chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: RSV
Symptoms: Cellulitis, Impaired healing, Incorrect route of product administration, Ulcer
Clinical narrative: cellullitis; ulcer; given the vaccine improperly and not given IM; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of cellulitis in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 23-OCT-2023, the patient received the 1st dose of Arexvy. On 23-OCT-2023, an unknown time after receiving Arexvy, the patient experienced intramuscular formulation administered by other route (Verbatim: given the vaccine improperly and not given IM). On an unknown date, the patient experienced cellulitis (Verbatim: cellullitis) and ulcer (Verbatim: ulcer). The outcome of the cellulitis and ulcer were not resolved and the outcome of the intramuscular formulation administered by other route was unknown.   It was unknown if the reporter considered the cellulitis and ulcer to be related to Arexvy.     It was unknown if the company considered the cellulitis and ulcer to be related to Arexvy.   Additional Information: GSK receipt date: 19-JAN-2024 The case was received from the patient via interactive digital media. The patient reported developing cellulitis and an ulcer that still had not healed up, after having gotten the RSV vaccine.  The patient also stated being given the vaccine improperly and not given intramuscularly, which led to intramuscular formulation administered by other route. (consumer posted in response to AREXVY controlled content) The patient stated that effectiveness questionable but not going to get another one. The follow-up could not be possible as no contact details were available.
Age: 1.0
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Extra dose administered
Clinical narrative: received a dose of Pediarix instead of a dose of Infanrix; Extra dose administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 1-year-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number E9Y29, expiry date 26-OCT-2024) for prophylaxis.   On 18-JAN-2024, the patient received the 4th dose of Pediarix. On 18-JAN-2024, an unknown time after receiving Pediarix, the patient experienced wrong vaccine administered (Verbatim: received a dose of Pediarix instead of a dose of Infanrix) and extra dose administered (Verbatim: Extra dose administered). The outcome of the wrong vaccine administered and extra dose administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date:18-JAN-2024 Clinical supervisor reported that the patient received a dose of Pediarix instead of a dose of Infanrix, which led to wrong vaccine administered. The patient received 4th dose of Pediarix, which led to extra dose administered. The reporter consented to follow up. Healthcare professional asked any safety follow up calls would be directed towards her phone.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Menveo: reconstituted with non GSK diluent; Menveo: reconstituted with non GSK diluent; This non-serious case was reported by a physician via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   In DEC-2023, the patient received Menveo. In DEC-2023, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: Menveo: reconstituted with non GSK diluent) and inappropriate dose of vaccine administered (Verbatim: Menveo: reconstituted with non GSK diluent). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 18-JAN-2024 The reporter reported that Menveo was reconstituted with non-GSK diluent and administered to a patient in December, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. Reporter asked the question that should the patient need revaccinated. The reporter consented to follow-up.
Age: 19.0
Sex: M
Vaccine: HEP, MMR
Symptoms: Bundle branch block right, Dizziness, Electrocardiogram T wave abnormal, Electrocardiogram abnormal, Fall
Clinical narrative: Patient stated he started to feel an itching sensation at vaccination site, then became dizzy and fell into wall locker then onto the ground. He did hit his head on the locker.
Age: 19.0
Sex: M
Vaccine: HEP, MMR
Symptoms: Head injury, Sinus bradycardia, Vaccination site pruritus
Clinical narrative: Patient stated he started to feel an itching sensation at vaccination site, then became dizzy and fell into wall locker then onto the ground. He did hit his head on the locker.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Musculoskeletal pain, Neck pain, Pain, Sensory disturbance
Clinical narrative: Patient reported that arm was sore the day of the vaccine and the day after she received the vaccine.   Now she feels as if that arm has a dead spot in it.    The pain is dull and constant.     The pain goes from where she got the shot in her deltoid muscle then up her shoulder.    The pain radiates into her shoulder blade and neck.    She feels like maybe there is a nerve pinched or something going on.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE GIVEN AFTER VIABILITY DATE
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE GIVEN AFTER VIABILITY DATE
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE GIVEN AFTER VIABILITY DATE
Age: 16.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Carditis, Echocardiogram abnormal, Pain, Troponin increased
Clinical narrative: Patient has been complaining about pain that we thought was gastritis, but we had to rush him to the hospital and they did blod test where the tripono was high when they did the ecocardiogram it showed his heart showed an inflammation
Age: 0.17
Sex: F
Vaccine: DTPPVHBHPB, PNC15, RV1
Symptoms: Unevaluable event
Clinical narrative: Unknown
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Eye swelling, Ocular hyperaemia, Pruritus, Rash, Urticaria
Clinical narrative: Chart Note written on 1/10/24:  *Approximately 2 minutes after MMRV, DTaP/IPV, and flu shots were given at well check today, patient started vomiting. No more vomiting episodes since, but dad just called stating pt is very itchy on his face and arms, had bumps (possible hives) on his head/scalp, low grade fever (99 per dad), and right eye swelling/redness. Per Dr., have dad give pt Children's Benadryl 5mL every 6-8 hours and monitor very closely for and mouth/tongue swelling, difficulty breathing, or fevers not coming down with medication. Will check on patient in 2 hours per Dr. to see how he is doing. Instructed dad to take pt to ER or UC (if closer) for eval and possible epi if pt worsening. "Addendum: Called dad at 12:45pm to see how patient is doing. Dad states, he has not worsening and itching and redness slightly better after benadryl. Dad will continue benadryl every 6 hours and call with any worsening symptoms. Dad will continue benadryl every 6 hours and call with any worsening symptoms. Dad monitoring for worsening swelling, respiratory distress, fever worsening, etc. [R.N].
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Vomiting
Clinical narrative: Chart Note written on 1/10/24:  *Approximately 2 minutes after MMRV, DTaP/IPV, and flu shots were given at well check today, patient started vomiting. No more vomiting episodes since, but dad just called stating pt is very itchy on his face and arms, had bumps (possible hives) on his head/scalp, low grade fever (99 per dad), and right eye swelling/redness. Per Dr., have dad give pt Children's Benadryl 5mL every 6-8 hours and monitor very closely for and mouth/tongue swelling, difficulty breathing, or fevers not coming down with medication. Will check on patient in 2 hours per Dr. to see how he is doing. Instructed dad to take pt to ER or UC (if closer) for eval and possible epi if pt worsening. "Addendum: Called dad at 12:45pm to see how patient is doing. Dad states, he has not worsening and itching and redness slightly better after benadryl. Dad will continue benadryl every 6 hours and call with any worsening symptoms. Dad will continue benadryl every 6 hours and call with any worsening symptoms. Dad monitoring for worsening swelling, respiratory distress, fever worsening, etc. [R.N].
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Asthma, Hypersensitivity, Injection site erythema, Injection site warmth, Skin reaction
Clinical narrative: 17year old male with localized superficial redness, warmth at site of Menquafi Left Deltoid. Pt also has K Pilaris, 11xq Asthma & Allergies given cold compress Zyrtec (no pruritis).
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Anal incontinence, Arthralgia, Arthritis, Dizziness, Fall
Clinical narrative: on 01/23/2024 pt had following symptoms: H/A pain and inflamation all joints, pain to the touch on skin, muscel pain weakness, cramping, legs "gave out" on pt at home had fall at home, no injury. dizziness 01/24/2024 early am worsening pain, weakness. loss of bladder & bowel control. Sent to ER 01/24/2024 Labs done given 2 liters NS No other loss of Bowel/bladder control simptom lessening 01/25/24
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Laboratory test, Muscle spasms, Muscular weakness, Myalgia
Clinical narrative: on 01/23/2024 pt had following symptoms: H/A pain and inflamation all joints, pain to the touch on skin, muscel pain weakness, cramping, legs "gave out" on pt at home had fall at home, no injury. dizziness 01/24/2024 early am worsening pain, weakness. loss of bladder & bowel control. Sent to ER 01/24/2024 Labs done given 2 liters NS No other loss of Bowel/bladder control simptom lessening 01/25/24
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain of skin, Urinary incontinence
Clinical narrative: on 01/23/2024 pt had following symptoms: H/A pain and inflamation all joints, pain to the touch on skin, muscel pain weakness, cramping, legs "gave out" on pt at home had fall at home, no injury. dizziness 01/24/2024 early am worsening pain, weakness. loss of bladder & bowel control. Sent to ER 01/24/2024 Labs done given 2 liters NS No other loss of Bowel/bladder control simptom lessening 01/25/24
Sex: M
Vaccine: PPV
Symptoms: Pneumonia pneumococcal
Clinical narrative: Pneumonia; This spontaneous report has been downloaded from Regulatory Authority", concerning an elderly male patient 85+ years old. Their concurrent conditions, medical history, drug reactions/allergies, and concomitant medications were not provided.   On an unspecified date, the patient was vaccinated with the first dose of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection, administered as prophylaxis (dosage regimen, route of administration, lot number and expiration date were not reported).   On an unknown date in 2010, the patient experienced pneumonia (Pneumonia pneumococcal) and streptococcus pneumoniae serotyping was not available. At the time of the report, outcome of the event was not reported.   Causal relationship between suspect vaccine and the event was not reported. Upon internal review, the event pneumonia pneumococcal was determined to be medically significant.
Sex: F
Vaccine: PPV
Symptoms: Pneumococcal bacteraemia
Clinical narrative: Bacteraemia; This spontaneous report has been downloaded from Regulatory Authority concerning to an adult female patient (age: 60-64). The patient's medical history, concurrent conditions, and concomitant drugs were not reported.  On an unknown date, the patient was vaccinated with the first dose of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection (strength, dose, route of administration, lot#, and expiration date were not reported) for prophylaxis.   On an unknown date in 2014, the patient experienced pneumococcal bacteraemia. On an unknown date in 2014, streptococcus pneumoniae serotyping was not available. At the time of reporting, the outcome of the event pneumococcal bacteraemia was unknown.   The causal relationship between the event and pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) was not provided.  Upon internal review, the event of pneumococcal bacteraemia was determined to be medically significant.
Sex: F
Vaccine: PPV
Symptoms: Pneumonia pneumococcal
Clinical narrative: Pneumonia; This spontaneous report has been downloaded from Regulatory Authority, regarding to an elderly (reported as between 65-to-69-year-old) female patient.   The patient's pertinent medical history, previous drug reactions or allergies, concurrent conditions, and concomitant medications were not provided.  On an unknown date, the patient was vaccinated with the first dose of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection (strength, dosage, vaccination scheme frequency, route of administration, anatomical location, lot number, and expiration date were not provided) for prophylaxis.   On an unspecified date in 2020, streptococcus pneumoniae serotyping was reported as not available. On the same date, the patient experienced Pneumonia pneumococcal. At the time of reporting, the outcome of the event and the causality assessment between the event with the pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) were not reported.  Upon internal review, the Pneumonia pneumococcal event was determined to be medically significant.
Sex: F
Vaccine: PPV
Symptoms: Pneumonia pneumococcal
Clinical narrative: Pneumonia; This spontaneous report has been downloaded from Regulatory Agency, regarding to an adult (reported as between 40-to-44-year-old) female patient.   The patient's pertinent medical history, previous drug reactions or allergies, concurrent conditions, and concomitant medications were not provided.  On an unknown date, the patient was vaccinated with the first dose of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection (strength, dosage, vaccination scheme frequency, route of administration, anatomical location, lot number, and expiration date were not provided) for prophylaxis. On an unknown date, the patient was vaccinated with the second dose of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection (strength, dosage, vaccination scheme frequency, route of administration, anatomical location, lot number, and expiration date were not provided).  On an unspecified date in 2020, streptococcus pneumoniae serotyping was reported as Not Available. On the same date, the patient experienced Pneumonia pneumococcal. At the time of reporting, the outcome of the event and the causality assessment between the event with the pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) were not reported.  Upon internal review, the Pneumonia pneumococcal event was determined to be medically significant.
Sex: F
Vaccine: PPV
Symptoms: Pneumococcal infection
Clinical narrative: No data provided; This spontaneous report has been downloaded from Regulatory Authority and refers to an adult (45-49-year-old) 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 (strength, lot #, expiry date, and route of administration were not provided).  On an unknown date in 2021, the patient experienced pneumococcal infection (also reported as no data provided). On an unknown date in 2021, Streptococcus pneumoniae serotyping showed not available. At the time of reporting, the outcome of the events was unknown.   The causal relationship between pneumococcal infection and pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) was unknown.   Upon internal review, Pneumococcal infection was determined to be medically significant.
Sex: F
Vaccine: PPV
Symptoms: Pneumonia pneumococcal, Streptococcus test
Clinical narrative: clinical category: pneumonia; This spontaneous report has been downloaded from regulatory agency on 12-JAN-2024, concerning an elderly (reported as 75-79-year-old) female patient. The patient's medical history, concurrent conditions, and concomitant medications were not provided.  On an unknown date, the patient was vaccinated with the first dose of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection (strength, dose, vaccination scheme frequency, route of administration, anatomical location, lot number, and expiration date were not provided), as prophylaxis.  On an unspecified date in 2012, the patient experienced streptococcus pneumoniae pneumonia (pneumonia pneumococcal) (clinical category: pneumonia), with a streptococcus pneumoniae serotyping result reported as "not available".  The outcome of the event and the causality assessment between the event and pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) were not reported.  Upon internal review, the event of pneumonia pneumococcal was determined to be medically significant.
Sex: F
Vaccine: PPV
Symptoms: Pneumonia pneumococcal, Streptococcus test
Clinical narrative: clinical category: pneumonia; This spontaneous report has been downloaded from regulatory authority on 12-JAN-2024, concerning an adult (reported as 55-59-year-old) female patient. The patient's medical history, concurrent conditions, and concomitant medications were not provided.  On an unknown date, the patient was vaccinated with the first dose of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection (strength, dose, vaccination scheme frequency, route of administration, anatomical location, lot number, and expiration date were not provided), as prophylaxis.  On an unspecified date in 2012, the patient experienced streptococcus pneumoniae pneumonia (pneumonia pneumococcal) (clinical category: pneumonia), with a streptococcus pneumoniae serotyping result reported as "not available".  The outcome of the event and the causality assessment between the event and pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) were not reported.  Upon internal review, the event of pneumonia pneumococcal was determined to be medically significant.
Sex: F
Vaccine: PPV
Symptoms: Pneumonia pneumococcal
Clinical narrative: Streptococcus pneumoniae pneumonia; This spontaneous report as received from a Regulatory Authority refers to an adult female patient of unknown age (age group reported as 50 and 44). No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided.  On an unknown date, the patient was vaccinated with 2 doses of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection (dose, route of administration, anatomical location, lot number and expiration date were not reported) for prophylaxis.    On an unknown date in 2014, the patient experienced Pneumonia (Streptococcus pneumoniae pneumonia). At the time of the report, Streptococcus pneumoniae serotyping was not available. The outcome of the event was not reported.  The causal relationship between the event and pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) was not reported.  Upon internal review, the event was determined to be medically significant event.
Sex: M
Vaccine: PNC13, PPV
Symptoms: Pneumococcal bacteraemia
Clinical narrative: Bacteraemia; This spontaneous report has been downloaded from Regulatory Authority concerning to a child male patient (age: 05-09). The patient's medical history, concurrent conditions, and concomitant drugs were not reported.  On an unknown date, the patient was vaccinated with the first dose of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection and on unknown dates, with the first, second and third doses of pneumococcal vaccine conj 7v (crm197)(PREVENAR) (strength, dose, route of administration, lot#, and expiration date were not reported) for prophylaxis.   On an unknown date in 2021, the patient experienced pneumococcal bacteraemia. On an unknown date in 2021, streptococcus pneumoniae serotyping was not available. At the time of reporting, the outcome of the event pneumococcal bacteraemia was unknown.   The causal relationship between the event and pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) and pneumococcal vaccine conj 7v (crm197)(PREVENAR) was not provided.  Upon internal review, the event of pneumococcal bacteraemia was determined to be medically significant.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: Patches of total hair loss. Regrowth after several months, increased number and size as time progresses.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE GIVEN AFTER VIABILITY DATE
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE GIVEN AFTER VIABILITY DATE
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE GIVEN AFTER VIABILITY DATE
Age: 23.0
Sex: M
Vaccine: YF
Symptoms: Malaise, Nausea, Pyrexia
Clinical narrative: Malaise, subjective fever, nausea
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: Patient reported swelling of left arm, she was treated for infection
Age: 80.0
Sex: F
Vaccine: RSV, VARZOS
Symptoms: Pain in extremity, Sleep disorder, Tenderness
Clinical narrative: Pt called pharmacy and reported adverse reaction to vaccines (Shingrix and RSV) received on 1/4/2024. Starts her symptoms of pain in Left Arm started a few days later and that her arm hurts to the touch and she cannot sleep on it. She reported symptoms to her PCP on 1/24/24 and was told to just take OTC APAP.
Age: 53.0
Sex: M
Vaccine: COVID19-2
Symptoms: Cardiac disorder, Cardiomegaly, Chest X-ray abnormal, Cough, Dyspnoea
Clinical narrative: acute cough and dyspnea starting 1/6/2024
Age: 53.0
Sex: M
Vaccine: COVID19-2
Symptoms: Echocardiogram abnormal, Ejection fraction decreased, Influenza virus test negative, Mitral valve incompetence, Pneumonia
Clinical narrative: acute cough and dyspnea starting 1/6/2024
Age: 53.0
Sex: M
Vaccine: COVID19-2
Symptoms: SARS-CoV-2 test negative
Clinical narrative: acute cough and dyspnea starting 1/6/2024
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Feeling abnormal, Thrombosis
Clinical narrative: Approximately 24 hours after vaccine patient started feeling bad.  Daughter went to check on her and patient was SOB.  She was taken to the hospital and admitted for blood clots.
Age: 75.0
Sex: M
Vaccine: PNC20
Symptoms: Chest X-ray abnormal, Chest discomfort, Dyspnoea, Electrocardiogram normal, Pulmonary function test abnormal
Clinical narrative: After exercising, I had the acute onset of shortness of breath, dyspnea, and tightness in my chest. I did have a similar reaction after the covid 19 booster in 2020.
Age: 75.0
Sex: M
Vaccine: PNC20
Symptoms: SARS-CoV-2 test negative
Clinical narrative: After exercising, I had the acute onset of shortness of breath, dyspnea, and tightness in my chest. I did have a similar reaction after the covid 19 booster in 2020.
Age: 66.0
Sex: F
Vaccine: RSV
Symptoms: Injection site erythema
Clinical narrative: Redness on the site of the injection.
Age: 15.0
Sex: F
Vaccine: HEP, HEPA, IPV, MMR, MNQ, TDAP, VARCEL
Symptoms: Pallor, Syncope
Clinical narrative: After vaccines were administered, patient had a syncopal episode where she fainted but did not lose consciousness. Patient was sitting in the exam room chair and did not fall. She was laid back with feet up by this RN. Two other RNs assisted with fanning patient and getting her water. Patient regained color within 45 seconds and did not lose a pulse. Patient was assessed by this RN after episode for 20 minutes. Blood pressure after the event was 97/73 (81), Heart rate (59) and oxygen saturation 98% on room air. Patient was able to verbalize that she was feeling better. She was able to stand and put her jacket on without complications or additional dizzy spells. Patient and father educated that patient should take Tylenol for fever or pain and to bring patient to hospital if she were to have any additional episodes or symptoms. Patient and father verbalized understanding
Age: 61.0
Sex: F
Vaccine: HEPAB
Symptoms: Chills, Decreased appetite, Diarrhoea, Fatigue, Feeling abnormal
Clinical narrative: Began around 24 hours after administration (1/18/2024) with headache and diarrhea which progressed to vomiting, 101.2 fever, body aches, and chills on the evening of 1-18-24. I was very sick with all of the previously described symptoms all day of the 19th. I was able to take oral Ibuprofen around 11 AM on 1-19-24. Only other thing PO this day was Gatorade. Felt poorly 1-20-24 but most symptoms had lessened/subsided. Continued recovery on 1-21-24 with mostly fatigue and anorexia. Returned to work 1-22-24.
Age: 61.0
Sex: F
Vaccine: HEPAB
Symptoms: Feeling cold, Headache, Pain, Pyrexia, Vomiting
Clinical narrative: Began around 24 hours after administration (1/18/2024) with headache and diarrhea which progressed to vomiting, 101.2 fever, body aches, and chills on the evening of 1-18-24. I was very sick with all of the previously described symptoms all day of the 19th. I was able to take oral Ibuprofen around 11 AM on 1-19-24. Only other thing PO this day was Gatorade. Felt poorly 1-20-24 but most symptoms had lessened/subsided. Continued recovery on 1-21-24 with mostly fatigue and anorexia. Returned to work 1-22-24.
Age: 54.0
Sex: M
Vaccine: RSV
Symptoms: Wrong product administered
Clinical narrative: Physician order was to receive Shingrix.  Nurse gave Arexvy by mistake.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: 1/10/24 Immediate swelling, redness to varivax injection site, mild redness later to MMR site. Benedryl / Ibuprofen given, observed and improved with time. No other symptoms developed. Allergy referral
Age: 4.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Immediate post-injection reaction, Urticaria, Vomiting
Clinical narrative: immediate hives/vomiting, sent to ER
Age: 67.0
Sex: F
Vaccine: RSV
Symptoms: Erythema, Feeling hot, Pruritus, Skin papilloma, Swelling
Clinical narrative: I am not sure which of the RSV vaccines I received, or the manufacturer.  I experienced Swelling, redness, itching, hot eyes/face.  Treated with Steroids/anti-histamines in emergency room and then follow up with doctor.  Symptoms improved during 5 day course but then returned, so am on that same medication today
Age: 7.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine was given 2 days past the 10 week refrigerated expiration date. No adverse reaction reported.
Age: 25.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site warmth
Clinical narrative: Injection site reaction, 5.5 cm in diameter. Area is red, warm, and tender to palpation. Gradually developed within 24-48 hrs of receiving the immunization. No systemic symptoms. Encouraged patient to ice the affected area for 10-15 minutes, 3x per day. Start OTC Ibuprofen TID for the next 3 days. Seek immediate care in the case of new/worsening symptoms. Contact the clinic on Monday if symptoms have not started to improve
Age: 55.0
Sex: M
Vaccine: FLU4, UNK
Symptoms: Chronic obstructive pulmonary disease, Condition aggravated, Dyspnoea, Dysstasia, Feeling abnormal
Clinical narrative: I received these shots per my doctor's orders. next day I went downstairs and wasn't feeling too good. thought it was normal side effects. I went out and pushed myself to do some grocery shopping but was still unwell. It became hard to breathe, stand, walk as the days went by. Wanted to get through Christmas. Christmas eve, I was with family and after a few gifts I was too sick to stay with them and I went upstairs and went to bed. I slept through Christmas. On the 26th, It took me 2 hours to get down the stairs to go to the hospital by scooting down on my behind. I couldn't walk. I called 911. They took me to the emergency room. I thought I was having a COPD attack. Emergency Doctor informed me I had severe pneumonia and pleurisy.  On 12/26 148lbs... They asked if I wanted to be DNR, if I had a POA, etc. They said if I went on vent `I'd only live 2 weeks. hospital until 1/11 or 1/12. Taken to a respiratory rehab (old folks home). I needed a specific medication that was over $900 if I went home so I went to a nursing facility so they would cover this treatment. Antibiotics, inhaler (turbomycin). I was seen by Doctor, the nursing facility drove me there and he checked my lungs and they looked better but I was still having trouble breathing good. Right now, 1/25, I have put on 25lbs since then and am doing better but still recovering.
Age: 55.0
Sex: M
Vaccine: FLU4, UNK
Symptoms: Gait disturbance, Gait inability, Laboratory test, Malaise, Pleurisy
Clinical narrative: I received these shots per my doctor's orders. next day I went downstairs and wasn't feeling too good. thought it was normal side effects. I went out and pushed myself to do some grocery shopping but was still unwell. It became hard to breathe, stand, walk as the days went by. Wanted to get through Christmas. Christmas eve, I was with family and after a few gifts I was too sick to stay with them and I went upstairs and went to bed. I slept through Christmas. On the 26th, It took me 2 hours to get down the stairs to go to the hospital by scooting down on my behind. I couldn't walk. I called 911. They took me to the emergency room. I thought I was having a COPD attack. Emergency Doctor informed me I had severe pneumonia and pleurisy.  On 12/26 148lbs... They asked if I wanted to be DNR, if I had a POA, etc. They said if I went on vent `I'd only live 2 weeks. hospital until 1/11 or 1/12. Taken to a respiratory rehab (old folks home). I needed a specific medication that was over $900 if I went home so I went to a nursing facility so they would cover this treatment. Antibiotics, inhaler (turbomycin). I was seen by Doctor, the nursing facility drove me there and he checked my lungs and they looked better but I was still having trouble breathing good. Right now, 1/25, I have put on 25lbs since then and am doing better but still recovering.
Age: 55.0
Sex: M
Vaccine: FLU4, UNK
Symptoms: Pneumonia, Weight increased
Clinical narrative: I received these shots per my doctor's orders. next day I went downstairs and wasn't feeling too good. thought it was normal side effects. I went out and pushed myself to do some grocery shopping but was still unwell. It became hard to breathe, stand, walk as the days went by. Wanted to get through Christmas. Christmas eve, I was with family and after a few gifts I was too sick to stay with them and I went upstairs and went to bed. I slept through Christmas. On the 26th, It took me 2 hours to get down the stairs to go to the hospital by scooting down on my behind. I couldn't walk. I called 911. They took me to the emergency room. I thought I was having a COPD attack. Emergency Doctor informed me I had severe pneumonia and pleurisy.  On 12/26 148lbs... They asked if I wanted to be DNR, if I had a POA, etc. They said if I went on vent `I'd only live 2 weeks. hospital until 1/11 or 1/12. Taken to a respiratory rehab (old folks home). I needed a specific medication that was over $900 if I went home so I went to a nursing facility so they would cover this treatment. Antibiotics, inhaler (turbomycin). I was seen by Doctor, the nursing facility drove me there and he checked my lungs and they looked better but I was still having trouble breathing good. Right now, 1/25, I have put on 25lbs since then and am doing better but still recovering.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Anaemia, Blood test abnormal, Injected limb mobility decreased, Peripheral swelling
Clinical narrative: Severe left arm swelling 2/3 of arm for three weeks, couldn't lift arm. Severe Anemia 9 out of 10 blood work was severe, one was normal for several months. Still have to take medications/suppliments to keep bloodwork within normal range.
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Angiocardiogram, Atrial fibrillation, Chest pain, Coronary artery disease, Echocardiogram
Clinical narrative: 2023 DEVELOPED PAROXYSMAL ATRIAL FIBRILLATION REQUIRING HOSPITALIZATION ANTICOAGULATION AND BETA-BLOCKERS,  2023 DEVELOPED MYOPERICARDITIS AND PLEURODYNIA REQUIRING 3 EMERGENCY ROOM VISITS, CORTICOSTEROIDS, COLCHICINE. FOUND TO HAVE COINCIDENT CAD BY CT ANGIOGRAPHY.   HAS BEEN UNABLE TO WORK FOR > 30 DAYS DUE TO CHEST PAIN.
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Electrocardiogram, Electrocardiogram ambulatory, Impaired work ability, Laboratory test, Myopericarditis
Clinical narrative: 2023 DEVELOPED PAROXYSMAL ATRIAL FIBRILLATION REQUIRING HOSPITALIZATION ANTICOAGULATION AND BETA-BLOCKERS,  2023 DEVELOPED MYOPERICARDITIS AND PLEURODYNIA REQUIRING 3 EMERGENCY ROOM VISITS, CORTICOSTEROIDS, COLCHICINE. FOUND TO HAVE COINCIDENT CAD BY CT ANGIOGRAPHY.   HAS BEEN UNABLE TO WORK FOR > 30 DAYS DUE TO CHEST PAIN.
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Pleuritic pain, Troponin normal
Clinical narrative: 2023 DEVELOPED PAROXYSMAL ATRIAL FIBRILLATION REQUIRING HOSPITALIZATION ANTICOAGULATION AND BETA-BLOCKERS,  2023 DEVELOPED MYOPERICARDITIS AND PLEURODYNIA REQUIRING 3 EMERGENCY ROOM VISITS, CORTICOSTEROIDS, COLCHICINE. FOUND TO HAVE COINCIDENT CAD BY CT ANGIOGRAPHY.   HAS BEEN UNABLE TO WORK FOR > 30 DAYS DUE TO CHEST PAIN.
Age: 62.0
Sex: M
Vaccine: RSV
Symptoms: Product preparation error
Clinical narrative: MD ordered Arexvy RSV Vaccine for patient.  Manufacturer supplied adjuvant suspension diluent was not dispensed with lyophilized powder.   Arexvy vaccine diluted with sterile diluent intended for live vaccines.  Patient will require re-vaccination at next clinic visit.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Injection site pain, Mobility decreased, Muscle spasms
Clinical narrative: I experienced, at first, the typical arm soreness, but it progressed for next few hours. My entire arm hurt (not only injection site) severely to the point it was difficult to move and lift objects. My hand cramped. I also broke out in a rosacea rash on my face and chest (red hives). I have rosacea, but have never experienced an outbreak with past COVID-19 vaccines. My rash was gone the next day. I also experienced chills and a headache, but a normal amount. I am primarily reporting the arm pain and rosacea, which were abnormal. My arm continues to be sore the next day, but the pain has subsided.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Rosacea
Clinical narrative: I experienced, at first, the typical arm soreness, but it progressed for next few hours. My entire arm hurt (not only injection site) severely to the point it was difficult to move and lift objects. My hand cramped. I also broke out in a rosacea rash on my face and chest (red hives). I have rosacea, but have never experienced an outbreak with past COVID-19 vaccines. My rash was gone the next day. I also experienced chills and a headache, but a normal amount. I am primarily reporting the arm pain and rosacea, which were abnormal. My arm continues to be sore the next day, but the pain has subsided.
Age: 81.0
Sex: M
Vaccine: COVID19-2, RSV
Symptoms: Peripheral swelling
Clinical narrative: Patient's arms became swollen up the day after getting both shots.  Patient returned to pharmacy on 1/25 to inform us that arm swelling was still occuring. We suggested some benadryl.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Fatigue, Hypophagia, Injection site induration, Injection site pain
Clinical narrative: Fever of 101.7, at shot site: redness, swelling, hardness, pain, warmth to touch?all greater than 6 itches, severe body aches and pains, nausea, fatigue and sleeping, decreased eating and drinking. It required in person doctor?s visit with oncology (surgical) NP.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site reaction, Injection site swelling, Injection site warmth, Nausea, Pain
Clinical narrative: Fever of 101.7, at shot site: redness, swelling, hardness, pain, warmth to touch?all greater than 6 itches, severe body aches and pains, nausea, fatigue and sleeping, decreased eating and drinking. It required in person doctor?s visit with oncology (surgical) NP.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Somnolence
Clinical narrative: Fever of 101.7, at shot site: redness, swelling, hardness, pain, warmth to touch?all greater than 6 itches, severe body aches and pains, nausea, fatigue and sleeping, decreased eating and drinking. It required in person doctor?s visit with oncology (surgical) NP.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Rash
Clinical narrative: Patient noted she had a rash/cellulitis related to a Trumenba vaccine that she received on 1/8/24. The patient was seen in clinic on 1/8/24 and began noticing rash like symptoms that began 1/9/24 and she called in to report to the clinic on 1/10/24. She stated that her left arm was swollen, red, hot, painful to the touch and there are streaks from where the injection was given.  I encouraged her to be seen in the UC and she was treated appropriately.
Age: 72.0
Sex: F
Vaccine: RSV
Symptoms: Cellulitis, Erythema, Fatigue, Injection site erythema, Injection site pain
Clinical narrative: Redness, pain, swelling, and warmth at injection site in upper right deltoid.   Swelling with tenderness and EXTREME itching deep in right armpit (history of lymph node biopsy).  Fever (up to 101 degree F) with erethyma, general malaise, and fatigue.  Minimal response to oral Benadryl.  Urgent care FNP diagnosed cellulitis and treated with antibiotics,  additional medications.  Itching and pain gradually subsided over 3-4 days.  Swelling and redness on skin lasted about 3 weeks.
Age: 72.0
Sex: F
Vaccine: RSV
Symptoms: Injection site swelling, Injection site warmth, Malaise, Oedema peripheral, Pruritus
Clinical narrative: Redness, pain, swelling, and warmth at injection site in upper right deltoid.   Swelling with tenderness and EXTREME itching deep in right armpit (history of lymph node biopsy).  Fever (up to 101 degree F) with erethyma, general malaise, and fatigue.  Minimal response to oral Benadryl.  Urgent care FNP diagnosed cellulitis and treated with antibiotics,  additional medications.  Itching and pain gradually subsided over 3-4 days.  Swelling and redness on skin lasted about 3 weeks.
Age: 72.0
Sex: F
Vaccine: RSV
Symptoms: Pyrexia, Tenderness
Clinical narrative: Redness, pain, swelling, and warmth at injection site in upper right deltoid.   Swelling with tenderness and EXTREME itching deep in right armpit (history of lymph node biopsy).  Fever (up to 101 degree F) with erethyma, general malaise, and fatigue.  Minimal response to oral Benadryl.  Urgent care FNP diagnosed cellulitis and treated with antibiotics,  additional medications.  Itching and pain gradually subsided over 3-4 days.  Swelling and redness on skin lasted about 3 weeks.
Age: 85.0
Sex: M
Vaccine: COVID19, FLUA4
Symptoms: Product storage error
Clinical narrative: The Comirnaty Pfizer vaccine was discovered to not have been stored according to the labeling and was kept in the freezer longer than what the manufacturer requires. We've reached to the manufacturer and CDC and unfortunately they don't have the data to support storage beyond the recommended time allowed. The vaccine was unfortunately administered before the discovery. Patient was contacted and offered to revaccinate. Patient did not experience any adverse reaction from this vaccination.
Age: 24.0
Sex: F
Vaccine: MMR
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Localized redness and swelling around injection site, warm to touch.
Age: 81.0
Sex: F
Vaccine: COVID19, FLUA4
Symptoms: Product storage error
Clinical narrative: The Comirnaty Pfizer vaccine was discovered to not have been stored according to the labeling and was kept in the freezer longer than what the manufacturer requires. We've reached to the manufacturer and CDC and unfortunately they don't have the data to support storage beyond the recommended time allowed. The vaccine was unfortunately administered before the discovery. Patient was contacted and offered to revaccinate. Patient did not experience any adverse reaction from this vaccination.
Age: 66.0
Sex: F
Vaccine: FLU4, PNC20, VARZOS
Symptoms: Mobility decreased, Muscular weakness, Neck pain, Pain, Pain in extremity
Clinical narrative: Day following injection, had a temp and arm pain, took Tylenol and went to bed, no improvement to arm.  Tried ice and heat, took Tylenol x 3 days.  Took Meloxycam from previous ailment and did not improve arm pain.  Pain with lifting arm causes pain in upper arm.  Hurts to move the arm and causes radiating pain up into neck and down into lower arm.  Most of the time arm hurts even at rest.  Can not lift arm, has pain and weakness.  Arm pain is at a 10 on a scale of 1-10 at time of report being made.  She thinks she may have had a pinched nerve in 2022 in right arm but is uncertain.  Patient has been advised to call Primary Care Provider or seek care at ER.  Vaccine was private paid vaccine.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: The Comirnaty Pfizer vaccine was discovered to not have been stored according to the labeling and was kept in the freezer longer than what the manufacturer requires. We've reached to the manufacturer and CDC and unfortunately they don't have the data to support storage beyond the recommended time allowed. The vaccine was unfortunately administered before the discovery. Patient was contacted and offered to revaccinate. Patient did not experience any adverse reaction from this vaccination.
Age: 35.0
Sex: M
Vaccine: TDAP
Symptoms: Blood glucose normal, Disorientation, Hyperhidrosis, Loss of consciousness, Pallor
Clinical narrative: The injection had just been completed, and as I was placing a band aid, the patient became pale and started to lose consciousness.  It appeared to be a vaso-vagal syncopal event.  He was completely unresponsive to verbal stimuli, and require a significant sternal rub to regain consciousness.  This was about a minute post onset.  At the time he was diaphoretic, pale and shaky.  Initially, he was very disoriented, but slowly cleared.  His blood sugar was 124.  He was placed in a recliner, given water and juice/food.  No vitals obtained but he was tachypnic, with a faint tachycardic radial pulse.  After 15-20 minutes he was transferred to a wheel chair and monitored elsewhere
Age: 35.0
Sex: M
Vaccine: TDAP
Symptoms: Syncope, Tachycardia, Tachypnoea, Tremor, Unresponsive to stimuli
Clinical narrative: The injection had just been completed, and as I was placing a band aid, the patient became pale and started to lose consciousness.  It appeared to be a vaso-vagal syncopal event.  He was completely unresponsive to verbal stimuli, and require a significant sternal rub to regain consciousness.  This was about a minute post onset.  At the time he was diaphoretic, pale and shaky.  Initially, he was very disoriented, but slowly cleared.  His blood sugar was 124.  He was placed in a recliner, given water and juice/food.  No vitals obtained but he was tachypnic, with a faint tachycardic radial pulse.  After 15-20 minutes he was transferred to a wheel chair and monitored elsewhere
Age: 0.75
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema
Clinical narrative: Patient developed localized redness around injection site with no other symptoms after being monitored for 15 minutes.  Patient was given hydrocortisone to apply topically to the affected area on the left thigh.  Patient was safe to leave facility.
Age: 58.0
Sex: F
Vaccine: COVID19-2
Symptoms: Chills, Injection site mass, Injection site warmth, Pain in extremity, Pyrexia
Clinical narrative: Chills, fever, sore arm, lump and red warm rash at injection site.
Age: 3.0
Sex: F
Vaccine: TYP
Symptoms: Incorrect route of product administration, Injection site discharge
Clinical narrative: Gave vaccine subcutaneously when it was supposed to be given intramuscularly. Additionally, there was some leakage of vaccine upon injection at injection site.
Age: 76.0
Sex: F
Vaccine: FLU4, PNC20
Symptoms: Hypoaesthesia, Injected limb mobility decreased, Pain in extremity
Clinical narrative: Patient came to pharmacy stating she has had a sore, numb arm since receiving 2 vaccines here approximately 2 months ago. Both vaccines were given in the same arm. She states it is worse in the evening and feels like it could be nerve related. She states when her arm is numb it is difficult to move it. She states this started shortly after her vaccinations and has continued since.
Age: 79.0
Sex: F
Vaccine: COVID19, FLUA4
Symptoms: Product storage error
Clinical narrative: The Comirnaty Pfizer vaccine was discovered to not have been stored according to the labeling and was kept in the freezer longer than what the manufacturer requires. We've reached to the manufacturer and CDC and unfortunately they don't have the data to support storage beyond the recommended time allowed. The vaccine was unfortunately administered before the discovery. Patient was contacted and offered to revaccinate. Patient did not experience any adverse reaction from this vaccination.
Age: 73.0
Sex: F
Vaccine: COVID19-2, RSV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: A FEW HOURS AFTER IMMUNIZATION, PATIENT STATED BOTH ARMS BEGAN TO SWELL AND TURN RED AROUND INJECTION SITE.  THE AREXVY SITE WAS SLIGHTLY MORE SWOLLEN AND RED TO IT IS ASSUMED THAT IS THE INITIAL REACTION SIDE. THERE WAS NO DECREASE IN MOVEMENT AND PATIENT DID NOT SEEK MEDICAL CARE OTHER THAN TO ASK IF REACTION WAS TO BE EXPECTED. THE SPIKEVAX ARM DID DECREASE FASTER, AND AFTER A FEW DAYS BOTH ARMS WERE FINE.
Age: 62.0
Sex: F
Vaccine: COVID19, FLUC4
Symptoms: Product storage error
Clinical narrative: The Comirnaty Pfizer vaccine was discovered to not have been stored according to the labeling and was kept in the freezer longer than what the manufacturer requires. We've reached to the manufacturer and CDC and unfortunately they don't have the data to support storage beyond the recommended time allowed. The vaccine was unfortunately administered before the discovery. Patient was contacted and offered to revaccinate. Patient did not experience any adverse reaction from this vaccination.