chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Fatigue, Headache, Immediate post-injection reaction, Injection site pain
Clinical narrative: Patient's husband had same vaccine with no problem.  Patient had no reaction after first dose. Patient received Hep A in last 3 months.  Patient is active, plays sports and not overweight.    Arm hurt at injection site right away but at about 10pm started to hurt more.  Patient felt tired and started to get headache by midnight.  Patient also felt achy so took 1 Excedrin.  Patient woke up at 6am and got vertigo when went down to pick up something.  Patient sat on bed but felt dizzy. Patient not as dizzy as before but head still spinning.  This morning patient is very nauseous and vomited this morning. Patient had bad headache all day--took Tylenol. Patient called pharmacist who specified vertigo is not normal so encouraged to report.   Patient spoke to relatives who a doctor/pharmacist to check in.   Recovery at 50%.   Patient does not feel like she would be able to drive safely.  Arm is doing better; arm is not as swollen or tender
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pain, Peripheral swelling, Tenderness, Vertigo
Clinical narrative: Patient's husband had same vaccine with no problem.  Patient had no reaction after first dose. Patient received Hep A in last 3 months.  Patient is active, plays sports and not overweight.    Arm hurt at injection site right away but at about 10pm started to hurt more.  Patient felt tired and started to get headache by midnight.  Patient also felt achy so took 1 Excedrin.  Patient woke up at 6am and got vertigo when went down to pick up something.  Patient sat on bed but felt dizzy. Patient not as dizzy as before but head still spinning.  This morning patient is very nauseous and vomited this morning. Patient had bad headache all day--took Tylenol. Patient called pharmacist who specified vertigo is not normal so encouraged to report.   Patient spoke to relatives who a doctor/pharmacist to check in.   Recovery at 50%.   Patient does not feel like she would be able to drive safely.  Arm is doing better; arm is not as swollen or tender
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: Patient's husband had same vaccine with no problem.  Patient had no reaction after first dose. Patient received Hep A in last 3 months.  Patient is active, plays sports and not overweight.    Arm hurt at injection site right away but at about 10pm started to hurt more.  Patient felt tired and started to get headache by midnight.  Patient also felt achy so took 1 Excedrin.  Patient woke up at 6am and got vertigo when went down to pick up something.  Patient sat on bed but felt dizzy. Patient not as dizzy as before but head still spinning.  This morning patient is very nauseous and vomited this morning. Patient had bad headache all day--took Tylenol. Patient called pharmacist who specified vertigo is not normal so encouraged to report.   Patient spoke to relatives who a doctor/pharmacist to check in.   Recovery at 50%.   Patient does not feel like she would be able to drive safely.  Arm is doing better; arm is not as swollen or tender
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Headache, Injection site erythema, Injection site induration, Injection site inflammation, Injection site pain
Clinical narrative: Fever( 101.8 F) inflammed, hot to the touch, painful, red and hard around the injection site, headaches continuing for 48 hours, then still painful
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site warmth, Pyrexia
Clinical narrative: Fever( 101.8 F) inflammed, hot to the touch, painful, red and hard around the injection site, headaches continuing for 48 hours, then still painful
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Nausea, Phonophobia, Photophobia
Clinical narrative: Rigors for several hours.  Fever within 1 hour >101 that lasted through the following afternoon.  Sick headache - pulsatile with photo and phonophobia.  Severe nausea - took Zofran to keep from vomiting.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Rigors for several hours.  Fever within 1 hour >101 that lasted through the following afternoon.  Sick headache - pulsatile with photo and phonophobia.  Severe nausea - took Zofran to keep from vomiting.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Pruritus
Clinical narrative: itching on November 24 at injection site and also along ribs start at waistline
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Pain
Clinical narrative: I also had a second shingle shot in left arm. Developed chills and body aches for 24 hours
Age: 3.0
Sex: F
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No known adverse events or outcome of administration error. Coding notified me of error. I have been attempting to get ahold of the parent to notify her of error and to assess for adverse reaction.
Age: 1.42
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Diarrhoea, Lethargy, Rash, Rhinorrhoea
Clinical narrative: The same evening, lethargic, runny nose.  The third or fourth day, still lethargic, runny nose, diarrhea and rash.
Age: 30.0
Sex: F
Vaccine: HEPA, IPV, TYP
Symptoms: Capillary nail refill test abnormal, Peripheral coldness, Raynaud's phenomenon, Skin discolouration
Clinical narrative: Approximately 2.5 hours after vaccinations, patient returned to clinic with bilateral hand discoloration (purple) and cool to touch.  Delayed capillary refill time ~ 4-5 seconds.  Patient sent to urgent care and was then referred to local emergency room.  Physician in the Emergency Department believes the symptoms are Raynaud's Phenomenon triggered by vaccinations.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Arthralgia, Delirium, Feeling abnormal, Headache, Injection site erythema
Clinical narrative: Patient came in for a well check up,  she felt great, blood pressure was good and weight was down. She accepted the vaccines while in the clinic.  The  MA gave both vaccines in the left arm. She rubbed her arm, did big arm circles and took ibuprofen that night. She noticed that night that she felt achy and joints hurt. The next day she had a fever and was delirious. Her arm was inflamed , red , hard, and the size of a softball.  They called the office and was told they didn't have openings to see her.  within a few days her arm was red from her shoulder to her elbow, it was warm to touch, red, swollen.  On Saturday she decided to go into urgent care.  The physician didn?t think it was infected but, her immune system was having a violent reaction to the vaccine. They gave her a number to call but, she didn?t call. Urgent care gave a steroid cream and prednisone. She then sent a letter to Dr. via our application. Someone from the clinic contacted her Monday and she came in on Tuesday/Wednesday. Dr. put her on doxycycline and prednisone. She couldn?t sleep well after that but, the knot on her arm reduced to the size of an egg. She again came in again and Dr. said he could lance it and try to drain the area but, she refused due to her planned trip that following week.  Last Thursday (11/22/20119) she was seen in the clinic and there is a lump in her arm. The arm is really weak. She said she hasn?t been herself, she feels lethargic, headaches, joint aches- the physician said he feels like it triggers fibromyalgia. She?s been keeping that under control. Feels like she is in a fog. Prior to that date 09/30/2019 she didn?t feel that way.  This was her first time receiving the pneumonia shot.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site induration, Injection site inflammation, Injection site nodule, Injection site warmth, Lethargy
Clinical narrative: Patient came in for a well check up,  she felt great, blood pressure was good and weight was down. She accepted the vaccines while in the clinic.  The  MA gave both vaccines in the left arm. She rubbed her arm, did big arm circles and took ibuprofen that night. She noticed that night that she felt achy and joints hurt. The next day she had a fever and was delirious. Her arm was inflamed , red , hard, and the size of a softball.  They called the office and was told they didn't have openings to see her.  within a few days her arm was red from her shoulder to her elbow, it was warm to touch, red, swollen.  On Saturday she decided to go into urgent care.  The physician didn?t think it was infected but, her immune system was having a violent reaction to the vaccine. They gave her a number to call but, she didn?t call. Urgent care gave a steroid cream and prednisone. She then sent a letter to Dr. via our application. Someone from the clinic contacted her Monday and she came in on Tuesday/Wednesday. Dr. put her on doxycycline and prednisone. She couldn?t sleep well after that but, the knot on her arm reduced to the size of an egg. She again came in again and Dr. said he could lance it and try to drain the area but, she refused due to her planned trip that following week.  Last Thursday (11/22/20119) she was seen in the clinic and there is a lump in her arm. The arm is really weak. She said she hasn?t been herself, she feels lethargic, headaches, joint aches- the physician said he feels like it triggers fibromyalgia. She?s been keeping that under control. Feels like she is in a fog. Prior to that date 09/30/2019 she didn?t feel that way.  This was her first time receiving the pneumonia shot.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Muscular weakness, Pain, Pyrexia, Sleep disorder
Clinical narrative: Patient came in for a well check up,  she felt great, blood pressure was good and weight was down. She accepted the vaccines while in the clinic.  The  MA gave both vaccines in the left arm. She rubbed her arm, did big arm circles and took ibuprofen that night. She noticed that night that she felt achy and joints hurt. The next day she had a fever and was delirious. Her arm was inflamed , red , hard, and the size of a softball.  They called the office and was told they didn't have openings to see her.  within a few days her arm was red from her shoulder to her elbow, it was warm to touch, red, swollen.  On Saturday she decided to go into urgent care.  The physician didn?t think it was infected but, her immune system was having a violent reaction to the vaccine. They gave her a number to call but, she didn?t call. Urgent care gave a steroid cream and prednisone. She then sent a letter to Dr. via our application. Someone from the clinic contacted her Monday and she came in on Tuesday/Wednesday. Dr. put her on doxycycline and prednisone. She couldn?t sleep well after that but, the knot on her arm reduced to the size of an egg. She again came in again and Dr. said he could lance it and try to drain the area but, she refused due to her planned trip that following week.  Last Thursday (11/22/20119) she was seen in the clinic and there is a lump in her arm. The arm is really weak. She said she hasn?t been herself, she feels lethargic, headaches, joint aches- the physician said he feels like it triggers fibromyalgia. She?s been keeping that under control. Feels like she is in a fog. Prior to that date 09/30/2019 she didn?t feel that way.  This was her first time receiving the pneumonia shot.
Age: 29.0
Sex: U
Vaccine: FLUC4
Symptoms: Hypoaesthesia, Pain in extremity
Clinical narrative: Arm numbness and sharp, sudden pain in left arm that goes down to wrist and hand.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Asthenia, Chills, Dizziness, Myalgia
Clinical narrative: 11:30 am nausea, then weakness, shaky, chills, sinus headache, body aches, dizziness, felt like fainting, joint and muscle pain, that evening had nightmares.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Nightmare, Pain, Sinus headache, Tremor
Clinical narrative: 11:30 am nausea, then weakness, shaky, chills, sinus headache, body aches, dizziness, felt like fainting, joint and muscle pain, that evening had nightmares.
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Per pt, he had pain right after injection and next day it became swollen and redness under the skin. The swelling eventually went down and redness faded but he still has pain on the arm. Pt then went to the doctor on Thursday 11/21/19 and MD ordered a MRI for pt.
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Peripheral swelling, Pruritus
Clinical narrative: SWELLING IN UPPER ARM WITH REDDNESS AND ITCHY.  DR RECCOMMENDED REST AND ICE.  ARM IS IMPROVING AND SOME REDDNESS, SWELLING AND ITCHYNESS STILL PRESENT.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Erythema, Pruritus
Clinical narrative: patient states arm began to turn red and itch, began to become a little black and blue within 36 hours...still some redness but wearing off
Age: 58.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Hyperhidrosis, Hypoaesthesia, Pain in extremity, Pyrexia
Clinical narrative: patient woke up next morning, fever,sweats,arm very sore even numb for a few hrs  states today she is not feverish, only mild pain
Age: 0.58
Sex: M
Vaccine: DTAPIPVHIB, FLU4
Symptoms: Culture wound positive, Drain placement, Incisional drainage, Injection site abscess, Injection site cellulitis
Clinical narrative: Patient developed cellulitis and abscess of left thigh, requiring surgical I&D and penrose drain placement. Wound culture grew MRSA. Was treated with course of Bactrim.
Age: 0.58
Sex: M
Vaccine: DTAPIPVHIB, FLU4
Symptoms: Staphylococcal infection, Staphylococcus test positive
Clinical narrative: Patient developed cellulitis and abscess of left thigh, requiring surgical I&D and penrose drain placement. Wound culture grew MRSA. Was treated with course of Bactrim.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Ulcer
Clinical narrative: Breaking out in sores around waist area next morning, went to urgent care and treated with steroid injections
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Accidentally received second dose, last dose given 09/19/2019.  No current s/s of any immediate reaction
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Mobility decreased, Myalgia, Pain, Pain in extremity
Clinical narrative: Severe pain in arm and shoulder muscles and inability to raise arm in front or beside body more than 5 degrees without severe pain.  First noticed 2-3 hours after injection; pain increased over next 8 hours.  Took ibuprofen over next four days (2 every six hours for first 24 hours, 1 every six hours for next 3 days).  Pain began decreasing and mobility increased after72 hours. There is still slight pain but tolerable five days after injection.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: patient received 3 doses of Shingrix.  He received doses on Feb 2, 2019; Aug 13, 2019 and today Nov 25, 2019. no reaction so far, BUT it does exceed ACIP recommendations and package insert.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Fatigue, Pain in extremity, Rash, Rash erythematous, Rash pruritic
Clinical narrative: Patient received the influenza shot, which she gets every year, and also the Pneumovax. Both were administered in the same arm, and that arm was slightly sore as can be expected. The next day she woke up and it was more sore and there was also a red, bumpy rash that was itchy and painful. The rash covered not only that arm but up to the neck area and even part of her other arm. She also felt a little fatigued/run down. She asked for recommendations and ended up taking benadryl and other self medicating parameters to help with the symptoms,which eventually subsided.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient came in to report adverse event that happened the morning after the shot. The area of the injection was very red, with some swollenness, and was hot to the touch. The area was slightly raised. It was mildly sore, but not extremely so. The borders of the red area spread as the days progressed according to the patient. No other symptoms. The patient was advised to alternate between hot and cold compresses and to use Tylenol or advil (whichever the patient preferred or was able to tolerate) and to monitor the area. If it continued to grow or did not resolve, the patient needed to seek care with a physician.
Age: 68.0
Sex: F
Vaccine: FLUA3
Symptoms: Injection site pain
Clinical narrative: Patient called pharmacy about 3 hours after getting vaccination to report injection site pain. she denied any allergy symptoms. over the counter tylenol was recommended and 4 hours after reporting pain, patient is doing better and pain has subsided.
Age: 55.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Decreased appetite, Malaise, Pyrexia
Clinical narrative: FEVER, MALAISE, CHILLS, LACK OF APPETITE, ABOUT 48 HOURS
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain
Clinical narrative: I received the first dose of the Shingrix vaccine, and for approximately 10 days following my upper arm over the entire deltoid muscle region (the site of the injection) was a pronounced red and  mild to moderately sore. The redness then disappeared, but the soreness not only remained but grew worse, to the point where I discussed it with my doctor at his office on September 9.  He recommended applying heat to the area and an exercise (both of which I did) but by October the soreness continued to increase to the point where  my range of motion in the right arm was significantly impacted.  It is now more 3.5 months since the injection; the soreness seems to have plateaued (not gotten worse or better since October) and the range of motion  is perhaps slightly improved. I have been applying heat and massage to the deltoid muscle area which may be helping.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling, Pruritus
Clinical narrative: PATIENT REPORTED TO PHARMACY TODAY, 11/25/2019, WITH SWELLING AND REDNESS OVER ENTIRE DELTOID AREA AND ABOUT 1/4 INCH PAST THE MUSCLE. PATIENT STATES SWELLING HAS REDUCED A LOT AND JUST HAS ITCHING. SHE WANTED TO SHOW ME BECAUSE SHE HAD CONCERN THE RPH GAVE THE SHOT TOO LOW.  SHE REPORTED NO PAIN OR FEVER AT THIS TIME, JUST SWELLING AND ITCHING. I RECOMMENDED SHE BE SEEN BY A PHYSICIAN BUT SHE REPORTS SHE DOES NOT HAVE MONEY TO GO. ADVISED TO GO TO ER IMMEDIATELY IF SYMPTOMS WORSEN OR REDNESS SPREADS BEYOND CURRENT AREA OR NEW RASH DEVELOPS AWAY FROM INJECTION SITE
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Horrible horrible horrible rash covering head to toe of my one year olds body. We are on day four and the rash continues to get worse. Two trips to the dr and a trip to the ER and it has been said to be the MMR vaccine given at her one year old appt. she is non stop scratching and is just unsettled. Looks like hives covering her little body. I am pro vaccines but there has to be a different way to keep her safe.
Age: 45.0
Sex: F
Vaccine: FLUX
Symptoms: Anxiety, Condition aggravated, Depression, Pain
Clinical narrative: Body aches,worsening depression,anxiety
Age: 57.0
Sex: M
Vaccine: UNK
Symptoms: Abdominal pain upper, Dehydration, Diarrhoea, Eye irritation, Flatulence
Clinical narrative: Terrible diarrhea, stomach cramps, gas, fever, burning eyes, dehydration.
Age: 57.0
Sex: M
Vaccine: UNK
Symptoms: Pyrexia
Clinical narrative: Terrible diarrhea, stomach cramps, gas, fever, burning eyes, dehydration.
Age: 64.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Cough, Hypoaesthesia, Neuralgia, Pain, Paraesthesia
Clinical narrative: 2 days after the Shingles vaccine I experienced  severe shooting nerve pain in my left arm and left ribs. My left hand felt numb and tingly. This pain lasted 1 week and returned 3 weeks later during coughing episode. The pain lasted 20 hours after the cough ing
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash
Clinical narrative: Small bumps broke out on the lower part of my back, and I continue to itch to this day.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Mobility decreased, Pyrexia, Sensory disturbance
Clinical narrative: Patient's wife called on Monday, 11/25/19 to inform me of patient reaction following vaccine given the afternoon of 11/23/19.  She states that patient experienced numbness and difficulty moving his fingers, arm, and some sensation in his legs.   He also developed a fever after receiving the vaccine.  She states that they went to the hospital, though he was not admitted.  She said the physician discussed the possibility of Guillain-Barre syndrome.  When I asked how he was doing today, she stated that he seemed to be doing better and had gone to work today.  She said they'll call me back if he has any additional problems.  I told her I would report what she had described as a potential reaction to the vaccine.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Decreased appetite, Fatigue, Injection site pain, Pyrexia
Clinical narrative: customer had fever of 102.3 for 3 days accompanied by horrible chills and severe pain at injection site.   She also developed a blotchy rash for  days and had fatigue for 2 days and decreased appetite
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash macular
Clinical narrative: customer had fever of 102.3 for 3 days accompanied by horrible chills and severe pain at injection site.   She also developed a blotchy rash for  days and had fatigue for 2 days and decreased appetite
Age: 34.0
Sex: F
Vaccine: VARCEL
Symptoms: Cough, Injection site erythema, Injection site infection, Injection site pain, Injection site reaction
Clinical narrative: Patient started having fever, cough, injection site pain (stiffness and red), runny nose, congestion which worsened throughout Saturday, 11/23/19. She went to the emergency department after work on Saturday evening. She was given antibiotics because she had infection at the injection site along with the other symptoms mentioned above.
Age: 34.0
Sex: F
Vaccine: VARCEL
Symptoms: Musculoskeletal stiffness, Pyrexia, Respiratory tract congestion, Rhinorrhoea
Clinical narrative: Patient started having fever, cough, injection site pain (stiffness and red), runny nose, congestion which worsened throughout Saturday, 11/23/19. She went to the emergency department after work on Saturday evening. She was given antibiotics because she had infection at the injection site along with the other symptoms mentioned above.
Age: 1.0
Sex: U
Vaccine: DTAPIPVHIB, FLU4, MMR, PNC13, VARCEL
Symptoms: Computerised tomogram normal, Endotracheal intubation, Intensive care, Lumbar puncture normal, Neurological decompensation
Clinical narrative: Parents woke up to patient seizing at ~ 0700 11/22/19. Status Epilepticus x 45 minutes. Intubated Remained in ICU x 28 hours. CT scan, LP and all labs negative. Still has altered neurological status. Still hospitalized
Age: 1.0
Sex: U
Vaccine: DTAPIPVHIB, FLU4, MMR, PNC13, VARCEL
Symptoms: Seizure, Status epilepticus
Clinical narrative: Parents woke up to patient seizing at ~ 0700 11/22/19. Status Epilepticus x 45 minutes. Intubated Remained in ICU x 28 hours. CT scan, LP and all labs negative. Still has altered neurological status. Still hospitalized
Sex: F
Vaccine: FLUX
Symptoms: Exfoliative rash, Pruritus, Rash
Clinical narrative: I developed a Harold patch followed by a generalized rash shortly after a mandatory influenza vaccination (about 4 days). I did not make this connection until today. Nov 4th, I went to my PCP and she recommended I went to the ED that day for IV steroids. Pityriasis Rosea was the possible diagnosis. I received Decadron IM and Prednisone taper. After researching this, my rash looked closer to a "Lichenoid drug eruption" than the typical Christmas tree pattern of PR. My rash is finally clearing up now, but I am still dealing with the residuals and itchiness of course. Should I be concerned about future vaccinations? as I stated, Influenza vaccine is mandatory for me.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: I received a shingrix vaccination at Pharmacy approximately nov 10th, mild rash was noted on chest about nov. 18th. By November 20 the rash was prominent and pruritic and distributed thru my groin, arm pits, chest, scalp and back. On Thursday Nov. 21st I saw my pcp Dr. at Primary care who consulted with a dermatology practice. I then left for an immediate dermatology consultation. I was examined by PA-C on Nov. 22nd. Her diagnosis was hives, given no other changes in diet, household products, etc. we suspected my Shingrix vaccination and the proximate cause. PA-C started an immediate treatment with prednisone, cetirizine, montelukast. Additionally I applied generous OTC Benadryl gel to the affected areas. The hives are responding to this initial treatment. My only other allergy is to wasp / bee venom.
Age: 36.0
Sex: M
Vaccine: FLU4
Symptoms: Chest discomfort, Chills, Dyspnoea, Headache, Pain
Clinical narrative: Rt arm began to tingle + ache 2 hours after injection. 6-7 hours after injection ache, chills, headache + fever 101.7 8-10 hr felt chest pressure and shortness of breath similar to pericarditis pain he had 7 yrs previous.
Age: 36.0
Sex: M
Vaccine: FLU4
Symptoms: Pain in extremity, Paraesthesia, Pyrexia
Clinical narrative: Rt arm began to tingle + ache 2 hours after injection. 6-7 hours after injection ache, chills, headache + fever 101.7 8-10 hr felt chest pressure and shortness of breath similar to pericarditis pain he had 7 yrs previous.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Angina pectoris, Bedridden, Musculoskeletal chest pain, Nausea, Pneumonia
Clinical narrative: After I got the shot I got nauseous then the pain around my heart and rib on the left side began it was so sharp it made me scream. I had to use heat and take pain pills and I couldn't do anything I was bedridden for days! I won't have the second shot!!! Please warn people 67 years old that smoke that this is a high risk shot! I had pneumonia last year then I had double pneumonia! I don't want pneumonia but I don't want this pain either. I'll take my changes from now on.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Screaming
Clinical narrative: After I got the shot I got nauseous then the pain around my heart and rib on the left side began it was so sharp it made me scream. I had to use heat and take pain pills and I couldn't do anything I was bedridden for days! I won't have the second shot!!! Please warn people 67 years old that smoke that this is a high risk shot! I had pneumonia last year then I had double pneumonia! I don't want pneumonia but I don't want this pain either. I'll take my changes from now on.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthropod bite, Blepharospasm, Blood test normal, Chest X-ray normal, Electrocardiogram normal
Clinical narrative: I took shingle shot on Aug-15; by Aug. 27 I had twitch in eyelid and lip also I felt tingle in left breast area. I described tingle like "cell phone vibration, bee buzzing or sensation when arm goes numb". I went to immediate care center, as soon as I said left breast area, doctor sent me to ER for test (thought it could be heart related). However, I did not think this was a heart issue and after 5 hours, doctor there did not find anything wrong. I counted about 25 times the tingle occurred and subsided within few minutes. Doctor saw chigger bit under my arm and suggested it could be shingles. Tingling stopped about Sept. 10. On Nov. 11, I had second shingle shot; I have experienced a few tingles, but  not as often or strong as before. I was wondering if this could be side effect from shot.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Muscle twitching, Paraesthesia
Clinical narrative: I took shingle shot on Aug-15; by Aug. 27 I had twitch in eyelid and lip also I felt tingle in left breast area. I described tingle like "cell phone vibration, bee buzzing or sensation when arm goes numb". I went to immediate care center, as soon as I said left breast area, doctor sent me to ER for test (thought it could be heart related). However, I did not think this was a heart issue and after 5 hours, doctor there did not find anything wrong. I counted about 25 times the tingle occurred and subsided within few minutes. Doctor saw chigger bit under my arm and suggested it could be shingles. Tingling stopped about Sept. 10. On Nov. 11, I had second shingle shot; I have experienced a few tingles, but  not as often or strong as before. I was wondering if this could be side effect from shot.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Pyrexia
Clinical narrative: Fever 105°F ibuprofen, cool cloth on head, Tylenol suppository sent to urgent care
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Herpes zoster, Musculoskeletal chest pain, Rash
Clinical narrative: I received my first Shingrix 50MCG/0.5ML SUSR vaccine on 11/10/2019. On 11/16/2019 I developed a sharp pain in the left side of my back which kept getting worse. The pain extended all the way around the ribs over the next few day. On 11/16/2019 I developed a rash and saw my doctor who confirmed I had the Shingles. Several years ago I also had the Shingles and had the old Shingle vaccine in 2018.
Sex: M
Vaccine: VARZOS
Symptoms: Dyspnoea, Oxygen saturation decreased, Restlessness, Seizure
Clinical narrative: SHINGRIX VACCINE (LOT Z4359 EXP 09/19/2020) WAS GIVEN TO PATIENT LEFT ARM DELTOID MUSCLE(IM) ON 11/20/2019 IN THE EVENING 4 PM. REPORTED TO ME AT 9:10AM(11/21/2019) THAT PATIENT WAS TAKEN TO HOSPITAL VIA AMBULANCE. NURSE FROM GROUP HOME STATED THAT 5;30AM THAT MORNING PATIENT HAD DIFFICULTY BEATHING( O2 SATURATION DONE TO 82%) RESTLESS THEN HAD A SEIZURE. LAST SEIZURE WAS IN 2012 AS STATED BY NURSE WORKING AT GROUP HOME WERE PATIENT RESIDES.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Pain, Peripheral swelling
Clinical narrative: vaccine given on Oct 24 2019 - sore & red ever since I received it - red area on arm that seems to encircle the shot area - arm swollen.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: RASH DEVELOPED ON BUTTOCKS, ARMS, LEGS. STILL PRESENT THIS DAY BUT NOT AS PRONOUNCED DOCTOR PRESCRIBED STEROID MEDPAK
Age: 50.0
Sex: F
Vaccine: UNK
Symptoms: Cough, Fatigue, Pyrexia, Respiratory symptom
Clinical narrative: Fever of 100.9 - 102 for 3 days 24° after - Fatigue - x3 days 2 weeks later Respiratory & Cough symptoms
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Dysphagia, Erythema, Feeling hot, Swelling face, Swelling of eyelid
Clinical narrative: (4 hours after shot) FACE AND EYE Lid swelling FACE Hot and Red. TROUBLE swallowing Benedryl 5 days
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Injection site bruising, Pain in extremity, Pruritus, Skin warm
Clinical narrative: arm was itchy. redness developed 2" wide 5 in band. hot arm was very achey Nov22nd & the redness was at it's worse. Took advil & warm compress 2-3 times Bruised area distal to injection site
Age: 43.0
Sex: M
Vaccine: FLU4
Symptoms: Asthenia, Dyspnoea, Malaise, Pain, Pyrexia
Clinical narrative: Sudden pain, malaise, weakness, fever 101.8 the first night. Fever up to 103 degrees - felt immediately "in blood" shortness of breath
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Mobility decreased, Myalgia
Clinical narrative: Severe Muscle pain all over (back, neck, leggs, arms hands, feet) 2-3 days  Headache - 4-5 days Shivering - 1 day Completely bedfast 2 days
Age: 66.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Dizziness, Injection site erythema, Peripheral swelling, Pruritus
Clinical narrative: after Receiving Both shots my arms Began itching & swelling. My Right arm about 4 inches my left arm By the Time I woke up in the AM the 10/30 my left arm was 2 Times it's size & Bright Red from the Top To the quarter: I went To work & felt Dizzy & went To ER-
Age: 66.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Injection site pruritus, Injection site swelling, Pain in extremity
Clinical narrative: after Receiving Both shots my arms Began itching & swelling. My Right arm about 4 inches my left arm By the Time I woke up in the AM the 10/30 my left arm was 2 Times it's size & Bright Red from the Top To the quarter: I went To work & felt Dizzy & went To ER-
Age: 1.25
Sex: M
Vaccine: DTAPIPVHIB, MMR, PNC13
Symptoms: Erythema multiforme, Rash
Clinical narrative: Rash, erythema multiforme appearance Diffuse body
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Ear pruritus, Hypersensitivity, Pruritus, Rash, Urticaria
Clinical narrative: Broke out in hives and rash And itched all over body, even in ears. Went to ER. Had a acute allergic reaction, Allergic-reaction major, Urticaria.
Age: 55.0
Sex: F
Vaccine: FLUC4, VARZOS
Symptoms: Axillary pain, Blister, Bone pain, Burning sensation, Discomfort
Clinical narrative: I received these two shots (listed above) on Saturday 11/9/19 my left arm became sore the next day, every day for four days. On Thursday Nov 14, 2019, I woke up with pain, itching, and burning to my Right shoulder blade at 5:00am, and I asked my husband to look at it because I could not see or reach the area. He said it was red, inflamed and has small blisters. I had him apply some gold bond anti itching cream to the area. That help relief some of the discomfort, but by that night on Thursday 11/14/19 it looked more irritated and gradually getting worse over time. At night was the worst pain because it felt deep to the bone and radiated from right shoulder blade to under RT arm pit. I had my husband take a picture of it so I could see what it looked like as it became more red & raised and blistered became larger. On Friday Nov 15, 2019, I went to urgent care. Urgent care and was seen by PA for this rash & was DX with Herpes Zoster without complication. I was prescribed Valacyclovir (Valtrex) 1 gram Tablet. Take one Tablet by mouth three times a day for 7 days. And verbally told to take Tylenol & Ibuprofen for pain, in which it didn't help much for the pain. At this time I no longer have any blisters or itching, but the area to my RT shoulder blade is still red and I still have mild discomfort to this area periodically. I have a follow up doctor's apt scheduled for Dec. 2, 2019.
Age: 55.0
Sex: F
Vaccine: FLUC4, VARZOS
Symptoms: Erythema, Herpes zoster, Inflammation, Musculoskeletal pain, Pain
Clinical narrative: I received these two shots (listed above) on Saturday 11/9/19 my left arm became sore the next day, every day for four days. On Thursday Nov 14, 2019, I woke up with pain, itching, and burning to my Right shoulder blade at 5:00am, and I asked my husband to look at it because I could not see or reach the area. He said it was red, inflamed and has small blisters. I had him apply some gold bond anti itching cream to the area. That help relief some of the discomfort, but by that night on Thursday 11/14/19 it looked more irritated and gradually getting worse over time. At night was the worst pain because it felt deep to the bone and radiated from right shoulder blade to under RT arm pit. I had my husband take a picture of it so I could see what it looked like as it became more red & raised and blistered became larger. On Friday Nov 15, 2019, I went to urgent care. Urgent care and was seen by PA for this rash & was DX with Herpes Zoster without complication. I was prescribed Valacyclovir (Valtrex) 1 gram Tablet. Take one Tablet by mouth three times a day for 7 days. And verbally told to take Tylenol & Ibuprofen for pain, in which it didn't help much for the pain. At this time I no longer have any blisters or itching, but the area to my RT shoulder blade is still red and I still have mild discomfort to this area periodically. I have a follow up doctor's apt scheduled for Dec. 2, 2019.
Age: 55.0
Sex: F
Vaccine: FLUC4, VARZOS
Symptoms: Pain in extremity, Pruritus, Rash, Skin irritation, Swelling
Clinical narrative: I received these two shots (listed above) on Saturday 11/9/19 my left arm became sore the next day, every day for four days. On Thursday Nov 14, 2019, I woke up with pain, itching, and burning to my Right shoulder blade at 5:00am, and I asked my husband to look at it because I could not see or reach the area. He said it was red, inflamed and has small blisters. I had him apply some gold bond anti itching cream to the area. That help relief some of the discomfort, but by that night on Thursday 11/14/19 it looked more irritated and gradually getting worse over time. At night was the worst pain because it felt deep to the bone and radiated from right shoulder blade to under RT arm pit. I had my husband take a picture of it so I could see what it looked like as it became more red & raised and blistered became larger. On Friday Nov 15, 2019, I went to urgent care. Urgent care and was seen by PA for this rash & was DX with Herpes Zoster without complication. I was prescribed Valacyclovir (Valtrex) 1 gram Tablet. Take one Tablet by mouth three times a day for 7 days. And verbally told to take Tylenol & Ibuprofen for pain, in which it didn't help much for the pain. At this time I no longer have any blisters or itching, but the area to my RT shoulder blade is still red and I still have mild discomfort to this area periodically. I have a follow up doctor's apt scheduled for Dec. 2, 2019.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Limb discomfort, Mobility decreased, Muscular weakness, Pain
Clinical narrative: Patient reports soreness, and feels like she is  "unable to lift" her arm up - "it feels heavy".  Patient reports unable to life weights  with arm due to lack of strength, pain  soreness. Shoulder joint aches.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Patient reports soreness, and feels like she is  "unable to lift" her arm up - "it feels heavy".  Patient reports unable to life weights  with arm due to lack of strength, pain  soreness. Shoulder joint aches.
Age: 65.0
Sex: F
Vaccine: FLUC4, FLUC4
Symptoms: Immediate post-injection reaction, Injection site swelling
Clinical narrative: Patient requested a flu shot at her visit. Patient stated she has never had a reaction to the flu vaccine before. I cleaned the site and injected the 1 in needle and released the medication. The patient's arm instantly started to bubble up. I ask the patient id she was feeling okay, she said she felt fine. I asked her to wait a few minutes so Dr. could evaluate her. Dr. came in looked at injection site asked if she felt okay told the patient if the site gets warm or swells or gets red to come back to office or go to urgent care.
Age: 67.0
Sex: F
Vaccine: UNK
Symptoms: Unevaluable event
Clinical narrative: Pharmacy gave me a shot in my right arm
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site bruising, Injection site pain
Clinical narrative: Nov 22, 19 Pt c/o pain & bruising RT deltoid Nov 25th, 19. OVisit. Bruise & 2 smaller bruises Rt deltoid, pain @ bruise areas. Steroid Injection Rt shoulder Nov 14th
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Asthenia, Decreased appetite, Headache, Nausea
Clinical narrative: Patient called on 11/25 and stated that starting the morning after vaccine both legs and hips felt like they had "knives in them". Skin was very tender to touch on different parts of the body. She had nausea/headache and no energy or appetite. Now using ibuprofen and has a dull headache. Other symptoms have resolved.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Patient called on 11/25 and stated that starting the morning after vaccine both legs and hips felt like they had "knives in them". Skin was very tender to touch on different parts of the body. She had nausea/headache and no energy or appetite. Now using ibuprofen and has a dull headache. Other symptoms have resolved.
Age: 1.0
Sex: F
Vaccine: MMR, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Pt had vaccines 11/21 and 11/22 an noted to have quarter sized redness of deltoid area. No warmth or tenderness, 1 cm of induration. Pt well acting.
Age: 61.0
Sex: F
Vaccine: FLUR4
Symptoms: Blood pressure increased, Dizziness, Ear pruritus, Hot flush, Pruritus
Clinical narrative: Face, neck and ears itching; hot flush; highly elevated BP; dizziness
Age: 88.0
Sex: M
Vaccine: FLU3
Symptoms: Contusion, Injection site haemorrhage, Injection site pain
Clinical narrative: pt reports 2 days after vaccination noted soreness/ pain below injection site as well as ecchymosis extending from below injection site to just above elbow . pain resolved after few days,  Bruising has presisted
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Back pain, Chills, Headache, Influenza like illness, Injection site pain
Clinical narrative: Severe flu like symptoms - myalgia, malaise, fever (subjective), terrible shivering, diffuse body ache including severe headache and back pain. Moderate pain at injection site radiating down the left arm to wrist.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Malaise, Myalgia, Pain, Pain in extremity, Pyrexia
Clinical narrative: Severe flu like symptoms - myalgia, malaise, fever (subjective), terrible shivering, diffuse body ache including severe headache and back pain. Moderate pain at injection site radiating down the left arm to wrist.
Age: 0.58
Sex: M
Vaccine: DTAPIPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Kinrix (DTAP-IPV)  vaccine is for the ages of 4-6 yrs old and patient received vaccine at 7 months. No adverse reaction was reported.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects were reported in the patient.; a patient received a vaccine following a temperature excursion.; Information has been received from a medical assistant, referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant medications were not provided.  On an unknown date, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (dose, strength, lot #, expiration date were unknown), which had been following a temperature excursion (lowest temperature below 36 degrees Fahrenheit/2 degrees Celcius (35 degrees Fahrenheit) for 430 minutes) (incorrect product storage). There was no previous temperature excursion. No data logger was involved. No adverse effects were reported in the patient.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects were reported in the patient.; a patient received a vaccine following a temperature excursion; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Information about concomitant medications, pertinent medical history, drug reactions or allergies was not provided.           On 29-OCT-2019 the patient was vaccinated with one dose of improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dosage detail, route, strength, lot # and expiration date were not reported) for prophylaxis.  Administered dose of vaccine experienced temperature excursion of below 36 Fahrenheit degrees (2 Celsius degree) (also reported as 35 Fahrenheit degrees) for 430 minutes. There was no previous temperature excursion. Digital data logger was not involved. No adverse effects were reported in the patient.
Age: 33.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Induration, Pain, Swelling
Clinical narrative: Swelling from biceps to the shoulder blade and up to chest and all in between; the patient stated she had pain, induration, redness, and swelling; the patient stated she had pain, induration, redness, and swelling; the patient stated she had pain, induration, redness, and swelling; indication: asthma; This spontaneous report was received from a registered nurse, referring to a 33-year-old female patient. The patient's pertinent medical history included closed head injury, and concurrent conditions included asthma, anaemia, carpal tunnel syndrome, uterine fibroids, hypertension and migraines. Her previous allergies or drug reactions included allergy to shellfish and iodine. The patient's concomitant therapies included ergocalciferol (Vitamin D2), eszopiclone (LUNESTA), ascorbic acid (Vitamin C), docusate sodium (COLACE), iron (unspecified), sumatriptan, hydrochlorothiazide, fluticasone furoate (+) vilanterol trifenatate (BREO ELLIPTA), albuterol sulfate (PROAIR) and albuterol treatments (manufacturer unknown).   On 28-OCT-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, administered intramuscularly, for asthma (product use in unapproved indication) (dose number and anatomical location were not reported and lot number S018405 has been verified to be a valid lot number, expiration date reported as 28-MAR-2021, but upon internal validation established as 23-MAR-2021).   On that same day after receiving vaccination, the patient experienced swelling from the biceps to the shoulder blade and up to chest and all in between, pain, induration and redness. It was reported that the patient sought medical attention in an office visit, however she refused steroid treatment. No laboratory diagnostics studies were performed.  On 30-OCT-2019, the patient recovered from the events swelling, pain, induration and redness.  The causal relationship between pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) and the aforementioned events was not reported.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects were reported.; A patient received an improperly stored ROTATEQ; Information has been received from a medical assistant, referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant medication were not provided.     On 04-NOV-2019 or 05-NOV-2019, exact date of administration date unknown, the patient was vaccinated with an improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # S004253, expiration date 21-OCT-2020, dose and strength were unknown) orally for prophylaxis. It was reported vaccine was exposed to the temperature at lowest below 36 degrees Fahrenheit or 2 degrees Celsius (1.3 degrees Celsius) for 2 hours 18 minutes (incorrect product storage).  There was no previous temperature excursion. The data logger was involved. Upon this report, no adverse effects were reported.
Sex: F
Vaccine: VARZOS
Symptoms: Cataract, Herpes zoster, Nerve injury, Neuralgia, Post herpetic neuralgia
Clinical narrative: Cataract; Nerve Damage; Post Herpetic Neuralgia; Shingles; Information has been received from a lawyer regarding a case in litigation concerning a female patient(pt) of unknown age.The pt's medical history, concurrent conditions and concomitant medications were not provided. On an unknown date, the pt was vaccinated with zoster vaccine live(ZOSTAVAX)(dose, route of administration, anatomical location, lot#, expiration date were unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). After injection, pt suffered a painful blistering rash, issues with her vision and nerve pain. As a result of her symptoms, pt presented to a medical provider and was diagnosed with Shingles, Post Herpetic Neuralgia, Cataract and Nerve Damage. As a direct and proximate result of zoster vaccine live(ZOSTAVAX), pt's symptoms had resulted in physical limitations not present prior to using zoster vaccine live(ZOSTAVAX). Pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the zoster vaccine live(ZOSTAVAX), pt sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live(ZOSTAVAX),pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live(ZOSTAVAX), pt had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages.   Cataract, herpes zoster, post herpetic neuralgia and nerve injury were considered to be disability. Upon internal review, cataract was determined to be medically significant.