chrisvoncsefalvay/vaers-outcomes huggingface dataset:
acthib may have been administered when it was reconstituted with sterile water with no reported adverse event; acthib may have been administered when it was reconstituted with sterile water with no reported adverse event; Initial information received on 21-Jun-2022 regarding an unsolicited valid non-serious case received from a pharmacist. Inquiry number: 01156214  This case reports ACT-HIB (HIB (PRP/T) VACCINE) may have been administered when it was reconstituted with sterile water with no reported adverse event.  The patient past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect acthib may have been administered when it was reconstituted with sterile water at (unknown formulation, strength, dose, lot number, route, administration site) for prophylactic vaccination (product preparation error, poor quality product administered, same day latency). It was not the first-time product was used. Patient was not using product now.  It was reported that "Caller states that ACTHIB may have been administered when it was reconstituted with sterile water. She would like to know the steps they could do moving forward. This situation is reported as a medication error due to administration of the vaccine using incorrect diluent."   Action taken: Not applicable.  At time of reporting, the outcome was Unknown for both events.    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. 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.
After I received the vaccine I had a sore muscle for three days, I also had joint pain in my hip and knees for about 36 hours . I also had a headache for 24 hours.  I took Tylenol for these pains.
Information has been received from a registered nurse concerning an actually 20 year old female patient with no known drug reaction or allergies or pertinent medical history who was vaccinated with the first, second and third dose of RECOMBIVAX HB (manufacturer unknown) on 20-MAY-1998, 30-JUL-1998 and 18-JAN-1999 respectively. There was no concomitant medication. The registered nurse reported that the patient had negative hepatitis B surface antibodies. The patient sought medical attention by an office visit. At the time of the report, the patient hepatitis B titers were negative. No further information is available.
Hard knot at injection site followed by approx. 4" diameter rash that started to wrap around arm. Pt started on cephalexin 500mg QID x 10 days. Pt was given an intradermal flu shot. Injection site was prepped with alcohol pad prior to admin. Needle cover was removed immediately prior to administration.
Large raised red area at injection site.  3x3 inches Also headache and muscle aches.
Pregnant - due 10/19/2022 Seasonal allergies  Fever/chills, fatigue, body aches - symptoms bad enough to stop me from doing my normal daily activities.  Lasted most of the day.  Sore arm at injection site - lasted about 3 days.
Pt received MMR on 9/10/2010, returned on 9/14/2010 with fever, tmax 102/8, diagnosed with otitis media and started on augmentin. Fever subsided after 1 day and she developed a rash on 9/21/2010 per the mother who brought the kid back to the office on 9/27/2010. That day baby had maculopapular rash over the body and koplik spots in the mouth and minimal cough that had started that day. Otherwise, baby was feeding well and active.
After 4/5 hours I started getting hives all over my body, when I?d touched something I got hives in that part of my body or when something would touch my skin hives would appear and itch. Shortness of breath also increased as I got hives.
Case had a physical in late  2020 that was unremarkable. He saw his PCP and had EKG done on 3/23/21 and showed Atrial Fib. PCP was concerned and referred him to Dr who diagnosed him with Atrial Fib as well. He had his  second dose of Moderna vaccine on 4/1/21. Has has since been placed on Eliquis. indicated that Dr could not rule out this was due to the Moderma vaccine and requested it be reported to VARES.
At 11:00 pt attempted to walk down stairs and legs gave out an fall down several stairs. Also that day brain "fog" started - still experiencing. On 11/5 - was showering - saw white light almost passed out. -Still experiencing
Rash on lower left arm appeared within 6 hours of injection Next morning awoke with 103 fever that persisted for 26 hours
Pt has history of asthma but no attack x 1 yr. Had runny nose at time of visit but no cough. Within 2 hrs of vaccines had cough, wheezing. Was seen in office spirometry showed severe airway obstruction, 02 sat 92% on room air. Reviewed-5 pages of office notes for 4/28 and 4/29/06, immunization records. Visit with Dr on 4/28/06 documents well 12 year. c/o nasal drainage and 'tick' bite. Returned to office on 4/29/04 1 day after vaccine of Adacel and Menactra-c/o coughing and wheezing since 4/28/06-assessment documents expiratory wheezes throughout, unlabored breathing. History of asthma (no attack in past year)treated with Albuteral inhaler 1 hour prior to office visit.  DC from office visit with RX Prednisone dose pack. DX Wheeze, cough, allergic rhinitis.
Had sharp pain in right ear 2 days after booster. Pain cam and went quickly. 5 days later on 10/17  experienced vertigo every 20-30 minutes for about 24 hours. Room spinning out of control. Saw my ENT on 10/20. He examined my ears and saw nothing unusual. Administer hearing test and all good. Told me it was probably viral, but to call if it continued past 11/1. I was fine until 11/9 when vertigo returned with vomiting, buzzing in right ear and severe balance issues. Back to ENT next day and found I had lost all hearing in right ear. Could not hear t uninformed fork and audio test show dr attic decline on chart for right ear. On 14 day prednisone pack, meclizine and Scopolamine.
Weakness, sudden onset of extreme and uncontrollable shaking, cold, high fever (up to 103)and vomiting later in night.
Elbow bursitis , about the size of a golfball right now , no pain, no impeding of motion , jut the welling and it's warm to the touch
the next day his leg was blistered, really red and hot dont know if it was from shots or the broken needle i found in his leg
This case was reported by a consumer via call center representative and described the occurrence of mobility decreased in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, unknown after receiving SHINGRIX, the patient experienced mobility decreased (serious criteria hospitalization) and walking difficulty (serious criteria hospitalization). On an unknown date, the outcome of the mobility decreased and walking difficulty were unknown. It was unknown if the reporter considered the mobility decreased and walking difficulty to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced difficulty getting up from chair and walking and had to be hospitalized. The reporter did not consent to follow up.
Rash after vaccination; This case was reported by a consumer via interactive digital media and described the occurrence of rash in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 02-OCT-2022 Reporter's Comment: The patient self-reported this case via interactive digital media. The patient received dose of Shingles vaccine and experienced rash after the vaccination. Additional supportive information: The follow-up would not possible, as no contact, details were available.
Leg, thigh and chest pain since October 22,2021. Rapid heartbeat on October 28, 2021 at 6:00 am.
Experienced chills, nausea, vomiting, fatigue for 3 days following injection. 2 weeks later experienced significant menstrual spotting for a period of 1 week. Has never experienced spotting before. This occurred 1 1/2 weeks after period.
Information has been received from a registered nurse concerning a female patient between the age of 19 and 39 years who between 23-OCT-2006 and 27-OCT-2006 was vaccinated subcutaneously with a dose of Pneumovax 23 (lot #654981/0674F). Within five minutes of receiving the vaccine the patient fainted. Unspecified medical attention was sought. Subsequently, the patient recovered from fainting. The nurse requested a lot check for lot Number 0674F. No product quality complaint was involved. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met the requirements of the government and was released by the agency. Additional information has been requested.
63 year old female patient, at the end of her waiting time in the observation area, she refers to the EMT --(Lic. #) verbalizing palpitations. The patient is transported to the EMT evaluation area to take her vital signs and evaluate the patient. EKG is performed by paramedics.
4-30-09 VARICELLA vaccine given all following info received from clinic 5-6 DEPO PROVERA shot - 5-11 " Lump on arm" - Pain shoulder to elbow" 5-13 AUGMENTIN for cellulitis in left deltoid
Irregular heart rate, abnormal ekg, irregular blood pressure, irregular heartbeats, chest pain, chest heaviness,  crippling insomnia, numbness and tingling in ams, legs, hands and feet. Feeling of electric current through whole body. Feeling of fizzing bubbles under skin. Feels like hot fizzy water being poured over legs and hands. Jerky muscle spasms mainly in arms. Fever, severe whole body muscle pain, joint pain, feel so revved up like adrenalin is pouring through my body not in a good way. Swollen thyroid and thyroid  numbers  dropped way under oprimal.
arm was sore in the same muscle as the injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (arm was sore in the same muscle as the injection) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced VACCINATION SITE PAIN (arm was sore in the same muscle as the injection). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Pain, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (arm was sore in the same muscle as the injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-063853 (E2B Linked Report).
Information has been received from a consumer concerning her 7 yr old son with no medical history or allergies who in Nov 1999, at one yr of age, was vaccinated SC with a 0.5mL dose of varicella virus vaccine live. There was no concomitant therapy. The mother reported that on 07Mar06, her son developed a mild case of breakthrough varicella. Unspecified medical attention was sought, but no lab/diagnostic tests were performed. At the time of this report, the pt was noted to be recovering. Additional information has been requested. Additional information received on 16-MAY-2006 from a  physician indicated that she did not know who the patient was and, therefore, had no further information regarding this case. Additional information is not expected.
Noticed a significant increase in my tinnitus (ringing in ears) a few days after the 1st dose. It has not improved after 2 weeks so far.  I have had mild tinnitus for 20 years.
Breakthrough covid positive (sympomatic) with outpatient positive test on 5/21/21 (symptom onset) and worsening symptoms with positive repeat test and hospitalization on 5/26/21.
Brother called pharmacy on 04.13.2021 at approximately 10am and informed pharmacist that his sister had passed away due to a pulmonary embolism about 2 weeks after receiving her first dose of the Moderna COVID vaccination at our pharmacy. He mentioned that healthcare provider was looking at possible gene mutation in family that may have contributed.
Received 2m vaccination with oral Rotavirus on 6/30/09. Aphthous ulcer - onset  5 days after ROTATEQ.
The patient has hypersensitivity, generalized maculopapular rashes. Treated Benadryl.
3:45pm pt stated throat feels funny; rechecked in 15 minutes; 4pm patient stated he feels fine and wants to leave; instructed to go to er if it occurs again; also instructed to take benadryl and pepcid fi okay with hx.
Patient reported migraine headache in lower head/neck, nausea, and dizziness.
Peri-oral numbness and tingling starting about 20 minutes after vaccination.  Onset of what was diagnosed as non length dependent small fiber neuropathy of both hands and legs during the  week of Jan 17 2021 with acute worsening on  Fri 1/22/2021.
section at injection site same day was sore; red; arm pit was really sore; swollen; This is a spontaneous case received from a contactable female consumer (patient). A 63-years-old female patient received bnt162b2 (BNT162B2, Solution for injection, Lot Number was not reported) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced section at injection site same day was sore, red, also her arm pit left side (side she got the shot is on left) was sore and still is and the next morning when she notices her arm pit was really sore which is a size of pinky finger, like a vein swollen and two weeks later it's still like this. The outcome of section at injection site same day was sore was unknown while other events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Clinician prepared vial with 1.3ml Normal Saline diluent rather than 1.8ml Normal Saline.  Pt states she was sick for 3 days after with fever, chills and nausea. After 3 days felt better & no clinical concerns
This spontaneous report was received from a medical assistant referring to 21 patients of unknown age and gender. The patient's concurrent conditions and medical history were not reported. Concomitant therapies included sterile diluent (manufacturer unknown). It was reported that, between 15-AUG-2017 and 18-SEP-2017, patients received 21 separate doses of improperly stored VARIVAX reported lot# N00204 with expiration date of 19-JAN-2019, for prophylaxis (strength, dose, route and frequency were not reported). No adverse effects reported. It was stated that the vaccines underwent a temperature excursion of -9°C (degrees Celsius) to 8°C for 1 hour and 6 minutes; previous temperature excursion was -9°C to 8°C for 1 hour and 54 minutes (worst case). The call was because of a "data logger". Lot number N00204 is an invalid lot number for varicella virus vaccine live (oka/merck). Sender's Comments: US-009507513-1709USA010133.
Dose administered past the expiration/beyond use date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered past the expiration/beyond use date) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered past the expiration/beyond use date). On 17-May-2021, EXPIRED PRODUCT ADMINISTERED (Dose administered past the expiration/beyond use date) had resolved.        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.   Concomitant product use was not provided by the reporter. The vaccine was kept in the refrigerator at a normal refrigerator temperature for 33 days. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: Follow-up received on 18-MAY-2021 contains reporter information.
Headache & Fever Narrative:  employee states after receiving the vaccine he experienced a low grade fever, headache, and overall body soreness that lasted about 24 hours
Information has been received from a physician and a head nurse concerning a 32 year old female who has never had chicken pox and received her first vaccination with Varivax (Oka/Merck) in August 2007.  On 20-SEP-2007 patient presented to the physician's office for her second dose of Varivax (Oka/Merck) and was inadvertently vaccinated with Zostavax (Oka/Merck) (Lot #657765/0585U).  The patient was notified of the mixup and had no side effects from receiving Zostavax (Oka/Merck).  It was reported the patient will not be vaccinated again with Varivax (Oka/Merck).  Additional information has been requested.
AFLURIA 2016-2017 was administered around approximately 7pm on 10/21/16 and patient states she had severe dizziness around 9pm on 10/21/16. On the morning of 10/22/16 patient states she had a headache. The dizziness was resolved on 10/22/2016.
received vaccine on 07-Apr-2022 which was expired on 27-Mar-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received vaccine on 07-Apr-2022 which was expired on 27-Mar-2022) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (received vaccine on 07-Apr-2022 which was expired on 27-Mar-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received vaccine on 07-Apr-2022 which was expired on 27-Mar-2022) outcome was unknown. Not Provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No treatment information was provided.
This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (felt under the weather) in a female patient of an unknown age 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MALAISE (felt under the weather). At the time of the report, MALAISE (felt under the weather) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported. No treatment related information has been reported.
After receiving the  4th dose of Pfizer Bivalent Booster my allergies worsened over the couple of months.  I was having difficulty breathing so I made the decision to see a Pulmonologist. I went to her some time in March.  she did Pulmonary function test, Chest X-ray and blood test. The chest X-ray and blood tests were normal but my lung function got worst so, she prescribe me an inhaler for me .  I  am still experiencing this issue now. It hasn't resolved yet.
Patient was given vaccine that was beyond "use by" date of 8/16/22. Patient did not experience any adverse effects.
pt recvd vax;devel redness, warmth,induration & pain over a 1 inch area at inject site;
Approximately two weeks after patient received her first MMR vaccine, she began to complain vigorously of bilateral knee pain.  It became difficult for her to walk upstairs or for an extended period of time.  She has never had swelling but consistent pain and absolutely nothing helps. We have done two courses of physical therapy, seen a chiropractor, had an MRI, visited the pediatric orthopedist, seen a pediatric rheumatologist--all without answers or relief. Patient had to give up ballet (her passion) within one month of the vaccine and has been unable to return to date, sixteen months later.
Non responsive to eye contact, weakness, thighs swelling, poor appetite, lethargic, mild fever, vomiting, BM - foul odor.
Patient developed 101.6 temp within 12 hours of vaccination. No seizure, no rash, no prolonged crying. Three hours after Tylenol given, temp returned to 100.1 (axillary). ** Fever has fully resolved within 72 hours of onset **
Injection of 5th dose of DTAP in upper arm. Within hours, had pronounced redness (almost black) of upper arm and extreme swelling, ER doctor prescribed Zyrtec and sent home.
POSITIVE COVID TEST AFTER TAKING VACCINE; This spontaneous report received from a patient concerned a 44 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 29-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 28-AUG-2021, the patient experienced positive covid test after taking vaccine. Laboratory data included: COVID-19 virus test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from positive covid test after taking vaccine. This report was non-serious. This report was associated with product quality complaint: 90000191409.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
This spontaneous report was received from a pharmacist refers to a patient of unknown demographics. On 20-NOV-2013, the patient was vaccinated with PNEUMOVAX23 injection 25/0.5 Y, dose 1, intramuscular. On an unknown date in January 2014 (also reported as February 2014) the patient was vaccinated with PNEUMOVAX23 injection 25/0.5 Y, dose 2, intramuscular. Approximately on an unknown date in January 2014 (also reported as February 2014) the patient received two doses of PNEUMOVAX23 within 2-3 months inadvertently. First dose was administered on 20-NOV-2013 at pharmacy and second dose was given at unspecified physician office on an unknown date in January or February 2014. No adverse effects to report. There was no product quality compliant (PQC) involved. The outcome of patient received two doses of PNEUMOVAX within 2-3 months inadvertently is unknown. Additional information has been requested.
pt recvd vax on 27AUG92 & 28AUG92 pt started feeling bad; 29AUG92 devel a sore throat, stuffy head & runny nose;