chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaemia, Heavy menstrual bleeding
Clinical narrative: Bad anemia. Plus, 12 day periods every 21 days since the first dosage.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: Hard raised lump at injection site 4-5 cm in diameter; red, itchy rash around injection site 8-10 cm in diameter. Began 2 days after vaccination, worsened for 1-2 days, began to subside on day 5, still present on day 6 but continuing to resolve. Cortisone cream helped the itching, no other treatment provided.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Adnexa uteri pain, Back pain, Hypoaesthesia, Pain in extremity, Peripheral swelling
Clinical narrative: I woke up the next morning with a painful UTI and extrene ovary and back pain. I have occaaional sharp pains in my left leg and foot. Today (day 3) my left arm is numb and swollen. I had surgery in this arm in the past and have a metal plate/screws.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Urinary tract infection
Clinical narrative: I woke up the next morning with a painful UTI and extrene ovary and back pain. I have occaaional sharp pains in my left leg and foot. Today (day 3) my left arm is numb and swollen. I had surgery in this arm in the past and have a metal plate/screws.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives on torso and some on the inside the forearm where elbow is
Age: 24.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Throat tightness
Clinical narrative: Pt experienced chest and throat tightness approx. 15min following vaccine
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: Swelling in lymph nodes creating significant pain
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Computerised tomogram, Magnetic resonance imaging, Rheumatoid arthritis, Ultrasound scan
Clinical narrative: Severe joint pain possibly RA requiring multiple trips to ER and urgent care.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: X-ray
Clinical narrative: Severe joint pain possibly RA requiring multiple trips to ER and urgent care.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Menstrual disorder, Thrombosis
Clinical narrative: More severe menstruation with cramps and large clots
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Muscular weakness, Pain, Paraesthesia
Clinical narrative: Numbness, tingling sensation, pins and needles, muscle weakness, and pain in my right arm. This is the OPPOSITE arm of the injection site. The pain and symptoms started right away when I woke up the next morning. It was constant and high level for about 1 week and for the last 7 weeks the pain and symptoms vary from day to day, most recently symptoms are getting worse.  Sometimes I may just feel one of the symptoms and sometimes all. I also have muscle weakness, sometimes difficult to lift things, carry bags, hold a hairdryer. The pain increase with my arm being lifted over my head, out to the side, and pulled towards my back. Most of the pain is in my upper arm muscles, with the tingling, pins and needles, and numbness sensation extending out and down to my forearm and fingertips. I have felt the tingly feeling in my left hand and both of my feet.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Hot flush, Injection site swelling, Pain in extremity, Rash
Clinical narrative: m swollen over the injection site 10/06. 10/08 on left hand and ring finger a small rash develops. Hot flashes. Sore arm.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blood pressure increased, Chills, Dizziness, Dry skin
Clinical narrative: Difficult breathing; fast heartbeat /pounding heart. Tingling of arms and hands; numbness of arms and fingers; tingling of face; Tingling of ears; Tingling of jaw; Tingling of throat; Dizziness; Could not swallow; Nurse took blood pressure and it was at 171; heaviness feeling of legs (as if they were being pulled down); Lips were swelling up (upper lip); I received Epi Pen in right thigh by center; Got a allergy pill with a bit of water after Epi Pen was injected into thigh/ I could swallow the pill and the water w difficulty; felt numbness even after epi pen was given in arms & hands; Went to ER by ambulance; At home, felt very fatigued; had rash in throat area skin and face (reddish/pinkish); My right arm has a pink hive at injection site; Soar Arm and heaviness & achy; headaches; Sensitive to light; Chills; muscles aches; my taste buds changed; Use inhaler more; heaviness feeling in legs; itchy skin all over hands and face and feet even more; currently very dry skin as if I went to the sun and got sun burned;  lymph nodes under arms are swollen; a bigger swollen lymph node under right arm is bigger; Very tired/ sleepy as if I have not slept / under eyes puffiness; Very forgetful; Joints hurt/hands & feet, shoulder area/legs; Heart pounds as if I were sacred; fast beating at times; tired when I walk; out of breathe even on short distance walk.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Dyspnoea, Dyspnoea exertional, Fatigue, Headache
Clinical narrative: Difficult breathing; fast heartbeat /pounding heart. Tingling of arms and hands; numbness of arms and fingers; tingling of face; Tingling of ears; Tingling of jaw; Tingling of throat; Dizziness; Could not swallow; Nurse took blood pressure and it was at 171; heaviness feeling of legs (as if they were being pulled down); Lips were swelling up (upper lip); I received Epi Pen in right thigh by center; Got a allergy pill with a bit of water after Epi Pen was injected into thigh/ I could swallow the pill and the water w difficulty; felt numbness even after epi pen was given in arms & hands; Went to ER by ambulance; At home, felt very fatigued; had rash in throat area skin and face (reddish/pinkish); My right arm has a pink hive at injection site; Soar Arm and heaviness & achy; headaches; Sensitive to light; Chills; muscles aches; my taste buds changed; Use inhaler more; heaviness feeling in legs; itchy skin all over hands and face and feet even more; currently very dry skin as if I went to the sun and got sun burned;  lymph nodes under arms are swollen; a bigger swollen lymph node under right arm is bigger; Very tired/ sleepy as if I have not slept / under eyes puffiness; Very forgetful; Joints hurt/hands & feet, shoulder area/legs; Heart pounds as if I were sacred; fast beating at times; tired when I walk; out of breathe even on short distance walk.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Hypoaesthesia, Injection site pain, Injection site urticaria, Laboratory test
Clinical narrative: Difficult breathing; fast heartbeat /pounding heart. Tingling of arms and hands; numbness of arms and fingers; tingling of face; Tingling of ears; Tingling of jaw; Tingling of throat; Dizziness; Could not swallow; Nurse took blood pressure and it was at 171; heaviness feeling of legs (as if they were being pulled down); Lips were swelling up (upper lip); I received Epi Pen in right thigh by center; Got a allergy pill with a bit of water after Epi Pen was injected into thigh/ I could swallow the pill and the water w difficulty; felt numbness even after epi pen was given in arms & hands; Went to ER by ambulance; At home, felt very fatigued; had rash in throat area skin and face (reddish/pinkish); My right arm has a pink hive at injection site; Soar Arm and heaviness & achy; headaches; Sensitive to light; Chills; muscles aches; my taste buds changed; Use inhaler more; heaviness feeling in legs; itchy skin all over hands and face and feet even more; currently very dry skin as if I went to the sun and got sun burned;  lymph nodes under arms are swollen; a bigger swollen lymph node under right arm is bigger; Very tired/ sleepy as if I have not slept / under eyes puffiness; Very forgetful; Joints hurt/hands & feet, shoulder area/legs; Heart pounds as if I were sacred; fast beating at times; tired when I walk; out of breathe even on short distance walk.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Lip swelling, Lymphadenopathy, Memory impairment, Myalgia
Clinical narrative: Difficult breathing; fast heartbeat /pounding heart. Tingling of arms and hands; numbness of arms and fingers; tingling of face; Tingling of ears; Tingling of jaw; Tingling of throat; Dizziness; Could not swallow; Nurse took blood pressure and it was at 171; heaviness feeling of legs (as if they were being pulled down); Lips were swelling up (upper lip); I received Epi Pen in right thigh by center; Got a allergy pill with a bit of water after Epi Pen was injected into thigh/ I could swallow the pill and the water w difficulty; felt numbness even after epi pen was given in arms & hands; Went to ER by ambulance; At home, felt very fatigued; had rash in throat area skin and face (reddish/pinkish); My right arm has a pink hive at injection site; Soar Arm and heaviness & achy; headaches; Sensitive to light; Chills; muscles aches; my taste buds changed; Use inhaler more; heaviness feeling in legs; itchy skin all over hands and face and feet even more; currently very dry skin as if I went to the sun and got sun burned;  lymph nodes under arms are swollen; a bigger swollen lymph node under right arm is bigger; Very tired/ sleepy as if I have not slept / under eyes puffiness; Very forgetful; Joints hurt/hands & feet, shoulder area/legs; Heart pounds as if I were sacred; fast beating at times; tired when I walk; out of breathe even on short distance walk.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Paraesthesia, Periorbital swelling, Pharyngeal paraesthesia, Pruritus
Clinical narrative: Difficult breathing; fast heartbeat /pounding heart. Tingling of arms and hands; numbness of arms and fingers; tingling of face; Tingling of ears; Tingling of jaw; Tingling of throat; Dizziness; Could not swallow; Nurse took blood pressure and it was at 171; heaviness feeling of legs (as if they were being pulled down); Lips were swelling up (upper lip); I received Epi Pen in right thigh by center; Got a allergy pill with a bit of water after Epi Pen was injected into thigh/ I could swallow the pill and the water w difficulty; felt numbness even after epi pen was given in arms & hands; Went to ER by ambulance; At home, felt very fatigued; had rash in throat area skin and face (reddish/pinkish); My right arm has a pink hive at injection site; Soar Arm and heaviness & achy; headaches; Sensitive to light; Chills; muscles aches; my taste buds changed; Use inhaler more; heaviness feeling in legs; itchy skin all over hands and face and feet even more; currently very dry skin as if I went to the sun and got sun burned;  lymph nodes under arms are swollen; a bigger swollen lymph node under right arm is bigger; Very tired/ sleepy as if I have not slept / under eyes puffiness; Very forgetful; Joints hurt/hands & feet, shoulder area/legs; Heart pounds as if I were sacred; fast beating at times; tired when I walk; out of breathe even on short distance walk.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Somnolence, Taste disorder
Clinical narrative: Difficult breathing; fast heartbeat /pounding heart. Tingling of arms and hands; numbness of arms and fingers; tingling of face; Tingling of ears; Tingling of jaw; Tingling of throat; Dizziness; Could not swallow; Nurse took blood pressure and it was at 171; heaviness feeling of legs (as if they were being pulled down); Lips were swelling up (upper lip); I received Epi Pen in right thigh by center; Got a allergy pill with a bit of water after Epi Pen was injected into thigh/ I could swallow the pill and the water w difficulty; felt numbness even after epi pen was given in arms & hands; Went to ER by ambulance; At home, felt very fatigued; had rash in throat area skin and face (reddish/pinkish); My right arm has a pink hive at injection site; Soar Arm and heaviness & achy; headaches; Sensitive to light; Chills; muscles aches; my taste buds changed; Use inhaler more; heaviness feeling in legs; itchy skin all over hands and face and feet even more; currently very dry skin as if I went to the sun and got sun burned;  lymph nodes under arms are swollen; a bigger swollen lymph node under right arm is bigger; Very tired/ sleepy as if I have not slept / under eyes puffiness; Very forgetful; Joints hurt/hands & feet, shoulder area/legs; Heart pounds as if I were sacred; fast beating at times; tired when I walk; out of breathe even on short distance walk.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Vaginal haemorrhage
Clinical narrative: I have a nexplanon implant for birth control and have not had any periods or bleeding for the last 2 years. About a week after receiving the shot, I began moderate bleeding that has not stopped yet. I have had no other changes to my diet, medications, or normal daily routines.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Heavy menstrual bleeding, Menstruation irregular, Migraine, Muscle spasms
Clinical narrative: Three days after receiving second dose of Moderna, I received my period even though it wasn?t due for another two weeks. It was very heavy and huge clots of blood. I had intense cramps and headaches. My period lasted 9 days and is normally only 4 days. After this period, I went through my normal 28 day cycle. But every period since the vaccine comes with daily migraines that don?t go away with medicine. I have several headaches 1-2 days before my period, every day of my period, and a day after or so. This has been like clockwork since the vaccine and was never an issue before.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: Three days after receiving second dose of Moderna, I received my period even though it wasn?t due for another two weeks. It was very heavy and huge clots of blood. I had intense cramps and headaches. My period lasted 9 days and is normally only 4 days. After this period, I went through my normal 28 day cycle. But every period since the vaccine comes with daily migraines that don?t go away with medicine. I have several headaches 1-2 days before my period, every day of my period, and a day after or so. This has been like clockwork since the vaccine and was never an issue before.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Contusion, Peripheral swelling
Clinical narrative: Patient had bruising and swelling of arm for 30 days after first Pfizer vaccine.  Patient has hx of G6PD and believes it is correlated.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Discomfort, Dyspnoea
Clinical narrative: Approximately 3-days after receiving the injection, I first began to experience a gradually increasing, dull chest pain, where this pain finally reached a steady-state level of 2/10 on 10/17/2021 involving a hand-sized area under my left breast.  Additionally, accompanying this discomfort was a slight  increase in my shortness of breath at rest and on exertion.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Thrombosis
Clinical narrative: I had 2 weeks of heavy menstruation (Sep 16-30) and passing big blood clots from my menstruation period.  I am pre menopausal so my period is lighter and lesser days now, so I'm shocked this suddenly happened after my 1st dose of vaccine. Other friends and many women per reading experienced the same and yet you are not mentioning this as side effect.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Menstruation irregular, Pain in extremity
Clinical narrative: I have my birth control arm implant in my left arm. I asked the medical assistant if it will affect it. I was told it won't. I had a very sore arm that felt like it was going to fall off both times. Then the 2nd one suddenly had me start my period the same day a couple hours later. I am currently still on my period flow. The birth control was inserted way back in June of 2021. My body had adjusted to it finally in August. It was normally on the 20th of the month that it starts. With the 2nd vaccine it just started my period. My period is actually a heavier flow, too. I will be arranging an appointment with my doctor to discuss it. With both vaccines it felt like something travel in my body.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: unable to receive second dose; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 0.5 ml intramuscularly in an unknown arm on an unknown date in November 2018).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive second dose, which led to incomplete course of vaccination. The reporter did not consent to follow up.
Age: 47.0
Sex: M
Vaccine: TDAP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: dose of Tdap on 2020 and Boostrix on 2021; This case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a 47-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number PN7KN, expiry date 29th January 2023) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included ADACEL (TDAP) (received on an unknown date in September 2020).   On 8th October 2021, the patient received Boostrix and Boostrix Pre-Filled Syringe Device. On 8th October 2021, unknown after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The reporter was patient's assistance. The patient received a dose of Boostrix one year apart from Tdap Adacel which led to shortening of vaccination schedule. The reporter did consent to follow-up.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Extra dose administered
Clinical narrative: received 2 doses of boostrix; This case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 29-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 57GJ2, expiry date 29th May 2023) for prophylaxis.   Concomitant products included DIPHTHERIA TOXOID + PERTUSSIS TOXOID ACELLULAR + TETANUS TOXOID (BOOSTRIX).   On 24th August 2021, the patient received the 2nd dose of Boostrix. On 24th August 2021, unknown after receiving Boostrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were provided as follows: The patient had received 2nd dose of Boostrix additionally, which led to extra dose administered. The reporter consented to follow up via Email.
Sex: U
Vaccine: COVID19
Symptoms: Amnesia, Asthenia, Blood pressure measurement, Cardiac disorder, Chest pain
Clinical narrative: PARALYSIS OF LOWER EXTREMITIES; INJURED; WEIGHT LOSS; MEMORY LOSS; HEARTBURN; CONSTIPATION; IMPAIRED/BLURRED VISION; SLEEP DISTURBANCE; HEART ISSUES; MENTAL STATUS CHANGES; ELEVATED BLOOD PRESSURE; MUSCLE TWITCHING; ELEVATED HEART RATE; CHEST PAIN; MUSCLE SPASMS; BRAIN FOG; BULGING VEINS; INTERNAL VIBRATIONS AND TREMORS; FACIAL AND SINUS PRESSURE; DIZZINESS; SEVERE WEAKNESS; FATIGUE; HEADACHES; PAINFUL PARESTHESIA THROUGHOUT THE BODY, FACE, TONGUE, SCALP; DIARRHEA; TINNITUS; NAUSEA; This spontaneous report received from a physician concerned multiple patients of unspecified race and ethnicity. No past medical history or concurrent conditions were reported. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported, 1 total for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  The reporter reported that, on an unspecified date, "the patients experienced very similar adverse reactions to vaccines. The reactions included nausea, weight loss, heartburn, diarrhea or constipation, sleep disturbances, chest pains, headaches, facial and sinus pressure, dizziness, severe weakness and fatigue, painful paresthesia throughout the body, severe painful paresthesia focused on the face, tongue and scalp, internal vibrations and tremors, muscle twitching and muscle spasms, brain fog and mental status changes, memory loss, tinnitus, impaired or blurred vision, elevated blood pressure of 186 over 127 and heart rate, bulging veins, heart issues and weakness. Several in their group experienced paralysis of the lower extremities and to this day remain paralyzed.  These patients were previously healthy individuals and reactions occurred within minutes to a few short days after receiving the vaccines".  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from paralysis of lower extremities, and the outcome of injured, nausea, weight loss, heartburn, diarrhea, constipation, sleep disturbance, chest pain, headaches, facial and sinus pressure, dizziness, severe weakness, fatigue, painful paresthesia throughout the body, face, tongue, scalp, internal vibrations and tremors, muscle twitching, muscle spasms, brain fog, mental status changes, memory loss, tinnitus, impaired/blurred vision, elevated blood pressure, elevated heart rate, bulging veins and heart issues was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211021799 -COVID-19 VACCINE AD26.COV2.S-  paralysis of lower extremities. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: U
Vaccine: COVID19
Symptoms: Constipation, Diarrhoea, Diplegia, Dizziness, Dyspepsia
Clinical narrative: PARALYSIS OF LOWER EXTREMITIES; INJURED; WEIGHT LOSS; MEMORY LOSS; HEARTBURN; CONSTIPATION; IMPAIRED/BLURRED VISION; SLEEP DISTURBANCE; HEART ISSUES; MENTAL STATUS CHANGES; ELEVATED BLOOD PRESSURE; MUSCLE TWITCHING; ELEVATED HEART RATE; CHEST PAIN; MUSCLE SPASMS; BRAIN FOG; BULGING VEINS; INTERNAL VIBRATIONS AND TREMORS; FACIAL AND SINUS PRESSURE; DIZZINESS; SEVERE WEAKNESS; FATIGUE; HEADACHES; PAINFUL PARESTHESIA THROUGHOUT THE BODY, FACE, TONGUE, SCALP; DIARRHEA; TINNITUS; NAUSEA; This spontaneous report received from a physician concerned multiple patients of unspecified race and ethnicity. No past medical history or concurrent conditions were reported. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported, 1 total for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  The reporter reported that, on an unspecified date, "the patients experienced very similar adverse reactions to vaccines. The reactions included nausea, weight loss, heartburn, diarrhea or constipation, sleep disturbances, chest pains, headaches, facial and sinus pressure, dizziness, severe weakness and fatigue, painful paresthesia throughout the body, severe painful paresthesia focused on the face, tongue and scalp, internal vibrations and tremors, muscle twitching and muscle spasms, brain fog and mental status changes, memory loss, tinnitus, impaired or blurred vision, elevated blood pressure of 186 over 127 and heart rate, bulging veins, heart issues and weakness. Several in their group experienced paralysis of the lower extremities and to this day remain paralyzed.  These patients were previously healthy individuals and reactions occurred within minutes to a few short days after receiving the vaccines".  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from paralysis of lower extremities, and the outcome of injured, nausea, weight loss, heartburn, diarrhea, constipation, sleep disturbance, chest pain, headaches, facial and sinus pressure, dizziness, severe weakness, fatigue, painful paresthesia throughout the body, face, tongue, scalp, internal vibrations and tremors, muscle twitching, muscle spasms, brain fog, mental status changes, memory loss, tinnitus, impaired/blurred vision, elevated blood pressure, elevated heart rate, bulging veins and heart issues was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211021799 -COVID-19 VACCINE AD26.COV2.S-  paralysis of lower extremities. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Headache, Heart rate, Heart rate increased
Clinical narrative: PARALYSIS OF LOWER EXTREMITIES; INJURED; WEIGHT LOSS; MEMORY LOSS; HEARTBURN; CONSTIPATION; IMPAIRED/BLURRED VISION; SLEEP DISTURBANCE; HEART ISSUES; MENTAL STATUS CHANGES; ELEVATED BLOOD PRESSURE; MUSCLE TWITCHING; ELEVATED HEART RATE; CHEST PAIN; MUSCLE SPASMS; BRAIN FOG; BULGING VEINS; INTERNAL VIBRATIONS AND TREMORS; FACIAL AND SINUS PRESSURE; DIZZINESS; SEVERE WEAKNESS; FATIGUE; HEADACHES; PAINFUL PARESTHESIA THROUGHOUT THE BODY, FACE, TONGUE, SCALP; DIARRHEA; TINNITUS; NAUSEA; This spontaneous report received from a physician concerned multiple patients of unspecified race and ethnicity. No past medical history or concurrent conditions were reported. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported, 1 total for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  The reporter reported that, on an unspecified date, "the patients experienced very similar adverse reactions to vaccines. The reactions included nausea, weight loss, heartburn, diarrhea or constipation, sleep disturbances, chest pains, headaches, facial and sinus pressure, dizziness, severe weakness and fatigue, painful paresthesia throughout the body, severe painful paresthesia focused on the face, tongue and scalp, internal vibrations and tremors, muscle twitching and muscle spasms, brain fog and mental status changes, memory loss, tinnitus, impaired or blurred vision, elevated blood pressure of 186 over 127 and heart rate, bulging veins, heart issues and weakness. Several in their group experienced paralysis of the lower extremities and to this day remain paralyzed.  These patients were previously healthy individuals and reactions occurred within minutes to a few short days after receiving the vaccines".  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from paralysis of lower extremities, and the outcome of injured, nausea, weight loss, heartburn, diarrhea, constipation, sleep disturbance, chest pain, headaches, facial and sinus pressure, dizziness, severe weakness, fatigue, painful paresthesia throughout the body, face, tongue, scalp, internal vibrations and tremors, muscle twitching, muscle spasms, brain fog, mental status changes, memory loss, tinnitus, impaired/blurred vision, elevated blood pressure, elevated heart rate, bulging veins and heart issues was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211021799 -COVID-19 VACCINE AD26.COV2.S-  paralysis of lower extremities. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: U
Vaccine: COVID19
Symptoms: Hypertension, Injury, Mental status changes, Muscle spasms, Muscle twitching
Clinical narrative: PARALYSIS OF LOWER EXTREMITIES; INJURED; WEIGHT LOSS; MEMORY LOSS; HEARTBURN; CONSTIPATION; IMPAIRED/BLURRED VISION; SLEEP DISTURBANCE; HEART ISSUES; MENTAL STATUS CHANGES; ELEVATED BLOOD PRESSURE; MUSCLE TWITCHING; ELEVATED HEART RATE; CHEST PAIN; MUSCLE SPASMS; BRAIN FOG; BULGING VEINS; INTERNAL VIBRATIONS AND TREMORS; FACIAL AND SINUS PRESSURE; DIZZINESS; SEVERE WEAKNESS; FATIGUE; HEADACHES; PAINFUL PARESTHESIA THROUGHOUT THE BODY, FACE, TONGUE, SCALP; DIARRHEA; TINNITUS; NAUSEA; This spontaneous report received from a physician concerned multiple patients of unspecified race and ethnicity. No past medical history or concurrent conditions were reported. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported, 1 total for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  The reporter reported that, on an unspecified date, "the patients experienced very similar adverse reactions to vaccines. The reactions included nausea, weight loss, heartburn, diarrhea or constipation, sleep disturbances, chest pains, headaches, facial and sinus pressure, dizziness, severe weakness and fatigue, painful paresthesia throughout the body, severe painful paresthesia focused on the face, tongue and scalp, internal vibrations and tremors, muscle twitching and muscle spasms, brain fog and mental status changes, memory loss, tinnitus, impaired or blurred vision, elevated blood pressure of 186 over 127 and heart rate, bulging veins, heart issues and weakness. Several in their group experienced paralysis of the lower extremities and to this day remain paralyzed.  These patients were previously healthy individuals and reactions occurred within minutes to a few short days after receiving the vaccines".  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from paralysis of lower extremities, and the outcome of injured, nausea, weight loss, heartburn, diarrhea, constipation, sleep disturbance, chest pain, headaches, facial and sinus pressure, dizziness, severe weakness, fatigue, painful paresthesia throughout the body, face, tongue, scalp, internal vibrations and tremors, muscle twitching, muscle spasms, brain fog, mental status changes, memory loss, tinnitus, impaired/blurred vision, elevated blood pressure, elevated heart rate, bulging veins and heart issues was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211021799 -COVID-19 VACCINE AD26.COV2.S-  paralysis of lower extremities. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: U
Vaccine: COVID19
Symptoms: Nausea, Paraesthesia, Paranasal sinus discomfort, Sleep disorder, Tinnitus
Clinical narrative: PARALYSIS OF LOWER EXTREMITIES; INJURED; WEIGHT LOSS; MEMORY LOSS; HEARTBURN; CONSTIPATION; IMPAIRED/BLURRED VISION; SLEEP DISTURBANCE; HEART ISSUES; MENTAL STATUS CHANGES; ELEVATED BLOOD PRESSURE; MUSCLE TWITCHING; ELEVATED HEART RATE; CHEST PAIN; MUSCLE SPASMS; BRAIN FOG; BULGING VEINS; INTERNAL VIBRATIONS AND TREMORS; FACIAL AND SINUS PRESSURE; DIZZINESS; SEVERE WEAKNESS; FATIGUE; HEADACHES; PAINFUL PARESTHESIA THROUGHOUT THE BODY, FACE, TONGUE, SCALP; DIARRHEA; TINNITUS; NAUSEA; This spontaneous report received from a physician concerned multiple patients of unspecified race and ethnicity. No past medical history or concurrent conditions were reported. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported, 1 total for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  The reporter reported that, on an unspecified date, "the patients experienced very similar adverse reactions to vaccines. The reactions included nausea, weight loss, heartburn, diarrhea or constipation, sleep disturbances, chest pains, headaches, facial and sinus pressure, dizziness, severe weakness and fatigue, painful paresthesia throughout the body, severe painful paresthesia focused on the face, tongue and scalp, internal vibrations and tremors, muscle twitching and muscle spasms, brain fog and mental status changes, memory loss, tinnitus, impaired or blurred vision, elevated blood pressure of 186 over 127 and heart rate, bulging veins, heart issues and weakness. Several in their group experienced paralysis of the lower extremities and to this day remain paralyzed.  These patients were previously healthy individuals and reactions occurred within minutes to a few short days after receiving the vaccines".  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from paralysis of lower extremities, and the outcome of injured, nausea, weight loss, heartburn, diarrhea, constipation, sleep disturbance, chest pain, headaches, facial and sinus pressure, dizziness, severe weakness, fatigue, painful paresthesia throughout the body, face, tongue, scalp, internal vibrations and tremors, muscle twitching, muscle spasms, brain fog, mental status changes, memory loss, tinnitus, impaired/blurred vision, elevated blood pressure, elevated heart rate, bulging veins and heart issues was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211021799 -COVID-19 VACCINE AD26.COV2.S-  paralysis of lower extremities. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: U
Vaccine: COVID19
Symptoms: Tremor, Vasodilatation, Visual impairment, Weight decreased
Clinical narrative: PARALYSIS OF LOWER EXTREMITIES; INJURED; WEIGHT LOSS; MEMORY LOSS; HEARTBURN; CONSTIPATION; IMPAIRED/BLURRED VISION; SLEEP DISTURBANCE; HEART ISSUES; MENTAL STATUS CHANGES; ELEVATED BLOOD PRESSURE; MUSCLE TWITCHING; ELEVATED HEART RATE; CHEST PAIN; MUSCLE SPASMS; BRAIN FOG; BULGING VEINS; INTERNAL VIBRATIONS AND TREMORS; FACIAL AND SINUS PRESSURE; DIZZINESS; SEVERE WEAKNESS; FATIGUE; HEADACHES; PAINFUL PARESTHESIA THROUGHOUT THE BODY, FACE, TONGUE, SCALP; DIARRHEA; TINNITUS; NAUSEA; This spontaneous report received from a physician concerned multiple patients of unspecified race and ethnicity. No past medical history or concurrent conditions were reported. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported, 1 total for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  The reporter reported that, on an unspecified date, "the patients experienced very similar adverse reactions to vaccines. The reactions included nausea, weight loss, heartburn, diarrhea or constipation, sleep disturbances, chest pains, headaches, facial and sinus pressure, dizziness, severe weakness and fatigue, painful paresthesia throughout the body, severe painful paresthesia focused on the face, tongue and scalp, internal vibrations and tremors, muscle twitching and muscle spasms, brain fog and mental status changes, memory loss, tinnitus, impaired or blurred vision, elevated blood pressure of 186 over 127 and heart rate, bulging veins, heart issues and weakness. Several in their group experienced paralysis of the lower extremities and to this day remain paralyzed.  These patients were previously healthy individuals and reactions occurred within minutes to a few short days after receiving the vaccines".  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from paralysis of lower extremities, and the outcome of injured, nausea, weight loss, heartburn, diarrhea, constipation, sleep disturbance, chest pain, headaches, facial and sinus pressure, dizziness, severe weakness, fatigue, painful paresthesia throughout the body, face, tongue, scalp, internal vibrations and tremors, muscle twitching, muscle spasms, brain fog, mental status changes, memory loss, tinnitus, impaired/blurred vision, elevated blood pressure, elevated heart rate, bulging veins and heart issues was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211021799 -COVID-19 VACCINE AD26.COV2.S-  paralysis of lower extremities. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Therapy non-responder
Clinical narrative: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a consumer concerned a 56 year old male. The patient's weight was 198 pounds, and height was 67 inches. The patient had no known allergies and no medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, and expiry: 23-AUG-2021) dose was not reported, 1 total, administered on 27-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 17-SEP-2021, the patient had an antibody test which was negative (confirmed immunological vaccine failure). Laboratory data included: SARS-CoV-2 antibody test (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000197564 This case, from the same reporter is linked to 20211028400.; Sender's Comments: V0: 20211028354-covid-19 vaccine ad26.cov2.s-Confirmed Immunological vaccine failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Therapy non-responder
Clinical narrative: Confirmed Immunological Vaccine Failure; This spontaneous report received from a patient concerned a 47 year old (age at the time of vaccination 46 year old) female. The patient's weight was 123 pounds, and height was 59 inches. The patient's pre-existing medical conditions included: Patient has no medical history and no known allergies. The patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029 expiry: 23-AUG-2021) dose was not reported, 1 total, administered at left arm on 27-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 17-SEP-2021, the patient had bloodwork and tested negative for COVID antibody (confirmed immunological vaccine failure).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition).  This report was associated with product quality complaint: 90000197563. This case, from the same reporter is linked to 20211028354.; Sender's Comments: V0:20211028400-Covid-19 vaccine ad26.cov2.s-Confirmed Immunological vaccine Failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose administered >12 hours post puncture; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered >12 hours post puncture) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039D21A) for COVID-19 vaccination.     Concomitant products included PREDNISONE for an unknown indication.  On 06-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered >12 hours post puncture). On 06-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Dose administered >12 hours post puncture) had resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered EXPIRED PRODUCT ADMINISTERED (Dose administered >12 hours post puncture) to be possibly related.    No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 12-Oct-2021: Significant follow-up received: Concomitant medication was added and outcome was updated.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     Concurrent medical conditions included Sulfonamide allergy.    On 03-Sep-2021 at 11:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Sep-2021, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) dosing remained unchanged.       No concomitant medications was reported. No treatment drug details was reported.   This case was linked to MOD-2021-344282 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 12-Oct-2021: Follow-up received on 12-oct-2021 contain significant information about Patient demographic details added, medical history was added
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: had Moderna for 1st and 2nd doses; given Pfizer as booster dose; This spontaneous case was reported by a health care professional and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (had Moderna for 1st and 2nd doses; given Pfizer as booster dose) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A and 037K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Oct-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (had Moderna for 1st and 2nd doses; given Pfizer as booster dose). On 07-Oct-2021, INTERCHANGE OF VACCINE PRODUCTS (had Moderna for 1st and 2nd doses; given Pfizer as booster dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported. No Treatment medications were reported.   This case was linked to MOD-2021-345542 (Patient Link).
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: A patient received an expired vaccine as a 1st dose.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A patient received an expired vaccine as a 1st dose.) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (A patient received an expired vaccine as a 1st dose.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (A patient received an expired vaccine as a 1st dose.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported No treatment medications were reported   Most recent FOLLOW-UP information incorporated above includes: On 12-Oct-2021: Followup document received- Patient initials added, vaccine facility information added
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebral disorder, Dizziness, Fall, Head injury, Memory impairment
Clinical narrative: hard for her to remember things; felt down; half of her brain is dead/brain problems; dizzy spells; Her head hit the concrete; This spontaneous case was reported by a consumer and describes the occurrence of MEMORY IMPAIRMENT (hard for her to remember things), FALL (felt down), CEREBRAL DISORDER (half of her brain is dead/brain problems), DIZZINESS (dizzy spells) and HEAD INJURY (Her head hit the concrete) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002B21A and 037B21A) for COVID-19 vaccination.     Concurrent medical conditions included Fall (had two previous falls). Concomitant products included PRAVASTATIN, LEVOTHYROXINE and VITAMINS NOS for an unknown indication.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Mar-2021, the patient experienced MEMORY IMPAIRMENT (hard for her to remember things), FALL (felt down), CEREBRAL DISORDER (half of her brain is dead/brain problems), DIZZINESS (dizzy spells) and HEAD INJURY (Her head hit the concrete). At the time of the report, MEMORY IMPAIRMENT (hard for her to remember things), FALL (felt down), CEREBRAL DISORDER (half of her brain is dead/brain problems), DIZZINESS (dizzy spells) and HEAD INJURY (Her head hit the concrete) outcome was unknown.            No treatment drug details was reported.