chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027H21B and 012020A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 30-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant and treatment medication was not reported. Patients received expired vaccine which was stored in the refrigerator beyond 30 days.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: All patients received Expired Moderna COVID-19 vaccine from a vial that was stored in the refrigerator beyond 30 days; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (All patients received Expired Moderna COVID-19 vaccine from a vial that was stored in the refrigerator beyond 30 days) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (All patients received Expired Moderna COVID-19 vaccine from a vial that was stored in the refrigerator beyond 30 days). On 30-Dec-2021, EXPIRED PRODUCT ADMINISTERED (All patients received Expired Moderna COVID-19 vaccine from a vial that was stored in the refrigerator beyond 30 days) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were provided No treatment medications were provided.
Age: 33.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: All patients received Expired Moderna COVID-19 vaccine from a vial that was stored in the refrigerator betond 30 days; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (All patients received Expired Moderna COVID-19 vaccine from a vial that was stored in the refrigerator betond 30 days) in a 33-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (All patients received Expired Moderna COVID-19 vaccine from a vial that was stored in the refrigerator betond 30 days). On 30-Dec-2021, EXPIRED PRODUCT ADMINISTERED (All patients received Expired Moderna COVID-19 vaccine from a vial that was stored in the refrigerator betond 30 days) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication was reported. No concomitant medication was reported.  None of the patients have reported side effects, so far.
Sex: F
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: got a flu shot and has been sick since; Initial information received on 07-Jan-2022 regarding an unsolicited valid non-serious case received from consumer/non-hcp.  This case involves Adult female patient who experienced got a flu shot and has been sick since while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by Sanofi manufacturer lot number not reported via unknown route in unknown administration site.  On an unknown date the patient developed a non-serious "got a flu shot and has been sick since" (Malaise) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported that: "Product name was not provided, since this is a public post on the Sanofi flu shot campaign, we are assuming the consumer is referring to the Sanofi flu vaccine. Reporter Commented that his sister got a flu shot and has been sick since. Reporter rephrased same as if its like, a person  dont have the flu but let if person got a shot so I would".   Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (got a flu shot and has been sick since).  At time of reporting, the outcome was Unknown for the event got a flu shot and has been sick since.
Sex: F
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: Got very sick from the last one 8 yrs ago; Initial information received on 07-Jan-2022 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves an unknown age female patient who got very sick from the last one 8 yrs ago while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (form, strength, dose, frequency, route, lot number, expiry date  unknown) in unknown administration site as prophylactic vaccination.  On an unknown date the patient developed a non-serious event "got very sick from the last one 8 yrs ago" (malaise) (unknown latency) following the administration of INFLUENZA VACCINE.  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (Got very sick from the last one 8 yrs ago).  At time of reporting, the outcome was Unknown for the event got very sick from the last one 8 yrs ago.
Sex: U
Vaccine: FLUX
Symptoms: Emotional distress, Feeling abnormal
Clinical narrative: Getting a flu shot means misery and suffering; Initial information received on 07-Jan-2022 with live follow-up 08-Jan-2022 (processed together) regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves Adult and unknown gender patient who experienced getting a flu shot means misery and suffering while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious event "getting a flu shot means misery and suffering" (emotional distress) (unknown latency) following the administration of INFLUENZA VACCINE.  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (Getting a flu shot means misery and suffering).  At time of reporting, the outcome was Unknown for the event getting a flu shot means misery and suffering.
Sex: U
Vaccine: COVID19, FLUX
Symptoms: Injection site pain, Joint range of motion decreased, Musculoskeletal disorder, Pain in extremity
Clinical narrative: couldn't lift my arms because they hurt; couldn't lift my arms because they hurt; Initial information received on 07-Jan-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves a patient of unknown demographics who couldn't lift my arms because they hurt, while receiving vaccine INFLUENZA VACCINE.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included COVID-19 VACCINE (COVID-19 VACCINE) for COVID-19 immunisation.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient couldn't lift my arms because they hurt (injection site pain) (unknown latency) following the administration of INFLUENZA VACCINE. On an unknown date the patient couldn't lift my arms because they hurt (musculoskeletal disorder) (unknown latency) following the administration of INFLUENZA VACCINE.  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the events   At time of reporting, the outcome was Unknown for the events
Sex: U
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: deathly sick; Initial information received on 07-Jan-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves patient of unknown age and gender who experienced deathly sick while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   In 2014, the patient received a  dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported in unknown administration site for immunization .  On an unknown date the patient developed a non-serious event of "deathly sick " (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported " Got my last flu shot 8 years ago and got deathly sick. Never got the flu and I will never get another vaccine again for anything."  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (deathly sick).  At time of reporting, the outcome was Unknown for the event deathly sick.
Sex: U
Vaccine: FLUX
Symptoms: Pain in extremity
Clinical narrative: Different arms, both are sore; Initial information received on 08-Jan-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves a patient of unknown demographics who experienced different arms, both are sore, while receiving vaccine INFLUENZA VACCINE.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed different arms, both are sore (vaccination site pain) (unknown latency) following the administration of INFLUENZA VACCINE.  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (Different arms, both are sore).  At time of reporting, the outcome was Unknown for the event different arms, both are sore.
Sex: U
Vaccine: FLUX
Symptoms: Illness, Malaise
Clinical narrative: got sick; Initial information received on 08-Jan-2022 regarding an unsolicited valid Social Media non-serious case received from a patient.   This case involves Adult and unknown gender patient who got sick while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer via unknown route in unknown administration site (dose, formulation, strength, lot number and expiry date not reported) as prophylactic vaccination.  On an unknown date the patient developed a non-serious event "got sick" (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "I had one. Then I got sick as a dog that year"  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (got sick).  At time of reporting, the outcome was Unknown for the event got sick.
Sex: U
Vaccine: FLUX
Symptoms: Autoimmune disorder, Malaise
Clinical narrative: autoimmune disease caused by the vaccine; still got sick; Initial information received on 10-Jan-2022 from United states regarding an unsolicited valid Social Media serious case received from a consumer/non-hcp.  This case involves Adult and unknown demographic patient who had autoimmune disease caused by the vaccine and still got sick while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site.  On an unknown date the patient developed a serious autoimmune disease caused by the vaccine (autoimmune disorder) (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant. On an unknown date the patient developed a non-serious still got sick (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the events (autoimmune disease caused by the vaccine, still got sick).  At time of reporting, the outcome was Unknown for the event autoimmune disease caused by the vaccine and was Unknown for the event still got sick.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: One flu shot that gave flu s' all ever needed; Initial information was received on 07-Jan-2022 regarding an unsolicited valid Social Media non-serious case received from a patient.  This case involves an unknown demographics patient who experienced one flu shot that gave flu s' all ever needed while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (strength, formulation, dose, route, batch number and expiry date: unknown) in unknown administration site for prophylactic vaccination  On an unknown date the patient developed a non-serious event "one flu shot that gave flu s' all ever needed" (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (One flu shot that gave flu s' all ever needed).  At time of reporting, the outcome was Unknown for the event one flu shot that gave flu s' all ever needed.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This case involves 28 years old female patient who was exposed to vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] in context of patient is pregnant with no reported adverse event. Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The reported patient is pregnant with no reported adverse event occurred at 33 weeks of pregnancy. The date of last menstrual period was reported as 18-May-2021. The estimated due date is 22-Feb-2022. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had unknown previous pregnancy/ies. On 07-Jan-2022, the patient received 0.5 ml dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE, frequency once, lot U7283AA, expiry date: 02-Feb-2024 via intramuscular route in the left deltoid (formulation, strength: not reported) as prophylactic vaccination (TB skin test--immunization). On 07-JAN-2022 the patient developed a non-serious event "patient is pregnant with no reported adverse event "(exposure during pregnancy) (latency same day) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. It was reported "Dose = 0.25 mL to 2 mL for vaccines or 0.1 mL for TB skin test--0.5ml o Strength = standard except for Fluzone HD--standard o Indications = Immunization or TB skin test--immunization" Action taken with DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (ADACEL) was not applicable. It was not reported if the patient received a corrective treatment for the event (patient is pregnant with no reported adverse event). At time of reporting, the outcome was Unknown for the event patient is pregnant with no reported adverse event. Additionally, at time of reporting, the pregnancy is still ongoing.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Incorrect dose administered, Medication error, Product preparation error
Clinical narrative: Pentacel was not reconstituted properly with no reported adverse event; Lyophilized portion was not given with no reported adverse event; Initial information received on 07-Jan-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 6 months old male patient who experienced pentacel was not reconstituted properly with no reported adverse event and lyophilized portion was not given with no reported adverse event while receiving vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 07-Jan-2022, the patient received a  dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot UJ580AA via intramuscular route in unknown administration site. First time product used : No   On 07-JAN-2022 the patient developed a non-serious pentacel was not reconstituted properly with no reported adverse event (product preparation issue) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE. On 07-JAN-2022 the patient developed a non-serious lyophilized portion was not given with no reported adverse event (incorrect dose administered) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE.  It was reported "from reporting manager office that PENTACEL was not reconstituted properly, and the lyophilized portion was not given. It was questioned that what should be done now. This was an potential AE because of medication error. The patient has been Still using product".  Action taken with DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE (PENTACEL) was not applicable.  It was not reported if the patient received a corrective treatment for the events (Pentacel was not reconstituted properly with no reported adverse event, Lyophilized portion was not given with no reported adverse event).  At time of reporting, the outcome was Unknown for the event pentacel was not reconstituted properly with no reported adverse event and was Unknown for the event lyophilized portion was not given with no reported adverse event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: M
Vaccine: RAB
Symptoms: Expired product administered, No adverse event
Clinical narrative: received an expired dose, with no reported adverse event; Initial information received on 07-Jan-2022 regarding an unsolicited valid  non-serious case received from a health professional.  This case involves a 22 years old male patient who received an expired dose, with no reported adverse event while receiving vaccine RABIES (HDC) VACCINE [IMOVAX RABIES].     The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.    On 07-Jan-2022, the patient received a 1 ml dose once of suspect RABIES (HDC) VACCINE lot T1B491M , expiry date: 07-Dec-2021 via intramuscular route at right deltoid. First time product used : Yes  On 07-JAN-2022 the patient developed a non-serious event "received an expired dose, with no reported adverse event" (expired product administered)(latency: same day) following the administration of RABIES (HDC) VACCINE.  It was reported "Caller states that a patient that was due for their second dose of IMOVAX received a dose of expired product. Caller would like to know if the product was still suitable for use? Caller would also like to know how soon should the patient be revaccinated?  Caller states patient is receiving IMOVAX for a dog bite and was there for their second dose in the series".   Action taken with RABIES VACCINE (IMOVAX RABIES) was not applicable.  It was not reported if the patient received a corrective treatment for the event (received an expired dose, with no reported adverse event).  At time of reporting, the outcome was Unknown for the event received an expired dose, with no reported adverse event.     This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Inflammation, Vasodilatation
Clinical narrative: Hyper vascular inflammation with bulging veins and abdomen pain. Has continued for seven months.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Concussion, Fall, Feeling abnormal, Head injury, Presyncope
Clinical narrative: 1510 ? Received COVID vaccine. Asked to stay for 15 minutes of observation to end at 1535.  1520 ? Patient had a presumed vasovagal reaction with syncope and an unassisted fall to the floor with impact to back of head per the mother and sibling, who were the primary witnesses. Staff immediately responded for triage. Patient was already AOx4, but dazed. Placed on back, legs elevated onto chair. BP 117/65. HR 60s-90s. Patient reports being well hydrated and did eat lunch. No hx of vagovagal. Focused neurological assessment performed by on-site provider (PA) due to head injury, but stable with no overtly concerns for concussion. Recovering from vagovagal.  1525 ? Placed in reclining chair with ongoing monitoring and recovery time. Patient, mother, and sibling advised as to s/s of concussion for monitoring at home and when emergency medical assistance required by on-site provider. While gathering patient information for event reporting, also discovered that patient was given Moderna COVID vaccine, which he is not eligible for as a 15 yo. Patient and family notified of this error. Patient consented for his sister to be called at a future date to advise them of current guidelines on what to do for 2nd dose.   1540 ? Patient sat up in recliner for 3-5  minutes and provided orange juice. Stable. Asked to stand for 1 minute. Stable. Asked to step in place 10x. Stable. Ambulated around room with staff supervision. Stable. Neuro status also stable. Patient and family advised that he may leave and reminded of s/s to monitor for.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: 1510 ? Received COVID vaccine. Asked to stay for 15 minutes of observation to end at 1535.  1520 ? Patient had a presumed vasovagal reaction with syncope and an unassisted fall to the floor with impact to back of head per the mother and sibling, who were the primary witnesses. Staff immediately responded for triage. Patient was already AOx4, but dazed. Placed on back, legs elevated onto chair. BP 117/65. HR 60s-90s. Patient reports being well hydrated and did eat lunch. No hx of vagovagal. Focused neurological assessment performed by on-site provider (PA) due to head injury, but stable with no overtly concerns for concussion. Recovering from vagovagal.  1525 ? Placed in reclining chair with ongoing monitoring and recovery time. Patient, mother, and sibling advised as to s/s of concussion for monitoring at home and when emergency medical assistance required by on-site provider. While gathering patient information for event reporting, also discovered that patient was given Moderna COVID vaccine, which he is not eligible for as a 15 yo. Patient and family notified of this error. Patient consented for his sister to be called at a future date to advise them of current guidelines on what to do for 2nd dose.   1540 ? Patient sat up in recliner for 3-5  minutes and provided orange juice. Stable. Asked to stand for 1 minute. Stable. Asked to step in place 10x. Stable. Ambulated around room with staff supervision. Stable. Neuro status also stable. Patient and family advised that he may leave and reminded of s/s to monitor for.
Age: 29.0
Sex: M
Vaccine: UNK
Symptoms: Anaphylactic reaction, Hypersensitivity
Clinical narrative: Anaphylaxis randomly, new allergies
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Contusion, Haemorrhage, Incorrect route of product administration, Musculoskeletal stiffness
Clinical narrative: Shot improperly administered, resulted in blood spurting, bruised area. Arm and shoulder stiffness persists.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Disturbance in attention, Dysstasia, Feeling abnormal, Feeling hot
Clinical narrative: The shot was given at 0130pm on Jan 13. Symptoms woke me up at 0130am on Jan 14th. Chills that were not helped by putting multiple blankets and or clothes on. Unable to get up and walk, tried to put weight on legs felt like they were breaking, inflammation in the left armpit lymph nodes. noticed a small swell at the shot site that I thought was normal. But the swelling in the armpit/ node area hindered the movement of my left arm. Needed support getting to the bathroom ( I am fully capable of reaching the middle of my back and going to the bathroom by myself on a regular day) I reported similar symptoms to my primary care MD when I received the 2nd dose of Pfizer Biotech Lot EL3302 given at the hospital I work at on 1/27/2021. I did not realize I could self-report at that time otherwise I would of. I have all of those symptoms written down if they are needed. The major difference between that time and this time is that after 4 days I still currently have limited mobility in my left arm due to the swelling in the armpit/nodes. The hospitals are crazy right now and I am also trying to get a response from my primary care to see what to do next. I experienced chills for 48 hours. I then was extremely hot for 24 hours. I was groggy ( unable to focus and was abnormally very upset) and had severe pain all over my body. A migraine type of headache started on Saturday jan15th. I took Imitrex to try and relieve that. I took 2 x200mg ibuprofen w/ 1 500 mg Tylenol trying to help relieve the symptoms. It did not help much.  I honestly thought the reaction to the seconnd shot would not happen on the third shot. Because on the first shot I had no issues. I obviously was wrong.  I want to report these symptoms to try and help studies. Maybe it is because I have no Thyroid. I am not sure but this is awful and I will be refusing any future COVID vaccines this is dangerous, unfortunately.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Gait inability, Injected limb mobility decreased, Injection site swelling, Lymphadenopathy, Migraine
Clinical narrative: The shot was given at 0130pm on Jan 13. Symptoms woke me up at 0130am on Jan 14th. Chills that were not helped by putting multiple blankets and or clothes on. Unable to get up and walk, tried to put weight on legs felt like they were breaking, inflammation in the left armpit lymph nodes. noticed a small swell at the shot site that I thought was normal. But the swelling in the armpit/ node area hindered the movement of my left arm. Needed support getting to the bathroom ( I am fully capable of reaching the middle of my back and going to the bathroom by myself on a regular day) I reported similar symptoms to my primary care MD when I received the 2nd dose of Pfizer Biotech Lot EL3302 given at the hospital I work at on 1/27/2021. I did not realize I could self-report at that time otherwise I would of. I have all of those symptoms written down if they are needed. The major difference between that time and this time is that after 4 days I still currently have limited mobility in my left arm due to the swelling in the armpit/nodes. The hospitals are crazy right now and I am also trying to get a response from my primary care to see what to do next. I experienced chills for 48 hours. I then was extremely hot for 24 hours. I was groggy ( unable to focus and was abnormally very upset) and had severe pain all over my body. A migraine type of headache started on Saturday jan15th. I took Imitrex to try and relieve that. I took 2 x200mg ibuprofen w/ 1 500 mg Tylenol trying to help relieve the symptoms. It did not help much.  I honestly thought the reaction to the seconnd shot would not happen on the third shot. Because on the first shot I had no issues. I obviously was wrong.  I want to report these symptoms to try and help studies. Maybe it is because I have no Thyroid. I am not sure but this is awful and I will be refusing any future COVID vaccines this is dangerous, unfortunately.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Sensory disturbance, Somnolence
Clinical narrative: The shot was given at 0130pm on Jan 13. Symptoms woke me up at 0130am on Jan 14th. Chills that were not helped by putting multiple blankets and or clothes on. Unable to get up and walk, tried to put weight on legs felt like they were breaking, inflammation in the left armpit lymph nodes. noticed a small swell at the shot site that I thought was normal. But the swelling in the armpit/ node area hindered the movement of my left arm. Needed support getting to the bathroom ( I am fully capable of reaching the middle of my back and going to the bathroom by myself on a regular day) I reported similar symptoms to my primary care MD when I received the 2nd dose of Pfizer Biotech Lot EL3302 given at the hospital I work at on 1/27/2021. I did not realize I could self-report at that time otherwise I would of. I have all of those symptoms written down if they are needed. The major difference between that time and this time is that after 4 days I still currently have limited mobility in my left arm due to the swelling in the armpit/nodes. The hospitals are crazy right now and I am also trying to get a response from my primary care to see what to do next. I experienced chills for 48 hours. I then was extremely hot for 24 hours. I was groggy ( unable to focus and was abnormally very upset) and had severe pain all over my body. A migraine type of headache started on Saturday jan15th. I took Imitrex to try and relieve that. I took 2 x200mg ibuprofen w/ 1 500 mg Tylenol trying to help relieve the symptoms. It did not help much.  I honestly thought the reaction to the seconnd shot would not happen on the third shot. Because on the first shot I had no issues. I obviously was wrong.  I want to report these symptoms to try and help studies. Maybe it is because I have no Thyroid. I am not sure but this is awful and I will be refusing any future COVID vaccines this is dangerous, unfortunately.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Pericardial effusion, Pericarditis
Clinical narrative: pericardial effusion,  pericarditis, atrial fibrillation
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac discomfort, Chills, Dyspnoea, Fatigue, Pyrexia
Clinical narrative: heart discomfort, heavy breath after about 4 hours chilling, low fever, and fatigue after about 12hours
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Pruritus, Urticaria
Clinical narrative: Sudden, intense itching followed by hives at day 10 after the Modern booster shot. Hives and discomfort continuing 6+ weeks post-booster. Itching started on scalp and ears, then spread to the rest of the body.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Nausea, Vomiting
Clinical narrative: Patient began feeling ?offs? and then from Monday through Friday he could not keep any food down. No other symptoms other than nausea and vomiting. He went from  191 to 176 in 6 days.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Mechanical urticaria, Pain, Pruritus, Urticaria
Clinical narrative: Extremely itchy all over body. Breaking out all over the body in hives. Experiencing dermatographia. Never had an allergic reaction to anything before, and no family history of anything like this. Difficulty sleeping because I am in so much pain.  Took benadryl but symptoms are not going away. Hesitant to take prednisone because I am only a few weeks into my pregnancy.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Restless legs syndrome
Clinical narrative: Every night since the 9th i keep having restless leg syndrome from somewhere between12-2am. I have to get up and walk around and get an ice pack to help it go away.  It was my first covid vaccine dose and i thought maybe it was the seroquel but i didn't have any issues with it before and already been taking it for a while. THEN i realized the vaccine was the only thing i did different so that has to be it since it started the very next day. I want it to go away, i can't sleep as it is
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Erythema, Rash, Rash macular, SARS-CoV-2 test
Clinical narrative: Red, hot, and splotchy area appeared on the left side of my neck 12 days after receiving Moderna booster. Rash started at about 7:30 pm on 12/02/2021 and continued to spread to my scalp and other areas of my neck. By 7 am on 12/03/2021, the rash had started to spread to other areas of my body including legs, feet, torso, back, hands, face. Rash continued to get worse throughout the next several days, very reactive to touch and heat. Very itchy, hot, raised, red, hives in splotches and linear pattern. Improved immediately after starting oral steroid. Still present over one month later but less severe.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Skin warm, Swelling, Urticaria
Clinical narrative: Red, hot, and splotchy area appeared on the left side of my neck 12 days after receiving Moderna booster. Rash started at about 7:30 pm on 12/02/2021 and continued to spread to my scalp and other areas of my neck. By 7 am on 12/03/2021, the rash had started to spread to other areas of my body including legs, feet, torso, back, hands, face. Rash continued to get worse throughout the next several days, very reactive to touch and heat. Very itchy, hot, raised, red, hives in splotches and linear pattern. Improved immediately after starting oral steroid. Still present over one month later but less severe.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Extreme non stop itching on the soles of my feet without presentation of rash, bumps or redness. 24 hours after second dose, duration of at least 48 hours.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Menstrual disorder, Menstruation delayed, Muscle spasms, Pregnancy test negative
Clinical narrative: Abnormal period.  Heavy bleeding, late period. Severe cramping  especially on the right. Ovary
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Angiogram cerebral, Arteriogram carotid, Ischaemic stroke, Thrombosis
Clinical narrative: blood clot caused ischemic stroke after covid vaccine.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac disorder, Computerised tomogram thorax, Dyspnoea, Fibrin D dimer, Pleural effusion
Clinical narrative: Bilateral PE's after Booster 1/15/22.  Acute onset Shortness of breath after Moderna Booster.  Pfizer for the initial two doses of vaccine.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Pulmonary embolism, SARS-CoV-2 test negative
Clinical narrative: Bilateral PE's after Booster 1/15/22.  Acute onset Shortness of breath after Moderna Booster.  Pfizer for the initial two doses of vaccine.
Age: 14.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: C-reactive protein increased, Chest X-ray normal, Chest pain, Intensive care, Pain in extremity
Clinical narrative: Patient developed chest pain and left arm pain the day following the vaccination. Presented to the emergency center with continued symptoms and labs were performed.
Age: 14.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Troponin increased, White blood cell count increased
Clinical narrative: Patient developed chest pain and left arm pain the day following the vaccination. Presented to the emergency center with continued symptoms and labs were performed.
Age: 14.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, C-reactive protein increased, Chest pain, Echocardiogram normal, Myocarditis
Clinical narrative: Patient developed chest pain and left arm pain the day following the vaccination. Presented to the emergency center with continued symptoms and labs were performed.
Age: 14.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Troponin increased
Clinical narrative: Patient developed chest pain and left arm pain the day following the vaccination. Presented to the emergency center with continued symptoms and labs were performed.
Age: 14.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: C-reactive protein increased, Chest X-ray normal, Chest pain, Intensive care, Pain in extremity
Clinical narrative: Chest pain, left arm/shoulder pain x36 hours, myopericarditis with troponin leak >48 hours
Age: 14.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Troponin increased, White blood cell count increased
Clinical narrative: Chest pain, left arm/shoulder pain x36 hours, myopericarditis with troponin leak >48 hours
Age: 14.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, C-reactive protein increased, Chest pain, Echocardiogram normal, Myocarditis
Clinical narrative: Chest pain, left arm/shoulder pain x36 hours, myopericarditis with troponin leak >48 hours
Age: 14.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Troponin increased
Clinical narrative: Chest pain, left arm/shoulder pain x36 hours, myopericarditis with troponin leak >48 hours
Sex: U
Vaccine: COVID19
Symptoms: Adverse drug reaction
Clinical narrative: SERIOUS SIDE EFFECTS; This spontaneous report received from a patient 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, and batch number were not reported) dose, start therapy date were not reported 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 an unspecified date, the patient experienced serious side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of serious side effects was not reported. This report was non-serious.; Sender's Comments: V0-Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Blindness unilateral, Computerised tomogram, Diplopia, Eye movement disorder, Magnetic resonance imaging
Clinical narrative: LEFT NERVE PALSY IN EYE (LEFT); GIANT NERVE SYNDROME (LEFT EYE); DOUBLE VISION IN LEFT EYE; AT ONE POINT UNABLE TO SEE OUT HER LEFT EYE; BLURRY VISION IN BOTH EYES; INABILITY TO MOVE LEFT EYE; This spontaneous report received from a patient concerned a 62 year old African American and not Hispanic or Latino female. The patient's height, and weight were not reported. The patient's concurrent conditions included: hypertension. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, expiry: UNKNOWN) dose was not reported, 1 total, administered at left arm on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date in AUG-2021, the patient experienced inability to move left eye and double vision for 2.5 months and blurry vision in both. These started in AUG-2021 and lasted 2.5 months. At one point patient was unable to see out of her left eye at all. Consumer was constantly at Emergency room (ER) and saw ophthalmologists. They did a Magnetic resonance imaging (MRI) and Computerised tomogram (CAT) scan and it had to do with the nerve in her eye. On an unspecified date in SEP-2021, patient was told, she had left nerve palsy in eye(left) and giant nerve syndrome (left eye). Laboratory data (dates unspecified) included: Computerised tomogram (CAT) scan (NR: not provided) left nerve palsy in eye(left) and giant nerve syndrome (left eye), and Magnetic resonance imaging (MRI) (NR: not provided) left nerve palsy in eye(left) and giant nerve syndrome (left eye). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from at one point unable to see out her left eye, and inability to move left eye on NOV-2021, was recovering from blurry vision in both eyes, and double vision in left eye, and the outcome of left nerve palsy in eye (left) and giant nerve syndrome (left eye) was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20220122189-COVID-19 VACCINE AD26.COV2.S-Left nerve palsy in eye(left),At one point unable to see out her left 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).
Sex: F
Vaccine: COVID19
Symptoms: Nervous system disorder, Paralysis, Vision blurred
Clinical narrative: LEFT NERVE PALSY IN EYE (LEFT); GIANT NERVE SYNDROME (LEFT EYE); DOUBLE VISION IN LEFT EYE; AT ONE POINT UNABLE TO SEE OUT HER LEFT EYE; BLURRY VISION IN BOTH EYES; INABILITY TO MOVE LEFT EYE; This spontaneous report received from a patient concerned a 62 year old African American and not Hispanic or Latino female. The patient's height, and weight were not reported. The patient's concurrent conditions included: hypertension. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, expiry: UNKNOWN) dose was not reported, 1 total, administered at left arm on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date in AUG-2021, the patient experienced inability to move left eye and double vision for 2.5 months and blurry vision in both. These started in AUG-2021 and lasted 2.5 months. At one point patient was unable to see out of her left eye at all. Consumer was constantly at Emergency room (ER) and saw ophthalmologists. They did a Magnetic resonance imaging (MRI) and Computerised tomogram (CAT) scan and it had to do with the nerve in her eye. On an unspecified date in SEP-2021, patient was told, she had left nerve palsy in eye(left) and giant nerve syndrome (left eye). Laboratory data (dates unspecified) included: Computerised tomogram (CAT) scan (NR: not provided) left nerve palsy in eye(left) and giant nerve syndrome (left eye), and Magnetic resonance imaging (MRI) (NR: not provided) left nerve palsy in eye(left) and giant nerve syndrome (left eye). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from at one point unable to see out her left eye, and inability to move left eye on NOV-2021, was recovering from blurry vision in both eyes, and double vision in left eye, and the outcome of left nerve palsy in eye (left) and giant nerve syndrome (left eye) was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20220122189-COVID-19 VACCINE AD26.COV2.S-Left nerve palsy in eye(left),At one point unable to see out her left 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).
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: SORENESS; This spontaneous report received from a patient concerned a 76 year old male. The patient's weight was 76.4 kilograms, and height was not reported. The patient's concurrent conditions included: primary pulmonary hypertension. The patient 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 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included macitentan, and selexipag. On an unspecified date, the patient experienced soreness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of soreness was not reported. This report was non-serious. This case, involving the same patient is linked to 20211015198.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure fluctuation, Heart rate irregular, Inflammation, Malaise
Clinical narrative: I was sick for 3 and a half months. My blood pressure would not regulate. My heart rate kept going over 130  and l ended up in the ER about 13 times in the space of 3 months.  Finally My pop sent me to a specialist and he said l had inflammation and it had to wear off. It wS the worst experience of my life. Now l donot know what to do about the booster shot because the doctors cannot tell me what they will do if it happens again. I have filled this firm out two times already and you all won't tell me what to do either. What do l do? I need to know if you all know what to do if l get the same reactions as before.