chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.75
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Product preparation issue
Clinical narrative: The MA that drew up the vaccine did not add the HIB lyophilized component to the DTaP and IPV. Patient received the injection and afterward, the MA realized there was the powdered HIB that she did not add. Provider was notified and family has been contacted.  Patient will need to return to the clinic to receive a single dose of ActHIB to be fully immunized.
Age: 74.0
Sex: M
Vaccine: TDAP
Symptoms: Myalgia, Pain
Clinical narrative: R deltoid muscle when lifting arm 1 week following vaccine. 5/10 pain when moving. Constant for the last month.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Blindness unilateral, Cough, Eye infection, Eye pain, Vitreous floaters
Clinical narrative: Black dot appeared in right eye, called a ?floater. I?ve never had eye problems until I got the vaccine. Shortly after this occurred I also nearly completely lost my vision for 24 hours with a completely painful eye infection that I was told ?was a side effect of a cough?
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Patient had redness, itchiness, and warm to the touch on injection site
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Pain in extremity
Clinical narrative: Severe lower back pain that lasted 12 days and incapacitated me. After 5 days of feeling better the pain returned. The pain moved from my lower back to my hips and legs.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Rash, Rash papular
Clinical narrative: Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Rash Generalized-Medium, Additional Details: Raised body rash on trunk, arms and legs. Told patient to take benadryl and go see doctor.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild
Age: 69.0
Sex: F
Vaccine: RSV
Symptoms: Fatigue, Headache, Hypersensitivity, Injection site bruising, Injection site pain
Clinical narrative: Site: Bruising at Injection Site-Mild, Site: Pain at Injection Site-Severe, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: Exhaustion / Lethargy-Medium, Systemic: upper right arm feels hot-Medium, Systemic: Headache-Medium, Systemic: Unable to Sleep-Medium, Other Vaccines:  VaccineTypeBrand: COVID Moderna Spikevax; Manufacturer: Moderna; LotNumber: 203J23A; Route: IM; BodySite: Left arm deltoid; Dose: ; VaxDate: UNKNOWN
Age: 69.0
Sex: F
Vaccine: RSV
Symptoms: Injection site swelling, Insomnia, Lethargy, Rash, Skin warm
Clinical narrative: Site: Bruising at Injection Site-Mild, Site: Pain at Injection Site-Severe, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: Exhaustion / Lethargy-Medium, Systemic: upper right arm feels hot-Medium, Systemic: Headache-Medium, Systemic: Unable to Sleep-Medium, Other Vaccines:  VaccineTypeBrand: COVID Moderna Spikevax; Manufacturer: Moderna; LotNumber: 203J23A; Route: IM; BodySite: Left arm deltoid; Dose: ; VaxDate: UNKNOWN
Age: 38.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: pain at injection site, swelling at injection site, muscle soreness at injection site
Age: 29.0
Sex: M
Vaccine: COVID19-2
Symptoms: Hypoaesthesia, Muscular weakness, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Mild, Systemic: Numbness (specify: facial area, extremities)-Mild, Systemic: Weakness-Mild, Additional Details: Patient received Moderna Bivalent Covid shot. Patient was instructed to sit for 15 minutes, but patient said they felt fine and went to leave. Few minutes passed and patient found themselves on a chair, reporting weakness and numbness in arms.
Age: 52.0
Sex: F
Vaccine: COVID19-2
Symptoms: Arthralgia, Injection site pain, Injection site swelling, Weight bearing difficulty
Clinical narrative: Site: Pain at Injection Site-Medium, Systemic: Joint Pain-Medium, Additional Details: Patient states she is experiencing continued pain and slight swelling through out her left arm with most of the pain localized around elbow. She also states that she is now limited in how much weight she can carry/lift with left arm as compared to before vaccination.
Age: 18.0
Sex: F
Vaccine: COVID19-2
Symptoms: Arthralgia, Injected limb mobility decreased, Injection site pain, Pain in extremity
Clinical narrative: Site: Pain at Injection Site-Medium, Systemic: Joint Pain-Medium, Additional Details: Continued pain throughout left arm and limited ability to lift objects with affected arm
Age: 70.0
Sex: F
Vaccine: COVID19-2
Symptoms: Joint injury, Limb injury
Clinical narrative: Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-
Age: 22.0
Sex: M
Vaccine: COVID19-2
Symptoms: Dizziness, Dyskinesia, Hypotonia, Immediate post-injection reaction, Nausea
Clinical narrative: Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Shakiness-Severe, Systemic: Vomiting-Mild, Additional Details: Patient let me know ahead of time that he usually does develop syncope from vaccines but it is usually mild.  he received a flu and covid vaccine, w/father. immediately after his body went limp and his head tilted to the side. His father attempted to bring him back to, but he made a sound as though he were snoring. He jerked back almost seizure like and i prevented his head from hitting the wall. He came to and was nauseous and left under his own power after 20 min. declined 911 call., Other Vaccines:  VaccineTypeBrand: fluzone quadrivalent; Manufacturer: sanofi pasteur; LotNumber: u8070ba; Route: im; BodySite: left deltoid; Dose: ; VaxDate: UNKNOWN
Age: 22.0
Sex: M
Vaccine: COVID19-2
Symptoms: Posture abnormal, Syncope, Tremor, Unresponsive to stimuli, Vomiting
Clinical narrative: Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Shakiness-Severe, Systemic: Vomiting-Mild, Additional Details: Patient let me know ahead of time that he usually does develop syncope from vaccines but it is usually mild.  he received a flu and covid vaccine, w/father. immediately after his body went limp and his head tilted to the side. His father attempted to bring him back to, but he made a sound as though he were snoring. He jerked back almost seizure like and i prevented his head from hitting the wall. He came to and was nauseous and left under his own power after 20 min. declined 911 call., Other Vaccines:  VaccineTypeBrand: fluzone quadrivalent; Manufacturer: sanofi pasteur; LotNumber: u8070ba; Route: im; BodySite: left deltoid; Dose: ; VaxDate: UNKNOWN
Age: 15.0
Sex: M
Vaccine: COVID19-2
Symptoms: Dizziness, Nausea, Tremor
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: Nausea-Mild, Systemic: Shakiness-Mild
Age: 61.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site mass, Injection site pain, Injection site swelling
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: Pt had a concern about her Tdap vaccine they received at a DIFFERENT institution on 11/16/23 (ER). Pt was concerned since there was a "lump" where the vaccine was given. Upon inspection of the area the vaccinate did not appear to be given in the correct location if the "lump" was truly where the vaccine was administered (inferior to deltoid towards bicep of left arm). Pt had slight tenderness of area when palpated, otherwise no other additional symptoms.
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: NDC 59267-4331-02 was used on 6/10/24 past BUD, which was 3/20/24.
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: NDC  59267-4331-02, was used on 6/14/24, past BUD,  3/20/24. Unable to contact patient after multiple attempts
Age: 8.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: NDC 59267-4331-02 was used on 6/9/24, past its BUD, 3/20/24. Per parents, pt reported no side effects
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: NDC 59267-4331-02 was used on 6/9/24, past its BUD, 3/20/24. Parent reported no side effects
Age: 7.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: NDC 59267-4331-02 was used on 6/10/24, past its BUD, 3/20/24. Per father, pt has not displayed any adverse effects
Age: 7.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: NDC 59267-4331-02 was used on 3/22/24, past its BUD, 3/20/24. According to Pfizer Medical Information, vaccine is still stable for 2 more days past BUD.
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: NDC 59267-4331-02 was used on 3/22/24, past its BUD, 3/20/24. According to Pfizer Medical Information, vaccine is still stable for 2 more days past BUD.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, VARCEL
Symptoms: Injection site pain, Injection site swelling, Nausea, Pyrexia, Streptococcus test positive
Clinical narrative: pain and swelling to the thigh that moved down to the knee. parent only had pictures of the event. he was evaluated in clinic 1 week following vaccines. swelling/pain resolved within 3-4 days. able to ambulate the entire time. per mom he also had a fever and nausea for 24 hours following the vaccines.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Consciesness painful
Age: 1.75
Sex: F
Vaccine: HEPA, COVID19
Symptoms: Unevaluable event
Clinical narrative: Entered vaccine did flag, but expired 3 days prior
Age: 1.75
Sex: F
Vaccine: HEPA, COVID19
Symptoms: Expired product administered
Clinical narrative: Entered vaccine did flag, but expired 3 days prior
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive
Clinical narrative: FBE called on behalf of an HCP to report adverse reaction. HCP advised that within 1 week she had two different women test positive for HPV.  One was 32 years old and the other 33 years old. They had both been vaccinated with the Quadrivalent HPV vac; This spontaneous report was received from a physician and refers to a 32 or 33 year old non-pregnant female patient. The patient's concurrent conditions, medical history, concomitant medications, drug reactions or allergies were not reported.   On an unspecified date (reported as many years ago), the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) (strength, lot #, expiration date, route of administration, anatomical location not provided) as prophylaxis.   On an unspecified date, the patient was tested positive for human papillomavirus (HPV) test, but the HPV type was not identified in laboratory studies; therefore, it was reported that she would receive a colposcopy. At the reporting time, the outcome of the event was unknown.  Causality assessment between HPV test positive and quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) was not reported.  This is one of 2 cases reported by the same reporter.; Sender's Comments:  US-009507513-2406USA001881:
Sex: F
Vaccine: PPV
Symptoms: Antibody test negative
Clinical narrative: She had protective antibodies to 6 out of 23 serotypes of streptococcus pneumonia;   This literature marketed report was received from the authors and refers to a 20-months-old child female patient. The patient had a family history of Common variable immune deficiency (CVID), which was later diagnosed in her. The patient's historical conditions and concomitant medications were not provided.  On an unspecified date, the patient was vaccinated with pneumococcal 23v polysaccharide vaccine (manufacturer unknown) (strength, dose, route of administration, anatomical location, lot# and expiration date were not provided) as prophylaxis.  On an unspecified date (reported as post-vaccination), a protective antibody test  was performed which showed that there were 6 out of 23 serotypes of streptococcus pneumoniae (antibody test negative). At the reporting time, the outcome for the event of antibody test negative was unknown.  The authors considered the event of antibody test negative to be related to pneumococcal 23v polysaccharide vaccine (manufacturer unknown).  A copy of the published article is attached as further documentation of the patient's experience.  Lot# is being requested and will be submitted if received.  This is one of two cases received from the same literature article.; Sender's Comments:  US-009507513-2406USA001458:
Age: 26.0
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Received Series With Heplisav-B, and The Second Dose of Engerix-B, Engerix Was Given in Error; Received HEPLISAV-B 164 Days After First Dose; Initial report received on 29-Apr-2024.  A nurse reported that a 26-year-old female (race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and then received ENGERIX-B as the second dose for hepatitis B immunization.  Medical history and concomitant medications were not reported.  On 10-Oct-2023, the patient received the first dose of HEPLISAV-B (Lot #, expiration date, NDC #, site and route not reported).     On 09-Nov-2023, 30 days after receiving the first dose of HEPLISAV-B, the patient received ENGERIX-B (Lot #, expiration date, NDC #, site and route not reported) as the second dose for hepatitis B immunization.  ENGERIX-B was given in error.    On 21-Mar-2024, 164 days after receiving the first dose of HEPLISAV-B, the patient received the second dose of HEPLISAV-B (Lot #, expiration date, NDC #, site and route not reported).  No adverse events were reported. 161616  No additional information was reported.   Company Comment:  The company assessed the events as non-serious.       No queries required.  All information received.; Sender's Comments: The company assessed the event as non-serious.
Age: 39.0
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Received First Dose, and Came back For Second Dose Four Years Later; Initial report received on 07-Jun-2024.  A pharmacist reported that a 42-year-old female (race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and the patient returned for the second dose four years later.  No medical history or concomitant medications were reported.    On 30-Dec-2020, the patient received the first dose of HEPLISAV-B (lot # 933623, expiration date 22-Aug-2021; NDC # not reported) intramuscularly in the left deltoid. On an unknown date in 2024, four years after receiving the first dose of HEPLISAV-B, the patient came back for the second dose of HEPLISAV-B.  It was not reported if the patient received the second dose.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Incomplete course of vaccination
Clinical narrative: Received First Dose, and Has Not Received The Second Dose; Initial report received on 07-Jun-2024.  A nurse reported that a 49-year-old female (race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and the patient has not received the second dose.  No medical history or concomitant medications was reported.    On 06-Jun-2023, the patient received the first dose of HEPLISAV-B (lot # 941583, expiration date 28-Jan-2025, NDC # 43528-003-05; route and site not reported).  As of 07-Jun-2024, 368 days after receiving the first dose of HEPLISAV-B, the patient has not received the second dose of HEPLISAV-B.  No additional information was reported.    Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Bedridden, Blood copper, Dystonia, Electromyogram, Impaired driving ability
Clinical narrative: Diagnosed with cervical and arm dystonia with functional neurological disorder. Currently unable to turn head to left or use right arm normally. Waiting for disability hearing with judge. Treated with hydrocodone tyzanadine lyrica and EMG guided Botox injections every three months Hard Date: 2nd Pfizer Jab March 24 2021 April May problems stirring things, reaching, favoring left arm. Drinking and eating with left hand started.  fish trip June 7 2021 symptoms were mid level. Difficulty tying knots and casting strange movements pain in right arm. Arm movement in bed. Hard to sleep. Difficulty staying still. Constant movement. July: fishing unable to reel with my right hand. After getting out of the boat I had trouble driving home due to painful spasms in my upper right quadrant. Immediately I was couch ridden and didn t leave the house and couldn t feed myself for about a year. Saw 6 neurologists as well as ORS, IM and 3 ER visits. Same answer  I ve never scceen anything like this  It progressively got  worse for about a year. Over time and treatment by Neurologist  and PT CBT and Pain Management I am headed toward a path of recovery.  Started taking spike protein protocol April 24 seems to help (nattokinase bromelain circumin
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Insomnia, Laboratory test, Loss of personal independence in daily activities, Magnetic resonance imaging, Mobility decreased
Clinical narrative: Diagnosed with cervical and arm dystonia with functional neurological disorder. Currently unable to turn head to left or use right arm normally. Waiting for disability hearing with judge. Treated with hydrocodone tyzanadine lyrica and EMG guided Botox injections every three months Hard Date: 2nd Pfizer Jab March 24 2021 April May problems stirring things, reaching, favoring left arm. Drinking and eating with left hand started.  fish trip June 7 2021 symptoms were mid level. Difficulty tying knots and casting strange movements pain in right arm. Arm movement in bed. Hard to sleep. Difficulty staying still. Constant movement. July: fishing unable to reel with my right hand. After getting out of the boat I had trouble driving home due to painful spasms in my upper right quadrant. Immediately I was couch ridden and didn t leave the house and couldn t feed myself for about a year. Saw 6 neurologists as well as ORS, IM and 3 ER visits. Same answer  I ve never scceen anything like this  It progressively got  worse for about a year. Over time and treatment by Neurologist  and PT CBT and Pain Management I am headed toward a path of recovery.  Started taking spike protein protocol April 24 seems to help (nattokinase bromelain circumin
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Muscle spasms, Nerve conduction studies, Nervous system disorder, Pain in extremity, Spinal X-ray
Clinical narrative: Diagnosed with cervical and arm dystonia with functional neurological disorder. Currently unable to turn head to left or use right arm normally. Waiting for disability hearing with judge. Treated with hydrocodone tyzanadine lyrica and EMG guided Botox injections every three months Hard Date: 2nd Pfizer Jab March 24 2021 April May problems stirring things, reaching, favoring left arm. Drinking and eating with left hand started.  fish trip June 7 2021 symptoms were mid level. Difficulty tying knots and casting strange movements pain in right arm. Arm movement in bed. Hard to sleep. Difficulty staying still. Constant movement. July: fishing unable to reel with my right hand. After getting out of the boat I had trouble driving home due to painful spasms in my upper right quadrant. Immediately I was couch ridden and didn t leave the house and couldn t feed myself for about a year. Saw 6 neurologists as well as ORS, IM and 3 ER visits. Same answer  I ve never scceen anything like this  It progressively got  worse for about a year. Over time and treatment by Neurologist  and PT CBT and Pain Management I am headed toward a path of recovery.  Started taking spike protein protocol April 24 seems to help (nattokinase bromelain circumin
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Torticollis, X-ray limb
Clinical narrative: Diagnosed with cervical and arm dystonia with functional neurological disorder. Currently unable to turn head to left or use right arm normally. Waiting for disability hearing with judge. Treated with hydrocodone tyzanadine lyrica and EMG guided Botox injections every three months Hard Date: 2nd Pfizer Jab March 24 2021 April May problems stirring things, reaching, favoring left arm. Drinking and eating with left hand started.  fish trip June 7 2021 symptoms were mid level. Difficulty tying knots and casting strange movements pain in right arm. Arm movement in bed. Hard to sleep. Difficulty staying still. Constant movement. July: fishing unable to reel with my right hand. After getting out of the boat I had trouble driving home due to painful spasms in my upper right quadrant. Immediately I was couch ridden and didn t leave the house and couldn t feed myself for about a year. Saw 6 neurologists as well as ORS, IM and 3 ER visits. Same answer  I ve never scceen anything like this  It progressively got  worse for about a year. Over time and treatment by Neurologist  and PT CBT and Pain Management I am headed toward a path of recovery.  Started taking spike protein protocol April 24 seems to help (nattokinase bromelain circumin
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Blood test, Injection site erythema, Injection site swelling, Injection site warmth, Pain
Clinical narrative: Skin mild erythema by the injection site/ bruising in area of blood draw as well on R arm, no cyanosis or pallor, normal turgor and capillary refill.   Ext R arm with palpable swelling and warmth in area of the injection / not red more of a faint pink spreading out from the site of injection / able to move arm with some discomfort but not in joints
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Vessel puncture site bruise
Clinical narrative: Skin mild erythema by the injection site/ bruising in area of blood draw as well on R arm, no cyanosis or pallor, normal turgor and capillary refill.   Ext R arm with palpable swelling and warmth in area of the injection / not red more of a faint pink spreading out from the site of injection / able to move arm with some discomfort but not in joints
Sex: F
Vaccine: COVID19, HPV9, MEN, TDAP
Symptoms: Autoimmune hepatitis
Clinical narrative: Autoimmune hepatitis; Information was obtained on a request by The Company from the agency via a Public Case Detail (# AU-TGA-0000781845) On 11-JUN-2024.  The spontaneous report received from a Consumer or other non health professional referring a female patient of unknown age (Ethnicity sub-group: (PRIVACY). The patient's medical history, historical conditions, concurrent conditions and concomitant therapies were not reported. There was no previous vaccine reaction.  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 (strength, dose, lot #, expiry date, route of administration, anatomical site of administration and indication were not provided) at left arm, diphtheria vaccine toxoid, pertussis vaccine acellular 3-component, tetanus vaccine toxoid (BOOSTRIX); tozinameran (COMIRNATY); and meningococcal vaccine a/c/y/w conj (tet tox) (NIMENRIX) (strength, formulation, dose description, lot #, expiry date, route of administration, anatomical site of administration and indication were not provided) at left arm.  On an unknown date, the patient experienced Autoimmune hepatitis. It was unsure of onset of symptoms as autoimmune hepatitis took over two years undetected for cirrhosis to develop. Outcome was unknown but ongoing (reported as not recovered). general practitioner (GP) assessment involved. Further details as provided: Life time of ongoing scans, blood tests and medication. The action taken with all suspect vaccines was Not Applicable. The reporting institution considered Autoimmune hepatitis to be related to all suspect vaccines.  Upon internal review, the event of Autoimmune hepatitis was determined to be medically significant.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC20, RV1
Symptoms: Cardiac arrest, Chest X-ray, Death, Dyspnoea, Resuscitation
Clinical narrative: Baby found in bed gasping and unresponsive.  Did have resuscitation effort by EMS and ER.  Had apparent cardiac arrest and passed away on 6/15/24.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC20, RV1
Symptoms: Unresponsive to stimuli
Clinical narrative: Baby found in bed gasping and unresponsive.  Did have resuscitation effort by EMS and ER.  Had apparent cardiac arrest and passed away on 6/15/24.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: 6/18/24: Patient monitored in office-no adverse reaction noted. On 6/18/24, Parent reports patient is doing well-no adverse reactions.
Age: 5.0
Sex: M
Vaccine: DTPPVHBHPB
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Pt was given a Vaxelis. Pt out of age range for that vaccination. No adverse effects noted.
Age: 9.0
Sex: F
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: Syncope
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Blister, Pruritus, Rash
Clinical narrative: Patient had full body rash with blisters, no fever noted. Started approximately three weeks ago and has progressively getting worse.  Patient to start Zyrtec BID x 7 days, along with Benadryl cream for itching.
Age: 19.0
Sex: F
Vaccine: HEP
Symptoms: Exposure during pregnancy
Clinical narrative: patient is pregnant and received Heplisav B
Age: 49.0
Sex: F
Vaccine: RAB
Symptoms: Fatigue, Headache, Musculoskeletal stiffness, Neck pain, Pyrexia
Clinical narrative: reaction to vaccine. generalized fatigue, stiff left arm. fever over night. headache rates 4/10. vaccine received yesterday. symptoms started about 1 am. donor called center to report symptoms. recommended rest, hydration and OTC pain/fever relief.
Age: 70.0
Sex: F
Vaccine: COVID19, RSV
Symptoms: Asthenia, Balance disorder, Fall, Fatigue, Muscle disorder
Clinical narrative: Patient reported feeling "like she had no bones" the day after administration. She was weak & fatigued and reported falling multiple times. She felt off balanced and had a loss of muscle control. Symptoms lasted for 6-7 hours
Age: 58.0
Sex: F
Vaccine: PNC20
Symptoms: Wrong product administered
Clinical narrative: cma reported to me she had given Prevnar 20 to this patient instead of Tetanus.
Age: 12.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Autonomic nervous system imbalance, Connective tissue disorder, Gastrointestinal haemorrhage, Growth failure, Underweight
Clinical narrative: The patient's mother, reported that adverse event.  She states that the patient hasn't gotten any taller in the last two years and is under weight compared to 2021. Since then, he has also been diagnosed with dysautonomia and connective tissue disorder. The patient received two Pfizer Covid vaccines: Lot BW0185 on 5/18/2021 and Lot EW0191 on 06/08/21 (both administered at a Pharmacy.  The patient has also suffered from gastrointestinal bleeding over the last year, leading to emergency room visits.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered
Clinical narrative: Pt was administer a expired vaccination on 06/05/2024, re did the dose on 06/13/2024
Age: 11.0
Sex: M
Vaccine: DTAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: client should had received Tdap instead of Dtap because of age. no adverse reaction
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Myocardial infarction
Clinical narrative: heart attack
Age: 11.0
Sex: M
Vaccine: DTAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: client should have received Dtap instead of Tdap, because of age. no adverse effects
Age: 16.0
Sex: F
Vaccine: DTAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: client should had received Tdap instead Dtap, because of age. no adverse reactions
Age: 65.0
Sex: F
Vaccine: COVID19-2
Symptoms: Acute kidney injury, Blood creatinine increased, Blood urea increased, Dehydration, Glomerular filtration rate normal
Clinical narrative: Vaccine around noon. 2-3 hours later with muscle aches, fatigue, frequent urination.  That night with high volume and frequent urination every hour. Unable to keep hydrated enough which led to acute renal failure. Resolved within 36-48hours
Age: 65.0
Sex: F
Vaccine: COVID19-2
Symptoms: Haemoglobin increased, Myalgia, Pollakiuria
Clinical narrative: Vaccine around noon. 2-3 hours later with muscle aches, fatigue, frequent urination.  That night with high volume and frequent urination every hour. Unable to keep hydrated enough which led to acute renal failure. Resolved within 36-48hours
Age: 78.0
Sex: F
Vaccine: PNC20
Symptoms: Feeling abnormal, Injection site erythema, Injection site warmth
Clinical narrative: on 6/12/24 and had a PCV20 vaccine. patient noticed redness and warmth around the injection site on her left deltoid. The redness has spread down her arm, approx 4 inches in length. She states that she didn't feel "up to snuff" this morning, but felt better once up and around. Oral temp was 97.0.
Age: 1.25
Sex: M
Vaccine: HIBV, PNC20
Symptoms: Febrile convulsion, Influenza virus test negative, Respiratory syncytial virus test negative, SARS-CoV-2 test negative
Clinical narrative: FEBRILE SEIZURE UNRELATED TO VIRAL ILLNESS
Age: 74.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: hospitalized with covid; fully vaccinated with 3 boosters
Age: 66.0
Sex: F
Vaccine: RSV
Symptoms: Arthritis, Injection site inflammation, Injection site pain, Pain, X-ray normal
Clinical narrative: Mild arthritis and increased pain by 60%. States the vaccine was given 5 1/2 inches below the shoulder bone and has been inflamed and painful since.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Injection site pain, Pain
Clinical narrative: Patient reporting ongoing arm pain and reduced mobility.  Pain is below injection site and radiated to interior arm.  Pain started 1-2 hours after vaccine administration.  Ice, ibuprofen and acetaminophen not providing relief.
Age: 0.08
Sex: F
Vaccine: DTPPVHBHPB, PNC20, RV5
Symptoms: Circumstance or information capable of leading to medication error
Clinical narrative: Valxelis ordered, and nurse confirms said order, although the computer states Varivax given. Patient asymptomatic and at her baseline per mother since vaccination.
Age: 81.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: RN administered vaccine that was expired by 2 days. Vaccine given on 6/14/24 and expired on 6/12/2024. No adverse reaction present, Medication error
Age: 59.0
Sex: F
Vaccine: HEP
Symptoms: Abdominal distension, Blister, Dizziness
Clinical narrative: Pt stated that Last night around 8:00 pm she felt Very Dizzy,  Stomach bloating and develop 4 blisters on Right side of her face. Pt states that Blisters still present today 6/18/2024.  Pt declined an appointment for further evaluation due to working schedule. A Telemedicine appointment schedule for Today at 5:00 pm for further evaluation.  Pt denies any dizziness or stomach bloating at the time of call; No other S/S were reported.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Peripheral swelling, Pyrexia, Skin warm
Clinical narrative: Patient states arm red/warm to hot to touch/swollen/fever 102/aches
Age: 3.0
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling, Urticaria
Clinical narrative: Patient received both vaccines in the left thigh, MA reports they were given IM.  Unsure which one was given superiorly and which was inferiorly. But mom noticed a red, swollen welt on the inferior vaccine site, pt reports pain and tenderness with palpation. no lethargy, SOB, other rashes.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, HEP, HEPA, MMRV
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Administered Kinrix as first dose of Dtap and IPV. Awaiting further instruction. No adverse reaction noted.
Age: 65.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: injection site red, warm and sore-followed up in urgent care, antibiotics given
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site urticaria, Urticaria
Clinical narrative: 14:00 Kinrix, Varicella and MMR vaccine given. 14:04 Hives noted bilaterally on face, arms and both MMR and Varicella injection sites. No respiratory distress noted. 14:05 Children's Chewable Benadryl 12.5mg given PO. Pulse Oximetry reading 98% and Heart Rate 98. 1415 Hives notes to be decreasing. 1419 New hives noted on left side of face and one on upper back. Children's Benadryl Chewable 12.5mg given PO. 1430 Nurse remains at bedside. Hives decreasing, Pulse Oximetry reading 99% and heart rate 88. 15:00 No hives noted at this time. Patient states "feels better." Pulse Oximetry reading 99 % and Heart Rate 101. No distress noted. Left clinic stable condition after observing x 1 hour per FNP.  Mother states will follow up with PCP. Educated mother on allergic reactions, signs/symptoms anaphylaxix and when to seek emergency care. Voiced understanding.
Age: 0.25
Sex: F
Vaccine: DTPPVHBHPB, PNC20
Symptoms: Anti-cyclic citrullinated peptide antibody negative, Atonic seizures, Electrocardiogram normal, Electroencephalogram normal, Full blood count normal
Clinical narrative: she became pale listless eyes rolled back and unresponsive approximately 5 hours after her vaccines. this lasted for 15 minutes then she gradually returned to baseline after another 45 mins
Age: 0.25
Sex: F
Vaccine: DTPPVHBHPB, PNC20
Symptoms: Gaze palsy, Listless, Pallor, Ultrasound head normal, Unresponsive to stimuli
Clinical narrative: she became pale listless eyes rolled back and unresponsive approximately 5 hours after her vaccines. this lasted for 15 minutes then she gradually returned to baseline after another 45 mins
Age: 0.25
Sex: F
Vaccine: DTPPVHBHPB, PNC20
Symptoms: Viral test negative
Clinical narrative: she became pale listless eyes rolled back and unresponsive approximately 5 hours after her vaccines. this lasted for 15 minutes then she gradually returned to baseline after another 45 mins
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Extra dose administered
Clinical narrative: Patient was due for her 2nd Bexsero vaccine today, but with a mix of confusion and drama with a boyfriend coming in and out of the patient room, one of the lab staff gave the vaccine and obtained other labs that were ordered, but then the MA working with the physician also came to the lab to verbally let them know what was ordered. The first lab staff was not in the room when the verbal was given and so another lab staff went and gave the vaccine as well. The patient never said anything to the second lab staff about having already gotten a vaccine.
Age: 48.0
Sex: M
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: right arm localized reaction at injection site with spreading erythema/itching
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site erythema, Injection site swelling
Clinical narrative: Site: Bruising at Injection Site-Medium, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Medium
Age: 67.0
Sex: M
Vaccine: PNC20, TDAP, VARZOS
Symptoms: Arthralgia
Clinical narrative: Patient received three vaccines on 5/30. Two vaccines (Boostrix and Prevnar 20) in the left arm and one vaccine (Shingrix) in the right arm. Patient came in the morning of 6/18 and complained of joint pain in his left shoulder that he has had since receiving the vaccines until now. Patient was referred to PCP to further evaluate shoulder pain.
Age: 34.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: Patient reports a localized swelling on her left arm at the site of vaccine administration. It began as a small red, raised area, grew substantially in size and severe by 24 hours and continued to get larger over 4 days. It grew to a size larger than her hand - red, raised, painful. No loss of motor or sensory function in the arm or hand. No fever. She took benadryl and used ice and is improving.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Patient came into the pharmacy stating that pharmacist had gave her the vaccination 6 days ago and she is unable to lift her left arm. Patient stated that the pharmacist had injected her at her left bicep and not the deltoid, therefore her pain is lingering. She did not experience any fever body ache. The pharmacist that administer the vaccine only gives "IM" in the deltoid of the arm and never the bicep.  Patient has a history of left shoulder pain, and she might be confused about the where the pain came from.
Age: 5.0
Sex: F
Vaccine: HEPA
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Injection site pustule, Pyrexia
Clinical narrative: she got a 104 fever and red painful area spreading down her arm, two pustules near the site, went to ER they diagnosed it as a cellulitis and prescribed her bactrim, she quickly improved on bactrim
Age: 3.0
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Patient did not have a reaction. MA administered an adult Hep A vaccine instead of the pediatric dose for Hep A. Parent stated that patient has been fine.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Chills, Dysarthria, Full blood count normal, Gait inability, Injection site pain
Clinical narrative: Pt received MMR and Quad in L thigh. VZV in R thigh. 10am appt yesterday.  Pt's Dad noted penile and scrotal swelling around 10 pm last night after he had a urinary accident. Video called Mom and promptly went to ER. Never any redness to penis or scrotum. Mom pulled over tick several weeks ago from scrotum. Exposure to chiggers. ER thought summer penile syndrome, not related to vaccine reaction.   On the way to ER, pt's father noticed abnormal/slurred speech. Seemed to have bilateral LE weakness/sensation differences. Was not able to walk into ER.  While at ER, developed full body shivering/shaking per Mom. Pain in upper thighs. Seem lethargic/out of it.  Was given Benadryl, tylenol, toradol without change in shaking. Was not able to walk out of ER.   This morning, seems totally back to normal. Penile swelling is gone. Walking, eating, talking, playing normally.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Lethargy, Metabolic function test normal, Muscular weakness, Penile swelling, Scrotal swelling
Clinical narrative: Pt received MMR and Quad in L thigh. VZV in R thigh. 10am appt yesterday.  Pt's Dad noted penile and scrotal swelling around 10 pm last night after he had a urinary accident. Video called Mom and promptly went to ER. Never any redness to penis or scrotum. Mom pulled over tick several weeks ago from scrotum. Exposure to chiggers. ER thought summer penile syndrome, not related to vaccine reaction.   On the way to ER, pt's father noticed abnormal/slurred speech. Seemed to have bilateral LE weakness/sensation differences. Was not able to walk into ER.  While at ER, developed full body shivering/shaking per Mom. Pain in upper thighs. Seem lethargic/out of it.  Was given Benadryl, tylenol, toradol without change in shaking. Was not able to walk out of ER.   This morning, seems totally back to normal. Penile swelling is gone. Walking, eating, talking, playing normally.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Tremor
Clinical narrative: Pt received MMR and Quad in L thigh. VZV in R thigh. 10am appt yesterday.  Pt's Dad noted penile and scrotal swelling around 10 pm last night after he had a urinary accident. Video called Mom and promptly went to ER. Never any redness to penis or scrotum. Mom pulled over tick several weeks ago from scrotum. Exposure to chiggers. ER thought summer penile syndrome, not related to vaccine reaction.   On the way to ER, pt's father noticed abnormal/slurred speech. Seemed to have bilateral LE weakness/sensation differences. Was not able to walk into ER.  While at ER, developed full body shivering/shaking per Mom. Pain in upper thighs. Seem lethargic/out of it.  Was given Benadryl, tylenol, toradol without change in shaking. Was not able to walk out of ER.   This morning, seems totally back to normal. Penile swelling is gone. Walking, eating, talking, playing normally.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Dizziness, Fatigue, Headache, Injection site erythema
Clinical narrative: onset of dizziness, arthralgia, headache, and fatigue systemically; locally had large area of tender redness at injection site
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: onset of dizziness, arthralgia, headache, and fatigue systemically; locally had large area of tender redness at injection site
Age: 4.0
Sex: U
Vaccine: MMRV, MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; HCP calling to report that patient received inappropriately stored PROQUAD.  No adverse effects reported.  No PQC. Please see case 02607099 note section for 34 associated AE cases.  PROQUAD  LOT Y003143   7/27/2025 Temp: 19.8 F Time: 20 Hours 15 Minu; This spontaneous report was received from a medical assistant and refers to a 4-year-old patient of unknown gender.  There was no information about the patient's pertinent medical history, concomitant medications or drug reactions and allergies provided.  On 15-MAY-2024, the patient was vaccinated with an inappropriately stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) injection, single dose, lot #Y003143, expiration date: 27-JUL-2025, administered for prophylaxis (strength, and route of administration were not provided) (Product storage error). Temperature excursion of 19.8 degrees Fahrenheit for 20 hours and 15 minutes was reported. No previous temperature excursion reported.   No adverse effects reported (No adverse event).  This is one of 34 reports received from the same reporter.; Sender's Comments:  US-009507513-2405USA007600:1 US-009507513-2405USA007648: US-009507513-2405USA007916: US-009507513-2405USA007905: US-009507513-2405USA007924:5 US-009507513-2405USA007935: US-009507513-2405USA007720: US-009507513-2405USA007700: US-009507513-2405USA007912: US-009507513-2405USA007488:10 US-009507513-2405USA007692: US-009507513-2405USA007909:MSD US-009507513-2405USA007771: US-009507513-2405USA007901: US-009507513-2405USA007722:15 US-009507513-2405USA007713: US-009507513-2405USA008015:MSD US-009507513-2405USA007454: US-009507513-2405USA007588: US-009507513-2405USA007667: US-009507513-2405USA007763: US-009507513-2405USA007791: US-009507513-2405USA007833: US-009507513-2405USA007841: US-009507513-2405USA007911: US-009507513-2405USA007617: US-009507513-2405USA007573: US-009507513-2405USA007724: US-009507513-2405USA007728: US-009507513-2405USA007727: US-009507513-2405USA007731: US-009507513-2405USA007578: US-009507513-2405USA007684:
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; HCP calling to report that patient received inappropriately stored PROQUAD.  No adverse effects reported.  No PQC. Please see case 02607099 note section for 34 associated AE cases.  PROQUAD  LOT Y003143   7/27/2025 Temp: 19.8 F Time: 20 Hours 15 Minu; This spontaneous report was received from a medical assistant and refers to a 4-year-old patient of unknown gender.  There was no information about the patient's pertinent medical history, concomitant medications or drug reactions and allergies provided.  On 13-MAY-2024, the patient was vaccinated with an inappropriately stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) injection, single dose, lot #Y003143, expiration date: 27-JUL-2025, administered for prophylaxis (strength, and route of administration were not provided) (Product storage error). Temperature excursion of 19.8 degrees Fahrenheit for 20 hours and 15 minutes was reported. No previous temperature excursion reported.   No adverse effects reported (No adverse event).  This is one of 34 reports received from the same reporter.; Sender's Comments:  US-009507513-2405USA007600: US-009507513-2405USA007648: US-009507513-2405USA007916: US-009507513-2405USA007905: US-009507513-2405USA007573: US-009507513-2405USA007924:2405USA007763 US-009507513-2405USA007935: US-009507513-2405USA007720: US-009507513-2405USA007700: US-009507513-2405USA007912: US-009507513-2405USA007488: US-009507513-2405USA007692: US-009507513-2405USA007909:MSD US-009507513-2405USA007771: US-009507513-2405USA007901: US-009507513-2405USA007722: US-009507513-2405USA007713: US-009507513-2405USA008015:MSD US-009507513-2405USA007454: US-009507513-2405USA007588: US-009507513-2405USA007617: US-009507513-2405USA007667: US-009507513-2405USA007761: US-009507513-2405USA007833: US-009507513-2405USA007841: US-009507513-2405USA007901: US-009507513-2405USA007911: US-009507513-2405USA007578: US-009507513-2405USA007727: US-009507513-2405USA007728: US-009507513-2405USA007724: US-009507513-2405USA007731: US-009507513-2405USA007684:
Age: 0.33
Sex: M
Vaccine: RV5
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AEs or PQC; Caller reported patient received first dose of ROTATEQ at 21 weeks old.; This spontaneous report was received from a nurse prescriber and refers to a 4-month-old male.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 30-MAY-2024, the patient was vaccinated with first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 2 milliliter, lot #2003177, expiration date: 23-SEP-2025, administered orally for prophylaxis (strength was not provided) (Product administered to patient of inappropriate age). No additional adverse event was reported.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; GARDASIL 9 was administered following a TE; This spontaneous report was received from a heathcare business partner (HBP) and referred to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant therapies, drug reactions and allergies were not reported.  On an unknown date, hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) underwent a temperature excursion (TE). On 03-JUN-2024, the patient was vaccinated with the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (after TE), lot #1957405, expiration date: 11-NOV-2025, administered for prophylaxis (strength, dose and route of administration were not provided) (Product storage error). No additional AE.
Sex: U
Vaccine: HPV9
Symptoms: Extra dose administered, Intentional product misuse, No adverse event
Clinical narrative: No additional AE; a patient who received a fourth dose of GARDASIL 9 at their own request.; 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 and concomitant therapies were not provided.  On 22-MAY-2024, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5ml/dose, administered for prophylaxis (anatomical location, strength, lot #, expiry date, and route of administration were not provided), and it was already a fourth dose, administered at the patient's own request (Intentional product misuse). No symptoms reported. No additional adverse events.  Lot # is being requested and will be submitted if received.