chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Itching on and off; Red big circle; Itchy; sore arm; Case reference number MOD-2021-013765 is a spontaneous case report sent by a Other on 25-JAN-2021 00:00:00 , which refers to a Female aged 77 Years The following drugs are known to have been taken by the patient prior to the event: GABAPENTIN[] ,CARBAMAZEPIN  The patient got the 1st dose of the moderna covid-19 vaccine on 16jan2021 and afterwards it was really sore, then itchy for fewdays that stopped on 20th Jan 2021. Over a period of the next 5 days, the patient also developed Itching on and off, and red big circle has developed.   The patient was treated for the event with CORTISONE Cream.    The medical reviewer may provide a case evaluation statement, including other possible etiological and confounding factors, e.g. (only limited information has been obtained so far, it is difficult to assess the cause and effect relationship; the co-medications y and x should also be considered causative as the reported event is labeled for both drugs; the company's view is the event is not due to the drug for the following reasons  (probably due to pre existing disease); there is no plausible mechanism to implicate the drug.  .   Terse Narrative (for PSUR narratives and signal review) Brief 3 line summary of above for CIOMS listing: Report Source- Other,  Age- 77 Years,  Sex- Female,  Suspect Drug- Moderna COVID-19 Vaccine,  Treatment- CORTISONE  Diagnosis\Outcome- Red big circle - Unknown,Itching on and off - Unknown,Itchy - Recovered/Resolved,sore arm - Recovered/Resolved.
LADD bands; volvulus; Information was downloaded (US-EMA-20110128-raevhumanwt-144336890).  This spontaneous report was received from a physician via consumer and a health care professional and refers to a 2 month old male patient. The patient's concurrent conditions, medical history and concomitant therapies were not provided.  On 02-FEB-1999, the patient was vaccinated with hepatitis b vaccine (recombinant)(RECOMBIVAX HB) lot # reported as "1678H"(dose, frequency, route, vaccination site, expiration date and indication were not provided).  Other suspect therapies started on the same date, included diphtheria toxoid, pertussis acellular 4-component vaccine, tetanus toxoid(ACEL-IMUNE) Injection, lot# 456-819 "(dose, frequency, route, vaccination site, expiration date and indication were not provided), hib conj vaccine (unspecified carrier)(HIB-TITER VACCINE) lot# 393103A (dose, frequency, route, vaccination site, expiration date and indication were not provided), and rotavirus g1 g2 g3 g4 reassortant vaccine live (human-rhesus)(ROTASHIELD) oral solutio, orally, Dose Duration: 1 doses, for Immunisation.  On 15-FEB-1999, the patient experienced Ladd's bands (intestinal obstruction) and volvulus which caused hospitalization on an unspecified dates. At the time of reporting, the patient had recovered from intestinal obstruction and volvulus.  The reporter did not provide a causality assessment between suspect therapies and the events.  Lot number 1678H is an invalid lot number for hepatitis b vaccine (recombinant).
Ulcers in mouth/teeth hurt, constipation/trouble urinating, eyes light sensitive, fluctuating blood pressure.
EVENING OF VACCINATION PATIENT FELT WEAK, ARM PAIN, HEADACHE, HIGHFEVER, FELT AS THOUGH HE COULD NOT SPEAK FOR 2 DAYS. THEN CONTINUES TO HAVE A SEVERE HEADACHE ON AND OFF
Patient had negative urine HCG test done the day of the Smallpox administration. However, HCG result done on 4 Jul 10 was positive indicating that she was presumed to have been pregnant at the time of the vaccine.
Mom called and son had developed a red "knot" at injection site as big as an egg. Not hot to touch but hurt. I told her to put cold compresses on sight or bag of frozen peas and monitor him periodically. I called to check on patient in morning and the bump was gone.
Patient called the pharmacy to report adverse reactions after getting their flu shot. Patient's arm started getting red and swelled up 1 and 1/2 hours after getting their vaccine. Patient reported that it swelled up to 3x in size. It has come  down today and has not spread further. The patient did report they have a history of reactions caused by an unknown cause. I told the patient to take ibuprofen and put ice on the area. They cannot take Benadryl. If they have worsening signs to seek emergency care.
This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 69-year-old female patient who received SHINGRIX (batch number EH9Z7, expiry date 8th March 2019) for prophylaxis. In September 2018, the patient received SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were reported as follows: The patient was complaining of soreness in the arm which was vaccinated. The reporter however could not state which arm or when the soreness began. The vaccination site of injected arm was unknown. The registered pharmacist was transferred to medical information for additional assistance.
The patient 17 years of age which does not meet the age requirement of the Modern Vaccine.  The patient had no adverse reaction to the vaccine at the time it was given.
Patient given vaccine and dose for 12 year old or older, a full 7 months before 12th birthday.  Vaccinator thought patient was 13, despite  documentation otherwise.
HORRIBLE AND STRONG SIDE EFFECTS WORSE THAN THE VIRUS; This spontaneous report received from a patient concerned a female of unspecified age. 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, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced horrible and strong side effects worse than the virus. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of horrible and strong side effects worse than the virus was not reported. This report was non-serious.
Administered Pfizer Covid-19 vaccine. At time of vaccination patient bled and within one minute had a dime sized nodule at site of injection. Patient said his arm did not hurt and could not feel the nodule. I cleaned up the patient's arm to wipe away the small amount of blood and changed bandages from the inject safe bandage to a coverlet bandage. Monitored the patient for 15 minutes and patient had no other adverse reaction.
STAFF MEMBER REPORTED ABOUT SIX HOURS AFTER ADMINISTRATION OF THE VACCINE SHE BEGAN WHEEZING, HAVING ITCHY EYES AND NOSE AND COMPLAINED OF RASH ON ARMS AND FACE.  EMPLOYEE WENT HOME, TOOK BENADRYL AND SYMPTOMS RESOLVED.  SHE RETURNED TO WORK THE FOLLOWING DAY.
Oct 27 0530 am Trans Ischemic Attack, lose control of my left arm and leg, heat Issues and admitted to the hospital.
Patient reports that after Prevnar vaccine was given on Friday (10/20) that her left arm, where the vaccine was administered, was swollen, and she had limited range of motion, as well as stiff joints in both hands. She reports that both hands were so stiff and in pain that she could not use them for daily activities and almost went to the ER to be checked out. She bought some OTC wrap to wrap them for the day and took naproxen for pain. They are both still bothering her, but they arent as bad today (10/23). She has a doctor appointment on 10/27 to check in with her doctor and plans to seek his advice on this issue.
Bloody noses 3 days after 2nd dose of Pfizer COVID vaccine; This is a spontaneous report from a Pfizer-sponsored program. A non-contactable consumer (patient) reported that a patient of an unknown gender and age received second dose of bnt162b2 (Pfizer-Biontech COVID-19 Vaccine, solution for injection, Batch/Lot Number: unspecified), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received first dose of bnt162b2 (Pfizer-Biontech COVID-19 Vaccine, solution for injection, Batch/Lot Number: unspecified) on an unspecified as historical vaccination as single dose for covid-19 immunisation. On an unspecified date, the patient had bloody noses 3 days after 2nd dose of Pfizer COVID vaccine. The outcome of the event was unknown.  Reporter does not wish to be contacted for follow-up.  No follow-up attempts are possible. Information about lot/batch number cannot been obtain. No further information is expected.
Initial information received on 30-Jul-2018 regarding an unsolicited valid non-serious case received from a nurse via phone. This case involves a 4 months old male patient who received Dtap and polio portion of the vaccine PENTACEL (Frequency once), 0.5 ml, lot C5456AA via intramuscular route in the left thigh on 30 Jul 2018. Concomitant medications included PREVNAR; and ROTAVIRUS VACCINE "also reported as Rodo virisu". It was a case of actual adverse event due to Inappropriate reconstitution technique as patient received only the Dtap and the polio portion and did not give the HIB portion of vaccine PENTACEL. It was unknown if any adverse event occurred. 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 Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 03-MAR-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 0.5ml, (lot # K012424, expiration date 05-JUN-2016). This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time of the first time was 48 hours with the lowest recorded temperature of 32 Fahrenheit degree. The total cumulative excursion time of the second time was 24 hours with the lowest recorded temperature of 33 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
on 16MAY97 pt presented to clinic w/irreg menses;denied intercourse x 8mo;20MAY97 pt seen by a RN had positive urine HCG test & dx w/probable IUP @ 13wk;
27 year old recieved pediatric dose; 27 year old recieved pediatric dose; This case was reported by a other health professional via call center representative and described the occurrence of underdose in a 27-year-old female patient who received HBV (Engerix B pediatric) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 7th October 2021, the patient received Engerix B pediatric .5 ml and Engerix B Pre-Filled Syringe Device. On 7th October 2021, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The medical assistant reported that, the adult patient received Engerix B pediatric, which led to underdose and adult use of a child product. No symptoms were reported. The reporter consented to follow up. This case was linked with case US2021215523, reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021215523:same reporter
2/6/2021 3 hours post vaccine itching on face and scalp and burning on tongue and gums  Resolved taking cetirizine 10mg tab 2/8/21 uvulitis
Received vaccine around 1700-1730. At 0300 the next morning woke up in severe gi distress. Abdominal cramping, diarrhea. No fever. I was sweating but I believe that was pain related. Diarrhea lasted until 0600. Then abdominal distention and gas persist. It is currently 2000. I am able to eat and keep food in but the pain is pretty extreme for a vaccine. Right now it?s a 5/10. At 0300 it was 8/10.
under the age of 18 years old has received the first dose; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (under the age of 18 years old has received the first dose) in an adolescent male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (under the age of 18 years old has received the first dose). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (under the age of 18 years old has received the first dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   The reporter called for guidance on how long the patient should wait to receive his second dose of the Moderna vaccine.  Concomitant medications were not reported.; Sender's Comments: This report refers to a case of Product administered to patient of Inappropriate age for mRNA-1273, lot # unknown with no associated AEs.
Patient had diagnosis of chicken pox at emergency room on 2/5/2022. Varicella vaccine not needed.
soreness; Itchy area around the injection site; a very red, swollen & itchy area around the injection site.; a very red, swollen & itchy area around the injection site.; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (soreness), VACCINATION SITE PRURITUS (Itchy area around the injection site), VACCINATION SITE ERYTHEMA (a very red, swollen & itchy area around the injection site.) and VACCINATION SITE SWELLING (a very red, swollen & itchy area around the injection site.) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.    Co-suspect product included non-company product INFLUENZA VACCINE (FLU VACCINE VII) for an unknown indication.    Previously administered products included for Product used for unknown indication: Pfizer Covid Vaccines (Patient had 5 Pfizer Covid Vaccines since 2020 & never had an itchy rash. Just the soreness). Past adverse reactions to the above products included No adverse reaction with Pfizer Covid Vaccines.   On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form and dose of INFLUENZA VACCINE (FLU VACCINE VII) (unknown route) 1 dosage form. On an unknown date, the patient experienced TENDERNESS (soreness), VACCINATION SITE PRURITUS (Itchy area around the injection site), VACCINATION SITE ERYTHEMA (a very red, swollen & itchy area around the injection site.) and VACCINATION SITE SWELLING (a very red, swollen & itchy area around the injection site.). The patient was treated with HYDROCORTISONE at an unspecified dose and frequency. At the time of the report, TENDERNESS (soreness) and VACCINATION SITE PRURITUS (Itchy area around the injection site) had not resolved and VACCINATION SITE ERYTHEMA (a very red, swollen & itchy area around the injection site.) and VACCINATION SITE SWELLING (a very red, swollen & itchy area around the injection site.) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported.  Patient received Covid booster vaccine 2 days ago along with flu shot. Just this morning, patient awoke with soreness (no big deal) & a very red, swollen & itchy area around the injection site. Patient applying Hydrocortisone Cream to help contain the itch. Patient just wanted to know how long will this last and if it gets worse, what should she do.   Most recent FOLLOW-UP information incorporated above includes: On 03-Nov-2023: Live follow-up received with significant information. AE reference number added.
Menveo reconstituted with unapproved diluent.; Menveo reconstituted with unapproved diluent.; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 21-year-old male patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Menveo lyophilized powder reconstituted with unapproved diluent, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter consented to follow up. This case is linked with case US2021178414, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021178414:Same reporter.
Received shot Sunday - symptoms visible by Monday PM; pain began Monday AM. Pain/physical charac. subsided Friday time frame. Physical charac. were: itching, swelling down to elbow - pass elbow (looked deformed), skin very hot to touch. Small welt still evident at injection site, decreased movement. Treatment: Ibuprofen (800 mg) and instant cold compresses.
About a month after my second dose, I seem to have gotten psoriasis across about half my back. I have never had any kind of condition like this before in my life. I have had it since about July.
Right upper arm redness and swelling at injection site. Cool Compress and pain reliever given by mother.
This case was reported by a healthcare professional, via another manufacturer, and described the occurrence of stomach pain in a child subject of unspecified gender who was vaccinated with Dtap (with small D + P), manufacturer unspecified, Menactra. On an unspecified date, the subject received unspecified dose of Dtap (with small D + P) (unknown, unknown arm) and unspecified dose of Menactra (unknown, unknown arm). Two seconds after vaccination with Dtap (with small D + P) and Menactra in the same arm, the subject experienced sharp, burning stomach pain. According to the reporter, four other child subject's experienced the same event (sharp, burning stomach pain) two seconds after administration of Dtap (with small D + P) and Menactra in the same arm (see case id's A0887425A, A0887434A, A0887435A, and A0887436A for the other child subjects reports). After the 5th patient complained, the vaccinations were administered in separate arms and there were no further adverse reactions. At the time of reporting the outcome of the event was unspecified.
Chest pain; Lung pain; Back pain; back pain on her left side; joint pain; Warm wave went across my chest after the shot; Full blown flu-like symptoms; Slept all day; Joint Pain; fatigue; fever; Nausea; Dizziness; joint pain; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Warm wave went across my chest after the shot), INFLUENZA LIKE ILLNESS (Full blown flu-like symptoms), SOMNOLENCE (Slept all day), CHEST PAIN (Chest pain) and PULMONARY PAIN (Lung pain) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced FEELING HOT (Warm wave went across my chest after the shot), INFLUENZA LIKE ILLNESS (Full blown flu-like symptoms), SOMNOLENCE (Slept all day), ARTHRALGIA (Joint Pain), FATIGUE (fatigue), PYREXIA (fever), NAUSEA (Nausea), DIZZINESS (Dizziness), the first episode of ARTHRALGIA (joint pain) and the second episode of ARTHRALGIA (joint pain). On 17-Jan-2021, the patient experienced CHEST PAIN (Chest pain), PULMONARY PAIN (Lung pain), BACK PAIN (Back pain) and BACK PAIN (back pain on her left side). On 17-Jan-2021, FEELING HOT (Warm wave went across my chest after the shot), INFLUENZA LIKE ILLNESS (Full blown flu-like symptoms), SOMNOLENCE (Slept all day), ARTHRALGIA (Joint Pain), FATIGUE (fatigue), PYREXIA (fever), NAUSEA (Nausea), DIZZINESS (Dizziness) and the last episode of ARTHRALGIA (joint pain) outcome was unknown. At the time of the report, CHEST PAIN (Chest pain), PULMONARY PAIN (Lung pain), BACK PAIN (Back pain) and BACK PAIN (back pain on her left side) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Severe regression in development; loss of language, tantrum behaviors, loss of eye contact with others, loss of socialization, sleep regression, developmentally set back over six months to year in skills
Fever, chills, rigors, body aches, myalgia starting 12 hours after and lasting a full 24 hours. Myalgia, body aches and fatigue have been present to lesser extent now for a full week.
tinnitus/he's suffering like me; he's stop to hearing; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A male patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: TINNITUS (non-serious), outcome "unknown", described as "tinnitus/he's suffering like me"; HYPOACUSIS (non-serious), outcome "unknown", described as "he's stop to hearing".  Additional information: Caller said that "Today after 2 hours I'm gonna take MRI." and added, "I read yesterday about the statement, I'm not alone in my school also this guy get the vaccine, he's suffering like me but he's one year he's stop to hearing and also he has noise ha start to do this all and little be better, and his doctor told him don't take a lot of medication your body will cause a lot of different problem. Any medication is bad. So he has some problem like me, he tried to workout." No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Significant, debilitating pain in both feet to stand/walk: ongoing >1 year Inflammed/Swollen legs, feet and hands: ongoing >1 year Burning and "Full" sensation in feet, legs and hands: ongoing > 1 year Increased Tinnitus in both ears Leg/Feet cramps  Treatments: 26 doctor appts to date, 139 therapy visits to date, ~47 OTC meds/supplements/products, xrays and MRIs. Treatments ongoing.