chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: 8/16 - parent Denies Adverse Reaction to 0.5ml dose given instead of 0.3ml dose.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Loss of consciousness, Muscle twitching, Pallor, Syncope
Clinical narrative: - Fainted, but woke up after 1 min - Body twitching before regain consciousness - Pale skin - Pt noted as a child same Adverse event happen with MMR possible due to anxiety
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chest pain, Erythema, Feeling abnormal, Mobility decreased, Pain
Clinical narrative: On 5/24/21, my right side broke-out in large welts that itched and were painful (it was as though I had shingles). On the evening of 8/5/21 after vaccine # 2, I had hest pain, could hardly move (it felt like I Fell down a Flight of stairs). The next three days I had a hot, red, swelling
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pruritus, Skin warm, Swelling, Urticaria
Clinical narrative: On 5/24/21, my right side broke-out in large welts that itched and were painful (it was as though I had shingles). On the evening of 8/5/21 after vaccine # 2, I had hest pain, could hardly move (it felt like I Fell down a Flight of stairs). The next three days I had a hot, red, swelling
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Blood lactic acid decreased, Dyskinesia, Electroencephalogram abnormal, Laboratory test normal, Magnetic resonance imaging head normal
Clinical narrative: 7/30/21 Pt had 4-5 episodes of seizure-like activity throughout the day. Parents took him to the ER where doctors there doctors witnessed approx 20 secs of legs jerking. Pt admitted to peds floor floor. EEG done: done; focal onset seizure from C2-C4, Jerking of legs, staring starting off Patient started on Keppra
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Seizure like phenomena, Simple partial seizures, Staring
Clinical narrative: 7/30/21 Pt had 4-5 episodes of seizure-like activity throughout the day. Parents took him to the ER where doctors there doctors witnessed approx 20 secs of legs jerking. Pt admitted to peds floor floor. EEG done: done; focal onset seizure from C2-C4, Jerking of legs, staring starting off Patient started on Keppra
Age: 12.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Abdominal pain upper, Dizziness, Hypoacusis, Vision blurred
Clinical narrative: PT RECEIVED VACCINES FROM HOSPITAL. WITHIN 15 MIN PT BECAME PALE AND STARTED TO C/O OF THE FOLLOWING S/S FEELING LIKE GOING TO PASS OUT. STOMACH PAIN, DIZZY, BLURRED VISION, HEARING MUFFLED. PT WAS GIVEN SOME COLD COMPRESSES TO THE BACK OF THE NECK AND FACE AND WATER TO SIP ON. WITHIN 5 MIN, PT COLOR RETURNED TO NORMAL AND HER S/S BEGAN TO RESOLVE. WITHIN 10 MIN ALL SYMPTOMS THAT WERE REPORTED HAD RESOLVED. EDUCATION ON THE SIDE EFFECTS FROM THE VACCINATIONS AND CONTINUED MONITORING ADVISED. DR. NOTIFIED. 92% O2 SATS 97.4 T; 1B R.
Age: 12.0
Sex: M
Vaccine: COVID19, HPV9, MNQ
Symptoms: No adverse event
Clinical narrative: administered at 256 no reaction noted and discharged at 311
Age: 17.0
Sex: M
Vaccine: COVID19, MENB, MNQ
Symptoms: No adverse event
Clinical narrative: admin at 1325 and discharged at 1340 with no adverse reaction noted.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pyrexia, Urticaria
Clinical narrative: 6.10.21 Urticaria, HA, fever seen in ER 6.13.21 Treated with drapred & benadryl
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Arthritis, Condition aggravated, Musculoskeletal chest pain
Clinical narrative: worsening arthritis, severe pain in my ribs
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Vaccination site reaction
Clinical narrative: I developed Shingles at my vaccination site
Age: 17.0
Sex: F
Vaccine: HPVX
Symptoms: Asthenia, Back pain, Crying, Headache, Pain
Clinical narrative: I got my HPV shot today I was given two doses, an hour later I was not able to use the arm that was injected at all without sever pain to the point of crying, my back then started to develop severe pain as well feeling similar to my arm felt like I got the shot in my spine it took over my entire lower back, I then developed shooting pain down both legs more serious in one then the other. And developed a headache and weakness. I recently came out of recovery from a car accident and I cna say the pain was almost worse then the pain had from my injuries from that witch is astonishing. Ibuprofen was not successful in reliving my pain nor was Tylenol. I had to take a sleeping pil in order to fall asleep so I couldn't feel the pain even then I woke up a little and had a lot of pain still in severe pain and if not gone in a couple days I will be going to the hospital and then making another report I spend hours online trying to find and answer only one similar to mine was from another country this needs to be talked about and resolved because this is not safe.
Age: 17.0
Sex: F
Vaccine: HPVX
Symptoms: Pain in extremity, Sleep disorder
Clinical narrative: I got my HPV shot today I was given two doses, an hour later I was not able to use the arm that was injected at all without sever pain to the point of crying, my back then started to develop severe pain as well feeling similar to my arm felt like I got the shot in my spine it took over my entire lower back, I then developed shooting pain down both legs more serious in one then the other. And developed a headache and weakness. I recently came out of recovery from a car accident and I cna say the pain was almost worse then the pain had from my injuries from that witch is astonishing. Ibuprofen was not successful in reliving my pain nor was Tylenol. I had to take a sleeping pil in order to fall asleep so I couldn't feel the pain even then I woke up a little and had a lot of pain still in severe pain and if not gone in a couple days I will be going to the hospital and then making another report I spend hours online trying to find and answer only one similar to mine was from another country this needs to be talked about and resolved because this is not safe.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Heavy menstrual bleeding, Menstruation irregular
Clinical narrative: I got the first dose of the Pfizer covid-19 vaccine on 8/10/2021. I started my period on 8/12/2021 and have not had heavy periods outside of 5 days with cramping usually only lasting 2-3. I'm currently on the 6th day of my period and it is heavy with very painful cramping.
Sex: U
Vaccine: MNQ
Symptoms: Product preparation issue
Clinical narrative: administered / liquid conjugate portion only / not reconstituted with the lyophilized / portion; administered / liquid conjugate portion only / not reconstituted with the lyophilized / portion; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The nurse reported that the patient received Men CYW liquid conjugate portion only of Menveo vaccine and the vaccine was not reconstituted with the lyophilized Men A portion, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The health care professional did not have patient details or vaccine lot number and expiration date. The reporter consented to follow up. This case was 1 of 8 linked cases, reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021169160:Same reporter US-GLAXOSMITHKLINE-US2021AMR170397:Same reporter US-GLAXOSMITHKLINE-US2021AMR170398:Same reporter US-GLAXOSMITHKLINE-US2021AMR170399:Same reporter US-GLAXOSMITHKLINE-US2021AMR170400:Same reporter US-GLAXOSMITHKLINE-US2021AMR170403:Same reporter US-GLAXOSMITHKLINE-US2021AMR170402:Same reporter
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: administered / liquid conjugate portion only / not reconstituted with the lyophilized / portion; Inappropriate preparation of medication; This case was reported by a nurse via call center representative and described the occurrence of inappropriate dose of vaccine administered in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced inappropriate dose of vaccine administered and inappropriate preparation of medication. On an unknown date, the outcome of the inappropriate dose of vaccine administered and inappropriate preparation of medication were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The nurse reported that the patient received Men CYW liquid conjugate portion only of Menveo vaccine and the vaccine was not reconstituted with the lyophilized Men A portion, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The health care professional did not have patient details or vaccine lot number and expiration date. The reporter consented to follow up. This case was 1 of 8 linked cases, reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021169160:Same reporter US-GLAXOSMITHKLINE-US2021AMR170398:Same reporter US-GLAXOSMITHKLINE-US2021AMR170399:Same reporter US-GLAXOSMITHKLINE-US2021AMR170401:Same reporter US-GLAXOSMITHKLINE-US2021AMR170400:Same reporter US-GLAXOSMITHKLINE-US2021AMR170403:Same reporter US-GLAXOSMITHKLINE-US2021AMR170402:Same reporter
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: administered / liquid conjugate portion only / not reconstituted with the lyophilized / portion; administered / liquid conjugate portion only / not reconstituted with the lyophilized / portion; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The nurse reported that the patient was administered MenCYW liquid conjugate portion only of Menveo vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. Vaccine was not reconstituted with the lyophilized MenA portion. The nurse did not have any patient details or vaccine lot number and expiration date. The reporter consented to follow up. This case is one of the 8 cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR170398:Same reporter US-GLAXOSMITHKLINE-US2021AMR170403:Same reporter US-GLAXOSMITHKLINE-US2021AMR170399:Same reporter US-GLAXOSMITHKLINE-US2021AMR170397:Same reporter US-GLAXOSMITHKLINE-US2021AMR170401:Same reporter US-GLAXOSMITHKLINE-US2021AMR170400:Same reporter US-GLAXOSMITHKLINE-US2021AMR170402:Same reporter
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: administered / liquid conjugate portion only / not reconstituted with the lyophilized / portion; administered / liquid conjugate portion only / not reconstituted with the lyophilized / portion; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The nurse reported that the patient received Men CYW liquid conjugate portion only of Menveo vaccine and the vaccine was not reconstituted with the lyophilized Men A portion, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The health care professional did not have patient details or vaccine lot number and expiration date. The reporter consented to follow up. This case was 1 of 8 linked cases, reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021169160:Same reporter US-GLAXOSMITHKLINE-US2021AMR170397:Same reporter US-GLAXOSMITHKLINE-US2021AMR170398:Same reporter US-GLAXOSMITHKLINE-US2021AMR170399:Same reporter US-GLAXOSMITHKLINE-US2021AMR170400:Same reporter US-GLAXOSMITHKLINE-US2021AMR170401:Same reporter US-GLAXOSMITHKLINE-US2021AMR170402:Same reporter
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Single component of a two-component product administered
Clinical narrative: inadvertently administered Menveo Diluent only; inadvertently administered Menveo Diluent only; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The quality assurance specialist called to report that, the patient inadvertently administered menveo diluent only, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The specialist was unable to provide any patient or vaccines details. The specialist also declined follow up from safety. The reporter did not consent to follow up. This case was 1 of 11 linked cases, reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021170620:same reporter US-GLAXOSMITHKLINE-US2021AMR170931:same reporter US-GLAXOSMITHKLINE-US2021AMR170932:same reporter US-GLAXOSMITHKLINE-US2021AMR170933:same reporter US-GLAXOSMITHKLINE-US2021AMR170930:same reporter US-GLAXOSMITHKLINE-US2021AMR170929:same reporter US-GLAXOSMITHKLINE-US2021AMR170928:same reporter US-GLAXOSMITHKLINE-US2021AMR170927:same reporter US-GLAXOSMITHKLINE-US2021AMR170934:same reporter US-GLAXOSMITHKLINE-US2021170619:same reporter US-GLAXOSMITHKLINE-US2021AMR170926:same reporter US-GLAXOSMITHKLINE-US2021170620:same reporter
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Single component of a two-component product administered
Clinical narrative: inadvertently administered Menveo Diluent only; inadvertently administered Menveo Diluent only; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The quality assurance specialist called to report that, the patient inadvertently administered menveo diluent only, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The specialist was unable to provide any patient or vaccines details. The specialist also declined follow up from safety. The reporter did not consent to follow up. This case was 1 of 11 linked cases, reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021170620:same reporter US-GLAXOSMITHKLINE-US2021170619:same reporter US-GLAXOSMITHKLINE-US2021AMR170925:same reporter US-GLAXOSMITHKLINE-US2021170620:same reporter
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Single component of a two-component product administered
Clinical narrative: inadvertently administered Menveo Diluent only; inadvertently administered Menveo Diluent only; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The quality assurance specialist called to report that, the patient inadvertently administered menveo diluent only, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The specialist was unable to provide any patient or vaccines details. The specialist also declined follow up from safety. The reporter did not consent to follow up. This case was 1 of 11 linked cases, reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021170620:same reporter US-GLAXOSMITHKLINE-US2021170619: US-GLAXOSMITHKLINE-US2021AMR170925:same reporter US-GLAXOSMITHKLINE-US2021170620:same reporter
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Single component of a two-component product administered
Clinical narrative: inadvertently administered Menveo Diluent only; inadvertently administered Menveo Diluent only; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The quality assurance specialist called to report that, the patient inadvertently administered menveo diluent only, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The specialist was unable to provide any patient or vaccines details. The specialist also declined follow up from safety. The reporter did not consent to follow up. This case was 1 of 11 linked cases, reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021170620:same reporter US-GLAXOSMITHKLINE-US2021AMR170925:same reporter US-GLAXOSMITHKLINE-US2021170619:same reporter US-GLAXOSMITHKLINE-US2021170620:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation error, Product preparation issue
Clinical narrative: Administered Shingrix Diluent only; Administered Shingrix Diluent only; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient was inadvertently administered Shingrix diluent only, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter was unable to provide the patient or vaccines details. The reporter also declined follow up from safety. The reporter did not consent to follow up. This is 1 of 41 linked cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021170619:same reporter US-GLAXOSMITHKLINE-US2021AMR170931:same reporter US-GLAXOSMITHKLINE-US2021AMR170925:same reporter US-GLAXOSMITHKLINE-US2021AMR170932:same reporter US-GLAXOSMITHKLINE-US2021AMR170933:same reporter US-GLAXOSMITHKLINE-US2021AMR170930:same reporter US-GLAXOSMITHKLINE-US2021AMR170929:same reporter US-GLAXOSMITHKLINE-US2021AMR170928:same reporter US-GLAXOSMITHKLINE-US2021AMR170927:same reporter US-GLAXOSMITHKLINE-US2021AMR170934:same reporter US-GLAXOSMITHKLINE-US2021AMR170926:same reporter US-GLAXOSMITHKLINE-US2021AMR171145:
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation error, Product preparation issue
Clinical narrative: administered Shingrix Diluent only; administered Shingrix Diluent only; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient was inadvertently administered Shingrix diluent only, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter was unable to provide the patient or vaccines details. The reporter also declined follow up from safety. The reporter did not consent to follow up. This is 1 of 41 linked cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021170619:same reporter US-GLAXOSMITHKLINE-US2021AMR170931:same reporter US-GLAXOSMITHKLINE-US2021AMR170925:same reporter US-GLAXOSMITHKLINE-US2021AMR170932:same reporter US-GLAXOSMITHKLINE-US2021AMR170933:same reporter US-GLAXOSMITHKLINE-US2021AMR170930:same reporter US-GLAXOSMITHKLINE-US2021AMR170929:same reporter US-GLAXOSMITHKLINE-US2021AMR170928:same reporter US-GLAXOSMITHKLINE-US2021AMR170927:same reporter US-GLAXOSMITHKLINE-US2021AMR170934:same reporter US-GLAXOSMITHKLINE-US2021AMR170926:same reporter US-GLAXOSMITHKLINE-US2021AMR171145:
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation error, Product preparation issue
Clinical narrative: administered Shingrix Diluent only; administered Shingrix Diluent only; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate dose of vaccine administered in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate dose of vaccine administered and inappropriate preparation of medication. On an unknown date, the outcome of the inappropriate dose of vaccine administered and inappropriate preparation of medication were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The quality assurance specialist called to report that, the patient inadvertently administered shingrix diluent only, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The specialist was unable to provide any patient or vaccines details. The specialist also declined follow up from safety. The reporter did not consent to follow up. This case was 1 of 41 linked cases, reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021170619:same reporter US-GLAXOSMITHKLINE-US2021AMR170931:same reporter US-GLAXOSMITHKLINE-US2021AMR170925:same reporter US-GLAXOSMITHKLINE-US2021AMR170932:same reporter US-GLAXOSMITHKLINE-US2021AMR170933:same reporter US-GLAXOSMITHKLINE-US2021AMR170930:same reporter US-GLAXOSMITHKLINE-US2021AMR170929:same reporter US-GLAXOSMITHKLINE-US2021AMR170928:same reporter US-GLAXOSMITHKLINE-US2021AMR170927:same reporter US-GLAXOSMITHKLINE-US2021AMR170934:same reporter US-GLAXOSMITHKLINE-US2021AMR170926:same reporter US-GLAXOSMITHKLINE-US2021AMR171145:
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation error, Product preparation issue
Clinical narrative: administered Shingrix Diluent only; administered Shingrix Diluent only; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The quality assurance specialist called to report that, the patient inadvertently administered shingrix diluent only, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The specialist was unable to provide any patient or vaccines details. The specialist also declined follow up from safety. The reporter did not consent to follow up. This case was 1 of 41 linked cases, reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021170619:same reporter US-GLAXOSMITHKLINE-US2021AMR170931:same reporter US-GLAXOSMITHKLINE-US2021AMR170925:same reporter US-GLAXOSMITHKLINE-US2021AMR170932:same reporter US-GLAXOSMITHKLINE-US2021AMR170933:same reporter US-GLAXOSMITHKLINE-US2021AMR170930:same reporter US-GLAXOSMITHKLINE-US2021AMR170929:same reporter US-GLAXOSMITHKLINE-US2021AMR170928:same reporter US-GLAXOSMITHKLINE-US2021AMR170927:same reporter US-GLAXOSMITHKLINE-US2021AMR170934:same reporter US-GLAXOSMITHKLINE-US2021AMR170926:same reporter US-GLAXOSMITHKLINE-US2021AMR171145:
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect route of product administration
Clinical narrative: administered Shingrix Diluent only; administered Shingrix Diluent only; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The quality assurance specialist called to report that, the patient inadvertently administered shingrix diluent only, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The specialist was unable to provide any patient or vaccines details. The specialist also declined follow up from safety. The reporter did not consent to follow up. This case was 1 of 41 linked cases, reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021170619:same reporter US-GLAXOSMITHKLINE-US2021AMR170931:same reporter US-GLAXOSMITHKLINE-US2021AMR170925:same reporter US-GLAXOSMITHKLINE-US2021AMR170932:same reporter US-GLAXOSMITHKLINE-US2021AMR170933:same reporter US-GLAXOSMITHKLINE-US2021AMR170930:same reporter US-GLAXOSMITHKLINE-US2021AMR170929:same reporter US-GLAXOSMITHKLINE-US2021AMR170928:same reporter US-GLAXOSMITHKLINE-US2021AMR170927:same reporter US-GLAXOSMITHKLINE-US2021AMR170934:same reporter US-GLAXOSMITHKLINE-US2021AMR170926:same reporter US-GLAXOSMITHKLINE-US2021AMR171145:
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered
Clinical narrative: administered Shingrix Diluent only; administered Shingrix Diluent only; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate dose of vaccine administered in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate dose of vaccine administered and inappropriate preparation of medication. On an unknown date, the outcome of the inappropriate dose of vaccine administered and inappropriate preparation of medication were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The quality assurance specialist called to report that, the patient inadvertently administered shingrix diluent only, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The specialist was unable to provide any patient or vaccines details. The specialist also declined follow up from safety. The reporter did not consent to follow up. This case was 1 of 41 linked cases, reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021170619:same reporter US-GLAXOSMITHKLINE-US2021AMR170931:same reporter US-GLAXOSMITHKLINE-US2021AMR170925:same reporter US-GLAXOSMITHKLINE-US2021AMR170932:same reporter US-GLAXOSMITHKLINE-US2021AMR170933:same reporter US-GLAXOSMITHKLINE-US2021AMR170930:same reporter US-GLAXOSMITHKLINE-US2021AMR170929:same reporter US-GLAXOSMITHKLINE-US2021AMR170928:same reporter US-GLAXOSMITHKLINE-US2021AMR170927:same reporter US-GLAXOSMITHKLINE-US2021AMR170934:same reporter US-GLAXOSMITHKLINE-US2021AMR170926:same reporter US-GLAXOSMITHKLINE-US2021AMR171145:
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Single component of a two-component product administered
Clinical narrative: administered Shingrix Diluent only; administered Shingrix Diluent only; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate dose of vaccine administered in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate dose of vaccine administered and inappropriate preparation of medication. On an unknown date, the outcome of the inappropriate dose of vaccine administered and inappropriate preparation of medication were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The quality assurance specialist called to report that, the patient inadvertently administered shingrix diluent only, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The specialist was unable to provide any patient or vaccines details. The specialist also declined follow up from safety. The reporter did not consent to follow up. This case was 1 of 41 linked cases, reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021170619:same reporter US-GLAXOSMITHKLINE-US2021AMR170931:same reporter US-GLAXOSMITHKLINE-US2021AMR170925:same reporter US-GLAXOSMITHKLINE-US2021AMR170932:same reporter US-GLAXOSMITHKLINE-US2021AMR170933:same reporter US-GLAXOSMITHKLINE-US2021AMR170930:same reporter US-GLAXOSMITHKLINE-US2021AMR170929:same reporter US-GLAXOSMITHKLINE-US2021AMR170928:same reporter US-GLAXOSMITHKLINE-US2021AMR170927:same reporter US-GLAXOSMITHKLINE-US2021AMR170934:same reporter US-GLAXOSMITHKLINE-US2021AMR170926:same reporter US-GLAXOSMITHKLINE-US2021AMR171145:
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation error, Product preparation issue
Clinical narrative: Administered Shingrix Diluent only; Administered Shingrix Diluent only; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate dose of vaccine administered in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate dose of vaccine administered and inappropriate preparation of medication. On an unknown date, the outcome of the inappropriate dose of vaccine administered and inappropriate preparation of medication were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The quality assurance specialist called to report that, the patient inadvertently administered shingrix diluent only, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The specialist was unable to provide any patient or vaccines details. The specialist also declined follow up from safety. The reporter did not consent to follow up. This case was 1 of 41 linked cases, reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021170619:same reporter US-GLAXOSMITHKLINE-US2021AMR170931:same reporter US-GLAXOSMITHKLINE-US2021AMR170925:same reporter US-GLAXOSMITHKLINE-US2021AMR170932:same reporter US-GLAXOSMITHKLINE-US2021AMR170933:same reporter US-GLAXOSMITHKLINE-US2021AMR170930:same reporter US-GLAXOSMITHKLINE-US2021AMR170929:same reporter US-GLAXOSMITHKLINE-US2021AMR170928:same reporter US-GLAXOSMITHKLINE-US2021AMR170927:same reporter US-GLAXOSMITHKLINE-US2021AMR170934:same reporter US-GLAXOSMITHKLINE-US2021AMR170926:same reporter US-GLAXOSMITHKLINE-US2021AMR171145:
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Burning sensation, Fatigue, Hypoaesthesia, Lethargy, Pharyngeal hypoaesthesia
Clinical narrative: Sore Injection Site; Numbness of the right side of her face; Burning sensation in the chest for 30 seconds; Numbness of the right side of her neck; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Numbness of the right side of her face), SKIN BURNING SENSATION (Burning sensation in the chest for 30 seconds), HYPOAESTHESIA (Numbness of the right side of her neck) and VACCINATION SITE PAIN (Sore Injection Site) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA (Numbness of the right side of her face), SKIN BURNING SENSATION (Burning sensation in the chest for 30 seconds), HYPOAESTHESIA (Numbness of the right side of her neck) and VACCINATION SITE PAIN (Sore Injection Site).        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Hypoaesthesia, Vaccination site pain
Clinical narrative: Sore Injection Site; Numbness of the right side of her face; Burning sensation in the chest for 30 seconds; Numbness of the right side of her neck; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Numbness of the right side of her face), SKIN BURNING SENSATION (Burning sensation in the chest for 30 seconds), HYPOAESTHESIA (Numbness of the right side of her neck) and VACCINATION SITE PAIN (Sore Injection Site) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA (Numbness of the right side of her face), SKIN BURNING SENSATION (Burning sensation in the chest for 30 seconds), HYPOAESTHESIA (Numbness of the right side of her neck) and VACCINATION SITE PAIN (Sore Injection Site).        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema of eyelid, Eye discharge, Eye pruritus, Eye swelling, Eyelid margin crusting
Clinical narrative: Diagnosed with a case of shngles; Right eye began watering a lot; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RETINAL DISORDER (Right eye began watering a lot) and HERPES ZOSTER (Diagnosed with a case of shngles) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jan-2021, the patient experienced RETINAL DISORDER (Right eye began watering a lot). On 20-Jan-2021, the patient experienced HERPES ZOSTER (Diagnosed with a case of shngles). At the time of the report, RETINAL DISORDER (Right eye began watering a lot) and HERPES ZOSTER (Diagnosed with a case of shngles) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lacrimation increased, Ophthalmological examination, Tenderness, Urticaria, Visual impairment
Clinical narrative: Diagnosed with a case of shngles; Right eye began watering a lot; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RETINAL DISORDER (Right eye began watering a lot) and HERPES ZOSTER (Diagnosed with a case of shngles) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jan-2021, the patient experienced RETINAL DISORDER (Right eye began watering a lot). On 20-Jan-2021, the patient experienced HERPES ZOSTER (Diagnosed with a case of shngles). At the time of the report, RETINAL DISORDER (Right eye began watering a lot) and HERPES ZOSTER (Diagnosed with a case of shngles) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Herpes zoster, Retinal disorder
Clinical narrative: Diagnosed with a case of shngles; Right eye began watering a lot; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RETINAL DISORDER (Right eye began watering a lot) and HERPES ZOSTER (Diagnosed with a case of shngles) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jan-2021, the patient experienced RETINAL DISORDER (Right eye began watering a lot). On 20-Jan-2021, the patient experienced HERPES ZOSTER (Diagnosed with a case of shngles). At the time of the report, RETINAL DISORDER (Right eye began watering a lot) and HERPES ZOSTER (Diagnosed with a case of shngles) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 86.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain upper, Apparent life threatening event, Computerised tomogram abnormal, Computerised tomogram intestine, Death
Clinical narrative: She developed a pain in her upper abdomen and was take. To the ER.  CT showed a perforation in her small bowel.  She passed away 49 hours after the perforation,  she had NO bowel or history of bowel problems. Ever!!!
Age: 86.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Intestinal perforation
Clinical narrative: She developed a pain in her upper abdomen and was take. To the ER.  CT showed a perforation in her small bowel.  She passed away 49 hours after the perforation,  she had NO bowel or history of bowel problems. Ever!!!
Age: 86.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain upper, Computerised tomogram abdomen abnormal, Death, Intestinal perforation, Laboratory test
Clinical narrative: She developed a pain in her upper abdomen and was take. To the ER.  CT showed a perforation in her small bowel.  She passed away 49 hours after the perforation,  she had NO bowel or history of bowel problems. Ever!!!
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus, Swollen tongue
Clinical narrative: Within 8 minutes of the shot by mouth became very watery, I became itchy all over my neck and my tongue started to swelling  in my mouth and throat. Physician was with me within a couple minutes and immediately administered an Epi-Pen. I was then taken into the clinic. (it was originally a drive thru vaccine site), I was in the clinic under observation for almost 3 hours. I was given additional shots to get the anaphylactic shock under control, including a steroid shot, high dose benadryl and I'm not sure what the others were. I was sent home early in the evening with a phone number for Physician and medication. I had to contact her in the AM of the next day, Feb 13 as I started having another anaphylactic reaction. My husband was able to get the allergy medication to me quickly and we were able to get it under control.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic reaction, Anaphylactic shock, Pharyngeal swelling, Pruritus, Salivary hypersecretion
Clinical narrative: Within 8 minutes of the shot by mouth became very watery, I became itchy all over my neck and my tongue started to swelling  in my mouth and throat. Physician was with me within a couple minutes and immediately administered an Epi-Pen. I was then taken into the clinic. (it was originally a drive thru vaccine site), I was in the clinic under observation for almost 3 hours. I was given additional shots to get the anaphylactic shock under control, including a steroid shot, high dose benadryl and I'm not sure what the others were. I was sent home early in the evening with a phone number for Physician and medication. I had to contact her in the AM of the next day, Feb 13 as I started having another anaphylactic reaction. My husband was able to get the allergy medication to me quickly and we were able to get it under control.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Swollen tongue
Clinical narrative: Within 8 minutes of the shot by mouth became very watery, I became itchy all over my neck and my tongue started to swelling  in my mouth and throat. Physician was with me within a couple minutes and immediately administered an Epi-Pen. I was then taken into the clinic. (it was originally a drive thru vaccine site), I was in the clinic under observation for almost 3 hours. I was given additional shots to get the anaphylactic shock under control, including a steroid shot, high dose benadryl and I'm not sure what the others were. I was sent home early in the evening with a phone number for Physician and medication. I had to contact her in the AM of the next day, Feb 13 as I started having another anaphylactic reaction. My husband was able to get the allergy medication to me quickly and we were able to get it under control.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site swelling, Pain in extremity, Skin warm
Clinical narrative: Body ache; Fever; Chills; Joint aches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body ache), PYREXIA (Fever), CHILLS (Chills) and ARTHRALGIA (Joint aches) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced PAIN (Body ache), PYREXIA (Fever), CHILLS (Chills) and ARTHRALGIA (Joint aches). At the time of the report, PAIN (Body ache), PYREXIA (Fever), CHILLS (Chills) and ARTHRALGIA (Joint aches) outcome was unknown.            Concomitant medication included Vitamins and Natural supplements. Treatment included Advil and Tylenol.   Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2021: reporter's email address and last name correction
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Chills, Pain, Pyrexia
Clinical narrative: Body ache; Fever; Chills; Joint aches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body ache), PYREXIA (Fever), CHILLS (Chills) and ARTHRALGIA (Joint aches) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced PAIN (Body ache), PYREXIA (Fever), CHILLS (Chills) and ARTHRALGIA (Joint aches). At the time of the report, PAIN (Body ache), PYREXIA (Fever), CHILLS (Chills) and ARTHRALGIA (Joint aches) outcome was unknown.            Concomitant medication included Vitamins and Natural supplements. Treatment included Advil and Tylenol.   Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2021: reporter's email address and last name correction