chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Compression fracture, Memory impairment, Muscle spasms
Clinical narrative: had a compression fracture in his vertebrae; He suffers from back cramps, sometimes severe back spasms cramps; memory problems; This spontaneous case was reported by a patient and describes the occurrence of COMPRESSION FRACTURE (had a compression fracture in his vertebrae), MUSCLE SPASMS (He suffers from back cramps, sometimes severe back spasms cramps) and MEMORY IMPAIRMENT (memory problems) in a 68-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. A57148B) for COVID-19 prophylaxis.     Patient sometimes exercises and had a mostly vegetarian diet.  The patient's past medical history included Hyperventilation and Herpes NOS. Concurrent medical conditions included Anxiety (He has anxiety that has been going on for decades). Concomitant products included VALACICLOVIR HYDROCHLORIDE (VALTREX), CHLORDIAZEPOXIDE (LIBRIUM [CHLORDIAZEPOXIDE]) and DIAZEPAM for Prophylaxis, ENALAPRIL MALEATE (ENALAPRIL AL), METOPROLOL and ESOMEPRAZOLE MAGNESIUM (ESOMEPRAZOLE [ESOMEPRAZOLE MAGNESIUM]) for an unknown indication.    On 15-Sep-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced COMPRESSION FRACTURE (had a compression fracture in his vertebrae), MUSCLE SPASMS (He suffers from back cramps, sometimes severe back spasms cramps) and MEMORY IMPAIRMENT (memory problems). At the time of the report, COMPRESSION FRACTURE (had a compression fracture in his vertebrae), MUSCLE SPASMS (He suffers from back cramps, sometimes severe back spasms cramps) and MEMORY IMPAIRMENT (memory problems) had not resolved.            On 24-Jan-2022, the patient received monovalent Moderna COVID-19 vaccine with lot number 007J21-2A.  Patient reported that, he had some health problems. He explains that he had a compression fracture in his vertebrae. He suffers from back cramps, sometimes severe back spasms cramps. He went to emergency room, but they did not provide him proper medications to alleviate the symptoms. He also had short-term memory problems. Patient further reported that, he had scheduled for an upper endoscopy in Apr-2023.  No treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error, No adverse event
Clinical narrative: No Adverse Event; She states that the vaccination card states Bivalent but the paperwork states Monovalent; This spontaneous case was reported by a patient and describes the occurrence of CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (She states that the vaccination card states Bivalent but the paperwork states Monovalent) and NO ADVERSE EVENT (No Adverse Event) in an adult female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7145B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Sep-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 12-Sep-2022,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (She states that the vaccination card states Bivalent but the paperwork states Monovalent). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (She states that the vaccination card states Bivalent but the paperwork states Monovalent) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessment was provided for CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (She states that the vaccination card states Bivalent but the paperwork states Monovalent).    Concomitant product use was not provided by the reporter. Patient received additional booster shot. Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Underdose
Clinical narrative: Vaccine Underdose; No adverse Event; This spontaneous case was reported by a nurse and describes the occurrence of UNDERDOSE (Vaccine Underdose) and NO ADVERSE EVENT (No adverse Event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced UNDERDOSE (Vaccine Underdose) and NO ADVERSE EVENT (No adverse Event). At the time of the report, UNDERDOSE (Vaccine Underdose) and NO ADVERSE EVENT (No adverse Event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse Event) to be not related. No further causality assessment was provided for UNDERDOSE (Vaccine Underdose).    No concomitant medications were reported. It was unknown whether patient received any other vaccines in the 4 weeks prior to COVID-19.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 27-Dec-2022: Live Significant Follow-up appended: Patient details (Age group) was added.
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Underdose
Clinical narrative: Patient received 0.25 mL of Moderna Covid-19 Vaccine, Bivalent; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of UNDERDOSE (Patient received 0.25 mL of Moderna Covid-19 Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced UNDERDOSE (Patient received 0.25 mL of Moderna Covid-19 Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (Patient received 0.25 mL of Moderna Covid-19 Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for UNDERDOSE (Patient received 0.25 mL of Moderna Covid-19 Vaccine, Bivalent).    Dosage text was reported as additional booster.  No concomitant medications were provided by the reporter.  It was reported that 196 patients had received 0.25 ml of Bivalent Moderna vaccine.   It was unknown if the patient had received any other vaccine 4 weeks prior to COVID-19 vaccine.  No treatment medications were provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 27-Dec-2022: Live follow-up information included patient's age group updated.
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: 6month-5 yr old patient received 0.2mL of Moderna Covid-19 (monovalent) for 2nd dose.; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (6month-5 yr old patient received 0.2mL of Moderna Covid-19 (monovalent) for 2nd dose.) and NO ADVERSE EVENT (No adverse event) in a child patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1417B) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .2 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (6month-5 yr old patient received 0.2mL of Moderna Covid-19 (monovalent) for 2nd dose.) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (6month-5 yr old patient received 0.2mL of Moderna Covid-19 (monovalent) for 2nd dose.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (6month-5 yr old patient received 0.2mL of Moderna Covid-19 (monovalent) for 2nd dose.).    No concomitant medications were reported.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 29-Dec-2022: Significant follow up received contains patient details updated. On 29-Dec-2022: Live follow up received contains no new information.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse reaction; Patient received dose 1 on 13-May-2022 and dose 2 on 31-Aug-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received dose 1 on 13-May-2022 and dose 2 on 31-Aug-2022) and NO ADVERSE EVENT (No adverse reaction) in a 67-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     It was unknown if the patient was ever diagnosed with or tested positive for COVID-19.    On 13-May-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 31-Aug-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 31-Aug-2022,  after starting mRNA-1273 (Spikevax), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received dose 1 on 13-May-2022 and dose 2 on 31-Aug-2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse reaction). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received dose 1 on 13-May-2022 and dose 2 on 31-Aug-2022) and NO ADVERSE EVENT (No adverse reaction) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse reaction) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received dose 1 on 13-May-2022 and dose 2 on 31-Aug-2022).    No concomitant drug information was provided.  No treatment drug information was provided.   This case was linked to MOD-2022-688372 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: He has been experiencing bilateral upper arm pain for 3 weeks getting progressively worse.; He has been experiencing bilateral upper arm pain for 3 weeks getting progressively worse.; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (He has been experiencing bilateral upper arm pain for 3 weeks getting progressively worse.) and PAIN IN EXTREMITY (He has been experiencing bilateral upper arm pain for 3 weeks getting progressively worse.) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.   On 28-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (He has been experiencing bilateral upper arm pain for 3 weeks getting progressively worse.) and PAIN IN EXTREMITY (He has been experiencing bilateral upper arm pain for 3 weeks getting progressively worse.). At the time of the report, PAIN (He has been experiencing bilateral upper arm pain for 3 weeks getting progressively worse.) and PAIN IN EXTREMITY (He has been experiencing bilateral upper arm pain for 3 weeks getting progressively worse.) had not resolved.      The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.   For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was reported as unknown that the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Patient has been experiencing bilateral upper arm pain for 3 weeks getting progressively worse. No treatment medications were reported.
Age: 70.0
Sex: M
Vaccine: COVID19-2, COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: Fell in parking lot, stroke
Age: 70.0
Sex: M
Vaccine: COVID19-2, COVID19
Symptoms: Cerebrovascular accident, Fall
Clinical narrative: Fell in parking lot, stroke
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: Vaccine frozen rather than refrigerated. Dose administered. Offered revaccination. Wants new booster, not revax
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: Vaccine frozen rather than refrigerated. Dose administered. Offered revaccination. Revax unwanted
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: Vaccine frozen rather than refrigerated. Dose administered. Offered revaccination. Wants new booster instead of revax
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: Vaccine frozen rather than refrigerated. Dose administered. Offered revaccination. Revax unwanted
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: Vaccine frozen rather than refrigerated. Dose administered. Offered revaccination. Wants new booster instead of revax
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: Vaccine frozen rather than refrigerated. Dose administered. Offered revaccination. Revax unwanted
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: Vaccine frozen rather than refrigerated. Dose administered. Offered revaccination. Will consider revaccination
Age: 19.0
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: Vaccine frozen rather than refrigerated. Dose administered. Offered revaccination. Will consider revaccination
Age: 8.0
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: Vaccine frozen rather than refrigerated. Dose administered. Offered revaccination. Revax unwanted
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: Vaccine frozen rather than refrigerated. Dose administered. Offered revaccination. Revax unwanted
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: Vaccine frozen rather than refrigerated. Dose administered. Offered revaccination. Revax unwanted
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: Vaccine frozen rather than refrigerated. Dose administered. Offered revaccination. Will consider revax
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: Vaccine frozen rather than refrigerated. Dose administered. Offered revaccination. Will consider revax
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine frozen rather than refrigerated. Dose administered. Offered revaccination. Revax unwanted
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: Vaccine frozen rather than refrigerated. Dose administered. Offered revaccination. Recently had new booster, no revax
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: Vaccine frozen rather than refrigerated. Dose administered. Offered revaccination. Recently had new booster, no revax
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine frozen rather than refrigerated. Dose administered. Offered revaccination. Revax unwanted
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: Vaccine frozen rather than refrigerated. Dose administered. Offered revaccination. Revax unwanted
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: Vaccine frozen rather than refrigerated. Dose administered. Offered revaccination. Recently had new booster, no revax
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: Vaccine frozen rather than refrigerated. Dose administered. Offered revaccination. Recently had new booster, no revax
Age: 82.0
Sex: M
Vaccine: COVID19-2
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: Vaccine frozen rather than refrigerated. Dose administered. Offered revaccination. Revax wanted
Age: 77.0
Sex: F
Vaccine: COVID19-2
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: Vaccine frozen rather than refrigerated. Dose administered. Offered revaccination. Revax unwanted
Age: 79.0
Sex: F
Vaccine: COVID19-2
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: Vaccine frozen rather than refrigerated. Dose administered. Offered revaccination. Revax unwanted
Age: 68.0
Sex: U
Vaccine: COVID19-2
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: Vaccine frozen rather than refrigerated. Dose administered. Offered revaccination. Recently had new booster, no revax
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: Vaccine frozen rather than refrigerated. Dose administered. Offered revaccination. Will consider revax
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: Vaccine frozen rather than refrigerated. Dose administered. Offered revaccination. Recently had new booster, no revax
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Discomfort, Dyspnoea, Mobility decreased, Palpitations
Clinical narrative: about one hour after getting the shot, i had trouble breatheg, sharp pains in my chest and my heart was pounding. i could not move, ilive alone and thought i was going to die.about an hour went by and i was able to get up and i was stll laboring to breath still with sharp pains. luckily i woke up the next day. i contacted my doctors office to be seen to find out what went wrong and concerned about getting the second shot which would have been on 08/25/2021 i was denied an appointment by intake. they said discomfort was normal and to get the second shot. i caaled repeatedly trying to get an appointment to do a test or somthingbefore i got the second shot and kept getting denied. i even went to the doctors office without an appointment the day before i was supposed to get the second shot and was not allowed to talk to a nurse or my doctor, so i never got the second shot, i was able to talk to the manager but she offered no appointment and also recommended i just take the second shot. that doctor is no longer my doctor. i just found out that their is a way to report these affects.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: Vaccine frozen rather than refrigerated. Dose administered. Offered revaccination. Wants new booster instead of revax
Age: 8.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: Vaccine frozen rather than refrigerated. Dose administered. Offered revaccination.
Age: 48.0
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: Vaccine frozen rather than refrigerated. Dose administered. Offered revaccination.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: Vaccine frozen rather than refrigerated. Dose administered. Offered revaccination.
Age: 31.0
Sex: M
Vaccine: COVID19-2
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: Vaccine frozen rather than refrigerated. Dose administered. Offered revaccination. Will consider revax
Age: 51.0
Sex: M
Vaccine: COVID19-2
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: Vaccine frozen rather than refrigerated. Dose administered. Offered revaccination.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: Vaccine frozen rather than refrigerated. Dose administered. Offered revaccination. Will consider revax
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: Vaccine frozen rather than refrigerated. Dose administered. Offered revaccination. Will consider revax
Age: 75.0
Sex: M
Vaccine: COVID19-2
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: Vaccine frozen rather than refrigerated. Dose administered. Offered revaccination. Will consider revax
Age: 8.0
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: Vaccine frozen rather than refrigerated. Dose administered. Offered revaccination. May revaccinate.
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: Vaccine frozen rather than refrigerated. Dose administered. Offered revaccination. May revaccinate.
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: Vaccine frozen rather than refrigerated. Dose administered. Offered revaccination. May revaccinate
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: Vaccine frozen rather than refrigerated. Dose administered. Offered revaccination.
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: Vaccine frozen rather than refrigerated. Dose administered. Offered revaccination.
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: Vaccine frozen rather than refrigerated. Dose administered. Offered revaccination. May revaccinate.
Age: 6.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: Vaccine frozen rather than refrigerated. Dose administered. Offered revaccination. May revaccinate
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Anal incontinence, Asthenia, Cold sweat, Discomfort, Fatigue
Clinical narrative: At first I had no idea what was going on and just thought I may have been going through a stage or just getting older, but ever since I got the shot I have symptoms of Guillian Barre syndrome meaning constant twitching of muscles that started in the legs and progressed through to my upper body and even my face and groin area, on top of this I have experienced a permanent state of fatigue, and loss of energy and control of my bowels and urination habbits. Sleeping at night is now no longer the same for me because of the uncomfortable state of my body and twitching of my muscles I can't relax anymore. There were 2 instances of waking up and not being able to remember how to walk I could not move my legs to walk. On top of all of this I get random headaches that I never got up until this last year.  Also it feels like my insides are twitching as well in my chest and stomach and groin area. It comes and goes but happens multiple times everyday ever since. The day after I got the Jannssen vaccine I couldn't sleep and when I laid down my body felt like it was under attack with cold sweats and my heart was racing like never before in my life. I'm not sure what the government is doing but I will NEVER get another vaccine again in my life.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Gait inability, Headache, Memory impairment, Muscle twitching, Musculoskeletal disorder
Clinical narrative: At first I had no idea what was going on and just thought I may have been going through a stage or just getting older, but ever since I got the shot I have symptoms of Guillian Barre syndrome meaning constant twitching of muscles that started in the legs and progressed through to my upper body and even my face and groin area, on top of this I have experienced a permanent state of fatigue, and loss of energy and control of my bowels and urination habbits. Sleeping at night is now no longer the same for me because of the uncomfortable state of my body and twitching of my muscles I can't relax anymore. There were 2 instances of waking up and not being able to remember how to walk I could not move my legs to walk. On top of all of this I get random headaches that I never got up until this last year.  Also it feels like my insides are twitching as well in my chest and stomach and groin area. It comes and goes but happens multiple times everyday ever since. The day after I got the Jannssen vaccine I couldn't sleep and when I laid down my body felt like it was under attack with cold sweats and my heart was racing like never before in my life. I'm not sure what the government is doing but I will NEVER get another vaccine again in my life.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Neurological symptom, Palpitations, Sleep disorder, Urinary incontinence
Clinical narrative: At first I had no idea what was going on and just thought I may have been going through a stage or just getting older, but ever since I got the shot I have symptoms of Guillian Barre syndrome meaning constant twitching of muscles that started in the legs and progressed through to my upper body and even my face and groin area, on top of this I have experienced a permanent state of fatigue, and loss of energy and control of my bowels and urination habbits. Sleeping at night is now no longer the same for me because of the uncomfortable state of my body and twitching of my muscles I can't relax anymore. There were 2 instances of waking up and not being able to remember how to walk I could not move my legs to walk. On top of all of this I get random headaches that I never got up until this last year.  Also it feels like my insides are twitching as well in my chest and stomach and groin area. It comes and goes but happens multiple times everyday ever since. The day after I got the Jannssen vaccine I couldn't sleep and when I laid down my body felt like it was under attack with cold sweats and my heart was racing like never before in my life. I'm not sure what the government is doing but I will NEVER get another vaccine again in my life.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 40-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for COVID-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, COVID-19 with Paxlovid.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Sulfa drugs" (unspecified if ongoing), notes: known allergies: Sulfa drugs. Concomitant medication(s) included: PRAMIPEXOLE (ongoing). The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; Positive, notes: I tested positive with symptoms after completing Paxlovid; Negative, notes: I tested positive with symptoms after completing Paxlovid and testing negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 26-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Nov2022 at 11:30 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 26 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Acne" (unspecified if ongoing). Concomitant medication(s) included: SPIRONOLACTONE, start date: 11Nov2022, stop date: 03Dec2022; DOXYCYCLINE HYCLATE, start date: 11Nov2022, stop date: 03Dec2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Dec2022) Positive, notes: Still positive; (21Dec2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient was taking any other medications/products within 2 weeks of starting COVID-19 treatment was Spironolactone, Doxycycline Hyclate. The patient was previously receive a COVID-19 Vaccine. Patient known allergies was none reported. Patient received Paxlovid start date: 10Dec2022 and stop date: 15Dec2022 for COVID-19 Treatment. Initial sore throat symptoms cleared up by day 7-10 after initial test (17Dec2022-20Dec2022), but runny nose and congestion (new symptoms) appeared on 21Dec2022 with a positive rapid antigen test. Runny nose and congestion has continued, tapering off until today 26Dec2022 (5th day of re-isolation) where little to no congestion or runny nose is present. However, RAT is still positive and am continuing to isolate.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to its Lack of efficacy cannot be ruled out.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Feb2021 at 16:00 as dose 1, single (Lot number: 031M20A), in left arm, on 12Mar2021 at 16:00 as dose 2, single (Lot number: 001B21A), in left arm, on 10Sep2021 at 16:00 as dose 3 (booster), single (Lot number: 004P21A), in left arm and on 07Jul2022 at 16:00 as dose 4 (booster), single (Lot number: 056A221A) at the age of 60 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Crohn's" (unspecified if ongoing), notes: Other medical history: Crohn's; "Interstitial Cystitis" (unspecified if ongoing), notes: Other medical history: Interstitial Cystitis; "Lichen Sclerosis" (unspecified if ongoing), notes: Other medical history: Lichen Sclerosis; "Branch duct IPMN" (unspecified if ongoing), notes: Other medical history: Branch duct IPMN; "Osteoporosis" (unspecified if ongoing), notes: Other medical history: Osteoporosis; "Wheat allergy" (unspecified if ongoing), notes: known allergies: wheat. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Patient received other medication in 2 weeks, Anti viral details: product: COVID 19 Treatment Brand: Paxlovid Treatment start date: 15Dec2022,Treatment stop date: 20Dec2022 Indication: Treatment of COVID-19. Other medication in 2 weeks product=Humira, Other medication in 2 weeks brand=Company, Other medication in 2 weeks start date and stop date was reported as 11Dec2022.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Sep2022 as dose 4 (booster), single (Lot number: 6h9964) at the age of 32 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: SINGULAIR. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient was Adult (18-64 Years). Other medication in 2weeks was reported as yes. Patient received Paxlovid treatment from 14Dec2022 to 18Dec2022 for Covid-19.  No follow-up attempts are possible. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Oct2022 at 17:30 as dose 4 (booster), single (Lot number: gj2524) at the age of 70 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Smoldering myeloma" (unspecified if ongoing); "Osteoporosis" (unspecified if ongoing). Concomitant medication(s) included: TAMIFLU, start date: 09Dec2022, stop date: 13Dec2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Treatment of COVID-19; (13Dec2022) Positive, notes: Tested positive for Covid on 13Dec2022. Therapeutic measures were taken as a result of drug ineffective, covid-19 included PAXLOVID from 13Dec2022 to 17Dec2022.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Sep2022 at 15:45 as dose 5 (booster), single (Lot number: GH9694) at the age of 64 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Fibromyalgia" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin; "Hormone replacement" (unspecified if ongoing), notes: Other medication in 2weeks product = Hormone replacement. Concomitant medication(s) included: STRESS B COMPLEX [AMINOBENZOIC ACID;ASCORBIC ACID;BIOTIN;CALCIUM PANTOTHENATE;CHOLINE BITARTRATE;CYANOCOBALAMIN;FOLIC ACID;INOSITOL;NICOTINIC ACID;PYRIDOXINE HYDROCHLORIDE;RIBOFLAVIN;ROSA CANINA;THIAMINE MONONITRATE] taken for hormone replacement therapy, start date: 04Jan2021. Past drug history included: Cefzil, reaction(s): "Known allergies: Cefzil", notes: Known allergies: Cefzil. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient was Adult (18-64 Years). Other medication in 2weeks was reported as yes. Patient received Paxlovid treatment from 15Dec2022 to 20Dec2022 for Covid-19.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Sep2022 at 13:00 as dose 5 (booster), single (Lot number: GJ5342) at the age of 73 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 25Feb2021 at 14:00 as dose 1, single (Lot number: EL8982), in left arm, on 18Mar2021 at 14:00 as dose 2, single (Lot number: EP7534), in left arm, on 29Sep2021 at 10:00 as dose 3 (booster), single (Lot number: FF2588), in left arm and on 06Apr2022 at 11:00 as dose 4 (booster), single (Lot number: FJ4991), in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Reoccurrence of Covid symptoms with positive test 4 days after all symptoms had disappeared and had a negative COVID TEST; (unspecified date) Negative, notes: Reoccurrence of Covid symptoms with positive test 4 days after all symptoms had disappeared and had a negative COVID TEST; (21Dec2022) Positive, notes: Reoccurrence of Covid symptoms with positive test 4 days after all symptoms had disappeared and had a negative COVID TEST. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: Reoccurrence of Covid symptoms with positive test 4 days after all symptoms had disappeared and had a negative COVID TEST. Known allergies: No. Other medical history: None. Other medication in 2weeks: No
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; vaccine_brand_other=moderna/vaccine_dose_number=4; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Sep2022 at 17:00 as dose 5 (booster), single (Lot number: GH9694) at the age of 53 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 30Jun2022 at 12:00 as dose 4 (booster), single (Lot number: 037A22B), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 15Sep2022 at 17:00, outcome "unknown", described as "vaccine_brand_other=moderna/vaccine_dose_number=4"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient received Anti-viral drug Paxlovid from 07Dec2022 to 12Dec2022 for the treatment of COVID-19. The other medication received by patient in 2 weeks was unknown.
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; Pfizer 4 th dose: 07Oct2022/Moderna 3 rd dose: 16Aug2021; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Oct2022 at 12:00 as dose 4 (booster), single (Lot number: GJ6665) at the age of 56 years, in left arm for covid-19 immunisation; elasomeran (COVID-19 VACCINE MODERNA), on 16Aug2021 at 12:00 as dose 3 (booster), single (Lot number: 037A21B), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing), notes: Other medical history: High blood pressure and Known allergies were None .Concomitant medication(s) included: LISINOPRIL, start date: 01Jun2014.The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 07Oct2022, outcome "unknown", described as "Pfizer 4 th dose: 07Oct2022/Moderna 3 rd dose: 16Aug2021"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; Pfizer / BioNTech/ moderna; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 34-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Sep2022 at 19:30 as dose 4 (booster), single (Lot number: GM9703) at the age of 34 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 26Mar2021 at 16:30 as dose 1, single (Lot number: ER8735), in right arm and on 20Apr2021 at 16:30 as dose 2, single (Lot number: EW0161), in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 17Dec2021 at 14:00 as dose 3 (booster), single (Lot number: O12H21B), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Known allergies: apple family" (unspecified if ongoing); "ADHD" (unspecified if ongoing). Concomitant medication(s) included: ADDERALL; LEXAPRO; MELATONIN; ALEVE; D3; VICKS NYQUIL taken for covid-19 immunisation; FISH OIL. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 17Dec2021 at 14:00, outcome "unknown", described as "Pfizer / BioNTech/ moderna"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient treated with Paxlovid (Anti-viral) for COVID-19 treatment from 13Dec2022 to 17Dec2022. Other medication in 2 weeks received Men's multi-vitamin.