chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unspecified age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 2015, the patient was inoculated with zoster vaccine live (ZOSTAVAX) for the long-term prevention of shingles and/or zoster-related conditions. Subsequent to patient's zoster vaccine live (ZOSTAVAX) inoculation, patient was treated by the physician, for shingles. As a direct and proximate result of patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, patient had and would 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 will continue to suffer such losses, and damages in the future.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unspecified age . No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 2015, the patient was inoculated with zoster vaccine live (ZOSTAVAX) for the long-term prevention of shingles and/or zoster-related conditions. Subsequent to patient's zoster vaccine live (ZOSTAVAX) inoculation, patient was treated by the healthcare provider, for shingles. As a direct and proximate result of patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, patient had and would 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 will continue to suffer such losses, and damages in the future.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unspecified age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 2016, the patient was inoculated with zoster vaccine live (ZOSTAVAX) for the long-term prevention of shingles and/or zoster-related conditions. Subsequent to patient's zoster vaccine live (ZOSTAVAX) inoculation in the pharmacy, patient was treated by the physician, for shingles. As a direct and proximate result of patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, patient had and would 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 will continue to suffer such losses, and damages in the future.
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Pruritus
Clinical narrative: redness; itching; This case was reported by a consumer via call center representative and described the occurrence of erythema in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   In August 2019, the patient received the 1st dose of Shingrix. In August 2019, less than a month after receiving Shingrix, the patient experienced erythema and pruritus. On an unknown date, the outcome of the erythema and pruritus were not recovered/not resolved.   It was unknown if the reporter considered the erythema and pruritus to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient had redness and itching from the Shingrix vaccine. It has been 10 days.
Sex: U
Vaccine: VARZOS
Symptoms: Asthenia, Joint range of motion decreased, Muscular weakness, Pain
Clinical narrative: pain; weakness; Arm feels week when holding it; Decreased range of motion; This case was reported by a other health professional via call center representative and described the occurrence of pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced pain, weakness, weakness of arms and joint range of motion decreased. On an unknown date, the outcome of the pain, weakness, weakness of arms and joint range of motion decreased were unknown.   It was unknown if the reporter considered the pain, weakness, weakness of arms and joint range of motion decreased to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The health professional reported that the patient had daily pain, weakness was 2 to 4, at worst 6 or 7 out of 10.  The patient's arm felt weak sometimes when holding it up.  If thought about it was always there.  The reporter disinclined to did this again getting the second dose.  The patient had decreased range of motion.      Lab Comments: Lab test performed on unknown date
Age: 37.0
Sex: U
Vaccine: VARZOS
Symptoms: Adverse event, Product administered to patient of inappropriate age
Clinical narrative: feeling all the secondary symptoms; inappropriate age at vaccination; This case was reported by a consumer and described the occurrence of adverse event in a 37-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th August 2019, the patient received Shingrix. On 15th August 2019, unknown after receiving Shingrix, the patient experienced inappropriate age at vaccine administration. On 16th August 2019, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was not recovered/not resolved and the outcome of the inappropriate age at vaccine administration was unknown.   It was unknown if the reporter considered the adverse event to be related to Shingrix.  Additional information received were as follows: The day before the reporting date, the patient received Shingrix at 37 years of age, which led to inappropriate age at vaccine administration. The patient experienced feeling all the secondary systems. The patient asked how could improve this and how long did it take to be gone.
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Herpes zoster, Neuritis cranial, Optic neuritis
Clinical narrative: Right face/eye nerve inflammation; Right face/eye nerve inflammation; stapling symptoms of shingles; erythema/  Redness; This case was reported by a consumer via call center representative and described the occurrence of optic neuritis in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   In August 2019, the patient received the 1st dose of Shingrix. In August 2019, less than 2 weeks after receiving Shingrix, the patient experienced optic neuritis (serious criteria GSK medically significant), neuritis cranial (serious criteria GSK medically significant), shingles and red face. On an unknown date, the outcome of the optic neuritis, neuritis cranial, shingles and red face were unknown.   It was unknown if the reporter considered the optic neuritis, neuritis cranial, shingles and red face to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported but it could be 61 years or 62 years. The week before the date of reporting, the patient received Shingrix. In the week of reporting date, the patient experienced stapling symptoms of shingles, right face or eye nerve inflammation and redness.
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Ophthalmic herpes simplex
Clinical narrative: Simplex Keratitis; Condition aggravated; This case was reported by a physician via call center representative and described the occurrence of herpes simplex keratitis in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included herpes zoster (developed zoster about 6 months ago). Concurrent medical conditions included herpes simplex keratitis (suffering from bouts of simplex keratitis for 6 months).   In August 2019, the patient received the 1st dose of Shingrix. In August 2019, less than a week after receiving Shingrix, the patient experienced herpes simplex keratitis (serious criteria GSK medically significant) and condition aggravated. On an unknown date, the outcome of the herpes simplex keratitis and condition aggravated were unknown.   The reporter considered the herpes simplex keratitis and condition aggravated to be unrelated to Shingrix.  Additional information received were as follows: The age at vaccination was not reported but it could be 59 or 60 years. About a week before the reporting date, the patient received Shingrix. The patient experienced bout of simplex keratitis. The physician wanted to put the patient on Acyclovir. The physician did not believed the simplex keratitis was related to Shingrix given her history. No lot or expiration date or information regarding administration of Shingrix was available. The reporter consented to follow up.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: intermittent arm pain; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 70-year-old female patient who received Herpes zoster (Shingrix) (batch number E523B, expiry date unknown) for prophylaxis.   On 29th July 2019, the patient received the 2nd dose of Shingrix (intramuscular). In July 2019, 1 day after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix on an unknown deltoid. The pharmacist reported that the patient had experienced intermittent arm pain after receiving Shingrix. The reporter consented to follow up. Exact site of administration was unknown. Symptoms was in same arm.
Sex: F
Vaccine: MENB
Symptoms: Culture, Injection site erythema, Injection site vesicles
Clinical narrative: Lt deltoid has large blister with multiple smaller blisters and erythematous area around blisters
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Swelling, Urticaria
Clinical narrative: Redness, swelling, welts on arm with in hours improved within 48 - 72 hr
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Pain in extremity, Paraesthesia, Pyrexia, Tremor
Clinical narrative: On 7/21/19 pt had leg sensitivity & tingling. On 8/5 pt had: Fever, chills, shaking & needed electric blanket. After 1 day, all symptoms resolved.
Age: 79.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Abdominal discomfort, Chills, Headache, Pyrexia
Clinical narrative: HeadacHe Shivering Fever 102.4 upset stomach
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: diffuse redness at area of injection 7 cm in diameter.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Anterior right thigh with induration diffusely surrounding DTap, IPV, (Quadracel) vaccine injection site 12 cm x 12 cm erythema on 8/22/2019 swelling and erythema started late 8/20/19 per father the patient was seen at hospital 8/21/2019.
Age: 68.0
Sex: M
Vaccine: FLUA3
Symptoms: Computerised tomogram head normal, Facial paresis
Clinical narrative: He developed right sided facial weakness the following day, clinically suggestive of Bell's palsy
Age: 56.0
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Computerised tomogram, Feeling hot, Injection site pain, Injection site warmth, Middle insomnia
Clinical narrative: Patient has high pain tolerance. Within 1-2 hours after vaccination, excruciating pain started on left arm at injection sitefeels like burning and stabbing.   Overnight, was very nauseous, woke up in a sweat, shaking, and felt like hot daggers going into the injection site.  The area was warm from elbow to shoulder.  Warmth was going down the inside of body radiated to hips. The patient avoided the slightest movement because she felt like she would pass out and/or became nauseous.  Patient went to ER by 10pm. They did a CAT scan, prescribed antibiotics (Sulfamethoxazole- TPMS) because UTI identified, shot of anti-inflammatory (Ketorolac) and received a prescription during discharge. Patient has not followed-up with doctor yet.  Today, patient cannot move arm more than 2 inches to left without feeling that she would pass out because of the pain.  In terms of recovery, only at 5% because cannot lean on that side at all.   At home has tried using ice packs but simply trying not to move it.    Pain radiating towards hip still is there and shoulder is a little better.
Age: 56.0
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Nausea, Night sweats, Pain, Tremor, Urinary tract infection
Clinical narrative: Patient has high pain tolerance. Within 1-2 hours after vaccination, excruciating pain started on left arm at injection sitefeels like burning and stabbing.   Overnight, was very nauseous, woke up in a sweat, shaking, and felt like hot daggers going into the injection site.  The area was warm from elbow to shoulder.  Warmth was going down the inside of body radiated to hips. The patient avoided the slightest movement because she felt like she would pass out and/or became nauseous.  Patient went to ER by 10pm. They did a CAT scan, prescribed antibiotics (Sulfamethoxazole- TPMS) because UTI identified, shot of anti-inflammatory (Ketorolac) and received a prescription during discharge. Patient has not followed-up with doctor yet.  Today, patient cannot move arm more than 2 inches to left without feeling that she would pass out because of the pain.  In terms of recovery, only at 5% because cannot lean on that side at all.   At home has tried using ice packs but simply trying not to move it.    Pain radiating towards hip still is there and shoulder is a little better.
Age: 77.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Injection site rash, Injection site warmth
Clinical narrative: Vaccine given 8/19/2019. Rash, tenderness, warmth occurred 8/26/2019 on right upper arm deltoid-injection site. No fever or joint pain. Patient took Benadryl 8/26 and rash improved by next day of appointment 8/27/2019. Prescribed Benadryl and prednisone. Referred to PCP.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain, Arthralgia, Chills, Headache, Nausea
Clinical narrative: Patient received Pneumococcal 23 in her left arm at clinic.  Lot # S002640 exp 9/19/20.  Then she went to Pharmacy that same day and received the Shingrix vaccine.   She developed the following symptoms:  Bad Headache, chills (didn't take temperature), nausea, abdominal cramping, body aches, joint aches.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Patient received Pneumococcal 23 in her left arm at clinic.  Lot # S002640 exp 9/19/20.  Then she went to Pharmacy that same day and received the Shingrix vaccine.   She developed the following symptoms:  Bad Headache, chills (didn't take temperature), nausea, abdominal cramping, body aches, joint aches.
Age: 78.0
Sex: F
Vaccine: FLUA3, VARZOS
Symptoms: Pain
Clinical narrative: Patient was vaccinated with Fluad-Left arm and Shingrix-right arm on 8/15/19. She presented to the pharmacy on 8/20/19 stating that I tried to hurt her and she knows what I did. She stated that she would put it on social media so everyone would know. I apologized that she felt that way and told her I would not try to hurt her. I tried to get info from her to see if she was having any adverse rxn, but she wasn't interested in giving me info and she just left. There is no real adverse rxn to report other that pain after fluad administration. She did state in way the flu shot, but no sure it that is accurate. Employer wants this reported on VAERS.
Age: 47.0
Sex: M
Vaccine: HEP
Symptoms: Blood culture, Blood lactic acid, Chest X-ray normal, Cough, Pain
Clinical narrative: Patient awoke at 2 am with fever, cough and body aches.  AT ED visit temp 102.7
Age: 47.0
Sex: M
Vaccine: HEP
Symptoms: Pyrexia
Clinical narrative: Patient awoke at 2 am with fever, cough and body aches.  AT ED visit temp 102.7
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site pain, Nausea, Pyrexia
Clinical narrative: Fever and chills, headache, nausea, very sore injection site
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Dizziness, Headache, Heart rate increased
Clinical narrative: Chills, shivering, alternating with hot flashes, rapid heart rate preventing sleep, headache, nausea, panic symptoms.  Symptoms lasted 24 hours with a subsequent 24 hours feeling weak and dizzy.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Hot flush, Insomnia, Nausea, Panic disorder
Clinical narrative: Chills, shivering, alternating with hot flashes, rapid heart rate preventing sleep, headache, nausea, panic symptoms.  Symptoms lasted 24 hours with a subsequent 24 hours feeling weak and dizzy.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Skin warm, Urticaria
Clinical narrative: Severe itching  and  angry red hives approximately 2.5 inches by 5 inches.  No controlled by hydrocortisone.  Hot to touch.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Injection site erythema, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: On 8/23/2019 @ 6:30 PM patient reported warmth, swelling and a tear drop size of redness at site of injection but no pain.  He then experienced a fever with chills.  (Actual temperature info not available)  He reports that it lasted until 3 PM Saturday afternoon, 8/24/2019.  He was then without any complaints after that and continues to be.  8/27/19 - warmth and redness gone, afebrile, slight puffiness at site but no complaints.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chest discomfort, Fatigue, Headache, Myalgia
Clinical narrative: Fever, Headache, tightness in chest, fatigue, muscle and joint pain....
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Fever, Headache, tightness in chest, fatigue, muscle and joint pain....
Age: 38.0
Sex: F
Vaccine: PPV
Symptoms: Musculoskeletal disorder, Peripheral swelling, Pyrexia, Tenderness
Clinical narrative: tender, swollen left arm, feels feverish. Can't use her arm much. Patient states she is feeling better now.
Age: 20.0
Sex: F
Vaccine: VARCEL
Symptoms: Headache, Injection site erythema, Injection site induration, Injection site warmth, Rash vesicular
Clinical narrative: 8/11/19 Golf ball size redness, heat, hardness at injection site.  8/16/19 Vesticular rash on legs, arms, stomach, headache 8/19/19 Vesticular rash remains the same  8/27/19 rash improving
Age: 4.0
Sex: U
Vaccine: DTAPIPV, MMRV
Symptoms: Activated partial thromboplastin time, Culture urine, Epididymitis, International normalised ratio, Prothrombin time
Clinical narrative: Pt developed epididymitis one day post receiving vaccines. Pt treated with Septra suspension (oral antibiotics) given x 10 days - given on 8/21/19 after visiting Hospital ER. Pt given Rocephin (IM antibiotics) while in ER. Pt given Ibuprofen on 8/21/19 while in ER. being seen for epididymitis. Pt given Kinrix and Proquad vaccines on 8/19/19. Pt seen in Hospital ER on 8/21/19 with right testicular pain and swelling. Pt seen at Pediatrics on 8/27/19 for a follow up visit from being diagnosed with epididymitis and is feeling better. Pt has no more teste swelling on 8/27/19 office visit.
Age: 4.0
Sex: U
Vaccine: DTAPIPV, MMRV
Symptoms: Testicular pain, Testicular swelling, Ultrasound testes, Urine analysis, White blood cell count
Clinical narrative: Pt developed epididymitis one day post receiving vaccines. Pt treated with Septra suspension (oral antibiotics) given x 10 days - given on 8/21/19 after visiting Hospital ER. Pt given Rocephin (IM antibiotics) while in ER. Pt given Ibuprofen on 8/21/19 while in ER. being seen for epididymitis. Pt given Kinrix and Proquad vaccines on 8/19/19. Pt seen in Hospital ER on 8/21/19 with right testicular pain and swelling. Pt seen at Pediatrics on 8/27/19 for a follow up visit from being diagnosed with epididymitis and is feeling better. Pt has no more teste swelling on 8/27/19 office visit.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Influenza like illness, Malaise
Clinical narrative: Malaise, fatigue, headache, flu-like Sxs - saw his Dr mid July for persistent headache + fatigue
Age: 97.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Patient came in with a severely swollen left arm especially in the bicep and triceps areas with severe redness. Her Doctor advised her to take benedryl and apply ice to the area.
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Injection site warmth
Clinical narrative: The patient was diagnosed with cellulitis; the patient reported redness around the injection site; the injection site was red and warmth to touch; This spontaneous report has been received from a medical assistant, concerning to a 55-year-old female patient. The patient was a nurse.  The patient's concurrent conditions included diabetes, sarcoidosis, osteoarthritis, thrombocytopenia, hypertension, reaction to atorvastatin (Muscle cramp, joint pain), reaction to fluoxetine hydrochloride (PROZAC) (nausea), reaction to eszopiclone (LUNESTA) (bad dreams) and reaction to dapaglifozin (FARXIGA) (nausea). The patient's concomitant medications included glimepiride, magnesium (unspecified), tramadol hydrochloride, lisinopril, bupropion hydrochloride (WELLBUTRIN), metformin and naproxen.  On 13-AUG-2019, the patient received a dose of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) 0.5 ml administered once, intramuscularly on the left arm (lot#: S009237, expiration date: 22-DEC-2020) for prophylaxis (indication also reported as pneumonia prevention).  On 14-AUG-2019, the patient experienced redness around the injection site (injection site redness); the patient sought medical attention and after a further examination by a provider, it was determined that the injection site was red and warm to touch (injection site warmth) and the area or redness was about 4 inches, coming down the upper left arm and going to the inner left arm. On the same day, the patient was also diagnosed with cellulitis and she was started on therapy with prednisone 10mg, 6 tablets daily, as treatment for the events. On 15-AUG-2019, the patient received prednisone 10 mg, 5 tablets daily. On 16-AUG-2019, the patient received prednisone 10 mg, 4 tablets daily. On 17-AUG-2019, the patient received prednisone 10 mg, 3 tablets daily. On 18-AUG-2019, the patient received prednisone 10 mg, 2 tablets daily. On 19-AUG-2019, the patient received prednisone 10 mg, 1 tablet daily, and then, the prednisone was discontinued. On an unspecified day in August 2019, the patient was recovered from the events of cellulitis, injection site redness and injection site warmth.  The causal relationship between the Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) and the events of cellulitis, injection site redness and injection site warmth was unknown.  Upon internal review, the event of cellulitis was considered to be medically significant.
Sex: U
Vaccine: ANTH
Symptoms: Skin reaction
Clinical narrative: Localized skin reaction at the injection site; Spontaneous report received on 10JUN2019.  An office staff member reported that a patient (unknown demographics) developed localized skin reaction at the BioThrax injection site. It was reported that patient received BioThrax couple of weeks ago but the reporter was not sure about the dates as he did not have access to the patient's medical record. At the time of the report the patient was under the observation of a physician. The reporter did not have any additional details to provide. Outcome of the event was unknown.  Company Comment: The Company considers the event of localized skin reaction to be possibly related to the BioThrax injection.  Due to the lack of additional information at this time, a definitive causal relationship is difficult to determine.  Localized injection reactions which this may represent are know to occur following injection with BioThrax; Sender's Comments: The Company considers the event of localized skin reaction to be possibly related to the BioThrax injection.  Due to the lack of additional information at this time, a definitive causal relationship is difficult to determine.  Localized injection reactions which this may represent are know to occur following injection with BioThrax
Sex: F
Vaccine: TDAP
Symptoms: Brain oedema, Pertussis, Screaming
Clinical narrative: Whooping cough; caused her brain to swell; Screaming; This case was reported by a consumer via interactive digital media and described the occurrence of whooping cough in a 11-year-old female patient who received DTPa (DTPa vaccine) for prophylaxis.   The patient had a Family History of whooping cough (to her father when he was 12 years of age).   On an unknown date, the patient received the 1st dose of DTPa vaccine. On an unknown date, unknown after receiving DTPa vaccine, the patient experienced whooping cough (serious criteria GSK medically significant), brain swelling (serious criteria GSK medically significant) and screaming. The patient was treated with analgesic, nos (Pain Killer). On an unknown date, the outcome of the whooping cough and brain swelling were unknown and the outcome of the screaming was recovered/resolved.   It was unknown if the reporter considered the whooping cough, brain swelling and screaming to be related to DTPa vaccine.  Additional details were provided as follows: The patient's father reported the case. The age at vaccination was not reported. The patient got whooping cough at 11 years of age. As per the reporter it was a side effect of the 1st shot, which caused her brain to swell and she screamed for 3 hours. He called the doctor, who prescribed something to kill her pain and said she could never have another DPT shot again.
Age: 11.0
Sex: M
Vaccine: HPV9, MENB, TDAP
Symptoms: Wrong product administered
Clinical narrative: RMA took out MenB vaccine instead of Menactra vaccine for patient. Pt will still need to received Menactra or MCV4 vaccine. RMA retrieved it out of the AccuVac machine by accident and someone else administered it.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Dizziness, Feeling cold
Clinical narrative: Patient reported symptoms of dizziness, weakness and feeling extremely cold. symptoms started after midnight.(same day as vaccination given) lasted for 6-8 hours then felt fine in the AM Patient reported the same symptoms after the 2 shot (given 8/22/2019) but did not last as long(about 3 hrs ) Patient reported this reaction on 8/22/2019 when getting 2nd shot. She called back to say it happened again after 2nd shot
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Confusional state, Diarrhoea, Dizziness, Vomiting
Clinical narrative: Pt. felt dizzy and confused several hours after imz. Had to lay down, vomited and had diarrhea.
Age: 65.0
Sex: M
Vaccine: FLUR4
Symptoms: Injection site erythema, Rash
Clinical narrative: Patient reported having rash on his legs that started around bedtime the day flu shot was administered.  Had mild redness at injection site with no to minimal swelling.  No reports of fever, rash near injection site, or breathing issues.
Age: 16.0
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse effect, however vaccine administered past the recommended age of 12 years.
Age: 16.0
Sex: M
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No adverse reaction at time of leaving clinic.  Patient was given Adult Hep A vs Peds Hep A
Age: 1.58
Sex: F
Vaccine: DTAP, HIBV, MMR
Symptoms: Rash, Vaccination complication
Clinical narrative: Mom reports the child having a generalized rash 1 day after vaccination.  Mom is a nurse, but she did contact the child's PCP who stated the child had a reaction to the DTAP.  Mom treated child at home. This information was obtained from mom.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Diarrhoea, Headache, Nausea
Clinical narrative: fever, chills, nausea, joint pain, headache. diarrhea started over night (approx 9-10 hours after injection) started to subside 24 hours after injection, or at least I was able to get out of bed and eat something at that time.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: fever, chills, nausea, joint pain, headache. diarrhea started over night (approx 9-10 hours after injection) started to subside 24 hours after injection, or at least I was able to get out of bed and eat something at that time.
Age: 7.0
Sex: F
Vaccine: MMR
Symptoms: Polymerase chain reaction, Rash, Rash papular, Viral test
Clinical narrative: Rash on chest, back, papular
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Injected limb mobility decreased, Injection site pain, Product administered at inappropriate site, X-ray limb normal
Clinical narrative: Pain in the left shoulder with restricted range of motion. Injection site was noted to be high on the deltoid and injection might have been given into the left shoulder joint.
Age: 16.0
Sex: F
Vaccine: HEPA, MENB, MNQ
Symptoms: Balance disorder, Blood potassium decreased, Disturbance in attention, Intensive care, Limb discomfort
Clinical narrative: Mother called to report. Patient began to complain of tingling and "heavy" legs on 8/8/19.  Patient went to ER the evening of 8/10/19 with complete leg paralysis. Patient was admitted to Pediatric ICU. Mom states patient had a low but normal potassium so they gave her a potassium drip and she was discharged 8/12/19 with better function. Still not completely recovered. Mother states she is having trouble concentrating and keeping her balance. Patient is seeing Dr. and Neurologist.
Age: 16.0
Sex: F
Vaccine: HEPA, MENB, MNQ
Symptoms: Monoplegia, Paraesthesia
Clinical narrative: Mother called to report. Patient began to complain of tingling and "heavy" legs on 8/8/19.  Patient went to ER the evening of 8/10/19 with complete leg paralysis. Patient was admitted to Pediatric ICU. Mom states patient had a low but normal potassium so they gave her a potassium drip and she was discharged 8/12/19 with better function. Still not completely recovered. Mother states she is having trouble concentrating and keeping her balance. Patient is seeing Dr. and Neurologist.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Dizziness, Feeling hot, Nausea, Pallor
Clinical narrative: Pt in today for her first Bexsero injection. Pt was given injection and was asked to wait in office for 15 minutes to make sure she does not experience any reactions. After about 10 minutes the patient complained that she was feeling warm, lightheaded, pale  and had some nausea. We got the Dr. to help assess the patient and her symptoms. Pts blood pressure at 10:45am was 108/80 with heart rate of 108. We layed the  patient down with a cold pack on forehead. Within a few minutes she was starting to feel better. At 10:53am patients vitals were rechecked with blood pressure of 108/76 and heart rate of 60. Per pt her symptoms are resolving and Dr. came back to reevaluate the patient. At that time patient sat up in a chair for few minutes and at 11:02am we had patient walk the hallway to see how she felt. Per pt she felt better and he heart rate at that time was 88. Explained to pt when she has her second injection at school to notify them of her reaction and make sure she is laying down. Pt understood.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Computerised tomogram normal, Eye movement disorder, Fall, Head injury, Presyncope
Clinical narrative: Got vaccines at approximately 9 am on day of event, then about 15 minutes after went down to lab for a blood draw. At the thought of getting blood drawn, patient fainted then hit his head. After hitting head had brief episode of tonic clinic movements, eyes rolling back of head. No known post ictal period. Episode witnessed by lab staff, lasted approx 1 min. Sent to ED for further eval, had neg CT, subsequently asymptomatic without further events. No prior known vax reactions.  Most likely vasovagal event and brief seizure like episode related to fall. Unclear if related at all to vaccines.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Seizure like phenomena, Syncope, Tonic clonic movements
Clinical narrative: Got vaccines at approximately 9 am on day of event, then about 15 minutes after went down to lab for a blood draw. At the thought of getting blood drawn, patient fainted then hit his head. After hitting head had brief episode of tonic clinic movements, eyes rolling back of head. No known post ictal period. Episode witnessed by lab staff, lasted approx 1 min. Sent to ED for further eval, had neg CT, subsequently asymptomatic without further events. No prior known vax reactions.  Most likely vasovagal event and brief seizure like episode related to fall. Unclear if related at all to vaccines.
Age: 1.08
Sex: M
Vaccine: VARCEL
Symptoms: Polymerase chain reaction, Rash, Varicella virus test
Clinical narrative: Patient started developing rash on 8-19-19, concerning Mom for Chicken Pox Virus. Patient seen in office 8-20-19
Age: 16.0
Sex: M
Vaccine: HPV9, HPV4, MENB, MNQ
Symptoms: Headache
Clinical narrative: constant headache Saturday, Sunday, Monday and today Tuesday.  Treatment is acetominphen extra strength and ice packs, tried excedrin migraine, no relief
Age: 16.0
Sex: M
Vaccine: HPV9, HPV4, MENB, MNQ
Symptoms: Unevaluable event
Clinical narrative: constant headache Saturday, Sunday, Monday and today Tuesday.  Treatment is acetominphen extra strength and ice packs, tried excedrin migraine, no relief
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Blood glucose normal, Inappropriate affect, Incoherent, Mood altered, Posture abnormal
Clinical narrative: 1147 am After blood draw and 2 immunizations patient became unable to sit up, incoherent and improper affect, laughing inappropriately, layed patient down. kept trying to get up, appeared out of it, gave gatorade and donut, shaking soon started, patient would be in and out of coherent speech, was able to identify where she was then she would shake and denied breathing issues or nausea, Bp glucose wnl, EMS called @ 11:58am and arrived @ 12:10, pt being transported to hospital by ems
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Tremor
Clinical narrative: 1147 am After blood draw and 2 immunizations patient became unable to sit up, incoherent and improper affect, laughing inappropriately, layed patient down. kept trying to get up, appeared out of it, gave gatorade and donut, shaking soon started, patient would be in and out of coherent speech, was able to identify where she was then she would shake and denied breathing issues or nausea, Bp glucose wnl, EMS called @ 11:58am and arrived @ 12:10, pt being transported to hospital by ems
Age: 61.0
Sex: F
Vaccine: FLUR4, VARZOS
Symptoms: Chills, Hyperhidrosis, Pain, Pyrexia, Tremor
Clinical narrative: Patient reports fever, chills, shaking, body pain, sweating.
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Pyrexia, Tremor
Clinical narrative: Fever; shaking; flu-type soreness all over; This case was reported by a consumer via call center representative and described the occurrence of fever in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced fever, tremor and flu-like aching. On an unknown date, the outcome of the fever, tremor and flu-like aching were recovered/resolved.   The reporter considered the fever, tremor and flu-like aching to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported, but it could be 58 or 59 years. About this time in last year 2018, the patient received vaccine. The reporter stated that his wife received the second shot of Shingrix around this time last year and experienced fever, shaking, and flu-type all over soreness.  These events fully resolved within 48-72 hours. The reporter gave permission to follow up.
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site reaction, Urticaria
Clinical narrative: A reddened and hard welt has formed, where the shot was administered; A reddened and hard welt has formed where the shot was administered; administered a vaccination intradermally when it's supposed to be intramuscular; Initial information received on 19-Aug-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves female patient (age not reported) who experienced reddened and hard welt has formed, where the shot was administered, while she received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history and concomitant therapies were not provided.  The patient was postpartum  On 19-Aug-2019, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot number not reported via intradermal route in unknown administration site.  On an unknown date, the patient developed a non-serious a reddened and hard welt has formed where the shot was administered (vaccination site erythema and vaccination site urticaria) with unknown latency following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  It was also a case of inappropriate route of vaccination.  Final diagnosis was vaccination site urticaria and vaccination site erythema.  It was not reported if the patient received a corrective treatment.  The outcome was unknown for vaccination site urticaria and vaccination site erythema.  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.  Information on the batch number was requested.  List of documents held by sender: none.
Sex: U
Vaccine: DT
Symptoms: Peripheral swelling, Swelling
Clinical narrative: severe swelling of their whole arm and chest; severe swelling of their whole arm and chest; Initial information received on 20-Aug-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a patient of unknown demography who received vaccine DIPHTHERIA AND TETANUS TOXOIDS and experienced severe swelling of their whole arm and chest.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect DIPHTHERIA AND TETANUS TOXOIDS produced by unknown manufacturer lot number not reported via unknown route in unknown administration site.  On an unknown date, following the vaccination the patient experienced swelling arm (peripheral swelling) and swelling.  (Other relevant tests included no lab data.)  Final diagnosis was swelling arm and swelling.  It was not reported if the patient received a corrective treatment.  The outcome of the events was unknown at the time of reporting.  Information on the batch number was requested.  List of documents held by sender: none.
Sex: U
Vaccine: MEN, MNQ
Symptoms: Wrong product administered
Clinical narrative: patient wants to have Menactra, but had Meningicocal vaccine group B; Initial information received on 20-Aug-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves patient of an unknown demographics who received vaccine MENINGOCOCCAL VACCINE B instead of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] lot number not reported via unknown route in unknown administration site on an unknown date.   It was a case of actual medication error due to Wrong vaccine administered.  It was unknown whether the patient had any adverse event.  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.  Information on the batch number was requested.  Documents held by sender: none.
Age: 11.0
Sex: M
Vaccine: DTAP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Daptacel was inadvertently administered to an 11 years old, no AE; Initial information received on 20-Aug-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 11 years old male patient who was inadvertently administered 0.5 ml booster dose of vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] lot C5818AA and Exp. Date 21-Oct-2019 via intramuscular route in the right deltoid, on 20-Aug-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MENINGOCOCCAL VACCINE A/C/Y/W CONJ (DIP TOX) (MENACTRA) for Immunisation.  It was a case of actual medication error due to  inappropriate age at vaccine administration.  No reaction 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.  List of documents held by sender: none.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Bone pain, Chills, Feeling of body temperature change, Inappropriate schedule of product administration, Influenza like illness
Clinical narrative: I had the first vaccine almost a year ago. NOTE: The only reason that I delayed my 2nd vaccine is because it was not available.  At that time my reaction was a golf-sized bump on my arm and was very sore for a week and then somewhat sore for another week.  It gradually got better. I felt a little achy, but I didn't think much of it.  This time, I developed a very sore arm almost immediately and felt like I was getting the flu (body aches, gone aches but no sore throat, etc) and by the evening I was chattering, felt like I had a fever, then chills.  This lasted for a few hours. I had a very restless night from the pain and chattering/feeling cold then hot. When I awoke in the morning, I was no longer having the sensation of fever/chills and felt better.  My husband was close to taking me to the ER the night before because I couldn't stop shaking/chattering.  My arm, like the first time around, was even more swollen when I awoke then the day before and I still have some residual discomfort in my right arm, but it is mostly gone now.  NOTE:  I did have shingles when I was approx 27 years old, may have been 28 years old.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Limb discomfort, Pain, Pain in extremity, Peripheral swelling, Poor quality sleep
Clinical narrative: I had the first vaccine almost a year ago. NOTE: The only reason that I delayed my 2nd vaccine is because it was not available.  At that time my reaction was a golf-sized bump on my arm and was very sore for a week and then somewhat sore for another week.  It gradually got better. I felt a little achy, but I didn't think much of it.  This time, I developed a very sore arm almost immediately and felt like I was getting the flu (body aches, gone aches but no sore throat, etc) and by the evening I was chattering, felt like I had a fever, then chills.  This lasted for a few hours. I had a very restless night from the pain and chattering/feeling cold then hot. When I awoke in the morning, I was no longer having the sensation of fever/chills and felt better.  My husband was close to taking me to the ER the night before because I couldn't stop shaking/chattering.  My arm, like the first time around, was even more swollen when I awoke then the day before and I still have some residual discomfort in my right arm, but it is mostly gone now.  NOTE:  I did have shingles when I was approx 27 years old, may have been 28 years old.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Product availability issue, Pyrexia, Tremor
Clinical narrative: I had the first vaccine almost a year ago. NOTE: The only reason that I delayed my 2nd vaccine is because it was not available.  At that time my reaction was a golf-sized bump on my arm and was very sore for a week and then somewhat sore for another week.  It gradually got better. I felt a little achy, but I didn't think much of it.  This time, I developed a very sore arm almost immediately and felt like I was getting the flu (body aches, gone aches but no sore throat, etc) and by the evening I was chattering, felt like I had a fever, then chills.  This lasted for a few hours. I had a very restless night from the pain and chattering/feeling cold then hot. When I awoke in the morning, I was no longer having the sensation of fever/chills and felt better.  My husband was close to taking me to the ER the night before because I couldn't stop shaking/chattering.  My arm, like the first time around, was even more swollen when I awoke then the day before and I still have some residual discomfort in my right arm, but it is mostly gone now.  NOTE:  I did have shingles when I was approx 27 years old, may have been 28 years old.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: Patient called over 72 hours after getting vaccination stating 2 small dots, redness, swelling, and itching on the front part of the arm in which she received the shot. Was able to clarify was not where the shot was given but on the same arm, closer to her body on the front part of the arm.  Patient insisted I report the reaction to the VAERS reporting system despite my asking if it could possible be a bug bite. Patient refused to believe symptoms could be caused by anything other than the vaccine. Recommended oral Benadryl to the patient at a dose of 25mg every 4-6 hours and to let her doctor know/ go to closest Emergency Room if develops trouble breathing or if symptoms don't subside with treatment of Benadryl.