with covid vaccine
I became nauseous, dizzy, lethargic, and lost my apatite for apx 5 days. I missed two days of work, which is unheard of for me.
Initial misuse report received from a nurse on 14-October-2013. The 12-year-old patient had received FLUZONE ID. No adverse event was reported. List of documents held by sender: none.
This case was reported by a physician via call center representative and described the occurrence of generalized rash in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced generalized rash. On an unknown date, the outcome of the generalized rash was unknown. It was unknown if the reporter considered the generalized rash to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The healthcare professional (HCP) reported that the patient experienced full body rash following administration of SHINGRIX. The HCP terminated the call when asked for patient details. No further information was obtained. This case has been linked with cases US2018GSK192914 and US2018GSK192915 reported by the same reporter.
Dizzy within couple hours of vaccine. Next day headache, respiratory problems, cold sweats, red around injection site. Went to doctor on 2nd day after vaccine. Better now but still a little dizzy. As reported by husband on 6/3/13.
This case involves a 5 weeks and 5 days old female patient who was vaccinated with a dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] (Product administered to patient of inappropriate age). The patient's medical history, medical treatment(s), past vaccination(s) and family history were not provided. Concomitant medications included ROTAVIRUS VACCINE LIVE ORAL 1V (ROTARIX) for prophylactic vaccination. On 23-Nov-2021, the patient received a 0.5 ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE produced by Sanofi Pasteur (lot number: UJ474AA and expiry date: 09-Jul-2022) via intramuscular route in the left thigh for prophylactic vaccination. It was a case of actual medication error due to inappropriate age at vaccine administration (latency same day). It was reported "Physician states a dose of PENTACEL was administered to a patient on 23Nov2021, and it was realized the patient was just under 6 weeks old. Physician is looking for information on how to handle, and if there are any issues as the patient will be turning 6 weeks old soon. The physician reported that a patient received a dose of PENTACEL at 5 weeks and 5 days old. The caller would like to know if this is considered a valid dose and whether it should be repeated". No adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
7/1/09 pt. seen in MC for temp 102-104. 9/1/09 pt. admit. to MC temp up to 105. 10/15/09 ER records received for date of service 7/1/09 and 7/2/09, 9/2/09. DX for ER visits: Febrile illness, URI.  Presenting symptoms: Child seen in ER on 7/1/09 with fever, cough, nasal discharge, congestion. CXR(-). Assessment: Febrile illness, URI. D/C.  Child seen in ER on 7/2/09 with fever, cough, nasal discharge, congestion. CXR(-). Assessment: Febrile illness, URI. D/C 9/2/09 Presented child to ER. Parent states received vaccinations on 9/1/09 and then pt had fever x2-4 days, cough, congestion. CXR(-). Assessment: Febrile illness, URI.
Sudden onset of left arm numbness and weakness on 5/5/21, admitted for CVA evaluation
Severe sudden diarrhea,  headache, weakness, taste of smoke with burning sensation.  Today unable to do anything, very tired.
Rash on arm around injection site started to develop 2 days afterward. Measures ~15cm long and 7.5 cm wide
No additional AE; HCP reported an adverse event. Caller explained GARDASIL 9 was administered after the expiry date. Caller said the GARDASIL 9 administration occurred on 14NOV2022 and the date of expiration was 25AUG2022.; This spontaneous report has been received from a pharmacist concerning to a patient of an unknown age and gender. The patient's medical history, current conditions, previous drug reactions or allergies, and concomitant therapies were not reported.  On 14-NOV-2022,the patient was vaccinated with an expired dose of  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) syringe injection, at a dose of 0.5 milliliter (ml) (strength, vaccination scheme frequency, route of administration and anatomical site of application were not provided; lot number 1687292 that was verified to be valid with an expiration date reported and established as 25-AUG-2022) for prophylaxis (expired product administered).  By the reporting time, the caller confirmed that the suspect vaccine had no history of temperature excursions.   No additional adverse event (AE) was reported (no adverse event).
It started with full body muscle aches, fever, chills, and nauseas. It felt like I was getting stabbed in random body parts. That lasted a couple of days then it resolved, except for the muscle aches and stabbing pains. After that everything was fine for 2 or 3 weeks. Then I started having pain in my shoulders, legs, and hips. I had a low grade fever. That pain went to my whole body and my muscles were weak. It was hard to go upstairs and raise up my arms to do my hair or put on clothes or shoes. I could barely walk my dog outside. My job is physical because I am a nurse. Holding weight while my arm is extended became difficult. I started missing work because I was unable to get dressed. When I went to my doctor's office, they ended up putting me on Prednisone. I had to go up on the dosage. I am still on it now. I started taking it at the end of October of 2021. When they ran test on me they said my C reactive protein and macrophages was high. The Physician Assistant diagnosed me with Fibromyalgia Rheumatica. When I saw the Rheumatologist, they said it could be an inflammatory reaction from the vaccine or giant cell arteritis.
Chills, upset stomach, muscle ache, fatigue upon waking up on 3/16/21. Lasted through the day, remained bedridden for the most part. Symptoms became slightly alleviated at approximately 7:00 PM, did not take pain relievers.
7 days after injection developed redness and itching on R deltoid along with a flare of her chronic generalized pruritis primarily involving  both breasts.  8X11 cm area of redness on arm; no discernable rash on breasts, some excoriation change on chest and back
2/18/2021 Developed fatigue, low grade fever and chills. 2/19/2021 Around 5:00PM noted new sudden onset of blurriness of vision on the left eye. 2/20/2021 Opthalmologist evaluation noted cataract like changes on posterior lens capsule of left eye; no treatment recommended.
Peripheral neuropathy in hands and feet, developed several weeks after the 2nd dose.  Treatment was 6 acupuncture sessions with some gradual improvement.
pt woke up Saturday AM w/rash over body trunk-t101;inc temp for approx 2 days-rash fading 5FEB97;mom called MD-no office or tx persisted;
33 yr.. female AAO x4, CC possible allergic reaction. Pt. had Pfizer Covid-19 vaccination (lot EP6955 exp 06/31/21) and started to experience some tightness in her throat. Paramedics on site evaluated and of medical site lead a decision was made to activate EMS due to pt. advising her bottom lip was swelling a little and her voice was changing slightly. Crew showed up scene, evaluated pt. and got an AMA release with the caveat that her mom would drive her direct to the hospital. On site paramedics also advised pt. Had wheezing in upper R lobe, which resolved upon arrival. Pt. has medical hx of anaphylaxis to peanuts (carries EpiPen) and bipolar type ii disorder, medications of Lamictal and bupropion. Tx: pt was administered 25 mg Benadryl PO . Pt was further evaluated with course listed as above. Vitals were BP 110/72, P 90 R 16 97% on RA Pox. Follow-up: pt went, was seen in ED and was given diphenhydramine, Pepcid and a steroid. Pt. discharged to home with no further incident. Pt. advised to advise vaccination staff of reactions she had for second appointment.
Extreme fatigue began within 1st 24 hours after shot. Fatigue became worse after 24 hours an continued from 04/12/21 through 4/16/21.  Fatigue was so severe it kept patient home from work 4/13/21 through 4/16/21. Patient took B complex vitamin supplements, but they had little to no effect.   Patient also experienced chills with sweating on 4/12/21 through 4/14/21.  Fatigue became less starting 4/17/21 but still continued on 4/18/21.
Patient reports she got Flu shot and shingles shot on 9/10/12 on left arm and her arm today 9/12/12 is swollen and itching. Only has put cold compresses on it.
Systemic: Dizziness / Lightheadness-Mild, Additional Details: pt felt dizzy/like he was going ot faint after vaccine. sat with him for a few mins (held head between legs) and checked his vitals. all were good. pt was very anxious because he was diagnosed with afib recently and felt like his heart was being fast (vitals normal) - had us call an ambulance. they came and did vitals as well and more specific cardiac readings and everything was normal. they left and pt went home fine.
Initial information received on 18-Sep-2018 regarding an unsolicited valid non-serious case received from other health professional. This case involves a four months old female patient she received vaccine IPOL and KINRIX. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. Concomitant medications included KINRIX; PREVENAR; Rotavirus Vaccine; and HIB Vaccine. On 18-Sep-2018, the patient received a 0.5 ml dose of suspect IPV (VERO) (lot number: N1K9, expiry date: 18-Nov-2019) (dose in series and route was not reported) in the right thigh. It was a case of actual medication error due to extra dose administered. No adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
mom reports that got shot 12-1PM on 17JUL97;gave APAP as instructed q 4hr;pt started crying 2PM;pt only cried about 3min & didn't act like self;to MD t100.5;adm to hosp;tx w/ATB;t101 in hosp;unable to take formula, r/o sepsis;on IV fluids;
Had pain at the back of "my" neck starting from approximately 24 hours after the vaccine that persisted for approximately 2 days; This is a spontaneous report from a contactable healthcare professional, the patient. A 59-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 05Mar2021 at 15:30 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history.  Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 06Mar2021 at 21:00, the patient had experienced pain at the back of his neck starting from approximately 24 hours after the vaccine that persisted for approximately 2 days and then had mostly, but not completely dissipated. The event did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event had pain at the back of his neck starting from approximately 24 hours after the vaccine that persisted for approximately 2 days was resolving at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
12/24/2021 Patient received a Pfizer 12+ COVID-19 vaccine from Employee Health.  A staff member reports that the patient was unusually anxious prior to the vaccine and was allowed to lay in a bed while receiving the vaccine.  The patient reports that 12-14 hours later, she had an allergic reaction involving red patches on her skin (arms, thighs), sweating, a racing heart, difficulty breathing, fatigue and vomiting.  She stated that she did not seek medical attention or disclose this information to Employee Health. 12/26/2021 Patient took a COVID test at Employee Health which turned out negative. 1/4/2022 patient came to Employee Health to request a COVID test but was experiencing symptoms of shortness of breath. 1/4/2022 Continued: ... She was advised to proceed to the ER but declined.  She proceeded to the Walk In Clinic in the Ambulatory Care Center where she was treated and tested for COVID, which came out positive.  Patient states that she went to the ER later, feeling that she needed treatment.  She returned to the ER 1/8 and 1/12, when she states she was diagnosed with Pneumonia via X-Ray.  She also states that she took 1,000 mg acetaminophen twice a day for most of this period of time. 2/9/2022  Patient called the Vaccine Clinic to request information about the vaccine she received at which point she disclosed to the Vaccine Coordinator that she believed she had a reaction to the vaccine.  She stated that she had reactions in the past to flu vaccines (2010, 2017  skin blotches and shortness of breath) and CT contrast (? date  "hot flashes", breathing problems and high heart rate).  Patient is currently ambulatory and seeking care for pneumonia.
Extreme muscle pain, under arms, thighs especially. Right knee and ankle swelling and pain on week 2 after vaccination. Prednisone and antibiotic prescribed. Can still feel vague muscle aches and thinks pain will return at conclusion of prednisone.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date between 07-MAY-2018 and 10-JUL-2018, the patient was vaccinated with an improperly stored dose of VAQTA, lot # N026997, expiration date 10-NOV-2018; and ROTATEQ, lot # R002060, expiration date 05-JUN-2019 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 47 to 77 degrees (also reported as "max 55 degrees") Fahrenheit for 30 minutes and above 32 up to 35 degrees Fahrenheit for 16 hours (also reported as "brief intervals of being too cold lasting for 30 minutes each, ranging from 34 to 35.6 degrees Fahrenheit"). Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1808USA006765: US-009507513-1808USA006766: US-009507513-1808USA006767: US-009507513-1808USA006768: US-009507513-1808USA006769: US-009507513-1808USA006770: US-009507513-1808USA006771: US-009507513-1808USA006772: US-009507513-1808USA006773: US-009507513-1808USA006774: US-009507513-1808USA006775: US-009507513-1808USA006776: US-009507513-1808USA006777: US-009507513-1808USA006778.
Swollen tongue following the vaccine.  Vitals remained stable.  Patient was treated with Benadryl.
Pateient received HPV vaccines on 7/17/13, 9/18/13, and 1/20/14 through another provider.  He started having significant panic and anxiety symptoms requiring psychologist follow up on 8/16/13 and again on 1/24/14.  The second episode more significant and patient was placed on medication for anxiety.  Sister also had the same type of reaction from one of her HPV vaccines.  There is FH of anxiety, so difficult to tell if vaccine related, but mom reports that before this vaccine. Child exhibited no signs of anxiety or panic.
L arm swollen and warm after vaccination - DX with cellulitis - Tx with Cefzil 500 BID