chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.25
Sex: F
Vaccine: UNK
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: administration of Pentacel that has expired on 07Oct2023 to a patient today with no reported adverse event; Initial information was received on 10-Oct-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 15 months old female patient who was treated with diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine [PENTACEL (VERO)] that has expired on 07oct2023 to a patient today 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 hepatitis a vaccine and influenza vaccine for Immunisation.  On 10-Oct-2023, the patient received 0.5 ml, 1X (total) of suspect diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine, suspension for injection (lot UJ804AA, expiry-07-10-23 and strength: unknown) via intramuscular route in left leg  on  07oct2023 given to a patient today with no reported adverse event (expired product administered) (latency same day) for prophylactic immunization (immunization).  Action taken: not applicable.  At time of reporting, the outcome.  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: 1.33
Sex: U
Vaccine: MMR, MMRV
Symptoms: Product use issue, Wrong product administered
Clinical narrative: No side effects were reported by HCP; 16-month-old child received inadvertently both MMR II and PROQUAD the same day on 10/11/2023; patient should have received MMR II and VARIVAX; This spontaneous report was received from a medical assistant referring to a 16-month-old patient of unknown age. The patient's medical history, historical drugs, past drug reactions or allergies, concurrent conditions, and concomitant drugs were not reported.   On 11-OCT-2023, the patient received 1 dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (rHA) injection (lot#: W029554, expiration date was reported as 18-FEB-2024 but upon internal validation indicated as 14-MAR-2024; strength and route of administration were not reported) for prophylaxis and 1 dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (rHA) injection (lot#: W039972, expiration date: 02-JUN-2024; strength and route of administration were not reported) for prophylaxis inadvertently (accidental overdose). The patient should have received Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) and varicella virus vaccine live (Oka/Merck) (VARIVAX) (wrong product administered). No side effects were reported (no adverse event).
Age: 69.0
Sex: F
Vaccine: UNK
Symptoms: Dizziness, Fatigue, Feeling cold, Injection site pain, Injection site swelling
Clinical narrative: very dizzy; tired and achy/aches and pains; felt cold; tired and achy/ very fatigued; joint pain/ joint pains; low grade temperature all day; body aches; headache; swelling and had residual soreness at the injection site; soreness at the injection site; This spontaneous case was reported by a patient and describes the occurrence of PAIN (tired and achy/aches and pains), FEELING COLD (felt cold), DIZZINESS (very dizzy), VACCINATION SITE PAIN (soreness at the injection site) and VACCINATION SITE SWELLING (swelling and had residual soreness at the injection site) in a 69-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-Oct-2023, the patient received fourth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 06-Oct-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced VACCINATION SITE PAIN (soreness at the injection site). On 07-Oct-2023, the patient experienced VACCINATION SITE SWELLING (swelling and had residual soreness at the injection site). On 08-Oct-2023, the patient experienced HEADACHE (headache). On 09-Oct-2023, the patient experienced PAIN (tired and achy/aches and pains), FEELING COLD (felt cold), FATIGUE (tired and achy/ very fatigued), ARTHRALGIA (joint pain/ joint pains), PYREXIA (low grade temperature all day) and MYALGIA (body aches). On 11-Oct-2023, the patient experienced DIZZINESS (very dizzy). The patient was treated with PARACETAMOL (TYLENOL) on 08-Oct-2023 at a dose of 2 Tylenol 500mg; PARACETAMOL (TYLENOL) on 09-Oct-2023 at a dose of two Tylenol 500mg tablets and PARACETAMOL (TYLENOL) on 10-Oct-2023 at a dose of two Tylenol 500mg tablets. At the time of the report, PAIN (tired and achy/aches and pains), FEELING COLD (felt cold), DIZZINESS (very dizzy), VACCINATION SITE PAIN (soreness at the injection site), VACCINATION SITE SWELLING (swelling and had residual soreness at the injection site) and FATIGUE (tired and achy/ very fatigued) had not resolved, HEADACHE (headache), ARTHRALGIA (joint pain/ joint pains) and MYALGIA (body aches) was resolving and PYREXIA (low grade temperature all day) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Oct-2023, Body temperature: low grade temperature all day.         No relevant concomitant medications were reported. The patient received a total of 4 Moderna Covid-19 vaccinations The patient had no adverse reactions to her first 3 Moderna Covid-19 vaccines. On Monday Morning 09-Oct-2023 at 6AM patient woke up with a headache. Patient was tired and achy. Aches and pains joint pain very fatigued. On Tuesday, 10-Oct-2023, patient had a headache and took two Tylenol 500mg tablets and headache got better joint pains, body aches, and fatigue were all less intense. When the patient woke up on Wednesday, 11-Oct-2023, she was very fatigued and could not get out of bed.
Age: 69.0
Sex: F
Vaccine: UNK
Symptoms: Pain
Clinical narrative: very dizzy; tired and achy/aches and pains; felt cold; tired and achy/ very fatigued; joint pain/ joint pains; low grade temperature all day; body aches; headache; swelling and had residual soreness at the injection site; soreness at the injection site; This spontaneous case was reported by a patient and describes the occurrence of PAIN (tired and achy/aches and pains), FEELING COLD (felt cold), DIZZINESS (very dizzy), VACCINATION SITE PAIN (soreness at the injection site) and VACCINATION SITE SWELLING (swelling and had residual soreness at the injection site) in a 69-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-Oct-2023, the patient received fourth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 06-Oct-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced VACCINATION SITE PAIN (soreness at the injection site). On 07-Oct-2023, the patient experienced VACCINATION SITE SWELLING (swelling and had residual soreness at the injection site). On 08-Oct-2023, the patient experienced HEADACHE (headache). On 09-Oct-2023, the patient experienced PAIN (tired and achy/aches and pains), FEELING COLD (felt cold), FATIGUE (tired and achy/ very fatigued), ARTHRALGIA (joint pain/ joint pains), PYREXIA (low grade temperature all day) and MYALGIA (body aches). On 11-Oct-2023, the patient experienced DIZZINESS (very dizzy). The patient was treated with PARACETAMOL (TYLENOL) on 08-Oct-2023 at a dose of 2 Tylenol 500mg; PARACETAMOL (TYLENOL) on 09-Oct-2023 at a dose of two Tylenol 500mg tablets and PARACETAMOL (TYLENOL) on 10-Oct-2023 at a dose of two Tylenol 500mg tablets. At the time of the report, PAIN (tired and achy/aches and pains), FEELING COLD (felt cold), DIZZINESS (very dizzy), VACCINATION SITE PAIN (soreness at the injection site), VACCINATION SITE SWELLING (swelling and had residual soreness at the injection site) and FATIGUE (tired and achy/ very fatigued) had not resolved, HEADACHE (headache), ARTHRALGIA (joint pain/ joint pains) and MYALGIA (body aches) was resolving and PYREXIA (low grade temperature all day) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Oct-2023, Body temperature: low grade temperature all day.         No relevant concomitant medications were reported. The patient received a total of 4 Moderna Covid-19 vaccinations The patient had no adverse reactions to her first 3 Moderna Covid-19 vaccines. On Monday Morning 09-Oct-2023 at 6AM patient woke up with a headache. Patient was tired and achy. Aches and pains joint pain very fatigued. On Tuesday, 10-Oct-2023, patient had a headache and took two Tylenol 500mg tablets and headache got better joint pains, body aches, and fatigue were all less intense. When the patient woke up on Wednesday, 11-Oct-2023, she was very fatigued and could not get out of bed.
Age: 71.0
Sex: F
Vaccine: UNK
Symptoms: Fatigue, Headache, Insomnia, Peripheral swelling, Tinnitus
Clinical narrative: she was not able to sleep; tired; arm swole like a big watermelon, real bad; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (arm swole like a big watermelon, real bad), INSOMNIA (she was not able to sleep), HEADACHE (Headache) and FATIGUE (tired) in a 71-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. 057182496208) for COVID-19 vaccination.     Question:Describe relevant medical history/conditions, allergy, concomitant diseases and risk factor.Answer:Caller has an appointment with their doctor for a wellness appointment and was told she was in excellent health. Allergies to outside in the air, penicillin and sulfa.  Previously administered products included for an unreported indication: MODERNA COVID-19 VACCINE (1st dose: 19-Feb-2021, batch number: 022M20A  2nd dose: 22-Mar-2021, Batch number: 037A21B Booster 2dose: 05-Oct-2021, Batch number: 048F21A  2nd booster: 03-May-2022, batch number: 056A22A  Last one: 14-Oct-202, batch number: 030G22B) and RSV since an unknown date. Past adverse reactions to the above products included No adverse event with RSV. Concurrent medical conditions included Allergy (Air), Penicillin allergy and Drug allergy (Sulfa drugs).    On 10-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 10-Oct-2023, the patient experienced PERIPHERAL SWELLING (arm swole like a big watermelon, real bad) and HEADACHE (Headache). On an unknown date, the patient experienced INSOMNIA (she was not able to sleep) and FATIGUE (tired). At the time of the report, PERIPHERAL SWELLING (arm swole like a big watermelon, real bad) and HEADACHE (Headache) had not resolved and INSOMNIA (she was not able to sleep) and FATIGUE (tired) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medications were reported.  The caller said they had given Moderna since day one, the patient was not able to sleep last night, arm swollen like a big watermelon, really bad and had to get some arm from the freezer to try to diminish the swelling. Caller said she could feel her heartbeat in her head, throbbing. Caller was kind of tired, has a slight headache. Caller reported with her previous doses were just a little discomfort and told it could take the flu or RSV vaccine with the COVID. Caller denied consent to follow up with HCP.   This case was linked to US-MODERNATX, INC.-MOD-2021-291002, US-MODERNATX, INC.-MOD-2021-291257 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-291002:same reporter, different dose US-MODERNATX, INC.-MOD-2021-291257:same reporter, different dose
Age: 0.25
Sex: F
Vaccine: UNK
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired PENTACEL vaccine was inadvertently administered with no reported adverse event; Initial information received on 10-Oct-2023 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp (Non-healthcare professional).  This case involves a 4 months old female patient who received expired Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)] inadvertently 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 rotavirus vaccine live reassort oral 5v (rotateq) for immunisation; and pneumococcal vaccine conj 15v (crm197) (vaxneuvance) for immunisation.  On 09-Oct-2023, the patient received 0.5 ml Total (1 X) of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine Suspension for injection (lot number: UJ794AB) (Expiry date: 08-Oct-2023) (Strength: Standard) (Frequency: Once) via intramuscular route in unknown administration site for immunization.  On 09-Oct-2023, the patient received expired Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) vaccine inadvertently with no reported adverse event (expired product administered) (latency: same day).  It was reported, Office manager reports an expired PENTACEL vaccine was inadvertently administered yesterday, 09Oct2023 and that the product expired a day earlier on 08Oct2023. This situation is reported as a medication error due to the administration of an expired vaccine.   Action taken: not applicable.  Outcome: Unknown   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: 68.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Pyrexia, Rash
Clinical narrative: Rash; fever; achey
Age: 14.0
Sex: M
Vaccine: COVID19, FLUA4, COVID19, FLUC3
Symptoms: Urticaria
Clinical narrative: Hives
Age: 14.0
Sex: M
Vaccine: COVID19, FLUA4, COVID19, FLUC3
Symptoms: Product administration error, Urticaria
Clinical narrative: Hives
Age: 4.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Confusional state, Electrocardiogram normal, Electroencephalogram normal, Fall
Clinical narrative: Patient was at daycare, experiencing a typical day, sitting and eating a snack, when she made a sqeak/squeal and her arms first curled and then went straight up overhead. The daycare staff stated patient's entire body when stiff which caused her to push away from the table. She fell back off of chair and landed on left side. Patient had loss of consciousness after the accident for about 30 seconds before becoming alert again. When she was alert, she was confused of what happened, pale, and a little weak feeling. Patient correctly answered all cognitive questions immediately after the incident. Staff also stated patient was afebrile after accident. This incidence prompted her parents to bring her to the ED.
Age: 4.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness, Musculoskeletal stiffness, Pallor
Clinical narrative: Patient was at daycare, experiencing a typical day, sitting and eating a snack, when she made a sqeak/squeal and her arms first curled and then went straight up overhead. The daycare staff stated patient's entire body when stiff which caused her to push away from the table. She fell back off of chair and landed on left side. Patient had loss of consciousness after the accident for about 30 seconds before becoming alert again. When she was alert, she was confused of what happened, pale, and a little weak feeling. Patient correctly answered all cognitive questions immediately after the incident. Staff also stated patient was afebrile after accident. This incidence prompted her parents to bring her to the ED.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Underdose
Clinical narrative: PATIENT PRESENTED TO PHARMACY FOR AN ADULT COVID VACCINATION AND WAS GIVEN A PEDIATRIC DOSE OF THE COVID VACCINE. PRESCRIPTION WAS PROCESSED FOR THE ADULT DOSE BUT WHEN ADMINISTERED THE PEDIATRIC DOSE WAS INADVERTENTLY ADMINISTERED. PER RECOMMENDATIONS AN ADULT COVID DOSE WAS ADMINISTERD THE FOLLOWING DAY. PATIENT EXPERIENCED NO ILL EFFECTS. ADULT DOSE ADMINISTERED 10/3/23.
Age: 21.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Rash, Respiratory tract congestion, Throat tightness
Clinical narrative: Within 10 minutes of receiving the vaccine patient was feeling dizzy and light headed. We gave her a juice and pretzels. She had a few pretzels and then began complaining of throat tightening/feeling congested.  She started to get a rash on her neck, sides of face, and down her back. (ARNP) gave her a shot of 25mg Benadryl. After about 15 to 20 minutes patient gave another dose of Benadryl.  We waited at our location until 4:45 pm and then I (Office Manager) drove her to our local urgent care. Urgent care observed her for 30 minutes and then sent her home. She is doing well.
Age: 10.0
Sex: F
Vaccine: HPV9
Symptoms: Fall, Immediate post-injection reaction, Loss of consciousness, Tremor
Clinical narrative: Patient fell forward off exam table immediately after receiving HPV Gardasil vaccine.   Vaccine administrator was able to catch patient but she did appear to lose consciousness briefly and briefly appeared to be shaking as if seizing.   She regained consciousness and was talking to administrator and parent within 1-2 minutes of this happening.   Blood pressure and vital signs remained stable. She did not hit her head or incur any injuries from the fall.   We had her sit and drink water for about 10 minutes then after that, and she was back to normal.  She left with father who took her home.
Age: 0.75
Sex: F
Vaccine: DTAPHEPBIP, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: none
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Atrial fibrillation, Pericarditis, Psoriasis
Clinical narrative: Pericarditis, Rapid Atrial Fibrillation, Psoriasis
Age: 60.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling, redness at injection site. Chills.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash, Rash, Rash erythematous, Rash pruritic
Clinical narrative: RED ITCHY RASH SPREAD FROM INJECTION SITE, DOWN TO ELBOW AND UP THE SIDE OF THE NECK AND ONTO THE BACK SHOULDER. PATIENT HAD BEEN USING HYDROCORTISONE CREAM 1% TO RELIEVE ITCHING. PATIENT WAS INFORMED TO TRY BENADRYL CREAM ON THE RASH AND TAKE AN ANTI-HISTAMINE.
Age: 43.0
Sex: F
Vaccine: UNK, UNK
Symptoms: Pruritus, Urticaria
Clinical narrative: hives onset the next morning with itching; treated today with steroids/zyrtec/pepci
Age: 28.0
Sex: M
Vaccine: FLU4
Symptoms: Dizziness, Pallor, Syncope, Unresponsive to stimuli
Clinical narrative: * Final Report * Patient presented to influenza mass vaccination site at 0829.  Negative Screening - okay to give vaccine.    0830: Vaccine Administered.  Patient sat down in chair due to 'feeling dizzy' 0831: Patient Syncopal Episode. RN Alerted. Provider entered room, proceeded to assess patient.  Code was initiated due to no patient response.  Patient had pulse and respirations Within 30 seconds, patient was responsive to verbal stimuli. Code Cancelled. No vital signs machine on deck, runner sent. Patient AOx4 - stated no SOB, no trouble breathing. Patient has pale lips.  0836: Nurse remains at chairside, Patient reported no shortness of breath. Reports feeling better. Patient states that he 'has a 50-50 chance to pass out after getting any vaccine.' Patient educated to let staff know this prior to getting another vaccine.  0839: Nurse leaves bedside. Calls report to Dr. Plan for vital signs as soon as the machine arrives and again 30 minutes post-vaccine.   0845: Vitals: 131/81, R 17, SpO2 99%, HR 76, T 98.5.  0910: Vitals: 127/76, R 16, SpO2 99%, HR 79, T 98.9 0915: Patient released back to workspace.  ER precautions given.
Age: 29.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus
Clinical narrative: Full body itching starting 45 minutes after injection. Continued for 2 days.
Age: 32.0
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Patient was 32 weeks pregnant at the time of vaccination. Prescription was sent by patient's MD and pharmacist administered the vaccine. At the time of vaccination, according to state law the patient was not eligible to receive vaccine at the pharmacy even though it is approved for her patient population. Patient has not reported any adverse effects.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema
Clinical narrative: Red Skin rash from injection site down center/left side of forearm to elbow
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: 103-104 degree fever for 24 hours
Age: 65.0
Sex: F
Vaccine: FLUA4
Symptoms: Abdominal pain upper, Chest pain, Cough, Discomfort, Dyspepsia
Clinical narrative: Pt reports patch-like rashes on the arms, legs and neck, runny nose, headache, cough, stomach pain, left-side chest pain described as a feeling of uncomfortable indigestion as if the food or liquids are stuck, increased heart rate, and sore arm. The symptoms peaked one day (10/13/2023 in the afternoon) after receiving the Influenza, quadrivalent, adjuvanted [FLUAD Quadrivalent] vaccine. On Sunday, 10/15/2023 at around 9:30pm, pt reports experiencing left-sided pain feeling as if she is going to have a heart attack.
Age: 65.0
Sex: F
Vaccine: FLUA4
Symptoms: Headache, Heart rate increased, Pain in extremity, Rash, Rhinorrhoea
Clinical narrative: Pt reports patch-like rashes on the arms, legs and neck, runny nose, headache, cough, stomach pain, left-side chest pain described as a feeling of uncomfortable indigestion as if the food or liquids are stuck, increased heart rate, and sore arm. The symptoms peaked one day (10/13/2023 in the afternoon) after receiving the Influenza, quadrivalent, adjuvanted [FLUAD Quadrivalent] vaccine. On Sunday, 10/15/2023 at around 9:30pm, pt reports experiencing left-sided pain feeling as if she is going to have a heart attack.
Age: 20.0
Sex: F
Vaccine: FLUC4
Symptoms: Pruritus
Clinical narrative: Patient began itching right after the shot was administered.  I gave her a benadryl 25mg tablet and she felt okay to leave.  I checked back in with the patient after the clinic and she said that she felt fine.
Age: 71.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Body temperature increased, Chest X-ray, Chills, Electrocardiogram
Clinical narrative: Temp over 103, weakness, chills, and shaking evening of shot. Next morning had severe weakness.
Age: 71.0
Sex: F
Vaccine: FLU4
Symptoms: Tremor, Urine analysis
Clinical narrative: Temp over 103, weakness, chills, and shaking evening of shot. Next morning had severe weakness.
Age: 8.0
Sex: F
Vaccine: HPV9
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Provider meant to order Influenza Vaccine. Inadvertently clicked HPV. Medical Assistant administered HPV to an 8 year old female.
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: Haematochezia
Clinical narrative: blood in stool 1 week after vaccine given, lasted one day , small amount
Age: 58.0
Sex: U
Vaccine: COVID19-2
Symptoms: Pruritus, Pyrexia, Rash, Rash vesicular
Clinical narrative: Patient complained of fever and blistering rash like chickenpox that were all over her body and itching.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site induration, Injection site pruritus
Clinical narrative: Excessive itching at injection site, pain, hard knot about 3-5" in diameter across injection site that lasted approximately 5 days.  Today is day 7.  Only slight knot remains; other symptoms subsided
Age: 33.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Injection site pain
Clinical narrative: After administered the Pfizer Comirnaty XBB 1.5 in the right deltoid writer injected 0.5ml in the left deltoid from a vial of Modrna Spikewav XBB 1.5 that was placed by the previous immunizer in the same basket as the Flulaval vial that was intended to be used instead.  Patient was stable for the watchful waiting period inside the pharmacy after injections administration and reported no adverse events other than injection site soreness upon follow up and reporting the incident to the patient via phone at 10:35pm same evening Oct 15, 2023.  Patient agreed to monitor for any adverse effects and report the same and to accept follow up from writer via phone and or email while he is travelling on a business trip outside the country following day via plan  Writer reported the incident to the pharmacy manager and owner same evening.
Age: 49.0
Sex: F
Vaccine: UNK
Symptoms: Diarrhoea, Headache, Lip swelling, Nausea, Swelling face
Clinical narrative: headache, nausea, face swelling, lip swelling, and diarrhea
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Injection site pain, Nausea, Pain
Clinical narrative: Patient was given an inadvertent dose of Moderna Spikevax COVID-19 vaccine on 10/15/23. Patient had registered and intended to receive an influenza immunization, but was erroneously given a COVID-19 vaccine dose. Patient had received a previous Pfizer/Comirnaty COVID-19 vaccine on 9/21/23. Patient is reporting body aches/pains, general fatigue, feverishness, nausea, headache, and pain/tenderness at the injection site (left arm).
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: Patient was given an inadvertent dose of Moderna Spikevax COVID-19 vaccine on 10/15/23. Patient had registered and intended to receive an influenza immunization, but was erroneously given a COVID-19 vaccine dose. Patient had received a previous Pfizer/Comirnaty COVID-19 vaccine on 9/21/23. Patient is reporting body aches/pains, general fatigue, feverishness, nausea, headache, and pain/tenderness at the injection site (left arm).
Age: 78.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: At about 24+ hr, pruritis, warmth, elevation, about 5 cm around injection site, although not symmetrically, clearly more cephalad, margin slightly irregular.  Mild improvement with triamcinolone. 0.5% bid.  However, due to persistence of symptoms, Keflex 500 mg tid was started.  It was clearly improved, but near next dose symptoms recurred though less intense.  3 days later it is clearly improved but not resolved.  Was this cellulitis and/or covid arm?  I think it was both.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: Patient given high dose flu when she is not over 65
Age: 72.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Pruritus, Rash
Clinical narrative: rash and itching the next day
Age: 82.0
Sex: F
Vaccine: RSV
Symptoms: Arthralgia, Blood magnesium, Blood thyroid stimulating hormone, C-reactive protein, Full blood count
Clinical narrative: generalized body aches for 2 weeks. residual left knee and hip pain that is chronic but worse than her normal. this is now improving.
Age: 82.0
Sex: F
Vaccine: RSV
Symptoms: Metabolic function test, Pain, Red blood cell sedimentation rate
Clinical narrative: generalized body aches for 2 weeks. residual left knee and hip pain that is chronic but worse than her normal. this is now improving.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Diarrhoea, Initial insomnia, Pain
Clinical narrative: Difficulty falling asleep, body aches, loss of appetite, and diarrhea
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Back pain, Blood cholesterol increased, Blood test, Cerebrovascular accident
Clinical narrative: Late February I had headaches. Eye disturbances on the right. I had shoulder and back pain that went back-and-forth. I also had right leg and right foot on the lower end in pain. Has all gone away except I see double now and I have mild headaches since the  VAD and strokes I had an episode where I couldn?t walk. My legs got weak on August 12, 2023 at work. I also gained a headache. The doctor looked at me for a little and said if my headache gets worse to go to the hospital  I went to Hospital around 8 o?clock at night. They did bloodwork, gave me a IV Reglan and Toradol and send me home. I was a hospital working with a patient. I had to leave the room cause I had upper right and left shoulder pain that went away in exactly 20 minutes. My eye disturbances were exactly 20 minutes also. I also had a CAT scan in May 2021 with no contrast showed nothing  NO CONTRAST  MY CHOLESTEROL  was going up. The doctor said my HDL is higher and it should balance out. I think I should?ve been put on medicine. August 13, 2021 in the morning is when it all happened they should have given me TPA in the hospital is what I felt but I was not able to think and I really don?t remember much All in all I felt like I was just getting older and I was not thinking right but that comes with ages is what I thought I also had an episode at work where the screen got fuzzy and I had that eye disturbance again and they did an EKG and also check my blood pressure. It was high. My bullet pressure and I went to the eye doctor downstairs on the second floor and he said both eyes were fine.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram normal, Diplopia, Electrocardiogram, Eye disorder, Gait inability
Clinical narrative: Late February I had headaches. Eye disturbances on the right. I had shoulder and back pain that went back-and-forth. I also had right leg and right foot on the lower end in pain. Has all gone away except I see double now and I have mild headaches since the  VAD and strokes I had an episode where I couldn?t walk. My legs got weak on August 12, 2023 at work. I also gained a headache. The doctor looked at me for a little and said if my headache gets worse to go to the hospital  I went to Hospital around 8 o?clock at night. They did bloodwork, gave me a IV Reglan and Toradol and send me home. I was a hospital working with a patient. I had to leave the room cause I had upper right and left shoulder pain that went away in exactly 20 minutes. My eye disturbances were exactly 20 minutes also. I also had a CAT scan in May 2021 with no contrast showed nothing  NO CONTRAST  MY CHOLESTEROL  was going up. The doctor said my HDL is higher and it should balance out. I think I should?ve been put on medicine. August 13, 2021 in the morning is when it all happened they should have given me TPA in the hospital is what I felt but I was not able to think and I really don?t remember much All in all I felt like I was just getting older and I was not thinking right but that comes with ages is what I thought I also had an episode at work where the screen got fuzzy and I had that eye disturbance again and they did an EKG and also check my blood pressure. It was high. My bullet pressure and I went to the eye doctor downstairs on the second floor and he said both eyes were fine.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, High density lipoprotein increased, Hypertension, Impaired work ability, Injection site pain
Clinical narrative: Late February I had headaches. Eye disturbances on the right. I had shoulder and back pain that went back-and-forth. I also had right leg and right foot on the lower end in pain. Has all gone away except I see double now and I have mild headaches since the  VAD and strokes I had an episode where I couldn?t walk. My legs got weak on August 12, 2023 at work. I also gained a headache. The doctor looked at me for a little and said if my headache gets worse to go to the hospital  I went to Hospital around 8 o?clock at night. They did bloodwork, gave me a IV Reglan and Toradol and send me home. I was a hospital working with a patient. I had to leave the room cause I had upper right and left shoulder pain that went away in exactly 20 minutes. My eye disturbances were exactly 20 minutes also. I also had a CAT scan in May 2021 with no contrast showed nothing  NO CONTRAST  MY CHOLESTEROL  was going up. The doctor said my HDL is higher and it should balance out. I think I should?ve been put on medicine. August 13, 2021 in the morning is when it all happened they should have given me TPA in the hospital is what I felt but I was not able to think and I really don?t remember much All in all I felt like I was just getting older and I was not thinking right but that comes with ages is what I thought I also had an episode at work where the screen got fuzzy and I had that eye disturbance again and they did an EKG and also check my blood pressure. It was high. My bullet pressure and I went to the eye doctor downstairs on the second floor and he said both eyes were fine.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Memory impairment, Muscular weakness, Pain in extremity, Thinking abnormal, Vision blurred
Clinical narrative: Late February I had headaches. Eye disturbances on the right. I had shoulder and back pain that went back-and-forth. I also had right leg and right foot on the lower end in pain. Has all gone away except I see double now and I have mild headaches since the  VAD and strokes I had an episode where I couldn?t walk. My legs got weak on August 12, 2023 at work. I also gained a headache. The doctor looked at me for a little and said if my headache gets worse to go to the hospital  I went to Hospital around 8 o?clock at night. They did bloodwork, gave me a IV Reglan and Toradol and send me home. I was a hospital working with a patient. I had to leave the room cause I had upper right and left shoulder pain that went away in exactly 20 minutes. My eye disturbances were exactly 20 minutes also. I also had a CAT scan in May 2021 with no contrast showed nothing  NO CONTRAST  MY CHOLESTEROL  was going up. The doctor said my HDL is higher and it should balance out. I think I should?ve been put on medicine. August 13, 2021 in the morning is when it all happened they should have given me TPA in the hospital is what I felt but I was not able to think and I really don?t remember much All in all I felt like I was just getting older and I was not thinking right but that comes with ages is what I thought I also had an episode at work where the screen got fuzzy and I had that eye disturbance again and they did an EKG and also check my blood pressure. It was high. My bullet pressure and I went to the eye doctor downstairs on the second floor and he said both eyes were fine.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus, Rash macular
Clinical narrative: Employee received flu vaccine at 1330 and returned to office at 1410 with red blotchy areas on arms and trunk (sternal area).  Neck also red, and employee c/o itching and scratching at skin. Employee denied SOB or any other symptoms. Oxygen sats 98-100%. B/P 140's over 80's. Employee given 25mg benadryl at 1420 and within one half hour, symptoms started improving. Employee pruritis improved, and redness on neck and trunk improved. Employee monitored for one hour after reaction and symptoms improved. VS remained stable.  Employee declined going to ER and went home as was her preference. Spoke with employee for update 4 hours after incident and she denied pruritis and stated redness was resolved. Employee planned to take benadryl as indicated on box x 24 hours.
Age: 94.0
Sex: F
Vaccine: COVID19, FLU4, RSV
Symptoms: Death, Feeling abnormal, Intensive care, Vomiting
Clinical narrative: The 3 vaccines were administered to patient on 10/12/2023 at 11:39 a.m.  She was instructed on common side effects and asked to remain in waiting area for 15 minutes.  Patient then left area with no issues.  That evening, she began feeling bad and saw the facility nurse the next morning for vomiting.  The nurse kept an eye non her until Saturday morning when she was sent to hospital and admitted to ICU.  She then died sometime between then and Monday morning.
Age: 71.0
Sex: F
Vaccine: RSV
Symptoms: Cough, Pyrexia, Secretion discharge
Clinical narrative: Mucus, cough, and fever
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Pain, Peripheral swelling, Pyrexia
Clinical narrative: Chills, diarrhea starting around 3pm 48 hours after shot.  Arm started to swell at that point and because very red and hot.  Followed by fever and aches that lasted into the next day.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Skin reaction, Skin warm
Clinical narrative: Chills, diarrhea starting around 3pm 48 hours after shot.  Arm started to swell at that point and because very red and hot.  Followed by fever and aches that lasted into the next day.
Age: 28.0
Sex: F
Vaccine: HEP, MMR
Symptoms: Exposure during pregnancy
Clinical narrative: Employee was administered Heplisav B on 10/4/23 and MMR on 10/6/23. Prior to both vaccinations the employee was asked the questions on the Screening Checklist for Contraindications to Vaccines for Adults, which includes asking about being pregnant. Both times the employee denied being pregnant. An interpreter was used during these interactions. She was educated to avoid pregnancy for 1 month following vaccination with MMR. On 10/9/23, the employee called notifying EHS that she found out she was pregnant. She spoke with EHS provider, who referred her to OB/GYN for follow up. No known adverse outcomes at this time, but did want to document since pregnancy was a contraindication, but again, employee was asked the screening question for pregnancy prior to administration, which she denied pregnancy both times.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal disorder
Clinical narrative: Patient said that after receiving the Comirnaty on October 6th, she have not been able to move her arm. She called today because it have been 10 days but she did not see any improvement.
Age: 74.0
Sex: F
Vaccine: COVID19-2
Symptoms: Biopsy bone, Biopsy skin, Blood immunoglobulin M increased, Blood test abnormal, Computerised tomogram
Clinical narrative: High Ig M (over 1000) and internal lumps at bottom of my feet from toes to arch and continuing up foot. Caused meniscus to tear while running and can't do tennis, yoga, running etc.  have to be cautious about falling.
Age: 74.0
Sex: F
Vaccine: COVID19-2
Symptoms: Electrophoresis protein, Laboratory test, Limb mass, Loss of personal independence in daily activities, Magnetic resonance imaging
Clinical narrative: High Ig M (over 1000) and internal lumps at bottom of my feet from toes to arch and continuing up foot. Caused meniscus to tear while running and can't do tennis, yoga, running etc.  have to be cautious about falling.
Age: 74.0
Sex: F
Vaccine: COVID19-2
Symptoms: Meniscus injury, Positron emission tomogram
Clinical narrative: High Ig M (over 1000) and internal lumps at bottom of my feet from toes to arch and continuing up foot. Caused meniscus to tear while running and can't do tennis, yoga, running etc.  have to be cautious about falling.
Age: 65.0
Sex: F
Vaccine: FLUA4, RSV
Symptoms: CSF glucose normal, CSF protein normal, CSF red blood cell count positive, CSF white blood cell count increased, Dysstasia
Clinical narrative: Patient received both vaccines at the same time on 10/2/23. Developed bilateral hand numbness on 10/10/23 and it became more persistent the next day. She started to experience some weakness affecting both upper extremities and having foot numbness that progressed to bilateral leg weakness. She was having difficulty ambulating and was using her husbands walker but the weakness progressively worsened.  No issues with vision, no trouble with swallowing, no SOB. Had a mild headache and went to the urgent care on 10/12/23 and was given a shot of ketorolac. Her symptoms became worse where she was unable to stand or walk by herself so she went to the emergency department. Tests determined that she was suffering from Guillain-Barre syndrome
Age: 65.0
Sex: F
Vaccine: FLUA4, RSV
Symptoms: Gait disturbance, Gait inability, Guillain-Barre syndrome, Headache, Hypoaesthesia
Clinical narrative: Patient received both vaccines at the same time on 10/2/23. Developed bilateral hand numbness on 10/10/23 and it became more persistent the next day. She started to experience some weakness affecting both upper extremities and having foot numbness that progressed to bilateral leg weakness. She was having difficulty ambulating and was using her husbands walker but the weakness progressively worsened.  No issues with vision, no trouble with swallowing, no SOB. Had a mild headache and went to the urgent care on 10/12/23 and was given a shot of ketorolac. Her symptoms became worse where she was unable to stand or walk by herself so she went to the emergency department. Tests determined that she was suffering from Guillain-Barre syndrome
Age: 65.0
Sex: F
Vaccine: FLUA4, RSV
Symptoms: Magnetic resonance imaging head abnormal, Magnetic resonance imaging spinal abnormal, Muscular weakness, Spinal osteoarthritis, Vertebral foraminal stenosis
Clinical narrative: Patient received both vaccines at the same time on 10/2/23. Developed bilateral hand numbness on 10/10/23 and it became more persistent the next day. She started to experience some weakness affecting both upper extremities and having foot numbness that progressed to bilateral leg weakness. She was having difficulty ambulating and was using her husbands walker but the weakness progressively worsened.  No issues with vision, no trouble with swallowing, no SOB. Had a mild headache and went to the urgent care on 10/12/23 and was given a shot of ketorolac. Her symptoms became worse where she was unable to stand or walk by herself so she went to the emergency department. Tests determined that she was suffering from Guillain-Barre syndrome
Age: 65.0
Sex: F
Vaccine: FLUA4, RSV
Symptoms: Walking aid user
Clinical narrative: Patient received both vaccines at the same time on 10/2/23. Developed bilateral hand numbness on 10/10/23 and it became more persistent the next day. She started to experience some weakness affecting both upper extremities and having foot numbness that progressed to bilateral leg weakness. She was having difficulty ambulating and was using her husbands walker but the weakness progressively worsened.  No issues with vision, no trouble with swallowing, no SOB. Had a mild headache and went to the urgent care on 10/12/23 and was given a shot of ketorolac. Her symptoms became worse where she was unable to stand or walk by herself so she went to the emergency department. Tests determined that she was suffering from Guillain-Barre syndrome
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Impaired work ability, Insomnia, Loss of personal independence in daily activities
Clinical narrative: Nausea, vomiting, swelling of upper arm, severe upper arm pain, total body ache, loss of appetite, headache, insomnia, fever, chills, inability to work or perform normal daily activities for 2 days.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pain, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: Nausea, vomiting, swelling of upper arm, severe upper arm pain, total body ache, loss of appetite, headache, insomnia, fever, chills, inability to work or perform normal daily activities for 2 days.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Nausea, vomiting, swelling of upper arm, severe upper arm pain, total body ache, loss of appetite, headache, insomnia, fever, chills, inability to work or perform normal daily activities for 2 days.
Age: 8.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age, Underdose, Wrong product administered
Clinical narrative: Child was given the Pfizer Covid 23/24 vaccine for age 6 months to 4 years instead of the correct Covid vaccine for ages 5 to 11
Age: 58.0
Sex: F
Vaccine: COVID19, FLUC4
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Patient had red and warm localized area on left arm and pain that was uncomfortable in area of vaccine and also went further into shoulder which made it difficult to move arm.
Age: 73.0
Sex: F
Vaccine: FLU4
Symptoms: Cellulitis
Clinical narrative: cellulitis noted at specialist apt 2 days later
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: Underdose, Wrong product administered
Clinical narrative: Child is 10 years old and received the Covid 23/24 Pfizer vaccine for ages 6 months to 4 years instead of the correct dose of Covid 5-11 years
Age: 70.0
Sex: F
Vaccine: FLU4, PNC20, VARZOS
Symptoms: Blood glucose normal, Disorientation, Malaise, Vision blurred
Clinical narrative: Patient's caregiver called reporting that patient received 3 vaccines 3 days ago and believes she is having a reaction. She reports the patient as being disoriented, with the inability to write a check or open her phone. She wasn't sure if the patient was eating or drinking as usual. She reports that the patient isn't experiencing any flu like symptoms. The symptoms started today, 2 days after receiving the vaccine. She was unable to provide any additional information as she wasn't with the patient during the phone call. After the call, I immediately called the phone number we have on file to reach the patient for a follow up and to gather additional information. A male caregiver answered the phone and informed us that he believed she was having side effects from receiving 3 vaccines. He reports that the patient had blurry vision today and was disoriented. She was eating and drinking normally, but wasn't feeling well. He reported that she did eat food today and took her insulin and reports that her sugar level was 77.  Advised caregivers to have patient follow up with a physician.
Age: 57.0
Sex: F
Vaccine: FLUR4
Symptoms: Erythema, Headache, Induration, Inflammation, Pruritus
Clinical narrative: inflamed, red, hard, and itchy arm headache
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Psoriasis, Pustular psoriasis, Secretion discharge
Clinical narrative: Patient was administered Moderna Spikevax 12+ at a Pharmacy and experienced severe psoriasis flare-up leading to pustular psoriasis.  Pus secretions were severe and lead to clumping in the hair. The patient experienced severe scalp and head pain for four days and self-administered ibuprofen before being seen by a dermatologist on six days later.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Mobility decreased, Pain, Vaccine positive rechallenge
Clinical narrative: Chest pain that is worse with any movement. This is the same reaction I had with Moderna and was unable to move around for six months and with the Pfizer later for three or four months. There has been no treatment in the past when I was hospitalized with this. Rest is the treatment as far as I know. So rest.
Age: 15.0
Sex: F
Vaccine: FLU4
Symptoms: Loss of consciousness, Nausea, Seizure, Vomiting
Clinical narrative: Patient received flu vaccine and ~3 minutes later appeared to pass out in her chair and convulse. She came to fairly quick and was immediately nauseous and vomited. We observed for 20 minutes and no additional reaction- she felt OK. Left with mother, advised she get future vaccinations at the provider's office to be able to lay down.
Age: 69.0
Sex: F
Vaccine: COVID19, FLUA4
Symptoms: Muscle spasms
Clinical narrative: Patient received a covid and a influenza vaccine in our vaccine clinic.  Within 4 minutes of administration she started to experience intense low back/let cramping.  It lasted a few minutes and then subsided and went away.  She denied any other symptoms during the episode and declined the recommendation she be evaluated by a clinician in our clinic today..