chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: first dose given on 17 Sep 2018; second dose given on 26 Aug 2019; This case was reported by a physician via call center representative and described the occurrence of drug dose administration interval too long in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 17th September 2018).   On 29th August 2019, the patient received the 2nd dose of Shingrix. On 26th August 2019, unknown after receiving Shingrix, 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.    Additional Information: GSK Receipt Date: 05-Oct-2022 Reporter's comment: The physician stated a patient who received the second dose of Shingrix late wanted to repeat the series. No additional doses had been given as of the time of call. The permission was granted for safety to follow up. No additional information provided during the call. The consent to follow-up was granted. Additional Supportive Information: The patient received 2nd dose later than recommended time interval, which led to lengthening of vaccination schedules.
Age: 20.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No Adverse event; Monovalent vaccine for 6-11 years old administered instead of bivalent vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Monovalent vaccine for 6-11 years old administered instead of bivalent vaccine) and NO ADVERSE EVENT (No Adverse event) in a 20-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR6965B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Oct-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 08-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Monovalent vaccine for 6-11 years old administered instead of bivalent vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Monovalent vaccine for 6-11 years old administered instead of bivalent vaccine) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Monovalent vaccine for 6-11 years old administered instead of bivalent vaccine). Concomitant medications details were not reported by the reporter. It was reported that patient received 0.5ml of the dark blue cap vaccine for 6-11 years old instead of the new Bivalent vaccine. Treatment details were not reported by the reporter. This case was linked to US-MODERNATX, INC.-MOD-2022-657506, US-MODERNATX, INC.-MOD-2022-657525, US-MODERNATX, INC.-MOD-2022-657552, US-MODERNATX, INC.-MOD-2022-657555, US-MODERNATX, INC.-MOD-2022-657558, US-MODERNATX, INC.-MOD-2022-657564, US-MODERNATX, INC.-MOD-2022-657565, US-MODERNATX, INC.-MOD-2022-657567, US-MODERNATX, INC.-MOD-2022-657613, US-MODERNATX, INC.-MOD-2022-657621, US-MODERNATX, INC.-MOD-2022-657622, US-MODERNATX, INC.-MOD-2022-657623, US-MODERNATX, INC.-MOD-2022-657629 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-657506: US-MODERNATX, INC.-MOD-2022-657525: US-MODERNATX, INC.-MOD-2022-657552: US-MODERNATX, INC.-MOD-2022-657555: US-MODERNATX, INC.-MOD-2022-657558: US-MODERNATX, INC.-MOD-2022-657564: US-MODERNATX, INC.-MOD-2022-657565: US-MODERNATX, INC.-MOD-2022-657567: US-MODERNATX, INC.-MOD-2022-657621: US-MODERNATX, INC.-MOD-2022-657622: US-MODERNATX, INC.-MOD-2022-657623: US-MODERNATX, INC.-MOD-2022-657629:
Age: 61.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No Adverse event; monovalent vaccine for 6-11 years old administered instead of bivalent vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (monovalent vaccine for 6-11 years old administered instead of bivalent vaccine) and NO ADVERSE EVENT (No Adverse event) in a 61-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR6965B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Oct-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 08-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (monovalent vaccine for 6-11 years old administered instead of bivalent vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (monovalent vaccine for 6-11 years old administered instead of bivalent vaccine) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (monovalent vaccine for 6-11 years old administered instead of bivalent vaccine).    No concomitant medications were reported. No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-657547.; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-657547: US-MODERNATX, INC.-MOD-2022-657560:Same reporter
Age: 3.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; Patient received a bivalent dose as a second dose; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (patient received a bivalent dose as a second dose) and NO ADVERSE EVENT (No adverse event) in a 3-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7166B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Oct-2022, the patient received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 12-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Patient received a bivalent dose as a second dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient received a bivalent dose as a second dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Patient received a bivalent dose as a second dose).    No concomitant medication information was provided. No treatment medication were provided.
Age: 1.0
Sex: F
Vaccine: IPV
Symptoms: Medication error, No adverse event, Poor quality product administered, Product storage error
Clinical narrative: temperature excursion at 16.6C, 8.9C, +9.6C, +8.6C, +12.8C for 1st excursion 6 HOURS and 17 MINUTES, 2nd excursion 23 MINUTES, 3rd excursion 15 MINUTES, 4th excursion 8 MINUTES and 5th excursion 6HOURS and 16 MINUTES with no reported adverse event; received IPOL from a punctured vial after it was exposed to a temperature excursion with no reported adverse event; Initial information received on 07-Oct-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case is linked to case 2022SA418179.  This case involves a 1 years old female patient who experienced received ipol from a punctured vial after it was exposed to a temperature excursion at 16.6 Celsius, 8.9 Celsius, +9.6 Celsius, +8.6 Celsius, +12.8 Celsius for 1st excursion 6 hours and 17 minutes, 2nd excursion 23 minutes, 3rd excursion 15 minutes, 4th excursion 8 minutes and 5th excursion 6hours and 16 minutes with no reported adverse event while receiving vaccine IPV (VERO) [IPOL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the IPV (VERO) was exposed to temperature excursion at 16.6 Celsius, 8.9 Celsius, +9.6 Celsius, +8.6 Celsius, +12.8 Celsius for 1st excursion 6 hours and 17 minutes, 2nd excursion 23 minutes, 3rd excursion 15 minutes, 4th excursion 8 minutes and 5th excursion 6hours and 16 minutes with no reported adverse event (product storage error).  On 28-Sep-2022, the patient received 0.5 mL total dose of suspect IPV (VERO) (lot V1B901M and expiry date: 22-Jun-2024) via unknown route in unknown administration site for prophylactic immunization.  On 28-Sep-2022, (latency: same day) the patient received ipol from a punctured vial after it was exposed to a temperature excursion with no reported adverse event (poor quality product administered) following the administration of IPV (VERO).  Action taken with POLIOMYELITIS VACCINE (INACTIVATED) (IPOL) was not applicable.  At time of reporting, the outcome was Unknown for both the events.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments:  01312611: 01312677: 01312679: 01312681: 01312683: 01312686: 01312658:
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: COVID vaccine breakthrough case. Moderna 2/16/21 010M20A, 3/16/21 032H20A and boosted Pfizer 5/24/22 FK9894
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: COVID vaccine breakthrough case. Pfizer 1/27/21 EL3247, 2/17/21 EM9810, and boosted 9/28/21 EW0169 and 6/10/22 FN2908
Age: 17.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Dizziness, Eye movement disorder, Feeling abnormal, Seizure
Clinical narrative: Patient had seizure shortly after being given 2nd of 2 vaccinations. Pfizer bivalent was given in right deltoid, followed by Fluzone quadrivalent being given in same right deltoid. First reaction was non-descript. When I turned around after placing shot into sharps container, the patient appeared to be stretching with her neck thrown back over the top of the chair. Then I saw her eyes roll back a little bit, then she began convulsing. Mom and eye made eye contact and she asked what was going on. I caught her from falling by the arm which ripped her band aids off. Within 5 to 10 seconds, incident was over. Patient felt off, dizzy, and had no memory of seizure. Paramedics were called, assessed patient in consultation room and felt patient was safe to go home. Patient had no history of seizures.  In the two days post seizure, patient has experienced no setbacks of any kind per her mother.
Age: 27.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (ex. temp./location)-
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Site: Pain at Injection Site-Mild
Age: 88.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium
Age: 73.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Site: Bruising at Injection Site-Medium, Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium
Age: 82.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness
Clinical narrative: Systemic: Dizziness / Lightheadness-Severe
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Limb injury, Paraesthesia
Clinical narrative: Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Burning sensation, Rash
Clinical narrative: Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Additional Details: patient came in 10/10 and said she had rash on right arm--felt some burning--She went home and took a benadryl and said it was getting better and almost resolved.  patient did not call md
Age: 28.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Autoimmune disorder, Guillain-Barre syndrome, Hypoaesthesia, Injection site bruising
Clinical narrative: Site: Bruising at Injection Site-Medium, Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Autoimmune Disease (diagnosed by MD)-Medium, Systemic: Fever-Medium, Systemic: sepsis, guillen barr-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Systemic: Weakness-Medium, Additional Details: lower etremeties weakness
Age: 28.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Muscular weakness
Clinical narrative: Site: Bruising at Injection Site-Medium, Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Autoimmune Disease (diagnosed by MD)-Medium, Systemic: Fever-Medium, Systemic: sepsis, guillen barr-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Systemic: Weakness-Medium, Additional Details: lower etremeties weakness
Age: 28.0
Sex: F
Vaccine: PPV
Symptoms: Paraesthesia, Pyrexia, Sepsis
Clinical narrative: Site: Bruising at Injection Site-Medium, Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Autoimmune Disease (diagnosed by MD)-Medium, Systemic: Fever-Medium, Systemic: sepsis, guillen barr-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Systemic: Weakness-Medium, Additional Details: lower etremeties weakness
Age: 74.0
Sex: F
Vaccine: COVID19-2
Symptoms: Back pain, Dyspnoea, Fatigue, Hypersensitivity, Lethargy
Clinical narrative: Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Tremors and back pain-Medium, Systemic: Shakiness-Medium, Systemic: Tachycardia-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: emergency and EMS were called, patient left the pharmacy with them. Initially she was fine after the vaccination, but came back a few minutes later complaining of severe back pain and difficulty breathing. She developed tremors a couple of minutes later.
Age: 74.0
Sex: F
Vaccine: COVID19-2
Symptoms: Paraesthesia, Tachycardia, Tremor
Clinical narrative: Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Tremors and back pain-Medium, Systemic: Shakiness-Medium, Systemic: Tachycardia-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: emergency and EMS were called, patient left the pharmacy with them. Initially she was fine after the vaccination, but came back a few minutes later complaining of severe back pain and difficulty breathing. She developed tremors a couple of minutes later.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure systolic increased, Hypertension, Pain in extremity
Clinical narrative: Systemic: Hypertension-Medium, Additional Details: PT REPORTED SORE ARM THE DAY AFTER BUT IT SUBSIDED A DAY AFTER. SHE DID NOT FEEL ANYTHING DIFFERENT UNTIL A CHECK UP IN JAN 2021 REVEALED HIGH SYSTOLIC BP OF 220. SHE REPORTED THAT PRIOR TO VACCINATION, SHE NEVER HAVE ANY CARDIAC OR BLOOD PRESSURE ISSUE. NOW HER BP IS MANAGED WITH ORAL ANTIHYPERTENSIVE
Age: 68.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild
Age: 81.0
Sex: F
Vaccine: COVID19-2
Symptoms: Dizziness
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium
Age: 66.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site erythema, Injection site pain, Needle issue
Clinical narrative: Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Error: Wrong Needle Length-
Age: 50.0
Sex: M
Vaccine: COVID19-2
Symptoms: Chest discomfort, Chills, Discomfort, Dyspnoea, Hot flush
Clinical narrative: Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Chills-Mild, Systemic: Flushed / Sweating-Mild
Age: 50.0
Sex: M
Vaccine: COVID19-2
Symptoms: Hyperhidrosis, Pain
Clinical narrative: Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Chills-Mild, Systemic: Flushed / Sweating-Mild
Age: 61.0
Sex: F
Vaccine: COVID19-2
Symptoms: Aneurysm, Angiogram cerebral abnormal, Cerebral endovascular aneurysm repair, Computerised tomogram head abnormal, International normalised ratio normal
Clinical narrative: aneurysmal subarachnoid hemorrhage 10/10/22, presented to hospital 10/12/22 IR stent assisted embolization of aneurysm 10/13/22 vasopressors required 10/14/22 for symptomatic vasospasm
Age: 61.0
Sex: F
Vaccine: COVID19-2
Symptoms: Platelet count normal, Subarachnoid haemorrhage, Vasospasm
Clinical narrative: aneurysmal subarachnoid hemorrhage 10/10/22, presented to hospital 10/12/22 IR stent assisted embolization of aneurysm 10/13/22 vasopressors required 10/14/22 for symptomatic vasospasm
Age: 45.0
Sex: F
Vaccine: COVID19-2
Symptoms: Anaphylactic reaction, Dysphagia, Dyspnoea, Injection site bruising, Injection site erythema
Clinical narrative: Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Anaphylaxis-Mild, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Additional Details: pt was given bivalent as a primary series.... 1st dose as this pharmacy dc-ed all the monovalent. pt has no complaints. pt was advised to wait for 4 weeks to get the monovalent as primary series.  pt will see the primary doctor to discuss getting monovalent series
Age: 45.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling, Throat tightness
Clinical narrative: Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Anaphylaxis-Mild, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Additional Details: pt was given bivalent as a primary series.... 1st dose as this pharmacy dc-ed all the monovalent. pt has no complaints. pt was advised to wait for 4 weeks to get the monovalent as primary series.  pt will see the primary doctor to discuss getting monovalent series
Age: 50.0
Sex: M
Vaccine: COVID19-2
Symptoms: Conjunctivitis, Herpes zoster, Ophthalmic herpes zoster
Clinical narrative: Left herpes zoster with herpes zoster ophthalmicus conjunctivitis. Currently in treatment with valacyclovir 1 gm TID x 14 days
Age: 12.0
Sex: F
Vaccine: COVID19-2
Symptoms: Dizziness postural, Electrocardiogram normal, Laboratory test normal, Pallor, Vertigo
Clinical narrative: Teacher noticed they looked pale. Patient felt dizzy upon trying to stand, felt like the world was spinning. Teacher had to catch them. Patient was really upset. Had heart rates from 90s to 120s.
Age: 72.0
Sex: F
Vaccine: COVID19-2
Symptoms: Arthralgia, Back pain, Bone pain, Injection site pain
Clinical narrative: Site: Pain at Injection Site-Severe, Systemic: Joint Pain-Severe, Additional Details: severe pain in shoulder area, clavicle, back. Hx of tendonitis.
Age: 37.0
Sex: F
Vaccine: FLUC4
Symptoms: Dizziness, Flushing, Hyperhidrosis, Paraesthesia, Visual impairment
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Visual Changes/Disturbances-Mild, Additional Details: tingling of arms/hands
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Granuloma annulare, Rash
Clinical narrative: Granuloma Annulare
Age: 90.0
Sex: F
Vaccine: FLUA4
Symptoms: Dizziness, Headache, Ocular hyperaemia
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: headache, and red eye also-Medium
Age: 18.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (ex. temp./location)-
Age: 41.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (ex. temp./location)-
Age: 79.0
Sex: F
Vaccine: COVID19-2
Symptoms: Arthralgia, Injection site pain
Clinical narrative: Site: Pain at Injection Site-Medium, Additional Details: patient reported having sore shoulder up to neck 5 minutes after getting vaccine. at 15 minutes she stated nothing was worse or better. no signs of allergic reaction.
Age: 47.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (ex. temp./location)-
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Balance disorder, Blood test, Dizziness, Influenza like illness, Mobility decreased
Clinical narrative: I began to feel flu like symptoms and then I got very dizzy and had to lay down for 24 hours.  I felt dizzy for day later and on Monday 22nd at about 9 pm into Tuesday 23rd at about 5pm I was in bed with another dizzy spell.  Then again days later I got another dizzy spell and was in bed for about 14 hours.  My equilibriumwas off for about 2 months.  Every day I felt some type of dizzy spell.
Age: 77.0
Sex: M
Vaccine: COVID19-2
Symptoms: Wrong product administered
Clinical narrative: Error: Wrong Vaccine/Product Administered-
Age: 18.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: My nurse gave the Bivalent Booster believing the patient had the primary series already but this ended up to not be the case.  No side effects reported.
Age: 14.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (ex. temp./location)-
Age: 54.0
Sex: F
Vaccine: COVID19-2, FLUC4
Symptoms: Blood test normal, Computerised tomogram normal, Electrocardiogram normal, Vertigo
Clinical narrative: Severe Vertigo - the room is spinning with even the slightest movement of my head
Age: 89.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Moderna 2/12/21, 3/12/21, 11/5/21. Positive on 10/13/22
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Site: Redness at Injection Site-Mild
Age: 65.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Deafness unilateral, Malaise, Tinnitus
Clinical narrative: Hearing lost in right ear causing a tinny sounding echo.  Contracted Covid 19 with symptoms presenting on 10/9/22.  Sudden constant ringing in right ear began on  10/11/2022 (at least it masks the tinny echo)
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Diarrhoea, Dizziness, Fatigue, Nausea
Clinical narrative: Pt. reported dizziness, joint pain, fatigue, N/V/D after second dose of Shingrix received at pharmacy.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: Pt. reported dizziness, joint pain, fatigue, N/V/D after second dose of Shingrix received at pharmacy.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Pfizer 4/9/21, 5/7/21, 10/7/21, 9/15/22. Positive on 10/13/22
Age: 69.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (ex. temp./location)-
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Janssen 3/5/21, 12/17/21. Positive on 10/13/22
Age: 19.0
Sex: F
Vaccine: FLUC4
Symptoms: Dizziness
Clinical narrative: Systemic: Dizziness / Lightheadness-Severe, Additional Details: The patient felt lightheaded after receiving the vaccine but she did not faint. EMS was called and evaluated the patient and she seemed fine. The patient's mother arrived and drove her home.
Age: 5.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (ex. temp./location)-
Age: 51.0
Sex: M
Vaccine: COVID19-2
Symptoms: Abdominal pain, Chills, Diarrhoea, Nausea
Clinical narrative: Systemic: Abdominal Pain-Severe, Systemic: Chills-Medium, Systemic: Diarrhea-Severe, Systemic: Nausea-Severe
Age: 40.0
Sex: F
Vaccine: COVID19-2
Symptoms: Back pain, Pain
Clinical narrative: Systemic: Body Aches Generalized-Severe, Systemic: severe back pain-Severe, Additional Details: previous series was moderna with no adverse events
Age: 26.0
Sex: M
Vaccine: UNK
Symptoms: Injection site irritation, Respiration abnormal, Skin irritation, Syncope, Vomiting
Clinical narrative: I had two shots the flu and the bivalent COVID. My reactions were fainting, vomiting, hard breathing, skin irritation at site and all over body. I had this for days after
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Insomnia, Nausea, Vomiting
Clinical narrative: Chills, no sleep, nausea (threw up several times).
Age: 28.0
Sex: M
Vaccine: COVID19-2
Symptoms: Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Mild, Additional Details: He was receiving two vaccine one for flu and other for bivalent covid pfizer vaccine. He got flu shot first and then when I administer the covid pfizer bivalent shot on other arm upon administration he fainted to the floor and was unresponsive for like 15 seconds
Age: 89.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: COVID vaccine breakthrough case. Pfizer 3/17/21 ER2613, 4/7/21 EW0158 and boosted 11/17/21 JT1620
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Recalled product administered
Clinical narrative: reporting because Pfizer is recalling this lot  of Covid IMZ. for  short dating.  Expiration date was supposed to be  10/21/2022 but we received notification that it expired on 9/30/2022.  So, this IMZ was given after that
Age: 11.0
Sex: M
Vaccine: FLU4, HPV9, MNQ
Symptoms: Loss of personal independence in daily activities, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: Patient with significant swelling to right arm also is itchy, and warm to touch. Symptoms started on 10/13 while at school, he was sent home early. Patient seen in the office same afternoon, no n/v/d/ no SOB. No fevers. Patient was able to move arm well. No rash or reaction anywhere else on body.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient was given first dose of Covid Pfizer vaccine 21 days past the beyond use date. Pfizer was contacted about it. Patient was contacted. Patient report no side effects following  administration.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Blood iron decreased, Blood test abnormal, Borrelia test, Epstein-Barr virus test, Fatigue
Clinical narrative: Starting in May I started experiencing compete exhaustion. I would sleep with my sleep apnea machine and get a good night's sleep wake up and within two hours be ready to take a nap. I have started to experience extreme hot flashes that not related menopause as I had a hysterectomy years ago. My doctors have run blood work to test for iron deficiency, I had a blood transfusion as my iron was extremely low. They were checking make sure I did not have internal bleeding. The doctors are still trying to find what is causing my exhaustion.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Full blood count, Hot flush, Positive airway pressure therapy, Transfusion
Clinical narrative: Starting in May I started experiencing compete exhaustion. I would sleep with my sleep apnea machine and get a good night's sleep wake up and within two hours be ready to take a nap. I have started to experience extreme hot flashes that not related menopause as I had a hysterectomy years ago. My doctors have run blood work to test for iron deficiency, I had a blood transfusion as my iron was extremely low. They were checking make sure I did not have internal bleeding. The doctors are still trying to find what is causing my exhaustion.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Anticoagulant therapy, Blood creatinine increased, Blood pressure increased, Bradycardia, Bronchitis
Clinical narrative: Comes to ED with complaint of a shortness of breath that started 2 weeks ago.  She has been having a nonproductive cough for the last 1 week.  The patient denies any fever, chills, nausea, vomiting, chest pain or diaphoresis.  The shortness of breath is aggravated by any physical activity.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: C-reactive protein increased, Chest X-ray normal, Computerised tomogram abdomen abnormal, Computerised tomogram thorax abnormal, Condition aggravated
Clinical narrative: Comes to ED with complaint of a shortness of breath that started 2 weeks ago.  She has been having a nonproductive cough for the last 1 week.  The patient denies any fever, chills, nausea, vomiting, chest pain or diaphoresis.  The shortness of breath is aggravated by any physical activity.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Diarrhoea, Dyspnoea, Dyspnoea exertional, Eosinophilia, Exposure to SARS-CoV-2
Clinical narrative: Comes to ED with complaint of a shortness of breath that started 2 weeks ago.  She has been having a nonproductive cough for the last 1 week.  The patient denies any fever, chills, nausea, vomiting, chest pain or diaphoresis.  The shortness of breath is aggravated by any physical activity.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Fibrin D dimer increased, Hepatic lesion, Oropharyngeal pain, Productive cough, Sputum discoloured
Clinical narrative: Comes to ED with complaint of a shortness of breath that started 2 weeks ago.  She has been having a nonproductive cough for the last 1 week.  The patient denies any fever, chills, nausea, vomiting, chest pain or diaphoresis.  The shortness of breath is aggravated by any physical activity.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Ultrasound Doppler normal, Ventilation/perfusion scan normal, Wheezing
Clinical narrative: Comes to ED with complaint of a shortness of breath that started 2 weeks ago.  She has been having a nonproductive cough for the last 1 week.  The patient denies any fever, chills, nausea, vomiting, chest pain or diaphoresis.  The shortness of breath is aggravated by any physical activity.
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Death, SARS-CoV-2 test positive
Clinical narrative: Death on 10/08/2022
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient was given Covid vaccine 28 days after the beyond use date. Patient reports no side effects to vaccine administration. Pfizer has been notified. Patient has been notified.
Age: 39.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pruritus
Clinical narrative: Pt was instructed to wait for observation for 30 minutes by vaccinator due to multiple drug, peanut allergies and history of hives, swelling from previous vaccines.  Pt refused to wait, stated she was going back to her office to work, patient was educated to return if she began to experience any side effects.  Pt returned at 340pm c/o itching (no hives were visible, no respiratory distress noted) patient was assessed and given 1 Benadryl 25 mg tablet PO.  Immediate Supervisor was informed via phone.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: chronic arm pain in both arms
Age: 39.0
Sex: F
Vaccine: COVID19-2
Symptoms: Alopecia, Thyroid function test normal
Clinical narrative: Hair falling out in clumps
Age: 69.0
Sex: F
Vaccine: COVID19-2
Symptoms: Extra dose administered
Clinical narrative: Patient presented to primary care clinic for routine follow up and requested COVID bivalent booster.  Denied having had a booster within the last year.  Patient completed vaccine registration form and vaccination was administered.  Admin staff proceeded to log vaccine and noted that a Pfizer bivalent booster vaccination was already logged as being administered on 9/27/2022 at an outside facility.  A staff member here called patient to discuss this and patient adamantly denied having had a booster prior to this date.  Our office contacted the outside facility listed as the vaccinator and they confirmed there was supporting documentation showing she was vaccinated on 9/27/2022 at their facility.
Age: 1.58
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Diarrhea for 3 weeks, 4 times a day,  blowouts, very watery
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Fatigue, Laboratory test abnormal, Renal failure, Urine analysis
Clinical narrative: I would go in for lab work and they would do a urinalysis. I am prone to kidney infections. I was going into kidney doctor. I can't say that I noticed anything different. I just felt really tired. My lab work in September reflected that I was in kidney failure. He advised that he would keep monitoring me to see if it would resolve itself. I have had a Urinalysis since then and I had an elevated WBC but otherwise everything. I have another one scheduled for November.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: White blood cells urine positive
Clinical narrative: I would go in for lab work and they would do a urinalysis. I am prone to kidney infections. I was going into kidney doctor. I can't say that I noticed anything different. I just felt really tired. My lab work in September reflected that I was in kidney failure. He advised that he would keep monitoring me to see if it would resolve itself. I have had a Urinalysis since then and I had an elevated WBC but otherwise everything. I have another one scheduled for November.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Oropharyngeal pain, Respiratory tract congestion, SARS-CoV-2 test positive
Clinical narrative: developed sx of sore throat and congestion- tested positive on rapid test 10/14/22
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: Patient presented to clinic for Pfizer booster with vaccination record.  Registration team followed CDC's recommendations for vaccination follow-up out of vaccine schedule.  Due to different spelling of Sinovac on the record, registration team made recommendation to receive Pfizer monovalent to complete primary series, when in fact patient was eligible for pfizer bivalent booster, which they came requesting that day.  Medical provider (myself) was consulted after vaccination was administered and determination was made that wrong vaccination was administered.  Patient was still in office and I spoke with them in detail, utilizing interpreter service.  Opportunity was given to ask questions and explained to patient that they may choose to receieve bivalent booster after 2 months, per CDC's errors and deviations guidelines.
Age: 96.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccine breakthrough infection
Clinical narrative: COVID breakthrough
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient presented to clinic for Pfizer booster with vaccination record.  Registration team followed CDC's recommendations for vaccination follow-up out of vaccine schedule.  Due to different spelling of Sinovac on the record, registration team made recommendation to receive Pfizer monovalent to complete primary series, when in fact patient was eligible for pfizer bivalent booster, which they came requesting that day.  Medical provider (myself) was consulted after vaccination was administered and determination was made that wrong vaccination was administered.  Patient was still in office and I spoke with them in detail, utilizing interpreter service.  Opportunity was given to ask questions and explained to patient that they may choose to receieve bivalent booster after 2 months, per CDC's errors and deviations guidelines.
Age: 88.0
Sex: F
Vaccine: COVID19-2
Symptoms: Imaging procedure abnormal, Movement disorder, Spinal compression fracture
Clinical narrative: Per patients daughter-the morning  following the administration of vaccine she was unable to move her right leg. She was transported to the emergency room. Imaging per the daughter noted that she had a relatively new compression fracture of her back that they felt might have contributed to her not being able to move her leg.
Age: 81.0
Sex: F
Vaccine: COVID19-2
Symptoms: Extra dose administered, Interchange of vaccine products
Clinical narrative: PATIENT RECEIVED A SECOND DOSE OF BI-VALENT VACCINE.  FIRST BI-VALENT VACCINE (PFIZER LOT GH9694) WAS GIVEN ON 9/14/22.  MODERNA BI-VALENT VACCINE WAS THEN GIVEN ON 10-12-22 (MODERNA LOT AS7144B)
Age: 69.0
Sex: F
Vaccine: COVID19-2
Symptoms: Extra dose administered, Interchange of vaccine products
Clinical narrative: PATIENT RECEIVED A SECOND DOSE OF BI-VALENT VACCINE.  FIRST BI-VALENT VACCINE (PFIZER LOT GH9694) WAS GIVEN ON 9/14/22.  MODERNA BI-VALENT VACCINE WAS THEN GIVEN ON 10-12-22 (MODERNA LOT AS7144B)
Age: 85.0
Sex: F
Vaccine: COVID19-2
Symptoms: Extra dose administered, Interchange of vaccine products
Clinical narrative: PATIENT RECEIVED A SECOND DOSE OF BI-VALENT VACCINE.  FIRST BI-VALENT VACCINE (PFIZER LOT GH9694) WAS GIVEN ON 9/14/22.  MODERNA BI-VALENT VACCINE WAS THEN GIVEN ON 10-12-22 (MODERNA LOT AS7144B)
Age: 9.0
Sex: F
Vaccine: FLU4, FLUC4
Symptoms: Extra dose administered
Clinical narrative: patient received 2 flu vaccines in one day 1st shot was at pcp office 2nd shot was later that morning at the elementary school during flu clinic child not reporting any issues family notified pcp notified
Age: 57.0
Sex: M
Vaccine: COVID19-2, FLU4
Symptoms: Blood pressure increased, Hyperhidrosis, Hypertension, Malaise, Nervousness
Clinical narrative: pt didn't feel well after vaccines given. nervous, sweaty, had high blood pressure. was monitored for 20 minutes, water given. no medication intervention necessary.
Sex: M
Vaccine: DTAP, FLUC4, HIBV
Symptoms: Infant irritability, Injection site erythema, Injection site swelling
Clinical narrative: Large, raised, red area on leg where DTap was given measuring 4" x 2". Mother noticed about 5 hours after vaccines were given. Slept well, eating and drinking well but fussy. RTC or ER if fussiness does not improve with Ibuprofen and cool compressor or worsing symptoms.
Age: 62.0
Sex: F
Vaccine: COVID19-2, FLUX
Symptoms: Blood test, Borrelia test, Hypersensitivity, Injection site discolouration, Intensive care
Clinical narrative: I got home from the vaccine and within about a half an hour was extremely sleepy. I woke up around 9PM and my tongue, face and neck were swollen on my right side as well as the lymph nodes under my right armpits so I went to the hospital. After being in the hospital 3 days I noticed the area around the injection site was white. Once I was discharged, I continued to have allergic reactions of swelling and itching. It happened under my arms and on my thighs. It was extreme swelling like I had a baseball under my arm. Also on my feet, it looked like I had pads on the balls of my feet. They were sometimes hot to touch as well. It continued for about 2 and a half weeks. The last thing I remember having was itchy rashes. Then I woke up and my tongue again was really big and my throat was close to closing. I came back to the hospital and am currently in ICU. It took the doctors a long time to get the swelling down. More doctors are being called in to see why it happened again and was worse than the first event. I hope to be discharged today. I am just waiting to hear my blood work results.
Age: 62.0
Sex: F
Vaccine: COVID19-2, FLUX
Symptoms: Lymphadenopathy, Peripheral swelling, Pruritus, Rash pruritic, SARS-CoV-2 test
Clinical narrative: I got home from the vaccine and within about a half an hour was extremely sleepy. I woke up around 9PM and my tongue, face and neck were swollen on my right side as well as the lymph nodes under my right armpits so I went to the hospital. After being in the hospital 3 days I noticed the area around the injection site was white. Once I was discharged, I continued to have allergic reactions of swelling and itching. It happened under my arms and on my thighs. It was extreme swelling like I had a baseball under my arm. Also on my feet, it looked like I had pads on the balls of my feet. They were sometimes hot to touch as well. It continued for about 2 and a half weeks. The last thing I remember having was itchy rashes. Then I woke up and my tongue again was really big and my throat was close to closing. I came back to the hospital and am currently in ICU. It took the doctors a long time to get the swelling down. More doctors are being called in to see why it happened again and was worse than the first event. I hope to be discharged today. I am just waiting to hear my blood work results.
Age: 62.0
Sex: F
Vaccine: COVID19-2, FLUX
Symptoms: Skin warm, Somnolence, Staphylococcus test, Swelling, Swelling face
Clinical narrative: I got home from the vaccine and within about a half an hour was extremely sleepy. I woke up around 9PM and my tongue, face and neck were swollen on my right side as well as the lymph nodes under my right armpits so I went to the hospital. After being in the hospital 3 days I noticed the area around the injection site was white. Once I was discharged, I continued to have allergic reactions of swelling and itching. It happened under my arms and on my thighs. It was extreme swelling like I had a baseball under my arm. Also on my feet, it looked like I had pads on the balls of my feet. They were sometimes hot to touch as well. It continued for about 2 and a half weeks. The last thing I remember having was itchy rashes. Then I woke up and my tongue again was really big and my throat was close to closing. I came back to the hospital and am currently in ICU. It took the doctors a long time to get the swelling down. More doctors are being called in to see why it happened again and was worse than the first event. I hope to be discharged today. I am just waiting to hear my blood work results.
Age: 62.0
Sex: F
Vaccine: COVID19-2, FLUX
Symptoms: Swollen tongue, Throat tightness
Clinical narrative: I got home from the vaccine and within about a half an hour was extremely sleepy. I woke up around 9PM and my tongue, face and neck were swollen on my right side as well as the lymph nodes under my right armpits so I went to the hospital. After being in the hospital 3 days I noticed the area around the injection site was white. Once I was discharged, I continued to have allergic reactions of swelling and itching. It happened under my arms and on my thighs. It was extreme swelling like I had a baseball under my arm. Also on my feet, it looked like I had pads on the balls of my feet. They were sometimes hot to touch as well. It continued for about 2 and a half weeks. The last thing I remember having was itchy rashes. Then I woke up and my tongue again was really big and my throat was close to closing. I came back to the hospital and am currently in ICU. It took the doctors a long time to get the swelling down. More doctors are being called in to see why it happened again and was worse than the first event. I hope to be discharged today. I am just waiting to hear my blood work results.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chest tube insertion, Chills, Cough, Death
Clinical narrative: pt had a positive COVID test on 10/10/21 at Facility; pt also received the antibody infusion; pt to hospital with increasing SOB, fever, chills, non-productive cough; given IV steroids and ABX; required intubation; pneumothorax that required chest tube; pt on high ventilator settings; poor prognosis; status changed to DNR; pt showed no improvement; family chose to remove life support and focus on comfort; extubated and pt passed away in the hospital
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Endotracheal intubation, Mechanical ventilation, Pneumothorax, Pyrexia
Clinical narrative: pt had a positive COVID test on 10/10/21 at Facility; pt also received the antibody infusion; pt to hospital with increasing SOB, fever, chills, non-productive cough; given IV steroids and ABX; required intubation; pneumothorax that required chest tube; pt on high ventilator settings; poor prognosis; status changed to DNR; pt showed no improvement; family chose to remove life support and focus on comfort; extubated and pt passed away in the hospital
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: pt had a positive COVID test on 10/10/21 at Facility; pt also received the antibody infusion; pt to hospital with increasing SOB, fever, chills, non-productive cough; given IV steroids and ABX; required intubation; pneumothorax that required chest tube; pt on high ventilator settings; poor prognosis; status changed to DNR; pt showed no improvement; family chose to remove life support and focus on comfort; extubated and pt passed away in the hospital
Age: 34.0
Sex: M
Vaccine: ANTH
Symptoms: Expired product administered
Clinical narrative: anthrax given past expiration date
Age: 81.0
Sex: F
Vaccine: COVID19-2
Symptoms: Ear pain, Headache, Injection site reaction, Limb discomfort, Nausea
Clinical narrative: She got her vaccine, the only original sensation was the vaccine site.  Then as the day went on she got a headache.  Then at night she was in a lot of pain head to toe.  She could not sleep, her legs had a terrible sensation.  Her right leg had a knee replacement about 5 years ago, and that leg throughout the night felt like it was going to explode.  Her left leg has also had surgery, and that also was in a lot of pain.  She took Tylenol for her pain which helped minimally.  Her teeth started to hurt and she had pain in her ears as well.  The following morning which would be 24 hours later the vaccine she got very nauseous, started vomiting, and she had a throbbing belly, could see it moving up and down.  The pain was a major issue for her.  Throughout the day yesterday the symptoms and pain eased off.  Today, she is almost normal, still has a headache, but all the other pain seems to have subsided.  She did not call her doctor, she did call the pharmacist and asked if she should call the FDA and they told her yes.  She called them and they gave her VAERS phone #.   The pulsations in her stomach did go away within a minute or two.