chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 42.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Dyspnoea, Erectile dysfunction, Gastrointestinal pain, Headache
Clinical narrative: initially began as what felt like jolts to my chest area from inside my chest over five days beginning on March 31, 21 @ 1:20am; next on April 01, 2021 @ 12:02am; then April 02, 2021 @1:02am; then April 03, 2021 @ 1:36am; and on April 04, 2021 @ 2:46am. I ended up in the emergency room the afternoon of Sunday March 04, 2021 with severe chest, abdominal, and intestinal pain. I followed up with doctors on April 05, 2021; April 09, 2021; and April 28, 2021 with continued painful symptoms described below. All they has done so far is 1) took a chest X-ray, 2) taken blood, and 3) referred me to a sleep laboratory.  The X-ray and blood work came back negative per ER.  Symptoms: 1. Inability to sleep. most nights feels as if I just drank five cups of coffee before bed. When I am able to fall asleep, pain and/or jolts coming from inside my trunk/core area wake me up within about an hour.  2. Constant pain coming from my chest, abdomen, and intestines. Intestinal and abdominal pain (gut wrenching, pain/burning sensation, cramps). At times feels like radiation or waves/currents are passing through my intestines/trunk. I wake up with intestines feeling sore. I also have discomfort when I eat or drink something the following morning. Also, my trunk/core area feels tight all day and night. I constantly feel a burning sensation in my chest and gut areas. The discomfort in my chest area (tightness, burning sensation) with occasional burst of pain the size of a nickel that comes from the left side of my chest and underneath my rib cage.  3. Limbs twitch/jerk on their own (both hands, both feet, neck, both shoulders, both legs, fingers) during the day and during the night. tingling sensations in legs.  4. ringing in the ears with headaches. 5. Woke up from sleep due to both nostrils getting clogged while I slept; woke up gasping for air.  6. Penis no longer has the same sensation and difficulty with erection.
Age: 42.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Insomnia, Muscle twitching, Nasal congestion, Pain, Paraesthesia
Clinical narrative: initially began as what felt like jolts to my chest area from inside my chest over five days beginning on March 31, 21 @ 1:20am; next on April 01, 2021 @ 12:02am; then April 02, 2021 @1:02am; then April 03, 2021 @ 1:36am; and on April 04, 2021 @ 2:46am. I ended up in the emergency room the afternoon of Sunday March 04, 2021 with severe chest, abdominal, and intestinal pain. I followed up with doctors on April 05, 2021; April 09, 2021; and April 28, 2021 with continued painful symptoms described below. All they has done so far is 1) took a chest X-ray, 2) taken blood, and 3) referred me to a sleep laboratory.  The X-ray and blood work came back negative per ER.  Symptoms: 1. Inability to sleep. most nights feels as if I just drank five cups of coffee before bed. When I am able to fall asleep, pain and/or jolts coming from inside my trunk/core area wake me up within about an hour.  2. Constant pain coming from my chest, abdomen, and intestines. Intestinal and abdominal pain (gut wrenching, pain/burning sensation, cramps). At times feels like radiation or waves/currents are passing through my intestines/trunk. I wake up with intestines feeling sore. I also have discomfort when I eat or drink something the following morning. Also, my trunk/core area feels tight all day and night. I constantly feel a burning sensation in my chest and gut areas. The discomfort in my chest area (tightness, burning sensation) with occasional burst of pain the size of a nickel that comes from the left side of my chest and underneath my rib cage.  3. Limbs twitch/jerk on their own (both hands, both feet, neck, both shoulders, both legs, fingers) during the day and during the night. tingling sensations in legs.  4. ringing in the ears with headaches. 5. Woke up from sleep due to both nostrils getting clogged while I slept; woke up gasping for air.  6. Penis no longer has the same sensation and difficulty with erection.
Age: 42.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Penis disorder, Sleep disorder, Tinnitus
Clinical narrative: initially began as what felt like jolts to my chest area from inside my chest over five days beginning on March 31, 21 @ 1:20am; next on April 01, 2021 @ 12:02am; then April 02, 2021 @1:02am; then April 03, 2021 @ 1:36am; and on April 04, 2021 @ 2:46am. I ended up in the emergency room the afternoon of Sunday March 04, 2021 with severe chest, abdominal, and intestinal pain. I followed up with doctors on April 05, 2021; April 09, 2021; and April 28, 2021 with continued painful symptoms described below. All they has done so far is 1) took a chest X-ray, 2) taken blood, and 3) referred me to a sleep laboratory.  The X-ray and blood work came back negative per ER.  Symptoms: 1. Inability to sleep. most nights feels as if I just drank five cups of coffee before bed. When I am able to fall asleep, pain and/or jolts coming from inside my trunk/core area wake me up within about an hour.  2. Constant pain coming from my chest, abdomen, and intestines. Intestinal and abdominal pain (gut wrenching, pain/burning sensation, cramps). At times feels like radiation or waves/currents are passing through my intestines/trunk. I wake up with intestines feeling sore. I also have discomfort when I eat or drink something the following morning. Also, my trunk/core area feels tight all day and night. I constantly feel a burning sensation in my chest and gut areas. The discomfort in my chest area (tightness, burning sensation) with occasional burst of pain the size of a nickel that comes from the left side of my chest and underneath my rib cage.  3. Limbs twitch/jerk on their own (both hands, both feet, neck, both shoulders, both legs, fingers) during the day and during the night. tingling sensations in legs.  4. ringing in the ears with headaches. 5. Woke up from sleep due to both nostrils getting clogged while I slept; woke up gasping for air.  6. Penis no longer has the same sensation and difficulty with erection.
Age: 42.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Chest pain, Gastrointestinal disorder, Headache, Muscle twitching
Clinical narrative: initially began as what felt like jolts to my chest area from inside my chest over five days beginning on March 31, 21 @ 1:20am; next on April 01, 2021 @ 12:02am; then April 02, 2021 @1:02am; then April 03, 2021 @ 1:36am; and on April 04, 2021 @ 2:46am. I ended up in the emergency room the afternoon of Sunday March 04, 2021 with severe chest, abdominal, and intestinal pain. I followed up with doctors on April 05, 2021; April 09, 2021; and April 28, 2021 with continued painful symptoms described below. All they has done so far is 1) took a chest X-ray, 2) taken blood, and 3) referred me to a sleep laboratory.  The X-ray and blood work came back negative per ER.  Symptoms: 1. Inability to sleep. most nights feels as if I just drank five cups of coffee before bed. When I am able to fall asleep, pain and/or jolts coming from inside my trunk/core area wake me up within about an hour.  2. Constant pain coming from my chest, abdomen, and intestines. Intestinal and abdominal pain (gut wrenching, pain/burning sensation, cramps). At times feels like radiation or waves/currents are passing through my intestines/trunk. I wake up with intestines feeling sore. I also have discomfort when I eat or drink something the following morning. Also, my trunk/core area feels tight all day and night. I constantly feel a burning sensation in my chest and gut areas. The discomfort in my chest area (tightness, burning sensation) with occasional burst of pain the size of a nickel that comes from the left side of my chest and underneath my rib cage.  3. Limbs twitch/jerk on their own (both hands, both feet, neck, both shoulders, both legs, fingers) during the day and during the night. tingling sensations in legs.  4. ringing in the ears with headaches. 5. Woke up from sleep due to both nostrils getting clogged while I slept; woke up gasping for air.  6. Penis no longer has the same sensation and difficulty with erection.
Age: 42.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Penis disorder, Sleep disorder
Clinical narrative: initially began as what felt like jolts to my chest area from inside my chest over five days beginning on March 31, 21 @ 1:20am; next on April 01, 2021 @ 12:02am; then April 02, 2021 @1:02am; then April 03, 2021 @ 1:36am; and on April 04, 2021 @ 2:46am. I ended up in the emergency room the afternoon of Sunday March 04, 2021 with severe chest, abdominal, and intestinal pain. I followed up with doctors on April 05, 2021; April 09, 2021; and April 28, 2021 with continued painful symptoms described below. All they has done so far is 1) took a chest X-ray, 2) taken blood, and 3) referred me to a sleep laboratory.  The X-ray and blood work came back negative per ER.  Symptoms: 1. Inability to sleep. most nights feels as if I just drank five cups of coffee before bed. When I am able to fall asleep, pain and/or jolts coming from inside my trunk/core area wake me up within about an hour.  2. Constant pain coming from my chest, abdomen, and intestines. Intestinal and abdominal pain (gut wrenching, pain/burning sensation, cramps). At times feels like radiation or waves/currents are passing through my intestines/trunk. I wake up with intestines feeling sore. I also have discomfort when I eat or drink something the following morning. Also, my trunk/core area feels tight all day and night. I constantly feel a burning sensation in my chest and gut areas. The discomfort in my chest area (tightness, burning sensation) with occasional burst of pain the size of a nickel that comes from the left side of my chest and underneath my rib cage.  3. Limbs twitch/jerk on their own (both hands, both feet, neck, both shoulders, both legs, fingers) during the day and during the night. tingling sensations in legs.  4. ringing in the ears with headaches. 5. Woke up from sleep due to both nostrils getting clogged while I slept; woke up gasping for air.  6. Penis no longer has the same sensation and difficulty with erection.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Significant allergy and unseen before skin rash
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash pruritic
Clinical narrative: Itchy rash on  neck, more on left than right.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Menstruation irregular, Oligomenorrhoea
Clinical narrative: Just reporting that I have had irregularities in my menstrual cycle since getting my first shot.  Not sure if it is related to the Pfizer vaccine, but thought I should report since you all are collecting data and monitoring.  Period had started on time the day before I got first shot (Mar 7) and stopped the day of shot (Mar 8).  Then it  came back and had normal duration 17 days later.    Received second shot on Mar 30.  This month, period came on time (28 days since last one) but has lasted longer than normal (currently at 8 days).   I have noticed no other issues since getting shots, other than fatigue and lightheadedness in the days right after.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: The patient inadvertently received a dose of 0.51 to 0.52 ml as opposed to 0.5 ml. The manufacturer instructed us to reach out to the patient to let them know they have received a higher dose which may have the potential for increased local and or systemic side effects. No serious adverse reactions were experienced or reported by the patient.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Urticaria
Clinical narrative: COVID arm.  Itchy, red welts in an area 7cm x 5 cm occurred 8 days post first immunization at injection site.  Treated with hydrocortisone cream to relieve the itch.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Inflammation, Stool analysis
Clinical narrative: diarrhea explosive, inflammation
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Loss of consciousness, Nausea
Clinical narrative: Patient received the dose of vaccine and waited in a chair for 15 minutes. Once the patient got up to stand he said that he felt lightheaded and then he passed out. He regained consciousness within 1 minute. After the patient regained consciousness the only side effect he reported was light-headedness and nausea. 911 was called and the patient was evaluated by EMS and was cleared to return home with his girlfriend.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Pulmonary embolism, Thrombosis
Clinical narrative: Pulmonary embolism; died - autopsy showed multiple blood clots all over his body - pelvic area, hearts,arteries, lungs; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (died - autopsy showed multiple blood clots all over his body - pelvic area, hearts,arteries, lungs) and PULMONARY EMBOLISM (Pulmonary embolism) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039A21A and 003A21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes, Prostate cancer and Memory loss. Concomitant products included METFORMIN for Diabetes.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Apr-2021, the patient experienced THROMBOSIS (died - autopsy showed multiple blood clots all over his body - pelvic area, hearts,arteries, lungs) (seriousness criterion death). On an unknown date, the patient experienced PULMONARY EMBOLISM (Pulmonary embolism) (seriousness criterion death). The patient died on 04-Apr-2021. The reported cause of death was Pulmonary embolism. An autopsy was performed. The autopsy-determined cause of death was multiple blood clots.            Action taken with mRNA-1273 in response to the event was not applicable  Other concomitant medications were reported included unspecified medications for memory loss and diabetes.  No treatment information was provided.; Sender's Comments: This is an 83-year-old, male patient who received mRNA-1273 Vaccine who experienced multiple thrombosis and died, 2 days after receiving second dose of vaccine.  Medical history includes Diabetes, and Prostate cancer.  Conmeds including some unspecified medications for memory loss and diabetes. The autopsy-determined cause of death was multiple blood clots.  Very limited information has been reported at this time. Further information is expected,; Reported Cause(s) of Death: Pulmonary embolism; Autopsy-determined Cause(s) of Death: multiple blood clots
Age: 68.0
Sex: U
Vaccine: COVID19
Symptoms: Cough, Pneumonia
Clinical narrative: pneumonia; experiencing cough; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (pneumonia) in a 68-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included COPD.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PNEUMONIA (pneumonia) (seriousness criterion medically significant) and COUGH (experiencing cough). At the time of the report, PNEUMONIA (pneumonia) and COUGH (experiencing cough) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant and treatment medications were not reported.  Company comment: There is not enough information to assess the causal association between the reported event and the administration mRNA-1273   Although based on the established profile of the vaccine product, the event is unlikely related to the product use. Critical details such as the onset of the event in investigations are lacking.  Additional information is being requested.   Reporter did not allow further contact; Sender's Comments: There is not enough information to assess the causal association between the reported event and the administration mRNA-1273   Although based on the established profile of the vaccine product, the event is unlikely related to the product use. Critical details such as the onset of the event in investigations are lacking.  Additional information is being requested
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Eye disorder, Speech disorder, Vaccination site erythema
Clinical narrative: Bell's Palsy; Right Eye does not close; Sometimes she can not talk; Red Left Arm (from injection site all the way to elbow); This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FACIAL PARALYSIS (Bell's Palsy) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 14-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced FACIAL PARALYSIS (Bell's Palsy) (seriousness criterion medically significant), EYE DISORDER (Right Eye does not close), SPEECH DISORDER (Sometimes she can not talk) and VACCINATION SITE ERYTHEMA (Red Left Arm (from injection site all the way to elbow)). At the time of the report, FACIAL PARALYSIS (Bell's Palsy), EYE DISORDER (Right Eye does not close), SPEECH DISORDER (Sometimes she can not talk) and VACCINATION SITE ERYTHEMA (Red Left Arm (from injection site all the way to elbow)) outcome was unknown. Not Provided          On 21 Apr 2021, the patient was diagnosed with Bell's Palsy.   Treatment information included unspecified oral antibiotics and steroids.  This case concerns a 60-year-old female with a serious unexpected event of facial paralysis, and nonserious unexpected eye disorder and speech disorder and expected vaccination site erythema. Event onset 2 days after first dose mRNA-1273. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: This case concerns a 60-year-old female with a serious unexpected event of facial paralysis, and nonserious unexpected eye disorder and speech disorder and expected vaccination site erythema. Event onset 2 days after first dose mRNA-1273. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Hypothermia
Clinical narrative: felt "hypothermic"; freezing; This spontaneous case was reported by a consumer and describes the occurrence of HYPOTHERMIA (felt "hypothermic") in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Menopause since an unknown date. Concomitant products included BIOTIN for an unknown indication.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 23-Mar-2021, the patient experienced HYPOTHERMIA (felt "hypothermic") (seriousness criterion medically significant) and FEELING COLD (freezing). At the time of the report, HYPOTHERMIA (felt "hypothermic") and FEELING COLD (freezing) outcome was unknown.            Patient takes Estrovera (dietary supplement) concomitantly. No treatment medications were reported.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   This case was linked to MOD21-081823 (E2B Linked Report). This case was linked to MOD-2021-090525 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. MOD21-081823:another product (pfizer )
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: Blood clots; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Blood clots) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011J20A and 038K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (Blood clots) (seriousness criterion medically significant). At the time of the report, THROMBOSIS (Blood clots) outcome was unknown. Not Provided          No concomitant medications were reported.  The patient had no problems after her second dose. Treatment information was not provided. Action taken with mRNA-1273 in response to events was not applicable.  Company comment: 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.; Sender'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: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Lip swelling, Swelling face, Swollen tongue
Clinical narrative: swollen cheek and tongue; severly swollen tongue; swollen lip; This spontaneous case was reported by a consumer and describes the occurrence of SWOLLEN TONGUE (severly swollen tongue) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0394209) for an unknown indication. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Proctitis from 01-Jan-2021 to 01-Apr-2021.    On 08-Feb-2021 at 9:30 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 09-Feb-2021 at 7:00 AM, the patient experienced LIP SWELLING (swollen lip). On 10-Feb-2021, the patient experienced SWOLLEN TONGUE (severly swollen tongue) (seriousness criterion hospitalization). On 11-Feb-2021 at 7:00 AM, the patient experienced SWELLING FACE (swollen cheek and tongue). At the time of the report, SWOLLEN TONGUE (severly swollen tongue), LIP SWELLING (swollen lip) and SWELLING FACE (swollen cheek and tongue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.; Sender'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: 0.17
Sex: M
Vaccine: DTAPIPVHIB, IPV
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Infant patient received a dose of PENTACEL and IPOL, the provider said he forgot that Polio is part of PENTACEL, with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from a physician via Medical Information (MI) (Reference number-00573543) and transmitted to Sanofi on  22-Apr-2021.  This case is linked to case 2021SA138683.  This case involves a twin 2 months old male patient who were vaccinated with a 0.5 mL dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot R1F97 and expiry date 03-Oct-2021) once on 21-Apr-2021 and POLIOMYELITIS VACCINE (INACTIVATED) [IPOL] via unknown route in unknown administration site for prophylactic vaccination on an unknown date, Polio is part of PENTACEL; the provider looked at the box and packaging but was focused on looking at the HIB part that he did not focus on the IPV part, what issues might two doses of IPV cause (inappropriate schedule of product administration).  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for Immunisation; and HEPATITIS B VACCINE RHBSAG (YEAST) (ENGERIX B) for prophylactic vaccination.  This was an actual medication error case due to inappropriate schedule of product administration (latency was same day).   At the time of reporting, no adverse event reported.  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.
Age: 0.83
Sex: M
Vaccine: HIBV
Symptoms: Syringe issue, Underdose
Clinical narrative: medical assistant attempted to administer ActHib to patient, MA was able to administer only half of the dose, and other half shot out of the needle when the patient jerked away, so the patient got only about 0.25 mL with no reported adverse event; Initial information was received on 13-Apr-2021 regarding an unsolicited valid non-serious case received from other health professional (Inquiry number: 00559199).  It was reported that a medical assistant was able to administer only half of the dose, and other half shot out of the needle when the patient jerked away, so the patient got only about 0.25 ml of HIB (PRP/T) VACCINE [ACT-HIB] (lot number: UJ524AAB, expiry date not reported) (Suspension For Injection) via an intramuscular route for prophylactic vaccination (underdose).  It was a case of actual medication error due to vaccine underdose.  At the time of report, no adverse event reported.  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.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: Menactra was administered to a patient one day after the expiration date; Initial information was received on 13-Apr-2021 regarding an unsolicited valid non-serious case from a other health professional (GMI inquiry number: 00559908).  It was reported that MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot number: U6585AB, expiry date: 11-Apr-2021) (Suspension For Injection) was administered to a 16 year old female patient one day after its expiry day on 12-Apr-2021 via intramuscular route in right deltoid for prophylactic vaccination (expired product administered).  It was a case of actual medication error due to expired vaccine used.  At the time of report, no adverse event reported.  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 guidelines. 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.
Age: 0.33
Sex: M
Vaccine: FLU4
Symptoms: Medication error, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 4 month-old patient was given the FLUZONE QUAD (prefilled) by mistake with no reported adverse event; Initial information was received on 13-Apr-2021 regarding an unsolicited valid non-serious case received from other health professional (Inquiry number: 00560052).  It was reported that INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (lot number: UJ559AC, expiry date not reported) (Suspension For Injection) was administered to a four month old female patient via an unknown route for prophylactic vaccination (product administered to patient of inappropriate age).  It was a case of actual medication error due to inappropriate age at vaccine administration.  At the time of report, no adverse event reported.  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. 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 on batch number for this case.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Skin induration
Clinical narrative: Patient reports big red circle on her arm.  She said its a little hard and itchy.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Disorientation, Dizziness, Nausea, Syncope, Vital signs measurement
Clinical narrative: Patient was in the post-vaccination area seated after her shot.  About 10 minutes after receiving the vaccine, she stated that she started feeling lightheaded.  She fainted and fell out of her chair.  I  immediately went to her and found her conscious, but very disoriented.  She stated that she felt nauseated.  911 had been called;  I stayed with her until they arrived.  They fitted her with a cervical counter and raised her to  a seated position and took her vitals.  She was able to stand and get on the stretcher with their assistance.  The EMTs stayed with her and monitored her  vitals until her mother arrived to take her home.  I spoke with her by phone at 6PM.   She stated that she felt fine  now (except for a bump on her head).  She stated that she was afraid of needles and that anxiety probably caused the incident.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: I initially had the standard "pain, swelling, and redness at the injection site," but it went away after a few days. Suddenly about four days after that, my arm was red again in the same spot, swollen, very hot, and ITCHY. I have not noticed any rashes anywhere else (so far!).
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site warmth
Clinical narrative: I initially had the standard "pain, swelling, and redness at the injection site," but it went away after a few days. Suddenly about four days after that, my arm was red again in the same spot, swollen, very hot, and ITCHY. I have not noticed any rashes anywhere else (so far!).
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Dry skin, Injection site erythema, Pruritus, Tenderness
Clinical narrative: About 2 inches from the injection site I have a red patch of skin. It is not raised like a typical rash. There is no swelling or bruising. It is roughly 1 inch in diameter. It is tender to the touch, very hot compared to surrounding normal skin, and is itchy. I first noticed it at approximately 8:30pm on April 28, 2021. It has not gotten larger since it was first noticed. It has gotten itchier and more uncomfortable throughout the day of April 29, 2021.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Arthralgia
Clinical narrative: Left shoulder pain hx of
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Joint swelling, Nausea, Peripheral swelling, Pyrexia
Clinical narrative: Patient called two days after receiving the vaccine and state he was experiencing swelling in his legs and ankles (along with fatigue, nausea, and fever)
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Blood glucose normal, Cold sweat, Deafness, Dizziness
Clinical narrative: Within 10 minutes of vaccination, patient developed increasingly blurry vision, hearing loss, a feeling of faintness, cold, clammy skin, and sweating. Patient was asked to lie down on the floor with feet elevated but patient did not want to leave the chair she was sitting in. Patient was feeling increasingly faint and experiencing increasing panic due to her vision and hearing loss. EMTs were called and responded within 20 minutes of the call. Patient vision and hearing were returning by the time EMTs arrived. They checked her blood pressure, heart rate, oxygen saturation,  and blood glucose - all were within normal range. The patient refused transport to the hospital and left with her significant other as her driver after she was feeling normal again.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Hyperhidrosis, Vision blurred, Vital signs measurement
Clinical narrative: Within 10 minutes of vaccination, patient developed increasingly blurry vision, hearing loss, a feeling of faintness, cold, clammy skin, and sweating. Patient was asked to lie down on the floor with feet elevated but patient did not want to leave the chair she was sitting in. Patient was feeling increasingly faint and experiencing increasing panic due to her vision and hearing loss. EMTs were called and responded within 20 minutes of the call. Patient vision and hearing were returning by the time EMTs arrived. They checked her blood pressure, heart rate, oxygen saturation,  and blood glucose - all were within normal range. The patient refused transport to the hospital and left with her significant other as her driver after she was feeling normal again.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Contusion, Dyspnoea, Erythema, Fatigue
Clinical narrative: Severe pain after the first injection. Headache for two days and the lymph node under that arm swelled and hurt for two weeks. After second injection, arm pain started within two hours. 18 hours after shot, I had chills and hot flashes. It felt like my bones were cold and my skin was hot. 101.7 fever that lasted two days. Light and sound sensitivity with killer headache. Exhausted and short of breath for two days also. Today, third day after the shot, I still have a bruise and large, hot, red welt on my arm. My lymph node is more swollen than the other one was. Hurts to put my arm down all the way. I have been taking Tylenol and Motrin for fever and pain. Warm towels to the lymph node also.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Feeling hot, Headache, Hot flush, Hyperacusis
Clinical narrative: Severe pain after the first injection. Headache for two days and the lymph node under that arm swelled and hurt for two weeks. After second injection, arm pain started within two hours. 18 hours after shot, I had chills and hot flashes. It felt like my bones were cold and my skin was hot. 101.7 fever that lasted two days. Light and sound sensitivity with killer headache. Exhausted and short of breath for two days also. Today, third day after the shot, I still have a bruise and large, hot, red welt on my arm. My lymph node is more swollen than the other one was. Hurts to put my arm down all the way. I have been taking Tylenol and Motrin for fever and pain. Warm towels to the lymph node also.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain, Photophobia, Urticaria
Clinical narrative: Severe pain after the first injection. Headache for two days and the lymph node under that arm swelled and hurt for two weeks. After second injection, arm pain started within two hours. 18 hours after shot, I had chills and hot flashes. It felt like my bones were cold and my skin was hot. 101.7 fever that lasted two days. Light and sound sensitivity with killer headache. Exhausted and short of breath for two days also. Today, third day after the shot, I still have a bruise and large, hot, red welt on my arm. My lymph node is more swollen than the other one was. Hurts to put my arm down all the way. I have been taking Tylenol and Motrin for fever and pain. Warm towels to the lymph node also.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient, who is a 16-year-old male, came to the COVID vaccine clinic provided by insurance provider in off-site clinic to receive his first Moderna covid vaccine with his parents. It was an off-site clinic with a lot of patients. Pharmacist did not realize his age is a 16-year-old, and gave the Moderna vaccine to him. He denied any side effects or symptoms from the vaccine. His parents were fine with this event.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Patient states she received Pfizer, but  card showed Moderna.
Age: 62.0
Sex: F
Vaccine: UNK
Symptoms: Joint range of motion decreased, Limb mass, Pain in extremity
Clinical narrative: Patient had 15 cm mass on her L upper arm for one month, painful and limiting range of motion.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Heart rate increased, Lip swelling, Nervousness, Pruritus
Clinical narrative: 1815: Fifteen minutes after injection given the patient felt, "hot, shaky, ears itching, swollen lips, itchy all over." She was given 100mg total of Benadryl. Patient AOx3 1830: Continues with increased heart rate, complaining of swollen tongue. Patient's personal Epi pen given and EMS called. Patient AOx3 1845: EMS arrived 1855: EMS departed for Emergency Room.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Swollen tongue
Clinical narrative: 1815: Fifteen minutes after injection given the patient felt, "hot, shaky, ears itching, swollen lips, itchy all over." She was given 100mg total of Benadryl. Patient AOx3 1830: Continues with increased heart rate, complaining of swollen tongue. Patient's personal Epi pen given and EMS called. Patient AOx3 1845: EMS arrived 1855: EMS departed for Emergency Room.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac arrest, Computerised tomogram head normal, Confusional state, Culture positive, Death
Clinical narrative: Confusion 6 days after shot. Within a week lost ability to walk, became urinary incontinent. Major chest congestion, slept all the time. Rushed by ambulance at day 12.. Diagnosed with pneumonia amd uti. Cardiac arrest at day 14, never woke up. Taken off life support 3/20/21.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Gait inability, Hypersomnia, Magnetic resonance imaging head abnormal, Neurological symptom, Pneumonia
Clinical narrative: Confusion 6 days after shot. Within a week lost ability to walk, became urinary incontinent. Major chest congestion, slept all the time. Rushed by ambulance at day 12.. Diagnosed with pneumonia amd uti. Cardiac arrest at day 14, never woke up. Taken off life support 3/20/21.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Respiratory tract congestion, Urinary incontinence, Urinary tract infection, Withdrawal of life support
Clinical narrative: Confusion 6 days after shot. Within a week lost ability to walk, became urinary incontinent. Major chest congestion, slept all the time. Rushed by ambulance at day 12.. Diagnosed with pneumonia amd uti. Cardiac arrest at day 14, never woke up. Taken off life support 3/20/21.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site mass, Injection site swelling, Injection site warmth
Clinical narrative: Just over a week since my first shot, I've developed a red lump where the vaccine was administered. The red area is hot to the touch and raised slightly.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Menstruation delayed, Menstruation irregular
Clinical narrative: The patient inadvertently received a dose of 0.51 to 0.52 ml as opposed to 0.5 ml. The manufacturer instructed us to reach out to the patient to let them know they have received a higher dose which may have the potential for increased local and or systemic side effects. Mariah reported that her period was 8 days late and she is normally very regular. No other side effects reported by Mariah.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Head discomfort, Headache, Injection site bruising, Injection site induration
Clinical narrative: The day of the vaccine almost immediately after there was bad pain at the injection site, and the site is painful and bruised, itchy, and feels like a knot is under my skin.  The day after receiving the second shot, around 12:30pm, I became very drowsy, dizzy, and developed a migraine. I left work around 3:00pm, and came home. By this time I was also experiencing head spasms when I moved. I layed in bed from 3:30-10:30 am the next day trying to sleep off the symptoms, also I couldn?t move without the head spasms and dizziness starting, and the migraine was too bad to want to get up. The next day the migraine finely reduced to a faint headache, and dizziness was down to a minimum. By the third day after the vaccine I was fine.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site pruritus, Migraine, Somnolence
Clinical narrative: The day of the vaccine almost immediately after there was bad pain at the injection site, and the site is painful and bruised, itchy, and feels like a knot is under my skin.  The day after receiving the second shot, around 12:30pm, I became very drowsy, dizzy, and developed a migraine. I left work around 3:00pm, and came home. By this time I was also experiencing head spasms when I moved. I layed in bed from 3:30-10:30 am the next day trying to sleep off the symptoms, also I couldn?t move without the head spasms and dizziness starting, and the migraine was too bad to want to get up. The next day the migraine finely reduced to a faint headache, and dizziness was down to a minimum. By the third day after the vaccine I was fine.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood test, Dizziness, Fatigue, Limb discomfort
Clinical narrative: 4/13/21 - Lymph nodes in armpit (size of lemon), breasts, and near collar bone became very large and extremely painful. Leg weakness, exhaustion, and dizziness also began.  Contacted doctor when symptoms did not subside.  Visited doctor on 4/22/21 for leg pain and dizziness. Lymph nodes no longer painful or as large but still present. Ordered a doppler on right leg - no clots. Visited doctor on 4/29/21 because legs hurt all the time, still exhausted, still occasional dizziness. Ordered blood tests for 4/30/21.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy, Ultrasound Doppler
Clinical narrative: 4/13/21 - Lymph nodes in armpit (size of lemon), breasts, and near collar bone became very large and extremely painful. Leg weakness, exhaustion, and dizziness also began.  Contacted doctor when symptoms did not subside.  Visited doctor on 4/22/21 for leg pain and dizziness. Lymph nodes no longer painful or as large but still present. Ordered a doppler on right leg - no clots. Visited doctor on 4/29/21 because legs hurt all the time, still exhausted, still occasional dizziness. Ordered blood tests for 4/30/21.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Chest X-ray, Electrocardiogram, Laboratory test, Nausea, Pain
Clinical narrative: Pt presented to the ED with fever, nausea and bodyaches
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Pt presented to the ED with fever, nausea and bodyaches
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Agitation, Anxiety, Arthralgia, Crying, Depressed mood
Clinical narrative: Severe joint pain, muscle aches, extreme fatigue; increased anxiety.  Also, I was incredibly sad and I do not know why; I just began crying and getting agitated for no apparent reason.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia
Clinical narrative: Severe joint pain, muscle aches, extreme fatigue; increased anxiety.  Also, I was incredibly sad and I do not know why; I just began crying and getting agitated for no apparent reason.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Blood calcium, Blood creatinine, Blood magnesium, Blood phosphorus, Blood thyroid stimulating hormone
Clinical narrative: Pt received the pfizer vaccine yesterday and at 0100 today began feeling short of breath, HA, chills, tachycardia with HR in the 160's, and disorientation.  Pt treated with IV fluids and EKG completed.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Differential white blood cell count, Disorientation, Dyspnoea, Electrocardiogram
Clinical narrative: Pt received the pfizer vaccine yesterday and at 0100 today began feeling short of breath, HA, chills, tachycardia with HR in the 160's, and disorientation.  Pt treated with IV fluids and EKG completed.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Fibrin D dimer, Full blood count, Headache, Human chorionic gonadotropin, Laboratory test
Clinical narrative: Pt received the pfizer vaccine yesterday and at 0100 today began feeling short of breath, HA, chills, tachycardia with HR in the 160's, and disorientation.  Pt treated with IV fluids and EKG completed.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Metabolic function test, Tachycardia, Thyroxine, Troponin I
Clinical narrative: Pt received the pfizer vaccine yesterday and at 0100 today began feeling short of breath, HA, chills, tachycardia with HR in the 160's, and disorientation.  Pt treated with IV fluids and EKG completed.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram thorax abnormal, Dyspnoea, Fibrin D dimer increased, Pulmonary embolism
Clinical narrative: About 1 week after receiving 2nd dose of a moderna vaccination,  patient states she  experienced gradual onset of shortness of breath.  Patient presents to PCP at week 3 post vaccination  due to increased shortness of breath.  PCP send patient for CT of chest and discovered bilateral PEs.  Patient was sent to emergency room, was treated with anticoagulants and sent home on anticoagulant therapy of Eliquis.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Swelling face
Clinical narrative: Swollen red face itching  skin is flaking.   Sore throat, slight aches and pains.  The swollen red face, and skin flaking  was more severe on the second shot.   The first shot I had just a sore throat , aches and pains.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site reaction, Urticaria
Clinical narrative: Large red, extremely itchy welt, 3" plus diameter at injection site.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Hyperhidrosis, Injection site pain
Clinical narrative: Beginning approximately 12 hours after the shot the following symptoms occurred and became progressively extreme throughout the night, causing an inability to sleep until the next day; Sweating; Fever; Headache; Chills; Nausea; Fatigue; Inability to sleep due to extreme side effects; Pain at injection site; Pain in arm muscles; Decreased arm mobility; The day following the shot the symptoms continued at an extreme intensity, until becoming less extreme but still disruptive in the evening. That night I was able to sleep and the next day the fever, sweat, and chills were gone. That day the rest of the symptoms continued in a milder way and by the day after I was feeling nearly normal again.