chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of cellulitis in a 60-year-old female patient who received SHINGRIX (batch number C7B9P, expiry date unknown) for prophylaxis. On 27th August 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 27th August 2018, less than a day after receiving SHINGRIX, the patient experienced cellulitis (serious criteria GSK medically significant), fever, headache, chills, injection site induration, injection site pain, injection site warmth and injection site erythema. The patient was treated with cephalexin (Keflex). On an unknown date, the outcome of the cellulitis, headache, injection site induration, injection site pain, injection site warmth and injection site erythema were not recovered/not resolved and the outcome of the fever and chills were recovered/resolved.  It was unknown if the reporter considered the cellulitis, fever, headache, chills, injection site induration, injection site pain, injection site warmth and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: At 11:08 hours, the patient experienced on left deltoid. On the same evening, the patient experienced shaking, fever, chills and a headache. Next day after vaccination, the patient also experienced redness, pain, warmth and induration at the injection site. The caller stated that the redness was approximately the size of her full hand. The caller states that the site was hot as well. The caller states that she did seek medical attention and was prescribed Keflex and believed she might had cellulitis. The patient stated that she reported this to the pharmacy where she received the vaccine and they reported the event to the vaccine hotline.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Cellulitis, Chills, Headache, Injection site erythema, Injection site induration
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of cellulitis in a 60-year-old female patient who received SHINGRIX (batch number C7B9P, expiry date unknown) for prophylaxis. On 27th August 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 27th August 2018, less than a day after receiving SHINGRIX, the patient experienced cellulitis (serious criteria GSK medically significant), fever, headache, chills, injection site induration, injection site pain, injection site warmth and injection site erythema. The patient was treated with cephalexin (Keflex). On an unknown date, the outcome of the cellulitis, headache, injection site induration, injection site pain, injection site warmth and injection site erythema were not recovered/not resolved and the outcome of the fever and chills were recovered/resolved.  It was unknown if the reporter considered the cellulitis, fever, headache, chills, injection site induration, injection site pain, injection site warmth and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: At 11:08 hours, the patient experienced on left deltoid. On the same evening, the patient experienced shaking, fever, chills and a headache. Next day after vaccination, the patient also experienced redness, pain, warmth and induration at the injection site. The caller stated that the redness was approximately the size of her full hand. The caller states that the site was hot as well. The caller states that she did seek medical attention and was prescribed Keflex and believed she might had cellulitis. The patient stated that she reported this to the pharmacy where she received the vaccine and they reported the event to the vaccine hotline.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Injection site warmth, Pyrexia, Tremor
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of cellulitis in a 60-year-old female patient who received SHINGRIX (batch number C7B9P, expiry date unknown) for prophylaxis. On 27th August 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 27th August 2018, less than a day after receiving SHINGRIX, the patient experienced cellulitis (serious criteria GSK medically significant), fever, headache, chills, injection site induration, injection site pain, injection site warmth and injection site erythema. The patient was treated with cephalexin (Keflex). On an unknown date, the outcome of the cellulitis, headache, injection site induration, injection site pain, injection site warmth and injection site erythema were not recovered/not resolved and the outcome of the fever and chills were recovered/resolved.  It was unknown if the reporter considered the cellulitis, fever, headache, chills, injection site induration, injection site pain, injection site warmth and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: At 11:08 hours, the patient experienced on left deltoid. On the same evening, the patient experienced shaking, fever, chills and a headache. Next day after vaccination, the patient also experienced redness, pain, warmth and induration at the injection site. The caller stated that the redness was approximately the size of her full hand. The caller states that the site was hot as well. The caller states that she did seek medical attention and was prescribed Keflex and believed she might had cellulitis. The patient stated that she reported this to the pharmacy where she received the vaccine and they reported the event to the vaccine hotline.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: A very sore, red, and swollen upper arm where shot was given that lasted 5 days.
Age: 1.08
Sex: M
Vaccine: DTAPIPVHIB, PPV
Symptoms: Aphasia, Developmental regression
Clinical narrative: Patient was 13 months old and speaking single words. After the vaccines were given the patient stopped speaking any words and regressed without saying anything for months.
Age: 1.58
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Head banging, Intentional self-injury
Clinical narrative: Patient started hitting himself in the head and banging his head on the couch after a few hours of being home after the injections.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Injection site erythema, Injection site pain, Injection site swelling, Myalgia
Clinical narrative: Pain and swelling and redness at the injection site (5 days). Muscle aches and weakness(1 day).
Sex: F
Vaccine: VARCEL
Symptoms: Expired product administered, Injection site erythema, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a female patient of an unknown age. The patient had no pertinent medical history and no concomitant medications. She was allergic to penicillin and cephalosporins. On 10-AUG-2018, the patient was inadvertently vaccinated with an expired dose of VARIVAX lot# M030138, expiration date: 15-JUN-2018 (exact dose and route of administration were not reported) for prophylaxis, reconstituted with sterile diluent (MRK INJ) lot# N034444, expiration date: 27-MAR-2019. On an unknown date in August 2018 (reported as after the vaccination), the patient experienced raised, red, warm welt-like area at injection site. The patient did not seek medical attention, no treatment was given for the events. No lab diagnostic tests were performed. The outcome of the events was reported as recovered on an unknown date. The relatedness between the events and suspect therapies was not reported.
Sex: F
Vaccine: VARCEL
Symptoms: Urticaria
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a female patient of an unknown age. The patient had no pertinent medical history and no concomitant medications. She was allergic to penicillin and cephalosporins. On 10-AUG-2018, the patient was inadvertently vaccinated with an expired dose of VARIVAX lot# M030138, expiration date: 15-JUN-2018 (exact dose and route of administration were not reported) for prophylaxis, reconstituted with sterile diluent (MRK INJ) lot# N034444, expiration date: 27-MAR-2019. On an unknown date in August 2018 (reported as after the vaccination), the patient experienced raised, red, warm welt-like area at injection site. The patient did not seek medical attention, no treatment was given for the events. No lab diagnostic tests were performed. The outcome of the events was reported as recovered on an unknown date. The relatedness between the events and suspect therapies was not reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX lot # N017699, expiration date (09-JUN-2019) (dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion between 6 to 14 (also reported as 6.3) degrees Fahrenheit for 3 hours and 46 minutes and between 6 to 14 degrees Fahrenheit (also reported as 11.3) for 23 hours and 58 minutes and between 15 to 46 (also reported as 22.5) degrees Fahrenheit for 7 hours and 56 minutes. Data logger was involved. There were no previous excursions reported. Product quality complaint (PQC) was not involved.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 70 years old female patient with hypertension, osteopenia and allergies to: sulfa, amide-type anesthetics, sumatriptan and egg derived. The patient's historical conditions were not reported. The patient's concomitant therapies included: albuterol, alprazolam, aspirin, vitamin D, ubidecarenone (COQlO), cyanocobalamin (VITAMIN Bl2), estradiol, fexofenadine hydrochloride (ALLEGRA), nebivolol hydrochloride (BYSTOLIC), olmesartan medoxomil (BENICAR) and pitavastatin calcium (LIVALO).    On 16-AUG-2018, the patient was vaccinated with a dose of PNEUMOVAX 23 by intramuscular route (lot number: R009163 and expiration date 06-JAN-2020) as prevention of pneumococcal disease. On an unknown date in August 2018, following the vaccination, the patient experienced injection site swelling, which was treated with ice and heat . Then, on an unknown date in August 2018 (reported as "within 48 hours"), the patient recovered of injection site swelling. No laboratory diagnoses were performed. Additionally, it was reported that the patient called the physician (details were not provided). The causal assessment between the events and therapy with PNEUMOVAX 23 was not provided. This case is linked to another case reported by the same reporter.; Sender's Comments: US-009507513-1808USA009735:
Age: 18.0
Sex: U
Vaccine: MMRV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: This spontaneous report was received from a nurse and refers to an 18-year-old patient. There was no information about the patient's medical history, concurrent conditions, and concomitant medications provided. On 21-AUG-2018, the patient received a dose of PROQUAD recombinant Human albumin (rHA), lot # R001543, expiration date 15-JUL-2019 (site and route of administration were not reported) for prophylaxis. The vaccine was reconstituted with sterile diluent.
Age: 11.0
Sex: U
Vaccine: HPV9
Symptoms: Somnolence
Clinical narrative: This spontaneous report has been received from a physician regarding an 11 year old twin patient (gender not reported). No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unknown date, the patient was vaccinated with the first dose of GARDASIL 9 for prophylaxis (dose, route of administration, lot number and expiration date were not reported). After receiving the vaccine GARDASIL 9, the patient experienced sleepiness, described as "sleeping off and on for a whole day". The patient is currently 17 years old and the physician is inquiring whether would be appropriate to continue to vaccinate. The reporter did not assess the causal relationship between therapy with GARDASIL 9 and the event. The next day after vaccination, on an unknown date, the patient recovered from the event. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1808USA007442.
Age: 29.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Headache, Pain, Pain in extremity, Pyrexia
Clinical narrative: Information has been received from an office manager via a field representative referring to 29 year old female patient. The patient's pre-existing physician-diagnosed allergies, birth defects, medical conditions and illness at time of vaccination were reported as none. On 08-AUG-2018 the patient was vaccinated with her first dose of PNEUMOVAX 23 (lot # R002084, expiration date 26-OCT-2019; route, strength and dose were not reported) at right deltoid for prophylaxis. About 12 hours after vaccine was administered (on 08-AUG-2018), the patient started with severe arm pain. About 30 hours later (approximately on 09-AUG-2018), the patient experienced fever, chills, body aches and headache. The outcome of the events was reported as recovering. The causality between the events and PNEUMOVAX 23 was not reported. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1808USA005591.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 28-AUG-2018, the patient was vaccinated with a dose of VARIVAX lot # R002054, expiry date 22-JAN-2020, in a right leg subcutaneously for prophylaxis, and was also administered a dose of PROQUAD lot# R003292, expiry date 31-JUL-2019, in the left leg subcutaneously for prophylaxis. No lot information was provided for sterile diluent used to reconstitute the vaccines. No adverse effects were reported.
Age: 1.0
Sex: M
Vaccine: PNC13, VARCEL
Symptoms: Dyspnoea, Respiratory symptom, Vomiting
Clinical narrative: Information has been received from a medical assistant referring to a 12 months old male patient. The patient had no concurrent condition and medical history. Concomitant therapy included sterile diluent. On 30-AUG-2018 the patient was vaccinated with doses of VARIVAX lot # R009411, expiration date 29-MAR-2020 (strength, dose, frequency and route were not provided) for vaccination. Other suspect therapies included PREVNAR lot # T94425, expiration date April 2020 (strength, dose, frequency and route were not provided) for vaccination. On 30-AUG-2018, the patient experienced respiratory symptom, vomiting and "wasn't breathing well". The events were considered to be life threatening. The patient was taken to the emergency room where he received EPIPEN (also reported as unknown treatment) and was released. The outcome of the events was reported as recovered (approximately in August 2018). The causality assessment was not provided. No product quality compliance (PQC) involved.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 14-AUG-2018, the patient was vaccinated with a dose of improperly stored VARIVAX (lot # N029631, expiration date: 23-OCT-2019, dose and route of administration were not provided) for prophylaxis. Sterile diluent used to reconstitute the vaccine was properly stored. Administered dose of vaccine experienced temperature excursion between 6 and 14 Fahrenheit degrees for 30 minutes. There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported.
Sex: F
Vaccine: VARZOS
Symptoms: Breast cancer female, Breast cancer recurrent, Lymphadenectomy
Clinical narrative: This spontaneous report was received from a female patient of unknown age, reporting on herself. The patient's concurrent conditions included breast cancer diagnosed on an unspecified date. Due to it, approximately in 2004 (reported as "14 years ago"), she had some lymph nodes removed.   No other information was provided regarding the patient's drug reaction/allergies or concomitant medications. On approximately 2013, reported as "4-5 years ago", the patient was vaccinated with ZOSTAVAX for shingles prevention (dose, route of administration, lot number and expiration date were not reported). On an unspecified day in June 2018, the patient had one lymph node removed due to breast cancer in her left breast. The patient received an unspecified treatment for the events. The outcome of breast cancer recurrent was unknown. The reporter did not assess the causal relationship between therapy with ZOSTAVAX and the events. The patient was planning on getting re-vaccinated with "the new shingles vaccine" for an unspecified reason but had not been re-vaccinated at the time of the report. Upon internal review, the events of breast cancer recurrent was considered to be medically significant.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant and historical drugs was not provided. On 28-AUG-2018, the patient was vaccinated with an improperly stored dose of ROTATEQ lot # N026663, expiration date 25-MAY-2019, orally for prophylaxis. The vaccine was exposed to a temperature at or above 32°F up to 35 °F during 60 hours. There was not previous temperature excursion. It was reported that digital data logger was involved. No adverse effects were reported.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information was provided regarding the patient's concurrent conditions, medical history or concomitant medications. On 04-SEP-2018, the patient was vaccinated with VARIVAX lot # R011808 with expiration date on 23-APR-2020 via intramuscular instead of subcutaneous for prophylaxis (dose not reported). Nonetheless, no adverse effects were reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistance concerning a patient of unknown age and gender. No pertinent medical history, drug reactions/ allergies or concurrent conditions were reported. On 05-SEP-2018, the patient was vaccinated with one dose of improperly stored PROQUAD (which had a lot # of R002932 and an expiration date of 29-JUL-2019; however, dosage number and route of administration were not reported), for prophylaxis. The sterile diluent (manufacturer unknown) used to reconstitute the PROQUAD was not improperly stored. No adverse effects were reported. On an unspecified date, the vaccine experienced a temperature excursion of -14 degree C to -10 degree C for 16 minutes. Reportedly, there had been no previous temperature excursion and the aforementioned one was identified due to a data logger. Furthermore, no product quality complaint was involved.
Age: 23.0
Sex: M
Vaccine: HPV9
Symptoms: Laboratory test, Papilloma excision, Skin papilloma
Clinical narrative: This spontaneous report has been received from a 23 year old male patient referring to himself. The patient's pertinent medical history included papilloma viral infection (HPV). The patient's drug reaction/allergy included amoxicillin. Concomitant therapy included active hexose correlated compound (AHCC, mushroom). From March 2018 the patient was vaccinated with three doses of GARDASIL 9 (three dose injection schedule; strength, batch/lot # and expiration date were not reported) intramuscularly in the left deltoid muscle as a form of treatment to prevent re-infection and spreading of the HPV. The last dose was on 04-SEP-2018. The patient stated that the "vaccination didn't give him full immunity, and that at the beginning of August 2018 his warts spread a couple of times when touching other parts of his body while using GARDASIL 9". The patient "had taken topical treatment such as apple cider, and thuja oil as a form of treatment, which temporarily removed the warts, but then reappeared after one week". The patient visited physician to seek medical attention. The patient was hospitalized for a duration of one day to undergo a surgery for removal of warts. Unspecified tests were performed. The outcome of the events was reported as not recovered/not resolved. The causality between the events and suspect therapy was not reported. No product quality complaint (PQC) was involved.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash, Skin lesion
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 15-MAY-2013, the patient was inoculated with the ZOSTAVAX for its intended purpose: the prevention of shingles (dose, route, and lot # not provided). The patient did not have a shingles outbreak until 21-OCT-2016, in addition to chronic pain, rash and lesions to various parts of 'his' (patient is a female) body. As a direct result of the vaccine, the patient suffered mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of the ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, the patient suffered permanent and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The patient has incurred medical expenses and other economic harm as a direct result of use of ZOSTAVAX. Shingles outbreak was considered to be disabling. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash, Skin lesion
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 11-SEP-2016, the patient received the ZOSTAVAX (lot number, dosage and route of administration not provided) for its intended purpose: the prevention of shingles. As a direct result of the ZOSTAVAX, the patient suffered from a shingles outbreak, in addition to chronic pain, rash and lesions to various parts of her body. The patient did not have a shingles outbreak until 16-FEB-2017. The outcome of the shingles outbreak is unknown. As a direct result of the ZOSTAVAX, the patient suffered mental and emotional distress due to the resulting physical limitations and seriousness of her condition. As a result of ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The patient has incurred medical expenses and other economic harm as a direct result of her use of ZOSTAVAX. Shingles outbreak was considered to be disabling. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Oral herpes, Paraesthesia
Clinical narrative: Tingling and burning sensation on left side of face. Fever blister on bottom lip.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Injection site swelling, Pyrexia
Clinical narrative: Fever between 100-102.5 for four days, swelling of 2 inch diameter around the injection site, rash of 2 inch diameter around the injection site.
Age: 7.0
Sex: F
Vaccine: DTAPHEPBIP, HEPA, MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Pt did not have a reaction to vaccine. PEDIARIX was given to pt.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site erythema, Injection site pain, Pain, Pyrexia
Clinical narrative: Fever, chills, aching, redness and tenderness at site.
Age: 2.0
Sex: M
Vaccine: DTAP
Symptoms: Pyrexia, Vomiting
Clinical narrative: Fever 104 and vomiting- symptomatic Tx, improving on day 2 with fever down to 99.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site erythema, Injection site warmth
Clinical narrative: Patient started to notice erythema and warmth at the injection site on her left deltoid on Friday evening around 10pm. On Monday, 9/10 around 8:30am, she was getting dressed and noticed an area of erythema (about the size of a palm) under her left breast. No itching, burning, or vesicles present.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness and swelling and left bicep pain within one day of injection.
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Fall, Pruritus, Swollen tongue, Urticaria
Clinical narrative: States she received her Influenza vaccine on 9/7/18 at 0831, site of shot starting itching during the day at about 1030. States that during the afternoon and the evening continued to have itching and she got hives all over, states during the night she was dizzy and fell down at home about 0700, no injury when she fell at home. States her tongue started swelling in the morning.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from an administrator via a company representative and refers to a patient of unknown age and gender. The patient's pertinent medical history, concomitant therapies, drug reactions or allergies were not reported. On 14-AUG-2018, the patient was vaccinated with a dose of VARIVAX subcutaneously (lot # R002508, expiration date: 25-JAN-2020), reconstituted with an expired lot of sterile diluent (lot # L025372, expiration date: 20-MAR-2018) for prophylaxis. No adverse effect was reported.
Sex: U
Vaccine: VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 23-AUG-2018 the patient was vaccinated with VARIVAX (lot #R009411 and expiration date 29-MAR-2020), subcutaneous (dose, units and frequency were unknown) despite an unspecified history of immunity (extra dose administered and circumstance or information capable of leading to medication error). The vaccine was reconstituted with sterile diluent (MERCK). No adverse effect reported. There was no product quality complaint reported.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Oxygen saturation decreased, Pruritus, Swelling face, Swelling of eyelid, Swollen tongue
Clinical narrative: Facial and eyelid swelling first, then when at ER, tongue swelling and O2 started to drop. (not by much, but some).
Age: 52.0
Sex: M
Vaccine: RAB
Symptoms: Hypersensitivity, Urticaria
Clinical narrative: Patient had an allergic reaction with diffuse urticaria.
Age: 22.0
Sex: F
Vaccine: VARCEL
Symptoms: Eyelid pain, Neck pain, Pyrexia, Rash, Rash erythematous
Clinical narrative: Symptom onset 13 days post vaccination. Patient presents with fever and scattered red bumps on torso. Right lower eyelid sore and puffy. Right side of neck is sore.
Age: 22.0
Sex: F
Vaccine: VARCEL
Symptoms: Swelling of eyelid
Clinical narrative: Symptom onset 13 days post vaccination. Patient presents with fever and scattered red bumps on torso. Right lower eyelid sore and puffy. Right side of neck is sore.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Diarrhoea, Dizziness, Headache, Loss of consciousness
Clinical narrative: Legs ached, headache, dizziness to point of passing out, diarrhea, weakness.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Legs ached, headache, dizziness to point of passing out, diarrhea, weakness.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Blood test, Body temperature increased, Gait inability, Injected limb mobility decreased, Pain
Clinical narrative: Could not move legs or walk. Purple rash all over feet and small spots various places of his body, 103 temperature, extreme pain.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Rash generalised, Urine analysis
Clinical narrative: Could not move legs or walk. Purple rash all over feet and small spots various places of his body, 103 temperature, extreme pain.
Age: 32.0
Sex: F
Vaccine: HEPAB, TDAP
Symptoms: Injection site erythema, Injection site swelling, Loss of personal independence in daily activities, Pain in extremity
Clinical narrative: After the initial soreness stopped, patient states that about 2 days later the area on the right arm of the TWINRIX began to swell and become red. Today the patient contacted us and stated the arm is painful, still red and swollen, and is interfering with daily activities. Patient has not yet sought any treatment but has been referred to her primary care.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity
Clinical narrative: Patient reports pain in arm that is "severe". Patient has not tried anything to help with it. It is listed as a side effect on the package insert.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Pain
Clinical narrative: Patient c/o headache and body ache after the vaccination of SHINGRIX.
Age: 31.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Bilevel positive airway pressure, CSF glucose normal, CSF pressure increased, CSF protein normal
Clinical narrative: Patient developed fever, chills, and tachycardia within hours of the dose. She presented to the ER and was admitted to the ICU for presumed sepsis (h/o immunosuppression plus known immunodeficiency) and was started on brand spectrum antibiotics but no infection was found. She remained febrile to about 40C for approximately 18 hours and then defervesced. She was tired and weak with new headache thought to be due to underlying myasthenia gravis so she was transferred to near ICU for bipap overnight. She became confused, started vomiting, and complained of neck stiffness and headache worsening overnight. A head CT performed the following AM was completely normal and LP revealed an opening pressure of 55cmH2O. Protein of 22, glucose of 50, 4wbc, 10rbc, meningoencephalitis panel was negative including crypto antigen. Cultures were also negative.  Patient's symptoms resolved completely with removal of CSF via LP. 8 hours later, she again developed worsening headache, nausea/cvomiting, and confusion. A repeat LP revealed OP of 55cmH20 again and more fluid was removed with same result of complete resolution of symptoms. An MRI/MRV was done and venous sinus thrombosis was ruled out. In fact there were no abnormalities shown at all. Patient had recurrence of symptoms again about 8-10 hours after the LP and a lumbar drain was placed. Over the last 2 days, her drain as been putting out less and less CSF and she has felt well and is without symptoms. During this time, CBC and CMP remained normal. She will undergo plex today as she is due for this to treat her MG. We hope it will also reduce the vaccine reaction. Of note, patient regularly receives IVIG and got her most recent dose about 2 weeks prior to vaccination.
Age: 31.0
Sex: F
Vaccine: VARZOS
Symptoms: CSF red blood cell count positive, CSF white blood cell count negative, Chills, Computerised tomogram head normal, Condition aggravated
Clinical narrative: Patient developed fever, chills, and tachycardia within hours of the dose. She presented to the ER and was admitted to the ICU for presumed sepsis (h/o immunosuppression plus known immunodeficiency) and was started on brand spectrum antibiotics but no infection was found. She remained febrile to about 40C for approximately 18 hours and then defervesced. She was tired and weak with new headache thought to be due to underlying myasthenia gravis so she was transferred to near ICU for bipap overnight. She became confused, started vomiting, and complained of neck stiffness and headache worsening overnight. A head CT performed the following AM was completely normal and LP revealed an opening pressure of 55cmH2O. Protein of 22, glucose of 50, 4wbc, 10rbc, meningoencephalitis panel was negative including crypto antigen. Cultures were also negative.  Patient's symptoms resolved completely with removal of CSF via LP. 8 hours later, she again developed worsening headache, nausea/cvomiting, and confusion. A repeat LP revealed OP of 55cmH20 again and more fluid was removed with same result of complete resolution of symptoms. An MRI/MRV was done and venous sinus thrombosis was ruled out. In fact there were no abnormalities shown at all. Patient had recurrence of symptoms again about 8-10 hours after the LP and a lumbar drain was placed. Over the last 2 days, her drain as been putting out less and less CSF and she has felt well and is without symptoms. During this time, CBC and CMP remained normal. She will undergo plex today as she is due for this to treat her MG. We hope it will also reduce the vaccine reaction. Of note, patient regularly receives IVIG and got her most recent dose about 2 weeks prior to vaccination.
Age: 31.0
Sex: F
Vaccine: VARZOS
Symptoms: Confusional state, Cryptococcus test, Culture negative, Drain placement, Fatigue
Clinical narrative: Patient developed fever, chills, and tachycardia within hours of the dose. She presented to the ER and was admitted to the ICU for presumed sepsis (h/o immunosuppression plus known immunodeficiency) and was started on brand spectrum antibiotics but no infection was found. She remained febrile to about 40C for approximately 18 hours and then defervesced. She was tired and weak with new headache thought to be due to underlying myasthenia gravis so she was transferred to near ICU for bipap overnight. She became confused, started vomiting, and complained of neck stiffness and headache worsening overnight. A head CT performed the following AM was completely normal and LP revealed an opening pressure of 55cmH2O. Protein of 22, glucose of 50, 4wbc, 10rbc, meningoencephalitis panel was negative including crypto antigen. Cultures were also negative.  Patient's symptoms resolved completely with removal of CSF via LP. 8 hours later, she again developed worsening headache, nausea/cvomiting, and confusion. A repeat LP revealed OP of 55cmH20 again and more fluid was removed with same result of complete resolution of symptoms. An MRI/MRV was done and venous sinus thrombosis was ruled out. In fact there were no abnormalities shown at all. Patient had recurrence of symptoms again about 8-10 hours after the LP and a lumbar drain was placed. Over the last 2 days, her drain as been putting out less and less CSF and she has felt well and is without symptoms. During this time, CBC and CMP remained normal. She will undergo plex today as she is due for this to treat her MG. We hope it will also reduce the vaccine reaction. Of note, patient regularly receives IVIG and got her most recent dose about 2 weeks prior to vaccination.
Age: 31.0
Sex: F
Vaccine: VARZOS
Symptoms: Full blood count normal, Headache, Intensive care, Metabolic function test normal, Musculoskeletal stiffness
Clinical narrative: Patient developed fever, chills, and tachycardia within hours of the dose. She presented to the ER and was admitted to the ICU for presumed sepsis (h/o immunosuppression plus known immunodeficiency) and was started on brand spectrum antibiotics but no infection was found. She remained febrile to about 40C for approximately 18 hours and then defervesced. She was tired and weak with new headache thought to be due to underlying myasthenia gravis so she was transferred to near ICU for bipap overnight. She became confused, started vomiting, and complained of neck stiffness and headache worsening overnight. A head CT performed the following AM was completely normal and LP revealed an opening pressure of 55cmH2O. Protein of 22, glucose of 50, 4wbc, 10rbc, meningoencephalitis panel was negative including crypto antigen. Cultures were also negative.  Patient's symptoms resolved completely with removal of CSF via LP. 8 hours later, she again developed worsening headache, nausea/cvomiting, and confusion. A repeat LP revealed OP of 55cmH20 again and more fluid was removed with same result of complete resolution of symptoms. An MRI/MRV was done and venous sinus thrombosis was ruled out. In fact there were no abnormalities shown at all. Patient had recurrence of symptoms again about 8-10 hours after the LP and a lumbar drain was placed. Over the last 2 days, her drain as been putting out less and less CSF and she has felt well and is without symptoms. During this time, CBC and CMP remained normal. She will undergo plex today as she is due for this to treat her MG. We hope it will also reduce the vaccine reaction. Of note, patient regularly receives IVIG and got her most recent dose about 2 weeks prior to vaccination.
Age: 31.0
Sex: F
Vaccine: VARZOS
Symptoms: Myasthenia gravis, Nausea, Nuclear magnetic resonance imaging normal, Pyrexia, Sepsis
Clinical narrative: Patient developed fever, chills, and tachycardia within hours of the dose. She presented to the ER and was admitted to the ICU for presumed sepsis (h/o immunosuppression plus known immunodeficiency) and was started on brand spectrum antibiotics but no infection was found. She remained febrile to about 40C for approximately 18 hours and then defervesced. She was tired and weak with new headache thought to be due to underlying myasthenia gravis so she was transferred to near ICU for bipap overnight. She became confused, started vomiting, and complained of neck stiffness and headache worsening overnight. A head CT performed the following AM was completely normal and LP revealed an opening pressure of 55cmH2O. Protein of 22, glucose of 50, 4wbc, 10rbc, meningoencephalitis panel was negative including crypto antigen. Cultures were also negative.  Patient's symptoms resolved completely with removal of CSF via LP. 8 hours later, she again developed worsening headache, nausea/cvomiting, and confusion. A repeat LP revealed OP of 55cmH20 again and more fluid was removed with same result of complete resolution of symptoms. An MRI/MRV was done and venous sinus thrombosis was ruled out. In fact there were no abnormalities shown at all. Patient had recurrence of symptoms again about 8-10 hours after the LP and a lumbar drain was placed. Over the last 2 days, her drain as been putting out less and less CSF and she has felt well and is without symptoms. During this time, CBC and CMP remained normal. She will undergo plex today as she is due for this to treat her MG. We hope it will also reduce the vaccine reaction. Of note, patient regularly receives IVIG and got her most recent dose about 2 weeks prior to vaccination.
Age: 31.0
Sex: F
Vaccine: VARZOS
Symptoms: Tachycardia, Vaccination complication, Venogram normal, Vomiting
Clinical narrative: Patient developed fever, chills, and tachycardia within hours of the dose. She presented to the ER and was admitted to the ICU for presumed sepsis (h/o immunosuppression plus known immunodeficiency) and was started on brand spectrum antibiotics but no infection was found. She remained febrile to about 40C for approximately 18 hours and then defervesced. She was tired and weak with new headache thought to be due to underlying myasthenia gravis so she was transferred to near ICU for bipap overnight. She became confused, started vomiting, and complained of neck stiffness and headache worsening overnight. A head CT performed the following AM was completely normal and LP revealed an opening pressure of 55cmH2O. Protein of 22, glucose of 50, 4wbc, 10rbc, meningoencephalitis panel was negative including crypto antigen. Cultures were also negative.  Patient's symptoms resolved completely with removal of CSF via LP. 8 hours later, she again developed worsening headache, nausea/cvomiting, and confusion. A repeat LP revealed OP of 55cmH20 again and more fluid was removed with same result of complete resolution of symptoms. An MRI/MRV was done and venous sinus thrombosis was ruled out. In fact there were no abnormalities shown at all. Patient had recurrence of symptoms again about 8-10 hours after the LP and a lumbar drain was placed. Over the last 2 days, her drain as been putting out less and less CSF and she has felt well and is without symptoms. During this time, CBC and CMP remained normal. She will undergo plex today as she is due for this to treat her MG. We hope it will also reduce the vaccine reaction. Of note, patient regularly receives IVIG and got her most recent dose about 2 weeks prior to vaccination.
Age: 1.33
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Ataxia, Band neutrophil percentage increased, Irritability, Joint hyperextension, Lymphocyte percentage increased
Clinical narrative: Day 11 post vaccine fever and irritability. Day 12 typical measles like rash and fever. Day 13 increase rash, fever, irritability. Day 14 rash and ataxia and hyperextension of head intermittently. Hospitalized. Ataxia confirmed. Labs showed neutropenia. Day 15 ataxia began to subside.
Age: 1.33
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Neutropenia, Neutrophil percentage decreased, Pyrexia, Rash, Rash morbilliform
Clinical narrative: Day 11 post vaccine fever and irritability. Day 12 typical measles like rash and fever. Day 13 increase rash, fever, irritability. Day 14 rash and ataxia and hyperextension of head intermittently. Hospitalized. Ataxia confirmed. Labs showed neutropenia. Day 15 ataxia began to subside.
Age: 1.33
Sex: F
Vaccine: MMR, VARCEL
Symptoms: White blood cell count decreased
Clinical narrative: Day 11 post vaccine fever and irritability. Day 12 typical measles like rash and fever. Day 13 increase rash, fever, irritability. Day 14 rash and ataxia and hyperextension of head intermittently. Hospitalized. Ataxia confirmed. Labs showed neutropenia. Day 15 ataxia began to subside.
Age: 39.0
Sex: F
Vaccine: PPV
Symptoms: Injection site induration, Injection site swelling, Peripheral swelling
Clinical narrative: Swelling and induration at injection site. Swelling extended down entire arm. Reported by pt at 8:52am. 8/25/18 Pt reports swelling is mostly resolved, 8/30/18.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Headache, Injection site erythema, Injection site induration
Clinical narrative: Became lightheaded, nauseated with a medicinal taste. Advised pharmacist. He told me I looked alert  and I could leave when I was ready. I left 10 min. later and drove home. I live alone. Laid down in bed for a short nap. Had severe headache. I did not/could not get up for 2 days. During those 2 days I had headache, chills and injection site was red hot, hard, and size of an apple. After 2 days the On the 15th of May I went to Pharmacy to get the SHINGRIX shot that you and I talked about. After the injection I began to feel a little light-headed and after 10 minutes of sitting in the pharmacy I was nauseated and tasted a medicinal taste. The pharmacist came over after 30 min. and said after the feeling subsided I could leave because I seemed alert. I was in bed for 2 days with severe headache, low grade fever, chills and the injection site was red hot, hard, and the size of an apple. After 2 days the headaches lessened, as well as the fever and chills. The injection site was the same and by the 5th day a painful rash broke out over all the redness and swelling. By day 7 there was some itching but everything began to stop. The injection site is still sensitive to touch. My question to you is: Should I go ahead and get the second vaccine in 2-4 months? I am asking this by mail since my next appt. with you is not until the fall.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site reaction, Injection site swelling, Injection site warmth, Nausea
Clinical narrative: Became lightheaded, nauseated with a medicinal taste. Advised pharmacist. He told me I looked alert  and I could leave when I was ready. I left 10 min. later and drove home. I live alone. Laid down in bed for a short nap. Had severe headache. I did not/could not get up for 2 days. During those 2 days I had headache, chills and injection site was red hot, hard, and size of an apple. After 2 days the On the 15th of May I went to Pharmacy to get the SHINGRIX shot that you and I talked about. After the injection I began to feel a little light-headed and after 10 minutes of sitting in the pharmacy I was nauseated and tasted a medicinal taste. The pharmacist came over after 30 min. and said after the feeling subsided I could leave because I seemed alert. I was in bed for 2 days with severe headache, low grade fever, chills and the injection site was red hot, hard, and the size of an apple. After 2 days the headaches lessened, as well as the fever and chills. The injection site was the same and by the 5th day a painful rash broke out over all the redness and swelling. By day 7 there was some itching but everything began to stop. The injection site is still sensitive to touch. My question to you is: Should I go ahead and get the second vaccine in 2-4 months? I am asking this by mail since my next appt. with you is not until the fall.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Pyrexia, Rash
Clinical narrative: Became lightheaded, nauseated with a medicinal taste. Advised pharmacist. He told me I looked alert  and I could leave when I was ready. I left 10 min. later and drove home. I live alone. Laid down in bed for a short nap. Had severe headache. I did not/could not get up for 2 days. During those 2 days I had headache, chills and injection site was red hot, hard, and size of an apple. After 2 days the On the 15th of May I went to Pharmacy to get the SHINGRIX shot that you and I talked about. After the injection I began to feel a little light-headed and after 10 minutes of sitting in the pharmacy I was nauseated and tasted a medicinal taste. The pharmacist came over after 30 min. and said after the feeling subsided I could leave because I seemed alert. I was in bed for 2 days with severe headache, low grade fever, chills and the injection site was red hot, hard, and the size of an apple. After 2 days the headaches lessened, as well as the fever and chills. The injection site was the same and by the 5th day a painful rash broke out over all the redness and swelling. By day 7 there was some itching but everything began to stop. The injection site is still sensitive to touch. My question to you is: Should I go ahead and get the second vaccine in 2-4 months? I am asking this by mail since my next appt. with you is not until the fall.
Age: 78.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Chills, Fatigue, Tremor
Clinical narrative: Chills (shaking); Fatigue.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Injection site pain, Pyrexia
Clinical narrative: Fever of 101, soreness at injection sight, fatigue, chills.