chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Nausea, Oropharyngeal pain, Pyrexia, Vaccination site pain
Clinical narrative: sore throat; congestion; Yellow skin similar to jaundice; dizziness; nausea; vomiting; fatigue; headache; chills; body aches; sore injection site; fever; This spontaneous case was reported by a patient and describes the occurrence of OROPHARYNGEAL PAIN (sore throat), NASAL CONGESTION (congestion), YELLOW SKIN (Yellow skin similar to jaundice), DIZZINESS (dizziness) and NAUSEA (nausea) in a 22-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 208H23A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 28-May-2024, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) 1 dosage form. On 29-May-2024, the patient experienced OROPHARYNGEAL PAIN (sore throat), NASAL CONGESTION (congestion), YELLOW SKIN (Yellow skin similar to jaundice), DIZZINESS (dizziness), NAUSEA (nausea), VOMITING (vomiting), FATIGUE (fatigue), HEADACHE (headache), CHILLS (chills), MYALGIA (body aches), VACCINATION SITE PAIN (sore injection site) and PYREXIA (fever). At the time of the report, OROPHARYNGEAL PAIN (sore throat), NASAL CONGESTION (congestion), YELLOW SKIN (Yellow skin similar to jaundice), DIZZINESS (dizziness), NAUSEA (nausea), VOMITING (vomiting), FATIGUE (fatigue), HEADACHE (headache), CHILLS (chills), MYALGIA (body aches), VACCINATION SITE PAIN (sore injection site) and PYREXIA (fever) was resolving.            Concomitant medication not reported.  It was unknown if the patient experienced any additional symptoms/events. Treatment medication not reported.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting, Yellow skin
Clinical narrative: sore throat; congestion; Yellow skin similar to jaundice; dizziness; nausea; vomiting; fatigue; headache; chills; body aches; sore injection site; fever; This spontaneous case was reported by a patient and describes the occurrence of OROPHARYNGEAL PAIN (sore throat), NASAL CONGESTION (congestion), YELLOW SKIN (Yellow skin similar to jaundice), DIZZINESS (dizziness) and NAUSEA (nausea) in a 22-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 208H23A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 28-May-2024, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) 1 dosage form. On 29-May-2024, the patient experienced OROPHARYNGEAL PAIN (sore throat), NASAL CONGESTION (congestion), YELLOW SKIN (Yellow skin similar to jaundice), DIZZINESS (dizziness), NAUSEA (nausea), VOMITING (vomiting), FATIGUE (fatigue), HEADACHE (headache), CHILLS (chills), MYALGIA (body aches), VACCINATION SITE PAIN (sore injection site) and PYREXIA (fever). At the time of the report, OROPHARYNGEAL PAIN (sore throat), NASAL CONGESTION (congestion), YELLOW SKIN (Yellow skin similar to jaundice), DIZZINESS (dizziness), NAUSEA (nausea), VOMITING (vomiting), FATIGUE (fatigue), HEADACHE (headache), CHILLS (chills), MYALGIA (body aches), VACCINATION SITE PAIN (sore injection site) and PYREXIA (fever) was resolving.            Concomitant medication not reported.  It was unknown if the patient experienced any additional symptoms/events. Treatment medication not reported.
Age: 24.0
Sex: M
Vaccine: HEP
Symptoms: Wrong product administered
Clinical narrative: Patient was scheduled on nurse schedule to have HPV vaccine given to her and a Hep B was given instead.
Age: 0.17
Sex: M
Vaccine: DTPPVHBHPB, PNC20, RV1
Symptoms: Haematochezia
Clinical narrative: On 5/29, presented to clinic with blood in stool. Diagnosed with likely cow's milk protein allergy/intolerance. Follow up on 5/31, mom discovered blood on the pacifier. No oral or nasal source of blood identified. Baby continued on maternal breast milk with maternal diet to exclude dairy and soy.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Body temperature increased, Chills, Fatigue, Malaise
Clinical narrative: Wife reports via phone call that client c/o feeling tired starting 5/25/24, did not rest, continued doing work outside during the following days, c/o balls of feet hurting after working in the garden and using a shovel, symptoms continued the following week of feeling unwell until 1 week after vaccine developed a temp of 101.3 with c/o joint pain, skin and scalp hurting, no appetite, exhausted, chills, nerve sensitivity above the elbow of the left arm. Today temps is 100.6, still feeling tired, not eating or drinking much. States she plans to push fluids and protein shakes today. Recommended that they contact PCP to advise/consult.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity, Pain of skin, Sensitive skin
Clinical narrative: Wife reports via phone call that client c/o feeling tired starting 5/25/24, did not rest, continued doing work outside during the following days, c/o balls of feet hurting after working in the garden and using a shovel, symptoms continued the following week of feeling unwell until 1 week after vaccine developed a temp of 101.3 with c/o joint pain, skin and scalp hurting, no appetite, exhausted, chills, nerve sensitivity above the elbow of the left arm. Today temps is 100.6, still feeling tired, not eating or drinking much. States she plans to push fluids and protein shakes today. Recommended that they contact PCP to advise/consult.
Age: 42.0
Sex: M
Vaccine: HPV9
Symptoms: Urticaria
Clinical narrative: Total body hives, resolved with 50 mg benadryl
Age: 1.25
Sex: M
Vaccine: MENB
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: There were no effects. Provider aware at time of mis-vaccination. Child was supposed to get Prevnar 20 instead received Trumenba.  Provider looked it up and there were no side effects of getting this vaccination at this age and that they actually give it in country at this age. Mom is aware and has no questions
Age: 72.0
Sex: M
Vaccine: PPV
Symptoms: Expired product administered
Clinical narrative: patient needed a Pneumococcal23 Vaccine. Patient was given the injection as requested by provider. After patient left I was charting the vaccine and making notes and when typing in the info I noticed the vaccine expired on 08/29/2023.  Nurse and Provider were notified.
Age: 75.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Patient was administered a vaccine that was beyond expiration date
Age: 18.0
Sex: F
Vaccine: HEP
Symptoms: Hypersensitivity, Injection site pruritus, Injection site rash, Rash, Rash pruritic
Clinical narrative: Allergic reaction to Hepatitis B vaccine. Rash began at the injection site and was described as itchy. Rash spread to both upper arms and then down to forearms. No other symptoms but rash and itchiness.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site haemorrhage, Injection site pain, Injection site rash
Clinical narrative: Rash at site of Dtap-IPV- red, painful, ecchymotic that improved but was present for 1 month.
Age: 67.0
Sex: M
Vaccine: DTAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: no known adverse event. Patient given wrong type of vaccine.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Chest pain, Echocardiogram normal, Myocarditis, Pyrexia, Troponin increased
Clinical narrative: Given vaccine 5/28. Fever on Wednesday and Thursday (5/29-30).  Developed chest pain 6/1. Seen in cardiology clinic and now admitted to hospital with myocarditis without other known cause.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Viral test negative
Clinical narrative: Given vaccine 5/28. Fever on Wednesday and Thursday (5/29-30).  Developed chest pain 6/1. Seen in cardiology clinic and now admitted to hospital with myocarditis without other known cause.
Age: 22.0
Sex: F
Vaccine: VARCEL
Symptoms: Expired product administered, Product storage error
Clinical narrative: The Varicella vaccine had a temperature incident during transit. Merck advised Supervisor on 2/21/24 that the vaccine was still viable but had a reduced shelf life of 3 months. The expiration date of 5/12/24 was updated on the outside of the box.
Age: 60.0
Sex: M
Vaccine: PNC20
Symptoms: C-reactive protein, Cellulitis, Differential white blood cell count, Erythema, Full blood count
Clinical narrative: Per the provider note:  "Cellulitis Post-Vaccination  Assessment: - The patient presents with pain, redness, and swelling in the left arm following a pneumonia vaccine. - The cellulitis has been present for more than seven days and has been gradually worsening. - The patient has a history of a severe reaction to a tetanus shot 30 years ago.  Plan: - Prescribed Augmentin (amoxicillin-clavulanate) for the underlying skin infection. - Instructed the patient to monitor the marked area for 24 hours and ensure it's not expanding. - Schedule a follow-up appointment on Monday to assess the progress. - Advised the patient to send a photo of the affected area on Friday evening. - Reporting the case to the vaccine manufacturer for further investigation.  "
Age: 60.0
Sex: M
Vaccine: PNC20
Symptoms: Metabolic function test, Pain in extremity, Peripheral swelling, Skin infection
Clinical narrative: Per the provider note:  "Cellulitis Post-Vaccination  Assessment: - The patient presents with pain, redness, and swelling in the left arm following a pneumonia vaccine. - The cellulitis has been present for more than seven days and has been gradually worsening. - The patient has a history of a severe reaction to a tetanus shot 30 years ago.  Plan: - Prescribed Augmentin (amoxicillin-clavulanate) for the underlying skin infection. - Instructed the patient to monitor the marked area for 24 hours and ensure it's not expanding. - Schedule a follow-up appointment on Monday to assess the progress. - Advised the patient to send a photo of the affected area on Friday evening. - Reporting the case to the vaccine manufacturer for further investigation.  "
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: Patient requested her second dose of Shingrix which we gave on 5/6/2024.  While entering the record of vaccination on database I noticed that this was her third dose.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: CSF protein increased, Guillain-Barre syndrome, Hypoaesthesia, Muscular weakness, Myelitis transverse
Clinical narrative: Patient started to have lower extremities weakness, tingling and numbness bilaterally but more on right and was subsequently hospitalized and diagnosed with  transverse myelitis and atypical GBS.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Paraesthesia
Clinical narrative: Patient started to have lower extremities weakness, tingling and numbness bilaterally but more on right and was subsequently hospitalized and diagnosed with  transverse myelitis and atypical GBS.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Dizziness, Dysarthria, Skin discolouration, Vision blurred
Clinical narrative: About 15 min after the pt got vaccines, she complained of being light headed, dizzy, color became gray. Then she complained of blurry vision and not being able to see and words were slurred. Ice packs and cold washcloth were given. After a few minutes of no improvement, epi was administered. Within 5 mins of epi, pt started feeling better. Pt was monitored for 30 mins afterwards by nursing staff. Encouraged to go to local hospital for any further episodes.
Age: 14.0
Sex: M
Vaccine: FLU3, FLU4, HPV9, UNK
Symptoms: Anxiety, Dizziness, Feeling abnormal, Injury, Loss of consciousness
Clinical narrative: Pharmacy gave me 4 vaccine injections, since I was forced to by my school to get the up to date vaccine injections. 10 minutes after I received the injection, I collapsed on the floor and went Unconscious. When I became coscious, they tried to give me over the counter medicine and had my drink water before my mom told them don't. Ever since that day, I have severe trauma and anxiety. I went to the hospital multiple time because I felt like I was dying, but they just said it was my anxiety. Days after I got the injections, I was in bed all day because I felt so ill and lightheaded. For a few years after the vaccination, I couldn't anywhre in public because I felt like I was going to pass out. The vaccinations prevented me quiting sports because of how bad my anxiety became and how lightheaded I have got.
Age: 14.0
Sex: M
Vaccine: FLU3, FLU4, HPV9, UNK
Symptoms: Loss of personal independence in daily activities, Malaise, Syncope
Clinical narrative: Pharmacy gave me 4 vaccine injections, since I was forced to by my school to get the up to date vaccine injections. 10 minutes after I received the injection, I collapsed on the floor and went Unconscious. When I became coscious, they tried to give me over the counter medicine and had my drink water before my mom told them don't. Ever since that day, I have severe trauma and anxiety. I went to the hospital multiple time because I felt like I was dying, but they just said it was my anxiety. Days after I got the injections, I was in bed all day because I felt so ill and lightheaded. For a few years after the vaccination, I couldn't anywhre in public because I felt like I was going to pass out. The vaccinations prevented me quiting sports because of how bad my anxiety became and how lightheaded I have got.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Bladder catheterisation, Immunoglobulin therapy, Laboratory test, Magnetic resonance imaging head, Magnetic resonance imaging spinal
Clinical narrative: My son was paralyzed and had Myelitis after receiving the covid vaccine, which was mandatory for anyone flying abroad. This happened during our vacation and he was hospitalized for 5 weeks. He went through many tests and treatments, including MRI's of the brain and spine, Plasma exchange treatment, IVIG treatment. He had no control of his bladder and was using a catheter for several months and he had a blood clot for which he was on blood thinner medication for 6 months. Today, he remains with 2 drop feet and his nerves below his knees down to his toes are not functioning.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Myelitis, Nervous system disorder, Paralysis, Peroneal nerve palsy, Plasmapheresis
Clinical narrative: My son was paralyzed and had Myelitis after receiving the covid vaccine, which was mandatory for anyone flying abroad. This happened during our vacation and he was hospitalized for 5 weeks. He went through many tests and treatments, including MRI's of the brain and spine, Plasma exchange treatment, IVIG treatment. He had no control of his bladder and was using a catheter for several months and he had a blood clot for which he was on blood thinner medication for 6 months. Today, he remains with 2 drop feet and his nerves below his knees down to his toes are not functioning.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Thrombosis, Urinary incontinence
Clinical narrative: My son was paralyzed and had Myelitis after receiving the covid vaccine, which was mandatory for anyone flying abroad. This happened during our vacation and he was hospitalized for 5 weeks. He went through many tests and treatments, including MRI's of the brain and spine, Plasma exchange treatment, IVIG treatment. He had no control of his bladder and was using a catheter for several months and he had a blood clot for which he was on blood thinner medication for 6 months. Today, he remains with 2 drop feet and his nerves below his knees down to his toes are not functioning.
Age: 80.0
Sex: F
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: Client received child dose of Havrix. She was still in office so was explained to her that she had only received a child dose and would need another child dose to make the 1 ML adult dose. She received total of 1 ml of Havrix on the same visit.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Face injury, Haemorrhage, Head injury, Syncope
Clinical narrative: Syncopal Episode while getting height/weight during appointment.  Patient hit his head and landed on his face, and started bleeding.
Age: 21.0
Sex: F
Vaccine: VARCEL
Symptoms: Expired product administered
Clinical narrative: This is an error report.  Given even though out of date.  Contacted Merck to see if there were any studies demonstrating efficacy past expiration date but none were available.  Plan to readminister and draw titer as appropriate for followup.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Abdominal pain lower, Diarrhoea, Pain in extremity, Swelling
Clinical narrative: He got his vaccine, had no problems other than the arm pain, then about 5:30 PM he started with cramps and pains in lower abdomen that lasted 24-30 seconds and then had 3 episodes of diarrhea at that time, and has not had any cramping or pain since that.  He feels fine and has no other adverse reactions and is totally clear and cognizant.  He is easing himself into food and eating lightly today.  He also had a sore arm around 6:00 PM and it's going down, the swelling and feeling a lot of better.  He did not take anything for his symptoms.  He called the pharmacy and he was told to call the nurses station if he did not improve.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Aspiration bone marrow, B-cell lymphoma, Biopsy lymph gland abnormal, Blood test, Chronic lymphocytic leukaemia
Clinical narrative: Swollen R cervical lymph node after 2nd and 4th doses.  2weeks following 2nd booster in 2021.  Lymph node was ultrasounded,  size returned to normal 2 months later.  Annual booster in 2023, Feb, right arm led to an enlarged r cervical lymph node again.   Was biopsied since size didn't change.  Suspected lymphoma or chronic lymphocytic leukemia.   Developed trigeminal neuralgia in 06/2023, Right side of face.  R eyelids became droopy in September of 2023. Scan revealed a tumor in my right eye socket in Oct 2023.  Biopsy results indicated a large B cell lymphoma
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Eyelid ptosis, Laboratory test, Lymphadenopathy, Magnetic resonance imaging head, Ocular neoplasm
Clinical narrative: Swollen R cervical lymph node after 2nd and 4th doses.  2weeks following 2nd booster in 2021.  Lymph node was ultrasounded,  size returned to normal 2 months later.  Annual booster in 2023, Feb, right arm led to an enlarged r cervical lymph node again.   Was biopsied since size didn't change.  Suspected lymphoma or chronic lymphocytic leukemia.   Developed trigeminal neuralgia in 06/2023, Right side of face.  R eyelids became droopy in September of 2023. Scan revealed a tumor in my right eye socket in Oct 2023.  Biopsy results indicated a large B cell lymphoma
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Positron emission tomogram, Scan abnormal, Trigeminal neuralgia, Ultrasound lymph nodes
Clinical narrative: Swollen R cervical lymph node after 2nd and 4th doses.  2weeks following 2nd booster in 2021.  Lymph node was ultrasounded,  size returned to normal 2 months later.  Annual booster in 2023, Feb, right arm led to an enlarged r cervical lymph node again.   Was biopsied since size didn't change.  Suspected lymphoma or chronic lymphocytic leukemia.   Developed trigeminal neuralgia in 06/2023, Right side of face.  R eyelids became droopy in September of 2023. Scan revealed a tumor in my right eye socket in Oct 2023.  Biopsy results indicated a large B cell lymphoma
Age: 3.0
Sex: F
Vaccine: DTAPHEPBIP, HEPA, MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient's R thigh was swollen, red and warm to the touch and growing within 24 hours of injection. Mother took patient to ER on 6/1/2024.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Breakthrough COVID-19
Clinical narrative: Covid-19 Breakthrough Infection
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Behaviour disorder, Developmental regression
Clinical narrative: Parent and daycare provider report that he is a different child since getting this vaccine. Behavioral problems at school, some regression. Not the kid he used to be.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Deafness, Myalgia, Pain in extremity, Pyrexia
Clinical narrative: Left Arm Pain, Fever, Chills, Muscle Aches ---- on 6/1 Patient also experienced loss of hearing
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: 11 year old   patient  received a wrong dose of Covid vaccine. She received an adult dose in stead of pediatric dose
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: No adverse reaction
Age: 22.0
Sex: M
Vaccine: HPV9, TDAP
Symptoms: Dizziness, Loss of consciousness
Clinical narrative: Patient did not tolerate HPV vaccine well. As soon as I gave the vaccine IM in right arm/deltoid, he stated felt dizzy and passed out on exam table. Alerted using call bell and called out for help. At which point Dr., Dr.,  (CA), (RN) and (COM) showed up to assist. Member's vitals taken, cold packs applied and once alert, juice was given. Member stated felt better and went to have his labs done.
Age: 12.0
Sex: M
Vaccine: PNC20
Symptoms: Dyspnoea
Clinical narrative: patient was on his way out of the clinic he stated that he felt like he couldn't breathe. Started massaging his neck.  During the visit today, was given Prevnar 20 and had a few snacks from clinic snack supply.   Only allergy is augmentin.  H/o asthma and episodes of hyperventilating due to anxiety.  Sated that this did not feel like those episodes and that that he felt like his throat was closing.  Oxygen started, pulse ox 100%.  Respiratory rate 28.  No audible wheezing.  Epi-pen administered at 1210pm in right thigh.  Squad was called.  Patient complained of feeling weak and seemed panicked while waiting for squad.  Patient kept in chair until squad came and transferred care to squad personel.
Age: 50.0
Sex: M
Vaccine: PNC13
Symptoms: Coronary artery disease, Hodgkin's disease
Clinical narrative: cancer (Hodgkins); CAD; This is a spontaneous report received from an Other HCP from medical information team.  An adult male patient received pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein) (PREVNAR 13), in 2018 as dose number unknown, single (Batch/Lot number: unknown) at the age of 50 years for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HODGKIN'S DISEASE (medically significant), outcome "recovered", described as "cancer (Hodgkins)"; CORONARY ARTERY DISEASE (non-serious), outcome "unknown", described as "CAD". The reporter inquired if the patient would be eligible to receive Prevnar 20 even though he no longer had cancer.  The information on the batch/lot number for valent conjugate vaccine (diphtheria CRM197 protein) will be requested and submitted if and when received.; Sender's Comments: There is not a reasonable possibility that the reported event was related to the suspect product event most likely due to patient underlying contributory factors.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Urticaria
Clinical narrative: Hives/rash of b/l UEs, torso, and b/l thighs beginning day after vaccination. Mild improvement with oral and topical Benadryl. Provided additional treatment with medial dose pack.
Age: 19.0
Sex: F
Vaccine: HEP
Symptoms: Vaccination site discomfort, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: Redness to the vaccine site that is warm to touch and measures 1 in X 1 in. Employee states to feel itching to area as well as slight discomfort. Employee noticed redness and itching 2 days after vaccination that has been ongoing till today.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Redness, swelling at injection site, tightness and pain at site until base of neck on the left side, & a lot of heat while touching it and while holding hand away (radiating heat). Patient reports no trouble breathing and no other issues. She is managing symptoms with OTC benadryl and zyrtec.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Neck pain
Clinical narrative: Redness, swelling at injection site, tightness and pain at site until base of neck on the left side, & a lot of heat while touching it and while holding hand away (radiating heat). Patient reports no trouble breathing and no other issues. She is managing symptoms with OTC benadryl and zyrtec.
Age: 11.0
Sex: M
Vaccine: DTAP, MNQ
Symptoms: Syncope
Clinical narrative: Vasovagal syncope within 5 minutes of shot
Age: 1.67
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Single component of a two-component product administered
Clinical narrative: Vaccine is two vial vaccine that requires the solution provided be mixed with the power vial. Patient given only the mixing solution.  Vaccine incident found when counting inventory. Client's mother updated. Plan to revaccinate client.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Dry mouth, Dysphagia, Loss of personal independence in daily activities, Seborrhoea
Clinical narrative: She got her vaccine, 2 weeks later she started getting oozing from her skin, very slick, oily, and she believes it's from the glands under the skin.  It feels like tiny marbles under her skin and when she presses on them the stuff oozes out.  She has gone to her doctor for this, and they do not know what this is.  She has been to a dermatologist, her PCP and her rheumatologist and again they do not know what it is.  She has been given lotions, but they did not work.  I had the boosters also and they continue with each vaccine and has gotten worse.  It is on the side of her face, on her shoulders, back, arms, my whole chest, now my stomach to my thighs.  She also has very dry mouth and it's hard to talk or swallow due to it.  She had no skin issues prior to the vaccines.  She also did not have any problems with the mouth dryness prior to the vaccines.  The skin feels sticky with the stuff coming out of her pores.  She cannot hold onto paper very well as her hands feel wet all the time.  Other people feel her skin and they do not feel the oiliness or wetness.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Sensory disturbance, Skin mass, Skin weeping, Speech disorder, Sticky skin
Clinical narrative: She got her vaccine, 2 weeks later she started getting oozing from her skin, very slick, oily, and she believes it's from the glands under the skin.  It feels like tiny marbles under her skin and when she presses on them the stuff oozes out.  She has gone to her doctor for this, and they do not know what this is.  She has been to a dermatologist, her PCP and her rheumatologist and again they do not know what it is.  She has been given lotions, but they did not work.  I had the boosters also and they continue with each vaccine and has gotten worse.  It is on the side of her face, on her shoulders, back, arms, my whole chest, now my stomach to my thighs.  She also has very dry mouth and it's hard to talk or swallow due to it.  She had no skin issues prior to the vaccines.  She also did not have any problems with the mouth dryness prior to the vaccines.  The skin feels sticky with the stuff coming out of her pores.  She cannot hold onto paper very well as her hands feel wet all the time.  Other people feel her skin and they do not feel the oiliness or wetness.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic product ineffective
Clinical narrative: She got her vaccine, 2 weeks later she started getting oozing from her skin, very slick, oily, and she believes it's from the glands under the skin.  It feels like tiny marbles under her skin and when she presses on them the stuff oozes out.  She has gone to her doctor for this, and they do not know what this is.  She has been to a dermatologist, her PCP and her rheumatologist and again they do not know what it is.  She has been given lotions, but they did not work.  I had the boosters also and they continue with each vaccine and has gotten worse.  It is on the side of her face, on her shoulders, back, arms, my whole chest, now my stomach to my thighs.  She also has very dry mouth and it's hard to talk or swallow due to it.  She had no skin issues prior to the vaccines.  She also did not have any problems with the mouth dryness prior to the vaccines.  The skin feels sticky with the stuff coming out of her pores.  She cannot hold onto paper very well as her hands feel wet all the time.  Other people feel her skin and they do not feel the oiliness or wetness.
Age: 56.0
Sex: M
Vaccine: HPV9
Symptoms: Insurance issue, Product administered to patient of inappropriate age
Clinical narrative: 56 year old patient presented to clinic for routine visit. Patient stated interest in HPV vaccine. Nurse educated patient about risk factors for HPV transmission. Nurse educated patient about HPV vaccine. Patient consented to getting the HPV vaccine. Nurse dispensed HPV vaccine. Nurse administered HPV vaccine to patient's right deltoid.  Patient tolerated IM injection well. Patient informed the HPV vaccine, when started at his age, is a 3-dose series.  Patient advised to return to clinic for the following doses. Patient left nurses exam room. Nurse received email on 5/21/2024, regarding vaccine unable to be billed out due to patient's age exceeding the recommended age range set by the CDC, 26-45 years old.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Computerised tomogram, Dizziness, Electroencephalogram, Headache
Clinical narrative: About 5 days later had real bad burning of my skin and bad headache, dizziness. A few months later seen doctor about the dizzy spells and tests were performed heart tests came back diagnosed as SVT. Placed on heart medicine to control the SVT
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Skin burning sensation, Supraventricular tachycardia
Clinical narrative: About 5 days later had real bad burning of my skin and bad headache, dizziness. A few months later seen doctor about the dizzy spells and tests were performed heart tests came back diagnosed as SVT. Placed on heart medicine to control the SVT
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Blindness, Computerised tomogram, Decreased appetite, Diplopia, Disability
Clinical narrative: He got his vaccine, and after the person gave him the shot she said that she should not have given it to him since it had only been 2 months since his last one, and he should have waited 4 more months to get the other one.  She did not look at his shot record to begin with.  He was visiting his sister-in-law, his brother was not doing good as well as his sister, he went to visit him in the hospital and was driving on 10/3/23 and went to get some sample pens of Insulin.  On his way back he stopped over at store and got some groceries and he pulled into a gas station, got gas and within 4-5 miles there was a construction zone and was talking on the phone, his vision went out and was within inches of a barrier and swerved and hit the barrier anyway and messed his car up.  He has been dealing with his eyes and stuff and they bug him really bad as he cannot see out of his left eye as it is real blurry and also sees double up to 4 different things at one time.  His eye is messed up since the accident.  He has gone to doctors for his condition and he has no appetite for any food other than fruits.  He cannot eat pizza as it does not taste right.  He went to a urologist a week ago and he says that his condition is related to COVID.  He is going to see an Ophthalmologist on 6/12/24 by bus.  He has been seeing Dr. for his eyes at store vision and he says that he would not think about going to work again.  He is on a medical leave for disability and he told him that he would back him 100%.    He had his eyes dilated, pictures of his eyes and was told that he has been doing this for 13 years and he has never seen anything like this.   His left eye points in one direction, but his right eye is OK.   He wears sunglasses when he goes out because he does not want to be seen the way that he looks.  Says it ain't pretty.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Eye movement disorder, Imaging procedure abnormal, Impaired work ability, Inappropriate schedule of product administration, Laboratory test
Clinical narrative: He got his vaccine, and after the person gave him the shot she said that she should not have given it to him since it had only been 2 months since his last one, and he should have waited 4 more months to get the other one.  She did not look at his shot record to begin with.  He was visiting his sister-in-law, his brother was not doing good as well as his sister, he went to visit him in the hospital and was driving on 10/3/23 and went to get some sample pens of Insulin.  On his way back he stopped over at store and got some groceries and he pulled into a gas station, got gas and within 4-5 miles there was a construction zone and was talking on the phone, his vision went out and was within inches of a barrier and swerved and hit the barrier anyway and messed his car up.  He has been dealing with his eyes and stuff and they bug him really bad as he cannot see out of his left eye as it is real blurry and also sees double up to 4 different things at one time.  His eye is messed up since the accident.  He has gone to doctors for his condition and he has no appetite for any food other than fruits.  He cannot eat pizza as it does not taste right.  He went to a urologist a week ago and he says that his condition is related to COVID.  He is going to see an Ophthalmologist on 6/12/24 by bus.  He has been seeing Dr. for his eyes at store vision and he says that he would not think about going to work again.  He is on a medical leave for disability and he told him that he would back him 100%.    He had his eyes dilated, pictures of his eyes and was told that he has been doing this for 13 years and he has never seen anything like this.   His left eye points in one direction, but his right eye is OK.   He wears sunglasses when he goes out because he does not want to be seen the way that he looks.  Says it ain't pretty.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Magnetic resonance imaging head, Pupil dilation procedure, Road traffic accident, Taste disorder, Vision blurred
Clinical narrative: He got his vaccine, and after the person gave him the shot she said that she should not have given it to him since it had only been 2 months since his last one, and he should have waited 4 more months to get the other one.  She did not look at his shot record to begin with.  He was visiting his sister-in-law, his brother was not doing good as well as his sister, he went to visit him in the hospital and was driving on 10/3/23 and went to get some sample pens of Insulin.  On his way back he stopped over at store and got some groceries and he pulled into a gas station, got gas and within 4-5 miles there was a construction zone and was talking on the phone, his vision went out and was within inches of a barrier and swerved and hit the barrier anyway and messed his car up.  He has been dealing with his eyes and stuff and they bug him really bad as he cannot see out of his left eye as it is real blurry and also sees double up to 4 different things at one time.  His eye is messed up since the accident.  He has gone to doctors for his condition and he has no appetite for any food other than fruits.  He cannot eat pizza as it does not taste right.  He went to a urologist a week ago and he says that his condition is related to COVID.  He is going to see an Ophthalmologist on 6/12/24 by bus.  He has been seeing Dr. for his eyes at store vision and he says that he would not think about going to work again.  He is on a medical leave for disability and he told him that he would back him 100%.    He had his eyes dilated, pictures of his eyes and was told that he has been doing this for 13 years and he has never seen anything like this.   His left eye points in one direction, but his right eye is OK.   He wears sunglasses when he goes out because he does not want to be seen the way that he looks.  Says it ain't pretty.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: X-ray
Clinical narrative: He got his vaccine, and after the person gave him the shot she said that she should not have given it to him since it had only been 2 months since his last one, and he should have waited 4 more months to get the other one.  She did not look at his shot record to begin with.  He was visiting his sister-in-law, his brother was not doing good as well as his sister, he went to visit him in the hospital and was driving on 10/3/23 and went to get some sample pens of Insulin.  On his way back he stopped over at store and got some groceries and he pulled into a gas station, got gas and within 4-5 miles there was a construction zone and was talking on the phone, his vision went out and was within inches of a barrier and swerved and hit the barrier anyway and messed his car up.  He has been dealing with his eyes and stuff and they bug him really bad as he cannot see out of his left eye as it is real blurry and also sees double up to 4 different things at one time.  His eye is messed up since the accident.  He has gone to doctors for his condition and he has no appetite for any food other than fruits.  He cannot eat pizza as it does not taste right.  He went to a urologist a week ago and he says that his condition is related to COVID.  He is going to see an Ophthalmologist on 6/12/24 by bus.  He has been seeing Dr. for his eyes at store vision and he says that he would not think about going to work again.  He is on a medical leave for disability and he told him that he would back him 100%.    He had his eyes dilated, pictures of his eyes and was told that he has been doing this for 13 years and he has never seen anything like this.   His left eye points in one direction, but his right eye is OK.   He wears sunglasses when he goes out because he does not want to be seen the way that he looks.  Says it ain't pretty.
Age: 1.25
Sex: M
Vaccine: DTAPIPV
Symptoms: Incorrect dose administered, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient was given the incorrect vaccine dosage. Patient was due for " catch up" vaccine of Dtap-IPV and patient was given combination vaccine for the 4-6 yr old range. This is outside of the recommended age range
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse reaction, I am reporting that this vaccine was expirer when administer to the patient. It was expirer 05/19/2024
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Drug Ineffective; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 64-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Marginal diabetes" (unspecified if ongoing), notes: all managed with medications and c-pap; "acid reflux" (unspecified if ongoing), notes: all managed with medications and c-pap; "sleep apnea" (unspecified if ongoing), notes: all managed with medications and c-pap; "high cholesterol" (unspecified if ongoing), notes: all managed with medications and c-pap. The patient had no known allergies. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 3, (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 4, (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: COVID-19 (medically significant) with onset May2024, outcome "unknown"; DRUG INEFFECTIVE (medically significant) with onset May2024, outcome "unknown". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 21May2024 to 26May2024.
Age: 34.0
Sex: M
Vaccine: COVID19, HEP
Symptoms: Chills, Pain, Pyrexia, Vomiting
Clinical narrative: Spoke with client by phone 5/31/24. Client reports symptoms began 4/02/24 at 6 PM. Symptoms included body aches, chills, fever, and vomiting. Friend drove client to local hospital 4/02/24 at 10 PM. Client reports he was in the hospital for 2 nights. Received IV fluids and antiemetics.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse reaction, I am reporting that this vaccine was expirer when administer to the patient. It was expirer 05/19/2024, no adverse reaction noted.
Age: 71.0
Sex: M
Vaccine: COVID19, PNC20
Symptoms: Injection site erythema
Clinical narrative: PINK REDNESS INJECTION SITE REACTION-
Age: 61.0
Sex: F
Vaccine: COVID19-2
Symptoms: Unevaluable event
Clinical narrative: none
Age: 39.0
Sex: F
Vaccine: COVID19-2
Symptoms: Unevaluable event
Clinical narrative: NONE
Age: 76.0
Sex: M
Vaccine: RSV
Symptoms: Arthralgia, Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain, X-ray limb
Clinical narrative: Pain left shoulder immediately upon administration; pain ever since.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site cellulitis, Injection site erythema
Clinical narrative: Patient returns to pharmacy approximately 3 days after administration of the second dose of her Shingrix vaccine. She shows her left arm which has a visible red patch (approximately 1.5 x 2.5 inches in size), just below the deltoid, slightly below where the vaccine was administered. Patient states she was diagnosed with cellulitis. Doxycycline hyclate filled per order from NP.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Swelling, Vomiting
Clinical narrative: Swollen left side, vomiting, diarhea
Age: 56.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injected limb mobility decreased, Injection site pain, Pain
Clinical narrative: I have extreme pain in my left shoulder when using arm such as lifting, throwing, putting on and taking off my coat or shirt, simply closing a car door, cannot move my arm backwards at all.
Age: 56.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Impaired work ability, Injected limb mobility decreased, Pain, Pain in extremity
Clinical narrative: I have extreme pain in my left shoulder when using arm such as lifting, throwing, putting on and taking off my coat or shirt, simply closing a car door, cannot move my arm backwards at all.
Age: 56.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Paraesthesia
Clinical narrative: I have extreme pain in my left shoulder when using arm such as lifting, throwing, putting on and taking off my coat or shirt, simply closing a car door, cannot move my arm backwards at all.
Age: 11.0
Sex: F
Vaccine: UNK, UNK, UNK
Symptoms: Pallor, Syncope
Clinical narrative: After 3rd injection (HPV) was given. Child turned pale in face, Syncope episode occurred with possible myoclonic seizure. Child laid on exam table with legs elevated. Child awoke a minute later. Child instructed to lay down with continued leg elevation for five minutes, child told to sit up for another 5 minutes and monitored another 10 minutes before leaving clinic .
Age: 64.0
Sex: F
Vaccine: RSV
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: PAIN IN ARM, CAN'T PICK HER ARM UPWARDS. TOOK TYLENOL AND USED ICE PACK AS DIRECTED
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, SARS-CoV-2 test
Clinical narrative: I just feel bad. I just really bad; This is a spontaneous report received from a Consumer or other non HCP.  A 75-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 27Sep2023 as dose 1, single (Lot number: WG4628) at the age of 75 years for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Vaccination history included: Covid-19 vaccine (PRIMARY IMMUNIZATION SERIES COMPLETE; UNKNOWN MANUFACTURER), for COVID-19 immunization; Covid-19 vaccine (DOSE NUMBER UNKNOWN (BOOSTER) , SINGLE), for COVID-19 immunization. The following information was reported: FEELING ABNORMAL (non-serious), outcome "unknown", described as "I just feel bad. I just really bad". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of feeling abnormal.  Additional information: Patient went yesterday (as reported) because her husband had been in a skill facility, and he came home, and he got to acting strange (Further not clarified). So, she got the nurse, the ambulance to pick him up and he had covid and just that you know her being around here waiting on him. Patient decided to take the Covid test. She went yesterday and her doctor called her a little while ago and said that she has sent some medicine to the pharmacy for her but the pharmacist called her back and said that they couldn't sell because patient insurance wouldn't pay for it. Patient have Medicare and they wouldn't pay for it. So, she told her to call this number. Name of medication patient stated, "Pfizer, she took all the shots and the booster shots and everything. When confirm if need the medication Consumer stated, Yes, she need medication, she said. Patient stated she just feel bad just really bad. Prescribing Healthcare Professional: Name of the doctor: Consumer stated, "Her name is REDACTED, she is new in the office of REDACTED which is patient primary doctor but he wasn't there. So, patient saw her. Patient sated current took every shot every booster shot, everything. She have her card here. Regarding expiration date, NDC# and UPC#: Consumer stated, "It has two date on which she took it. The last one she took was a booster shot and believe it was 27Sep2023. Other medical conditions and concomitant medication Consumer stated, "Yes, taking other medications. Regarding Lab test consumer stated, "Yes, she went yesterday to get a covid shot, mean test because her husband (Incomplete). (Lab details were not available over the call). Treatment: Consumer stated, "No.". Consumer stated, she was just trying to keep herself from catching covid. That's why she took all the shots booster shots.
Age: 17.0
Sex: F
Vaccine: RAB, TBE, TDAP, TYP
Symptoms: Dizziness, Hyperhidrosis, Immediate post-injection reaction, Syncope
Clinical narrative: Client received Tdap and Pre-exp Rabies #1 injections to right arm. She immediately became diaphoretic, lightheaded and had syncopal episode. Client was placed in supine position with legs elevated, ice pack was placed to back of neck, airway maintained. Syncopal episode lasted approximately 5 minutes and she completely recovered after approximately 15 minutes. Client/parent opted to continue with Typhoid and TBE vaccines with no further adverse reactions/events.
Age: 28.0
Sex: F
Vaccine: HEP
Symptoms: Injection site swelling
Clinical narrative: Swelling in right deltoid
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: COVID-19; COVID-19; Interchange of vaccine products; This is a spontaneous report received from a Consumer or other non HCP.  A 58-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Jun2023 as dose number unknown, single (Lot number: GJ6743) at the age of 57 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), in Oct2023 as dose number unknown, single (Lot number: R058081), in right arm for covid-19 immunisation. The patient's relevant medical history included: "diabetes" (unspecified if ongoing); "asthma" (unspecified if ongoing); "obesity" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset Oct2023, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2024, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 21May2024 to 25May2024.