chrisvoncsefalvay/vaers-outcomes huggingface dataset:
vision loss; other zoster-related conditions; Information has been received from a lawyer regarding a case in litigation and refers to a patient (pt) of an unknown age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 01-JUN-2014, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (strength, dose, dose number, route, anatomical site of vaccination, lot number and expiration date were not provided) as prescribed and/or administered by a pharmacist for the long-term prevention of shingles and/or zoster-related conditions. On an unknown date (reported as subsequent to pt's zoster vaccine live (ZOSTAVAX) inoculation), the pt was treated by a physician for vision loss (blindness) and other zoster-related conditions (ill-defined disorder). On an unknown date, he was admitted to the hospital due to the events. As a direct and proximate result of pt's use of the zoster vaccine live (ZOSTAVAX) vaccine, the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. At the time of this report, the outcome of blindness and ill-defined disorder was unknown. The lawyer considered the events to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, blindness was considered a medically significant event.
Moderna COVID-19 Vaccine EUA I received my 2nd vaccine on Friday and had a little soreness in my left arm.  When I got up Saturday morning  I felt a little dizzy and achy.  This continued during the entire day/night along with chills, warmth, and fatigue.  I took a 1.5 hour morning nap and a 4 hour afternoon nap.  Later I slept 8 hours at night.  I took an acetaminophen twice during the day and drank a lot of water.  On Sunday, I felt pretty much back to normal.  I just had slight dizziness a couple of times.  I reported this to my doctor.
left arm was bruised; big knot on her arm; she received her Menveo and Bexsero; This case was reported by a consumer via call center representative and described the occurrence of bruising of arm in a 70-year-old female patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   Co-suspect products included Men B NVS (Bexsero) (batch number ABX797AB, expiry date 30th September 2020) for prophylaxis, Hib UNK (Hib vaccine) for prophylaxis and PNEUMOCOCCAL 13 VALENT CONJUGATE VACCINE (PREVNAR 13) for prophylaxis.   The patient's past medical history included spleen operation. Concurrent medical conditions included appendix cancer and platelet count high. Concomitant products included acetylsalicylic acid (Aspirin (Baby)).   On 22nd June 2020, the patient received the 1st dose of Menveo, the 1st dose of Bexsero (intramuscular), the 1st dose of Hib vaccine and the 1st dose of PREVNAR 13. On an unknown date, less than 3 months after receiving Menveo, Bexsero and Hib vaccine, the patient experienced bruising of arm, mass and inappropriate age at vaccine administration. On an unknown date, the outcome of the bruising of arm, mass and inappropriate age at vaccine administration were unknown.   It was unknown if the reporter considered the bruising of arm and mass to be related to Menveo, Bexsero and Hib vaccine.  Additional details were as follows: After receiving 1st dose of Bexsero, the patient experienced left arm was bruised and she had a big knot on her arm from the vaccinations. The patient received Menveo and Bexsero vaccinations at the age of 70 years, which led to inappropriate age at vaccine administration. The patient reported that she had her spleen removed after being diagnosed with appendix cancer and she was told to get the Menveo, Bexsero, Prevnar 13 and Hemophilus influenzae type B (HIB) vaccine after her surgery. It was unknown if the reporter considered the bruising of arm and mass to be related to Prevnar 13. The reporter consented to follow up. The case was considered as medication error with harm. his case has been linked with US2020AMR187009 reported by same reporter and same patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR187009:same reporter
patient was administered an expired dose of Moderna vaccine; second dose received on day 40; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 28-Sep-2021 and was forwarded to Moderna on 28-Sep-2021.    This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient was administered an expired dose of Moderna vaccine) and INCORRECT DOSE ADMINISTERED (second dose received on day 40) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018B21A and 021B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient was administered an expired dose of Moderna vaccine) and INCORRECT DOSE ADMINISTERED (second dose received on day 40). On 27-Sep-2021, EXPIRED PRODUCT ADMINISTERED (patient was administered an expired dose of Moderna vaccine) and INCORRECT DOSE ADMINISTERED (second dose received on day 40) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   There are no treatment or concomitant medications. There is no previous history given   Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: fallow up received  contains New event updated
pt recv vax 13JUL98 & pt had sl diaper rash on 13JUL98;T97.8ax;returned 15JUL98 rash has spread over body;16JUL98 rash ha worsened & spread;bright red-temp 100 ax;probable allerg rxn;
CHILD'S DATE OF BIRTH WRITTEN AND AGE WRITTEN AS 12 ON CONSENT SIGNED BY PERSON IDENTIFYING AS FATHER. CHILD IDENTIFIED IN INFORMATION SYSTEM  WITH DATE OF BIRTH. CHILD IS TOO YOUNG FOR VACCINE ON 8/5/2021.
states had covid vaccine on 12/28, had L arm pain that extended down the arm, also had joints pains, now noticing R thumb pain and swelling;   f/u 1/14/21: My thumb is resolved and it lasted 1.5 days of swelling and redness. Pain now in one specific spot on my deltoid
Hospitalized elsewhere for UTI and concern for graft vs host disease post transplant. Pt positive for COVID in October and continues to test positive.
Rash on upper stomach, chest, back, and neck. Does not itch or hurt as of now.  First noticed it at appx. 5pm April 25 (54 hours after vaccine injection). Heart rate seems elevated too but I am anxious that this is an allergic reaction so it may be due to that anxiety.
sore arm after first injection.  about a week later started experiencing tinnitus in my ears.  got second shot on 2/5.  tinnitus continued and got a little worse and has now continued into May.  Nurse practitioner recommended reducing doses on meds I am taking but that provided no relief to the ringing in my ears.
The wrong vaccine, Pfizer was pulled instead of Janssen for the client. An RN drew up Pfizer 0.5 ml and incorrectly, labeled  l it Janssen. The client received Pfizer 0.5 ml via left deltoid. The client was notified byRN (supervisor) and the client was very upset but stable. A copy of the incident report was given to pt upon request. RN supervisor sat with the client during her 15 minutes observation. RN supervisor re-educated staff regarding medication errors.
Chest pain, inflammation of chest wall, lightheadedness, short of breath, stabbing pain between shoulder blades, tingling on left side of body and face
320PM pt had red spots on lt foot which spread to body;mom states pt stopped breathing short time then was crying w/o stopping;seen in ER (via ambulance)
AFTER VACCINES, PT AND MOTHER LEFT TO GO TO STORE. MOM CALLED AND REPORTED THAT PT HAD SUDDEN SWELLING OF BOTH EYES AND THROAT CLEARING APPROX. 20 MINS AFTER VACCINES ADMINISTERED. PARENT WAS ADVISED TO RETURN TO CLINIC. UPON EXAMINATION, PT WAS FOUND TO HAVE MODERATE EDEMA BIL. UPPER AND LOWER EYELIDS AND MILD FACIAL SWELLING. NO RESPIRATORY SYMPTOMS OR RASHES NOTED. BENADRYL  AND  PREDNISOLONE ADMINISTERED IMMEDIATLEY UPON PT'S RETURN AND PT OBSERVED IN OFFICE X 45 MINS. PT WAS SIGNIFICANTLY IMPROVED PRIOR TO D/C HOME. MOM WAS INSTRUCTED TO CONTINUE BENADRYL AND PRED. X 3 DAYS RTC
Generalized hives and edema onset within 48 hours of administration of H1N1. Treated with prednisone and antihistamine.
Swollen ankle; Itches; Tenderness to touch; A spontaneous report was received from a consumer concerning a 81-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events swollen ankle, itches, tenderness to touch.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 3 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 028L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 5 Feb 2021, the patient experienced the event(s) swollen ankle, itches, tenderness to touch.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), swollen ankle, itches, tenderness to touch was unknown.
I got my vaccine 10/08/2021 it was still hurting and later that night I had fever 103 and than I was having flu like symptoms and than fatigue, weak, body aches and not feeling well at all. I took Tylenol alone with my other medications. I started having swelling in my finger tips and redness for 3 days. I am reporting pain on my lateral fingers. I was taking ibuprofen over over the counter and then the doctor put me on Naproxen 500 mg 12/23/2021.
Pain; This is a spontaneous report from a Patient Program. A contactable other health care professional and consumer reported that a 60-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as UNKNOWN, SINGLE DOSE for covid-19 immunisation; tofacitinib citrate (XELJANZ), oral from Jan2021 (Batch/Lot number was not reported) and ongoing, at 5 mg, twice a day for an unspecified indication. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced pain. The outcome of the event was recovered. The action taken in response to the event for tofacitinib citrate was unknown.  Information on the lot/batch number has been requested. Follow up letter has been generated for further information.
?Moderna COVID- 19 Vaccine EUA    Received Moderna vaccine on 1/7/2021 on right arm. Experienced pain and tingling sensation afterwards on vaccinated arm. No adverse events noted during observation time. Pain provoked with laying on unvaccinated arm and alleviated with shaking and moving vaccinated arm. No systemic symptoms, no warmth noted on right deltoid, no erythema, no swelling or effusion, no weakness. Physical and neurological exam unremarkable.  Medrol dose pack and Voltarene gel scripts given. Return to clinic for follow up as needed if no improvement after steroid course.  Moderna Lot 012L20A  IM injection Right arm
Info has been received from a health professional concerning a 16 year old male who was vaccinated at 18 months of age with a dose of MMRII. Subsequently, the pt had a reaction. Unspecified medical attention was sought. There was no product quality complaint involved. Additional info is not expected.
On the initial day about 5 minutes getting the shot I had right eye cramping lasted 25 minutes  12/18 neck stiffness worst on 12/19 On 12/19 I had extreme fatigue and headaches also on 12/20, and 12/21. Felt very dehydrated as well.
About 6 hours after injection both my arms started itching and I got a red rash on upper chest, both arms and face.
swollen lymph nodes; pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (pain) and LYMPHADENOPATHY (swollen lymph nodes) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021A21A) for COVID-19 vaccination.     Concurrent medical conditions included Cancer and Chemotherapy.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced PAIN (pain). On an unknown date, the patient experienced LYMPHADENOPATHY (swollen lymph nodes). At the time of the report, PAIN (pain) and LYMPHADENOPATHY (swollen lymph nodes) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information not provided. List of concomitant medication were not given.
Case previously recorded as MA2009-3292. Initial case report received from a health care professional via MedCom on 26 OCT 2009. A patient, age and gender unknown, was vaccinated i.m. with S-OIV FLUVIRIN (batch no. unknown) on 23 OCT 2009. The patient, under 4 years, was inadvertently given Novartis H1N1 vaccine. No adverse event was reported. Reference no.: NA09-007031.
FIRST DOSE GIVEN WAS PFIZER VACCINE (6/7/21), SECOND DOSE WAS MODERNA (7/22/21).   PATIENT'S CARD WAS FILLED OUT INCORRECTLY ON FIRST DOSE. PFIZER WAS ADMINISTERED BUT CARD SAID MODERNA SO WHEN PATIENT CAME FOR 2ND DOSE, MODERNA WAS ADMINISTERED.   CDC WEBSITE STATES THAT THIS VACCINATION ERROR (MIXING VACCINES) SHOULD BE REPORTED.
aching arm within couple hours, by end of night upper arm and armpit swollen at injection site,  lymph node in armpit swollen and felt like knot size of golf ball, unable to fully extend arm without stabbing shooting pain down arm, constant throbbing pain in dotoid muscle,  unable to use left arm for typical personal care (pull up pants, brush hair, put on shirt) without pain in left shoulder area. Used ice pack for 3 days, then tried using heat pad with limited results. Used "Icy Hot" and termacare patch with limited results.  Ice pad would allow me to stretch arm with less pain but pain not completely gone.  Have tried generic passive stretching exercises to prevent cramping in upper arm.
Chronic diarrhea. Normal ?sickness? reaction (fatigue, chills, body ache) about 24 hrs after injection, diarrhea onset same timeframe (24 hrs).  Stool was very light brown in color, almost orange/beige. Diarrhea continues for 5 months now. Occasional ?normal? stool, but predominantly soft with urgent timing to restroom.
Patient complained of "Whooshing" in her ears and nervousness.  Blood pressure taken.  BP elevated.  Patient's husband states that this "whooshing" has been going on for about a year.  No trouble breathing, no itching, no rash, no swelling of mouth our throat.  Patient advised to consult a physician related to elevated blood pressure.  Patient declined EMS.
Within 2-3 hr. developed pain in arm that vaccine was given; pain radiated down mid chest, pain midline, stay froze; visual hallucination "seeing spiders in the room".
Shingles-rash and blisters, still have pain. Treatment- Valtrex, Gabapentin, Oxycodone
Patient received ZOSTAVAX on 12/9/13 - later that evening started a headache. On 12/10/13 complained of tightness of chest and difficulty in breathing (middle of night) thereafter experiences fatigue.
Abdominal cramping started in the am, then diarrhea started that evening and has not stopped since. Also having abdominal cramping & severe gas.
Patient fainted within 15 minutes of vaccination.  Felt better after lying down and was released to home.
This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in an elderly male patient who received Herpes zoster (Shingle's vaccine).    Co-suspect products included Herpes zoster (Shingle's vaccine).   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingle's vaccine and Shingle's vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingle's vaccine and Shingle's vaccine.  Additional details were provided as follows: The case was reported by the wife of the patient. The age at vaccination was not reported. The patient had received the shingles vaccine a couple of years ago and he had shingles six times already. The reporter stated that the patient received the vaccine from his druggist. The patient took the 'first two' and then they told them about the second one, the reporter was referring to shingles vaccine but did not know the name of the vaccine when asked. The reporter stated she was told there was a better one a year later. The reporter did not provide further information about patient's adverse event. This case was considered as suspected vaccination failure as laboratory test confirmation and time to onset for the event was unknown at the time of reporting. The reporter consented to follow up and did not provide the healthcare providers details.
Information has been received from a 27 year old female with sulfonamide allergy who "about a year ago", in approximately 2008 was vaccinated with the first dose of GARDASIL vaccine injection. Concomitant therapy included EFFEXOR and ADVAIR. "After getting the vaccine", the patient experienced a lump, itchiness and warmth at the injection site that lasted about 4 months when the patient was recovered. No further information is available.
Left deltoid - redness, swelling, pain 1 hr after injection given. Pt iced the (L) deltoid, took BENADRYL and ZYRTEC.
Information has been received from a medical assistant concerning multiple unknown patients of unknown age and gender. The patients' concurrent conditions, medical histories and concomitant therapies were not provided. On unknown dates, the patients were vaccinated with doses of improperly stored ROTATEQ oral liquid (lot # L035636 with expiration date 21-MAY-2017, lot # L033694 with expiration date 16-JUN-2017; dose and route were unknown). The vaccines were exposed to temperature excursion of 47.8 degrees Fahrenheit for 67 hours. There were no previous temperature excursions. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
lt upper arm by 4th day has baseball size lump & red, hot to touch, lymph node in arm pit swollen & tender, chills, low grade temp;sl lethargy, sl nausea;
This spontaneous report as received from a Registered Nurse refers to 6 patients of unknown demographics. The patient's medical history and current conditions were not reported. On 20-SEP-2014 the 6 patients were inadvertently administered improperly stored RECOMBIVAX HB injection 10 Y (strength, dose and frequency not reported) (Lot # and expiry date not reported). No adverse effects reported. Product quality complaint was not involved. The outcome of the events was unknown. This is one of the several reports received from the same reporter and Linked to cases MARRS # (1410USA000627, 1410USA007242, 1410USA007240 and 1410USA007241). Additional information has been requested.
Chest pain, heart palpitations, shortness of breath, tight chest-resolved in 4 months . Treatment: increase dose of Mirtazapine, Ativan, ibuprophen , rest  Burning lips - resolved in 2weeks  Sore arm-resolved in 4 days  Sore joints, neck, clavicle  & leg pain -resolved in 2weeks
Pt anxious at the time of vaccination. Nauseated.  BP 88/57, at discharge 104/62.  OxSat 99%.  HR 65, 71 @ Discharge.  Blood sugar 94.
Showing a tiny bit of arthritis in there; She feels crippled by the shot/She feels if she takes a step or moves the wrong way like she has ripped out her knee; Adverse reaction to the shot; She has some arm pain after receiving the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRITIS (Showing a tiny bit of arthritis in there), MOBILITY DECREASED (She feels crippled by the shot/She feels if she takes a step or moves the wrong way like she has ripped out her knee), VACCINATION COMPLICATION (Adverse reaction to the shot) and VACCINATION SITE PAIN (She has some arm pain after receiving the vaccine) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021C21A and 021C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ARTHRITIS (Showing a tiny bit of arthritis in there), MOBILITY DECREASED (She feels crippled by the shot/She feels if she takes a step or moves the wrong way like she has ripped out her knee), VACCINATION COMPLICATION (Adverse reaction to the shot) and VACCINATION SITE PAIN (She has some arm pain after receiving the vaccine). The patient was treated with METHYLPREDNISOLONE on 24-Sep-2021 for Adverse event, at a dose of 40 mg and LIDOCAINE on 24-Sep-2021 for Adverse event, at a dose of 1 dosage form. At the time of the report, ARTHRITIS (Showing a tiny bit of arthritis in there), MOBILITY DECREASED (She feels crippled by the shot/She feels if she takes a step or moves the wrong way like she has ripped out her knee), VACCINATION COMPLICATION (Adverse reaction to the shot) and VACCINATION SITE PAIN (She has some arm pain after receiving the vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Magnetic resonance imaging: abnormal (abnormal) A tiny bit of arthritis in there.         No relevant concomitant medications were reported.  Patient has had 2 x-rays for her knee prior to dose 1 and showed no changes, as well as multiple doctor visits as she felt crippled post the shot at the time.   This case was linked to MOD-2021-352971 (Patient Link).; Sender's Comments: This case concerns a 59-year-old female patient with no relevant medical history, who experienced the unexpected event of Arthritis. The event occurred an unknown date after receiving the first dose of mRNA-1273 (Moderna COVID-19 Vaccine). Rechallenge was not applicable since the outcome of events were unknown. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.