chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 12.0
Sex: M
Vaccine: UNK
Symptoms: Chills, Headache, Injection site erythema, Injection site urticaria, Nausea
Clinical narrative: Sore / sore arm; red welt at injection site; red welt at injection site; High fever; chills; nausea; headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore / sore arm), URTICARIA (red welt at injection site), INJECTION SITE ERYTHEMA (red welt at injection site), PYREXIA (High fever) and CHILLS (chills) in a 12-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 205E23A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 11-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) 1 dosage form. On 12-Oct-2023, the patient experienced PAIN IN EXTREMITY (Sore / sore arm), URTICARIA (red welt at injection site), INJECTION SITE ERYTHEMA (red welt at injection site), PYREXIA (High fever), CHILLS (chills), NAUSEA (nausea) and HEADACHE (headache). At the time of the report, PAIN IN EXTREMITY (Sore / sore arm), URTICARIA (red welt at injection site), INJECTION SITE ERYTHEMA (red welt at injection site), PYREXIA (High fever), CHILLS (chills), NAUSEA (nausea) and HEADACHE (headache) was resolving.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use), the reporter did not provide any causality assessments.   Concomitant medication use information was not provided by reporter.  It was unknown if the patient experienced any additional symptoms/events.  Treatment medication use information was not provided by reporter.
Age: 12.0
Sex: M
Vaccine: UNK
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Sore / sore arm; red welt at injection site; red welt at injection site; High fever; chills; nausea; headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore / sore arm), URTICARIA (red welt at injection site), INJECTION SITE ERYTHEMA (red welt at injection site), PYREXIA (High fever) and CHILLS (chills) in a 12-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 205E23A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 11-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) 1 dosage form. On 12-Oct-2023, the patient experienced PAIN IN EXTREMITY (Sore / sore arm), URTICARIA (red welt at injection site), INJECTION SITE ERYTHEMA (red welt at injection site), PYREXIA (High fever), CHILLS (chills), NAUSEA (nausea) and HEADACHE (headache). At the time of the report, PAIN IN EXTREMITY (Sore / sore arm), URTICARIA (red welt at injection site), INJECTION SITE ERYTHEMA (red welt at injection site), PYREXIA (High fever), CHILLS (chills), NAUSEA (nausea) and HEADACHE (headache) was resolving.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use), the reporter did not provide any causality assessments.   Concomitant medication use information was not provided by reporter.  It was unknown if the patient experienced any additional symptoms/events.  Treatment medication use information was not provided by reporter.
Age: 6.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: FLUZONE HD QIV was administered to children under 18 years of age with no adverse event; Initial information received on 12-Oct-2023 regarding an unsolicited valid non-serious case received from a Nurse.  This case involves a 6 years old female patient and Nurse was administered Influenza Quadrival A-B High Dose Hv Vaccine [Fluzone High-Dose Quadrivalent] to children under 18 years of age with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 11-Oct-2023, the 6 years old female patient received a 0.7 ml dose of suspect Influenza Quadrival A-B High Dose Hv Vaccine (expiry date: unknown, strength: standard, frequency: once and lot U8138CA) via intramuscular route in the right deltoid as Immunization (product administered to patient of inappropriate age) (latency: same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.   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.; Sender's Comments:  US-SA-2023SA317318:01802208
Sex: U
Vaccine: FLU4
Symptoms: Vaccination site bruising
Clinical narrative: bruising at the injection site; Initial information received on 12-Oct-2023 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case is linked to case 2023SA314994(CLUSTER).  This case involves an unknown age and gender patient who had bruising at the injection site after receiving vaccine influenza quadrival A-B high dose HV vaccine [Fluzone High-Dose Quadrivalent].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received unknown dose of suspect influenza quadrival A-B high dose HV vaccine, injection (batch number, expiry date unknown) via unknown route in unknown administration site for prophylactic vaccination (immunization). Information on the batch number was requested.  On an unknown date the patient had bruising at the injection site (vaccination site bruising) (unknown latency) following the administration of influenza quadrival A-B high dose HV vaccine.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (bruising at the injection site).  At time of reporting, the outcome was Unknown for the event bruising at the injection site.  The reporter consented to follow up.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Headache, Myalgia, Nausea
Clinical narrative: Extreme Fever, body aches, stomach ache, nasuea, headache, muscle pain shivering
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: Extreme Fever, body aches, stomach ache, nasuea, headache, muscle pain shivering
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Gait disturbance, Headache
Clinical narrative: Worst headache I ever had.  I very rarely get any headache, this was a whole different kind of pain.  I did not have access to a fever thermometer.  Very low energy, I could barely complete my walk and had only done half the usual 10,000 steps a day.  I fought the pain with the only available medication, aspirin and a can of Coke.  Pain lasted ten hours, then I managed to get to sleep and was OK next day.  I already had 5 Pfizer Covid shots and don't recall an effect like this.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Headache, Pruritus, Urticaria
Clinical narrative: Pt stated she had hives and itching on the back of her neck and upper back on the night of the vaccine administration. She had a headache that started 2 days after administration.  Pt was taking tylenol for the headache and was going to try benadryl cream for the neck and itching. Hives were no longer present on Thursday when pt came into office however, there were still some areas of redness.
Age: 1.0
Sex: M
Vaccine: MMRV, PNC15, VARCEL
Symptoms: Product administration error
Clinical narrative: No (so far); Mother was notified of this error, and given instructions on what to watch for (adverse effects) and to seek medical advice or return to clinic or ER if pt demonstrates any concerning side effects. RN
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Heart rate irregular, Palpitations
Clinical narrative: Heart pounding, discomfort, irregular heart beat confirmed by blood pressure machine
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Expired product administered
Clinical narrative: Patient was administered an expired dose of vaccine. Expiration date was 9-25-23. Parents were informed and vaccine dose was rescheduled in 5 weeks.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Flushing, Heart rate increased
Clinical narrative: After she received her COVID booster she had a sensation of being flushed with elevation of her blood pressure and pulse; she started taking some Benicar at request of physician with some improvement of her symptoms and blood pressure
Age: 6.0
Sex: M
Vaccine: MMR
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Child inadvertently received the second dose of MMR just 2 weeks after the last dose (verses 28 days)
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Decreased appetite, Dizziness, Feeling of body temperature change, Heart rate increased
Clinical narrative: "I received the Covid vaccine at about 11am on Tuesday 10/17/23  and by 2pm i was starting to get nauseated. I finished the day and went home. on the way home i was experiencing rapid heartbeats. I felt like i was going to collapse. I was unable to take public transportation so I called an Uber to take me home. Throughout the night I experienced muscle aches and muscle (all over my body) contractions, cold and hot flashes. I thought I was going to have a heart attack. Today (10/20/23)  I'm still feeling weakness."
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Impaired work ability, Muscle contracture, Myalgia, Nausea
Clinical narrative: "I received the Covid vaccine at about 11am on Tuesday 10/17/23  and by 2pm i was starting to get nauseated. I finished the day and went home. on the way home i was experiencing rapid heartbeats. I felt like i was going to collapse. I was unable to take public transportation so I called an Uber to take me home. Throughout the night I experienced muscle aches and muscle (all over my body) contractions, cold and hot flashes. I thought I was going to have a heart attack. Today (10/20/23)  I'm still feeling weakness."
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Nausea, Pain in extremity
Clinical narrative: Headache, nausea, sore arm
Age: 31.0
Sex: M
Vaccine: FLU4
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Diffuse urticaria and erythematous wheals, between 1-2 cm in size, covering arms, legs, and torso. Rash is worse on back. Mild itching. Taking Benadryl every 4-6 hours.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Gaze palsy, Lymphadenopathy, Nausea, Pain, Pyrexia
Clinical narrative: I have had severe reactions to ALL Covid vaccines since 2021.  body aches, fever, headache, nausea and bad rashes on arm plus swelling of lymph nodes under arm.  I had the current Moderna vaccine on Oct 5, 2023. Yesterday October 19 i noticed a rash beginning on my neck and upper chest.  2 weeks after taking the vacinne!!  A slight rash did develop on left arm but it did not spread.  Now the rash is coming out on my neck and chest!  Rash seems t be getting worse since yesterday (today is Oct 20)  ocassionaly a bit ichy.    never had rash on neck before.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash pruritic
Clinical narrative: I have had severe reactions to ALL Covid vaccines since 2021.  body aches, fever, headache, nausea and bad rashes on arm plus swelling of lymph nodes under arm.  I had the current Moderna vaccine on Oct 5, 2023. Yesterday October 19 i noticed a rash beginning on my neck and upper chest.  2 weeks after taking the vacinne!!  A slight rash did develop on left arm but it did not spread.  Now the rash is coming out on my neck and chest!  Rash seems t be getting worse since yesterday (today is Oct 20)  ocassionaly a bit ichy.    never had rash on neck before.
Age: 67.0
Sex: F
Vaccine: RSV
Symptoms: Arthralgia, Chills, Discomfort, Dizziness, Feeling cold
Clinical narrative: She got her vaccine, nothing immediately until approximately 8 hours later she started getting severe nausea with violent chills.  She had to lie down, put a hot water bottle and had a lot of covers on her.  her temp was 101, went to 102.  She had terrible neck pain, ridig and painful down to her shoulders.  Just terrible terrible nausea.  She took some Tylenol once she knew her temp was 102.  Later on she took Odansetron for nausea, which helped some.  Once her fever came down she was a little better, but was beside herself as she could not get comfortable.  It stopped and she thought she dozed off about 3 hours and at 3:15 she had a flood of nausea again very very bad and felt like she was getting chills again.  S She did not take hre temp again she just stayed in bed.  At 7:00 AM her daughter gave her 2 more Tylenol.  She was also dizzy in the middle of the night when she got up to use the restroom and almost lost her balance.  Felt she was dehydrated and started to drink fluids.  She doesn't feel well this morning, feels about 80% better, but thinks that the worst has passed.  She has not called her doctor.
Age: 67.0
Sex: F
Vaccine: RSV
Symptoms: Malaise, Muscle rigidity, Nausea, Neck pain, Pyrexia
Clinical narrative: She got her vaccine, nothing immediately until approximately 8 hours later she started getting severe nausea with violent chills.  She had to lie down, put a hot water bottle and had a lot of covers on her.  her temp was 101, went to 102.  She had terrible neck pain, ridig and painful down to her shoulders.  Just terrible terrible nausea.  She took some Tylenol once she knew her temp was 102.  Later on she took Odansetron for nausea, which helped some.  Once her fever came down she was a little better, but was beside herself as she could not get comfortable.  It stopped and she thought she dozed off about 3 hours and at 3:15 she had a flood of nausea again very very bad and felt like she was getting chills again.  S She did not take hre temp again she just stayed in bed.  At 7:00 AM her daughter gave her 2 more Tylenol.  She was also dizzy in the middle of the night when she got up to use the restroom and almost lost her balance.  Felt she was dehydrated and started to drink fluids.  She doesn't feel well this morning, feels about 80% better, but thinks that the worst has passed.  She has not called her doctor.
Age: 5.0
Sex: F
Vaccine: HEPA
Symptoms: Erythema, Rash
Clinical narrative: Child received Hep A vaccine only on  8/17/23 at 10:26am. Per mother, child started having symptoms around 7pm on the day of the vaccine. Symptoms include redness and "mosquito-like bites" on the face, neck and shoulders. No fever. Denies any SOB or swelling of the face or throat. Child took over the counter allergy medicine and symptoms subsided in 3 days. Did not go to hospital for any treatment.
Age: 0.5
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, Manufacturing issue
Clinical narrative: More than 0.25ml administered as single dose vials were overfilled by manufacturer.
Age: 1.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Product packaging quantity issue
Clinical narrative: More than 0.25ml administered as single dose vials were overfilled by manufacturer.
Age: 74.0
Sex: M
Vaccine: FLU4
Symptoms: Dizziness, Injection site rash
Clinical narrative: Rash developed on right arm from elbow to the injection mark on the morning of 10/5/23. In addition I had extreme dizziness which continued into he afternoon and evening.
Age: 42.0
Sex: F
Vaccine: FLUC4
Symptoms: Induration, Peripheral swelling, Pyrexia
Clinical narrative: Arm quickly started swelling down to the elbow and patient started running 101-102 temperature 12 hours later. By next day fever was gone, patient was icing the area and taking benadryl for the swelling but arm was still hard feeling and swollen.
Age: 65.0
Sex: F
Vaccine: COVID19-2
Symptoms: Chills, Headache, Injection site pain, Neck pain
Clinical narrative: Chills, Headache, sore neck, tenderness at site
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, Product packaging quantity issue
Clinical narrative: More than 0.25ml administered as single dose vials were overfilled by manufacturer.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient is 63 years old and by accident received the high dose  flu shot recommended for patients 65 and older.
Age: 2.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Product packaging quantity issue
Clinical narrative: More than 0.25ml administered as single dose vials were overfilled by manufacturer.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Patient reports arm became swollen and red. Patient reported to us on 10/20/2023. No actions were taken as her arm is now back to normal, no lingering effects reported
Age: 66.0
Sex: M
Vaccine: PNC20
Symptoms: Ear pain
Clinical narrative: Only symptom is a sore left earlobe.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Hypoaesthesia, Hypoaesthesia oral, Paraesthesia, Paraesthesia oral
Clinical narrative: Head and neck suddenly became very hot. My head, neck, face, particularly my lips, and upper limbs were tingling and numb
Age: 81.0
Sex: F
Vaccine: COVID19, FLUA4
Symptoms: Hypoaesthesia, Pain in extremity, Paraesthesia
Clinical narrative: Pt's sister, called pharmacy to notify us about the patients reaction. Sister asked to remain contact with any questions. Pt received both Fluad and Pfizer Comirnaty (Lot: HF9275, EXP: 12-1-24)  on 10/10/23 IM in the right deltoid. ***Please note, the option box above did not have the Pfizer Comirnaty Covid-19  vaccine as an option and when I tried to select "Other vaccine" and type in the information, the form kept stating I had an error and had to select from the listed options.  4 days after vaccination the patient woke up in the morning with severe pain in the right hand and numbness in the index and middle finger. I instructed sister to have her sister evaluated by a physician and we would report the reaction via VAERS.  Upon follow up with sister on 10/20/23, patient has not seen the doctor. The patient is taking a "wait and see" approach. Per sister, patient said the pain has gone away and she is experiencing more a tingling sensation in the affected fingers that comes and goes. Sister stated she will encourage sister to see a physician if the symptoms do not subside.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Cough, Oral discomfort, Paraesthesia oral, Sleep disorder, Tongue discomfort
Clinical narrative: After receiving the flu vaccine, I've been experiencing intermittent burning tongue and tingling sensations on my tongue/ top of mouth.  I experienced this sensation 2 days prior to testing positive for COVID19 on 12/16/22.  The intermittent burning tongue/ tingling occurred off and on for several months after I tested negative for COVID19 but resolved.   The burning tongue/ tingling returned after receiving the flu vaccine.  The burning tongue/ tingling sensation is disrupting my sleep and causing discomfort to my tongue/ roof of mouth.  The sensation causes me to have intermittent coughing.
Age: 16.0
Sex: M
Vaccine: MENB, TDAP
Symptoms: Seizure, Staring
Clinical narrative: Patient  had two seizures after getting these two vaccinations.  He had one at 2 am on 10/20/2023 and another one at 8:00am.  He has never had more than one seizure in a day.  Each lasted about one minute with the convulsions and then ending with him staring off and then falling asleep. NOT SURE WHICH TYPE OF EACH VACCINE HE ACTUALLY HAD.  The Tdap does not state whether it was Adacel or Boostrix.  The meningococcal states ACWY Vaccine.
Age: 55.0
Sex: F
Vaccine: COVID19, FLUC4
Symptoms: Dysgeusia, Feeling hot, Photopsia
Clinical narrative: Patient was given the Covid vaccination, then the influenza. Immediately thereafter, patient reported feeling hot, having a strange taste in mouth, and seeing sparkles in her eyes. We had the patient lean forward and put her head between her legs. this appeared to alleviate the symptoms. We monitored the patient in the waiting area for 15 minutes, and she reported no residual symptoms. We informed the side effects to her physician.
Age: 41.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pain in extremity
Clinical narrative: Severe arm pain (10 on a scale of 0-10) for first 24 hrs.  Pain persisting 11 days later (3 on scale 0-10).
Age: 27.0
Sex: F
Vaccine: UNK
Symptoms: Injection site bruising, Injection site erythema, Injection site pruritus
Clinical narrative: Pt stated had flu vaccine on 10/18/23 at 0500 to right arm. Pt stated site was ok on 10/18/23. Pt stated when woke up on 10/19/23 at 0630 she noticed a little redness and bruising at injection site. On 10/20/23 she noticed increase in redness at injection site and site was itchy. Pt concerned and will go to Occ. Health to be seen.
Age: 1.0
Sex: M
Vaccine: FLU4, HEPA, HIBV, MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient was given a dose of MMRV instead of MMR.  It had been over a week once it was noticed that a wrong dose had been given. Was discovered while doing inventory. Patient has now received two doses of Varicella in one visit on 10/10/23. There was no reaction with the patient that was discovered.
Age: 5.0
Sex: M
Vaccine: COVID19, FLUC4
Symptoms: Incorrect dose administered, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Moderna for 12+ given to a 5 year old. Parent informed, encouraged to watch for extra side effects and call or have the child be seen if have any concerns. Parent reported child was doing fine at time of call; had been about 2 hours since shot administration.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: The patient was in the office for a routine visit with Dr. She was due for a Pneumovax 23 Vaccination. MA was the administrator. She pulled the vaccine from the back of the shelf, which was the oldest and only expired vaccination in the fridge. Expiration date was missed at the time of the administration. After the patient left the office, she noticed that the expiration date was 9/30/2023. At the time that the patient left the office, no reaction was noticed. The physician was notified of event.  Incident was ruled accidental. Merck was called about the incident, and they researched the vaccination information. Based on the expiration date and the administer date, there is data to support the potency of the drug.  The patient was notified of the incident by the administrator.
Age: 10.0
Sex: F
Vaccine: COVID19, FLUC4
Symptoms: Incorrect dose administered, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Moderna for 12+ given to a 10 year old. Parent informed, encouraged to watch for extra side effects and call or have the child be seen if have any concerns. Parent reported child was doing fine at time of call; had been about 2 hours since shot administration.
Age: 3.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, Manufacturing issue
Clinical narrative: More than 0.25ml administered as single dose vials were overfilled by manufacturer.
Age: 66.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site indentation, Injection site pruritus, Injection site scab, Injection site swelling
Clinical narrative: Patient says she developed a small hole at the site that was itchy- she says she scratched it and then it started to become red.  She says a small bump appeared and she tried not to scratch it anymore but she did in her sleep scratching the bump off and making a scab, she saw NP about it and she said it was not a vaccine reaction but rather from the scratching.   However, patient believes it is possibly caused by the vaccine.   She was advised to use Neosporin on it which she is doing and she said it is healing up but is worried because it is taking so long.  We talked about the signs and symptoms of infection- to watch for worsening or spreading redness, any puss or discharge, any swelling, any fever, any warmth at site.  She said she is not having any of those.  Advised her to see a doctor/ NP again if if she has any of those symptoms or remains concerned.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site pain, Injection site rash, Injection site warmth, Rash erythematous, Rash papular
Clinical narrative: Right arm was warm to touch, raised red rash measuring 8.5 in L x 8in W, tenderness present . Starting 2 inches below right shoulder.  Left arm, warm to touch raised red rash measuring 3in L x 4W, tenderness present. Vaccines were administered on 10/16/2023, mother state during time at home only zytec was administered. Pt was seen in clinic on 10/19/23 for evaluation of reaction by Dr., and second Dr. assessed pt. Treatment: Ibuprofen and Tylenol alternating for discomfort, cool compress. Instructed to continue to monitor adverse reaction, contact office with any changes.
Sex: U
Vaccine: COVID19, FLUA4, RSV
Symptoms: Balance disorder, Dizziness
Clinical narrative: Pt reports a small amount of balance/equilibrium problems and some dizziness. Pt was concerned since was ongoing after 3 days post vaccination and wanted to know if vaccine could be cause and how long this may continue
Age: 24.0
Sex: F
Vaccine: COVID19, FLUC4
Symptoms: Immunisation reaction
Clinical narrative: Idiopathic response after vaccination.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Paraesthesia, Peripheral swelling, Ultrasound Doppler abnormal
Clinical narrative: Vaccine Monday Tingling in the right foot Tuesday Swelling  Wednesday NP visit Thursday increased swelling Friday US confirmed DVT to the popliteal vein
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Headache, Photophobia, Vision blurred, Vitreous floaters
Clinical narrative: Headache, blurry vision and black floaters as well as light sensitivity
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Immunisation reaction, Injection site pain, Injection site reaction, Rash
Clinical narrative: Developed "covid arm" at the injection site which has happened before, this time it was worse and the pain spread to my armpit. I treated the rash with hydrocortisone cream, and the pain subsided in about 3-4 days.
Age: 1.25
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Product packaging quantity issue
Clinical narrative: More than 0.25 ml given as single dose vials were overfilled by manufacturing.
Age: 58.0
Sex: F
Vaccine: COVID19, VARZOS
Symptoms: Skin warm, Urticaria
Clinical narrative: 2 Red welts, warm to touch
Age: 0.5
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, Product packaging quantity issue
Clinical narrative: More than 0.25 ml given as single dose vials were overfilled by manufacturing.
Age: 71.0
Sex: F
Vaccine: RSV
Symptoms: Rash, Skin warm
Clinical narrative: has a  4 inch by 2 inch rash on vaccine arm that is hot to the touch
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Back pain, Chest pain, Headache, Myalgia, Neck pain
Clinical narrative: Pt reported muscle aches (primarily neck/ back/ arm pain), headache, low grade fever (<101.0) 1-2 days after vaccination.   Reports tachycardia & chest pain 1 week after vaccination, had gone to school nurse.
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Pain in extremity, Pyrexia, Tachycardia
Clinical narrative: Pt reported muscle aches (primarily neck/ back/ arm pain), headache, low grade fever (<101.0) 1-2 days after vaccination.   Reports tachycardia & chest pain 1 week after vaccination, had gone to school nurse.
Age: 8.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, Product packaging quantity issue
Clinical narrative: More than 0.25 ml given as single dose vials were overfilled by manufacturing.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Bursitis, Mobility decreased, Pain, Pain in extremity
Clinical narrative: FLU VACCINE SITE - SHOULDER BURSITIS , UNABLE TO ROTATE LEFT ELBOW , RADIATING PAIN ANTERIO SHOULDER, PAIN RADIATIONG TO LEFT LOWER ARM WITH EXRTERNAL AND INTERNAL ROTATION OF LEFT ELBOW
Age: 64.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site reaction, Injection site warmth
Clinical narrative: Evening of 10/12/23 after receiving shot injection site reaction occurred.  A red circular rash about 4" in diameter appeared that was warm to touch.  Patient took some OTC Tylenol and applied ice.  She monitored it over the next week before reporting it to the pharmacy on 10/19/23.  At the time patient reported the reaction the circular rash had faded and was barely visible, but you could still tell where it had been.  She said it was a little bit itchy so recommended that she take benadryl but warned that it may cause drowsiness.
Age: 9.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Manufacturing issue
Clinical narrative: More than 0.25 ml given as single dose vials were overfilled by manufacturing.
Age: 74.0
Sex: F
Vaccine: FLU4
Symptoms: Rash, Rash erythematous
Clinical narrative: Patient developed a rash to bilateral legs on 10/13/23. Has been using Cerave lotion which states has helped the redness but still has the bumps. Plans to call her rheumatologist today and then PCP.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Urticaria
Clinical narrative: HIVES OUTBREAK ON BODY, TREATMENT BENADRYL AND HYDROCORTISONE CREAM AND CETIRIZINE, OUTCOME PENDING.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Vaccination site pruritus, Vaccination site swelling
Clinical narrative: BOTH VACCINATION SITES SWELLED UP TO THE SIZE OF A GOLFBALL, WERE VERY ITCHY
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Fatigue, Headache, Pain
Clinical narrative: All over severe body aches in joints and back, headache lasting 12 hours, fever of 99.0°-101° 14+ hours, extreme fatigue
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: All over severe body aches in joints and back, headache lasting 12 hours, fever of 99.0°-101° 14+ hours, extreme fatigue
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Angiogram pulmonary abnormal, Fibrin D dimer increased, Pulmonary embolism
Clinical narrative: Pulmonary Embolism in LLL and LUL
Age: 66.0
Sex: M
Vaccine: FLU4
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: Patient  inadvertently received Fluarix intravenously (not intramuscularly).  No known adverse effects.
Age: 75.0
Sex: F
Vaccine: FLU4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received Fluarix vaccine at our vaccine clinic, but she had already received a Fluad 65+ vaccination on 9-14-23 No known side effects or problems known  as of 10-20-23  Advised to follow up with her healthcare provider
Age: 68.0
Sex: M
Vaccine: PNC13
Symptoms: Wrong product administered
Clinical narrative: Patient was scheduled for a pneumonia vaccine on nurse schedule. Patient was administered prevnar 13 and should have received prevnar 20. Currently awaiting doctor's guidance on revaccination.
Age: 11.0
Sex: M
Vaccine: TD
Symptoms: Incorrect dose administered
Clinical narrative: 11 year old patient presented to clinic to receive TDaP, which was past due.  The clinical staff member gave the adult dose of Tetanus instead.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Nausea, Rash, Vomiting
Clinical narrative: Patient experienced nausea and vomiting the evening after receiving the vaccine. She also developed a rash on bilateral forearms and hands. Patient states that symptoms resolved after 25mg of oral benadyl. Patient states she did not seek medical attention.
Age: 32.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Administration site pruritus, Dizziness, Lip pruritus, Pruritus, Urticaria
Clinical narrative: 10/20/2023-Flu vaccine and COVID booster admin at approx 1000.  Employee returned to the Occ Health office at 1015 with c/o itching at flu admin site and right arm.  Hives noted to R arm and chest.  Employee denied SOB.  Benadryl 25mg po given per S.O.  Employee remained in Occ Health for observation.  BP 122/84, pulse 76.  EE c/o itching to lips, denies SOB.  Additional dose of Benadryl 25mg po given.  Employee drinking water.  Rechecked BP at 1030.  BP 127/85, Pulse 75, lungs clear.  Employee reports feeling slightly dizzy.  Employee declines to go to ER.  S/s resolved at 1050.  Employee left work with family to go home and rest.
Age: 52.0
Sex: M
Vaccine: COVID19, FLUC4
Symptoms: Influenza like illness, Muscular weakness
Clinical narrative: Sick with flu like symptoms for two days after vaccine.   One month later, there is still a noticeable weakness in the arm that was used for the vaccination.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased
Clinical narrative: My blood pressure started spiking as high as 146/77 or 80+ . I have not had previous issues with high blood pressure. It has remained higher than usual, often going back to more than 140 systolic.  If I lie down and close my eyes it returns to normal, but has continued more than 24 hours now. Kaiser doctor's office thinks it's a reaction to the vaccine.
Age: 36.0
Sex: F
Vaccine: PNC20
Symptoms: Flushing, Pruritus, Throat irritation
Clinical narrative: Throat itchiness followed by flushing and full body itchiness. Took 3 benadryl.
Age: 82.0
Sex: F
Vaccine: TDAP
Symptoms: Confusional state, Dysarthria
Clinical narrative: Husband presented to the Health Department on 10/20/2023 to report that patient began with confusion and "not making sense" with her speech at approximately at 6PM 10/18/23. The symptoms continued into the next day (10/19/23) and status had returned to normal by AM of 10/20/2023. She had received the Tdap vaccine at 12 noon on 10/18/2023. She and completed the 15-minute post-vaccination observation period without any complaints or adverse effects.
Age: 32.0
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Product use issue, Wrong product administered
Clinical narrative: Pt is 34 weeks pregnant and came in for new RSV vaccine (Abrysvo) but received Arexvy in error. There are no contraindications of use for Arexvy in pregnant patients, but it is not approved for administration, so patient was concerned. We did submit the appropriate paperwork to our risk management department and apologized to the patient. We are now waiting for clinical guidance from our clinical services team. Pharmacy staff is now being coached to prevent any future errors like this.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: Patient reported events of palpitations after receiving the pfizer covid vaccine in July 2023. These palpitations lasted for about a month. they would happen when the patient would walk or exercise. Palpitations started almost immediately after receiving it and lasted just for a month.
Age: 52.0
Sex: F
Vaccine: RSV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient did not have an adverse reaction to vaccine - reporting for charting purposes  Patient received RSV vaccine too early - she is aged 52 and the recommended dosage is for 60 years old and older.  Nursing called patient 10/20/23 to notify of invalid vaccine adminstration and to check for symptoms of an adverse reaction. Patient stated that she feels fine and never had any problems - no site soreness, color changes to skin, no fever or feelings of "illness"
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Diarrhoea, Diarrhoea haemorrhagic, Faecaloma, Hypophagia, Infant irritability
Clinical narrative: Intussusception. On 10/12/23 had 8 episodes of runny, mucous, non-bloody diarrhea. On 10/13 had streaks of blood in the diarrhea. Parents reported fever to 101.3, fussiness, decreased oral intake. No emesis or sick contacts at home. Went to urgent care 10/13 and found to be afebrile, fussy, with bloody diarrhea in diaper. Was sent to ED. KUB in ED revealed intussusception vs stool burden. RLQ ultrasound revealed small bowel-small bowel intussusception, that spontaneously resolved by end of exam. Pediatric surgery determined no surgical intervention was required. Patient discharged home 10/13.
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Intussusception, Pyrexia, Ultrasound abdomen abnormal, Urinary tract imaging abnormal
Clinical narrative: Intussusception. On 10/12/23 had 8 episodes of runny, mucous, non-bloody diarrhea. On 10/13 had streaks of blood in the diarrhea. Parents reported fever to 101.3, fussiness, decreased oral intake. No emesis or sick contacts at home. Went to urgent care 10/13 and found to be afebrile, fussy, with bloody diarrhea in diaper. Was sent to ED. KUB in ED revealed intussusception vs stool burden. RLQ ultrasound revealed small bowel-small bowel intussusception, that spontaneously resolved by end of exam. Pediatric surgery determined no surgical intervention was required. Patient discharged home 10/13.
Age: 73.0
Sex: F
Vaccine: COVID19-2
Symptoms: Asthenia, Dizziness, Headache, Mobility decreased, Pain
Clinical narrative: Fever (101), overall extreme body aches, severe headache, body weakness, light headedness, severity of symptoms such that I had to go to bed and stay there lying as still as possible through that day (symptoms began later in the day of vaccination) and all the next
Age: 73.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pyrexia
Clinical narrative: Fever (101), overall extreme body aches, severe headache, body weakness, light headedness, severity of symptoms such that I had to go to bed and stay there lying as still as possible through that day (symptoms began later in the day of vaccination) and all the next
Age: 77.0
Sex: F
Vaccine: COVID19-2
Symptoms: Chills, Erythema, Peripheral swelling
Clinical narrative: Severe chills first night, arm red and swollen from shoulder to elbow 2 days later
Age: 69.0
Sex: F
Vaccine: COVID19, RSV
Symptoms: Decreased appetite, Disorientation, Fear, Gait disturbance, Hyperhidrosis
Clinical narrative: She got her vaccines, the right arm vaccine hurt, it was painful.  She was fine at home, both arms were sore from the shots.  Then she could not sleep at night, she tossed and turned and then got up for a while and was walking sideways like she was drunk.  She was scared as she was wanting to know if she was dying or not.  She would switch from the bed to the couch and her clothes were wet from perspiration.  She had no appetite Thursday or today.  She was disoriened, still not 100% but glad that she is alive.  She drove to the pharmacy today and pulled into the wrong parking lot and wrong business, and then went over the curb leaving the Pharmacy.  She took 2 Ibuprofen in the middle of the night which seemed to help.  She did not talk to her daughter, she just talked to the pharmacy who told her to contact us and report it.    She did have a reaction to the shingles vaccine, the 2nd one.
Age: 69.0
Sex: F
Vaccine: COVID19, RSV
Symptoms: Impaired driving ability, Insomnia, Pain in extremity, Poor quality sleep, Vaccination site pain
Clinical narrative: She got her vaccines, the right arm vaccine hurt, it was painful.  She was fine at home, both arms were sore from the shots.  Then she could not sleep at night, she tossed and turned and then got up for a while and was walking sideways like she was drunk.  She was scared as she was wanting to know if she was dying or not.  She would switch from the bed to the couch and her clothes were wet from perspiration.  She had no appetite Thursday or today.  She was disoriened, still not 100% but glad that she is alive.  She drove to the pharmacy today and pulled into the wrong parking lot and wrong business, and then went over the curb leaving the Pharmacy.  She took 2 Ibuprofen in the middle of the night which seemed to help.  She did not talk to her daughter, she just talked to the pharmacy who told her to contact us and report it.    She did have a reaction to the shingles vaccine, the 2nd one.
Age: 60.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Arthralgia, Injected limb mobility decreased, Injection site bruising, Musculoskeletal stiffness, Neck pain
Clinical narrative: I had the flu vaccine in my left arm and the covid vaccine in my right arm on Friday 10/13/2023. The next day I had what I felt was normal soreness. Later that evening my left arm pain intensified beyond normal. By Sunday 10/15/2023, my arm was swollen, and I could not lift my arm above my head. The pain spread from my shoulder through my neck. On Monday I noted a large bruise covering my deltoid, and halfway through my bicep. Since then, the bruise has turned darker and covered my shoulder down to my elbow. As of Friday 10/20/2023 , I still have  intense pain and stiffness with limited motion.
Age: 60.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Pain in extremity, Peripheral swelling, X-ray normal
Clinical narrative: I had the flu vaccine in my left arm and the covid vaccine in my right arm on Friday 10/13/2023. The next day I had what I felt was normal soreness. Later that evening my left arm pain intensified beyond normal. By Sunday 10/15/2023, my arm was swollen, and I could not lift my arm above my head. The pain spread from my shoulder through my neck. On Monday I noted a large bruise covering my deltoid, and halfway through my bicep. Since then, the bruise has turned darker and covered my shoulder down to my elbow. As of Friday 10/20/2023 , I still have  intense pain and stiffness with limited motion.
Age: 67.0
Sex: M
Vaccine: FLUA4
Symptoms: Extra dose administered
Clinical narrative: Patient had already received a high-dose flu shot on 09/26/23 and received a second high-dose flu shot on 10/20/23.
Sex: M
Vaccine: HPV9
Symptoms: Tremor
Clinical narrative: hands were shaking; This spontaneous report was received from a nurse practitioner referred to an 18-year-old male patient. The patient's medical history, concurrent conditions, concomitant therapies were not reported. Concomitant therapy included unspecified COVID-19 shot.  On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, as prophylaxis (dose, strength, lot #, expiry date, and route of administration were not provided).   On an unknown date, after getting this shot the patient's hands were shaking (tremor). The patient had a COVID19 shot on an unknown date. The patient's mother did not clarify when the shaking began and/or if the COVID 19 shot was administered on the same visit. It was unknown whether treatment was given to the patient for event. At the time of reporting, the outcome of the event tremor was unknown. The action taken with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) regarding tremor was not applicable.   The causal relationship between tremor and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was unknown.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; VAQTA was administered after temperature excursion; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant therapies were not reported.  On 30-AUG-2023, the patient was vaccinated with improperly stored dose (product storage error) of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, 1 dose, lot # reported as: Y3ME2, expiration date reported as: 23-FEB-2025, administered for prophylaxis (exact dose, formulation, site and route of administration were not provided) by a healthcare provider. Temperature excursion details: 8.9 degree Celsius for 12 hours and 20 minutes (14-AUG-2023), 9.4 degree Celsius for 8 hours and 20 minutes (28-AUG-2023); no previous temperature excursions. There was no additional adverse event reported.   Lot number Y3ME2 is an invalid lot number for hepatitis a vaccine, inactivated (VAQTA).
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; TE with VARIVAX, Improperly stored; This spontaneous report has been received from a medical assistant referring to a 4-year-old patient of unknown gender. The patient's medical history, historical drugs, past drug reactions or allergies, concurrent conditions, and concomitant drugs were not reported.   On 21-SEP-2023, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) injection (0.5 mL; lot# W018825 has been verified to be a valid lot number and expiration date was 14-JUN-2024; strength, and route of administration were not reported) for prophylaxis. The vaccine administered was improperly stored and experienced temperature excursion (TE) (product storage error). No adverse effects were reported (no adverse event).    This is one of twenty reports received from the same reporter.; Sender's Comments:  US-009507513-2310USA007229: US-009507513-2310USA004910: US-009507513-2310USA007057: US-009507513-2310USA007161: US-009507513-2310USA005031: US-009507513-2310USA007286: US-009507513-2310USA007121: US-009507513-2310USA007332: US-009507513-2310USA007059: US-009507513-2310USA006693: US-009507513-2310USA007217: US-009507513-2310USA007118: US-009507513-2310USA007066: US-009507513-2310USA005525: US-009507513-2310USA005744: US-009507513-2310USA005372: US-009507513-2310USA007218: US-009507513-2310USA008042: US-009507513-2310USA007123:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: improperly stored VARIVAX were administered to patients.; no additional adverse events were reported; This spontaneous report was received from an Office Manager referring to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant therapy and drug reactions or allergies were provided.  On an unknown date, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # W039294 and expiration date: 11-DEC-2024 (strength, dose, dose number, route and anatomical location were not provided) for prophylaxis. No adverse event reported.  The temperature excursion was 17.4°F during 2 hours 0 minutes 0 seconds and there was no previous temperature excursion.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; VARIVAX was administered during a T/E; This spontaneous report was received from a nurse, regarding to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, and previous drug reactions or allergies were not reported.  On 16-OCT-2023, the patient was vaccinated with an improperly stored dose of with improperly storage dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) injection, for prophylaxis (lot number: X010525, which has been verified to be valid, expiration date reported and validated as 11-APR-2025) (strength, dose, vaccination scheme, route of administration, and anatomical site of injection were not reported).   Administered dose was stored at a temperature of 12.5 degrees degrees Fahrenheit (F), during a time frame of 25 minutes (product storage error).   No additional adverse events were reported in the patient.