chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 50.0
Sex: M
Vaccine: FLU4
Symptoms: Vomiting
Clinical narrative: patients girlfriend stated when he got home he started vomiting and needed help getting up the steps because he couldn't walk up them alone, she also said he had a fever. Later that day I checked in and she said he stopped vomiting but was sweating and still had leg pain(muscle cramps).
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Influenza like illness, Mobility decreased, Myalgia, Pain in extremity
Clinical narrative: Extremely sore arm to the point of not being able to lift more than 10 degrees without pain. Aches in many muscles in body that felt similar to flu-like symptoms. Very tired for about 24 hours.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Influenza like illness, Injection site pain
Clinical narrative: Significant soreness in vicinity of injection site, muscle aches, body aches, headache, shivering, night sweats, fatigue, tiredness into the second night after the injection.  This felt like a case of the seasonal flu.  By the second morning after the injection I awoke mostly recovered from all the symptoms.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia, Night sweats, Pain
Clinical narrative: Significant soreness in vicinity of injection site, muscle aches, body aches, headache, shivering, night sweats, fatigue, tiredness into the second night after the injection.  This felt like a case of the seasonal flu.  By the second morning after the injection I awoke mostly recovered from all the symptoms.
Age: 41.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Pyrexia
Clinical narrative: FEVER OF 103 FOR 3 DAYS
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Chills, Dizziness, Lethargy, Nausea
Clinical narrative: Woke up with pain across the back of my neck and severe lethargy. Dizziness, nausea, chills and severe lethargy throughout the day caused me to stay in bed until about 4pm - a very rare event. Began to feel better at about 7pm. Felt much better the next day.
Age: 71.0
Sex: M
Vaccine: FLUA4, PPV
Symptoms: Injected limb mobility decreased, Injection site swelling, Loss of personal independence in daily activities, Pain, Peripheral swelling
Clinical narrative: Patient reported swelling in right arm from injection site down to  right hand (noting increased swelling around elbow). Patient stated he could not bend arm to touch face as arm was so swollen. He reported icing arm and taking Advil which reduced some swelling, but still reported pain and swelling 24 hours post vaccines. He reported inability to attend golf tournament he was in due to swelling. He reported no shortness of breath, no chest pain or tightness, and no swelling or tingling anywhere else. Advised patient to seek medical attention if swelling got worse or if he developed any symptoms previously reported as negatives.
Age: 27.0
Sex: F
Vaccine: FLUC4
Symptoms: Erythema, Swelling
Clinical narrative: pt has a raised red area that has been getting larger for 2 days
Age: 33.0
Sex: F
Vaccine: UNK
Symptoms: Contusion
Clinical narrative: PATIENT HAD BRUISING
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Axillary pain, Back pain, Chest pain, Fatigue, Herpes zoster
Clinical narrative: One week after vaccination, developed inflamed, painful back, underarm, chest - all on right side.  10 days after vaccination rash appeared in same area as inflammation - spreading from upper right back  around underarm to right chest.  General fatigue, eyes sensitive to light.  Diagnosed with shingles 8/22/2020.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Inflammation, Photophobia, Rash
Clinical narrative: One week after vaccination, developed inflamed, painful back, underarm, chest - all on right side.  10 days after vaccination rash appeared in same area as inflammation - spreading from upper right back  around underarm to right chest.  General fatigue, eyes sensitive to light.  Diagnosed with shingles 8/22/2020.
Age: 10.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Fall, Head injury, Syncope
Clinical narrative: Guest received a flu shot at Pharmacy, fainted & fell and hit head on floor (said she was dizzy)
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site haemorrhage, Injection site swelling, Peripheral swelling
Clinical narrative: Administered IM flu shot to pt in left deltoid. Pt bled a bit, so removed the sticker and placed a cotton ball on site to apply pressure and stop the bleeding, which it did. Put a regular band-aid on site and began to notice some swelling about the band-aid area. Had technician get an ice pack and had pt apply that to area while we administered 2 IMZ's to her husband. Area was still swollen after several minutes. Gave pt one 25 mg diphenhydramine to take, cautioning drowsiness. Pt said she was feeling fine, but just had the swelling in the arm. We gave her a VIS form and a copy of the exact strains in the Afluria. She said she had gotten flu shots before, but not at this location, so not sure which brand she had in the past. She said she wasn't allergic to eggs or anything else that she was aware of. Tried to call pt that evening to check on her and again the next day, but had not yet heard back from pt.
Age: 65.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Cellulitis, Injection site inflammation, Malaise, Pyrexia
Clinical narrative: Approximately 1 day after vaccination, patient had fever, general malaise inflammation at injection site going down towards elbow. Physician believes cellulitis infection inflammation on right arm only (Prevnar site)
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Fatigue, Headache, Injected limb mobility decreased, Injection site pain
Clinical narrative: Vaccine administered PM 8/17/2020. Developed fever, chills, headache, muscle aches & fatigue starting that same night. Temp was as high as 103.5 Malaise lasted 72 hrs. Also had injection site tenderness and difficulty raising (R) arm, which decreased daily (improved)
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Malaise, Myalgia, Pyrexia, SARS-CoV-2 test negative
Clinical narrative: Vaccine administered PM 8/17/2020. Developed fever, chills, headache, muscle aches & fatigue starting that same night. Temp was as high as 103.5 Malaise lasted 72 hrs. Also had injection site tenderness and difficulty raising (R) arm, which decreased daily (improved)
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: PATIENT REPORTED ARM TO BE STILL SORE AT SITE OF INJECTION. SITE OF INJECTION IS RED, ABOUT 4 INCHES IN DIAMETER AND WARM TO THE TOUCH. NO REPORTS OF PUS/DISCHARGE. RECEIVED VACCINATION 2 DAYS AGO. NO REPORTS OF TROUBLE BREATHING, RASH, HIVES, OR TIGHTNESS IN THE CHEST. PATIENT COUNSEL TO TAKE BENADRYL IN CASE OF ALLERGIC REACTION, COOL COMPRESS TO SITE OF INJECTION AND TO CONSULT WITH PCP SOON. WE ALSO ADVISE PATIENT THAT WE WILL CALL THEIR PCP ALSO TO FORWARD THE INFORMATION AND CHECK WITH THEM IF PATIENT NEEDS TO BE SEEN.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Fatigue, Headache, Nausea, Pain
Clinical narrative: Redness in arm Headache Nausea aches, Body pain exhaustion
Age: 58.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia, Rash
Clinical narrative: fever + face rash after 5 days
Age: 3.0
Sex: F
Vaccine: UNK, UNK, UNK
Symptoms: Amnesia, Crying, Pyrexia, Staring, Unresponsive to stimuli
Clinical narrative: After the shot(s) were given, she went silent from crying, threw up and got down on the floor. She crawled to the corner, sat there and zoned out staring at the corner of the wall. She wouldn't respond to anybody calling her name, you could approach her and there was no response. Like she was frozen. Wouldn't respond to any verbal or physical stimuli. The nurse ran to get the doctor and he came in and just stood there. She finally "came to" but did not recognize me or her father or anything. I tried to pick her up and she would push herself away, crying as if she was scared of me. After everything had happened she finally "snapped" out of it, came to me and said I want to go. She had a high fever for 3-4 days straight. All she remembers is throwing up and that she got a shot. Nothing afterwards.
Age: 3.0
Sex: F
Vaccine: UNK, UNK, UNK
Symptoms: Vomiting
Clinical narrative: After the shot(s) were given, she went silent from crying, threw up and got down on the floor. She crawled to the corner, sat there and zoned out staring at the corner of the wall. She wouldn't respond to anybody calling her name, you could approach her and there was no response. Like she was frozen. Wouldn't respond to any verbal or physical stimuli. The nurse ran to get the doctor and he came in and just stood there. She finally "came to" but did not recognize me or her father or anything. I tried to pick her up and she would push herself away, crying as if she was scared of me. After everything had happened she finally "snapped" out of it, came to me and said I want to go. She had a high fever for 3-4 days straight. All she remembers is throwing up and that she got a shot. Nothing afterwards.
Age: 24.0
Sex: F
Vaccine: ANTH
Symptoms: Local reaction
Clinical narrative: large local reaction right deltoid region, 5 x 7 cm, otherwise no symptoms.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Ageusia, Chest pain, Chills, Dizziness, Headache
Clinical narrative: Fever (temp 100-102 degrees); chills followed by sweats; headache; nausea; severe muscle pain; sharp pains in chest, neck and pelvis; dizziness; loss of taste (coffee/water tasted very tinny) Lasted through out the day Main treatment - Advil and rest
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Hyperhidrosis, Myalgia, Nausea, Neck pain, Pelvic pain
Clinical narrative: Fever (temp 100-102 degrees); chills followed by sweats; headache; nausea; severe muscle pain; sharp pains in chest, neck and pelvis; dizziness; loss of taste (coffee/water tasted very tinny) Lasted through out the day Main treatment - Advil and rest
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Fever (temp 100-102 degrees); chills followed by sweats; headache; nausea; severe muscle pain; sharp pains in chest, neck and pelvis; dizziness; loss of taste (coffee/water tasted very tinny) Lasted through out the day Main treatment - Advil and rest
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood test normal, Computerised tomogram head normal, Dizziness, Fall, Feeling hot
Clinical narrative: The morning after I received the injection, I was sitting at the table on our back porch tending to an injured bird that had hit one of our windows.  Only a minute or two after having sat down, I became extremely hot, light-headed, and nauseous.  I sat the bird down on the table, stood up, and began walking toward the patio door.  As I approached the door, my left arm (the same arm in which I received the injection) began twitching uncontrollably.  I had to reach across my body to open the door with my right hand.  Upon entering our house, I collapsed to my knees and fell forward.  I was able to catch myself from completely collapsing, but then my upper body began to convulse forward and I was unable to stop myself from slamming my head against the floor.  I was completely aware of what was happening, but I just couldn?t control my body.  After multiple convulsions, perhaps 10 ? 12, the convulsions stopped.  During the repetitive impacts with the floor, my nose was cut rather severely, and my forehead suffered a significant abrasion.  Roughly a minute after the convulsions stopped, I began to feel extremely hot and nauseous once again and then vomited.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Head injury, Muscle twitching, Nausea, Seizure, Skin abrasion
Clinical narrative: The morning after I received the injection, I was sitting at the table on our back porch tending to an injured bird that had hit one of our windows.  Only a minute or two after having sat down, I became extremely hot, light-headed, and nauseous.  I sat the bird down on the table, stood up, and began walking toward the patio door.  As I approached the door, my left arm (the same arm in which I received the injection) began twitching uncontrollably.  I had to reach across my body to open the door with my right hand.  Upon entering our house, I collapsed to my knees and fell forward.  I was able to catch myself from completely collapsing, but then my upper body began to convulse forward and I was unable to stop myself from slamming my head against the floor.  I was completely aware of what was happening, but I just couldn?t control my body.  After multiple convulsions, perhaps 10 ? 12, the convulsions stopped.  During the repetitive impacts with the floor, my nose was cut rather severely, and my forehead suffered a significant abrasion.  Roughly a minute after the convulsions stopped, I began to feel extremely hot and nauseous once again and then vomited.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Skin laceration, Syncope
Clinical narrative: The morning after I received the injection, I was sitting at the table on our back porch tending to an injured bird that had hit one of our windows.  Only a minute or two after having sat down, I became extremely hot, light-headed, and nauseous.  I sat the bird down on the table, stood up, and began walking toward the patio door.  As I approached the door, my left arm (the same arm in which I received the injection) began twitching uncontrollably.  I had to reach across my body to open the door with my right hand.  Upon entering our house, I collapsed to my knees and fell forward.  I was able to catch myself from completely collapsing, but then my upper body began to convulse forward and I was unable to stop myself from slamming my head against the floor.  I was completely aware of what was happening, but I just couldn?t control my body.  After multiple convulsions, perhaps 10 ? 12, the convulsions stopped.  During the repetitive impacts with the floor, my nose was cut rather severely, and my forehead suffered a significant abrasion.  Roughly a minute after the convulsions stopped, I began to feel extremely hot and nauseous once again and then vomited.
Age: 77.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Patient called and stated that her arm is red, swollen, and hot down by the elbow. The patient reports that this is 6 inches below the injection site on the left arm. Patient unsure if this was caused by her flu shot. Patient is going to check with her physician if this gets worse or does not improve.
Age: 72.0
Sex: F
Vaccine: FLU4
Symptoms: Vomiting projectile
Clinical narrative: Approximately 4 hours after receiving the flu shot she started projectile vomiting for about 4 times, it lasted a total of 30 minutes and then stopped.
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pain, swelling, and redness at injection site. Patient was unable to move arm the day after injecton, 2 days post injection, patient is able to move arm slightly more.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: patient called and said she has really bad swelling and red at injection site and warm to touch
Age: 88.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Headache, Nausea, Vomiting
Clinical narrative: husband called next day and said patient had headache, nausea, vomiting. He stated patient did not have a fever or any other symptoms. kept calling in following days no answer. patient had to have both in right arm because of  mastectomy.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Malaise, Pain, Vaccination site bruising, Vaccination site swelling
Clinical narrative: Swelling at the vaccine site at upper left arm. Bruised feeling at site. Approximately 4 hours after the injection. General achiness and malaise this morning
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: Itchy, red, rash.  Under right eye, above right eye brow, back of neck on right side, along  waist, front, on right side
Age: 18.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Musculoskeletal stiffness, Pruritus
Clinical narrative: My arm itched for about 3 days after I received the Meningitis ACWY vaccine. I also had stiffness in varying parts of my body for about a week after.
Age: 67.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Injection site irritation, Injection site urticaria, Mobility decreased, Pain in extremity, Skin warm
Clinical narrative: Patient received both vaccines in right arm separated by an inch apart on Friday 8/21/20. Patient returned to pharmacy on Sunday 8/23/20 with complaints of being unable to move arm, very sore, and warm to the touch. She had three small welts that were pink and raised and irritated that were not at the site of injection but around it. She explained that she did not have the same effect with the first dose of Shingrix but she did not have any other vaccine at the same time as that one. This was her first Pneumonia vaccine however.
Age: 35.0
Sex: F
Vaccine: HPV9
Symptoms: Generalised tonic-clonic seizure, Loss of consciousness
Clinical narrative: EMS activated since pt had grandmal seziure for 30 seconds after getting HPV vaccine, loss of conciousness less than 10 seconds alert & oriented, no acute distress noted, vitals signs within normal limit. Pt and family member refused and left the clinic prior to EMS arrival. EMS arrived @1426 on 8/22/2020.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Eczema, Rash
Clinical narrative: I had my first Shingrix vaccine on May 1  2020.  Approx 8 to  10 days later I broke out in a rash across my chest.  My physician diagnosed eczema and said it wasn't related to vaccine.  On August 11 I had my second Shingrix vacvine and 9 days later my right hand has erupted with an ecxema rash.  I don't  think that this is coincidence.   Knowing that I have an autoimmune gastritis and that eczema is an autoimmune dermatitis and that many people have more than one autoimmune disease,  I felt it important to report this reaction, especially since it is not mentioned in the literature given ro patients.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Diarrhoea, Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Patient had redness and swelling at injection site when she was home. She also had symptoms of diarrhea, chills, fever, runny nose and still has that several days later.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Rhinorrhoea
Clinical narrative: Patient had redness and swelling at injection site when she was home. She also had symptoms of diarrhea, chills, fever, runny nose and still has that several days later.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Nausea, Pain, Vomiting
Clinical narrative: Vomiting, Chills, nausea, body aches, headache
Age: 72.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Headache, Injection site pain, Nausea, Pyrexia
Clinical narrative: Patient states that she has a mild fever, headache, injection site soreness and mild nausea
Age: 25.0
Sex: M
Vaccine: FLUC4
Symptoms: Seizure
Clinical narrative: Pt had seizure. Pts guardian did not feel it was related and pt has had flu shots each year with no adverse effects per guardian.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: Patient reports noticing some red itchy bumps presenting below her buttocks and behind her knees the morning after vaccination. She initially thought that they were bug bites, but as the day progressed, more spots appeared. They are not painful, just itchy and patient describes them as small and thinks they are hives. Patient was advised to continue monitoring reaction and to seek treatment at a local urgent care or PCP for evaluation.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Mass
Clinical narrative: Patient states there is a circle on her upper arm which is red. She also feels a lump under the  skin.
Age: 74.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Discomfort, Erythema, Injection site pain, Pain, Swelling
Clinical narrative: Pt. started by stating she didn't feel any pain from the vaccinations at the time of injection but later reported some swelling, pain and discomfort. She didn't state the exact time when it started but presumable either Friday night or Saturday morning.  Symptoms as of the 23rd (when reported to pharmacy) are pain at the actual injection site (when touched), swelling, hot to the touch, and redness.  The redness has primarily dissipated from the injection site but has migrated down and around (migrated toward bicep and down to about 4in from elbow).  Pt. states the redness is dissipating slowly but still present. No breathing problems or other ADRs.  Pt. was told to take some diphenhydramine and her regular acetaminophen for pain. **NSAIDs not tolerated per pt.  Pharmacist, told pt. he would check with her Tuesday morning after starting diphenhydramine. **pt was counseled on safe usage and potential side effects of diphenhydramine tablets. Ice packs wrapped in a thin towel were also recommended to help reduce swelling and discomfort.  Lastly, pt was told to report to primacy or ED if symptoms worsen, ie breathing problems but pharmacist will check with pt. Tuesday morning.
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site bruising, Injection site discolouration, Injection site inflammation, Injection site pain
Clinical narrative: Mum  reported today  pain, inflammation, and bruising at site of injection since it was given on friday so she sent patient over. When patient came I observed the injection site was bruised and darkened but did not see swelling. I advised patient to take tylenol for the pain and see if things improve by tomorrow.
Age: 2.08
Sex: F
Vaccine: FLU4
Symptoms: Alopecia, Alopecia universalis, Asthma, Autoimmune disorder, Food allergy
Clinical narrative: Pt had alopecia ophiasis only to areas above ears prior to vaccine. The next day after vaccine given, the rest of her hair on her head fell out in clumps and thinned out and she had alopecia totalis within a week. To this day, patient has lost her eyebrows, has no hair on her head and she has alopecia universalis (an autoimmune disease.) She now also has many food and environmental allergies and asthma (autoimmune diseases). After her 1 year vaccines given 9/29/15- Prevnar 13, MMR, Hep A, Influenza  (Fluzone) HIB and DTAP patient developed wheezing, asthma symptoms on 12/21/15 along with Oititis media and was given Fluzone that same day. She had multiple MD visits for viral problems since then until 10/3/16.
Age: 2.08
Sex: F
Vaccine: FLU4
Symptoms: Hypersensitivity, Otitis media, Viral infection, Wheezing
Clinical narrative: Pt had alopecia ophiasis only to areas above ears prior to vaccine. The next day after vaccine given, the rest of her hair on her head fell out in clumps and thinned out and she had alopecia totalis within a week. To this day, patient has lost her eyebrows, has no hair on her head and she has alopecia universalis (an autoimmune disease.) She now also has many food and environmental allergies and asthma (autoimmune diseases). After her 1 year vaccines given 9/29/15- Prevnar 13, MMR, Hep A, Influenza  (Fluzone) HIB and DTAP patient developed wheezing, asthma symptoms on 12/21/15 along with Oititis media and was given Fluzone that same day. She had multiple MD visits for viral problems since then until 10/3/16.
Age: 74.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Chills, Confusional state, Dizziness, Injection site pain, Musculoskeletal discomfort
Clinical narrative: PATIENT STATED HE RECEIVED TWO VACCINES IN THE SAME ARM. PATIENT WAS HAVING ISSUES WITH HIS SHOULDER ON THE OTHER ARM. PATIENT STATED THAT THE PERSON THAT ADMINSTERED THE VACCINE CLEANED THE AREA THOROUGHLY AND KEPT THE IMMINUZATIONS 2 INCHES APART. PATIENT DID NOT HAVE ANY PAIN OR ADVERSE REACTIONS AT TIME OF VACCINATIONS. PATIENT WENT HOME AND AT NIGHT HAD ADVERSE REACTIONS TO THE VACCINATIONS INCLUDING: PAIN IN THE ARM WHERE THE VACCINES WERE ADMINSTERED, HAD A HARD SPOT DEVELOP IN THE ARM, PATIENT TEETH WERE "CHATTERING" ALL NIGHT, PATIENT SUFFERED FROM DIZZINESS AND CONFUSION AS WELL. PATIENT STATED THE ADVERSE SYMPTOMS HE WAS EXPERIENCING ARE GETTING BETTER BUT HE HAS NOT FULLY RECOVERED FROM THE SHOTS. PATIENT WAS ADVISED TO GO SEE A DOCTOR DUE TO THE ADVERSE REACTIONS HE WAS HAVING.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Fatigue, Headache, Menstruation irregular, Migraine
Clinical narrative: Within a couple hours of administration, patient got a "pounding headache" or migraine and tiredness that lasted for about 2 days. She also claims that she started her period that same day despite being on a regular oral hormonal contraceptive (she wasn't supposed to get her period for another 2 weeks). She denied it was spotting and said it lasted for about 3 weeks, though unsure if triggered by vaccine.
Age: 85.0
Sex: F
Vaccine: FLUA4, PPV
Symptoms: Cellulitis, Chills, Injection site erythema, Injection site warmth, Pyrexia
Clinical narrative: Patient called the morning of August 22 stating that on  the evening that she had her immunizations she developed a fever and chills. She also stated there was warmth and  redness around the injection site. She stated subsequently that the redness began to progress. She said the area is warm to touch as well.  I advised her to be seen by a physician  as the redness and warmth  instead of receding  was now spreading down to her elbow. I was concerned that she may have developed cellulitis.
Age: 74.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Erythema, Injection site warmth, Pruritus, Pyrexia, Swelling
Clinical narrative: swollen, redness,  itching, fever the site felt hot
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling, Rash
Clinical narrative: Pt has rashes on legs, arms, belly, chest. Non-itchy. Non-painful. Happened within 24 hrs of getting 2nd Shingrix Shot. Got shingrix (Dose 2/2) 8/19, rashes started 8/20. Sometimes get worse, sometimes better. Some swelling of fingers. No airway swelling/difficulty breathing.  Pt called to report this. Treated with Prednisone 40mg Once Daily x 5 days.
Age: 74.0
Sex: F
Vaccine: PNC13, TDAP
Symptoms: Injection site rash
Clinical narrative: Patient received three vaccines on 8/19/20. She also received the first dose of Shingrix, but it was in the right arm. Patient developed a small rash on the left deltoid where the Boostrix and Prevnar were administered. Patient has just experienced a rash and no other complications
Age: 64.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Abdominal pain upper, Chills, Decreased appetite, Lethargy
Clinical narrative: lethargy, loss of appetite, stomach pain, chills
Age: 85.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Blood test, Computerised tomogram head, Dry mouth, Fall
Clinical narrative: Trembling, shaking, weakness, headache, extreme dry mouth, Cold to the touch - Dr advised Benadril, gave her 1, she slept and woke up 2 hours later extremly weak and fell.  2 hours later we still couldn't get her off the floor, called police to help.  They helped get her into bed.  She slept trembling all night. Woke around 9am, got out of bed, fell and hit her head.  Spent entire day in the emergency room.
Age: 85.0
Sex: F
Vaccine: FLU4
Symptoms: Head injury, Headache, Peripheral coldness, Tremor
Clinical narrative: Trembling, shaking, weakness, headache, extreme dry mouth, Cold to the touch - Dr advised Benadril, gave her 1, she slept and woke up 2 hours later extremly weak and fell.  2 hours later we still couldn't get her off the floor, called police to help.  They helped get her into bed.  She slept trembling all night. Woke around 9am, got out of bed, fell and hit her head.  Spent entire day in the emergency room.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Malaise, Myalgia, Nausea
Clinical narrative: Shot site pain and skin was pink, severe nausea which lessened over 3 days, mild fever(98.7) normal temperature is 97.1. Muscle pain especially the neck. Felt sick for two days.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Shot site pain and skin was pink, severe nausea which lessened over 3 days, mild fever(98.7) normal temperature is 97.1. Muscle pain especially the neck. Felt sick for two days.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Lethargy, Pain in extremity
Clinical narrative: Lethargic, very red and sore right arm
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect product formulation administered, No adverse event, Product preparation issue
Clinical narrative: I forgot to reconstitute the lyophilized shingrix vaccine component.  I drew out the adjuvant, portion.  I mistakenly thought, I had already reconstituted it. I switched to the safety needle.  I adminstered it to the left deltoid IM.  After the patient left, I recognized I had failed to reconstitute the vaccine because it was still in the vial.  I called the patient to report the error.  I called the manufacturer for step by step instructions on how to remedy the error.  They were closed.  I informed the patient I will call them on Monday.  Patient was experiencing no adverse effects of incomplete vaccination.
Age: 33.0
Sex: F
Vaccine: HEP, MMR, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: The next day The patient noticed her right upper arm was red, swollen, and warm to the touch. About 2 inches wide & 3 inches long around the area of the shot.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Facial paralysis
Clinical narrative: Bell's palsy developed 3 days after injection. Patient reported to ED on 8/22/2020 and was given Bell's palsy diagnosis.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Atrial fibrillation, Blood test, Condition aggravated, Dyspnoea, Echocardiogram
Clinical narrative: This was 2nd shingles vaccine - Awoke at 1205 AM on 8/5/2020 with sore Bicep at injection site (same as 1st vaccine) then after taking 2 Tylenol 650mg at 12:15 AM my heart rate went to 185 beats per minute and continued with S.O.B. - I was capturing beats with my I watch/finger pulse equipt. I woke spouse and went to ER where I was started on IV. The EKG at 2:06 11 8/5/2020 in ER showed Heart rate at 160 bpm - Atrial Fibrillation with Rapid Ventricular Response - Septal Infarct, ST & T wave abnormality with consideration for inferolateral ischemia - Abnormal EKG. I was given a anticoagulant shot in stomach & at 5:00 ? AM taken to room where Cardizem was given IV with Bld thinners. Around 530pm I converted to Normal sinus rhythm Echocardiogram done & blood work. Released on 8/6 from hospital on XARELTO (Rivaroxaban) 20mg TOPROL XL (Metoprolol) Had 2 days of migraine (like 1st shingles vaccine). No further episodes Followup with Holter Monitor for 48 hrs 8/11/2020 - (Normal results) Put on XARELTO & TOPROL XL)
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Electrocardiogram ST-T segment abnormal, Electrocardiogram ambulatory normal, Heart rate increased, Injection site pain, Migraine
Clinical narrative: This was 2nd shingles vaccine - Awoke at 1205 AM on 8/5/2020 with sore Bicep at injection site (same as 1st vaccine) then after taking 2 Tylenol 650mg at 12:15 AM my heart rate went to 185 beats per minute and continued with S.O.B. - I was capturing beats with my I watch/finger pulse equipt. I woke spouse and went to ER where I was started on IV. The EKG at 2:06 11 8/5/2020 in ER showed Heart rate at 160 bpm - Atrial Fibrillation with Rapid Ventricular Response - Septal Infarct, ST & T wave abnormality with consideration for inferolateral ischemia - Abnormal EKG. I was given a anticoagulant shot in stomach & at 5:00 ? AM taken to room where Cardizem was given IV with Bld thinners. Around 530pm I converted to Normal sinus rhythm Echocardiogram done & blood work. Released on 8/6 from hospital on XARELTO (Rivaroxaban) 20mg TOPROL XL (Metoprolol) Had 2 days of migraine (like 1st shingles vaccine). No further episodes Followup with Holter Monitor for 48 hrs 8/11/2020 - (Normal results) Put on XARELTO & TOPROL XL)
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Myocardial infarction
Clinical narrative: This was 2nd shingles vaccine - Awoke at 1205 AM on 8/5/2020 with sore Bicep at injection site (same as 1st vaccine) then after taking 2 Tylenol 650mg at 12:15 AM my heart rate went to 185 beats per minute and continued with S.O.B. - I was capturing beats with my I watch/finger pulse equipt. I woke spouse and went to ER where I was started on IV. The EKG at 2:06 11 8/5/2020 in ER showed Heart rate at 160 bpm - Atrial Fibrillation with Rapid Ventricular Response - Septal Infarct, ST & T wave abnormality with consideration for inferolateral ischemia - Abnormal EKG. I was given a anticoagulant shot in stomach & at 5:00 ? AM taken to room where Cardizem was given IV with Bld thinners. Around 530pm I converted to Normal sinus rhythm Echocardiogram done & blood work. Released on 8/6 from hospital on XARELTO (Rivaroxaban) 20mg TOPROL XL (Metoprolol) Had 2 days of migraine (like 1st shingles vaccine). No further episodes Followup with Holter Monitor for 48 hrs 8/11/2020 - (Normal results) Put on XARELTO & TOPROL XL)
Age: 69.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Musculoskeletal stiffness, Nausea, Pain, Pyrexia
Clinical narrative: 102' fever, shaking, stiff neck & shoulder, locked Jaw, vomiting, weak, nausea pain that gradually subsided. -Advised patient on 8/21/20 evening when reported the reaction to go to ER. -Contacted patient again on 8/23/20. Patient indicated she did not go to ER or contact Doctors about it but feeling better. -Advised patient on Sunday 8/23/20 to at least call her doctor tomorrow to describe the event & get advise on what to do.
Age: 69.0
Sex: F
Vaccine: FLU4
Symptoms: Tremor, Trismus, Vomiting
Clinical narrative: 102' fever, shaking, stiff neck & shoulder, locked Jaw, vomiting, weak, nausea pain that gradually subsided. -Advised patient on 8/21/20 evening when reported the reaction to go to ER. -Contacted patient again on 8/23/20. Patient indicated she did not go to ER or contact Doctors about it but feeling better. -Advised patient on Sunday 8/23/20 to at least call her doctor tomorrow to describe the event & get advise on what to do.
Age: 88.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site pain, Injection site rash
Clinical narrative: Patient's caregiver/relative, called and stated parent had a 3 inch rash on injection site and a 1 inch tender bubble. Per immunizing RPh were injection correctly (IM) suggest patient take Tylenol for pain cold compress. if no relief see doctor who prescribed antibiotics
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site pain, Neck pain, Pain
Clinical narrative: Patient called 08/23 advising pharmacy manager that she had immediate (08/04/2020) radiation of pain from injection site to neck, pain was irritating the first day, and minimized to dull irritation but has continued every day until 08/23 and continues. She has been alleviating pain with Advil PM and Advil but it is not ceasing pain.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Mobility decreased
Clinical narrative: Patient reported numbness in Left arm and fingers on left hand starting shortly after receiving vaccine and still experiencing symptoms also having trouble moving arm
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Chronic inflammatory demyelinating polyradiculoneuropathy, Hypoaesthesia, Immunoglobulin therapy, Neurological decompensation, Paraesthesia
Clinical narrative: peripheral neuropathies; suspected autoimmune reaction; chronic inflammatory demyelinating polyneuropathy; Paresthesia/tingling; numbness/numbness of both lower legs/shoulder numbness; Progressive neurological deficit; zoster Shingles; This case was reported by a lawyer and described the occurrence of peripheral neuropathy in a patient who received Herpes zoster (Shingrix) for prophylaxis.  The initial information received on 17 August 2020 via medical records(the case was medically confirmed). The patient had Drug allergy towards prolia in 2014. The patient family history included brain aneurysm to her sister. On 11 August 2018, the patient injected Zoster (Shingles) Shingrix every 2 months ending after two times. As per Reported on 29 August 2018, Paresthesia/numbness Progressive neurological deficit, tingling. She reported that, she had second dose of shingrix about 3 weeks ago on, however, over the last week, she has noted waxing and waning paresthesias/numbness of both lower legs and also in her arms up to her shoulders, begin gabapentin. As per medical records, start of care on 15 November 2018 for the diagnosis CIDP (chronic inflammatory demyelinating polyneuropathy, to treat CIDP patient took IVIG 50gm infusion. The patient had a difficult year with newly diagnosed CIDP thought 2/2 shingrix vaccination in august 2018. As per data reported on 13 June 2019, the patient had suspected autoimmune reaction to Shingrix vaccine in 2018, Shingrix *VACCINES* developed CIDP after 2nd dose.
Age: 74.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia
Clinical narrative: Injection given mid morning March 2, 2020. By afternoon running temperature with muscle aches. Temperature lasted approx 24 hrs. on March 3. I woke up with a very itchy rash. It took 3 months of xolair injections plus xyzal oral tab before rash deminished. Not taking second injection.
Age: 74.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Body temperature increased, Myalgia, Rash pruritic
Clinical narrative: Injection given mid morning March 2, 2020. By afternoon running temperature with muscle aches. Temperature lasted approx 24 hrs. on March 3. I woke up with a very itchy rash. It took 3 months of xolair injections plus xyzal oral tab before rash deminished. Not taking second injection.
Sex: F
Vaccine: PPV, PPV
Symptoms: Paraesthesia
Clinical narrative: tingling in her arm; she has a bruise where the vaccine was given; This spontaneous report was received from a 77-year-old female patient, who was reporting on herself. The patient's pertinent medical history, drug reactions and concomitant medication was not provided. She had allergy to ibuprofen.  On 17-JUL-2020, reported as about 10 days ago, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) in the upper right arm for prevention of pneumonia (lot #, expiration date, exact dose, vaccine schedule, route of administration were not provided).  On 18-JUL-2020, reported as a day after vaccination, she experienced tingling in her arm. Since an unknown date in July 2020, she had a bruise where the vaccine was given. The patient took diphenhydramine hydrochloride (BENADRYL) as a treatment, but she stated it did not help. The outcome of the events was reported not resolved.   The causality assessment was not provided.
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site bruising, Paraesthesia
Clinical narrative: tingling in her arm; she has a bruise where the vaccine was given; This spontaneous report was received from a 77-year-old female patient, who was reporting on herself. The patient's pertinent medical history, drug reactions and concomitant medication was not provided. She had allergy to ibuprofen.  On 17-JUL-2020, reported as about 10 days ago, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) in the upper right arm for prevention of pneumonia (lot #, expiration date, exact dose, vaccine schedule, route of administration were not provided).  On 18-JUL-2020, reported as a day after vaccination, she experienced tingling in her arm. Since an unknown date in July 2020, she had a bruise where the vaccine was given. The patient took diphenhydramine hydrochloride (BENADRYL) as a treatment, but she stated it did not help. The outcome of the events was reported not resolved.   The causality assessment was not provided.
Age: 54.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Blister, Lip swelling, Pyrexia, Rash
Clinical narrative: Patient woke up with chills/Fever (102-7)/Sweating/entire body redness, blurry vision, red eyes. Post 72 hours of vaccination patient saw rash from both ankles progressing to Lower torso (belly, upper thigh). Patient had occasional difficulty breathing.
Age: 54.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Stevens-Johnson syndrome, Swelling
Clinical narrative: Patient woke up with chills/Fever (102-7)/Sweating/entire body redness, blurry vision, red eyes. Post 72 hours of vaccination patient saw rash from both ankles progressing to Lower torso (belly, upper thigh). Patient had occasional difficulty breathing.
Age: 54.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Dyspnoea, Erythema, Hyperhidrosis, Ocular hyperaemia
Clinical narrative: Patient woke up with chills/Fever (102-7)/Sweating/entire body redness, blurry vision, red eyes. Post 72 hours of vaccination patient saw rash from both ankles progressing to Lower torso (belly, upper thigh). Patient had occasional difficulty breathing.
Age: 54.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia, Rash, Vision blurred
Clinical narrative: Patient woke up with chills/Fever (102-7)/Sweating/entire body redness, blurry vision, red eyes. Post 72 hours of vaccination patient saw rash from both ankles progressing to Lower torso (belly, upper thigh). Patient had occasional difficulty breathing.
Age: 67.0
Sex: F
Vaccine: FLU4, UNK
Symptoms: Atrial fibrillation, Heart rate increased, Respiratory rate increased
Clinical narrative: About an hour after receiving the vaccines, I was breathing heavy and I was having flutters in my heart. I thought they would go away. However, it kept me up all night. The next day, Monday, 8/18/2020, I called my doctor and asked to have my blood pressure checked. They sent me to Medical center Emergency Room, where I stayed until released on Tuesday, in the afternoon.
Age: 67.0
Sex: F
Vaccine: FLU4, UNK
Symptoms: Cardiac flutter, Dyspnoea
Clinical narrative: About an hour after receiving the vaccines, I was breathing heavy and I was having flutters in my heart. I thought they would go away. However, it kept me up all night. The next day, Monday, 8/18/2020, I called my doctor and asked to have my blood pressure checked. They sent me to Medical center Emergency Room, where I stayed until released on Tuesday, in the afternoon.
Age: 18.0
Sex: M
Vaccine: HPV9
Symptoms: Presyncope, Urinary incontinence
Clinical narrative: Brief near-syncopal event, self-resolved, with associated loss of bladder control.
Age: 1.0
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: improperly stored vaccine was administered to a patient; This spontaneous report was received from a medical assistant and refers to a 12-month-old male patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 27-JUL-2020, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) rHA, 0.5 ml, injected (not further specified) once lot # T003833 and expriation date 01-AUG-2021 (formulation, exact dose and route of administration were not reported) for prophylaxis. No additional adverse events were reported. A temperature excursion of -11.17 degrees Celsius (C) for 19 hours was noted. There was a previous temperature excursion of -11.17 degrees C for 2 hours. A data logger was used to capture the temperature excursions.  This is one of multiple reports from the same reporter.; Sender's Comments:  US-009507513-2007USA010509:
Age: 1.5
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse symptoms reported; inadvertently administered an expired dose of VAQTA; This spontaneous report was received from a medical assistant and refers to a 18-month-old patient of unknown gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medication were not provided.  On 29-JUL-2020, the patient was inadvertently vaccinated with an expired dose of hepatitis a vaccine, inactivated(VAQTA) lot # S007768 confirmed to be valid, expiration date reported as 24-JUL-2020 for prophylaxis (exact dose, route of administration and anatomical location were not provided). No adverse symptoms were reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; manufactureraddress:; manufacturercity:; manufacturerstate:; manufacturercountry:; devicelotnumber: S007768; expirationdate: 24-JUL-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: M
Vaccine: MMR
Symptoms: Deformity, Granuloma skin, Papule, Rubivirus test positive, Skin plaque
Clinical narrative: 1-year-old male patient. He was born at term following an uncomplicated twin pregnancy and delivery. The patient demonstrated mild gross motor and speech delay as an infant and was diagnosed with Ataxia-Telangiectasia (AT) at age of 3-year-old. On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) (dose, route of administration, lot # and expiration date were not reported) for routine immunization. On an unknown date he received all routine immunizations, including live vaccinations (unspecified). On an unknown date, the patient developed granulomatous skin lesions at age of 1-year-old, initially small papules on his cheeks and ears, which subsequently formed large disfiguring plaques on sun-exposed areas cheeks, arms and hands. On an unknown date, following an extensive workup, his lesions were found to be secondary to a mutated vaccine-strain Rubella (RA27/3) based on 739bp genotyping. His lesions had been refractory to multiple treatments including nitazoxanide. He was currently on daily oral and topical steroids (unspecified), sulfamethoxazole (+) trimethoprim (reported as TMP/SMX) and intravenous immunoglobulin (IVIG). The outcome of granuloma skin and rubivirus test positive was unknown. Granuloma skin and rubivirus test positive to be related to Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (manufacturer unknown), as the therapy led to the debilitating granulomas in the older patient.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: a patient received a dose of VARIVAX after a temperature excursion; No other adverse effects were reported; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On an unknown date, the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck) (VARIVAX) after temperature excursion, lot # S038177, expiry date 26-NOV-2021 (dose, route of administration and anatomical location were not provided) for prophylaxis. The vaccine experienced temperature excursion of -1.3 Celsius degrees (temperature range -9 to 8 Celsius degrees) for 44 minutes. There were previous temperature excursions of -10.4 Celsius degrees (temperature range -14 to -10 Celsius degrees) for 29 minutes, -13 Celsius degrees (temperature range - 14 to -10 Celsius degrees) for 24 minutes and -5.6 Celsius degrees (temperature range -9 to 8 Celsius degrees) for 39 minutes. Digital data logger was involved. The vaccine was reconstituted with 0.5 ml of sterile diluent. No additional adverse effects were reported.