chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Acoustic stimulation tests abnormal, Balance disorder, Deafness unilateral, Middle ear inflammation
Clinical narrative: equilibrium off; inflammation middle ear; hear loss/hearing loss in her right ear/ deaf in her ear/deafness; This case was reported by a consumer via call center representative and described the occurrence of hearing loss in a female patient who received Herpes zoster (Shingrix) (batch number 49Y35, expiry date unknown) and (batch number 92NA4, expiry date unknown) for prophylaxis.   Previously administered products included zostavax (vaccine several years ago from the date of reporting).   On 6th August 2019, the patient received the 1st dose of Shingrix. On an unknown date, the dose was an unknown dose. On 13th August 2019, 7 days after receiving Shingrix, the patient experienced hearing loss (serious criteria GSK medically significant) and middle ear inflammation. On 16th August 2019, the patient experienced disorder equilibrium. The patient was treated with ambiguous medication nos (Cortisone (Nos)) and antivirals nos (Anti-Viral Medicine (Nos)). On an unknown date, the outcome of the hearing loss was not recovered/not resolved and the outcome of the disorder equilibrium and middle ear inflammation were unknown.   The reporter considered the hearing loss and disorder equilibrium to be related to Shingrix. It was unknown if the reporter considered the middle ear inflammation to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. Seven days later the patient found to be hearing loss in her right ear.    She noted she was deaf in her ear, and there had been no change or improvement.    The patient went to see her primary physician on 13th August 2019, who noted the issue as inflammation of the ear and referred her to an ENT (ears, nose, and throat).  He did prescribe a nasal spray  with cortisone  for inflammation.  Three days later she saw an ENT. She initially saw a Physician Assistant, who had an audiology test peformed with results of deafness in right  ear or profound hearing loss in Right ear.  The patient then was seen by  another physician due to the results of the test. She noted he checked her equilibrium which was off, and prescribed her prednisone and an anti-viral. The physician planned to give her a shot of cortisone in the middle ear.  The patient noted she had no history of hearing loss or issues and none in her family.  She noted the cause of the events directly related to the product. The reporter consented to follow up. This case is linked with case US2019153177, reported by the same reporter.
Sex: U
Vaccine: MENB
Symptoms: Abdominal pain upper, Nausea
Clinical narrative: Nausea; Stomach pain; This is a spontaneous report from a contactable nurse (patient's mother). A patient of unspecified age and gender received meningococcal group b rlp2086 (TRUMENBA), via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient's mother reported that meningococcal group b rlp2086 was administered, the patient had stomach pain and nausea on an unspecified date. The patient's mother was asking if stomach pain has been reported as an adverse effect of meningococcal group b rlp2086. Outcome of the events was unknown.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Chills, Injection site pain, Injection site rash, Pyrexia, Rash macular
Clinical narrative: developed Fever and chills; temperature was going up and down; rash at the injection site was at first, it was raised, now it was more macular and red and itchy; pain in her arm at the injection site; This is a spontaneous report from a contactable physician (patient's mother). A 19-year-old female patient received meningococcal group b rlp2086 (TRUMENBA), via an unspecified route of administration in the arm on 19Aug2019 at a single dose for meningitis B vaccination given at physician's office. Medical history included food allergy, asthma and allergies (unspecified). Concomitant medication included cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for allergies. It was reported that the patient received meningococcal group b rlp2086 on 19Aug2019. She started with a pain in her arm at the injection site on 19Aug2019 and then she developed a rash at the injection site on 22Aug2019. The paint in her arm started out severe and had since decreased. She also developed fever and chills. She felt that her temperature was going up and down. She never took her temperature but felt like it was going up and down. Treatment for these events included alternating with Ibuprophen every 4 hours and then Tylenol. The rash at the injection site was at first, it was raised, now it was more macular and red and itchy. Treatment for the event rash at the injection site was Zyrtec at night. Outcome of the event "pain in her arm at the injection site" and "rash at the injection site was at first, it was raised, now it was more macular and red and itchy" was recovering while unknown for other events.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Rash pruritic
Clinical narrative: developed Fever and chills; temperature was going up and down; rash at the injection site was at first, it was raised, now it was more macular and red and itchy; pain in her arm at the injection site; This is a spontaneous report from a contactable physician (patient's mother). A 19-year-old female patient received meningococcal group b rlp2086 (TRUMENBA), via an unspecified route of administration in the arm on 19Aug2019 at a single dose for meningitis B vaccination given at physician's office. Medical history included food allergy, asthma and allergies (unspecified). Concomitant medication included cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for allergies. It was reported that the patient received meningococcal group b rlp2086 on 19Aug2019. She started with a pain in her arm at the injection site on 19Aug2019 and then she developed a rash at the injection site on 22Aug2019. The paint in her arm started out severe and had since decreased. She also developed fever and chills. She felt that her temperature was going up and down. She never took her temperature but felt like it was going up and down. Treatment for these events included alternating with Ibuprophen every 4 hours and then Tylenol. The rash at the injection site was at first, it was raised, now it was more macular and red and itchy. Treatment for the event rash at the injection site was Zyrtec at night. Outcome of the event "pain in her arm at the injection site" and "rash at the injection site was at first, it was raised, now it was more macular and red and itchy" was recovering while unknown for other events.
Sex: M
Vaccine: PNC13
Symptoms: Allergy to vaccine
Clinical narrative: Allergies: Prevnar 13; This is a spontaneous report from a contactable healthcare professional. A male patient of an unspecified age received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13), via an unspecified route of administration from an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced allergies: pneumococcal 13-valent conjugate vaccine on an unspecified date. Outcome of the event was unknown.
Sex: U
Vaccine: PNC13
Symptoms: Pain
Clinical narrative: Pain post injection; This is a spontaneous report from a contactable healthcare professional via a Pfizer-sales representative.  A patient of unspecified age and gender received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced pain post injection on an unspecified date. Outcome of the event was unknown.     No follow-up attempts are possible. No further information is expected.
Age: 17.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Body temperature increased, Gait disturbance, Hypoaesthesia, Kidney infection, Laboratory test normal
Clinical narrative: first 2 days ran temperature in the 101-102 degree range, UTI and kidney infection, migraine headache, tingling and numbness in arms/hands and legs/feet as if the extremities had fallen asleep, decreased ability to walk
Age: 17.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Migraine, Paraesthesia, Urinary tract infection, Vaccination complication
Clinical narrative: first 2 days ran temperature in the 101-102 degree range, UTI and kidney infection, migraine headache, tingling and numbness in arms/hands and legs/feet as if the extremities had fallen asleep, decreased ability to walk
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Hot flush, Hyperhidrosis, Influenza like illness
Clinical narrative: A couple of hours after receiving the injection, I started feeling like I had the flu. It progreesed through the night and got worse, fever, chills, hot flashes and sweating, serious headache. It continued the next 2 days, the day after being the worst. I still feel like hell today 4 days later.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Malaise, Pyrexia
Clinical narrative: A couple of hours after receiving the injection, I started feeling like I had the flu. It progreesed through the night and got worse, fever, chills, hot flashes and sweating, serious headache. It continued the next 2 days, the day after being the worst. I still feel like hell today 4 days later.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling, Tenderness
Clinical narrative: Right red arm swelling and tenderness, no itching.
Age: 17.0
Sex: M
Vaccine: HPV9
Symptoms: Blood glucose, Electrocardiogram, Fall, Head injury, Malaise
Clinical narrative: Pt presented for immunizations accompanied by his mother. Pt and his mother decided to receive all 3 immunizations that were due today. After immunizations were administered, pt was observed sitting on the table for 2 minutes, talking and stated that he was feeling well. Pt started walking down the hallway while the mother turned back to talk to Clinical Staff when she saw and heard pt collapse. He reportedly slid down the wall and then hit the floor, CS observed the pt's head "bouncing of the floor". When CS approached pt, his eyes were open but he was unresponsive for a few seconds, flexion posturing of the upper extremity was noted for less than 5 seconds with no posturing of the lower extremity. Pt then responded to CS and was A&O x 3. Provider heard the loud thud and joined in. EKG and Glucose POC were ordered and performed. C-spine was held by provider, Pt denied HA, N/V but was observed to be very pale, breathing was regular and had clear and equal breath sounds. CMS was intact bilaterally for upper and lower extremities. 911 was called and Ambulance responded.
Age: 17.0
Sex: M
Vaccine: HPV9
Symptoms: Pallor, Posturing, Syncope, Unresponsive to stimuli
Clinical narrative: Pt presented for immunizations accompanied by his mother. Pt and his mother decided to receive all 3 immunizations that were due today. After immunizations were administered, pt was observed sitting on the table for 2 minutes, talking and stated that he was feeling well. Pt started walking down the hallway while the mother turned back to talk to Clinical Staff when she saw and heard pt collapse. He reportedly slid down the wall and then hit the floor, CS observed the pt's head "bouncing of the floor". When CS approached pt, his eyes were open but he was unresponsive for a few seconds, flexion posturing of the upper extremity was noted for less than 5 seconds with no posturing of the lower extremity. Pt then responded to CS and was A&O x 3. Provider heard the loud thud and joined in. EKG and Glucose POC were ordered and performed. C-spine was held by provider, Pt denied HA, N/V but was observed to be very pale, breathing was regular and had clear and equal breath sounds. CMS was intact bilaterally for upper and lower extremities. 911 was called and Ambulance responded.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Dyspnoea, Nausea, Throat tightness
Clinical narrative: Pt got nauseous, then felt short of breath like she does with asthma flare.  Took 2 puffs of albuterol.  Then felt like her throat was tight. Pt is still pregnant at this time
Age: 22.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: pt c/o redness, swelling at L Deltoid spreading from injection site, 4 days post receiving immunization. Did not report symptoms until  8 days post immunization.  NP examined student and recommended OTC Zyrtec.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site pain, Peripheral swelling, Rash macular, Tongue disorder
Clinical narrative: Tongue "feels thick", tight red swollen (L) arm, Diffuse macular rash of the trunk and extremities with some tenderness over the Left upper arm. -Denies chest pain, SOB, diaphoresis, nausea/vomiting & palpitations, fever, chills
Age: 50.0
Sex: U
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site pruritus, Injection site rash, Oropharyngeal pain
Clinical narrative: Patient states she had a red, itchy rash at the site of administration, sore throat, & headache - symptoms lasted 3 days -  pt took Benadryl & symptoms subsided
Age: 1.0
Sex: F
Vaccine: UNK
Symptoms: Febrile convulsion, Influenza like illness, Pyrexia
Clinical narrative: Patient was determined to be healthy at her 1-year check-up, given the HepB vaccine; 3 days later, on Friday, she started presenting with flu-like symptoms, continued on Saturday, Sunday,  and finally spiked a sudden fever on Sunday evening and had a febrize seizure.  Local fire dept/EMS responders transported her to emergency.
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Blood thyroid stimulating hormone, Condition aggravated, Fatigue, Full blood count, Metabolic function test
Clinical narrative: Pt states that she has had ongoing problems with fatigue but it worsened the day she got the Gardasil.  Pt sent for labwork today 8/28/2019 to see what the underlying problem could be.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Erythema, Headache, Injection site swelling, Malaise
Clinical narrative: Subjective history of arm swelling at injection site, erythema, malaise and headache started the afternoon he received the injection
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Full blood count normal, Glycosylated haemoglobin normal, Headache, Lipids normal, Metabolic function test normal
Clinical narrative: Headache developed that afternoon.  Since then he has been having intermittent headaches.  Was not prone to headaches in the past.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Thyroid function test normal
Clinical narrative: Headache developed that afternoon.  Since then he has been having intermittent headaches.  Was not prone to headaches in the past.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site swelling, Pruritus, Swelling face
Clinical narrative: Father stated that patient informed him on Friday, 08/23/2019 that left arm was big. He looked at it and agreed there was some swelling from left shoulder down to bicep, but thought this was a normal local reaction. On Saturday 08/24/2019, she had facial swelling and itching and so he took her to Urgent Care. He was instructed to give her Benadryl as needed and was also prescribed Prednisone 5mg/5ml oral solution. He brought her in to clinic 08/26/2019 after lunch and patient no longer presents with facial or arm swelling.
Age: 70.0
Sex: M
Vaccine: FLUA3, PPV, TDAP
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Patient's right arm was in severe pain & patient couldn't lift arm.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Rash erythematous
Clinical narrative: Patient had the shot on 8-26-19, she came into pharmacy 8-28-19 with a red, raised area around site of injection. Her back was completely broken out with a red rash and it also showed up on cheeks, arms and neck. She left with Benadryl and will contact MD.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Haematochezia, Mucous stools, Occult blood positive, Ultrasound abdomen normal
Clinical narrative: Rotavirus vaccine given orally in clinic at ~1200. Parent called clinic around 1400 saying there was a stool with mucus and bright red blood steak (<teaspoon amount). Advised to go to local ER. In ER, infant had bedside stool guiaic that was Hemoccult positive. Ultrasound of abdomen done to rule out intussusception; negative for intussusception. Returned to clinic following day, mom reported there have been no more bloody stools, and infant is feeding well. He is afebrile and breastfeeding well. Mom wondering why this occurred.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Angiotensin converting enzyme, Antineutrophil cytoplasmic antibody negative, Antinuclear antibody negative, Aspiration joint, Blood immunoglobulin G decreased
Clinical narrative: 7/15 Swelling arm worse; 7/17/19 - Admitted by oncology for further workup 7/20/19 - Arthrocentesis (-) infection - now w/ LUE Edema - DVT ruled out (arm where Shingrix given) - Prednisone 40g - responded well
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood immunoglobulin M decreased, Blood lactate dehydrogenase increased, C-reactive protein, Hepatitis B antibody, Hepatitis C virus test positive
Clinical narrative: 7/15 Swelling arm worse; 7/17/19 - Admitted by oncology for further workup 7/20/19 - Arthrocentesis (-) infection - now w/ LUE Edema - DVT ruled out (arm where Shingrix given) - Prednisone 40g - responded well
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Infection, Mononucleosis heterophile test negative, Oedema peripheral, Peripheral swelling, Red blood cell sedimentation rate normal
Clinical narrative: 7/15 Swelling arm worse; 7/17/19 - Admitted by oncology for further workup 7/20/19 - Arthrocentesis (-) infection - now w/ LUE Edema - DVT ruled out (arm where Shingrix given) - Prednisone 40g - responded well
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Injection site swelling, Insomnia, Mobility decreased, Pain
Clinical narrative: Received Men B vaccine (2nd dose) yesterday morning at a well visit; soon after, developed a lot of swelling of upper right arm, progressed during the day. Difficulty moving arm, a lot of pain, unable to sleep due to pain, no numbness or tingling, but hurts to even move elbow/hand. Tried ibuprofen. Diffuse swelling to upper arm, no redness, swelling to elbow, normal circulation. Patient treated with cool pack; arm sling; tried ibuprofen, but also provided with Tylenol 3 as needed for severe pain.
Age: 72.0
Sex: M
Vaccine: FLUA3, VARZOS
Symptoms: Pain, Rash macular, Skin warm, Swelling, Tenderness
Clinical narrative: RED BLOTCHY, HOT, SWOLLEN, SORE & TENDER TO THE TOUCH
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Pyrexia, Vomiting
Clinical narrative: Pt hAd fever + vomiting for 2 dAys
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse effect; Patient received Gardasil 9 1st dose on 01-JUN-2016 and 2nd dose on 08-AUG-2017; This spontaneous report as received from a Medical Assistant referring to a 13-year-old female patient. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications.    On 01-JUN-2019, when the patient was 11 years old, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) for prophylaxis (dose, route of administration, lot number and expiration date were not reported).  On 08-AUG-2017, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) for prophylaxis (dose, route of administration, lot number and expiration date were not reported) "slightly delayed". No adverse effect was reported. No additional doses were administered.  At the time of the report, the patient's outcome was unknown.
Age: 63.0
Sex: M
Vaccine: PPV
Symptoms: Headache, Nausea, Pain, Pain in extremity, Pyrexia
Clinical narrative: extreme arm pain/being the same arm that vaccine was administered in; headaches; nausea; generalized body aches; a low grade fever; This spontaneous report was received from an Office Manager referring to a 63 year old male patient. The patient's concurrent conditions included allergy to bee venom and statins. The patient's medical history included atrial fibrillation. The patient was not taking concomitant medications.  On 05-AUG-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) lot # S013490, expiration date: 06-MAR-2019) intramuscular for shingles prevention. On 06-AUG-2019, the patient experienced extreme arm pain, headaches, nausea, a low grade fever, and generalized body aches after receiving pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23). It was reported that the extreme arm pain was the same arm that vaccine was administered in. The patient sought for unspecified medical attention and was instructed to take NSAIDs. No lab diagnostics/studies were performed. On 12-AUG-2019, the patient recovered from the adverse events. The causality assessment betweent therapy with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) and the adverse events was not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: redness surrounding the injection site; itching surrounding the injection site; This case was reported by a consumer and described the occurrence of injection site erythema in a patient who received Herpes zoster (Shingrix) for prophylaxis.   In August 2019, the patient received Shingrix. In August 2019, less than 2 weeks after receiving Shingrix, the patient experienced injection site erythema and injection site itching. The patient was treated with paracetamol (Tylenol), ambiguous medication nos (Claritin (Nos)), naproxen (Aleve) and cortisone (non-proprietary) (Cortisone Cream). On an unknown date, the outcome of the injection site erythema and injection site itching were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema and injection site itching to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not reported. The patient received initial Shingrix vaccination 10 days before the reportng date. The patient experienced redness and itchiness surrounding the injection site. The patient had tried Tylenol, Claritin, Alleve, and Cortisone cream, and nothing was alleviating the itch.  The patient would appreciate any suggestions.
Age: 85.0
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Headache
Clinical narrative: headache; chills; This case was reported by a consumer via call center representative and described the occurrence of headache in a 85-year-old 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 headache and chills. On an unknown date, the outcome of the headache and chills were unknown.   It was unknown if the reporter considered the headache and chills to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient had a bad reaction to the 2nd dose of Shingrix headache and chills.
Sex: M
Vaccine: TDAP
Symptoms: Apparent death, Personality change, Seizure
Clinical narrative: Seizures; Changed his personality; This case was reported by a consumer via interactive digital media and described the occurrence of seizure in a male patient who received DTPa (DTPa vaccine) for prophylaxis.   On an unknown date, the patient received DTPa vaccine at an unknown dose. On an unknown date, unknown after receiving DTPa vaccine, the patient experienced seizure (serious criteria GSK medically significant and life threatening) and personality change (serious criteria life threatening). On an unknown date, the outcome of the seizure and personality change were unknown.   It was unknown if the reporter considered the seizure and personality change to be related to DTPa vaccine.  Additional details were provided as follows: The age at vaccination was not reported. It was reported that, the patient almost died from DPT vaccine, mainly seizures. The vaccine had changed patient's personality also. It was reported that vaccines are harmful and useless.
Sex: F
Vaccine: HEP
Symptoms: Hypersensitivity
Clinical narrative: Allergic reaction; This case was reported by a nurse via call center representative and described the occurrence of allergic reaction in a female patient who received Hepatitis B vaccine for prophylaxis.   On an unknown date, the patient received Hepatitis B vaccine at an unknown dose. On an unknown date, unknown after receiving Hepatitis B vaccine, the patient experienced allergic reaction. On an unknown date, the outcome of the allergic reaction was unknown.   It was unknown if the reporter considered the allergic reaction to be related to Hepatitis B vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The nurse reported that she had an allergic reaction to an unspecified Hepatitis B vaccine. The reporter did not consent to follow up. Collected from chat.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site mass, Injection site warmth
Clinical narrative: Warm around injection site; Redness around injection site; knotty area around injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site warmth in an unspecified number of adult patients 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 injection site warmth, injection site erythema and injection site lump. On an unknown date, the outcome of the injection site warmth, injection site erythema and injection site lump were unknown.   It was unknown if the reporter considered the injection site warmth, injection site erythema and injection site lump to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not applicable for this report. The age group was captured as adult as per Shingrix indication.  The reporter reported some patients had told him they had a warm, red, knotty area around Shingrix injection site. The reporter provided specific details other than what was stated at time of initial report.  No other details, including patients or products was available. The reporter did not consent to follow up. This case has been linked with US2019153979, reported by same reporter.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Rash macular, Skin warm, Swelling
Clinical narrative: Red blotchy, hot, swollen, sore & tender to the touch Tylenol for TX
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Tenderness
Clinical narrative: Red blotchy, hot, swollen, sore & tender to the touch Tylenol for TX
Age: 57.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Injection site erythema, Malaise, Pain
Clinical narrative: Complaints of body aches, chills, temp but did not check temp, and generalized not feeling well. Arm redness at injection site.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Insomnia, Pruritus, Rash erythematous
Clinical narrative: after received patient waited for 15 mins and was ok when leaving. next day patient call pharmacy stating that she has red bump/rash and her whole body was itching inside and outside. pharmacist suggest patient to buy otc Benadryl. patient been taking Benadryl but is still experience itching for 20 days now.  can't sleep at night due to itchy. no more rash but still very itchy
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Erythema, Loss of personal independence in daily activities, Malaise, Nausea, Peripheral swelling
Clinical narrative: 08/28/2019 At 1140am got a call from patient's mother who said that she is concerned about her son's right arm since he got vaccines on the 26th. Mom reports to this nurse that patient's arm is very swollen, area is dark red and hot to touch. Mom states that patient is not feeling well today and that she had to pick him up from school d/t his symptoms. Mom says that he's having issues not being able to move his arm d/t the swelling and redness. Asked mom if patient had a fever which mom stated she has not taken it so she was unsure. This nurse also asked if he had vomited today? Mom said no but feels very sick to his stomach. Mom said that that she is going to take patient to the ER. Mom said that she is not going to their PCP office because of an unknown issue at the office.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Skin warm
Clinical narrative: 08/28/2019 At 1140am got a call from patient's mother who said that she is concerned about her son's right arm since he got vaccines on the 26th. Mom reports to this nurse that patient's arm is very swollen, area is dark red and hot to touch. Mom states that patient is not feeling well today and that she had to pick him up from school d/t his symptoms. Mom says that he's having issues not being able to move his arm d/t the swelling and redness. Asked mom if patient had a fever which mom stated she has not taken it so she was unsure. This nurse also asked if he had vomited today? Mom said no but feels very sick to his stomach. Mom said that that she is going to take patient to the ER. Mom said that she is not going to their PCP office because of an unknown issue at the office.
Age: 15.0
Sex: F
Vaccine: MENB
Symptoms: Headache, Throat tightness, Vomiting
Clinical narrative: Parent called office at 12:00pm. stating that patient had a headache, vomiting, and felt like her throat was closing.  Mom brought her immediately to Emergency room. Was given epipen, solumedrol, Pepcid, Benadryl, Zofran and Tylenol.  Given IV fluids (normal saline)Monitored. Discharged home at 4:37PM. Was given prednisone and epipen prescription on discharge.
Age: 36.0
Sex: M
Vaccine: UNK
Symptoms: Aspiration, Asthenia, Bilevel positive airway pressure, CSF cell count normal, CSF protein increased
Clinical narrative: 36 y/o/m presents with tingling/numbness and tightness to arms and feet that came on today. Recently seen for dehydration a couple of days ago after walking for a long period of time in the sun. After that episode he was having trouble ambulating and does not have muscle control. He states since then he has been relaxing and sleeping but continued to feel the tightness in his extremities.  Having a harder time speaking. He was able to eat and drink normally. No pain. Denies vomiting. He continued to become weaker over the course if the following day and was crawling.  LP was performed and CSF studies revealed high protein and normal cell counts, surmised to be consistent with Guillain-Barre or variant. IVIG was started via PIV on the evening of HD 1.  On HD 2 he was assessed to be generally weaker, breathing faster (RR in 20s), phonating less well, swallowing weaker, and having more trouble managing his secretions. He was stepped up to ICU for monitoring. IVIG was continued.  After two days, weakness was stable/mildly improved and he was stepped down. Patient finished 5 days of IVIG therapy on 7/24. Slow recovery of strength. Pt had asp episode on 7/23 and required BiPAP. CXR showed RLL infiltrate. Empiric Rocephin started for 5-day course.
Age: 36.0
Sex: M
Vaccine: UNK
Symptoms: Chest X-ray abnormal, Dehydration, Dyskinesia, Dysphagia, Dysphonia
Clinical narrative: 36 y/o/m presents with tingling/numbness and tightness to arms and feet that came on today. Recently seen for dehydration a couple of days ago after walking for a long period of time in the sun. After that episode he was having trouble ambulating and does not have muscle control. He states since then he has been relaxing and sleeping but continued to feel the tightness in his extremities.  Having a harder time speaking. He was able to eat and drink normally. No pain. Denies vomiting. He continued to become weaker over the course if the following day and was crawling.  LP was performed and CSF studies revealed high protein and normal cell counts, surmised to be consistent with Guillain-Barre or variant. IVIG was started via PIV on the evening of HD 1.  On HD 2 he was assessed to be generally weaker, breathing faster (RR in 20s), phonating less well, swallowing weaker, and having more trouble managing his secretions. He was stepped up to ICU for monitoring. IVIG was continued.  After two days, weakness was stable/mildly improved and he was stepped down. Patient finished 5 days of IVIG therapy on 7/24. Slow recovery of strength. Pt had asp episode on 7/23 and required BiPAP. CXR showed RLL infiltrate. Empiric Rocephin started for 5-day course.
Age: 36.0
Sex: M
Vaccine: UNK
Symptoms: Gait disturbance, Guillain-Barre syndrome, Hypoaesthesia, Immunoglobulin therapy, Intensive care
Clinical narrative: 36 y/o/m presents with tingling/numbness and tightness to arms and feet that came on today. Recently seen for dehydration a couple of days ago after walking for a long period of time in the sun. After that episode he was having trouble ambulating and does not have muscle control. He states since then he has been relaxing and sleeping but continued to feel the tightness in his extremities.  Having a harder time speaking. He was able to eat and drink normally. No pain. Denies vomiting. He continued to become weaker over the course if the following day and was crawling.  LP was performed and CSF studies revealed high protein and normal cell counts, surmised to be consistent with Guillain-Barre or variant. IVIG was started via PIV on the evening of HD 1.  On HD 2 he was assessed to be generally weaker, breathing faster (RR in 20s), phonating less well, swallowing weaker, and having more trouble managing his secretions. He was stepped up to ICU for monitoring. IVIG was continued.  After two days, weakness was stable/mildly improved and he was stepped down. Patient finished 5 days of IVIG therapy on 7/24. Slow recovery of strength. Pt had asp episode on 7/23 and required BiPAP. CXR showed RLL infiltrate. Empiric Rocephin started for 5-day course.
Age: 36.0
Sex: M
Vaccine: UNK
Symptoms: Lung infiltration, Paraesthesia, Respiratory rate increased, Skin tightness, Speech disorder
Clinical narrative: 36 y/o/m presents with tingling/numbness and tightness to arms and feet that came on today. Recently seen for dehydration a couple of days ago after walking for a long period of time in the sun. After that episode he was having trouble ambulating and does not have muscle control. He states since then he has been relaxing and sleeping but continued to feel the tightness in his extremities.  Having a harder time speaking. He was able to eat and drink normally. No pain. Denies vomiting. He continued to become weaker over the course if the following day and was crawling.  LP was performed and CSF studies revealed high protein and normal cell counts, surmised to be consistent with Guillain-Barre or variant. IVIG was started via PIV on the evening of HD 1.  On HD 2 he was assessed to be generally weaker, breathing faster (RR in 20s), phonating less well, swallowing weaker, and having more trouble managing his secretions. He was stepped up to ICU for monitoring. IVIG was continued.  After two days, weakness was stable/mildly improved and he was stepped down. Patient finished 5 days of IVIG therapy on 7/24. Slow recovery of strength. Pt had asp episode on 7/23 and required BiPAP. CXR showed RLL infiltrate. Empiric Rocephin started for 5-day course.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash, Rash erythematous
Clinical narrative: patient broke out in a rash all over body with red bump. suggest patient take Benadryl and rash went away couple day later
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Patient states that after she received the Shingrix vaccine, the place on her arm where she received the vaccine became hot, red, and swollen and these symptoms have continued into the next day (2 days after receiving it). The pharmacist recommended taking ibuprofen and putting an ice pack on the arm. Planning to follow-up with patient in the next day to see if she is still experiencing these symptoms.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Anal incontinence, Dizziness, Malaise, Presyncope, Syncope
Clinical narrative: vasovagal syncope, approximately 8 hours after administration. patient stated started to feel sick around noon or one o'clock and rested, then around 8pm, felt severe lightheadedness and almost fainted and lost control of bowels. he stated he does have heart condition and was not feeling well a month prior to vaccine, July 28, 29, 2019. he also stated took a tramadol prior to reaction and wondered if that could have contributed. he stated he has had flu shots in past and didn't recall any adverse reaction. he stated he would contact doctor for follow up.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Pain
Clinical narrative: Right upper arm presents with swelling, redness and pain. Pain is throbbing in nature 6/10.  Warm to touch. Treated with HYDROXYZINE HCL 50 MG ORAL TABLET (HYDROXYZINE HCL) 1 by mouth 3 times a day as needed
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Arthritis, Burning sensation, Injected limb mobility decreased, Injection site pain
Clinical narrative: Immunization was the most painful I've ever had.  I expected a sore arm, but the soreness moved into my shoulder joint.  Have had 5 weeks of acupuncture, a PRP injection, and 6 weeks of physical therapy.  Nothing is helping.  My arm is in pain every minute of every day.  I cannot raise it up or move it back.  I get a painful sharp pain in the joint and a burning sensation, sometimes down to my elbow.  The pain now is getting worse - going from my elbow to the back of my left arm on my abdomen to the left side of my neck. Have never had a problem with either of my shoulders , and had no falls or any reason for this to happen. I believe it is directly related to the immunization itself or the way it was administered.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, X-ray limb abnormal
Clinical narrative: Immunization was the most painful I've ever had.  I expected a sore arm, but the soreness moved into my shoulder joint.  Have had 5 weeks of acupuncture, a PRP injection, and 6 weeks of physical therapy.  Nothing is helping.  My arm is in pain every minute of every day.  I cannot raise it up or move it back.  I get a painful sharp pain in the joint and a burning sensation, sometimes down to my elbow.  The pain now is getting worse - going from my elbow to the back of my left arm on my abdomen to the left side of my neck. Have never had a problem with either of my shoulders , and had no falls or any reason for this to happen. I believe it is directly related to the immunization itself or the way it was administered.
Age: 37.0
Sex: M
Vaccine: TDAP
Symptoms: Dizziness, Fall, Nausea, Syncope
Clinical narrative: Pt was very nervous right before the injection,  I had him take a deep breath and then let it out and administered the immunization.  Pt felt woozy about 30-45 seconds after the immunization.  I offered him a lollipop which he took and then he fell forward, (i caught him) and he fainted.   I repeatedly shook the patient and called his name until he came to about 15 seconds later.   Pt woke up without any recollection of what occurred.   He said he was dreaming and heard the song.  His wife giggled and said that they were listening to that song before they got here.   His wife was present for the whole thing and said her husband is very afraid of needles and that this happens all the time (even when their 5yr old son receives immunizations).   We gave the patient a bottle of water and I sat with him for about 10-15min.     I administered a vaccine to his wife and patient wanted to sit on the bench and wait for her which was about 25ft away.  After I administered hers he came over and said he was going to throw up, but he never did.  His wife just wanted to take him home.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV9, TDAP, VARZOS
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Patient received the Shingrix as an extra vaccine.  Shingrix is for ages 50 years and older.  She was to receive her Meningococcal vaccine.  No adverse events were reported.
Age: 60.0
Sex: M
Vaccine: FLUC4
Symptoms: Mobility decreased
Clinical narrative: pt reports he can not lift his arm
Age: 13.0
Sex: M
Vaccine: HEP, HEPA, HPV9, IPV, MMRV, TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: I am reporting an administration error not an adverse event.
Age: 26.0
Sex: M
Vaccine: SMALL
Symptoms: Erythema, Fatigue, Headache, Pruritus
Clinical narrative: Date:20190828  Patient states he has had an increase headaches, and fatigue since he was vaccinated for small pox. Patient states he is drinking 80 oz of water a day and has not changed his diet. Patient reported he was having local itching and redness which resolved when he started using different Band-Aids. 1L of NS was given via 18ga IV in the patient's right AC after being seen by a provider to rule out dehydration. PRE and POST IV administration NS documented. Patient was released on 24hrs Quarters with instruction to return if symptoms worsen or fail to improve.
Age: 32.0
Sex: M
Vaccine: UNK
Symptoms: Arthralgia, Headache, Pyrexia
Clinical narrative: Joint pain 6 days after vaccine, fever of 102.6 and headache 8 days after vaccine Treated with advil
Age: 12.0
Sex: F
Vaccine: HEP
Symptoms: Cold sweat, Eye movement disorder, Pallor, Seizure like phenomena, Unresponsive to stimuli
Clinical narrative: After patient received vaccine, turned pale, became clammy, eyes rolled back, and had several seconds of seizure like activity. During this time patient was not responsive to voice.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Decreased appetite, Diarrhoea, Erythema, Fatigue, Nausea
Clinical narrative: Large area of redness with warmth and slight swelling (about the size of a man's hand and fingers) / Fever as high as 101 / Nausea / Diarrhea / Loss of Appetite / Pain in arm / Extreme exhaustion / Relief after 7 days
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia, Skin warm, Swelling
Clinical narrative: Large area of redness with warmth and slight swelling (about the size of a man's hand and fingers) / Fever as high as 101 / Nausea / Diarrhea / Loss of Appetite / Pain in arm / Extreme exhaustion / Relief after 7 days
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia, Pain, Pain in extremity
Clinical narrative: Patient reports sore arm a month after shot. Reports that pain has migrated from deltoid muscle to beneath the bone and collar bone. Patient reports that severe, dull, aching pain has not diminished since shot was given. It faded for a bit but then came back.
Age: 67.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Skin infection
Clinical narrative: Fluad was given in the right arm in the upper portion and the pneumovax was given at approximately 2 inches below . Patient presented 4 days later with what appeared to be a skin infection. I recommended that she go to the urgent care immediately (6 doors down).
Age: 72.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Injected limb mobility decreased, Pain
Clinical narrative: pt experienced numbing pain, went to ED. Couldnt lift right arm as per pt.
Age: 68.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Chest X-ray, Computerised tomogram head, Decreased appetite, Electrocardiogram, Headache
Clinical narrative: *Patient received Shingrix series at Pharmacy* Patient had 2nd Shingrix August 5, 2019 and had achiness (first one was 6/3/19), HA Skin tingling, couldn't regulate body temperature and had fever; went to Hospital and was admitted 08/15/19-08/17/19; back to ER 08/23/19; given Fioricet, and subsequently Ketorolac 10mg q 8 hours, and then Zofran ODT (but made him more nauseous); not currently with HA; but taking Ketorolac q 7.5 hours; decreased appetite, started eating 08/26/19;  couldn't practice guitar for 3 weeks as guitar "too heavy"; just started driving again 08/26/19.
Age: 68.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Impaired driving ability, Laboratory test, Loss of personal independence in daily activities, Nausea, Pain
Clinical narrative: *Patient received Shingrix series at Pharmacy* Patient had 2nd Shingrix August 5, 2019 and had achiness (first one was 6/3/19), HA Skin tingling, couldn't regulate body temperature and had fever; went to Hospital and was admitted 08/15/19-08/17/19; back to ER 08/23/19; given Fioricet, and subsequently Ketorolac 10mg q 8 hours, and then Zofran ODT (but made him more nauseous); not currently with HA; but taking Ketorolac q 7.5 hours; decreased appetite, started eating 08/26/19;  couldn't practice guitar for 3 weeks as guitar "too heavy"; just started driving again 08/26/19.
Age: 68.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Paraesthesia, Pyrexia, Temperature regulation disorder
Clinical narrative: *Patient received Shingrix series at Pharmacy* Patient had 2nd Shingrix August 5, 2019 and had achiness (first one was 6/3/19), HA Skin tingling, couldn't regulate body temperature and had fever; went to Hospital and was admitted 08/15/19-08/17/19; back to ER 08/23/19; given Fioricet, and subsequently Ketorolac 10mg q 8 hours, and then Zofran ODT (but made him more nauseous); not currently with HA; but taking Ketorolac q 7.5 hours; decreased appetite, started eating 08/26/19;  couldn't practice guitar for 3 weeks as guitar "too heavy"; just started driving again 08/26/19.
Age: 68.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Confusional state, Decreased appetite, Dehydration, Injection site swelling, Laboratory test
Clinical narrative: *Patient received Shingrix series at Pharmacy* Patient had 2nd Shingrix August 5, 2019 and had achiness (first one was 6/3/19), HA Skin tingling, couldn't regulate body temperature and had fever; went to Hospital and was admitted 08/15/19-08/17/19; back to ER 08/23/19; given Fioricet, and subsequently Ketorolac 10mg q 8 hours, and then Zofran ODT (but made him more nauseous); not currently with HA; but taking Ketorolac q 7.5 hours; decreased appetite, started eating 08/26/19;  couldn't practice guitar for 3 weeks as guitar "too heavy"; just started driving again 08/26/19.
Age: 68.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Loss of personal independence in daily activities, Migraine, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: *Patient received Shingrix series at Pharmacy* Patient had 2nd Shingrix August 5, 2019 and had achiness (first one was 6/3/19), HA Skin tingling, couldn't regulate body temperature and had fever; went to Hospital and was admitted 08/15/19-08/17/19; back to ER 08/23/19; given Fioricet, and subsequently Ketorolac 10mg q 8 hours, and then Zofran ODT (but made him more nauseous); not currently with HA; but taking Ketorolac q 7.5 hours; decreased appetite, started eating 08/26/19;  couldn't practice guitar for 3 weeks as guitar "too heavy"; just started driving again 08/26/19.
Age: 68.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Sensitive skin, Swelling, Thinking abnormal
Clinical narrative: *Patient received Shingrix series at Pharmacy* Patient had 2nd Shingrix August 5, 2019 and had achiness (first one was 6/3/19), HA Skin tingling, couldn't regulate body temperature and had fever; went to Hospital and was admitted 08/15/19-08/17/19; back to ER 08/23/19; given Fioricet, and subsequently Ketorolac 10mg q 8 hours, and then Zofran ODT (but made him more nauseous); not currently with HA; but taking Ketorolac q 7.5 hours; decreased appetite, started eating 08/26/19;  couldn't practice guitar for 3 weeks as guitar "too heavy"; just started driving again 08/26/19.