chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt stated that she felt DIZZINESS and LIGHTHEADEDNESS. I gave her water and had her sit with head between knees with fists clenched. I also gave a cold pack to put on neck . Blood pressure check was 138/93 HR93. I had her sit for 15 minutes. BP recheck 15 minutes later was 125/80 HR 88
On reconstitution of the vaccine, 1.5 ml of saline was used inadvertently - 0.3ml less that required volume.  A dose of 0.3ml was drawn from this vial and administered.  The patient was monitored for 15 minutes with no adverse effects observed.  The issue was identified after the patient left the facility.  5 telephone attempts were made to try to advise the patient with messages left to call the clinic.
Dizziness, Myalgia, Fever, NauseaVomiting, Fever, Chills, sweats, HA, Dizzy, body aches, nausea
Throat closure sensation 3 hours after second dose.  Currently on day 3 and still experiencing symptoms.
feels very sleepy; sinus post nasal drip; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LOSARTAN. The following information was reported: SOMNOLENCE (non-serious), outcome "unknown", described as "feels very sleepy"; RHINORRHOEA (non-serious), outcome "unknown", described as "sinus postnasal drip". Therapeutic measures were taken as a result of rhinorrhoea.  Additional information: She stated that she took the first vaccine and asked if it made you drowsy. She further stated that she feels very sleepy and knows people who took it but did not feel sleepy rather just had pain in their arm. She also mentioned that she took Zyrtec after the vaccine because she had sinus postnasal drip and was going to go to sleep. She also confirmed that her doctors know that she takes this and Losartan. The caller asked if you can take Zyrtec and Losartan with the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Initial information received on 01-Nov-2018 regarding an unsolicited valid non-serious case received from other health professional (Medical Assistance). This case involves a 45 years old female patient who received vaccine IMOVAX RABIES. The patients past medical history and family history were not provided. Concomitant medications included TYPHIM VI for Immunisation; and FLUCELVAX for Immunisation on 01-Nov-2018. On 01-Nov-2018, the patient received a 0.5 ml dose of suspect RABIES (HDC) VACCINE lot M1492, expiry date 02-Oct-2018 via intramuscular route in the left deltoid. It was an actual medication error due to expired vaccine used. It was reported that patient was administered an expired dose (expiry date 02-Oct-2018) of IMOVAX on 01-Nov-2018. The patient did not experience any adverse reaction after the injection. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender none.
Mucusy blood in stool starting 6 days after vaccines given including ROTATEQ. No fever, no abd pain, no vomiting.
mom called 10MAR95 to report that child devel raised area on rt thigh @ inj site & a rash that spread around thigh area;took pt to see MD;
10-10-16 Influenza vaccine administered left deltoid. That night client complained of sore arm, no fever or redness at the site of injection. 10/11/2016 child woke up with fever, sore arm with knot, redness at site that migrated down to antecubital/elbow area. TYLENOL and Ibuprofen given on alternate schedule. MOC states she placed cortisol cream at site of injection. 10/12/2016 Fever continued, swelling (knot), redness still noted per MOC upper arm. TYLENOL and Ibuprofen given on alternate schedule. 10/13/2016 Redness not as evident around antecubital/elbow area but still red and knot present at the injection site. No fever per MOC. 10/15/2016 Child still complaining of sore arm, MOC took child to see pediatrician- Per MOC, pediatrician stated to rub and place heat at site of injection. No further actions needed. 10/16/2016 Slight knot at site, redness gone and no pain per MOC.
Patient received Pfizer COVID vaccine on 2/9/21, 3/9/21, 8/16/21, 1/24/22, 5/28/22, and Moderna Bivalent COVID vaccine on 9/28/22. On 1/22/23, patient admitted to our inpatient facility (med/surg unit) with acute on chronic hypoxic respiratory failure likely secondary to COVID-19 infection in addition to pulmonary fibrosis in the right lung/left lung transplant, and sinus tachycardia with palpitations. Patient discharged home on 1/24/23.
Severe abdominal pain, vomiting approx. 15 hours. after onset of initial pain.
Patient presented with new onset seizures and fever 2 days after receiving routine 4 month vaccines.  Pt developed diarrhea and low grade temp one day after routine visit.  Pt had sepsis work up on arrival to local hospital .  Pt given Ativan for tonic-clonic movements on route to hospital (on 2/26/05).  Pt given phenobarbital and intubated for repeated seizures.  Pt now with diagnosis of meningitis, pending cultures. Pt being evaluated by neurology for spindle coma and complex febrile seizures.
Patient complained of having pain at the injection site when he lies down to sleep at night.  The pain is so severe that he can't sleep in a bed, but if he sleeps upright in his Barcalounger, he is able to go to sleep.
Redness, slight itch near sight and swelling 7 days after injection.  No doctor.  Look up online after two days swelling down redness less red but slightly larger.  No real problem
Presents now with blotchy erythematous areas on trunk. ~ 6 areas varying from size of tennis ball to grapefruit. Areas are under both arms, chest and belly. Nothing on back. Pt. had influenza injection at 12:00  given by Medical Assistant. Did not feel any reaction for several hours. Red areas developed about 3-3:30 and increased over next 1 1/2 hours. Pt. decided he should have someone take a look and presented to clinic about 4:45. Benadryl 25 mgs at 5:01 PM. Pt. left at 5:50 feeling much improved. The area on the neck has completely resolved. There was no itching and the other areas affected were lighter. Contacted pt. next am and all had resolved.
Shingles on left side of face, on upper lip, interior lip, nose, below left eye. Also left eye is aches, like a pulsating headache. Went to Urgent Care 4/28/2021. Prescription issued, Valacyclovir.
AFTER X2 IM FELT DIZZY AND BECAME PALE SAYING SHE'S HUNGRY, PUT HER LAYING DOWN EXAM TABLE LOOKING PALE LIPS & CONJUNCTIVA. HR 52/MIN REGULAR STRONG. IMPROVED AFTER REST AND FOOD INTAKE. HR UP TO 70/MIN STRONG, @ 12:10 PM PT. CLAIMED FELT BETTER BP 94/60 LESS PALLOR, NEG DIZZY ABLE TO STAND AND WALK OUT THE OFFICE WAITING FOR THE RIDE.
Pt recv vax on 1/10/97; on 3/31/99 pt exp chicken pox, cough, runny nose
This spontaneous case reported by a consumer, describes the occurrence of chest pain (chest started hurting/chest felt like it was on fire) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# unknown) for COVID-19 immunization. Concurrent medical conditions included hypertension. On Mar 3, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Mar 6, 2021, patient experienced chest pain (chest started hurting/chest felt like it was on fire). The patient treated with Advil (ibuprofen), at an unspecified dose and frequency; and clonidine for hypertension, at an unspecified dose and frequency. At the time of the report, chest pain (chest started hurting/chest felt like it was on fire) outcome: unknown. Diagnostic results: On Mar 1, 2021, blood pressure measurement: 200/105 (high). The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. Concomitant product use not provided.
The pt became lethargic, mildly hypotonic, vomiting began 1 1/2 hours post vax, resolved by the following day, placed on pedialyte for vomiting.
Patient came in for 2nd dose of Moderna COVID-19 vaccine on 04/17/2021. They reported fainting spells after receiving the 1st dose on 03/20/2021. Patient stated they fainted 3 times later in the evening after receiving their 1st dose. Patient said that she never hit her head. Patient was denied their 2nd dose at the pharmacy on 04/17/2021. Patient did not seek medical treatment and was fine thereafter.
Two weeks after first dose, developed 2" itchy rash at site. Faded after several days but remained itchy.  Second dose 015 M20A  2/20/21 Left arm/same arm   Next day Huge, egg size swelling at site and return of rash. Almost two weeks after no swelling nor rash but still itchy and slight discoloration.
Information has been received from a veterinarian concerning his 24 year old pregnant daughter with a history of chickenpox as infant. The patient's 18 month old daughter was vaccinated about a month ago (in approximately May 2008) with a dose of VARIVAX (Merck) (WAES # 0806USA03425). On 12-JUN-2008 the patient experienced spots all over her body such as on the face, arms and legs. It was most noticeable on the stomach and thighs. She was not being treated with any medication and had a follow-up appointment next week. She has a conception date of 20-MAY-2008. Estimated due date is 10-FEB-2009. At the time of reporting the outcome of the patient was unknown. There was no product quality complaint. Follow up information was received from the patient's father who reported that his granddaughter had an itchy rash after vaccination (WAES # 0806USA03425). His daughter then developed a rash with hard bumps that itches and was seen by her dermatologist. The reporter stated that his daughter was not seen by her obstetrician/gynecologist yet, but had an appointment scheduled. Additional information is expected.
SHOULDER PAIN, INABILITY TO RAISE ARM, BURSITIS. SLIGHT IMPROVEMENT WITH MOTRIN, HEAT PACKS, CBD CREAM. BRUISING FROM SHOULDER DOWN TO 2" ABOVE ELBOW. GRADUALLY FADING.
Headache, muscle aches, joint pain, low grade fever, sore throat. Lasted about 24 hours. Starting around 24 hours after the injection.
This spontaneous report as received from an approximately 70 year old male consumer via Pfizer refers to himself. The patient's concurrent conditions included high blood pressure. No medical history was reported. On 17-DEC-2014, the patient was inappropriately vaccinated with a single shot of PNEUMOVAX 23 (dose, frequency, lot number, expiration date, route and administration site were not reported) instead of PREVNAR 13. Concomitant therapies included metoprolol succinate, amlodipine, chlorthalidone (also reported as Water pill) and simvastatin (manufacturer unknown). On 25-DEC-2014, the patient developed first sign of getting sick, cough, and was bad for another week. The patient mentioned that it was pneumonia after he went to the doctor. As reported "it kept getting worse and worse and worse and worse" and that was the point the patient could not even walk. The patient reported that it was terrible, he felt like he was going to die, for two weeks he couldn't walk more than two steps and was so weak he lost forty pounds. The patient sought medical attention via visiting the doctor. Antibiotics (unspecified by the reporter) were given for the treatment. The patient mentioned that he had never had pneumonia in seventy years and he got it after few days he took the shot of PNEUMOVAX 23 that he thought was a big coincidence. On an unspecified date, X-rays were performed and showed that there were some scarring and fluid in the bottom of one of the patient's lungs, that is hoped to go away the day he will cough it out. The outcome of pneumonia, inability to walk and weight decreased was reported as still recovering at the time of the report. According to the patient, was much much better at the time of the report but still had something in his lungs. As reported he will go back in a month to take an X-ray to see if it's gone away. The relatedness between the events and PNEUMOVAX 23 was not reported. Additional information is not expected.
Fatigue; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30 year-old male patient received bnt162b2 (BNT162B2), administration date 20Apr2021 (Lot number: ER9731) at the age of 30 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE (Lot No: EN6207)), administration date: 01Apr2021, when the patient was 30 years old, for COVID-19 Immunisation, reaction(s): "Brief spells of fever like warming of body multiple times throughout day.". The following information was reported: FATIGUE (non-serious) with onset 21Apr2021, outcome "unknown", described as "Fatigue".  No follow-up attempts are needed. No further information is expected.
Information has been received from a medical assistant referring to a patient of unknown age and gender. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported. On 02-NOV-2018, the patient was vaccinated with improperly stored VAQTA (lot # R013858, expiration date: 12-JUN-2019, strength, dose, frequency and route were unknown) for prophylaxis (Incorrect product storage). No adverse effects were reported. The vaccines were exposed to temperature of 47 Fahrenheit (F) for 37 minutes. The temperature excursion was detected by a data logger. Previous temperature excursions were reported as 47 Fahrenheit (F) for 50 minutes. The case was one of the cases received from the same reporter. Sender's Comments: US-009507513-1901USA004786.
Rashes all over my body was getting extremely itchy; I hope our hives eventually go away; Same side effects; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Rashes all over my body was getting extremely itchy), URTICARIA (I hope our hives eventually go away) and VACCINATION COMPLICATION (Same side effects) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH PRURITIC (Rashes all over my body was getting extremely itchy), URTICARIA (I hope our hives eventually go away) and VACCINATION COMPLICATION (Same side effects). At the time of the report, RASH PRURITIC (Rashes all over my body was getting extremely itchy), URTICARIA (I hope our hives eventually go away) and VACCINATION COMPLICATION (Same side effects) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient had second dose of Moderna in mid June. Patient's doctor prescribed steroid pills and cream which was yet to be taken by the patient.  No concomitant medications were reported. No other treatment details were reported.
erythematous, urticarial rash on chest & neck around 30-45" p/vax;
3rd dose from a vial punctured over a week ago; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 16-Sep-2021 and was forwarded to the company on 16-Sep-2021.    Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (3rd dose from a vial punctured over a week ago) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033B21A) for COVID-19 vaccination.     The patient's past medical history included Immunocompromised.    On 16-Sep-2021 at 8:00 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Sep-2021 at 8:00 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (3rd dose from a vial punctured over a week ago). At the time of the report, EXPIRED PRODUCT ADMINISTERED (3rd dose from a vial punctured over a week ago) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   vial was first punctured on 09-Sep-2021 at 1.18 PM& after that it was stored in fridgeThe time of minimal exposure of dose was drawn up. No concomitant medication was reported by reporter No treatment medications were reported by reporter
A report has been received from a physician concerning a subject of unknown gender, who had been receiving Nasal FLUMIST (intranasal), 0.2 Millilitres, Unknown. FLUMIST (intranasal) started on an unknown date. It was reported that there was a vaccine cold chain failure. The outcome of the event of VACCINE COLD CHAIN FAILURE is unknown. The report was considered to be non-serious.
It's been 6 days and I'm still feeling headache slight and I didn't get it until 3 days after still going during this writing.
Information has been received from a medical assistant, referring to a patient of unknown age and gender. Information about medical history, concurrent condition and concomitant therapy was unknown. On 22-MAY-2018, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (therapy type: thimerosal free, lot# N006321, expiration date: 08-NOV-2019; dose, strength, route and frequency unknown) for prophylaxis. No adverse effects was reported. Temperature excursion was reported as below 0 Celsius degrees (C) for time frame 30 minutes. There was no previous temperature excursion. A digital data logger was involved. This is one of two cases received from the same reporter. Sender's Comments: US-00950713-1810USA007244.
Sore arm; 17 year old patient received of Moderna covid-19 vaccine; This spontaneous case was reported by a nurse and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old patient received of Moderna covid-19 vaccine) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Sep-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old patient received of Moderna covid-19 vaccine). On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm). On 17-Sep-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old patient received of Moderna covid-19 vaccine) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment information was reported.   This case was linked to MOD-2021-354561 (Patient Link).
A vaccine administration error occurred.  I went to a store on Saturday 09/18/21 to receive my third shot (because I am on an immunosuppressive drug).  I gave the pharmacist my vaccine card with the dates of the primary vaccines.  The vaccines were clearly listed as Moderna.  I did not get the vaccine card back until after the vaccine was administered.  The vaccine given was Pfizer.   After I pointed this out to the pharmacist, she said she would speak to her supervisor and call me back on Monday 09/20/21.  She did call me back and told me that her supervisor told her the vaccines are interchangeable and that a VAERS report does not have to be made.    Because I am in healthcare, I knew that this was not true so I called your 800 number to verify this.  I was told that administering  a different vaccine as the third shot is an administrative error.  I am filing this report because the store is not going to do so.  You probably need to tell them that they should be reporting vaccine administration  errors.
This spontaneous report has been received from a nurse practitioner regarding a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated (Oka/Merck) VARIVAX dose 1, (dose, lot # and expiry date unknown) On 02-MAY-2012, the patient was vaccinated with improperly stored (Oka/Merck) VARIVAX dose 2, from lot # 1273AA (dose and expiry date unknown). No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review of records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provided 100 percent assurance on vaccine stability. This is one of several reports received from the same reporter. Additional information has been requested.
Headache, fever (101.8), chills, body aches, sore throat, swelling and 3 inch pink circle around injection site, fatigue.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. Information regarding medical history, concurrent conditions and concomitant medications was not provided. During 2014, the patient was inoculated with ZOSTAVAX at a pharmacy for routine adult health maintenance and for the prevention of shingles (lot #, dose and route not provided). The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. During 2016, the patient was treated by a family physician for a blistering vesicular outbreak and decreased immune symptoms which was then diagnosed as severe herpes zoster, or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcomes of the events were unknown at the time of reporting. Causality assessment was related. Additional information has been requested.
After about 4 hrs patient became lethargic and nearly passed out as oxygen dropped to under 60%.  Rose after trip to hospital with an overnite stay.  Its been three weeks and it takes him longer to catch his breath and return to 94%+ oxygen saturation.
pt recvd vax at 2pm; began screaming at 4pm & cont until 5 9dec94; t 105 max;ant fontanel bulging at er & resolved over 3 hrs as t resolved to 101;
4/3: Massive fatigue set in around 1pm 4pm the muscle/joint aches and pains started 4.4.21:  Same symptoms plus slight chills Elbow started to itch Swollen arm at or above injection site and in armpit lymph node (injection arm side) Night sweats 4.5.21: Rash on opposite elbow of arm that got the injection and rash around injection site Swollen lymph nodes and red around neck area and clavicle 4.6.21 Small rash spot on clavicle All other symptoms started to improve
Ringing ears, malaise. Syncope 1130pm 12-31-14. 1-1-15 -> redness injection site and lethargy.