chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 29-MAY-2018 and 30-JUL-2018, the patient was vaccinated with an improperly stored dose of ROTATEQ (strength were unknown) (lot# N028258 and expiration date 30-MAY-2019; lot# N030174 and expiration date 13-JUN-2019) orally for prophylaxis, respectively. The sterile diluent (MERCK) (lot# and expiration date were unknown) was properly stored. No adverse event was reported. The excursion temperature on 08-NOV-2017, 16-NOV-2017, 23-JAN-2018, 06-JUN-2018, 03-JUL-2018 and 14-AUG-2018 was 47 degree Celsius for maximize 15 hours. The excursion temperature on 07-DEC-2017 was 50 degree Celsius for maximize 8.75 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA003709: US-009507513-1810USA001951: US-009507513-1810USA001952: US-009507513-1810USA001953: US-009507513-1810USA001954: US-009507513-1810USA001955: US-009507513-1810USA001956: US-009507513-1810USA001957: US-009507513-1810USA001958.
Information regarding Haemophilus influenzae type B conjugate vaccine, was received from a published literature article. The article discusses that the elimination of Haemophilus influenzae type B disease may be achievable as a result of the use of Haemophilus influenzae type B vaccines since 1987. The authors specifically focus on 3 cases of Hib bacteremia over a 12 month period (October 1999-September 2000), providing insight into the kinds of cases that may still occur in the haemophilus influenzae type B vaccine era. Only 2 of the 3 patients mentioned had received the vaccination. This report concerns an 11 month old male, who was immunized with a Haemophilus influenzae type B conjugate vaccine at 3, 5 and 11 months of age (last dose was 6 days prior to admission), who developed haemophilus bacteremia and respiratory syncytial virus. The pt presented to a hospital in respiratory distress. Physical examination revealed a pulse of 217 beats/minute and temp of 39.7 deg C. Oxygen saturation was 73% on room air. Chest auscultation revealed wheezing and retractions were apparent. Bilateral conjunctival injection was present. A chest x-ray demonstrated bilateral parenchymal infiltrates with hyperinflation of the lung fields. A nasopharyngeal washing yielded respiratory syncytial virus (RSV) antigen. The child was hospitalized and treated with ceftriaxone and azithromycin. The next day, Haemophilus influenzae type B ausceptible to ampicillin, was isolated from a blood culture. Examination of cerebral spinal fluid (CSF) was normal. The pt was prescribed a 10-day course of ceftriaxone, and recovered without sequelae. The authors stated that this case was atypical because most reported cases of Haemophilus influenzae type B occur in children who have not been vaccinated. As was established with this child, the receipt of Haemophilus influenzae type B vaccine is not always sufficient to protect from bacteremia even after the third or fourth dose. The authors concluded that the occurrence of this case "suggests that despite an effective immunization program, the organism must still be circulating. If we are to achieve the goal of elimination of invasive Hib disease, additional strategies may be required." See related case(s): HQWYE238012JAN04. No additional info was available at the date of this report.
Severe Sudden onset tinnitus 12 days after for a shot. Has not resolved.
Information has been received from a nurse via a company representative referring to a 12 month old male patient. Information about concurrent conditions and medical history were not provided. On 17-DEC-2014 the patient was vaccinated with M-M-R II, VAQTA, VARIVAX (Merck) and PREVNAR (lot#, dose, dose#, route and vaccination site was not provided for all these vaccines). On 07-JAN-2015 the patient experienced Idiopathic thrombocytopenic purpura (ITP), Norovirus, and enteropathogenic Escherichia coli (EPEC) Diarrhea. The patient was admitted to a Hospital from 07-JAN-2015 to 09-JAN-2015. Upon admittance to the hospital an unspecified blood platelet test revealed that the patient had a low blood platelet count (unspecified date in January 2015). The outcome of all the events was reported as recovered on an unspecified date in 2015. Upon internal review, the event idiopathic thrombocytopenic purpura (ITP) was considered to be serious due to medically significant. Additional information has been requested.
One week after vaccine, patient complained of muscle soreness and some nerve pain at injection site that radiated up to her neck. It lasted two days then left. Nine days after vaccine, patient reports a rash with small pustules at injection site that extended sporadically down to her forearm.
Pt states approx 3 hours after vaccines she experienced tightening in her throat...she went to a local facility.
Numbness, tingling, paresthesia of bilateral upper extremities.  Patient condition improved over period of 40 min observation.
Flu vaccine administered on 10/31/15 at 11:00PM. Employee developed hives over neck, chest and abdomen within 48 hours of administration. Called PCP and told to take BENADRYL.
no adverse effect reported; improperly stored VARIVAX; This spontaneous report was received from a registered nurse referring to a 5-year-old patient of unknown gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications.  On 12-AUG-2019 and 13-AUG-2019, vaccines had a temperature excursion.  On 30-AUG-2019, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) lot # R006221 with expiration date on 29-FEB-2020 or R029517 with expiration date on 14-OCT-2020 (dosage schedule, route and anatomical location were not reported), for prophylaxis (incorrect product storage).  Administered doses of vaccine experienced temperature excursion of -14 degrees Celsius (C) to -10 C (-11.91 C) for 8 hours. There was no previous temperature excursion. Digital data logger was involved. Vaccines were reconstituted with a properly stored sterile diluent. No adverse effects were reported.
1 week after injection site where it was injected is very icy red and inflamed. Looked online for example and it says Covid Arm. Taking Benedryl to help with itching.
Extremely sore muscle at injection site, fatigue, joints hurting occasionally (although with fatigue I'm not moving much),fever 99.4 - 100.7, and blood sure elevated between 162 and 190. Don't know of any other reason for it to be this high. Had sleepless night and then 4:00 a.m. blood sugar was 190. Blood sugar is what I'm most concerned about.
My first vaccine was Feb 14, 2021, my second Mar 7, 2021. Following both I had <24 hours of headache and lethargy before returning to normal.  Symptoms were noted during hikes with cub scouts, so not particularly difficult terrain  On March 27 I was very short of breath during an uphill hike and almost gasping at the top.  I did no more uphill hiking until the next event May 1, at where I experienced shortness of breath and dizziness on an uphill hike. After resting a few minutes I continued for a brief period before it returned requiring me to back. May 7, short of breath and dizzy while doing yard work requiring ladder climbing May 10, short of breath and dizzy on a quick 1/2 mile walk May 10, visited GP and was admitted to hospital with abnormal ECG
Sore arm; Severe tinnitus in both ears; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FP7533) via an unspecified route of administration in the left arm on an unknown date in 2021 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. Medical history included sleep apnea and tinnitus. Concomitant medications included multivitamin (MANUFACTURER UNKNOWN) and fish oil (MANUFACTURER UNKNOWN) for an unknown indication and from an unknown date. The patient received varicella zoster vaccine rgE (CHO) (SHINGRIX), dose number 1 in the arm on 27Mar2021 for an unknown indication. The patient previously took simvastatin and experienced allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. On 01Apr2021 (day 1) at 18:00, the patient experienced sore arm with no other significant symptoms. On an unknown date in Apr2021 (day 5), the patient experienced sudden onset of fairly severe tinnitus in both ears, continued constantly through day 6. The patient had minor tinnitus from time to time before, but this was more intense. It was annoying, but not debilitating at the time of this report. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events sore arm and severe tinnitus in both ears was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Patient experienced nausea, fatigue, slight headache. Redness/soreness on left arm that was size of a tennis ball. No fever was reported/observed.
Fever of 102.9 began about 12 hours after 2nd vaccine dose.  Fever persisted for approx 48 hours.  I took Tylenol at first sign of fever without relief. I took Advil 1 hour after Tylenol was ineffective with adequate relief of fever.  Fever recurred approx every 8 hours for 48 hours. Other symptoms include fatigue and sore arm at injection site.
patient mother called and said patient is in a lot of pain and vaccine was given near shoulder bone (5 inches above where it should be)
Booster dose received on 6/1, on night of 6/3 armpit became so sore that it interrupted his sleep multiple times during the night. Was also extremely fatigued upon waking on 6/3. He was unable to do normal activities or attend school on 6/3. Because of the pain intensity ( reported a 7 out of a 10 for pain), I reached out to his pediatrician's office (where we received the booster dose) for guidance. The RN recommended alternating Motrin and Tylenol, and applying ice and heat to armpit area. They advised if not improved by 6/6 to reach out for additional help. We took the recommended actions. The soreness persisted and started to improve on 6/5. As of today 6/8, there is still some soreness, but no longer impacting activities.
11/19/15 Rash on entire arm, sprad to chest area, 11/10/15 prednisone prescribed by MD.
Patient developed left shoulder pain two hours after receiving injection. Continued with pain and decreased range of motion.
Rash - nearly confluent pink tiny papules, from (L) thigh to (L) flank & (L) arm , mildly itchy
Pt began to experience fatigue, fever, headache, chills and nausea. At the site of injection it felt hot and swollen lump like a hive.
Red swollen area at injection site told patient to go to urgent care or ER. Patient described at cellulitis or have a Dr look at it. She is a pharmacist and works at hospital.
One day post immunization: localized pain at injection site, no tx. One week post immunization: decreased ROM in L arm due to increased pain, no redness or swelling, tx with ibuprofen; continued for 5 wks and evaluated 11/19/02. Symptoms and treatment ongoing as of this date.
The refrigerator that houses the vaccines experienced a temperature excursion. The FLUARIX vaccine was considered to be out of range and therefore invalid.
Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Headache-Mild, Systemic: Hypotension-Mild, Systemic: Shakiness-Mild, Systemic: Tachycardia-Mild, Additional Details: Patient refused Benadryl, was monitored for 30 minutes. Patient felt dizzy and faint, we monitored, gave water, an ice pack. Patient's symptoms resolved after 30 minutes.
meniere's ringing in right ear; head felt fuzzy; unable to concentrate; Nausea; Vomiting; Vertigo; This is a spontaneous report from a contactable healthcare professional (patient). A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL8982 and expiry date: unknown), via an unspecified route of administration on the right arm, on 25Jan2021 08:30 at a single dose for COVID-19 immunization. Medical history included HTN and Meniere's disease. Patient was not pregnant at the time of vaccination. Concomitant medication included amlodipine and hydrochlorothiazide. No other vaccine was received in the four weeks. The patient experienced head felt fuzzy, unable to concentrate, Meniere's ringing in right ear, nausea and vomiting, vertigo on 25Jan2021 10:30. Events resulted in emergency room/department or urgent care. Meclizine, IV Fluids, Maalox and Zofran were given as treatment for the adverse events. Outcome of the events was recovered. Patient was not diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination.; Sender's Comments: The patient had medical history of Meniere's disease.  The reported event was more likely due to underlying disease, and less likely causally related to the BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE).  The case will be reassessed should additional information become available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.
VARIVAX was administered intramuscularly instead of subcutaneously; VARIVAX was administered when Shingrix was the intended vaccine; This spontaneous report as received from a nurse practitioner referring to a 62 years old male patient. The patient's concurrent condition, medical history and concomitant medication were not reported.    On 23-MAY-2021, the patient was supposed to received his second dose of varicella zoster vaccine rge (cho)(SHINGRIX). However, on that day, he was given varicella virus vaccine live (oka/merck) (VARIVAX) instead (wrong product administered). In addition, the patient was given varicella virus vaccine live (oka/merck) (VARIVAX) intramuscularly instead of subcutaneously (incorrect route of product administration) (strength, dose and lot # not reported; expiration date reported as 23-JAN-2022; indication: prophylaxis). It was reported that the lot number and expiration date for the sterile diluent (manufacturer unknown) were T006519 and 31-OCT-2022 (strength and dose not reported; route: intramuscular) (incorrect route of product administration). No product quality compliance was reported.
This spontaneous report was received from a registered nurse via a company representative referring to a 11 year old patient of unknown gender. The patient's concurrent conditions, medical history or concomitant medication were not reported. On an unspecified date in 2008 or 2009, the patient was vaccinated with an unspecified dose of M-M-R II (strength, dose, route of administration, lot number and expiration date were not reported) as routine vaccination (prophylaxis). On an unspecified date, the patient developed measles even though he/she had received the vaccine in the past. The registered nurse called back with additional information regarding to the lot number of second dose of the M-M-R II series of vaccination related to the adverse event. At the time of reporting the outcome for the event measles and vaccination failure was not reported.  Upon internal review measles was considered to be a medically significant event. Additional information has been requested.
Swelling & tightness in arm, itching, rash dime size knot at injection site, muscle aches limited mobility of arm, headache flu like. Took Tylenol & Benadryl.
3rd dose administered as a 0.25 mL dose; 3rd dose administered off schedule; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (3rd dose administered as a 0.25 mL dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (3rd dose administered off schedule) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012F21A, 027A21A and 025B21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Flu (flu shot) on 06-Sep-2021. Past adverse reactions to the above products included No adverse event with Flu. Concurrent medical conditions included Drug allergy, Drug allergy, Drug allergy, Drug allergy and Immunocompromised. Concomitant products included SIMVASTATIN for Cholesterol.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, the patient experienced ACCIDENTAL UNDERDOSE (3rd dose administered as a 0.25 mL dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (3rd dose administered off schedule). On 25-Oct-2021, ACCIDENTAL UNDERDOSE (3rd dose administered as a 0.25 mL dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (3rd dose administered off schedule) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Treatment were reported.
Suicidal ideation - behavioral health admission. Patient responded very well to medication changes, psychoeducation, group therapy, and milieu therapy. Lithium was discontinued, lamictal was increased to 100 mg BID, and clonidine was started for anxiety. Her need for clonazepam decreased significantly. Wellbutrin was increased to address residual depressed mood with good effect. SI remitted and the patient requested discharge to resume outpatient care. She discharged in stable condition. ED visit and hospital admission within 6 weeks of receiving the COVID Vaccine.
Information has been received from a medical assistant concerning an unspecified patient of unknown age and gender. There was no information patient's medical history, drug allergies, previously drug reactions, concurrent conditions or concomitant medication. On 24-MAY-2017, the patient were vaccinated with an improperly stored ROTATEQ orally, lot number M012495 with expiration date of 09-OCT-2017 (strength, dose, dosage schedule and anatomical location were not provided) for prophylaxis, and the administered dose was exposed to a temperature between 32°F to 35°F (digital data logger) for 13 hours and 42 minutes without any previous temperature excursion. No adverse effects were reported.
Aprroximately 0900 on 10/25/2006 received vaccination to right deltoid. Blisters noted this morning when itching began at site.
Pfizer vaccine (0.3ml) given IM to 11 year old child. The error was caught after the dose had been given by the admin staff. When father of patient was confronted (while still in the clinic) he stated he "provided false information about his child's age because he heard from other parents in the school district that the  Health Department does not verify age prior to administration of vaccine".
A pharmacist reported the inability of an adult female to respond to the third injection of Hep B vaccine recombinant (Engerix-B). Medical history, concurrent conditions, and concomitant medications were not provided. Approximately in 1998,the subject received her third injection of Engerix-B and reported that she "may have not responded." The subject stated that her titer was measured 6 to 12 months after the completion of the series (results not provided).
LARGE 8CM CIRCULAR ERYTHEMATOUS PATCH WITH CENTRAL INDURATION AND PAIN.
For about 5 days it really hurt to brush my teeth - they were very sensitive to brushing.  No other pain during the day - just when brushing  morning and night.  Reporting because I saw that some people have lost a tooth to long Covid and I wondered if there was any relation.  It resolved on its own.
Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Headache-Mild, Systemic: Hypotension-Medium, Systemic: Numbness (specify: facial area, extremities)-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild
Patient had tachycardia after the vaccine, and ended up in the ER room the next day after vaccination. She states her HR went up to 150
"It resurfaced again May 19, 2021 if like just had the shot again. Arm is very sore and tender to the touch at injection site"; "Sore arm at injection site and when moving arm, as if patient just got the vaccine"; This is a spontaneous report from a contactable consumer, the patient. A non-pregnant female patient of unknown age received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0162) via an unspecified route of administration in the left arm on 19Apr2021 at 10:00 as a single dose for COVID-19 immunisation. Medical history included congestive heart failure (CHF), histoplasmosis, thyroid disease, diabetic, penicillin allergy and sulfonamide allergy. The patient did receive unknown medications within two weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6204) via an unspecified route of administration in the left arm on 18Mar2021 at 13:00 as a single dose for COVID-19 immunisation. The patient previously received BYDUREON for unknown indication and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 04May2021 the patient experienced, sore arm at injection site and when moving arm, as if the patient just got the vaccine. It resurfaced about 2 weeks after 2nd shot and lasted 3-4 days and then went away. It resurfaced again on 19May2021, as if the patient just had the shot again. Arm was very sore and tender to the touch at injection site. There were no other symptoms. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the event "sore arm at injection site and when moving arm, as if patient just got the vaccine" was recovered on an unknown date in May2021. The clinical outcome of the event "It resurfaced again May 19, 2021 if like just had the shot again. Arm was very sore and tender to the touch at injection site" was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
?Lump? on arm that has been present since the day of the vaccination. Site was red that evening but not the next morning. The only thing that has been present since then is the lump. It isn?t painful, red. There is no rash.
Large red circle emanating from injection site. about 5 inches by 6 inches today 2/17/2021, On 2/10/21 had sore left armpit that lasted til 2/13/2021 then it migrated to my right armpit for 2/15/2021 til 2/16/2021