chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pediatric patient received adult dose of Havrix; pediatric patient received adult dose of Havrix; This non-serious case was reported by a nurse via call center representative and described the occurrence of overdose in a 8-year-old male patient who received HAV (Havrix 1440 adult) (batch number GSK95, expiry date 13-DEC-2024) for prophylaxis.   On 31-OCT-2023, the patient received the 1st dose of Havrix 1440 adult. On 31-OCT-2023, an unknown time after receiving Havrix 1440 adult, the patient experienced overdose (Verbatim: pediatric patient received adult dose of Havrix) and adult product administered to child (Verbatim: pediatric patient received adult dose of Havrix). The outcome of the overdose and adult product administered to child 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 Information: GSK Receipt Date: 02-NOV-2023 It was reported that male pediatric patient received adult dose of Havrix which led to overdose and adult product administered to child. The reporter consented to follow up. This case is linked to US2023152358, same reporter.; Sender's Comments:  US-GSK-US2023152358:Same reporter
Injection site is hot to touch; Injection site is red; Injection site is itchy; Injection site is swollen; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Injection site is hot to touch), VACCINATION SITE ERYTHEMA (Injection site is red), VACCINATION SITE PRURITUS (Injection site is itchy) and VACCINATION SITE SWELLING (Injection site is swollen) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Injection site is hot to touch), VACCINATION SITE ERYTHEMA (Injection site is red), VACCINATION SITE PRURITUS (Injection site is itchy) and VACCINATION SITE SWELLING (Injection site is swollen). At the time of the report, VACCINATION SITE WARMTH (Injection site is hot to touch), VACCINATION SITE ERYTHEMA (Injection site is red), VACCINATION SITE PRURITUS (Injection site is itchy) and VACCINATION SITE SWELLING (Injection site is swollen) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. No treatment information provided.
sudden onset EXTREME chills about 3p.m. on the same day. followed by fever of 102.8 and nausea and vomiting x 2. The fever and vomiting were not present the next day, but dizziness, nausea and fatigue were very prevalent the first 10 days. The fatigue and periodic dizziness and nausea have persisted through now, though they have lessened.
This spontaneous report was received from a physician via company representatives referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 08-OCT-2014, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 0.5 mL (VIs 10 SDV) (Lot # K007822, expiration date 15-AUG-2015) dose, route and anatomical location were not provided. There was no concomitant medication provided. On an unknown date, the PNEUMOVAX had a temperature excursion for 72 hours, the lowest recorded temperature was 28 F (-2.2 Celsius). The vaccine status was reported as "in excursion", and was storage in a Refrigerator (R). There was no product quality complaint involved and no adverse effects were reported. This is one of several cases received from the same reporter. Additional information has been requested.
Pt had fever, extreme weakness, N & V, Bell's Palsy. PT was seen by provider and sent to the ER.
From initial information received on 9/22/04 from a healthcare professional regarding an adverse event occurring, it was reported that a three year old male patient received a first dose of FLUZONE, lot number U1489AA, administered in the left thigh on 9/15/04. Six days later, on 9/21/04, the patient was seen in the physician's office with coughing, sneezing, congestion, shortness of breath, and fever (per the patient's mother). He was sent to the emergency room and was admitted to the hospital the same day. A chest x-ray showed pneumonia. The results of cultures were not available at the time of this report. The patient is currently still hospitalized and has not recovered from these events. From additional information received on 13Oct04 from a health care professional, it was reported that the pt had a cough, low grade fever and intermittent wheezing three to four days prior to being seen in the ER, where he was diagnosed with pneumonia and perscribed Azithromycin. For the next 24 hours the pt continued with a cough, but had become afebrile. He was seen by a physician on 21Sep04 and it was noted that he had some papular lesions developing on his upper extremities, left forehead and his left ear lobe seemed to be erythematous and swollen. The pt had decreased oral intake and his mother stated he probably had been urinating somewhat less than normal. He was admitted to the hospital that same day. His physical examination was normal, except for some scant mucoid rhinorrhea and a few bilateral anterior cervical lymph nodes. His chest was clear to ausculatation. He had one small papular region on the dorsal aspect of the left wrist and one on the ventral aspect near the elbow, as well as a small papula on the left upper forehead. The pt was diagnosed with probable pneumonia. The Azithromycin was continued, as well as encouraged increased oral fluids. A consulting physician expressed doubts that the papular lesions were another outbreak of shingles or HSV, since the lesions were not vesicular at that time. He did not recommend acyclovir at that time, but would reconsider antiviral therapy, along with submission of a specimen for viral isolation if the lesions became vesicular. It was not reported if the pt recovered.
slight pressure in left temple; some aches in the bones; light headedness for 2 days; brain fog; smelling a burnt smell/smelling burnt leaf smell; runny nose; fatigue for a couple of days; arm sore at left shoulder/left side muscle pain; axillary area sore for couple days; left lymph node sore for couple days; rapid heart rate/highest heart rate 110; half hour of chills; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (rapid heart rate/highest heart rate 110), HEAD DISCOMFORT (slight pressure in left temple), BONE PAIN (some aches in the bones), DIZZINESS (light headedness for 2 days) and CONFUSIONAL STATE (brain fog) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Long QT and Allergy. Concomitant products included LEVOTHYROXINE and VITAMIN D3 for an unknown indication.    On 04-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Sep-2021, the patient experienced PALPITATIONS (rapid heart rate/highest heart rate 110). On an unknown date, the patient experienced HEAD DISCOMFORT (slight pressure in left temple), BONE PAIN (some aches in the bones), DIZZINESS (light headedness for 2 days), CONFUSIONAL STATE (brain fog), PAROSMIA (smelling a burnt smell/smelling burnt leaf smell), RHINORRHOEA (runny nose), FATIGUE (fatigue for a couple of days), MYALGIA (arm sore at left shoulder/left side muscle pain), AXILLARY PAIN (axillary area sore for couple days), CHILLS (half hour of chills) and LYMPH NODE PAIN (left lymph node sore for couple days). At the time of the report, HEAD DISCOMFORT (slight pressure in left temple), BONE PAIN (some aches in the bones), DIZZINESS (light headedness for 2 days), CONFUSIONAL STATE (brain fog), PAROSMIA (smelling a burnt smell/smelling burnt leaf smell), RHINORRHOEA (runny nose), MYALGIA (arm sore at left shoulder/left side muscle pain), AXILLARY PAIN (axillary area sore for couple days), CHILLS (half hour of chills) and LYMPH NODE PAIN (left lymph node sore for couple days) had resolved and FATIGUE (fatigue for a couple of days) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Sep-2021, Blood pressure measurement: normal (normal) Normal. On 04-Sep-2021, Heart rate: 110-100 (High) highest was 110and the lowest was 100.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided. ?   Most recent FOLLOW-UP information incorporated above includes: On 10-Sep-2021: Non-Significant follow-up contain no new information
Episode of looking pale, loss of consciousness for few seconds, then feeling tired/sleepy/confused for several hours on 8/11/2018. Multiple subsequent episodes of similar feeling, difficulty walking, without LOC during next several days. Parent describes eventual diagnosis of POTS syndrome, anemia, multiple vitamin deficiencies after evaluation by neurologist at Hospital. Patient continues to have difficulty with daily activities, limited ability to participate in school. Complaints of photophobia, episodes of tachycardia with anxiety and hyperesthesia.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021 at 2:32 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 15-Apr-2021 at 2:32 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 32.62. No concomitant medications were reported. On 15-Apr-2021 at 09:00 A.M., the temperature recorded was 34 degree Fahrenheit and vial was initially moved to the fridge on 06-Apr-2021 and beyond use date was 09-May-2021. Product moved to clinic on 15-Apr-2021. Vial was stored on cooler 1, on 15-Apr-2021, Excursion duration At 9 AM: 34, 10 AM: 36, 11 AM: 38, 12 AM: 39, 1PM: 43, 2 PM : 44, 3 PM: 44, 4 PM: 42 and 5 PM : 42.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour. No treatment medications were reported.
None on the first shot. Severe headaches, high fever, tiredness, cough, chills, sweats for2-3 days. Developed cough and shortness of breath which has persisted. Now I get winded easily while walking or talking. This has become concerning as a long time runner. I went to urgent care and they said seems like bronchitis contracted prior possibly, though I socially distance, always wear a mask and only go out if it is needed. I avoid crowds and indoors. Cough persists and winded easily
after getting her third dose; after getting her third dose; after getting her third dose she could not raise her injected arm as high as dining table; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received third dose (BOOSTER) of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: FD8448), via an unspecified route of administration, administrated in left arm on 03Sep2021, as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/ Lot Number: EM9809), via an unspecified route of administration on an unspecified date, as a single dose for COVID-19 immunization and experienced Sore arm and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EN6198), via an unspecified route of administration on 24Feb2021, as a single dose for COVID-19 immunization and experienced Sore arm. The patient took third dose was on 03Sep2021, rash that was about 3 inches across and in a circle at the injection site, pain at the injection site in her left arm, extreme fatigue, in her left arm where she received the injection, when she bends her arm a certain way, like a 90-degree angle at the elbow, her arm locks there, left arm is immobile for a time. Added that she knows a woman that after getting her third dose she could not raise her injected arm as high as dining table on Sep2021. Asking maybe if she should have tested her antibody first before getting her third dose. As maybe if her antibody result was high, the side effect that she would. The outcome for all the events was Unknown.  The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow-up.
Patient received 2nd Shingrix dose on 2/17/2020, came back to pharmacy 2/29/2020 complaining of rash on buttocks. When patient received 2nd dose, RPh asked if she experienced any side effects from previous dose and she noted she had a rash after the first dose of Shingrix (no blistering, "dried up" within 3-5 days). She went to her doctor as a precaution, who informed her that this can occur after getting the vaccine and did not prescribe any treatment.
Itching a little bit; I have a low like low welt or like a hive but very small and not all over, may be in a couple of places/Hive may be on a couple of areas like on my knee, on my left leg; This is a spontaneous report received from a contactable consumer or other non hcp. A patient of unspecified age and gender received 2nd dose of bnt162b2 (COMIRNATY,Batch/Lot Number: EWO/87),via an unspecified route of administration,administered in Arm Left on 2021,as Dose 2,single for covid-19 immunization.The patient medical history and concomitant medications were not reported.The patient experienced itching a little bit on 2021,may be in a couple of places/hive may be on a couple of areas like on knee,on patient left leg on 2021.Consumer was provided with the number of Pfizer Medical Information.Consumer was informed that can contact Pfizer Drug Safety anytime as the department remains open 24/7.Patient wanted to know how many people are facing the same side effect.The outcome of the event was unknown.  Further probing could not be done as consumer was unwilling to further answer the questions. Hence, other details were unknown and limited information was available over the call.
Case number PHEH2011US02604 is an initial spontaneous report received from a health care professional on 25 Aug 2011: This report refers to an 12-year-old female patient. She was vaccinated with only liquid component of MENVEO (batch number: X100034) without being reconstituted with the MenA conjugate component, intramuscularly, 0.5 ml, on 25 Aug 2011. No adverse reaction occurred following this drug administration error.
left eye became blurry  all of sudden , went to see Dr - opthalmalogist, NOthing seen on exam,  As of today, blurriness has improved but has not gone away.
Patient started with normal arm soreness after injection. She states in the last 4-5 days her discomfort has increased and she has pain with movement. She has no trouble while just sitting. She experienced no redness or her arm did not swell at all.
Immediately after the 2nd dose of the Pfizer Vaccine, I felt a blood rush on my face and my jaw became very heavy and numb for 15 minutes.  Two months later I began having pain on my back left side of my neck.  Six months later (Sept 2021) experienced jitters, anxiety and rapid heartbeat for two days followed by two weeks of muscle spasms, tingling, paresthesia and weakness to my left hand and foot.  I continue to have severe neck pain and bulging to my left back side of my neck and burning pain and weakness to my left arm.  Xrays show nerve damage and muscle spasms.  MRI revealed Cervical Myelopathy.
no adverse effect; vaccine administered to patient of inappropiate age; This spontaneous report was received from a pharmacist via company representative refers to an unspecified patient who was over 50 years of age with unknown gender. Information on pertinent medical history, drug reactions/allergies and concomitant medications were not reported. Approximately on an unknown date in January 2020 (reported as "may be a month ago"), the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis (dose, strength, route, vaccination site, # lot, expiry date unspecified) (product administered to patient of inappropriate age). No additional adverse effect was reported. Product quality complaint (PQC) was not involved.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2002USA010092:
PT CALLED INTO THE OFFICE REPORTING THAT HER ARM IS RED, HOT, RAISED, FIFTY CENT PIECE IN SIZE, DENIES RED STREAKS OR FEVER, ADVISED TO TREAT WITH OTC MEDICATIONS , IF S/S CONTINUE TO SEE MEDICAL ATTENTION WITH HER PCP, AWARE, VERBALIZED UNDERSTANDING, VARES REPORT FILED WITH THE CDC
I had the vaccine, and I was fine for the first 27 hours. Then on 4/5 at 3:30pm I started to feel not so great, and I took my temp in the evening and it was 100.2 degrees and when I went to bed it was 100.4 degrees. I also had chills and achy joints. Then on 4/6 my temp was 99.1 degrees then it rose to 100.7 degrees. It got up as high as 101.6 degrees that day. I took an at home COVID test and it came back negative. On the 4/7 my temp was 101.4 degrees at 2:15 in the morning. I took two Tylenol and when I woke up later it went down. Then it rose again throughout the day reaching 101.4 degrees. That night I decided to contact my doctor and explained my symptoms. Then the next morning I noticed my temp was going down. The doctor called me back and informed me that she thought it was a reaction to the vaccine. Then on 4/8 my temp went from 98.9 to 101.4 degrees. From 4/9-4/10 I noticed that my temp started to revert back to normal.
Very bad cold fever, cough, chill body aches for about 10 days C-PACK  TYLENOL & MUCINEX FLONACE
Bruising, rash (approx. 3 inches), itching - all has lasted for at least 5 days.
Patient staring having a headache within 10 minutes of injection.  Patient took Tylenol to relieve pain without relief.  Patient was sent home.
Injection site swollen as big as tangerine fruit. Red itchy, headache for two days. Very discomfort from pain.
Almost immediate - soreness at injection site Four hours post injection - nausea lasting approx 6 hours Five hours post injection - vomiting lasting approx 5 hours Five hours post injection - chills, fever, headache, bodyaches lasting 20 approx hours Five hours post injection - exhaustion lasting 2 days Two weeks post injection - painful swollen lump under right armpit lasting 3 days, lump did not completely go away for 7 days, but pain/swelling subsided after 3 days.
inject administered @ 5PM; approx 3 hrs post inject pt devel onset of fever, stomach ache, h/a, vomiting happened through the nite;
No adverse effects; patient was administered an expired dose ofMMR II; This spontaneous report was received from a pharmacist and refers to a 2-year-old patient of an unknown gender. There was no information regarding patient's pertinent medical history, drug reactions, allergies and concomitant therapies provided. On 11-JUL-2019, the patient was administered an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, albumin status rHA (lot # N019615 has been verified to be a valid lot number, expiration date 09-JUL-2019) for prophylaxis (exact dose and route of administration were not reported). No adverse effects were reported.
RECEIVED VACCINE 02/22/21 @ 1000,  WOKE UP APPROX 0300 TO WHAT SEEMED TO UNCONTROLLABLE FULL BODY STRETCHING TO THE POINT IT FELT  LIKE SKIN ACROSS ABDOMEN WOULD SPLIT.  STRETCH SEEEMED TO REPEAT WITH ANY MOVEMENT.  ONCE FULLY AWAKE TOOK TEMPERATURE AND WAS 101.1.  TOOK MED TO LOWER TEMP, EACH TIME MED WORE OFF TEMP WENT BACK TO 101-101.9, CONTINUED FOR 24 HOURS.  ABDOMINAL MUSCLES EXTREMELY SORE 24 HOURS AFTER STRETCHING
Patient developed arm discomfort at site of injection one month post administration. No medical treatment was sought. Patient took over-the-counter pain relievers. There was no disability or inability to use the arm.
no adverse effect; improperly stored PEDVAX HIB were administered/patient received one dose; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided. On 18-APR-2019, the patient was vaccinated with an improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) injection, lot # R027320 with expiration date on 08-JUL-2021 (dose and route of administration were not reported) for prophylaxis. The vaccine underwent the temperature excursion of above 47 (55.4) degrees Fahrenheit for 10 hours 45 minutes and below 36 (34.4) degrees Fahrenheit for 20 minutes. Digital Data Logger was involved in recording of the excursion. No previous temperature excursions were reported. No adverse effects were reported.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-1904USA012614: US-009507513-1904USA012967: US-009507513-1904USA012968: US-009507513-1904USA012969: US-009507513-1904USA012977: US-009507513-1904USA012971: US-009507513-1904USA012972: US-009507513-1904USA012973: US-009507513-1904USA012974: US-009507513-1904USA012975: US-009507513-1904USA012976: US-009507513-1904USA012978: US-009507513-1904USA012979: US-009507513-1904USA012980: US-009507513-1904USA012981: