chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Myalgia, Oropharyngeal pain, Paranasal sinus hypersecretion, SARS-CoV-2 test negative
Clinical narrative: Sore throat, swollen glands, muscle and joint pain, sweating, fatigue, loss of appetitie, dizziness, and upper respiratory drainage.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Dermatosis, Erythema, Lip swelling, Mechanical urticaria, Peripheral swelling
Clinical narrative: he is a 45 year-old man who had his Moderna COVID19 booster at the end of November. Eleven days after his booster, he developed swelling in his hands and periocular skin as well as red, raised itchy hives. Some lesions were spontaneous and some occurred after scratching the skin. He had uncontrolled symptoms on Allegra 180 mg and Pepcid. He saw Dr of Rheumatology. He was placed on Prednisone 50 mg and it was tapered to 20 mg over 2 weeks. He has stayed at a 20 mg dose for the last 2 weeks. He continues to have hives and some lip swelling. He had no illness, antibiotic use or NSAID use prior to the onset. He has a history of CNS vasculitis. He has had some vision changes on prednisone. He has had no fever or joint pain.   Physical exam: he has dermatographic skin. Cell phone pictures reveal round, erythematous wheals.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Urticaria, Visual impairment
Clinical narrative: he is a 45 year-old man who had his Moderna COVID19 booster at the end of November. Eleven days after his booster, he developed swelling in his hands and periocular skin as well as red, raised itchy hives. Some lesions were spontaneous and some occurred after scratching the skin. He had uncontrolled symptoms on Allegra 180 mg and Pepcid. He saw Dr of Rheumatology. He was placed on Prednisone 50 mg and it was tapered to 20 mg over 2 weeks. He has stayed at a 20 mg dose for the last 2 weeks. He continues to have hives and some lip swelling. He had no illness, antibiotic use or NSAID use prior to the onset. He has a history of CNS vasculitis. He has had some vision changes on prednisone. He has had no fever or joint pain.   Physical exam: he has dermatographic skin. Cell phone pictures reveal round, erythematous wheals.
Age: 94.0
Sex: F
Vaccine: COVID19, FLUA4, COVID19, FLU4
Symptoms: Angiogram abnormal, Angiogram cerebral abnormal, Cerebrovascular accident
Clinical narrative: 4 days later patient presented to the emergency department due to acute onset of left-sided weakness with hemineglect and hemiparesis. Patient was found to have a very large right-sided CVA which appears to be due to the right ICA. The patient was outside the window for TPA as her last known well was 1600 the day before. Due to the size of the infarct recommendations were made for comfort care and hospice as the patient would likely have significant swelling and likely herniate. The option to do a partial hemicraniotomy was offered to the family but the family and patient decided to follow comfort measures. She passed away on January 24.
Age: 94.0
Sex: F
Vaccine: COVID19, FLUA4, COVID19, FLU4
Symptoms: Angiogram cerebral abnormal, Cerebral infarction, Cerebrovascular accident, Death, Hemiparesis
Clinical narrative: 4 days later patient presented to the emergency department due to acute onset of left-sided weakness with hemineglect and hemiparesis. Patient was found to have a very large right-sided CVA which appears to be due to the right ICA. The patient was outside the window for TPA as her last known well was 1600 the day before. Due to the size of the infarct recommendations were made for comfort care and hospice as the patient would likely have significant swelling and likely herniate. The option to do a partial hemicraniotomy was offered to the family but the family and patient decided to follow comfort measures. She passed away on January 24.
Age: 94.0
Sex: F
Vaccine: COVID19, FLUA4, COVID19, FLU4
Symptoms: Neurologic neglect syndrome
Clinical narrative: 4 days later patient presented to the emergency department due to acute onset of left-sided weakness with hemineglect and hemiparesis. Patient was found to have a very large right-sided CVA which appears to be due to the right ICA. The patient was outside the window for TPA as her last known well was 1600 the day before. Due to the size of the infarct recommendations were made for comfort care and hospice as the patient would likely have significant swelling and likely herniate. The option to do a partial hemicraniotomy was offered to the family but the family and patient decided to follow comfort measures. She passed away on January 24.
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product administered to patient of inappropriate age, Vaccination complication
Clinical narrative: kind of quiet/ A few hours was quiet not quite his self; Her 16 year old son has received 2 doses of the Moderna Covid-19 vaccine by IM injection to the leg on 5MAY2021; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (kind of quiet/ A few hours was quiet not quite his self) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Her 16 year old son has received 2 doses of the Moderna Covid-19 vaccine by IM injection to the leg on 5MAY2021) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026C21A and 046A21A) for COVID-19 vaccination.     Patient had chronic/long standing health conditions since birth, from 14 Feb 2005.  Concurrent medical conditions included Drug allergy (Vanco), Seizure, Respiratory abnormality, unspecified and Tic. Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) for Respiratory abnormality, unspecified, CLONAZEPAM for Seizure and Tic.   On 05-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Jun-2021, the patient experienced FEELING ABNORMAL (kind of quiet/ A few hours was quiet not quite his self) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Her 16 year old son has received 2 doses of the Moderna Covid-19 vaccine by IM injection to the leg on 5MAY2021). On 03-Jun-2021, FEELING ABNORMAL (kind of quiet/ A few hours was quiet not quite his self) had resolved. At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Her 16 year old son has received 2 doses of the Moderna Covid-19 vaccine by IM injection to the leg on 5MAY2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered FEELING ABNORMAL (kind of quiet/ A few hours was quiet not quite his self) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Her 16 year old son has received 2 doses of the Moderna Covid-19 vaccine by IM injection to the leg on 5MAY2021) to be related.    Patient's height reported as 4'6".  Patient wanted to know if he would be able to get booster.  No Treatment medications reported.   This case was linked to MOD-2022-458050, MOD-2022-458129, MOD-2022-457985, MOD-2022-458344 (Patient Link).
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Feeling abnormal, Product administered to patient of inappropriate age
Clinical narrative: kind of quiet/ A few hours was quiet not quite his self; Her 16 year old son has received 2 doses of the Moderna Covid-19 vaccine by IM injection to the leg on 5MAY2021; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (kind of quiet/ A few hours was quiet not quite his self) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Her 16 year old son has received 2 doses of the Moderna Covid-19 vaccine by IM injection to the leg on 5MAY2021) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026C21A and 046A21A) for COVID-19 vaccination.     Patient had chronic/long standing health conditions since birth, from 14 Feb 2005.  Concurrent medical conditions included Drug allergy (Vanco), Seizure, Respiratory abnormality, unspecified and Tic. Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) for Respiratory abnormality, unspecified, CLONAZEPAM for Seizure and Tic.   On 05-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Jun-2021, the patient experienced FEELING ABNORMAL (kind of quiet/ A few hours was quiet not quite his self) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Her 16 year old son has received 2 doses of the Moderna Covid-19 vaccine by IM injection to the leg on 5MAY2021). On 03-Jun-2021, FEELING ABNORMAL (kind of quiet/ A few hours was quiet not quite his self) had resolved. At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Her 16 year old son has received 2 doses of the Moderna Covid-19 vaccine by IM injection to the leg on 5MAY2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered FEELING ABNORMAL (kind of quiet/ A few hours was quiet not quite his self) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Her 16 year old son has received 2 doses of the Moderna Covid-19 vaccine by IM injection to the leg on 5MAY2021) to be related.    Patient's height reported as 4'6".  Patient wanted to know if he would be able to get booster.  No Treatment medications reported.   This case was linked to MOD-2022-458050, MOD-2022-458129, MOD-2022-457985, MOD-2022-458344 (Patient Link).
Age: 22.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: No adverse event
Clinical narrative: The caller's daughter stated she began feeling dizzy after the GARDASIL 9 was administered and continued t feel dizzy; daughter received a fourth dose of GARDASIL 9, instead of receiving an unspecified Hepatitis B vaccine; daughter received a fourth dose of GARDASIL 9; This spontaneous report as received from a father refers to a 22-year-old female patient. The patient's concurrent conditions, concomitant therapies and medical history was not provided.  On 31-JAN-2022, the patient was vaccinated with a fourth dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), intramuscular dose, (site of administration, lot # and expiration date were not provided) for prophylaxis instead of receiving an unspecified Hepatitis B Vaccine (manufacturer unknown) (extra dose administered, wrong product administered). On the same day, the patient started feeling dizzy and continued to feel dizzy at the time of the report. It was not specified in patient received the dose of Hepatitis B Vaccine (manufacturer unknown) as scheduled. The outcome of the event was reported as not recovered. It was unknown if the patient received treatment. She did not seek medical attention.  The relatedness between hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) and feeling dizzy was not reported.
Age: 22.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Dizziness, Extra dose administered, Wrong product administered
Clinical narrative: The caller's daughter stated she began feeling dizzy after the GARDASIL 9 was administered and continued t feel dizzy; daughter received a fourth dose of GARDASIL 9, instead of receiving an unspecified Hepatitis B vaccine; daughter received a fourth dose of GARDASIL 9; This spontaneous report as received from a father refers to a 22-year-old female patient. The patient's concurrent conditions, concomitant therapies and medical history was not provided.  On 31-JAN-2022, the patient was vaccinated with a fourth dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), intramuscular dose, (site of administration, lot # and expiration date were not provided) for prophylaxis instead of receiving an unspecified Hepatitis B Vaccine (manufacturer unknown) (extra dose administered, wrong product administered). On the same day, the patient started feeling dizzy and continued to feel dizzy at the time of the report. It was not specified in patient received the dose of Hepatitis B Vaccine (manufacturer unknown) as scheduled. The outcome of the event was reported as not recovered. It was unknown if the patient received treatment. She did not seek medical attention.  The relatedness between hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) and feeling dizzy was not reported.
Age: 65.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Decreased appetite, Fatigue, Headache, Malaise, Nausea
Clinical narrative: From Provider note on 2/10/2022 per patient account: 4 day hospitalization for cellulitis/vaccine reaction. Last primary care visit we did a epidermoid cyst extraction, and got a prevnar vaccine at end of visit.  After getting vaccine, she saw that there was a warning about h/o tetanus reaction on it, and became concerned.  Previously, had a TDAP vaccine and had large local reaction, seen in clinic afterwards and placed on antibiotics with working diagnosis of cellulitis.   This time, a few days after her prevnar vaccine, on Sunday, noticed that the area of swelling was large, and was growing by Monday.  To clinic on day 5 post vaccine, where placed on antihistamines and tylenol for treatment of skin reaction to vaccine.  Went back to clinic 3 days later, with progression of pain/swelling/redness (a level 10 pain), and some systemic symptoms, which prompted her hospitalization.  Notably, during hospitalization, WBC was quite elevated, and didn't seem to respond to abx, but by d/c her WBC was trending down.  She's finished the abx, and feeling much better, but remains somewhat concerned about the WBC count, and hospitalization bills.   Her back where cyst excision was done feels great, she is happy to have that issue resolved.   Per Discharge Note on 2/5/22 Hospital Course       RUE Cellulitis with sepsis versus Pneumovax vaccine reaction.  more likely severe inflammatory response to the Pneumovax vaccine She developed worsening right arm erythema, swelling and pain associated with fever and leukocytosis concerning for sepsis.  2/2 -started on vancomycin and cefazolin -received 1.75L IVF in ED 2/3:  right arm redness progressed some down her arm.   2/4: arm feels slightly better overall. however worsening redness in right forearm and WBC is higher at 19.4 with 16% bands.  Suspect severe inflammatory response to the Pneumovax vaccine. changed antibiotics to oral cephalexin 2/5: erythema and swelling in R arm much improved since admission. Repeat WBC 14K  stable for discharge to home  continue cephalexin 250mg q6 x 5 days  - f/u with PCP if needed.
Age: 65.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Pain, Pain in extremity, Peripheral swelling, Pyrexia, Rash erythematous
Clinical narrative: From Provider note on 2/10/2022 per patient account: 4 day hospitalization for cellulitis/vaccine reaction. Last primary care visit we did a epidermoid cyst extraction, and got a prevnar vaccine at end of visit.  After getting vaccine, she saw that there was a warning about h/o tetanus reaction on it, and became concerned.  Previously, had a TDAP vaccine and had large local reaction, seen in clinic afterwards and placed on antibiotics with working diagnosis of cellulitis.   This time, a few days after her prevnar vaccine, on Sunday, noticed that the area of swelling was large, and was growing by Monday.  To clinic on day 5 post vaccine, where placed on antihistamines and tylenol for treatment of skin reaction to vaccine.  Went back to clinic 3 days later, with progression of pain/swelling/redness (a level 10 pain), and some systemic symptoms, which prompted her hospitalization.  Notably, during hospitalization, WBC was quite elevated, and didn't seem to respond to abx, but by d/c her WBC was trending down.  She's finished the abx, and feeling much better, but remains somewhat concerned about the WBC count, and hospitalization bills.   Her back where cyst excision was done feels great, she is happy to have that issue resolved.   Per Discharge Note on 2/5/22 Hospital Course       RUE Cellulitis with sepsis versus Pneumovax vaccine reaction.  more likely severe inflammatory response to the Pneumovax vaccine She developed worsening right arm erythema, swelling and pain associated with fever and leukocytosis concerning for sepsis.  2/2 -started on vancomycin and cefazolin -received 1.75L IVF in ED 2/3:  right arm redness progressed some down her arm.   2/4: arm feels slightly better overall. however worsening redness in right forearm and WBC is higher at 19.4 with 16% bands.  Suspect severe inflammatory response to the Pneumovax vaccine. changed antibiotics to oral cephalexin 2/5: erythema and swelling in R arm much improved since admission. Repeat WBC 14K  stable for discharge to home  continue cephalexin 250mg q6 x 5 days  - f/u with PCP if needed.
Age: 65.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Blood culture, Blood iron, Blood lactic acid, Cellulitis, Differential white blood cell count
Clinical narrative: From Provider note on 2/10/2022 per patient account: 4 day hospitalization for cellulitis/vaccine reaction. Last primary care visit we did a epidermoid cyst extraction, and got a prevnar vaccine at end of visit.  After getting vaccine, she saw that there was a warning about h/o tetanus reaction on it, and became concerned.  Previously, had a TDAP vaccine and had large local reaction, seen in clinic afterwards and placed on antibiotics with working diagnosis of cellulitis.   This time, a few days after her prevnar vaccine, on Sunday, noticed that the area of swelling was large, and was growing by Monday.  To clinic on day 5 post vaccine, where placed on antihistamines and tylenol for treatment of skin reaction to vaccine.  Went back to clinic 3 days later, with progression of pain/swelling/redness (a level 10 pain), and some systemic symptoms, which prompted her hospitalization.  Notably, during hospitalization, WBC was quite elevated, and didn't seem to respond to abx, but by d/c her WBC was trending down.  She's finished the abx, and feeling much better, but remains somewhat concerned about the WBC count, and hospitalization bills.   Her back where cyst excision was done feels great, she is happy to have that issue resolved.   Per Discharge Note on 2/5/22 Hospital Course       RUE Cellulitis with sepsis versus Pneumovax vaccine reaction.  more likely severe inflammatory response to the Pneumovax vaccine She developed worsening right arm erythema, swelling and pain associated with fever and leukocytosis concerning for sepsis.  2/2 -started on vancomycin and cefazolin -received 1.75L IVF in ED 2/3:  right arm redness progressed some down her arm.   2/4: arm feels slightly better overall. however worsening redness in right forearm and WBC is higher at 19.4 with 16% bands.  Suspect severe inflammatory response to the Pneumovax vaccine. changed antibiotics to oral cephalexin 2/5: erythema and swelling in R arm much improved since admission. Repeat WBC 14K  stable for discharge to home  continue cephalexin 250mg q6 x 5 days  - f/u with PCP if needed.
Age: 65.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Epidermoid cyst excision, Erythema, Full blood count, Inflammation, Laboratory test
Clinical narrative: From Provider note on 2/10/2022 per patient account: 4 day hospitalization for cellulitis/vaccine reaction. Last primary care visit we did a epidermoid cyst extraction, and got a prevnar vaccine at end of visit.  After getting vaccine, she saw that there was a warning about h/o tetanus reaction on it, and became concerned.  Previously, had a TDAP vaccine and had large local reaction, seen in clinic afterwards and placed on antibiotics with working diagnosis of cellulitis.   This time, a few days after her prevnar vaccine, on Sunday, noticed that the area of swelling was large, and was growing by Monday.  To clinic on day 5 post vaccine, where placed on antihistamines and tylenol for treatment of skin reaction to vaccine.  Went back to clinic 3 days later, with progression of pain/swelling/redness (a level 10 pain), and some systemic symptoms, which prompted her hospitalization.  Notably, during hospitalization, WBC was quite elevated, and didn't seem to respond to abx, but by d/c her WBC was trending down.  She's finished the abx, and feeling much better, but remains somewhat concerned about the WBC count, and hospitalization bills.   Her back where cyst excision was done feels great, she is happy to have that issue resolved.   Per Discharge Note on 2/5/22 Hospital Course       RUE Cellulitis with sepsis versus Pneumovax vaccine reaction.  more likely severe inflammatory response to the Pneumovax vaccine She developed worsening right arm erythema, swelling and pain associated with fever and leukocytosis concerning for sepsis.  2/2 -started on vancomycin and cefazolin -received 1.75L IVF in ED 2/3:  right arm redness progressed some down her arm.   2/4: arm feels slightly better overall. however worsening redness in right forearm and WBC is higher at 19.4 with 16% bands.  Suspect severe inflammatory response to the Pneumovax vaccine. changed antibiotics to oral cephalexin 2/5: erythema and swelling in R arm much improved since admission. Repeat WBC 14K  stable for discharge to home  continue cephalexin 250mg q6 x 5 days  - f/u with PCP if needed.
Age: 65.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Leukocytosis, Pain, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: From Provider note on 2/10/2022 per patient account: 4 day hospitalization for cellulitis/vaccine reaction. Last primary care visit we did a epidermoid cyst extraction, and got a prevnar vaccine at end of visit.  After getting vaccine, she saw that there was a warning about h/o tetanus reaction on it, and became concerned.  Previously, had a TDAP vaccine and had large local reaction, seen in clinic afterwards and placed on antibiotics with working diagnosis of cellulitis.   This time, a few days after her prevnar vaccine, on Sunday, noticed that the area of swelling was large, and was growing by Monday.  To clinic on day 5 post vaccine, where placed on antihistamines and tylenol for treatment of skin reaction to vaccine.  Went back to clinic 3 days later, with progression of pain/swelling/redness (a level 10 pain), and some systemic symptoms, which prompted her hospitalization.  Notably, during hospitalization, WBC was quite elevated, and didn't seem to respond to abx, but by d/c her WBC was trending down.  She's finished the abx, and feeling much better, but remains somewhat concerned about the WBC count, and hospitalization bills.   Her back where cyst excision was done feels great, she is happy to have that issue resolved.   Per Discharge Note on 2/5/22 Hospital Course       RUE Cellulitis with sepsis versus Pneumovax vaccine reaction.  more likely severe inflammatory response to the Pneumovax vaccine She developed worsening right arm erythema, swelling and pain associated with fever and leukocytosis concerning for sepsis.  2/2 -started on vancomycin and cefazolin -received 1.75L IVF in ED 2/3:  right arm redness progressed some down her arm.   2/4: arm feels slightly better overall. however worsening redness in right forearm and WBC is higher at 19.4 with 16% bands.  Suspect severe inflammatory response to the Pneumovax vaccine. changed antibiotics to oral cephalexin 2/5: erythema and swelling in R arm much improved since admission. Repeat WBC 14K  stable for discharge to home  continue cephalexin 250mg q6 x 5 days  - f/u with PCP if needed.
Age: 65.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: SARS-CoV-2 test, Sepsis, Skin reaction, Staphylococcus test, Urine analysis
Clinical narrative: From Provider note on 2/10/2022 per patient account: 4 day hospitalization for cellulitis/vaccine reaction. Last primary care visit we did a epidermoid cyst extraction, and got a prevnar vaccine at end of visit.  After getting vaccine, she saw that there was a warning about h/o tetanus reaction on it, and became concerned.  Previously, had a TDAP vaccine and had large local reaction, seen in clinic afterwards and placed on antibiotics with working diagnosis of cellulitis.   This time, a few days after her prevnar vaccine, on Sunday, noticed that the area of swelling was large, and was growing by Monday.  To clinic on day 5 post vaccine, where placed on antihistamines and tylenol for treatment of skin reaction to vaccine.  Went back to clinic 3 days later, with progression of pain/swelling/redness (a level 10 pain), and some systemic symptoms, which prompted her hospitalization.  Notably, during hospitalization, WBC was quite elevated, and didn't seem to respond to abx, but by d/c her WBC was trending down.  She's finished the abx, and feeling much better, but remains somewhat concerned about the WBC count, and hospitalization bills.   Her back where cyst excision was done feels great, she is happy to have that issue resolved.   Per Discharge Note on 2/5/22 Hospital Course       RUE Cellulitis with sepsis versus Pneumovax vaccine reaction.  more likely severe inflammatory response to the Pneumovax vaccine She developed worsening right arm erythema, swelling and pain associated with fever and leukocytosis concerning for sepsis.  2/2 -started on vancomycin and cefazolin -received 1.75L IVF in ED 2/3:  right arm redness progressed some down her arm.   2/4: arm feels slightly better overall. however worsening redness in right forearm and WBC is higher at 19.4 with 16% bands.  Suspect severe inflammatory response to the Pneumovax vaccine. changed antibiotics to oral cephalexin 2/5: erythema and swelling in R arm much improved since admission. Repeat WBC 14K  stable for discharge to home  continue cephalexin 250mg q6 x 5 days  - f/u with PCP if needed.
Age: 65.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Vaccination complication, White blood cell count increased
Clinical narrative: From Provider note on 2/10/2022 per patient account: 4 day hospitalization for cellulitis/vaccine reaction. Last primary care visit we did a epidermoid cyst extraction, and got a prevnar vaccine at end of visit.  After getting vaccine, she saw that there was a warning about h/o tetanus reaction on it, and became concerned.  Previously, had a TDAP vaccine and had large local reaction, seen in clinic afterwards and placed on antibiotics with working diagnosis of cellulitis.   This time, a few days after her prevnar vaccine, on Sunday, noticed that the area of swelling was large, and was growing by Monday.  To clinic on day 5 post vaccine, where placed on antihistamines and tylenol for treatment of skin reaction to vaccine.  Went back to clinic 3 days later, with progression of pain/swelling/redness (a level 10 pain), and some systemic symptoms, which prompted her hospitalization.  Notably, during hospitalization, WBC was quite elevated, and didn't seem to respond to abx, but by d/c her WBC was trending down.  She's finished the abx, and feeling much better, but remains somewhat concerned about the WBC count, and hospitalization bills.   Her back where cyst excision was done feels great, she is happy to have that issue resolved.   Per Discharge Note on 2/5/22 Hospital Course       RUE Cellulitis with sepsis versus Pneumovax vaccine reaction.  more likely severe inflammatory response to the Pneumovax vaccine She developed worsening right arm erythema, swelling and pain associated with fever and leukocytosis concerning for sepsis.  2/2 -started on vancomycin and cefazolin -received 1.75L IVF in ED 2/3:  right arm redness progressed some down her arm.   2/4: arm feels slightly better overall. however worsening redness in right forearm and WBC is higher at 19.4 with 16% bands.  Suspect severe inflammatory response to the Pneumovax vaccine. changed antibiotics to oral cephalexin 2/5: erythema and swelling in R arm much improved since admission. Repeat WBC 14K  stable for discharge to home  continue cephalexin 250mg q6 x 5 days  - f/u with PCP if needed.
Age: 40.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Death
Clinical narrative: HOSPITALIZATION
Age: 40.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Unevaluable event
Clinical narrative: HOSPITALIZATION
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Pain, Sarcoidosis, Urticaria
Clinical narrative: allergic reaction; hives; This case was reported by a consumer via call center representative and described the occurrence of allergic reaction in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included immune disorder (nos) (had immune disorder that affect problems).   In October 2021, the patient received Shingrix. On an unknown date, less than 5 months after receiving Shingrix, the patient experienced allergic reaction and hives. The patient was treated with steroids nos (Steroids), allergy medication {nos} (Allergy Medicine (Unspecified)), prednisone and fexofenadine hydrochloride (Allegra). On an unknown date, the outcome of the allergic reaction and hives were not recovered/not resolved.   It was unknown if the reporter considered the allergic reaction and hives to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was unknown, but it could be 58 or 59 years old. The patient received Shingrix vaccine 5 month ago and had hives ever since. The patient also had immune disorder which was also affecting the problem. The patient visited 4 doctors and received Steroids and allergy medicine, but nothing was working. The patient stated that, had severe hives for 4 months and currently took 40 mg of predinsone and allegra, but still had extreme hives. Was there anything that could counter this Shingrix vaccine.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Hypersensitivity, Urticaria
Clinical narrative: allergic reaction; hives; This case was reported by a consumer via call center representative and described the occurrence of allergic reaction in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included immune disorder (nos) (had immune disorder that affect problems).   In October 2021, the patient received Shingrix. On an unknown date, less than 5 months after receiving Shingrix, the patient experienced allergic reaction and hives. The patient was treated with steroids nos (Steroids), allergy medication {nos} (Allergy Medicine (Unspecified)), prednisone and fexofenadine hydrochloride (Allegra). On an unknown date, the outcome of the allergic reaction and hives were not recovered/not resolved.   It was unknown if the reporter considered the allergic reaction and hives to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was unknown, but it could be 58 or 59 years old. The patient received Shingrix vaccine 5 month ago and had hives ever since. The patient also had immune disorder which was also affecting the problem. The patient visited 4 doctors and received Steroids and allergy medicine, but nothing was working. The patient stated that, had severe hives for 4 months and currently took 40 mg of predinsone and allegra, but still had extreme hives. Was there anything that could counter this Shingrix vaccine.
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Malaise, Meningitis viral
Clinical narrative: 2 day after taking the vaccine he had chills, headache and fever. It lasted 5 days and he went to the doctor. He was given an antibiotic and after taking them he still didnt get better. He went back and was admitted to the hospital.
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: 2 day after taking the vaccine he had chills, headache and fever. It lasted 5 days and he went to the doctor. He was given an antibiotic and after taking them he still didnt get better. He went back and was admitted to the hospital.
Age: 26.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pruritus, Rash, Sensitive skin, Urticaria
Clinical narrative: Urticaria and hives over back and arms with some on legs. Started 02/11/2022 and have continued for 5 days off and on.   Benadryl helps, over-the-counter hydrocortisone helps  Rx prescribed for prednisone
Age: 26.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Urticaria
Clinical narrative: Urticaria and hives over back and arms with some on legs. Started 02/11/2022 and have continued for 5 days off and on.   Benadryl helps, over-the-counter hydrocortisone helps  Rx prescribed for prednisone
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Acne, Blood follicle stimulating hormone, Blood prolactin, Blood test abnormal, Blood testosterone
Clinical narrative: I had been charting my period cycle and my period following the vaccine was delayed by 7 days (37 day long cycle). I continued to see abnormal periods as well as an increase in acne. My doctor suspected I had developed PCOS. On 8/17/21 I had blood work done which confirmed the diagnosis of PCOS. Additionally, I have been trying to get pregnant since 10/2/2021 with no luck. I have one son (born 9/22/19) and no prior infertility issues. I really feel the vaccine caused the PCOS and infertility issues due to the correlation of the vaccine with the  timing of symptom development.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Blood thyroid stimulating hormone, Infertility female, Menstrual disorder, Menstruation delayed, Oestradiol
Clinical narrative: I had been charting my period cycle and my period following the vaccine was delayed by 7 days (37 day long cycle). I continued to see abnormal periods as well as an increase in acne. My doctor suspected I had developed PCOS. On 8/17/21 I had blood work done which confirmed the diagnosis of PCOS. Additionally, I have been trying to get pregnant since 10/2/2021 with no luck. I have one son (born 9/22/19) and no prior infertility issues. I really feel the vaccine caused the PCOS and infertility issues due to the correlation of the vaccine with the  timing of symptom development.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Polycystic ovaries, Progesterone, Thyroxine, Tri-iodothyronine
Clinical narrative: I had been charting my period cycle and my period following the vaccine was delayed by 7 days (37 day long cycle). I continued to see abnormal periods as well as an increase in acne. My doctor suspected I had developed PCOS. On 8/17/21 I had blood work done which confirmed the diagnosis of PCOS. Additionally, I have been trying to get pregnant since 10/2/2021 with no luck. I have one son (born 9/22/19) and no prior infertility issues. I really feel the vaccine caused the PCOS and infertility issues due to the correlation of the vaccine with the  timing of symptom development.
Age: 1.17
Sex: M
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: 15mo M with rash, small bumps- left and right side and lower back. Improving currently from yesterday but still present. Denies itching or fevers. He continues to eat, drink, void/stool normally. He received MMR and Varicella vaccines on 31Jan2022, symptoms developed on 15Feb22.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Impaired work ability, Muscle tightness, Myalgia
Clinical narrative: Muscle pain and muscle tightening all over my body, fatigue, fever, chills, night sweats that lasted overnight. Muscle pain and fatigue lasted for 1 day after vaccination. Tylenol 500mg helped but I had to call out of work.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Night sweats, Pyrexia
Clinical narrative: Muscle pain and muscle tightening all over my body, fatigue, fever, chills, night sweats that lasted overnight. Muscle pain and fatigue lasted for 1 day after vaccination. Tylenol 500mg helped but I had to call out of work.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebral endovascular aneurysm repair, Computerised tomogram head abnormal, Headache, Hypoaesthesia, Inappropriate schedule of product administration
Clinical narrative: Head pain, numbness and vomiting- brought to ER - dx with Subarachnoid Bleed-air flighted to hospital- aneurysm coil procedure, 4 days in ICU, 11 days in hospital
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Intensive care, Ruptured cerebral aneurysm, SARS-CoV-2 test negative, Scan with contrast abnormal, Subarachnoid haemorrhage
Clinical narrative: Head pain, numbness and vomiting- brought to ER - dx with Subarachnoid Bleed-air flighted to hospital- aneurysm coil procedure, 4 days in ICU, 11 days in hospital
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Head pain, numbness and vomiting- brought to ER - dx with Subarachnoid Bleed-air flighted to hospital- aneurysm coil procedure, 4 days in ICU, 11 days in hospital
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling abnormal, Muscle tightness, Myalgia
Clinical narrative: Muscle pain and tightening, significant fatigue, fever, chills lasting overnight. Muscle pain, fatigue and brain fog lasted for 2 days after vaccination but improved each day. No medications taken.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Muscle pain and tightening, significant fatigue, fever, chills lasting overnight. Muscle pain, fatigue and brain fog lasted for 2 days after vaccination but improved each day. No medications taken.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Muscle tightness
Clinical narrative: Muscle tightening, fatigue, chills lasting overnight. Tylenol 1000mg helped. This improved the next day.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Urticaria, Urticaria chronic
Clinical narrative: About 10 days after covid booster, I started to feel intense itching/ bumps on stomach, then spread to most of upper torso and scalp. Days later, on arms, legs, feet, and hands. Itch intensely in evening.   Intense on scalp, and neck and itching hives come on all areas of my body.  Any pressure or clothing can create bumps.    I have no history of hives, have no new foods, detergent, environmental exposures or stress. I tried taking Benadryl and claritin.  With only mild success, but nothing helped. Went to urgent care and prescribed steroid cream.  Did not help Went to doctor and was diagnosed Chronic Urticaria. After 3 weeks no relief, intense hives still occurring any place on body. On 1/20/22 prescribed Prednisone (4mg Dospak 21s)  and Famotidine 20 mg taking Claritin during the day and Benadryl at night. The 5 day prednisone helped the hives.  But after the 5 day dose the hives returned. So a 10 day prednisone was prescribed.  Again it helped and the itching was less severe while still taking antihistamine. But now on 2/16/22 3 days after 2nd dose of prednisone.  The hives are back on neck and face and anywhere on body
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Feeling cold, Headache, Hot flush
Clinical narrative: Diarrhea, nausea, headache, fever, hot flashes, cold flashes, insomnia, fatigue, muscle aches and soreness
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Myalgia, Nausea, Pyrexia
Clinical narrative: Diarrhea, nausea, headache, fever, hot flashes, cold flashes, insomnia, fatigue, muscle aches and soreness
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Echocardiogram normal, Electrocardiogram ambulatory, Electrocardiogram normal, Palpitations
Clinical narrative: Last summer I noticed I was having frequent palpitations. I had experienced them in the past, just not at this frequency; and they had gone away. They were occurring every day, multiple times a day. I went to my PCP about it, and he did an EKG, ordered an echocardiogram, which I had done on 9/20/2021, a Holter monitory which I wore for a week, and referred me to a cardiologist. The cardiologist put me on Toprol XL 25mg daily. At my next follow up with the cardiologist, I was still having the frequent palpitations, so he switched me to Lopressor 25mg twice daily. The change in medication did not help, so at my follow up on 2/9, he increased the Lopressor to 50mg twice daily and ordered a Holter monitor again that I will wear for 4 weeks. That will be placed on 2/17. I continue to have the palpitations at the present time.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Injection site pain, Injection site swelling
Clinical narrative: Fever up to high of 102.6, chills, headache, body aches. Painful swollen injection site, fatigue.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: Fever up to high of 102.6, chills, headache, body aches. Painful swollen injection site, fatigue.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Patient had been  administered with Pediatric Pfizer vaccine (5 to 11yrs) . Pediatric Vaccine is not strong enough get protection. He was contacted to get revaccinated. Patient has not been back yet to Pharmacy
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Patient had administered with Pediatric Pfizer Vaccine(5 to 11yrs). Pediatric  vaccine is not strong enough to get protection. patient was contacted to revaccinated but she has not come back yet to pharmacy
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Patient had been administered with Pediatric Pfizer Vaccine(5 to 11yrs). Pediatric vaccine is not strong enough to get protection Patient has been contacted to revaccinated but he has not come back to pharmacy yet.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Blood test, Contusion, Headache, Hypoaesthesia
Clinical narrative: Loss of feeling in left leg, bruises rotating on left leg, arthritis flare up in right hand (swollen middle finger) restless
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Peripheral swelling, Restlessness, Sleep study
Clinical narrative: Loss of feeling in left leg, bruises rotating on left leg, arthritis flare up in right hand (swollen middle finger) restless
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Patient administered pediatric Pfizer vaccine (5 to 11 years old). It is not strong enough to get protection. Patient contacted for revaccination but has not yet came back.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Audiogram abnormal, Deafness, Deafness bilateral, Ear discomfort, Endolymphatic hydrops
Clinical narrative: Moderate vertigo within 24 hours of receiving Pfizer booster. 4 weeks later awakened with sudden RIGHT ear severe hearing loss, aural fullness, and severe tinnitus. LEFT ear with steady mild tinnitus. Saw Nurse Practioner at allergist who prescribed prednisone and azithromycin, Xyzal, Mucinex, and Flonase. No improvement with treatment and returned to the office and received an additional steroid course. No improvement and sent to ENT. ENT ordered audiogram/tympanogram and MRI. An audiogram revealed moderately severe reverse ski-slope hearing loss RIGHT ear in low frequencies. MRI was within normal limits and revealed no structural issues. ENT sent me to Ear Clinic where I was diagnosed with Cochlear Hydrops and prescribed HCTZ and Potassium chloride, vestibular exercises, and a change of diet to avoid tyramines.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging normal, Tinnitus, Vertigo
Clinical narrative: Moderate vertigo within 24 hours of receiving Pfizer booster. 4 weeks later awakened with sudden RIGHT ear severe hearing loss, aural fullness, and severe tinnitus. LEFT ear with steady mild tinnitus. Saw Nurse Practioner at allergist who prescribed prednisone and azithromycin, Xyzal, Mucinex, and Flonase. No improvement with treatment and returned to the office and received an additional steroid course. No improvement and sent to ENT. ENT ordered audiogram/tympanogram and MRI. An audiogram revealed moderately severe reverse ski-slope hearing loss RIGHT ear in low frequencies. MRI was within normal limits and revealed no structural issues. ENT sent me to Ear Clinic where I was diagnosed with Cochlear Hydrops and prescribed HCTZ and Potassium chloride, vestibular exercises, and a change of diet to avoid tyramines.
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arteriogram coronary normal, Chest pain, Electrocardiogram normal, Myocarditis, Troponin increased
Clinical narrative: myocarditis. initially thought to be non-stemi MI but coronary angiogram did not show severe stenosis. Patient had chest pain, elevated troponin
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Carditis, Myocardial infarction
Clinical narrative: myocarditis. initially thought to be non-stemi MI but coronary angiogram did not show severe stenosis. Patient had chest pain, elevated troponin
Age: 6.0
Sex: M
Vaccine: COVID19
Symptoms: Product preparation issue, Pyrexia
Clinical narrative: Patient was administered with undiluted Pediatric Pfizer vaccine . patient had fever for 2days and fever was broken on 3rd day after vaccine administeraion
Age: 7.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient administered undiluted pediatric Pfizer vaccine.
Age: 7.0
Sex: F
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: Patient was administered with undiluted pediatric Pfizer Vaccine
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Dysphonia
Clinical narrative: Honestly, this is a very helpful and effective vaccine that seems to be efficient in protecting people from spreading and contracting covid-19. The adverse event was mild: it had a reverse effect on my voice and lung power in regards to vocal projection and singing. More specifically, it seemed as if it reversed aging, whether just in the lungs and vocal organs or perhaps overall genetic age. The adverse effects are mild, simply the state of experiencing pubescent changes in the voice such as voice cracking. After two to three weeks, a better diet, immunity boosting vitamins and adjustment to the vaccine brought this youthful trend into waning.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: A 17-year-old patient inadvertently given Moderna (dose #1), which is indicated for ages 18+.
Age: 6.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient was inadvertently given dose #2 of Pfizer (pediatric) outside of the recommended 21-day interval.  According to ASIIS, dose #1 was administered on 12/27/21 and dose #2 was administered 1/3/22.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test abnormal, Chest pain, Computerised tomogram, Dyspnoea, Electrocardiogram abnormal
Clinical narrative: Initial symptoms in the first 24 hours matched with prior exposures to the vaccine. Significant arm swelling, a small rash, and muscle aches. The trend changed after 24 hours. In prior exposures, influenza-like/COVID-19-like symptoms lasted for up to 12 days. In this exposure, none of these symptoms was present. Instead, muscle aches worsened significantly, Vitamin D levels dropped to dangerously low levels, heart rate became increased, and chest pain was present upon exerted movements such as getting out of a chair. The chest pain resolved after 4-5 days but breathless has remained to the present day that impacts day to day exertions.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate increased, Inflammation, Influenza like illness, Lymphocyte count increased, Malaise
Clinical narrative: Initial symptoms in the first 24 hours matched with prior exposures to the vaccine. Significant arm swelling, a small rash, and muscle aches. The trend changed after 24 hours. In prior exposures, influenza-like/COVID-19-like symptoms lasted for up to 12 days. In this exposure, none of these symptoms was present. Instead, muscle aches worsened significantly, Vitamin D levels dropped to dangerously low levels, heart rate became increased, and chest pain was present upon exerted movements such as getting out of a chair. The chest pain resolved after 4-5 days but breathless has remained to the present day that impacts day to day exertions.