chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Incomplete course of vaccination, Injection site cellulitis, Injection site pain, Injection site warmth
Clinical narrative: Developed cellulitis at injection site; Developed / at injection site / warm; Pt refused 2nd dose (1st dose given 7/15/20); Developed / at injection site / Pain since injection; This case was reported by a nurse via sales rep and described the occurrence of injection site cellulitis in a 64-year-old male patient who received Herpes zoster (Shingrix) (batch number 97C2S, expiry date unknown) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 15th July 2020, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On 15th July 2020, immediately after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the patient experienced injection site cellulitis, injection site warmth and incomplete course of vaccination. The patient was treated with cephalexin (Keflex). On an unknown date, the outcome of the injection site cellulitis, injection site pain and injection site warmth were recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the injection site cellulitis, injection site pain and injection site warmth to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable for 2nd dose. The patient received 1st dose of Shingrix and less than a week after receiving Shingrix, developed cellulitis at injection site. On 22nd July 2020, the nurse called, the patient stated pain since injection, warm and treated for cellulitis with Keflex for 10 days. The nurse stated that the infection (adverse events) resolved. The patient refused the 2nd dose and till the time of reporting, did not received it, which led to incomplete course of vaccination.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Lacrimation increased, Ocular hyperaemia, Ophthalmic herpes zoster
Clinical narrative: left eye was red; increased tearing; after first dose / developed shingles in her left eye; This case was reported by a consumer and described the occurrence of ophthalmic herpes zoster in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In November 2020, the patient received the 1st dose of Shingrix. On an unknown date, between 2 and 3 months after receiving Shingrix, the patient experienced ophthalmic herpes zoster (serious criteria GSK medically significant), eye red and lacrimation increased. The patient was treated with ophthalmologicals (nos) (Eye Drops (Ingredients Unknown)). On an unknown date, the outcome of the ophthalmic herpes zoster, eye red and lacrimation increased were recovered/resolved.   It was unknown if the reporter considered the ophthalmic herpes zoster, eye red and lacrimation increased to be related to Shingrix.  Additional details were provided as follows: This case was reported by patient herself. Around 5 months back, the patient received 1st dose of Shingrix and about 2 to 3 months after the 1st dose of Shingrix, she developed shingles in her left eye and the symptoms were her left eye was red with increased tearing. The patient stated there was no blister in the eye. The physician started her on eye drops, the patient did not remember the names. After about 2 weeks the shingles in her eye resolved. The patient stated she had not had shingles before, and she was shortly due for the 2nd dose. The reporter consented to follow-up. For 2nd and 3rd outbreak refer case US2021AMR078994 and US2021AMR078995 respectively, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR078994:same reporter (2nd outbreak) US-GLAXOSMITHKLINE-US2021AMR078995:same reporter (3rd outbreak)
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Herpes zoster, Lacrimation increased, Ocular hyperaemia, Ophthalmic herpes zoster
Clinical narrative: left eye was red; increased tearing; after first dose / developed shingles in her left eye; This case was reported by a consumer and described the occurrence of ophthalmic herpes zoster in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In November 2020, the patient received the 1st dose of Shingrix. On an unknown date, between 2 and 3 months after receiving Shingrix, the patient experienced ophthalmic herpes zoster (serious criteria GSK medically significant), eye red and lacrimation increased. The patient was treated with ophthalmologicals (nos) (Eye Drops (Ingredients Unknown)). On an unknown date, the outcome of the ophthalmic herpes zoster, eye red and lacrimation increased were recovered/resolved.   It was unknown if the reporter considered the ophthalmic herpes zoster, eye red and lacrimation increased to be related to Shingrix.  Additional details were provided as follows: This case was reported by patient herself. Around 5 months back, the patient received 1st dose of Shingrix and about 2 to 3 months after the 1st dose of Shingrix, she developed shingles in her left eye and the symptoms were her left eye was red with increased tearing. The patient stated there was no blister in the eye. The physician started her on eye drops, the patient did not remember the names. After about 2 weeks the shingles in her eye resolved. The patient stated she had not had shingles before, and she was shortly due for the 2nd dose. The reporter consented to follow-up. For 2nd and 3rd outbreak refer case US2021AMR078994 and US2021AMR078995 respectively, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR078994:same reporter (2nd outbreak) US-GLAXOSMITHKLINE-US2021AMR078995:same reporter (3rd outbreak)
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Lacrimation increased, Ocular hyperaemia, Ophthalmic herpes zoster
Clinical narrative: second episode of shingles in her left eye; This case was reported by a consumer and described the occurrence of ophthalmic herpes zoster in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, between 2 and 4 months after receiving Shingrix, the patient experienced ophthalmic herpes zoster (serious criteria GSK medically significant). The patient was treated with ophthalmologicals (nos) (Eye Drop Medication {Nos}). On an unknown date, the outcome of the ophthalmic herpes zoster was recovered/resolved.   It was unknown if the reporter considered the ophthalmic herpes zoster to be related to Shingrix.  Additional details were provided as follows: Age at vaccination was not reported. The patient  received the first dose of Shingrix vaccine around 5 months back and was shortly due for the second dose.  The patient stated that about 2 to 3 months after the first dose of Shingrix vaccine, she developed shingles in her left eye and the symptoms were her left eye was red with increased tearing; refer case US2021075982. The patient stated that there was no blister in the eye. The doctor started her on eye drops after about 2 weeks the shingles in her eye resolved.  Again after a month, she was diagnosed with second episode of shingles in her left eye and the doctor started her on eye drops and it resolved. For 3rd shigles outbreak, refer case US2021AMR078995. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021075982:same reporter (1stnd outbreak) US-GLAXOSMITHKLINE-US2021AMR078995:same reporter (3rd outbreak)
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Herpes zoster, Lacrimation increased, Ocular hyperaemia, Ophthalmic herpes zoster
Clinical narrative: second episode of shingles in her left eye; This case was reported by a consumer and described the occurrence of ophthalmic herpes zoster in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, between 2 and 4 months after receiving Shingrix, the patient experienced ophthalmic herpes zoster (serious criteria GSK medically significant). The patient was treated with ophthalmologicals (nos) (Eye Drop Medication {Nos}). On an unknown date, the outcome of the ophthalmic herpes zoster was recovered/resolved.   It was unknown if the reporter considered the ophthalmic herpes zoster to be related to Shingrix.  Additional details were provided as follows: Age at vaccination was not reported. The patient  received the first dose of Shingrix vaccine around 5 months back and was shortly due for the second dose.  The patient stated that about 2 to 3 months after the first dose of Shingrix vaccine, she developed shingles in her left eye and the symptoms were her left eye was red with increased tearing; refer case US2021075982. The patient stated that there was no blister in the eye. The doctor started her on eye drops after about 2 weeks the shingles in her eye resolved.  Again after a month, she was diagnosed with second episode of shingles in her left eye and the doctor started her on eye drops and it resolved. For 3rd shigles outbreak, refer case US2021AMR078995. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021075982:same reporter (1stnd outbreak) US-GLAXOSMITHKLINE-US2021AMR078995:same reporter (3rd outbreak)
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Lacrimation increased, Ocular hyperaemia, Ophthalmic herpes zoster
Clinical narrative: second episode /it resolved / recently she has a third episode of shingles in her eye; This case was reported by a consumer and described the occurrence of ophthalmic herpes zoster in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, between 3 and 5 months after receiving Shingrix, the patient experienced ophthalmic herpes zoster (serious criteria GSK medically significant). The patient was treated with trifluridine and timolol. On an unknown date, the outcome of the ophthalmic herpes zoster was unknown.   It was unknown if the reporter considered the ophthalmic herpes zoster to be related to Shingrix.  Additional details were provided as follows: Age at vaccination was not reported. The patient received the first dose of Shingrix vaccine around 5 months back and was shortly due for the second dose.  The patient stated that about 2 to 3 months after the first dose of Shingrix vaccine, she developed shingles in her left eye and the symptoms were her left eye was red with increased tearing; refer case US2021075982. The patient stated that there was no blister in the eye. The doctor started her on eye drops after about 2 weeks the shingles in her eye resolved.  Again after a month, she was diagnosed with second episode of shingles in her left eye and the doctor started her on eye drops and it resolved refer case: US2021AMR078994. Again recently the patient had a third episode of shingles in her eye and was being treated with Trifluridine eye drop twice a day and timolol eye drops twice a day. The patient stated she had not had shingles before. The patient did not have the lot no of the Shingrix vaccine. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021075982:same reporter (3rd outbreak) US-GLAXOSMITHKLINE-US2021AMR078994:same reporter (3rd outbreak)
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Herpes zoster, Lacrimation increased, Ocular hyperaemia, Ophthalmic herpes zoster
Clinical narrative: second episode /it resolved / recently she has a third episode of shingles in her eye; This case was reported by a consumer and described the occurrence of ophthalmic herpes zoster in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, between 3 and 5 months after receiving Shingrix, the patient experienced ophthalmic herpes zoster (serious criteria GSK medically significant). The patient was treated with trifluridine and timolol. On an unknown date, the outcome of the ophthalmic herpes zoster was unknown.   It was unknown if the reporter considered the ophthalmic herpes zoster to be related to Shingrix.  Additional details were provided as follows: Age at vaccination was not reported. The patient received the first dose of Shingrix vaccine around 5 months back and was shortly due for the second dose.  The patient stated that about 2 to 3 months after the first dose of Shingrix vaccine, she developed shingles in her left eye and the symptoms were her left eye was red with increased tearing; refer case US2021075982. The patient stated that there was no blister in the eye. The doctor started her on eye drops after about 2 weeks the shingles in her eye resolved.  Again after a month, she was diagnosed with second episode of shingles in her left eye and the doctor started her on eye drops and it resolved refer case: US2021AMR078994. Again recently the patient had a third episode of shingles in her eye and was being treated with Trifluridine eye drop twice a day and timolol eye drops twice a day. The patient stated she had not had shingles before. The patient did not have the lot no of the Shingrix vaccine. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021075982:same reporter (3rd outbreak) US-GLAXOSMITHKLINE-US2021AMR078994:same reporter (3rd outbreak)
Sex: U
Vaccine: TDAP
Symptoms: Incorrect route of product administration
Clinical narrative: administration via IV administration versus IM administration; This case was reported by a pharmacist via call center representative and described the occurrence of intramuscular formulation administered by other route in a patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe (batch number Unknown, expiry date unknown) for prophylaxis.   On 7th April 2021, the patient received Boostrix (intravenous) and Boostrix Pre-Filled Syringe Device. On 7th April 2021, unknown after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced intramuscular formulation administered by other route. On 7th April 2021, the outcome of the intramuscular formulation administered by other route was not recovered/not resolved.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: The age at vaccination was not applicable for this report. The pharmacy manager reported that Boostrix vaccine was administered via Intravenous administration instead Intramuscular administration, which led to intramuscular formulation administered by other route. At the time of call, the patient was in Emergency room( ER ) at hospital. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Erythema, Incomplete course of vaccination, Joint swelling
Clinical narrative: swelling in the shoulder and elbow; redness in the shoulder and elbow; pain in the shoulder and elbow; is late for the second dose of Shingrix / first dose was administrated 1 year ago; This case was reported by a physician via call center representative and described the occurrence of swelling of elbows in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced swelling of elbows, localized erythema, shoulder pain and incomplete course of vaccination. On an unknown date, the outcome of the swelling of elbows, localized erythema and shoulder pain were recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the swelling of elbows, localized erythema and shoulder pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported for 1st dose and was not applicable for 2nd dose. The patient received 1st dose of Shingrix a year ago and experienced swelling, redness and pain in shoulder and elbow. The patient had recovered from all symptoms. The physician started that the patient was late for the 2nd dose of Shingrix and till the time of reporting, the patient did not receive 2nd dose, which led to incomplete course of vaccination. No other information was provided. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Myalgia, Pyrexia
Clinical narrative: achy muscles; joint pain; fever; This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th April 2021, the patient received the 1st dose of Shingrix. On 6th April 2021, less than a week after receiving Shingrix, the patient experienced muscle pain, joint pain and fever. On an unknown date, the outcome of the muscle pain, joint pain and fever were not recovered/not resolved.   It was unknown if the reporter considered the muscle pain, joint pain and fever to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient. The age at vaccination was not reported. The patient had achy muscles, joint pain and fever, which was not yet resolved till the time of reporting. The patient did not consent to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Feeling abnormal, Influenza like illness, Injection site pain, Pain in extremity
Clinical narrative: Described it as "kicking his butt"; Sore at the injection site; Second day his arm hurt more; He felt flu like for a day; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In November 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced injection site pain, pain in arm, influenza-like symptoms and feels awful. On an unknown date, the outcome of the injection site pain, pain in arm, influenza-like symptoms and feels awful were recovered/resolved.   It was unknown if the reporter considered the injection site pain, pain in arm, influenza-like symptoms and feels awful to be related to Shingrix.  Additional details were provided as follows: The patient had reported the case for himself. The age at vaccination was not reported. The patient received 1st dose of Shingrix prior to the pandemic and was sore at the injection site and the 2nd day his arm hurt more, and it took 3 to 4 days to resolve. The patient also reported that he felt flu like for a day and he described it as kicking his butt.    The patient mentioned that he had received the flu short for over 65 patients within 3 to 4 weeks of the Shingrix vaccine, however, he could not confirm which vaccine he received first. The reporter did not consent to follow-up. For tolerance of 2nd dose and Flu vaccine, refer case US2021AMR080315 and US2021AMR080271, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR080271:Same reporter. US-GLAXOSMITHKLINE-US2021AMR080315:Same reporter.
Sex: U
Vaccine: FLUR4
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient administered an expired Flublok vaccine with no reported adverse event; Initial information received on 22-Mar-2021 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves patient (unknown demographics) who was vaccinated with an expired dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (expired product administered).  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot number and expiry date: not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  It was a case of actual medication error due to expired vaccine used (latency on same day).  It was also reported that they administered an expired Flublok vaccine and want to know what to do. He wanted to know if we had any treatment recommendations for the patient because he said he knows the patient will ask. This is all the information he provided at the time of his call. Reporter relationship: HCP (health care professional)  At the time of report, no adverse event was reported.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pyrexia, Tremor
Clinical narrative: Shaking uncontrollably. Feverish still
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Illness, Tremor
Clinical narrative: Shaking uncontrollably. Feverish still
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Fatigue, Feeling hot, Influenza like illness
Clinical narrative: Day of shot - extreme nausea.  First night - no sleep due to waves of shivers/chills and then fever and overheating. Shortness of breathe Day after shot - fatigue; some flu-like symptoms Day 2 after shot - fatigue and shortness of breathe
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Sleep disorder
Clinical narrative: Day of shot - extreme nausea.  First night - no sleep due to waves of shivers/chills and then fever and overheating. Shortness of breathe Day after shot - fatigue; some flu-like symptoms Day 2 after shot - fatigue and shortness of breathe
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: When presented to clinic for dose #2 she states that shortly after dose #1 she had numbness on the left side of her face extending down her left arm.  The numbness lasted approx 3 hours.  Her PCP did recommend she receive dose #2.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Gait disturbance, Headache, Hypersensitivity, Myalgia
Clinical narrative: I began having a really bad allergic reaction and I was itching all over my body. That same night I began having a horrible headache, and my muscles and joints began aching and hurting. It felt like I was holding a two ton rock over my head when I would try to walk. I took Benadryl and used Sarna lotion for the itching, and took tylenol for the headache and muscle aches. IF symptoms don't subside, then I will visit the clinic at my job to be treated and see what they could recommend.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: I began having a really bad allergic reaction and I was itching all over my body. That same night I began having a horrible headache, and my muscles and joints began aching and hurting. It felt like I was holding a two ton rock over my head when I would try to walk. I took Benadryl and used Sarna lotion for the itching, and took tylenol for the headache and muscle aches. IF symptoms don't subside, then I will visit the clinic at my job to be treated and see what they could recommend.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Fatigue, Headache, Injection site pain
Clinical narrative: Headache, pain where the vaccine was inoculated, tiredness/fatigue, pain in the back
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Postmenopausal haemorrhage, Ultrasound uterus normal, Uterine spasm
Clinical narrative: I received my first dose on 2/08. I started my period 10 days later. I have been in menopause for a year with only one very short period of bleeding. I did not stop bleeding despite treatment by my OBGYN. I received my second dose on 3/22 and the bleeding became more severe. I again did not stop bleeding despite treatment by my OBGYN. It is 4/12 and I have just stopped bleeding. All bleeding was accompanied by severe uterine cramps.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Loss of personal independence in daily activities
Clinical narrative: Extreme fatigue. Feel better when lying down. Can only be upright and active for about an hour or so before needing to lie down again.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Feeling hot, Pallor, Unresponsive to stimuli
Clinical narrative: Patient felt warmth in his arm and became faint. He had his eyes open and remained sitting, but became pale and not responding appropriately. He was reclined with his feet up, cold cloth and returned to normal rather quickly.  His vitals were withing normal limits, drank water, was observed x 30 minutes. His mother, who was present the entire episode, stated he has had a sililar reaction to a previous routine vaccine. Instructed to contact Primary Care MD to discuss further immunizations. Patient walked out with his mother feeling fine.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Injection site pain, Pyrexia, Vertigo
Clinical narrative: Initially, had pain and soreness at the injection site. Within 12 hours, developed a low grade fever (99.6) and fatigue. At around 8pm started to feel dizziness and by 9pm was experiencing severe vertigo (feeling like the room was wrenching violently to the right, not just spinning) and near constant dizziness. I was advised by the nurses who administered the vaccine to "over-hydrate" which I have been doing since leaving the Vaccination Pod; hydrating has had no positive effect on the vertigo.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Confusional state, Dizziness, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Feeling abnormal, Injection site pain, Pain
Clinical narrative: Sore injection site after vaccine; no other symptoms same-day. The morning after (04/12), woke up with chills, body aches, skin very sensitive to pressure, minor brain fog, minor body weakness. Possibly a fever overnight.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Sensitive skin
Clinical narrative: Sore injection site after vaccine; no other symptoms same-day. The morning after (04/12), woke up with chills, body aches, skin very sensitive to pressure, minor brain fog, minor body weakness. Possibly a fever overnight.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Chromaturia, Flank pain
Clinical narrative: Dark urine post-vaccination on first void and on second void 2 hours later followed by severe bilateral flank pain that lasted approximately 48 hours following vaccination.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Headache, Nausea
Clinical narrative: Nausea, headache, dizziness, chills
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Injection site pain, Myalgia, Pain
Clinical narrative: COVID-19 Vaccine EUA About 12 hours after injection of vaccine I started to get a head ache; and about 16 hours after injection I started to get full body aches (mostly muscle) especially at injection site.  Body aches lasted a full 24 hours after they started,
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature increased, Chills, Fatigue, Heart rate increased
Clinical narrative: SORE ARM, EXHAUSTED ON SATURDAY. SUNDAY MORNING TEMP OF 102, NAUSEA, CHILLS, JOINT PAIN ITCHING LEFT NECK AND LEFT FACE FAST HEART RATE (102 AT REST NORMAL IS 60 AT REST) CONTINUED TO MONDAY MORNING.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity, Pruritus
Clinical narrative: SORE ARM, EXHAUSTED ON SATURDAY. SUNDAY MORNING TEMP OF 102, NAUSEA, CHILLS, JOINT PAIN ITCHING LEFT NECK AND LEFT FACE FAST HEART RATE (102 AT REST NORMAL IS 60 AT REST) CONTINUED TO MONDAY MORNING.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Pain, Palpitations
Clinical narrative: Short term side effects:  fatigue, achy, dizziness. Experiencing heart palpitations
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Deafness unilateral, Ear discomfort, Tinnitus
Clinical narrative: The day receiving the second dose I began to have problems in my ears . They felt plugged and there was a ringing in both . It gradually worsened for the remainder of that day and the next . Currently I have no hearing in my left ear . The ear feels plugged but I am unable to clear it . It has a ringing noise within the ear that is constant . The doctor observed no wax build up or infection and said the looks great . Prescribed steroids . The ringing has not stopped and there is very little hearing on the left side .
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Confusional state, Memory impairment
Clinical narrative: Confusion, forgetfulness, still going on now  (4-12-2021)
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Blindness, Retinal detachment, Retinal operation
Clinical narrative: Patient received Moderna vaccination on 3/11 and was starting to lose vision like a curtain coming across his eye. Made appointment with Doctor and he determined it was a detached retina.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Hot flush, Pain in extremity
Clinical narrative: Sore arm, hot flashes. Approximately 4 hot flashes over 24 hours
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Vaccine administration error, Moderna is licensed for 18 and up and this person is 16 years old.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Spinal pain
Clinical narrative: Chills, extremely sore joints, entire spinal pain, extreme fatigue. Soreness lasted and fatigue lasted 24 jours
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: I remember right after the shot, during the 15 minutes I had to sit and wait before leaving the vaccine location, I asked my husband if it itched where he got the shot.  His did not and for me it only lasted a minute or so.  It did not itch when we left.  About 4 hours later, I noticed my arm was red around the injection site, probably a 1 inch diameter.  It was very warm, sore to the touch and hard.  The next morning, the redness had spread to a n oval shape and was about 3 inches long and 2" tall.  It is now  60 hours since getting the shot and it is still sore, hard, but not is red, although still visible.  It has itched some but not constant itching.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Hyperhidrosis, Lymphadenopathy, Pain
Clinical narrative: Soreness in shoulder.  Chills/sweating/body aches.  Swollen lymph node in left arm.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Hypokinesia, Joint noise
Clinical narrative: All the fingers on my left hand, of the arm that got the shot) began popping constantly after the first vaccine and have continued to do so every since the first shot. It seems to have negatively impacted the joints of the fingers only on that hand. This is impacting my playing the piano, and I regularly play piano for church services. To date there has been no improvement. My fingers have been doing this continuously since my first shot on March 11.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Breast engorgement, Breast tenderness, Chills, Epistaxis, Fatigue
Clinical narrative: Chills, low grade temperature, headache, very tired, arm soreness for days, body aches, bloody nose(the day after vaccine I had pinkish discharge from left side of nose that lasted 8 days. On day 11 I had a bloody nose on right side that took approx 15 minutes to stop. Also starting day after vaccine,  breast tenderness and fullness in both breasts..have had this everyday since and still have this.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Gaze palsy, Pain, Pain in extremity, Pyrexia
Clinical narrative: Chills, low grade temperature, headache, very tired, arm soreness for days, body aches, bloody nose(the day after vaccine I had pinkish discharge from left side of nose that lasted 8 days. On day 11 I had a bloody nose on right side that took approx 15 minutes to stop. Also starting day after vaccine,  breast tenderness and fullness in both breasts..have had this everyday since and still have this.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Projectile vomiting over several hours
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: patient came in several weeks after the first dose to complain of pain in her arm stating that she saw her doctor and may need to get an mri. patient came in for second dose and said she felt better but some pain was still there. has not gotten  mri yet.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspepsia, Rash, Rash erythematous, Rash macular, Rash pruritic
Clinical narrative: I developed a rash (red splotchy marks on my skin) that started localized under my arms in the arm pit region. I noticed it during my daily shower on 4/9. It was very itchy and then overnight it seemed to spread to other parts of my body including my back, back of my legs behind my knee, upper groin area, down to the tops of my feet and even the palms of my hand were very itchy as well as between my fingers. Basically only my face/head/neck were NOT affected.   Over the next couple of days the rash continued to subside temporarily but then with itching, it would return.   Finally, I am not sure if it is related but I had heart burn like symptoms over night on 4/9 and again on 4/10. That could be a coincidence but I only suffer from heart burn about once every 3 months so it seems strange that I would have it on back to back nights.   This all occurred just over 2 weeks from my vaccination so I thought it might have another cause but I could not figure out another possible explanation for it. I also took pictures if that would be helpful to see.
Age: 34.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood test normal, Fatigue, Incomplete course of vaccination, Neuralgia, Paraesthesia
Clinical narrative: 2-4 hours after the injection experienced ulnar nerve pain and paraesthesia, tingles and pins and needles sensation in pinky and ring finger of the right (injection side) hand. Over the course of 6 days the paraesthesia spread distally to both hands and feet and cheeks. Symptoms persist at day 38 accompanied by mild fatigue. Per my Dr's recommendation I've skipped the second dose. Reading a lot of folks online are experiencing tingles, paraesthesias and similar side effects. Worried that this may be  nerve damage or cause chronic peripheral neuropathy. Completely healthy with no known medical issues prior to vaccination other than food allergies to certain seafood as a child.
Age: 34.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia
Clinical narrative: 2-4 hours after the injection experienced ulnar nerve pain and paraesthesia, tingles and pins and needles sensation in pinky and ring finger of the right (injection side) hand. Over the course of 6 days the paraesthesia spread distally to both hands and feet and cheeks. Symptoms persist at day 38 accompanied by mild fatigue. Per my Dr's recommendation I've skipped the second dose. Reading a lot of folks online are experiencing tingles, paraesthesias and similar side effects. Worried that this may be  nerve damage or cause chronic peripheral neuropathy. Completely healthy with no known medical issues prior to vaccination other than food allergies to certain seafood as a child.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose increased, Cerebrovascular accident, Computerised tomogram head normal, Death, Dysphagia
Clinical narrative: Death by clot
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Gastrointestinal tube insertion, Neurological symptom, Surgery, Thrombosis, Unresponsive to stimuli
Clinical narrative: Death by clot
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Discomfort, Eye pain, Fatigue
Clinical narrative: April 9 Morning: woke up with a mild headache. April 9 Afternoon (12 pm): feeling fatigued and headache grew worse. Plus chills. April 9 (5pm): feeling very cold and tired (worse than noon) April 9 (11:30pm): This time was the most severe for me in respect to side effects. I believe my headache woke me up. The headache was so bad that my eyes hurt as well (swollen almost). I think my fever broke. I felt very ?heavy? all over. The main concern was that around midnight I was having sharp pains on the right side of my body, near where my Liver is located. That was one effect that I did not read about. The sharp pains happened once every few minutes. I considered going to the ER but wasn?t sure. I ended up just changing my shirt, got some water, and went back to bed.  April 10: My appetite was not normal, I ate but very little. The sharp pain on my right side went away but I had a minor headache for the rest of the day.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling cold, Headache, Pain, Sleep disorder
Clinical narrative: April 9 Morning: woke up with a mild headache. April 9 Afternoon (12 pm): feeling fatigued and headache grew worse. Plus chills. April 9 (5pm): feeling very cold and tired (worse than noon) April 9 (11:30pm): This time was the most severe for me in respect to side effects. I believe my headache woke me up. The headache was so bad that my eyes hurt as well (swollen almost). I think my fever broke. I felt very ?heavy? all over. The main concern was that around midnight I was having sharp pains on the right side of my body, near where my Liver is located. That was one effect that I did not read about. The sharp pains happened once every few minutes. I considered going to the ER but wasn?t sure. I ended up just changing my shirt, got some water, and went back to bed.  April 10: My appetite was not normal, I ate but very little. The sharp pain on my right side went away but I had a minor headache for the rest of the day.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Ringing in ears
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Discomfort, Dizziness, Nausea
Clinical narrative: Nauseous,  chills, body aches, dizziness, diarrhea,  sleepiness, body heaviness
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Somnolence
Clinical narrative: Nauseous,  chills, body aches, dizziness, diarrhea,  sleepiness, body heaviness
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Dry mouth, Paraesthesia, Vision blurred
Clinical narrative: Dry mouth, tingling in face, slight blurry vision (anxiety)
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Dermatitis, Pruritus, Urticaria
Clinical narrative: Hives, I Have taken antihistamines for this, they have reduced the itchiness and inflammation, but the symptoms are still occurring
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Chills, Pain
Clinical narrative: 2 days Chills aches...very weak
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: Horrible Migraine that has not responded to treatment
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Dental discomfort, Fatigue, Hypoaesthesia, Pain in extremity, Thirst
Clinical narrative: Topical numbness of forehead, nose, and top front teeth.  Forehead and tooth numbness Adverse symptoms resolved within 18 hours (not noticeable next morning when I woke up at 7 a.m.).  Nose numbness duller but persisted for about 24 hours after onset. Numbness can be described akin to Novocain.   Additional (common symptoms): Fatigue and thirst on set about 2 hours after injection.  Sore arm after about 6 hours of injection. Sore arm persisted for about 4 days.  Of note:  NO loss of taste or smell. NO fever.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient was only 17 at time of vaccination.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: Very high fever that lasted over 12 hours. Came with major chills.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Musculoskeletal stiffness
Clinical narrative: Pain at the injection site for about 2 days after the shot. No treatment was administered.  The pain went away on its own after 2 days.   Almost immediately after noticing that the pain from the infection site was gone, I began to notice a soreness/ache/stiffness in the area of my right elbow. This ache, which is very similar to the initial pain at the injection site, has continued since the first injection. I just received my second injection yesterday morning.   I've been hoping that the soreness will go away eventually. No treatment has been given at this time. I am planning to give it some more time to go away. If the ache continues to linger much longer,  I will see my primary care physician.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dry throat, Headache, Nausea, Pyrexia
Clinical narrative: Headache, fever, nausea, dry throat, mild cough
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: About an hour after the shot, I began hearing a faint ringing in my right ear.  It is very low volume, but it is there.  It now occurs about every 2 hours and the ringing lasts for only about 15 seconds before going away again.   This does not happen in my left ear.   The tone of the ringing is equivalent to a C4 on a piano.  It is not harsh, and sounds like a synthesizer tone.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache, Nausea, Pain
Clinical narrative: Saturday- had severe headache and nauseous  Sunday- had body aches and tiredness Monday-dizziness or vertigo with nauseous
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache
Clinical narrative: Minor chills the night of shot #2. Headache and exhaustion the day after. By day 3, I was feeling back up to 90% and been feeling fine since.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Joint swelling, Mobility decreased, Pain in extremity
Clinical narrative: Pain and swelling in joints of left hand making movement difficult. Low level pain in right armpit. Both symptoms are currently present.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Dehydration, Hyperhidrosis, Loss of consciousness, Pallor, Presyncope
Clinical narrative: Pt was sitting in chair approximately 15 minutes following receiving the vaccine. he became unconscious, pale and sweaty. I checked and he had a pulse and was breathing and we called 911. I was able to yell at him and he regained consciousness and could tell me his name, date of birth and other info. He was able to grab my hand and squeeze. he said he he had been dehydrated and had had covid before. we gave him Gatorade and he felt better.  paramedics checked him out and said most likely a vasovagal response. pt refused transport to hospital. his mother came and got him and was going to monitor
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Skin mass, Tinnitus, Urticaria
Clinical narrative: Within 30 minutes I had a headache, fatigue that lasted 2 days. I had small hives on my face starting day 2 lasting 2 days. I had a lump behind left ear that lasted 5 days. I have had ringing in my ears, louder in the left ear, since the injection, for 2 weeks now. It is quite loud and annoying. I have recovered from all side effects except the ear ringing.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Swollen tongue
Clinical narrative: Swollen lower lip and tongue 15 minutes after shot. Benadryl every 12 hours is managing the situation
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Dysuria, Escherichia infection, Haematuria, Kidney infection
Clinical narrative: UTI progressing to kidney infection (burning with urination, increased frequency of urination, back pain), progressively worsening from Saturday until 1.5 days after beginning antibiotics.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Pollakiuria, Proteinuria, Urinary tract infection, Urine analysis abnormal
Clinical narrative: UTI progressing to kidney infection (burning with urination, increased frequency of urination, back pain), progressively worsening from Saturday until 1.5 days after beginning antibiotics.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Fatigue, Headache, Pain
Clinical narrative: 1st dose 3/6/2021: large red welt that was itchy, hot to the touch, raised and very painful. Lasted about a week. I also has fatigue for several days after.  2nd dose 4/9/2021: same symptoms as first dose but the day after I had a headache, mild body aches, chills and fatigue.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: It's been 11 days and injection site is swelling and red, feels like a bee sting.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Fatigue, Headache, Oropharyngeal pain, Rhinorrhoea
Clinical narrative: headache, runny nose, fatigue, sore throat.,
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: headache, runny nose, fatigue, sore throat.,
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Rash, Skin warm
Clinical narrative: my arm has a big bump it is hot to the touch and painful. It started as 2 bumps that looked like a bee sting or bite. Then by Saturday 4/10/21 it was one big bump. I believe it is called the covid arm.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Chills, fatigue; redness, swelling, and itching at injection site lasting days after injection
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Dizziness, Fatigue, Gait disturbance, Headache
Clinical narrative: Vomiting, headache, dizziness, need assistance walking to bathroom,  exhaustion . Joint pain throughout spine and feet. Tylenol did not improve symptoms. Lasted all day on day following second injection.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vomiting
Clinical narrative: Vomiting, headache, dizziness, need assistance walking to bathroom,  exhaustion . Joint pain throughout spine and feet. Tylenol did not improve symptoms. Lasted all day on day following second injection.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Musculoskeletal stiffness, Nausea, Pyrexia
Clinical narrative: NAUSEA SEVERE HEADACHE STIFF MUSCLES (ENTIRE BODY) FEVER CHIVERS (ABOUT 2 HOURS)
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Diarrhoea, Headache, Nausea
Clinical narrative: Chills, fever, joint pain, headache, nauseau, diarrahea all started about 7 hours after the shot.  Lasted for about 9 hours.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Chills, fever, joint pain, headache, nauseau, diarrahea all started about 7 hours after the shot.  Lasted for about 9 hours.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Rash erythematous, Rash papular, Vaccination site rash, Vaccination site reaction
Clinical narrative: Extreme pain in arm for 2.5 days. Rash at vaccine site, 3-4 inches wide raised red itchy bumps, 8 days after vaccination.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Extreme pain in arm for 2.5 days. Rash at vaccine site, 3-4 inches wide raised red itchy bumps, 8 days after vaccination.