chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Cold sweat, Fatigue, Psoriasis, Pyrexia
Clinical narrative: Continued joint soreness, low grade fever, fatigue, clammy, plaque psoriasis continuing to flare up after a year of none!
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Pt c/o dizziness and numbness in head initially but resolved.  BP 105/49, HR 56, RR 16 -- > 108/56, 62, 16.  Pt given water, juice.  Recommended pt f/u with their healthcare provider.  Pt stable and released from the vaccination site.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Computerised tomogram abnormal, Hyperhidrosis, Lipase increased, Magnetic resonance imaging normal
Clinical narrative: Night of second shot had low fever and diaphoresis lasting 3 nights.  On 5th am post injection had severe upper abdominal pain. Upon arrival in ER had bloodwork, CT, and MRI (results below)  Diagnosed as idiopathic pancreatitus since no reason could be found.  No alcohol at all, no stones, and no routine meds known to cause this. Admitted NPO and on IV fluids.  Discharged next evening after pain resolved and tolerating po fluids. Hospital physicians told me they did not think the vaccine could have been the issue but I still feel this was such a coincidence that it should be reported.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Pancreatitis, Pyrexia
Clinical narrative: Night of second shot had low fever and diaphoresis lasting 3 nights.  On 5th am post injection had severe upper abdominal pain. Upon arrival in ER had bloodwork, CT, and MRI (results below)  Diagnosed as idiopathic pancreatitus since no reason could be found.  No alcohol at all, no stones, and no routine meds known to cause this. Admitted NPO and on IV fluids.  Discharged next evening after pain resolved and tolerating po fluids. Hospital physicians told me they did not think the vaccine could have been the issue but I still feel this was such a coincidence that it should be reported.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Induration, Lymphadenopathy, Mass, Ultrasound scan
Clinical narrative: Within days of receiving my first dose of the Moderna vaccine, I developed a large, mobile, hard lump near my left clavicle. It was visible and I could  move over my clavicle bone. Unsure of what it was I scheduled an e-visit for 1/19/21. I was referred to my PCP and was seen on 1/20/21. I informed the provider that I had recently received the Covid vaccine. The provider originally referred me to dermatology for cyst removal but later called me to recommend an ultrasound of the mass.  I had an ultrasound on 1/26/21 which showed multiple enlarged lymph nodes including the one I had been able to see and move. It was determined to be a reaction to the vaccine and no other treatment was necessary unless it worsened. It has since returned to normal.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Amnesia, Hypoxia, Respiratory distress
Clinical narrative: Respiratory distress, hypoxia, memory loss
Age: 27.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Hypoaesthesia, Tinnitus
Clinical narrative: Nothing and normal the first two days. From day three and continuing today, I have severe fatigue, severe numbness, severe ear ringing.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Lymphadenopathy, Pain
Clinical narrative: Around 12 am after the dose of my vaccine, I got a fever, chills, body aches, headache and fatigue. I knew all of these things to be normal. My arm was sore and I also knew that was expected. I could hardly move out of bed. At 0700 this morning, on 6/4, I finally got the energy to shower. That is when I noticed my lymph node in my armpit of the same arm I received my vaccine in was swollen to about the size of a tennis ball. I had a PA that I work with recommend me to go to an urgent care to be seen because she did not believe this to be normal. I received a Toradol injection and a course of antibiotics to take in case it turned out to be infected.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Around 12 am after the dose of my vaccine, I got a fever, chills, body aches, headache and fatigue. I knew all of these things to be normal. My arm was sore and I also knew that was expected. I could hardly move out of bed. At 0700 this morning, on 6/4, I finally got the energy to shower. That is when I noticed my lymph node in my armpit of the same arm I received my vaccine in was swollen to about the size of a tennis ball. I had a PA that I work with recommend me to go to an urgent care to be seen because she did not believe this to be normal. I received a Toradol injection and a course of antibiotics to take in case it turned out to be infected.
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Patient had received 1st dose of Pfizer vaccine on 05/21/2021, 6 days later noted lump on clavicle.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Product preparation issue
Clinical narrative: Reconstituted incorrectly, only given the Lyophilized MenA component and reconstituted in sterile water. Patient reports no reactions.
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: Patient's daughter came in to find out when he received Covid vaccination because he just had a stroke. It occurred exactly 4 weeks after receiving his second dose. Patient's daughter is trying to get him into a rehab facility that would not accept him without his vaccine card.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac murmur, Chest X-ray, Chest pain, Echocardiogram, Electrocardiogram
Clinical narrative: 5/12 Had the vaccine on Wednesday and chest pain occurred on the following Monday Mother who is a nurse checked oxygen, which was in the 80s and pulse was elevated  5/18  Next day condition didn't resolve, went to urgent care center where nurse practitioner heard a heart murmur and EKG was abnormal  Chest pain, saturation, and increased pulse lasted for four more days Mother who is a nurse suggested decreased stressful events such as exercise and increased rest
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Full blood count, Heart rate increased, Metabolic function test
Clinical narrative: 5/12 Had the vaccine on Wednesday and chest pain occurred on the following Monday Mother who is a nurse checked oxygen, which was in the 80s and pulse was elevated  5/18  Next day condition didn't resolve, went to urgent care center where nurse practitioner heard a heart murmur and EKG was abnormal  Chest pain, saturation, and increased pulse lasted for four more days Mother who is a nurse suggested decreased stressful events such as exercise and increased rest
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Patient ambulated by herself after vaccine and appeared steady but did begin to complain of lightheadedness. EMTs on site took vitals which were normal. After a few minutes of sitting and talking symptom resolved with no additional symptoms developed. Walked with patient to exit after 15 minutes in observation.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Chest pain, Fatigue, Flank pain
Clinical narrative: The first day after I received the vaccine I experienced symptoms in guidance with all available resources. I was fatigued, my arm was sore at the sight of injection. I remember sleeping at least 12 hours.  A few days later I began to experience severe intermittent chest pain. The area under my arm was extremely tender, as were the area behind my left knee. The adverse event as stated in the report was a sudden jolt of searing pain on my left side. It lasted only a few moments and felt like it traveled from my left shoulder down to my left thigh and behind my knee. It nearly knocked me off my feet. I remained with a lingering pain in my leg and upper left back until today.  I reached out the pharmacist  who administered the vaccine about the side effects and she advised me to immediately contact my doctor's office. I visited my doctor's office yesterday (6/3/21) and he assured me I didn't have any blood clots. He advised me to use a heating pad for the pain in my leg. He also said that sometimes the lingering side effects from the vaccine may last weeks in rare cases. Those discomforts are finally starting to subside. I had no treatment outside of elevated levels of hydration, taking Tylenol and resting.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Hypersomnia, Injection site pain, Pain in extremity, Tenderness
Clinical narrative: The first day after I received the vaccine I experienced symptoms in guidance with all available resources. I was fatigued, my arm was sore at the sight of injection. I remember sleeping at least 12 hours.  A few days later I began to experience severe intermittent chest pain. The area under my arm was extremely tender, as were the area behind my left knee. The adverse event as stated in the report was a sudden jolt of searing pain on my left side. It lasted only a few moments and felt like it traveled from my left shoulder down to my left thigh and behind my knee. It nearly knocked me off my feet. I remained with a lingering pain in my leg and upper left back until today.  I reached out the pharmacist  who administered the vaccine about the side effects and she advised me to immediately contact my doctor's office. I visited my doctor's office yesterday (6/3/21) and he assured me I didn't have any blood clots. He advised me to use a heating pad for the pain in my leg. He also said that sometimes the lingering side effects from the vaccine may last weeks in rare cases. Those discomforts are finally starting to subside. I had no treatment outside of elevated levels of hydration, taking Tylenol and resting.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Cardiac monitoring, Chest X-ray normal, Chest pain, Dizziness
Clinical narrative: Carpopedal spasm, chest pain, heart palpations, trachycadia, dizziness, light headedness, anxiety, panic attacks, paricarditis. 2 ambulance rides, 5 ER visits, 3 clinic visits, halter monitor for one week and cardiologist apt. Treatments included in fluids, 3 chest x-ray, Ativan, beta blocker for rapid heart rate, MRI of brain, various blood lab tests, 6 EKGs, and echocardiogram. Treatment is Ativan and beta blocker medication persribed.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Echocardiogram normal, Electrocardiogram normal, Laboratory test normal, Magnetic resonance imaging head normal, Palpitations
Clinical narrative: Carpopedal spasm, chest pain, heart palpations, trachycadia, dizziness, light headedness, anxiety, panic attacks, paricarditis. 2 ambulance rides, 5 ER visits, 3 clinic visits, halter monitor for one week and cardiologist apt. Treatments included in fluids, 3 chest x-ray, Ativan, beta blocker for rapid heart rate, MRI of brain, various blood lab tests, 6 EKGs, and echocardiogram. Treatment is Ativan and beta blocker medication persribed.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Panic attack, Pericarditis, Tachycardia, Tetany
Clinical narrative: Carpopedal spasm, chest pain, heart palpations, trachycadia, dizziness, light headedness, anxiety, panic attacks, paricarditis. 2 ambulance rides, 5 ER visits, 3 clinic visits, halter monitor for one week and cardiologist apt. Treatments included in fluids, 3 chest x-ray, Ativan, beta blocker for rapid heart rate, MRI of brain, various blood lab tests, 6 EKGs, and echocardiogram. Treatment is Ativan and beta blocker medication persribed.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Heart rate irregular, Loss of consciousness, Pallor, Syncope
Clinical narrative: Patient became dizzy, collapsed, and was unconscious for approximately 30 seconds. Called 911. Patient became aroused, still complained of lightheadedness, had an irregular heartbeat, remained laying down until EMS arrived, very pale in the face. Remained with the patient until EMS arrived. Patient went to the hospital.
Age: 88.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Death
Clinical narrative: Patient passed away 4/14/2021
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Illness
Clinical narrative: I had the COVID vaccine on 3/4/21 was sick beginning the next morning. on 3/6/21 began having difficulty with breathing.  went to urgent care on 3/7/21 due to difficulty breathing.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: had shot when it first came out. Got shingles 3 times/ Suspected Vaccination failure; Got shingles 3 times; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows:  The age at vaccination was not reported. The patient got the Shingrix shot when it first came out and got shingles 3 times.  The patient said never again. This case was considered as suspected vaccination failure, as details regarding completion of primary vaccination schedule, laboratory test confirmation for shingles infection and time to event onset were unknown.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Gait disturbance, Herpes zoster, Pain, Vaccination failure
Clinical narrative: Three to four years after vaccines, the first case / the second was / 5 months after the first/suspected Vaccination failure; First case was near my tail bone / second was / 5 months after the first; First case was near my tail bone, I could barely walk for several weeks; The second / less painful, but lingered longer; This case was reported by a consumer via media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, more than 2 years after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, walking difficulty and pain. On an unknown date, the outcome of the vaccination failure, shingles, walking difficulty and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, walking difficulty and pain to be related to Shingles vaccine and Shingles vaccine.  Additional details were reported as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. Three to four years after vaccines, the first case of shingles was near tail bone and the patient could barely walk for several weeks. The second case of shingles was a mere 5 months after the first, less painful, but lingered longer. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I had the shot. Got shingle several times afterwards\ suspected Vaccination failure; Got shingle several times; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. The patient got shingle several times after receiving shot. This case was considered as suspected vaccination failure since details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Got shot-got shingles-very very mild\ suspected Vaccination failure; Got shot-got shingles-very very mild; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. The patient got shingles and it was very mild. The patient stated there was no problem. This case was considered as suspected vaccination failure since details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were not provided.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose of Shingrix in 2018 / like to get her second dose today? Does she have to restart the series?; This case was reported by a other health professional via (Shingrix) and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in 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 age at vaccination was not applicable for this report. Till the time if reporting, the patient did not receive second dose of Shingrix, which led to incomplete course of vaccination. The reporter asked whether the patient get her dose today of if she need to restart the series.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Pain
Clinical narrative: feeling "tired"; feeling/  "achy"; This case was reported by a consumer via call center representative and described the occurrence of tiredness in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th January 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced tiredness and pain. On an unknown date, the outcome of the tiredness and pain were recovered/resolved.   It was unknown if the reporter considered the tiredness and pain to be related to Shingrix.  The additional details were provided as follow: The patient self-reported the case. The patient received 1st dose of Shingrix and experienced tiredness and pain but these lasted for 12 hours only. No consent given to follow up with his HCP. The patient did not consent to follow up. The patient did not receive his 2nd dose, please refer case US2021AMR117971.; Sender's Comments:  US2021AMR117971:
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Patient who received one dose only of shingrix on 7/19/2018; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 19th July 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 age group was not reported but was captured as an adult as per the vaccine indication. The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete vaccination schedule. The reporter did not consent to follow up. Adverse event received via webchat. Healthcare professional denied any demographic data on self or patient.  Disconnected the webchat and said that he/she would call into Medical Information instead; therefore, this adverse event might be reported duplicate times.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect route of product administration
Clinical narrative: Inadvertently administered the/vaccine/subcutaneously; This case was reported by a pharmacist via call center representative and described the occurrence of intramuscular formulation administered by other route in a patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix (subcutaneous). On an unknown date, unknown after receiving Shingrix, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown. Additional details were provided as follows: The age at vaccination was not reported. The pharmacist informed that a student inadvertently administered the Shingrix vaccine to a patient subcutaneously instead the recommended intramuscular injection, which led to intramuscular formulation administered by other route. No data about the patient was reported. The reporter consented to follow up.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: second dose given 3 years apart form first / May 16th 2018/ May 28th 2021; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 16th May 2018).   On 28th May 2021, the patient received the 2nd dose of Shingrix. On 28th May 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: The pharmacist was looking for more data about a Shingrix second dose given 3 years apart from 1st dose to the patient, which led to lengthening of vaccinations schedule. The reporter consented to follow up.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Product preparation error
Clinical narrative: reconstituted Menveo lyophilized powder with sterile water and administered to a patient; reconstituted Menveo lyophilized powder with sterile water and administered to a patient; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 16-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA397A, expiry date 31st August 2021) for prophylaxis.   On 30th April 2021, the patient received Menveo. On 30th April 2021, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The case was reported by a medical assistant. The reporter stated that, they reconstituted Menveo lyophilized powder with sterile water and administered to the patient, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter did not consent to follow up.
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Expired product administered
Clinical narrative: Kinrix expired dose was given to a male patient / Kinrix vaccine expired on Jan 18th 2021.; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 5-year-old male patient who received DTPa-IPV (Kinrix) (batch number unknown, expiry date 18th January 2021) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 17th May 2021, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 17th May 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used 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 a medical assistant. The patient was administered with Kinrix, which was expired on 18th Jan 2021, which led to expired vaccine used. The reporter was looking for some guidance. The reporter consented to follow up by fax.
Sex: U
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Swelling face
Clinical narrative: FACIAL SWELLING; STIFFNESS; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced facial swelling, and stiffness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the facial swelling and stiffness was not reported. This report was non-serious.
Age: 45.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Fatigue, Headache, Muscle spasms, Pain in extremity
Clinical narrative: FATIGUE; HEADACHE; CHEST PAIN; TACHYCARDIA; CRAMPS ON HANDS, ARMS AND RIGHT LEG; PAIN ON  LEFT ARM; This spontaneous report received from a patient concerned a 45 year old white and Hispanic or Latino male. The patient's height, and weight were not reported. The patient's past medical history included gastritis, and concurrent conditions included glaucoma, avocado allergy(it causes nausea). Patient had Reglan allergy which causes nervousness. Patient was alcohol user (one time a month socially) and non-smoker.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, and expiry: unknown) dose was not reported, administered on 28-MAR-2021 on left arm  for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date in APR-2021, the patient experienced chest pain, tachycardia, cramps on hands, arms and right leg and pain on left arm. On an unspecified date in MAY-2021, the patient had fatigue, headache. On 01-MAY-2021, patient underwent PCR Covid-19 test which was negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chest pain, headache, cramps on hands, arms and right leg, fatigue, pain on left arm, and tachycardia. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210604719-COVID-19 VACCINE AD26.COV2.S-Chest Pain, Tachycardia. 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: 45.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Polymerase chain reaction, Tachycardia
Clinical narrative: FATIGUE; HEADACHE; CHEST PAIN; TACHYCARDIA; CRAMPS ON HANDS, ARMS AND RIGHT LEG; PAIN ON  LEFT ARM; This spontaneous report received from a patient concerned a 45 year old white and Hispanic or Latino male. The patient's height, and weight were not reported. The patient's past medical history included gastritis, and concurrent conditions included glaucoma, avocado allergy(it causes nausea). Patient had Reglan allergy which causes nervousness. Patient was alcohol user (one time a month socially) and non-smoker.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, and expiry: unknown) dose was not reported, administered on 28-MAR-2021 on left arm  for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date in APR-2021, the patient experienced chest pain, tachycardia, cramps on hands, arms and right leg and pain on left arm. On an unspecified date in MAY-2021, the patient had fatigue, headache. On 01-MAY-2021, patient underwent PCR Covid-19 test which was negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chest pain, headache, cramps on hands, arms and right leg, fatigue, pain on left arm, and tachycardia. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210604719-COVID-19 VACCINE AD26.COV2.S-Chest Pain, Tachycardia. 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: 45.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Chest pain, Computerised tomogram, Feeling abnormal, Headache
Clinical narrative: FATIGUE; HEADACHE; CHEST PAIN; TACHYCARDIA; CRAMPS ON HANDS, ARMS AND RIGHT LEG; PAIN ON  LEFT ARM; This spontaneous report received from a patient concerned a 45 year old white and Hispanic or Latino male. The patient's height, and weight were not reported. The patient's past medical history included gastritis, and concurrent conditions included glaucoma, avocado allergy(it causes nausea). Patient had Reglan allergy which causes nervousness. Patient was alcohol user (one time a month socially) and non-smoker.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, and expiry: unknown) dose was not reported, administered on 28-MAR-2021 on left arm  for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date in APR-2021, the patient experienced chest pain, tachycardia, cramps on hands, arms and right leg and pain on left arm. On an unspecified date in MAY-2021, the patient had fatigue, headache. On 01-MAY-2021, patient underwent PCR Covid-19 test which was negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chest pain, headache, cramps on hands, arms and right leg, fatigue, pain on left arm, and tachycardia. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210604719-COVID-19 VACCINE AD26.COV2.S-Chest Pain, Tachycardia. 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: 45.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Neck pain, Pain, Pain in extremity
Clinical narrative: FATIGUE; HEADACHE; CHEST PAIN; TACHYCARDIA; CRAMPS ON HANDS, ARMS AND RIGHT LEG; PAIN ON  LEFT ARM; This spontaneous report received from a patient concerned a 45 year old white and Hispanic or Latino male. The patient's height, and weight were not reported. The patient's past medical history included gastritis, and concurrent conditions included glaucoma, avocado allergy(it causes nausea). Patient had Reglan allergy which causes nervousness. Patient was alcohol user (one time a month socially) and non-smoker.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, and expiry: unknown) dose was not reported, administered on 28-MAR-2021 on left arm  for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date in APR-2021, the patient experienced chest pain, tachycardia, cramps on hands, arms and right leg and pain on left arm. On an unspecified date in MAY-2021, the patient had fatigue, headache. On 01-MAY-2021, patient underwent PCR Covid-19 test which was negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chest pain, headache, cramps on hands, arms and right leg, fatigue, pain on left arm, and tachycardia. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210604719-COVID-19 VACCINE AD26.COV2.S-Chest Pain, Tachycardia. 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: Dysphonia, Feeling abnormal, Hyperhidrosis, Skin odour abnormal
Clinical narrative: BODY DIFFERENT; SWEAT A LOT MORE; PEOPLE HAVING HARD TIME HEARING ME; BODY ODOR  STRONGER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced body different, sweat a lot more, people having hard time hearing me, and body odor stronger. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the body different, sweat a lot more, people having hard time hearing me and body odor stronger was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: COVID 19 VACCINE SYRINGE WAS PLACED IN A COOLER WITH LOWEST TEMPERATURE 20.6 F AND HIGHEST 40.8 F FOR APPROXIMATELY 1 HOUR AND 15 MINUTES; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980 expiry: 20-JUN-2021) dose was not reported, administered on 01-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On 01-JUN-2021, the subject experienced covid 19 vaccine syringe was placed in a cooler with lowest temperature 20.6 f and highest 40.8 f for approximately 1 hour and 15 minutes. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid 19 vaccine syringe was placed in a cooler with lowest temperature 20.6 f and highest 40.8 f for approximately 1 hour and 15 minutes was not reported. This report was non-serious. This case, from the same reporter is linked to 20210605045, 20210603408 and 20210602705.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Eye disorder, Feeling hot, Headache, Pain in extremity
Clinical narrative: WARM ARM; EYES WERE BOTHERING; LEFT ARM PAIN THAT WENT UP TO SHOULDER TO BACK AND DOWN TO HAND; HEADACHE; This spontaneous report received from a patient concerned an 85 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A214 expiry: UNKNOWN) dose was not reported, administered on 01-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On JUN-2021, the subject experienced warm arm. On JUN-2021, the subject experienced eyes were bothering. On JUN-2021, the subject experienced left arm pain that went up to shoulder to back and down to hand. On JUN-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, left arm pain that went up to shoulder to back and down to hand, warm arm and eyes were bothering was not reported. This report was non-serious.
Age: 27.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a pharmacist concerned a 27 year old of unspecified sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A expiry: 30/JUN/2021) dose was not reported, administered on 02-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-JUN-2021, the subject experienced expired vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine administered was not reported. This report was non-serious. This case, from the same reporter is linked to 20210606143.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: FEVER; HEADACHES; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on MAY-2021 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. On 31-MAY-2021, the subject experienced fever. On 31-MAY-2021, the subject experienced headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever, and headaches. This report was non-serious.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Poor quality product administered, Product storage error, Syncope
Clinical narrative: FAINTED AFTER VACCINATION BECAUSE WAS ANXIOUS; THE VACCINE WAS KEPT IN THE FREEZER AFTER DELIVERY, THAWED OVERNIGHT AND KEPT IN THE FRIDGE TILL VACCINATION.; POOR QUALITY VACCINE ADMINISTERED; ANXIOUS; This spontaneous report received from a pharmacist concerned a 21-year-old female patient of unspecified race and ethnic origin. The patient's height, weight, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821288, and expiry: unknown) dose was not reported, 1 total, administered on 31-MAY-2021 for prophylactic vaccination.  No concomitant medications were reported.  On 28-MAY-2021, the reporter received 20 vials of the JANSSEN COVID-19 VACCINE which they kept in the freezer (the reporter did not know whether they received the vaccine in a frozen state or at fridge temperature). They took out 2 vials out of the freezer and moved into the fridge on the night of 29-MAY-2021, 1 vial on the night of 30-MAY-2021 and 1 vial on the night of 31-May-2021. On the same day the patient fainted after vaccination because she was anxious, the vaccine was kept in the freezer after delivery, thawed overnight and kept in the fridge till vaccination and poor-quality vaccine administered. On 01-JUN-2021 at 12:30, they took out the rest of the vials.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fainted after vaccination and anxious, and the outcome of the vaccine was kept in the freezer after delivery, thawed overnight and kept in the fridge till vaccination and poor quality vaccine administered were not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210605104, 20210605028, 20210605010, 20210605009 and 20210604703.; Sender's Comments: V0: 20210605120-COVID-19 VACCINE AD26.COV2.S-Fainted after vaccination because was Anxious. 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: M
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: This spontaneous report received from a pharmacist concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821288, expiry: 01-AUG-2021) dose was not reported, administered on 01-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-JUN-2021, the subject experienced stored in the fridge for over 6 hours. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of stored in the fridge for over 6 hours was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Blindness unilateral, Blood test
Clinical narrative: BLIND IN THE RIGHT EYE; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included non alcohol user, and non smoker, and other pre-existing medical conditions included no known allergies, no drug abuse or illicit drug usage, no relevant medical history and not taking any medications.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, frequency once total, administered on MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 12-MAY-2021, the patient noticed some vision issues. Patient went to the emergency room approximately 3 weeks ago. Patient was then referred to the ophthalmologist. Patient has since gone blind in her right eye. Patient never had any vision problems before. The ophthalmologist confirmed that it wasn't cataracts, glaucoma, macular degeneration, or optic neuritis. The ophthalmologist said that he has no idea what it could be. On an unspecified date in MAY-2021, Laboratory data included: Blood test (NR: not provided) nothing of note was found. Patient was hospitalized for unspecified number of days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blind in the right eye was not reported. This report was serious (Hospitalization Caused / Prolonged, and Disability Or Permanent Damage).; Sender's Comments: V0: 20210605555-covid-19 vaccine ad26.cov2.s-blind in the right eye. 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: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Confusional state, Constipation, Diarrhoea, Gastrointestinal motility disorder
Clinical narrative: CONSTIPATION; PROBLEMS WITH BOWEL MOVEMENTS; DIARRHEA; PANIC ATTACK; HOT FLASHES; PAIN IN KNEES; PAIN IN CALVES,LEGS AND RIGHT ARM; COULDN'T SEE WELL; FELT CONFUSED; This spontaneous report received from a patient concerned a 49 year old male. The patient's height, and weight were not reported. The patient's past medical history included patient has taken tylenol.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 25-MAY-2021 for an unspecified indication. The batch number was not reported and has been requested Concomitant medications included paracetamol. On 25-MAY-2021, the subject experienced couldn't see well. On 25-MAY-2021, the subject experienced felt confused. On 25-MAY-2021, the subject experienced pain in calves, legs and right arm. On 26-MAY-2021, the subject experienced hot flashes. On 26-MAY-2021, the subject experienced pain in knees. On 01-JUN-2021, the subject experienced panic attack. On 02-JUN-2021, the subject experienced constipation. On 02-JUN-2021, the subject experienced problems with bowel movements. On 02-JUN-2021, the subject experienced diarrhea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from couldn't see well, and felt confused, had not recovered from pain in knees, hot flashes, problems with bowel movements, and pain in calves,legs and right arm, and the outcome of panic atack, diarrhea and constipation was not reported. This report was non-serious.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Hot flush, Pain in extremity, Panic attack, Visual impairment
Clinical narrative: CONSTIPATION; PROBLEMS WITH BOWEL MOVEMENTS; DIARRHEA; PANIC ATTACK; HOT FLASHES; PAIN IN KNEES; PAIN IN CALVES,LEGS AND RIGHT ARM; COULDN'T SEE WELL; FELT CONFUSED; This spontaneous report received from a patient concerned a 49 year old male. The patient's height, and weight were not reported. The patient's past medical history included patient has taken tylenol.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 25-MAY-2021 for an unspecified indication. The batch number was not reported and has been requested Concomitant medications included paracetamol. On 25-MAY-2021, the subject experienced couldn't see well. On 25-MAY-2021, the subject experienced felt confused. On 25-MAY-2021, the subject experienced pain in calves, legs and right arm. On 26-MAY-2021, the subject experienced hot flashes. On 26-MAY-2021, the subject experienced pain in knees. On 01-JUN-2021, the subject experienced panic attack. On 02-JUN-2021, the subject experienced constipation. On 02-JUN-2021, the subject experienced problems with bowel movements. On 02-JUN-2021, the subject experienced diarrhea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from couldn't see well, and felt confused, had not recovered from pain in knees, hot flashes, problems with bowel movements, and pain in calves,legs and right arm, and the outcome of panic atack, diarrhea and constipation was not reported. This report was non-serious.