chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Child dose administered to adult patient; Child dose administered to adult patient; This case was reported by a other health professional via other manufacturer and described the occurrence of underdose in a adult patient who received HAV (Havrix pediatric) for prophylaxis.   On an unknown date, the patient received Havrix pediatric. On an unknown date, unknown after receiving Havrix pediatric, 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.   Additional Information: GSK Receipt Date: 20-OCT-2022 Reporter's comment: Health Care Professional (HCP) reported that the Havrix vaccine was given to an adult, and it was a child dose. No additional information was provided. No lot number and expiration date known by reporter. Customer was in a rush to get off phone therefore no additional adverse event questions asked and were marked as refused by agent. Additional Supportive Information: The Havrix pediatric administered to the adult patient, which led to Underdose and Adult use of a child product. The reporter consented to follow-up.
Very sore arm at site. Mild headache, tired, slight itchy throat. 1 day after getting the shot. Head alittle foggy.
No additional AE reported; temperature excursion and administered to patient; This spontaneous report was received from an other health care professional referring to 15-month-old female patient. Information about the patient's medical history, concurrent conditions, concomitant medications and drug reactions/ allergies was not provided.  On 27-FEB-2023, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (Oka/Merck) injection (VARIVAX) intramuscularly in right thigh, lot #W018828, expiration date 14-JUN-2024, (exact dose and dose number were not provided) for prophylaxis.  On 05-DEC-2022, the suspect vaccine experienced a temperature excursion from -14 to -10 degrees Celsius for 1 hour (product storage error). There were no reported previous temperature excursions. No additional adverse events (AEs) or product quality complaints (PQC) were reported (no adverse event). It was indicated that medication error could occur during storage in clinical practice. Adverse event had been reported previously to manufacturer. The patient was vaccinated at private doctor's office/hospital. Temperature excursion occurred as a result of a reading from a Digital Data Logger.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2304USA007931:
Anthrax lot #FAV110 administered after expired date due to administrative oversight.  No adverse reaction at this time.  Report submitted per authority direction.
Pt recvd vax 22JAN93 & 23JAN93 pt devel conjunctivitis; presented to MD & was treated w/eye drops; also devel a rash, fever of 103-104 & abdo pain, malaise, faitgue & felt awful; returned to MD on 26JAN93; pt treated w/unspecified meds;
(R) upper thigh became red & swollen, lower (R) leg became bright red & purplish. Baby cried inconsolably.
flu; Initial information received on 02-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer.  This case involves an unknown age and unknown gender patient who experienced flu while receiving vaccine influenza vaccine.  The patient's 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 influenza vaccine produced by unknown manufacturer (formulation, strength, dose and lot number not reported) via unknown route in unknown administration site for prophylactic immunization.  On an unknown date, the patient developed a non-serious event of flu (influenza) (unknown latency) following the administration of influenza vaccine.  It was reported, No I got the flu and it sucks.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event flu.
3-5 MINUTES AFTER ADMINISTRATION, THE CHILD BROKE OUT IN HIVES ALL OVER HER BODY. SHE SEEMED HAPPY AND DID NOT SEEM TO EXPERIENCE ANY DIFFICULTY BREATHING. SHE WAS GIVEN 3.5 MG OF DECADRON (IM) AND 2.5 mL OF BENADRYL (ORAL). SHE WAS MONITORED HERE IN THE CLINIC FOR AN HOUR AND BEFORE SHE LEFT, ALL HIVES HAD GONE AWAY.
Case number PHEH2014US006182 is an initial spontaneous report received from a nurse on 26 Mar 2014. This report refers to a patient of an unspecified age and gender. The patient's past medical history and concomitant medications were not reported. The patient received only Men A lyophilized conjugate component of MENVEO (batch number: not reported), reconstituted with a sterol water instead of MenCYW 135 liquid component intramuscularly on an unspecified date. No adverse events were reported following this medication error.
Vaccine given at 9.30 am. Chills at 4.pm,weakness,headache,chough,sneezing and fever of 103.01 by 5pm.At 9pm,temp.102.02. Difficulty breathing,I have Asthma and COPD and use Oxygen.By morning felt much better.rough night of trying to sleep.Am doing OK now.
STORAGE IN REFRIGERATOR (2C-8C) UP TO 30 DAYS. (VACCINE USED AFTER 10-16-2021)
Patient said heart was racing, advised her to sit, relax and take off coat/scarf. Offered to take B.P. pt said no, tried to stand to walk and collapsed on floor. Unconscious, then had seizure. Taken to hospital where pt check herself out and refused further treatment.
Increased crying episodes, parents insist happened after IPV.  Infant with gas/Gastroesophageal reflux disease previously.  Relationship to shot not likely.  Parents agree.
Child had a cold, temp was taken prior to vaccine administration by the nurse. It was 97.1F, later that evening child had fever (never physically taken by parent but reported as a high fever), chills, shivers, emesis, body pains. No ER or walk-in clinic care sought, given fluids, cold compress. Mother insistent that this be reported!
Dizzyness and lightheaded 10 minutes after shot and periodically 1-3 days after. Bruising on arm and itchyness
I had a fever that was 103; Headache; Body aches; Nausea; Vomiting; Chills; Fatigue; My arm now has a big knot at the injection site.; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 12Apr2021 at 15:30 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism and high blood pressure. The patient had known allergies to penicillin and sulfa. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) and lisinopril (MANUFACTURER UNKNOWN); from an unknown date for unspecified indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 22Mar2021 at 15:00 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 13Apr2021 at 04:00, the day after receiving the shot, the patient experienced fever that was 103 (unspecified units), headache, body aches, nausea, vomiting, chills and fatigue. It took 8 hours for the fever to break but was not under 101 (unspecified units) for 2 days. These side effects lasted 4 days. On an unknown date in Apr2021, after the 4th day, the patient experienced that the arm had a big knot at the injection site. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measure was taken as a result of reported events which included call to the primary care physician (PCP). The clinical outcome of the events fever, headache, body aches, nausea, vomiting, chills and fatigue was recovered on 17Apr2021. The clinical outcome of the event arm had a big knot at the injection site was unknown at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
approx 12 hrs p/vax pt t104 ax w/some crying & irritability; given APAP, temp down to 100 in AM 23MAR94; carried on 23MAR94 pt was afebrile, playful & asymptomatic;
Very sore left arm with inability to lift arm above shoulder height.  Area surrounding injection site with swelling, redness, warmth to touch.
dizziness; nausea; vomiting; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), NAUSEA (nausea), VOMITING (vomiting) and PAIN IN EXTREMITY (sore arm) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     Concomitant products included NAPROXEN SODIUM (ALEVE) for an unknown indication.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Mar-2021, the patient experienced DIZZINESS (dizziness), NAUSEA (nausea), VOMITING (vomiting) and PAIN IN EXTREMITY (sore arm). At the time of the report, DIZZINESS (dizziness), NAUSEA (nausea), VOMITING (vomiting) and PAIN IN EXTREMITY (sore arm) outcome was unknown.            No concomitant medication was reported. treatment to the events given as Aleve.  Treatment medication include, Aleve for sore arm and unknown for other events.      Action taken with mRNA-1273 in response to the events was not Applicable.
The night of the vaccine I got a headache that got worse and I had to call into work. I also felt exhausted and the headaches came and went. It has been twelve weeks and I am still getting headaches every day. They start in different areas of my head sometimes in the front and sometimes in the front or on the side. They vary in intensity and they are sometimes very painful and sometimes mild. The only thing that seems to help is Excedrin. It is random which time of day it starts and the more intense ones last longer. The length of time that the headaches last is between 30 minutes to 4 hours.
Soreness at injection site initially for 3 days. Rash with raised, red, indurated area approx 3 inches long and 2 inches wide developed on day #8 (01-31-2021) and is ongoing at this time. Some improvement with cold compresses and hydrocortisone cream to area.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Concurrent conditions ad medical history were not reported. On an unknown date in October 2013, the patient was vaccinated with the first dose of GARDASIL 9 (lot number, expiration date, routed were not provided). Then, on an unknown date in September, the patient received the second dose of GARDASIL 9. No adverse effect were reported. Additional information has been requested.
platelets went down / her palettes went down; she immediately got sick; This is a spontaneous report from a contactable consumer (patient herself). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number, and expiration date not reported)  via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunisation.  The patient's medical history and concomitant medications were not reported.  The patient's platelets went down (reported as "her palettes went down")  and immediately got sick on an unspecified date.  The patient underwent lab tests and procedures which included platelet count: went down on an unspecified date. Events resulted to patient ending in the emergency room.  The outcome of the events reported was unknown.  Information about lot/batch number has been requested.
No adverse effects were reported; administered improperly stored PROQUAD; Information has been received from a medical assistant, concerning a patient of unknown age and gender. The patient's pertinent medical history, previously drug reactions, allergies, concurrent conditions and concomitant medication were not reported.      On 18-JUN-2019, the patient was administered with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot number S002503 with expiration date in 23-JUL-2020 (strength, dose and route of administration were not provided) for prophylaxis, that was reconstituted with sterile diluent (DILUENT MRK) (strength, dose, lot number, expiration date and route of administration were not provided) (it was not reported if the sterile diluent (DILUENT MRK) used had an excursion).   The measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was stored at a temperature range of -9 degrees Celsius (C) to 8 C (-3 C), for the time frame of 3 hours and 39 minutes. There was no previous temperature excursion and the call was because of a data logger. No adverse effects were reported.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA008662: US-009507513-1906USA008643: US-009507513-1906USA010325: US-009507513-1906USA010323: US-009507513-1906USA008695: US-009507513-1907USA011955: US-009507513-1906USA008903:
Covid arm questions; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Covid arm questions) 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) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Covid arm questions). At the time of the report, PAIN IN EXTREMITY (Covid arm questions) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Treatment information was not provided. No concomitant medication was provided.
Scattered hives started 11/26 (no changed in eating or body creams, soaps, detergents), continued on 11/27 with start of chest pain, 11/28 hives became full body and chest pain became consistent. Went to the ER, see next item.
Large, red, hot, itchy and hard at injection site that continues to spread. Full body aches
Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Body Aches Generalized-Medium, Systemic: Fever-Medium, Systemic: Joint Pain-Medium, Additional Details: Patient reports red bumps on hand  and body, body aches, fever, joint pain which has not improved.  Went to primary doctor and Urgent care.  Will call Pfizer to report side effects
This spontaneous report was received from a medical assistant and refers to a 65-year-old- patient of unknown gender. No information about the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 12-APR-2016, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 lot # L018503 and expiration date: 16-MAR-2017 )dose and route of administration were not reported). The vaccine underwent temperature excursion of 1 degree Celsius for 158 total cumulative hours, which was detected by a data logger. There was no previous temperature excursion. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information is not expected as all the data was already obtained.
COVID+ Narrative:  Patient administered COVID-19 vaccine (Moderna) dose #1 2/18/2021. On 3/17/2021, Patient developed a cough and fever and was brought by ambulance to tertiary care facility with diagnosis of COVID-19. Patient on BIPAP as of 3/22/2021. On 3/26/2021, Patient was initiated on morphine drip for comfort care and BIPAP was discontinued. Patient passed away 3/26/2021.
Initial I had fever, nausea, vomiting, headache, cough and congestion. On the third or fourth day I lost my sense of taste of smell and taste. I tested positive so I isolated and for two weeks. I flew back home and have now tested negative but still have no sense of taste or smell and I still have a cough and some nasal congestion, vertigo, a bad headache that won't go away. It's like a migraine or sinusitis and fatigue.
Within 2-3 weeks of this vaccination, I had what appears to be a shingles outbreak on my upper right abdomen.  It was sensitive to touch and any contact within two weeks after vaccination and within 4 weeks after vaccination, a red rash began to appear. While it is not blistering yet, the symptoms and location are IDENTICAL to a rash that appeared 2-3 weeks after my first Pfizer booster in September 2021. The Sep 2021 rash was treated as atopic dermatitis because the physician said since I was vaccinated against shingles, that is was unlikely to be shingles.
Mother sought treatment at ER on 04/13/2002 am as pt's right arm was "swollen, red and hot to touch." Pt was treated with oral Benedryla nd Ibuprofin. Told to follow-up with MD in one week.
You can still get the shingles after you get the shot / I never had them until about 6 weeks after the shot/Suspected vaccination failure; shingles / They were bad; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, more than a month after receiving Shingles 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 Shingles vaccine.  Additional details were reported as follows: The case was reported by patient. The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication.  The patient received shingle shot and still got the shingles and they were bad. The patient stated that he/she never had them until about 6 weeks after the shot. This case was considered as suspected vaccination failure as details regarding vaccination schedule, time to onset for target disease and laboratory confirmation were unknown at the time of reporting. No other information was reported. The follow-up would not possible, as no contact details were available.
Information has been received from a health professional concerning a 4 year old white male who on 16Aug2000 was vaccinated in the RQ with a first dose of varicella virus vaccine live. There was no illness at the time of vaccination. It was reported that the pt's father called the office to report that the pt had red pimples with vesicles consistent with the chickenpox. They began on 30Dec2003, were on the trunk, head and back and were itchy. The pt was not seen in the office, but chickenpox protocol advice was given. No labs or diagnostic tests were done. Follow up information from the doctors office indicated that the pt recovered with no problems. No additional information is expected.
Chest pain, arm pain that started for two days after the 2nd dose of vaccine was given, arm pain went away and returned with shooting and burning pain on April 29th, fever of 100.9 on April 30th when on antibiotic and pain killer 7 days after vaccine given
Leg pain starting about 3-4 hours after the shot... 6 hours after shot tingling in hands and feet which became more severe over rest of day... rash on sterum area of the chest and down left side and rash on back and on left arm .. day 2 less tingling and more deep pain in the legs.. rash subsided.  Really bad itching on the bottoms of my feet    Day 3 -5 more pain in calves and feeling like my feet are standing in ice water.   Feeli ng like you get when you sit along time and need to walk off the pain but the pain doesn?t leave with walking,... worse in left leg....  still tingling in feet and left arm.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's relevant medical history was not reported. On an unknown date, the patient was vaccinated with a dose of VARIVAX (Merck) (dose, route, lot# and expiration date were not reported) instead of a dose of ZOSTAVAX (dose, route, lot# and expiration date were not reported). Information  about concomitant medication was not reported. The reporter stated that the ZOSTAVAX was ordered for the patient but the healthcare worker who administered VARIVAX (Merck) "read the order wrong". No adverse events were reported. No PQC (product quality complaint) was involved. Additional information has been requested.
This spontaneous report as received from a medical assistant via a company representative and refers to a 15 month old patient of unknown gender. On 04-APR-2014 the patient was vaccinated with (oka/merck) VARIVAX (dose, units, route of administration, anatomical location were not reported, lot # J008170, expiration date: 02-JUL-2015). On 14-JUL-2014 the symptoms of chickenpox occurred (described as spots and fever). The outcome of event was reported as not recovered. The relatedness between event and (oka/merck) VARIVAX was not reported. Follow-up information has been received from a medical assistant. The reporter stated a VAERS (Vaccine Adverse Event Reporting System) report had been filed and additional information regarding patient was available at that time. The reporter also stated if any additional information becomes available she may fax that information. This is one of several reports from the same reporter. Additional information is not expected because address was correctly entered but the correspondence was returned.
Received Immuniz at 2pm on 9/8/09. At 7am on 9/9/09 Mom notice raised rash on inside of thighs,and on abdomen. Within 2 hrs rash covered trunk and extremites as well as face. Pt saw dr and was told vaccine reaction. Mom to give BENADRYL.
The next day I had a tingling sensation in my left arm all the way down to my fingers - similar to what it feels like when your arm is asleep.  It still occurs 3 months later.
2nd dose administered from vial that had been in refrigerator for 32 days; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (2nd dose administered from vial that had been in refrigerator for 32 days) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017c21a) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (2nd dose administered from vial that had been in refrigerator for 32 days). At the time of the report, EXPIRED PRODUCT ADMINISTERED (2nd dose administered from vial that had been in refrigerator for 32 days) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the events was not applicable. No Concomitant  information was  provided. No Treatment information was  provided.