chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: not experienced any AE; Received expired dose of vaccine; This spontaneous report was received from a pharmacist and refers to a female patient of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies, drug reactions, allergies or medical history provided.  On 09-OCT-2020, the patient was vaccinated with the expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) 0.5 ml, one time, lot # R033342, expiration date 03-AUG-2020, (anatomical location and route of administration were not reported) for prophylaxis. The vaccine had not undergone a temperature excursion. Furthermore, the patient did not experience any adverse event from the administration of the expired vaccine. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: R033342; expirationdate: 03-AUG-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: U
Vaccine: MMR
Symptoms: No adverse event
Clinical narrative: no additional AE; 1st dose of MMR II 08/24/2006 and patient's date of birth is 08/29/2005, the 2nd dose was given 08/17/2010.; This spontaneous report was received from a medical assistant and refers to a 11-month-old patient of an unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 24-AUG-2006, the patient was vaccinated with the first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) lot# reported as 095R, but upon internal validation verified to be a non-valid lot# (formulation, dose, route of administration, expiry date were not provided) for prophylaxis. On 17-AUG-2010, the patient received the second dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (formulation, dose, route of administration, lot # and expiry date were not provided) for prophylaxis (inappropriate schedule of product administration). There was no additional adverse event reported.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Product temperature excursion issue
Clinical narrative: PROQUAD was administered to a patient on 10/7/2020 when the excursion had occurred on 10/3/2020; This spontaneous report has been received from a nurse referring to a 4 years old male patient. Information about pertinent medical history, drug reactions/allergies and concomitant medication was not reported.  On 03-OCT-2020, the vaccine of measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (PROQUAD) underwent temperature excursion from 6 degrees Fahrenheit to 14 degrees Fahrenheit (7 Fahrenheit) for 15 minutes. Involved lot numbers of measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (PROQUAD) included lot # S021623, expiration date: 09-JAN-2021; lot # T015598, expiration date: 02-NOV-2021; lot # S022912, expiration date: 19-JAN-2021 and lot # S023014 is an invalid lot number for measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (PROQUAD), expiration date reported as 25-MAR-2021. There was previous temperature excursions of 9 Fahrenheit for 15 minutes. The digital data logger was involved in recording excursion details. On 07-OCT-2020, the patient was vaccinated with the improperly stored measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (PROQUAD) (lot # S021623, expiration date: 09-JAN-2021). No other lot numbers of measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (PROQUAD) were administrated.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received regarding a case in litigation, referring to a patient of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies was provided. On 10-DEC-2014, the patient was inoculated with zoster vaccine live (ZOSTAVAX) as prescribed and/or administered by a pharmacist, for the long-term prevention of shingles and/or zoster-related conditions (strength, route, frequency, lot# and expiration date were not reported). On an unknown date, subsequent to the zoster vaccine live (ZOSTAVAX) inoculation, the patient was treated by a healthcare provider for shingles. As a direct and proximate result of the patient's zoster vaccine live (ZOSTAVAX), the patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of shingles was not reported. The reporter considered shingles to be related to zoster vaccine live (ZOSTAVAX).
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness, Muscular weakness, Pain, Pain in extremity
Clinical narrative: feels as though she has the flu; Muscle Weakness; Chills; Pain; her left arm felt as though "it had been punched; This case was reported by a consumer via call center representative and described the occurrence of muscle weakness in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th October 2020, the patient received the 1st dose of Shingrix (intramuscular). On 19th October 2020, less than a day after receiving Shingrix, the patient experienced muscle weakness, chills, pain and pain in arm. On 20th October 2020, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the muscle weakness, chills, pain, pain in arm and influenza-like symptoms were unknown.   It was unknown if the reporter considered the muscle weakness, chills, pain, pain in arm and influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix (intramuscular) experienced  muscle weakness, chills, pain, pain in arm and influenza-like symptoms. The patient stated that she felt as though she has the flu because of chills and muscle weakness. The pateint states that initially, her left arm felt as though it had been punched.  The reporter did not consented to follow up. No further information was available.
Sex: M
Vaccine: FLU4
Symptoms: Exposure via skin contact, Injection site extravasation, No adverse event, Underdose
Clinical narrative: while administering, vaccine running down the patient's arm from the injection site, no AE; while administering, vaccine running down the patient's arm from the injection site, no AE; while administering, vaccine running down the patient's arm from the injection site, no AE; Initial information was received on 14-Sep-2020 regarding an unsolicited valid non-serious case from the pharmacist.  This case involves a male patient of unknown age who was vaccinated with a dose of FLUZONE QUADRIVALENT (0.5 ml single dose syringe, lot number: UT7005JA and expiration date 30-Jun-2021) via an unknown route in the arm on an unknown date for prophylactic vaccination on an unknown date. However, while administering, the vaccine was running down the patient's arm from the injection site.   The patient's medical history, past medical treatment(s), vaccination(s), family history and concomitant medication were not provided.   This was a case of vaccine underdose, exposure via skin contact and product leakage (latency was same day).  Upon clarification received on 14-Sep-2020, there was no noted damage or leakage to the syringe prior to injection. pharmacist states that she was unsure where the leakage was specifically coming from. She pushed the vaccine into the patient's arm and then the leakage was noted, and she pulled the needle out. Pharmacist wants to know if she should re-vaccinate the patient.  At the time of reporting, no adverse event was reported to the patient.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 10.0
Sex: M
Vaccine: FLU4
Symptoms: Dizziness postural
Clinical narrative: Administered flu shot to student after immunizing older sibling and parent.  Student anxious at time of vaccination. Mother calmed student down and he was able to receive immunization successfully. Pt A & O immediately following shot, stood up and became dizzy, patient was lowered to floor with feel elevated and  vitals taken.  4:30pm BP90/48 P 64 R 18 . 4:40pm BP 88/46 P 66 R 18. pupils equal and reactive.  Per mom, patient had not eaten or had anything to drink.  Patient feeling better after resting and eating banana. He was A&O and left to go home with mom and sibling. Symptoms resolved fully with no further adverse effects.
Age: 8.0
Sex: M
Vaccine: UNK
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Large raised area under injection site (right arm) warm to the touch.
Age: 10.0
Sex: F
Vaccine: FLU4
Symptoms: Dyspnoea, Erythema
Clinical narrative: Patient received Flulaval with no issue. Upon check-out of Clinic, patient began to appear red and complain that she couldn't breathe. RNs called to the front  at 1305 where the patient was sitting  in Waiting  Room. Brought to Exam Room, advised her to take her mask off and take some deep breaths. Dr. called into room who assessed patient. At this time, found out from Mom that patient had not eaten. Given juice and a lollipop, ice pack applied to neck. Pt able to breathe normal and feels much better with these measures.  1310 BP 112/73, HR 102. 1315 BP 101/63, HR 76. After resting 15 mins, cleared by Dr to be discharged. Follow up planned for tomorrow.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain
Clinical narrative: Prolonged soreness of left shoulder with movement 4 days after getting her injection on 10.22.20. Pain was rated 6/10 and unresponsive to Ibuprofen.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness, swelling, and fever in left arm below injection site
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Contusion
Clinical narrative: Right shoulder contusion.
Age: 8.0
Sex: F
Vaccine: FLUC4
Symptoms: Hunger, Nervousness, Pallor, Pulse abnormal, Syncope
Clinical narrative: Patient was given the flu shot with her mom and little sister present.  The patient was a little nervous about getting the vaccine.  After vaccine was given, mom and children walked around the store a little but and then proceeded to walk to car to leave.  As patient got into the car, mom says she fainted.  Mom then brought her back into the store and laid her on the floor at the front of the store entrance.  By the time I got to the scene EMS had already been called and the child was laying on the floor and talking.  I asked her if she knew her name and age and she did.  There was another bystander who took her pulse and felt it was slow.  The child also looked pale.  While waiting for EMS to arrive the child was talking more and then able to sit up.  Her pulse was taken again and was getting better.  She was also given a bottle of water.  No complaints at this point of dizziness or feeling sick.  EMS arrived and checked her vitals and determined she was ok but also gave mom the choice to be taken to the hospital to be looked at.  Mom refused as she lived close to the hospital if she needed to be taken.  It was also determined that maybe the child needed to eat a snack/was hungry so she was given a bag of Doritos while EMS was still there and was able to eat.  We followed up with mother the next day and she reported that the child felt really good and went to school that day.  The mom thinks she is having a growth spurt and was probably hungry at the time of the vaccine visit and also nervous which may have contributed to the fainting.
Age: 75.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site nerve damage, Pain in extremity, Paraesthesia, Skin burning sensation
Clinical narrative: Soreness, burning in arm, tingling in fingers  Went to doctor on 10/26/2020. She said they hit a nerve and there is nothing that can be done about it. She also said this could go on for weeks (it has already been weeks) or months!
Age: 9.0
Sex: M
Vaccine: FLU4
Symptoms: Dyspnoea, Immediate post-injection reaction, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Itching began immediately after vaccination. Injection site became red, hot, swollen and child started to run a fever of 99.8. Mother scheduled virtual visit on Saturday and gave topical benadryl and oral benadryl. Saturday evening child started to feel like something was stuck in his throat, kept clearing his throat and had trouble breathing. Mother gave benadryl again. Sunday mother used epi pen due to difficulty breathing. Injection site continued to swell, was red, hot and tender to touch. After patient received EPI all symptoms resolved. Injection site redness was gone by Monday evening and patient had no more difficulty breathing or felt like something was stuck in his throat.
Age: 9.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site warmth, Pruritus, Pyrexia, Sensation of foreign body, Throat clearing
Clinical narrative: Itching began immediately after vaccination. Injection site became red, hot, swollen and child started to run a fever of 99.8. Mother scheduled virtual visit on Saturday and gave topical benadryl and oral benadryl. Saturday evening child started to feel like something was stuck in his throat, kept clearing his throat and had trouble breathing. Mother gave benadryl again. Sunday mother used epi pen due to difficulty breathing. Injection site continued to swell, was red, hot and tender to touch. After patient received EPI all symptoms resolved. Injection site redness was gone by Monday evening and patient had no more difficulty breathing or felt like something was stuck in his throat.
Age: 11.0
Sex: M
Vaccine: FLU4, HPV9, MNQ, TDAP
Symptoms: Asthenia, Balance disorder, Dizziness, Eye movement disorder, Syncope
Clinical narrative: HPV #1 was administered to L arm, approximately 10-15 seconds after administration patient tried to stand and immediately lost balance, fainted for less than 5 seconds. Patient's eyes rolled back, became very limp as the MA caught him. Provider was immediately called into patient's room for examination. Patient was laying supine on exam table with eyes open when provider came into the room. Patient responsive, alert and oriented, pupils equal, round and reactive to light and accommodation, heart R&R regular, lungs CTA. Patient verbalized he felt a little dizzy and weak. Patient remained laying down, then sat up slowly when dizziness and weakness were gone. Patient sat up and drank water, at the end of the 20 minute observation patient stood up with no dizziness or weakness. Mother was contacted at the end of the day at 5:05 pm to check how patient was doing. Mother stated he was feeling better and was only complaining of a mild headache.
Age: 69.0
Sex: F
Vaccine: FLU4
Symptoms: Fungal infection, Rash, Rash pruritic, Vaccination complication
Clinical narrative: Reports getting a rash that "Goes down both side of my back,"started on Saturday 10/24/2020. Reports "rash painful and occasional itching." Injection site has no issues.  Seen PCP,  who feels its a fungal infection, gave her an injection of Ketortalac and recommended that she continue to monitor it and contact the health department to report Adverse reaction. Dr. referred her to dermatology which she has an apt scheduled for 12/22/2020.  "I get my flu shot every year and never have had issues in the past."
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain
Clinical narrative: local redness and aching, with erythema
Age: 44.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Pyrexia, Rash, Rash erythematous, Rash maculo-papular, Rash pruritic
Clinical narrative: Wheezing, low grade fever 4 hours after receiving vaccine. Generalized itchy red, maculopapular rash on trunk and limbs 48 hours after receiving vaccine.
Age: 44.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Wheezing
Clinical narrative: Wheezing, low grade fever 4 hours after receiving vaccine. Generalized itchy red, maculopapular rash on trunk and limbs 48 hours after receiving vaccine.
Age: 44.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Chills, Cough, Dyspnoea, Fatigue, Injection site bruising
Clinical narrative: Wheezing, low grade fever 4 hours after receiving vaccine. Generalized itchy red, maculopapular rash on trunk and limbs 48 hours after receiving vaccine.
Age: 44.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Ocular hyperaemia, Pyrexia, Rash, Throat tightness, Tremor
Clinical narrative: Wheezing, low grade fever 4 hours after receiving vaccine. Generalized itchy red, maculopapular rash on trunk and limbs 48 hours after receiving vaccine.
Age: 65.0
Sex: M
Vaccine: FLUA4
Symptoms: Injection site pruritus, Injection site rash
Clinical narrative: Injection site itchy rash 2 inch diameter, not warm to the touch.
Age: 29.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Dizziness, Dyspnoea, Nausea, Pharyngeal swelling
Clinical narrative: Swelling of throat, difficulty breathing, nausea, dizziness, weakness.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Pyrexia, Rash
Clinical narrative: all over body rash and fever
Age: 33.0
Sex: F
Vaccine: FLUC4
Symptoms: Tachycardia
Clinical narrative: Sustained tachycardia (150-180bpm) x8 hours. No treatment sought.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain, Loss of personal independence in daily activities, Muscular weakness
Clinical narrative: Pain and soreness immediately following vaccination (as expected).  Pain in site of shot has persisted ever since, now over 30 days since receiving vaccine. Causes sharp, sometimes excruciating pain when performing sudden movements. Cannot perform some basic tasks due to weakness and lack of mobility in that part of arm. Trouble stretching. Trouble sleeping due to pain when sleeping on that side. All symptoms remain consistent throughout this time period.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Sleep disorder
Clinical narrative: Pain and soreness immediately following vaccination (as expected).  Pain in site of shot has persisted ever since, now over 30 days since receiving vaccine. Causes sharp, sometimes excruciating pain when performing sudden movements. Cannot perform some basic tasks due to weakness and lack of mobility in that part of arm. Trouble stretching. Trouble sleeping due to pain when sleeping on that side. All symptoms remain consistent throughout this time period.
Age: 21.0
Sex: F
Vaccine: FLUC4
Symptoms: Dyspnoea, Loss of consciousness, Pallor, Wheezing
Clinical narrative: Symptoms: audible wheezing, pale, difficulty breathing, passed out approx 10 minutes after receiving the flu shot. EMS was called and she was given 2 doses of epinephrine and 1 dose of benadryl. She was then sent out to local hospital.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood magnesium normal, Blood phosphorus normal, Blood thyroid stimulating hormone, Headache, Metabolic function test normal
Clinical narrative: Intermittent twitching of right lower lip, headache on same side.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Muscle twitching
Clinical narrative: Intermittent twitching of right lower lip, headache on same side.
Age: 62.0
Sex: F
Vaccine: FLUR4, VARZOS
Symptoms: Injection site pain, Injection site swelling, Neck pain, Swelling
Clinical narrative: Patient had swelling and pain at injection site that spread up to neck and down to elbow.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects reported; the patient was inadvertently administered a dose of MMRII which was reconstituted with an expired dose of STERILE DILUENT; This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender.There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 08-OCT-2020, the patient was inadvertently vaccinated with dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection for prophylaxis (lot number was not reported), which was reconstituted with an expired dose of sterile diluent, lot# was reported as M029293 but upon internal review was evaluated and changed to the valid lot # N029293, expiration date was reported as 25-APR-2020 (formulation and indication was not reported). Strength, dose, frequency and route of administration for both therapies were not reported.
Age: 78.0
Sex: F
Vaccine: FLUA3
Symptoms: Blister, Diarrhoea, Erythema, Lip swelling, Rash
Clinical narrative: Rash (blister followed by flat large red patches) over extensive area Hives  also swelling (double) of lips  ew daysDiarrhea Had two separate reactions  separated by a few days relief
Age: 78.0
Sex: F
Vaccine: FLUA3
Symptoms: Urticaria
Clinical narrative: Rash (blister followed by flat large red patches) over extensive area Hives  also swelling (double) of lips  ew daysDiarrhea Had two separate reactions  separated by a few days relief
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Breast pain, Dizziness, Injection site pain, Nausea, Skin warm
Clinical narrative: Patient received the flu shot given at 8:00 am. on Tuesday, October 6th, 2020 at the High School. She had no issues with it until 3:00 pm. Wednesday, October 7th, 2020.  She felt nauseated and she thought she was going to faint, that?s when she put her head down between her legs.  Also, later that evening her left breast was hot and hurting where she had a lumpectomy and 2 lymph nodes removed earlier in January and had radiation 16 treatments in March and April.  Her right arm where she had the injection was also hurting. Patient contacted her oncologist and radiologist who were unsure if it was all related.  Patient is symptom free now.
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Flu shot site redness; swollen; painful; hot to touch. use a cool compress on it.  You can give him Ibuprofen/MOTRIN for swelling.  TYLENOL would help with the pain.  Please let us know if the redness increases in size and/or patient develops a fever.  Resolved spontaneously
Age: 21.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Fall, Fatigue, Nausea, Vomiting
Clinical narrative: About 5 minutes after vaccinnation patient felt dizzy, fell to her knees, and was nauseaous. She threw up a few times. She complained of being tired and drank some water and snicker bars which she ate while sitting. She felt better gradually and ws able to leave with her father.
Age: 74.0
Sex: F
Vaccine: FLU4
Symptoms: Balance disorder, Blood creatine phosphokinase, Brain natriuretic peptide, Fall, Full blood count
Clinical narrative: Bilateral leg weakness, loss of balance and increased falls.
Age: 74.0
Sex: F
Vaccine: FLU4
Symptoms: Metabolic function test, Muscular weakness, Urine analysis, Vitamin B12
Clinical narrative: Bilateral leg weakness, loss of balance and increased falls.
Age: 8.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Injection site vesicles, Injection site warmth
Clinical narrative: Mom states that the pt has a history of having a localized reaction to the flu shot in the past. He did have his flu shot done on 10/26 and he seems to be having a similar reaction to what he has had in the past. She states that there is a red, swollen, hot to the touch area about 5 inches in diameter surrounding his injection site. She states that she has noticed almost a blistering at the injection site before which she has not seen happen in the past. She has been giving benadryl which has helped to bring the swelling down and the pt isn't really bothered by the reaction but she did want to let the providers know.
Age: 13.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Localized swelling, erythema, pain
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: SEVERE REDNESS AND SWELLING IN THE ARM THE INJECTION WAS ADMINISTERED WITHIN 12 HOURS OF ADMINISTRATION.
Age: 67.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Blood test, Computerised tomogram head, Electrocardiogram, Full blood count, Hypoaesthesia
Clinical narrative: Immediately after discharge from the emergency department, the patient noted hives to the right neck and numbness to her face.  She fell asleep at 3am on 10/17/20 and woke at approximately 8:30am on 10/17/20 with numbness to the right side of her body.  This resolved by the time she arrived at the emergency department at 1049am.
Age: 67.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Magnetic resonance imaging, Magnetic resonance imaging brain, Urticaria
Clinical narrative: Immediately after discharge from the emergency department, the patient noted hives to the right neck and numbness to her face.  She fell asleep at 3am on 10/17/20 and woke at approximately 8:30am on 10/17/20 with numbness to the right side of her body.  This resolved by the time she arrived at the emergency department at 1049am.
Age: 67.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Computerised tomogram normal, Hypoaesthesia, Magnetic resonance imaging normal, Nervous system disorder, Paraesthesia
Clinical narrative: Immediately after discharge from the emergency department, the patient noted hives to the right neck and numbness to her face.  She fell asleep at 3am on 10/17/20 and woke at approximately 8:30am on 10/17/20 with numbness to the right side of her body.  This resolved by the time she arrived at the emergency department at 1049am.
Age: 67.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Urticaria
Clinical narrative: Immediately after discharge from the emergency department, the patient noted hives to the right neck and numbness to her face.  She fell asleep at 3am on 10/17/20 and woke at approximately 8:30am on 10/17/20 with numbness to the right side of her body.  This resolved by the time she arrived at the emergency department at 1049am.
Age: 0.67
Sex: M
Vaccine: DTAPIPV, PNC13
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Pt received Kinrix rather than pediarix; no adverse effects noticed.
Age: 41.0
Sex: M
Vaccine: FLU4
Symptoms: Complex regional pain syndrome, Intervertebral disc protrusion, Magnetic resonance imaging, Pain in extremity, Paraesthesia
Clinical narrative: after undergoing multiple MRIs and seeing several doctors, patient was diagnosed with Complex Regional Pain Syndrome (CRPS). patient says arm began hurting, tingling, and he can barely use his hand. the pain went down the arm and up the arm into the neck creating a bulging disc.
Age: 69.0
Sex: F
Vaccine: FLU4
Symptoms: Deafness neurosensory, Sudden hearing loss
Clinical narrative: Sudden hearing loss
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Patient had hives on tops and sides of legs and also lower trunk.
Age: 58.0
Sex: M
Vaccine: FLUN4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Administered to the patient outside the recommended manufacturer recommendations and FDA approved age range of 2-49 years old. Patient age is 58.
Age: 20.0
Sex: F
Vaccine: FLU4
Symptoms: Syncope
Clinical narrative: PATIENT EXPERIENCED SYNCOPE POST IMMUNIZATION, INCLUDING "SYNCOPE INDUCED CONVUSIONS" AS DETERMINED BY EMT.
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Axillary pain, Injection site pain, Pain
Clinical narrative: Woke up with pain in armpit and soreness in arm at injection site. Pain in armpit has continued throughout the day. Pain making movement very uncomfortable . If pain persists will follow up with doctor.
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Syncope
Clinical narrative: Patient was fainted after a couple minutes of receiving  a flu shot. Patient was feeling fine when she left the room. She walked out the room immediate toward her father in the waiting area. Patient felt better a couple minutes later and left the pharmacy with her parents.
Age: 0.08
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Vomiting
Clinical narrative: The individual threw up 60 seconds or less after receiving the RotaTeq vaccine. Contents were white - breast milk colored. Situation and contents assessed by individual's PCP directly after individual threw up. The individual did NOT have a systemic reaction after receiving the RotaTeq vaccine. Individual remained in office with his guardian for a period of time to monitor for any adverse reaction(s).
Age: 72.0
Sex: F
Vaccine: FLUA4
Symptoms: Pain in extremity, Sleep disorder
Clinical narrative: pt received shot on 10/7/2020.  when she came in to the pharmacy today 10/28/2020, she mentioned that her arm was very sore the following  day and that she still had a little soreness occurring currently.  she was able to raise and lower her arm, unrestricted, with no pain, but said that sometimes it still wakes her up at night.    She stated that it is feeling better at this time.
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Axillary pain, Breast pain, Cellulitis, Hypoaesthesia, Injection site pain
Clinical narrative: Extreme pain at time of injection.  Increased tenderness affecting sleep that night. Excessive swelling of injection site and surrounding lymph nodes. Pain in shoulder, underarm and side of left breast. Numbness and tingling down left arm and to fingers. Weakness in left arm. Cellulitis of left shoulder.
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site swelling, Lymphadenopathy, Muscular weakness, Paraesthesia, Sleep disorder
Clinical narrative: Extreme pain at time of injection.  Increased tenderness affecting sleep that night. Excessive swelling of injection site and surrounding lymph nodes. Pain in shoulder, underarm and side of left breast. Numbness and tingling down left arm and to fingers. Weakness in left arm. Cellulitis of left shoulder.
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Tenderness
Clinical narrative: Extreme pain at time of injection.  Increased tenderness affecting sleep that night. Excessive swelling of injection site and surrounding lymph nodes. Pain in shoulder, underarm and side of left breast. Numbness and tingling down left arm and to fingers. Weakness in left arm. Cellulitis of left shoulder.
Age: 73.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Fatigue, Nausea, Pain, Pyrexia
Clinical narrative: Pt said at 5:00 pm day of vaccination administration she had a fever of 101.7 degrees Fahrenheit, chills and nausea.   Pt reported  "sometime in middle of night fever broke" .  Pt said when she woke up she was achy and fatigued but no other symptoms
Age: 66.0
Sex: F
Vaccine: FLUC4, PPV
Symptoms: Body temperature increased, Chills, Injection site erythema, Injection site swelling, Tremor
Clinical narrative: Temp 101.6, shaking chills. Slight erythema below injection site with minor swelling
Age: 12.0
Sex: M
Vaccine: UNK
Symptoms: Abdominal pain upper, Dyspnoea, Headache, Injection site pain, Nausea
Clinical narrative: I just got a wave of sickness, wanting to vomit, stomach hurting, bad head ache, little trouble breathing (It began to hurt not a lot but enough to notice it), runny nose and when I got the vaccine it began to sting or burn where the vaccine was injected (all though my other two vaccines for different stuff did not hurt a bit).
Age: 12.0
Sex: M
Vaccine: UNK
Symptoms: Rhinorrhoea
Clinical narrative: I just got a wave of sickness, wanting to vomit, stomach hurting, bad head ache, little trouble breathing (It began to hurt not a lot but enough to notice it), runny nose and when I got the vaccine it began to sting or burn where the vaccine was injected (all though my other two vaccines for different stuff did not hurt a bit).
Age: 43.0
Sex: F
Vaccine: FLUR4
Symptoms: Pain, Pain in extremity
Clinical narrative: Has felt like a Tetnus shot reaction since the day after. When the pharmacist shot into arm, I felt it in my muscle. I am unable to get dressed and lift heavy things without pain.
Age: 85.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Injection site erythema, Injection site inflammation, Musculoskeletal stiffness, Pruritus
Clinical narrative: PATIENT RECIEVED PREVNAR 13 ON LEFT ARM 10/21/2020. PT STARTED EXPERIENCING REDNESS AND INFLAMMATION ON INJECTION SITE THE DAY OF ADMINISTRATION.  THE FOLLOWING DAY, PT EXPERIENCED FURTHER INFLAMMATION AND REDNESS, STIFFNESS ON THE LEFT SIDE OF HER NECK, ALONG WITH A LOW GRADE FEVER.  SHE CAME INTO THE PHARMACY 10/28/2020 AND HER LEFT ARE WAS RED DOWN TO HER ELBOW AND ITCHY.  HER ARM WAS STILL SWOLLEN, BUT HAD IMPROVED BASED ON PICTURES SHE SHOWED ON HER PHONE. SHE REPORTED USING A CORTICOSTEROID THAT WAS PREVIOUSLY PRESCRIBED TO HER, BUT SHE COULDN'T CONFIRM THE EXACT PRODUCT.
Age: 85.0
Sex: F
Vaccine: PNC13
Symptoms: Pyrexia
Clinical narrative: PATIENT RECIEVED PREVNAR 13 ON LEFT ARM 10/21/2020. PT STARTED EXPERIENCING REDNESS AND INFLAMMATION ON INJECTION SITE THE DAY OF ADMINISTRATION.  THE FOLLOWING DAY, PT EXPERIENCED FURTHER INFLAMMATION AND REDNESS, STIFFNESS ON THE LEFT SIDE OF HER NECK, ALONG WITH A LOW GRADE FEVER.  SHE CAME INTO THE PHARMACY 10/28/2020 AND HER LEFT ARE WAS RED DOWN TO HER ELBOW AND ITCHY.  HER ARM WAS STILL SWOLLEN, BUT HAD IMPROVED BASED ON PICTURES SHE SHOWED ON HER PHONE. SHE REPORTED USING A CORTICOSTEROID THAT WAS PREVIOUSLY PRESCRIBED TO HER, BUT SHE COULDN'T CONFIRM THE EXACT PRODUCT.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Pain, Pain in extremity
Clinical narrative: Fever, sore arm, headache, chills, tiredness amd achiness
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Fever, sore arm, headache, chills, tiredness amd achiness
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Chills, Headache, Paraesthesia, Pyrexia
Clinical narrative: chills, shivering, headache and feeling feverish for about 10 hours following vaccination.  also tingling/slight burning sensation at top of spine /  base of neck.
Age: 76.0
Sex: F
Vaccine: UNK
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Potential infection at injection site, patient was seen at an urgent care and was given antibiotics. Patient had pain, swelling, redness at injection site.
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Inflammation, Mobility decreased, Pain
Clinical narrative: Patient reported mild pain later in the day, then pain increased and could hardly move shoulder. Scheduled office visit with Dr., who prescribed steroids for inflammation. Has since reported feeling much better, although still not completely pain free with all movements. She reports continuing with a series of stretches/exercises prescribed by Dr.
Age: 6.0
Sex: F
Vaccine: UNK
Symptoms: Rash
Clinical narrative: Patient was given a seasonal flu shot and developed a rash over her entire upper arm and onto her back. Still in contact with the Doctors office regarding what to do. It has been 4 days and is still present and seems worse today compared to the previous days.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Patient can not raise her arm since her flu shot. This started right after the shot was given. Her arm is very sore still a month later. We recommended she see her doctor.
Age: 28.0
Sex: M
Vaccine: FLUC4
Symptoms: Dyskinesia, Muscle rigidity, Seizure like phenomena, Syncope, Urinary incontinence
Clinical narrative: Patient received vaccine at 1:45 PM then proceeded to check out in the grocery line at approximately 2:00 PM and fainted and exhibited epileptic-like symptoms (rigid body, uncontrollable movement, involuntary urination). EMS services were utilized and patient was transported to hospital for further evaluation.
Age: 62.0
Sex: F
Vaccine: FLUR4
Symptoms: Pain in extremity, Pruritus, Urticaria
Clinical narrative: vaccine date 10/26/2020.  Left arm soreness next morning and itching across chest and back and both arms reported to start evening of 10/27. Welts reported on both arms and across chest and back and lower  extremities morning of 10/28 .  Patient reported to physician and was instructed to take diphenhydramine which gave some relief of symptoms.  Patient reports these are similar symptoms that she experiences when she consumes red meat due to tick borne illness.  Patient has received influenza vaccine yearly for many years.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Hives around torso
Age: 27.0
Sex: F
Vaccine: UNK
Symptoms: Cough, Dysphonia, Facial pain, Fatigue, Headache
Clinical narrative: 2 hours after vaccine-Sudden fatigue 3 hours after vaccine-Throat irritation  and hoarseness with mild coughing  5 hours after vaccine- hoarseness, some throat irritation.  Eye redness of both eyes and a lot of pressure behind eyes and upper nose.  6.5 hours after vaccine-Eyes have gotten more red, fatigue continues. Facial pressure continues. Headache. Body aches. Hoarseness.  No fever as of yet.
Age: 27.0
Sex: F
Vaccine: UNK
Symptoms: Ocular hyperaemia, Pain, Throat irritation
Clinical narrative: 2 hours after vaccine-Sudden fatigue 3 hours after vaccine-Throat irritation  and hoarseness with mild coughing  5 hours after vaccine- hoarseness, some throat irritation.  Eye redness of both eyes and a lot of pressure behind eyes and upper nose.  6.5 hours after vaccine-Eyes have gotten more red, fatigue continues. Facial pressure continues. Headache. Body aches. Hoarseness.  No fever as of yet.
Age: 73.0
Sex: F
Vaccine: PNC13
Symptoms: Peripheral swelling, Skin infection, Skin irritation
Clinical narrative: Swollen and irritated arm following injection. Follow up appointment with physician confirmed a skin infection. Patient took a week of antibiotics and is doing fine now.
Age: 79.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Pain, Skin warm, Swelling, Tenderness
Clinical narrative: Patient had swelling about the size of a tennis ball, red, hot, and painful area later the evening after vaccination. Patient reported the area was painful upon moving the arm and hurt to touch on 10/26/2020. Patient showed me the area to report the adverse event on 10/28/2020, area still red and a bit swollen. said it did not hurt upon moving her arm but still sore when pressing on area, area was not hot to the touch. Patient did not follow up with primary care provider due to issue getting better. I informed her to follow up and to keep monitoring it, and if it gets work or signs of infection to follow up with medical care.
Age: 34.0
Sex: M
Vaccine: FLUC4
Symptoms: Blindness transient, Deafness, Mydriasis, Pallor
Clinical narrative: DILATED PUPILS, LOST HEARING AND VISION FOR SEVERAL SECONDS, PAIL SKIN. PATIENT WAS RESPONSIVE.  WHEN PARAMEDICS CAME IN AND CHECKED HIS VITALS. IT WAS IN NORMAL RANGE. PATIENT REFUSE TO GO TO THE HOSPITAL.
Age: 0.17
Sex: M
Vaccine: HIBV
Symptoms: Chills, Dyspnoea, Erythema, Restlessness, Swelling
Clinical narrative: Pt was given the HIB at 0900 during a well child check. Pts mother called at 1400 for further eval as the child was restless and appeared to be in distress. The child was seen in the clinic. While in the clinic the baby displayed rigors, increased work of breathing, generalized restlessness, swollen, and redness. The mother gave the child baby tylenol,  which did appear to have a good result as after the baby came into the clinic the child was calming and less restless. Dr.  saw the pt and did agree that it was a reaction but denied treatment as the  mom had medicated the child previously to her eval.
Age: 78.0
Sex: M
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: patient reported severe pain to his right arm for several days following the vaccine administration
Age: 13.0
Sex: M
Vaccine: FLU4
Symptoms: Vomiting
Clinical narrative: PATIENT RECEIVED  FLUZONE  VACCINATION IN RIGHT ARM.  PATIENT  PRESENTED  WITH PARENTS AND APPEARED  VERY ALERT AND KNOWLEDGABLE  ABOUT GETTING A VACCINE. SHOWED NO SIGNS OF PALENESS, WEAKNESS, OR HEAVY BREATHING.  PRESENTED WITH NORMAL APPEARANCE AND ACTIONS.   ABOUT  10 MINUTES AFTER VACCINE, PT VOMITED ONCE.  AFTER EVALUATION AND DISCUSSION WITH PARENTS AND PATIENT,  PATIENT FELT COMPLETELY FINE AND VOMITING.  HE REMAINED AT PHARMACY FOR ANOTHER 20 MINUTES TO WATCH.  PT DRANK WATER AND STATED FEELING FINE.  CHECKED ON PT AT 12:30 AND 7 PM.- PT COMPLETELY FINE PER MOTHER
Age: 46.0
Sex: F
Vaccine: UNK
Symptoms: Asthenia
Clinical narrative: I usually have a lot of energy and now I have trouble staying awake and my energy is low ever since the day I got the flu shot, I noticed the morning after and it?s been bad since then.
Age: 23.0
Sex: F
Vaccine: HPV9
Symptoms: Asthenia, Consciousness fluctuating, Eye movement disorder, Hypoacusis, Immediate post-injection reaction
Clinical narrative: Patient immediately started to experience blurred vision, said she felt nauseous, eyes were rolling towards the back of her head. She was coming in and out. Patient reported reduced hearing. Had difficulty keeping coherentthoughts. Felt weak and after 5-10 minutes the decision was made to call the ambulance as the patient's symptoms and general presentation were not resolving or getting better. EMS arrived and patient left pharmacy on stretcher and was taken to the hospital where further attention was provided but unknown to us here at the pharmacy. Will follow up with patient in two days.
Age: 23.0
Sex: F
Vaccine: HPV9
Symptoms: Incoherent, Nausea, Vision blurred
Clinical narrative: Patient immediately started to experience blurred vision, said she felt nauseous, eyes were rolling towards the back of her head. She was coming in and out. Patient reported reduced hearing. Had difficulty keeping coherentthoughts. Felt weak and after 5-10 minutes the decision was made to call the ambulance as the patient's symptoms and general presentation were not resolving or getting better. EMS arrived and patient left pharmacy on stretcher and was taken to the hospital where further attention was provided but unknown to us here at the pharmacy. Will follow up with patient in two days.
Age: 77.0
Sex: M
Vaccine: FLUR4
Symptoms: Hypoacusis
Clinical narrative: Pharmacy provided adult Flu Shot. My left ear suddenly has changed its frequency response. Testing with a telephone dial tone. The left ear delivers a higher tone than the right ear. Sensitivity is higher to sound. The stereo effect is shifted left. Received Adult Flu Shot. Not certain of correct data entry of Item 17.
Age: 1.83
Sex: M
Vaccine: FLU4
Symptoms: Unevaluable event
Clinical narrative: No adverse reactive
Age: 76.0
Sex: U
Vaccine: FLU4
Symptoms: Arthralgia, Arthritis, Blood creatine phosphokinase, Blood thyroid stimulating hormone, Bradycardia
Clinical narrative: Hardly work or get dressed Muscles tender to touch Shoulder & hip joints are stiff very tender with ROM
Age: 76.0
Sex: U
Vaccine: FLU4
Symptoms: C-reactive protein abnormal, Chest pain, Constipation, Differential white blood cell count abnormal, Essential hypertension
Clinical narrative: Hardly work or get dressed Muscles tender to touch Shoulder & hip joints are stiff very tender with ROM
Age: 76.0
Sex: U
Vaccine: FLU4
Symptoms: Faeces discoloured, Fatigue, Full blood count abnormal, Gait inability, Joint range of motion decreased
Clinical narrative: Hardly work or get dressed Muscles tender to touch Shoulder & hip joints are stiff very tender with ROM
Age: 76.0
Sex: U
Vaccine: FLU4
Symptoms: Joint stiffness, Loss of personal independence in daily activities, Malaise, Metabolic function test abnormal, Myalgia
Clinical narrative: Hardly work or get dressed Muscles tender to touch Shoulder & hip joints are stiff very tender with ROM
Age: 76.0
Sex: U
Vaccine: FLU4
Symptoms: Pain, Rheumatoid factor
Clinical narrative: Hardly work or get dressed Muscles tender to touch Shoulder & hip joints are stiff very tender with ROM
Age: 71.0
Sex: M
Vaccine: FLU4
Symptoms: Asthenia, Musculoskeletal disorder
Clinical narrative: Patient loss strength/usage in left hand
Age: 2.33
Sex: F
Vaccine: FLU4
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: R thigh with 10x10cm area of redness, warmth, pain, itching 2 days after injection. Presumed cellulitis. Pt treated with Keflex x 10 days
Age: 64.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Rash
Clinical narrative: Patient received this first dose of Shingrix on 10-12-20 and on 10/14/20 he developed a rash that started on his low back and wrapped around to umbilica lasted for 2 wks.
Age: 78.0
Sex: M
Vaccine: FLUA3
Symptoms: Confusional state, Fatigue, Feeling cold, Gait disturbance, Laboratory test
Clinical narrative: violent shaking, confusion, pale, temperature normale Blood sugar fine very cold, tired very similar to sepsis symptoms had trouble walking for 2 days
Age: 78.0
Sex: M
Vaccine: FLUA3
Symptoms: Pallor, SARS-CoV-2 test negative, Tremor
Clinical narrative: violent shaking, confusion, pale, temperature normale Blood sugar fine very cold, tired very similar to sepsis symptoms had trouble walking for 2 days
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Muscle spasms, Musculoskeletal stiffness
Clinical narrative: Patient Received vaccine 10/13 called teledoctor on 10/17 reported cramps in upper right leg muscle, did not report back to pharmacy until 10/27 per MD. Said symptoms started a few day after vaccine and lasted about 9 days. Along with cramping also felt stiffness. Teledoctor confirmed on conference call on 10/17 prescribed Diclofenac 75mg Tablet BID and also reported event Case. Patient did not report any bruising, redness at vaccine site only a day of some soreness at site. Thanked patient for reporting and explained the report will be sent in event others had similar reactions with same manufacture/lot.
Age: 71.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site bruising, Injection site erythema
Clinical narrative: Patient reports unusual bruising and redness of the arm/site of injection persisting for 2 weeks.
Age: 4.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: red, swollen R arm 26 hours after vaccine - 10/27 7 pm warm to touch
Age: 17.0
Sex: M
Vaccine: FLU4
Symptoms: Unevaluable event
Clinical narrative: none.
Age: 37.0
Sex: U
Vaccine: FLUC4
Symptoms: Heart rate increased, Hyperhidrosis, Tunnel vision
Clinical narrative: Patient experienced racing pulse, sweats and tunnel vision For about 10 - 15 minutes, Then it went away - no after affects
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site bruising, Injection site pain, Injection site swelling
Clinical narrative: soreness and a bump/lump at the injection site, 2 in bruise formed the next day, persisting 1+ wks after vaccination
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Decreased activity, Injection site pain, Injection site swelling
Clinical narrative: Patient complained of pain and swelling at injection site. Patient also complained of trouble using the impacted shoulder.