chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Felt like I was going to have a heart attack in it became hard for me to breathe what kind of steel expansion today
Information has been received from a health professional concerning a female pt who on 10/31/03 was vaccinated IM with a 0.5mL dose of pneumococcal 23v polysaccharide vaccine (Lot # 647654/0865N). Concomitant therapy included bisoprolol fumarate/HCTZ (Ziac). On 11/02/03 the pt experienced extreme fatigue. The nurse reported that the pt "felt wiped out and could barely left her head". No local symptoms were noted. Unspecified medical attention was sought and no treatment was required. It was reported that the therapy was "discontinued". There was no product quality complaint involved. Additional information has been requested.
Information has been received from an RN concerning a 78 year old white male who on 3/30/92 was vaccinated, IM, with pneumococcal vaccine 23 polyvalent (lot reported as 1503T-invalid lot number). In May, 1998, the pt developed pneumococcal pneumonia and was hospitalized. Subsequently, the pt recovered. The pt was revaccinated on 6/23/98. The nurse also reported another pt who had an adverse experience following the same vaccination (WAES00121033). No further information is available.
Localized reaction appeared one day after vaccine administration at vaccine injection site. Redness, swelling, warm and tender to touch, circular area 2.75" x 3" in diameter
A report was received from a health care professional on 12/2/03 concerning a 19 month male vaccinee who inadvertently received Fluvirin on 11/30/03. On 11/30/03, a vaccinee under 4 years of age inadvertently received Fluvirin. At the time of the report no adverse had been reported. There was insufficient information to determine the reporter's causality assessment. Update 4/13/04: Follow up information received from a health care professional indicated that the vaccinee received a second dose of Fluvirin on an unspecified date. The vaccinees' parents were contacted in January 2004 and stated that the vaccinee did not experience any adverse events. No follow up pending, all information received.
Patient is a 77 Y  male with history of A-fib with dual-chamber AICD on Pradaxa, coronary artery disease, diabetes, hypertension, heart failure with preserved ejection fraction, CKD stage III, morbid obesity, lymphedema, diabetes type 2 on insulin, epilepsy, hypothyroidism, hyperlipidemia, chronic low back pain on opiates repatriated to hospital from clinic on 2/13/2023.  Pt was admitted at hospital from 2/10-2/13 for hypoxemic resp failure due to covid and/or CHF.  Pt was briefly intubated, extubated 2/11/23.  Pt currently on RA.  Decadron stopped 2/14/23. Foley placed at hospital, removed 2/15/23 and pt able to urinate on own without difficulty Pt with stable vitals.  completed abx for UTI. Pt recommends daily PT.  Given that the patient is not sure of symptom onset, we will call his first test day 0, and should isolate for 20 days given hypoxemia.  Pt to be isolated through 4/2/23.
This is a spontaneous report from a contactable pharmacist reporting for two patients (Husband and Wife). This is the second of two reports (husband). An elderly male patient of an unspecified age received on 16Oct2017 PREVNAR 13, intramuscular in deltoid at single dose, and FLUZONE (Lot UI890AA, exp date 05Jun2018), both for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced redness, itching and soreness all on 17Oct2017 with outcome of not recovered. The reporter did not know if the events were related to pneumococcal 13-val conj vac because he also gave influenza vaccine, he wanted to get it in the same arm as the pneumococcal 13-val conj vac injection. The reporter didn't know if the reaction happened because of the combination of giving both products.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2017452856 same reporter/drug/event, different patient.
This spontaneous report was received from a registered nurse and refers to a 12 year old male patient. No information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies was reported. On 13-MAR-2018, the patient started series of GARDASIL 9 and on 27-JUN-2018 was vaccinated with a second dose of GARDASIL 9 lot # N022952, expiry date 14-JUN-2020 (route of administration was not reported) for prophylaxis. No adverse effects were reported.
Red, bumpy rash on inside of elbow of injected arm, called pt at 7:20pm that night and pt stated was almost gone.
Area (R) upper arm - red, painful, edematous since 11/3/12 - Rx'ed with cool compresses, watch for signs of infection.
Body and muscle pain, joint pain, fatigue, site pain-started within 24 hrs of injection lymphadenopathy and nausea- started 48 hrs after injection
Pt received Pfizer vaccine and felt dizzy and lightheaded with near syncope. This occurred approx 10 min post injection but Pt was still sitting at vaccine table as she has hx of syncope with injections/blood draws. Medics called to table. Medics transferred Pt to wheelchair and took Pt to medic area to provide privacy for the Pt. Medics evaluated Pt and d/c home with partner driving.  VS per EMT 1030  BP 97/72 HR 60 O2sat 100% on RA
Information has been received from a physician concerning a 10 week old male, with reflux issues, who on 15-MAR-2007was vaccinated with the oral first dose of Rotateq (Lot# 655485/1033F). Concomitant vaccines administered on the same day included an intramuscular first dose in the left thigh of PEDIARIX (Lot# AC21B079BA), a first intramuscular dose in the right thigh of PEDVAXHIB (Lot# 653301/0278F), a first intramuscular dose in the right thigh of PREVNAR (Lot# B08674B). Concomitant therapy also included REGLAN, ZANTAC, and DIFLUCAN. On the morning of 21-MAR-2007 the patient experienced diarrhea, about seven to eight times, and in the afternoon experienced vomiting, about four or five times. It was noted that the child was a little fussy according to the patient's mother. The patient's vomiting and diarrhea were gone by 23-MAR-2007, and the patient was noted to be recovered. There were no laboratory or diagnostic test performed. Unspecified medical attention was sought. No product quality complaint was involved. Additional information is not expected.
This spontaneous report was received from a nurse referring to unspecified number of patients of unknown age and gender. No information regarding patients' medical history, concurrent conditions and concomitant medications was provided. On an unknown dates starting on or after 02-JUL-2016, the patients were vaccinated with improperly stored doses of GARDASIL 9 (dose, route, lot # and expiry date not reported). The vaccine was exposed to temperature of 32.4 degree Fahrenheit for 95 hour. No previous temperature excursion and no adverse effects were reported. The call was not due to data logger. This is one of several reports received from the same reporter. Additional information has been requested.
has "major heart problems".; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558).  A 74 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as 1st dose, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CARDIAC DISORDER (non-serious), outcome "unknown", described as "has "major heart problems". Additional information: Reporter stated that the patient (reporter's parent) was told by his primary care doctor that he needs to wait to receive the second dose until 3 months later/next doses are scheduled 3 months from 1st dose. Reporter queried on administering the second dose at any time longer than 6 weeks, specifically 3 months after.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I now have Guillain-Barre Syndrome. I went to a Hospital, rehab, and then a nursing home.  Neurologist
pt recv vax & devel fever of 102;no further details known as of the date of this report;this is one of three patients from this site who exp above rxn;
2 weeks & 4 hours after shot I started having body aches, fatigue & a headache. That intensified to uncontrollable chills, fever of over 102, severe body aches, severe headache, severe fatigue, bright red cheeks, red blotchy hands & feet, swollen joints & thirst. Spoke w/ doctor, saw doctor in satellite office, had rapid Covid test which was negative. Based on symptoms concluded robust immune response to vaccine & thinks Entyvio infusion 1 week after may be a factor. PCR test 3 days later, negative. Fever lasted 24 hours, symptoms faded by day 3 except for headache, thirst & fatigue which lasted a little over a week.
I became very flush and lightheaded. I felt like i could not breath and had hear palpitations for about 15-20 min.
ADMINISTRATION VACCINE ERROR DUE TO AGE.  NO ADVERSE EVENT AT INJECTION OR IN FOLLOW UP CARE
Dermatologic. Swollen rash at injection site; very itchy; bright red. Slight relief via topical hydrocortisone cream and oral benadryl.
Skin rash, itchiness; Skin tightening; A spontaneous report was received from a physician concerning, a 34 year old, male patient who received Moderna Covid-19 vaccine (mRNA-1273) and developed a skin rash, itchiness and skin tightening.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   The patient received their first of two planned doses of mRNA-1273 (Lot number: 011J20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection on 22 Dec 2020.   On 28 Dec 2020, the patient started experiencing a skin rash, itchiness and skin tightening.   Treatment information was not provided.   Action taken with mRNA-1273 in response to the events was not applicable.   The outcome of skin rash, itchiness, skin tightening and condition worsened were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
itching; Little red pustules would swell into a whitehead, burst & scab over; Pretty soon my whole body was covered in these red marks; This is a spontaneous report from a contactable consumer. A 69-year-old non-pregnant female patient received first dose of bnt162b2 (BNT162B2; Solution for injection via unspecified route of administration on Left arm on 22Jan2021 14.30 at single dose for covid-19 immunization. other medical history includes Asthmatic, anemic, HBP, osteoarthritis, hypothyroidism, reflux, and allergic to Demerol. Other medications received in two weeks are acetaminophen 650 tablets. Calan SR, losartan, Si. It was reported that the day after the injection, I started itching - terribly! Little red pustules would swell into a whitehead, burst & scab over. Pretty soon my whole body was covered in these red marks & I was itching constantly!!!!! I had to take, plus get up in the middle of night, to take a Benadryl tablet each time to help me. It has been 2 ½ weeks now, and I am still itching constantly. Red Pustule development has lessened - finally. I'm actually hesitant to get the next inj scheduled in 5 days. I'm afraid these symptoms are going to magnify greatly. On 22Jan2021 14.30 adverse event was started and did not received any treatment. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient diagnosed with COVID-19 was unknown; Patient has not tested positive for COVID-19 since having the vaccine. The outcome of the event was "Not recovered".
PATIENT EXPERIENCED REDNESS/FEVER/SORE/ITCHY ON UPPER RIGHT ARM. PATIENT FELT COLD TOO. SYMPTOMS STARTED NEXT DAY AFTER RECEIVING VACCINE. PATIENT FELLS FINE TODAY (3/22/19).
Hearing loss-i can't hear as well in the left ear as the right; Ear popping sensation; numbness in lower right ear; sharp pain in the rear left ear canals; ringing ear; headache; 1st dose 14 jul 2021, 2nd dose 25 aug 2021; This spontaneous case was reported by a consumer and describes the occurrence of HYPOACUSIS (Hearing loss-i can't hear as well in the left ear as the right), EAR DISCOMFORT (Ear popping sensation), HYPOAESTHESIA (numbness in lower right ear), EAR PAIN (sharp pain in the rear left ear canals) and TINNITUS (ringing ear) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017c21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 14-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Jul-2021, the patient experienced HYPOACUSIS (Hearing loss-i can't hear as well in the left ear as the right), EAR PAIN (sharp pain in the rear left ear canals), TINNITUS (ringing ear) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose 14 jul 2021, 2nd dose 25 aug 2021). 14-Jul-2021, the patient experienced EAR DISCOMFORT (Ear popping sensation), HYPOAESTHESIA (numbness in lower right ear) and HEADACHE (headache). At the time of the report, HYPOACUSIS (Hearing loss-i can't hear as well in the left ear as the right), EAR DISCOMFORT (Ear popping sensation), HYPOAESTHESIA (numbness in lower right ear) and HEADACHE (headache) had not resolved and EAR PAIN (sharp pain in the rear left ear canals), TINNITUS (ringing ear) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose 14 jul 2021, 2nd dose 25 aug 2021) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications reported. No treatment information was provided.  About 20 minutes after receiving the Madonna COVID-19 vaccine patient started to experience what one would referred to as hearing loss at ?rst it was a sharp pain in the rear left ear canals. After a couple of weeks the pain has stopped the ringing has stopped but he still can't hear as well in the left ear as the right anymore this has happened since the Moderna vaccine.   Most recent FOLLOW-UP information incorporated above includes: On 24-Sep-2021: Follow up received and updated Patient demographics, second dose information,  and action taken. New events hearing impaired, ear pain and tinnitus, inappropriate schedule of product administered added. Removed event hearing disability
pt recv vax MAY92 & exp weakness, lesions on both arms, h/a & sweating;
tingling in  face, fever 99.4F,lethargic, fatigue ,muscle soreness on legs, headache
Moderna vaccine administered 11/28/2022 beyond published expiration date of 11/25/22  No adverse events reported.
weakness; Bad headache; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weakness) and HEADACHE (Bad headache) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included TAMOXIFEN for an unknown indication.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced ASTHENIA (weakness) and HEADACHE (Bad headache). At the time of the report, ASTHENIA (weakness) and HEADACHE (Bad headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.        No treatment information was provided.
Per her father on 5/2/21 she had kidney and liver failure and was admitted to the hospital. Was notified on 5/15/21 by her mother that she passed away. They are performing an autopsy to determine the cause.
Pt came with her parents and younger sister to receive flu shots at 7:10 pm on 1/18/13. At 7:15 pm her mom stated the pt had a reaction and was asked to call 911 first. The pt was complaining that she had blurry vision and felt hot and weak. Wet towel and ice pack were provided. No rash or edema was seen at injection site. Paramedic came in 5 minutes and checked pt's blood pressure & oxygen level. Pt refused to go to hospital. Pt went home with her parents afterward.
face is swollen; entire left arm is in a lot of pain; fever; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (face is swollen), PAIN IN EXTREMITY (entire left arm is in a lot of pain) and PYREXIA (fever) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SWELLING FACE (face is swollen), PAIN IN EXTREMITY (entire left arm is in a lot of pain) and PYREXIA (fever). At the time of the report, SWELLING FACE (face is swollen), PAIN IN EXTREMITY (entire left arm is in a lot of pain) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were reported.  No treatment was provided.
Day 1: Severe migrain headache,  blured vision and nausea.  Dizziness and acute fatigued.  Sore arm I had all those symptoms with the 1st shot too. Day 2: head ache,  fever. (Low grade 99.0) Visceral pain, nausea,  swollen lymph nodes under arm pit, size of baseball and painful. Lymph nodes have pain without touching.(right arm) Fatigue  occational dizziness.  Day 3: nausea,  loss of appetite,  swollen painful lymph node now the size of golfball.(right arm pit) Day 4: stomach sensitivity,  head ache, swollen painful lymph node about size of large marbel (right arm pit)
Narrative:  COVID infection following COVID vaccine series 05/21 Janssen, dose #1 08/17 COVID swab, result: not detected 09/09 pt cc: chills, cough, diarrhea, fatigue, fever, headache, loss of taste or smell , myalgias, nausea, rhinorrhea, sore throat vomiting exposure: unknown 09/13 COVID swab, result: detected 09/13 SARS-COV-2 Variant Sequencing result: pending
She had shortness of breath and said she could feel the medication travel from her arm to her legs.  She also was flushed.  She was observed and sat down quietly from about 30-45 and had a caregiver come get her.  Daughter came in later at night after 7pm to get ingredients in the medication to give to pcp and was told from the ER that she may have had a reaction the vaccine.  Pt seem to be stable at the moment and daughter got some Benadryl on hand just in case.
pt recvd vax in less than 1 min post vax exp dec BP & dec heart rate;pt passed out in less than 5 mins post vax;sx resolved;
Left axillary lymphadenopathy x 2 weeks, fevers, chills, nausea and headache x 4 days. Extreme fatigue x 2 days
patient received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored in the fridge; No adverse event; patient received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored in the fridge; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored in the fridge), PRODUCT STORAGE ERROR (patient received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored in the fridge) and NO ADVERSE EVENT (No adverse event) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 07-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored in the fridge). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (patient received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored in the fridge) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored in the fridge), PRODUCT STORAGE ERROR (patient received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored in the fridge) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (patient received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored in the fridge) and PRODUCT STORAGE ERROR (patient received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored in the fridge).    Concomitant product use was not provider by the reporter.  The vaccines were stored in the fridge on 30-Jun-2021. Best used date was reported as 30-Jul-2021. Doses were administered between 02-Aug-2021 and 20-Sep-2021. Patient did not report any side effects.  Treatment information was not provided.
Patient received immunizations 5/1/07, on 5/2/07 called our after hours number to report that the patient's left thigh was swollen from top of thigh down to the knee, area hot to touch, patient c/o pain, 4/5 on pain scale. Instructed to go to the ER - was given Prednisone in the CR and a RX for Prednisone. Patient seen in our office 5/3/07 - no redness noted to area, no c/o pain (only when area is touched) Area was not warm to touch. Small amount of puffiness noted to area.
Initial report received from Health Authority on 19 Jan 2010: This patient with medical history of chronic obstructive pulmonary disease with a pacemaker was vaccinated with Influenza virus vaccine H1N1 (manufacturer unknown) (batch number unknown), immunisation on 07 Jan 2009. On 08 Jan 2009 the patient experienced tremble and increased breathing. The outcomes of the events were not reported.
pt recv vax & had facial blotchiness (red) from crying blotchiness didn't go away p/10min;mom told to stay so pt could be observed for rxn;10min p/vax red blotchy skin change color to purplish mottling to face & scalp;pt limp & cyanotic
Information has been received from a nurse concerning her 17 year old daughter with asthma who on 8/22/06 was vaccinated IM with HPV rL1 6 11 16 18 VLP vaccine (0.5ml). On 8/23/06 the patient developed a swollen thumb and her palms became red and hot. The patient later developed a tightness in her chest. The patient was immediately taken to a physician (an allergist who was the mother's employer) who immediately gave the patient a huge dose of cetirizine hydrochloride and acetaminophen as an intervention. The patient was not hospitalized and did not got to the emergency room. It was unknown if the affected site was the same arm that the vaccine was given in. The patient subsequently recovered from the red and hot palms, swollen thumb, and chest tightness on an unspecified date. The red and hot palms, swollen thumb and chest tightness were felt to be other important medical events. Additional information has been requested.