chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: F
Vaccine: COVID19-2
Symptoms: Left ventricular dysfunction, Pleural effusion, Pulmonary congestion, Pulmonary oedema, Wheezing
Clinical narrative: It is unknown if this condition and hospitalization is related to the SARS-CoV-2 vaccine.  I developed Left lung congestion, wheezing, crackles.  Treated with bronchodilator without relief.  Chest CT on 1/9/23 showed pulmonary edema in the right lung and trace effusion.  Symptoms persisted for weeks, echocardiogram performed on 1/24/23 showed left ventricular dysfunction with ejection fraction of 15-20%.  Hospitalized at Medical Center for 4 days.  Cardiac catherterization/angiogram result = no blockages.  Diagnosis = heart failure.
Age: 60.0
Sex: F
Vaccine: HEP
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: 129/80-82-28 94% 97.7 - Pt had vaccine, waited 15 mins, the left, itching all over about 20 minutes after leaving, returned to vaccine site. Benadryl 25mg PO given, waited x 30 mins. Itching improved
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Covid Vaccine-Janssen amnitered 3 days after it expired.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, C-reactive protein increased, Chest X-ray normal, Chest discomfort, Chills
Clinical narrative: 2 hours after 2nd Covid vaccine she was sitting quietly @ home playing with baby on floor & suddenly felt increased heart rate & dizziness. Later that day, she developed fever/chills/soreness, & weakness with exertion. That evening she took 200mg Ibuprofen & twice the next day. The day after vaccination had increased body aches, fever, & chills, along with weakness. 2 days after vaccination, had tightness in chest & tenderness on chest well with palpitation. Also had an episode of tachycardia. PERICARDITIS.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram thorax abnormal, Dizziness, Echocardiogram abnormal, Electrocardiogram ST segment depression, Full blood count normal
Clinical narrative: 2 hours after 2nd Covid vaccine she was sitting quietly @ home playing with baby on floor & suddenly felt increased heart rate & dizziness. Later that day, she developed fever/chills/soreness, & weakness with exertion. That evening she took 200mg Ibuprofen & twice the next day. The day after vaccination had increased body aches, fever, & chills, along with weakness. 2 days after vaccination, had tightness in chest & tenderness on chest well with palpitation. Also had an episode of tachycardia. PERICARDITIS.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Haematocrit normal, Haemoglobin normal, Heart rate increased, Musculoskeletal chest pain, Pain
Clinical narrative: 2 hours after 2nd Covid vaccine she was sitting quietly @ home playing with baby on floor & suddenly felt increased heart rate & dizziness. Later that day, she developed fever/chills/soreness, & weakness with exertion. That evening she took 200mg Ibuprofen & twice the next day. The day after vaccination had increased body aches, fever, & chills, along with weakness. 2 days after vaccination, had tightness in chest & tenderness on chest well with palpitation. Also had an episode of tachycardia. PERICARDITIS.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Pericardial effusion, Pericarditis, Platelet count normal, Pyrexia
Clinical narrative: 2 hours after 2nd Covid vaccine she was sitting quietly @ home playing with baby on floor & suddenly felt increased heart rate & dizziness. Later that day, she developed fever/chills/soreness, & weakness with exertion. That evening she took 200mg Ibuprofen & twice the next day. The day after vaccination had increased body aches, fever, & chills, along with weakness. 2 days after vaccination, had tightness in chest & tenderness on chest well with palpitation. Also had an episode of tachycardia. PERICARDITIS.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Tachycardia, White blood cell count normal
Clinical narrative: 2 hours after 2nd Covid vaccine she was sitting quietly @ home playing with baby on floor & suddenly felt increased heart rate & dizziness. Later that day, she developed fever/chills/soreness, & weakness with exertion. That evening she took 200mg Ibuprofen & twice the next day. The day after vaccination had increased body aches, fever, & chills, along with weakness. 2 days after vaccination, had tightness in chest & tenderness on chest well with palpitation. Also had an episode of tachycardia. PERICARDITIS.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Autoimmune disorder, Chest discomfort, Condition aggravated, Dyspnoea exertional, Lyme disease
Clinical narrative: Since 2015 I have had a neurological condition (numbness and tingling below the waist); at first there was concern about Guillen-Barre, but that was ruled out. My neurologist mentioned that this was an autoimmune condition and had been triggered by a brief flu with fever which I had had 2 weeks before hte onset of neurological symptoms; he said this kind of timing was very typical. Since then I have not had a fever. The numbness and tingling have varied somewhat in intensity but never gone away.  three weeks after the vaccine I had a bigger increase in the numbness and tingling than during all the years I have had this condition. This made me reconsider getting the second vaccine (see continuation page)....... This made me reconsider getting the second vaccine since 1)this was just like the timing mentioned by the neurologist, who had also warned me that my condition could worsen and a leg might collapse under me, or I might lose bowel or bladder control. The symptoms people get after the second dose are usually worse. 2) if the vaccine stresses my immune system by a strong autoimmune reaction, the little bit of Covid protection I get from the vaccine is not going to make up for it (a recent headline announced that after the Delta variant, its effectiveness is only 66%, presumably much less in the senior population, say 33%).  It seems likely to me that getting the vaccine will only increase my chances of getting a bad case of Covid, and of spreading it to others.  As regards to the neurological symptoms alone, no treatment was sought or given (my neurologist said I did not need to see him unless something more drastic happened or seemed imminent).  At the same time as the neurological symptoms worsened, I developed other problems which I had in 2015 and haven't had for a long time. Five alternative practitioners have attributed these to Lyme, and the neurological symptoms as well: swelling  behind the knees (sometimes enough to interfere with wa lking), chest pressure (possibly costochondritis), slight shortness of breath on walking uphill (possibly heart.) Recently I was able to see one of these practitioners, who confirmed that I had a reactivation of Lyme, which had been well under control when I saw her in June. She added that other, less obvious problems had developed as well, that my immune system was down, and that she has seen a number of such cases with aggravation of preexisting illness following Covid vaccination. Again, I concluded that since the vaccine makes me sick with reactivation of a systemic infection, there is no point in my getting a second dose of vaccine.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: Since 2015 I have had a neurological condition (numbness and tingling below the waist); at first there was concern about Guillen-Barre, but that was ruled out. My neurologist mentioned that this was an autoimmune condition and had been triggered by a brief flu with fever which I had had 2 weeks before hte onset of neurological symptoms; he said this kind of timing was very typical. Since then I have not had a fever. The numbness and tingling have varied somewhat in intensity but never gone away.  three weeks after the vaccine I had a bigger increase in the numbness and tingling than during all the years I have had this condition. This made me reconsider getting the second vaccine (see continuation page)....... This made me reconsider getting the second vaccine since 1)this was just like the timing mentioned by the neurologist, who had also warned me that my condition could worsen and a leg might collapse under me, or I might lose bowel or bladder control. The symptoms people get after the second dose are usually worse. 2) if the vaccine stresses my immune system by a strong autoimmune reaction, the little bit of Covid protection I get from the vaccine is not going to make up for it (a recent headline announced that after the Delta variant, its effectiveness is only 66%, presumably much less in the senior population, say 33%).  It seems likely to me that getting the vaccine will only increase my chances of getting a bad case of Covid, and of spreading it to others.  As regards to the neurological symptoms alone, no treatment was sought or given (my neurologist said I did not need to see him unless something more drastic happened or seemed imminent).  At the same time as the neurological symptoms worsened, I developed other problems which I had in 2015 and haven't had for a long time. Five alternative practitioners have attributed these to Lyme, and the neurological symptoms as well: swelling  behind the knees (sometimes enough to interfere with wa lking), chest pressure (possibly costochondritis), slight shortness of breath on walking uphill (possibly heart.) Recently I was able to see one of these practitioners, who confirmed that I had a reactivation of Lyme, which had been well under control when I saw her in June. She added that other, less obvious problems had developed as well, that my immune system was down, and that she has seen a number of such cases with aggravation of preexisting illness following Covid vaccination. Again, I concluded that since the vaccine makes me sick with reactivation of a systemic infection, there is no point in my getting a second dose of vaccine.
Age: 5.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: 1.) 9/22/21 - IM injection to R upper arm in am, taken to daycare after appt & noted about "a quarter" size Redness & area warm; by 6pm redness was size of pt palm/warm & sore; used cool compress; 0 fever 2.) 9/23/21 - increased Redness from shoulder to elbow; increase swelling, used warm compress; 0 fever 3.) - f/u appt in office, decreased redness, increased pain/swelling to upper arm
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Headache, Immediate post-injection reaction, Laboratory test abnormal
Clinical narrative: Headache immediately following vaccine administration. Symptoms initially improved then returned. Patient reports 3 weeks of headache. Labs demonstrated elevation in AST/ALT
Age: 23.0
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: temperature excursion with our Moderna Covid-19 vaccine; No adverse event; Received vaccne after temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursion with our Moderna Covid-19 vaccine), POOR QUALITY PRODUCT ADMINISTERED (Received vaccne after temperature excursion) and NO ADVERSE EVENT (No adverse event) in a 23-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 074B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 24-Feb-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 24-Feb-2023, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Received vaccne after temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursion with our Moderna Covid-19 vaccine) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursion with our Moderna Covid-19 vaccine), POOR QUALITY PRODUCT ADMINISTERED (Received vaccne after temperature excursion) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursion with our Moderna Covid-19 vaccine) and POOR QUALITY PRODUCT ADMINISTERED (Received vaccne after temperature excursion).    No concomitant medications were reported. No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-715674 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-715674:Master case
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; lot numbers AS1903B...045H22A...074B22A were involved in a temperature excursion that to place at HCP office on 2-13-23; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (lot numbers AS1903B...045H22A...074B22A were involved in a temperature excursion that to place at HCP office on 2-13-23) and NO ADVERSE EVENT (No adverse event) in a 5-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. AS1903B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-Feb-2023, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) dosage form. On 25-Feb-2023, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (lot numbers AS1903B...045H22A...074B22A were involved in a temperature excursion that to place at HCP office on 2-13-23). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (lot numbers AS1903B..045H22A..074B22A were involved in a temperature excursion that to place at HCP office on 2-13-23) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No treatment medications were reported No concomitant medications were reported   This case was linked to US-MODERNATX, INC.-MOD-2023-715951, US-MODERNATX, INC.-MOD-2023-716061, US-MODERNATX, INC.-MOD-2023-716062, US-MODERNATX, INC.-MOD-2023-716063 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-715951:Master Case for Lot AS1903B. Patient-JP US-MODERNATX, INC.-MOD-2023-716061:Patient-VO US-MODERNATX, INC.-MOD-2023-716062:Patient-LP US-MODERNATX, INC.-MOD-2023-716063:Patient-CPM
Age: 0.75
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered, No adverse event, Wrong product administered
Clinical narrative: No adverse event; A pediatrician reports that they inadvertently administered the bivalent dose instead of the monovalent dose for the primary series (2 as 2nd doses and 1 as 1st dose) to 3 patients today, 15Mar2023.; This spontaneous case was reported by a physician and describes the occurrence of WRONG PRODUCT ADMINISTERED (A pediatrician reports that they inadvertently administered the bivalent dose instead of the monovalent dose for the primary series (2 as 2nd doses and 1 as 1st dose) to 3 patients today, 15Mar2023.) and NO ADVERSE EVENT (No adverse event) in a 9-month-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 216K22A) for COVID-19 prophylaxis.     No Medical History information was reported.  On 15-Mar-2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 15-Mar-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced WRONG PRODUCT ADMINISTERED (A pediatrician reports that they inadvertently administered the bivalent dose instead of the monovalent dose for the primary series (2 as 2nd doses and 1 as 1st dose) to 3 patients today, 15Mar2023.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (A pediatrician reports that they inadvertently administered the bivalent dose instead of the monovalent dose for the primary series (2 as 2nd doses and 1 as 1st dose) to 3 patients today, 15Mar2023.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.   For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (A pediatrician reports that they inadvertently administered the bivalent dose instead of the monovalent dose for the primary series (2 as 2nd doses and 1 as 1st dose) to 3 patients today, 15Mar2023.).    Concomitant product use was not provided by the reporter.  It was reported that the patient was inadvertently administered the bivalent dose instead of the monovalent dose for the primary series, 2 as second dose and 1 as first dose to 3 patients on 15-Mar-2023.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-716012, US-MODERNATX, INC.-MOD-2023-716007 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 15-Mar-2023: Live follow-up information received included updated Patient details and Dosage information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-716012:3rd infant patient US-MODERNATX, INC.-MOD-2023-716007:2nd infant patient
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was initially stored in the refrigerator on 19-Dec-2022 and was administered on 03-Feb-2023, 10-Feb-2023 and 11-Mar-2023; No adverse event; Patient received dose after its BUD date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received dose after its BUD date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 19-Dec-2022 and was administered on 03-Feb-2023, 10-Feb-2023 and 11-Mar-2023) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7171B) for COVID-19 prophylaxis.     It was unknown that patient receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 10-Feb-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 10-Feb-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received dose after its BUD date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 19-Dec-2022 and was administered on 03-Feb-2023, 10-Feb-2023 and 11-Mar-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received dose after its BUD date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 19-Dec-2022 and was administered on 03-Feb-2023, 10-Feb-2023 and 11-Mar-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient received dose after its BUD date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 19-Dec-2022 and was administered on 03-Feb-2023, 10-Feb-2023 and 11-Mar-2023).    No concomitant medications were provided. It was reported that 3 Patients received doses after its BUD date on 03-Feb-2023, 10-Feb-2023 and 11-Mar-2023. The vial did not undergo any temperature excursions. No treatment medication was provided. This case contains information for the 2nd out of 3 adult patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-716127 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-716127:case for adult patient 1 out of 3 patients US-MODERNATX, INC.-MOD-2023-716134:case for adult patient 2 out of 3 patients
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Fatigue, Pain in extremity, SARS-CoV-2 test positive
Clinical narrative: sore arm; tiredness; COVID-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID-19), PAIN IN EXTREMITY (sore arm) and FATIGUE (tiredness) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Oct-2022, the patient experienced COVID-19 (COVID-19). On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm) and FATIGUE (tiredness). At the time of the report, COVID-19 (COVID-19), PAIN IN EXTREMITY (sore arm) and FATIGUE (tiredness) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Oct-2022, SARS-CoV-2 test: Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant information was reported. No treatment information was provided.   This case was linked to MOD-2023-716298 (Patient Link).   Reporter did not allow further contact
Age: 23.0
Sex: F
Vaccine: HPV9
Symptoms: Aphasia, Blood test, Burning sensation, Cognitive disorder, Computerised tomogram
Clinical narrative: Heart rate went from 70s to 180s within 30 minutes of injection. Palpitations, sweating, tremors, convulsions, indescribably painful burning sensations in head. Unable to talk, think, or form sentences.
Age: 23.0
Sex: F
Vaccine: HPV9
Symptoms: Headache, Heart rate increased, Hyperhidrosis, Magnetic resonance imaging, Magnetic resonance imaging heart
Clinical narrative: Heart rate went from 70s to 180s within 30 minutes of injection. Palpitations, sweating, tremors, convulsions, indescribably painful burning sensations in head. Unable to talk, think, or form sentences.
Age: 23.0
Sex: F
Vaccine: HPV9
Symptoms: Mental impairment, Pain, Palpitations, Seizure, Tremor
Clinical narrative: Heart rate went from 70s to 180s within 30 minutes of injection. Palpitations, sweating, tremors, convulsions, indescribably painful burning sensations in head. Unable to talk, think, or form sentences.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19, COVID19, COVID19-2
Symptoms: Drug ineffective, Myelitis transverse, Suspected COVID-19
Clinical narrative: 11/18/2022 in work. Got weak and sat down and could not get up. Waist down was paralyzed. Went to local ER by ambulance. Inpatient one week 11/18/2022 to 11/25/2022 then alternate facility for rehab 11/25/2022 to 12/10/22 then senior care for rehab 12/10/2022 to 01/07/2023 then home and doing outpatient therapy at Local rehab facility and now still in wheelchair and with walker. Diagnosis is transverse myelitis and stroke of the spinal cord.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19, COVID19, COVID19-2
Symptoms: Malaise, Myelitis transverse, Wheelchair user
Clinical narrative: 11/18/2022 in work. Got weak and sat down and could not get up. Waist down was paralyzed. Went to local ER by ambulance. Inpatient one week 11/18/2022 to 11/25/2022 then alternate facility for rehab 11/25/2022 to 12/10/22 then senior care for rehab 12/10/2022 to 01/07/2023 then home and doing outpatient therapy at Local rehab facility and now still in wheelchair and with walker. Diagnosis is transverse myelitis and stroke of the spinal cord.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19, COVID19, COVID19-2
Symptoms: Myelitis transverse, Spinal stroke
Clinical narrative: 11/18/2022 in work. Got weak and sat down and could not get up. Waist down was paralyzed. Went to local ER by ambulance. Inpatient one week 11/18/2022 to 11/25/2022 then alternate facility for rehab 11/25/2022 to 12/10/22 then senior care for rehab 12/10/2022 to 01/07/2023 then home and doing outpatient therapy at Local rehab facility and now still in wheelchair and with walker. Diagnosis is transverse myelitis and stroke of the spinal cord.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19, COVID19, COVID19-2
Symptoms: Asthenia, Computerised tomogram thorax, Diplegia, Dysstasia, Laboratory test
Clinical narrative: 11/18/2022 in work. Got weak and sat down and could not get up. Waist down was paralyzed. Went to local ER by ambulance. Inpatient one week 11/18/2022 to 11/25/2022 then alternate facility for rehab 11/25/2022 to 12/10/22 then senior care for rehab 12/10/2022 to 01/07/2023 then home and doing outpatient therapy at Local rehab facility and now still in wheelchair and with walker. Diagnosis is transverse myelitis and stroke of the spinal cord.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19, COVID19, COVID19-2
Symptoms: Lumbar puncture, Magnetic resonance imaging, Myelitis transverse, Spinal cord infarction, Walking aid user
Clinical narrative: 11/18/2022 in work. Got weak and sat down and could not get up. Waist down was paralyzed. Went to local ER by ambulance. Inpatient one week 11/18/2022 to 11/25/2022 then alternate facility for rehab 11/25/2022 to 12/10/22 then senior care for rehab 12/10/2022 to 01/07/2023 then home and doing outpatient therapy at Local rehab facility and now still in wheelchair and with walker. Diagnosis is transverse myelitis and stroke of the spinal cord.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19, COVID19, COVID19-2
Symptoms: Wheelchair user
Clinical narrative: 11/18/2022 in work. Got weak and sat down and could not get up. Waist down was paralyzed. Went to local ER by ambulance. Inpatient one week 11/18/2022 to 11/25/2022 then alternate facility for rehab 11/25/2022 to 12/10/22 then senior care for rehab 12/10/2022 to 01/07/2023 then home and doing outpatient therapy at Local rehab facility and now still in wheelchair and with walker. Diagnosis is transverse myelitis and stroke of the spinal cord.
Age: 40.0
Sex: M
Vaccine: MMR, UNK
Symptoms: No adverse event, Product preparation error
Clinical narrative: No other AE; Received a dose of MMRII that was reconstituted with normal saline; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant medications and drug reaction/allergies were not reported.  On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection (dose, lot number, expiration date, anatomical site of administration, and route of administration were not provided) as prophylaxis, which was reconstituted with normal sodium chloride (SALINEX) (strength, dose, formulation, dose description, lot number, expiration date, route of administration, and indication were not provided) (Product preparation issue). No other adverse event (AE) (no AE).  This case is non-valid due to lack of patient's identifiers.  Follow-up information has been received from the pharmacist on 22-MAR-2023.  The patient was a 40-year-old male.  On 03-MAR-2023, he was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneously at the left (unspecified) (Lot Number W032499 with expiration date reported as 22-NOV-2023 is NOT valid for measles, mumps, and rubella [wistar ra 27-3] virus vaccine, live [M-M-R II]), however the vaccine was reconstituted with the wrong diluent, as it was used normal sodium chloride (INNO.N 0.9% SODIUM CHLORIDE) instead of diluent (Product preparation error). The patient was fine and no complications or reactions were reported.
Sex: U
Vaccine: HIBV, RV5
Symptoms: Brief resolved unexplained event
Clinical narrative: BRUE; This spontaneous report was received via a company representative from the patient's mother and refers to an infant of an unspecified age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 01-MAR-2023, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided); and with haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, unk, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided).  On the same date (reported as hours after receiving vaccine), the patient was taken to the emergency room and experienced Brief resolved unexplained event (BRUE). At the time of reporting, the outcome of the event BRUE was not known.   The patient's mother stated that she was told by attending doctor that the event was most likely related to rotavirus vaccine, live, oral, pentavalent (ROTATEQ) and haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB).
Sex: F
Vaccine: HIBV
Symptoms: Vaccination failure
Clinical narrative: vaccination failure; This literature marketed report has been received from the authors of a published literature article, titled as stated above, concerning a 29-year-old female patient, who was referred to hematology for severe neutropenia. The patient had a history of cardiovascular malformation (ventricular septal defect) surgically repaired at the age of 5 and recurrent skin and oto-sinopulmonary infections (sinusitis, otitis media, and pneumonia) since childhood resulting in progressive hearing loss and chronic bronchiectasis. The patient also reported anosmia and recurrent blisters of the philtrum, likely herpetic lesions, although no such lesions were present at the time of our examination. Additionally, her HSV-1 antibodies were positive on serology. Her family history was notable for brother with recurrent infections. The patient also underwent a bone marrow biopsy to evaluate incidentally discovered neutropenia and the biopsy showed a largely normal marrow with trilineage hematopoiesis, erythroid hypoplasia, and plasmacytosis without light chain restriction. On the day of presentation to the hematologic clinic, her laboratory examination was notable for bicytopenia with a total white blood cell count of 2.1 10^3/uL, absolute neutrophil count of 1.1 10^3/uL, absolute lymphocyte counts 0.7 10^3/uL, absolute monocyte counts 0.3 and hemoglobin of 7.9 g/dL. Additionally, it was reported the patient immunoglobulins were high: IgA 523 mg/dL, IgG 1804 mg/dL, IgM 185 mg/dL and IgE 260 mg/dL. The patient's vaccine history included vaccination to diphtheria, tetanus, mumps, and rubeola.  On an unspecified date, the patient was vaccinated with Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) for prophylaxis (formulation, concentration, dose, route of administration, anatomical location, lot number, and expiration date were not reported). However, the response to this vaccine was suboptimal (vaccination failure).  The outcome of vaccination failure was unknown.  The causality assessment between vaccination failure event and Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) was considered related.  Literature Report. A copy of the published article is attached as further documentation of the patient's experience.
Age: 0.5
Sex: M
Vaccine: DTPPVHBHPB, PNC13, RV1
Symptoms: Injection site rash, Pruritus, Urticaria
Clinical narrative: Started itching and broke into hives. Rash on injection sight (right thigh). Slight fever. Gave Benadryl. Barely ate that day. Hives cleared some in a few hours and completely cleared the next day.
Age: 58.0
Sex: F
Vaccine: TDAP
Symptoms: Eye swelling, Injection site pain, Mouth swelling, Pyrexia, Rash
Clinical narrative: Site: Pain at Injection Site-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: Fever-Mild
Age: 58.0
Sex: F
Vaccine: TDAP
Symptoms: Swelling face, Swollen tongue
Clinical narrative: Site: Pain at Injection Site-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: Fever-Mild
Age: 47.0
Sex: F
Vaccine: COVID19-2
Symptoms: Hypoaesthesia
Clinical narrative: Systemic: numbness in ear, jaw, and neck on side she recieved the shot-Severe, Systemic: Numbness (specify: facial area, extremities)-Severe
Age: 9.0
Sex: F
Vaccine: FLU4, HEPA, IPV, MMRV, TDAP
Symptoms: Lung infiltration, Pulmonary tuberculosis, Rash vesicular, Varicella, Varicella virus test positive
Clinical narrative: Developed diffuse vesicular rash, that was VZV PCR positive c/w Chicken Pox Disease. Extended hospitalization stay which had been for the management of TB pulmonary infection (approximately an additional 1 week) to receive IV therapy (acyclovir), developed an infiltration while on therapy requiring antidote administration.  Plan to complete total 14 day course of acyclovir/valtrex pending rash improvement.
Age: 76.0
Sex: M
Vaccine: UNK
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No Adverse event happened. The patient received inadvertently received 2nd updated Pfizer bivalent shot
Age: 54.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Cough, Diarrhoea, Headache, Oropharyngeal pain
Clinical narrative: I was diagnosed with COVID-19 after experiencing fever, cough, sore throat, headache, congestion, and diarrhea.
Age: 54.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pyrexia, Respiratory tract congestion, SARS-CoV-2 test positive
Clinical narrative: I was diagnosed with COVID-19 after experiencing fever, cough, sore throat, headache, congestion, and diarrhea.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Arthralgia, Blood test, Colectomy, Computerised tomogram, Diverticulitis
Clinical narrative: Shot1: March  22 2021 severe injection site arm and shoulder pain  Shot 2:April 19 2021 severe injection site arm shoulder pain, flu- like illness for week.       July- recurring diverticulitis, mesenteric abscess culminating in colon resection 5/22      August- progressive left hand/ arm weakness.  shot 3: December 17, 2021 severe injection site injury, flu like illness week to 10 days, speech impairment begins followed by difficulty swallowing.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dysphagia, Electromyogram, Influenza like illness, Injection site injury, Injection site pain
Clinical narrative: Shot1: March  22 2021 severe injection site arm and shoulder pain  Shot 2:April 19 2021 severe injection site arm shoulder pain, flu- like illness for week.       July- recurring diverticulitis, mesenteric abscess culminating in colon resection 5/22      August- progressive left hand/ arm weakness.  shot 3: December 17, 2021 severe injection site injury, flu like illness week to 10 days, speech impairment begins followed by difficulty swallowing.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Lumbar puncture, Magnetic resonance imaging, Mesenteric abscess, Muscular weakness, Speech disorder
Clinical narrative: Shot1: March  22 2021 severe injection site arm and shoulder pain  Shot 2:April 19 2021 severe injection site arm shoulder pain, flu- like illness for week.       July- recurring diverticulitis, mesenteric abscess culminating in colon resection 5/22      August- progressive left hand/ arm weakness.  shot 3: December 17, 2021 severe injection site injury, flu like illness week to 10 days, speech impairment begins followed by difficulty swallowing.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Ultrasound scan, X-ray
Clinical narrative: Shot1: March  22 2021 severe injection site arm and shoulder pain  Shot 2:April 19 2021 severe injection site arm shoulder pain, flu- like illness for week.       July- recurring diverticulitis, mesenteric abscess culminating in colon resection 5/22      August- progressive left hand/ arm weakness.  shot 3: December 17, 2021 severe injection site injury, flu like illness week to 10 days, speech impairment begins followed by difficulty swallowing.
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Death
Clinical narrative: Death.
Age: 15.0
Sex: M
Vaccine: HPV9
Symptoms: Fall, Pallor, Skin discolouration
Clinical narrative: Patient stated after his first dose he felt dizzy, but went home and took a nap and felt fine when he woke up. After his second dose, we got up to check the date for his third and final dose, and within about two minutes of standing up he fell face first onto the ground. He came to within about 30 seconds (enough time for us to get EMS on the phone) and when he got up his face was very pale and greenish, and he sat down while medics came in to help. They did a check up on him, cleared him, and sent him home.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient got Pfizer Monovalent one week ago and came to have second dose Pfizer administered by nurse during visit. Pt notify that Immunization will not count. He will have to be giving second doe again on 4/29/23. He verbalizes understanding to nurse.
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Rash
Clinical narrative: Body wide rash on arms legs , back, stomach
Age: 85.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Diarrhoea, Dizziness, Nausea
Clinical narrative: Patient reports dizziness, diarrhea and nausea daily since receiving vaccines.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Pt called pharmacy 2 days later complaining of swollen, warm to touch, painful arm at the injection site.  Pt went to doctor's office to get it checked out.
Age: 85.0
Sex: M
Vaccine: COVID19-2
Symptoms: Extra dose administered, No adverse event
Clinical narrative: THE PATIENT ARRIVED FOR THEIR SHOT, PRESENTED THEIR COVID CARD AND FILLED OUT THE IMMUNIZATION  INTAKE FORM. THE SHOT WAS ENTERED INTO THE  PHARMACY SYSTEM AND ADJUDICATED TO INSURANCE. AFTER REVIEWING THE FORM AND COVID CARD, REVIEWING ANY QUESTIONS THE PATIENT HAS THE SHOT WAS PREPARED AND ADMINISTERED .   AT THE END OF THE WORK DAY WHEN ENTERING PATIENT INFO INTO VACCINE SYSTEM IT WAS DISCOVERED THAT THE PATIENT HAS ALREADY RECEIVED THE MODERNA BIVALENT BOOSTER ON 9/22/2022.  CALLS WERE PLACED TO MODERNA AND TO THE CDC FOR ADVISEMENT ON COUNSELING THE PATIENT. THE PATIENT WAS IMMEDIATELY NOTIFIED. NO ADVERSE SIDE EFFECTS NOTED AT THE TIME, NO ASE REPORTED SINCE THAT TIME.
Age: 82.0
Sex: F
Vaccine: COVID19-2
Symptoms: Extra dose administered, No adverse event
Clinical narrative: THE PATIENT PRESENTED AT THE PHARMACY FOR THE COVID BIVALENT SHOT. THE COVID SHOT INTAKE FORM WAS FILLED OUT, THE PRESCRIPTION WAS ENTERED INTO THE PHARMACY FILLING SYSTEM AND ADJUDICATED TO INSURANCE. THE PATIENTS COVID CARD WAS REVIEWED AND UPDATED. THE SHOT WAS PREPARED, THE PATIENT WAS GIVEN AN OPPORTUINITY TO ASK AND HAVE QUESTIONS ANSWERED AND THE SHOT WAS ADMINISTERED. WHEN INPUTING THE PATIENTS INFORMATION INTO LOCAL TRACKING SYSTEM AT THE END OF THE DAY IT WAS DISCOVERED THAT THE PATIENT HAD ALREADY RECEIVED THE BIVALENT SHOT SEVERAL MONTHS PRIOR. A CALL WAS PLACED TO MODERNA FOR ADVISE ON HOW TO COUNSEL THE PATIENT, MODERNA REFERED THIS CALLER TO THE CDC. THE CDC WAS CONTACTED AND THE PATIENT CONTACTED IMMEDIATELY AFTER THAT. NO ASE REPORTED AT THE TIME, NONE REPORTED AS OF THIS DATE.
Age: 72.0
Sex: F
Vaccine: COVID19-2
Symptoms: Giant cell arteritis, Headache
Clinical narrative: Giant Cell Arteritis. Pain at left temple, headaches .  Still treating with prednisone
Age: 49.0
Sex: F
Vaccine: COVID19-2
Symptoms: Unevaluable event
Clinical narrative: NONE
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Delivery, Exposure during pregnancy
Clinical narrative: Estimated date of conception June 11, 2022. Vaccine received July 11, 2022, 1 month pregnant at this time. Due Date March 18, 2023. Vaginal delivery. baby was full term prenatal care unremarkable.  Baby had a positive Coombs test, elevated bilirubin w/hemolytic anemia requiring higher level of care NICU admission where she received aggressive phototherapy, IV/IG  and albumin infusions, Iv fluids, blood transfusion. At the time of infusion it was discovered that the baby had acquired antigen C , the source of the problem. Prior to delivery baby mother and baby father both had blood work with no indication of the antigen C.
Age: 64.0
Sex: F
Vaccine: COVID19-2
Symptoms: Condition aggravated, Urticaria
Clinical narrative: My chronic hives were relatively calm prior to the vaccine. The next day they became severe and were severe for several days before calming down.
Age: 25.0
Sex: F
Vaccine: PNC20
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: patient stated that she had not had a pneumonia vaccines prior; vaccine was given due to the chronic condition of diabetes upon further investigation she had a pneumonvax 23 in September so the prevnar was given early. no adverse effects reported at this time
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Decreased appetite, Fatigue, Fluid intake reduced, Nausea
Clinical narrative: Arm pain, fatigue, shivering, fever, chills, nausea all that night and next day until about 2 pm, but still had arm pain until Friday morning.   I took Tylenol a couple times but couldn?t drink or eat much with it.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Arm pain, fatigue, shivering, fever, chills, nausea all that night and next day until about 2 pm, but still had arm pain until Friday morning.   I took Tylenol a couple times but couldn?t drink or eat much with it.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccine breakthrough infection
Clinical narrative: Breakthrough COVID 1 year later
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Redness, warm to the touch and mild swelling approx 4 days post injection
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia
Clinical narrative: Left shoulder pain
Age: 76.0
Sex: F
Vaccine: COVID19-2
Symptoms: Extra dose administered
Clinical narrative: the pt came in to the clinic for OV and provider ordered Pfizer booster Bivalent. when pt asked if she had covid card pt stated NO and that vaccine  info should in her chart. based on info in pt's chart she was due to receive bivalent booster. pt was directed to nurse, the nurse again verified covid pre screening questions and asked for covid vaccine card to verify dates in chart. pt stated I do not have it and info should be in my chart. nurse continue with administration of Pfizer covid bivalent booster as per chart she was due.. during post vaccine waiting period pt found covid card in her purse. after nurse reviewed covid vaccine card. pt had received covid vaccine on 12/14/2022 at pharmacy that was not documented in her chart. nurse contacted pharmacy to verify if it was a covid bivalent booster that she had received and confirmed that she had already received a covid bivalent booster and now had received an additional COVID bivalent booster. pt and provider both informed. pt did not have any reaction reported for 15 min observation.
Age: 47.0
Sex: F
Vaccine: COVID19-2
Symptoms: Menstruation irregular
Clinical narrative: Menstrual period siezed the following month, came back the following month for 1 month, then seized again until date.
Age: 51.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: administration error.   vaccine in refrigerator past expiration date by 3 days past  the 10 week expiration date from when vaccine taken out of  ultra cold storage.  patient experienced no adverse  events or side effects.
Age: 40.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Underdose
Clinical narrative: PATIENT RECEIVED THE PEDIATRIC PFIZER BIVALENT BOOSTER DOSE INSTEAD OF THE ADULT PFIZER BIVALENT DOSE. PATIENT DID NOT RECIEVE A SECOND VACCINE AFTER. PATIENT HAD NO SYMPTOMS OR ADVERSE EVENT. PATIENT WAS TOLD SHE WOULD BE CONTACTED AFTER REVIEWING CDC GUIDELINES, WHICH STATES PATIENT CAN BE REVACCINATED WITHOUT A PERIOD OF TIME IN BETWEEN.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Anti-thyroid antibody, Autoimmune thyroiditis, Biopsy thyroid gland, Biopsy thyroid gland abnormal, Blood thyroid stimulating hormone decreased
Clinical narrative: Thyroiditis with throat and neck pain.  9/3/21 - First dose of Moderna COVID-19 vaccine 10/1/21 - Second dose of Moderna COVID-19 vaccine Beginning spring of 2022 I began feeling pain and discomfort on the lower right side of my neck.  During my annual well visit to my primary care physician in July of 2022, he noticed my thyroid seemed to be enlarged and set upon the diagnostic course of action described in detail below in Item 19.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Goitre, Musculoskeletal discomfort, Neck pain, Oropharyngeal pain, Thyroid mass
Clinical narrative: Thyroiditis with throat and neck pain.  9/3/21 - First dose of Moderna COVID-19 vaccine 10/1/21 - Second dose of Moderna COVID-19 vaccine Beginning spring of 2022 I began feeling pain and discomfort on the lower right side of my neck.  During my annual well visit to my primary care physician in July of 2022, he noticed my thyroid seemed to be enlarged and set upon the diagnostic course of action described in detail below in Item 19.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Thyroiditis, Ultrasound thyroid abnormal
Clinical narrative: Thyroiditis with throat and neck pain.  9/3/21 - First dose of Moderna COVID-19 vaccine 10/1/21 - Second dose of Moderna COVID-19 vaccine Beginning spring of 2022 I began feeling pain and discomfort on the lower right side of my neck.  During my annual well visit to my primary care physician in July of 2022, he noticed my thyroid seemed to be enlarged and set upon the diagnostic course of action described in detail below in Item 19.
Age: 88.0
Sex: F
Vaccine: PNC20, VARZOS
Symptoms: Pain, Pain in extremity, Sensory disturbance
Clinical narrative: 3/25/23 pt came to pharmacy to inform us of the left arm pain she has been experiencing since her shingles vaccine was administered (2/23/2023). she experiences pain when she uses her arm, mainly when lifting it. She also stated she feels a "popping" sensation in her shoulder ever since the vaccine. She has not seen a doctor about this pain. I explained that if the pain is linked to the shingrix vaccine, it could be because the imz was administered too close to the shoulder joint. (SIRVA injury). took down the pts name, dob and phone number. filing vaers report. ---- PT HAS NOT SEEN A DOCTOR TO ADDRESS THIS PAIN.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Injection site erythema, Injection site nodule, Injection site pain, Injection site swelling
Clinical narrative: Patient has right thigh swelling, redness, and 1.5 cm nodule that was tender to palpation