chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A non-serious spontaneous report of received only 0.1 ml in one nostril was received from a consumer concerning a 31-month-old female. Neither relevant medical history nor concomitant medications were reported for this patient. The patient received 0.1ml of FLUMIST in one nostril on 29-Sep-2011. On 03-Oct-2011, the patient received 0.1 ml of FLUMIST in each of the nostril. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age.
BREATHING ISSUES; BAD MUSCLE CRAMPS; BAD CHILLS; HEADACHE; FEELING TIRED; This spontaneous report received from a patient concerned a 53 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included sulfonamide allergy, and asthma. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 09-APR-2021, the subject experienced breathing issues. On 09-APR-2021, the subject experienced bad muscle cramps. On 09-APR-2021, the subject experienced bad chills. On 09-APR-2021, the subject experienced headache. On 09-APR-2021, the subject experienced feeling tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from breathing issues, bad muscle cramps, bad chills, and headache on 09-APR-2021, and had not recovered from feeling tired. This report was non-serious.; Sender's Comments: V0:Medical assessment comment not required as per standard procedure as case assessed as non serious.
Not feeling to well; He had cold chills; Muscle aches; Joint pain; Fatigue; He is not able to work; Aches; He had cold chills; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A male patient received bnt162b2 (BNT162B2), administration date Feb2022 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete;  unknown manufacturer), for COVID-19 immunization. The following information was reported: MALAISE (non-serious) with onset Feb2022, outcome "unknown", described as "Not feeling to well"; CHILLS (non-serious), NASOPHARYNGITIS (non-serious) all with onset Feb2022, outcome "unknown" and all described as "He had cold chills"; MYALGIA (non-serious) with onset Feb2022, outcome "unknown", described as "Muscle aches"; ARTHRALGIA (non-serious) with onset Feb2022, outcome "unknown", described as "Joint pain"; FATIGUE (non-serious) with onset Feb2022, outcome "unknown", described as "Fatigue"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) with onset Feb2022, outcome "unknown", described as "He is not able to work"; PAIN (non-serious) with onset Feb2022, outcome "unknown", described as "Aches".  Additional Information: Other products and investigation assessment was not provided. Reporter stated that she was calling for her husband. Stated he took his booster shot yesterday and last night as he was getting ready for work, he was complaining he was not feeling to well, he had cold chills. Stated he went to work and today came back and all day he had cold chills and muscle aches and not feeling too well, he also had joint pain.  Reporter clarified that patient was not in need of emergent care, he felt more like fatigue, joint pain, aches and all that. Reporter was asking how long the report takes as she needs to get going. Stated he got the batch number was either FK or FC 9896 on his card. It was Stated he got it because his job needed him to get the booster.  The lot number for bnt162b2 was not provided and will be requested during follow up.
< 24 hrs after injection woke next day with red, slightly swollen area size of quarter and sore to touch. Temp 98.5. Instructed by Dr. to apply cold compresses to arm intermittently and Ibuprofen with meal for a couple of days. Report expanding redness or fever.
8 days later I have localized redness, swelling underskin, and my throat started to feel tight, or like something was in it. And it felt like I kept having to clear it  I went to the store and bought zyrtec. I had to take zyrtec everyday for at least 5 days. And benadryl at night.   The redness, swelling underskin and itching in arm lasted for almost a week.  The throat tightness went away within two hours of taking the medicine.
Nausea, Vomiting, Diarrhea, Dehydration for greater than 18 hours. went to ER for Treatment
THE FIRST 2 DAYS I HAVE PAIN ON THE ARM, ON THE THIRD DAY I STARTED WITH SWELLING. SINCE MARCH 3RD I HAVE A RED LESION AROUND THE INJECTION SITE
Case number PHEH2013US023212 is an initial spontaneous report received from a consumer on 04 Nov 2013. This case refers to a 14-year-old unknown gender patient. Past medical history and concomitant medication were not reported. The patient was vaccinated with FLUCELVAX, (batch number: not reported) at dose of 0.5 ml on an unknown date. No adverse event was reported following this administration error.
Swelling in my left leg groin area; Albumin down to 2.2; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Swelling in my left leg groin area) and HYPOALBUMINAEMIA (Albumin down to 2.2) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     Concurrent medical conditions included Ovarian cancer NOS (Dx Ovarian CA) since 2018.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, the patient experienced SWELLING (Swelling in my left leg groin area). In February 2021, the patient experienced HYPOALBUMINAEMIA (Albumin down to 2.2). At the time of the report, SWELLING (Swelling in my left leg groin area) and HYPOALBUMINAEMIA (Albumin down to 2.2) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Feb-2021, Computerised tomogram: results not reported CT scan related to ovarian cancer history. In February 2021, Blood albumin (3.5-3.7): 2.2 (Low) Albumin down to 2.2.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient stated that albumin ranges normally 3.5 to 3.7 but in early February it was down to 2.2 and she was not able to get it back to the normal level. Patient reported that the swelling in her left leg groin area was worsening.  No concomitant medications were reported.  No treatment medications were reported.   This case was linked to MOD-2022-490077 (Patient Link).
I was vaccinated on Wednesday afternoon. Friday morning I woke up with a sore spine. As the day continued my ability to move, level of pain, and level of functioning significantly decreased. By 4 pm that afternoon I was having severe back spasms which prevented me from walking. The pain was intolerable. I was taken to the ER where I had 2 more full back spasms while entering the ER. I was unable to straighten my spine. I was treated at the ER but was unable to have full mobility of my body until 2/21. My back still does not feel ok.
Within 2 hours, extreme pain/soreness in injection arm, extreme fatigue, low grade fever, body aches, headache
Information has been received from an MA concerning a 78 year old female who was vaccinated with pneumococcal vaccine 23 polyvalent. Subsequently, the pt developed a local reaction which included swelling, redness and heat. The MA reported that the reaction was more pronounced than she thought "was customary". The outcome of the pt's local reaction was unknown. Additional information has been requested.
PATIENT REFERS TO BOTH LEGS FALLING ASLEEP, BOTH ARMS, DRY MOUTH, ITCHY THROAT, HEAVY TONGUE.
Moderna side effects after a week; Redness on injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Redness on injection site) and VACCINATION COMPLICATION (Moderna side effects after a week) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (Redness on injection site) and VACCINATION COMPLICATION (Moderna side effects after a week). At the time of the report, VACCINATION SITE ERYTHEMA (Redness on injection site) and VACCINATION COMPLICATION (Moderna side effects after a week) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medication was  not reported. Relevant concomitant medications were not provided by the reporter.    Reporter did not allow further contact
PATIENT DEVELOPED HERPES ZOSTER TO FACE AND LEFT PERIORBITAL AREA 14 DAYS AFTER MODERNA IMMUNIZATION
sudden onset of left droopy face associated with slurred speech and left arm pressure 4 days after injection.  All symptoms resolved within 20 min and was diagnosed with a transient ischemic attack due to acute thrombotic event.
For 2 days had fever of 104-105 degrees; eyes glassy & pale; eyes glassy & pale; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 79 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 05Feb2021 11:00 (Lot number: EM9810) as dose 2, single for covid-19 immunisation. Relevant medical history included: "known allergies: Possibly penicillin" (unspecified if ongoing). Concomitant medication(s) included: ATENOLOL. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3247, Location of injection: Arm Left, Vaccine Administration Time: 11:15 AM, Route of administration: Intramuscular), administration date: 15Jan2021, when the patient was 78 years old, for COVID-19 immunization.  The following information was reported: PYREXIA (non-serious) with onset Feb2021, outcome "recovered" (Feb2021), described as "For 2 days had fever of 104-105 degrees"; PALLOR (non-serious), GLASSY EYES (non-serious) all with onset Feb2021, outcome "recovered" (Feb2021) and all described as "eyes glassy & pale". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, pallor, glassy eyes.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was tested for COVID-19. Device Date :16Oct2021. The patient was concerned if the Booster shot had the side effects same as with the 2nd dose. By taking aspirin after booster shot, will the high fever alleviate.   Follow-up attempts are completed. No further information is expected.
A non-serious spontaneous report of runny nose and sneezing was received from the consumer concerning an eight year-old female, subsequent to FLUMIST.  The patient received FLUMIST on 11-Nov-2008.  The mother of the child reported that on 13-Nov-2008 the child was sent home with a runny nose and sneezing a lot.  The outcome was not reported.
Pfizer Dose 1 4/13/21 (Er8732) Pfizer Dose 2 5/5/21 (ER8736) Pfizer Dose 3 1/11/22 (FH8027) COVID Positive 3/23/22  3/23/22: Patient is a 65-year-old female with past medical history of alcoholism, cirrhosis, chronic hepatitis C, rheumatoid arthritis, spinal stenosis, and history of smoking.  She presented to ED on 03/23/2022 after having an alcohol withdrawal seizure at home.  This is her 5th or 6th alcohol withdrawal seizure in total.  She has been unable to drink as much alcohol the last few days as her stomach has been upset.  Her last alcoholic drink was yesterday.  She has been vomiting recently.  No blood in her vomit.  No blood in her stools or dark stools.  She denies history of being told that she has esophageal varices.  She otherwise denies fever, chills, sweats.  No chest pain or shortness of breath.  After her seizure, her significant other brought her to the emergency department. Her blood pressure was elevated on arrival.  She was also mildly tachycardic.  Abdominal x-ray showed a moderate amount of gas and stool throughout the colon and rectum but was otherwise unremarkable.  She denies any abdominal pain so CT was held.  Her lab work was notable for creatinine of 1.23 which is actually about her baseline.  ALT was 36 and AST was 119.  Total bilirubin 2.5.  Lactic acid was 10.6. Her CBC was unremarkable.  Patient was administered Benadryl, morphine, Zofran, Phenergan, and normal saline, and thiamine in the ED.  She was admitted for further management of her alcohol withdrawal.  The patient wants to get sober.  She has previously been able to stay sober for about 6 months, but relapsed when her mom got sick.  She does not want to pursue inpatient treatment facility for her alcoholism.  She feels that she will be okay at home with her significant other as she does feel she has support at home.  She did try to smoke some marijuana to settle her stomach, but otherwise denies any illicit drug use.  No current smoking history.  Her family history was reviewed and is noncontributory.  3/25/22: The patient was admitted with alcohol withdrawal seizure, had recurrent episodes of alcohol withdrawal seizures, and actually she is on Keppra.  Unfortunately, patient continues to drink.  She was admitted, monitored on a CIWA scale.  Patient was seen and examined on the day of discharge.  She was awake, alert, and oriented.  Not exhibiting any alcohol withdrawal symptoms.  She had a slight fever.  She had a mild fever overnight. Otherwise, no source of infection other than her COVID-19 positive test, no respiratory symptoms, no difficulty breathing nor requiring any oxygen. She was instructed to self isolate at home for 10 days.
became lethargic, pale, skin cool, dec moist, BP 100/54, P102, R22 laid child down & became more alert & able to sit up, OJ given p/5min skin w/d pink;15min p/ walked out w/pt;mom sated pt vomited p/returning home;no other sx;
Pt vaccinated with Engerix-B experienced extreme vertigo & nausea starting approx 1 hr after inject & lasted for greater then several days gradually lessening in intensity. Nausea was gone on 8NOV90.
A report has been received from a Health Professional concerning a 2 year old, Female subject, who had been receiving FLUMIST QUADRIVALENT (intranasal). FLUMIST QUADRIVALENT started on an unknown date. Registered Nurse stated that they administered expired FLUMIST QUADRIVALENT to a patient on 23-Dec-2013. Not reported any symptoms. The outcome of the event of inadvertently administered expired FLUMIST QUADRIVALENT is unknown. The report was considered to be non-serious.
patient received vaccination on 2/17, noticed redness and swelling on 2/25.  it is painful
I have like tingling and it is not really numbness but feels like my hands are asleep; I have like tingling and it is not really numbness but feels like my hands are asleep; This is a spontaneous report from a contactable nurse.  A 28-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number; EK5730), via an unspecified route of administration on at single dose for preventive measure for Covid.  Medical history included postural orthostatic tachycardia syndrome, migraine, cardiac disorder and ventricular tachycardia.  Concomitant medication included sertraline hydrochloride (ZOLOFT), topiramate (TROKENDI XR) and nadolol.  The patient stated that on 31Dec2020, "I have like tingling and it is not really numbness but feels like my hands are asleep".  The patient underwent lab tests and procedures which included weight: 130 lbs on an unspecified date.  The outcome of the events was unknown.
Core muscle tightness (extreme) to include back and stomach. Patient first noticed at 0230 on 4/5/2021z Patient took flexeril approx 24 hrs after injection. Almost immediate relief for extremely painful muscle tightness. Patient also reports continued fatigue one week after injection.
not feeling well; very sick right now; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number and Expiration date were not reported), via an unspecified route of administration on 25Feb2021 as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced not feeling well and very sick right now. The reporter was asking if the patient can take Tylenol or is there anything else to help her feel better. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information was identified on a social media page, from a female patient of unknown age. On an unknown date, the patient was vaccinated with an unspecified human papillomavirus vaccine (manufacturer, lot number, number of doses, dosage, and route of administration not provided). The text of post was as follows: "This vaccine ruined my life. Stay far, far away!"  No further adverse event was reported. Additional information is not expected.
Moderna COVID-19 Vaccine EUA - Pt received first dose of Moderna vaccine on 2/15/21 at 8:15am.  Pt was observed for 15 minutes in our waiting area without incident.  However, once returning home, pt experienced swelling and bruising in her hand and a swollen left wrist, the side she received the vaccine.  She stated that she also suffers from arthritis and may have been attributed to an arthritis flare as well.
11-10-05 Patient presented to the State Health Center concerned about redness at the injection site of her vaccines she received at State Health Center on 11-08-05. On assessment by doctor CHN the upper left arm was notably red and warm to touch. The patient was referred to her primary care physician. 11-10-05 up on telephone follow up with her. she state that doctor did start her on an antibiotic, Cephalexin 500mg. QID X 10 days. 11-14-05 Follow up telephone call to patient: client states that the concerned redness on her left upper arm has resolved.
Patient received a bivalent dose as her first covid vaccine by mistake. Spoke with the health department and they said to treat is as her first primary series dose and to return in 3 weeks to get a monovalent pfizer vaccine. No physical symptoms occurred.
Extreme fatigue, joint pain, dizziness and near fainting, rashes, vision disturbences, hair loss and confusion and inability to concentrate. She has seen 7 doctors and been diagnosed with juvenile rheumatoid arthritis, autoimmune thyroiditis and ADD. No medications for these conditions has relieved/cured the symptoms.
Patient stated that she was experiencing nausea lightheadedness, dizziness and felt like she was going to pass out. Patient was not have breathing complication. She was sweating and said her ears were muffled for about 30 seconds.
Information has been received from a physician concerning a 5 month old pt who on 8/24/02 was vaccinated with a dose of Haemophilus B conjugate vaccine (manuf unk). Ten days later, the pt was admitted to the hospital with E-Coli sepsis of the blood and urine. The child had developed an allergic rash. There were no organisms present in the spinal fluid but white blood cells were present in the spinal fluid. H Flu was cultured in the throat. Additional info has been requested. The pt's adverse events of Escherichia infection NOS and cystitis escherichia now read escherichia sepsis and escherichia urinary tract infection, respectively. Additional info has been requested.
A couple of days after the shot, pt noticed pain in the left deltoid area which progressed to the upper left arm and shoulder radiating to the left fingers like his tendons were stiffening up.  He said the pain worsened to a severe level and has continued since 10/25/03.  The pain is considered tolerable after he has taken over the counter pain relieving and worsens after use of left arm.  He states during sleep and after use of left arm.  He states his range of motion of left arm is decreased.  He saw a physician for the first time 3 weeks ago who did not do any tests, but according to pt, to continue OTC meds and increase range of motion of left arm.
08jan89, feb-89 and aug-89 pt vax hepta B. In feb-89 and mar-89 pt devel proximal interphangeal joint pain of fingers, one toe on rt foot, and rt hip.  tx w/ pres drug therapy.
Patient started showing signs of low grade fever, fatigue, sore throat with swelling a couple hours after receiving vaccine. About 10 hours after administration she took BENADRYL.
Patient  called to report that her arm became very sensitive and sore:  Her left arm and lymph nodes are "angry" after receiving her 1st vaccine.  she received the BioNtech Pzifer Covid 19 vaccine to her Left Arm.
No additional AE; Caller reported inadvertent administration of expired STERILE DILUENT that was used to reconstitute MMR-II; Caller reported inadvertent administration of expired STERILE DILUENT that was used to reconstitute MMR-II; This spontaneous report was received from a nurse and 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 01-JUN-2023, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, administered for prophylaxis (strength, dose, anatomical location, lot #, expiry date, and route of administration were not provided), which was inadvertently reconstituted in expired sterile diluent solution for injection/infusion, 1 dose, lot #T029529, expiration date: 16-APR-2023 (strength was not provided) (expired product administered, product preparation issue). No temperature excursion. No symptoms reported. Sterile diluent supported for 12 months post-expiry.  This is one of several reports from the same reporter.
Swelling, Redness, Warm to touch and itch around injection site on L thigh begin after 24 hours of vaccine administration.
Pt was exposed to an individual who was vaccinated with varicella virus vaccine live. The vaccinee developed a localized or generalized vaccine induced rash. Subsequently the pt developed varicella  after exposure to the vaccine. Follow up states no further information is available.
pt rcvd vax; approx 6-7dys later begun high fever; t 104; w/ apap t down to 102 for 1hr & back up to 104; ER MD prescribed ab but found no sign of infection;
This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical history, drug reactions, allergies or concomitant therapies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of Gardasil 9 (lot # M004116, expiration date 12-OCT-2017; exact doses and route of administration were not reported). No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as there was no consent for follow-up.
5/23/06 "felt fuzzy-headed and chilled" in the morning. By the afternoon, developed itching. 5/23/06 Early evening, hives (neck area). 5/23/06 19:00, hives progressed from thighs and ankles. Called MD and Prednisone 40mg po given. Now tapering Prednisone. Rash almost resolved 5/26/06.