chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 9.0
Sex: F
Vaccine: COVID19
Symptoms: Fall, Muscle tightness
Clinical narrative: Patient was advised to sit after receiving the shot but instead stood against the wall  there to watch her sister get the vaccine. Within 5 minutes after receiving the vaccine , she slowly fell on the floor, and was tight for few seconds. Patient's father and I lifted her and sat her in the chair and called 911. Over next 2-5 minutes, she felt normal. EMS personnel took her vitals and stated  that all of them are "Perfect", and there was no need to seek additional medical care or transportation required unless the patient's father would like to. Patient's father mentioned that Patient was nervous and did not want to get the vaccine but came to get the vaccine after some convincing on his end.
Age: 1.0
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite, Fatigue, Irritability, Pain, Pyrexia
Clinical narrative: Fever, fatigue, loss of appetite, fussy, in pain-achy
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Hypoaesthesia, Muscular weakness, Myalgia, Pain
Clinical narrative: Within 24 hours experienced severe muscle weakness and pain, treated with ice and ibuprofen. when no improvement went to walk in clinic on July 2 and received medal dose park and tizanidine muscle relaxer, continued to treat with ice/ibuprofen/rest. Would have short term relief and then reoccurrence with greater pain, weakness, and involvement of foot becoming numb while ambulating, tingling in toes, radiating pain. Went to PCP today Friday July 8th after a day of working and struggling to ambulate. Received an IM injection of dexadron.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Within 24 hours experienced severe muscle weakness and pain, treated with ice and ibuprofen. when no improvement went to walk in clinic on July 2 and received medal dose park and tizanidine muscle relaxer, continued to treat with ice/ibuprofen/rest. Would have short term relief and then reoccurrence with greater pain, weakness, and involvement of foot becoming numb while ambulating, tingling in toes, radiating pain. Went to PCP today Friday July 8th after a day of working and struggling to ambulate. Received an IM injection of dexadron.
Age: 4.0
Sex: M
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: When I  was drawing up 4 year vaccine . The  Assistant of that doctor in which i was helping with vaccine, told me to do COVID VACCINE to another Room Also. I misheard  and understood they were 7 years old. I drew up 5-11 PFIZER vaccine instead of  6month- 4 years MODERNA vaccine and administered to 4 year old patient.
Age: 4.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: When I  was drawing up 4 year vaccine . The  Assistant of that doctor in which i was helping with vaccine, told me to do COVID VACCINE to another Room Also. I misheard  and understood they were 7 years old. I drew up 5-11 PFIZER vaccine instead of  6month- 4 years MODERNA vaccine and administered to 4 year old patient.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Atrial septal defect, Blood test abnormal, Cerebrovascular accident, Echocardiogram abnormal, Rash
Clinical narrative: December 2021 6 days after booster broke out in hives head to toe.  Went to ER and needed steroids to calm them down. June 2022 Had a confirmed stroke  Still get random rash- take a zyrtec a day
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Urticaria
Clinical narrative: December 2021 6 days after booster broke out in hives head to toe.  Went to ER and needed steroids to calm them down. June 2022 Had a confirmed stroke  Still get random rash- take a zyrtec a day
Age: 1.75
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose normal, Cardiac monitoring, Crying, Decreased appetite, Eye movement disorder
Clinical narrative: Woke up after nap very tired.  Cried getting diaper changed. Refused snack/drink. Started to fall, eyes rolled back, skin tone looked gray/blue, body went rigid for about 2 minutes. EMS arrived within 10 min. HR at 180 bpm. Febrile 102F. Blood sugar 112 mg/dL
Age: 1.75
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Muscle rigidity, Pyrexia, Skin discolouration
Clinical narrative: Woke up after nap very tired.  Cried getting diaper changed. Refused snack/drink. Started to fall, eyes rolled back, skin tone looked gray/blue, body went rigid for about 2 minutes. EMS arrived within 10 min. HR at 180 bpm. Febrile 102F. Blood sugar 112 mg/dL
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Injection site erythema, Injection site hypersensitivity, Injection site pruritus, Injection site rash
Clinical narrative: 2nd booster (4th shot) given on 7/5 in right deltoid. Pt had all moderna vaccines without reaction but this time on 7/8 she developed area of raised erythema, warmth, itchy rash on the right arm from deltoid down lateral arm to elbow, consistent with large local hypersensitivity reaction. no s/sx systemic reaction or anaphylaxis.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: 2nd booster (4th shot) given on 7/5 in right deltoid. Pt had all moderna vaccines without reaction but this time on 7/8 she developed area of raised erythema, warmth, itchy rash on the right arm from deltoid down lateral arm to elbow, consistent with large local hypersensitivity reaction. no s/sx systemic reaction or anaphylaxis.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered, Medication error
Clinical narrative: Pt came in to receive, third shot of Pfizer, her booster. Pt was registered and brought back to vaccinators. According to pts vaccination card was she was good on time and date to receive third vaccine. Vaccination card only showed two prior shots. With lot numbers and dates. Pt mentioned prior to vaccine administration that she had trouble with getting her first shot, pt had gone to the convention center and was told she could not receive it as per the system she had already gotten it. According the pt this was false and in that instance was her first and onky shot. Per pt, ? had to spend 2 hours with onsite management ? of convention center vaccine clinc to resolve. In conclusion there was an identical persosn of the same name and similar DoB and SSN. For this reason she was ineligible at that time. Situation was resloved per the pt that day soemtime in April 2021.  Pt came in today with a vaccine card showing two prior shots, no reason to suspect more, pt passed screening and willing wanted to receive the shot. Pfizer 0.3ml was given to the pt intramuscular in the Right Arm. Pt waited her 15 mins and left facility. Hours later during a quality check of vaccinated patients , this said pts information showed todays visit was her fifth, unknown how the system did not alert earlier or brought into question. Vaccinator thought it was resolved as per the pts story and vaccine card.  Unable to prove whether the pts story is true or if the system is wrong, a medical error form is being filled up to address.
Age: 1.58
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Incorrect dosage of mRNA COVID-19 vaccine product was inadvertently administered. Patient received Moderna 100 ?g 0.5 ml age not indicated
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Swelling face, Urticaria
Clinical narrative: PT CALLED THE PHARMACY AT APPX 5:30pm 7-8-22. PT STATED THAT SHE RECEIVED SECOND MODERNA BOOSTER AT APPX 12:30PM TODAY. PT STATED THAT SHE FELT ITCHING ALL OVER BODY ABOUT 2 HOURS AFTER RECEVING VACCINE. PT STATED THAT SHE THEN DEVELOPED HIVES ALL OVER BODY, FACE WAS PUFFY. ASKED PATIENT REPEATEDLY IF ANY SWELLING OF LIPS, TONGUE, OR THROAT; ANY DIFFICULTY BREATHING; ANY ANXIETY OR FEELINGS OF ANXIETY. PT DENIED ANY OF THESE SYMPTOMS. I ADVISED PATIENT THAT IF ANY OF THESE SYMPTOMS DEVELOP TO CALL EMERGENCY . ADVISED PATIENT TO TAKE BENADRYL 50MG ASAP AND TO REPEAT IN 6 HOURS IF NECESSARY. ADVISED PATIENT TO SEEK MEDICAL ATTENTION ASAP IF SYMPTOMS PROGRESS. CALLED PATIENT AT 7:05pm TO CHECK ON HER STATUS AND RECEIVED HER VOICEMAIL. LEFT HER MESSAGE TO CALL BACK AND ADVISE OF HER STATUS. ASKED PATIENT IF SHE THOUGHT ANY THING ELSE COULD E CAUSING HIVES AND SHE SAD NO. THIS IS HER SECOND MODERNA VACCINE AFTER RECEIVING PFIZER FOR HER FIRST TWO DOSES.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Angiogram cerebral abnormal, Arthralgia, Aura, Carotid artery aneurysm, Computerised tomogram abdomen abnormal
Clinical narrative: Experienced Aura. Was daily initially and tapered off over the course of a month. Then in January an Abdominal/Pelvic CT (dr ordered) and a Cerebral CTA (in ER) revealed the following: 3 x 2 mm medially-directed saccular aneurysm arising from the cavernous right internal carotid artery;1 cm left renal artery aneurysm; Right colonic submucosal fat sack; Tiny fat-containing umbilical and supraumbilical hernias
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Fat tissue increased, Lumbar puncture normal, Migraine, Neck pain, Pain in jaw
Clinical narrative: Experienced Aura. Was daily initially and tapered off over the course of a month. Then in January an Abdominal/Pelvic CT (dr ordered) and a Cerebral CTA (in ER) revealed the following: 3 x 2 mm medially-directed saccular aneurysm arising from the cavernous right internal carotid artery;1 cm left renal artery aneurysm; Right colonic submucosal fat sack; Tiny fat-containing umbilical and supraumbilical hernias
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Renal aneurysm, Umbilical hernia
Clinical narrative: Experienced Aura. Was daily initially and tapered off over the course of a month. Then in January an Abdominal/Pelvic CT (dr ordered) and a Cerebral CTA (in ER) revealed the following: 3 x 2 mm medially-directed saccular aneurysm arising from the cavernous right internal carotid artery;1 cm left renal artery aneurysm; Right colonic submucosal fat sack; Tiny fat-containing umbilical and supraumbilical hernias
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine given.  Parent contacted.  Aware booster dose will need to be re-administered.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Headache, Pain, Respiratory tract congestion
Clinical narrative: Breakthrough Covid infection with headache, congestion, cough and body aches starting 7-3-2022. Negative home test on 7-4-2022 and 7-5-2022.  Positive Covid test 7-6-2022
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough Covid infection with headache, congestion, cough and body aches starting 7-3-2022. Negative home test on 7-4-2022 and 7-5-2022.  Positive Covid test 7-6-2022
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Cataplexy, Condition aggravated, Fatigue, Narcolepsy
Clinical narrative: Terrible fatigue and joint pain for about two weeks after shot.  Slow improvement since shot but now I have intermittent joint pain that I didn't have before the shot.  My narcolepsy and cataplexy symptoms seem worse since the third shot but I can't say that is from the vaccine.  It might be, though.
Sex: F
Vaccine: COVID19, RAB
Symptoms: Anxiety, Tinnitus
Clinical narrative: Horrible ringing buzzing in my ears; Anxiety; Case reference number US-BN-2021-002021, initially downloaded from Vaccine Adverse Event Reporting System (VAERS) on 21-Jun-2021, is a spontaneous case received from consumer via health authority (VAERS ID: 1258413-1) and concerns an 81-year-old female patient.  The patient had no current illnesses. The patient's past medical history included atrial fibrillation and hypertension.  The patient's concomitant medications included metoprolol tartrate, lisinopril and calcium, all for unknown indication.  On 02-Feb-2021, the patient was vaccinated with Rabavert (inactivated Rabies Virus Vaccine, batch number: not provided) at unknown dose or route of administration and for unknown indication.   On the same date, the patient was vaccinated with co-suspect Covid-19 vaccine at a dose reported as two (batch number: not provided) via subcutaneous route of administration on left arm and for unknown indication.   On 01-Mar-2021, approximately one month after the vaccination, the patient experienced horrible ringing buzzing in her ears. This started first with buzzing in ears just at night for about two weeks. After two weeks it was all the time buzzing. Seemed to be louder in the evening and night, and it was causing an anxiety.  On an unspecified date, the patient had doctor visit with general practitioner (GP) and she was going to see an audiologist.  At the time of this report, the patient had not recovered from the events.  The case was assessed as non-serious.  No further information was provided.; Reporter's Comments: Tinnitus and anxiety are unlisted for Rabipur according to the Prescriber Information. About a month after vaccination with RabAvert and co-suspect COVID-19 vaccine the patient experienced horrible ringing buzzing in her ears that caused anxiety. Major confounders for the events are patient's old age and hypertension. Due to not suggestive temporal relationship, lack of information and missing evidence for causal relationship between the suspect vaccine and the reported event, causality is assessed as unlikely related at the moment.; Sender's Comments: Tinnitus and anxiety are unlisted for Rabipur according to the Prescriber Information. About a month after vaccination with RabAvert and co-suspect COVID-19 vaccine the patient experienced horrible ringing buzzing in her ears that caused anxiety. Major confounders for the events are patient's old age and hypertension. Due to not suggestive temporal relationship, lack of information and missing evidence for causal relationship between the suspect vaccine and the reported event, causality is assessed as unlikely related at the moment.
Sex: F
Vaccine: RAB, UNK
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: Interchange of vaccine products; Case reference number US-BN-2021-002208, initially downloaded from Vaccine Adverse Event Reporting System (VAERS) on 23-Aug-2021, is a spontaneous case report received from a pharmacist via health authority (VAERS ID: 1384809-1) and concerns a 69-year-old female patient.   The patient's medical history and concomitant medication details were not provided.  On an unspecified date, reported as a first day zero, the patient was vaccinated with a dose of Imovax (Rabies Vaccine; batch number: not provided), at an unknown dose, via unknown route of administration, as a post-exposure prophylaxis.  On 17-May-2021, reported also as a day three, the patient received the dose of vaccine from another manufacturer named RabAvert (Inactivated Rabies Virus Vaccine; batch number: ARBA651B; Expiry date: 01-Mar-2023) at an unknown dose, via unknown route of administration, for post-exposure immunization (Interchange of vaccine products).  It was reported that, the patient was scheduled for a four-series vaccination. Also, the reporter wanted to ask if the entire post exposure series of Imovax needs to be performed if the consumer did not receive Imovax dose on day three'.  At the time of initial report, the patient did not experience any adverse event.  No further information was provided.; Reporter's Comments: Interchange of vaccine products is listed for RabAvert per convention. Reportedly, the patient received RabAvert for post-exposure immunization on day three, after receiving Imovax vaccine on day zero, which is considered as interchange of vaccine products. No information regarding concomitant medication and medical history were provided. No associated adverse event was reported. Causality is confounded by vaccination with co-suspect product Imovax. Reported event is not related to suspect vaccine, but to human action. The case is considered as non-serious.; Sender's Comments: Interchange of vaccine products is listed for RabAvert per convention. Reportedly, the patient received RabAvert for post-exposure immunization on day three, after receiving Imovax vaccine on day zero, which is considered as interchange of vaccine products. No information regarding concomitant medication and medical history were provided. No associated adverse event was reported. Causality is confounded by vaccination with co-suspect product Imovax. Reported event is not related to suspect vaccine, but to human action. The case is considered as non-serious.
Sex: M
Vaccine: RAB, TYP
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: Body aches; Headaches; Fever; Case reference number US-BN-2021-002207, initially downloaded from Vaccine Adverse Event Reporting System (VAERS) on 23-Aug-2021, is a spontaneous case report  received from a consumer via health authority (VAERS ID: 1390019-1) and concerns a 36-years-old male patient.  The patient's medical history was not provided.  The patient's concomitant medications included topiramate.  On 08-Jun-2021, the patient received the third dose of RabAvert (inactivated rabies virus; batch number was not provided), at an unknown dose and route of administration, for an unknown indication.  On the same date, the patient received the first dose of co-suspect Vivotif vaccine (Typhoid Vaccine Live Oral TY21A, batch number was not provided), at an unknown dose and route of administration, for an unknown indication.  On the same date, the patient experienced fever, body aches and headaches.   At the time of this report, the outcome of the events was not resolved.  The reporter assessed all of the events as non-serious. Causality assessment was not provided.  No further information was provided.; Reporter's Comments: Pain is not listed, and headache and pyrexia are listed for RabAvert per PI and PI. Reportedly, the patient experienced the mentioned events on the same day when third dose of RabAvert was received. On the same day the patient received co-suspect Vivotif vaccine. At the time of the report the outcome of the events is assessed as not resolved. No information regarding patient's medical history was provided. Causality is confounded by vaccination with co-suspect vaccine Vivotif and therapy with concomitant drug topiramate. Based on available information causality between suspect vaccine and all events is assessed as possibly related. The case is considered as non-serious.; Sender's Comments: Pain is not listed, and headache and pyrexia are listed for RabAvert per PI and PI. Reportedly, the patient experienced the mentioned events on the same day when third dose of RabAvert was received. On the same day the patient received co-suspect Vivotif vaccine. At the time of the report the outcome of the events is assessed as not resolved. No information regarding patient's medical history was provided. Causality is confounded by vaccination with co-suspect vaccine Vivotif and therapy with concomitant drug topiramate. Based on available information causality between suspect vaccine and all events is assessed as possibly related. The case is considered as non-serious.
Sex: M
Vaccine: RAB
Symptoms: Hypoaesthesia, Paraesthesia, Skin discolouration
Clinical narrative: Intermittent numbness/tingling in both arms; Intermittent discoloration of his hand; Tingling in his feet; Case reference number US-BN-2021-002251, initially downloaded from Vaccine Adverse Event Reporting System (VAERS) on 06-Sep-2021, is a spontaneous case report, received from a consumer via health authority (VAERS ID: 1420431-1) and concerns a 59-year-old male patient.  The patient's past medical history included arrhythmia, erectile dysfunction and benign prostatic hyperplasia.  The patient's concomitant medications included pindolol, sildenafil and tamsulosin, all for an unknown indication.  On 16-Mar-2021, the patient was vaccinated with Rabavert (inactivated Rabies Virus Vaccine, batch number: not provided) at a dose reported as one, via intramuscular route of administration, received in right arm and for an unknown indication.   On 22-Mar-2021, seven days after receiving the vaccine, the patient experienced intermittent numbness/tingling in both arms, intermittent discoloration of his hand and tingling in his feet.  The outcome for the events was not provided.  The reporter assessed the events as non-serious. Causality assessment was not provided.  No further information was provided.; Reporter's Comments: Paraesthesia is listed for Rabipur according to the Prescriber Information, while hypoesthesia and skin discolouration are unlisted for Rabipur according to the Prescriber Information. The patient experienced paraesthesia, hypoesthesia and skin discolouration seven days after RabAvert vaccine was administrated. Based on the available information, and having in mind pharmacodynamic effects of the vaccine, the causality for paraesthesia, hypoesthesia and skin discolouration is assessed as possibly related to Rabipur. The case is considered non serious.; Sender's Comments: Paraesthesia is listed for Rabipur according to the Prescriber Information, while hypoesthesia and skin discolouration are unlisted for Rabipur according to the Prescriber Information. The patient experienced paraesthesia, hypoesthesia and skin discolouration seven days after RabAvert vaccine was administrated. Based on the available information, and having in mind pharmacodynamic effects of the vaccine, the causality for paraesthesia, hypoesthesia and skin discolouration is assessed as possibly related to Rabipur. The case is considered non serious.
Sex: F
Vaccine: RAB
Symptoms: Paraesthesia
Clinical narrative: Paraesthesia; Case reference number US-BN-2021-002284, initially downloaded from Vaccine Adverse Event Reporting System (VAERS) on 20-Sep-2021, is a spontaneous case report received from a consumer via health authority (VAERS ID: 1454296-1) and concerns a 41-years-old female patient.  The patient's medical history and concomitant medication details were not provided.  On an unspecified date, the patient received the first dose of RabAvert (inactivated rabies virus; batch number was not provided), at an unknown dose, route or site of administration, for an unknown indication.  On 16-Jun-2021, the patient received the second dose of RabAvert (inactivated rabies virus; batch number: ARBA801B), at an unknown dose, administered intramuscularly at site reported as left arm, for an unknown indication.  On 26-Jun-2021, ten days after the second dose, the patient experienced paraesthesia. The event of paraesthesia was reported as a whole-body paraesthesia, more predominant in the face.  At the time of this report, the event of paraesthesia was not resolved.  The reporter assessed the event of paraesthesia as non-serious. Causality assessment was not provided.  No further information was provided.; Reporter's Comments: Paraesthesia is listed for RabAvert per PI and Prescriber Information. Reportedly, ten days after the second dose of RabAvert, the patient experienced paraesthesia. The patient's medical history and concomitant medication details were not provided. Due to known vaccine safety profile, and since contributory role of the given vaccine cannot be excluded, the causality for the event of paraesthesia is assessed as possibly related to the suspect product. This case is considered non-serious.; Sender's Comments: Paraesthesia is listed for RabAvert per PI and Prescriber Information. Reportedly, ten days after the second dose of RabAvert, the patient experienced paraesthesia. The patient's medical history and concomitant medication details were not provided. Due to known vaccine safety profile, and since contributory role of the given vaccine cannot be excluded, the causality for the event of paraesthesia is assessed as possibly related to the suspect product. This case is considered non-serious.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Apr2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 56 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  Clinical information: Anti viral details: product: COVID 19 Treatment brand: Plaxovid, treatment start date: 01Jun2022, Treatment stop date: 07Jun2022, indication: Treatment of COVID-19. The patient was not taking any other medications/ products within 2 weeks of starting COVID-19 treatment.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: RAB
Symptoms: Rash
Clinical narrative: Rash to bilateral chest, arms, and thighs; Case reference number US-BN-2021-002352, initially downloaded from Vaccine Adverse Event Reporting System (VAERS) on 18-Oct-2021, is a spontaneous case received from other health professional via health authority VAERS (1526347-1) and concerns a 28-year-old female patient.  The patient's medical history and concomitant medication details were not provided.  On 25-May-2021, the patient was vaccinated with RabAvert (inactivated rabies virus vaccine, batch number: ARBA801A) at a dose reported as one, administered intramuscularly, for an unknown indication.  On 26-May-2021, one day after first rabies vaccination, the patient reported rash to bilateral chest, arms, and thighs and states that the rash was not itchy or swollen, and that she was not short of breath or having any difficulty breathing.  The patient was advised that could take Benadryl (diphenhydramine) in addition to report this to her Doctor of Primary Medicine (PMD) and that could also take a non-drowsy antihistamine for relief as well.   On an unspecified date in 2021, it was reported that the patient visited an urgent care, where she received a steroid pack, which cleared up the reaction.   On an unspecified date in 2021, the patient recovered from the event.   The reporter assessed the event as non-serious. The reporter did not provide causality assessment for the event.  No further information was provided.; Reporter's Comments: The 28-year-old female patient was vaccinated with RabAvert for an unknown indication. As reported, one day after first rabies vaccination, the patient experienced the event of rash. The event of rash is listed for RabAvert according to the Datasheet. The patient's medical history and concomitant medication details were not provided. The outcome of the event of rash was recovered/resolved. Due to plausible temporal relationship and known vaccine safety profile the causality for the event of rash is assessed as possibly related to RabAvert. This case is considered non-serious.; Sender's Comments: The 28-year-old female patient was vaccinated with RabAvert for an unknown indication. As reported, one day after first rabies vaccination, the patient experienced the event of rash. The event of rash is listed for RabAvert according to the Datasheet. The patient's medical history and concomitant medication details were not provided. The outcome of the event of rash was recovered/resolved. Due to plausible temporal relationship and known vaccine safety profile the causality for the event of rash is assessed as possibly related to RabAvert. This case is considered non-serious.
Sex: M
Vaccine: RAB
Symptoms: Rash erythematous, Rash papular
Clinical narrative: Red, bumpy and elevated areas on and around face and chest; Red, bumpy and elevated areas on and around face and chest; Case reference number US-BN-2021-002370, initially downloaded from Vaccine Adverse Event Reporting System (VAERS) on 25-Oct-2021, is a spontaneous case report, received from a consumer via health authority (VAERS ID: 1574002-1) and concerns a 24-year-old male patient.  The patient's medical history and concomitant medication details were not provided.   On 14-Aug-2021, the patient was vaccinated with the dose of RabAvert (inactivated Rabies Virus Vaccine, batch number was not provided) at a dose reported as two, via unknown route of administration, received in the left arm and for an unknown indication.   On the same day, the patient developed red, bumpy and elevated areas on and around face and chest.  At the time of initial report, the patient had not recovered from the events.  The reporter assessed the case as non-serious. Causality assessment was not provided.  No further information was provided.; Reporter's Comments: The 24-year-old male patient was vaccinated with the dose of RabAvert for an unknown indication. On the same day, the patient developed non-serious events of rash papular and rash erythematous. The events of rash papular and rash erythematous are listed for RabAvert according to the Datasheet. The patient's medical history and concomitant medication details were not provided. The outcome of the events was not recovered/not resolved. Due to suggestive temporal relationship and known vaccine safety profile the causality for the events of rash papular and rash erythematous is assessed as possibly related to the suspect product. This case is considered non-serious.; Sender's Comments: The 24-year-old male patient was vaccinated with the dose of RabAvert for an unknown indication. On the same day, the patient developed non-serious events of rash papular and rash erythematous. The events of rash papular and rash erythematous are listed for RabAvert according to the Datasheet. The patient's medical history and concomitant medication details were not provided. The outcome of the events was not recovered/not resolved. Due to suggestive temporal relationship and known vaccine safety profile the causality for the events of rash papular and rash erythematous is assessed as possibly related to the suspect product. This case is considered non-serious.
Sex: F
Vaccine: RAB
Symptoms: Headache, Lymphadenopathy, Nausea, Pain in extremity
Clinical narrative: Swollen lymph node in left armpit; Case reference number US-BN-2021-00291, initially downloaded from Vaccine Adverse Event Reporting System (VAERS ID) on 01-Nov-2021, is a spontaneous case report, received from a consumer via health authority (VAERS ID: 1617492-1) and concerns a 32-year-old female patient.  The patient's current conditions included ADHD (Attention deficit hyperactivity disorder), OCD (Obsessive-compulsive disorder), depression and sleep apnea. Concomitant medication included fluoxetine, spironolactone, Adderall (amphetamine and dextroamphetamine), melatonin, l-tyrosine and Trivora (levonorgestrel and ethinyl estradiol).  The patient's historical vaccine included Moderna SARS-CoV-2 Vaccine after which the patient developed arm pain, headache and nausea, and unspecified rabies vaccine (no adverse event reported).  On 19-Aug-2021, the patient was vaccinated with RabAvert (inactivated Rabies Virus Vaccine, batch number: not reported) at a dose reported as one, via unknown route of administration, received in the left arm and for an unknown indication.   On 21-Aug-2021, two days after the vaccination the patient experienced swollen lymph node in the left armpit.  At the time of the report outcome of the event was not recovered.   The reporter assessed the event as non-serious. Causality assessment was not provided.  No further information was provided.; Reporter's Comments: The 32-year-old female patient was vaccinated with RabAvert administrated in the left arm for an unknown indication. As reported, two days after the vaccination the patient experienced swollen lymph node in the left armpit. The event of lymphadenopathy is listed for Rabipur according to the Datasheet. The patient's historical vaccine included Moderna SARS-CoV-2 Vaccine after which the patient developed arm pain, headache and nausea, and unspecified rabies vaccine (no adverse event reported). The outcome of the event of lymphadenopathy was not recovered/not resolved. Due to plausible temporal relationship and known vaccine safety profile, the causality for the event of lymphadenopathy is assessed as possibly related to RabAvert. This case is considered non-serious.; Sender's Comments: The 32-year-old female patient was vaccinated with RabAvert administrated in the left arm for an unknown indication. As reported, two days after the vaccination the patient experienced swollen lymph node in the left armpit. The event of lymphadenopathy is listed for Rabipur according to the Datasheet. The patient's historical vaccine included Moderna SARS-CoV-2 Vaccine after which the patient developed arm pain, headache and nausea, and unspecified rabies vaccine (no adverse event reported). The outcome of the event of lymphadenopathy was not recovered/not resolved. Due to plausible temporal relationship and known vaccine safety profile, the causality for the event of lymphadenopathy is assessed as possibly related to RabAvert. This case is considered non-serious.
Sex: F
Vaccine: RAB
Symptoms: No adverse event, Product administered at inappropriate site
Clinical narrative: Rabavert was administered in glueteal muscle instead of the deltoid; Case reference number US-BN-2021-002568, initially downloaded from Vaccine Adverse Event Reporting System (VAERS) on 27-Dec-2021, is a spontaneous case received from a consumer/non-health professional via health authority VAERS (1952214-1) and concerns a 25-year-old female patient.  The patient had no medical history and had no known drug allergies.  The patient's concomitant medication details included loratadine.  On an unspecified day, the patient received first dose of Rabavert (Inactivated Rabies Virus Vaccine, Batch no. was not provided) at unknown dose and route of administration in gluteal muscle for unknown indication. (explicitly coded as product administered at inappropriate site')  On 28-Sep-2021, the patient received second dose of Rabavert (Inactivated Rabies Virus Vaccine, Batch no. ARBA851C) at unknown dose intramuscularly in gluteal muscle for unknown indication. (explicitly coded as product administered at inappropriate site')  At the time of this report the patient was not reported any adverse symptoms post injection.  No further information was provided.; Reporter's Comments: The 25-year-old female patient received first dose of Rabavert in gluteal muscle for unknown indication, which is considered as product administered at inappropriate site. Reportedly, the patient received second dose of Rabavert in gluteal muscle for unknown indication, which is considered as product administered at inappropriate site. No associated adverse events have been reported with the reported medication error. The product administered at inappropriate site is considered as listed per convention. The patient had no medical history and had no known drug allergies, and concomitant medication included loratadine. The product administered at inappropriate site has been considered as not related to the suspect vaccine, but to a human action. This case is considered as non-serious.; Sender's Comments: The 25-year-old female patient received first dose of Rabavert in gluteal muscle for unknown indication, which is considered as product administered at inappropriate site. Reportedly, the patient received second dose of Rabavert in gluteal muscle for unknown indication, which is considered as product administered at inappropriate site. No associated adverse events have been reported with the reported medication error. The product administered at inappropriate site is considered as listed per convention. The patient had no medical history and had no known drug allergies, and concomitant medication included loratadine. The product administered at inappropriate site has been considered as not related to the suspect vaccine, but to a human action. This case is considered as non-serious.
Sex: F
Vaccine: RAB
Symptoms: Medication error, No adverse event, Product administered at inappropriate site
Clinical narrative: Rabavert was administered in gluteal muscle instead in the deltoid; Case reference number US-BN-2021-002569, initially downloaded from Vaccine Adverse Event Reporting System (VAERS) on 27-Dec-2021, is a spontaneous case received from a consumer/non-health professional via health authority VAERS (Safety report ID 1952215-1) and concerns a 24-year-old female patient.  The patient's medical history was not provided.  The patient's concomitant medication details was not provided.  On 21-Sep-2021, the patient received first dose of Rabavert (Inactivated Rabies Virus Vaccine, Batch no. ARBA851C) at unknown dose intramuscularly in gluteal muscle for unknown indication. (explicitly coded as product administered at inappropriate site')  At the time of this report the patient was not reported any adverse symptoms post injection.  No further information was provided.; Reporter's Comments: The 24-year-old female patient received first dose of Rabavert in gluteal muscle for unknown indication, which is considered as product administered at inappropriate site. No associated adverse events have been reported with the reported medication error. The product administered at inappropriate site is considered as listed per convention. The patient's medical history and concomitant medication details were not provided. The product administered at inappropriate site has been considered as not related to the suspect vaccine, but to a human action. This case is considered as non-serious.; Sender's Comments: The 24-year-old female patient received first dose of Rabavert in gluteal muscle for unknown indication, which is considered as product administered at inappropriate site. No associated adverse events have been reported with the reported medication error. The product administered at inappropriate site is considered as listed per convention. The patient's medical history and concomitant medication details were not provided. The product administered at inappropriate site has been considered as not related to the suspect vaccine, but to a human action. This case is considered as non-serious.
Sex: F
Vaccine: RAB
Symptoms: No adverse event, Product administered at inappropriate site
Clinical narrative: Rabavert was administered in gluteal muscle instead in deltoid; Case reference number US-BN-2021-002570, initially downloaded from Vaccine Adverse Event Reporting System (VAERS) on 27-Dec-2021, is a spontaneous case received from a consumer/non-health professional via health authority VAERS (1952223-1) and concerns a 25-year-old female patient.  The patient' medical history was not provided.  The patient's concomitant medication details was not provided.  On an unspecified day, the patient received first dose of Rabavert (Inactivated Rabies Virus Vaccine, Batch no. was not provided) at unknown dose and route of administration for unknown indication.   On an unspecified day, the patient received second dose of Rabavert (Inactivated Rabies Virus Vaccine, Batch no. was not provided) at unknown dose and route of administration for unknown indication.   On 12-Oct-2021, the patient received third dose of Rabavert (Inactivated Rabies Virus Vaccine, Batch no. ARBA851C) at unknown dose intramuscularly in gluteal muscle for unknown indication. (explicitly coded as product administered at inappropriate site')  At the time of this report it was known that the patient was not sick on immunisation and that patient had no adverse event after vaccination.  No further information was provided.; Reporter's Comments: The 25-year-old female patient received the third dose of Rabavert in gluteal muscle for unknown indication, which is considered as product administered at inappropriate site. No associated adverse events have been reported with the reported medication error. The product administered at inappropriate site is considered as listed per convention. The patient's medical history and concomitant medication details were not provided. The product administered at inappropriate site has been considered as not related to the suspect vaccine, but to a human action. This case is considered as non-serious.; Sender's Comments: The 25-year-old female patient received the third dose of Rabavert in gluteal muscle for unknown indication, which is considered as product administered at inappropriate site. No associated adverse events have been reported with the reported medication error. The product administered at inappropriate site is considered as listed per convention. The patient's medical history and concomitant medication details were not provided. The product administered at inappropriate site has been considered as not related to the suspect vaccine, but to a human action. This case is considered as non-serious.
Sex: F
Vaccine: RAB, RAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: The third dose was administered on day 15; Case reference number US-BN-2022-000113, initially downloaded from Vaccine Adverse Event Reporting System (VAERS) on 07-Feb-2022, is a spontaneous case received from a consumer via health authority VAERS (2057927-1) and concerns a 25-year-old adult female patient.  The patient had no medical history, no known current illnesses and no allergies.  The patient's concomitant medication included famotidine, fexofenadine and montelukast.  On an unspecified dates, the patient was vaccinated with the first two doses of RabAvert (inactivated rabies virus vaccine, batch number was not provided), both at an unknown dose or route of administration, for prophylaxis.  On 19-Dec-2021, reported as day 15, the patient was inadvertently vaccinated with the third dose of RabAvert (batch number: ARBA911C), at an unknown dose, administered intramuscularly in the left arm (explicitly coded as 'Inappropriate schedule of vaccine administered').   It was also reported that the patient felt fine, that no adverse reaction occurred and that the patient will consider measuring the titer in six months.  The reporter assessed the event as non-serious.  No further information was provided.; Reporter's Comments: A 25-year-old female patient was inadvertently vaccinated with the third dose of RabAvert for prophylaxis, on the day 15, as reported, which is considered as inappropriate schedule of product administration. No associated adverse events have been reported with the reported medication error. The inappropriate schedule of product administration is considered as listed per company convention. The patient had no medical history, no known current illnesses and no allergies, and concomitant medication included famotidine, fexofenadine and montelukast. The inappropriate schedule of product administration has been considered as not related to the suspect vaccine, but to a human action. This case is considered as non-serious.; Sender's Comments: A 25-year-old female patient was inadvertently vaccinated with the third dose of RabAvert for prophylaxis, on the day 15, as reported, which is considered as inappropriate schedule of product administration. No associated adverse events have been reported with the reported medication error. The inappropriate schedule of product administration is considered as listed per company convention. The patient had no medical history, no known current illnesses and no allergies, and concomitant medication included famotidine, fexofenadine and montelukast. The inappropriate schedule of product administration has been considered as not related to the suspect vaccine, but to a human action. This case is considered as non-serious.
Sex: F
Vaccine: RAB, RAB
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: The third dose was administered on day 15; Case reference number US-BN-2022-000113, initially downloaded from Vaccine Adverse Event Reporting System (VAERS) on 07-Feb-2022, is a spontaneous case received from a consumer via health authority VAERS (2057927-1) and concerns a 25-year-old adult female patient.  The patient had no medical history, no known current illnesses and no allergies.  The patient's concomitant medication included famotidine, fexofenadine and montelukast.  On an unspecified dates, the patient was vaccinated with the first two doses of RabAvert (inactivated rabies virus vaccine, batch number was not provided), both at an unknown dose or route of administration, for prophylaxis.  On 19-Dec-2021, reported as day 15, the patient was inadvertently vaccinated with the third dose of RabAvert (batch number: ARBA911C), at an unknown dose, administered intramuscularly in the left arm (explicitly coded as 'Inappropriate schedule of vaccine administered').   It was also reported that the patient felt fine, that no adverse reaction occurred and that the patient will consider measuring the titer in six months.  The reporter assessed the event as non-serious.  No further information was provided.; Reporter's Comments: A 25-year-old female patient was inadvertently vaccinated with the third dose of RabAvert for prophylaxis, on the day 15, as reported, which is considered as inappropriate schedule of product administration. No associated adverse events have been reported with the reported medication error. The inappropriate schedule of product administration is considered as listed per company convention. The patient had no medical history, no known current illnesses and no allergies, and concomitant medication included famotidine, fexofenadine and montelukast. The inappropriate schedule of product administration has been considered as not related to the suspect vaccine, but to a human action. This case is considered as non-serious.; Sender's Comments: A 25-year-old female patient was inadvertently vaccinated with the third dose of RabAvert for prophylaxis, on the day 15, as reported, which is considered as inappropriate schedule of product administration. No associated adverse events have been reported with the reported medication error. The inappropriate schedule of product administration is considered as listed per company convention. The patient had no medical history, no known current illnesses and no allergies, and concomitant medication included famotidine, fexofenadine and montelukast. The inappropriate schedule of product administration has been considered as not related to the suspect vaccine, but to a human action. This case is considered as non-serious.