chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse symptoms reported.; the patient was "inadvertently administered a dose of VARIVAX and a dose of PROQUAD at the same office visit on 11/22/19."; This spontaneous report was received from a medical assistance referring to a 15 months old patient of unknown gender. Concomitant therapies included sterile diluent.  Information about pertinent medical history, drug reactions or allergies was not provided.         On 22-NOV-2019, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) (lot # S022758, expiration date 22-JUL-2021; dosage detail, strength and route were not reported) and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (recombinant Human albumin (rHA)) (lot # S027464, expiration date 02-MAR-2021; dosage detail, strength and route were not reported) for prophylaxis at the same office visit (inappropriate schedule of product administration).  No adverse effects were reported.
4 month old got Kinrix; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 4-month-old female patient who received DTPa-IPV (Kinrix) (batch number 7p5j5, expiry date 30th September 2022) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 6th August 2021, the patient received the 1st dose of Kinrix (intramuscular) .5 ml and Kinrix Pre-Filled Syringe Device. On 6th August 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 19-Jul-2022 Reporter's Comments: The nurse reported from a medical office that a 4 months old patient received a Kinrix vaccine. The vaccine was recommended for 4-6 years. The patient did not experienced any side effect. The reporter consented to follow up. Additional Supportive Information: The four months old patient was given Kinrix which led to inappropriate age at vaccine administration.
10/12/00 at noon, had onset of malaise and noticed a 2" X 3" area at injection site. It was a "hot, hard lump", reddened, painful and slightly itchy. Tylenol taken. Cold compresses. Still reddened.
Fatigue, Week later, itchy at inj site. Next morning warm redness, irritated blotch. 2inx2in area.
Approx 10 min after receiving Zostavax, pt c/o dizziness, headache, chest/neck tightness.  No difficult breathing, no swollen tongue/throat, speech clear and fluent.  Evaluated in Imms clinic by Dr. and then taken to ER for further evaluation at 1120. Pt reported progressively worsening sx, now tongue felt "weird" and like "I might have trouble swallowing if I tried".  But speech still clear and fluent. Started on IV H-blocker, diphenhydramine, and PO prednisone at 1145.  At 1248 she was feeling better but sx seemed to be lessening.  BP still elevated 170's/80's.  Dc'd with spouse approx 2 PM.  Approx 7:30 PM pt initial sx returned:  headache, dizziness, chest/neck tightness. Spouse took her to local fire station for eval by paramedics.  HR in 190's.  Taken by Paramedics to ER where she lives.  Tightness/fullness extended to both axilla.  No SOB c/o or noted.  Given SL NTG, ASA 325 mg, IV Morphine. Given complete cardiac workup including stress test.
Within 4 hours of the first dose I started getting a headache, before bed I was fatigued and the headache became a migraine. I woke up with my entire body hurting. The migraine lasted for 4 days, the body aches lasted for approx 10 days. I was still fatigued and could not work my job due to the tiredness, I was affraid to drive in this condition. I did try to work.  Same as the first dose with an added factor, along with the migraines I was vomitting everything I ate or drank for four days. The body aches lasted approx 10 days and the fatigue became worse than the first dosage. I still havent worked my regular job since the second dosage.
This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. No medical history and concurrent conditions were reported. On an unknown dates the unspecified patients were vaccinated with an improperly stored dose of VAQTA (incorrect product storage) (lot # L034381, expiry date 21-DEC-2016) (dosing regimen and frequency unknown). No concomitant medications were reported. It was reported that the vaccines were exposed to a temperature of 53 degrees Fahrenheit, for a time frame of 3 hours and 15 minutes. It was also reported that these vaccines were administered. No adverse effect was reported. No product quality complaint was reported. The action taken with the therapy with VAQTA was unknown. The outcome of the event was unknown. It was reported that this case was reported due to a data logger. This case is related to case numbers 1603USA005893 and 1603USA006319 via same reporter link. Additional information has been requested.
Pt recv vax on 2/27/98; on same day pt exp numb hands, arms, legs
Temperature at 7:30 PM: 99.8; febrile seizures, vomiting, temperature at 9:00 PM: 107.5.
Event- In the process of drawing up two different COVID vaccines for different age ranges and influenza vaccines from different insurance refrigerators for five siblings, Moderna 6mo-5yr was drawn up and administered to the patient.  Treatment- Per pharmacy recommendation, a second dose of Moderna 6 mo-5 yr was administered on 11/08/2022  Outcomes- Patient never had any reaction or symptoms present due to event. No adverse outcome resulted from event.
Ears were constantly moist. Felt as thought I just popped them. Itchy and wet. Not extremely painful, but the discomfort was noticeable.  Recently subsided.
Information has been received from a 75 year old male who in approximately February 2007, was vaccinated with Zostavax (Oka/Merck) and shortly after developed shingles.  The patient recovered from shingles.  Medical attention was sought.  No further information is available.
Fever to 102.7 degrees, myalgia, rigors, severe left-lower quadrant abdominal pain.
Four days ago (December 11) I started feeling itchy all over my body. The itching is an internal sensation and there is no redness or other signs of irritation on my skin. It does not affect my entire body at the same time, but moves around between different areas, seemingly at random. I have no known allergies and had not changed anything recently (soap, detergent, etc) that would account for this. I consulted with my primary care physician, who said that she had seen many female patients experiencing similar symptoms about two weeks after getting the Moderna booster and recommended that I submit a report.
Pt had some erythema and warmth distal to injection site on (R) leg. Occurred several minutes after injection. Gave BENADRYL with quick resolution.
Nonarteritic Anterior Ischemic Optic Neuropathy; This is a literature report for the following literature source(s).  A 64-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunization, reaction(s): "developed acute, unilateral vision loss", "superior sectoral optic disc edema".  The following information was reported: OPTIC ISCHAEMIC NEUROPATHY (medically significant), outcome "recovered", described as "Nonarteritic Anterior Ischemic Optic Neuropathy". The patient underwent the following laboratory tests and procedures: All examination findings: normal OD; revealed superior sectoral optic disc edema; revealed peripapillary splinter hemorrhages in the, notes: optic nerve OS; Optical coherence tomography: showed diffuse thickening of the retinal nerve fib, notes: fiber layer OS; Visual acuity tests: 20/80; 20/100, notes: OS; Visual field tests: revealed dense constriction OS. Therapeutic measures were taken as a result of optic ischaemic neuropathy.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events with the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is 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.,Linked Report(s) : US-PFIZER INC-202201024250 Same patient/drug, events occcured in different time;US-PFIZER INC-PV202200035839 Master article.
Severe tinnitus in right ear, mild tinnitus in left ear; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: GL9264), via an unspecified route of administration in left arm on 16Mar2021 at 19:30 (at the age of 56-year-old), as a single dose for COVID-19 immunisation. Medical history included hypertension, hearing loss in right ear. The patient had no allergies to medications, food, or other products. Prior to vaccination the patient was not diagnosed with COVID-19. The patient had not been tested for COVID-19 since the vaccination. The patient received amlodipine 5 mg daily within 2 weeks of vaccination. On 17Mar2021, the patient experienced severe tinnitus in right ear, mild tinnitus in left ear. The patient did not receive any treatment for the event. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event severe tinnitus in right ear, mild tinnitus in left ear was not recovered. No follow-up attempts are needed. No further information is expected.
On the night of the 1/11, I was up vomiting. On 1/12, I started to experience the basic symptoms. By that Friday, all of that was resolved. Then on 2/13, I had red, rosy, blotchy cheeks that lasted until 2/17. I was told to take Claritin, Zyrtec and Pepcid AC twice a day 24 hours before my vaccine and I continued the same regimen after the vaccine, with the addition of Prednisone. That lasted for 10 days-2 weeks.
Mother states on June 4th child became ill, developed fever of 104-105, (R) lymph node in neck became enlarged. Mother took client to doctor. On June 7th client was admitted to hospital. She underwent surgery on June 8th - had (R) lymph node removed. Mom states when child received 4 yr old shots that she had bilat. lymph node enlargement with increased fever but recovered ok.  3/5/08 Reviewed hospital medical records. FINAL DX: right neck abscess. Records reveal patient experienced fever, enlarging right neck mass, HA x 7 days.  Had been seen by pcp 4 days prior to admit & tx w/oral antibiotics.  No improvement & admitted 6/7-6/8/2008.  ENT consult done.  Exam revealed 8 x 9 cm fluctuant, tender mass on posterior right submandibular inferior oracle; shotty, tiny inguinal ymph nodes, more on right side.  Taken to OR for I&D which revealed approx 5 cm purulent material.  Progressed well & d/c to home on continued antibiotics.
10 days after receiving the Moderna Covid vaccine, I woke up to a extremely sore arm.  As the day progressed, I was in extreme pain and could not move my arm.  On day 11, along with the extreme arm pain, I noticed a red rash around where I got the covid shot.  On day 12, rash went away, however, the extreme pain in my arm was still there.  On day 13, the arm pain greatly reduced and I could move my arm more so than in the past 3 days.  Still not full range in motion in shoulder.  I called my PCP and they advised I take an antihistamine for 2nd shot.
fever the day following the second injection (no adverse effects for the first one) lasting about 2 hours.
SWELLING IN ELBOW PROGRESSING TO BRUISING OF FOREARM---NO REACTION AT INJECTION SITE
Many elderly patients who had received the shingles shot at the physician's office had contracted the shingles; Information has been received regarding a case in litigation for zoster vaccine live (ZOSTAVAX) (# 1810USA013393) from a lawyer (via factsheet) and a letter from a female patient who on a visit to a physician on 02-NOV-2016 for care of her shingles reported that the physician related to her that many of his elderly patients who had received the shingles shot at his office had contracted the shingles.  She believed that he stated about 5 % of his elderly population and he was considering no longer dispensing the shot as he had serious concerns regarding it.  She reported the physician informed her many of his patients and others reported severe pain in a part of the body prior to the outbreak of the shingles. [The indication for the shingles shot was considered prophylaxis. No information was provided on the site of administration, route of administration, date of administration or Lot number.] Treatment and outcome of shingles was not reported.  No further information was provided.  Additional information was not expected.; Sender's Comments:  US-009507513-1810USA013393:
Systemic: Lymph Node Swelling-Severe, Additional Details: Knot size of a tennis ball developed under vaccinated arm, in armpit area.  very painful and swollen
I received the Moderna vaccine in January and February I didn't get my period for 3 months; Finally on April 4 I got my period and it's been super heavy for the past 22 days non-stop; This spontaneous case was reported by a patient and describes the occurrence of MENSTRUATION DELAYED (I received the Moderna vaccine in January and February I didn't get my period for 3 months) and HEAVY MENSTRUAL BLEEDING (Finally on April 4 I got my period and it's been super heavy for the past 22 days non-stop) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.   In January 2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In February 2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 04-Apr-2022, the patient experienced HEAVY MENSTRUAL BLEEDING (Finally on April 4 I got my period and it's been super heavy for the past 22 days non-stop). On an unknown date, the patient experienced MENSTRUATION DELAYED (I received the Moderna vaccine in January and February I didn't get my period for 3 months). At the time of the report, MENSTRUATION DELAYED (I received the Moderna vaccine in January and February I didn't get my period for 3 months) had resolved and HEAVY MENSTRUAL BLEEDING (Finally on April 4 I got my period and it's been super heavy for the past 22 days non-stop) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: Normal. On an unknown date, Pregnancy test: Normal. On an unknown date, Ultrasound scan: Normal.         No concomitant medications were reported. No treatment medications were reported. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   Reporter did not allow further contact
Initial: 12 hours following - fever, chills, nausea, diarrhea, dizziness  Following (since vaccination): extreme dizziness, eye pressure and blurry vision, tingling in scalp and face, back pain,  hearing loss, and tinnitus
Light headed; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8732) via an unspecified route of administration in the left arm on 03Apr2021 at 08:30 (at the age of 35-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received amoxycillin and experienced allergy. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. On 03Apr2021, the patient experienced light headedness. The event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported event. The clinical outcome of the event light headedness was unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.
Patient presented to our pharmacy on 9/26 saying this was first vaccine and requested Janssen  vaccine, stating this was her first vaccine. Vaccine was administered. Received call from local vaccine program on 10/5 letting us know she had received Moderna vaccine in March. Employee with vaccine program said no need to call patient, as it was already discussed, but file VAERs report.
10 hrs after vaccine woke to pain in muscle  approx 1 1/2 inches below injection site.  About 12 hours latter, discomfort moved to muscle around injection site, no longer below it.  approx 36 hours after injection, muscle sore only when touched.  All discomfort fron Vaccine gone within 48 hours.
vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine given 6 days post expiry) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) (batch number- 011L20A). The patient had no adverse events. No treatment details were reported.   This case was linked to (Patient Link).
patient presented to emergency room with left sided facial weakness. Symptoms were reported to have started around 0600 the day following the vaccination. Diagnosis was made for Bell's Palsy. Prescriptions given for Prednisone 50 mg daily x 5 days and Acyclovir 400 mg 5xdaily for 10 days
No adverse event; I was supposed to get the bivalent newupdated booster but instead I got the the original strength vaccine, the 0.5 mL, the 100mcg.; This spontaneous case was reported by a patient and describes the occurrence of INCORRECT DOSE ADMINISTERED (I was supposed to get the bivalent newupdated booster but instead I got the the original strength vaccine, the 0.5 mL, the 100mcg.) and NO ADVERSE EVENT (No adverse event) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Sep-2022, the patient experienced INCORRECT DOSE ADMINISTERED (I was supposed to get the bivalent newupdated booster but instead I got the the original strength vaccine, the 0.5 mL, the 100mcg.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INCORRECT DOSE ADMINISTERED (I was supposed to get the bivalent newupdated booster but instead I got the the original strength vaccine, the 0.5 mL, the 100mcg.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 13-JAN-2014, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On or about 13-APR-2016, the patient was treated for a blistering vesicular outbreak that was diagnosed as severe shingles. The outcome of the events is unknown. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for the long-term prevention of shingles, 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. Additional information has been requested.
achy; Fever; sick; This is a spontaneous report from a contactable other healthcare professional (HCP) (patient). A male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route single dose for COVID-19 immunization on unknown date. Medical history and concomitant medication were not reported. The patient was really sick. On the next day of the second shot, the patient did get sick with a fever and was achy. The patient symptoms were gone in 24 hours and the fevers broke. The reporter stated this was something expected. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
This case was reported by a physician via call center representative and described the occurrence of pain in adult's unspecified number of patients who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain, malaise and fever. On an unknown date, the outcome of the pain, malaise and fever were unknown. It was unknown if the reporter considered the pain, malaise and fever to be related to SHINGRIX. Additional details were provided as follows: The age group was not reported but was selected as adult as per vaccine indication. The health care professional reported that he had seen multiple patients who had experienced some or all of the reported symptoms (pain, fever, malaise, aches) as noted in the prescribing information. The health care professional did not administer the vaccine; his patients had been vaccinated at various locations.
Hives/itching post-dose. Patient received Influenza Quadrivalent (P-free) vaccine 0.5 mL IM in left arm. Patient stated that he took 25-50 mg of BENADRYL daily for 3 days in order for the hives to disappear. He reported his reaction to the nurse at his next clinic visit on 10-3-13.