chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 87.0
Sex: F
Vaccine: FLU4
Symptoms: Contusion
Clinical narrative: Patient presented at the pharmacy with extensive bruising from mid arm to elbow.  She claimed that the pharmacist applied a tourniquet, which is why she was bruised.  I spoke with the pharmacist that administered the vaccination and confirmed that he did NOT use a tourniquet (we don't even have tourniquets).  The patient insisted that one was used, and I explained to her that we do not have, nor have ever had tourniquets.  I encouraged her to consult with her MD regarding the bruising, since something clearly had happened to cause it.  The shoulder area where the shot was administered was not bruised, so I suspect that something else caused it.  The patient was very elderly and not a reliable witness to ascertain what else could have happened.
Age: 62.0
Sex: M
Vaccine: FLU4
Symptoms: Blood pressure increased, Dizziness, Vision blurred
Clinical narrative: C/O dizzy; blurred vision about 5 min after injection of flu vaccine see #17 130pm 10/7/2020- PC to participcat and he stated he went to the ER and stayed until 7pm. His BP went down to normal and he was discharged home. Feeling much better today.
Age: 16.0
Sex: F
Vaccine: FLUC4
Symptoms: Dizziness, Feeling abnormal, Loss of consciousness
Clinical narrative: Patient and patient's family presented for seasonal flu vaccine. Mom filled out VAR for daughter. All questions were checked as "NO". "No" was answered for feeling sick today, any health conditions, any allergies, ever had any reaction to a vaccine, any seizure disorder or pregnancy. Patient received vaccine intramuscular in left deltoid. Approximately 10 minutes later, patient felt light headed and sat down on the floor. Patient stated that she didn't feel good and passed out. Paramedics were summoned and patient was transported to Medical Center. Mom stopped in about 3 hours later to update me. Mom stated that daughter has orthostatic hypotension but was not affected by vaccines previously. Patient does develop a seizure when she passes out per mom. ER doctor did not believe the patient passing out was related to the flu vaccine. Patient was back home by about 1000.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain
Clinical narrative: Patient reported to pharmacy on 10/8/2020 that she has experienced pain and soreness in the left shoulder since she was administered vaccination. Patient does not have PCP and was instructed to be evaluated at an urgent care clinic or emergency room. She states she waited to report incident hoping pain would subside, but it has not
Age: 75.0
Sex: F
Vaccine: FLUA3
Symptoms: Musculoskeletal stiffness, Pain
Clinical narrative: patient came in complaining of sharp pain and stiff muscles over a week after flu shot.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Pyrexia, Seizure
Clinical narrative: Mother reports patient developed a fever of 103 degrees. He was treated with tylenol close to 1AM. Later during the middle of the night he started to have a seizure. Mother reports it lasted over 1min. Mother called 911. EMS took him to Hospital.
Age: 0.58
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; PNEUMOVAX 23 WAS ADMINISTERED IN ERROR INSTEAD OF PCV 13; PNEUMOVAX 23 WAS ADMINISTERED IN ERROR INSTEAD OF PCV 13; PNEUMOVAX 23 WAS ADMINISTERED TO 7 MONTH OLD; This spontaneous report as received from a medical assistant refers to a 7-month old child of an unknown gender. No information regarding patient's concurrent conditions, pertinent medical history, drug allergies and concomitant therapies was provided.  On 22-SEP-2020, the patient was vaccinated with dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (dose, site of administration not reported) (lot # S029916 confirmed to be valid; expiration date:12-JUN-2021) for prophylaxis instead of pneumococcal 13v conj vaccine (crm197) (reported as PCV 13). The first and second doses of PCV 13 was administered as prescribed per callers report. The third dose that was administered was pneumococcal vaccine, polyvalent (23-valent) (PNEUMOV AX 23) (also reported as It was 1 time dose in 3rd dose in series). The reporter stated, that this was alike medication error , which was discovered on 06-OCT-2020. The patient was well without any residual effects or side effects. No additional adverse event (AE) was reported.    combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S029916; expirationdate: 12-JUN-2021; 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
Age: 80.0
Sex: F
Vaccine: VARZOS, FLU4, FLUA4, MMR, VARZOS
Symptoms: Back pain, Chest pain, Herpes zoster, Lip swelling
Clinical narrative: got the shingles; chest pain; back pain; Lips were swollen; This case was reported by a nurse via patient support programs and described the occurrence of shingles in a 80-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd September 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 weeks after receiving Shingrix, the patient experienced shingles, chest pain, back pain and lip swelling. On an unknown date, the outcome of the shingles, chest pain and back pain were unknown and the outcome of the lip swelling was recovered/resolved.   The reporter considered the shingles, chest pain, back pain and lip swelling to be related to Shingrix.  Additional details were provided as follows: The called and stated that she had reactions due to the Shingrix vaccine. The patient had chest and back pain.  The patient's lips were swollen for a week plus got the shingles even after the vaccine. The patient consented to follow up and agreed to follow up with her health care provider.
Age: 80.0
Sex: F
Vaccine: VARZOS, FLU4, FLUA4, MMR, VARZOS
Symptoms: Allergy to vaccine, Cough, Diarrhoea, Nausea, Pain
Clinical narrative: got the shingles; chest pain; back pain; Lips were swollen; This case was reported by a nurse via patient support programs and described the occurrence of shingles in a 80-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd September 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 weeks after receiving Shingrix, the patient experienced shingles, chest pain, back pain and lip swelling. On an unknown date, the outcome of the shingles, chest pain and back pain were unknown and the outcome of the lip swelling was recovered/resolved.   The reporter considered the shingles, chest pain, back pain and lip swelling to be related to Shingrix.  Additional details were provided as follows: The called and stated that she had reactions due to the Shingrix vaccine. The patient had chest and back pain.  The patient's lips were swollen for a week plus got the shingles even after the vaccine. The patient consented to follow up and agreed to follow up with her health care provider.
Age: 80.0
Sex: F
Vaccine: VARZOS, FLU4, FLUA4, MMR, VARZOS
Symptoms: Pain in extremity, Vomiting
Clinical narrative: got the shingles; chest pain; back pain; Lips were swollen; This case was reported by a nurse via patient support programs and described the occurrence of shingles in a 80-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd September 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 weeks after receiving Shingrix, the patient experienced shingles, chest pain, back pain and lip swelling. On an unknown date, the outcome of the shingles, chest pain and back pain were unknown and the outcome of the lip swelling was recovered/resolved.   The reporter considered the shingles, chest pain, back pain and lip swelling to be related to Shingrix.  Additional details were provided as follows: The called and stated that she had reactions due to the Shingrix vaccine. The patient had chest and back pain.  The patient's lips were swollen for a week plus got the shingles even after the vaccine. The patient consented to follow up and agreed to follow up with her health care provider.
Age: 80.0
Sex: F
Vaccine: VARZOS, FLU4, FLUA4, MMR, VARZOS
Symptoms: Blister, Gingival blister, Herpes zoster, Influenza, Lip blister
Clinical narrative: got the shingles; chest pain; back pain; Lips were swollen; This case was reported by a nurse via patient support programs and described the occurrence of shingles in a 80-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd September 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 weeks after receiving Shingrix, the patient experienced shingles, chest pain, back pain and lip swelling. On an unknown date, the outcome of the shingles, chest pain and back pain were unknown and the outcome of the lip swelling was recovered/resolved.   The reporter considered the shingles, chest pain, back pain and lip swelling to be related to Shingrix.  Additional details were provided as follows: The called and stated that she had reactions due to the Shingrix vaccine. The patient had chest and back pain.  The patient's lips were swollen for a week plus got the shingles even after the vaccine. The patient consented to follow up and agreed to follow up with her health care provider.
Age: 80.0
Sex: F
Vaccine: VARZOS, FLU4, FLUA4, MMR, VARZOS
Symptoms: Oral mucosal blistering, Pain, Pain in extremity, Sleep disorder, Tongue blistering
Clinical narrative: got the shingles; chest pain; back pain; Lips were swollen; This case was reported by a nurse via patient support programs and described the occurrence of shingles in a 80-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd September 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 weeks after receiving Shingrix, the patient experienced shingles, chest pain, back pain and lip swelling. On an unknown date, the outcome of the shingles, chest pain and back pain were unknown and the outcome of the lip swelling was recovered/resolved.   The reporter considered the shingles, chest pain, back pain and lip swelling to be related to Shingrix.  Additional details were provided as follows: The called and stated that she had reactions due to the Shingrix vaccine. The patient had chest and back pain.  The patient's lips were swollen for a week plus got the shingles even after the vaccine. The patient consented to follow up and agreed to follow up with her health care provider.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea
Clinical narrative: diarrhea after eating certain foods and drinking coffee; This case was reported by a nurse via call center representative and described the occurrence of diarrhea in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25th September 2020, the patient received the 1st dose of Shingrix (intramuscular). On 25th September 2020, less than a day after receiving Shingrix, the patient experienced diarrhea. On an unknown date, the outcome of the diarrhea was not recovered/not resolved.   It was unknown if the reporter considered the diarrhea to be related to Shingrix.  Additional details were reported as follows: The patient complained of diarrhea after eating certain foods and drinking coffee ever since she got her first Shingrix shot in left deltoid. The reporter did not consent to follow-up.
Sex: U
Vaccine: FLU3
Symptoms: Malaise
Clinical narrative: sick from the shot; Initial information was received on 30-Sep-2020 regarding an unsolicited valid non-serious case received from a consumer or non health care professional.  This case is linked to case 2020SA270398 (same reporter).  This case involves a 65 years old patient who experienced sick (malaise), while he/she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  Medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient was sick (malaise) (Unknown latency) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. This event was considered non-serious.  Details of laboratory data were not reported.   It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the event was unknown.  There will be no information available on batch number for this case.
Age: 65.0
Sex: M
Vaccine: FLUA3
Symptoms: Injection site swelling
Clinical narrative: Swelling at site
Age: 48.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Chest discomfort, Dyspnoea, Injection site pruritus, Injection site rash
Clinical narrative: Rash and itching in injection area, as well as shortness of breath and chest discomfort about 20 to 30 minutes of receiving both vaccines. Treated immediately with one dose of Epi-pen (Epinephrine) auto-injector 0.3 mg/0.3 mL, with complete symptom resolution within 5-10 minutes.
Age: 64.0
Sex: M
Vaccine: FLU4
Symptoms: Product administered to patient of inappropriate age, SARS-CoV-2 test
Clinical narrative: Patient's daughter called the HD around 10 A.M. on 11/9/2020 and states that her dad is headed to the ER to be tested for COVID-19 she states on the morning on 10/8/2020, patient started having a headache, with fever and congestion, she stated he has had a cough for 5 days and its has progressively gotten worse.  She states her dad did no show any new symptoms after the vaccine that he was given around 1:30 in the office.  Patient did not have any signs or symptoms such as cough or shortness of breath while in the clinic.  Patient was asked current age and stated he was 65 years old.  Patient filled out form and stated on the Flu vaccination form that he was 65 years old.  Patient was then given the Fluzone HD.  Patient was in fact 64 years 11 months.
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: 10/07/20: Client presented with left upper arm induration the size of a golf ball, with visible redness and swelling.  Per client, the site was warm to touch, painful (3/10 scale), and itchy.  DON was informed and client was advised to call her supervisor for direction. 10/09/20: Client stated she did not seek medical attention for reaction.  Client stated the site is felling better, no pain, warmth, or itching.  I noted slight redness/discoloration at site, but swelling has resolved.
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site warmth
Clinical narrative: 10/07/20: Client presented with left upper arm induration the size of a golf ball, with visible redness and swelling.  Per client, the site was warm to touch, painful (3/10 scale), and itchy.  DON was informed and client was advised to call her supervisor for direction. 10/09/20: Client stated she did not seek medical attention for reaction.  Client stated the site is felling better, no pain, warmth, or itching.  I noted slight redness/discoloration at site, but swelling has resolved.
Age: 57.0
Sex: M
Vaccine: FLU4
Symptoms: Herpes zoster
Clinical narrative: Patient said started feeling symptoms on Saturday evening after receiving vaccine. Shingles outbreak on nose and left side of face (when facing patient.) Patient started on Valacyclovir 1g TID and Gabapentin 300mg HS on 10/9/20
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Rash morbilliform, Rhinorrhoea
Clinical narrative: MORBILIFORM RASH AND RUNNY NOSE
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Axillary mass, Malaise, Pain, Tenderness
Clinical narrative: Patient presents to clinic on 10/8/2020 for another reason and mentioned to me that he has a tennis ball size lump in his left armpit after receiving the shinrix vaccine on 10/1/2020.  He also notes that he felt unwell for a couple of days, but was warned that he may feel unwell, the lump was unexpected and he wonders if it is normal.  He notes that it became large on the day the vaccine was given, but has not changed since then.  It is no longer getting bigger and is only painful if he uses the arm too much or pushes on it.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Pyrexia
Clinical narrative: vaccines given 10/8, mom called 10/9 child with low grade fever of 100.1, not erythema or swelling, child moving both arms well. Mom concerned vaccine was given IM instead of SC. Mom concerned Dad did not receive VIS when vaccines were given. Mom concerned flu shot was given along with Proquad and Quadracel. Clinical Director and MD spoke with MA who states vaccine was given IM. MA states Dad was given binder containing VIS forms located in exam room. MA was counseled and  MA will be followed by Senior Nurse for the next 2 weeks to insure vaccines are being given correctly. All staff reminded of importance of VIS being given to parents, VAERS completed and mother will be given a copy along with a follow-up call.
Age: 65.0
Sex: M
Vaccine: FLU4
Symptoms: Arthralgia, Mobility decreased
Clinical narrative: Should pain: The patient came into the pharmacy on 10/06/20. He said that he received a shot on 09/28/20. He said that his shoulder started to have pain, and the pain slowly increased over a weeks time span.  The patient claimed he couldn't move his arm on 10/06/20. The patient had a provider appointment on 10/07/20. We are going to follow up with pt on 10/15/20 for more information.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Apnoea, Disorientation, Eye movement disorder, Hyperventilation, Loss of consciousness
Clinical narrative: After administering the last vaccine, which was HPV, the patient had fixed vision, turned his eyes, turned an ash color, began to hyperventilate until he stopped breathing and convulsed. When he finished convulsing, ventilation was given with an Ambu, he began to breathe slowly on his own, he begins to regain consciousness, and he begins to scream. He was disoriented in time, space or place. Patient continued to regain consciousness and stability. The ambulance was called to take him to the emergency room to stabilize him better. R / O syncope, vasovagal
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Pallor, Screaming, Seizure, Staring
Clinical narrative: After administering the last vaccine, which was HPV, the patient had fixed vision, turned his eyes, turned an ash color, began to hyperventilate until he stopped breathing and convulsed. When he finished convulsing, ventilation was given with an Ambu, he began to breathe slowly on his own, he begins to regain consciousness, and he begins to scream. He was disoriented in time, space or place. Patient continued to regain consciousness and stability. The ambulance was called to take him to the emergency room to stabilize him better. R / O syncope, vasovagal
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: red spot where vaccine was given
Age: 17.0
Sex: F
Vaccine: FLU4, MNQ
Symptoms: Consciousness fluctuating, Hypotension, Pallor, Syncope
Clinical narrative: On way out of visit, was walking in waiting room with dad and grabbed the wall and started to crumple. Dad caught her and led her to the chairs and sat her down, she looked "white as a sheet". She was in and out of consciousness but responding to her name for 30-45 seconds per dad.
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Chest X-ray normal, Condition aggravated, Cough, Pyrexia, Quarantine
Clinical narrative: Patient called the HD to report she was having a fever, cough and congestion, patient states that the fever started 2 days before she was given the vaccine.  She states it has progressively gotten worse and this morning 10/9/2020 she stated she went to the ER, the ER preformed a chest X-ray and was COVID tested and told to quarantine until results were received.  Patient states she did not develop any new symptoms after she received the flu vaccine, but her the symptoms of cough/congestion and fever did progressively get worse.  Patient did not have any of these symptoms while in the clinic receiving the vaccine.
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Respiratory tract congestion, SARS-CoV-2 test
Clinical narrative: Patient called the HD to report she was having a fever, cough and congestion, patient states that the fever started 2 days before she was given the vaccine.  She states it has progressively gotten worse and this morning 10/9/2020 she stated she went to the ER, the ER preformed a chest X-ray and was COVID tested and told to quarantine until results were received.  Patient states she did not develop any new symptoms after she received the flu vaccine, but her the symptoms of cough/congestion and fever did progressively get worse.  Patient did not have any of these symptoms while in the clinic receiving the vaccine.
Age: 68.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Arthralgia, Contusion, Mobility decreased, Myalgia
Clinical narrative: PT STATES THAT SHE IS HAVING SHOULDER PAIN. UNABLE TO LIFE ARM ABOVE SHOULDER LEVEL AFTER RECEIVING TWO VACCINATIONS. IT IS SLIGHTLY BRUISED AND PT COMPLAINS OF MUSCLE PAIN. VACCIANTION WAS GIVEN AND WITHIN 12-20 HRS EFFECTS WERE FELT AND PT CALLED PHARMACY
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Decreased appetite, Dizziness, Feeling abnormal, Fibromyalgia, Headache
Clinical narrative: at 5:00pm, call the pharmacy first. severe headache, nausea, more arm  pain than expected.  called doctor the next day, to let them know that she was still experiencing the symptoms. stayed home Tuesday and Wednesday. Yesterday felt lightheaded and couldn't eat much. Today  felt fine, a little nausea while eating breakfast so didn't finish eating. Having nausea today also and not able to finish any meals. On Tuesday, fibromyalgia flared up in right elbow. Had some fogginess.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pain in extremity
Clinical narrative: at 5:00pm, call the pharmacy first. severe headache, nausea, more arm  pain than expected.  called doctor the next day, to let them know that she was still experiencing the symptoms. stayed home Tuesday and Wednesday. Yesterday felt lightheaded and couldn't eat much. Today  felt fine, a little nausea while eating breakfast so didn't finish eating. Having nausea today also and not able to finish any meals. On Tuesday, fibromyalgia flared up in right elbow. Had some fogginess.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Eye oedema, Urticaria
Clinical narrative: Pt mother reports her Right Eye edema and urticaria.  right Eye edema  for 1 day and urticaria for 3 days even after administering Benedryl
Age: 71.0
Sex: F
Vaccine: FLUA4
Symptoms: Body temperature increased, Chills, Erythema, Feeling hot, Sluggishness
Clinical narrative: I wanted to tell you of my reaction to the flu shot that I received yesterday around 11:00 at the drive-thru clinic. Around bedtime at 10:00 I started to feel warm. All night I was burning up. I woke up at 5:30 and my temp was 100 degrees. I ran an errand then came home and at about 7:00 am, I started to get the feeling of hives. My face became bright red, then my underarms, then my back and chest, down to my legs to the ankles. I then started getting chills to the point where I could not hold a handmirror to look at my back. I did get out my Epipen in case my throat started to become affected. I decided to go back to bed under lots of covers to get warm and slept for 3 hours, which is highly unusual for me. I awoke at 11:00 am and no more hives and no more fever. I feel sluggish but otherwise, feel fine once again.
Age: 71.0
Sex: F
Vaccine: FLUA4
Symptoms: Urticaria
Clinical narrative: I wanted to tell you of my reaction to the flu shot that I received yesterday around 11:00 at the drive-thru clinic. Around bedtime at 10:00 I started to feel warm. All night I was burning up. I woke up at 5:30 and my temp was 100 degrees. I ran an errand then came home and at about 7:00 am, I started to get the feeling of hives. My face became bright red, then my underarms, then my back and chest, down to my legs to the ankles. I then started getting chills to the point where I could not hold a handmirror to look at my back. I did get out my Epipen in case my throat started to become affected. I decided to go back to bed under lots of covers to get warm and slept for 3 hours, which is highly unusual for me. I awoke at 11:00 am and no more hives and no more fever. I feel sluggish but otherwise, feel fine once again.
Age: 65.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Chills, Headache, Musculoskeletal stiffness, Oropharyngeal pain, Pain
Clinical narrative: Pain stiffness headache sore throat chills fever
Age: 65.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Pyrexia
Clinical narrative: Pain stiffness headache sore throat chills fever
Age: 57.0
Sex: F
Vaccine: FLUC4
Symptoms: Cold sweat, Condition aggravated, Dizziness, Erythema, Nausea
Clinical narrative: For past 4 years, patient had not had a SLE flareup, and also had not had blood clot in past 4 years.  Patient's lab work for SLE had been extremely healthy for past 4 years, with no indication of SLE or APS involvement.  Patient had been feeling healthy, with energy, and had easily went on a 3 mile run just 12 hours, the night before the shot.  So, the following symptoms, typical of a SLE flareup for the patient were abrupt and sudden, upon the flu shot injected at 9:15 AM on 9/29/2020.  Within 2 hours of flu shot, had Lupus red skin and Lupus red rash spots on cheeks.  Within 2 1/2 hours, had additional Lupus hard tissue on face in 1" to 2" section that was bright red.  From 3 hours to 3 days after shot, had bright red face on entire face.  Within 12 hours had extreme dizziness, nausea (but no stomach pain or cramping), and vomiting (food or water) that lasted for 3 days.  No fever, but clammy skin for 3 days.  Within 24 hours, had blood clot on lower right thigh, a few inches higher than a prior blood clot (about 20 years ago) when diagnosed with Antiphospholipid Syndrome, secondary to SLE.
Age: 57.0
Sex: F
Vaccine: FLUC4
Symptoms: Rash erythematous, Systemic lupus erythematosus, Thrombosis, Vomiting
Clinical narrative: For past 4 years, patient had not had a SLE flareup, and also had not had blood clot in past 4 years.  Patient's lab work for SLE had been extremely healthy for past 4 years, with no indication of SLE or APS involvement.  Patient had been feeling healthy, with energy, and had easily went on a 3 mile run just 12 hours, the night before the shot.  So, the following symptoms, typical of a SLE flareup for the patient were abrupt and sudden, upon the flu shot injected at 9:15 AM on 9/29/2020.  Within 2 hours of flu shot, had Lupus red skin and Lupus red rash spots on cheeks.  Within 2 1/2 hours, had additional Lupus hard tissue on face in 1" to 2" section that was bright red.  From 3 hours to 3 days after shot, had bright red face on entire face.  Within 12 hours had extreme dizziness, nausea (but no stomach pain or cramping), and vomiting (food or water) that lasted for 3 days.  No fever, but clammy skin for 3 days.  Within 24 hours, had blood clot on lower right thigh, a few inches higher than a prior blood clot (about 20 years ago) when diagnosed with Antiphospholipid Syndrome, secondary to SLE.
Age: 59.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Dizziness, Nausea, Pain in extremity, Pyrexia
Clinical narrative: Customer reported soreness in arm, nausea, light headness, fever 99 degrees. Claimed he wasn't counseled about the possibility of these side effects (he was)
Age: 69.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site swelling, Loss of consciousness
Clinical narrative: Patient said she was swollen on the site of the Pneumovax injection.  She also said she passed out at 5:30am on 10-8-2020 which she feels is related to her vaccination
Age: 4.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site erythema, Injection site induration, Injection site movement impairment, Injection site pain, Injection site reaction
Clinical narrative: On 9/25/2020, client vaccinated per standard protocol in clinic. No complaint after immunization and was released home with mother. In telephone call with mother on 10/9/2020, mother reported client complained of arm pain, redness and swelling of left arm the evening of 9/25/2020. The morning of 9/26/2020 the left arm swelling was hard and hot to the touch. Client complained of difficulty moving it. Mother took client to the ER for evaluation. ER physician stated there was fluid in the left muscle which suggested possible infection in the muscle. ER physician prescribed client PO antibiotics. Mother claimed limb returned to baseline after initiating antibiotic therapy.
Age: 4.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site swelling, Injection site warmth, Muscle oedema
Clinical narrative: On 9/25/2020, client vaccinated per standard protocol in clinic. No complaint after immunization and was released home with mother. In telephone call with mother on 10/9/2020, mother reported client complained of arm pain, redness and swelling of left arm the evening of 9/25/2020. The morning of 9/26/2020 the left arm swelling was hard and hot to the touch. Client complained of difficulty moving it. Mother took client to the ER for evaluation. ER physician stated there was fluid in the left muscle which suggested possible infection in the muscle. ER physician prescribed client PO antibiotics. Mother claimed limb returned to baseline after initiating antibiotic therapy.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain
Clinical narrative: Arm pain in muscle where shot was given
Age: 83.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain
Clinical narrative: experiencing pain and in shoulder area after injection. advised to take acetaminophen or ibuprofen to help relieve pain, ice and rest. if does not get better advised to see doctor for further examination. On 10/8 he still had pan, on 10/9 he noticed an improvement and able to move arm with less notable pain
Age: 69.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Chills
Clinical narrative: Patient started to shiver at 8 pm after receiving vaccine around 4 pm
Age: 60.0
Sex: F
Vaccine: FLUC4
Symptoms: Contusion, Joint range of motion decreased, Pain
Clinical narrative: bruising and soreness, limited range of motion and still complains of soreness/ pain
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Malaise, Nausea, Pyrexia
Clinical narrative: Patient reported rash on upper arm around injection site, fever, nausea, general malaise
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Myalgia, Pyrexia
Clinical narrative: HEADACHE, TIRENESS, MUSCLE PAIN, MILD FEVER (99.5 F), CHILLS, TYLENOL OR IBUPROFEN, MONITOR TEMPERATURE
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site erythema, Injection site streaking, Injection site swelling, Injection site warmth
Clinical narrative: Patient came into the pharmacy Friday Morning at approximately 8:50am stating that she had recieved her flu shot and pneumonia from us within the last couple of days. She stated that she had noticed a lot of soreness in her arm Wednesday 10/7/20 night, but did not notice any redness or swelling until Thursday 10/8/20. She also stated that she had body aches on Thursday, but didn't mention having them on Friday. The area around the injection site was slightly swollen, red, and warm to the touch, and was streaking down into the axillary (armpit) area. She said that she took some extra-strength tylenol but the spreading, swelling, and pain had not gone away, and said that it was continuing to spread and get bigger. I escorted the patient to the medical clinic, where she was seen by the APRN on site. She was prescribed Cephalexin 500 mg.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Pain, Pain in extremity, Swelling
Clinical narrative: Patient came into the pharmacy Friday Morning at approximately 8:50am stating that she had recieved her flu shot and pneumonia from us within the last couple of days. She stated that she had noticed a lot of soreness in her arm Wednesday 10/7/20 night, but did not notice any redness or swelling until Thursday 10/8/20. She also stated that she had body aches on Thursday, but didn't mention having them on Friday. The area around the injection site was slightly swollen, red, and warm to the touch, and was streaking down into the axillary (armpit) area. She said that she took some extra-strength tylenol but the spreading, swelling, and pain had not gone away, and said that it was continuing to spread and get bigger. I escorted the patient to the medical clinic, where she was seen by the APRN on site. She was prescribed Cephalexin 500 mg.
Age: 76.0
Sex: F
Vaccine: FLU4
Symptoms: Cellulitis, Erythema, Pain, Pruritus
Clinical narrative: cellulitis, redness itching pain
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Pain, Product administered at inappropriate site
Clinical narrative: Initially mild soreness at time of injection (9/25) then worsened x3 days. Eased, but then onset of pain with arm/shoulder movement/use on 10/4/20 (9 days after injection).  Patient states she believes that injection was given "too high" in her arm.
Age: 60.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site discolouration, Injection site vesicles
Clinical narrative: Pt presented with an elevated blister , purpura color down the injection site, blister were like to inches down /back were immunization was administered. Patient presented to the pharmacy 2 days after. recommended to see Dr and start taking antihistamines
Age: 80.0
Sex: M
Vaccine: FLUA4
Symptoms: Dizziness, Headache, Hypoaesthesia, Swelling face
Clinical narrative: Patient felt lightheaded after fluad quad shot at the pharmacy on 10-9-2020 at 12:40pm . He sat around pharmacy for a while and left without major symptoms. His symptoms and reported to pharmacy at 4:15pm progressively worsen with headache, dizzy, numbness around the face jar, slight puffiness on the face, and still light headed. Patient was advised to contact his primary immediately.  He made an appointment will see them at 5pm on 10-9-2020.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Cellulitis, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Child developed redness and swelling of whole left upper arm   with local warmth. no abscess or discharge or tender at vaccine site. Clinical diagnosis of cellulitis and prescription give for cephalexin antibiotics with 2 days follow up.
Age: 13.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: redness, swelling, hot to touch
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: arm is red, swollen, and warm to the touch
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site swelling
Clinical narrative: The patient was given a high dose flu shot on 10/9/20 around 11:50am. The patient called me at 3:50pm letting me know that she is having excessive swelling ("goose-egg", "half baseball-size") around the injection site. I asked the patient if she was having any other symptoms (shortness of breath, hives) but she denied these and stated that she may be feeling a little flushed. She mentioned that this was her first high-does flu shot since she just turned 65 this past September. I advised her to place an ice-pack on the swollen area (for 15-minute intervals) and to take ibuprofen to help with the swelling. The patient also took a Benadryl tablet. The patient does have a latex allergy but I made sure to use the Nitrile gloves and Latex-free bandage when giving the immunization. I called the patient to follow up on symptoms 30 minutes later and she said that she is still feeling fine overall just still has the "goose-egg" swelling. Advised her to call us with any changes.
Age: 70.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Sciatica
Clinical narrative: First, volume of vaccine is 0.7 ml,  VIS version date is 08/15/2019,  exp. date is  06/30/2021.  I started having sciatica pain from left buttocks radiating down the back of my left leg. Still have the pain.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient had redness, swelling and pain at site of vaccine. Contacted PCP and was able to get an antibiotic called in for her.
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Bursitis, Injection site pain, Joint range of motion decreased, Ultrasound scan abnormal, X-ray normal
Clinical narrative: states received flu shot on 09/02/20; states shot was on LUE and states she started having sharp pain shortly after the injection, denies any injuries to LUE; she states that she went to her PMD who prescribed her diclofenac; currently taking Meloxican; no swelling/redness noted to LUE; motor/sensory intact, able to lift BUE up; however states that she has some ROM issues with the LUE. Seen by sports medicine on 09/25/2020;
Age: 46.0
Sex: M
Vaccine: FLU4
Symptoms: Chills, Ocular hyperaemia, Pain, Pain in extremity
Clinical narrative: Patients wife stated he took a nap after the flu shot and woke up with really red blood shot eyes. Also complaints of body aches and chills. Was taking a cold shower. Has lasted for a couple hours now. Patient is diabetic and has a sensor he wears on the opposite arm. Complained of arm soreness also. wife was most concerned about the blood shot eyes.
Age: 10.0
Sex: M
Vaccine: FLU4
Symptoms: Cough, Dyspnoea, Hallucination, Nausea, Pain
Clinical narrative: Acute onset, high fever with hallucinations, nausea, vomiting, severe body aches such that patient was curled in a ball for 24 hours.  Cough and wheezing, shortness of breath.  Similar but less severe reaction last year.
Age: 10.0
Sex: M
Vaccine: FLU4
Symptoms: Pyrexia, Vomiting, Wheezing
Clinical narrative: Acute onset, high fever with hallucinations, nausea, vomiting, severe body aches such that patient was curled in a ball for 24 hours.  Cough and wheezing, shortness of breath.  Similar but less severe reaction last year.
Age: 88.0
Sex: M
Vaccine: FLU4
Symptoms: Chills, Nausea, Pain, Poor quality sleep
Clinical narrative: Extreme chills, maybe fever, slight nausea,aches and pains. Went to bed with many covers and had fitful night's sleep. Woke up with aches and pains but no other symptoms. Felt normal less than 24 hours from vaccination
Age: 46.0
Sex: M
Vaccine: FLU4, PPV, TDAP
Symptoms: Chills, Incorrect route of product administration, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Fever, Body Aches, Chills, Injection site redness, swelling and hot
Age: 46.0
Sex: M
Vaccine: FLU4, PPV, TDAP
Symptoms: Pain, Pyrexia
Clinical narrative: Fever, Body Aches, Chills, Injection site redness, swelling and hot
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Chest discomfort, Dysphagia, Erythema, Hypoaesthesia
Clinical narrative: Redness and numbness all over the body, unable to swallow, chest tightness. Went to ER was given epi pen to take home. Still currently being monitored
Age: 58.0
Sex: M
Vaccine: FLUR4, PPV, VARZOS
Symptoms: Injection site pain, Injection site swelling, Product administered at inappropriate site
Clinical narrative: On 10/9/20 the patients wife presented to the pharmacy to pick up a prescription for methylprednisolone 4mg pak that was sent in by the patient's primary care doctor.   The patient asked for the "person who gives shots," so I went over to consult.  She stated that her husband was in significant pain and had localized swelling in his right arm where he received pneumovax and flublok.  She stated that when they spoke to the doctor's office they stated that pharmacy gave the immunization too high on the arm, causing possible frozen shoulder, pain, and swellling.   I apologized for the harm caused and asked if I could follow up.  I will be contacting the patient every couple of days to make sure the problem doesn't get worse.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills
Clinical narrative: Chills/Shivering same evening when I received the shingles vaccination. Lasted 1 day.
Age: 18.0
Sex: M
Vaccine: HPV9
Symptoms: Allergy test positive, Alopecia, Anaphylactic reaction, Asthenia, Balance disorder
Clinical narrative: Patient developed exercise-induced anaphylaxsis following this vaccine. By fall of 2014, he was unable to exercise fully without breaking into hives, vomiting and requiring a visit to the ER due to constriction of air flow in his throat.  When exercising, his legs would begin to tingle and his body would develop hives and his face would swell.   In April of 2015, patient was diagnosed with exercise induced anaphylaxsis and  was tested for allergies by a local allergist.  He had never been allergic to anything but had now developed a life threatening allergy  to shellfish, treenuts. and a variety of fruits. He has has over ten ER visits and requires an Epipen with him at all times.  Patient began losing his hair shortly after the first dose of Gardisil in July 2013 (Lot No. H021861). Mood swings and depression also presented and his mental outlook was severely affected.   In April of 2019, patient was unable to walk  due to dizziness and weakness and was incorrectly diagnosed with "Labyrinthitis".   In August 2019, patient visited a primary care doctor to see why his hands, feet, and scalp were numba and tingling. Thyroid was checked but levels were normal.  Another bout of dizziness and loss of balance presented in  early  February 2020.  Following a visit and MRI with an ENT, the patient was rushed to the hospital on Feburary 24th where a battery of blood tests and a spinal tap confirmed multiple layers of lesions in his brain - he was diagnosed with MS.  He is currently a patient with a doctor.
Age: 18.0
Sex: M
Vaccine: HPV9
Symptoms: Blood test abnormal, Central nervous system lesion, Depression, Dizziness, Food allergy
Clinical narrative: Patient developed exercise-induced anaphylaxsis following this vaccine. By fall of 2014, he was unable to exercise fully without breaking into hives, vomiting and requiring a visit to the ER due to constriction of air flow in his throat.  When exercising, his legs would begin to tingle and his body would develop hives and his face would swell.   In April of 2015, patient was diagnosed with exercise induced anaphylaxsis and  was tested for allergies by a local allergist.  He had never been allergic to anything but had now developed a life threatening allergy  to shellfish, treenuts. and a variety of fruits. He has has over ten ER visits and requires an Epipen with him at all times.  Patient began losing his hair shortly after the first dose of Gardisil in July 2013 (Lot No. H021861). Mood swings and depression also presented and his mental outlook was severely affected.   In April of 2019, patient was unable to walk  due to dizziness and weakness and was incorrectly diagnosed with "Labyrinthitis".   In August 2019, patient visited a primary care doctor to see why his hands, feet, and scalp were numba and tingling. Thyroid was checked but levels were normal.  Another bout of dizziness and loss of balance presented in  early  February 2020.  Following a visit and MRI with an ENT, the patient was rushed to the hospital on Feburary 24th where a battery of blood tests and a spinal tap confirmed multiple layers of lesions in his brain - he was diagnosed with MS.  He is currently a patient with a doctor.
Age: 18.0
Sex: M
Vaccine: HPV9
Symptoms: Gait inability, Hypoaesthesia, Loss of personal independence in daily activities, Lumbar puncture abnormal, Magnetic resonance imaging
Clinical narrative: Patient developed exercise-induced anaphylaxsis following this vaccine. By fall of 2014, he was unable to exercise fully without breaking into hives, vomiting and requiring a visit to the ER due to constriction of air flow in his throat.  When exercising, his legs would begin to tingle and his body would develop hives and his face would swell.   In April of 2015, patient was diagnosed with exercise induced anaphylaxsis and  was tested for allergies by a local allergist.  He had never been allergic to anything but had now developed a life threatening allergy  to shellfish, treenuts. and a variety of fruits. He has has over ten ER visits and requires an Epipen with him at all times.  Patient began losing his hair shortly after the first dose of Gardisil in July 2013 (Lot No. H021861). Mood swings and depression also presented and his mental outlook was severely affected.   In April of 2019, patient was unable to walk  due to dizziness and weakness and was incorrectly diagnosed with "Labyrinthitis".   In August 2019, patient visited a primary care doctor to see why his hands, feet, and scalp were numba and tingling. Thyroid was checked but levels were normal.  Another bout of dizziness and loss of balance presented in  early  February 2020.  Following a visit and MRI with an ENT, the patient was rushed to the hospital on Feburary 24th where a battery of blood tests and a spinal tap confirmed multiple layers of lesions in his brain - he was diagnosed with MS.  He is currently a patient with a doctor.
Age: 18.0
Sex: M
Vaccine: HPV9
Symptoms: Mental disorder, Mood swings, Multiple sclerosis, Paraesthesia, Swelling face
Clinical narrative: Patient developed exercise-induced anaphylaxsis following this vaccine. By fall of 2014, he was unable to exercise fully without breaking into hives, vomiting and requiring a visit to the ER due to constriction of air flow in his throat.  When exercising, his legs would begin to tingle and his body would develop hives and his face would swell.   In April of 2015, patient was diagnosed with exercise induced anaphylaxsis and  was tested for allergies by a local allergist.  He had never been allergic to anything but had now developed a life threatening allergy  to shellfish, treenuts. and a variety of fruits. He has has over ten ER visits and requires an Epipen with him at all times.  Patient began losing his hair shortly after the first dose of Gardisil in July 2013 (Lot No. H021861). Mood swings and depression also presented and his mental outlook was severely affected.   In April of 2019, patient was unable to walk  due to dizziness and weakness and was incorrectly diagnosed with "Labyrinthitis".   In August 2019, patient visited a primary care doctor to see why his hands, feet, and scalp were numba and tingling. Thyroid was checked but levels were normal.  Another bout of dizziness and loss of balance presented in  early  February 2020.  Following a visit and MRI with an ENT, the patient was rushed to the hospital on Feburary 24th where a battery of blood tests and a spinal tap confirmed multiple layers of lesions in his brain - he was diagnosed with MS.  He is currently a patient with a doctor.