chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pruritus, Swelling
Clinical narrative: Swollen lymph nodes in her armpits, groin, and neck area/Supraclavicular swelling; Lungs were hyperinflated; Painful lymph nodes in her armpits, groin, and neck area; Itching; Achiness all over; Exhausted; Feeling crummy; Pain at injection site; This case was reported by a consumer via call center representative and described the occurrence of enlargement of lymph nodes in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th February 2022, the patient received the 2nd dose of Shingrix (intramuscular) 50 µg. On 13th February 2022, 1 days after receiving Shingrix, the patient experienced feeling bad and injection site pain. On 19th February 2022, the patient experienced pruritus, general body pain and exhaustion. On 1st March 2022, the patient experienced enlargement of lymph nodes, lung hyperinflation and lymph node pain. On 14th February 2022, the outcome of the feeling bad was recovered/resolved. On an unknown date, the outcome of the enlargement of lymph nodes, pruritus, general body pain, exhaustion, lung hyperinflation and lymph node pain were not recovered/not resolved and the outcome of the injection site pain was recovered/resolved.   The reporter considered the enlargement of lymph nodes, feeling bad, pruritus, general body pain, exhaustion, lung hyperinflation and lymph node pain to be possibly related to Shingrix. The reporter considered the injection site pain to be related to Shingrix.  Additional details reported were as follows: The patient self-reported this case. The patient received Shingrix into her right arm at her pharmacy. The reporter could not provide the lot or expiration date of the vaccine  The day after receiving the vaccine, patient feeling crummy and had pain at the injection site. After 1 day patient felt better, but then one week later on 19th February 2022, the pain in her arm at the injection site, transitioned into an itching that was not resolved. On 19th February 2022, 7 days after vaccination, the patient also began to feel achiness all over and exhausted.  The reporter stated that, she had been to her general practitioner, a pulmonologist, and an ENT for her symptoms. The patient had a chest x-ray and CT scan of her lungs which showed they were hyperinflated. Around 1st March 2022, ten days after the exhaustion began, the reporter stated patient been to had painful, swollen lymph nodes in her armpits, groin, and neck area and was diagnosed with supraclavicular swelling which was unresolved. The reporter's ENT had ordered a MRI. The reported stated that she feels these event could all potentially be due to the Shingrix vaccine she received. The reporter did not give consented to contact her HCP but stated s, herself, would like a call from the safety department to discuss. GSK note- there is descripancy in the reported onset date of painful, swollen lymph nodes as in structured field date is mentioned as 1st Mar 2022 and in narrative it is 10th March 2022. The onset date for these events captured as per structured field.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain, Pyrexia, Swelling
Clinical narrative: Swollen lymph nodes in her armpits, groin, and neck area/Supraclavicular swelling; Lungs were hyperinflated; Painful lymph nodes in her armpits, groin, and neck area; Itching; Achiness all over; Exhausted; Feeling crummy; Pain at injection site; This case was reported by a consumer via call center representative and described the occurrence of enlargement of lymph nodes in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th February 2022, the patient received the 2nd dose of Shingrix (intramuscular) 50 µg. On 13th February 2022, 1 days after receiving Shingrix, the patient experienced feeling bad and injection site pain. On 19th February 2022, the patient experienced pruritus, general body pain and exhaustion. On 1st March 2022, the patient experienced enlargement of lymph nodes, lung hyperinflation and lymph node pain. On 14th February 2022, the outcome of the feeling bad was recovered/resolved. On an unknown date, the outcome of the enlargement of lymph nodes, pruritus, general body pain, exhaustion, lung hyperinflation and lymph node pain were not recovered/not resolved and the outcome of the injection site pain was recovered/resolved.   The reporter considered the enlargement of lymph nodes, feeling bad, pruritus, general body pain, exhaustion, lung hyperinflation and lymph node pain to be possibly related to Shingrix. The reporter considered the injection site pain to be related to Shingrix.  Additional details reported were as follows: The patient self-reported this case. The patient received Shingrix into her right arm at her pharmacy. The reporter could not provide the lot or expiration date of the vaccine  The day after receiving the vaccine, patient feeling crummy and had pain at the injection site. After 1 day patient felt better, but then one week later on 19th February 2022, the pain in her arm at the injection site, transitioned into an itching that was not resolved. On 19th February 2022, 7 days after vaccination, the patient also began to feel achiness all over and exhausted.  The reporter stated that, she had been to her general practitioner, a pulmonologist, and an ENT for her symptoms. The patient had a chest x-ray and CT scan of her lungs which showed they were hyperinflated. Around 1st March 2022, ten days after the exhaustion began, the reporter stated patient been to had painful, swollen lymph nodes in her armpits, groin, and neck area and was diagnosed with supraclavicular swelling which was unresolved. The reporter's ENT had ordered a MRI. The reported stated that she feels these event could all potentially be due to the Shingrix vaccine she received. The reporter did not give consented to contact her HCP but stated s, herself, would like a call from the safety department to discuss. GSK note- there is descripancy in the reported onset date of painful, swollen lymph nodes as in structured field date is mentioned as 1st Mar 2022 and in narrative it is 10th March 2022. The onset date for these events captured as per structured field.
Sex: M
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose Sept2021 and 2nd dose Jan2022; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a male patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (received 1st dose on September 2021).   In January 2022, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. In January 2022, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacists reported that the patient was late for his 2nd dose of Twinrix, which led to lengthening of vaccination schedule.  The reporter consented to follow up. No additional information available from pharmacist since she didn't have their profiles available. This case has been linked with the case US2022047722 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022047722:Same reporter.
Age: 0.75
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Extra dose administered
Clinical narrative: administered a fourth dose; This case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 9-month-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number 5N259, expiry date 5th October 2023) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Pediarix (received 1st dose on 25 August 2021), Pediarix (received 2nd dose on 20th October 2021) and pediatrix (received 3rd dose on 16th December 2021).   On 9th March 2022, the patient received the 1st dose of Pediarix and Pediarix Pre-Filled Syringe Device. On 9th March 2022, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient received Pediarix series and the patient was then inadvertently administered a fourth dose which led to extra dose administered.   The reporter consented to follow up.  The health care professional gave permission for follow-up.
Age: 1.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Kinrix was administered instead of DTaP; Kinrix was administered to 15+ mo patient; DTaP as their 4th dose of DTaP; This case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 15-month-old male patient who received DTPa-IPV (Kinrix) (batch number D24G7, expiry date 4th June 2022) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 16th March 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 16th March 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered, inappropriate age at vaccine administration and inappropriate schedule of vaccine administered. On an unknown date, the outcome of the wrong vaccine administered, inappropriate age at vaccine administration and inappropriate schedule of vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: It was reported that the Kinrix was administered to 15 month old patient instead of DTaP as their 4th dose of DTaP, which led to wrong vaccine administered, inappropriate age at vaccine administration and inappropriate schedule of vaccine administered. Administration of Kinrix was the patient's 4th dose of IPV.  The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: dose1 on 12/23/2020, not yet received 2nd; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 23rd December 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The patient received dose 1 of the shingrix vaccine and at the time of the report, the patient had not received the 2nd dose of the vaccine, which led to incomplete course of vaccination. The reporter did not consent to follow-up.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Eating disorder, Hypoaesthesia, Hypoaesthesia oral, Incomplete course of vaccination, Laboratory test
Clinical narrative: Numbness in face and tongue, worse over time; Numbness in face and tongue; Impairing her speech; Impairing her ability to eat; This case was reported by a consumer via call center representative and described the occurrence of numbness facial in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included breast cancer (she completed chemotherapy and radiation as well as a lumpectomy for breast cancer).   In April 2019, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced numbness facial, numbness of tongue, speech disorder and eating disorder. On an unknown date, the outcome of the numbness facial was not recovered/not resolved and the outcome of the numbness of tongue, speech disorder and eating disorder were unknown.   It was unknown if the reporter considered the numbness facial, numbness of tongue, speech disorder and eating disorder to be related to Shingrix.  Additional details were reported as follows: The patient self-reported this case. The patient called in for the information regarding side effect she developed after receiving Shingrix. The reporter noted that she received her first dose of Shingrix in April of 2019 (exact date unknown) two weeks after she completed chemotherapy and radiation as well as a lumpectomy for breast cancer. After receiving the vaccination on the same day, she noticed some numbness on the right side of her face. She stated that this had gotten worse over time, with the numbness extending to her tongue and impairing her speech and ability to eat.  The reporter stated that due to this reason, she refused to receive the second dose of Shingrix. The reporter stated that she had been seen by multiple physicians including neurologists who ran tests but determined she did not had Guillain-Barre.  The reporter requested further information on Shingrix for which, she was provided with the Medical Information number for her healthcare professional to reach out for more information. The reporter consent to follow up and gave permission to contact health care professionals.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Speech disorder
Clinical narrative: Numbness in face and tongue, worse over time; Numbness in face and tongue; Impairing her speech; Impairing her ability to eat; This case was reported by a consumer via call center representative and described the occurrence of numbness facial in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included breast cancer (she completed chemotherapy and radiation as well as a lumpectomy for breast cancer).   In April 2019, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced numbness facial, numbness of tongue, speech disorder and eating disorder. On an unknown date, the outcome of the numbness facial was not recovered/not resolved and the outcome of the numbness of tongue, speech disorder and eating disorder were unknown.   It was unknown if the reporter considered the numbness facial, numbness of tongue, speech disorder and eating disorder to be related to Shingrix.  Additional details were reported as follows: The patient self-reported this case. The patient called in for the information regarding side effect she developed after receiving Shingrix. The reporter noted that she received her first dose of Shingrix in April of 2019 (exact date unknown) two weeks after she completed chemotherapy and radiation as well as a lumpectomy for breast cancer. After receiving the vaccination on the same day, she noticed some numbness on the right side of her face. She stated that this had gotten worse over time, with the numbness extending to her tongue and impairing her speech and ability to eat.  The reporter stated that due to this reason, she refused to receive the second dose of Shingrix. The reporter stated that she had been seen by multiple physicians including neurologists who ran tests but determined she did not had Guillain-Barre.  The reporter requested further information on Shingrix for which, she was provided with the Medical Information number for her healthcare professional to reach out for more information. The reporter consent to follow up and gave permission to contact health care professionals.
Age: 59.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Anaemia, Psoriatic arthropathy, Vaccination site pain
Clinical narrative: PSORIATIC ARTHRITIS AGGRAVATED; ANEMIA; VACCINATION SITE PAIN; This spontaneous report received from a patient via other manufacturer and concerned an adult male of unspecified race and ethnic origin. The patient was enrolled in a non-Company sponsored solicited program. The patient's height, and weight were not reported. The patient's concurrent conditions included: psoriatic arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported, expiry: unknown) dose was not reported, 1 total administered on an unspecified date in OCT-2021 for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: adalimumab (Humira) (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for psoriatic arthritis. No concomitant medications were reported. On an unspecified date, the patient experienced psoriatic arthritis aggravated (psoriatic arthritis flare), anemia, and vaccination site pain (sore arm following covid vaccine). It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported. The outcome of the vaccination site pain, anemia and psoriatic arthritis aggravated was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20220339476-COVID-19 VACCINE AD26.COV2.S- Psoriatic arthritis aggravated. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY( psoriatic arthritis.) Therefore, this event(s) is considered not related.
Age: 25.0
Sex: U
Vaccine: COVID19, FLUX
Symptoms: Expired product administered
Clinical narrative: Moderna Covid-19 vaccine was given to a patient from a vial that had been left out at room temperature for 18 hrs. post puncture; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine was given to a patient from a vial that had been left out at room temperature for 18 hrs. post puncture) in a 25-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 033K21-2A) for COVID-19 vaccination.    Co-suspect product included non-company product INFLUENZA VACCINE (FLU VACCINE VII) for an unknown indication.    No Medical History information was reported.   On 18-Mar-2022, the patient received dose of INFLUENZA VACCINE (FLU VACCINE VII) (unknown route) 1 dosage form. On 18-Mar-2022 at 8:15 AM, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 18-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine was given to a patient from a vial that had been left out at room temperature for 18 hrs. post puncture). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine was given to a patient from a vial that had been left out at room temperature for 18 hrs. post puncture) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Flushing, Hyperhidrosis
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Mild.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Interchange of vaccine products, Medication error
Clinical narrative: The wrong vaccine, Pfizer was pulled instead of Janssen for the client. An RN drew up Pfizer 0.5 ml and incorrectly, labeled  l it Janssen. The client received Pfizer 0.5 ml via left deltoid. The client was notified byRN (supervisor) and the client was very upset but stable. A copy of the incident report was given to pt upon request. RN supervisor sat with the client during her 15 minutes observation. RN supervisor re-educated staff regarding medication errors.
Age: 35.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Tinnitus, Visual impairment
Clinical narrative: Other than my firstly reported vision issues, I have no developed tinnitus, constant ringing of the ears
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Pharyngeal swelling
Clinical narrative: Throat & Lip swelling within 5 min. post 2nd Dose of Moderna vaccine
Age: 87.0
Sex: M
Vaccine: VARZOS
Symptoms: Oedema, Ultrasound Doppler normal
Clinical narrative: Narrative:  Edema was improving prior to apixaban being stopped, however apixaban was eventually stopped in late February 2022. Patient has not yet received second Shingrix dose, unsure he will.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Dizziness, Fatigue, Head discomfort
Clinical narrative: I felt a pressure at the posterior  base of my neck moving up and to the right of my head. I was not losing conscientiousness. However, I felt as if I was being pulled down to the ground. I grabbed the hand rail next to me and pulled myself up before falling to the floor. After the event, I became light headed and very fatigued. I sat down from an hour and the side effects went away. I did not seek medical attention. I work in a hospital and emergency help was only a code button away should I have experienced a medical emergency.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain lower, Anticoagulant therapy, COVID-19, Cardiac failure congestive, Chest X-ray abnormal
Clinical narrative: Patient is fully vaccinated. COVID positive at hospitalization on 3/9/2022. Patient presented with dyspnea.  In addition, he has had a cough for 3 months. States he tested positive for COVID19 at CVS 3 months ago. Since than he has had a chronic cough. He has left sided chest pain that is associated with his cough. In addition he has noticed swelling in both of his lower extremities.He admits to lower abdominal pain over the last 3 weeks as well. He has loss of appetite. + nausea, + vomiting.  He denies any headache, dizziness, rhinorrhea, nasal congestion, sore throat, fever, diarrhea, constipation,  weakness, and numbness. He admits to fatigue. + tachycardia. CXR:  correlate for mild CHF.  Troponin 0.04. D dimer 614. Treatment:  oxyen, Lasix, decadron, lovenox, SQ heparin, zofran, remdesivir, antibiotics. Discharge to home with endocrinology of his hyperparathyroidism and cardiology.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Cough, Decreased appetite, Dyspnoea, Fatigue
Clinical narrative: Patient is fully vaccinated. COVID positive at hospitalization on 3/9/2022. Patient presented with dyspnea.  In addition, he has had a cough for 3 months. States he tested positive for COVID19 at CVS 3 months ago. Since than he has had a chronic cough. He has left sided chest pain that is associated with his cough. In addition he has noticed swelling in both of his lower extremities.He admits to lower abdominal pain over the last 3 weeks as well. He has loss of appetite. + nausea, + vomiting.  He denies any headache, dizziness, rhinorrhea, nasal congestion, sore throat, fever, diarrhea, constipation,  weakness, and numbness. He admits to fatigue. + tachycardia. CXR:  correlate for mild CHF.  Troponin 0.04. D dimer 614. Treatment:  oxyen, Lasix, decadron, lovenox, SQ heparin, zofran, remdesivir, antibiotics. Discharge to home with endocrinology of his hyperparathyroidism and cardiology.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Fibrin D dimer increased, Hyperparathyroidism, Nausea, Peripheral swelling, SARS-CoV-2 test positive
Clinical narrative: Patient is fully vaccinated. COVID positive at hospitalization on 3/9/2022. Patient presented with dyspnea.  In addition, he has had a cough for 3 months. States he tested positive for COVID19 at CVS 3 months ago. Since than he has had a chronic cough. He has left sided chest pain that is associated with his cough. In addition he has noticed swelling in both of his lower extremities.He admits to lower abdominal pain over the last 3 weeks as well. He has loss of appetite. + nausea, + vomiting.  He denies any headache, dizziness, rhinorrhea, nasal congestion, sore throat, fever, diarrhea, constipation,  weakness, and numbness. He admits to fatigue. + tachycardia. CXR:  correlate for mild CHF.  Troponin 0.04. D dimer 614. Treatment:  oxyen, Lasix, decadron, lovenox, SQ heparin, zofran, remdesivir, antibiotics. Discharge to home with endocrinology of his hyperparathyroidism and cardiology.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Tachycardia, Troponin, Vomiting
Clinical narrative: Patient is fully vaccinated. COVID positive at hospitalization on 3/9/2022. Patient presented with dyspnea.  In addition, he has had a cough for 3 months. States he tested positive for COVID19 at CVS 3 months ago. Since than he has had a chronic cough. He has left sided chest pain that is associated with his cough. In addition he has noticed swelling in both of his lower extremities.He admits to lower abdominal pain over the last 3 weeks as well. He has loss of appetite. + nausea, + vomiting.  He denies any headache, dizziness, rhinorrhea, nasal congestion, sore throat, fever, diarrhea, constipation,  weakness, and numbness. He admits to fatigue. + tachycardia. CXR:  correlate for mild CHF.  Troponin 0.04. D dimer 614. Treatment:  oxyen, Lasix, decadron, lovenox, SQ heparin, zofran, remdesivir, antibiotics. Discharge to home with endocrinology of his hyperparathyroidism and cardiology.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Biopsy skin, Pemphigoid, Rash, Rash pruritic
Clinical narrative: Pt admitted 3/9/22-3/15/22 with pruritic rash which had been progressing over 3 months.  Patient noted the rash after getting his Covid booster.  It initially started in the left arm and then slowly spread to his upper body and lower extremities.  The rash worsened in the 2 to 3 weeks prior to admission. For his rash, patient was initiated on steroid therapy initially with IV.  Dermatology and infectious disease consultations were obtained.  Bullous pemphigoid was suspected.  Punch biopsy was obtained from the left thigh on 3/11.  Pathology results are still pending.  Patient has responded to steroid therapy. Discharged on tapering course of steroids and bacrtrim for PCP prophylaxis. Follow up with outpatient dermatology.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chest X-ray normal, Cough, Dizziness, Electrocardiogram normal
Clinical narrative: Patient is fully vaccinated.  COVID positive at ED visit on 3/12/2022. 88-year-old female presents to the ED complaining of cough, general malaise, lightheadedness for the last 4 to 5 days. No chest pain or shortness of breath.  No abdominal pain nausea vomiting or diarrhea.Vitals reviewed and found to be within acceptable limits.  She was given an IV fluid bolus.Normal troponin.  Chest x-ray unremarkable.  EKG nonischemic. No hypoxia. Discharged home.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, SARS-CoV-2 test positive, Troponin normal
Clinical narrative: Patient is fully vaccinated.  COVID positive at ED visit on 3/12/2022. 88-year-old female presents to the ED complaining of cough, general malaise, lightheadedness for the last 4 to 5 days. No chest pain or shortness of breath.  No abdominal pain nausea vomiting or diarrhea.Vitals reviewed and found to be within acceptable limits.  She was given an IV fluid bolus.Normal troponin.  Chest x-ray unremarkable.  EKG nonischemic. No hypoxia. Discharged home.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Influenza like illness, Lethargy
Clinical narrative: 2nd dose - lethargic the day after, flu like symptoms only the 2nd 24 hours
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site erythema
Clinical narrative: Red area around injection site
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Was administered a pediatric dose in error and was instructed to return to receive correct dose from Pfizer.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Epistaxis, Flatulence, Immediate post-injection reaction
Clinical narrative: 1. Chills (Started immediately after injection around 5 pm on date of injection and is still going ongoing)2.Nausea (2hrs) 3. Gas (Flatus and flatulence)(12 hrs) 4. Nose Bleed ( once) 5. Vomiting (once) 6. Diarrhea (Started at 7 pm on date of injection & is still ongoing) 7. Body aches (started at 2 am the early morning after injection and still ongoing at time of reporting) 8. General malaise (woke up with it at at 7 am on the day after injection.)
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Nausea, Pain, Vomiting
Clinical narrative: 1. Chills (Started immediately after injection around 5 pm on date of injection and is still going ongoing)2.Nausea (2hrs) 3. Gas (Flatus and flatulence)(12 hrs) 4. Nose Bleed ( once) 5. Vomiting (once) 6. Diarrhea (Started at 7 pm on date of injection & is still ongoing) 7. Body aches (started at 2 am the early morning after injection and still ongoing at time of reporting) 8. General malaise (woke up with it at at 7 am on the day after injection.)
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Patient waited the 15 minute time frame no symptoms or signs, patient was well and no swelling in area, notice wrong dose was given once patient was gone
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Muscular weakness, Myalgia
Clinical narrative: Both arms muscle pain and loss of power to lift anything with my arms
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Vaccinated pt admitted with covid infection
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Dizziness, Headache, Nausea
Clinical narrative: Dizziness, vertigo, lightheadedness, mild headache, nausea, chills, body aches, loose stool.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Vertigo
Clinical narrative: Dizziness, vertigo, lightheadedness, mild headache, nausea, chills, body aches, loose stool.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blood test, Chills, Impaired work ability, Joint swelling
Clinical narrative: The night of the vaccination, while I was sleeping I had very bad rigors. It woke my up and had gelling phenomenon, where my joints were filled and swollen. I called my doctor and referral to a rheumatologist. I could not lift my arm. It was painful. My whole body hurt in my joints and I could not move due to joint swelling in all of my joints, bilaterally with the worse in my shoulders and neck. I also got a large lymph node on my left armpit which was the injection site. My rheumatologist referred to it as gelling phenomenon. Was diagnosis Polymyalgia Rheumatica. I had to get PT and get high dose steroids which I am trying to wean off. When I got to a half a dose, it comes back and I have to take them again. I was out of work for a month. This is affecting my arm strength which is overall arm weakness and hard to work. I still have a lot of joint pain all over and hard getting dressed in the mornings to go to work. I am now on a new medication which takes months to kick in. This is still continuing but the steroids is helping, I just don't need to be on this high of a dose for too long.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of personal independence in daily activities, Lymphadenopathy, Mobility decreased, Muscular weakness, Pain
Clinical narrative: The night of the vaccination, while I was sleeping I had very bad rigors. It woke my up and had gelling phenomenon, where my joints were filled and swollen. I called my doctor and referral to a rheumatologist. I could not lift my arm. It was painful. My whole body hurt in my joints and I could not move due to joint swelling in all of my joints, bilaterally with the worse in my shoulders and neck. I also got a large lymph node on my left armpit which was the injection site. My rheumatologist referred to it as gelling phenomenon. Was diagnosis Polymyalgia Rheumatica. I had to get PT and get high dose steroids which I am trying to wean off. When I got to a half a dose, it comes back and I have to take them again. I was out of work for a month. This is affecting my arm strength which is overall arm weakness and hard to work. I still have a lot of joint pain all over and hard getting dressed in the mornings to go to work. I am now on a new medication which takes months to kick in. This is still continuing but the steroids is helping, I just don't need to be on this high of a dose for too long.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Polymyalgia rheumatica, Sleep disorder, Steroid therapy
Clinical narrative: The night of the vaccination, while I was sleeping I had very bad rigors. It woke my up and had gelling phenomenon, where my joints were filled and swollen. I called my doctor and referral to a rheumatologist. I could not lift my arm. It was painful. My whole body hurt in my joints and I could not move due to joint swelling in all of my joints, bilaterally with the worse in my shoulders and neck. I also got a large lymph node on my left armpit which was the injection site. My rheumatologist referred to it as gelling phenomenon. Was diagnosis Polymyalgia Rheumatica. I had to get PT and get high dose steroids which I am trying to wean off. When I got to a half a dose, it comes back and I have to take them again. I was out of work for a month. This is affecting my arm strength which is overall arm weakness and hard to work. I still have a lot of joint pain all over and hard getting dressed in the mornings to go to work. I am now on a new medication which takes months to kick in. This is still continuing but the steroids is helping, I just don't need to be on this high of a dose for too long.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Vaccinated pt admitted with covid infection
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Vomiting projectile, Weight decreased
Clinical narrative: Took the 1st dose of Pfizer at 10:45am on 3/1. Began projectile vomiting ahoetly after at 12:00pm. Vomiting & diarrhea continued through the fay until 10:00pm. Lost 5 lbs in 9 hours.
Age: 0.75
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Extra dose administered
Clinical narrative: Extra dose given
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation
Clinical narrative: Patient presented to the ED and was subsequently hospitalized for Atrial fibrillation with RVR within 6 weeks of receiving covid vaccination.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: PATIENT RECIEVED SECOND DOSE ON  11/12/2021. BOOSTER DOSE WAS ADMINISTERES ON 02/23/2022 AND THE 5 MONTH PERIOD WAS NOT COMPLETED
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, COVID-19 pneumonia, Hypoxia, Respiratory failure, SARS-CoV-2 test positive
Clinical narrative: Transferred  with respiratory failure to a higher level of care with hypoxia, COVID 19 pneumonia. Covid 19 Positive 3/10/2022 hospital.
Age: 41.0
Sex: U
Vaccine: COVID19
Symptoms: Mechanical urticaria
Clinical narrative: Experienced the onset of dermatographic urticaria around Dec 1, 2022 with no other causes except possibly stress or weight gain .
Age: 3.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Pt was 3 years old at time of administration. No adverse reaction reported. Pt is too young to receive vaccine, but was administered.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature increased, Chills, Condition aggravated, Dysgeusia
Clinical narrative: Metallic taste in mouth, left hand numbness, left arm swelling from shoulder to below elbow, fever to arm, muscle pain in (shoulder blade, shoulder joint, up neck to base of skull, entire left arm, armpit), baseball size knot to arm for 1 week, severe left shoulder pain for 1 month and unable to have full ROM of left arm, fever to left arm, cold hard chills, 103°temperature off and on for 3 days, severe headache for 4-5 days, fatigue, body aches, abnormal periods
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling cold, Headache, Hypoaesthesia, Injection site swelling
Clinical narrative: Metallic taste in mouth, left hand numbness, left arm swelling from shoulder to below elbow, fever to arm, muscle pain in (shoulder blade, shoulder joint, up neck to base of skull, entire left arm, armpit), baseball size knot to arm for 1 week, severe left shoulder pain for 1 month and unable to have full ROM of left arm, fever to left arm, cold hard chills, 103°temperature off and on for 3 days, severe headache for 4-5 days, fatigue, body aches, abnormal periods
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Joint range of motion decreased, Menstruation irregular, Myalgia, Nodule, Pain
Clinical narrative: Metallic taste in mouth, left hand numbness, left arm swelling from shoulder to below elbow, fever to arm, muscle pain in (shoulder blade, shoulder joint, up neck to base of skull, entire left arm, armpit), baseball size knot to arm for 1 week, severe left shoulder pain for 1 month and unable to have full ROM of left arm, fever to left arm, cold hard chills, 103°temperature off and on for 3 days, severe headache for 4-5 days, fatigue, body aches, abnormal periods
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Skin warm
Clinical narrative: Metallic taste in mouth, left hand numbness, left arm swelling from shoulder to below elbow, fever to arm, muscle pain in (shoulder blade, shoulder joint, up neck to base of skull, entire left arm, armpit), baseball size knot to arm for 1 week, severe left shoulder pain for 1 month and unable to have full ROM of left arm, fever to left arm, cold hard chills, 103°temperature off and on for 3 days, severe headache for 4-5 days, fatigue, body aches, abnormal periods
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Vaccine breakthrough infection
Clinical narrative: Breakthrough COVID case.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Arrhythmia, Arthralgia, Dysphagia, Extrasystoles, Eye pain
Clinical narrative: Immediately as injection being administered felt burning form injection site to elbow.  4hours later had swollen lymph nodes to neck bilaterally and under jaw, unable to swallow. Temp 99.9 every joint in body aches.  8hours later had increased heart rate with any exercise( walking up stairs)  Day1 still swollen lymph nodes and now with night sweats Day 2 now with pressure and pain behind Left eye- advised by employee health NP to see Ophthalmologist Day 3 Ophthalmologist was told it was likely secondary to swollen lymph nodes   Day 5 went for thyroid sono - "shotty lymph nodes"  Day 6 petechiae to bottom of feet, lymph node swelling decreased on right and under chin now able to swallow without difficulty Day 11  Bruising noted on tongue and under tongue 4weeks  to the day arrhythmias- bigeminy trigeminy
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Immediate post-injection reaction, Injection site pain, Laboratory test, Lymphadenopathy
Clinical narrative: Immediately as injection being administered felt burning form injection site to elbow.  4hours later had swollen lymph nodes to neck bilaterally and under jaw, unable to swallow. Temp 99.9 every joint in body aches.  8hours later had increased heart rate with any exercise( walking up stairs)  Day1 still swollen lymph nodes and now with night sweats Day 2 now with pressure and pain behind Left eye- advised by employee health NP to see Ophthalmologist Day 3 Ophthalmologist was told it was likely secondary to swollen lymph nodes   Day 5 went for thyroid sono - "shotty lymph nodes"  Day 6 petechiae to bottom of feet, lymph node swelling decreased on right and under chin now able to swallow without difficulty Day 11  Bruising noted on tongue and under tongue 4weeks  to the day arrhythmias- bigeminy trigeminy
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Night sweats, Ocular discomfort, Oral contusion, Petechiae, Ultrasound scan abnormal
Clinical narrative: Immediately as injection being administered felt burning form injection site to elbow.  4hours later had swollen lymph nodes to neck bilaterally and under jaw, unable to swallow. Temp 99.9 every joint in body aches.  8hours later had increased heart rate with any exercise( walking up stairs)  Day1 still swollen lymph nodes and now with night sweats Day 2 now with pressure and pain behind Left eye- advised by employee health NP to see Ophthalmologist Day 3 Ophthalmologist was told it was likely secondary to swollen lymph nodes   Day 5 went for thyroid sono - "shotty lymph nodes"  Day 6 petechiae to bottom of feet, lymph node swelling decreased on right and under chin now able to swallow without difficulty Day 11  Bruising noted on tongue and under tongue 4weeks  to the day arrhythmias- bigeminy trigeminy
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Ocular hyperaemia, Pruritus, Rhinorrhoea, Sensation of foreign body, Tryptase
Clinical narrative: 30yo M with PMH concerning for possible allergy to PEG.  Because of this further evaluation was undergone with SPT to PEG330.  Patient was found to be reactive to 170mg/ml on testing.  Given this and his prior reaction to the bowel prep I discussed with patient that this likely represents a true allergy.  We discussed next steps moving forward such as the risks/benefits of receiving a booster dose of the COVID-19 mRNA vaccine (Pfizer).  After discussion of possible risks of anaphylaxis despite him tolerating 2 doses of the vaccine previously we decided that the benefits outweighed the risks of proceeding with the vaccine.  After receiving the vaccine he remained asymptomatic for the first 15 minutes.  After that he developed a globus sensation in his throat and some subjective itchiness of the hand/scalp.  VS were taken at that time which were normal and no objective symptoms were noted.  About 10 minutes later patient endorses some diffuse pruritus, with objective rhinorrhea and conjunctival erythema.  At that time we administered 0.3mg of epinephrine via EAI into the anterolateral left thigh.  Patient was subsequently given an OAH Zyrtec 10mg.  10 minutes after receiving the epinephrine patient endorsed resolution of the pruritus and conjunctival erythema as well as improvement in the globus sensation. 10 minutes later the globus sensation had completely resolved.  throughout this time lungs remained CTAB with no urticaria noted and stable vital signs throughout.  Patient was observed for an hour after resolution of symptoms and discharged home.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Pain, Pyrexia, Vomiting
Clinical narrative: PRESENTS WITH HA, N/V, FEVER, BODY PAIN FOR 3 DAYS PTA
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Fatigue, Influenza like illness, Mobility decreased
Clinical narrative: It felt like my bones were on fire.  Extreme heat radiating from bones, particularly arms and legs.  Highly fatigued.  Flu like symptoms (hard to lift arms). Rested for 2 days, plenty of fluids while symptoms persisted.
Age: 44.0
Sex: F
Vaccine: COVID19, VARZOS
Symptoms: Flank pain, Injection site pain, Pyrexia
Clinical narrative: Slight fever, pain on site of the injection, pain on my sides
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Convalescent plasma transfusion, Death, General physical health deterioration, Lung infiltration
Clinical narrative: pt presents to ED in respiratory failure; positive COVID test in ED; bilateral pulmonary infiltrates, toxic metabolic encephalopathy, UTI, sepsis; given convalescent plasma and Decadron; pt's condition worsened, needing intubation, pt and family refused intubation; pt's condition deteriorated, poor prognosis and he passed away in the hospital
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Respiratory failure, SARS-CoV-2 test positive, Sepsis, Toxic encephalopathy, Urinary tract infection
Clinical narrative: pt presents to ED in respiratory failure; positive COVID test in ED; bilateral pulmonary infiltrates, toxic metabolic encephalopathy, UTI, sepsis; given convalescent plasma and Decadron; pt's condition worsened, needing intubation, pt and family refused intubation; pt's condition deteriorated, poor prognosis and he passed away in the hospital
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Malaise, Oropharyngeal pain, Pain, SARS-CoV-2 test negative
Clinical narrative: Received Covid 19 Pfizer vaccine booster on 03/18/2022. States she started to have side effects on 03/20/2022 of Sore throat body aches no fever bad headache, she took Tylenol and ibuprofen to help alleviate some of the pain but wasn't able to maintain to have it assist.  Went to ER due to not still feeling well and having this sore throat, and thought she might have contracted Covid. She went and got a test done but came back negative for Covid  and still is having sore throat and feeling sick. She states she had a reaction to the 2nd dose she took last year of respiratory issues and seen a provider . States that she will get another Covid test done because it might have been to early
Age: 81.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Chest pain, Dyspnoea, Influenza A virus test positive, SARS-CoV-2 test positive
Clinical narrative: SOB, TACHYPNEA, CHEST PAIN; FLU A AND COVID POSITIVE
Age: 81.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Tachypnoea
Clinical narrative: SOB, TACHYPNEA, CHEST PAIN; FLU A AND COVID POSITIVE
Age: 76.0
Sex: F
Vaccine: PNC13
Symptoms: Rash, Rash erythematous, Rash papular
Clinical narrative: Red, raised rash to left deltoid that started day after vaccine. Patient was seen in office on 03/17/2022 and prescribed Triamcinolone Acetonide 0/5% External Cream to use to area BID.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Antinuclear antibody negative, Blood thyroid stimulating hormone normal, C-reactive protein increased, Cardiomegaly, Chest X-ray abnormal
Clinical narrative: Chest pain starting 1 week after Moderna booster dose. The quality is a ?pressure? at baseline that becomes more severe and sharp when he lays flat. At baseline it is 3/10. No other associated symptoms. Initial diagnostic evaluation for this issue to included an EKG, CXR, troponin, ESR, CRP, TSH, and a battery of rheumatologic labs and has revealed an enlarged cardiac silhouette on CXR and an elevated CRP. All other studies have been normal. Cardiology visit on 2-19-2022 revealed trace pericardial effusion, which may be a normal benign finding, otherwise normal. EF 65%. The EKG demonstrated sinus tachycardia to 102bpm with diffuse PR segment depression but was otherwise normal. Cardiac physical exam demonstrated a normal S1 and S2 with a friction rub suggestive of pericarditis. Lab abnormalities (elevated CRP), symptoms, exam, and EKG consistent with acute pericarditis in temporal association to Moderna booster dose.