chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Injection site erythema, Injection site warmth, Rash, Rash erythematous
Clinical narrative: On 1/15/2021 I noticed that at the injection site it was warm, red, and the redness was spreading. I went to my local urgent care who prescribed me antibiotics (Cleocin) 3x for 7 days.   I completed the antibiotics on 1/23/2021. On 01/25/2021, I noticed a red rash on my chest, stomach, and inner arms. I returned to the same Urgent Care who confirmed that I am having an allergic reaction. I am prescribed Prednisone and Hydroxyzine.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Throat irritation
Clinical narrative: itching and sore throat
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Hypoaesthesia, Lumbar puncture, Magnetic resonance imaging brain, Magnetic resonance imaging spinal
Clinical narrative: Patient had the second shot 1/12. Experienced numbness of feet within first 24 hrs. That continued up both legs and then weakness set in. Called PCP on the 15th as symptoms were getting worse not better. Patient advised me to go to ED. Went to ED here last Friday and was released. The weakness in legs got much worse and early the following week she started getting the numbness and weakness in arms. She went for the follow up post ED visit with NP at PCP office on 1/20 and due to the continued weakness, after consulting with one of the MDs, decision was made to send her back to ED for further work up to check for GBS including the LP in ED, labs and MRI of head, spine, lumbar and thoracic. Patient was release on Saturday 1/23 and diagnosis was a severe immune response to the vaccine.  Patient still has unsteady gait and weakness.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging thoracic, Muscular weakness
Clinical narrative: Patient had the second shot 1/12. Experienced numbness of feet within first 24 hrs. That continued up both legs and then weakness set in. Called PCP on the 15th as symptoms were getting worse not better. Patient advised me to go to ED. Went to ED here last Friday and was released. The weakness in legs got much worse and early the following week she started getting the numbness and weakness in arms. She went for the follow up post ED visit with NP at PCP office on 1/20 and due to the continued weakness, after consulting with one of the MDs, decision was made to send her back to ED for further work up to check for GBS including the LP in ED, labs and MRI of head, spine, lumbar and thoracic. Patient was release on Saturday 1/23 and diagnosis was a severe immune response to the vaccine.  Patient still has unsteady gait and weakness.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Autoimmune disorder, Chills, Dyspnoea, Fatigue, Piloerection
Clinical narrative: 1st Dose admininstered 1/10/2021 @0800 hrs.  Approx. 5 min later, 1st whole body Goosebumps/Chills lasting 3-5min. with clear nasal dripping/congestion. On 1/19/2021 in AM, started having SOB at rest, Febrile (101.1F), extreme fatigue,  whole body goosebumps/chills preceding every episode of SOB (upper airway compromised) and a total autoimmune response,   I am having episodes of whole body immune responses with severe SOB (>30 bpm), fever (Tmax 105.1F), whole body goosebumps (chills) preceding every episode.  Never became hypoxemia/hypoxic.  SpO2 was always >95%, with Blood Pressure and Heartrate always were WNL (115\75 +-20mmHg, HR 75-100 bpm, . Episodes lasted 4-5 days, after that episodes in a 'tolerable' range with full body goosebumps preceding each episode. Tx with 50-100mg Benadryl, 400-600mg Ibuprofen.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Respiratory tract congestion, Upper-airway cough syndrome
Clinical narrative: 1st Dose admininstered 1/10/2021 @0800 hrs.  Approx. 5 min later, 1st whole body Goosebumps/Chills lasting 3-5min. with clear nasal dripping/congestion. On 1/19/2021 in AM, started having SOB at rest, Febrile (101.1F), extreme fatigue,  whole body goosebumps/chills preceding every episode of SOB (upper airway compromised) and a total autoimmune response,   I am having episodes of whole body immune responses with severe SOB (>30 bpm), fever (Tmax 105.1F), whole body goosebumps (chills) preceding every episode.  Never became hypoxemia/hypoxic.  SpO2 was always >95%, with Blood Pressure and Heartrate always were WNL (115\75 +-20mmHg, HR 75-100 bpm, . Episodes lasted 4-5 days, after that episodes in a 'tolerable' range with full body goosebumps preceding each episode. Tx with 50-100mg Benadryl, 400-600mg Ibuprofen.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Nausea, Photophobia
Clinical narrative: Migraine, light sensitive, nausea
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Impaired work ability, Malaise
Clinical narrative: Felt fatigued after first Moderna  Covid vaccine (fatigue, arm soreness, malaise). Took motrin, did well and able to work. Second vaccine worked 12 hour day. Still with malaise, cold but able to work. Went home. Still cold but able to eat. Took shower went to bed. Woke up at 11:40 chilled, severe body aches, severe headache, Temp 99, nausea (emesis x1). Unable to take any motrin at this time due to nausea. Called into work at 4:30 AM since headaches and body aches still severe at that time, unable to work today. Able at 5;30 to take some Motrin. Slept till 11;30 AM, before getting out of bed. Still with slight headache and body aches but improving at this time 1:10 PM today 1/26. Motrin starting to help now,
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis, Nausea, Pain, Pain in extremity, Vomiting
Clinical narrative: Felt fatigued after first Moderna  Covid vaccine (fatigue, arm soreness, malaise). Took motrin, did well and able to work. Second vaccine worked 12 hour day. Still with malaise, cold but able to work. Went home. Still cold but able to eat. Took shower went to bed. Woke up at 11:40 chilled, severe body aches, severe headache, Temp 99, nausea (emesis x1). Unable to take any motrin at this time due to nausea. Called into work at 4:30 AM since headaches and body aches still severe at that time, unable to work today. Able at 5;30 to take some Motrin. Slept till 11;30 AM, before getting out of bed. Still with slight headache and body aches but improving at this time 1:10 PM today 1/26. Motrin starting to help now,
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: Individual experienced nausea and vomiting.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased
Clinical narrative: Temperature of 103.3 degrees Fahrenheit on 1/18/2021 @ 5:42pm. Acetaminophen 650mg administered as well as cold compresses.  Temperature of 101.5 degrees Fahrenheit on 1/18/2021 @ 9:18pm. Orders obtained to administer one liter of normal saline via intravenous route due to patient's poor oral intake. IV fluids initiated.  Temperature of 99.9 degrees Fahrenheit on 1/18/2021 @ 11:25pm. Patient resting comfortably.  Temperature of 98.4 degrees Fahrenheit on 1/19/2021 @ 05:47am.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Malaise, Pain
Clinical narrative: Body aches, malayes, soreness around the injection.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Bilevel positive airway pressure, Cough, Dyspnoea, Increased bronchial secretion, Pain in extremity
Clinical narrative: Pfizer-BioNTech COVID-19 Vaccine EUA I went to bed at 8 pm and noticed my arm was sore. I awoke at 11 pm to use the restroom and when I returned to bed I had a cough and SOB. This continued with copious secretions with worsening over time until I was fighting for air at 4:30 am. My husband called the ambulance because he did not feel he could get me to the hospital in time. In the ambulance I was started on 4L of O2. Upon arrival at the ER I was given a breathing treatment and started on the BiPap. I was admitted to the hospital and received 3 more breathing treatments and recovered to be on room air by 11:00 pm. The tests and observations, the doctor reported that there was no other cause than the vaccine.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Chest pain, Dizziness, Dyspnoea
Clinical narrative: HISTORY OF PRESENT ILLNESS:  SHORTNESS OF BREATH (CHEST PAIN, sob , BACK PAIN STARTING TODAY AT 0900, STATES ADVIL AT 1000, SSENCOND COVID VACCINE YESTERDAY AT 1500) 32-year-old female with past medical history of anxiety, asthma, Hashimoto's thyroiditis, psoriasis who presents the emergency department with chief complaint of body aches and shortness of breath.  Patient is a nurse.  She received her 2nd dose of the Moderna vaccine for COVID-19 the day prior to arriving in the emergency department.  This morning she did feel some mild body aches but otherwise was feeling fine.  Starting later today after her shift at work she developed severe body aches bilateral upper shoulders and down her spine, she also reports some shortness of breath, dizziness.  She felt unsafe to drive home feeling like this.  She had taken some Advil earlier in the day around 10:00.  She denies any fever, nausea or vomiting.  No history of severe vaccine reaction or anaphylaxis.  She has had anaphylactic reaction to Enbrel prior.  She denies any throat swelling, muffled voice, difficulty swallowing, abdominal pain.    patient is mildly tachycardic and hypertensive.  Likely due to pain.  Patient is experiencing adverse reaction to the 2nd dose of the Moderna COVID-19 vaccine.  I discussed with her she is having an immune response to the vaccine.  She does have a history of rheumatoid arthritis which could contribute to the elevated immune response as well.  The patient is given 30 mg of IM Toradol for body aches here in the emergency department.  She is instructed to call PCP for close follow-up, rest, drink plenty of fluids.  She has no signs or symptoms consistent with anaphylaxis at this point.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Hypertension, Impaired driving ability, Pain, Spinal pain, Tachycardia
Clinical narrative: HISTORY OF PRESENT ILLNESS:  SHORTNESS OF BREATH (CHEST PAIN, sob , BACK PAIN STARTING TODAY AT 0900, STATES ADVIL AT 1000, SSENCOND COVID VACCINE YESTERDAY AT 1500) 32-year-old female with past medical history of anxiety, asthma, Hashimoto's thyroiditis, psoriasis who presents the emergency department with chief complaint of body aches and shortness of breath.  Patient is a nurse.  She received her 2nd dose of the Moderna vaccine for COVID-19 the day prior to arriving in the emergency department.  This morning she did feel some mild body aches but otherwise was feeling fine.  Starting later today after her shift at work she developed severe body aches bilateral upper shoulders and down her spine, she also reports some shortness of breath, dizziness.  She felt unsafe to drive home feeling like this.  She had taken some Advil earlier in the day around 10:00.  She denies any fever, nausea or vomiting.  No history of severe vaccine reaction or anaphylaxis.  She has had anaphylactic reaction to Enbrel prior.  She denies any throat swelling, muffled voice, difficulty swallowing, abdominal pain.    patient is mildly tachycardic and hypertensive.  Likely due to pain.  Patient is experiencing adverse reaction to the 2nd dose of the Moderna COVID-19 vaccine.  I discussed with her she is having an immune response to the vaccine.  She does have a history of rheumatoid arthritis which could contribute to the elevated immune response as well.  The patient is given 30 mg of IM Toradol for body aches here in the emergency department.  She is instructed to call PCP for close follow-up, rest, drink plenty of fluids.  She has no signs or symptoms consistent with anaphylaxis at this point.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling, Pain in extremity, Rash, Skin warm
Clinical narrative: Pt got her second dose of Moderna on 01/22/2021 01/23/2021 @ 9AM pt states feeling pain in her left arm.  She noticed a red bump around site of injection (deltoid)  She contacted her provider yesterday and was instructed to take Benadryl.  Today she still has the rash, warm at touch.  She will see her provider for FU on Thursday.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Dizziness postural, Fatigue, Headache
Clinical narrative: At about 3 -4 am on the morning after the vaccine I went to the Bathroom to Urinate, upon rising I slumped to the floor and passed out. I also had sweating and profound weakness. I crawled back to the bedroom and was placed in bed with assistance. I also experience feverish ness, sweating, chills, insomnia, muscle aches, and nausea throughout the night. The next morning I am able to stand, eat, and walk. I still have a headache, muscle aches, and fatigue. It is now 1pm on 1/26.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Insomnia, Loss of consciousness, Myalgia, Nausea
Clinical narrative: At about 3 -4 am on the morning after the vaccine I went to the Bathroom to Urinate, upon rising I slumped to the floor and passed out. I also had sweating and profound weakness. I crawled back to the bedroom and was placed in bed with assistance. I also experience feverish ness, sweating, chills, insomnia, muscle aches, and nausea throughout the night. The next morning I am able to stand, eat, and walk. I still have a headache, muscle aches, and fatigue. It is now 1pm on 1/26.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: At about 3 -4 am on the morning after the vaccine I went to the Bathroom to Urinate, upon rising I slumped to the floor and passed out. I also had sweating and profound weakness. I crawled back to the bedroom and was placed in bed with assistance. I also experience feverish ness, sweating, chills, insomnia, muscle aches, and nausea throughout the night. The next morning I am able to stand, eat, and walk. I still have a headache, muscle aches, and fatigue. It is now 1pm on 1/26.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Cardio-respiratory arrest, Death, Resuscitation, Unresponsive to stimuli
Clinical narrative: RESIDENT RECEIVED THE VACCINE ON 1/20/2021, RESIDENT HAD BEEN MONITORED EVERY SHIFT AND HAS NOT EXHIBITED ANY SYMPTOMS. RESIDENT WAS OBSERVED TO BE UNRESPONSIVE WITH NO PRESENCE OF VITAL SIGNS ON 1/24/2021. RESIDENT WAS A FULL CODE, CPR INITIATED UNSUCESSFULLY. BASED ON REVIEW WITH PRIMARY CARE PHYSICIAN AND MEDICAL DIRECTOR, THE RESIDENT HAD NOT HAVE ANY OTHER EVENTS PRIOR TO RECEIVING THE COVID VACCINE 4 DAYS PRIOR TO EVENT.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Diarrhoea, Feeling abnormal, Headache, Nasopharyngitis
Clinical narrative: Had vaccine, didn't feel much at all.  Came home, did not feel bad, day and half later started feeling bad, as  well as kind of like a cold with drainage to her throat, a little coughing.  Has had diarrhea for the last 3 days, nausea and generally feeling bad.  The first week had a lot of drowsiness, had fogginess as far as thinking.   The first few days took Tylenol and did not take anymore as her daughter said it contained aspirin for the pain.  Still having the headache, feeling like she is not thinking real good.  About a month ago had blood work and everything was perfect, no problems.  Due to the fact that she is still having these reactions 2 weeks from the injections wanted to report it.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Somnolence, Thinking abnormal, Throat clearing
Clinical narrative: Had vaccine, didn't feel much at all.  Came home, did not feel bad, day and half later started feeling bad, as  well as kind of like a cold with drainage to her throat, a little coughing.  Has had diarrhea for the last 3 days, nausea and generally feeling bad.  The first week had a lot of drowsiness, had fogginess as far as thinking.   The first few days took Tylenol and did not take anymore as her daughter said it contained aspirin for the pain.  Still having the headache, feeling like she is not thinking real good.  About a month ago had blood work and everything was perfect, no problems.  Due to the fact that she is still having these reactions 2 weeks from the injections wanted to report it.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Eye pruritus, Hypoaesthesia, Laboratory test normal, Peripheral swelling
Clinical narrative: On 1/20/21 9am had swollen right hand knuckles and numbness of hand and right toes. Knuckles on hands are still swollen. On 1/25/21 at 2am had difficulty breathing, itchy eyes and hives. Took albuterol for breathing, Zyrtec generic and 2 Quercetin with Bromlein. Resolved in 1 hour.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: On 1/20/21 9am had swollen right hand knuckles and numbness of hand and right toes. Knuckles on hands are still swollen. On 1/25/21 at 2am had difficulty breathing, itchy eyes and hives. Took albuterol for breathing, Zyrtec generic and 2 Quercetin with Bromlein. Resolved in 1 hour.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Condition aggravated
Clinical narrative: ?Moderna COVID-19 Vaccine EUA.    Mild-moderate exacerbation of asthma
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Breast pain, Impaired quality of life, Pain in extremity, Sleep disorder
Clinical narrative: Two days (Friday) after the injection (Wednesday) a pain arose in my shoulder muscle on my left side just behind the injection site.  By Sunday afternoon the pain became debilitating and the pain spread to my underarm and the edge of the breast area. I applied heat and rested.  The sharp pain interfered with sleep and regular life activities.  On Tuesday morning I applied an ice pack, which relieved the pain.  After applying ice for two more times, the pain subsided and the swelling under my arm disappeared. I was able to resume normal activities with slight discomfort.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Dizziness
Clinical narrative: Symptoms: Lightheaded, elevated blood pressure. Treatment: Given water, monitored another 15 minutes. No further symptoms or treatment.
Sex: M
Vaccine: HEP
Symptoms: Dyspepsia, Infantile back arching, Petit mal epilepsy, Strabismus
Clinical narrative: Arching of the back that lasted for weeks after the 19th. The lining of his eyes was off - strabismus that resolved itself months after the vaccine. Silent seizures, problems with digestion.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Induration, Pain in extremity, Peripheral swelling
Clinical narrative: Right arm induration - aching swelling redness golf ball size started on day 8 post vaccine and lasted until day 10- I have pictures if needed
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Hypertension
Clinical narrative: dizziness, and increased of high blood pressure,
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site rash, Injection site swelling, Paraesthesia, Pruritus
Clinical narrative: Rash and Swelling of injection site, itching of injection site, down left arm, itching and tingling  in left hand.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Full blood count, Nausea, Pyrexia
Clinical narrative: chills, fever, nausea, fatigue lasting 10 days
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Red blood cell sedimentation rate normal, SARS-CoV-2 test negative
Clinical narrative: chills, fever, nausea, fatigue lasting 10 days
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Erythema, Feeling abnormal, Mass, Pruritus
Clinical narrative: Had the Moderna vaccine on 1/12/21 and started with mild itching sensations on the palms of my hands on 1/14/21.  This became worse between 1/21/21 through 1/25/21 with intense itching, burning sensation, palms turning red, feeling "lots of cuts" through out my hand and developing small lumps through out my palms and in between my fingers.  This also spread to my feet but not as severe and not as long (a couple of days with intense itching and small lumps).
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased
Clinical narrative: A very high spike in blood pressure.  My normal BP is 117/74.   For about 4 hours after the vaccination was administered, my BP was 158/95.
Age: 95.0
Sex: M
Vaccine: COVID19
Symptoms: Bradycardia, Chills, Death, Diarrhoea, Hyperhidrosis
Clinical narrative: ON 1/21/2020 RESIDENT WAS EXPERINCING CHILLS AND LOOSE STOOLS.  FOLLOWING THIS EPISODE BECAME UNRESPONSIVE, PALE, DIAPHORETIC AND BRADYCARDIC. PALLIATIVE CARE WAS PROVIDED.  RESIDENT PASSED AWAY APPROX. 10 HOURS LATER.
Age: 95.0
Sex: M
Vaccine: COVID19
Symptoms: Pallor, Unresponsive to stimuli
Clinical narrative: ON 1/21/2020 RESIDENT WAS EXPERINCING CHILLS AND LOOSE STOOLS.  FOLLOWING THIS EPISODE BECAME UNRESPONSIVE, PALE, DIAPHORETIC AND BRADYCARDIC. PALLIATIVE CARE WAS PROVIDED.  RESIDENT PASSED AWAY APPROX. 10 HOURS LATER.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Feeling abnormal, Pain
Clinical narrative: I felt worse than when I began covid in Dec. Temp up to 102, achy  body, just felt terrible
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Rash, Swelling
Clinical narrative: Redness, swelling, itching, bumpy rash
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: No further AE; received an improperly stored dose; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not provided.  On 12-JAN-2021, the patient was vaccinated with improperly stored pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) 1 injection, lot # T024557 was valid with an expiration date of 15-MAR-2022 (exact dose, route of administration and anatomical location were not reported) for prophylaxis (product storage error). The temperature excursion was reported as above 9 degrees Celsius (C) (8.7C) for 25 minutes. There was no previous temperature excursion. A digital data logger was used to capture the temperature. No further adverse event reported. The outcome of the event was unknown.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Ill-defined disorder
Clinical narrative: shingles; ill defined disorder; This spontaneous report as received from a lawyer refers to a patient of unknown age and gender. Medical history, concurrent conditions and concomitant medications were not reported.  On or about 03-OCT-2012, the patient was vaccinated with a dose of zoster vaccine live(ZOSTAVAX) for prophylaxis (dose, route, anatomical location, lot number and expiration date were not provided) for the long-term prevention of shingles and zoster-related conditions.         Subsequent, on unknown date, after zoster vaccine live(ZOSTAVAX) inoculation, the pt was treated by healthcare providers, including the physiciaN for shingles, and other zoster-related conditions. As a direct and proximate result of zoster vaccine live(ZOSTAVAX), the pt had and would continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future.
Sex: F
Vaccine: HPV9
Symptoms: Tic
Clinical narrative: A couple weeks ago she started developing ticks.; Information has been received from a pharmacist via an unspecified reporter, referring to a 13 years old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date in October 2020, the patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), intramuscularly (dose, lot number, expiration date and anatomical location were not reported) for prophylaxis.    On an unspecified date in October 2020 (discrepant information also reported as "a couple weeks ago"), the patient started developing tics (also reported as"ticks"). The reporter stated that she researched and found there were some nasty side effects for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) and tics was one of them. Now the patient's mother was taking her to a neurologist. The outcome of tic was reported as not resolved.    The casuality assessment between the vaccination with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) and the tics was not provided.
Sex: M
Vaccine: ANTH
Symptoms: Vaccination complication
Clinical narrative: Squalene in Anthrax vaccine has caused the reaction; Spontaneous report received on 02DEC2020 from P?zer.  A healthcare professional reported regarding a male consumer to whom "squalene in anthrax vaccine has caused the reaction" (PT: Vaccination complication). The healthcare professional was inquiring if COVID-19 mRNA vaccine (BNT162) had squalene in it. The patient was exposed to squalene in his career with anthrax vaccine and it was documented that there was squalene in that vaccine that had caused the reaction to him. The outcome of the reported event was unknown at the time of report.  Company Comment: It was reported that squalene in anthrax vaccine has caused the reaction (vaccination complication) in a consumer who received presumably BioThrax. Further information of the event is limited. Squalene is an adjuvant used in several vaccinations, and considering the case information the causality of vaccination complication is assessed as related.; Sender's Comments: It was reported that squalene in anthrax vaccine has caused the reaction (vaccination complication) in a consumer who received presumably BioThrax. Further information of the event is limited. Squalene is an adjuvant used in several vaccinations, and considering the case information the causality of vaccination complication is assessed as related.
Sex: M
Vaccine: TYP
Symptoms: Expired product administered
Clinical narrative: Vivotif was expired on November 30th and the patient started his course on December 1st and completed the course correctly; Spontaneous report received on 10DEC2020.  A pharmacist reported regarding a male consumer where "Vivotif was expired on November 30th and the patient started his course on December 1st and completed the course correctly" (PT: Expired product administered). He was receiving Vivotif for immunisation. On 01DEC2020, the consumer started his course of Vivtoif, which had been expired on 30NOV2020. It was reported that the consumer completed his course correctly. Action taken with Vivotif with respect to reported event was not applicable. The outcome of the reported event was unknown.  Company Comment: It was reported that a consumer started Vivotif course after the expiration date and completed the course correctly (expired product administered). Further information of the event is limited. The causality of expired product administered is not applicable with Vivotif due to the nature of the event.; Sender's Comments: It was reported that a consumer started Vivotif course after the expiration date and completed the course correctly (expired product administered). Further information of the event is limited. The causality of expired product administered is not applicable with Vivotif due to the nature of the event.
Sex: F
Vaccine: ANTH
Symptoms: Lip swelling, Mycobacterium tuberculosis complex test positive
Clinical narrative: Lip got very swollen; Spontaneous report received on 11JAN2021 from P?zer.  A female consumer reported that her "lip got very swollen" (PT: Lip swelling) following the administration of anthrax vaccine. She inquired if it was safe for her to take Pfizer-Biontech coronavirus disease 2019 (COVID-19) vaccine as she had allergies. She reported that when she took other vaccines (smallpox and rubella) when she was at work she had to go to the hospital and get a spinal tap, and was informed that she cannot get those vaccines. She was not given any vaccine but received 2 rounds of anthrax vaccine. Her lip got very swollen the next day and was given Benadryl (diphenhydramine). She was tuberculosis (TB) positive and did not complete her isonicotinic acid hydrazide (INH) treatment due to her joint hurting. When she got a booster for Hep A (hepatitis A vaccine), she had to be given epinephrine. For typhoid her arm got swollen, more than regular, and for meningococcal she had a small reaction. Currently, she had rhabdomyolysis and malignant hyperthermia. She added that it could be due to other vaccines being live vaccines. The outcome of the reported event was unknown at the time of report.  Company Comment: It was reported that a consumer had lip swelling the next day after receiving presumably BioThrax (Anthrax vaccine). In response to the event, she was treated with Benadryl. This consumer developed several reactions (allergies) to various vaccines over the course of many years. Considering the case information and known effects of BioThrax, the causality of lip swelling is assessed as possible.; Sender's Comments: It was reported that a consumer had lip swelling the next day after receiving presumably BioThrax (Anthrax vaccine). In response to the event, she was treated with Benadryl. This consumer developed several reactions (allergies) to various vaccines over the course of many years. Considering the case information and known effects of BioThrax, the causality of lip swelling is assessed as possible.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: Fainted; A spontaneous report was received from a consumer, who was an 82-year old, female, patient who received Moderna's COVID-19 vaccine (mRNA-1273) and fainted.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 07 Jan 2021, approximately 6 hours prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 07 Jan 2021 at 19:30, the patient fainted. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event, fainted, was unknown.; Reporter's Comments: This case concerns a 82 year old female patient who experienced a serious unexpected event of Syncope. The event occurred 6 hours after first dose of mRNA-1273. Very limited information regarding this event has been provided at this time.  Based on temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Computerised tomogram, Magnetic resonance imaging head, Pulmonary oedema
Clinical narrative: Stroke like symptoms; Water in lungs; A spontaneous report was received from a consumer concerning an 83-year-old, male, patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced stroke like symptoms and water in lungs.   The patient's medical history was not provided. Concomitant products known to have been used by the patient included, insulin aspart, insulin glargine, ticagrelor, sacubitril valsartan sodium hydrate, furosemide, carvedilol, omeprazole, and sertraline.    On 04 Jan 2021, one day prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 05 Jan 2021, the patient began experiencing stroke-like symptoms and had water in his lungs.    On 06 Jan 2021, the patient was hospitalized and had a computed tomography (CT) scan and magnetic imaging resonance (MRI) scan of the brain.  On 09 Jan 2021, the patient was discharged from the hospital. Treatment information for the events was not provided.   Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the events, stroke like symptoms and water in lungs , was not reported.; Reporter's Comments: This case concerns an 83 year old male patient who experienced serious unexpected events of Cerebrovascular accident and Pulmonary oedema. The events occurred the next day of their first dose of their first of two planned doses of mRNA-1273. Concomitant medications included, insulin aspart, insulin glargine, ticagrelor, sacubitril valsartan sodium hydrate, furosemide, carvedilol, omeprazole, and sertraline. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Injection site extravasation, Product administered at inappropriate site
Clinical narrative: Appeared that most of the vaccine flowed down patient's left arm during administration; vaccination was given in left arm between elbow and shoulder not upper shoulder; Nurse said she overfilled the syringe/Appeared that most of the vaccine flowed down patient's left arm during administration; A spontaneous report was received from a consumer who was an 80-year-old, female patient who received Moderna's COVID-19 vaccine in her left arm between her elbow and shoulder not the upper shoulder, from an overfilled syringe, and most of the vaccine flowed down her arm during administration.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 01 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025L20A) in the left arm for prophylaxis of COVID-19 infection.    On 01 Jan 2021, the patient was administered the vaccine between her elbow and shoulder. It was reported the vaccine was not given in her upper shoulder. During administration  of the vaccine, most of it flowed down her left arm. The patient stated the nurse advised her the syringe had been overfilled. No treatment information was provided for the event.   Action taken with the second dose of mRNA-1273 in response to the event was not reported.    The outcome for the events, of the vaccine given in between her elbow and shoulder, an overfilled syringe and the vaccine that flowed down the patient's arm, were not provided.; Reporter's Comments: This case concerns a 80-year-old, female patient, who experienced an unexpected event of incorrect dose administered, vaccine leakage and Product administered at inappropriate site. The event occurred during the administration of the first dose of mRNA-1273 (Lot number: 025L20A). This report refers to product administration error for mRNA-1273 (Lot number: 025L20A).
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: After the vaccines lost temperature they were administered; A spontaneous report was received from a nurse concerning a 67-year-old, White, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the event, after the vaccines lost temperature they were administered.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 11 Jan 2021, a refrigerator in a vaccine clinic lost power and rose up to room temperature overnight. At approximately 9 p.m., the vaccines inside the refrigerator reached room temperature.  On 12 Jan 2021, after the vaccine lost temperature, the patient received their first of two planned doses of mRNA-1273 (Lot number: 027L20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.  No treatment information was provided.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.  The event, after the vaccines lost temperature they were administered, was considered resolved on 12 Jan 2021.; Reporter's Comments: This report refers to a case of out of specification product use for mRNA-1273, lot # 027L20A.  There were no reported AEs associated with this case of out of specification product use.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: Four Moderna vaccine doses that were administered from vials which had been more than 6 hours post initial puncture; A spontaneous report was received from a physician concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and had four Moderna vaccine doses that were administered from vials which had been more than 6 hours post initial puncture.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On an unspecified date, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Lot number unknown) intramuscularly for prophylaxis of COVID-19 infection.   The physician reported that four Moderna vaccine doses were administered from vials which had been more than 6 hours post initial puncture.   No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event had four Moderna vaccine doses that were administered from vials which had been more than 6 hours post initial puncture was considered resolved on an unspecified date.; Reporter's Comments: This case concerns a patient of unknown gender and age who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Out of specification product use.
Age: 16.0
Sex: U
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Vaccine administered to a 16 year old; A spontaneous report was received from a nurse concerning a 16-year-old patient who received Moderna's COVID-19 vaccine (mRNA-1273) resulting in the event, vaccine administered to a 16-year-old.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On an unknown date, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. The patient was 16-year-old. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, vaccine administered to a 16-year-old, was considered resolved.; Reporter's Comments: This case concerns a 16-year-old patient who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Product administered to patient of inappropriate age.
Sex: U
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Not sure if she received or not the vaccine in the syringe, they do not know if there was vaccine or air on it; A spontaneous report was received from a nurse concerning a patient who received Moderna's COVID-19 Vaccine, and who is not sure if she received the vaccine in the syringe. They do not know if there was vaccine or air on it.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   The patient received their first of two planned doses of mRNA-1273  on an unspecified date intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, a patient was not sure if she received the COVID-19 vaccine or if there was only air in the vaccine syringe  Treatment information was not provided.   Action taken with mRNA-1273 in response to the event was unknown.   The outcome of the event "not sure if she received the vaccine in the syringe, they do not know if there was vaccine or air on it" is considered resolved.; Reporter's Comments: This case concerns a patient who received their first of two planned doses of mRNA-1273  (Lot#: unknown) intramuscularly for prophylaxis of COVID-19 infection and patient was not sure if she received the COVID-19 vaccine or if there was only air in the vaccine syringe.  There were no reported AEs associated with this case of not sure if she received the COVID-19 vaccine or if there was only air in the vaccine syringe.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure via skin contact, Incorrect dose administered, Syringe issue
Clinical narrative: When the plunger was pushed the liquid ran down the side of her arm; When the plunger was pushed the liquid ran down the side of her arm; when the plunger was pushed the liquid ran down the side of her arm; A spontaneous report was received from a nurse who was a 71-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and when the plunger was pushed the liquid ran down the side of her arm.   The patient's medical history, as provided by the reporter, included an allergy to Macrobid, breast cancer, hypothyroidism, and hypertension. Concomitant medications included Metoprolol Succinate, Bupropion Hydrochloride, Fluoxetine Hydrochloride, Liothyronine Sodium, and Valaciclovir Hydrochloride.  On 07 Jan 2021 at 10:45 a.m., the patient received their first of two planned doses of mRNA-1273 (Lot Number: 011J20A) in her right deltoid for prophylaxis of COVID-19 infection.   On 07 Jan 2021, the patient noticed that when the vaccine plunger was pushed, liquid ran down the side of her arm. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, when the plunger was pushed the liquid ran down the side of her arm, was considered resolved on 07 Jan 2021.; Reporter's Comments: This report refers to a case of incorrect dose administered, exposure via skin contact, and syringe issue for mRNA-1273, lot # 011J20A.  There were no reported AEs associated with this case of incorrect dose administered, exposure via skin contact, and syringe issue.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: A spontaneous report was received from a nurse concerning a White, 82-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the event, after the vaccines lost temperature they were administered. The patient's medical history was not provided. No relevant concomitant medications were reported. On 11 Jan 2021, a refrigerator in a vaccine clinic lost power and rose up to room temperature overnight. At approximately 9 p.m., the vaccines inside the refrigerator reached room temperature. On 12 Jan 2021, after the vaccine lost temperature, the patient received their first of two planned doses of mRNA-1273 (Lot number: 027L20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.  No treatment information was provided.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.  The event, after the vaccines lost temperature they were administered, was considered resolved on 12 Jan 2021.  .; Reporter's Comments: This case concerns a 82-year-old female patient who received their first of two planned doses of mRNA-1273 (Lot: 027L20A), reporting Out of specification product use.
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, Syringe issue
Clinical narrative: A spontaneous report was received from a pharmacist concerning a male patient of unspecified age, who received Moderna's COVID-19 vaccine, where more than half of patient's 1st dose of Moderna COVID19 vaccine was leaked from the syringe. The patient's medical history was not provided. No relevant concomitant medications were reported. On an unknown date, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Lot number unknown) intramuscularly for prophylaxis of COVID-19 infection. The pharmacist reported that, during the administration of vaccine more than half of the dose was leaked from the syringe. No treatment information was provided. Action taken with mRNA-1273 in response to the event more than half of patient's 1st dose of Moderna COVID19 vaccine was leaked from the syringe was not reported. The outcome of the event more than half of patient's 1st dose of Moderna COVID19 vaccine was leaked from the syringe was resolved on an unspecified date. Reporter's Comments: This spontaneous report refers to a case of male patient who experienced non-serious event of more than half of patient's 1st dose of Moderna COVID19 vaccine leaked from the syringe, (Incomplete dose administered, syringe issue) for mRNA-1273 (lot # unknown), Exp. date-unknown). There were no reported AEs associated with the event of more than half of patient's 1st dose of Moderna COVID19 vaccine leaked from the syringe
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: After the vaccines lost temperature they were administered; A spontaneous report was received from a healthcare professional concerning a 77-year-old, White female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the event, after the vaccines lost temperature they were administered.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 11 Jan 2021, a refrigerator in a vaccine clinic lost power and rose up to room temperature overnight. At approximately 9 p.m., the vaccines inside the refrigerator reached room temperature.  On 12 Jan 2021, after the vaccine lost temperature, the patient received their first of two planned doses of mRNA-1273 (Lot number: 027L20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.  No treatment information was provided.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.  The event, after the vaccines lost temperature they were administered, was considered resolved on 12 Jan 2021.; Reporter's Comments: This case concerns a 77-year-old female patient who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Out of specification product use.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: A spontaneous report was received from a healthcare professional concerning a 65-year-old, White, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the event, after the vaccines lost temperature they were administered.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 11 Jan 2021, a refrigerator in a vaccine clinic lost power and rose up to room temperature overnight. At approximately 9 p.m., the vaccines inside the refrigerator reached room temperature.  On 12 Jan 2021, after the vaccine lost temperature, the patient received their first of two planned doses of mRNA-1273 (Lot number: 027L20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.  No treatment information was provided.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.  The event, after the vaccines lost temperature they were administered, was considered resolved on 12 Jan 2021.; Reporter's Comments: This case concerns a 65-year-old female patient who received their first of two planned doses of mRNA-1273 (Lot number: 027L20A), reporting Out of specification product use.