chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: This was after receiving the Moderna Booster:   Chest pain (feeling of constant tightness, lasted approx 24 hours), increased heart rate (between 89 - 125), shortness of breath, reduced oxygen level (between 88-93), extensive joint pain where it hurt to walk, muscles aches, headache, tiredness, severe chills and could not get warm (house was 75/76 degrees and I had on full pj's, furry robe and blanket and couldn't get warm)
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: Administration of a third dose of Shingrix; This case was reported by a consumer via interactive digital media and described the occurrence of extra dose administered in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 3rd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional information was provided as follows: The age at vaccination was not reported. The patient received 3rd dose of Shingrix which led to extra dose administered.
Sex: U
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Burning sensation, Extra dose administered, Herpes zoster, Pain, Pruritus
Clinical narrative: had the third vaccine and got shingles/suspected vaccination failure; shingles; worse burning; itchy; Pain; had the third vaccine; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis and Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine, the 2nd dose of Shingles vaccine and the 3rd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, burning sensation, pruritus, pain and extra dose administered.On an unknown date, the outcome of the vaccination failure, shingles, burning sensation, pruritus, pain and extra dose administered were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, burning sensation, pruritus and pain to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine.   Additional details were reported as follows: This case was reported by the patient for herself/himself. The age at vaccination was not reported. The patient had the 3rd Shingles vaccine, which led to extra dose administered and he/she got shingles and had worse burning itchy pain. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure, since the details regarding the time to onset and laboratory confirmation for shingles were not provided.
Sex: U
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Vaccination failure
Clinical narrative: had the third vaccine and got shingles/suspected vaccination failure; shingles; worse burning; itchy; Pain; had the third vaccine; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis and Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine, the 2nd dose of Shingles vaccine and the 3rd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, burning sensation, pruritus, pain and extra dose administered.On an unknown date, the outcome of the vaccination failure, shingles, burning sensation, pruritus, pain and extra dose administered were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, burning sensation, pruritus and pain to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine.   Additional details were reported as follows: This case was reported by the patient for herself/himself. The age at vaccination was not reported. The patient had the 3rd Shingles vaccine, which led to extra dose administered and he/she got shingles and had worse burning itchy pain. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure, since the details regarding the time to onset and laboratory confirmation for shingles were not provided.
Sex: F
Vaccine: VARZOS
Symptoms: Death, Pain
Clinical narrative: After being vaccinated, was dead within 10 weeks; Pain was so bad; This case was reported by a consumer via social media interactive digital media and described the occurrence of death in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included neurological disorder nos and shingles.   On an unknown date, the patient received Shingles vaccine. On an unknown date, less than 3 months after receiving Shingles vaccine, the patient experienced death (serious criteria death and GSK medically significant) and pain. The patient was treated with analgesic, nos (Painkiller) and opioids {nos} (Opioids). On an unknown date, the outcome of the death was fatal and the outcome of the pain was unknown. The reported cause of death was death.   It was unknown if the reporter considered the death and pain to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by the patient's son/daughter. The age at vaccination was not reported. The reporter stated that the patient had nerve disorder and then got shingles. After being vaccinated with Shingles vaccine the pain was so bad the patient needed pain intervention from a doctor who came to her at home and the reporter stated imagine pain that bad. The reporter stated that no amount of painkiller eased patient's pain, opioids too. The patient was dead within 10 weeks. The follow up would not possible as no contact information was available; Reported Cause(s) of Death: was dead within 10 weeks
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Pyrexia, Restlessness
Clinical narrative: fever; restlessness; chills; This case was reported by a consumer via call center representative and described the occurrence of fever in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced fever, restlessness and chills. On an unknown date, the outcome of the fever, restlessness and chills were recovered/resolved.   It was unknown if the reporter considered the fever, restlessness and chills to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient's wife. The age at vaccination was not reported. The reporter stated that her husband had the Shingrix vaccine about two years ago.  He experienced fever, chills, and restlessness for about a day and a half afterwards.   The reporter was referred to health care professional.  The reporter did not consent to followup.
Sex: U
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: missed the second dose of Twinrix at appropriate time; This case was reported by a pharmacist  and described the occurrence of drug dose administration interval too long in a patient who received HAB (Twinrix) (batch number 3PP42, expiry date 16th March 2022) 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 of Twinrix on an unknown date in February 2020).   On 16th November 2021, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 16th November 2021, 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 pharmacist reported that, the patient received 1st dose and missed second dose of Twinrix at appropriate time. The patient received the dose but later than recommended interval, which led to lengthening of vaccine schedule. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Inappropriate schedule of product administration, Social problem
Clinical narrative: Shingles after first dose; blister on ear; did not receive second dose due to COVID pandemic; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 83-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (Family History).   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shingles, blister and social problem. On an unknown date, the outcome of the shingles, blister and social problem were unknown.   It was unknown if the reporter considered the shingles and blister to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient herself. The age at vaccination was not reported for 1st dose and it was not applicable for 2nd dose. The patient received first dose of Shingrix vaccine over 18 months ago, possibly 2 years ago.  She stated she did not go back to receive her second dose due to the COVID pandemic. She mentioned she had a family history of shingles, and she also had shingles (her physician thought it was shingles; blister was on her ear) but did not recall if this occurred before or after her first dose of Shinhgrix. She did not have further information about her first dose. The reporter consented to follow up.
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Poor quality product administered
Clinical narrative: This spontaneous report received from a physician concerned an adult female.The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855194, expiry: 09-APR-2022) dose was not reported, administered on 19-NOV-2021 for prophylactic vaccination. No concomitant medications were reported.On 19-NOV-2021, the patient experienced janssen covid 19 vaccine administered after 1 hour past 6 hours expiration, and off label use.The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the janssen covid 19 vaccine administered after 1 hour past 6 hours expiration and off label use was not reported.This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: VACCINE TEMPERATURE DROPPED TO 1.4C; TEMPERATURE EXCURSION AND VACCINE GIVEN TO FIVE PATIENTS; This spontaneous report received from a health care professional concerned multiple patients.No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 213b21a and expiry: UNKNOWN) dose was not reported, administered on 19-NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On 19-NOV-2021, the patient experienced temperature excursion and vaccine given to five subjects. On an unspecified date, the patient experienced vaccine temperature dropped to 1.4c.The action taken with covid-19 vaccine ad26.cov2.s was not applicable.The outcome of the temperature excursion and vaccine given to five patients and vaccine temperature dropped to 1.4c was not reported.This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; GOT COVID; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN, expiry: UNKNOWN) dose not reported, start therapy date were not reported, 1 total for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced suspected clinical vaccination failure and got covid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from got covid, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000203270.; Sender's Comments: V0:20211145268-COVID-19 VACCINE AD26.COV2.S-Suspected clinical Vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive 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: SPECIAL SITUATIONS
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Moderna arm rash/redness in lateral aspect of the injection arm, and it had an irregular border; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Moderna arm rash/redness in lateral aspect of the injection arm, and it had an irregular border) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025L20A and 037K20A) for COVID-19 vaccination. Concurrent medical conditions included Dementia.On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RASH (Moderna arm rash/redness in lateral aspect of the injection arm, and it had an irregular border). At the time of the report, RASH (Moderna arm rash/redness in lateral aspect of the injection arm, and it had an irregular border) outcome was unknown.no concomitant medication is reported.No treatement of medication is reported. Most recent FOLLOW-UP information incorporated above includes. On 15-Nov-2021: follow up includes: Reporter details, Patient details, Current illness, vaccine dosage information and event verbatim.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Migraine, Neck pain, Pyrexia, Spinal pain
Clinical narrative: felt terribly sick; migraine; fever; severe spine and neck pain; severe spine and neck pain; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (felt terribly sick), MIGRAINE (migraine), PYREXIA (fever), SPINAL PAIN (severe spine and neck pain) and NECK PAIN (severe spine and neck pain) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051F21A) for COVID-19 vaccination. No medical history was provided by the reporter. On 11-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Nov-2021, the patient experienced MALAISE (felt terribly sick), MIGRAINE (migraine), PYREXIA (fever), SPINAL PAIN (severe spine and neck pain) and NECK PAIN (severe spine and neck pain). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, MALAISE (felt terribly sick), MIGRAINE (migraine), PYREXIA (fever), SPINAL PAIN (severe spine and neck pain) and NECK PAIN (severe spine and neck pain) outcome was unknown.    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. The patient took muscle relaxant as treatment medications.No concomitant medications were reported.This case was linked to MOD-2021-385695 (Patient Link).
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Lethargy, Pyrexia
Clinical narrative: lethargic; high fever/ temperature of 104 Fahrenheit; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (lethargic) and PYREXIA (high fever/ temperature of 104 Fahrenheit) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 11-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LETHARGY (lethargic) and PYREXIA (high fever/ temperature of 104 Fahrenheit). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency. At the time of the report, LETHARGY (lethargic) and PYREXIA (high fever/ temperature of 104 Fahrenheit) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available):On an unknown date, Body temperature: 104 fahrenheit (High) 104 Fahrenheit. No concomitant medications were reported.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Extreme sore shoulder; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (extreme sore shoulder) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A23A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (extreme sore shoulder). At the time of the report, ARTHRALGIA (extreme sore shoulder) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2021-387033, MOD-2021-386605 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: family members having covid right now; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (family members having covid right now) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced COVID-19 (family members having covid right now). At the time of the report, COVID-19 (family members having covid right now) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter stated that the patients having COVID-19 on 7,8,9,10 of November 2021. No relevant concomitant medications were reported. Treatment medication was not provided by the reporter.  This is a Spontaneous case concerning a female patient of unknown age with unknown medical history,  who experienced the unexpected  non serious (AESI) event of COVD 19. The event occurred after a dose of a COVID 19 vaccine that wasn´t confirm to be mRNA 1273 vaccine. Unknown time to onset or dosage number.  The rechallenge is not applicable. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.   This case was linked to MOD-2021-164247, MOD-2021-164267 (Patient Link). Sender's Comments: This is a Spontaneous case concerning a female patient of unknown age with unknown medical history,  who experienced the unexpected  non serious (AESI) event of COVD 19. The event occurred after a dose of a COVID 19 vaccine that wasn´t confirm to be mRNA 1273 vaccine. Unknown time to onset or dosage number.  The rechallenge is not applicable. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product temperature excursion issue
Clinical narrative: Expired vaccine used; Excursion from the freezer; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Excursion from the freezer) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination. No Medical History information was reported. On 01-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Oct-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Excursion from the freezer). On 01-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 01-Oct-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (Excursion from the freezer) had resolved. On 01-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.They used the excursion from their freeze on 01-Oct-2021.It was reported that the storage condition at the time of the excursion was frozen, vial size was 7.5 ml.  Product was storage minimum -4.2 degree and maximum 5.7 degree F. Excursion duration was 6 minutes . All vials are used up. 10 vials are impacted.  The vials were thawed before administration and there were no color changes of any things  abnormal. No concomitant medication were reported.No treatment drug were reported.This case was linked to MOD-2021-383410 (Patient Link).Most recent FOLLOW-UP information incorporated above includes: On 15-Nov-2021: Follow-up received on 15-NOV-2021 updated patient demographics.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: There was an excursion from the freezer; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Nov-2020, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Oct-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer). On 01-Oct-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment reported
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Menstrual disorder, Thrombosis
Clinical narrative: Shortly after I received the vaccination my menstrual cycle started early and was extremely heavy. Oct 9th I passed 2 clots that were slightly larger than a quarter and several penny sized clots. I?ve never had this happen in any of my other cycles my entire life. My cycle lasted for 4 days then subsided. I only passed clots on the first day of my cycle (10/9/21).
Age: 48.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Angiogram, Anticoagulant therapy, Computerised tomogram abdomen, Computerised tomogram thorax abnormal, Deep vein thrombosis
Clinical narrative: Event: DVT in right leg, large volume PE.  Treatment: Admitted to Erlanger East on 10/22/21, heparin gtt initiated, continued until 10/21/21 then transitioned to Xarelto 15 mg BID for 21 days, then 20 mg daily. Outcome: pending
Age: 48.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Echocardiogram normal, Pelvic venous thrombosis, Pulmonary embolism, Ultrasound Doppler abnormal
Clinical narrative: Event: DVT in right leg, large volume PE.  Treatment: Admitted to Erlanger East on 10/22/21, heparin gtt initiated, continued until 10/21/21 then transitioned to Xarelto 15 mg BID for 21 days, then 20 mg daily. Outcome: pending
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Injection site pain, Pain
Clinical narrative: Injection site pain, fatigue, body aches,
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Pain, Pyrexia, Sleep disorder
Clinical narrative: Couldn?t sleep due to fever, chills, body aches.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered, Injection site pain, Injection site swelling, Peripheral swelling
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Swelling at Injection Site-Severe, Systemic: Patient states his left hand became and has stayed extremely swollen 2 weeks after covid booster vaccine-Severe, Additional Details: Patient's left hand is very swollen. He states it became that way 2 weeks after he received his booster shot and has stayed that way for 3 weeks now. He went to the ER, they treated him with ice packs and a wrap but it hasn't resolved. He states he has an appointmetn with his PCP on Wed 11/24/21 to discuss.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered, Pain, Urinary tract infection
Clinical narrative: I woke up in the night with a raging urinary tract infection.  Pain level was 7 or 8 out of 10.  The shot I got was a booster.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Site: Pain at Injection Site-Medium
Age: 9.0
Sex: F
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: Error: Incorrect Reconstitution-
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: Error: Incorrect Reconstitution-
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: Heart palpitations/heart racing approximately a week after receiving vaccine.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Extra dose administered, Mobility decreased, Muscle tightness, Pain
Clinical narrative: Received Booster COVID vaccine on 11/17/21, less than 12 hours developed symptoms.  After receiving COVID booster developed left sided body pain and weakness.  Difficulty moving the left arm due to pain and left arm tightness.  Developed 99.9F Temp, treated with Tylenol and Motrin for 24 hours every 3-4 hours.  Reports weakness.  Reports symptoms lasted until Saturday 11/20/21.  Reports all symptoms resolved.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Received Booster COVID vaccine on 11/17/21, less than 12 hours developed symptoms.  After receiving COVID booster developed left sided body pain and weakness.  Difficulty moving the left arm due to pain and left arm tightness.  Developed 99.9F Temp, treated with Tylenol and Motrin for 24 hours every 3-4 hours.  Reports weakness.  Reports symptoms lasted until Saturday 11/20/21.  Reports all symptoms resolved.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Muscle soreness entire body
Age: 7.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Nausea, Vomiting
Clinical narrative: Systemic: Chills-Medium, Systemic: Nausea-Medium, Systemic: Vomiting-Severe
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Low fever, mild body aches, lasted for less than 24 hours
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysphagia, Dyspnoea, Injection site erythema, Injection site swelling, Throat tightness
Clinical narrative: Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Additional Details: patient used epipen on themselves at home after leaving the store.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Injection site urticaria, Throat tightness, Urticaria
Clinical narrative: Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Additional Details: patient used epipen on themselves at home after leaving the store.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysphagia, Dyspnoea, Injection site erythema, Injection site swelling, Throat tightness
Clinical narrative: After injection of 1st Pfizer covid vaccine, my throat began to close. Hives formed on my back and near injection site. I took allergy medication and had to administer my epipen. Within 20mins.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Injection site urticaria, Throat tightness, Urticaria
Clinical narrative: After injection of 1st Pfizer covid vaccine, my throat began to close. Hives formed on my back and near injection site. I took allergy medication and had to administer my epipen. Within 20mins.
Age: 8.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Lethargy, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Severe
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered, Injection site pain, Interchange of vaccine products, Pyrexia
Clinical narrative: Patient was previously infected with COVID?19, November. 2020 and experienced heavy fatigue, skin pain, difficulty breathing and fever over 102 for 9 days. Patient was injected with Johnson and Johnson COVID vaccine in May 2021 and within hours following injection experienced severe injection site pain, lethargy, and fever over 101 for 3 days.  Immediately following  Pfizer booster in November. 2021, patient experienced  injection site pain and fever over 101 for 36 hours. In each case patient experienced a full recovery. Patient is in above average physical condition with daily physical activity.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Dyspnoea, Throat tightness
Clinical narrative: Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Additional Details: Minutes after administeration of vaccine, patient reported that she thinks she is having trouble breathing and it is possible that her throat is swelling shut, she was unsure. Administered bendaryl to patient with a sip of water. After observation for 15-30 minutes, patient said that she feels fine. Patient said that she also has asthma which may have contributed to her symptom(s).
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Seizure
Clinical narrative: Systemic: Nausea-Severe, Systemic: Seizure-Severe
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Chest discomfort, Chest pain, Dizziness
Clinical narrative: Chest pain/constriction after physical activity. Trouble with equilibrium/dizziness while going up or down stairs
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Rash arms, chest, neck, scalp itches
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Dizziness, Flushing, Hyperhidrosis
Clinical narrative: Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium
Age: 6.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered, Injection site extravasation, Pyrexia
Clinical narrative: A small amount of vaccine leaked out from the arm of a 6 yo during administration of dose. I could not find guidance in the FDA EUA document, but the CDC interim clinical considerations guidance does address (last updated 11/19/21) and now seems to recommend more clearly to repeat the dose immediately for lower than authorized dose administered e.g. leaked out:  Lower-than-authorized dose volume administered of the correct formulation (e.g., leaked out, equipment failure, recipient pulled away): Repeat dose immediately (no minimum interval). See: https://www.cdc.gov/vaccines/covid-19/clinical-considerations/covid-19-vaccines-us.html. Based on this, spoke to family, reviewed the limited data available from the phase 1 portion of the Pfizer trial, both 10 and 20 mcg doses were overall well tolerated, though high fever did develop in one child after dose 2 of the 20 mcg dose, lasting 3 days. Since this patient has both an underlying urea cycle defect and periodic fever syndrome, risk of fever bears consideration due to a higher predisposition as well as potential risk of metabolic sequelae arising from fever- so the discussion mostly focused around this increased risk of fever/ reactogenicity. Parents had a chance to talk to his geneticist and discuss amongst themselves, weighed risks vs benefits, felt they could likely manage a fever if it developed by working closely with his genetics team and they ultimately desired to ensure optimal protection by vaccination. He returned to the clinic, and was re-dosed without event. We have not had any other reports of this. The nurse is a seasoned vaccinator so I would trust her vaccination method. It could be an issue with the syringe itself or a faulty syringe that was leaking around the hub.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Neck pain, Trismus
Clinical narrative: Patient indicates when administering the third dose Moderna " his mouth got locked" also reports neck pain. The reaction lasted 7 days.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired medication administered to the patient.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Injection site pain, Insomnia, Tachycardia
Clinical narrative: Site: Pain at Injection Site-Severe, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Tachycardia-Severe, Systemic: Unable to Sleep-Severe
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired medication administered to the patient.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Pruritus, Rash
Clinical narrative: Site: Redness at Injection Site-Medium, Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Rash Generalized-Medium
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired medication administered to the patient.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Electrocardiogram
Clinical narrative: I developed atrial fibrillation
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Extra dose administered, Headache, Injection site pain, Neck pain
Clinical narrative: Booster shot (3rd dose) Soreness at injection site got progressively worse, wrapping under my arm and up my neck.  At 10:30p, I started trembling and i had chills. I also had a terrible headache.  At 5am the following morning, I awoke to take more headache medicine.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Tremor
Clinical narrative: Booster shot (3rd dose) Soreness at injection site got progressively worse, wrapping under my arm and up my neck.  At 10:30p, I started trembling and i had chills. I also had a terrible headache.  At 5am the following morning, I awoke to take more headache medicine.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Headache, Injection site pain, Mobility decreased
Clinical narrative: Headache, nausea, chills, extreme body ache/weakness, extremely painful injection site (couldn't lift left arm more than 25 degrees), NO fever.  I utilized self-care procedures - aspirin, warm blankets, stayed in bed for 24 hours. Injection site still very painful 24 hours later, but have  regained 100% range of motion.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pain
Clinical narrative: Headache, nausea, chills, extreme body ache/weakness, extremely painful injection site (couldn't lift left arm more than 25 degrees), NO fever.  I utilized self-care procedures - aspirin, warm blankets, stayed in bed for 24 hours. Injection site still very painful 24 hours later, but have  regained 100% range of motion.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: The vial was reconstituted incorrectly. Rather than adding 1.8 ml of diluent, 0.8 ml of diluent was added.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Epistaxis
Clinical narrative: 3 separate nose bleeds 2 less severe after first shot. One the day after the 1st shot in the am and 6 days later in the am.  1 more severe after 2nd shot. 2 hours after the shot   The shot was given to me around 4 pm. Went to the emergency room because I couldn?t get the blood to stop.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dysgeusia, Fatigue, Headache
Clinical narrative: Extreme headache, body chills, fatigue  Metallic taste still after 3 days
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: The vial was reconstituted incorrectly. Rather than adding 1.8 ml of diluent, 0.8 ml of diluent was added.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Diarrhoea, Flatulence, Pain, Stool analysis normal
Clinical narrative: The day after my first Moderna COVID-19 shot, I began having diarrhea multiple times. It was pretty bad that first week after shot #1--to the point that I was afraid to leave the house for fear that I might have to urgently use the bathroom. After that, the diarrhea gradually improved over the course of that month. Then, a couple days before shot #2, I relapsed and had loose stools 4 times. The day right before shot #2 and almost for two weeks after shot #2, my stools were normal.  Then, almost two weeks after shot #2, I relapsed again having loose stools three times in a row. Since then, I occasionally have loose stools or "shaggy looking" stools. When the diarrhea was at its worst, I also had painful burning gas pain before going #2. Even now, I sometimes have gas pain that is mildly burning.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Oedema peripheral
Clinical narrative: Swollen armpit on side of injection, unable to lift arm
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Diarrhoea, Dizziness, Electrocardiogram
Clinical narrative: Two months after vaccination I started to get severe diarrhea (5-6 times per day) for 3 days. Two days after the diarrhea started I got a throbbing pain shooting up my left arm to my shoulder.  The pain was significant enough that it made me nauseous.   Soon after the pain started in my left arm I had chest pain/tightness.  When I went to standup I nearly passed out.    The symptoms subsided after ~1 week
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pain, Pain in extremity
Clinical narrative: Two months after vaccination I started to get severe diarrhea (5-6 times per day) for 3 days. Two days after the diarrhea started I got a throbbing pain shooting up my left arm to my shoulder.  The pain was significant enough that it made me nauseous.   Soon after the pain started in my left arm I had chest pain/tightness.  When I went to standup I nearly passed out.    The symptoms subsided after ~1 week
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood pressure increased, Chest pain, Dyspnoea
Clinical narrative: Patient returned to hospital with SOB, chest pain and increase BP
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: The vial was reconstituted incorrectly. Rather than adding 1.8 ml of diluent, 0.8 ml of diluent was added.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product preparation issue
Clinical narrative: Pfizer was administered undiluted to patient. No harm to patient.
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: Neurological examination normal, Yawning
Clinical narrative: Patient began having excessive yawning day after vaccination. No prior history of motor tics. Yawning as often as once a minute when not talking. Persisted over the weekend. Evaluated in clinic on 11/23/21 with normal neurologic exam. When patient talking, no yawning. When not talking, yawning once a minute at rest. He has no other motor tics observed by parents or this physician
Age: 44.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Fatigue, Headache, Insomnia, Lymphadenopathy, Pain
Clinical narrative: I received both vaccines simultaneously on 11/19/2021 shortly after 11 AM. 12 hours later around 11 PM the following symptoms occurred - extensive body aches, fever, headache, fatigue, inability to sleep, sore arms. These  symptoms continued for the next two days. Also very noticeable are swollen lymph nodes under both arms. Fatigue continues as of today, 11/23/2021.
Age: 44.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: I received both vaccines simultaneously on 11/19/2021 shortly after 11 AM. 12 hours later around 11 PM the following symptoms occurred - extensive body aches, fever, headache, fatigue, inability to sleep, sore arms. These  symptoms continued for the next two days. Also very noticeable are swollen lymph nodes under both arms. Fatigue continues as of today, 11/23/2021.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Heavy menstrual bleeding, Thrombosis
Clinical narrative: My period is so heavy I cannot leave the house I believe through an ultra tampon which is the biggest tampon possible in 25 minutes. I also have gigantic clots coming out the first three days of my period the pain is unbearable and the blood flow is so heavy I?ve never seen anything like it before
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Within 3o seconds of receiving the shot I noticed a constant, loud ringing in my ears
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Dizziness, Dyspnoea, Nausea
Clinical narrative: Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: itchty throat-Medium, Systemic: Nausea-Mild, Additional Details: Patient stated self administer benadryl after arriving home
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Throat irritation
Clinical narrative: Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: itchty throat-Medium, Systemic: Nausea-Mild, Additional Details: Patient stated self administer benadryl after arriving home
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Client, age 14 years old, received a 3rd (booster) dose of Pfizer vaccine.  No adverse event reported at the time of the injection.  Attempted to call mother of child (who also received a 3rd (booster) doe of Pfizer vaccine, but no response.  The vaccine was administered at a 'Pop-Up' clinic.
Age: 38.0
Sex: F
Vaccine: UNK
Symptoms: Chills, Dizziness, Headache, Influenza like illness, Pain
Clinical narrative: flu like symptoms, fever, body aches, chills, headache, dizziness
Age: 38.0
Sex: F
Vaccine: UNK
Symptoms: Pyrexia
Clinical narrative: flu like symptoms, fever, body aches, chills, headache, dizziness
Age: 21.0
Sex: F
Vaccine: UNK
Symptoms: Dizziness
Clinical narrative: Patient became dizzy after receiving her first shot
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Wrong patient received product
Clinical narrative: Error: Wrong Patient (documentation in EMR)-
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient received Moderna COVID vaccine and was only 17yrs of age.  This was the first vaccine in the series.  Patient will be 18yrs of age when she receives her 2nd dose of Moderna in the series.  No adverse events reported.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Injection site pain, Palpitations
Clinical narrative: Site: Pain at Injection Site-Mild, Additional Details: Patient called on 11/22, states that starting the night after his Moderna booster (11/17) that his heart was racing and chest was painful "like an elephant was sitting on his chest". It is now feeling somewhat better, reduced pain but still painful during the day and racing heart. Pt states he is not the picture of his and that night of vaccination 11/17 he spoke to friend  said they knew someone  had this happen and it lasted 3 months. He has not gotten any F/u, I recc calling dr or going to ER
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Hyperhidrosis, Mobility decreased, Myalgia
Clinical narrative: Severe sore arm, could not lift arm for 2 days. Fever and chills (shaking) the night after the shot.  Tiredness, achy muscles, chills comes back when Advil wears off around 6 hours after taken.  Woke up the next night sweating, muscles ache.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Severe sore arm, could not lift arm for 2 days. Fever and chills (shaking) the night after the shot.  Tiredness, achy muscles, chills comes back when Advil wears off around 6 hours after taken.  Woke up the next night sweating, muscles ache.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Pain
Clinical narrative: Site: Pain at Injection Site-Medium, Additional Details: Pain in upper arm when putting pressure on arm while sleeping.  Also pain when lifting arm.  If resting arm, no pain.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Hypersensitivity, Hypoaesthesia oral, Influenza like illness
Clinical narrative: I had my first Covid vaccine on 11/20/21 at Pharmacy. The vaccine provided was Moderna. I have never had bad reactions to vaccines in the past. However 10 minutes after the vaccine was administered I started feeling dizzy. About 20 minutes later it was hard to see, my tongue started to feel numb, my skin felt like it was on fire, my throat started swelling and it was harder to breathe. My husband rushed me to the ER and when we arrived it was still getting worse, but I was shaking very badly. At the hospital, I was given a steroid shot and a shot of Benadryl to counteract the vaccine. This stopped the symptoms and I started to feel better. I was later discharged and did not have anymore allergic reaction symptoms. I am however experiencing severe flu like symptoms and fever that started on 11/22.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Pharyngeal swelling, Pyrexia, Skin burning sensation, Tremor, Visual impairment
Clinical narrative: I had my first Covid vaccine on 11/20/21 at Pharmacy. The vaccine provided was Moderna. I have never had bad reactions to vaccines in the past. However 10 minutes after the vaccine was administered I started feeling dizzy. About 20 minutes later it was hard to see, my tongue started to feel numb, my skin felt like it was on fire, my throat started swelling and it was harder to breathe. My husband rushed me to the ER and when we arrived it was still getting worse, but I was shaking very badly. At the hospital, I was given a steroid shot and a shot of Benadryl to counteract the vaccine. This stopped the symptoms and I started to feel better. I was later discharged and did not have anymore allergic reaction symptoms. I am however experiencing severe flu like symptoms and fever that started on 11/22.