chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: lips tingling and radiate to left arm and right arm-Medium, Additional Details: at first she felt lips tingling, we gave her a benadryl and let her sit for the other 15 minutes. after that, she felt tingling more on her right arm and left arm, warmness on her neck and her chest, a little redness. she did not have any trouble breathing, no shortness of breath.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fall, Hypotension, Pallor, Syncope
Clinical narrative: Systemic: Dizziness / Light headiness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Hypotension-Severe, Additional Details: Patient was given the 1st dose of the Pfizer COVID vaccine around 4:50pm PST without incident and she was directed to wait for 15 minutes in the store. the pharmacy technician monitoring patients noticed around 4:57pm that patient was pale and slumped over in her chair & alerted me. Immediately, patient fainted while seated, into arms. 911 was alerted & they came 10 mins afterwards. EMS found her BP to be low and recommended she go to the ER, but she refused.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Unresponsive to stimuli
Clinical narrative: Systemic: Dizziness / Light headiness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Hypotension-Severe, Additional Details: Patient was given the 1st dose of the Pfizer COVID vaccine around 4:50pm PST without incident and she was directed to wait for 15 minutes in the store. the pharmacy technician monitoring patients noticed around 4:57pm that patient was pale and slumped over in her chair & alerted me. Immediately, patient fainted while seated, into arms. 911 was alerted & they came 10 mins afterwards. EMS found her BP to be low and recommended she go to the ER, but she refused.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Hyperhidrosis, Hypoaesthesia
Clinical narrative: Systemic: Flushed / Sweating-Mild, Systemic: Numbness (specify: facial area, extremities)-Mild, Additional Details: Patient had no issues during 15 minute wait period, but informed MD that experienced facial flushing, numbness, and warmness for total of 30 minutes on way home. Symptoms have resolved without any treatment.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Error: Wrong Dose of Vaccine - Too High
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Eye swelling, Mouth swelling, Swelling face, Swollen tongue
Clinical narrative: Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Throat tightness
Clinical narrative: Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Fatigue, Headache, Pain, Swelling
Clinical narrative: Extreme tired Headache Achy and sore body Swelling and  pain in armpit.
Age: 59.0
Sex: M
Vaccine: UNK
Symptoms: Dysgeusia
Clinical narrative: metallic taste
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Flushing, Hyperhidrosis, Injection site pain
Clinical narrative: Flushing and sweating - started 10-15min post-injection, lasted about 1 hr  Chills, nausea, malaise- started 45min post-injection, lasted 8-9 hrs  Injection site pain, joint and muscle pain (severe) - started 12 hrs post-injection, has not yet abated and has been 38-ish hours
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Myalgia, Nausea
Clinical narrative: Flushing and sweating - started 10-15min post-injection, lasted about 1 hr  Chills, nausea, malaise- started 45min post-injection, lasted 8-9 hrs  Injection site pain, joint and muscle pain (severe) - started 12 hrs post-injection, has not yet abated and has been 38-ish hours
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Error: Wrong Dose of Vaccine - Too High
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Error: Wrong Dose of Vaccine - Too High
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Breast tenderness, Chills, Discomfort, Head discomfort, Headache
Clinical narrative: I got uncontrollable chills for 2 hours, a fever of 100.6 that has lasted at least 23 hours as of the time of submission, extreme body aches, breast tenderness, and a headache that felt like my skull was being crushed in--the worst of my life.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: I got uncontrollable chills for 2 hours, a fever of 100.6 that has lasted at least 23 hours as of the time of submission, extreme body aches, breast tenderness, and a headache that felt like my skull was being crushed in--the worst of my life.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Headache, Vertigo
Clinical narrative: Headache, vertigo, dizziness
Age: 0.75
Sex: M
Vaccine: DTAPIPV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Kinrix given instead of pediarix. No adverse reaction noted. Patient will require additional vaccine at regularly scheduled interval.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Pain, Pyrexia
Clinical narrative: Fever, headache, body aches, nausea, chills
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Error: Wrong Dose of Vaccine - Too High.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Pain in extremity
Clinical narrative: Day of injection for 2 days, arm sore, however starting 8 days after injection arm is now red and sore at injection site.  This is new.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity, Pyrexia
Clinical narrative: Arm pain but significantly less arm pain than the first shot. I also have a fever and I feel tired.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Error: Wrong Dose of Vaccine - Too High
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Myalgia
Clinical narrative: Swelling, redness, itching, pain and muscle aches at injection site and down the arm one week after receiving the shot.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Error: Wrong Dose of Vaccine - Too High
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia
Clinical narrative: Muscle pain in upper back, shoulders, right arm, extreme fatigue
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Injection site pain, Pyrexia
Clinical narrative: injection site soreness ~4 hours after vaccine injection; Fatigue set in ~12 hours after vaccine injection; Chills set in ~14 hours after vaccine injection; feverish ~17 hours after injection
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Error: Wrong Dose of Vaccine - Too High
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Vomiting
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Blood glucose normal, Orthostatic hypotension, Pruritus, Rash, Syncope
Clinical narrative: Twenty minutes after injection, patient and father were leaving building.  Patient had orthostatic hypotension, syncope with collapse in elevator.  Developed diffuse rash with some pruitis. Administered 25mg of oral Benadryl and oral hydration.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Error: Wrong Dose of Vaccine - Too High
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Death, Oxygen saturation decreased, SARS-CoV-2 test positive
Clinical narrative: 2/13/21 Patient had covid like symptoms 2/15/21 Patient admitted to Hospital with covid like sx and decreased O2 sat; tested positive for Covid on 2/15/21; treated with Remdesivir and convalesent Plasma. Sx worsened and patient died 2/26/21..
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Loss of personal independence in daily activities, Sleep disorder
Clinical narrative: EXTREME HIP PAIN THAT INTERFERES WITH SLEEP AND DAILY LIFE. DOES NOT ABATE WITH TIME.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Paraesthesia oral
Clinical narrative: Dizziness, weakness, tingling sensation to tongue
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Error: Wrong Dose of Vaccine - Too High
Age: 46.0
Sex: F
Vaccine: FLUX
Symptoms: Mobility decreased, Pain, Pain in extremity, Sleep disorder
Clinical narrative: I received the FLU Shot, after getting it I was sure it was given way "too low" on my left arm compared to shots I have received in the past.  After several weeks have gone by and even more time goes by I have constant pain in this arm and now limited mobility - It hurts to raise my arm to a certain extent,  (washing my hair, putting on a shirt, all cause pain as I can not raise my left arm over my head any longer or move it behind my back to stretch).    It seems to get worse as time goes by.  Note--this is NOT in my upper shoulder area as at first people asked if I had a "frozen shoulder" and it is not....it is well below the shoulder more in the muscle area.  I can no longer sleep on my left side as well.    I know it was the Influenza Vaccine but was not sure which one to mark in the Above section---
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Error: Wrong Dose of Vaccine - Too High.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular
Clinical narrative: Irregular menstral cycle
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Pain in extremity
Clinical narrative: 1-3 days after the vaccination, I had the typical sore arm, but no major reaction.  On the morning of the 8th day after vaccination, I noticed a quarter-sized very itchy red hive at the injection site.  Today is the 9th days after vaccination, and the red hive is no longer itchy, but it has grown to a diameter of 4 centimeters.  I take Claritin daily for allergies, and have continued taking it daily throughout this event.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site reaction, Rash, Rash erythematous, Rash pruritic
Clinical narrative: Bright red rash around injection site. Rash formed a circle around injection. Itchy and mildly sore. Referred to as ?Covid arm.?
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Thirst
Clinical narrative: Patient is a volunteer at a vaccine distribution center.  She was able to get a vaccine herself because of this.  She reports a persistent vice-like headache that began the day she received her first dose of vaccine that has persisted.  Her blood pressure went up with this, so she was started on metoprolol which brought her blood pressure down, but did not affect the headaches. Patient received her 2nd dose of the Pfizer vaccine on 2/27/21 and reports that in addition to the headache she feels fatigued and reports excessive thirst.  She is still be worked up for the headaches.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Oral pruritus, Tongue pruritus
Clinical narrative: 30 minutes after receiving 1st dose, headache set in and my tongue and the inside of my mouth starting itching.  Arrived home 15 min later.  Immediately took a Benadryl.  Suspected I was having an allergic reaction.  It stopped the itching.  A Tylenol stopped the headache.   A 2nd headache set in later in the afternoon.  Another Tylenol stopped it
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Nausea
Clinical narrative: Patient is a 45-year-old male that five (5)-minutes after receiving COVID-19 vaccine, experienced nausea and became light headed. Patient indicated that he always has been afraid of needles and in particular he was afraid of receiving the COVID-19 vaccine. Paramedic on site evaluated the vitals on the patient, revealing an oxygen saturation of 98%, HR 100, RR20 and BP 110/70. The patient was placed on a medical cot for about 20-minutes (supine position) and recovered without the need of administering any medication. At 12:30pm. the patient left the facility accompanied by his wife and walking on his own without any assistance.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac death, Death, Myocardial infarction
Clinical narrative: On 3/2/2021, clinic was notified by patient's family that patient had deceased on 2/28/2021 from a heart attack. Unsure of any relation to the Moderna vaccine but reporting for due diligence.
Age: 94.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash across her cheeks, nose, and forehead.  patient went to er 02/26/2021 and was prescribed Cetirizine
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Eye contusion, Periorbital swelling
Clinical narrative: Dark bruise below left eye, puffiness below right eye
Age: 22.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Error: Wrong Dose of Vaccine - Too High
Age: 22.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chills, Diarrhoea, Ear pain, Fatigue, Headache
Clinical narrative: Error: Wrong Dose of Vaccine - Too High
Age: 22.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Incorrect dose administered, Injection site pain, Injection site swelling, Laboratory test, Myalgia
Clinical narrative: Error: Wrong Dose of Vaccine - Too High
Age: 22.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Nausea, Pain in extremity, Pyrexia
Clinical narrative: Error: Wrong Dose of Vaccine - Too High
Age: 22.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chills, Ear pain, Headache, Impaired work ability, Muscular weakness
Clinical narrative: Error: Wrong Dose of Vaccine - Too High
Age: 22.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Neuralgia, Overdose, Pain, Pain in extremity, Pyrexia
Clinical narrative: Error: Wrong Dose of Vaccine - Too High
Age: 75.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chills, Pain
Clinical narrative: chills, achiness
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus
Clinical narrative: Hardness and redness around injection site; REDNESS and ITCHINESS around injection site and extending around and under arm and onto edge of chest area. Anti-itch creme helps, but the itchiness and redness is persisting.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: Nausea & Vomiting
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea, Electrocardiogram ST segment depression, Electrocardiogram T wave inversion, Headache
Clinical narrative: Pt received vaccine and was being monitored following receipt. After ~30 minutes, developed right sided chest pressure with shortness of breath. Used her inhaler, which helped with shortness of breath. EMS was called and patient was transported to the ED where she also endorsed a headache. EKG showed some ST depression with T-wave inversion that was not present in 2008. Patient was monitored for a few hours - had 2 negative troponins and repeat EKG and was discharged home.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Troponin normal
Clinical narrative: Pt received vaccine and was being monitored following receipt. After ~30 minutes, developed right sided chest pressure with shortness of breath. Used her inhaler, which helped with shortness of breath. EMS was called and patient was transported to the ED where she also endorsed a headache. EKG showed some ST depression with T-wave inversion that was not present in 2008. Patient was monitored for a few hours - had 2 negative troponins and repeat EKG and was discharged home.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Error: Wrong Dose of Vaccine - Too High
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: On 3/1/21 the injection site became bright red (2" W x 3 1/2" L)and very slightly swollen.  No change on 3/2/21.  Morning of 3/3/21, redness appears to be starting to fade.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Discomfort, Fatigue, Night sweats, Tremor
Clinical narrative: At 5:30 PM, March 2nd I began severe chills, shaking, and teeth chattering.  My hands were shaking, whole body trembling.  Then around 10 PM I began perspiring.  Very uncomfortable for the night.  This morning I feel okay, a little tired.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Error: Wrong Dose of Vaccine - Too High
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: hurt both times; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, less than a year after receiving Shingles vaccine, the patient experienced pain. On an unknown date, the outcome of the pain was recovered/resolved.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but it was captured as adult as per vaccine indication. The patient received shingle shot in 2019 and stated that it really hurt. This case had been linked with US2021AMR024828 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR024828:same patient
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: redness / at injection site; swelling at injection site/ small amount of swelling; injection site  / area was hot as well; Raah; This case was reported by a consumer and described the occurrence of injection site erythema in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site swelling (1st dose received on 13th June 2019, also experienced injection site erythema and injection site warmth, refer case US2021029258).   On 4th December 2019, the patient received the 2nd dose of Shingrix. On 4th December 2019, less than a day after receiving Shingrix, the patient experienced injection site erythema and injection site swelling. In December 2019, the patient experienced injection site warmth and rash. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site erythema, injection site swelling, injection site warmth and rash were recovered/resolved.   It was unknown if the reporter considered the injection site erythema, injection site swelling, injection site warmth and rash to be related to Shingrix.  Additional details were reported as follows: The patient received the dose in the right arm.  The patient had redness and swelling at injection site presented that same day. It was described as a large red circle and progressed up to the shoulder and down past the elbow with a small amount of swelling.  The area was hot as well.  She sought medical attention on 6th December 2019, medication was provided.  The symptoms were resolved within 10 days. The reporter did not consent to follow-up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021029258:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: I had 2 friends who got shingles after the first shot; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details were reported as follows: The age at vaccination was not reported. Age group was selected as an adult as per vaccine indication. The reporter stated that the patient got shingles after the 1st shot of Shingles vaccine. The information regarding consent to follow up was not reported. No other information was available. The case had been linked with US2021AMR041553 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR041553:Same reporter. Friend 1/2
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: My arm was really sore; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination were not reported. The age group was captured as adult as per vaccine indication. The patient got the shot and no problems but arm was really sore for a few days but now it was fine at the time of reporting.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pain, Pruritus, Pyrexia, Rash
Clinical narrative: Chills; Fever; Itching; Stinging; Rash; This case was reported by a consumer via call center representative and described the occurrence of rash in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2020-2021 season) for prophylaxis.   Previously administered products included Shingrix (1st dose received on unknown date).   In October 2020, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml and Influenza vaccine Quadrivalent 2020-2021 season (intramuscular). In October 2020, 3 days after receiving Shingrix and Influenza vaccine Quadrivalent 2020-2021 season, the patient experienced rash, chills, fever, pruritus and stinging. On an unknown date, the outcome of the rash, chills, fever, pruritus and stinging were recovered/resolved.   It was unknown if the reporter considered the rash, chills, fever, pruritus and stinging to be related to Shingrix and Influenza vaccine Quadrivalent 2020-2021 season.  Additional details were provided as follows: The patient received dose of Shingrix during the first week of October (unknown day). The patient received the shingrix and Flu vaccine on unknown deltoid nuscle. The patient experienced experienced rash, chills, fever, itching, and stinging 3 days after vaccination. The reporter stated that the event fever and chills resolved quickly,but rash, itching and stinging lasted between 4-6 weeks but later resolved.  The patient atient provided permission to contact HCP. The reporter consented to follow up. .
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Pregnancy
Clinical narrative: pregnant; 1st dose 19 Jan 2021, received 2nd dose on 12 Feb 2021; A spontaneous report was received from a 33-year old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) 24 days apart and is pregnant.   The patient's medical history included two previous pregnancies. No relevant concomitant medications were reported.  The patient received her first of two planned doses of mRNA-1273 (Batch number: 026L20A) on 19 Jan 2021.  On 12 Feb 2021, the patient received her second of two planned doses of mRNA-1273 (Batch number: 013M20) intramuscularly for prophylaxis of COVID-19 infection.  On 12 Feb 2021, when the patient received her second dose of the Moderna vaccine, the patient was 5 weeks pregnant. The patient's last menstrual period was 10 Jan 2021. The estimated date of conception was not provided. The estimated due date is 17 Oct 2021. The patient received the first and second dose 24 days apart. No treatment information was provided.   The patient received both scheduled doses of mRNA-1273; therefore, action taken with the drug in response to the event is not applicable.  The outcome of the events, pregnancy and inappropriate schedule of vaccine administration, were considered resolved on 12 Feb 2021.; Reporter's Comments: This is a case of product exposure during pregnancy and inappropriate schedule of vaccine administration (Lot # 026L20A and 013M20) with no associated AEs for this 33-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 17 year old received the first injection of the Moderna vaccine; A spontaneous report was received from a consumer concerning a 17-year-old, female patient who received Moderna's COVID-19 (m-RNA-1273) vaccine.  The patient medical history was not provided. No relevant concomitant medication was provided.  The patient received their first of two planned doses of mRNA-1273 (batch number not provide) on 13JAN2021 intramuscularly for prophylaxis of COVID-19 infection.  On 13-Jan-2021, the patient experienced product administered to patient of inappropriate age.  She went back to receive the 2nd dose and was sent home due to being under 18 yo.  Treatment taken was not reported. Action taken was not reported.  The outcome of event was recovered.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age (17 year old female) for mRNA-1273 (lot number unknown) with no associated AEs reported.
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration, Vaccination site discolouration, Vaccination site pain
Clinical narrative: Localized burning; White patch near injection site; Not administered in deltoid, was not at a 90 degree angle; A spontaneous report ), was received from a consumer concerning 55 year old female patient who was administered Moderna's COVID-19 vaccine had experienced burning immediately after injection (PT: vaccination site pain), a white patch near the injection site (PT: vaccine site discoloration), and Incorrect route of product administration. (PT: Incorrect route of product administration)  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 06 Feb 2021, the patient received her first of two planned doses of mRNA-1273 (Batch number unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 06 Feb 2021, the patient experienced localized burning immediately following vaccine administration. The burning subsided after 10 minutes. Once the burning subsided, the patient noted a white patch near the vaccination site that was present for 24 hours.  . Action taken with mRNA-1273 in response to the event(s) was not provided.  The events, localized burning resolved on 06 Feb 2021. The event, white patch near injection site, resolved on 07 Feb 2021.; Reporter's Comments: This report refers to vaccination site pain, vaccination site discoloration and incorrect route of product administration. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded..
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Received the vaccine at 17 years of age; A spontaneous report  was received from a consumer, concerning a 17 year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and who experienced receiving the vaccine at 17 years of age.  The patient's medical history included no relevant adverse event. No relevant concomitant medications were reported.   On 29 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot: number: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 29 Jan 2021, the patient received Moderna COVID-19 Vaccine and he was 17-year-old.  Action taken with the second dose of mRNA-1273 in response to the events was not reported.  The outcome of the event was resolved on 29 Jan 2021.; Reporter's Comments: This case concerns a 17-year-old male patient who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Product administered to patient of inappropriate age without any associated adverse events.
Sex: M
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: Some of the vaccine leaked out as she administered a customer's 1st dose; A spontaneous report  was received from a pharmacist concerning a male patient who had some of the vaccine leaked out as she administered a customer's 1st dose (accidental under dose).  Patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On an unknown date, prior to onset of the event, the patient received their first of two planned doses of mRNA-1273 (Lot/batch: unknown) for prophylaxis of COVID-19 infection.  Some of the vaccine leaked out as she administered a customer1s first dose (accidental under dose).  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not applicable.  The outcome of the event Some of the vaccine leaked out as she administered a customer1s first dose (accidental under dose) was considered resolved.; Reporter's Comments: This case concerns a male patient of unknow age who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting accidental under dose without any associated adverse events.
Sex: U
Vaccine: FLUX
Symptoms: Influenza, Influenza virus test positive, SARS-CoV-2 test
Clinical narrative: flu; Initial information was received on 11-Feb-2021 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional (patient) via media.  This case involves patient (gender and age not specified) who had flu (influenza), after patient received INFLUENZA VACCINE.  Past medical treatment(s), vaccination(s) , concomitant medication and family history were not provided.  It was unknown if the patient had any medical history, concomitant disease or risk factor.   On an unknown date in October, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date were not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date in last week they performed laboratory test: covid test with an unknown result and flu test with result indicating that patient has flu.   On an unknown date, the patient developed a non-serious flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was unknown if the patient experienced any additional symptoms/events.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome of event was unknown.  There will be no information available on the batch number for this case.
Age: 82.0
Sex: F
Vaccine: FLU4
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site rash, Vaccination site warmth
Clinical narrative: 3-inch area of skin that turned bright red; the area was like a hot rash but no itching; the area being hot to the touch; the area feeling like rocks under the skin; Initial information was received on 16-Feb-2021 regarding an unsolicited valid non-serious case was received from a Consumer or Non-healthcare professional via Medical Information (Reference number- 00478096) and transmitted to Sanofi on 16-Feb-2021.  This case involves a 82-year-old female patient who experienced 3-inch area of skin that turned bright red (vaccination site erythema), the area was like a hot rash but no itching (vaccination site rash), the area being hot to the touch (vaccination site warmth) and the area feeling like rocks under the skin (vaccination site induration), while she received vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  Medical history, medical treatment(s), concomitant medications and family history were not provided. The patient's past vaccination(s) included FLUARIX.  On 16-Oct-2020, the patient received 0.7 mL dose (total) of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [lot number not reported and expiry date not provided] via intramuscular route in left arm for prophylactic vaccination.  On 16-Oct-2020, the patient developed non-serious 3-inch area of skin that turned bright red (vaccination site erythema), the area was like a hot rash but no itching (vaccination site rash), the area being hot to the touch (vaccination site warmth) and the area feeling like rocks under the skin (vaccination site induration), on the same day following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  Details of laboratory data were not reported.  The daughter reported that for the first 72-hours after the vaccine administration, was the worst, then the area on the 6th day began going down, that the color had changed back to normal within a week, that the consumer did apply an ice pack to the area, that the ice pack was not felt due to the area being hot, that Arnica cream was applied and it helped; that the prescriber does not feel it was an allergic reaction, that another patient in the clinic reported the same injection site reaction to the FLUZONE Quadrivalent High Dose this year.  On an unknown date, patient had recovered from the events.  The consumer had almost the same reaction with other flu vaccines in the past, that the consumer had reactions for most flu vaccines but the usual reaction is not as visible as the most recent, that she had the reaction with Fluarix, that the consumer is scheduled to get the Moderna COVID-19 vaccine. and that there have been reports of people getting the Moderna COVID-19 Vaccine having reactions on the arm.The daughter wanting to know would a reaction to the Fluzone Quadrivalent High Dose mean a similar reaction with the Moderna COVID-19 vaccine.  There will be no information available on batch number for this case.
Age: 34.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Asthenia, Chills, Headache, Myalgia
Clinical narrative: Shot #1: Sore Arm and felt weak the next day Shot #2: After 12 hours headache, chills, muscle & joint pain, fever, felt like a bad hangover with the the flu. Last for 36 hours.
Age: 34.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Shot #1: Sore Arm and felt weak the next day Shot #2: After 12 hours headache, chills, muscle & joint pain, fever, felt like a bad hangover with the the flu. Last for 36 hours.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased interest, Feeling abnormal
Clinical narrative: moderna COVID-19 vaccine   EUA  mental fogginess.  no physical symptoms.  not tired.    for example,  I usually update my financial records to the nearest dollar.   I left  the information several dollars out of balance.   I lost interest in  personal phone calls after 10  minutes.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Muscle contractions involuntary
Clinical narrative: Frequent fasciculations all over my body, they do not cause pain but are bothersome physically and psychologically.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache, Injection site pain, Nausea
Clinical narrative: headache, severe dizziness, fatigue, slight fever, slight nausea, soreness at injection site
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: headache, severe dizziness, fatigue, slight fever, slight nausea, soreness at injection site
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Unknown
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Pain in extremity, Peripheral swelling
Clinical narrative: Moderna COVID?19 Vaccine EUA Sx appeared 2 days after injection: *Soreness to injection site - lasted x3 days *Underarm pain/swelling - remains ongoing
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot
Clinical narrative: heat and redness throughout entire face
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Face injury, Fall, Nausea, Syncope
Clinical narrative: severe naseau and dizziness fainted 2xs  out 2 minutes injured chin and jaw from falling face first on bathroom tile floor
Age: 1.0
Sex: F
Vaccine: HIBV, PNC13
Symptoms: Pyrexia, Tremor
Clinical narrative: 101 degree fever, irratibility, muscle tremors for 2 days
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Malaise, Pain in extremity, Pyrexia
Clinical narrative: Fever 100.5, injection site arm sore to touch, headache, "feels yucky"
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Dermatitis atopic, Erythema, Pain in extremity, Pruritus, Rash erythematous
Clinical narrative: Pt developed a reddened rash over the left antecubital fossa approx. 10-15 min after she received her vaccination. It was her first dose in the PFIZER series.  Pt received her vaccination in the L arm and started noticing an itchy sensation to the left antecubital fossa. Realized it was reddened and alerted staff. This RN noted reddened rash, approx. 6 inches in length, with one raised hive to area. Pt denied any difficulty breathing or trouble swallowing/speaking. Pt was speaking in full sentences throughout whole event. Pt's vital signs were obtained with HR 70, 97% on room air for oxygenation, and BP 152/88. Pt was given 25mg of Benadryl PO by this RN.  Pt was reassessed at approx. 0804 and noted that the itchiness was going away as well as the rash. She continued to hold conversation and denied any further symptoms. Redness within rash was fading and pt states she just had a slight burning sensation to the area.  Repeat BP was 160/90.  Pt was released home at 0815 with her husband. Rash improved and pt denied any further concerns or symptoms. recommended to get Benadryl to have at home in case needed.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Pt developed a reddened rash over the left antecubital fossa approx. 10-15 min after she received her vaccination. It was her first dose in the PFIZER series.  Pt received her vaccination in the L arm and started noticing an itchy sensation to the left antecubital fossa. Realized it was reddened and alerted staff. This RN noted reddened rash, approx. 6 inches in length, with one raised hive to area. Pt denied any difficulty breathing or trouble swallowing/speaking. Pt was speaking in full sentences throughout whole event. Pt's vital signs were obtained with HR 70, 97% on room air for oxygenation, and BP 152/88. Pt was given 25mg of Benadryl PO by this RN.  Pt was reassessed at approx. 0804 and noted that the itchiness was going away as well as the rash. She continued to hold conversation and denied any further symptoms. Redness within rash was fading and pt states she just had a slight burning sensation to the area.  Repeat BP was 160/90.  Pt was released home at 0815 with her husband. Rash improved and pt denied any further concerns or symptoms. recommended to get Benadryl to have at home in case needed.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Headache
Clinical narrative: Headache on only the left side of the head - treated with Advil 200 mg 4X daily.  Lasted 11 days and was worse late in the day.   Fatigue and weakness for 48 hours.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Exposure during pregnancy, Hypoaesthesia, Hypoaesthesia oral, Immediate post-injection reaction
Clinical narrative: Lost feeling in face, tongue, mouth. Numbness in cheeks - 2 hours after vaccine Metallic taste immediate after vaccine.  Treated with Benadryl.   27 weeks pregnant - Due May 31, 2021.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Sensory loss
Clinical narrative: Lost feeling in face, tongue, mouth. Numbness in cheeks - 2 hours after vaccine Metallic taste immediate after vaccine.  Treated with Benadryl.   27 weeks pregnant - Due May 31, 2021.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Delayed itchiness, redness and soreness at injection site. Lasting approximately 24 hours.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Left arm itchy, hot and swelling
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Headache, Pain
Clinical narrative: Temperature 99.8, headache like my head is in a vice a little achy starting on second day of symptoms
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Lichenification, Limb discomfort, Paraesthesia
Clinical narrative: The vaccine was given in the left arm. The left arm began to tingle and get heavy as expected.  However, during the 15 minute waiting period after receiving the vaccine, the left side of my face began to feel ever so slightly thick and numb. It felt as if I had been to the dentist for a filling a hours ago.  I never lost speech or had a discernable facial deformity, but the numbing caught me off guard.   The facial feeling faded in about the same manner as the arm recovery.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Computerised tomogram, Magnetic resonance imaging
Clinical narrative: stroke occurred five days after receiving vaccine.  I was hospitalized overnight in General Hospital.  Have had two MRI's.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site reaction, Rash papular
Clinical narrative: Today, March 3, 2021, Day 10, I woke with a red, raised rash surrounding the injection site.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Skin discolouration, Skin exfoliation, Urticaria
Clinical narrative: 10 days after vaccine, I developed random hive like rash on my arms, and back. They were circular in shape, sometimes itchy and some were flaky. They would get darker in color as time pasted. The hive like rash was the worst on my arms and my flanks. A few were on my legs but a lot less, compared to my arms. I took methylprednisolone and hydroxyzine. A month later they are present, however they are fading away but no new ones are present.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Vaccination complication
Clinical narrative: Covid arm, headache, body aches
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Appendicectomy, Appendicitis, Chills, Computerised tomogram abdomen abnormal
Clinical narrative: Approximately thirteen hours after I received my second dose of the vaccine I started having cramping in my abdomen.  The cramping got increasingly worse and I started to get really bad chills.  The cramping feeling turned into a stabbing pain and reached a threshold that I could no longer stand so my husband had to drive me to the ER.  I have never been in so much pain.  Once it the ER I received medicine for the pain and a CT scan that revealed that I had appendicitis and needed to have it removed with an appendectomy.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Pharyngeal swelling, Swelling face
Clinical narrative: Swelling of face and throat, did not require epinephrine. Treated with steroids and allergy medications.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Moderna Covid-19 Vaccine EUA  Itching, swelling and heat at  and around injection site
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Dizziness, Headache, Nausea
Clinical narrative: Originally - headache, sore arm, chills, body aches everywhere, sneezing, coughing  For the past 5 days - extreme headache that will not go away along with a feeling of dizziness or nauseousness.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Sneezing
Clinical narrative: Originally - headache, sore arm, chills, body aches everywhere, sneezing, coughing  For the past 5 days - extreme headache that will not go away along with a feeling of dizziness or nauseousness.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: Ran low fever with body aches night of vaccine. Fever gone the next day, but came back about 6PM and went up to 101.5, with hard chills, body aches and headache. Continued all night. Fever broke the next morning and did not return.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Bone pain, Feeling cold, Hypoaesthesia, Injection site reaction
Clinical narrative: Approximately 60 hours after my second injection I was awoken from my sleep with the most intense, excruciating pain in my right arm (arm where the vaccine was injected), It felt like every muscle was being torn off. I had been laying on my back at the time and the pain did not go away by repositioning my arm. The pain would eventually radiate all the way down to my right hand and my ring and pinky fingers experienced numbness as did my right hand which also felt colder than my left hand. The pain also ran up to my shoulder around to my scapula, under my arm and up my neck. The pain still exists today 18 days post vaccine. I have been taking ibuprofen and Tylenol around the clock to alleviate the pain. I also was given a steroid dose pack by my neurologist. Sometimes the pain subsides but it always comes back. Sometimes I still feel like I have been punched in the arm where the injection occurred and other times it is my scapula that is so tender I cannot lay on my back. I have to sleep on my back at night and if I try to roll over on my left side, the side where I was not injected, my right arm feels tingly.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Pain, Pain in extremity, Paraesthesia, Sleep disorder
Clinical narrative: Approximately 60 hours after my second injection I was awoken from my sleep with the most intense, excruciating pain in my right arm (arm where the vaccine was injected), It felt like every muscle was being torn off. I had been laying on my back at the time and the pain did not go away by repositioning my arm. The pain would eventually radiate all the way down to my right hand and my ring and pinky fingers experienced numbness as did my right hand which also felt colder than my left hand. The pain also ran up to my shoulder around to my scapula, under my arm and up my neck. The pain still exists today 18 days post vaccine. I have been taking ibuprofen and Tylenol around the clock to alleviate the pain. I also was given a steroid dose pack by my neurologist. Sometimes the pain subsides but it always comes back. Sometimes I still feel like I have been punched in the arm where the injection occurred and other times it is my scapula that is so tender I cannot lay on my back. I have to sleep on my back at night and if I try to roll over on my left side, the side where I was not injected, my right arm feels tingly.