chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Seizure
Clinical narrative: Seizure and Allergic reaction
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Loss of consciousness, Vision blurred
Clinical narrative: blurred vision, dizzeness, passed out  went to hospital by ambilance heart rate was 40
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain in extremity, Pyrexia
Clinical narrative: 10 hours after injection strong pain in the left arm.   Lasted 3 days. fever, chills 2nd night, low grade fever.  lasted about 8 hours then ceased. General tiredness for 2-3 days
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Anosmia, Arthralgia, Body temperature decreased, Headache, Influenza virus test
Clinical narrative: aches and pains (headache/hips), fever (101.6), loss of smell, nausea, low temp (95.5)
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, SARS-CoV-2 test
Clinical narrative: aches and pains (headache/hips), fever (101.6), loss of smell, nausea, low temp (95.5)
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Muscular weakness, Pain
Clinical narrative: 18 hours after the shot I had chills, fatigue, headache, muscle weakness, aches and pains. This lasted all day. The next day I was fine, but would tire easily by about 4pm for about a week.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Blood test, Injection site pain, Loss of personal independence in daily activities, Pain, X-ray limb abnormal
Clinical narrative: I received my flu vaccine on 12/1/2020 and have had upper right arm pain ever since.  I did not have arm pain before receiving the shot.  I had pain on the day I received the vaccine and ever since the pain has continued to get worse.  I have difficulty removing clothing and also have pain with most movements of the arm.  Because I am right side dominant, this has also affected my left side as I have over-compensated using my left arm more.  I have used home remedies such as Aleve, Advil, Tylenol, heating pad, topical creams with very little relief. I had a shoulder x-ray that did not show anything but mild arthritis.  Was sent to PT which provided little help.  Finally saw a MD  for face-to-face consultation. I was prescribed Cymbalta which hasn't help with the pain as I am not able to take a 30mg tablet and work.  The medication makes me extremely tired and yet does not take the pain away. This has been VERY frustrating as it has affected my day to day living/activities and work.  I have received a flu shot for the past 30+ years and have never had a reaction such as this.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blister, Cough, Erythema, Injection site rash, Lip swelling
Clinical narrative: Face red and hot. Lips red and swollen, blisters in mouth. Feet, hands, all over itchy. Cough, runny nose .Shot arm rash, both times. About 8 to 9 days after both shots, had full head to toe blisters. Had to seek out treatment from my DR. Was given 1 round of Methylprednisolone tabs. One week after still had rash. Put on anther cycle of same rx. At time of second shot still had small signs. Given 2nd shot, 8to 9 days same reaction. I am now into my 3rd round of same rx...and it has been one month since my second shot at time of this report.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Oral mucosal blistering, Pruritus, Rhinorrhoea, Skin warm
Clinical narrative: Face red and hot. Lips red and swollen, blisters in mouth. Feet, hands, all over itchy. Cough, runny nose .Shot arm rash, both times. About 8 to 9 days after both shots, had full head to toe blisters. Had to seek out treatment from my DR. Was given 1 round of Methylprednisolone tabs. One week after still had rash. Put on anther cycle of same rx. At time of second shot still had small signs. Given 2nd shot, 8to 9 days same reaction. I am now into my 3rd round of same rx...and it has been one month since my second shot at time of this report.
Age: 77.0
Sex: F
Vaccine: UNK
Symptoms: Death, SARS-CoV-2 test negative
Clinical narrative: Unknown Covid vaccine; no known side effects; postmortem Covid-19 test negative  Date of death:   02/22/2021
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Rash
Clinical narrative: At first I did not associate the rash to the COVID vaccine but have been hearing others reporting rash similar to mine.  It has been ongoing to quite some time now and it seems to be spreading.  I have a rash in my armpits and upper arms, on my trunk-back and front and on my Right forearm.  I am also noticing small bruises under my breast which occurred first and bumps on the sides of my breasts.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain in extremity
Clinical narrative: Sore arm since time of vaccination till next day; Chills developed at 10pm same day; Headache next day not alleviated with Excedrin
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Red, warm raised large circle extending 3 inches from injection sites. Itching. Occured on day 11 after the injection.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Diarrhoea, Dizziness, Vomiting
Clinical narrative: Vomiting  Diarrhea  Temp Weak Dizzy
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: Day of vaccine: Tiredness, headache, slept for 3 hrs Following evening: aches, fever, sore throat, coughing, can't sleep for 8 hours, wake up at 3:30 am.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Sleep disorder, Somnolence
Clinical narrative: Day of vaccine: Tiredness, headache, slept for 3 hrs Following evening: aches, fever, sore throat, coughing, can't sleep for 8 hours, wake up at 3:30 am.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Pain in extremity, Visual impairment
Clinical narrative: After the vaccine client started c/o seeing spots, feeling dizzy and "almost passing out". She was given water to drink, a snack and to relax. She was not given any medications. Vital signs stable. No problems since except a sore arm.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Erythema, Headache, Pain, Peripheral swelling
Clinical narrative: 2/25/21 swelling and redden around arm.  On 2/26/21 headache, body aches, chills and fever - 102.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: 2/25/21 swelling and redden around arm.  On 2/26/21 headache, body aches, chills and fever - 102.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Death, SARS-CoV-2 test negative
Clinical narrative: No known side effects; postmortem Covid-19 test negative  Date of death:  02/16/2021
Age: 65.0
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient was vaccinated for the second dose of COVID vaccine on the 21st day after receiving the first dose - Moderna recommends administering the vaccine at least 24 days apart
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain in extremity, Pyrexia
Clinical narrative: Chills, low grade fever(100.7), headache, sore arm
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain, Pruritus
Clinical narrative: Some pain on Day 2. Later Itching, large area of red   I made up the dose # because I don?t know it.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Eyelid oedema, Headache, Myalgia
Clinical narrative: While I did experience most of the common side effects - headache, chills, muscle aches, joint aches, short fever - I wanted to report a side effect that surprised me.  My eyelids became puffy and the area around my eyes was swollen and ached. My eyes were also very sensitive to light. This started on the morning of day 2 and is still lingering, but better, by day 4.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Periorbital swelling, Photophobia
Clinical narrative: While I did experience most of the common side effects - headache, chills, muscle aches, joint aches, short fever - I wanted to report a side effect that surprised me.  My eyelids became puffy and the area around my eyes was swollen and ached. My eyes were also very sensitive to light. This started on the morning of day 2 and is still lingering, but better, by day 4.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Musculoskeletal stiffness
Clinical narrative: Patient completed second COVID vaccine and stated had a headache and some neck stiffness, but overall is doing really well.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Fall, Seizure, Upper limb fracture
Clinical narrative: Patient's wife reported that he broke both of his shoulders four days after his first vaccine. He had a seizure and fell off the bed breaking his shoulders. No hx of seizures, TBI or stroke. His wife stated they were told by the PCP he could get the second dose of the vaccine.  None of these records are accessible by the vaccinating site. No known ED visit or hospitalization related to the event.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Headache, Pain
Clinical narrative: Extreme vertigo and headache  3 days after vaccine. I had headache, extreme fatigue, body aches, dizziness and chills for 24 hours after vaccine. Then felt ok. Work up on March 2 with extreme vertigo and exploding headache.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: Extreme vertigo and headache  3 days after vaccine. I had headache, extreme fatigue, body aches, dizziness and chills for 24 hours after vaccine. Then felt ok. Work up on March 2 with extreme vertigo and exploding headache.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Pain in extremity
Clinical narrative: Almost 2 weeks after injection I noticed a red spot the size of a quarter at my injection site - it was itchy.  The next morning my left arm ached and the red spot spread a little.  I was concerned due to length of time since shot.  Went to - doctor said it appeared to be a reaction to the injection and to use cortazone cream - no other symptoms at that time.  The red spot continued to spread over the next couple days to about the size of the palm of my hand, no more aching and then started to fade. This is day 6 I can still see the spot and slightly itchy but no other symptoms.  Odd that it would take so long to react.  I am allergic to some types of medical tape but at the time of injection they just used a band-aid.  Due for next injection March 13.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Injection site pruritus, Injection site rash, Muscle twitching, Paraesthesia
Clinical narrative: SEIZURE SYMPTOMS SOON AFTER. About 15 mins after I had early signs of focal aware seizure (aura) - pins and needles in the face, hands, feet, and very warm face.   (RASH AND ITCHING  AROUND INJECTION SITE NEXT DAY  AND ONGOING.  )  Slowly, twitching started sporadically lasting 1 - 3 seconds with 5 - 10 minutes in between. Length of twitching stayed the same but slowly became more often. I knew something was going to happen, so I did not want to go home not knowing if it would become more severe or when it would become severe.  As time wore on,  twitching and body movement increased especially in left thigh where a stronger seizure usually starts. In time,  it became almost constant with arm, shoulder and leg movement and then increased to sporadic whole body movement. Took Klonopin. Took about 15 - 20 minutes to take effect I was attended to by doctor and EMS.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Partial seizures
Clinical narrative: SEIZURE SYMPTOMS SOON AFTER. About 15 mins after I had early signs of focal aware seizure (aura) - pins and needles in the face, hands, feet, and very warm face.   (RASH AND ITCHING  AROUND INJECTION SITE NEXT DAY  AND ONGOING.  )  Slowly, twitching started sporadically lasting 1 - 3 seconds with 5 - 10 minutes in between. Length of twitching stayed the same but slowly became more often. I knew something was going to happen, so I did not want to go home not knowing if it would become more severe or when it would become severe.  As time wore on,  twitching and body movement increased especially in left thigh where a stronger seizure usually starts. In time,  it became almost constant with arm, shoulder and leg movement and then increased to sporadic whole body movement. Took Klonopin. Took about 15 - 20 minutes to take effect I was attended to by doctor and EMS.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Dry eye, Eye irritation, Eye pain, Eye pruritus
Clinical narrative: On 2/26/21 my left eye started to itch, burn, and the eye felt drier than normal. On 2/27/21 there was a noticeable red patch on the eyelid with small scaly looking spots, I assumed it to be a patch of dry skin. There was a 30 minute period of intense tingling pain and shooting/stabbing intermittent pain. There was also some numbness later on that day. Also on 2/27/21 I noticed a large lymphnode swelling on my jawline adjacent to my left ear. On 3/1/21 I saw my primary care provider and was diagnosed with shingles. After reviewing the preliminary symptoms of shingles, I had been experiencing abnormal fatigue and stomach upset for about 5 days prior to the eruption.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Eyelid disorder, Fatigue, Herpes zoster, Hypoaesthesia eye, Lymphadenopathy
Clinical narrative: On 2/26/21 my left eye started to itch, burn, and the eye felt drier than normal. On 2/27/21 there was a noticeable red patch on the eyelid with small scaly looking spots, I assumed it to be a patch of dry skin. There was a 30 minute period of intense tingling pain and shooting/stabbing intermittent pain. There was also some numbness later on that day. Also on 2/27/21 I noticed a large lymphnode swelling on my jawline adjacent to my left ear. On 3/1/21 I saw my primary care provider and was diagnosed with shingles. After reviewing the preliminary symptoms of shingles, I had been experiencing abnormal fatigue and stomach upset for about 5 days prior to the eruption.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Ophthalmological examination
Clinical narrative: On 2/26/21 my left eye started to itch, burn, and the eye felt drier than normal. On 2/27/21 there was a noticeable red patch on the eyelid with small scaly looking spots, I assumed it to be a patch of dry skin. There was a 30 minute period of intense tingling pain and shooting/stabbing intermittent pain. There was also some numbness later on that day. Also on 2/27/21 I noticed a large lymphnode swelling on my jawline adjacent to my left ear. On 3/1/21 I saw my primary care provider and was diagnosed with shingles. After reviewing the preliminary symptoms of shingles, I had been experiencing abnormal fatigue and stomach upset for about 5 days prior to the eruption.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dry throat, Feeling abnormal, Nausea, Paraesthesia oral
Clinical narrative: Patient called Health Dept 3/2/2021 at 9:30 am reporting reactions after receiving first Moderna vaccine on 2/26/21.  Patient received vaccine at approximately 10:20 am on 2/26/21.  She reports that a few minutes after receiving vaccine that her throat felt really dry.  It felt 'like when you wake up from anesthesia'.  She had no breathing problems so she didn't think much of it.  About an hour after receiving vaccine,  she went through a drive thru to order food and 'wasn't thinking right, like I had brain fog'.  That lasted a short time.  About an hour after receiving vaccine, patient noticed lips and mouth were tingling 'like I had ate something really spicy'.  This lasted off an on for about an hour.  Later that evening, patient felt dizzy and nauseated.  She laid down and took a nap and woke up feeling better.  Skin started to feel itchy that night.  On 2/27/21, patient woke up with an itchy rash all over back.  Rash is still there.  No other symptoms at this time.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash pruritic
Clinical narrative: Patient called Health Dept 3/2/2021 at 9:30 am reporting reactions after receiving first Moderna vaccine on 2/26/21.  Patient received vaccine at approximately 10:20 am on 2/26/21.  She reports that a few minutes after receiving vaccine that her throat felt really dry.  It felt 'like when you wake up from anesthesia'.  She had no breathing problems so she didn't think much of it.  About an hour after receiving vaccine,  she went through a drive thru to order food and 'wasn't thinking right, like I had brain fog'.  That lasted a short time.  About an hour after receiving vaccine, patient noticed lips and mouth were tingling 'like I had ate something really spicy'.  This lasted off an on for about an hour.  Later that evening, patient felt dizzy and nauseated.  She laid down and took a nap and woke up feeling better.  Skin started to feel itchy that night.  On 2/27/21, patient woke up with an itchy rash all over back.  Rash is still there.  No other symptoms at this time.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Fatigue, Headache, Influenza like illness
Clinical narrative: Severe flu like symptoms.  Headache, chills, fever, body aches, shortness of breath and extreme fatigue.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Severe flu like symptoms.  Headache, chills, fever, body aches, shortness of breath and extreme fatigue.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Rash developed on my face within the first hour of receiving shot. Have taken an antihistamine to help reduce the itching--which is only annoying, not extreme. Seems to be lessening after 13 hours.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Eye pain, Flushing, Ocular discomfort
Clinical narrative: Patient presented today for second dose of COVID vaccine. She tolerated her first dose well. She has h/o elevated BP and "flushed" feeling with various meds including once when she was doing a bowel prep for a colonoscopy. We decided to monitor her for 30 minutes and she felt fine throughout. As she was walking to her car she felt "flushed" and a bit light headed so she returned to the monitoring area. Initial BP was 189/77, pulse 110, O2 sat 100%. We brought her to the back room so she could sit in a recliner and remove her mask. Subsequent BP 186/77, pulse 86 then 184/69, pulse 80 about 20 minutes later. O2 sat remained upper 90s to 100%.  She continued to report feeling "flushed" and noted pressure/pain behind her left eye so we elected to call EMS (and this was also patient request to go to the ED) so she could be evaluated. She drove herself to appointment. Her plan was to call her son to have him meet her at the ED. She left via ambulance in stable condition.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Fatigue, Headache
Clinical narrative: headache tiredness back and shoulder ache treated with ibuprofen
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal discomfort, Abdominal distension, Abdominal pain upper, Blood pressure increased, Blood pressure measurement
Clinical narrative: 1st dose: Reaction within a few minutes of injection: Vertigo type dizziness, extremely nauseous, elevated blood pressure (checked by emt 174/89) and tachycardia 96 bpm. Dizziness and nausea were intermittent for three days afterwards. Developed GI symptoms within 3 days (bloating, diarrhea, gastroparesis, stomach fullness, stomach pain) required lab testing and CT scan. Flare up of RA symptoms lasting three weeks.  2nd dose: Reaction within a few minutes of injection: Vertigo type dizziness, extremely nauseous, very dry mouth, elevated blood pressure (checked by emt 170/90) and tachycardia 99 bpm. 2.5 hours later developed itchy red rash on neck and chest. Within 4 hours of injection developed intermittent and random itching and red patches all over body, from scalp to bottom of feet, and bad heart palpitations. Required visit to the emergency room for treatment and released. Itching persisted to next day (day 2.) On day three, the same GI symptoms returned: bloating, diarrhea, gastroparesis, stomach fullness, stomach pain with increase in diarrhea. Increase in fatigue that started on Day two still remains on day four, along with bouts of dizziness, diarrhea, and nausea.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Diarrhoea, Dizziness, Dry mouth, Fatigue
Clinical narrative: 1st dose: Reaction within a few minutes of injection: Vertigo type dizziness, extremely nauseous, elevated blood pressure (checked by emt 174/89) and tachycardia 96 bpm. Dizziness and nausea were intermittent for three days afterwards. Developed GI symptoms within 3 days (bloating, diarrhea, gastroparesis, stomach fullness, stomach pain) required lab testing and CT scan. Flare up of RA symptoms lasting three weeks.  2nd dose: Reaction within a few minutes of injection: Vertigo type dizziness, extremely nauseous, very dry mouth, elevated blood pressure (checked by emt 170/90) and tachycardia 99 bpm. 2.5 hours later developed itchy red rash on neck and chest. Within 4 hours of injection developed intermittent and random itching and red patches all over body, from scalp to bottom of feet, and bad heart palpitations. Required visit to the emergency room for treatment and released. Itching persisted to next day (day 2.) On day three, the same GI symptoms returned: bloating, diarrhea, gastroparesis, stomach fullness, stomach pain with increase in diarrhea. Increase in fatigue that started on Day two still remains on day four, along with bouts of dizziness, diarrhea, and nausea.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Immediate post-injection reaction, Impaired gastric emptying, Nausea, Palpitations, Pruritus
Clinical narrative: 1st dose: Reaction within a few minutes of injection: Vertigo type dizziness, extremely nauseous, elevated blood pressure (checked by emt 174/89) and tachycardia 96 bpm. Dizziness and nausea were intermittent for three days afterwards. Developed GI symptoms within 3 days (bloating, diarrhea, gastroparesis, stomach fullness, stomach pain) required lab testing and CT scan. Flare up of RA symptoms lasting three weeks.  2nd dose: Reaction within a few minutes of injection: Vertigo type dizziness, extremely nauseous, very dry mouth, elevated blood pressure (checked by emt 170/90) and tachycardia 99 bpm. 2.5 hours later developed itchy red rash on neck and chest. Within 4 hours of injection developed intermittent and random itching and red patches all over body, from scalp to bottom of feet, and bad heart palpitations. Required visit to the emergency room for treatment and released. Itching persisted to next day (day 2.) On day three, the same GI symptoms returned: bloating, diarrhea, gastroparesis, stomach fullness, stomach pain with increase in diarrhea. Increase in fatigue that started on Day two still remains on day four, along with bouts of dizziness, diarrhea, and nausea.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash, Rash erythematous, Rheumatoid arthritis, Tachycardia, Vertigo
Clinical narrative: 1st dose: Reaction within a few minutes of injection: Vertigo type dizziness, extremely nauseous, elevated blood pressure (checked by emt 174/89) and tachycardia 96 bpm. Dizziness and nausea were intermittent for three days afterwards. Developed GI symptoms within 3 days (bloating, diarrhea, gastroparesis, stomach fullness, stomach pain) required lab testing and CT scan. Flare up of RA symptoms lasting three weeks.  2nd dose: Reaction within a few minutes of injection: Vertigo type dizziness, extremely nauseous, very dry mouth, elevated blood pressure (checked by emt 170/90) and tachycardia 99 bpm. 2.5 hours later developed itchy red rash on neck and chest. Within 4 hours of injection developed intermittent and random itching and red patches all over body, from scalp to bottom of feet, and bad heart palpitations. Required visit to the emergency room for treatment and released. Itching persisted to next day (day 2.) On day three, the same GI symptoms returned: bloating, diarrhea, gastroparesis, stomach fullness, stomach pain with increase in diarrhea. Increase in fatigue that started on Day two still remains on day four, along with bouts of dizziness, diarrhea, and nausea.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Feeling abnormal, Neck pain
Clinical narrative: Sore arm, aches across neck and shoulders, minor chills, extreme fatigue, brain fog
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm, aches across neck and shoulders, minor chills, extreme fatigue, brain fog
Age: 70.0
Sex: U
Vaccine: VARZOS
Symptoms: Deafness, Injury
Clinical narrative: hearing loss and other zoster related injuries; hearing loss and other zoster related injuries; This initial spontaneous report was received on from a lawyer regarding a case in litigation and refers to a currently 76 year old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant medication were not provided.   On or about 04-NOV-2014, the patient was vaccinated with a dose zoster vaccine live (ZOSTAVAX) (strength, dose, route of administration, lot # and expiration date were not reported) for the long-term prevention of shingles and zoster related conditions.  On an unspecified date, the patient was treated by a physician for the following injuries resulting from Plaintiff's zoster vaccine live (ZOSTAVAX) use: hearing loss and other zoster related injuries. The outcome of the events was not provided.   Upon internal review, hearing loss was determined to be medically significant.  The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).
Sex: M
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: Completed the course of Vivotif which was left at room temperature; Spontaneous report received on 05FEB2020.  A consumer's mother reported that her son "completed the course of Vivotif which was left at room temperature" (PT: Product storage error). He was receiving Vivotif for immunisation. The consumer got Vivotif from the pharmacy on 17DEC2019 and left that at room temperature. He started taking Vivotif on 24DEC2019 and took the last dose on 30DEC2019. It was reported that he did not refrigerate the Vivotif since the day he got that from pharmacy until the day he finished his last dose of Vivotif. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the reported event was unknown.  Company Comment: A consumer completed the entire course of Vivotif which was left at room temperature (Product storage error). Vivotif must be stored at the recommended temperature in a refrigerator and not be left at room temperature. Considering the nature of the event, the causality of product storage error is assessed as not applicable to Vivotif.; Sender's Comments: A consumer completed the entire course of Vivotif which was left at room temperature (Product storage error). Vivotif must be stored at the recommended temperature in a refrigerator and not be left at room temperature. Considering the nature of the event, the causality of product storage error is assessed as not applicable to Vivotif.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Malaise, Pain, Pyrexia
Clinical narrative: Severe pain; Fever; Redness; "Not feeling well"; This case was reported by a consumer and described the occurrence of pain in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included chronic urticaria. Concomitant products included omalizumab (Xolair).   On 20th November 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced pain, fever, erythema and malaise. On an unknown date, the outcome of the pain, fever, erythema and malaise were unknown.   It was unknown if the reporter considered the pain, fever, erythema and malaise to be related to Shingrix.  Additional details were provided as follows: The patient received the vaccine eight weeks ago from date of reporting and experienced severe pain, fever, redness and was not well. The reporter did not consent to follow-up.
Sex: U
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: partial dose; A spontaneous report was received from a pharmacist concerning a partial dose Modern's COVID-19 vaccine (mRNA-1273) received.  The patient's medical history was not provided. No relevant concomitant medications were reported.  No treatment information was provided.   Action taken with mRNA-1273 in response to the event was not reported.; Reporter's Comments: This report refers to Product administration error with no associated AEs for mRNA-1273.
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: partial first dose; A spontaneous report was received from a Healthcare Provider (HCP) concerning an unknown age female patient who was administer Moderna Covid- 19 Vaccine patient only received a partial dose. It was reported by the register nurse is the Director at vaccine clinic, and they had a patient received a partial first dose, wanted to see recommendation for that patient. The reported was unaware that this will be reported as an adverse event AE.  The patient medical history was not provided, no concomitant medications were reported.   On 05 Feb 2021, the patient received her first dose of two dose of mRNA-1273(Batch number 007M20A) for prophylaxis of COVID-19 infectious route unknow. It was reported by the Register Nurse the patient only received a partial dose.  The patient was administered first dose of mRna-1273 Vaccine. the patient only received a partial dose.  Action Taken with the second dose, is unknown.  The event patient reported only received a partial dose was administrated was considered resolved.; Reporter's Comments: This report refers to a case of incorrect dose administered for mRNA-1273, lot # 007M20A with no associated AEs.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation
Clinical narrative: Atrial fibrillation; A spontaneous report was received from a consumer, concerning herself, a 74-year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced medically important event of atrial fibrillation.  The patient's medical history included heart surgery on an unspecified date in 2017. No concomitant medications were reported.  On 05 FEB 2021, prior to the onset of event, the patient received their second of two planned doses of mRNA-1273 (batch number: 015L20A) for the prophylaxis of COVID-19 infection.  On an unspecified date in FEB 2021, the patient experienced fast heart rate, felt weakness, dizziness, and had atrial fibrillation. No treatment medication information was provided.  Action taken with second dose of mRNA-1273 in response to the event was not applicable.   The outcome of the event, atrial fibrillation was not reported.; Reporter's Comments: Based on current information the event was assessed as unlikely related to mRNA-1273 vaccine, because of biological implausibility, no clear temporal association, and the patient's history of heart surgery which may promote atrial fibrillation episodes.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: Stroke; A spontaneous report was received from a consumer concerning a 48-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced stroke (cerebrovascular accident).   The patient's medical history was not provided by the reporter.  Concomitant product use was not reported.  On 30 Dec 2020, approximately 11 days prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Lot #: 037K20A) intramuscularly in the right upper arm for prophylaxis of COVID-19 infection.  The reporter stated that on 10 Jan 2021, the onset of symptoms of stroke began.  The patient reports that he was discharged from the hospital on 20 Jan 2021 and was later discharged from patient rehabilitation on 26 Jan 2021.  Treatment for the event included apixaban, acetylsalicyclic acid, and atorvastatin as advised by patient's HCP (health care provider).  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the event, stroke, was unknown.; Reporter's Comments: This case concerns a 48 year old male who experienced stroke 11 days after the vaccine was administered. Very limited information regarding this event has been provided at this time.  Further information has been requested.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous, Exposure during pregnancy
Clinical narrative: Miscarriage; Received vaccine when pregnant; A spontaneous report was received from a 34-year old female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) when pregnant and experienced a miscarriage.  The patient's medical history included three prior pregnancies, with two live births and one miscarriage. Products known to have been used by the patient, within two weeks prior to the event, included prenatal vitamins and doxylamine succinate/pyridoxine hydrochloride.   The patient received their first of two planned doses of mRNA-1273 (Batch number: 011J20A) on 30 Dec 2020. On 27 Jan 2021, the patient received their second of two planned doses of mRNA-1273 (Batch number: 028L20A) intramuscularly for prophylaxis of COVID-19 infection.  At 7 weeks gestation, the fetus had a normal heart beat. She reported that she had no complications with the pregnancy.  On 08 Feb 2021, the patient had a miscarriage. Treatment information was not provided.  The patient received both scheduled doses of mRNA-1273; therefore, action taken with the drug in response to the event is not applicable.  The events received vaccine when pregnant and miscarriage were considered recovered.; Reporter's Comments: This report concerns a 34-year-old, P2G4 who experienced miscarriage 1 month 9 days post administration of first dose and 12 days after the last dose of mRNA-1273 vaccine. There is not enough information such as the last menstrual period, estimated date of conception and delivery and gestational age at the time of miscarriage. In addition, the patient's detailed medical history including any trauma  and reason for previous miscarriage is lacking. Vaccine exposure during pregnancy is assessed as not applicable.
Sex: M
Vaccine: COVID19
Symptoms: Diplopia, Fatigue
Clinical narrative: Double vision; FATIGUED; A spontaneous report was received from a consumer concerning a 65-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced double vision and fatigue.  The patient's medical history, as provided by the reporter included cancer, diabetes, hypertension, celiac disease and whipple's operation. No concomitant medications were reported.  On 21 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 029K20A) intramuscularly for prophylaxis of COVID-19 infection.   On 22 Jan 2021, the patient experienced double vision and fatigue. The patient was advised by the eye doctor to go into the emergency room (ER) if the symptoms didn't subside. However, it was reported that the vision did get better. No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not provided.  The event, double vision, was considered resolved on an unknown date. The outcome for the event fatigue was unknown.; Reporter's Comments: Based on the current available information, a strong temporal association between the use of the product and the onset of the reported event, a causal relationship cannot be excluded. Fatigue is consistent with the known safety profile of the mRNA-1273 vaccine.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Gave vaccine to 17 year old; A spontaneous report  was received from a nurse concerning a 17-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and resulting in the event, gave vaccine to a 17-year-old/inappropriate age of dose of administration.  The patient's medical history was not provided. Concomitant medications were not reported.  On 05 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Batch number: 013M20A) for prophylaxis of COVID-19 infection.  On 05 Feb 2021, the patient received the vaccine resulting in the event of inappropriate age of dose of administration.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event, gave vaccine to a 17-year-old, was considered resolved on 05 Feb 2021.; Reporter's Comments: This report refers to a case of Product administered to patient of inappropriate age for mRNA-1273, lot # 013M20A with no associated AEs.
Sex: F
Vaccine: COVID19
Symptoms: Immunodeficiency
Clinical narrative: mildly immunocompromised; This is a spontaneous report from a contactable consumer (patient's husband). A 61-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19),  via an unspecified route of administration on an unspecified date at single dose for covid-19 immunization, hydroxychloroquine sulfate (PLAQUENIL), via an unspecified route of administration from an unspecified date at unknown dose for mild rheumatoid arthritis for 15-20 years. The patient's medical history and concomitant medications were not reported. The patient experienced mildly immunocompromised on an unspecified date with outcome of unknown. The action taken in response to the event for hydroxychloroquine sulfate was not applicable.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Autoimmune thyroiditis
Clinical narrative: Hashimoto's thyroiditis; This is a spontaneous report from a contactable physician. A 74-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced Hashimoto's thyroiditis on an unspecified date. The outcome of the event was unknown.   Information on lot/batch number has been requested.; Sender's Comments: The event Hashimoto's thyroiditis is most likely an underlying/ intercurrent condition and unrelated to suspect vaccine BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood thyroid stimulating hormone, CSF cell count, CSF culture, CSF protein
Clinical narrative: Was found by her family after collapsing on 06Jan2021 /syncope; extreme fatigue; sleepiness; headache; vomiting; weakness /notes 3/5 strength; difficulty speaking /speech disorder /vocal weakness; difficulty walking /gait disturbance; lower extremity weakness /progressive lower extremity /Muscular Weakness; hyporeflexia; Vitamin B12 Decreased; difficulty speaking /speech disorder /vocal weakness; This is a spontaneous report from a non-contactable consumer (patient). A (age: 39; unit: unknown) female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot: EJ1686), intramuscularly at left arm on 04Jan2021 at single dose for covid-19 immunisation. Medical history included hypothyroidism, attention deficit hyperactivity disorder, shellfish allergy. Current illness was none. Concomitant medication included levothyroxine, lisdexamfetamine mesilate (VYVANSE). The patient previously took ceclor and experienced drug hypersensitivity, took first dose of bnt162b2 at single dose for covid-19 immunisation and experienced mild symptoms after the first vaccination, but no neurologic or vascular symptoms at that time. Patient experienced extreme fatigue and sleepiness the day following her second vaccination for Covid 19 and was found by her family after collapsing on 06Jan2021 at 05:30. Upon arousal, she experienced headache, vomiting, weakness, difficulty speaking and difficulty walking with lower extremity weakness. She was taken to urgent care and subsequently admitted for evaluation at hospital and found to have a normal chemistry, blood count, normal lumbar puncture and normal imaging of her neck and brain. Discharge summary notes 3/5 strength and hyporeflexia throughout. Patient had tele visit consult with Psychiatry and Neurology. She was subsequently to be discharged to a Facility without explanation for her sudden onset of progressive lower extremity and vocal weakness. Symptom: Asthenia, Blood Thyroid Stimulating Hormone Normal, Computerized Tomogram head, Computerized tomogram head normal, CSF cell count normal, CSF culture, CSF protein normal, fatigue, full blood count normal, gait disturbance, headache, Hyporeflexia, Lumbar Puncture Normal, Metabolic Function Test Normal, Muscular Weakness, somnolence, speech disorder, Spinal X-Ray Normal, syncope, Vitamin B12 Decreased, vomiting. Serious criteria was permanent disability and the patient was hospitalized for 4 days and had emergency room vist. Existing hospitalization was not prolonged. Lab Data on 06Jan2021 included: Normal BMP, CBC, normal TSH (thyroid stimulating hormone), low B12, Lumbar Puncture: normal, cell count and protein, culture pending, Cervical Spine X-ray: Normal, CT brain (non contrast): normal. The outcome of events was not recovered.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram head, Fatigue, Full blood count, Gait disturbance, Headache
Clinical narrative: Was found by her family after collapsing on 06Jan2021 /syncope; extreme fatigue; sleepiness; headache; vomiting; weakness /notes 3/5 strength; difficulty speaking /speech disorder /vocal weakness; difficulty walking /gait disturbance; lower extremity weakness /progressive lower extremity /Muscular Weakness; hyporeflexia; Vitamin B12 Decreased; difficulty speaking /speech disorder /vocal weakness; This is a spontaneous report from a non-contactable consumer (patient). A (age: 39; unit: unknown) female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot: EJ1686), intramuscularly at left arm on 04Jan2021 at single dose for covid-19 immunisation. Medical history included hypothyroidism, attention deficit hyperactivity disorder, shellfish allergy. Current illness was none. Concomitant medication included levothyroxine, lisdexamfetamine mesilate (VYVANSE). The patient previously took ceclor and experienced drug hypersensitivity, took first dose of bnt162b2 at single dose for covid-19 immunisation and experienced mild symptoms after the first vaccination, but no neurologic or vascular symptoms at that time. Patient experienced extreme fatigue and sleepiness the day following her second vaccination for Covid 19 and was found by her family after collapsing on 06Jan2021 at 05:30. Upon arousal, she experienced headache, vomiting, weakness, difficulty speaking and difficulty walking with lower extremity weakness. She was taken to urgent care and subsequently admitted for evaluation at hospital and found to have a normal chemistry, blood count, normal lumbar puncture and normal imaging of her neck and brain. Discharge summary notes 3/5 strength and hyporeflexia throughout. Patient had tele visit consult with Psychiatry and Neurology. She was subsequently to be discharged to a Facility without explanation for her sudden onset of progressive lower extremity and vocal weakness. Symptom: Asthenia, Blood Thyroid Stimulating Hormone Normal, Computerized Tomogram head, Computerized tomogram head normal, CSF cell count normal, CSF culture, CSF protein normal, fatigue, full blood count normal, gait disturbance, headache, Hyporeflexia, Lumbar Puncture Normal, Metabolic Function Test Normal, Muscular Weakness, somnolence, speech disorder, Spinal X-Ray Normal, syncope, Vitamin B12 Decreased, vomiting. Serious criteria was permanent disability and the patient was hospitalized for 4 days and had emergency room vist. Existing hospitalization was not prolonged. Lab Data on 06Jan2021 included: Normal BMP, CBC, normal TSH (thyroid stimulating hormone), low B12, Lumbar Puncture: normal, cell count and protein, culture pending, Cervical Spine X-ray: Normal, CT brain (non contrast): normal. The outcome of events was not recovered.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Hyporeflexia, Investigation, Lumbar puncture, Metabolic function test, Muscular weakness
Clinical narrative: Was found by her family after collapsing on 06Jan2021 /syncope; extreme fatigue; sleepiness; headache; vomiting; weakness /notes 3/5 strength; difficulty speaking /speech disorder /vocal weakness; difficulty walking /gait disturbance; lower extremity weakness /progressive lower extremity /Muscular Weakness; hyporeflexia; Vitamin B12 Decreased; difficulty speaking /speech disorder /vocal weakness; This is a spontaneous report from a non-contactable consumer (patient). A (age: 39; unit: unknown) female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot: EJ1686), intramuscularly at left arm on 04Jan2021 at single dose for covid-19 immunisation. Medical history included hypothyroidism, attention deficit hyperactivity disorder, shellfish allergy. Current illness was none. Concomitant medication included levothyroxine, lisdexamfetamine mesilate (VYVANSE). The patient previously took ceclor and experienced drug hypersensitivity, took first dose of bnt162b2 at single dose for covid-19 immunisation and experienced mild symptoms after the first vaccination, but no neurologic or vascular symptoms at that time. Patient experienced extreme fatigue and sleepiness the day following her second vaccination for Covid 19 and was found by her family after collapsing on 06Jan2021 at 05:30. Upon arousal, she experienced headache, vomiting, weakness, difficulty speaking and difficulty walking with lower extremity weakness. She was taken to urgent care and subsequently admitted for evaluation at hospital and found to have a normal chemistry, blood count, normal lumbar puncture and normal imaging of her neck and brain. Discharge summary notes 3/5 strength and hyporeflexia throughout. Patient had tele visit consult with Psychiatry and Neurology. She was subsequently to be discharged to a Facility without explanation for her sudden onset of progressive lower extremity and vocal weakness. Symptom: Asthenia, Blood Thyroid Stimulating Hormone Normal, Computerized Tomogram head, Computerized tomogram head normal, CSF cell count normal, CSF culture, CSF protein normal, fatigue, full blood count normal, gait disturbance, headache, Hyporeflexia, Lumbar Puncture Normal, Metabolic Function Test Normal, Muscular Weakness, somnolence, speech disorder, Spinal X-Ray Normal, syncope, Vitamin B12 Decreased, vomiting. Serious criteria was permanent disability and the patient was hospitalized for 4 days and had emergency room vist. Existing hospitalization was not prolonged. Lab Data on 06Jan2021 included: Normal BMP, CBC, normal TSH (thyroid stimulating hormone), low B12, Lumbar Puncture: normal, cell count and protein, culture pending, Cervical Spine X-ray: Normal, CT brain (non contrast): normal. The outcome of events was not recovered.  No follow-up attempts are possible. No further information is expected.