chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: PPV
Symptoms: Pneumonia pneumococcal
Clinical narrative: Pneumonia; This spontaneous report has been downloaded from Regulatory Authority via Company representative, concerning to an adult (age group reported as 45-49-year-old) female patient.   Her medical history, concurrent conditions and concomitant therapies were not provided. Vaccination history was reported as vaccine not available for serotype.   On an unspecified date, the patient was vaccinated with the 1st dose of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection (exact dose, lot #, expiry date, anatomical location and route of administration were not provided). On an unspecified date, she received the 2nd dose of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection (exact dose, lot #, expiry date, anatomical location and route of administration were not provided). On an unknown date, the patient was vaccinated with the 3rd dose of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection (exact dose, lot #, expiry date, anatomical location and route of administration were not provided). All vaccine doses were administered as prophylaxis.   On an unknown date in 2014, the patient experienced pneumonia (pneumonia pneumococcal), and Streptococcus pneumoniae serotyping was reported as not available.   The outcome of the event was not provided.    The causal relationship between pneumonia pneumococcal and pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) was not reported.  Upon internal review, pneumonia pneumococcal was considered to be medically significant.
Sex: M
Vaccine: PPV
Symptoms: Pneumococcal infection
Clinical narrative: Streptococcus pneumoniae disease, clinical category: other; Information has been received from Health Authority on 12-JAN-2024.  This spontaneous report was received from Regulatory Authority and refers to an elderly male patient (age group reported as 80-84 years). Information regarding the patient's concurrent conditions, medical history, and concomitant medications was not provided.  On unknown dates, the patient was vaccinated with 2 doses of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection, administered for prophylaxis (exact dose, strength, lot #, expiry date, site and route of administration were not provided).  On an unknown date in 2015, the patient experienced Streptococcus pneumoniae disease, clinical category: other (pneumococcal infection). On an unknown date in 2015, Streptococcus pneumoniae serotyping was not available. The outcome of the event was not reported.  The causal relationship between pneumococcal infection and pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) was not provided.  Upon internal review, the event of pneumococcal infection was determined to be medically significant.
Sex: M
Vaccine: PPV
Symptoms: Pneumonia
Clinical narrative: Pneumonia; Information has been received from regulatory authority on 12-JAN-2024.  This spontaneous report has been downloaded from regulatory authority and refers to an adult (between 55 and 59 years old; reported as age group 55-59) female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with 2 doses of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection, administered for prophylaxis (exact dose, strength, lot #, expiry date, and route of administration were not provided). It was reported that the patient received total of 2 vaccinations.  In 2019, the patient experienced pneumonia, serotype: not available. The outcome of the event was not provided.   The causal relationship between pneumonia and pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) was not reported.  Upon internal review, the event of pneumonia has been determined to be medically significant.
Sex: F
Vaccine: PPV
Symptoms: Pneumococcal infection, Pneumonia
Clinical narrative: Pneumonia; Clinical category: Other; Information has been received from a Health Authority on 12-JAN-2024.  This spontaneous report was received from a Regulatory Authority and refers to an adult female patient of unknown exact age (age group reported as 60-64 years old). No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided.  On unknown dates, the patient was vaccinated with pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection, 2 times in total, administered for prophylaxis (strength, dose, anatomical location, lot #, expiry date, and route of administration were not provided).  On an unknown date in 2015, the patient experienced pneumonia and "other" (Pneumococcal infection). On an unknown date in 2015, Streptococcus pneumoniae serotyping was "not available". The outcome of the events was not reported.   The causal relationship between the events and pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) was not reported.  Upon internal review, the events pneumonia and "other" (Pneumococcal infection) were determined to be medically significant.
Sex: M
Vaccine: PPV
Symptoms: Pneumonia pneumococcal, Streptococcus test positive
Clinical narrative: Pneumonia; Information has been received from a Health Authority on 12-JAN-2024.  This spontaneous report has been received from a Regulatory Authority, referring to an elderly male patient of an unspecified age (age group reported as 85+). No information regarding the patient's medical history, concurrent conditions, and concomitant medications was provided.  On an unknown date, the patient was vaccinated with pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection, administered for prophylaxis (dose, route of administration, anatomical location, lot number and expiration date were not reported).  On an unknown date in 2016, the patient experienced Streptococcus pneumoniae pneumonia. On an unknown date in 2016, Streptococcus pneumoniae serotyping was performed (results not available). The outcome of the event was not reported.  The causal relationship between the event and suspected vaccine was not reported.  Upon internal review, the event of Streptococcus pneumoniae pneumonia was determined to be medically significant.
Sex: F
Vaccine: PPV
Symptoms: Pneumonia streptococcal, Streptococcal bacteraemia, Streptococcus test positive
Clinical narrative: Streptococcus pneumoniae bacteraemia; Information has been received from Health Authority on 12-JAN-2024.  This spontaneous report was received from Regulatory Authority and refers to an elderly female patient (age group reported as 85+ years). Information regarding the patient's concurrent conditions, medical history, and concomitant medications was not provided.  On unknown dates, the patient was vaccinated with 2 doses of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection, administered for prophylaxis (exact dose, strength, lot #, expiry date, site and route of administration were not provided).  On an unknown date in 2018, the patient experienced Streptococcus pneumoniae bacteraemia. On an unknown date in 2018, Streptococcus pneumoniae serotyping was not available. The outcome of the event was not reported.  The causal relationship between Streptococcus pneumoniae bacteraemia and pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) was not provided.  Upon internal review, the event of Streptococcus pneumoniae bacteraemia was determined to be medically significant.
Sex: F
Vaccine: PPV
Symptoms: Pneumococcal bacteraemia, Streptococcus test positive
Clinical narrative: bacteremia; This spontaneous report has been downloaded from Regulatory Authority and refers to an adult female patient (age reported as 50-54 years old).  The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with the first dose of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) (strength, lot #, expiry date, anatomical location, and route of administration were not provided) as prophylaxis.  On an unspecified date in 2011, the patient developed bacteremia (Pneumococcal bacteraemia). The Streptococcus pneumoniae serotyping was not available. It was reported that vaccine was not available for serotype (conflicting information). At the time of the report, the outcome of the event was unknown. Action taken with pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) regarding the event was not applicable.  The causal relationship between Pneumococcal bacteraemia and pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) was unknown.  Upon internal review, the event was determined to be medically significant.
Sex: M
Vaccine: PPV
Symptoms: Pneumonia pneumococcal, Streptococcus test
Clinical narrative: pneumonia; Information has been received from a Health Authority on 12-JAN-2024.  This spontaneous report has been received from a database, referring to a male patient of an unspecified age (age group reported as 15-19). No information regarding the patient's medical history, concurrent conditions, and concomitant medications was provided.  On an unknown date, the patient was vaccinated with pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection, administered for prophylaxis (dose, route of administration, anatomical location, lot number and expiration date were not reported).  On an unknown date in 2019, the patient experienced Streptococcus pneumoniae pneumonia. On an unknown date in 2019, Streptococcus pneumoniae serotyping was performed (results not available). The outcome of the event was not reported.  The causal relationship between the event and suspected vaccine was not reported.  Upon internal review, the event of Streptococcus pneumoniae pneumonia was determined to be medically significant.
Sex: M
Vaccine: PPV
Symptoms: Pneumonia pneumococcal, Streptococcus test positive
Clinical narrative: Pneumonia; Information has been received from a Health Authority on 12-JAN-2024.  This spontaneous report as received from a Regulatory Authority refers to an adult male patient of unknown exact age (age group reported as 50-54). No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided.   On unknown date, the patient was vaccinated with the first dose of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) (dose, route of administration, anatomical location, lot number and expiration date were not reported) for prophylaxis. On an unknown date in 2019, the patient experienced Streptococcus pneumoniae pneumonia (reported as pneumonia). On an unknown date in 2019, streptococcus pneumoniae serotyping result was reported as not available. The outcome of the event was not reported.  The relatedness between Streptococcus pneumoniae pneumonia and pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) was not provided.  Upon internal review, the event of Streptococcus pneumoniae pneumonia was determined to be medically significant.
Sex: F
Vaccine: PPV
Symptoms: Pneumococcal bacteraemia, Streptococcus test
Clinical narrative: Bacteraemia; Information has been received from a Health Authority on 12-JAN-2024.  This spontaneous report as received from a database refers to an elderly female patient of unknown exact age (age group reported as "70-74"). No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided.   On unknown date, the patient was vaccinated with the first dose of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) (dose, route of administration, anatomical location, lot number and expiration date were not reported) for prophylaxis. On an unknown date in 2019, the patient experienced Pneumococcal bacteraemia (reported as Bacteraemia). On an unknown date in 2019, streptococcus pneumoniae serotyping result was reported as not available. The outcome of the event was not reported.  The relatedness between Pneumococcal bacteraemia and pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) was not provided.  Upon internal review, the event of Pneumococcal bacteraemia was determined to be medically significant.
Sex: M
Vaccine: PNC, PPV
Symptoms: Pneumonia pneumococcal
Clinical narrative: pneumonia; Information has been received from HA on 12-JAN-2024.  This spontaneous report has been downloaded from Regulatory Authority and refers to a male patient (15-19 years old). His medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with a first dose of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection, administered for prophylaxis (anatomical location, strength, lot #, expiry date, and route of administration were not provided); and third dose of pneumococcal vaccine conj 7v (crm197) (PREVENAR) (anatomical location, strength, formulation, lot #, expiry date, route of administration, and indication were not provided).  On an unknown date in 2019, the patient experienced pneumonia (Pneumonia pneumococcal). On an unknown date in 2019, Streptococcus pneumoniae serotyping was not available. At the time of reporting, the outcome of the event was not known.  The causal relationship between the event and pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) was not reported.  Upon internal review, the event of pneumonia (Pneumonia pneumococcal) was determined to be medically significant.
Sex: F
Vaccine: PPV
Symptoms: Pneumonia pneumococcal
Clinical narrative: pneumonia; Information has been received from HA on 12-JAN-2024.  This spontaneous report has been downloaded from National Notifiable Diseases Surveillance System (NNDSS) and refers to a female patient (55-59 years old). Her medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with a second dose of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection, administered for prophylaxis (anatomical location, strength, lot #, expiry date, and route of administration were not provided).  On an unknown date in 2016, the patient experienced pneumonia (Pneumonia pneumococcal). On an unknown date in 2016, Streptococcus pneumoniae serotyping was not available. At the time of reporting, the outcome of the event was not known.  The causal relationship between the event and pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) was not reported.  Upon internal review, the event of pneumonia (Pneumonia pneumococcal) was determined to be medically significant.
Sex: F
Vaccine: PPV
Symptoms: Pneumonia pneumococcal
Clinical narrative: Streptococcus pneumoniae pneumonia; This spontaneous report has been downloaded from database and refers to an adult female patient (age group reported as 25-29 years). Information regarding the patient's concurrent conditions, medical history, and concomitant medications was not provided.  On unknown dates, the patient was vaccinated with 2 doses of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection, administered for prophylaxis (exact dose, strength, lot #, expiry date, site and route of administration were not provided).  On an unknown date in 2016, the patient experienced Streptococcus pneumoniae pneumonia. On an unknown date in 2016, Streptococcus pneumoniae serotyping was not available. The outcome of the event was not reported.  The causal relationship between Streptococcus pneumoniae pneumonia and pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) was not provided.  Upon internal review, the event of Streptococcus pneumoniae pneumonia was determined to be medically significant.
Sex: F
Vaccine: PPV
Symptoms: Pneumonia pneumococcal, Streptococcus test
Clinical narrative: Pneumonia; Information has been received from a Health Authority on 12-JAN-2024.  This spontaneous report has been received from a database, referring to an elderly female patient of an unspecified age (age group reported as 85+). No information regarding the patient's medical history, concurrent conditions, and concomitant medications was provided.  On an unknown date, the patient was vaccinated with pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection, administered for prophylaxis (dose, route of administration, anatomical location, lot number and expiration date were not reported).  On an unknown date in 2016, the patient experienced Streptococcus pneumoniae pneumonia. On an unknown date in 2016, Streptococcus pneumoniae serotyping was performed (results not available). The outcome of the event was not reported.  The causal relationship between the event and suspected vaccine was not reported.  Upon internal review, the event of Streptococcus pneumoniae pneumonia was determined to be medically significant.
Age: 1.08
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Lethargy, Pallor, Vomiting
Clinical narrative: One the patient was in the car and the parents started to drive away the patient became lethargic pale and then started to vomit. The parents turned around and came back to the office. The patient was examined and was found to be alert and oriented. All systems negative. Parents were encouraged to monitor the patient for any worsening symptoms and give water and bland foods today.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Hallucination, Moaning, Pyrexia, Screaming
Clinical narrative: Started getting chills, then fever, then groaning and screaming in sleep...hallucinating in sleep.  This was my 6th Covid shot and I never had a reaction like this. By morning on the 22nd, I was alright.  Most likely, I will not get any more Covid shots. This was a very unsettling experience. I have had chills and a fever from the other Covid shots but this was a very strange experience.  This is also the first time I ever reported any adverse effects because fever and chills is not unexpected but the strange screaming in my sleep is disturbing. My husband heard me. By the way, he had no side effects at all. We both got the mRNA Moderna Covid-19 Spikevax at the same time.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Lethargy, Pain in extremity
Clinical narrative: Sore arm (pain scale 1-10, pt rated a 4/10) and lethargy
Age: 69.0
Sex: M
Vaccine: RSV
Symptoms: Arthralgia, Neck pain
Clinical narrative: STARTING LATER P.M. 01.21 SHOULDER AND NECK ACHE .  CONTINUED INTO AND ALL DAY 01.22.  CONTINUE TODAY A.M 01.23
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Lymphadenopathy, Musculoskeletal stiffness
Clinical narrative: Patient presented with severe bruising on outer and inner side of right arm, extending to the axillary and breast area.  Swollen lymph node involvement in the axillary and neck are.  Complaining of stiff neck as well. Contacted patient discussed symptons, still bruised as of the day of this notice, still healing.  Advised to hold off mammogram until bruising is gone. No fever, vomiting or diarrhea.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Depression, Facial paralysis, Hypogeusia, Hyposmia
Clinical narrative: Bells Palsy left face nerve
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Lacrimation increased, Lip disorder, Loss of personal independence in daily activities, Peripheral coldness, Photophobia
Clinical narrative: Bells Palsy left face nerve
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Tongue paralysis
Clinical narrative: Bells Palsy left face nerve
Age: 7.0
Sex: F
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered
Clinical narrative: Pt received a double dose of Varicella. Pt was seen 12/19/23 and was given ProQuad(MMRV) and Varivax(Varicella). ProQuad is the combo vaccine, therefore an additional doe of Varicella should not have been given.
Age: 0.25
Sex: M
Vaccine: RSV
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: The patient did not experience an adverse event. Patient received Abrysvo in error. Patient is an infant and should have received Beyfortus.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: Hospitalized
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU4
Symptoms: Injection site cellulitis, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient was given the two-vaccines listed above into her left deltoid on 1/16/2024. On 1/17/2024, patients mother took patient to ER at 9:42pm. Stated around 7:00pm that evening she started noticing redness, swelling and warm to touch skin at the are of the two injections. Was given Tylenol 454.4mg at 10pm. Sent home with no medications, just advised to follow up in no improvement or worsening. 1/19/2024 patient was then seen at Clinic with NP with worsening of redness and swelling. Diagnosed with cellulitis and prescribed cephalexin to treat.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Covid 23/24 vaccine given 1/10/24, on 1/16 he states a Herpetic type rash developed on both arms and upper torso.
Age: 14.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Incorrect dose administered
Clinical narrative: Patient received lower than age dose for covid vaccine (5-11) versus 12+.  Doses was originally allocated for sibling, sibling declined at time of administration, parent elected to received dose for singling (older 14 years old) to avoid "wasting" and administering MA failed to recognize age discrepancy.  No further doses needed, no expected adverse outcome expected.
Age: 79.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient inadvertently received a 2nd arexvy vaccine, less than a month after receiving the  vaccine for the first time. Patient has reported no issues to receiving the 2nd dose of the RSV vaccine.
Age: 69.0
Sex: F
Vaccine: RSV
Symptoms: Burning sensation, Erythema, Immediate post-injection reaction, Injection site erythema, Injection site infection
Clinical narrative: Instantly burning and still burning and jagging. Redness, swelling and black and blue all the way around the arm. Injection sight turned very red with bumps and later turned into a large scab which still exists. Still have bumps and redness.  Sight was infected. Broke down the skin. Visited Dr. 3 times and Dr. 1 time. Dr. prescribed  steroid, 2 different antibiotics.
Age: 69.0
Sex: F
Vaccine: RSV
Symptoms: Injection site rash, Injection site reaction, Injection site scab, Peripheral swelling, Skin discolouration
Clinical narrative: Instantly burning and still burning and jagging. Redness, swelling and black and blue all the way around the arm. Injection sight turned very red with bumps and later turned into a large scab which still exists. Still have bumps and redness.  Sight was infected. Broke down the skin. Visited Dr. 3 times and Dr. 1 time. Dr. prescribed  steroid, 2 different antibiotics.
Age: 69.0
Sex: F
Vaccine: RSV
Symptoms: Skin disorder
Clinical narrative: Instantly burning and still burning and jagging. Redness, swelling and black and blue all the way around the arm. Injection sight turned very red with bumps and later turned into a large scab which still exists. Still have bumps and redness.  Sight was infected. Broke down the skin. Visited Dr. 3 times and Dr. 1 time. Dr. prescribed  steroid, 2 different antibiotics.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac disorder, Laboratory test, Magnetic resonance imaging, Respiratory disorder
Clinical narrative: developed long term heart condi tion and other respitory issues after mandated vaccine and boosters
Age: 46.0
Sex: F
Vaccine: COVID19-2
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Patient complained of left harm soreness and lack of mobility in arm
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient came into Public Health to receive a second COVID-19 vaccine explained to mother that a child 5y-11y is only recommended 1 dose at this time. He is considered up to date. He is not immunocompromised. Upon observation of his  Immunization Record I noticed that his dose given at Pharmacy was for the incorrect age group. He was given Comirnaty 12y+. instead of 5y-11y. Mother was informed of this, and she states that he has had no adverse side effects from the vaccination. Educated Mother that if he starts to develop in side effects to let us know. Child was not revaccinated because the CDC states if given a higher than recommended dose that vaccination with the correct dosage does not have to be repeated. Mother had no questions or concerns. Verbalized understanding.
Age: 1.25
Sex: M
Vaccine: FLUC4, HEPA, HIBV, VARCEL
Symptoms: Incorrect route of product administration, Product preparation error, Product preparation issue
Clinical narrative: The medical assistant mixed the influenza with the varicella. Medical assistant thought the influenza vaccine was the diluent of the varicella vaccine. Influenza vaccine was given subcutaneous.
Age: 76.0
Sex: F
Vaccine: RSV
Symptoms: Angina pectoris
Clinical narrative: Patient received Arexvy on left Deltoid on 1/13/2024.  After receiving the vaccine, she experienced pain in her Heart on the same day.
Age: 30.0
Sex: F
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: Vaccine given was expired.
Age: 0.08
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: patient did not have an adverse event.  Patient due for 2 month vaccines, and had already been given 2nd Hep B vaccine.  Provider ordered Quadracel which is indicated for 4yr-6yr old and it was administered.  Spoke with Practice Pharmacist who spoke with the CDC and advised even though a DTaP/IPV dose (Quadracel ) is indicated between the ages of 4-6 year olds, if it is inadvertently given to a younger child (2 month old in this case) the dose still counts and the child does not need to be re-vaccinated. Is still safe dose as is no change is amount that is in the vial. Patients mom notified.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: pt given dtap & ipv on 25th week instead of 6 consecutive months after the 3rd dose which was on 07/24/23.  Database failed due to time frame. Pt did not have any adverse reactions in clinic. Legal guardian was notified of event and to return to clinic in 6 months for repeat vaccines.
Age: 69.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Magnetic resonance imaging abnormal, Periarthritis
Clinical narrative: I was given a vaccine and ended up with a frozen Shoulder . Shot in August 2023 . Diagnosed  January 12,2024
Age: 69.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Magnetic resonance imaging, Mobility decreased, Musculoskeletal stiffness, Pain in extremity, Periarthritis
Clinical narrative: I was given a vaccine and ended up with a frozen Shoulder . Shot in August 2023 . Diagnosed  January 12,2024
Age: 66.0
Sex: F
Vaccine: RSV, VARZOS
Symptoms: Erythema, Swelling
Clinical narrative: local redness and swelling
Age: 64.0
Sex: F
Vaccine: COVID19-2
Symptoms: Gait disturbance
Clinical narrative: 10 days after vaccination I woke up and could barely walk
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Mobility decreased, Musculoskeletal pain, Myositis, Neck pain
Clinical narrative: My shot was given high up on my shoulder not in the triangle that?s recomended. A week out my shoulder, shoulder blade and neck pain is increasing. I have limited range in my neck because of sharp pain in my shoulder. Radiating tingling and soft pain across my shoulder up my neck under my jaw/ear. I have pain when i sleep on that side, slight pins and needles on my left side shoulder blade. And soft pain with movement when i lift my arm up, to the side and in circles. Doctor recommended Rest and ibuprofen for a week while the muscles are inflamed and to follow up with Physical Therapy if needed if its not getting better in a week.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Pain in jaw, Paraesthesia, Product administered at inappropriate site, Sleep disorder
Clinical narrative: My shot was given high up on my shoulder not in the triangle that?s recomended. A week out my shoulder, shoulder blade and neck pain is increasing. I have limited range in my neck because of sharp pain in my shoulder. Radiating tingling and soft pain across my shoulder up my neck under my jaw/ear. I have pain when i sleep on that side, slight pins and needles on my left side shoulder blade. And soft pain with movement when i lift my arm up, to the side and in circles. Doctor recommended Rest and ibuprofen for a week while the muscles are inflamed and to follow up with Physical Therapy if needed if its not getting better in a week.
Age: 73.0
Sex: M
Vaccine: RSV, RSV
Symptoms: Acute respiratory failure, Asthenia, Cough, Endotracheal intubation, Guillain-Barre syndrome
Clinical narrative: Admitted to the hospital 1/13 with leg weakness that started on 1/12. This rapidly progressed to ascending weakness that progressed to acute respiratory failure; was intubated 1/16. Underwent lumbar puncture 1/14 that was negative. Was diagnosed with AIDP (acute inflammatory demyelinating polyneuritis)/GBS (Guillan Barre Syndrome) and started on plasmapheresis (underwent 8 sessions, starting 1/14) and IVIG (2 doses daily, starting 1/14). Improved with supportive care, extubated 1/20. Being discharged to acute rehab on 1/23.
Age: 73.0
Sex: M
Vaccine: RSV, RSV
Symptoms: Immunoglobulin therapy, Laboratory test normal, Lumbar puncture normal, Muscular weakness, Plasmapheresis
Clinical narrative: Admitted to the hospital 1/13 with leg weakness that started on 1/12. This rapidly progressed to ascending weakness that progressed to acute respiratory failure; was intubated 1/16. Underwent lumbar puncture 1/14 that was negative. Was diagnosed with AIDP (acute inflammatory demyelinating polyneuritis)/GBS (Guillan Barre Syndrome) and started on plasmapheresis (underwent 8 sessions, starting 1/14) and IVIG (2 doses daily, starting 1/14). Improved with supportive care, extubated 1/20. Being discharged to acute rehab on 1/23.
Age: 73.0
Sex: M
Vaccine: RSV, RSV
Symptoms: Pyrexia, Respiratory tract congestion, Viral upper respiratory tract infection
Clinical narrative: Admitted to the hospital 1/13 with leg weakness that started on 1/12. This rapidly progressed to ascending weakness that progressed to acute respiratory failure; was intubated 1/16. Underwent lumbar puncture 1/14 that was negative. Was diagnosed with AIDP (acute inflammatory demyelinating polyneuritis)/GBS (Guillan Barre Syndrome) and started on plasmapheresis (underwent 8 sessions, starting 1/14) and IVIG (2 doses daily, starting 1/14). Improved with supportive care, extubated 1/20. Being discharged to acute rehab on 1/23.
Age: 73.0
Sex: M
Vaccine: RSV, RSV
Symptoms: Immunoglobulin therapy, Lumbar puncture normal, Muscular weakness, Plasmapheresis, Pyrexia
Clinical narrative: Admitted to the hospital 1/13 with leg weakness that started on 1/12. This rapidly progressed to ascending weakness that progressed to acute respiratory failure; was intubated 1/16. Underwent lumbar puncture 1/14 that was negative. Was diagnosed with AIDP (acute inflammatory demyelinating polyneuritis)/GBS (Guillan Barre Syndrome) and started on plasmapheresis (underwent 8 sessions, starting 1/14) and IVIG (2 doses daily, starting 1/14). Improved with supportive care, extubated 1/20. Being discharged to acute rehab on 1/23.
Age: 73.0
Sex: M
Vaccine: RSV, RSV
Symptoms: Respiratory tract congestion, Respiratory viral panel, Viral test negative, Viral upper respiratory tract infection
Clinical narrative: Admitted to the hospital 1/13 with leg weakness that started on 1/12. This rapidly progressed to ascending weakness that progressed to acute respiratory failure; was intubated 1/16. Underwent lumbar puncture 1/14 that was negative. Was diagnosed with AIDP (acute inflammatory demyelinating polyneuritis)/GBS (Guillan Barre Syndrome) and started on plasmapheresis (underwent 8 sessions, starting 1/14) and IVIG (2 doses daily, starting 1/14). Improved with supportive care, extubated 1/20. Being discharged to acute rehab on 1/23.
Age: 73.0
Sex: F
Vaccine: COVID19, RSV
Symptoms: Peripheral swelling, Urticaria
Clinical narrative: My arm swelled up about 3 by 4 inches and was very warm to the touch. The swelling had 6 or 8 hives. I put moisture lotion on it. After 5 days the hives disappeared, swelling went down and my arm started to get better.
Age: 65.0
Sex: F
Vaccine: FLUC4
Symptoms: Pain, Pain in extremity
Clinical narrative: SHOOTING PAIN ON LEFT ARM AND DOES NOT GO AWAY EVEN WHEN USEING IBUPROFEN. PATIENT DES NOT WANT TO GO TO SEE A DOCTOR
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Patients states that she has had arm pain (upper left arm pain) since oct 10,2023 after receiving the shingrix shot.
Age: 10.0
Sex: F
Vaccine: COVID19, FLU4, TDAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Patient was given wrong vaccine.... Administered Spikevax 12+ when she should have received Moderna- 6months-11 years.
Sex: M
Vaccine: PNC, PPV
Symptoms: Pneumonia pneumococcal, Streptococcus test
Clinical narrative: Pneumonia; This spontaneous report has been downloaded from Surveillance System, and refers to a male patient of unknown age (age group reported as 10-14 years old). There was no information about the patient's concurrent conditions, concomitant medications, drug reactions, allergies or medical history provided.   On unknown dates, the patient was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection (exact dose, route of administration, anatomical location, lot number and expiration date were not provided) for prophylaxis; and four doses of pneumococcal vaccine conj 7v (crm197) (PREVENAR) (formulation, exact doses, route of administration, anatomical location, lot number, expiration date and indication were not provided).  On an unknown date in 2019, the patient experienced Streptococcus pneumoniae pneumonia (pneumonia pneumococcal), and his Streptococcus pneumoniae serotyping result was reported as not available. The outcome of the event was not reported.   The causal relationship between the event and pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) was not provided by the reporter.   Upon internal review, the event of pneumonia pneumococcal was determined to be medically significant.
Age: 4.0
Sex: F
Vaccine: COVID19, FLUC4, MMRV, UNK
Symptoms: Immunisation reaction
Clinical narrative: Postvaccination fever on 2023-11-28.
Age: 4.0
Sex: M
Vaccine: UNK, VARCEL
Symptoms: Rash
Clinical narrative: Rash and other nonspecific skin eruption on 2023-12-04.
Age: 52.0
Sex: F
Vaccine: COVID19, PNC20
Symptoms: Rash
Clinical narrative: Rash and other nonspecific skin eruption on 2023-12-07.
Age: 0.67
Sex: F
Vaccine: COVID19, DTPPVHBHPB, FLUC4, PNC20, RV5
Symptoms: Immunisation reaction
Clinical narrative: Adverse effect of vaccines and biological substances, init on 2023-11-30.
Age: 1.08
Sex: F
Vaccine: COVID19, FLUC4, MMR, PNC20, VARCEL
Symptoms: Immunisation reaction
Clinical narrative: Adverse effect of vaccines and biological substances, init on 2023-12-04.
Age: 0.67
Sex: F
Vaccine: DTPPVHBHPB, PNC20, RV5
Symptoms: Immunisation reaction
Clinical narrative: Postvaccination fever on 2023-11-30.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: Rash and other nonspecific skin eruption on 2023-12-06.
Age: 68.0
Sex: M
Vaccine: FLU4, PNC20
Symptoms: Bell's palsy
Clinical narrative: Bell''s palsy on 2023-12-13, Bell''s palsy on 2023-12-13.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: Adverse effect of vaccines and biological substances, init on 2023-10-24.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: Adverse effect of vaccines and biological substances, init on 2023-11-29.
Age: 34.0
Sex: F
Vaccine: COVID19, FLUC4, UNK
Symptoms: Immunisation reaction
Clinical narrative: Adverse effect of vaccines and biological substances, init on 2023-12-26.
Age: 0.58
Sex: M
Vaccine: DTPPVHBHPB, FLUC4, PNC20, RV5
Symptoms: Adverse event
Clinical narrative: Adverse effect of vaccines and biological substances, init on 2024-01-12.
Age: 15.0
Sex: F
Vaccine: FLUC4
Symptoms: Syncope
Clinical narrative: Syncope and collapse on 2024-01-16.
Age: 0.5
Sex: F
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: was given heplisav-b instead of hep b child
Age: 44.0
Sex: F
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: Adult pt received a peds/adol dose of Engerix
Age: 27.0
Sex: M
Vaccine: HEPA
Symptoms: Underdose
Clinical narrative: Adult pt was given a peds dose of Havrix. LASA is one cause.
Age: 31.0
Sex: F
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: pt given peds dose of ENgerix, due in part to Agency.
Age: 12.0
Sex: M
Vaccine: FLU4, MNQ
Symptoms: Dizziness, Headache, Nausea
Clinical narrative: Patient came in for nurse appointment for meningococcal and flu vaccine. After receiving pt stated he was nauseous, lightheaded and had headache at 9:45AM 1/23/2024.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Patient was given the COVID vaccine for 5-11 instead of the COVID 12+ vaccine
Age: 3.0
Sex: M
Vaccine: UNK
Symptoms: Expired product administered, No adverse event
Clinical narrative: On 1/16/2024 and expired vaccine was mistakenly administered to a child. There has been no adverse reactions. No issues of any kind.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: A Moderna Spikevax Covid-19 vaccine was given 2 days beyond use by date:    Expiration date on box 03/2024,  was taken out of freezer on 12/21/2023 and given a use by 01/20/2024  date, which was written on box, and a dose was given on 01/22/2024.
Age: 68.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: Duplicate vaccine given - first RSV vaccination given on 9-27-2023 at Pharmacy and second RSV given 12-20-2023 at Pharmacy.
Age: 12.0
Sex: M
Vaccine: HEP, IPV, MMR, TDAP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: The above vaccines were administered to the client even though he was up to date with his vaccinations and did not require them. His prior records were not available. When client's father was called, he stated that client did not experience any adverse reactions from the unnecessary doses of vaccines received.
Age: 66.0
Sex: F
Vaccine: PNC20, PNC20
Symptoms: Fatigue, Headache, Myalgia, Vomiting
Clinical narrative: Severe headache(5 days), muscle pain (7 days), vomiting (4 days) Fatigue
Age: 66.0
Sex: F
Vaccine: PNC20, PNC20
Symptoms: Headache, Pain, Vomiting
Clinical narrative: Severe headache(5 days), muscle pain (7 days), vomiting (4 days) Fatigue
Age: 66.0
Sex: F
Vaccine: PNC20, PNC20
Symptoms: Fatigue, Headache, Myalgia, Vomiting
Clinical narrative: BODY ACHES, SEVERE HEADACHE, AND VOMITTING
Age: 66.0
Sex: F
Vaccine: PNC20, PNC20
Symptoms: Headache, Pain, Vomiting
Clinical narrative: BODY ACHES, SEVERE HEADACHE, AND VOMITTING
Age: 2.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Covid vaccine was ordered for 6m-4yo dose. MA and MA extern were in the lab at the time of draw, and after discussion with both, MA was responsible for drawing up vaccination and was not verified by MA. New vial of vaccine was opened and should have been diluted with 1.1mL of solution, with a following 0.3mL dose draw up after dilution for administration. new vial was not diluted, and entire vial was drawn up and equaled 0.5mL and administered to patient. Recognition by other staff when 1 dose was documented in vaccine log, but 1 vial was missing and should have had 2 remaining doses in vial.
Age: 76.0
Sex: M
Vaccine: PNC20, VARZOS
Symptoms: Dizziness, Pallor
Clinical narrative: Patient states that during dinner on 1/20/2024 they started to feel lightheaded and dizzy. Wife states that the patient looked pale as well. Patient went to the emergency room and was given IV fluids and held overnight. Patient was released the next day and is doing well.
Age: 16.0
Sex: M
Vaccine: COVID19-2
Symptoms: Discontinued product administered
Clinical narrative: Patient received Bivalent COVID 19 vaccine when no longer authorized. Monovalent was authorized at time of administration. No adverse reaction status post this administration.
Age: 5.0
Sex: F
Vaccine: COVID19, IPV
Symptoms: Extra dose administered
Clinical narrative: Notified site manager who informed me to notify senior nurse manager who informed me to                                                                                                        1- the parents will need to be notified and the child will need the 5-11 doses ASAP (no minimum interval) 2- VAERS form will need to be completed online since it was a covid vaccine error 3- an incident report will need to be completed.                                                                                                                                                                                                                                                                                                                      Called parent to immediately notify then of above information and that they need to come in for a vaccine for 5-11 year old. Filled out this documentation. Filled out incident report.
Age: 15.0
Sex: M
Vaccine: FLUR4
Symptoms: Product administered to patient of inappropriate age, Rash
Clinical narrative: The patient was given the Flublok, but he is only 15 years old. He did, a day later develop a rash for which he took benadryl.
Age: 5.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Nothing reported
Age: 70.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Patient was given a dose of expired vaccine.  The vaccine was placed into the fridge on 12/16/2023 and the manufacturer states it is only good for 30 days after the administration of the vaccine.  The vaccine was administered on 1/19/2024.
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Amyotrophic lateral sclerosis, Computerised tomogram, Electromyogram, Laboratory test, Magnetic resonance imaging
Clinical narrative: Diagnosed with ALS, 8/2022. Slight hand weakness (left hand) began 5/2021 ,which worsened until I started going to doctor appointments to figure out what was going on spring of 2022.
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Muscular weakness
Clinical narrative: Diagnosed with ALS, 8/2022. Slight hand weakness (left hand) began 5/2021 ,which worsened until I started going to doctor appointments to figure out what was going on spring of 2022.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Erythema, Fatigue, Headache, Injection site erythema
Clinical narrative: Area around injection site skin red, hot and raised. I am fatigued, have muscle pain, chills, mild fever and major headache.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Injection site warmth, Myalgia, Pyrexia, Skin swelling
Clinical narrative: Area around injection site skin red, hot and raised. I am fatigued, have muscle pain, chills, mild fever and major headache.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin warm
Clinical narrative: Area around injection site skin red, hot and raised. I am fatigued, have muscle pain, chills, mild fever and major headache.
Age: 42.0
Sex: M
Vaccine: HEPA
Symptoms: Hypoaesthesia
Clinical narrative: PATIENT CAME IN FOR HAVRIX VACCINE, FOR ENTRANCE INTO PROFESSIONAL SCHOOL. STATES THAT SINCE THE VACCINATION WAS GIVEN THE PATIENT HAS BEEN EXPERIENCING NUMBNESS IN THE LEFT ARM. WAS INSTRUCTED TO NOTIFY PRESCRIBER WHILE THE PHARMACIST NOTIFIED VAERS. THE PATIENT HAS NOT VISITED ANY EMERGENCY DEPT OR HIS PRIMARY CARE PHYSICIAN.
Age: 76.0
Sex: F
Vaccine: RSV
Symptoms: Injection site reaction, Injection site swelling, Injection site warmth, Rash erythematous
Clinical narrative: Swelling  at injection site; warm at injection site; red rash at injection site
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Dyspnoea, Facial paresis, Laboratory test normal, Magnetic resonance imaging head normal, Magnetic resonance imaging spinal normal
Clinical narrative: Was admitted to the emergency department with a two-week history of weakness and paresthesia. It started in the lower extremities and then spread to the upper extremities. She also later developed shortness of breath. She was evaluated at a hospital where an MRI brain and C spine and workup were largely unremarkable. She returned to the same hospital a few days later after her legs gave out. A neurologist at an outside hospital evaluated her and was concerned for Guillain Barre syndrome. The patient and her parents declined admission at that time, opting to be worked up closer to home. The next day she developed right-sided facial weakness. Her mother brought her to ED on 1/21
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Muscular weakness, Paraesthesia
Clinical narrative: Was admitted to the emergency department with a two-week history of weakness and paresthesia. It started in the lower extremities and then spread to the upper extremities. She also later developed shortness of breath. She was evaluated at a hospital where an MRI brain and C spine and workup were largely unremarkable. She returned to the same hospital a few days later after her legs gave out. A neurologist at an outside hospital evaluated her and was concerned for Guillain Barre syndrome. The patient and her parents declined admission at that time, opting to be worked up closer to home. The next day she developed right-sided facial weakness. Her mother brought her to ED on 1/21
Age: 1.0
Sex: M
Vaccine: HEPA, HIBV, MMRV, PNC13
Symptoms: Irritability, Myalgia, Pyrexia, Rash
Clinical narrative: pt irritable after vaccines with low grade intermittant fever and myalgias. Rash started on 1/22/24 and  located in groin and abdomen. Tx is use Tylenol and supportive care.
Age: 85.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pruritus, Rash
Clinical narrative: Rash on torso, arms, and upper body reported. "Shingles bumpy looking rash" per patient. He reported severe itching.
Age: 41.0
Sex: M
Vaccine: FLU4
Symptoms: Condition aggravated, Psoriasis
Clinical narrative: Psoriasis plaques appeared  on hands 2-3 weeks after the vaccine. Pt has psoriasis flare-ups correlated with flu vaccine administration in the past.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site warmth, Swelling
Clinical narrative: Redness and swollen, Patient is feeling warm around the injection area.
Age: 70.0
Sex: M
Vaccine: COVID19-2
Symptoms: Cerebral thrombosis, Intensive care, Laboratory test, Magnetic resonance imaging head
Clinical narrative: brain blood clot
Age: 79.0
Sex: F
Vaccine: RSV
Symptoms: Laboratory test normal, Pruritus
Clinical narrative: itching without rash
Age: 7.0
Sex: M
Vaccine: HEPA, TDAP
Symptoms: Cough, Pruritus, Pyrexia, Respiratory tract congestion, Rhinorrhoea
Clinical narrative: itchy/hives on trunk, arms.  Since then, low grade fever off and on 38.3, runny nose, congestion, cough. Mom gave Claritin.
Age: 7.0
Sex: M
Vaccine: HEPA, TDAP
Symptoms: Urticaria
Clinical narrative: itchy/hives on trunk, arms.  Since then, low grade fever off and on 38.3, runny nose, congestion, cough. Mom gave Claritin.
Age: 0.5
Sex: F
Vaccine: UNK
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Client received the Hepatitis B vaccine too early and did not reach the date of the minimum interval for Hep B.
Age: 72.0
Sex: F
Vaccine: TDAP
Symptoms: Dyspnoea, Hypoaesthesia oral, Swelling
Clinical narrative: Following vaccine administration while in Lab,  patient reported tongue numbness, swelling and shortness of breath believed to be caused by Tdap vaccine. Patient was taken back into the Primary Care department and received Epinephrine 0.3mg injection immediately. Patient also reported shortness of breath. Vitals recorded by nursing and updated to chart. EMS was called and 2L oxygen placed. Patient maintained alertness throughout visit and called her husband to report she would be going to the hospital. EMS transported to hospital.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash, Skin warm, Urticaria
Clinical narrative: about 4 hrs after it started itching then sunday she had a rash then monday had welts and hot to touch she's been taking benadryl and its been helping treat it.
Age: 4.0
Sex: M
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: NO SYMPTOMS