chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site swelling, Nausea
Clinical narrative: swelling at Injection site; redness at the injection site; Headache; Nausea; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of headache (1st dose received on unknown date. Please refer the case US2020AMR119387).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced injection site swelling, injection site erythema, headache and nausea. On an unknown date, the outcome of the injection site swelling and injection site erythema were not recovered/not resolved and the outcome of the headache and nausea were recovered/resolved.   It was unknown if the reporter considered the injection site swelling, injection site erythema, headache and nausea to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient recently received 2nd dose of shingrix injection.  After vaccination the patient experienced large, size not specified redness and swelling at the injection site.  The swelling and redness had gotten better per patient, but had not completely resolved. She also reported that a few days after getting the injection.  The patient experienced nausea and headache, which had resolved.  The reporter did not consent to follow up.
Age: 68.0
Sex: F
Vaccine: UNK
Symptoms: Burning sensation, Mobility decreased, Pruritus, Rash, Rosacea
Clinical narrative: Patient experienced a slight burn on her arm and couldn't move her arm for 2 days. She was experencing a slight swelling. By Thursday of 3 pm, she noticed that the inside of her arm had a rash, roscea, and it was slight itchy.
Age: 68.0
Sex: F
Vaccine: UNK
Symptoms: Swelling
Clinical narrative: Patient experienced a slight burn on her arm and couldn't move her arm for 2 days. She was experencing a slight swelling. By Thursday of 3 pm, she noticed that the inside of her arm had a rash, roscea, and it was slight itchy.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Injection site pain, Neck pain
Clinical narrative: " I felt the needle go in but did not feel the usual full feeling as the shot was injected. Within an hour I had a headache and pain up the left side of my neck, then severe pain in my left shoulder area a short time later. "
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Syncope
Clinical narrative: syncope
Age: 5.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: Injection site bruising, Injection site erythema
Clinical narrative: Bruising and redness at injections site on right thigh.  Discovered on 7/9/20, when pt was in the office 1 week after vaccine administration.  Pt had not c/o pain or discomfort to his mother.  While in office, the site was washed with Hibiclens and hydrocortisone ointment and an Op-site were applied.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Arthralgia, C-reactive protein increased, Epstein-Barr virus antibody positive, Full blood count, Gait disturbance
Clinical narrative: 6/29- Patient was seen in office and states that she received the Men B vaccines on 6/9. States that when she received the vaccine there was no pain. States that after the vaccine (she received vaccine in her left upper arm), started with pain at the site and trouble lifting her arm. Now she states that's he has a hard time getting up in the morning. Denies fever, diarrhea, emesis. States that she has to walk hunched over. Also with finger swelling and joint pain. States that the worst pain is in the morning and the pain wakes her up in the middle of the night.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Injected limb mobility decreased, Injection site pain, Metabolic function test, Middle insomnia, Peripheral swelling
Clinical narrative: 6/29- Patient was seen in office and states that she received the Men B vaccines on 6/9. States that when she received the vaccine there was no pain. States that after the vaccine (she received vaccine in her left upper arm), started with pain at the site and trouble lifting her arm. Now she states that's he has a hard time getting up in the morning. Denies fever, diarrhea, emesis. States that she has to walk hunched over. Also with finger swelling and joint pain. States that the worst pain is in the morning and the pain wakes her up in the middle of the night.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Red blood cell sedimentation rate increased
Clinical narrative: 6/29- Patient was seen in office and states that she received the Men B vaccines on 6/9. States that when she received the vaccine there was no pain. States that after the vaccine (she received vaccine in her left upper arm), started with pain at the site and trouble lifting her arm. Now she states that's he has a hard time getting up in the morning. Denies fever, diarrhea, emesis. States that she has to walk hunched over. Also with finger swelling and joint pain. States that the worst pain is in the morning and the pain wakes her up in the middle of the night.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Agitation, Arthralgia, Bone pain, Insomnia, Malaise
Clinical narrative: Feverish feeling with normal temperature.  Whole body aching and pain--extremities, torso, breasts, bones, joints.  Agitation.  Sleeplessness due to malaise.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: Feverish feeling with normal temperature.  Whole body aching and pain--extremities, torso, breasts, bones, joints.  Agitation.  Sleeplessness due to malaise.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient (pt) of unknown age. No information regarding the pt's pertinent medical history, drug reactions or allergies, and concomitant medications was provided. In approximately the fall of 2018, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, dose number, route of administration, anatomical site of vaccination, lot number and expiration date were not provided), for routine health maintenance and for the vaccine intended purpose: prevention of shingles (herpes zoster). On an unknown date, shortly after receiving the zoster vaccine live (ZOSTAVAX) vaccine, the pt suffered from painful rashes across her back and abdomen. On 15-OCT-2018, the pt was diagnosed with herpes zoster and underwent medical treatment for these injuries. As a direct and proximate result of the zoster vaccine live (ZOSTAVAX) vaccine, the pt's symptoms had resulted in physical limitations not present prior to using the zoster vaccine live (ZOSTAVAX). The pt also experienced mental and emotional distress due to physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of the zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. It was also claimed that as a tragic consequence of the company wrongful conduct, the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of the company conduct, the pt had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event was considered not recovered. The reporter assessed that the event was related to the zoster vaccine live (ZOSTAVAX).  The reporter considered the event of herpes zoster to be disabling.
Sex: M
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Neuralgia, Paraesthesia, Rash, Rash vesicular
Clinical narrative: nerve pain; numbness in the extremities; tingling in the extremities; painful blistering rash; Information has been received from a lawyer regarding a case in litigation concerning a currently approximately 78-year-old male patient (pt). No information was provided regarding the pt's past medical history, concurrent conditions and concomitant medications. On or about 26-OCT-2014, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (lot number, expiration date, dose and route of administration were not provided) at a pharmacy for the long-term prevention of shingles and zoster-related conditions. On an unknown date, reported as subsequently, the pt was treated by a provider for the following injuries resulting from zoster vaccine live (ZOSTAVAX) use: painful blistering rash, nerve pain, as well as, numbness and tingling in the extremities. The outcome of painful blistering rash, nerve pain, numbness and tingling in the extremities was not reported. The reporter considered the events of painful blistering rash, nerve pain, numbness and tingling in the extremities to be related to zoster vaccine live (ZOSTAVAX).
Age: 11.0
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional adverse effect reported; on 3/4/2020, a patient received a second dose of GARDASIL 9 that was later then the recommended dosing interval per PI.; This spontaneous report was received from a registered nurse referring to a 12-year-old patient of unknown gender. The patient's pertinent concurrent conditions, medical history, concomitant medications and previous drug reactions or allergies were not reported.  On 06-DEC-2018 and 04-MAR-2020, the patient was vaccinated with first and second respectively of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) by intramuscular route as prophylaxis (concentration was not reported, lot number and expiration date were unknown by the reporter) (inappropriate schedule of product administration). No additional adverse effect reported.
Sex: U
Vaccine: DTAPIPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Quadracel was given out of age indication/no AE; Initial information received on 08-Jun-2020 regarding an unsolicited valid non-serious case received from a non health care professional(office staff).  This case involves a patient (unknown demographics) who was vaccinated with DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] out of age indication (lot number and expiry date not reported) via unknown route in unknown administration site on an unknown date for prophylactic vaccination(product administered to patient of inappropriate age).  Medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error case due to Inappropriate age at vaccine administration.  At the time of report no adverse event was reported.  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.  There will be no information available on batch number for this case.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, UNK, UNK, UNK
Symptoms: Urticaria
Clinical narrative: At 1:30 pm started having wheals and urticaria. Treating with Benadryl.  Vaccine paperwork is incorrect. Shows HiB,  Pneumoconjugate,  and Rotavirus (unknown trade names) given on 07/07/2020 when the vaccines were administered on 07/09/2020.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Nausea, Rash pruritic, Vaccination site reaction
Clinical narrative: Nausea, diarrhea, bad, itchy rash all over entire arm of vaccination. Took Benadryl
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV, PNC13
Symptoms: Aphasia, Crying, Decreased appetite, Diarrhoea, Dizziness
Clinical narrative: Lethargic, febrile, loss of appetite, diarrhea, dizzy, uncontrollable crying, staring off into space,  head shaking, stumbling & uncontrolled gait and stopped communicating verbally.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV, PNC13
Symptoms: Electromyogram, Gait disturbance, Head titubation, Lethargy, Magnetic resonance imaging
Clinical narrative: Lethargic, febrile, loss of appetite, diarrhea, dizzy, uncontrollable crying, staring off into space,  head shaking, stumbling & uncontrolled gait and stopped communicating verbally.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV, PNC13
Symptoms: Orthopaedic examination, Pyrexia, Staring
Clinical narrative: Lethargic, febrile, loss of appetite, diarrhea, dizzy, uncontrollable crying, staring off into space,  head shaking, stumbling & uncontrolled gait and stopped communicating verbally.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Dysstasia
Clinical narrative: She is having pain on the inside of her left ankle. She does not have the pain when she elevates her leg.  She also is having trouble standing on her left foot.
Age: 0.33
Sex: M
Vaccine: RV5
Symptoms: Abdominal X-ray, Barium double contrast, Crying, Decreased activity, Decreased appetite
Clinical narrative: Patient is a4 month old male with no past medical or surgical  history presents  with bilious emesis on the morning of 7/7/20 .  The patient had been sick after  he got Rotavirus vaccine a week ago. Mom stated that he had decreased appetite  less activity and fever after 1st day of vaccination(Tmax 101.1F). Fever gone  after taking Tylenol. He hasn't had fever for 5 days and is getting better.  Since the night before admission the patient cried and was inconsolable. The  morning of presentation the patient had greenish color vomiting.  An Xray and ultrasound were performed and confirmed intussusception.
Age: 0.33
Sex: M
Vaccine: RV5
Symptoms: Discoloured vomit, Intussusception, Malaise, Mucous stools, Pyrexia
Clinical narrative: Patient is a4 month old male with no past medical or surgical  history presents  with bilious emesis on the morning of 7/7/20 .  The patient had been sick after  he got Rotavirus vaccine a week ago. Mom stated that he had decreased appetite  less activity and fever after 1st day of vaccination(Tmax 101.1F). Fever gone  after taking Tylenol. He hasn't had fever for 5 days and is getting better.  Since the night before admission the patient cried and was inconsolable. The  morning of presentation the patient had greenish color vomiting.  An Xray and ultrasound were performed and confirmed intussusception.
Age: 0.33
Sex: M
Vaccine: RV5
Symptoms: Ultrasound abdomen abnormal, Vomiting, X-ray, X-ray gastrointestinal tract abnormal
Clinical narrative: Patient is a4 month old male with no past medical or surgical  history presents  with bilious emesis on the morning of 7/7/20 .  The patient had been sick after  he got Rotavirus vaccine a week ago. Mom stated that he had decreased appetite  less activity and fever after 1st day of vaccination(Tmax 101.1F). Fever gone  after taking Tylenol. He hasn't had fever for 5 days and is getting better.  Since the night before admission the patient cried and was inconsolable. The  morning of presentation the patient had greenish color vomiting.  An Xray and ultrasound were performed and confirmed intussusception.
Age: 13.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Hyperhidrosis, Hypotension, Pallor, Syncope
Clinical narrative: Patient became pale, diaphoretic and fainted after receiving vaccines. BP low at 73/34 after fainting. No shortness of breath, no rash, no pain. Ammonia was used.  Patient was assisted to lying position with legs elevated. Also given crackers and water. Patient and vitals were monitored closely. Patient had BP of 91/54 and 95/58 while lying down. Assisted patient to sitting in a chair but patient became pale and felt faint again. BP 71/43 and 73/32.  Once lying down BP 96/47 and 88/54.  Decision made to call EMS due to low blood pressure and feeling faint while sitting. Client had been monitored from 11:45 to 12:35 when EMS was called. Prior to EMS arriving patient started feeling better and sat up in chair with good color and no complaints of dizziness. BP 104/59. Walked client around in office and rechecked BP 112/72. EMS arrived at 12:55pm for evaluation. Patient was feeling much better and was discharge home with mother at 1:10pm.  Only adverse effect was fainting and low Blood pressure.
Age: 18.0
Sex: M
Vaccine: MENB, TD
Symptoms: Epistaxis, Petechiae, Platelet count decreased, Thrombocytopenia
Clinical narrative: Thrombocytopenia - developed petechiae, prolonged epistaxis 6 days after vaccination. Found to have platelet count of 1
Age: 1.17
Sex: F
Vaccine: HEPA, MMRV, PNC, VARCEL
Symptoms: Extra dose administered
Clinical narrative: Provider ordered MMR + Varicella to be administered. Staff gave patient MMR-V + Varicella. Manufature was called. Mom was made aware. Staff education was Provided.
Sex: M
Vaccine: MMR, PNC, VARCEL
Symptoms: Pneumonia, Varicella post vaccine
Clinical narrative: pneumonia; chicken pox; Information has been downloaded from Agency (HQ4344208AUG2001).  This spontaneous report was received from a healthcare professional referring to a 13-month-old male patient. The patient's medical history, concurrent conditions, and concomitant medications were not disclosed.  On 11-JUN-2001, the patient was vaccinated with varicella virus vaccine live (oka/merck) (manufacturer unknown), administered via subcutaneous route, lot number unknown (expiration date was not reported). On that same day, he was also vaccinated with pneumococcal 4 6b 9v 14 18c 19f 23f conj vaccine (crm197) (PREVNAR) administered intramuscularly, lot number 474-947 (expiration date not provided); and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) administered via subcutaneous route, lot number 1181K, expiration date not reported but upon internal validation was established as 27-JUL-2002. All these vaccines were administered as immunization (strengths, dose numbers, frequencies, and anatomical vaccination sites were not reported).  On 05-JUL-2001, the patient experienced pneumonia and chicken pox (herpes zoster).  On an unspecified date in July 2001, the patient had to be hospitalized due to these events.   At the reporting time, the outcomes of the events pneumonia and herpes zoster were unknown.  The causality assessment between the suspect therapies and the aforementioned events was not reported.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia
Clinical narrative: multiple outbreaks of herpes zoster; Post herpetic neuralgia; This initial spontaneous report was received from a lawyer regarding a case in litigation concerning to a patient of unknown age and gender.  Information regarding medical history, concurrent conditions and concomitant medications was not provided. On or about 13-APR-2017, the patient was inoculated with zoster vaccine live (ZOSTAVAX) at a pharmacy (dosage regimen, route of administration, lot number and expiration date were not reported) for the long-term prevention of shingles and zoster-related conditions. On an unknown date, subsequently the patient was treated by a physician for the following injuries resulting from Plaintiffs ZOSTAVAX use: multiple outbreaks of herpes zoster and post (e) herpetic neuralgia. The outcome of the events was considered as not recovered. Causality assessment was related.
Sex: F
Vaccine: VARZOS
Symptoms: Balance disorder
Clinical narrative: a bad case of balance problems; Information has been received from a lawyer, regarding a case in litigation, and refers to a female patient (pt) of unknown age. No information about the pt's medical history, concurrent conditions and concomitant medications was provided. On or around 04-NOV-2013, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date, shortly after receiving zoster vaccine live (ZOSTAVAX), the pt suffered a bad case of balance problems. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt's symptoms had resulted in physical limitations not present prior to using the suspect product. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence, the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the pt Plaintiff had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event of a bad case of balance problems was considered to be not recovered. The reporter determined the event to be related to zoster vaccine live (ZOSTAVAX). The event of a bad case of balance problems was considered to be disabling.
Age: 0.33
Sex: M
Vaccine: RV1, RV5
Symptoms: Erythema, Incorrect route of product administration, Pain
Clinical narrative: Patient was administered a dose of ROTAVIRUS intramuscularly instead of orally; The pharmacist is not sure if ROTATEQ or ROTARIX was administered; The pharmacist is not sure if ROTATEQ or ROTARIX was administered; One unspecified leg does have some redness; The parent gave Tylenol for pain; This spontaneous report was received from a pharmacist concerning a 4 month old male patient. Information regarding the patient's medical history, concurrent conditions and concomitant medications was not reported.   On an unspecified date in 2020, the patient was vaccinated with a rotavirus vaccine for prophylaxis, intramuscularly instead of orally (incorrect route of product administration), the pharmacist was not sure if was rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (strength, frequency, lot number and expiration date were not provided) or rotavirus g1 p1 vaccine live (89-12) (ROTARIX) (interchange of vaccine products and circumstance or information capable of leading to medication error) (strength, frequency, lot number and expiration date were not provided); the reporter mentioned that this was the second dose and the parents were not sure which leg the rotavirus vaccine was administered in.       On 07-JUL-2020, the patient did has some redness on an unspecified leg (erythema) and the parent gave acetaminophen (TYLENOL) for pain.    The outcome of erythema and pain was reported as not recovered. The causality assessment between the suspect drugs and the events occurrence was not reported.
Age: 87.0
Sex: M
Vaccine: VARZOS
Symptoms: Decreased appetite, Pain in extremity, Somnolence
Clinical narrative: lay down for a few hours; lost appetite  (he said he didn't eat much for supper); arm hurt; This case was reported by a consumer via call center representative and described the occurrence of sleepiness in a 87-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (did not experience any side effects with the first injection). Concomitant products included fluticasone propionate + salmeterol xinafoate (Advair).   On 23rd June 2020, the patient received the 2nd dose of Shingrix. On 23rd June 2020, less than a day after receiving Shingrix, the patient experienced pain in arm. On 25th June 2020, the patient experienced sleepiness and appetite lost. On an unknown date, the outcome of the sleepiness, appetite lost and pain in arm were recovered/resolved.   It was unknown if the reporter considered the sleepiness, appetite lost and pain in arm to be related to Shingrix.  Additional details were provided as follows: It was reported that after the second injection his arm hurt. On the third day after the injection he experienced lost appetite (he said he didn't eat much for supper) and had to lay down for a few hours. The symptoms were gone the following day. The reporter did not consent to follow-up. This case was linked with the case US2020115708, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020115708:same reporter
Age: 58.0
Sex: M
Vaccine: UNK
Symptoms: Injection site pain, Mobility decreased, Pain in extremity
Clinical narrative: pain in arm was reported as worsened; pain at the injection site; pain in arm; can't lift arm; This is a spontaneous report from a contactable consumer, the spouse of the patient.  A 58-year-old male patient received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (MANUFACTURER UNKNOWN), via an unspecified route of administration in the right arm on 06Jul2020 at 15:30 as a single dose for immunisation.  Medical history included chronic obstructive pulmonary disease from an unknown date and unknown if ongoing.  The patient's concomitant medications included unspecified maintenance medications. The patient previously received another pneumonia vaccine (MANUFACTURER UNKNOWN) in 2015 for immunization with no issues.  On 06Jul2020, the patient had pain at the injection site, lot of pain in the arm and he could not lift it. On 07Jul2020, the pain was worse. The clinical outcome of the pain at the injection site, lot of pain in the arm, could not lift the arm, and pain was worse were not recovered.     Pfizer is the Marketing Authorization Holder of pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another Marketing Authorization Holder of pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) has submitted the same report to the regulatory authorities.                   No follow-up attempts are possible; information about lot number cannot be obtained.
Age: 1.0
Sex: U
Vaccine: UNK
Symptoms: Pyrexia, Skin warm, Urticaria
Clinical narrative: Box 17 - HepA, MMR, PCV13, Hib, Polio  Within the hour whelps appeared near injection site, then started to spread. He was given Tylenol. Approximately 7-8 hours later, whelps spread all over body. He was then taken to ER, where he was given Benadryl and steroids. Next day (7/7) he was warm to touch with a fever. Given Tylenol. Currently experiencing fever since 11am, going down but still feels warm.
Age: 17.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Dark circles under eyes, Dizziness, Fatigue, Somnolence, Vision blurred
Clinical narrative: Experienced blurred vision and felt faint around 2:30 pm on 07/02. Very tired and developed dark circles around eyes . Slept on/off for 2-3 days. Started feeling better in the afternoon of 07/04. Never experienced any SOB, difficulty breathing, or difficulty swallowing. No fevers. No signs/symptoms at injection sites. No redness, tenderness, swelling, bruising, or warmth. Mother contacted Pediatrician as soon as patient started experiencing the blurred vision and feel faint.
Age: 1.83
Sex: M
Vaccine: HEP
Symptoms: Cough, Croup infectious, Stridor
Clinical narrative: Developed stridor and croup-type cough shortly after vaccination
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, UNK, UNK
Symptoms: Chills, Cyanosis, Skin disorder, Tremor
Clinical narrative: My son began to shake/shiver violently.  Skin was pasty and his lips were bluish.  These were all given to him. I didn't know how to add this list on page..  VaccineDate AdministeredIMMUNIZ ADMIN; 1/COMBO VACCINE/TOXOID01/09/2020IMMUNIZ ADMIN; 2/> SING/COMBO VACCINES/TOXOIDS01/09/2020IIV3 VACC NO PRSV 0.25 ML IM01/09/2020PNEUMOCOCCAL VACC 13 VAL IM01/09/2020DTAP-HEP B-IPV VACCINE IM01/09/2020
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Feeling hot, Hyperhidrosis, Loss of consciousness, Pallor, Presyncope
Clinical narrative: Pt was in exam room with mom and 2 other siblings.  Room was warm and humid.  Gave immunization after confirming no previous reactions or allergies. Pt. tolerated well and allowed to walk out of exam room a few moments later.  Before exiting to sit in waiting room patient slowly helped himself to the floor and was unconscious x 20 seconds.  Pt. states he had not eaten yet that day and felt very hot.  Patient was able to sit up in chair with limited assistance.  Provider notified and vitals obtained. Provider states it was a Vasovagal response.  Pt was very pail and sweaty.  Answers questions appropriately and states he felt "everything go black and I just needed to lay down" Pt remained in clinic and vitals checked every 15 minutes x 1 hour.  BP came up to normal and pt. was smiling and feeling much better at time of discharge from clinic.  Mother called over next 2 days and no further complaints or symptoms noted.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Blood pressure decreased, Eye movement disorder, Fall, Headache, Heart rate decreased
Clinical narrative: Pt in for 2nd dose HPV. Mother confirmed no previous reaction or allergies to vaccines.  After injection, pt. tolerated well and after a few minutes with exam room so hot and multiple people in room allowed pt. to get up and make way to waiting room.  After walking about 20 feet, pt. fell to floor.  Pt. did twitch and eyes rolled back to head about 20 seconds.  After helping pt. to chair he did regain consciousness and complained of headache and sore arm where the arm rubbed against wall at time of fall.  Pt. very pale and diaphoretic vitals obtained and BP/HR very low.  Pt. did state "All I have eaten is fruit snacks today." Mother admitted they had not eaten and she planned to go out to eat after the appointment.  Pt. remained in clinic x 1 hour and vitals stable at time of discharge.  Called Mother to check on pt. over next 2 days and no further symptoms noted.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Hyperhidrosis, Limb injury, Loss of consciousness, Muscle twitching, Pain in extremity
Clinical narrative: Pt in for 2nd dose HPV. Mother confirmed no previous reaction or allergies to vaccines.  After injection, pt. tolerated well and after a few minutes with exam room so hot and multiple people in room allowed pt. to get up and make way to waiting room.  After walking about 20 feet, pt. fell to floor.  Pt. did twitch and eyes rolled back to head about 20 seconds.  After helping pt. to chair he did regain consciousness and complained of headache and sore arm where the arm rubbed against wall at time of fall.  Pt. very pale and diaphoretic vitals obtained and BP/HR very low.  Pt. did state "All I have eaten is fruit snacks today." Mother admitted they had not eaten and she planned to go out to eat after the appointment.  Pt. remained in clinic x 1 hour and vitals stable at time of discharge.  Called Mother to check on pt. over next 2 days and no further symptoms noted.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Pallor
Clinical narrative: Pt in for 2nd dose HPV. Mother confirmed no previous reaction or allergies to vaccines.  After injection, pt. tolerated well and after a few minutes with exam room so hot and multiple people in room allowed pt. to get up and make way to waiting room.  After walking about 20 feet, pt. fell to floor.  Pt. did twitch and eyes rolled back to head about 20 seconds.  After helping pt. to chair he did regain consciousness and complained of headache and sore arm where the arm rubbed against wall at time of fall.  Pt. very pale and diaphoretic vitals obtained and BP/HR very low.  Pt. did state "All I have eaten is fruit snacks today." Mother admitted they had not eaten and she planned to go out to eat after the appointment.  Pt. remained in clinic x 1 hour and vitals stable at time of discharge.  Called Mother to check on pt. over next 2 days and no further symptoms noted.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Abdominal pain upper, Nausea, Pyrexia
Clinical narrative: Gave 2nd dose of MMRV at 5 yr WCC.  Was given with Dtap-IPV.   Patient had already received MMRV  on 6/6/2019 and received MMR on 05/19/2016 and Varicella on 05/19/2016.  Parent is aware.    Spoke with Mom today and she states that patient is currently running low fever and is c/o nausea and stomach cramps.
Age: 6.0
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Erythema, Pain, Swelling
Clinical narrative: redness, swelling, pain and blisters
Age: 45.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Vaccine expired 07/07/20
Age: 23.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Arthralgia, Arthritis, Inflammation, Joint stiffness, Joint swelling
Clinical narrative: I started to experience stiff joints and a swollen knee. I have arthritis on my left knee and right elbow and both were painful to use. I also started to get some pain in my right hand. I never experienced inflammation in my right hand until after the vaccine was administered. I rested for a couple of days and took my Humira a day early to get some relief.  The Humira helped calm down some of the symptoms, but I am still experiencing more inflammation than usual. My left knee is warmer and swollen compared to my right knee. I am also more cautious when using my right elbow to prevent discomfort.
Age: 23.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Joint warmth
Clinical narrative: I started to experience stiff joints and a swollen knee. I have arthritis on my left knee and right elbow and both were painful to use. I also started to get some pain in my right hand. I never experienced inflammation in my right hand until after the vaccine was administered. I rested for a couple of days and took my Humira a day early to get some relief.  The Humira helped calm down some of the symptoms, but I am still experiencing more inflammation than usual. My left knee is warmer and swollen compared to my right knee. I am also more cautious when using my right elbow to prevent discomfort.
Age: 23.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Arthralgia, Condition aggravated, Feeling hot, Joint swelling, Peripheral swelling
Clinical narrative: I started to experience stiff joints and a swollen knee. I have arthritis on my left knee and right elbow and both were painful to use. I also started to get some pain in my right hand. I never experienced inflammation in my right hand until after the vaccine was administered. I rested for a couple of days and took my Humira a day early to get some relief.  The Humira helped calm down some of the symptoms, but I am still experiencing more inflammation than usual. My left knee is warmer and swollen compared to my right knee. I am also more cautious when using my right elbow to prevent discomfort.
Age: 23.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Rheumatoid arthritis
Clinical narrative: I started to experience stiff joints and a swollen knee. I have arthritis on my left knee and right elbow and both were painful to use. I also started to get some pain in my right hand. I never experienced inflammation in my right hand until after the vaccine was administered. I rested for a couple of days and took my Humira a day early to get some relief.  The Humira helped calm down some of the symptoms, but I am still experiencing more inflammation than usual. My left knee is warmer and swollen compared to my right knee. I am also more cautious when using my right elbow to prevent discomfort.
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Feeling hot, Headache, Injection site erythema, Oropharyngeal pain, Pain
Clinical narrative: Patient C/O sore throat, aching, warm, headache, redness around injection area since 07/08/2020, patient states she is feeling better today 07/10/2020
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Feeling abnormal, Hyperhidrosis, Injection site erythema
Clinical narrative: Patient reported feeling "weird" in the evening of 7/7/20 after his injection.  He then had two full days of sickness: low-grade fever, chills, sweats, extreme fatigue.  He reported pain at the injection site and showed me redness at the site of injection and the redness spread around the left arm and deltoid area.  Today, 7/10/20, was the first day patient felt a little better.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Malaise, Pyrexia
Clinical narrative: Patient reported feeling "weird" in the evening of 7/7/20 after his injection.  He then had two full days of sickness: low-grade fever, chills, sweats, extreme fatigue.  He reported pain at the injection site and showed me redness at the site of injection and the redness spread around the left arm and deltoid area.  Today, 7/10/20, was the first day patient felt a little better.
Age: 31.0
Sex: F
Vaccine: ANTH, JEV1, TYP
Symptoms: Acne, Chills, Dysphagia, Fatigue, Myalgia
Clinical narrative: Abnormal, severe facial acne, bodyaches,  chills, local and general muscle soreness, fatigue, swallowing difficulty, >100F fever;
Age: 31.0
Sex: F
Vaccine: ANTH, JEV1, TYP
Symptoms: Pain, Pyrexia, SARS-CoV-2 test
Clinical narrative: Abnormal, severe facial acne, bodyaches,  chills, local and general muscle soreness, fatigue, swallowing difficulty, >100F fever;
Age: 60.0
Sex: F
Vaccine: PNC13
Symptoms: Infection, Laboratory test, Mobility decreased, Pyrexia, Swelling
Clinical narrative: Fevers, swellings and difficulty to move her arm the day after she had the shot. She came in on 7/6 reporting the symptoms. I directed her to contact her PCP, who sent her to the emergency room the same day due to high fever. ER doc ran lab tests to rule out blood clot and came back with diagnosis of infection. She was given 10 days bactrim DS and was told to come back in 2 days for check up. On 7/10, I followed up with her husband and was told that she had no symptoms/fevers/swellings. She will finish her antibiotic course. No further concerns.
Age: 1.0
Sex: M
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Injection site rash
Clinical narrative: Clients mother reported rash at injection site of varicella injection, denies any other s/s.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Swelling, redness, itching.
Age: 1.67
Sex: M
Vaccine: MMR, MMRV, UNK
Symptoms: Blood test, Culture urine, Echocardiogram, Electrocardiogram, Electroencephalogram
Clinical narrative: Patient had a seizure with high fever on 7/10/20 at around 3:30am.
Age: 1.67
Sex: M
Vaccine: MMR, MMRV, UNK
Symptoms: Magnetic resonance imaging brain, Pyrexia, Seizure
Clinical narrative: Patient had a seizure with high fever on 7/10/20 at around 3:30am.
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Swollen and hot to the touch; muscular pain at injection site.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site reaction, Pain in extremity, Rash erythematous
Clinical narrative: After receiving the first Shingle shot, the patient feels sore on the injected arm the day after. Today, 07/10/2020, the patient came into the store to check with me, the pharmacist, about the issue. I examined the injection site privately with the patient, and saw that there is a red rash spreading continuously from the injection site all the way to his elbow. I suggested the patient to go check with the Doctor regarding the side effects that he's experiencing.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Chills, Headache, Nausea, Pyrexia
Clinical narrative: HA severe chills shoulder pain nausea fever swelling Tx- Tramadol, ice Tylenol, Advil, Cymbalta
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Swelling
Clinical narrative: HA severe chills shoulder pain nausea fever swelling Tx- Tramadol, ice Tylenol, Advil, Cymbalta
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Biopsy skin, Injection site oedema, Injection site swelling, Pemphigoid, Peripheral swelling
Clinical narrative: Patient Developed Bullous Pemphigoid, 2 weeks after Vaccination; was given 5 day course of steroid Seen by Dermatologist Had Swelling at site same day, with Shoulder Edema applied Ice to site. Swelling went down to back of arm. Developed mild Rash that Progressed
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Rash
Clinical narrative: Patient Developed Bullous Pemphigoid, 2 weeks after Vaccination; was given 5 day course of steroid Seen by Dermatologist Had Swelling at site same day, with Shoulder Edema applied Ice to site. Swelling went down to back of arm. Developed mild Rash that Progressed
Age: 1.33
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Kinrix was given inadvertently to a 1 yr old.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Discomfort, Headache, Pain, Pain of skin
Clinical narrative: Fever for 3 days-mild, every inch of my body is sore to the point that wearing clothes is uncomfortable, many joints ache, headaches, every hair follicle on my body is sore. Unable to sleep well for past 3 days.  I am rotating through tylenol and advil to alleviate symptoms.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Poor quality sleep, Pyrexia
Clinical narrative: Fever for 3 days-mild, every inch of my body is sore to the point that wearing clothes is uncomfortable, many joints ache, headaches, every hair follicle on my body is sore. Unable to sleep well for past 3 days.  I am rotating through tylenol and advil to alleviate symptoms.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event, Wrong product administered
Clinical narrative: No adverse events. administered 3rd dose instead of 2nd dose of hepatitis ana
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Decreased appetite, Fatigue, Headache
Clinical narrative: 12 hours post injection, - shivering that lasted for two hours or so,  upon awakening felt exhausted, very sore arm,  loss of appetite (very unusual for me), slept off and on all day, slight headache, nauseous, no fever.   Unable to complete normal daily activities.   No such reaction with first dose. 24 hours post injection - no fatigue but feeling weak (not as bad as previously),  feeling a little sweaty upon exhaustion much like recovering from the flu),  no fever.   Injection site soreness significantly reduced.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Hyperhidrosis, Injection site pain, Loss of personal independence in daily activities, Nausea, Pain in extremity
Clinical narrative: 12 hours post injection, - shivering that lasted for two hours or so,  upon awakening felt exhausted, very sore arm,  loss of appetite (very unusual for me), slept off and on all day, slight headache, nauseous, no fever.   Unable to complete normal daily activities.   No such reaction with first dose. 24 hours post injection - no fatigue but feeling weak (not as bad as previously),  feeling a little sweaty upon exhaustion much like recovering from the flu),  no fever.   Injection site soreness significantly reduced.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Somnolence
Clinical narrative: 12 hours post injection, - shivering that lasted for two hours or so,  upon awakening felt exhausted, very sore arm,  loss of appetite (very unusual for me), slept off and on all day, slight headache, nauseous, no fever.   Unable to complete normal daily activities.   No such reaction with first dose. 24 hours post injection - no fatigue but feeling weak (not as bad as previously),  feeling a little sweaty upon exhaustion much like recovering from the flu),  no fever.   Injection site soreness significantly reduced.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Condition aggravated, Neuralgia, Tourette's disorder
Clinical narrative: Tourette's Syndrome symptoms which were previously controlled for by medication became increasingly worse few days after shingles vaccination including uncontrollable verbal outbursts and nerve pain flare. No dose changes recently. Is now seeking help from doctor for both. No outcome from doctor yet.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site induration, Injection site swelling, Joint swelling
Clinical narrative: patient states the shot area is a little hard and a little swelled.  There is swelling down the bursa around the elbow about half the size of tennis ball.  it is a little sore where shot was given.  not too painful
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Fatigue, Heart rate increased, Injection site erythema, Injection site swelling, Myalgia
Clinical narrative: Severe fatigue, severe muscle aches, red and swollen at the site of injection, PERIODS OF RAPID HEART RATE
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Headache, Injection site erythema, Injection site swelling
Clinical narrative: Lethargy, muscle pain, joint pains, headache, chills, nausea.  After 24 hours, symptoms gone except for redness & swelling at injection site.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Lethargy, Myalgia, Nausea
Clinical narrative: Lethargy, muscle pain, joint pains, headache, chills, nausea.  After 24 hours, symptoms gone except for redness & swelling at injection site.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Joint stiffness, Muscle tightness, Musculoskeletal pain, Neck pain
Clinical narrative: Headache (unresponsive to acetaminophen)  Neck & shoulder soreness / tightness
Age: 16.0
Sex: F
Vaccine: FLUA3
Symptoms: Blood creatine phosphokinase increased, Cerebrovascular accident, Computerised tomogram, Cough, Dyskinesia
Clinical narrative: Approximately 1 week after she was ill.  Had cough, hand tingling and numbness bi-laterally.  Progressed into what appeared to be stroke-like symptoms.  Still experiencing neurological issues; including tightness in face, eyes and hands.   Neck jerking and other uncontrollable movements by eyes and face.
Age: 16.0
Sex: F
Vaccine: FLUA3
Symptoms: Electroencephalogram, Eye movement disorder, Hypoaesthesia, Magnetic resonance imaging, Malaise
Clinical narrative: Approximately 1 week after she was ill.  Had cough, hand tingling and numbness bi-laterally.  Progressed into what appeared to be stroke-like symptoms.  Still experiencing neurological issues; including tightness in face, eyes and hands.   Neck jerking and other uncontrollable movements by eyes and face.
Age: 16.0
Sex: F
Vaccine: FLUA3
Symptoms: Nervous system disorder, Paraesthesia, Skin tightness
Clinical narrative: Approximately 1 week after she was ill.  Had cough, hand tingling and numbness bi-laterally.  Progressed into what appeared to be stroke-like symptoms.  Still experiencing neurological issues; including tightness in face, eyes and hands.   Neck jerking and other uncontrollable movements by eyes and face.
Age: 15.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Blood creatine phosphokinase increased, Blood test, Computerised tomogram, Cough, Magnetic resonance imaging
Clinical narrative: initially, coughing and tingling in hands. Progressed into heightened tightness in hands, face, jaw, eyes and arms.
Age: 15.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Muscle tightness, Musculoskeletal stiffness, Paraesthesia, Skin tightness
Clinical narrative: initially, coughing and tingling in hands. Progressed into heightened tightness in hands, face, jaw, eyes and arms.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Blood creatine phosphokinase increased, Blood test, Computerised tomogram, Cough, Magnetic resonance imaging
Clinical narrative: Coughing, with tingling in hands. Progressed into severe tightness in arm, hands and face
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Paraesthesia, Skin tightness
Clinical narrative: Coughing, with tingling in hands. Progressed into severe tightness in arm, hands and face
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Myalgia, Nausea
Clinical narrative: Severe muscle pain, nausea, tiredness, severE headache - took migraine meds and tramadal and diazepam. - did not help much