chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Hepatic failure, Leukocytosis, Lung opacity, Organ failure, Pneumonia
Clinical narrative: 29 y/o female presented to hospital with complaints of SOB, skin flares secondary to history of discoid lupus, protracted vomiting, and joint pain. Side effects began 2 days after her 2nd COVID vaccine. Pt was transferred to hospital from another institution due to O2 sat in the 60s (room air), leukocytosis, and AKI. Patient was treated empirically for sepsis/pneumonia as well as lupus flare. She was also initiated on high dose steroids. Possible reaction to vaccine. Chest CT showed diffuse ground-glass opacities and no signs of pulmonary embolism. Pt was transferred from hospital to another facility given progressive organ failure, most specifically liver failure.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Sepsis, Systemic lupus erythematosus, Troponin increased, Vomiting, White blood cell count increased
Clinical narrative: 29 y/o female presented to hospital with complaints of SOB, skin flares secondary to history of discoid lupus, protracted vomiting, and joint pain. Side effects began 2 days after her 2nd COVID vaccine. Pt was transferred to hospital from another institution due to O2 sat in the 60s (room air), leukocytosis, and AKI. Patient was treated empirically for sepsis/pneumonia as well as lupus flare. She was also initiated on high dose steroids. Possible reaction to vaccine. Chest CT showed diffuse ground-glass opacities and no signs of pulmonary embolism. Pt was transferred from hospital to another facility given progressive organ failure, most specifically liver failure.
Sex: F
Vaccine: FLUX
Symptoms: Allergy to vaccine
Clinical narrative: Allergic to the flu shot; This spontaneous case was received on 02-Mar-2021 from other non-health professional (consumer's daughter) via company (reference number: NUS2021US032466) and concerned a female patient of an unreported age.  The patient's medical history and concomitant medications were not reported.   On an unspecified date, the patient was vaccinated with influenza virus vaccine polyvalent (brand not specified; indication, dose, route of administration and anatomical location: not reported). The batch number was not reported.  On an unspecified date, unknown amount of time after receiving influenza virus vaccine polyvalent, the patient developed allergy to the flu shot, reported as patient's daughter was even allergic to the flu shot and her mother was the same way (refer to the case 202101643).  The outcome of the event was not reported.  The reporter assessed the event of 'allergy to vaccine' as related to influenza virus vaccine polyvalent. Reporter stated that she's even allergic to the flu shot and ''my mother is the same way''.  The case was assessed as non-serious.  This case is linked with case 202101643 (due to the same reporter).  Company comment: The event of 'allergy to vaccine' is considered as unassessable to influenza virus vaccine polyvalent.; Reporter's Comments: Reporter stated that she's even allergic to the flu shot and ''my mother is the same way''.; Sender's Comments: The event of 'allergy to vaccine' is considered as unassessable to influenza virus vaccine polyvalent.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Mobility decreased
Clinical narrative: Shoulder pain and limited mobility (extremely limited d/t pain) for 48+ hours now; not quite 72 hours. pt taking high-dose ibuprofen and tylenol and will f/u this week with me if symptoms persist.
Age: 92.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Fatigue, Feeling cold, Hot flush
Clinical narrative: ALLERGIC REACTION WAS RASH IN BLOTCHES AND HIVES THAT MOVED ALL AROUND THE BODY, SEVERE ITCHING. DIZZINESS, WEAKNESS, TIREDNESS, HOT AND COLD FLASHES ALL CONTINUEING FOR  NOW THE 6TH DAY FOLLOWING VACCINE.
Age: 92.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Pruritus, Rash, Rash macular, Urticaria
Clinical narrative: ALLERGIC REACTION WAS RASH IN BLOTCHES AND HIVES THAT MOVED ALL AROUND THE BODY, SEVERE ITCHING. DIZZINESS, WEAKNESS, TIREDNESS, HOT AND COLD FLASHES ALL CONTINUEING FOR  NOW THE 6TH DAY FOLLOWING VACCINE.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea
Clinical narrative: Patient got light headed, laid down on ground, got nauseous. Patient left in ambulance, but was fully conscious and fine.
Sex: U
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: Patient felt fine immediately after shot and walked around to sit and wait for 30 minutes.  After 20 minutes of sitting, she starting seizing in her chair.  Her head tipped to the side and her right arm straightened and she seized for approximately 5 minutes.  She started coming to which took approximately 5 minutes until she was fully answering our questions.  She was checked out by our on-call physician, Dr.  We let her sit for a full 20 minutes or so and then she was able to leave and go home on her own two feet.
Sex: M
Vaccine: FLUC3
Symptoms: Product temperature excursion issue
Clinical narrative: The vaccine reached temperature of 12C, duration of excursion was 31-33 hours and was adminsitered to the patient; The vaccine reached temperature of 12C, duration of excursion was 31-33 hours and was adminsitered to the patient; This spontaneous case was received on 02-Mar-2021 from pharmacist (reference number: SEQW21-00866) with additional information received on 03-Mar-2021 and 04-Mar-2021 (being processed together) and concerned an adult male patient of an unspecified age.  The patient's medical history and concomitant medications were not reported.  On an unknown date, Flucelvax Quadrivalent (influenza vaccine, subunit influenza virus vaccine polyvalent) had temperature excursion that reached 12 degree Celsius (C) for 31 to 33 hours (explicitly coded as 'Product storage error temperature too high'). The batch number reported was 281835 and expiry date was 30-Jun-2021.  On an unspecified date, after temperature excursion, the patient was vaccinated with Flucelvax Quadrivalent (dose, route of administration, indication and anatomical location: not reported) (explicitly coded as 'Product administration error').  At the time of initial reporting on 02-Mar-2021, it was not reported if the patient had any adverse events after Flucelvax Quadrivalent administration.  Company comment: On an unknown date, Flucelvax Quadrivalent had temperature excursion that reached 12 degree Celsius for 31 to 33 hours. On an unspecified date, after temperature excursion, the patient was vaccinated with Flucelvax Quadrivalent. It was unknown if the patient experienced any adverse event after Flucelvax Quadrivalent administration. Product storage error and product administration error are assessed as unrelated per company's conventions.; Sender's Comments: On an unknown date, Flucelvax Quadrivalent had temperature excursion that reached 12 degree Celsius for 31 to 33 hours. On an unspecified date, after temperature excursion, the patient was vaccinated with Flucelvax Quadrivalent. It was unknown if the patient experienced any adverse event after Flucelvax Quadrivalent administration. Product storage error and product administration error are assessed as unrelated per company's conventions.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Fatigue, Headache, Pain in extremity, Peripheral swelling
Clinical narrative: 7-8 hrs after shot I was extremely tired,  could not do simple things, layed down all day, bed early and following day felt better. My arm is still sore when used, 3 days later. I've had a slight headache every day, arm still swollen. Abdominal pain but could be something else.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Pyrexia, Tinnitus, Vaccine positive rechallenge
Clinical narrative: I had a slight fever, body aches and headache for 2 days, after each dose.  Tinnitus, which I've had a few times over the years, started about 10 days after my first dose (01/18/21). I received my 2nd dose on 02/15/21.  The tinnitus has continued, about 4-5 days per week.  I have seen my ENT  twice.  He suggested I try melatonin.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Cold sweat, Nausea, Paraesthesia, Presyncope
Clinical narrative: Vasovagal event without syncope post vaccine.  Clammy and nauseous with tingling to hands.  EMS and  Dr  on site.  Blood pressure 90/49 at 18.10.  at 18.15 blood pressure was 114/81.  Released home and advised to seek medical attention later if needed, client verbalized understanding.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial flutter, Blood magnesium normal, Blood potassium normal, Chills, Computerised tomogram
Clinical narrative: On  Sunday 2/14, pt notes that she experienced chills and "just felt out of sorts." On 3/15 at 1:30pm, she was scheduled for a wellness exam with her primary care provider. She notes that when staff took her vital, they were concerned because she seemed short of breath. Pt notes that she is overweight and does have dypsnea on exertion at times, but staff were concerned because she had been at rest for some time and they considered the shortness of breath unusual. Pt reports that her blood pressure was normal and her O2 sats were running 97-98% on room air. However, her pulse was 150. An EKG was done and the physician voiced concern over how long her pulse had been elevated. She was transferred to the ED,  where per her report another EKG showed that she was in  atrial flutter. Pt reports that she was treated with IV Cardizem and given and IV bolus of magnesium.  At approximately 4:30pm, a CT with contrast was completed to rule out blood clot or PE. A third EKG done in the ED revealed that she had returned to normal sinus rhythm. She was discharged home at 6:30pm.  Pt reports that she was seen for follow up on 3/20. At that time, her physician ordered repeat labs - CMP, potassium, magnesium, and thyroid - all of which were normal per her report. He changed her medication from baby aspirin 81 mg to Zarelto 20 mg, noting that she is at high risk for stroke. Cardiology has been alerted and she has an ECHO scheduled . Since her discharge from the ED, pt has been monitoring her pulse daily and it have ranged from 66-72 bpm/
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Electrocardiogram abnormal, Feeling abnormal, Heart rate increased, Metabolic function test normal
Clinical narrative: On  Sunday 2/14, pt notes that she experienced chills and "just felt out of sorts." On 3/15 at 1:30pm, she was scheduled for a wellness exam with her primary care provider. She notes that when staff took her vital, they were concerned because she seemed short of breath. Pt notes that she is overweight and does have dypsnea on exertion at times, but staff were concerned because she had been at rest for some time and they considered the shortness of breath unusual. Pt reports that her blood pressure was normal and her O2 sats were running 97-98% on room air. However, her pulse was 150. An EKG was done and the physician voiced concern over how long her pulse had been elevated. She was transferred to the ED,  where per her report another EKG showed that she was in  atrial flutter. Pt reports that she was treated with IV Cardizem and given and IV bolus of magnesium.  At approximately 4:30pm, a CT with contrast was completed to rule out blood clot or PE. A third EKG done in the ED revealed that she had returned to normal sinus rhythm. She was discharged home at 6:30pm.  Pt reports that she was seen for follow up on 3/20. At that time, her physician ordered repeat labs - CMP, potassium, magnesium, and thyroid - all of which were normal per her report. He changed her medication from baby aspirin 81 mg to Zarelto 20 mg, noting that she is at high risk for stroke. Cardiology has been alerted and she has an ECHO scheduled . Since her discharge from the ED, pt has been monitoring her pulse daily and it have ranged from 66-72 bpm/
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Thyroid function test normal
Clinical narrative: On  Sunday 2/14, pt notes that she experienced chills and "just felt out of sorts." On 3/15 at 1:30pm, she was scheduled for a wellness exam with her primary care provider. She notes that when staff took her vital, they were concerned because she seemed short of breath. Pt notes that she is overweight and does have dypsnea on exertion at times, but staff were concerned because she had been at rest for some time and they considered the shortness of breath unusual. Pt reports that her blood pressure was normal and her O2 sats were running 97-98% on room air. However, her pulse was 150. An EKG was done and the physician voiced concern over how long her pulse had been elevated. She was transferred to the ED,  where per her report another EKG showed that she was in  atrial flutter. Pt reports that she was treated with IV Cardizem and given and IV bolus of magnesium.  At approximately 4:30pm, a CT with contrast was completed to rule out blood clot or PE. A third EKG done in the ED revealed that she had returned to normal sinus rhythm. She was discharged home at 6:30pm.  Pt reports that she was seen for follow up on 3/20. At that time, her physician ordered repeat labs - CMP, potassium, magnesium, and thyroid - all of which were normal per her report. He changed her medication from baby aspirin 81 mg to Zarelto 20 mg, noting that she is at high risk for stroke. Cardiology has been alerted and she has an ECHO scheduled . Since her discharge from the ED, pt has been monitoring her pulse daily and it have ranged from 66-72 bpm/
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypoaesthesia, Hypoaesthesia oral, Nausea, Pharyngeal swelling
Clinical narrative: Swelling tongue, swelling throat, numbness on face,  lips, headache nausea, numbness feet, numbness hands
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Swollen tongue
Clinical narrative: Swelling tongue, swelling throat, numbness on face,  lips, headache nausea, numbness feet, numbness hands
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling hot, Nausea
Clinical narrative: c/o feeling hot and nauseated after 25 minutes post vaccination.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Dizziness, Dysmetria, Fatigue, Headache
Clinical narrative: severe headache, severe dizziness, fatigue,  and feeling of confusion.  neurologic changes seen on exam include jerk horizontal nystagmus, dysmetria, and other imbalance
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Nystagmus
Clinical narrative: severe headache, severe dizziness, fatigue,  and feeling of confusion.  neurologic changes seen on exam include jerk horizontal nystagmus, dysmetria, and other imbalance
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Flushing, Headache, Pyrexia
Clinical narrative: Headache  Diarrhea  Flushed/feverish (no fever)
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Neck pain, Sleep disorder, X-ray
Clinical narrative: Day 4 after shot neck pain developed.  Never experienced pain in my neck.  Went to Rothman on day 8.  They said it was arthritis. I never had an issue before.  Pain in neck is on left side the same side as shot.  Can sleep on that side.  Pain is unbearable if I try sleeping on right side.  Took a steroid for 5 days.  Pain immediately went away and then return  day 5 of steroid.   Still have pain on day 24 since shot.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Dizziness, Fatigue, Headache, Malaise
Clinical narrative: got her first Moderna COVID19 vaccination on Wednesday 03/10/2021. She had no immediate problems with the shot such as arm pain or any other concerns, but by the next day 03/11/2021 she woke feeling very exhausted. They were having tests, and she is one of the main people in charge of this, so she just wrote it off as a reaction to stress. However as the day went on she was feeling worse including low-grade chronic headache, nausea, intermittent palpitations and waves of dizziness. She even had a little anxiety attack, thus she went home Thursday afternoon. She forced herself to go back to school the next day, knowing that if she could get through that day, she'd have a whole week off for spring break. Unfortunately, despite decreased stress, she continued to feel poorly. She has a feeling of profound fatigue, constant headache at the base of the skull that Tylenol really doesn't touch, nausea, stomach rumbling, intermittent dizziness, and intermittent palpitations.  Not surprisingly, her anxiety has increased, so she started sertraline 25 mg one half tab on Tuesday 03/16/2021, and on Saturday 03/20/2021 she increased it to a full tab. Now taking PharmaGABA at night to keep the anxiety and heart racing down.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Palpitations
Clinical narrative: got her first Moderna COVID19 vaccination on Wednesday 03/10/2021. She had no immediate problems with the shot such as arm pain or any other concerns, but by the next day 03/11/2021 she woke feeling very exhausted. They were having tests, and she is one of the main people in charge of this, so she just wrote it off as a reaction to stress. However as the day went on she was feeling worse including low-grade chronic headache, nausea, intermittent palpitations and waves of dizziness. She even had a little anxiety attack, thus she went home Thursday afternoon. She forced herself to go back to school the next day, knowing that if she could get through that day, she'd have a whole week off for spring break. Unfortunately, despite decreased stress, she continued to feel poorly. She has a feeling of profound fatigue, constant headache at the base of the skull that Tylenol really doesn't touch, nausea, stomach rumbling, intermittent dizziness, and intermittent palpitations.  Not surprisingly, her anxiety has increased, so she started sertraline 25 mg one half tab on Tuesday 03/16/2021, and on Saturday 03/20/2021 she increased it to a full tab. Now taking PharmaGABA at night to keep the anxiety and heart racing down.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Back pain, Muscle tightness, Painful respiration
Clinical narrative: Within the 24 hours after I experienced an intense tightening of my back between my shoulder blades and more to the right side.  It was  painful breathing in fully, taking a deep breath, lesser so when I breathe shallowly.  I felt very weak overall with multiple joints feeling pain (ankles, knees, wrist that was previously injured).  The intensity of the back/between shoulder blades pain remained throughout the following day and a bit lesser so into day three (now).
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Dysgeusia, Injection site rash, Myalgia
Clinical narrative: 20 min after the injection, patient started to develop itchness on his arms  and back.  for the next 48 hours the itchness came and went. small rash (raised red pimps) around the injection spot.  I have treated the itch with allergy meds and the rash with hydrocodone cream 4 days later, he still complains of sore arm, periodic metalic taste when he eats,  sore joints and arm muscles. Saturday evening he had brief chills, and sunday  reported sore throat.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pruritus, Rash erythematous, Rash papular
Clinical narrative: 20 min after the injection, patient started to develop itchness on his arms  and back.  for the next 48 hours the itchness came and went. small rash (raised red pimps) around the injection spot.  I have treated the itch with allergy meds and the rash with hydrocodone cream 4 days later, he still complains of sore arm, periodic metalic taste when he eats,  sore joints and arm muscles. Saturday evening he had brief chills, and sunday  reported sore throat.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Insomnia, Pain, Palpitations
Clinical narrative: Headache, body aches, insomnia, fever, rapid heart rate, brain fog
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Headache, body aches, insomnia, fever, rapid heart rate, brain fog
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: person reported feeling lightheaded. It was right before lunch. Accucheck was done by EMS and person was able to ambulate out of clinic.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Heart rate increased, Myalgia, Nausea
Clinical narrative: Headaches, muscle aches, racing pulse, nausea, chills, temp of 101.7
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Headaches, muscle aches, racing pulse, nausea, chills, temp of 101.7
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Nausea
Clinical narrative: At 9:45 Patient complained of nausea after smelling Lysol being sprayed. Patient stepped outside to get fresh air and I stepped out also to observe her. V/SBP 153/89, 98 % O2 and HR 74. Gave patient water and had her sit for additional 30 minutes. Patient said no signs of difficulty breathing ans she felt better after breathing fresh air.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dizziness, Dyspnoea, Musculoskeletal stiffness, Nausea, Paraesthesia oral
Clinical narrative: At 9:45 Patient complained of nausea after smelling Lysol being sprayed. Patient stepped outside to get fresh air and I stepped out also to observe her. V/SBP 153/89, 98 % O2 and HR 74. Gave patient water and had her sit for additional 30 minutes. Patient said no signs of difficulty breathing ans she felt better after breathing fresh air.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Throat tightness
Clinical narrative: At 9:45 Patient complained of nausea after smelling Lysol being sprayed. Patient stepped outside to get fresh air and I stepped out also to observe her. V/SBP 153/89, 98 % O2 and HR 74. Gave patient water and had her sit for additional 30 minutes. Patient said no signs of difficulty breathing ans she felt better after breathing fresh air.
Age: 74.0
Sex: F
Vaccine: FLUA3
Symptoms: Peripheral swelling
Clinical narrative: Arm swelled up; This spontaneous case  was received on 04-Mar-2021 from other non-health professional (consumer)(reference number: SEQW21-00896) and concerned a 74-year-old, female patient.  The patient's medical history included cancer surgery. The patient's concomitant medications were not reported.   On 01-Dec-2015, the patient was vaccinated with Fluad (TIV) (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59; route of administration: intramuscular, dose and anatomical location: not reported) as prevention of seasonal influenza. The batch number reported was 1413101.   On the same date, an unknown amount of time after receiving Fluad (TIV), the patient's arm swelled up.   On 11-Dec-2015, ten days after receiving Fluad (TIV) vaccine, the patient was vaccinated with non-company pneumonia vaccine (brand not specified; dose, route of administration, indication and anatomical location: not reported). The batch number was not reported.   The patient requested to know the ingredients of Fluad (TIV) vaccine as the patient was preparing to receive COVID vaccine.  The outcome of the event 'swelling arm' was not reported.  The reporter did not provide a causality assessment.  This case was assessed as non-serious.  Company comment: A 74-year-old patient was vaccinated with Fluad (TIV). On the same date after receiving Fluad (TIV), the patient's arm swelled up. No alternative aetiology was provided. Causality is assessed as possibly related.; Sender's Comments: A 74-year-old patient was vaccinated with Fluad (TIV). On the same date after receiving Fluad (TIV), the patient's arm swelled up. No alternative aetiology was provided. Causality is assessed as possibly related.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Headache, Pain, Pain in extremity
Clinical narrative: Friday afternoon: left arm started getting sore. by Friday evening developed pounding headache, complete body aches, fever through out the night. took Tylenol around 3 am Saturday morning. Saturday: chills, headache, feverish, and weakness. By Midnight was feeling better. Sunday 3/21/2021 back to normal self
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Friday afternoon: left arm started getting sore. by Friday evening developed pounding headache, complete body aches, fever through out the night. took Tylenol around 3 am Saturday morning. Saturday: chills, headache, feverish, and weakness. By Midnight was feeling better. Sunday 3/21/2021 back to normal self
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Decreased appetite, Fatigue, Headache, Injection site erythema
Clinical narrative: -fever of 110.7 (that was after taking Tylenol) -shivering for the whole night -chills for hours -headache that lasted until Sunday morning -red splotches from the injection site to about two inches out from the injection site -tiredness -lack of appetite
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: -fever of 110.7 (that was after taking Tylenol) -shivering for the whole night -chills for hours -headache that lasted until Sunday morning -red splotches from the injection site to about two inches out from the injection site -tiredness -lack of appetite
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Cheilitis, Headache, Herpes zoster, Nodule, Rash
Clinical narrative: Adverse event occurred after 2nd dose. Rash developed under lower lip across middle of the face and a lump developed inside the left nostril.  5 days later, rash and lump in nose still present, mild pain in back right side of the head (behind the ear) developed.   Pain behind the right ear grew more intense each day and on Thursday, March 11 was seen at Urgent Care with intense pain.  Was diagnosed with Shingles and prescribed Valacyclovir and Prednisone,  Acetaminophen-Codeine for pain.  Saw Dr.  on Monday, March 15.  Pain is gradually reducing, but still present today, March 22, 2021.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Rash maculo-papular
Clinical narrative: Maculopapular rash over back and torso, moving on to legs.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Medication administration error. Patient was given the Moderna vaccine before the 18th birthday.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Condition aggravated, Inflammation, Pain
Clinical narrative: 12 hours after shot, every place my arthritis is diagnosed, I had pain and likely inflammation.
Age: 24.0
Sex: M
Vaccine: FLUC3
Symptoms: Product temperature excursion issue, Vaccination site pain
Clinical narrative: Site pain after vaccination; The vaccine administered was exposed to 32F for max of 6 hours; The vaccine administered was exposed to 32F for max of 6 hours; This spontaneous case was received on 06-Mar-2021 from a pharmacist via Communications (reference number: SEQW21-00914) with additional information (being processed together) received on 11-Mar-2021 and concerned a 24-year-old, male patient.  The patient had no relevant medical history and was not taking any concomitant medications.   On an unspecified date, the Flucelvax Quadrivalent multidose vial (influenza vaccine, subunit influenza virus vaccine polyvalent) reached 32 degrees Fahrenheit (F) for maximum six hours (explicitly coded as 'Product storage error temperature too low'). There was another excursion at 35.5 F, but it was confirmed that the temperature was under the range of recommended storage conditions. The batch number was not reported.   On 05-Mar-2021, after temperature excursion, the patient was vaccinated with Flucelvax Quadrivalent (dose: 0.5 ml, route of administration: intramuscular and anatomical location: deltoid) for influenza prophylaxis (explicitly coded as 'Product administration error').  On the same day, after receiving Flucelvax Quadrivalent, the patient experienced site pain. No treatment measures were taken.  At the time of initial reporting on 06-Mar-2021, the patient had not recovered from the event of 'vaccination site pain'.   The reporter did not provide causality assessment.  The reporter assessed the case as non-serious.  Company comment: The event of 'vaccination site pain' is assessed as related to Flucelvax Quadrivalent. The events of 'product storage error temperature too low' and 'product administration error' are considered as not related to Flucelvax Quadrivalent.; Sender's Comments: The event of 'vaccination site pain' is assessed as related to Flucelvax Quadrivalent. The events of 'product storage error temperature too low' and 'product administration error' are considered as not related to Flucelvax Quadrivalent.
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Skin wrinkling
Clinical narrative: A FEW MINUTES AFTER GETTING THE VACCINE, HE DEVELOPED WRINKLES AND RED DISCOLOURATION ON BOTH OF HIS HANDS ON THE DORSAL ASPECT. NO DIFFICULTY BREATHING, OR SHORTNESS OR BREATH OR ITCHING. THE SKIN CHANGES RESOLVED WHILE IN THE MEDICAL TENT.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Injected limb mobility decreased, Injection site pain, Pain in extremity, Sleep disorder
Clinical narrative: My arm has been aching since the 1st one. I let the RN giving me the 2nd shot aware and he said that?s weird.  I just happened to have the same person injecting both times. Never reported or had me speak with anyone at that time. He said I could get it in the left, but I denied due to I didn?t want the pain in both arms. When he gave me the 2nd shot I felt it so much more than the first shot that I blurted out that hurts and a felt a twinge in my arm, as if it hit something other than the muscle. My arm 2 mos later is not let up the pain. I can only raise it so high. I cannot sleep on either side w/o pain. Same days are worse than others. The pain is right at the injection site. This is the only thing I have had done to my arm so I know it has something to do with the vaccine. I alternate ice and heat along with ibuprofen and it does not touch the pain/aches. It is a constant ache in my arm. I did contact my employee health at work and she advised me to fill out report on this website and in the Hospital safety report.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Erythema, Skin warm, Throat irritation
Clinical narrative: Bright red, hot to the touch cheeks Itchy throat Difficult swallowing
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash on face , ear and neck - Zyrtec and Benadryl
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Swollen tongue
Clinical narrative: Patient returned to vaccination POD after developing tongue swelling within one hour of vaccine administration Patient took her own Benadryl with resolution of symptoms.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Angiogram pulmonary abnormal, Asthenia, Back pain, Blood lactic acid increased, COVID-19
Clinical narrative: Pt is a 70 year old male who received first dose of Pfizer COVID-19 vaccine on 02/06/2021. Pt describes  that he was doing well for a few days after receiving the vaccine; however, on Friday February 12, 2021  pt states he began to feel poorly at dinner. His initial symptoms included back pain, myalgia, and  fatigue. Pt got tested for COVID-19 and received positive results on 02/14/2021. Pt presented to ER on  02/15/2021 due to weakness, dizziness, fatigue, and confusion. Pt also reports dry cough, fever, chills,  and loss of apetite. Pt was discharged on 02/16/2021 after improvement was observed.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Confusional state, Cough, Decreased appetite, Dizziness
Clinical narrative: Pt is a 70 year old male who received first dose of Pfizer COVID-19 vaccine on 02/06/2021. Pt describes  that he was doing well for a few days after receiving the vaccine; however, on Friday February 12, 2021  pt states he began to feel poorly at dinner. His initial symptoms included back pain, myalgia, and  fatigue. Pt got tested for COVID-19 and received positive results on 02/14/2021. Pt presented to ER on  02/15/2021 due to weakness, dizziness, fatigue, and confusion. Pt also reports dry cough, fever, chills,  and loss of apetite. Pt was discharged on 02/16/2021 after improvement was observed.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Lung opacity, Myalgia, Pyrexia
Clinical narrative: Pt is a 70 year old male who received first dose of Pfizer COVID-19 vaccine on 02/06/2021. Pt describes  that he was doing well for a few days after receiving the vaccine; however, on Friday February 12, 2021  pt states he began to feel poorly at dinner. His initial symptoms included back pain, myalgia, and  fatigue. Pt got tested for COVID-19 and received positive results on 02/14/2021. Pt presented to ER on  02/15/2021 due to weakness, dizziness, fatigue, and confusion. Pt also reports dry cough, fever, chills,  and loss of apetite. Pt was discharged on 02/16/2021 after improvement was observed.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Pt is a 70 year old male who received first dose of Pfizer COVID-19 vaccine on 02/06/2021. Pt describes  that he was doing well for a few days after receiving the vaccine; however, on Friday February 12, 2021  pt states he began to feel poorly at dinner. His initial symptoms included back pain, myalgia, and  fatigue. Pt got tested for COVID-19 and received positive results on 02/14/2021. Pt presented to ER on  02/15/2021 due to weakness, dizziness, fatigue, and confusion. Pt also reports dry cough, fever, chills,  and loss of apetite. Pt was discharged on 02/16/2021 after improvement was observed.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort
Clinical narrative: Tight chest on the way home from the Pharmacy. I did NOT wheeze though. I gave myself a Nebulizer Tx  with Albuterol Solution after I got home. The Nebulizer Tx was effective.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth, Rash
Clinical narrative: On day 8 after the shot I had a nickel size bump at the injection site.  By day 11 the spot had grown to 4 inches, was red and itchy.  It was also warm.  I took allergy medicine and by day 15 it had all cleared up.  Overall, the rash didn?t hurt but was annoying.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Feeling cold, Nausea, Pyrexia, Tremor
Clinical narrative: 22 hrs. after injection, on a Saturday 3/6/21, my husband suddenly felt chilled & shaky.  2 hrs. after that he felt nauscious & started a fever of 99 which climbed to 103 over the next 24 hrs.  He took Tylenol every 4-5 hrs. & stayed in bed. By Sunday his fever slowly started to go down.  And by the following  Mon. morning, 3/8/21, his fever was gone.  He felt weak but otherwise well enough to perform normal day-to-day activities/work.  12 days after that, on 3/20/21, he developed the exact same symptoms & went to bed immediately & took appropriate Tylenol.  His fever, this time, only went to just under 100.  He is scheduled for his second shot on 4/2/21.  Should he get it?  If not, what does he do???
Age: 59.0
Sex: M
Vaccine: FLU4
Symptoms: Magnetic resonance imaging, Neck pain, Pain in extremity, Vaccination site pain, X-ray
Clinical narrative: Site pain which spread up neck and down left arm and across to right arm; Site pain which spread up neck and down left arm and across to right arm; Site pain which spread up neck and down left arm and across to right arm; This spontaneous case was received on 06-Mar-2021 from other non-health professional (consumer) via Communications (reference number: SEQW21-00913) with additional information received on 11-Mar-2021 (being processed together) via Communications (reference number: SEQW21-00972) and concerned 59-year-old, male patient.  The patient's concurrent conditions included back pain. The patient's concomitant medications included unspecified antidepressant and vitamin D unspecified (NOS), both used for unreported indications, and hydrocodone used for pain. The patient received his first and second dose of the COVID-19 vaccine in his right arm and had no issues.  On an unspecified date in Oct-2020, the patient was vaccinated with Afluria Quadrivalent (influenza vaccine; dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid) as influenza prophylaxis. The batch number was not reported.  On the same day, after receiving Afluria Quadrivalent, the patient experienced site pain which spread up to neck and down to left arm and across to right arm. The patient stated that the pain only spread to his right side ''when it gets bad''.  On an unspecified date, the patient visited for evaluation for nerve damage with magnetic resonance imaging (MRI), however, the cause could not be determined. Also, X-rays of the affected area did not reveal anything. The patient was treated with hydrocodone for pain. The patient also stated that he had previously been to a chiropractor for his arm and shoulder, but this did not help. It was reported that the patient would visit a physical therapist in May-2021.  At the time of initial reporting on 06-Mar-2021, the patient had not recovered from the events.  The reporter did not provide a causality assessment.   The reporter assessed the case as non-serious.  Company comment: A 59-year-old patient was vaccinated with Afluria Quadrivalent. On the same day, after receiving Afluria Quadrivalent, the patient experienced vaccination site pain, which spread up to neck pain and down to left arm and across to right arm (pain in extremity). Chronology is plausible. Causality is assessed as possibly related.; Sender's Comments: A 59-year-old patient was vaccinated with Afluria Quadrivalent. On the same day, after receiving Afluria Quadrivalent, the patient experienced vaccination site pain, which spread up to neck pain and down to left arm and across to right arm (pain in extremity). Chronology is plausible. Causality is assessed as possibly related.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Injection site erythema, Injection site pruritus, Pain
Clinical narrative: 2nd dose resulted in fever, chills, headache, body aches sore arm one day after. Two days later my arm has red slightly itchy 5 by 2 patch at injection site. First dose resulted in dizziness and nausea 3 days later with need to go by ambulance to er
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: 2nd dose resulted in fever, chills, headache, body aches sore arm one day after. Two days later my arm has red slightly itchy 5 by 2 patch at injection site. First dose resulted in dizziness and nausea 3 days later with need to go by ambulance to er
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: 1st vaccine given 3/10/21, 2nd given 3/19/21. No adverse reaction known.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: Pt began having difficulty breathing 15 minutes after injection Vitals monitored, Oxygen 15 liters NRB applied. EMS alerted and gave EPI pen via Auto injector. Transported to local hospital by EMS ambulance.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Lip swelling, Paraesthesia oral, Pruritus
Clinical narrative: Pt is experiencing swelling and redness in bilateral lips, tingling, itchiness.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Diarrhoea
Clinical narrative: Diarrhea started on 3/16/21 at 10:00 am and continues daily.  Several bouts daily but is improving.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: pt reports intermittent redness and itching to administration site, sts some days appears to improve but then itching returns
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Rash, Tremor
Clinical narrative: After receiving the first does of the Moderna vaccine the patient was observed for 30min. The patient states she felt heat in her chest and was very shaky. A rash started to appear just before EMS arrived. Pt was given 2 325mg of Tylenol and an icepack was placed on the patients back to reduce heat. We followed up with the patient on 3/20/21 (the day after injection) Patient states she received Benadryl at the ER and is feeling better.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Patient experienced tingling down right lateral arm immediately following vaccination, symptoms had already started to resolve by 20 minutes, reassuring physical exam, no medications given
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Nausea, Pain in extremity
Clinical narrative: First vaccine and had side effects of headache, nausea, muscle ache, chills and 100 deg F fever for 8 hours within 30 hours after the shot in the arm.  Local soreness in the arm from the shot is still going 48 hours later otherwise all other systems have passed this morning the second day after receiving the shot.  I also tested positive for Covid on November 30, 2020 and had the same effects for 3 weeks with it then.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: First vaccine and had side effects of headache, nausea, muscle ache, chills and 100 deg F fever for 8 hours within 30 hours after the shot in the arm.  Local soreness in the arm from the shot is still going 48 hours later otherwise all other systems have passed this morning the second day after receiving the shot.  I also tested positive for Covid on November 30, 2020 and had the same effects for 3 weeks with it then.
Age: 79.0
Sex: F
Vaccine: FLUC3
Symptoms: Arthralgia, Eye swelling, Headache, Muscular weakness, Ocular hyperaemia
Clinical narrative: Vision disturbance; Pain in the shoulder and arm; Weakness in her leg; Red swollen eyes; Red swollen eyes; Pain in the shoulder and arm; Headache; This spontaneous case from was received on 09-Mar-2021 from other non-health professional (consumer) via Communications (reference number: SEQW21-00944) and concerned a 79-year-old, female patient.  The patient's medical history was not reported. It was reported that at that time the patient was in good health. The patient's concomitant medications included unspecified eye drops used for an unreported indication.   On 04-Sep-2014, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, route of administration and anatomical location: not reported) as flu prophylaxis. The batch number was not reported.  On 08-Sep-2014, four days after receiving Flucelvax Quadrivalent, the patient experienced weakness in her leg and pain in the shoulder and arm. The patient was concerned since she additionally developed red, swollen eyes, vision disturbance and headache. It was reported that she did not receive the flu vaccine again. It was unknown if the patient received any corrective treatment.  The outcome of the events was unknown.  The reporter did not provide a causality assessment.  The case was assessed as non-serious.  Company comment: A 79-year-old, female patient was vaccinated with Flucelvax Quadrivalent. Four days after receiving Flucelvax Quadrivalent, the patient experienced weakness in her leg and pain in the shoulder and arm. The patient was concerned since she additionally developed red, swollen eyes, vision disturbance and headache. No alternative aetiology was provided. Causal role of the suspect vaccine is assessed as possibly related for visual impairment, pain in extremity, muscular weakness, ocular hyperaemia, eye swelling, arthralgia and headache.; Sender's Comments: A 79-year-old, female patient was vaccinated with Flucelvax Quadrivalent. Four days after receiving Flucelvax Quadrivalent, the patient experienced weakness in her leg and pain in the shoulder and arm. The patient was concerned since she additionally developed red, swollen eyes, vision disturbance and headache. No alternative aetiology was provided. Causal role of the suspect vaccine is assessed as possibly related for visual impairment, pain in extremity, muscular weakness, ocular hyperaemia, eye swelling, arthralgia and headache.
Age: 79.0
Sex: F
Vaccine: FLUC3
Symptoms: Pain in extremity, Visual impairment
Clinical narrative: Vision disturbance; Pain in the shoulder and arm; Weakness in her leg; Red swollen eyes; Red swollen eyes; Pain in the shoulder and arm; Headache; This spontaneous case from was received on 09-Mar-2021 from other non-health professional (consumer) via Communications (reference number: SEQW21-00944) and concerned a 79-year-old, female patient.  The patient's medical history was not reported. It was reported that at that time the patient was in good health. The patient's concomitant medications included unspecified eye drops used for an unreported indication.   On 04-Sep-2014, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, route of administration and anatomical location: not reported) as flu prophylaxis. The batch number was not reported.  On 08-Sep-2014, four days after receiving Flucelvax Quadrivalent, the patient experienced weakness in her leg and pain in the shoulder and arm. The patient was concerned since she additionally developed red, swollen eyes, vision disturbance and headache. It was reported that she did not receive the flu vaccine again. It was unknown if the patient received any corrective treatment.  The outcome of the events was unknown.  The reporter did not provide a causality assessment.  The case was assessed as non-serious.  Company comment: A 79-year-old, female patient was vaccinated with Flucelvax Quadrivalent. Four days after receiving Flucelvax Quadrivalent, the patient experienced weakness in her leg and pain in the shoulder and arm. The patient was concerned since she additionally developed red, swollen eyes, vision disturbance and headache. No alternative aetiology was provided. Causal role of the suspect vaccine is assessed as possibly related for visual impairment, pain in extremity, muscular weakness, ocular hyperaemia, eye swelling, arthralgia and headache.; Sender's Comments: A 79-year-old, female patient was vaccinated with Flucelvax Quadrivalent. Four days after receiving Flucelvax Quadrivalent, the patient experienced weakness in her leg and pain in the shoulder and arm. The patient was concerned since she additionally developed red, swollen eyes, vision disturbance and headache. No alternative aetiology was provided. Causal role of the suspect vaccine is assessed as possibly related for visual impairment, pain in extremity, muscular weakness, ocular hyperaemia, eye swelling, arthralgia and headache.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Mobility decreased, Paraesthesia, Skin discolouration
Clinical narrative: Stark coloration differences in both hands, with fingers beyond first knuckle pale yellow and back of hand deep red, looking like images of Raynaud's. Numbness and loss of dexterity in both hands, to the point that it took more than 5 minutes to unbutton one button.  Onset with cold; duration of 30-45 minutes. This was on 3/21/21. On 3/22/21 coloration changes returned with tingling in left hand but normal dexterity. Duration approximately 10 minutes but repeated episodes throughout day. Perhaps entirely unrelated to vaccine -- second vaccine was 3/13/21 and nothing like this happened after first vaccine on 2/13/21.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site infection, Injection site swelling
Clinical narrative: Pt received Covid vaccine injection in L Arm on Thursday 1/28/21. It became red and swollen so she had it evaluated at ED, was told injection site was not properly cleaned and was placed on an antibiotics (changed 1x d/t ineffectiveness). She reports redness has decreased but swelling remains, no other side effects noted.. Encouraged patient to submit a patient report through our website and assured her I would also submit a report. Pt declined FU assessment with provider. Agreed to phone call check in ~1 week. flag placed for follow up. Report submitted.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Laboratory test, Rectal haemorrhage
Clinical narrative: RECTAL BLEEDING AND EASILY BRUISING NOTED IN THE LAST 2 DAYS
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash on the back of my neck, chest and the back of my right hand
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Pain
Clinical narrative: left arm itches where the injection took place. No redness, soreness for over a week, but itchy.