chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Headache
Clinical narrative: Headache; debilitating; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A female patient received BNT162b2 (BNT162B2), 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: HEADACHE (non-serious), outcome "unknown"; ASTHENIA (non-serious), outcome "unknown", described as "debilitating". The events "headache" and "debilitating" required physician office visit. Additional information: the patient experienced headache for two and a half years since took the vaccine This was debilitating. The patient had seen two different doctors already and to a headache specialist but didn't solve this.  Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Caller wanted guidance on if a patient may take Paxlovid after receiving a COVID-19 booster a week ago.; Caller wanted guidance on if a patient may take Paxlovid after receiving a COVID-19 booster a week ago.; This is a spontaneous report received from a Pharmacist from medical information team.  A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Jul2024 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete, unknown manufacturer), for COVID-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jul2024, latency 1 week after the suspect product(s) administration, outcome "unknown" and all described as "Caller wanted guidance on if a patient may take Paxlovid after receiving a COVID-19 booster a week ago." The information request was more related to the efficacy of Paxlovid rather than to recommend the use of the product or not.  The information on the batch/lot number for [BNT162B2 OMI XBB.1.5] will be requested and submitted if and when received.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by varied factors; however, a contributory role of the suspect product to the reported events Vaccination failure and COVID-19 cannot be ruled out.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Blood cholesterol abnormal, Diarrhoea, Flatulence
Clinical narrative: Cholesterol; gas; Diarrhea for the next 6 months; This is a spontaneous report received from a Consumer or other non HCP.  A 66-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Sep2023 at 13:00 as dose 6 (booster), single (Batch/Lot number: unknown) at the age of 66 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 4 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 5 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: DIARRHOEA (medically significant) with onset 13Sep2023 at 13:00, outcome "recovered" (07Mar2024), described as "Diarrhea for the next 6 months"; BLOOD CHOLESTEROL ABNORMAL (non-serious), outcome "unknown", described as "Cholesterol"; FLATULENCE (non-serious), outcome "unknown", described as "gas". Therapeutic measures were taken as a result of diarrhoea, which included: antidiarrheal (as reported), omeprazole (PRILOSEC).  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 will be requested and submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Muscle atrophy
Clinical narrative: it ate up all his muscle tissue / It deteriorated all the muscles; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): MOD-2024-771191 (Moderna).  A 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: "doesn't smoke" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: MUSCLE ATROPHY (non-serious), outcome "not recovered", described as "it ate up all his muscle tissue / It deteriorated all the muscles". Clinical course: The reporter's buddy took the Pfizer, against all his intuition, he finally broke down and took it after the reporter. In the left arm, it ate up all his muscle tissue and he's a weightlifter. He doesn't smoke. He's young, he's strong, So he finally took the Pfizer shot, and he has pictures of his arm, it ate all the muscle tissue on his bicep, just tore it up, now it's eating into his left arm.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: feelings of general malaise; This is a spontaneous report received from a Pharmacist, Program ID.  A male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 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: MALAISE (non-serious), outcome "unknown", described as "feelings of general malaise". Additional information: The patient experienced feelings of general malaise for the next day following administration of COVID-19 vaccine. He said that he has had this reaction each time he's received the shot.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: TDAP
Symptoms: Immunisation reaction
Clinical narrative: developed a reaction after the vaccines; Initial information received on 16-Jul-2024 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves an unknown age and unknown gender patient who developed a reaction after receiving the Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine [Adacel].  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 suspect Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine Suspension for injection (with an unknown expiry date and lot number) via unknown route in unknown administration site for immunization.  On an unknown date, the patient developed a reaction after the vaccines (immunisation reaction) (unknown latency).  Reportedly, Can you assist with identifying excipients for the following vaccines that were administered over 10 years ago. I'm sure the products have been updated so we need historical information. hasn't received a vaccine since. Looking to identify excipients as the potential cause.   Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.
Age: 72.0
Sex: M
Vaccine: FLUA4
Symptoms: Chest discomfort, Chest pain, Chills, Fatigue, Headache
Clinical narrative: Chest tightness/ heviness; Body aches generalized; Lethargy; Exhaustion; Unable to sleep; Chest pain; Headache; Fever; Chills; This spontaneous case from Country, initially received on 11-Jul-2024, was reported by a health authority and concerns an elderly male patient.  Administration of company suspect drug(s): On 13-Nov-2023, the patient received Fluad Quadrivalent (influenza vaccine inact sag 4v; dose) fur unknown indication, Dose: reported as '1', Route of administration: reported as 'SYR', Anatomical location: Left arm. Lot number: 371593.  Non-company suspect drugs: On an unknown date, the patient received Moderna Covid-19 vaccine 1013-1014 (active ingredients not reported) for unknown indication, Dose: not reported, Route of administration: intramuscular, Anatomical Location: Left Arm, Lot number: 8058877   Adverse reactions/events and outcomes: On 13-Nov-2023, the patient experienced medium Chest tightness/ heviness (outcome: Not recovered / Not resolved), severe Body aches generalized (outcome: Not recovered / Not resolved), medium Lethargy (outcome: Not recovered / Not resolved), medium Exhaustion (outcome: Not recovered / Not resolved), medium Unable to sleep (outcome: Not recovered / Not resolved), medium Chest pain (outcome: Not recovered / Not resolved), medium Headache (outcome: Not recovered / Not resolved), mild Fever (outcome: Not recovered / Not resolved), medium Chills (outcome: Not recovered / Not resolved).  Non-drug treatment/Other action taken:  Fluad Quadrivalent action taken: Not Applicable  Reporter's assessment: The reporter assessed the events as non-serious and did not provide a causality assessment.; Reporter's Comments: The events of headache, chills, pyrexia, lethargy, fatigue, pain, insomnia, chest pain and chest discomfort are assessed as possibly related to Fluad Quadrivalent due to plausible temporal relationship.
Age: 72.0
Sex: M
Vaccine: FLUA4
Symptoms: Insomnia, Lethargy, Pain, Pyrexia, Sleep disorder
Clinical narrative: Chest tightness/ heviness; Body aches generalized; Lethargy; Exhaustion; Unable to sleep; Chest pain; Headache; Fever; Chills; This spontaneous case from Country, initially received on 11-Jul-2024, was reported by a health authority and concerns an elderly male patient.  Administration of company suspect drug(s): On 13-Nov-2023, the patient received Fluad Quadrivalent (influenza vaccine inact sag 4v; dose) fur unknown indication, Dose: reported as '1', Route of administration: reported as 'SYR', Anatomical location: Left arm. Lot number: 371593.  Non-company suspect drugs: On an unknown date, the patient received Moderna Covid-19 vaccine 1013-1014 (active ingredients not reported) for unknown indication, Dose: not reported, Route of administration: intramuscular, Anatomical Location: Left Arm, Lot number: 8058877   Adverse reactions/events and outcomes: On 13-Nov-2023, the patient experienced medium Chest tightness/ heviness (outcome: Not recovered / Not resolved), severe Body aches generalized (outcome: Not recovered / Not resolved), medium Lethargy (outcome: Not recovered / Not resolved), medium Exhaustion (outcome: Not recovered / Not resolved), medium Unable to sleep (outcome: Not recovered / Not resolved), medium Chest pain (outcome: Not recovered / Not resolved), medium Headache (outcome: Not recovered / Not resolved), mild Fever (outcome: Not recovered / Not resolved), medium Chills (outcome: Not recovered / Not resolved).  Non-drug treatment/Other action taken:  Fluad Quadrivalent action taken: Not Applicable  Reporter's assessment: The reporter assessed the events as non-serious and did not provide a causality assessment.; Reporter's Comments: The events of headache, chills, pyrexia, lethargy, fatigue, pain, insomnia, chest pain and chest discomfort are assessed as possibly related to Fluad Quadrivalent due to plausible temporal relationship.
Age: 3.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: 11cm induration. Redness and swelling at the injection site
Age: 26.0
Sex: F
Vaccine: HEP
Symptoms: Chest discomfort, Chest pain, Dyspnoea, Throat tightness
Clinical narrative: Employee Hep B Vaccine was administered at 5:35pm, at about 6:25pm employee reported to medical staff feeling chest pain/tightness. EMTs was called, employee vitals was obtained BP was 116/70 HR was 82 and Temp was 97.7, after about 10 minutes employee stated she felt like it was moving up in her throat area and she was experiencing shortness of breath. EMTs arrived and employee went to ER to be evaluated.
Age: 1.67
Sex: M
Vaccine: DTAP, IPV
Symptoms: Swelling face, Urticaria
Clinical narrative: Seen on Sunday got DTaP and got the polio vaccines individually. Had hives in the night and ?face swelling. returned to clinic in the day with hives.
Age: 4.0
Sex: F
Vaccine: DTAP, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Mom noticed redness on right leg the day after vaccines. Patient started to complained  of pain in that area. Area become puffy and swollen. Today, she noticed that puffiness had decreased but more warm and spread out than previous day. There was no fever, vomiting, diarrhea. No recent people at home with rashes except for sister with similar reaction. Patient had received the varicella and DTaP vaccine on her right leg. Pt treated for possible cellulitis infection with cephalexin antibiotics and benadryl for itching.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site cellulitis, Injection site pain, Injection site pruritus, Injection site rash, Injection site reaction
Clinical narrative: 11 Years Male-patient is here to recheck rash on left upper outer arm.  Patient was seen for 11-year-old well-child check and received his immunizations.  Vaccine was given in the left upper deltoid area.  Ever since that visit patient has developed splotchy redness which spread slightly but has stabilized over today.  Patient describes the area as itchy when it is touched but not painful.  He has had no fever.  No redness spreading down his arm.  No numbness or tingling.   Patient reports his right arm where he received his Tdap/ HPV  is actually more sore but no redness.  10 yr old M accompanied by mom presents to clinic allergic reaction to one of the vaccine given this past 3 days. Pt states it kinda hurts where the shot is. MOC states notice rash/redness to the area.     LEFT DELTOID AREA-  SITE OF INJECTION IF NOT PUSTULAR OR RAISED.  BELOW INJECTION IS SPREADING SPLOTCHY RED AREA 8CM LONG X 4 CM WIDE, MARGINS ARE NOT DISTINCT. SLIGHTLY WARM TO TOUCH, NO STREAKING OF REDNESS DOWN ARM.  FULL ROM OF LEFT ARM
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site warmth, Local reaction, Rash macular
Clinical narrative: 11 Years Male-patient is here to recheck rash on left upper outer arm.  Patient was seen for 11-year-old well-child check and received his immunizations.  Vaccine was given in the left upper deltoid area.  Ever since that visit patient has developed splotchy redness which spread slightly but has stabilized over today.  Patient describes the area as itchy when it is touched but not painful.  He has had no fever.  No redness spreading down his arm.  No numbness or tingling.   Patient reports his right arm where he received his Tdap/ HPV  is actually more sore but no redness.  10 yr old M accompanied by mom presents to clinic allergic reaction to one of the vaccine given this past 3 days. Pt states it kinda hurts where the shot is. MOC states notice rash/redness to the area.     LEFT DELTOID AREA-  SITE OF INJECTION IF NOT PUSTULAR OR RAISED.  BELOW INJECTION IS SPREADING SPLOTCHY RED AREA 8CM LONG X 4 CM WIDE, MARGINS ARE NOT DISTINCT. SLIGHTLY WARM TO TOUCH, NO STREAKING OF REDNESS DOWN ARM.  FULL ROM OF LEFT ARM
Age: 1.0
Sex: F
Vaccine: DTAP, HEPA, HIBV, PNC20
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Mom noticed redness on right leg the day after vaccines. She started to complaint of pain in that area. Mom notes that the area become puffy and swollen. Today, the redness and puffiness had decreased. Denies fever, vomiting, diarrhea. No recent people at home with rashes except for sister with a similar reaction. Patient had received DTaP and Prevnar on right leg. HIB and Hep A on left. Provider prescribed topical mupirocin for cellulitis of the leg.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Gastric cancer, Gastrointestinal disorder, Laboratory test abnormal, Vomiting
Clinical narrative: Started to have stomach issues, not keeping down food food. Workup showed gastric cancer.  Got a booster and the cancer progressed.  THESE SHOTS ARE CAUSING CANCER!! FACILITY KNOWS AND IS MAKING ALL THE MONEY OFF THESE PATIENTS.  STOP ALL THE SHOTS. ESP THE COVID SHOTS!!!!
Age: 4.0
Sex: F
Vaccine: MMR
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: vaccine was given early morning; However, manufacturer informed that MMR was not vaible for use due to power outage. Parent of patient was notified and we asked if any reaction noticed parent stated No. Patient is doing well. If any concerned parent should call the office.
Age: 25.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Peripheral swelling, Pruritus, Urticaria
Clinical narrative: Sx Hives, Swelling, elevated temp and numbness. Tx Benadryl
Age: 25.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Body temperature increased, Hypoaesthesia, Swelling, Urticaria
Clinical narrative: Sx Hives, Swelling, elevated temp and numbness. Tx Benadryl
Age: 1.17
Sex: F
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: On 27-JUN-2024 came into clinic with full blown chicken pox rash.; This spontaneous report was received from other health professional regarding to a 14-month-old female patient. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not provided.  On 09-APR-2024, the patient was vaccinated with the first dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) injection (strength, dose, frequency, route of administration, anatomical injection site, lot number and expiration date were not provided) for prophylaxis.   On 27-JUN-2024, the patient came into clinic with full blown chicken pox rash (varicella). The outcome of the event was not provided.  The casual relationship between varicella virus vaccine live (Oka/Merck) (VARIVAX) and the event was not provided.  No additional adverse event (AE)/ no product quality complaint (PQC).  Lot number is being requested and will be submitted if received.  This is one case from the same reporter.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs; PROQUAD administered after temperature excursion; This spontaneous report was received from a consumer regarding to a patient of unspecified age and gender. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not provided.  On 05-JUL-2024, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin [rHA]) (PROQUAD) injection, at a dose of 0.5 milliliter (mL), via intramuscular, lot number X027623 (lot number X027623 had been verified to be valid lot number for measles, mumps, rubella and varicella [oka-merck] virus vaccine live [PROQUAD]), expiration date 28-MAY-2025 (anatomical injection site not provided) for prophylaxis; after temperature excursion (product storage error).    No other information provided. No additional adverse event (AE)s or product quality complaint (PQC) reported (no adverse event).
Sex: U
Vaccine: TD
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: vaccine was administered to a patient 15 days early with no reported adverse event; Initial information received on 15-Jul-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient to whom DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] was administered 15 days early with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT Suspension for injection via unknown route in unknown administration site for immunization (strength, dose, batch number and expiry date unknown) 15 days early with no reported adverse event (inappropriate schedule of product administration) (latency same day).  Information on batch number corresponding to the one at time of event occurrence was requested.   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.
Age: 17.0
Sex: F
Vaccine: MEN
Symptoms: Inappropriate schedule of product administration
Clinical narrative: patient received first dose of menquadfi   on 12-JUL-2023 and the next dose was given on 15-JUL-2024. with no reported adverse event; Initial information received on 16-Jul-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 17 years old female patient who  received first dose of Meningococcal A-C-Y-W135 (T CONJ) Vaccine [Menquadfi] on 12-jul-2023 and the next dose was given on 15-jul-2024. 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 HPV Vaccine for Prophylactic vaccination.  On 12-Jul-2023, the patient received dose 1 of suspect Meningococcal A-C-Y-W135 (T CONJ) Vaccine (Solution for injection) (lot number, expiry date and strength not reported) via intramuscular route in unknown administration site. On 15-Jul-2024 she also received 0.5 ml dose 2 of vaccine with no reported adverse event  (inappropriate schedule of product administration) (latency: same day) (lot number U7949AB, expiry date: 31-Mar-2026) strength not reported via intramuscular route in the right upper arm for Immunization.  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 and Module of the 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.
Age: 1.75
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site induration, Injection site reaction, Livedo reticularis, Use of accessory respiratory muscles
Clinical narrative: Modeling, webbing of skin, hardness and redness at the site of injection. Breathing issues landed us in the ER where she was monitored. Her ribs were pulling for air.
Sex: F
Vaccine: RSV, VARZOS
Symptoms: Cardiac monitoring, Immunisation reaction, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Chief Complaint Patient presents with Pain Arm Right upper arm swelling, warm to touch post vaccination 62-year-old female who presents for evaluation of redness and swelling of her right upper arm.Symptoms started 2 days ago. Says it is not quite as red today but still swollen. No numbness or tingling. Not warm to the touch. No fever or chills. States she got her shingles and RSV vaccines 4 days ago on this arm. No treatment thus far. ED Course Clinical Impressions as of 07/15/24 2148 Vaccine reaction, initial encounter  Orders Placed This Encounter diphenhydraMINE (Benadryl) capsule 50 mg  Medical Decision Making The patient was admitted to an ED treatment room, placed on cardiac & vital sign monitors cycled er ER protocol and monitored by nursing. Patient was interviewed and examined. Nursing notes reviewed and appreciated. EMR searched for old records and reviewed as applicable. IV obtained as needed. Any ordered laboratory, EKG, and/or radiologic studies as applicable were reviewed and results considered  in the medical decision making process. Any procedure performed can be found in the appropriate section. A wide range of DDx considered to exclude life & limb threatening emergencies. The patient's symptoms were addressed during the visit and patient was reassessed after all interventions. Any schedule II medications given were done in collaboration with ER Medical Director (taged to co-sign this note as applicable) via VO/RB as defined in standard of care practice guidelines. \  Problems Addressed: Vaccine reaction, initial encounter: acute illness or injury Details: Mild localized reaction to vaccine. Benadryl given. Recommended that she continue to take it until this resolves. Recommended f/u if symptoms worsen. BP did get a little low after the benadryl, but resolved without intervention. I recommended that she speak with PCP about her meds, because she stated that her bp gets low in the mornings anyway after she takes her meds. -ED noted by provider, PA-C
Sex: F
Vaccine: RSV, VARZOS
Symptoms: Local reaction
Clinical narrative: Chief Complaint Patient presents with Pain Arm Right upper arm swelling, warm to touch post vaccination 62-year-old female who presents for evaluation of redness and swelling of her right upper arm.Symptoms started 2 days ago. Says it is not quite as red today but still swollen. No numbness or tingling. Not warm to the touch. No fever or chills. States she got her shingles and RSV vaccines 4 days ago on this arm. No treatment thus far. ED Course Clinical Impressions as of 07/15/24 2148 Vaccine reaction, initial encounter  Orders Placed This Encounter diphenhydraMINE (Benadryl) capsule 50 mg  Medical Decision Making The patient was admitted to an ED treatment room, placed on cardiac & vital sign monitors cycled er ER protocol and monitored by nursing. Patient was interviewed and examined. Nursing notes reviewed and appreciated. EMR searched for old records and reviewed as applicable. IV obtained as needed. Any ordered laboratory, EKG, and/or radiologic studies as applicable were reviewed and results considered  in the medical decision making process. Any procedure performed can be found in the appropriate section. A wide range of DDx considered to exclude life & limb threatening emergencies. The patient's symptoms were addressed during the visit and patient was reassessed after all interventions. Any schedule II medications given were done in collaboration with ER Medical Director (taged to co-sign this note as applicable) via VO/RB as defined in standard of care practice guidelines. \  Problems Addressed: Vaccine reaction, initial encounter: acute illness or injury Details: Mild localized reaction to vaccine. Benadryl given. Recommended that she continue to take it until this resolves. Recommended f/u if symptoms worsen. BP did get a little low after the benadryl, but resolved without intervention. I recommended that she speak with PCP about her meds, because she stated that her bp gets low in the mornings anyway after she takes her meds. -ED noted by provider, PA-C
Sex: F
Vaccine: PNC20
Symptoms: Erythema, Headache, Injection site erythema, Injection site induration, Peripheral swelling
Clinical narrative: I received the Prevnar 20 Pneumococcal shot on Monday, July 15, 2024. On Tuesday, July 16th, my arm started swelling and it was turning red. My arm was hard as a rock at the shot site. I also had a headache. I went to see my primary care  physician on Thursday, July 18th and he told me to take 3 Advils 3 times a day for 3 days and to take Benadryl at night. As of Saturday, July 20th, the swelling is gone by my arm is still red at the shot site. I received the shot at the store.
Age: 0.42
Sex: M
Vaccine: DTPPVHBHPB, PNC15
Symptoms: Crying, Injection site nodule, Insomnia, Pyrexia
Clinical narrative: mom called on 07/22/2024 1318 to report her son cried for 3 days straight and never slept. Has a non-red knot on the RAT and ran a fever off/on and  she alternated tyl/Ibuprofen and used cool compresses on the leg but is still concerned because the knot is still there.  Mom reports not taking the child to the ER nor the pediatrician.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Injection site induration, Injection site nodule, Injection site warmth
Clinical narrative: 2 days after vaccine was administered patient started having a red, hard knot show up at the injection site that is slightly warm to the touch. She has been monitoring it and has not treated it. She will follow up with her doctor if symptoms become worse, she just wanted to let us know. Offered for patient to come to clinic to be evaluated, she declined at this time.  Left Voice mail on 07/22/2024 to check on patients status and I have not heard back from her as of 07/23/2024
Age: 10.0
Sex: F
Vaccine: TYP
Symptoms: Abdominal pain, Diarrhoea
Clinical narrative: 7/21 2p: Took first dose oral vaccine  7/22 5a: started to have severe abdominal pain. Mild diarrhea. No emesis.  7/23: Feeling better.
Age: 17.0
Sex: M
Vaccine: HPV9
Symptoms: Blood glucose normal, Syncope
Clinical narrative: VASOVAGAL SYNCOPE ABOUT 5 MINUTES AFTER ADMINISTRATION OF VACCINE. SEVERE SYNCOPE SYMPTOMS. RESOLVED ABOUT 10 MINS AFTER ADMINISTRATION
Age: 16.0
Sex: F
Vaccine: UNK
Symptoms: Wrong product administered
Clinical narrative: Pt was given wrong vaccine - HPV. Pt was supposed to get Menveo but received 3rd HPV. Pt was informed of the incident prior to leaving the office. Pt consulted w/ provider after the incident. Pt/MOC verbally stated they were good with 3rd dose and f/u care from provider. Pt did receive Menveo after conversation w/ provider.
Age: 35.0
Sex: M
Vaccine: MENB
Symptoms: Unevaluable event
Clinical narrative: Unable to reach patient. Left voicemail on 7/22/24 when notified of this.
Age: 35.0
Sex: M
Vaccine: COVID19-2
Symptoms: Endoscopy abnormal, Erosive oesophagitis, Gastrooesophageal reflux disease
Clinical narrative: horrid acid reflux started within weeks of the immunizations. No history of this and no lifestyle nor dietary changes ensued prior.
Age: 9.0
Sex: M
Vaccine: TDAP
Symptoms: Wrong product administered
Clinical narrative: Left voicemail on 7/22/2024 when notified of this. Patient received wrong vaccine.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine has been improperly stored for an undetermined amount of time. Patient has no reaction, signs or symptoms to report.
Age: 7.0
Sex: F
Vaccine: DTAP, HEPA, IPV, VARCEL
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: RN administered a dose of DTaP which was recommended by the system, but the patient had turned 7 years old the month prior to the administration of DTaP.
Age: 14.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine improperly stored for undetermined amount of time. ProQuad MMRV is meant to be stored at -58 degrees Fahrenheit to +5 degrees Fahrenheit. Vaccine stored at +36 degrees Fahrenheit to +46 degrees Fahrenheit. Patient has not reported any reaction, sign, or symptom.
Age: 5.0
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Extra dose administered
Clinical narrative: Shot given when patient was too old for immunization
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Wrong product administered
Clinical narrative: NO SYMPTOMS. TRUMENBA WAS ORDERED, BUT MENQUADFI WAS GIVEN INSTEAD.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthritis, Computerised tomogram abnormal, Magnetic resonance imaging abnormal, X-ray limb abnormal
Clinical narrative: I had no idea what I had. I heard from other people about Frozen Shoulder. I went to this orthopedic that I see for my foot (Dr.). He did an xray and MRI. He said I have terrible arthritis in that shoulder (left shoulder). I didnt do anything to hurt it. I went to him in October of 2023. I couldnt take it anymore, the pain was so bad. He did write me a prescription, he gave me an injection of a steroid, and it did not do anything. I went to rehab at Physical Therapy, was seen end of 2023 and beginning of year 2024. I also saw Dr. -April or May 2024
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Mobility decreased, Musculoskeletal stiffness, Pain
Clinical narrative: I had no idea what I had. I heard from other people about Frozen Shoulder. I went to this orthopedic that I see for my foot (Dr.). He did an xray and MRI. He said I have terrible arthritis in that shoulder (left shoulder). I didnt do anything to hurt it. I went to him in October of 2023. I couldnt take it anymore, the pain was so bad. He did write me a prescription, he gave me an injection of a steroid, and it did not do anything. I went to rehab at Physical Therapy, was seen end of 2023 and beginning of year 2024. I also saw Dr. -April or May 2024
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthritis, Computerised tomogram abnormal, Magnetic resonance imaging abnormal, X-ray limb abnormal
Clinical narrative: pt recieved 2nd dose 9/22/2023 and notified pharmacy on 7/23/24 that she was in contact with VAERS and has been having pain, stiffness and unable left  arm.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Mobility decreased, Musculoskeletal stiffness, Pain
Clinical narrative: pt recieved 2nd dose 9/22/2023 and notified pharmacy on 7/23/24 that she was in contact with VAERS and has been having pain, stiffness and unable left  arm.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine improperly stored for undetermined amount of time. ProQuad MMRV is meant to be stored at -58 degrees Fahrenheit to +5 degrees Fahrenheit. Vaccine stored at +36 degrees Fahrenheit to +46 degrees Fahrenheit. Patient has not reported any reaction, sign, or symptom.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Unevaluable event
Clinical narrative: Lot #: ZK9P4 Manufacturer: GlaxoSmithKline Exp.: 04-30-2027
Age: 0.5
Sex: M
Vaccine: DTPPVHBHPB
Symptoms: Extra dose administered
Clinical narrative: The patient accidentally received 2 doses of Vaxelis
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Patient received 0.5ml instead of 0.25mL.
Age: 0.25
Sex: F
Vaccine: DTAPHEPBIP, IPV, PNC20
Symptoms: Extra dose administered, No adverse event
Clinical narrative: RN gave the combination dose of Pediarix (DTaP, Hep B, Polio) and a dose of IPV (polio) in error. RN attempted to contact the patients family numerous times via telephone on file and left a voicemail instructing them to call back. No return call at this time. No known adverse affects a this time.
Age: 1.58
Sex: M
Vaccine: DTAPIPV
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: no reaction noted yet, incorrect vaccine given to patient based on age. Should not have gotten kinrix today, too young for this vaccine.
Age: 84.0
Sex: M
Vaccine: HEPAB, VARZOS
Symptoms: Arthralgia, Neck pain, Neuralgia
Clinical narrative: Patient reports nerve pain in his neck/shoulder starting the day after he received the two vaccines. He has done physical therapy and massage therapy over the last six weeks and it has not resolved the issue. He will be going for an MRI to determine why the pain is not going away. He believes the vaccines were administered too high in the shoulder area and thinks this caused the neck/shoulder pain.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Erythema, Induration, Swelling
Clinical narrative: Red, swelling and hard. Mom noticed at 6 pm last night and was giving tylenol after.
Age: 1.17
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Erythema, Swelling
Clinical narrative: redness and swelling
Age: 1.5
Sex: M
Vaccine: HPV9
Symptoms: No adverse event, Wrong product administered
Clinical narrative: ON 7-3-24 THE PROVIDER GAVE A VERBAL ORDER TO MA TO ADMINISTER HEP A VACCINE TO PT. BY THE TIME THE MA CAUGHT THE ERROR SHE HAD ADMINISTERED AN HPV 9-GARDASIL TO PT. ON RT THIGH AND AS SHE WAS RETRACTING NEEDLE SHE NOTICE THE HPV9 GARDASIL PF SYRINGE AFTER THIS HAPPENED SHE WENT TO INFORM OFFICE MANAGER. PROVIDER AND MA'S TRY REACHING BACK TO PARENT MULTIPLE TIMES TO EXPLAIN ERROR BUT NOT SUCCESSFUL DUE TO NO ANSWER AND NOT ABLE TO LEAVE VOICE MAIL DUE TO SET UP.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site hypersensitivity, Injection site induration, Injection site pain
Clinical narrative: My left arm at the injection site has been painful until now. That area cannot be exposed to cold, and it feels slightly hard to the touch.
Age: 1.0
Sex: F
Vaccine: HEP, MMRV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Wrong vaccine was given, she was given Hep B when she should have received Hep A. No reaction noted to the event.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram, Deep vein thrombosis, Hypoaesthesia
Clinical narrative: DVT, blood clot, arm numbness
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: Within a week or so after the vaccination I developed itchy skin all over the body that still persists if I pause taking Zyrtec.
Age: 63.0
Sex: M
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: EXPIRED VACCINE ADMINISTERED. EXP DATE 1/12/2024. CLIENT W/O SYMPTOMS.
Age: 3.0
Sex: F
Vaccine: DTAPIPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: none given outside age limit
Age: 8.0
Sex: F
Vaccine: HEP, IPV, TDAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Pt received errant dose of Hepatitis B instead of receiving Hepatitis A. Pt monitored for 20 minutes. No reaction.
Age: 14.0
Sex: F
Vaccine: MMRV
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Patient states right arm started getting red, swollen, and itchy at injection site. Thursday night (7/18/24). Symptoms started to resolve by Saturday night (7/20/24). Patient came in Monday afternoon (7/22/24) to health department to ask if something was wrong.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: Expired vaccination given
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Dysstasia, Muscular weakness
Clinical narrative: PATIENT STATES THAT ABOUT 2 DAYS AFTER THE VACCINE SHE SUFFERED SEVERE WEAKNESS IN HER LEGS TO THE POINT WHERE SHE COULDNT STAND FROM A SITTING POSITION.  ONCE UP SHE COULD MOVE AROUND BUT THAT INTIAL TRYING TO STAND WAS DIFFICULT
Age: 77.0
Sex: F
Vaccine: HEP
Symptoms: Underdose, Wrong product administered
Clinical narrative: Incorrect Vaccine Given Given, Patient received Engerix B (birth through 19 years of age) instead of the forecasted Hepislav B (Adult Only)
Age: 5.0
Sex: F
Vaccine: MMRV
Symptoms: Injection site vesicles
Clinical narrative: Bubble popped up on patient. Was done in the thigh. When Giving the vaccine it was at the 45 degree angle and yet a bubble popped up after vaccine was given
Age: 19.0
Sex: F
Vaccine: RAB
Symptoms: Burning sensation, Muscular weakness, Paraesthesia, Sleep disorder, Visual impairment
Clinical narrative: burning, tingling and weakness in bilateral arms, Fever of 100 degrees, lack of sleep, can't rest, and vision changes.  Pt advised to go to ER by immunizing clinic at 10:45, prior to her call to us.   When called to follow up with pt at 1330,  she states she did not go to ER, because she didn't feel "that bad", and that she had an appointment scheduled with her GP in a couple days.   Reinforced the need for her to be seen and evaluated today, and if she wasn't willing to go to an ER, that should at least get into an urgent care.   Advised her to hold off on completing the series until after cleared by a doctor, and that if she chooses to complete it, it will still be effective it dose is given up to one week late.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Arthropathy, COVID-19, Computerised tomogram head, Echocardiogram, Electrocardiogram
Clinical narrative: JANSSEN 0/12/2021 AND FIVE EPISODES OF ACUTE COVID-19 SOME BEFORE AND AFTER FAILED VACCINATION.  DEVELOPED COVID-19 VACCINE INDUCED LARGE AMPLITUDE INVOLUNTARY TREMORS OF ALL FOUR EXTREMITIES.  DEVELOPED COVID-19 VACCINE INDUCE POLYARTHROPATHY.  TREATED WITH HYDROXYCHLOROQUINE FOR TWO YEARS.   NEUROLOGIC VACCINE INJURY TREATED WITH CYMBALTA, IVERMECTIN, NICOTINE PATCH AND PROTOCOL BASE SPIKE DETOXIFICATION.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction, Laboratory test, Nervous system disorder, Tremor, Vaccination failure
Clinical narrative: JANSSEN 0/12/2021 AND FIVE EPISODES OF ACUTE COVID-19 SOME BEFORE AND AFTER FAILED VACCINATION.  DEVELOPED COVID-19 VACCINE INDUCED LARGE AMPLITUDE INVOLUNTARY TREMORS OF ALL FOUR EXTREMITIES.  DEVELOPED COVID-19 VACCINE INDUCE POLYARTHROPATHY.  TREATED WITH HYDROXYCHLOROQUINE FOR TWO YEARS.   NEUROLOGIC VACCINE INJURY TREATED WITH CYMBALTA, IVERMECTIN, NICOTINE PATCH AND PROTOCOL BASE SPIKE DETOXIFICATION.
Age: 63.0
Sex: F
Vaccine: UNK
Symptoms: Arthralgia, Blood test normal, Electromyogram normal, Eosinophil count normal, Hypoaesthesia
Clinical narrative: Patient is a 64 year old female with a history of cervical radiculopathy, knee osteoarthritis who presents with vaccine adverse reaction:   # Possible Vaccine Allergy: December 6, 2023, the patient received the RSV vaccine (Arexvy) and seven days later began experiencing persistent pain localized in the shoulder and hip. She described waking up with pain radiating from her shoulder blades into her neck and arms, along with discomfort in her right groin, thighs, and back. Notably, there was no joint swelling, rash, fever, angioedema, or respiratory symptoms such as SOB or wheezing. Normal inflammatory markers in blood tests conducted on January 30. Negative evaluations for autoimmune conditions by rheumatology. The patient experienced significant pain relief with high-dose prednisone and at one point was taking daily prednisone. Treatments including prednisone trials and steroid injections provided varying degrees of relief. She is following with orthopedic surgery. Completed course of PT. Current management now involving Meloxicam as needed. The patient also has a history of right C5-6 spinal stenosis. She reports recent symptoms of left shoulder/arm numbness and right wrist/hand numbness. EMG showed bilateral median nerve neuropathy which was mild. Seen by neurosurgery who did not recommend surgical intervention.   Hx of right knee ACL tear and meniscal repairs. Has right knee osteoarthritis and recommended for right knee replacement surgery. She denies any other significant joint pain prior to this episode.    Pfizer COVID-19 vaccine caused tender axillary lymphadenopathy that lasted for several days. Tolerates annual flu vaccines. No other previous adverse reactions to vaccines.   Medical record reviewed and summarized as follows: 6/19/24 Neurosurgery Office Visit: Patient presented with neck pain radiating to shoulder and digits bilaterally, following RSV vaccination on 12/06/2023. Imaging shows mild right C5-6 spinal stenosis, but EMG was negative. Rheumatology workup was negative. ESI at C7-T1 provided minimal relief, but shoulder injection improved symptoms after 2-3 weeks. Neurosurgeon suspects athralgia possibly due to immune response to vaccine, rather than spinal issue. Surgery not recommended at this time. Patient referred to immunology for further evaluation of potential etiology. Meloxicam trial suggested for symptom management.
Age: 63.0
Sex: F
Vaccine: UNK
Symptoms: Inflammatory marker test, Neck pain, Neuropathy peripheral, Pain
Clinical narrative: Patient is a 64 year old female with a history of cervical radiculopathy, knee osteoarthritis who presents with vaccine adverse reaction:   # Possible Vaccine Allergy: December 6, 2023, the patient received the RSV vaccine (Arexvy) and seven days later began experiencing persistent pain localized in the shoulder and hip. She described waking up with pain radiating from her shoulder blades into her neck and arms, along with discomfort in her right groin, thighs, and back. Notably, there was no joint swelling, rash, fever, angioedema, or respiratory symptoms such as SOB or wheezing. Normal inflammatory markers in blood tests conducted on January 30. Negative evaluations for autoimmune conditions by rheumatology. The patient experienced significant pain relief with high-dose prednisone and at one point was taking daily prednisone. Treatments including prednisone trials and steroid injections provided varying degrees of relief. She is following with orthopedic surgery. Completed course of PT. Current management now involving Meloxicam as needed. The patient also has a history of right C5-6 spinal stenosis. She reports recent symptoms of left shoulder/arm numbness and right wrist/hand numbness. EMG showed bilateral median nerve neuropathy which was mild. Seen by neurosurgery who did not recommend surgical intervention.   Hx of right knee ACL tear and meniscal repairs. Has right knee osteoarthritis and recommended for right knee replacement surgery. She denies any other significant joint pain prior to this episode.    Pfizer COVID-19 vaccine caused tender axillary lymphadenopathy that lasted for several days. Tolerates annual flu vaccines. No other previous adverse reactions to vaccines.   Medical record reviewed and summarized as follows: 6/19/24 Neurosurgery Office Visit: Patient presented with neck pain radiating to shoulder and digits bilaterally, following RSV vaccination on 12/06/2023. Imaging shows mild right C5-6 spinal stenosis, but EMG was negative. Rheumatology workup was negative. ESI at C7-T1 provided minimal relief, but shoulder injection improved symptoms after 2-3 weeks. Neurosurgeon suspects athralgia possibly due to immune response to vaccine, rather than spinal issue. Surgery not recommended at this time. Patient referred to immunology for further evaluation of potential etiology. Meloxicam trial suggested for symptom management.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Lip ulceration, Mouth ulceration, Oral pain, Oropharyngeal pain, Pyrexia
Clinical narrative: 24 hours after vaccination patient experienced low grade fever which resolved by 48 hours. On 7/17 patient began complaining of throat/mouth pain. When examined patient has mouth ulcers throughout the mouth and one on the inner lip.  No lesions elsewhere on the body. Still present today 7 days post vaccination, no other known contributing factors or signs of illness.  Continuing to monitor symptom resolution.
Age: 40.0
Sex: M
Vaccine: ANTH
Symptoms: Anxiety, Axillary mass, Chromaturia, Condition aggravated, Dizziness
Clinical narrative: Full body aches within 18hours. Lump at injection site. Lump under armpit. Dizzy, nauseous, headache all that first 2 nights. About 24 hours in eyes were yellow and urine was dark.  All these symptoms went away with OTC ibuprofen and advil by day 3.  However, my anxiety as been far worse every day since. Spoke with someone from Agency and they said it's normal and to talk to my own doctor about anxiety. I saw a doctor who has now put me on Lorazepam along with currently taking my citalopram.
Age: 40.0
Sex: M
Vaccine: ANTH
Symptoms: Eyelash discolouration, Headache, Injection site mass, Nausea, Rash
Clinical narrative: Full body aches within 18hours. Lump at injection site. Lump under armpit. Dizzy, nauseous, headache all that first 2 nights. About 24 hours in eyes were yellow and urine was dark.  All these symptoms went away with OTC ibuprofen and advil by day 3.  However, my anxiety as been far worse every day since. Spoke with someone from Agency and they said it's normal and to talk to my own doctor about anxiety. I saw a doctor who has now put me on Lorazepam along with currently taking my citalopram.