chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Autoimmune disorder, Sjogren's syndrome
Clinical narrative: Sjogrens disease; autoimmune response; This is a spontaneous report received from a Consumer or other non HCP.  A 28-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Anxiety" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: BNT162b2 (Dose 1, single, lot number: 1894792, Facility type vaccine: Hospital), administration date: 17Dec2020, when the patient was 27-year-old, for Covid-19 immunisation; Bnt162b2 (Dose 2, single), for Covid-19 immunisation. The patient had no known allergy. The patient did not had other vaccine same date. No other vaccine in four weeks; No other medications in two weeks. The following information was reported: SJOGREN'S SYNDROME (medically significant) with onset 10Oct2022, outcome "not recovered", described as "Sjogrens disease"; AUTOIMMUNE DISORDER (medically significant) with onset 10Oct2022, outcome "not recovered", described as "autoimmune response". Clinical course: Developed Sjogrens disease after getting two doses of Covid shot and booster. No family history of autoimmune disease and no symptoms prior to Covid shot. The patient was wondering with new info that Covid vaccine can cause autoimmune response if she developed Sjogrens due to Covid vaccine. The patient was on chronic medications for autoimmune disease.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Sex: U
Vaccine: FLUX
Symptoms: Respiratory tract infection
Clinical narrative: influenza vaccine causes respiratory infections; Initial information received on 04-Feb-2025 regarding an unsolicited valid social media non-serious case received from a patient.  This case involves an unknown age / gender patient who experienced respiratory infections after receiving influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received an unknown dose of influenza vaccine produced by unknown manufacturer (formulation, strength, expiry date and lot number not reported) via unknown route in unknown administration site as prophylactic vaccination (Immunization).   Information on the batch number was requested corresponding to the one at time of event occurrence.   On an unknown date the patient developed respiratory infections (respiratory tract infection) (unknown latency) following the administration of influenza vaccine.  Action taken with was not applicable.  It was not reported if the patient received a corrective treatment for the event.   At time of reporting, the outcome was Unknown for the event.
Age: 1.33
Sex: F
Vaccine: HIBV
Symptoms: No adverse event, Product preparation error
Clinical narrative: act-hib was reconstituted with a different diluent, only one of the vials was given with no reported adverse event; Initial information received on 04-Feb-2025 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 16 months old female patient who received haemophilus type B (HIB) vaccine [ACT-HIB] was reconstituted with a different diluent, only one of the vials was given with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included pneumococcal vaccine CONJ 20V (CRM197) (PREVNAR 20) for Immunisation; and Diphtheria vaccine toxoid, Pertussis vaccine acellular 3-component, Tetanus vaccine toxoid (Infanrix) for Immunisation.  On 31-Jan-2025, the patient received 0.5 ml of HIB (PRP/T) vaccine Powder and solvent for solution for injection with standard strength (expiry date- 30-SEP-2025 and lot UK107AB) once via intramuscular route in the right vastus lateralis as Immunization was reconstituted with a different diluent, only one of the vials was given with no reported adverse event (product preparation error) (latency- same day).   Reportedly, they want to know if the vaccine was still valid or should the patient be revaccinated. Only the lyophilized vaccine was given.   Action taken was not applicable.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: HEP
Symptoms: Incomplete course of vaccination, No adverse event
Clinical narrative: Heplisav-B Given After Starting A Three Dose Hep-B Series; Incomplete Course of Vaccination; Initial report received on 28-Jan-2025.  A pharmacist reported that a female (age and race not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization after starting a three dose hepatitis B series.  The patient has not received the second dose as of date of report.  No medical history or concomitant medications were reported.  On an unknown date, the patient received an unknown dose of a three-dose hepatitis B vaccine (brand name and lot number not provided).  In Oct-2024, after receiving a dose of an unknown three-dose hepatitis B vaccine, the patient received a dose of a hepatitis B vaccine HEPLISAV-B (lot number, expiration date, NDC number, route, and site not available). At the time of report, the patient has not received the second dose or HEPLISAV-B yet.  No adverse reactions were reported.  The reporter declined to provide further information.  Company Comment: The company assessed the events as non-serious.; Sender's Comments: The company assessed the events as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Received The 2nd Dose on Day 27; Initial report received on 30-Jan-2025.    A nurse reported that a patient (age, gender, race, ethnicity not reported) received the second dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization early.   No medical history or concomitant medications were reported.     On an unknown date, the patient received dose 1 of a hepatitis B vaccine [HEPLISAV-B (lot #, expiration date, route, and site not available)].   On an unknown date, 27 days after having been vaccinated with the first dose of HEPLISAV-B, the patient received the second dose of HEPLISAV-B (lot #, expiration date, route, and site not available).   No other information was available.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: accidentally received the adult formulation of Havrix; accidentally received the adult formulation of Havrix; This non-serious case was reported by a nurse via call center representative and described the occurrence of adult product administered to child in a 2-year-old male patient who received HAV (Havrix 1440 adult) (batch number T9TL9, expiry date 05-DEC-2025) for prophylaxis.   On 03-FEB-2025, the patient received the 1st dose of Havrix 1440 adult. On 03-FEB-2025, an unknown time after receiving Havrix 1440 adult, the patient experienced adult product administered to child (Verbatim: accidentally received the adult formulation of Havrix) and accidental overdose (Verbatim: accidentally received the adult formulation of Havrix). The outcome of the adult product administered to child and accidental overdose were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 03-FEB-2025 Nurse reported that one of their patients who is 2 years old accidentally received the adult formulation of Havrix, which led to adult product administered to child and accidental overdose.
Sex: M
Vaccine: COVID19
Symptoms: Loss of personal independence in daily activities, Musculoskeletal disorder, Pain in extremity
Clinical narrative: pain in his arm; unable to move his arm; had hard time washing his hands, washing his body; This is a spontaneous report received from a Consumer or other non HCP, Program ID:.  A male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "not recovered", described as "pain in his arm"; MUSCULOSKELETAL DISORDER (non-serious), outcome "not recovered", described as "unable to move his arm"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious), outcome "not recovered", described as "had hard time washing his hands, washing his body".  Additional information: When clarified if the issue occurred after taking vaccine, transferring agent stated patient mentioned that when he was injected with the Pfizer vaccine, he was unable to move his arm and he was also asking if that's normal but his main concern here was, he was experiencing what he experienced after getting the Pfizer Covid-19 vaccine. Consumer stated with this shot he had a pain in his arm, it began 2-3 years, patient still had it. Consumer stated he had to try somebody come on and help him around the house because he couldn't move his arm okay at the time of reporting. He had hard time washing his hands, washing his body.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: when I took the vaccine, it is very hard for me to perform; This is a spontaneous report received from a Consumer or other non HCP.  A 26-year-old patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FEELING ABNORMAL (non-serious), outcome "unknown", described as "when I took the vaccine, it is very hard for me to perform". Additional information:   Consumer stated, "I want to see if, I have been taking the vaccine and from then somewhere I took it, it is very hard for me to perform. From when I took the vaccine, it is very hard for me to perform."  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Cyst
Clinical narrative: Well the cyst is back; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 55-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "surgery" (unspecified if ongoing), notes: back in 90's/right when I was out of high school; "I had a cyst on my ovaries" (unspecified if ongoing); "I had a cyst", start date: 1990 (unspecified if ongoing), notes: back in the 1990s when I was 20 I had it taken out. The patient's concomitant medications were not reported.  The following information was reported: CYST (non-serious), outcome "unknown", described as "Well the cyst is back".  Additional information: The patient called to obtain a copy of their records. Patient stated, "I had surgery back in the 90s. I had a cyst on my ovaries, and the doctor retired. I know I was in the hospital for a little bit." Well, the cyst was back. So I was trying to get my medical records and find out what I took that made it better. I knew I had gotten the COVID vaccine too. I had surgery right when I was out of high school." The agent asked what the name of the medication was, and patient stated, I didn't know who made the Triphase product, but one of them was, of course, Depo." Patient stated again, "I had a cyst back in the 1990s when I was 20; I had it taken out, and it didn't really bother me because the doctor said dont worry about it. Well, now it's back well, something was back. So I was trying to figure out what it was that I took or what they gave me or what they found... Now I had it again, and I was wondering if they actually gave me something for the cyst or if it wasn't for the cyst. I had always had cysts on my ovaries when I was a teenager, so they put me on Triphase to try to control them, like follicular cysts. I got nausea from that when I was younger, and they said Depo Provera because I didn't have to take it every day. I didn't know if, after the surgery, that's what kept them from coming back or even what type of cyst it was. I could not find them, so I was trying to find out what I took.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: I got vaccinated for the last COVID shot in October/for Paxlovid/super sick; I got vaccinated for the last COVID shot in October/for Paxlovid/super sick; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 52-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in Oct2024 as dose 1, single (Batch/Lot number: unknown) at the age of 51 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "I got vaccinated for the last COVID shot in October/for Paxlovid/super sick". Clinical courses is as follows: During an inbound call for financial assistance, the patient stated, "I actually just called the pharmacists, and they gave me the number for assistance regarding the COVID medicine." The reason for the call was clarified. As the patient's demographics were gathered, the patient stated, "Bear with me because I'm super sick." While expectations of the call's timeframe were stated, the caller later said, "Okay, take your time as long as I can get assistance with this medication because I really need it." When the caller is told that they could use the program's assistance in the future again only for Paxlovid, the caller stated, "Okay, well, hopefully I don't have to do this again because this is the third time in five years. With vaccines, I'm actually vaccinated; I got vaccinated for the last COVID shot in October. So, I don't know, I haven't had luck with that."  The information on the batch/lot number for [BNT162B2 OMICRON (KP.2)] will be requested and submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Postural orthostatic tachycardia syndrome
Clinical narrative: diagnosed with pots; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME (non-serious), outcome "unknown", described as "diagnosed with pots".  Additional information: Patient reported, was recently diagnosed with pots and they were contributing other symptoms that patient was having to the shot but patient was told by someone.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Sex: U
Vaccine: PNC20
Symptoms: Malaise
Clinical narrative: very sick for a long time; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): 02742018 (Merck).  A patient (age and gender not provided) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "very sick for a long time".  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 36.0
Sex: M
Vaccine: COVID19, TDAP
Symptoms: Blood glucose decreased, Dizziness, Unresponsive to stimuli
Clinical narrative: Pt. had some dizziness and informed us of that. Pt was observed for 15-20 minutes. He was out for 10-15 seconds and not responsive. Might have had a seizure but came out of it and responded. He was cold to touch and had pulse at that moment. We called EMS and paramedics checked him out and his blood sugar was low. Pt will do follow up at hospital.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Chest discomfort, Dyspnoea, Immediate post-injection reaction, Productive cough
Clinical narrative: Right arm immediately began to burn, down my arm, into my hand, back up my arm, into my neck, then my lungs felt like they were filling with fluid. I had a difficult time breathing and began to cough up sputum. I had to sit in tripod position to catch a breath. The pharmacist offered an ambulance and benadryl.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Dermatitis acneiform, Nasopharyngitis, Pyrexia, Rash, Rash pruritic
Clinical narrative: 1/24/25, in the evening began experiencing an itchy rash in his armpit area, described by his mother as raised,  red "pimple-like" and in groups rather than what she would consider to be hives.  Sore when popped due to itching.  Believing it it be a new brand of deodorant, they washed his clothes and switched back to his usual deodorant but it  the rash remained.  Rash remained, on 1/27- he experienced fever and "head cold type symptoms" . Rash spread to groin area, not genitals on 2/2/25 and 2/6/25 spread covering abdomen, starting to spread to back and some on upper arms. Has been using corticosteroid cream to treat. no other medications.
Age: 73.0
Sex: M
Vaccine: RSV
Symptoms: Injection site erythema
Clinical narrative: Redness at injection site approximately 2 inches in diameter, no treatment warranted at this time
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: Redness, itching, soreness, warm to touch around injection site/arm area 4 days after vaccine.
Age: 10.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: A pediatric patient was due for Covid and Flu vaccines. Parent signed consent forms for both vaccines. The primary care clinic only had inventory for Covid 12+ vaccines. MA administered vaccine and allowed patient to rest in the room for 10 minutes in order to observe any adverse side effects. After patient had left. the MA noticed that the patient was 10 years old, and the incorrect vaccination had been administered. The MA notified the provider as soon as possible and reported the incident to clinic supervisors.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Gave a second dose of MenACWY-TT while patient already had received previous dose that day, giving two doses within one day. No reactions presented.
Age: 51.0
Sex: F
Vaccine: FLU3, HEPAB, PNC21, VARZOS
Symptoms: Dizziness, Feeling hot
Clinical narrative: Patient has a history of anxiety, after the last vaccine she felt faint and got overheated. I advised her to sit for awhile and we gave her some water. She requested some ibuprofen and started feeling better.
Age: 39.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site inflammation, Injection site warmth, Pain, Pain in extremity
Clinical narrative: baseball size erythema on left deltoid with a quarter size darker red/purple spot closer to injection site. along with redness is inflammation, skin is hot to the touch, and arm pain/tenderness/soreness
Age: 39.0
Sex: F
Vaccine: PNC20
Symptoms: Tenderness
Clinical narrative: baseball size erythema on left deltoid with a quarter size darker red/purple spot closer to injection site. along with redness is inflammation, skin is hot to the touch, and arm pain/tenderness/soreness
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Malaise, Mental impairment, Myalgia
Clinical narrative: Fever up to 102F, general malaise, muscle and joint aches, nausea, exhaustion, decrease in mental acuity
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: Fever up to 102F, general malaise, muscle and joint aches, nausea, exhaustion, decrease in mental acuity
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: C-reactive protein increased, Catheterisation cardiac normal, Chest pain, Dyspnoea, Echocardiogram abnormal
Clinical narrative: Adverse event: pericarditis  Presented to ER with chest pain, radiating to neck, shortness of breath, EKG showed ST elevation, so STEMI activated for . Cath: normal coronaries. Felt sx-: pleuritic chest pain, mild leukocytosis, CRP 19.3, felt indicative of acute pericarditis , Echo: ?  Left Ventricle: Mild concentric hypertrophy present. Normal systolic function with an estimated EF of 60 - 65%. ?  Right Ventricle: Right ventricle size is normal. Normal systolic function. ?  Normal valve function.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Ejection fraction normal, Electrocardiogram ST segment elevation, Left ventricular hypertrophy, Leukocytosis, Neck pain
Clinical narrative: Adverse event: pericarditis  Presented to ER with chest pain, radiating to neck, shortness of breath, EKG showed ST elevation, so STEMI activated for . Cath: normal coronaries. Felt sx-: pleuritic chest pain, mild leukocytosis, CRP 19.3, felt indicative of acute pericarditis , Echo: ?  Left Ventricle: Mild concentric hypertrophy present. Normal systolic function with an estimated EF of 60 - 65%. ?  Right Ventricle: Right ventricle size is normal. Normal systolic function. ?  Normal valve function.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Pericarditis, Pleuritic pain
Clinical narrative: Adverse event: pericarditis  Presented to ER with chest pain, radiating to neck, shortness of breath, EKG showed ST elevation, so STEMI activated for . Cath: normal coronaries. Felt sx-: pleuritic chest pain, mild leukocytosis, CRP 19.3, felt indicative of acute pericarditis , Echo: ?  Left Ventricle: Mild concentric hypertrophy present. Normal systolic function with an estimated EF of 60 - 65%. ?  Right Ventricle: Right ventricle size is normal. Normal systolic function. ?  Normal valve function.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Blindness, Impaired work ability, Malaise, Nausea
Clinical narrative: Loss of sight in both eyes resulting in loss of job like stroke after 3 day illness  stomach crampy & naucea (active convulsive) spike protein triggered acid immune response meds hyper sensitive w/ response
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Neurological symptom
Clinical narrative: Loss of sight in both eyes resulting in loss of job like stroke after 3 day illness  stomach crampy & naucea (active convulsive) spike protein triggered acid immune response meds hyper sensitive w/ response
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Feeling cold, Gait disturbance, Hypoaesthesia, Pain in extremity
Clinical narrative: I have swelling in my legs & my arms when I lay down. I feel real cold. I feel achey in my heel the right heel. My shoulders are still hurting. I feel numb in my right leg can't walk to good.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Peripheral swelling
Clinical narrative: I have swelling in my legs & my arms when I lay down. I feel real cold. I feel achey in my heel the right heel. My shoulders are still hurting. I feel numb in my right leg can't walk to good.
Age: 81.0
Sex: F
Vaccine: HEPAB
Symptoms: Extra dose administered
Clinical narrative: PATIENT RECEIVED TWINRIX ON 07/17/2024 WITHOUT KNOWING THAT PT HAD ALREADY RECEIVED 3 DOSES OF HEP B VACCINE BACK IN 2020/2021
Age: 60.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Impaired work ability, Injected limb mobility decreased, Injection site pain, Myalgia
Clinical narrative: Per pt, arm is still very sore 1 month after vaccination.
Age: 60.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Pain in extremity
Clinical narrative: Per pt, arm is still very sore 1 month after vaccination.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Biopsy skin abnormal, Rash, Rash pruritic, Urticaria
Clinical narrative: Two weeks later develop a widespread severe rash/hives on my legs and moved up to my lower back, hips,neck and continuing through out my body I was put on prednisone 3 times. It was extremely itchy.  The rash/hives would not stop. The rash/hives lasted 45 days.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash, Urticaria
Clinical narrative: Two weeks later develop a widespread severe rash/hives on my legs and moved up to my lower back, hips,neck and continuing through out my body I was put on prednisone 3 times. It was extremely itchy.  The rash/hives would not stop. The rash/hives lasted 45 days.
Age: 78.0
Sex: M
Vaccine: RSV, RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received 2 doses of Arexvy vaccination. Reported no adverse side effects.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Burning sensation, Hypoaesthesia, Lymphadenopathy, Mammogram normal, Metabolic function test
Clinical narrative: Patient experienced soreness in arm within hours. The following morning upon waking up, left axillary lymph nodes were swollen and patient was experiencing neuropathy and paresthesia in left arm. The lymph nodes were swollen for a few days. Over the next few weeks, neuropathy in the left arm persisted, radiating down the entire arm. The arm would burn, tingle, and sometimes go completely numb. After 2 months, the neuropathy reduced slightly, localizing to upper inner arm and armpit area where it still occurs. In Jan 2025, patient made appointment and was seen by plastic surgeon who performed breast augmentation in 2014 to have implants checked to rule out issues were being caused by implants. Plastic surgeon cleared patient and felt issues were caused by flu shot. Patient had PCP examine area, do lab work, and underwent an axillary ultrasound and mammogram in attempt to diagnosis/identify cause in Jan 2025. Results of tests did not reveal any anatomical abnormalities or identifiable cause.  As of Feb 2025, neuropathy and paresthesia persist.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Neuropathy peripheral, Pain in extremity, Paraesthesia, Ultrasound lymph nodes
Clinical narrative: Patient experienced soreness in arm within hours. The following morning upon waking up, left axillary lymph nodes were swollen and patient was experiencing neuropathy and paresthesia in left arm. The lymph nodes were swollen for a few days. Over the next few weeks, neuropathy in the left arm persisted, radiating down the entire arm. The arm would burn, tingle, and sometimes go completely numb. After 2 months, the neuropathy reduced slightly, localizing to upper inner arm and armpit area where it still occurs. In Jan 2025, patient made appointment and was seen by plastic surgeon who performed breast augmentation in 2014 to have implants checked to rule out issues were being caused by implants. Plastic surgeon cleared patient and felt issues were caused by flu shot. Patient had PCP examine area, do lab work, and underwent an axillary ultrasound and mammogram in attempt to diagnosis/identify cause in Jan 2025. Results of tests did not reveal any anatomical abnormalities or identifiable cause.  As of Feb 2025, neuropathy and paresthesia persist.
Age: 44.0
Sex: F
Vaccine: HEPA, TYP
Symptoms: Dehydration, Depressed level of consciousness, Dizziness, Loss of consciousness, Muscle tightness
Clinical narrative: Patient with syncopal episode after second vaccine given around 9:25 am.  Pt with no hx of fainting with vaccines in the past.  Pt immediatly pale and laid pt supine on exam table raising legs.  Pt with LOC for approx. 10-15 seconds, with some muscle tension present.  More difficult to arouse, pt with return of consciousness and pale but fully aware of surroundings.  Vital signs stable and able to sit up.  Given juice and chips with some relief.  Pt needing to lay down again in fear of faint.  Pt recovery seemed extended, possibly due to dehydration and recent cold which resolved.  Though initially refused ambulance, pt agree seemed a bit worse for her, I called EMS and ambulance came within minutes and evaluated by Paramedics, taken to Hospital near by.  AVS given to paramedics. Husband and son came to clinic as well to be with pt.  Pt agreeable to being evaluated further at ED.
Age: 44.0
Sex: F
Vaccine: HEPA, TYP
Symptoms: Pallor, Syncope
Clinical narrative: Patient with syncopal episode after second vaccine given around 9:25 am.  Pt with no hx of fainting with vaccines in the past.  Pt immediatly pale and laid pt supine on exam table raising legs.  Pt with LOC for approx. 10-15 seconds, with some muscle tension present.  More difficult to arouse, pt with return of consciousness and pale but fully aware of surroundings.  Vital signs stable and able to sit up.  Given juice and chips with some relief.  Pt needing to lay down again in fear of faint.  Pt recovery seemed extended, possibly due to dehydration and recent cold which resolved.  Though initially refused ambulance, pt agree seemed a bit worse for her, I called EMS and ambulance came within minutes and evaluated by Paramedics, taken to Hospital near by.  AVS given to paramedics. Husband and son came to clinic as well to be with pt.  Pt agreeable to being evaluated further at ED.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Fibrin D dimer increased, Platelet count decreased, Platelet disorder, Polymenorrhoea
Clinical narrative: Chest pain, low platelets, large platelets, high d-dimer, double periods.
Age: 65.0
Sex: M
Vaccine: RSV
Symptoms: Chills, Extra dose administered, Pain, Pyrexia
Clinical narrative: Patient accidentally received a 2nd dose of Arexvy on 2-7-25 when he already had one on 1-18-24. Patient was called to be notified that 2nd vaccine was done by mistake, and patient report minor to moderate chills, aches, and fever.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Developed shingles on left side of the buttocks, vagina, and rectum.
Age: 51.0
Sex: F
Vaccine: PNC21
Symptoms: Arthralgia, Discomfort, Hypoaesthesia, Joint range of motion decreased, Pain
Clinical narrative: per patient at approximately 3 weeks after vaccine administration, patient started to experience radiating pain of R shoulder with numbness from shoulder to fingers. Patient also experiencing less range of motion due to discomfort.
Age: 82.0
Sex: M
Vaccine: PNC20
Symptoms: Extra dose administered, No adverse event
Clinical narrative: The day after vaccine administration, it was brought to our attention that patient already came in and received Prevnar 20 on 3/12/24. Patient was informed. States no adverse effects so far.
Age: 3.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient was signed up to get the COVID shot, but was given the flu shot instead. Parents noticed after the vaccine was given.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Aldolase normal, Anaemia macrocytic, Biopsy bone marrow abnormal, Biopsy muscle abnormal, Blood creatine phosphokinase normal
Clinical narrative: In 9/15/23 she got a shingles shot. In October 2023 she has noticed it is hard to hold her head up and she was more hunched over in her walking. 10/5/23 she had flu shot. 10/27/23 she got covid shot. At the beginning of November 2023, she then had difficulty with lifting her arms to reach for things and shampooing her hair.  She has also had itchiness in her elbow and waist that is new around March 2024. In 4/2024 Dr started a trial of prednisone 10 mg daily x2 weeks then 5 mg x 2 weeks which led to room spinning dizziness. It was stopped early because of the dizziness. It did not help her muscles. Hot showers make her itchiness worse.  In May-June 2024 she began having difficulty with chewing food. She had to break food into small pieces, even a banana. Her dentist noticed that she cannot open her mouth wide. Food can get stuck in pockets in her mouth.  In July 2024, climbing stairs has become difficult and she has to use one step at a time. She has difficulty getting in and out of bed.  Since July 2024 she started using a walker. Going down the steps is not as hard. Her foot does not catch on the top of stairs. In July 2024 she noticed that her speech changed, such that it is softer. The pronunciation is also somewhat worse. She cannot whistle anymore. She has trouble licking her ice cream cone because her tongue is not able to extend as far anymore. In 8/2024 her hands started cramping up.   On examination she had diffuse muscular weakness in the arms, legs, trunk, and neck. She had difficulty standing unassisted.  prednisone 60 mg daily without benefit. has received IVIG in early 2/2025. too early to tell if it has led to benefit.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Bone marrow failure, Dysphonia, Dysstasia, Fasciitis, Gait disturbance
Clinical narrative: In 9/15/23 she got a shingles shot. In October 2023 she has noticed it is hard to hold her head up and she was more hunched over in her walking. 10/5/23 she had flu shot. 10/27/23 she got covid shot. At the beginning of November 2023, she then had difficulty with lifting her arms to reach for things and shampooing her hair.  She has also had itchiness in her elbow and waist that is new around March 2024. In 4/2024 Dr started a trial of prednisone 10 mg daily x2 weeks then 5 mg x 2 weeks which led to room spinning dizziness. It was stopped early because of the dizziness. It did not help her muscles. Hot showers make her itchiness worse.  In May-June 2024 she began having difficulty with chewing food. She had to break food into small pieces, even a banana. Her dentist noticed that she cannot open her mouth wide. Food can get stuck in pockets in her mouth.  In July 2024, climbing stairs has become difficult and she has to use one step at a time. She has difficulty getting in and out of bed.  Since July 2024 she started using a walker. Going down the steps is not as hard. Her foot does not catch on the top of stairs. In July 2024 she noticed that her speech changed, such that it is softer. The pronunciation is also somewhat worse. She cannot whistle anymore. She has trouble licking her ice cream cone because her tongue is not able to extend as far anymore. In 8/2024 her hands started cramping up.   On examination she had diffuse muscular weakness in the arms, legs, trunk, and neck. She had difficulty standing unassisted.  prednisone 60 mg daily without benefit. has received IVIG in early 2/2025. too early to tell if it has led to benefit.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Immune thrombocytopenia, Immunoglobulin therapy, Laboratory test normal, Lymphocytic infiltration, Magnetic resonance imaging abnormal
Clinical narrative: In 9/15/23 she got a shingles shot. In October 2023 she has noticed it is hard to hold her head up and she was more hunched over in her walking. 10/5/23 she had flu shot. 10/27/23 she got covid shot. At the beginning of November 2023, she then had difficulty with lifting her arms to reach for things and shampooing her hair.  She has also had itchiness in her elbow and waist that is new around March 2024. In 4/2024 Dr started a trial of prednisone 10 mg daily x2 weeks then 5 mg x 2 weeks which led to room spinning dizziness. It was stopped early because of the dizziness. It did not help her muscles. Hot showers make her itchiness worse.  In May-June 2024 she began having difficulty with chewing food. She had to break food into small pieces, even a banana. Her dentist noticed that she cannot open her mouth wide. Food can get stuck in pockets in her mouth.  In July 2024, climbing stairs has become difficult and she has to use one step at a time. She has difficulty getting in and out of bed.  Since July 2024 she started using a walker. Going down the steps is not as hard. Her foot does not catch on the top of stairs. In July 2024 she noticed that her speech changed, such that it is softer. The pronunciation is also somewhat worse. She cannot whistle anymore. She has trouble licking her ice cream cone because her tongue is not able to extend as far anymore. In 8/2024 her hands started cramping up.   On examination she had diffuse muscular weakness in the arms, legs, trunk, and neck. She had difficulty standing unassisted.  prednisone 60 mg daily without benefit. has received IVIG in early 2/2025. too early to tell if it has led to benefit.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Mastication disorder, Mobility decreased, Muscle spasms, Muscular weakness, Posture abnormal
Clinical narrative: In 9/15/23 she got a shingles shot. In October 2023 she has noticed it is hard to hold her head up and she was more hunched over in her walking. 10/5/23 she had flu shot. 10/27/23 she got covid shot. At the beginning of November 2023, she then had difficulty with lifting her arms to reach for things and shampooing her hair.  She has also had itchiness in her elbow and waist that is new around March 2024. In 4/2024 Dr started a trial of prednisone 10 mg daily x2 weeks then 5 mg x 2 weeks which led to room spinning dizziness. It was stopped early because of the dizziness. It did not help her muscles. Hot showers make her itchiness worse.  In May-June 2024 she began having difficulty with chewing food. She had to break food into small pieces, even a banana. Her dentist noticed that she cannot open her mouth wide. Food can get stuck in pockets in her mouth.  In July 2024, climbing stairs has become difficult and she has to use one step at a time. She has difficulty getting in and out of bed.  Since July 2024 she started using a walker. Going down the steps is not as hard. Her foot does not catch on the top of stairs. In July 2024 she noticed that her speech changed, such that it is softer. The pronunciation is also somewhat worse. She cannot whistle anymore. She has trouble licking her ice cream cone because her tongue is not able to extend as far anymore. In 8/2024 her hands started cramping up.   On examination she had diffuse muscular weakness in the arms, legs, trunk, and neck. She had difficulty standing unassisted.  prednisone 60 mg daily without benefit. has received IVIG in early 2/2025. too early to tell if it has led to benefit.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Speech disorder, Tongue movement disturbance, Trismus, Walking aid user
Clinical narrative: In 9/15/23 she got a shingles shot. In October 2023 she has noticed it is hard to hold her head up and she was more hunched over in her walking. 10/5/23 she had flu shot. 10/27/23 she got covid shot. At the beginning of November 2023, she then had difficulty with lifting her arms to reach for things and shampooing her hair.  She has also had itchiness in her elbow and waist that is new around March 2024. In 4/2024 Dr started a trial of prednisone 10 mg daily x2 weeks then 5 mg x 2 weeks which led to room spinning dizziness. It was stopped early because of the dizziness. It did not help her muscles. Hot showers make her itchiness worse.  In May-June 2024 she began having difficulty with chewing food. She had to break food into small pieces, even a banana. Her dentist noticed that she cannot open her mouth wide. Food can get stuck in pockets in her mouth.  In July 2024, climbing stairs has become difficult and she has to use one step at a time. She has difficulty getting in and out of bed.  Since July 2024 she started using a walker. Going down the steps is not as hard. Her foot does not catch on the top of stairs. In July 2024 she noticed that her speech changed, such that it is softer. The pronunciation is also somewhat worse. She cannot whistle anymore. She has trouble licking her ice cream cone because her tongue is not able to extend as far anymore. In 8/2024 her hands started cramping up.   On examination she had diffuse muscular weakness in the arms, legs, trunk, and neck. She had difficulty standing unassisted.  prednisone 60 mg daily without benefit. has received IVIG in early 2/2025. too early to tell if it has led to benefit.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Injection site reaction, Pruritus, Sleep disorder, Urticaria
Clinical narrative: broke out in itchy burning welts at injection site,over next few days spread down right arm, back , left arm,torso and legs. It has been 2 months and not completly healed,  tried antihistamines and prednisone. nothing eased the extreme burning and itching, sleep was difficult.
Age: 83.0
Sex: F
Vaccine: RSV
Symptoms: Rash
Clinical narrative: full body rash - arnica, symptoms resolving; recommended oatmeal and diphenhydramine
Age: 41.0
Sex: F
Vaccine: FLU3, HEP, MMR, TDAP
Symptoms: Anal incontinence, Dyspnoea, Loss of consciousness
Clinical narrative: Doctor have patient receiving 4 vaccines at the pharmacy (flu, Hep B, Tdap, and MMR). Patient passed out and soil on herself and stating that she could not breath with her hands on the heck after 5 mins receiving the vaccine. Epi pen 0.3 mg was used and called 911.  Paramedic arrived and check on patient's vital. Patient felt better after receiving the Epi pen and refused to go to the hospital. Pharmacist have patient stayed at the pharmacy for a little over 1 hour to make sure she felt ok
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site atrophy, Injection site discolouration
Clinical narrative: Not entirely sure when this started, but the last week of January I noticed fat atrophy to left deltoid in area of recent novavax vaccination 12/24/24. Two small spots of skin hyperpigmentation in center of ~1-1.5 inch area of atrophy. The indentation is very noticeable visually and with palpation. No pain or associated symptoms.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Breast enlargement, Burning sensation
Clinical narrative: First my hands were on fire and 2 months after the second  vaccination My breasts started to increase in size from a "B" cup to now a "DD" cup size and still growing. My breast have never changed even when I was 9 months pregnant for 3 pregnancys. Now, ever since having the Covid 19 vax my boobs keep growing. My weight has not changed. But because of this my back hurts my shoulders hurt as a result from the weight of my breasts and bra digging into my shoulders. I have had a hysterctomy so it is not from hormal change. This all happened after the VAX.
Age: 77.0
Sex: F
Vaccine: RSV
Symptoms: Dyspnoea, Extra dose administered, Oxygen saturation abnormal
Clinical narrative: Patient and husband received first dose of  Shingrix series on this date and caregiver also requested Arexvy for both of them. Pharmacy did not catch that both patients had already received Arexvy in October 2023 (single dose series) so they received 2 doses.  When it was discovered, caregiver was notified and asked if they had experienced any side effects. Caregiver first stated no. Then he mentioned that that next morning his wife woke up and had difficulty breathing. He called 911, he did say he mentioned to them that they had vaccines that previous afternoon but is unaware if he notified Dr at the hospital. Patient was admitted to hospital for 3 days as they could not get her oxygen levels to normalize.
Age: 69.0
Sex: F
Vaccine: RSV
Symptoms: Erythema, Feeling hot, Mobility decreased, Pain, Swelling
Clinical narrative: Swelling, heat, pain/soreness causing difficulty raising arm,  and red spots that have remained on left arm . Patient noticed yesterday, reaction was more severe when she woke up this morning. Advised patient to continue to monitor localized reaction, apply cold compress to arm are, taking  tylenol for the pain and benadryl for possible allergy.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site erythema, Injection site pruritus, Pruritus
Clinical narrative: Pt caretaker reported a red arm at the injection site and expanding down the arm. Slightly itchy.
Age: 67.0
Sex: M
Vaccine: TDAP
Symptoms: Extra dose administered
Clinical narrative: patient was given a duplicate vaccine outside of guidelines; previous dose was administered 07/29/24
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Malaise, Palpitations, Seizure
Clinical narrative: Husband became ill started with headaches,then persisted into heart palpitations and ending in seizures
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Injection site pain, Pain in extremity
Clinical narrative: Felt light headed within minutes of injection. Subsided after about 20 minutes. Within 2 hours had pain in injection area and arm, fever of 101, shaking, shivering, tired. Lasted 3 days.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Tremor
Clinical narrative: Felt light headed within minutes of injection. Subsided after about 20 minutes. Within 2 hours had pain in injection area and arm, fever of 101, shaking, shivering, tired. Lasted 3 days.
Age: 45.0
Sex: F
Vaccine: HPV9, VARZOS
Symptoms: Injected limb mobility decreased, Injection site pain, Pain, Pain in extremity
Clinical narrative: Pain during injection and entire arm sore after vaccine. Hard to move arm and hurts to move it.
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site rash, Injection site warmth
Clinical narrative: . Grandmother reported child was seen yesterday 020725 at Clinic and received a TDaP and Polio Vaccine in his RLE/thigh. Grandmother reported that pt has developed red, warm localized rash to his Right anterior thigh that was noted this morning 020825 but has increased in size. Pt denies pain or itching. Denies F/C, N/V, mucous membrane involvement, palms/soles involvement. . Denies Swelling of face, eyes, intraoral, trouble swallowing or breathing, wheezing, cough,coryza/ intranasal mucosal membrane inflammation. . Denies potential allergens, recent travel, risk for MRSA, family/friends/close contacts with similar SXs, sharing of clothing items.  . Denies known liver disease, recent jaundice appearance or alcoholism. . Denies being easily Bruised or bleeding, anemia, clots, recent transfusions.. Denies Joint pain/swelling/redness, back pain.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Palpitations
Clinical narrative: My heart began racing just under 24 hours after shot. I was laying down at the time yet my heart rate increased to 114, I tried to use some breathing techniques to bring it down and I could get it to 104. Pulsox was fine. This lasted for about an hour, other than a migraine I felt fine otherwise.
Age: 76.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient incorrectly received a second dose of Arexvy 1.5 years after first dose even though not clinically indicated. Patient did not report any adverse effects of the second dose.