chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 88.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Positive airway pressure therapy, Pyrexia, Respiratory failure, SARS-CoV-2 test positive, Tachycardia
Clinical narrative: PMH:  CAD DMT2, lipidemia; admitted to hosp with AHRF secondary to COVID/bacterial coinfection; on high flow BiPAP; DNR/DNI; pt's condition deteriorated even after treatment with Lovenox, redesivir, Decadron, antibiotics; pt died in the hospital
Age: 88.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Acute respiratory failure, Bacterial infection, COVID-19, Death, General physical health deterioration
Clinical narrative: PMH:  CAD DMT2, lipidemia; admitted to hosp with AHRF secondary to COVID/bacterial coinfection; on high flow BiPAP; DNR/DNI; pt's condition deteriorated even after treatment with Lovenox, redesivir, Decadron, antibiotics; pt died in the hospital
Age: 88.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Positive airway pressure therapy
Clinical narrative: PMH:  CAD DMT2, lipidemia; admitted to hosp with AHRF secondary to COVID/bacterial coinfection; on high flow BiPAP; DNR/DNI; pt's condition deteriorated even after treatment with Lovenox, redesivir, Decadron, antibiotics; pt died in the hospital
Age: 81.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Death, SARS-CoV-2 test positive
Clinical narrative: was sent to a local Hospital by clinic for SOB; O2 sats in 70s on RA; c/o SOB, diarrhea, fever, cough, positive COVID test before pt was transferred to another Medical Center for higher level of care; per death certificate, pt died in that hospital
Age: 81.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Cough, Death, Diarrhoea, Dyspnoea
Clinical narrative: was sent to a local Hospital by clinic for SOB; O2 sats in 70s on RA; c/o SOB, diarrhea, fever, cough, positive COVID test before pt was transferred to another Medical Center for higher level of care; per death certificate, pt died in that hospital
Age: 81.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, SARS-CoV-2 test positive
Clinical narrative: was sent to a local Hospital by clinic for SOB; O2 sats in 70s on RA; c/o SOB, diarrhea, fever, cough, positive COVID test before pt was transferred to another Medical Center for higher level of care; per death certificate, pt died in that hospital
Age: 16.0
Sex: F
Vaccine: FLU4, UNK
Symptoms: Bacterial test negative, Headache, Heart rate increased, Intracranial pressure increased, Nausea
Clinical narrative: developed headache shortly after receiving influenza vaccine from PCP.  rec'd vaccine on 12/2.  presented to hospital w/ 7 days of fever & headache
Age: 16.0
Sex: F
Vaccine: FLU4, UNK
Symptoms: Pyrexia, Viral test negative
Clinical narrative: developed headache shortly after receiving influenza vaccine from PCP.  rec'd vaccine on 12/2.  presented to hospital w/ 7 days of fever & headache
Age: 16.0
Sex: F
Vaccine: FLU4, UNK
Symptoms: Headache, Magnetic resonance imaging head abnormal, Meningitis, Pyrexia
Clinical narrative: developed headache shortly after receiving influenza vaccine from PCP.  rec'd vaccine on 12/2.  presented to hospital w/ 7 days of fever & headache
Age: 35.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Four hours after I received my COVID19 booster from Health Center, I received a call saying that I received an "undiluted vaccine." At this time, I do not know the amount of doses I have received and they also did not annotate a lot number on my vaccination card after I received it. Symptoms have mostly been uncontrollable body temperature regulation and exhaustion. Symptoms started ~12 hours after vaccination.
Age: 35.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Fatigue, Incorrect dose administered, Product preparation issue, Temperature regulation disorder
Clinical narrative: Four hours after I received my COVID19 booster from Health Center, I received a call saying that I received an "undiluted vaccine." At this time, I do not know the amount of doses I have received and they also did not annotate a lot number on my vaccination card after I received it. Symptoms have mostly been uncontrollable body temperature regulation and exhaustion. Symptoms started ~12 hours after vaccination.
Age: 35.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Body temperature fluctuation, Chills, Hyperhidrosis, Incorrect dose administered, Product preparation issue
Clinical narrative: Four hours after I received my COVID19 booster from Health Center, I received a call saying that I received an "undiluted vaccine." At this time, I do not know the amount of doses I have received and they also did not annotate a lot number on my vaccination card after I received it. Symptoms have mostly been uncontrollable body temperature regulation and exhaustion. Symptoms started ~12 hours after vaccination.
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Fully vaccinated, not boosted with COVID Infection breakthrough and inpatient hospital stay.   Immunosuppressed with organ transplant
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Vaccine breakthrough infection
Clinical narrative: Fully vaccinated, not boosted with COVID Infection breakthrough and inpatient hospital stay.   Immunosuppressed with organ transplant
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered, Herpes zoster, Stress
Clinical narrative: stress; she was due to get the shingles vaccine; She stated she was due to get the shingles vaccine but did not have time to get it done; Shingles; This spontaneous report has been received from the 67-year-old female patient via Glaxosmithkline (manufacturer report number: US2021AMR226575) referring to herself. The first outbreak of shingles was in 2006, if her memory serves her right, when she was recovering form colon cancer treatment. Concomitant therapy was not reported.  Zoster Vaccine Live (ZOSTAVAX) (reported as shingles vaccine (zoster historical)) (strength, dose, route, lot # and expiration date were not reported) was administrated on 05-AUG-2016 (also reported as in 2016) for prophylaxis when she was there with-insurance.   The patient stated she had a history of cancer and the stress of everything caused the shingles to come out. Her recent outbreak of shingles was mild. She staled she started taking valaciclovir (VALTREX) for shingles on 19-OCT-2021 and finished the 7-day course on 26-OCT-2021. She stated she was feeling better noting that she knew valaciclovir (VALTREX) did not cure shingles. It was also reported that shingles symptoms were almost gone. She stated she was due to get the shingles vaccine but did not have time to get it done (extra dose administered and circumstance or information capable of leading to medication error).   The causality between the events and Zoster Vaccine Live (ZOSTAVAX) was not reported.; Sender's Comments:  US-009507513-2112USA002933:
Sex: U
Vaccine: UNK, VARCEL
Symptoms: Expired product administered
Clinical narrative: No additional AEs or PQC reported; Product preparation issue (Inappropriate reconstitution technique); expired Merck Sterile Diluent used to reconstitute vaccine that was administered; This spontaneous report was received from a nurse concerning a patient of unknown age. No information about the medical history, concurrent condition, or concomitant therapy was reported.   On 22-NOV-2021, expired sterile diluent (MERCK STERILE DILUENT) (lot # S002625, expiration date 09-NOV-2021; dose and route were not reported) was used to reconstitute vaccine of varicella virus vaccine live (oka/merck) (VARIVAX) (lot# U007478, expiration date 08-MAR-2023; dose and route were not reported) that was administered (expired product administered and product preparation issue). No additional adverse event was reported.  ; Sender's Comments:  US-009507513-2112USA004666: US-009507513-2112USA004629:
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse, and refers to a patient of unknown age and gender. The information about patient's concurrent condition, medical and drug history and concomitant medications were not provided.  On an unknown date, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II), rHA, lot # S032825, dose: 0.5 milliliter, expiration date: 16-OCT-2021 as prophylaxis (route of administration and anatomical location were not provided) (Expired product administered).  No additional adverse event was reported.
Age: 60.0
Sex: F
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of underdose in a 60-year-old female patient who received HAV (Havrix 720) (batch number ce74n, expiry date 19th June 2022) for prophylaxis.   On 21st December 2021, the patient received Havrix 720. On 21st December 2021, unknown after receiving Havrix 720, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.  Additional details were provided as follows: The reporter reported that on 21st December 2021 an adult patient received a pediatric dose of Havrix, which led to underdose and adult use of child product.  The reporter consented to follow up.
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: received an expired dose; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 29-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA433A, expiry date 31st October 2021) for prophylaxis.   On 15th December 2021, the patient received Menveo. On 15th December 2021, unknown after receiving Menveo, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows: The age at the vaccination was not reported. The reporter reported that patient received an expired dose of Menveo during December, which led to expired vaccine used. The reporter consented to follow up. The was 1 of the 6 cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021261529:Same reporter US-GLAXOSMITHKLINE-US2021261533:Same reporter US-GLAXOSMITHKLINE-US2021261523:Same reporter US-GLAXOSMITHKLINE-US2021261528:Same reporter US-GLAXOSMITHKLINE-US2021261527:Same reporter
Sex: M
Vaccine: COVID19
Symptoms: Accident, Death
Clinical narrative: DEATH; SLIPPED AWAY; This spontaneous report received from a consumer via social media via a company representative concerned a male of unspecified age and race. 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 (dose number in series 1) (suspension for injection, route of admin, batch number and expiry date were not reported) dose was not reported, 1 total, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. The batch number was not reported. The company was unable to perform follow-up to request batch/lot numbers. On an unspecified date, the patient slipped away (accident) and died after 2 month (death). As per reporter "My bro in law got the Jab, 2 months later he died sitting on his sofa, he was cooking, just slipped away 1 week later." It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of slipped away was not reported. This report was serious (Death). This case, from the same reporter was linked to 20211254110, 20211254092, 20211247927 and 20211254072.; Sender's Comments: V0: 20211253879-covid-19 vaccine ad26.cov2.s - Death. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Vaginal haemorrhage
Clinical narrative: Vaginal bleeding. My last period was 12/03/21-12/09/21. I started bleeding late the night after I received the vaccine. It started light, became heavy two days later, and finally started to slow down two days ago. I am still bleeding but it seems to be coming to an end. Have felt fine otherwise. I am due to start my normal cycle in five days.
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient. Received second dose of COVID-19 vaccine Pediatric Pfizer (LOT#: FK5618) exp: 2/21/22 on 12/26/21 and first dose COVID-19 Pediatric Pfizer was given on 12/07/21. Patient came in with siblings and mother. Mother brought children two days early from second dose due date. RN submitted a medical consult via text message to Vaccine Operations Leads, requesting to proceed with the COVID second dose Pediatric Pfizer. Per Dr., approval to proceed with COVID second dose Pediatric Pfizer vaccine was obtained from medical consult team via text message from RN, Vaccine Operations Lead. Client received COVID vaccine Pediatric Pfizer 2 days before due date. The patient did not report any symptoms during the 15 minute observation period. RN educated client on possible adverse reactions and when to seek medical care. Patient left vaccination site with her mom and siblings at 1545 unassisted and with a steady gait.
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Insomnia, Myalgia, Pain, Pain in extremity
Clinical narrative: Minor constant pain in my left arm muscle.  Pain worsen significantly stretching my arm and lifting.  Pain severity restricts motion like bending my left arm to put on a coat.  Pain bothers me while sleeping if I lay on the arm.  I lived with this a while thinking it would go away over time.  I do moderate exercise to use the arm muscle.  The pain is now seeming to get worst and wider into my lower shoulder so I filed this report.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Lymphadenopathy
Clinical narrative: I noticed Sunday morning, December 26, 2021 the injection site on my upper left arm became red, raised and sore. Below the injection site, there were two other red, raised areas.  These two areas were not sore. Also, my left axillary had a very noticeable lump that was 3" in diameter. When I retired at 11 pm on Sunday, December 26, 2021, all the aforementioned conditions were the same.
Age: 8.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: The patient Received second dose of COVID-19 vaccine Pediatric Pfizer (LOT#: FK5618) exp: 2/21/22 on 12/26/21 and first dose COVID-19 Pediatric Pfizer was given on 12/07/21. Patient came in with siblings and mother. Mother brought children two days early from second dose due date. RN submitted a medical consult via text message to Vaccine Operations Leads, requesting to proceed with the COVID second dose Pediatric Pfizer. Per Dr., approval to proceed with COVID second dose Pediatric Pfizer vaccine was obtained from medical consult team via text message from RN, Vaccine Operations Lead. Client received COVID vaccine Pediatric Pfizer 2 days before due date. The patient did not report any symptoms during the 15 minute observation period. RN educated client on possible adverse reactions and when to seek medical care. Patient left vaccination site with her mom and siblings at 1545 unassisted and with a steady gait.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Mechanical urticaria, Scratch, Urticaria
Clinical narrative: Dermatographia Typical case - any minor scratch anywhere on my body causes hives. Zyrtec and Benadryl help a ton.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Adenovirus test, Angiogram pulmonary abnormal, Arthralgia, Blood culture negative, Bordetella test negative
Clinical narrative: This patient initially had 2 doses of the Pfizer COVID vaccine- on 3/29/2021, and 4/21/2021 She chose to get Moderna as her 3rd/booster shot She has never been diagnosed with COVID-19  She presented to the hospital 12/20/2021 with chest pain, dyspnea, arthralgias- had elevated troponin, reduced EF on ECHO with global hypokinesis- diagnosed with myocarditis. This was presumed from the Moderna vaccine- no other cause was established.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Brain natriuretic peptide increased, Cardiomyopathy, Chest pain, Dyspnoea, Echocardiogram
Clinical narrative: This patient initially had 2 doses of the Pfizer COVID vaccine- on 3/29/2021, and 4/21/2021 She chose to get Moderna as her 3rd/booster shot She has never been diagnosed with COVID-19  She presented to the hospital 12/20/2021 with chest pain, dyspnea, arthralgias- had elevated troponin, reduced EF on ECHO with global hypokinesis- diagnosed with myocarditis. This was presumed from the Moderna vaccine- no other cause was established.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Echocardiogram abnormal, Effusion, Ejection fraction decreased, Human metapneumovirus test, Human rhinovirus test
Clinical narrative: This patient initially had 2 doses of the Pfizer COVID vaccine- on 3/29/2021, and 4/21/2021 She chose to get Moderna as her 3rd/booster shot She has never been diagnosed with COVID-19  She presented to the hospital 12/20/2021 with chest pain, dyspnea, arthralgias- had elevated troponin, reduced EF on ECHO with global hypokinesis- diagnosed with myocarditis. This was presumed from the Moderna vaccine- no other cause was established.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Infarction, Influenza virus test negative, Lung infiltration, Lymphadenopathy mediastinal, Myocarditis
Clinical narrative: This patient initially had 2 doses of the Pfizer COVID vaccine- on 3/29/2021, and 4/21/2021 She chose to get Moderna as her 3rd/booster shot She has never been diagnosed with COVID-19  She presented to the hospital 12/20/2021 with chest pain, dyspnea, arthralgias- had elevated troponin, reduced EF on ECHO with global hypokinesis- diagnosed with myocarditis. This was presumed from the Moderna vaccine- no other cause was established.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Procalcitonin normal, Respiratory syncytial virus test negative, SARS-CoV-2 test negative, Scan myocardial perfusion abnormal, Troponin increased
Clinical narrative: This patient initially had 2 doses of the Pfizer COVID vaccine- on 3/29/2021, and 4/21/2021 She chose to get Moderna as her 3rd/booster shot She has never been diagnosed with COVID-19  She presented to the hospital 12/20/2021 with chest pain, dyspnea, arthralgias- had elevated troponin, reduced EF on ECHO with global hypokinesis- diagnosed with myocarditis. This was presumed from the Moderna vaccine- no other cause was established.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Ventricular hypokinesia, White blood cell count normal
Clinical narrative: This patient initially had 2 doses of the Pfizer COVID vaccine- on 3/29/2021, and 4/21/2021 She chose to get Moderna as her 3rd/booster shot She has never been diagnosed with COVID-19  She presented to the hospital 12/20/2021 with chest pain, dyspnea, arthralgias- had elevated troponin, reduced EF on ECHO with global hypokinesis- diagnosed with myocarditis. This was presumed from the Moderna vaccine- no other cause was established.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills, Fatigue, Muscle spasms, Myalgia
Clinical narrative: Long-term symptoms: Random sharp shooting pains down left arm and sometimes legs. Pain in forearm when flexing arm or making fist (feels like tendinitis). Short-term symptoms: Chills, fever, body aches, sore muscles in neck and fatigue. Also I had a lumbar fusion in my L5 S1 about 4 years ago. After the vaccine, I noticed I have worse lower back pain muscle spasms. Did not report to my doctor yet. I wasn't sure if it was a coincidence after the first vaccine. But today I got the second dose. I have the same symptoms. So it must be related. Doctor's office was closed today.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Pain, Pain in extremity, Pyrexia, Tendonitis
Clinical narrative: Long-term symptoms: Random sharp shooting pains down left arm and sometimes legs. Pain in forearm when flexing arm or making fist (feels like tendinitis). Short-term symptoms: Chills, fever, body aches, sore muscles in neck and fatigue. Also I had a lumbar fusion in my L5 S1 about 4 years ago. After the vaccine, I noticed I have worse lower back pain muscle spasms. Did not report to my doctor yet. I wasn't sure if it was a coincidence after the first vaccine. But today I got the second dose. I have the same symptoms. So it must be related. Doctor's office was closed today.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Mechanical urticaria, Pruritus, Urticaria
Clinical narrative: Apparent dermatographia urticharia. Any skin contact makes skin become bright red and itchy hives soon pop up.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Balance disorder, Decreased appetite, Dizziness
Clinical narrative: Very ill. Fever 102 degrees, no appetite, muscle aches, headache, light headed, unbalanced when standing, only sleeping. Symptoms eased second day a bit. Better by 3rd day, still low grade fever, still in bed. Today, 4th day: fever gone, but still weakness, light headed, headache, pain in right hip required ibuprofen for mobility.  This was my first Moderna. The first two jabs were Pfizer, and I was sick for only two days with only  the second jab.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Illness, Myalgia, Pyrexia
Clinical narrative: Very ill. Fever 102 degrees, no appetite, muscle aches, headache, light headed, unbalanced when standing, only sleeping. Symptoms eased second day a bit. Better by 3rd day, still low grade fever, still in bed. Today, 4th day: fever gone, but still weakness, light headed, headache, pain in right hip required ibuprofen for mobility.  This was my first Moderna. The first two jabs were Pfizer, and I was sick for only two days with only  the second jab.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Bedridden, Dysmenorrhoea, Heavy menstrual bleeding, Laboratory test, Menstruation irregular
Clinical narrative: Periods are awful. Heavy. Very heavy. Soaking through super tampon and pads in one hour. Cramping horrible. Starts about a week before period comes. And last a few days after. Last month had back to back twice.  Both heavy. Also have been on 5 antibiotics since then as well. I use a period tracker and see the data there too.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Joint range of motion decreased, Pain
Clinical narrative: Significant  left shoulder pain now for almost 10 months. decreasing in the past couple months. I had never had any problems with my left shoulder previously to having the Moderna vaccination. The left shoulder pain started the evening after first vaccination. Limited range of motion. Increase pain with movement of shoulder.  Second Moderna shot on 2/5/2021 in left shoulder  increased the pain and decreased range of motion even more. Severe pain with movement of shoulder.  Booster on 8/31/2021 in the right shoulder cause very little discomfort.   I had several Osteopathic doctors treat my shoulder with very little to no benefit. This fall I started a new therapy that directly targeted the rotator muscles of the left shoulder and upper arm.  I would say I have about 75 to 80 % improvement. Most of that in the past couple months.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Hot flush, Myalgia, Nausea
Clinical narrative: Muscle aches, headache that last for 3 days, chills and hot flashes throughout day that last three days. nausea
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray, Chest pain, Costochondritis, Rales
Clinical narrative: Chest Pain in the center of the chest.  Crackling feeling in the chest.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure fluctuation
Clinical narrative: BP  under control for 40 years with meds totally out of control since the second "jab"... Dailly range from 190/105 to 95/50 within q 12  hour period..  PB is starting to be under control  after  5 months since the last Moderna jab. Not there yet. The Devil himself will be organizing snowball fights before I take another Covid shot.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Crying, Depressed mood, Depression, Emotional distress, Inappropriate affect
Clinical narrative: First weird thing is I suddenly felt very sad and depressed and was uncontrollably flipping from crying to laughing like a crazy person! So it was definitely messing with my emotions. I took NyQuil after that to knock myself out lol. Second thing is the next day I suddenly developed a weird mark on my lower lip and they were kinda swollen too. The mark was a dark color that looked like a line. I have a picture
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Lip injury, Lip swelling
Clinical narrative: First weird thing is I suddenly felt very sad and depressed and was uncontrollably flipping from crying to laughing like a crazy person! So it was definitely messing with my emotions. I took NyQuil after that to knock myself out lol. Second thing is the next day I suddenly developed a weird mark on my lower lip and they were kinda swollen too. The mark was a dark color that looked like a line. I have a picture
Age: 31.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Autoscopy, Dizziness, Headache, Hypoaesthesia, Lymph node pain
Clinical narrative: Light headedness, dizziness, tingling/numbness in lower legs, faintness, blurry vision out of body experience, head ache sore/tender lymph nodes in armpit
Age: 31.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Paraesthesia, Syncope, Vision blurred
Clinical narrative: Light headedness, dizziness, tingling/numbness in lower legs, faintness, blurry vision out of body experience, head ache sore/tender lymph nodes in armpit
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Arthralgia, Blindness, Chills, Dizziness
Clinical narrative: Extremely sick starting the evening of the injection, chills, sweats, severe headache, nausea, dizzy, couldn't walk alone. This lasted a couple of days. Then all these symptoms subsided but left with a severe headache and hazy/blurry vision. Headaches are now a daily symptom, blurry vision is a constant along with extremely fatigued eyes. I visited an ophthalmologist who did testing. My vision has changed from my last appointment on March 2021. My entire life I have been nearsighted. I now can't see clearly near or far, I have a loss of vision. All other tests completed that day came back normal. I had to buy new glasses and contacts with a new prescription which only slightly help. I also am currently experiencing loss of hair, phantosmia, unexplained pain in shoulder.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Gait disturbance, Headache, Hyperhidrosis, Illness
Clinical narrative: Extremely sick starting the evening of the injection, chills, sweats, severe headache, nausea, dizzy, couldn't walk alone. This lasted a couple of days. Then all these symptoms subsided but left with a severe headache and hazy/blurry vision. Headaches are now a daily symptom, blurry vision is a constant along with extremely fatigued eyes. I visited an ophthalmologist who did testing. My vision has changed from my last appointment on March 2021. My entire life I have been nearsighted. I now can't see clearly near or far, I have a loss of vision. All other tests completed that day came back normal. I had to buy new glasses and contacts with a new prescription which only slightly help. I also am currently experiencing loss of hair, phantosmia, unexplained pain in shoulder.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Parosmia, Vision blurred
Clinical narrative: Extremely sick starting the evening of the injection, chills, sweats, severe headache, nausea, dizzy, couldn't walk alone. This lasted a couple of days. Then all these symptoms subsided but left with a severe headache and hazy/blurry vision. Headaches are now a daily symptom, blurry vision is a constant along with extremely fatigued eyes. I visited an ophthalmologist who did testing. My vision has changed from my last appointment on March 2021. My entire life I have been nearsighted. I now can't see clearly near or far, I have a loss of vision. All other tests completed that day came back normal. I had to buy new glasses and contacts with a new prescription which only slightly help. I also am currently experiencing loss of hair, phantosmia, unexplained pain in shoulder.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Tinnitus
Clinical narrative: Tinnitus for almost entire day Feeling like I?m going into labor Leg cramp  Treatment  baby aspirin-resolved above
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Blepharospasm, Burning sensation, Chest pain, Electroencephalogram, Fatigue
Clinical narrative: In the first two weeks on the 13th  I developed debilitating muscle pain and fatigue. Like I had a fever but I never got a fever.  Then I developed an eyelid twitch in my right eye that lasted for a week or so then resolved. Then I had chest pain sharp constant but that too resolved in a week or so. Now nearly 3 months out I have developed persistent muscle twitching primarily in legs and more so in right leg. My eyelid twitch has been back for awhile now maybe 2-3 weeks and it has been relentless. I have burning pain and tingling on and off particularly in legs but burning pain has occurred all over. Occasionally the soles of my feet if exposed to extremes in temp with burn. I have had trouble sleeping with brain fog. Memory issues as well. Persistent twitching and tremors like a shaking feeling have been most bothersome.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Full blood count, Immunology test, Insomnia, Magnetic resonance imaging
Clinical narrative: In the first two weeks on the 13th  I developed debilitating muscle pain and fatigue. Like I had a fever but I never got a fever.  Then I developed an eyelid twitch in my right eye that lasted for a week or so then resolved. Then I had chest pain sharp constant but that too resolved in a week or so. Now nearly 3 months out I have developed persistent muscle twitching primarily in legs and more so in right leg. My eyelid twitch has been back for awhile now maybe 2-3 weeks and it has been relentless. I have burning pain and tingling on and off particularly in legs but burning pain has occurred all over. Occasionally the soles of my feet if exposed to extremes in temp with burn. I have had trouble sleeping with brain fog. Memory issues as well. Persistent twitching and tremors like a shaking feeling have been most bothersome.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Memory impairment, Metabolic function test, Muscle twitching, Myalgia, Pain in extremity
Clinical narrative: In the first two weeks on the 13th  I developed debilitating muscle pain and fatigue. Like I had a fever but I never got a fever.  Then I developed an eyelid twitch in my right eye that lasted for a week or so then resolved. Then I had chest pain sharp constant but that too resolved in a week or so. Now nearly 3 months out I have developed persistent muscle twitching primarily in legs and more so in right leg. My eyelid twitch has been back for awhile now maybe 2-3 weeks and it has been relentless. I have burning pain and tingling on and off particularly in legs but burning pain has occurred all over. Occasionally the soles of my feet if exposed to extremes in temp with burn. I have had trouble sleeping with brain fog. Memory issues as well. Persistent twitching and tremors like a shaking feeling have been most bothersome.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Pyrexia, Tremor, Ultrasound scan
Clinical narrative: In the first two weeks on the 13th  I developed debilitating muscle pain and fatigue. Like I had a fever but I never got a fever.  Then I developed an eyelid twitch in my right eye that lasted for a week or so then resolved. Then I had chest pain sharp constant but that too resolved in a week or so. Now nearly 3 months out I have developed persistent muscle twitching primarily in legs and more so in right leg. My eyelid twitch has been back for awhile now maybe 2-3 weeks and it has been relentless. I have burning pain and tingling on and off particularly in legs but burning pain has occurred all over. Occasionally the soles of my feet if exposed to extremes in temp with burn. I have had trouble sleeping with brain fog. Memory issues as well. Persistent twitching and tremors like a shaking feeling have been most bothersome.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Mechanical urticaria, Type IV hypersensitivity reaction, Urticaria
Clinical narrative: Hives (uteracia) Outbreaks began in scalp, very itchy. Benadryl didn?t help. Progressed to all over body and face. Each hives for last approx 1 your but move elsewhere (multiple at one time) also dermatographia -, clothes and hats leave marks on body. This has been ongoing for over 2 weeks with no improvement. High doses of antihistamines being taken. Allergy specialist convinced it?s due to delayed reaction from booster.
Sex: F
Vaccine: MENB, MENB
Symptoms: Intercepted product prescribing error, Myasthenia gravis
Clinical narrative: Myasthenia Gravis; 52 year old patient has a prescription for Bexsero/received the vaccine before but will need to have it again; This case was reported by a other health professional via call center representative and described the occurrence of myasthenia gravis in a 52-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis, Men B NVS (Bexsero) for prophylaxis and meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Bexsero, Bexsero Pre-Filled Syringe Device, Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device and not applicable after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced myasthenia gravis (serious criteria GSK medically significant) and intercepted drug prescribing error. On an unknown date, the outcome of the myasthenia gravis and intercepted drug prescribing error were unknown.   It was unknown if the reporter considered the myasthenia gravis to be related to Bexsero and Bexsero Pre-Filled Syringe Device. 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 pharmacy student. The age at vaccination was not reported for dose received and not applicable for another dose. The patient had previously received a dose of Bexsero and had myasthenia gravis and would be taking treatment that would wipe her immune system out. The pharmacy student stated that the 52 years old patient had a prescription for Bexsero but not yet received, which led intercepted drug prescribing error. Health care professional also mentioned that the patient received the vaccine before but would need to have it again since the treatment would affect her immune system.  The reporter asked that it was okay to administer the vaccine to this patient since she was out of the age range. It was asked to the health care professional if she knew when the patient received Bexsero previously since she stated that she had myasthenia gravis, but she did not have any additional information as the patient was new and just happened to bring the prescription in. The reporter consented follow-up via postal.
Sex: M
Vaccine: TDAP
Symptoms: Expired product administered, Product administered to patient of inappropriate age
Clinical narrative: administered to a patient after the expiration date; boostrix vaccine has been given to neonate; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a neonate male patient who received DTPa (Reduced antigen) (Boostrix) (batch number FN74Z, expiry date 28th November 2021) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 6th December 2021, the patient received Boostrix and Boostrix Pre-Filled Syringe Device. On 6th December 2021, unknown after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced expired vaccine used and inappropriate age at vaccine administration. On an unknown date, the outcome of the expired vaccine used and inappropriate age at vaccine administration were 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 stated that, the Boostrix was administered to a neonate patient after the expiration date, which led to expired vaccine used and inappropriate age at vaccine administration. The reporter consented to follow up via postal.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: VACCINE GIVEN AFTER USE BY TIME. IT HAD BEEN SITTING AT ROOM TEMPERATURE FOR FOUR AND A HALF HOURS; OUT OF SPECIFICATION PRODUCT USE; 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: 1855191, and expiry: 11-APR-2022) dose was not reported, administered on 23-DEC-2021 for prophylactic vaccination. No concomitant medications were reported.  On 23-DEC-2021, the patient experienced vaccine given after use by time. it had been sitting at room temperature for four and a half hours, and out of specification product use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine given after use by time. it had been sitting at room temperature for four and a half hours and out of specification product use was not reported. This report was non-serious.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Respiratory tract congestion
Clinical narrative: Woke up on the morning of the 21st with a sore throat. On about the 25th, the sore throat was better, but I now have chest congestion. Treating with over the counter medication (Mucinex DM).
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Mechanical urticaria, Urticaria
Clinical narrative: Hive-like reaction and dermatographism
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Influenza like illness, Pain in extremity, Pyrexia
Clinical narrative: Fever, chest pain, arm pain, flu-like symptoms
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Headache, Inappropriate schedule of product administration, Incorrect product formulation administered
Clinical narrative: Systemic: Fatigue-Medium, Systemic: Headache-Medium, Systemic: Weakness-Medium, Error: Wrong Vaccine Formulation  (ex. different manufact. initial and booster)-, Additional Details: Patient received first Moderna dose on 10/28/21 and received Pfizer dose 12/13/2021. Did not receive the same manufacturer for the first 2 dose series of the mRNA vaccines.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Systemic: Fatigue-Medium, Systemic: Headache-Medium, Systemic: Weakness-Medium, Error: Wrong Vaccine Formulation  (ex. different manufact. initial and booster)-, Additional Details: Patient received first Moderna dose on 10/28/21 and received Pfizer dose 12/13/2021. Did not receive the same manufacturer for the first 2 dose series of the mRNA vaccines.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Angina pectoris, Arthralgia, Gait disturbance, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Heart pain (level 4 pain) lasting several hours, sporadic days. Hip pain (level 6 pain) stiffness and soreness - lasting several minutes after inactivity. Dissipates after a few minutes of activity. Returns throughout the day. Foot pain came with second dose having same frequency as hip pain. Difficult to walk on both feet until pain dissipates after a few minutes of walking. Exterior of left foot pain constant - level 2 pain, tender to touch. Heart pain increased in pain level (5-6) and frequency after 2nd dose. Occurs several times in a month.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tenderness
Clinical narrative: Heart pain (level 4 pain) lasting several hours, sporadic days. Hip pain (level 6 pain) stiffness and soreness - lasting several minutes after inactivity. Dissipates after a few minutes of activity. Returns throughout the day. Foot pain came with second dose having same frequency as hip pain. Difficult to walk on both feet until pain dissipates after a few minutes of walking. Exterior of left foot pain constant - level 2 pain, tender to touch. Heart pain increased in pain level (5-6) and frequency after 2nd dose. Occurs several times in a month.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: patient had redness and swelling at the injection site. It is still present after 6 days. I advised patient to see a doctor if it does not improve.
Age: 19.0
Sex: F
Vaccine: UNK
Symptoms: Condition aggravated, Eczema, Menstruation irregular, Pain
Clinical narrative: When I got the booster shot it activated my   Eczema   extremely it became more painful and went more places and my period has been coming and going for the past 10 days
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Heavy menstrual bleeding
Clinical narrative: Heavy vaginal bleeding and abdominal cramping. Symptoms lasted approx 20 hrs.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Error: Wrong Dose of Vaccine - Too Low-
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Hypoaesthesia, Pyrexia
Clinical narrative: Systemic: Chills-Medium, Systemic: Fever-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test, Serum ferritin decreased
Clinical narrative: Ferritin dropped to a 5, previous i have had always had good/high iron
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Death, Unresponsive to stimuli
Clinical narrative: Resident had no adverse side effects at time of injection and seemed to be doing well overall health wise. Resident goes out for dialysis and is picked up by family for this. On the date resident passed, he went to dialysis as typical but family decided to take him to their home for a get together. When they arrived they stayed only 5 minutes before they decided they would bring him back to the community. Resident was doing well talking and walked to vehicle. During car ride resident suddenly went unresponsive according to family. He was brought to the hospital and was pronounced dead with no further workup.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Product administered to patient of inappropriate age
Clinical narrative: Patient is given a Moderna Booster Vaccine, but he is supposed to get a Pfizer Booster due to his age (Moderna is approved for 18 years old and up while he is now 17 years old). He was contacted on 12/26/2021 and stated that he was only tired and has recovered from the tiredness.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Pain, Pain in extremity
Clinical narrative: Constant aching in all finger joints, both elbows, both shoulders, both knees and big toe joints. Shooting pains in forearms.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, COVID-19, Gait disturbance, SARS-CoV-2 test positive
Clinical narrative: Admitted with weakness and unsteady gait.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Injection site pain, Photophobia, Somnolence, Vision blurred
Clinical narrative: First, it started as soreness in the injection site a few hours after the vaccine. Around the same time, I developed extreme fatigue and tiredness. Also, I developed blurred vision and light sensitivity. I remember sleeping for several hours. When I woke up, I felt a little better. It only lasted one day.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Janssen 4/8 and 12/21. Positive on 12/24
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Dyspnoea, Influenza virus test negative, SARS-CoV-2 test positive
Clinical narrative: Admitted with dry cough, dyspnea, reportedly (-) COVID and flu tests
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Headache, Pain
Clinical narrative: I had light body aches the day of vaccination and a headache. The next morning, Saturday, the headache was aching more and I felt my blood pressure was raising. I was checked my blood pressure and noticed it was higher than normal. I called my PCP and was told to come in on Monday for examination. By Monday, the body aches were gone but I still had a headache and my BP was still high; my PCP increased my losartan dosage from 25mg to 50mg. By Thursday, my BP was still pretty high so I contacted my PCP again and he increased my losartan dosage again from 50mg to 75mg which helped reduce and drop my BP back to normal. My BP has never spiked like this before until after the vaccine; I don't want to blame the vaccine, but it's pretty coincidental.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Interchange of vaccine products
Clinical narrative: I have been experiencing bouts of mild to moderate discomfort in my chest, around what I believe is my heart area. These have occurred every day or every other day since first beginning a few days after the booster shot. I did not have any of these symptoms before the booster.  My first two shots in the series were Pfizer; my booster shot (third shot overall) was Moderna.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Pfizer 1/15 and 2/5. Positive on 12/24