chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I slept very poorly the night of the vaccination and kept dreaming that the arm with the Shingles injection was on fire and I couldn't lay on that side. When I awoke I found that wasn't the case and that both injections were only slightly tender. I did feel very tired and sort of dizzy. With a slight headache.  I got up and had breakfast but then fell asleep on the couch. By afternoon I felt I was continually sleeping and that my face was hotter than normal. I took my temperature and found it to be 99.9 and eventually it rose to 100.4 in the evening. Mostly just ate fruit and drank water and slept most of the day. I went to bed much earlier than normal and slept more but woke up earlier than normal and felt much better. My temperature was then 97.7. I still did not feel Peeps after all that sleep but otherwise feel the symptoms have all gone. I have never have had an adverse effect before. I was able to read the pharmacy papers today and so reported the incident to my DR.
None- No adverse events. Pt is age 66 and ADACEL. Tdap is limited to ages 11-64 y.o. Given in error.
Bell's Palsy; A spontaneous report was received from a consumer concerning a 85-years-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Bell's palsy.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 08 Feb 2021, approximately three days prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Batch Number: 013M20A) in the left arm for prophylaxis of COVID-19 infection.  On 11 Feb 2021, the patient experienced medically significant event Bell's palsy.  Treatment details for event Bell's palsy included antiviral medication.  Action taken with mRNA-1273 in response to the event Bell's palsy was not reported.  The outcome of the event Bell's palsy was not recovered.; Reporter's Comments: Very limited information regarding the events has been provided at this time.  Further information has been requested.
thumb started to swell; A little sore; its soft; feel like fluid; This spontaneous case was reported by a patient and describes the occurrence of PERIPHERAL SWELLING (thumb started to swell), PAIN IN EXTREMITY (A little sore), SOFT TISSUE INJURY (its soft) and OEDEMA (feel like fluid) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy. Concomitant products included ATORVASTATIN CALCIUM (LIPITOR), APIXABAN (ELIQUIS) and METOPROLOL for an unknown indication.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jan-2021, the patient experienced SOFT TISSUE INJURY (its soft) and OEDEMA (feel like fluid). On an unknown date, the patient experienced PERIPHERAL SWELLING (thumb started to swell) and PAIN IN EXTREMITY (A little sore). At the time of the report, PERIPHERAL SWELLING (thumb started to swell), PAIN IN EXTREMITY (A little sore), SOFT TISSUE INJURY (its soft) and OEDEMA (feel like fluid) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Treatment medications were not provided by reporter.
Initial information received on 02-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to cases 2018SA277148, 2018SA278726 and 2018SA278731 (same reporter). This case involves 16 years male patient who received vaccine IPOL (lot number: P1A171M, expiry date: 20-Apr-2014) via unknown route in the right Deltoid (expiry date and dose not reported) on 02-Oct-2018, which was stored incorrectly. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was an actual medication error due to incorrect product storage. It was reported that IPOL was exposed to temperature elevation for 3 days to 46.6 Fahrenheit and 48 Fahrenheit. It was reported that no reactions were 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. Documents held by sender: none.
This case meets criteria for vaccine breakthrough review. Known household exposure. SxS include a few days PTA of cough, SOB, poor appetite, diarrhea, lightheadedness.
Began my menses cycle the day after 1st dose which was >7 days early for me to do so.  I also had nightly episodes of hot flashes that lasted 5 days 4 weeks after my 1st dose.  I have never experienced a hot flash before in my life.  After my second dose, I began my period 6 days later which was 10 days earlier than expected.  It has also been much heavier than normal with unusual cramping in both my lower abdomen and lower back, much like my contractions I had with my first child during childbirth.
Elevated blood pressure, heart rate at 110+, fever within 24 hours of shot.  Significant leg muscle tightness ever since.  Have the medical bills to prove it and would like information on compensation.  Was required to get this shot to continue employment.
p/vax pt devel 50mm area of erythema, warm & itchy @ site of inj lt deltoid;no fever or discharge;tx w/duracef & allegra;another area has devel approx 3.5 x 8cm;
Information has been received from a nurse concerning a 4 month old female who on 15-APR-2009 was vaccinated with a first dose of ROTATEQ (LOT# not reported). Concomitant vaccinations included, "Usual 2 month routine vaccinations", DTAP (unspecified), HIB conj vaccine (unspecified carrier) and PREVNAR. On 04-JUN-2009 the patient developed intussusception. The patient was admitted to a hospital and after treating with air enema the patient recovered on an unspecified date. The intussusception was considered to be immediately life-threatening. Additional information has been requested.  7/31/09 Consultant medical records received DOS 6/03/09. Assessment: Intussusception. Patent reports patient fed formula. 2 hours later was screaming drawing her legs towards her chest, clenching fists, and had piercing scream. Burping made worse. Patient presents with hyperactive bowel sounds. Mild distension abdomen. Generalized rash, flat macular red lesions. Eczema abdomen.  ICD-9 Codes: Fussy baby 780.91   Free text DX - rule out intussusception 999.99   8/6/09 Hospital records received DOS 6/03/09 to 6/4/09. Assessment: Colicky Abdominal Pain. Patient presents with 8 hour history of intermittant colicky pain. Drawing legs up to chest and flailing her arms. Mild erythematous rash on trunk.  ICD-9 Codes: 789.00 Abdominal pain unspecified site.
Employee with known hx of asthma. She was out of her medication. She received the flu vaccine and then 2 days later complained of chest tightness and had an asthmatic episode. Employee stated that she had the same reaction last year, but forgot about it.She did not disclose this at the time of the vaccine administration.
This is a spontaneous report received from a contactable consumer or other non-HCP. A male patient received unknown dose number of BNT162B2 (Comirnaty, batch/lot# unknown), on Mar 7, 2021, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient experienced malaise/felt a little sick, with outcome of unknown. Additional information: The patient seemed fine and thought that it was just mental for him. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
pt recv vax 31DEC96 & 4JUN97 pt devel a very mild case of chickenpox between 30 to 40 spots p/being exposed @ school;reporter stated that no fever or other complications were noted, felt warm day before;
Fever to 101.7 body weakness sweats dysentery feeling of malaise, duration ran 48 hours
TOOK ONLY ONE DOSE; This spontaneous case (PVX2019-1127) was received from a physician on 06-May-2019. It describes an adult female consumer who "took only one dose". The consumer was receiving Vivotif for an unknown indication.  Case report: The consumer took a dose of Vivotif 10 days ago. She did not take any other dose yet.  Action taken with Vivotif was not applicable.  The clinical outcome of the event "took only one dose" was unknown.  Company's Comment: The causality of the event "took only one dose" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took only one dose" was considered as not applicable.
Information has been received from a health professional concerning a 7 year old male patient who on 07/19/2000 was vaccinated with a dose of varicella virus vaccine live.  Subsequently, on approximately 05/06/2004, the patient developed breakthrough chickenpox with less than 50 lesions.  Follow up information indicated that there was not a single report of adverse reaction following varicella vaccination.  The reporter indicated that 49 other patients developed breakthrough cases of chickenpox.  No additional information is expected.
General fatigue; Pain; Minimal headache; This is a spontaneous report received from a non-contactable consumer. The reporter is the patient.  A patient (no qualifiers provided) received BNT162B2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for COVID-19 immunization. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: BNT162B2 (DOSE 1), for COVID-19 immunization. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "General fatigue"; PAIN (non-serious), outcome "unknown", described as "Pain"; HEADACHE (non-serious), outcome "unknown", described as "Minimal headache".  Additional Information: The patient was healthy. The event took place after use of product - 12 hours after the second vaccine dose (injection). The patient had no fever.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101797815 Same patient; different events and dose
After having a wellness physical I received the flu shot on 10/20/17. Within 24 hrs. I had flu like symptoms - chills and fever. Within 48 hrs. I had sudden lower back pain on my right side going up my back and pain in chest. After a visit to ER heart was checked to rule out heart attack. I was discharged with diagnosis of SARS virus and muscle spasms. Four days later (8 days after receiving flu shot) I returned to the ER with severe legs weakness and incontinence. Paralysis began in toes and continued through torso. After MRI surgery was performed to remove abscess on spine. After five weeks of acute rehab and two weeks of subacute rehab. I continue to learn to to walk going to rehab. 3 days a week.  I am still unable to return to work.
Pt c/o localized irritation, headache and redness times 3 days to injection site where he received anthrax immunization as part of military recall processing. During ER visit on 5/9/08 pt was given benadryl 25-50 mg q 6 hrs, keflex 500 mg QID, ultram 50 mg Q 8 hrs
No additional AE reported.; Healthcare professional responsible for vaccines reported a dose of PROQUAD was administered after a temperature excursion.; This spontaneous report was received from a reporter and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unspecified date, a temperature excursion (TE) of measles, mumps, rubella, and varicella (OKA-MERCK) virus vaccine live rHA (PROQUAD) (valid lot #W017570, expiration date: 29-NOV-2023) occurred, at 6F up to 14F (9.1F) for 1 hour and 6 minutes. On 18-JUL-2022, TE occurred was reported to the same vaccine, at 6F up to 14F (10F) for 1 hour and 8 minutes. Then on an unspecified date, TE was reported again, at 5.7 Fahrenheit for 30 minutes. On 25-AUG-2022, the patient was vaccinated with an improperly storage measles, mumps, rubella, and varicella (OKA-MERCK) virus vaccine live rHA (PROQUAD) (valid lot #W017570, expiration date: 29-NOV-2023) (strength, anatomical location, and route of administration were not provided) for prophylaxis. No additional information or adverse event was provided.
Pt has a PMH of diastolic congestive heart failure and complains of increased shortness of breath and dizziness.  He has pulmonary hypertension, COPD, and is a former smoker.  He was admitted for acute on chronic diastolic heart failure, acute on chronic anemia, and asymptomatic COVID-19.
p/vax pt devel an erythematous, edematous area on the medial aspect of rt upper arm above the elbow that was warm to touch;it was reported that had diff moving arm because of tenderness @ inj site & area of swelling;pt sought med attention;
Her hands, fingers and muscle joints are aching; Her hands, fingers and muscle joints are aching; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient's aunt) reported for a 32-year-old female patient (reporters niece).   A 32-year-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), dose 1 via an unspecified route of administration on 2021 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021 the patient experienced her hands, fingers and muscle joints are aching. It was reported that patient received 1st Pfizer Covid vaccine 1 1/2 to 2 months ago. where the patient experienced pain in hand, fingers and muscle joints which she mentioned the events were coming and going. She also mentioned that it took 2-3 weeks for her to feel better. The reporter wanted to know will these go away and is it safe to take the second Pfizer vaccine dose. Outcome of all the events was recovering.   Information on the lot/batch number has been requested.
Large red area of the arm at the injection site; Warmth at the injection site; This is a spontaneous report from a contactable healthcare professional via a Pfizer sales representative. A female patient of an unspecified age received pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) (PREVNAR 13; lot number not reported), via an unspecified route of administration in arm on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced large red area of the arm at the injection site and warmth at the injection site, with no pain on an unspecified date. The outcome of the events was unknown.  No follow-up attempts are possible, information on the batch number could not be obtained. No further information is expected.
Waited at the facility for 30 minutes after my shot.  Left the premises of the hospital approximately 8:30am on 3/19/21. On my home approximately 15 minutes into my drive, my throat started closing, I was near Urgent Care, they treated my condition with urgency and I was given 25 mg of Benadryl and 40 mg of prednisone. After about 20-30minutes all swelling in throat had decreased tremendously.  The Doctor at urgent care, Dr. I would be ok and stated that I should get the second dose on April 9, 2021. He also recommended that I take another 25mg of Benadryl within 4 hours, in which I did. I also called my PCP, and he stated the same. They both told me not to take any medication prior to the shot. They state by taking the cough drops which contains antihistamine May have cause the allergic reaction. I  am feeling  fine now. My
On 09/30/22, Mother brought her 3-year-old son in for a flu vaccine. On the consent form, mother checked as her son had Guillain-Barre syndrome (GBS). Pharmacist asked when GBS was given and mother said it was a while ago and son is now fine. Pharmacist asked between the time of the GBS and now did the son receive any vaccines and mother said yes. Pharmacist asked if the son was okay with those vaccines and the mother said yes.  Pharmacist also asked if this is the first time the son received the flu shot, mother said yes. Pharmacist then recommended her son to get the flu at a doctor instead, and the mother said no as preferring the pharmacy.  Pharmacist checked Drug Facts and Comparison referencing that patient with history of GBS can receive flu vaccines. Fluzone Quad was given to patient on 09/30/22 around 3:00PM.  Mother came in on 10/25/22 having conversation with manager on duty. Mother reported that her son had been having adverse effects of fever, body ache, and unable to sleep the past 3 weeks. She had to stay at home to take care of her son because daycare would not. Mother said she took her son to a doctor and the doctor told her that the son shouldn?t even get the flu shot. Mother stated that she is talking to a lawyer about the case.
This spontaneous report as received from a pharmacist refers to a 59 year old female patient. The patient's medical history included shingles (8-10 months ago). She did not had any drug reactions/allergies. On 30-NOV-2016, the patient was vaccinated with ZOSTAVAX, (dose, lot # and expiry date unknown) subcutaneously for prophylaxis. Concomitant therapies included CHANTIX, phentermine, raloxifene, tramadol hydrochloride, amlodipine, clonidine, omeprazole, simvastatin (manufacturer unknown) and gemfibrozil. On 30-NOV-2016 evening, the patient became red. On 01-DEC-2016 (reported as about 24 hours later), the patient was still red, became incoherent and she was unable to answer the phone or get up from the chair. On the same day, the patient did not recognize anyone and she was brought to the hospital on an ambulance where she stayed for 12-18 hours. She received an unspecified treatment for the events. The patient had an unspecified lab work done and a computerized tomography scan, results of which were not provided. The outcome of the events was unknown. The causality assessment was not provided by the reporter. The reporter considered events to be life threatening. Upon internal review, the event of unable to answer the phone or get up from the chair was determined to be disability. Additional information has been requested.
Information has been received from a nurse referring to a patient of unknown age and gender. On 09-MAR-2016 the patient was vaccinated with an expired dose of VAQTA (lot # K001296, expiration date 15-JAN-2016) (dose and route were not reported). No adverse effects were reported. Additional information is not expected since the reporter does not wish to be contacted.
Appendicitis; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 10Jun2021 13:00 (Lot Number: ewo178), at the age of 59-year-old, as dose 2, single for COVID-19 immunisation. The vaccine was administered at Pharmacy or Drug Store. The patient did not receive other vaccines in four weeks. The patient had no relevant medical history. The patient did not have COVID-19 prior vaccination. There were no concomitant medications. The patient was not pregnant. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 20May2021 13:00 (Lot Number: ewo172), at the age of 59-year-old, as dose 1, single for COVID-19 immunisation. On 21Aug2021 the patient experienced appendicitis. The event resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care visit and Hospitalization. The appendicitis was removed, appendectomy was performed on 03Sep2021 and the patient was hospitalized for 4 days. The event was considered resolved on 03Sep2021. The patient was tested for COVID-19 post vaccination: Nasal Swab was negative on 01Sep2021.    Follow-up attempts are completed. No further information is expected.
Information has been received from a nurse practitioner concerning a 59 yr old male pt who in the last 10 days (approx Sep 2005) was vaccinated with a second dose of pneumococcal 23v polysaccharide vaccine (lot 649914/0578P). It was reported that within one day of the vaccination (approx Sep 2005), the pt developed a severe injection site reaction. He also developed a cellulitis, fever and chills. He was treated with an antibiotic. It was noted that the pt did receive the pneumococcal 23v polysaccharide vaccine in the past. There was no other information available regarding the adverse event or the pt's outcome. There was no product quality complaint reported. The pt sought unspecified medical attention. Additional information has been requested.
buzzing and humming sounds in ears; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 28Apr2021 11:00 (Lot number: EW0171) at the age of 71 years 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: TINNITUS (non-serious) with onset 08May2021, outcome "not recovered", described as "buzzing and humming sounds in ears". Therapeutic measures were not taken as a result of tinnitus.  Additional information: Within 14 days of first vaccine patient had buzzing and humming sounds in ears. Stayed about same even after vaccine second dose which was taken on 19May2021.  It was an annoyance for most part but definitely something new that he did not have until after the 1st Pfizer vaccine. However, after the booster vaccine on 19Nov21 it became much worse within 24-48 hours after this 3rd dose. It persists to this date and was louder with buzzing/humming and hissing sound in ears. At times seems to be more piercing sound. He looked on internet and did find that some Covid vaccine recipients experienced these sounds and even tinnitus with ringing in ears. He was not sure if he would describe it ringing, but it was a very annoying sound and is constant. It affects sleep patterns due to this persisting sound when everything should be quiet and ready to sleep. Continued to this late with buzzing/humming and hissing sound in ears, sound can be louder piercing sound at times. This also affects sleeping with constant background sound in ears all Tv's and electronic lights off more evident when should be quiet for sleeping. Woke up after during night and do not get sound sleep anymore. He has not taken any medications or prescriptions, but he would say this was a side effect of the vaccines, much like some people took medications had side effects. patient had no known allergies. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  The vaccine was administered at Pharmacy's or Drug Store.  No follow-up attempts are possible. No further information is expected.
Pt recvd vax & 24 hrs later exp muscle weakness & soreness in the rt arm;