chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain, Pyrexia
Clinical narrative: Fever, fatigue, chills, aches for a few days
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Flushing, Headache, Neck pain, Pyrexia
Clinical narrative: About 30 minutes after my face got flush. It stayed flush, but no temperature on work gun 97.2. Woke up with fever 100.5, joint pain, headache, and little pain in the right side of my neck.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site warmth
Clinical narrative: Redness and an itchy rash (appox 1.5" round)  at the site of the injections. It is also a little warm to the touch.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chronic obstructive pulmonary disease, Condition aggravated, Dyspnoea, General physical health deterioration
Clinical narrative: Following the 2nd dose, patient felt a "heaviness in chest." March 11th, two days post-vaccination, patient was admitted to hospital via ambulance due to shortness of breath-difficulty breathing. Tests were run, and health continued to decline. Doctors suggest an autoimmune reaction due to vaccine, which then exacerbated her COPD. They found fluid inner lungs.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary oedema
Clinical narrative: Following the 2nd dose, patient felt a "heaviness in chest." March 11th, two days post-vaccination, patient was admitted to hospital via ambulance due to shortness of breath-difficulty breathing. Tests were run, and health continued to decline. Doctors suggest an autoimmune reaction due to vaccine, which then exacerbated her COPD. They found fluid inner lungs.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Dizziness, Flushing, Hyperhidrosis
Clinical narrative: dizziness, lightheadiness, flushing, sweating, anxious, offered juice, observation done, symptoms resolved, pt went home
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: None noted.  Followed up today, 5 days after vaccination.  She only had a mildly sore arm.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Headache, Nausea, Pain in extremity, Peripheral swelling
Clinical narrative: left arm from deltoid down the arm painful with extensive swelling/erythema and possible cellulitis so prescribed cephalexin. fever, headache, nausea and vomiting.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: left arm from deltoid down the arm painful with extensive swelling/erythema and possible cellulitis so prescribed cephalexin. fever, headache, nausea and vomiting.
Age: 93.0
Sex: U
Vaccine: COVID19
Symptoms: Agitation, Aspiration, Deafness, Incoherent, Intensive care
Clinical narrative: Caller is pt's son, reporting side-effects/reaction of the father, to Janssen COVID-19 Vaccine. All information collected was by the caller (pt's son) and not by the pt. The pt received the Janssen COVID-19 Vaccine Lot# 1805029 at facility 03/13/2021, time unknown. The following day, 03/14/2021 the pt was speaking incoherently, easily agitated, wasn't speaking to gf. The pt's history of ministrokes lead to the family calling 9-1-1. Pt was admitted to Medical Center on 03/14/2021. Pt vomitted, aspirated, was put on a ventilator, admitted to the ICU for 2-3 days and discharged 03/19/2021.  Pt takes Atorvastatin (Eliquis) 2.5mg bid, Furosemide 20mg qd, Lisinopril 40mg qd, Metropolol tartrate 12.5mg bid, and Folic Acid 1mg qd. Pt has a pacemaker and hypertension. Caller denies pt has any allergies. Currently the pt is only experiencing a loss of hearing. Caller was advised to take pt to primary doctor to have ears and hearing examined. Agent was consulted and Dr. was notified.
Age: 93.0
Sex: U
Vaccine: COVID19
Symptoms: Mechanical ventilation, Speech disorder, Vomiting
Clinical narrative: Caller is pt's son, reporting side-effects/reaction of the father, to Janssen COVID-19 Vaccine. All information collected was by the caller (pt's son) and not by the pt. The pt received the Janssen COVID-19 Vaccine Lot# 1805029 at facility 03/13/2021, time unknown. The following day, 03/14/2021 the pt was speaking incoherently, easily agitated, wasn't speaking to gf. The pt's history of ministrokes lead to the family calling 9-1-1. Pt was admitted to Medical Center on 03/14/2021. Pt vomitted, aspirated, was put on a ventilator, admitted to the ICU for 2-3 days and discharged 03/19/2021.  Pt takes Atorvastatin (Eliquis) 2.5mg bid, Furosemide 20mg qd, Lisinopril 40mg qd, Metropolol tartrate 12.5mg bid, and Folic Acid 1mg qd. Pt has a pacemaker and hypertension. Caller denies pt has any allergies. Currently the pt is only experiencing a loss of hearing. Caller was advised to take pt to primary doctor to have ears and hearing examined. Agent was consulted and Dr. was notified.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Nausea, Oropharyngeal discomfort
Clinical narrative: Patient experienced nausea sensation 10 minutes after receiving the vaccination. After 15 minutes from vaccination administration,  symptoms progressed into labor breathing, difficulty breathing, and throat closing
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Cough, Fatigue
Clinical narrative: Chills, Fatigue, Dry cough
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Back pain, Blood test, Chest pain, Chills
Clinical narrative: The shot was given on Thursday. Flulike symptoms (chills, body aches, nausea, fatigue, headache) and left arm soreness continued through Friday and Saturday. Sunday I was feeling fatigued, but otherwise back to normal. I awoke Monday morning with severe  abdominal pain, shortness of breath, back /chest pain, fever, body aches, vomiting. I went to the Hospital Emergency Department and was subsequently diagnosed and treated for acute pancreatitis (and diverticulitis).
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram abnormal, Diverticulitis, Dyspnoea, Fatigue, Headache
Clinical narrative: The shot was given on Thursday. Flulike symptoms (chills, body aches, nausea, fatigue, headache) and left arm soreness continued through Friday and Saturday. Sunday I was feeling fatigued, but otherwise back to normal. I awoke Monday morning with severe  abdominal pain, shortness of breath, back /chest pain, fever, body aches, vomiting. I went to the Hospital Emergency Department and was subsequently diagnosed and treated for acute pancreatitis (and diverticulitis).
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Lipase increased, Magnetic resonance imaging normal, Nausea, Pain
Clinical narrative: The shot was given on Thursday. Flulike symptoms (chills, body aches, nausea, fatigue, headache) and left arm soreness continued through Friday and Saturday. Sunday I was feeling fatigued, but otherwise back to normal. I awoke Monday morning with severe  abdominal pain, shortness of breath, back /chest pain, fever, body aches, vomiting. I went to the Hospital Emergency Department and was subsequently diagnosed and treated for acute pancreatitis (and diverticulitis).
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pancreatitis acute, Pyrexia, Ultrasound biliary tract, Ultrasound liver normal
Clinical narrative: The shot was given on Thursday. Flulike symptoms (chills, body aches, nausea, fatigue, headache) and left arm soreness continued through Friday and Saturday. Sunday I was feeling fatigued, but otherwise back to normal. I awoke Monday morning with severe  abdominal pain, shortness of breath, back /chest pain, fever, body aches, vomiting. I went to the Hospital Emergency Department and was subsequently diagnosed and treated for acute pancreatitis (and diverticulitis).
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: The shot was given on Thursday. Flulike symptoms (chills, body aches, nausea, fatigue, headache) and left arm soreness continued through Friday and Saturday. Sunday I was feeling fatigued, but otherwise back to normal. I awoke Monday morning with severe  abdominal pain, shortness of breath, back /chest pain, fever, body aches, vomiting. I went to the Hospital Emergency Department and was subsequently diagnosed and treated for acute pancreatitis (and diverticulitis).
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspepsia, Fatigue, Pain in extremity
Clinical narrative: Pain in legs and feet (continues)  Extreme fatigue (continues)  Gastric distress (subsided)
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pyrexia, Tinnitus
Clinical narrative: I had the chills, fever, body aches, headache, and TINNITUS, which was what I saw my physician for.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Muscle tightness, Paraesthesia, Visual impairment
Clinical narrative: Within several minutes of administration, patient expressed feeling lightheaded/"woozy", vision beginning to close off. Also tightness and tingling between her neck and left shoulder.  She was assisted into a prone position with feet elevated.  After some questioning, she was given 3 glucose tablets  and also some water once she felt certain she was improving and unlikely to loose conciousness.  She remained lying down for approximately  25  minutes, at which point she was feeling much better and wanted to try sitting up.  She sat on the floor another 10minutes or so, then moved to a chair where she was monitor approximately 15 more minutes.   She stated at that time that she was feeling "fine", "back to normal" .   She chose to leave at that time, but on request, called the pharmacy within about 35minutes to report that she arrived safely home and still felt fine.  At 2pm, she was contacted to  confirm information for this submission and again stated she felt fine.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Headache, Pain
Clinical narrative: Headache started day of vaccine and persisted to the next day. Body aches started the day after around noon and face felt really hot. I do not have a fever.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Laboratory test normal, Paraesthesia, Vaccination complication, Vaccine positive rechallenge
Clinical narrative: Patient presented to the ER with complaints of tingling and numbness in the left upper and lower extremities along with the left side of her face. She said this lasted 5 minutes the first time and then it happened again when she laid down to go to sleep, lasting about 3 minutes. She noted these same symptoms last month approximately 2 weeks after her first covid vaccine. She was admitted for observation to the facility to rule out stroke/TIA and had negative tests across the board. Physician attributes symptoms to covid vaccine. Pt was discharged in stable condition.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: swollen lymp nodes on left side of her breast.  Started 3 days after receiving her first injection , reported it to me 5 days after injection.  3-23-21
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: tested positive for Covid on 3/22 had vaccine 3/12
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Computerised tomogram head, Contusion, Dizziness, Electrocardiogram normal
Clinical narrative: Fever - 100.4; body aches; mild headache and fatigue. And then about midweek, I was starting to walk downstairs at work and I had to grab onto rails so I wouldn't fall - had become so dizzy. I tried to get into my regular doctor -  he was full until April 5. I went into walk-in clinic - I  had to grab onto a board there (dizzy) and they told me to get to ER. My heart was rapid heart beat by time I got to ER. They had to give me wheelchair so I wouldn't fall over to go into the ER room. Horrible bruising on wrist - because the first IV didn't take. They gave me a bag of fluids - and gave me Meclizine to help dizziness subside and two Tylenols for headache. I'm taking 3  (per day)- 25 mg chewable HCI Meclizine. If symptoms aren't as bad I just take a half of one. Still needing the medication because I still have the pressure in the ear comes up and I need to take the Meclizine and Benadryl to get the pressure to go down.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Heart rate increased, Laboratory test normal, Pain
Clinical narrative: Fever - 100.4; body aches; mild headache and fatigue. And then about midweek, I was starting to walk downstairs at work and I had to grab onto rails so I wouldn't fall - had become so dizzy. I tried to get into my regular doctor -  he was full until April 5. I went into walk-in clinic - I  had to grab onto a board there (dizzy) and they told me to get to ER. My heart was rapid heart beat by time I got to ER. They had to give me wheelchair so I wouldn't fall over to go into the ER room. Horrible bruising on wrist - because the first IV didn't take. They gave me a bag of fluids - and gave me Meclizine to help dizziness subside and two Tylenols for headache. I'm taking 3  (per day)- 25 mg chewable HCI Meclizine. If symptoms aren't as bad I just take a half of one. Still needing the medication because I still have the pressure in the ear comes up and I need to take the Meclizine and Benadryl to get the pressure to go down.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever - 100.4; body aches; mild headache and fatigue. And then about midweek, I was starting to walk downstairs at work and I had to grab onto rails so I wouldn't fall - had become so dizzy. I tried to get into my regular doctor -  he was full until April 5. I went into walk-in clinic - I  had to grab onto a board there (dizzy) and they told me to get to ER. My heart was rapid heart beat by time I got to ER. They had to give me wheelchair so I wouldn't fall over to go into the ER room. Horrible bruising on wrist - because the first IV didn't take. They gave me a bag of fluids - and gave me Meclizine to help dizziness subside and two Tylenols for headache. I'm taking 3  (per day)- 25 mg chewable HCI Meclizine. If symptoms aren't as bad I just take a half of one. Still needing the medication because I still have the pressure in the ear comes up and I need to take the Meclizine and Benadryl to get the pressure to go down.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Head injury, Loss of consciousness, Mobility decreased
Clinical narrative: Pt recieved dose one of Moderna COVID19 Vaccine about 1255pm LOT 046A21A, Exp.9/3/21. Within about 3 min of entering waiting room, pt felt faint/ passed out, hit his head on end table, tried to get up into a seat and lost consciousness again for 1-2 SEC.  Assissted byt wife and NP to the floor. 911 called by PCT, BP 90/52, HR 65, o2 99%. After evaluation per EMS team, pt chooses not to go with EMS to ED for further care, recommended by NP and EMS. Pt chose to go with wife and will go to ED if worsening symptoms. AMA signed for EMS and clinic
Sex: U
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: Any additional adverse experience; Inadvertenly placed into the refrigerator and not the freezer; This spontaneous report Was received from a pharmacist referring to a patient of unknown age and gender. The patient's medical history, concomitant medications, drug allergies, or reactions were not reported.      On 26-JAN-2021, a  zoster vaccine live (ZOSTAVAX) was transported to a nursing home for storage and it was inadvertently placed into the refrigerator instead the freezer and on 03-FEB-2021 was administered to the patient for prophylaxis (dose, frequency, strength, route of administration, lot number, indication and expiry date were not reported) (product storage error).         The patient did not reported any additional adverse experiences.
Age: 15.0
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration
Clinical narrative: No additional AE reported; received first dose at another facility when they were 15 years old in September 2018/now 18 years old and did not complete the series; This spontaneous report has been received from a registered nurse referring to a 15 years old male patient and his twin brother. No information was provided regarding the patient's medical history, concurrent conditions, drug and allergy history or concomitant medications.  On an unknown date in September 2018, the patient received the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (strength, dose, frequency, lot# and expiration date were not provided) for prophylaxis. The reporter stated that at the reporting time, the boyis 18 years old, had not complete the series and missed the second and third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9)(inappropriate schedule of product administration). No additional adverse events were reported.       This is one of two reports from the same reporter (MARRS#2103USA005674 twin brother case).; Sender's Comments:  US-009507513-2103USA005674:
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: 0.5 ml injected; No additional adverse events or quality complaints were reported in this case; 0.5 ml injected; a single dose of ROTATEQ was administered following a temperature excursion on March 12, 2021.; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medication, previous drug reactions, and allergies were not reported.     On 12-MAR-2021, the patient was vaccinated, following a temperature excursion (product storage error), with a single dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot number 1660944, which has been verified to be valid, the expiration date was reported and validated as 16-APR-2021), 0.5 milliliters (ml) injected (incorrect dose administered and incorrect route of product administration), as prophylaxis.  The vaccine was exposed to several temperatures below 2 Celcius (C) degrees (1.68 C and 1.11 C) and above 9 C degrees (8.49 C) for a time frame of 45 minutes, as recorded by digital data logger. There was no previous temperature excursion and no additional adverse events or quality complaints were reported.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Back pain, Chills, Fatigue, Insomnia, Myalgia
Clinical narrative: muscle aches; a rash appeared on his back; has progressed to almost sores; complained of not being able to sleep for 3 days due to it; body aches in back and sides; fatigue; chills; body aches in back and sides; This case was reported by a consumer via call center representative and described the occurrence of general body pain in a 50-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain (also experienced aches in back and sides, chills and fatigue after receiving 1st dose in November 2020, for tolerance refer case US2021030867).   On 29th January 2021, the patient received the 2nd dose of Shingrix. On 31st January 2021, 2 days after receiving Shingrix, the patient experienced rash and skin ulcer. On an unknown date, the patient experienced general body pain, fatigue, chills, back pain, difficulty sleeping and muscle pain. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the general body pain, fatigue, chills, back pain, difficulty sleeping and muscle pain were recovered/resolved and the outcome of the rash and skin ulcer were unknown.   It was unknown if the reporter considered the general body pain, fatigue, chills, back pain, rash, skin ulcer, difficulty sleeping and muscle pain to be related to Shingrix.  Additional details were reported as follows: This case was reported by patient himself. Less than a week after receiving Shingrix, the patient had same symptoms of aches included body aches in back and sides, chills and fatigue presented and were resolved in 2 days. Two days after receiving the vaccine, a rash appeared on his back and it had progressed to almost sores. Less than a week after receiving Shingrix, the patient complained of not being able to sleep for 3 days due to it. The reporter consented to follow-up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021030867:same reporter
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Rash, Skin lesion, Skin ulcer, Vaccine positive rechallenge
Clinical narrative: muscle aches; a rash appeared on his back; has progressed to almost sores; complained of not being able to sleep for 3 days due to it; body aches in back and sides; fatigue; chills; body aches in back and sides; This case was reported by a consumer via call center representative and described the occurrence of general body pain in a 50-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain (also experienced aches in back and sides, chills and fatigue after receiving 1st dose in November 2020, for tolerance refer case US2021030867).   On 29th January 2021, the patient received the 2nd dose of Shingrix. On 31st January 2021, 2 days after receiving Shingrix, the patient experienced rash and skin ulcer. On an unknown date, the patient experienced general body pain, fatigue, chills, back pain, difficulty sleeping and muscle pain. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the general body pain, fatigue, chills, back pain, difficulty sleeping and muscle pain were recovered/resolved and the outcome of the rash and skin ulcer were unknown.   It was unknown if the reporter considered the general body pain, fatigue, chills, back pain, rash, skin ulcer, difficulty sleeping and muscle pain to be related to Shingrix.  Additional details were reported as follows: This case was reported by patient himself. Less than a week after receiving Shingrix, the patient had same symptoms of aches included body aches in back and sides, chills and fatigue presented and were resolved in 2 days. Two days after receiving the vaccine, a rash appeared on his back and it had progressed to almost sores. Less than a week after receiving Shingrix, the patient complained of not being able to sleep for 3 days due to it. The reporter consented to follow-up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021030867:same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Varicella
Clinical narrative: Got a few chicken pox rash around the shot itself; This case was reported by a other health professional via other manufacturer and described the occurrence of chickenpox in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced chickenpox. On an unknown date, the outcome of the chickenpox was unknown.   It was unknown if the reporter considered the chickenpox to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, after vaccination with shingrix, the patient got chicken pox rash around the shot but that was pretty normal. For tolerance of flu vaccine, refer case US2021AMR066247.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR066247:Same reporter US-GLAXOSMITHKLINE-US2021AMR066251:Same reporter
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: COVID-19, Incomplete course of vaccination
Clinical narrative: experienced Covid-19 about 6 months after receiving the first dose; is  on the 6 months window and has not received the second dose yet; This case was reported by a physician via call center representative and described the occurrence of covid-19 in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, 6 months after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced covid-19 and incomplete course of vaccination. On an unknown date, the outcome of the covid-19 and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the covid-19 to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported for 1st dose. The age at vaccination was not applicable for 2nd dose. The patient had Covid-19 about 6 months after receiving the first dose of Shingrix. The patient was on the 6 months window and had not receive the second dose yet. Till the time of reporting, the patient did not received 2nd dose which led to incomplete course of vaccination. The VAERS details were not applicable for 2nd dose of Shingrix vaccine. No other patient or vaccine data was provided. The reporter consented to follow up
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of product administration, Injection site cellulitis, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Developed cellulitis at the injection site; Developed cellulitis at the injection site / red; Developed cellulitis at the injection site / hot to the touch; Developed cellulitis at the injection site / tender to the touch; Injected the vaccine into the fatty tissue of / arm instead of in the muscle; This case was reported by a consumer via call center representative and described the occurrence of injection site cellulitis in a 67-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had shingles infection prior to receiving shingles vaccine).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced injection site cellulitis, injection site erythema, injection site warmth, injection site tenderness and vaccine administered at inappropriate site. The patient was treated with antibiotics nos (Antibiotics Therapy (Unknown)). On an unknown date, the outcome of the injection site cellulitis was recovered/resolved and the outcome of the injection site erythema, injection site warmth, injection site tenderness and vaccine administered at inappropriate site were unknown.   It was unknown if the reporter considered the injection site cellulitis, injection site erythema, injection site warmth and injection site tenderness to be related to Shingles vaccine.  Additional details were provided as follows: The reporter reported by patient herself. The age at vaccination was not reported but could be 64 or 65 years. In 2018 (but she was not 100 percent sure), the patient received Shingles vaccine in the left arm and she thought that the person injected the vaccine into the fatty tissue of her left arm instead of in the muscle, which led to vaccine administered at inappropriate site. After vaccination the patient developed cellulitis at the injection site and the patient described the cellulitis as red, hot to the touch and tender to the touch. The patient stated that she was prescribed an antibiotic and a cream, and the cellulitis resolved in a few days. The reporter consented to follow up.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: sore arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th September 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 6 months after receiving Shingrix, 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 Shingrix.  Additional details were provided as follows: The case was reported by patient himself. The patient received 1st dose and only had sore arm which was resolved on an unknown date. The patient did not consented to follow up. For tolerance with 2nd dose of Shingrix, refer linked case US2021AMR066815.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR066815:same patient (2nd dose)
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Chest pain, Chills, Decreased appetite
Clinical narrative: Under eyes feels like hives; No appetite; Left arm is stiff; Knees, legs and back all hurt; Having some chest pain; Left arm is swollen; Cheeks are puffy; Chills; Head hurts so bad can barley lift it off the pillow; Fainted after vaccine; High blood pressure; A spontaneous report  was received from a consumer concerning a 67-year old female patient, who experienced fainting after vaccine (syncope), high blood pressure, head hurts so bad and can barley lift it off the pillow (headache),  left arm is swollen (peripheral swelling), cheeks are puffy (swelling face), under eyes feel like hives (urticaria), left arm is stiff (limb discomfort), knees, legs and back hurt (pain), chills, no appetite(decreased appetite), and having some chest pain (chest pain).  The patient's medical history included breast cancer, seasonal allergies, and asthma. Products known to have been used by the patient, within two weeks prior to the events, included chemotherapy unspecified (chemo pills for breast cancer).  On 09 Mar 2021, prior to the onset of the events, the patient received the first of the two of their planned doses of mRNA-1273 (Lot number: 027A21A) for prophylaxis of COVID-19 infection.   On 09 Mar 2021, the patient passed out at the facility right after her shot. The patient also reported that her blood pressure was very high, and she was rushed to the hospital for a few hours where vitals got down to stable, and she was sent home.   On 10 Mar 2021, the patient reported that her head hurt so bad and she could barely lift her head off the pillow, her left arm is very swollen, her cheeks are puffy, under her eyes feels like hives, left arm is stiff, knees, legs and back all hurt. The patient also stated having chills, some chest pain,and no appetite.   Treatment information for the events was unknown.  Action taken with mRNA-1273 in response to the events was not provided.  The events, fainting after vaccine (syncope) and high blood pressure were considered as recovered on 09 Mar 2021. The outcomes for the events of  head hurts so bad and can barley lift it off the pillow (headache),  left arm is swollen (peripheral swelling), cheeks are puffy (swelling face), under eyes feel like hives (urticaria), left arm is stiff (limb discomfort), knees, legs and back hurt (pain), chills, no appetite (decreased appetite), and having some chest pain (chest pain) were considered as not recovered.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Limb discomfort, Pain, Peripheral swelling, Swelling face
Clinical narrative: Under eyes feels like hives; No appetite; Left arm is stiff; Knees, legs and back all hurt; Having some chest pain; Left arm is swollen; Cheeks are puffy; Chills; Head hurts so bad can barley lift it off the pillow; Fainted after vaccine; High blood pressure; A spontaneous report  was received from a consumer concerning a 67-year old female patient, who experienced fainting after vaccine (syncope), high blood pressure, head hurts so bad and can barley lift it off the pillow (headache),  left arm is swollen (peripheral swelling), cheeks are puffy (swelling face), under eyes feel like hives (urticaria), left arm is stiff (limb discomfort), knees, legs and back hurt (pain), chills, no appetite(decreased appetite), and having some chest pain (chest pain).  The patient's medical history included breast cancer, seasonal allergies, and asthma. Products known to have been used by the patient, within two weeks prior to the events, included chemotherapy unspecified (chemo pills for breast cancer).  On 09 Mar 2021, prior to the onset of the events, the patient received the first of the two of their planned doses of mRNA-1273 (Lot number: 027A21A) for prophylaxis of COVID-19 infection.   On 09 Mar 2021, the patient passed out at the facility right after her shot. The patient also reported that her blood pressure was very high, and she was rushed to the hospital for a few hours where vitals got down to stable, and she was sent home.   On 10 Mar 2021, the patient reported that her head hurt so bad and she could barely lift her head off the pillow, her left arm is very swollen, her cheeks are puffy, under her eyes feels like hives, left arm is stiff, knees, legs and back all hurt. The patient also stated having chills, some chest pain,and no appetite.   Treatment information for the events was unknown.  Action taken with mRNA-1273 in response to the events was not provided.  The events, fainting after vaccine (syncope) and high blood pressure were considered as recovered on 09 Mar 2021. The outcomes for the events of  head hurts so bad and can barley lift it off the pillow (headache),  left arm is swollen (peripheral swelling), cheeks are puffy (swelling face), under eyes feel like hives (urticaria), left arm is stiff (limb discomfort), knees, legs and back hurt (pain), chills, no appetite (decreased appetite), and having some chest pain (chest pain) were considered as not recovered.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope, Urticaria
Clinical narrative: Under eyes feels like hives; No appetite; Left arm is stiff; Knees, legs and back all hurt; Having some chest pain; Left arm is swollen; Cheeks are puffy; Chills; Head hurts so bad can barley lift it off the pillow; Fainted after vaccine; High blood pressure; A spontaneous report  was received from a consumer concerning a 67-year old female patient, who experienced fainting after vaccine (syncope), high blood pressure, head hurts so bad and can barley lift it off the pillow (headache),  left arm is swollen (peripheral swelling), cheeks are puffy (swelling face), under eyes feel like hives (urticaria), left arm is stiff (limb discomfort), knees, legs and back hurt (pain), chills, no appetite(decreased appetite), and having some chest pain (chest pain).  The patient's medical history included breast cancer, seasonal allergies, and asthma. Products known to have been used by the patient, within two weeks prior to the events, included chemotherapy unspecified (chemo pills for breast cancer).  On 09 Mar 2021, prior to the onset of the events, the patient received the first of the two of their planned doses of mRNA-1273 (Lot number: 027A21A) for prophylaxis of COVID-19 infection.   On 09 Mar 2021, the patient passed out at the facility right after her shot. The patient also reported that her blood pressure was very high, and she was rushed to the hospital for a few hours where vitals got down to stable, and she was sent home.   On 10 Mar 2021, the patient reported that her head hurt so bad and she could barely lift her head off the pillow, her left arm is very swollen, her cheeks are puffy, under her eyes feels like hives, left arm is stiff, knees, legs and back all hurt. The patient also stated having chills, some chest pain,and no appetite.   Treatment information for the events was unknown.  Action taken with mRNA-1273 in response to the events was not provided.  The events, fainting after vaccine (syncope) and high blood pressure were considered as recovered on 09 Mar 2021. The outcomes for the events of  head hurts so bad and can barley lift it off the pillow (headache),  left arm is swollen (peripheral swelling), cheeks are puffy (swelling face), under eyes feel like hives (urticaria), left arm is stiff (limb discomfort), knees, legs and back hurt (pain), chills, no appetite (decreased appetite), and having some chest pain (chest pain) were considered as not recovered.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Death
Clinical narrative: Death; A spontaneous report was received from a consumer concerning a 66-year-old, female patient, who received Moderna's covid-19 vaccine (mRNA-1273) and died.   The patient's medical history included covid-19 infection on 04 Nov 2020. No relevant concomitant medications were mentioned.   On 28 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Batch number:unknown) intramuscularly for prophylaxis of COVID-19 infection.   On 09 Mar 2021, the patient died.  CT was done and did not find any atherosclerosis but found her lungs were whited out,heavily filled with fluid which he described could've been pulmonary edema. She had tested Covid positive back on 04 Nov 2020.    Treatment information was not provided.  Action taken with mRNA-1273 in response to the event was not applicable.  The outcome of the event was fatal.  The patient died on 09 Mar 2021 and the cause of death was unknown. An autopsy was planned on 11 Mar 2021.; Reporter's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.; Reported Cause(s) of Death: Unknown cause of death
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chest pain, Nausea, Pain in jaw
Clinical narrative: Intense enough Chest pain; jaw pain; back pain; nausea; This is a spontaneous report from a contactable consumer.   A 62-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in left arm, on 18Feb2021 at 14:00 (Batch/Lot Number: EL9267) as SINGLE DOSE for covid-19 immunisation   Medical history included hypertension and allergy to penicillin. Concomitant medication and pravastatin (PRAVASTATIN. On 19Feb2021 at 100am, the patient experienced chest pain and jaw pain where she seriously considered going to the ER. Also, the other common side effects of back pain and nausea. The outcome of the events was recovering. The patient was not hospitalized nor was  treatment received.
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Cystitis, Urinary tract infection
Clinical narrative: bladder infection; This is a spontaneous report from a contactable consumer (patient). A 73-year-old non-pregnant female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on an unknown date as a single dose for COVID-19 vaccination. Medical history included cancer from an unknown date. Concomitant medications were not reported. The patient experienced a bladder infection on an unknown date reported as she developed a bladder infection and is "pretty sure I had it before and is not from the Covid shot." The patient underwent a physical in which they took blood work with no results reported and a urine test which revealed a bladder infection, both on an unknown date. Therapeutic measures were taken as a result of the bladder infection which included Bactrim/Septra which was started "yesterday", taken two times a day for three days. The patient is scheduled for the second dose of BNT162B2 the morning after the last dose of Bactrim/Septra. The outcome of the event bladder infection was unknown.    The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dyspepsia, Headache
Clinical narrative: Heartburn starting at 48hr post vaccination; Headache; chills; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 18Feb2021 08:00 (Batch/Lot Number: EL3247) as single dose for covid-19 immunisation at a workplace clinic. Medical history included allergies to sulfur drugs. Prior to vaccination, the patient was diagnosed with COVID-19. Concomitant medications included probiotics, vitamin d [vitamin d NOS] and multivitamin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously had the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot: EL3247) on 28Jan2021 08:00 in the left arm for COVID-19 immunization. The patient experienced heartburn starting at 48hr post vaccination, headache and chills on 20Feb2021 08:00. Since the vaccination, the patient has not been tested for COVID-19. Therapeutic measures were taken as a result of heartburn starting at 48hr post vaccination which included heartburn medicine. The outcome of the events was not recovered.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Circadian rhythm sleep disorder, Fatigue, Insomnia, Poor quality sleep
Clinical narrative: Not being able to sleep at normal bed time; Fall asleep during the day; Circadian rhythm seem to be disrupted; no energy during the day; fatigued; wide awake at 9 to 10pm; This is a spontaneous report from a contactable (consumer). This 67-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EN5318) via an unspecified route of administration in the left arm on 30Jan2021 at 09:15 (at the age of 67-years-old) as a single dose for COVID-19 immunisation. Medical history included psoriatic arthritis from an unknown date and unknown if ongoing. Prior to vaccination the patient was not diagnosed with COVID-19. Concomitant medications included multiple vitamins from unknown dates for unknown indications; the patient also reporting starting ixekizumab (TALTZ) 2 weeks after vaccination for an unknown indication. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient reported not being able to sleep at his normal bedtime and falling asleep during the day; further reporting his circadian rhythm seemed to be disrupted; awake and energetic at night, sleepy and no energy during the day. He reported it started 2 days after the vaccine and had been getting worse. Three weeks since the vaccine he was wide awake at 10PM, normal bedtime, could not sleep until 5 or 6AM then slept for 6 or 7 hours. He reported being wake and very fatigued during the day and getting wide awake at 9 to 10PM. The events were reported as non-serious and did not require hospitalization. Treatment was not provided for the events. The clinical outcomes of not being able to sleep at normal bedtime, falling asleep during the day, circadian rhythm seemed to be disrupted, no energy during the day, fatigued, and wide awake at 9 to 10PM were not recovered. It was also reported the patient was not tested for COVID-19 since vaccination.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: Not being able to sleep at normal bed time; Fall asleep during the day; Circadian rhythm seem to be disrupted; no energy during the day; fatigued; wide awake at 9 to 10pm; This is a spontaneous report from a contactable (consumer). This 67-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EN5318) via an unspecified route of administration in the left arm on 30Jan2021 at 09:15 (at the age of 67-years-old) as a single dose for COVID-19 immunisation. Medical history included psoriatic arthritis from an unknown date and unknown if ongoing. Prior to vaccination the patient was not diagnosed with COVID-19. Concomitant medications included multiple vitamins from unknown dates for unknown indications; the patient also reporting starting ixekizumab (TALTZ) 2 weeks after vaccination for an unknown indication. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient reported not being able to sleep at his normal bedtime and falling asleep during the day; further reporting his circadian rhythm seemed to be disrupted; awake and energetic at night, sleepy and no energy during the day. He reported it started 2 days after the vaccine and had been getting worse. Three weeks since the vaccine he was wide awake at 10PM, normal bedtime, could not sleep until 5 or 6AM then slept for 6 or 7 hours. He reported being wake and very fatigued during the day and getting wide awake at 9 to 10PM. The events were reported as non-serious and did not require hospitalization. Treatment was not provided for the events. The clinical outcomes of not being able to sleep at normal bedtime, falling asleep during the day, circadian rhythm seemed to be disrupted, no energy during the day, fatigued, and wide awake at 9 to 10PM were not recovered. It was also reported the patient was not tested for COVID-19 since vaccination.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic, Swelling face, Swelling of eyelid
Clinical narrative: Swollen face; Swollen puffy eyelids and below eye; itchy rash on face,neck, and chest; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not provided), via an unspecified route of administration in left arm on 14Feb2021 at 12:30 at single dose for COVID-19 immunization. Medical history included allergies to dust mites, dogs, and corn; Hashimoto's thyroid; and high blood pressure. Prior to vaccination, the patient was not diagnosed with COVID-19. She was not pregnant and did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included fluvoxamine maleate (LUVOX), thyroid (ARMOUR THYROID), and amlodipine. The facility where the most recent COVID-19 vaccine was administered was reported as other. The patient experienced swollen face, swollen puffy eyelids and below the eye, and itchy rash on face, neck, and chest on 14Feb2021 at 17:30. The events resulted in doctor or other healthcare professional office/clinic visit. The patient was told to take ALLEGRA and PEPCID in the morning and CLARITIN AND PEPCID in the evening by the allergist. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was not recovered. The events were assessed as non-serious.   Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Herpes zoster, Hyperaesthesia, Pain in extremity
Clinical narrative: "Covid arm"/ Arm so sensitive the sheet hurt-nothing could touch her arm; shingles; "Covid arm"/ Arm so sensitive the sheet hurt-nothing could touch her arm; This is a spontaneous report from a contactable consumer via a sales representative. A patient of unspecified age received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch/Lot number was not reported) on an unspecified date via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunization.  Historical Vaccine included first dose of BNT162B2 for COVID-19 immunization, on an unspecified date; the patient experienced severe vertigo for 3 days with nausea. Medical history was not reported. Concomitant medications were not reported. On an unspecified date, she experienced "Covid arm" and shingles one day post second dose; arm so sensitive the sheet hurt-nothing could touch her arm. The clinical outcome of the events Covid arm, shingles, arm so sensitive the sheet hurt-nothing could touch her arm was unknown.  Information about batch/lot number has been requested.