chrisvoncsefalvay/vaers-outcomes huggingface dataset:
odd sensation in her mouth; difficulty swallowing; mouth full of saliva; Her face, neck and chest were all very red and flushed; Her face, neck and chest were all very red and flushed; This is a spontaneous report from a contactable consumer (patiemt). A 60-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205), via an unspecified route of administration on 04Mar2021 13:00 (at the age of 60-years-old) as 1st dose, single for COVID-19 immunisation.  Medical history included shellfish allergy from 2011 and ongoing (patient had an Epi-pen prescription on her patient portal information but she has never filled or used that prescription), pneumonia in 2017 and 2018 (occurred 2 years in a row, probably around 2017 and 2018), bronchitis from 2016 (one year bronchitis without Pneumonia, may have been 2016), prediabetic (Onset date: Probably 2015), obesity (Onset Date: Probably 2000), compromised immune status, blood pressure and thyroid. Concomitant medications included lisinopril taken for blood pressure from 2016 and ongoing; atenolol taken for blood pressure from an unspecified start date and ongoing; amlodipine taken for blood pressure from an unspecified start date and ongoing; hydrochlorothiazide taken for blood pressure from an unspecified start date and ongoing; levothyroxine taken for thyroid from 2016 and ongoing.  On 04Mar2021 about at 13:50 the patient experienced odd sensation in her mouth, difficulty swallowing, mouth full of saliva, and her face, neck and chest were all very red and flushed. The patient stated that it was a slight reaction. The patient reported that she received her first dose of Pfizer COVID-19 Vaccine on 04Mar2021. She waited the 30 minutes and then left. As she was driving home felt she felt an odd sensation in her mouth, had difficulty swallowing and her mouth filled with saliva; so she pulled over and she looked in the mirror she was all red, her face, neck and chest were very flushed. She just did some breathing and tried to relax. She called her doctor and waited to hear back from her but didn't yesterday. She tried to drink water and just relax; she did not feel like she had to go to the emergency room. Her doctor got back to her today and had a teleconference. The patient did not have other vaccinations within four weeks prior to the first administration. The outcome of events was recovering.    No follow-up attempts are possible. No further information is expected.
ACUTE HYPOXEMIC RESPIRATORY FAILURE HYPOXIA  4/23/2022 &  5/22/2022 -- RECURRENCE OF SAME SYMPTOMS
Blood pressure and heart rate increased to 163/100 and heart rate was 105. I almost passed out and was very dizzy and disoriented. Fatigue for 7 days and heart rate is still elevated. Also experienced green bulging veins in hands and feet.
At the end of yearly visit, pt received 3 vaccines: HPV, MENACTRA, and Hep a. Pt started to pass out/when I called out to her. She started having a seizures. Her arms were twitching and her eyes were rolling back in her head.
Chronic Cough,  h/a, chest congestion  started 4/18/21 and continues today 5/7/21
Pt's arm was immediately sore she reported. She had fatigue and chills nausea pain in the neck and arm. Fever 101-102. Arm was edematous. Heart rate was tachycardic in the Emergency Room up to 153.
febrile (105.4 degrees F) 8 hr post vax sx care & fever resolved in 48 hr; after first 24 hr of rxn devel sx of URI- repeated exams normal CBC WNL
Information has been received from a nurse concerning a 27-year-old female who on 13-JUL-2007 was vaccinated with a 0.5 ml dose of MUMPSVAX. On 20-JUL-2007 the patient developed a rash on her abdomen and back. On 23-JUL-2007 the patient developed fever, aches and a headache. It was reported that the patient was seen in the clinic on 25-JUL-2007. It was reported that, at the time of the clinic visit, the rash was heat sensitive and fever was no longer present. There was no outcome reported. Additional information has been requested.
Fever 100.1, exhaustion, achiness, and chills starting about 12-18 hours after 2nd dose administered
THIS IS A REPORT OF FAILURE OF PAXLOVID TO CURE COVID-19 IN THE GIVEN 5 DAYS DOSEAGE! Positive test 8/19. Started 8/20/22. Testing started to be fainter. Some symptoms REOCCURED on 08/26/22 and continues full positive 0n 08/31/22!!! Paxlovid control number GE6419 exp. date: 04/23 Supplier #621 RX: 6738595. Doctor notified several times of results. DID NOT respond.
This non-serious spontaneous case, initially received from other health professional on 09-Oct-2018, concerning a 32-year-old, adult, female patient. The patient had no family history of major congenital malformations. The patient historical condition included four previous full-term live births, four previous spontaneous abortions and one previous ectopic pregnancy and the patients current condition included anaemia, constipation, gestational diabetes, nausea, chlamydia/yeast, urinary tract infection (UTI) and candidiasis. The patient's concomitant medications included Prenatal vitamins for pregnancy, Promethazine for nausea, COLACE for constipation, Ferrous sulphate for anaemia, MACROBID for urinary tract infections, terconazole for candidiasis and amoxicillin for chlamydia. The patient's last menstrual period date (LMP) was 15-Jan-2018. On an unspecified date, the pregnant patient received FLUCELVAX QIVc [dose, route of administration, anatomical location, batch number, expiry date: not reported). On 07-May-2018, the patient's first trimester screening was done and it was normal and no major congenital malformations noted. On 08-Aug-2018, 29-Aug-2018 and 01-Oct-2018, the patient underwent ultrasound and results were normal and no major congenital malformations noted. The patient's estimated date of delivery (EDD) was 22-Oct-2018.
Series of headaches and severe migraines. Saw doctor and received medications: Z-pak 5-day 250ml. Resolved.
Headache, Myalgia, Fever, SORE THROAT Narrative:  Other Relevant History:
Itching and Extertional SOA Narrative: Transported to ER and given Benadryl. Watched x 1 hour and dismissed to home
more than 36 days from first vaccination; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (more than 36 days from first vaccination) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (more than 36 days from first vaccination). At the time of the report, PRODUCT DOSE OMISSION ISSUE (more than 36 days from first vaccination) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment information was provided.
Pt had a vasovagal (hypotensive) episode will being given flu shot. Pt was sitting at time of injection, lost consciousness for approximately 10 seconds immediately following injection. Pt was placed in "head between legs" position for about 2 minutes. Pt slowly drank approximately 6oz of room temp water. Pt's blood pressure was taken and gave a reading of 137/95 but pt wiggled hand. Second reading showed BP of 137/76. Pt was released after 15 minutes saying that he felt fine. Pt left with his wife who said she was remaining with him for several hours.
Approx 2 hrs after receiving flu vaccine pt presented c/o hot flashes, flashing and generally not feeling well. BP 164/110, P 102 reg R 20 unlabored. Skin of face and legs red and very warm to touch. No facial swelling or dyponia. Advised to go to ER across the street. Seen treated sent home ER.
got the new vaccine and felt a little sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "got the new vaccine and felt a little sick".  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
No additional AE details available.; received a 3rd dose of GARDASIL 9 when she did not need to.; This spontaneous report was received from the patient's mother concerning an 18-year-old female patient. The patient's medical history, concurrent conditions, and concomitant medications were not reported.   On 17-OCT-2016, when the patient was 12 years old, she received the first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) for prophylaxis (dose, route of administration, injection anatomical location, lot # and expiration date were not reported).   On an unspecified day in May 2017, the patient received the second dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) for prophylaxis (dose, route of administration, injection anatomical location, lot # and expiration date were not reported), which aligned with the 2 dose regimen according to the patient's age at that moment.   On 16-JAN-2023, when the patient was 18 years old, her gynecologist told her that she should get a third dose of  HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) and administered the vaccine for prophylaxis when she did not need to (dose, route of administration, injection anatomical location, lot # and expiration date were not reported) (Extra dose administered). No additional adverse events were reported (No adverse event).
This spontaneous report as received from medical assistant refers to a 80 year old female patient. Patient's concurrent conditions and relevant medical history was not reported. Drug reactions/allergies were reported as none. On an unknown date in May 2014 the patient was vaccinated with ZOSTAVAX (lot number, dose, route and frequency unspecified). Concomitant medications were not reported. Approximately on an unknown date in January 2015 (reported as 10 days ago) the patient developed as rash on right side of her chest, which progressively became painful. The patient sought medical attention by visiting the physician on 26-JAN-2015. The physician diagnosed the patient with shingles. The reporter stated that rash had begun to crust over as of patient's appointment on 26-JAN-2015. The patient was treated with TYLENOL for pain and BORAX application to rash. The outcome of shingles was unknown. The causality of the event with ZOSTAVAX was not reported. VZVIP packet was accepted and sent. Additional information has been requested.
Dose 1- exasperation of muscle disease with spasms- slight discomfort for about 12 hrs.  Dose 2-  extreme chest pain with tachycardia/irregular heartbeat, high fever from 101-103 degrees, cough, difficulty breathing, pain, and spasms  Began 9/11  Still very ill (9/13)
Patient was suppose to receive second dose of Pfizer Covid-19 vaccine but instead received a dose of  Moderna Covid-19 vaccine. Child was monitored by a nurse for 30 min for any adverse reactions, mother was notified of vaccine error as well as Dr. with the department.
High Fever (102.5), Headache, Lethargy, Loss of Appetite, Nausea, and Sinus Congestion
Injection site became red and itchy at 10:30 am the following day, then proceeded to become a raised welt, 2mm high and roughly 2.5 inches in diameter after 24 hours and remained this way for 72 hours.  It was warm to the touch, painful, and itchy.  After 72 hours, welt went down and a small brown bruise remained.  On Thursday, January 14, my heart was racing on and off all day - I was off work and sitting in a calm and relaxed position with no reason for an increased heart rate - my resting heart rate was approx. 112 bpm and remained this way for 4 hours beginning around 1pm.  When changing for bed, I noticed that the welt at the injection site had returned but was doubled in size.   I applied ice to the area and hydrocortisone cream and went to bed.  The welt was still there the following morning (Friday,  January 15) and was slowly decreasing in redness and size.  At 7:30pm on Friday, January 15 I went to express care at the advice of my PCP and was evaluated.  I was told to take Zyrtec and continue to ice the area, apply hydrocortisone cream if I found it helpful, and to report symptoms here.
Patient experienced palpitations about 5 minutes after receiving second dose. Patient placed in recliner and vital signs monitored for 30 minutes. Vital signs within normal limits. Pulse Ox: 100%.  No shortness of breath, rash or discoloration noted. After 30 minutes observation, patient stable and stated she felt much better.
This spontaneous report was received from a 55 years old female consumer reporting on herself with allergy to antibiotics and narcotics and a history of cerebral palsy who on 25-SEP-2012, was vaccinated with a dose of ZOSTAVAX (dose, route and lot number not reported). No other co-suspects were reported. Concomitant medications included PRILOSEC and simvastatin (manufacturer unknown). The consumer reported that on 26-SEP-2012, she experienced an injection site reaction to ZOSTAVAX. After receiving the vaccine, the consumer experienced itching, swelling and redness. Hydrocortisone cream was given as a treatment for the experience. No lab diagnostics studies were performed. The symptoms were gone after 5 days on approximately 02-OCT-2012. The patient sought medical attention by contacting a health care professional. The relatedness for patient experiencing itching, redness and swelling was unknown for ZOSTAVAX. This is one of several reports from the same source. Additional information is not expected.
Pt's mother reported to me that pt developed swelling in his (L) axilla (vaccines were both given in his (L) upper arm with swelling extending to the (L) pectoralis area. I saw patient on 2/23/2010 and found same tender edema of his (L) pectoral area was tender.
p/vax pt devel rash;BP 122/80, T95.0;given DPH;
Information has been received from an office manager, concerning a 14 year old female patient, who on 16-JUN-2010, was vaccinated intramuscularly with the first dose of GARDASIL (dose and route not provided) (Lot number 666110/1539Y). Concomitant therapy included PPD. On 16-JUN-2010, the patient got dizzy and fainted. The blood pressure was taken and the results were not provided. The office manager reported that the patient was recovering from fainting but still had headaches at the time of reporting. Therapy series with GARDASIL continued. The patient sought unspecified medical attention. Additional information has been requested.
My right ear has a swooshing sound, almost like a swimmer's ear that has water in it.
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 being refrozen; This spontaneous case was reported by a 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 19-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 16-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-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) 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). On 16-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) 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) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter. No treatment information was provided by the reporter. It was reported that vaccine shipment received on 15 MAR 2021 and the temperature recorded on the graph at 6.45 AM  on 15 MAR 2021 was 0.4 degree Celsius and 2 degree Celsius in between 6.45 AM  and  7.00 AM.  After receiving the shipment it was  placed it at freezer temperature, at around -20 degree Celsius
Left arm red and bruised to mid forearm. Symptoms started 6 hrs after vaccination. Pt. stated took TYLENOL for discomfort. Vaccine (pneumonia) admin 8/11/14 approx 9 am pt. states she feels arm is improving.
Expired Vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Vaccine used) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Oct-2021 at 10:00 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Vaccine used). On 28-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired Vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitants medications was reported.  No treatments medications was reported. client asked them to return for redosing with unexpired vial lot 037C21A. Noted
On 7th day, woke up with tenderness in axilla on same side of. injection.
patient recieved pneumo 20, instead of pneumo 13- the wrong vaccine was given- this is the adverse event- no signs or symptoms were reported or observed - patient is 6 months old- notified mother- notified Immunization Coordinator for internal review
I did not have an adverse reaction to the vaccine. I started feeling sick on 12/22/2022 with elevated heart rate, tired and trouble breathing. I went to the emergency room on 12/24/2022 and was admitted to the hospital for three days. I was diagnosed with RSV. It took me over a month to get my strength back. As of today, I am feeling better with no lingering symptoms.
Pt never had MMR b/c thought to have egg allergy- but was tested 2x and allergist said not egg allergy- therefore able to get vaccine.  Pt recently diagnosed with Crohn's disease- 9/03. PMH: Asthma and Allergies. Pt seen on 9/22/03, pt started getting hives on MOnday 10/29/03.  Then, spead- very bad, circumferencial around her mouth- 10/01/03 febrile- 101-102 x 5 days. Pt brought to a dermatologist- Dr. Dermatology- dx with Erythema Multiforme.  Pt still has some rash left- bull's eye type rash dark center and paler around- pt still has rash primarily below waist line and a few around mouth.  No fever since 10/05/03.  Pt was given Zyrtec 10 mg qd x4 dyas till decreaased itch, now on Claritin 10 mg qd ( Zyrtec made pt drowsy)  and lotion Clobex 1% cortisone lotion qd.
Reaction began 9/91/12 am. Pink/red circle around inj site about 2 in diameter. 2 other red circles in same location. (Rt) deltoid.
administered vaccine after temp excursion NOT supported; This spontaneous report was received from a physician and a nurse referring to a 6 months patient of unknown gender. There was no information about the patient's concurrent conditions, drug reactions, allergies, medical history, and concomitant therapies provided.     On 22-JUL-2020, the patient was administered an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ)(dose 2 ml, lot # 1660946, expiration date 10-APR-2021; exact dose and route of administration were not reported) for prophylaxis. The vaccine was exposed to temperature excursions of 9.6 degree Celsius (C) for 2 hours and 1 minute. It was reported the vaccine was previously exposed to temperature excursions of 10.5 C for 40 hours and 5 minutes on 04-JUN-2020. A "data logger" was involved. No additional AE details are available.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2008USA011564: US-009507513-2008USA013130: US-009507513-2009USA002369: US-009507513-2009USA002370:
22DEC feet & torso bumpy area n/v, diarrhea; 24DEC ER t104.2 R, irritable, P160, morbilliform rash, blister; Tympanic membrane bulgy dx blister rash & impetigo rt OM; tx meds;
01/06/2021 5:30PM- I became dizzy lightheaded and clamy. My chest felt heavy and I was having labored breathing, My heart was racing at 160bpm and my blood pressure was 180/90, both of which are very high and abnormal for me.  I had severe joint and muscle pain. I had the chills and could not stop shaking.  I was very weak and could not even move out of bed, Leading to me calling 911 for an ambulance at 10:21pm. They kept me in the Emergency department until 5:30am because they could not get my heart rate to stay down. Stony Brook nurse told me it was okay to get vaccine even though I was infected with COVID-19 ON 12/15/2020.
started feeling sick that night; Cold sweats; Upset stomach; Constipated; pounding dull headache; Fever; Body aches and pains/sore arm; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (started feeling sick that night), COLD SWEAT (Cold sweats), ABDOMINAL DISCOMFORT (Upset stomach), CONSTIPATION (Constipated) and HEADACHE (pounding dull headache) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (put his heart in afib, ended up with triple bypass) in June 2020, Atrial fibrillation and Bypass surgery since an unknown date. Concomitant products included LISINOPRIL, EZETIMIBE, ATORVASTATIN, ACETYLSALICYLIC ACID (BABY ASPIRIN) and BISOPROLOL for an unknown indication.    On 01-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Aug-2021, the patient experienced ILLNESS (started feeling sick that night), COLD SWEAT (Cold sweats), ABDOMINAL DISCOMFORT (Upset stomach), CONSTIPATION (Constipated), HEADACHE (pounding dull headache), PYREXIA (Fever) and MYALGIA (Body aches and pains/sore arm). At the time of the report, ILLNESS (started feeling sick that night), COLD SWEAT (Cold sweats), ABDOMINAL DISCOMFORT (Upset stomach), CONSTIPATION (Constipated), HEADACHE (pounding dull headache), PYREXIA (Fever) and MYALGIA (Body aches and pains/sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided by the reporter.
Pt seen 4/12/07-Papules hands, feet-ulcers mouth Dx with Coxsackie virus, returned to DO office 4/13/07 with erythematous papules with coalescing plaques on elbows, behind ears, diaper area; rash from head to torso. Ulcers resembling Koplik spots on buccal mucosa, back of throat, low grade T-99.3, no other symptoms.
1st noc-congested,nl during next day;2nd noc & following 3 days-99-100 temp & aches in hands & arms just above elbows;gradual improvement followed;pt stayed in bed,drank water & juices,ch. soup