chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Cellulitis, Injection site discolouration, Injection site erythema, Injection site mass, Injection site pain
Clinical narrative: Got the shot on a Tuesday, had normal side effects (swelling, redness, pain at site). Those side effects were gone by Saturday. Noticed some discoloration of the injection site on Sunday/Monday. By Monday night a small lump and redness had reappeared. Tuesday morning the lump had gotten bigger and hot to the touch, itchy as well. Wednesday even itchier and bigger and hotter. Went to urgent care and was given cephalexin for cellulitis. Today is a Thursday, the itchiness has gone down but the lump is much bigger and still warm to the touch.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Pruritus, Skin warm
Clinical narrative: Got the shot on a Tuesday, had normal side effects (swelling, redness, pain at site). Those side effects were gone by Saturday. Noticed some discoloration of the injection site on Sunday/Monday. By Monday night a small lump and redness had reappeared. Tuesday morning the lump had gotten bigger and hot to the touch, itchy as well. Wednesday even itchier and bigger and hotter. Went to urgent care and was given cephalexin for cellulitis. Today is a Thursday, the itchiness has gone down but the lump is much bigger and still warm to the touch.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: REDNESS, SWELLING AND ITCHING AT THE VACCINE SITE.  INSTRUCTED TO TAKE OTC BENADRYL.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Nausea, Pain, Pyrexia
Clinical narrative: Head ache, low grade fever, body/muscle aches, fatigue, nausea
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Chest discomfort, Chills, Dizziness
Clinical narrative: Moderna COVID-19 Vaccine EUA.  I had a fast heartbeat of 130bpm, chest tightness, dizziness and weakness as well as fatigue, headache, muscle pain, joint pain, uncontrollable shaking and chills, nausea and fever of 101.4
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Heart rate increased, Myalgia, Nausea
Clinical narrative: Moderna COVID-19 Vaccine EUA.  I had a fast heartbeat of 130bpm, chest tightness, dizziness and weakness as well as fatigue, headache, muscle pain, joint pain, uncontrollable shaking and chills, nausea and fever of 101.4
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Moderna COVID-19 Vaccine EUA.  I had a fast heartbeat of 130bpm, chest tightness, dizziness and weakness as well as fatigue, headache, muscle pain, joint pain, uncontrollable shaking and chills, nausea and fever of 101.4
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Immediate post-injection reaction, Rash
Clinical narrative: presented to vaccine clinic - received vaccination and while waiting - observer noted person was swallowing  frequently and asked if she was doing okay - she stated she felt a pressure in her chest "like my asthma" - relayed she thought she needed some Benadryl.  Person was masked - observing staff asked for her to remove her mask and they noted where her mask was a pink to red outline of a fine rash.  Person was subsequently taken to the ED for further evaluation and any needed treatment.    ED notations:  Patient is a pleasant 57 year old female  with a history of asthma, eczema, obesity, LE edema presenting for vaccine reaction. Patient states she was upstairs at SCB getting her first COVID shot. She was sitting in the waiting area after receiving injection and noted to have sensation of chest tightness "similar to my asthma" within 10 minutes of receiving the vaccine. She was noted by nursing staff to also have redness to her face. Patient denied any difficulty breathing or swallowing, no raised rash/bumps to her face or body, no palpitations or fast heart rate, no swelling more than her usual baseline LE edema. She denies headache, feeling light headed, nauseous, or any symptoms of abdominal discomfort. Patient has a history of allergies to sulfa drugs and seasonal allergies, no food allergies/intolerances, or previous reactions to vaccines. Patient was determined to not be in anaphylactic shock but did have immediate symptoms after injection suggesting an allergic Type I hypersensitivity, redness and sensation in her chest improved with 50 mg of benadryl.  The patient was reassured after an observational period of about 1 hour and no additional symptoms. She was notified that CDC guidelines are that even with a mild allergic reaction to the vaccine, that she should avoid getting the 2nd in series, continuing to practice other preventative measures against COVID, maintaining social distance and wearing a mask.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Diarrhoea, Dizziness, Fatigue, Headache
Clinical narrative: Started with pain at site, then fatigue, dizziness. Extreme headache for 24 hours -  Bodyaches, joint pain, nausea, diarrhea
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Nausea, Pain
Clinical narrative: Started with pain at site, then fatigue, dizziness. Extreme headache for 24 hours -  Bodyaches, joint pain, nausea, diarrhea
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Erythema, Fatigue, Nausea
Clinical narrative: 2 inch diameter red mark area that was warm, hurt to touch, and lasted 5 days. Received vaccine on Friday, woke up Saturday morning with a fever of 102.3, chills, body aches, cough, fatigue and nausea. Ended up getting Covid tested on Monday, and tested positive because my cough and fatigue would not go away.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Skin warm, Tenderness
Clinical narrative: 2 inch diameter red mark area that was warm, hurt to touch, and lasted 5 days. Received vaccine on Friday, woke up Saturday morning with a fever of 102.3, chills, body aches, cough, fatigue and nausea. Ended up getting Covid tested on Monday, and tested positive because my cough and fatigue would not go away.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash pruritic
Clinical narrative: Itchy Rash on Stomach, and legs
Age: 51.0
Sex: M
Vaccine: UNK
Symptoms: Pain in extremity
Clinical narrative: I was able to receive the Moderna Vaccine on 1/19/2021 and have schedule my second shot on 2/27/2021. The last two days, I have had left arm soreness. Wear the Shot was administered!
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Extreme Fatigue
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Nodule, Pruritus, Swelling
Clinical narrative: redness, swelling, itching, growing lump ONE WEEK AFTER vaccine was administered.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: The patient developed a rash at the injection site on 1/20/21, after having the vaccine on 1/12/21. She stated that it was itchy and that it was slightly raised. The patient stated the rash has stopped itching some yesterday but was starting to itch again today. She stated that it was not itching severely and she didn't feel as though she needed to "dig" at the location. She had not tried to treat the rash yet.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chest discomfort, Electrocardiogram, Full blood count, Metabolic function test
Clinical narrative: Tightness in chest , Hives, weakness,  required visit to E.R. Given IV Benadryl Pepcid, prednisone
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Troponin I, Urticaria
Clinical narrative: Tightness in chest , Hives, weakness,  required visit to E.R. Given IV Benadryl Pepcid, prednisone
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Injection site is very swollen, red, and tender to the touch.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: 1 week after injection, my left arm started itching. Medium sized bumps appeared around injection site. Warm to touch. 12 hours later, medium bumps merged into one large approx. 2" bump that is red, tender, and warm to touch.
Age: 61.0
Sex: F
Vaccine: UNK
Symptoms: Anxiety, Eye swelling, Feeling abnormal, Hypoaesthesia, Hypoaesthesia eye
Clinical narrative: Immediately I had a taste in my mouth I did not have with first vaccine and I felt very strange. Almost like will I pass out? I reported to firefighter he said I was most likely anxious. I drove home and felt different all the way. just kept taking deep breathes. At home about 5:30 ish I started feeling better I had been drinking a lot of water then I realized my left side of my face felt odd.  My eye and Cheek felt numb/swollen I looked in the mirror it did not appear swollen.  Just felt that way. I went to bed at 8:30 woke several times in the night but this morning I can feel a tiny bit in my cheek eye area. nothing like last night. My arm is a little sore but I feel fine.
Age: 61.0
Sex: F
Vaccine: UNK
Symptoms: Immediate post-injection reaction, Pain in extremity, Presyncope, Swelling face, Taste disorder
Clinical narrative: Immediately I had a taste in my mouth I did not have with first vaccine and I felt very strange. Almost like will I pass out? I reported to firefighter he said I was most likely anxious. I drove home and felt different all the way. just kept taking deep breathes. At home about 5:30 ish I started feeling better I had been drinking a lot of water then I realized my left side of my face felt odd.  My eye and Cheek felt numb/swollen I looked in the mirror it did not appear swollen.  Just felt that way. I went to bed at 8:30 woke several times in the night but this morning I can feel a tiny bit in my cheek eye area. nothing like last night. My arm is a little sore but I feel fine.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Rash
Clinical narrative: Got rash from groan to my neck started last night around 5:00 pm, had dizziness that started this morning.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site reaction, Rash erythematous, Rash papular
Clinical narrative: Raised red rash at injection site
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Redness outline rash oval 4 inches wide, 5 inches long around injection site. Warm to touch, initially itchy. Outline 0.5 inches wide, color pink and slightly raised, interior skin a little more yellow than normal.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Injection site bruising, Injection site erythema
Clinical narrative: Moderna COVID-19 Vaccine EUA that day of the vaccine, my right arm was sore, the area was red, warm to touch, and itching. about 30 hours after the vaccine, I hade fatigue, extreme body aches, chills, headache, and my arm still had the above reactions. this continued every evening until 1/17/21. at that time my arm where the shot was given was discolored (purplish looked like a bruise) and was flat. then on 1/21/21 I woke up and the area where the injection was given my arm was bright red, warm to touch, raised and itching.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site pruritus, Injection site warmth, Pain
Clinical narrative: Moderna COVID-19 Vaccine EUA that day of the vaccine, my right arm was sore, the area was red, warm to touch, and itching. about 30 hours after the vaccine, I hade fatigue, extreme body aches, chills, headache, and my arm still had the above reactions. this continued every evening until 1/17/21. at that time my arm where the shot was given was discolored (purplish looked like a bruise) and was flat. then on 1/21/21 I woke up and the area where the injection was given my arm was bright red, warm to touch, raised and itching.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Nausea, Pain
Clinical narrative: EE received 2nd vaccine 1/20 0745 and began having s/s at 5pm: HA, nausea, fatigue, chills, body aches.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: fever 103, body aches, chills, joint pain, fatigue,  headache started 8:30 pm on day of vaccine.  Fever all night.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: acute voluminous diarrhea starting ~ 6 hours after vaccination, treated with conservative measures. improving by Day #3
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site pain
Clinical narrative: 1. severe headache began 2.5-3 hours after vaccination that lasted over 16 hours  2. soreness at injection site
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Eczema
Clinical narrative: Exacerbation of Eczema
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site warmth, Myalgia, Peripheral swelling
Clinical narrative: Delayed response at the injection site.  Initial muscles soreness at the injection site in the first 24 hours but then no other immediate side effects. Day 7 some let arm swelling and heat at the injection site appear.  Contacted my primary care and was informed what to look for and if it gets worse contact again or if it last more than 2 weeks post vaccine.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: On the early morning hours of Monday was woken up out my sleep. I had serve diarrhea for 5 hours  and then it stopped.  Has been fine every chance.   **believes that Moderna vaccine has Polyethylene Gylcol in it and wants a warning added that if you take Miralax daily to not take before/after receiving vaccine.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site rash
Clinical narrative: Mild rash at area of injection site
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Pain, Pyrexia
Clinical narrative: Started with fatigue about 4.5-5 hours after injection then low grade fever. (99 deg) Fever reduced with ibuprofen. About 12 hours after injection fever spiked to 100.7 deg with chills and body aches. Took ibuprofen but didn't reduce fever so an hour later took tylenol and then temp came down. Following day had low grade fever about 99 deg controlled with aspirin as needed and third day low grade fever in the morning only. Symptoms completely gone after that.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Neck pain, Pain in extremity, Pyrexia
Clinical narrative: fever 101-102 chills headache  sore neck sore left arm fogginess
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Pain in extremity, Restlessness
Clinical narrative: Had first injection in the upper left arm and now arm is still extremely sore and makes for restless sleep. Second injection done in right arm and know soreness except slight at injection site if touching it.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Chest X-ray, Chest pain, Hyperhidrosis, Loss of personal independence in daily activities
Clinical narrative: In less than 60 seconds, I became Diaphoretic, had substernal chest pain radiating to back, nausea and eventual vomiting. This lasted for a long period of time, I asked to go to ER because I was so alarmed. I felt great all day prior to injection. I had been at work as a nurse with Mobile County Public School System, until I came to get vaccination .
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Vomiting
Clinical narrative: In less than 60 seconds, I became Diaphoretic, had substernal chest pain radiating to back, nausea and eventual vomiting. This lasted for a long period of time, I asked to go to ER because I was so alarmed. I felt great all day prior to injection. I had been at work as a nurse with Mobile County Public School System, until I came to get vaccination .
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, COVID-19, Cough, Fatigue
Clinical narrative: Patient developed COVID infection 48hrs after vaccination. Lost sense of smell/taste and this progressed to cough, fever, chest congestion, fatigue, body aches, headaches.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain, Pyrexia, Respiratory tract congestion, SARS-CoV-2 test positive
Clinical narrative: Patient developed COVID infection 48hrs after vaccination. Lost sense of smell/taste and this progressed to cough, fever, chest congestion, fatigue, body aches, headaches.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea, Vertigo
Clinical narrative: Vertigo, dizziness nausea
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Dizziness, Dry mouth, Loss of personal independence in daily activities, Nasopharyngitis
Clinical narrative: I received the vaccine on Thursday 1-14-21, on Saturday I started feeling very thirsty and then severe dry mouth and cold on Sunday and Monday. I just made sure to stay hydrated.  On Tuesday I felt better but when I got up on Wednesday morning, I felt dizzy.  It progressed into the day and became worse.  I had to go  home from work and was unable to drive.  Today, I feel slightly better but still dizzy if I get up quickly.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Thirst
Clinical narrative: I received the vaccine on Thursday 1-14-21, on Saturday I started feeling very thirsty and then severe dry mouth and cold on Sunday and Monday. I just made sure to stay hydrated.  On Tuesday I felt better but when I got up on Wednesday morning, I felt dizzy.  It progressed into the day and became worse.  I had to go  home from work and was unable to drive.  Today, I feel slightly better but still dizzy if I get up quickly.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st and 2nd dose of Shingrix at less than recommended interval; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not provided but selected as adult as per vaccine indication. The patient received 1st and 2nd dose of Shingrix at less than recommended interval, which led to shortening of vaccination schedule.  The reporter wanted to know how to proceed further. The reporter consented to follow up. No details from patient or vaccination and no further details were provided.
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Wrong product administered
Clinical narrative: Second dose Moderna COVID-19 Vaccine administered 7 days after first dose; First dose received Pfizer COVID-19 Vaccine; A spontaneous report was received from a healthcare professional concerning a 34-years old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced inappropriate schedule of product administration and product use issue.   The patient's medical history and relevant concomitant medications were not reported.   On 17 Dec 2020, the patient had received their first dose of the Pfizer COVID-19 vaccine.    On 23 Dec 2020, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection and experienced inappropriate schedule of product administration and product use issue. No side effects were observed, and no treatment information was provided.  Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the event, inappropriate schedule of product administration, was resolved on 23 Dec 2020, and the outcome of the event, product use issue, was resolved on 17 Dec 2020.; Reporter's Comments: This case concerns a 34 year old, female patient.  The patient's medical history is not provided.  The event occurred on 23 Dec 2020 when the patient received the first dose of the mRNA-1273. This report refers to a case of wrong product administered and out of specification product use where mRNA-1273 has been administered to the patient, who had received the first dose of Pfizer COVID-19 vaccine.  There was no reported adverse reaction associated with this case.
Age: 44.0
Sex: U
Vaccine: COVID19
Symptoms: Incorrect dose administered, Syringe issue
Clinical narrative: Partial dose injection; Syringe leaked; A spontaneous report was received from a pharmacist concerning a 44 year old patient who received Moderna's COVID-19 Vaccine (mRNA-1273)and experienced a partial dose injection.   The patient's medical history and relevant concomitant medications were not reported.   On 29 Dec 2020 the patient received their first of two planned doses of mRNA-1273 intramuscularly  for prophylaxis of COVID-19 infection.   While the dose was being administered, some of the vaccine leaked out and caused a partial dose injection  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the event partial dose injection was recovered/resolved.; Reporter's Comments: This report refers to a case of Incorrect dose administered and syringe issue for mRNA-1273, lot # unknown. There were no reported AEs associated with this case of Incorrect dose administered and syringe issue.
Age: 8.0
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product administered to patient of inappropriate age
Clinical narrative: Immunized at age 8; Administered vials that were exposed to room temperature for more than 12 hours; A spontaneous report was received from a physician concerning an 8-year-old patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the events, immunized at age 8 and administered vials that were exposed to room temperature for more than 12 hours.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 04 Jan 2021, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On 04 Jan 2021, the patient received a vaccine dose of mRNA-1273 that had been left at room temperature more than 12 hours. It was originally thought that the freezer which stored the mRNA-1273 vaccine died on 04 Jan 2021 at 2am, so vaccine administration occurred up until 2pm. After checking freezer temperature logs, it was discovered the freezer had died at 1:11am. Treatment for the events was not provided.   Action taken with mRNA-1273 in response to the events was not provided.   The events, immunized at age 8 and administered vials that were exposed to room temperature for more than 12 hours, were considered resolved on 04 Jan 2021.; Reporter's Comments: This case concerns a 8-year old patient, who was administered the first dose of mRNA-1273 from the vials that were exposed to room temperature for more than 12 hours. This report refers to a case of Product storage error  and Product administration error for mRNA-1273, where out of specification product was administered to the patient of inappropriate age.
Age: 14.0
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product administered to patient of inappropriate age
Clinical narrative: Immunized at 14 years old; Administered vials that were exposed to room temperature for more than 12 hours; A spontaneous report was received from a physician concerning an 14-year-old patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the events, immunized at age 14 and administered vials that were exposed to room temperature for more than 12 hours.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 04 Jan 2021, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On 04 Jan 2021, the patient received a vaccine dose of mRNA-1273 that had been left at room temperature more than 12 hours. It was originally thought that the freezer which stored the mRNA-1273 vaccine died on 04 Jan 2021 at 2am, so vaccine administration occurred up until 2pm. After checking freezer temperature logs, it was discovered the freezer had died at 1:11am. Treatment for the events was not provided.   Action taken with mRNA-1273 in response to the events was not provided.   The events, immunized at age 14 and administered vials that were exposed to room temperature for more than 12 hours, were considered resolved on 04 Jan 2021.; Reporter's Comments: This report refers to a case of Product administered to patient of inappropriate age and Out of specification product use for mRNA-1273. There were no reported AEs associated with this case.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error, Product temperature excursion issue
Clinical narrative: Vaccinated with vial that might have had a temperature excursion; Vaccinated with vial that might have had a temperature excursion; Vaccinated with vial that might have had a temperature excursion; A spontaneous report  was received from a nurse concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and was vaccinated with vial that might have had a temperature excursion.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 22 Dec 2020, the nurse reported a shipment was received. The vial arrived frozen and was placed in a freezer at recommended temperature.   On 02 Jan 2021, the freezer had failed, and the temperature alarm system did not alert anyone. It was noted that the freezer temperature at 5:50 AM was -5 degrees Celsius (C), at 7:50 AM the freezer was a 1.5 C. It remained between from 9.7 C at 12:51 PM then went to 8.3 C at 1:51 PM then down to -8.7 C at 2:51 PM.  On 03 Jan 2021 8:45 PM, the freezer returned to its normal temperature of -20.9 C, -1 C then went to 5.5 C at 11:56 PM.  On 04 Jan 2021, the temperature climbed to 19.4 C. On the same day, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025J20-2A, 025L20A, or 027L20A) intramuscularly for prophylaxis of COVID-19 infection and experienced vaccination with vial that might have had a temperature excursion  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, vaccinated with vial that might have had a temperature excursion, was considered resolved on 04 Jan 2021.; Reporter's Comments: This report refers to a case of out of specification product use, product temperature excursion issue, and product storage error for mRNA-1273. There were no reported AEs associated with this case.
Sex: F
Vaccine: DTP
Symptoms: Anaphylactic reaction
Clinical narrative: anaphylactic reaction to DPT vaccine made with horse serum; Initial information regarding an unsolicited valid serious case received from non-healthcare professional (consumer) from Pfizer (Reference number: 2021013116) on 11-Jan-2021.  This case involved a female patient aged an approximately 3 to 4 year at around years 1964 or 1966 who experienced anaphylactic reaction (Anaphylactic reaction) to DIPHTHERIA, TETANUS AND NOS PERTUSSIS VACCINE made with horse serum.  Medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect DIPHTHERIA, TETANUS AND NOS PERTUSSIS VACCINE produced by unknown manufacturer (lot number and expiry date were not reported) via an unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, it was reported that the patient developed a serious anaphylactic reaction to DIPHTHERIA, TETANUS AND NOS PERTUSSIS VACCINE made with horse serum (Anaphylactic reaction).  No relevant laboratory details were provided.  The event of anaphylactic reaction was assessed as medically significant as per important medical event list.  It was not reported if the patient received a corrective treatment.  Outcome of the event of anaphylactic reaction was unknown.  There will be no information available on the batch number for this case.; Sender's Comments: This case involves an approximately 3 to 4 year old female patient who presented with anaphylactic reaction after receiving DIPHTHERIA, TETANUS AND NOS PERTUSSIS VACCINE produced by unknown manufacturer. Time to onset is unknown. Although, medical history, comorbidities, concomitant medications, additional information on investigations ruling out other etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.
Sex: U
Vaccine: FLUR4
Symptoms: Expired product administered
Clinical narrative: child was given an expired flu vaccine of a December 2020 expire date with no adverse event; Initial information was received on 07-Jan-2021 regarding an unsolicited valid non-serious case from a physician via other health care professional.  This case involved a child patient of unknown age who child was given an expired INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (PRE-FILLED SYRINGE) of a December 2020 expire date (expired product administered) (lot number: unknown and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  Medical history, Past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications were not reported.  It was an actual medication error due to expired vaccine used (latency: unknown).  At the time of report, no adverse event was reported.  It was not reported if the patient received a corrective treatment.  Disclaimer: This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available regarding batch number in this case.
Age: 3.0
Sex: F
Vaccine: DTAP
Symptoms: Erythema, Injection site nodule, Peripheral swelling, Skin warm
Clinical narrative: arm turned red with slight swelling; arm turned red; hot to the touch; injection site developed a knot that grew; Initial information was received on 12-Jan-2021 regarding an unsolicited valid non-serious from a physician via other health care professional.  This case involves a 03-Year-old female patient whose arm turned red with slight swelling (vaccination site swelling), arm turned red (vaccination site erythema), hot to the touch (vaccination site warmth) and injection site developed a knot that grew (vaccination site mass), while being received vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  Medical history, past medical treatment, vaccination, family history and concomitant medication were not reported.  Concomitant medications were not reported.  On 07-Jan-2021, the patient received a dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (batch number and other dosing details were not reported) at an unknown dose via unknown route and unknown administration site for prophylactic vaccination.  On an unknown date, (latency: unknown) after starting the suspect vaccine therapy, patients arm turned red with slight swelling (vaccination site swelling), arm turned red (vaccination site erythema), hot to the touch (vaccination site warmth) and injection site developed a knot that grew (vaccination site mass).  No laboratory data was reported.  Outcome of the events was reported as unknown.  There will be no information available regarding batch number in this case.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram, Heart rate increased, Muscle spasms, Pain, Pain in extremity
Clinical narrative: Received vaccination #2 1/18/21 at 1000am. Dr. appointment at 1pm. EKG no known abnormalities. 1530 feet achy R arm where got shot - had muscle spasms in back, Body aches, heart rate 110. 1/19/21-worked 1/19/21 no muscle spasms.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Vomiting
Clinical narrative: 24 hours post 2nd vaccine, vomiting, HA, fatigue
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Dysphonia, Musculoskeletal discomfort
Clinical narrative: Post vaccination symptom timeline 5 min- change in voice, no other symptoms, pt attributed to anxiety 7 min- could feel a sensation in her neck, but was not concerned about it 10min- was observed taking a occasional deep breath and change in swallowing was observed, Pt was given 50mg of Diphenhydramine orally 12 min- patient acknowledged she was starting to have difficulty swallowing. EMS was activated 16 min- EMS arrived and took over care.  Patient was transported to hospital  Received a message several hours later that patient had recovered and was doing fine
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Injection site pain, Loss of personal independence in daily activities, Nausea, Pyrexia
Clinical narrative: Mild nausea started around 6pm, 10 hours after initial dose. Chills started around 10:30pm and progressed to a 103 degree fever by 12:00am. Fever and chills persisted for the next 12-14 hours preventing me from going in to work.  Nausea became noticeable again as the chills subsided. Fever broke around 6:00pm the next day, 01/20/2021.  Significant soreness at the injection site was present almost immediately and through 01/20/2021
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Hyperhidrosis, Immediate post-injection reaction, Tachycardia
Clinical narrative: Patient reported feeling dizzy immediately after receiving vaccine. Patient reported dizziness resolved within 15 minute in observation area. Patient went back to work area, and felt "very faint", tachycardia, dizzy and diaphoretic after 30 minutes. Patient placed a cool rag on face and symptoms resolved shortly after.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Exposure during pregnancy
Clinical narrative: G2P1; 19 weeks pregnant; employee felt dizzy and lightheaded after receiving her vaccine.  employee given water and Cheez-Its and reported feeling much better.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Tongue discomfort
Clinical narrative: Patient complaint of extreme metal taste in mouth and burning on tongue.   25 mg of Benadryl po given.  Pt. waited 30 minutes after Benadryl and released by Dr. via telephone.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Fatigue, Impaired work ability, Nasopharyngitis
Clinical narrative: BODY ACHES, COLD CHILLS, STOMACH PAIN,  BAD FATIGUE
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: BODY ACHES, COLD CHILLS, STOMACH PAIN,  BAD FATIGUE
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Fatigue, Headache, Pain in extremity
Clinical narrative: Arm soreness, headache, dry cough, tiredness, possible AFIB.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac arrest, Chest X-ray abnormal, Death, Lung infiltration, Pyrexia
Clinical narrative: Patient developed 104.4 temp approximately 48 hours after being given the vaccine. I treated him with antibiotics, IV fluids, cooling methods. CXR does show a new right perihilar infiltrate. However, his fever came down within the next 24-48 hours. Unfortunately, he suffered a cardiac arrest on 1/21/21 in the early morning and expired.
Age: 57.0
Sex: F
Vaccine: UNK
Symptoms: Fatigue, Headache
Clinical narrative: tired and headache
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Injection site pain, Nausea
Clinical narrative: Body aches/joint pain, chills, nausea, fatigue, injection site muscle soreness
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Body aches/joint pain, chills, nausea, fatigue, injection site muscle soreness
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: Fever and chills
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Head discomfort, Headache, Lymph node pain
Clinical narrative: High Fever 102 Severe Headache Malaise / brain fog Chill Body Ache Exhaustion Swollen and tender lymph nodes in neck on left side Symptoms lasted for 3 days Today is day  4 and I still have Malaise, swollen lymph nodes and pressure in my head.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Malaise, Pyrexia
Clinical narrative: High Fever 102 Severe Headache Malaise / brain fog Chill Body Ache Exhaustion Swollen and tender lymph nodes in neck on left side Symptoms lasted for 3 days Today is day  4 and I still have Malaise, swollen lymph nodes and pressure in my head.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: 1/20 staff member reported to employee health that she was advised by her own PCP to not get the second Covid vaccination. She reports she developed an all over body rash and itching 2 weeks after her Covid vaccination and contacted her PCP - they advised Benydryl and that she should not receive her second vaccination In speaking with her - she is open to speaking to VAERS staff to relay her experience She reports she did not experience any issues immediately post vaccination
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Myalgia, Pyrexia
Clinical narrative: "fever 101, severe headache, myalgias, symptoms resolved over 36 hours"
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Nausea, SARS-CoV-2 test negative, Vertigo
Clinical narrative: 1525 - states she is experiencing vertigo. Transported via w/c to private observation area. EMT on site in attendance. Patient able to transfer from chair to w/c without difficulty. States, "my head is swimming and I have nausea"  States she has hx of vertigo but this is different as per statement above. HR 86; BP 148/68; O2 97% on room air. States she drove self, has service dog with her. States she ate a late breakfast. States she had a COVID test this morning at for pre op biopsy to be done this Friday 1/22/2021. Denies exposure to COVID.  3:50, examined per Dr. Gave patient gatorade and granola bar. Also drank about 2 ounces of water and tolerated with n/v. Ate about 1/4 granola bar.  O2 98%; HR 88 4:02 PERRL - NO nystagmus noted. Tol. 10oz gatorade without n/v. States she has too much nausea to eat anything.  Offered ambulance transport for further evaluation. Patient unsure what to do.  4:05 - Had patient stand up next to w/c. Mobility steady. Patient looking down at her dog without any swaying noted. Patient sat back down.  4:08 Patient ambulated independently to end of hallway. Gait steady, no assistance required. Reached outside doors. No symptoms of vertigo. No n/v. States she will go home and rest. Advised to seek medical attention if vertigo returns. Declined transport to hospital. Left with her service dog to personal vehicle
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Cough, Diarrhoea, Dyspnoea, Injection site erythema
Clinical narrative: CHILLS, FEVER, REDNESS AND PAIN AT INJ SITE; ITCHING AT INJ SITE; COUGH; SOB; UPPER RESPIRATORY SYMPTOMS; DIARRHEA TOOK IBUPROFEN, DAYQUIL; NYQUIL TO TREAT SYMPTOMS.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Pyrexia, Respiratory symptom
Clinical narrative: CHILLS, FEVER, REDNESS AND PAIN AT INJ SITE; ITCHING AT INJ SITE; COUGH; SOB; UPPER RESPIRATORY SYMPTOMS; DIARRHEA TOOK IBUPROFEN, DAYQUIL; NYQUIL TO TREAT SYMPTOMS.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Left Heal became gradually painful especially to weight bearing about 3 hours after vaccine.  No other symptoms.  24 hours latter it seems reddened somewhat compared to the right heal.  It is made worse with dorsiflexion of the foot or weight bearing.  It also appears a little swollen.  It does not feel warm to touch.  No sign of foreign body or history of any injury or new increased activity.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Fatigue, Migraine, Pain, Pyrexia
Clinical narrative: Fever, body aches, chills, migraine excessive tiredness
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Dysgeusia, Facial paralysis, Speech disorder, Taste disorder
Clinical narrative: So basically I believe I have Bell's palsy  .  After about an hour after receiving the vaccine I noticed I was having a weird taste in my mouth. Sort of a metallic taste. As the weekend went on it seemed to get worse. Then Monday morning I noticed when brushing my teeth that I wasn?t able to  gurgle my mouth wash. And saw that my mouth and eye seemed to be drooping slightly. Now Thursday the 21st and it seems to be effecting my speech to were I now have a lisp. Can definitely see it when I?m speaking to someone. Which people have commented on.  Not sure what can be done . But at this point I?m hoping it doesn?t get worse. Thanks
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pruritus, Taste disorder
Clinical narrative: Since 1 week after the vaccine she has been experiencing intermittent chills without fever, pruritis from the waist up starting 1/17/21 and changes in her taste with no loss of taste or smell.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Exposure during pregnancy, Myalgia, Oral herpes
Clinical narrative: Currently 9weeks pregnant with expected due date Aug 21 21.  OB office was contacted about reaction and they will continue to monitor during my pregnancy but as of now no signs of harm.  Adverse reaction started with minor muscle aches  then about 12hr after I started with a fever/ chills that got very severe during the night. Finally around 1am/2am the fever started to break.  I took Tyenol 500mg every 4 to 6 hours x 5 doses in the 24hr period.
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Immediate post-injection reaction, Paraesthesia
Clinical narrative: Body numbness and tingling. Pt felt this almost immediately, but it subsided after 10 minutes. He was monitored for a total of 30 minutes and felt fine after that time period.
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Body numbness and tingling. Pt felt this almost immediately, but it subsided after 10 minutes. He was monitored for a total of 30 minutes and felt fine after that time period.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Fatigue, Muscle spasms, Pyrexia
Clinical narrative: Intense back muscle spasms, fever, cough and significant fatigue.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Disturbance in attention, Erythema, Injected limb mobility decreased, Injection site pain, Nausea
Clinical narrative: Extreme pain at and around site within 3 hours. Difficult to use right arm, severe soreness with throbbing aching pain. Total body muscle pain at 12 hours after delivery. Unable to sleep due to uncontrollable shaking and could not lay on injection site. Nauseous, High fever, Swelling, Redness, Fatigue and lack of focus.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Sleep apnoea syndrome, Swelling, Tremor
Clinical narrative: Extreme pain at and around site within 3 hours. Difficult to use right arm, severe soreness with throbbing aching pain. Total body muscle pain at 12 hours after delivery. Unable to sleep due to uncontrollable shaking and could not lay on injection site. Nauseous, High fever, Swelling, Redness, Fatigue and lack of focus.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Radiculopathy
Clinical narrative: Left ulnar nerve irritation. Severe burning when leaning or applying pressure to the forearm
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain
Clinical narrative: Approximately 12.5 hours after vaccine injection for dose #2, experienced muscle aches and chills. Muscle aches and chills throughout body proceeded for 25 hours.  Symptoms resolved at 45 hours post injection on 1/21/21
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy, Movement disorder, Pain
Clinical narrative: Unilateral axillary lymphadenopathy that is painful and tender to the touch. Movements like stretching are difficult and painful. Treating with ibuprofen and heating pad to some improvement, but no sustained benefit. This issue is unresolved and ongoing.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia oral, Paraesthesia oral, Thirst
Clinical narrative: Received vaccine at 10:11AM, COVID-19 Moderna Lot #042L20A  @10:48AM: Provider was called to evaluate 28 y/o female patient complaining of numbness and tingling to both lips. No other adverse event. Patient is awake, alert and oriented x3 @10:51AM: Vital signs: BP - 122/76 HR-61 RR-23 O2 Sat 98%. Patient denies difficulty breathing and difficulty swallowing or chest pain. @10:52AM: Patient states: "I feel extremely thirsty.", "My lips feel like they're swelling but I checked and they are not actually swollen." No signs of anaphylaxis. No visible swelling of lips. @10:54AM: Patient given water, 8 ouces x2 bottles and states; "I feel better." @11:15AM-11:25AM: O2 Sat 99% HR-55 BP-118/70. No difficulty breathing, no visible swelling of lips, bilateral lip numbness almost resolved per patient. @12:05PM: Patient sitting in wheel chair, no signs and symptoms of acute distress. Patient denies numbness and tingling of lips. No signs and symptoms of anaphylaxis. O2 Sat 99% HR-61 BP-116/70. Patient wheeled to driveway and discharged home via private vehicle. Patient's father is the driver of the vehicle.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Skin warm
Clinical narrative: This morning I noticed a pink rash in the shape of a triangle below the vaccine site.  It is slightly warm to touch, does not itch or hurt but is in the shape of a perfect triangle approximately 2 inches large
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: Itchy red rash all over face
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: sore and swollen left arm within a couple hours,  later same day some fatigue, next day some aches, and low grade temperature.  Mild headache started suddenly around 8 hours after injection and continued for about 16 hours.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: sore and swollen left arm within a couple hours,  later same day some fatigue, next day some aches, and low grade temperature.  Mild headache started suddenly around 8 hours after injection and continued for about 16 hours.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Nausea, Pain, Pyrexia, Vomiting
Clinical narrative: Fever, chills, body aches, nausea/vomiting
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Hypoaesthesia, Swelling face
Clinical narrative: Patient received injection at 3:35PM. Called clinic ast 4:15pm from home reporting facial swelling, numbness and difficulty breathing. Sent to ER. Called patient next morning. Reports she received anthistamines and steroids in ER and told to stay home following day. She reports no further symptoms
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Head discomfort, Headache, Hot flush, Oropharyngeal discomfort
Clinical narrative: Patient received injection at 3:35PM. Called clinic ast 4:15pm from home reporting facial swelling, numbness and difficulty breathing. Sent to ER. Called patient next morning. Reports she received anthistamines and steroids in ER and told to stay home following day. She reports no further symptoms
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in jaw, Paraesthesia, Paraesthesia oral, Swelling face, Swollen tongue
Clinical narrative: Patient received injection at 3:35PM. Called clinic ast 4:15pm from home reporting facial swelling, numbness and difficulty breathing. Sent to ER. Called patient next morning. Reports she received anthistamines and steroids in ER and told to stay home following day. She reports no further symptoms