chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: F
Vaccine: UNK, UNK, VARZOS
Symptoms: Influenza like illness
Clinical narrative: flu like symptoms; falling off a ladder and hitting head; concussion; Head injury; dizzy; occasional fatigue; This case was reported by a consumer via other manufacturer and described the occurrence of influenza-like symptoms in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included palbociclib (Ibrance) for metastatic breast cancer and anastrozole (Arimidex) for metastatic breast cancer.   On an unknown date, the patient received the 1st dose of Shingrix. In April 2017, the patient started Ibrance 125 mg once daily (125 mg daily). In April 2019, the patient started Arimidex 1 mg once daily (1 mg daily). On an unknown date, unknown after receiving Shingrix, the patient experienced influenza-like symptoms (serious criteria hospitalization), fall, concussion, head injury, dizziness and fatigue. On an unknown date, the outcome of the influenza-like symptoms, fall, concussion, head injury, dizziness and fatigue were recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms, fall, concussion, head injury, dizziness and fatigue to be related to Shingrix.  Additional details were provided as follows: The patient received 1st dose of Shingrix on 27th February. The patient developed flu like symptoms for which he was on rest. The patient fell off a ladder and hit her head, the ladder incident was not related to the ibrance but was patient's stupidity in placing the ladder into the damp soil and the ladder was shifted once weight was too high. The patient experienced concussion but no broken bones and stated no more ladder the patient had to visit emergency room.. There was no side effect from the Ibrance except for occasional fatigue, especially around 14th day of pill cycle. It was unknown if the reporter considered the influenza-like symptoms, fall, concussion, head injury, dizziness and fatigue to be related palbociclib (Ibrance) and anastrozole (Arimidex). For tolerance to 2nd dose of Shingrix, refer case US2019GSK133032. Clarification was raised to confirm vaccination date and event onset dates. However, no reply received hence case processed as per worst case scenario.
Sex: F
Vaccine: VARZOS
Symptoms: Guillain-Barre syndrome
Clinical narrative: Guillain Barre Syndrome; This case was reported by a consumer and described the occurrence of guillain barre syndrome in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than a year after receiving Shingrix, the patient experienced guillain barre syndrome (serious criteria GSK medically significant). On an unknown date, the outcome of the guillain barre syndrome was unknown.   It was unknown if the reporter considered the guillain barre syndrome to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient's relative. The age at vaccination was not reported. The reporter asked whether the patient could get guillain barre syndrome from a shingles shot.   The reporter stated that the patient received Shingles shot and experienced guillain barre syndrome .
Sex: F
Vaccine: FLUX
Symptoms: Pain in extremity
Clinical narrative: soreness in arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 66-year-old female patient who received Flu unspecified (Influenza vaccine) for prophylaxis.   Previously administered products included Shingrix (Please refer the case US2019125959).   On an unknown date, the patient received Influenza vaccine at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Influenza vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient stated that, the flu shot always make her arm slightly sore. This case has been linked with cases US2019125959(same patient) and US2019125960 (husband case), reported by the same reporter.
Age: 67.0
Sex: F
Vaccine: UNK, UNK, VARZOS
Symptoms: Dizziness, Fatigue, Influenza like illness, Vaccine positive rechallenge
Clinical narrative: flu like symptoms; dizzy; occasional fatigue; This case was reported by a consumer via other manufacturer and described the occurrence of influenza-like symptoms in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included palbociclib (Ibrance) for metastatic breast cancer and anastrozole (Arimidex) for metastatic breast cancer.   Previously administered products included Shingrix (1st dose received on an unknown date, kindly refer case US2019AMR124296).   On an unknown date, the patient received the 2nd dose of Shingrix. In April 2017, the patient started Ibrance 125 mg once daily (125 mg daily). In April 2019, the patient started Arimidex 1 mg once daily (1 mg daily). On an unknown date, unknown after receiving Shingrix, the patient experienced influenza-like symptoms (serious criteria hospitalization), dizziness and fatigue. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the influenza-like symptoms, dizziness and fatigue were recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms, dizziness and fatigue to be related to Shingrix.  Additional details were provided as follows: The patient received 2nd dose of shingrix on 6th May. The patient developed flu like symptoms for which he was on rest. There was no side effect from the Ibrance except for occasional fatigue, especially around 14th day of pill cycle. It was unknown if the reporter considered the influenza-like symptoms, dizziness and fatigue to be related palbociclib (Ibrance) and anastrozole (Arimidex).
Sex: F
Vaccine: HEP, HEP, HEP
Symptoms: Hepatitis B antibody negative, Therapeutic response decreased
Clinical narrative: therapy non responder; This case was reported by a nurse via call center representative and described the occurrence of therapeutic response decreased in a female patient who received HBV (Engerix B) for prophylaxis.   Co-suspect products included HBV (Engerix B) for prophylaxis and HBV (Engerix B) for prophylaxis.   On an unknown date, the patient received the 1st dose of Engerix B, the 2nd dose of Engerix B and the 3rd dose of Engerix B. On an unknown date, unknown after receiving Engerix B, Engerix B and Engerix B, the patient experienced therapeutic response decreased. On an unknown date, the outcome of the therapeutic response decreased was unknown.   It was unknown if the reporter considered the therapeutic response decreased to be related to Engerix B, Engerix B and Engerix B.  Additional details were provided as follows: The age at vaccination was not reported. The patient was receiving full 4 dose series of Engerix B if titers testing immunity were low, which led to decreased therapeutic response.      Lab Comments: On an unknown date, the patient's lab test was low.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Dizziness, Muscle twitching, Pruritus
Clinical narrative: itching; dizziness; twitching in arm; This case was reported by a physician via sales rep and described the occurrence of pruritus in a 18-year-old male patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero. On an unknown date, unknown after receiving Bexsero, the patient experienced pruritus, dizziness and twitching of limbs. On an unknown date, the outcome of the pruritus was recovered/resolved and the outcome of the dizziness was resolved with sequelae and the outcome of the twitching of limbs was unknown.   It was unknown if the reporter considered the pruritus, dizziness and twitching of limbs to be related to Bexsero.   Additional details were provided as follows: The reporter stated that, the patient received a dose of Bexseo and started twitching in his arm  and developed dizziness. The patient recovered after few minutes.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness, Injection site pain, Myalgia, Nausea
Clinical narrative: teeth chattering; soreness in arm; fever; nauseated; muscle aches; soreness at injection site; flu-like symptoms; This case was reported by a consumer via call center representative and described the occurrence of teeth chattering in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Flu shot with an associated reaction of pain in extremity (received on an unknown date, refer case US2019AMR131657).   On 10th July 2019, the patient received Shingrix. On 10th July 2019, several hours after receiving Shingrix, the patient experienced teeth chattering, pain in arm, fever, nausea, muscle pain, injection site pain and influenza-like symptoms. On an unknown date, the outcome of the teeth chattering, pain in arm, nausea and muscle pain were recovered/resolved and the outcome of the fever was not recovered/not resolved and the outcome of the injection site pain and influenza-like symptoms were unknown.   It was unknown if the reporter considered the teeth chattering, pain in arm, fever, nausea, muscle pain, injection site pain and influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: On 10th July 2019, in the early afternoon, the patient received the vaccine in left deltoid and experienced teeth chattering a couple of hours after receiving the vaccine.  The Last night before the date of reporting, the patient she felt feverish and took her temperature was registered 102.2 degree F. Less than a day after receiving Shingrix, the patient also felt nauseous and had muscle aches like the flu. The patient also had slight soreness at the injection site following the vaccine.  No additional details provided. The reporter consented to follow up. This case has been linked with and US2019125960 (husband's case), reported by the same reporter
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: teeth chattering; soreness in arm; fever; nauseated; muscle aches; soreness at injection site; flu-like symptoms; This case was reported by a consumer via call center representative and described the occurrence of teeth chattering in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Flu shot with an associated reaction of pain in extremity (received on an unknown date, refer case US2019AMR131657).   On 10th July 2019, the patient received Shingrix. On 10th July 2019, several hours after receiving Shingrix, the patient experienced teeth chattering, pain in arm, fever, nausea, muscle pain, injection site pain and influenza-like symptoms. On an unknown date, the outcome of the teeth chattering, pain in arm, nausea and muscle pain were recovered/resolved and the outcome of the fever was not recovered/not resolved and the outcome of the injection site pain and influenza-like symptoms were unknown.   It was unknown if the reporter considered the teeth chattering, pain in arm, fever, nausea, muscle pain, injection site pain and influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: On 10th July 2019, in the early afternoon, the patient received the vaccine in left deltoid and experienced teeth chattering a couple of hours after receiving the vaccine.  The Last night before the date of reporting, the patient she felt feverish and took her temperature was registered 102.2 degree F. Less than a day after receiving Shingrix, the patient also felt nauseous and had muscle aches like the flu. The patient also had slight soreness at the injection site following the vaccine.  No additional details provided. The reporter consented to follow up. This case has been linked with and US2019125960 (husband's case), reported by the same reporter
Age: 0.5
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Diarrhoea, Laboratory test normal, Listless, Vomiting
Clinical narrative: Patient received Infanrix and Pedvax HIB on 7/9/2019 at his 6 mo WCC He had neve rbeen vaccinated before due to parental refusal. On 7/10 afternoon, he was brought to clinic by his Mother because he developed vomiting. Diarrhea and listlessness that morning. (i.e. morning after receiving immunizations). Patient was seen in clinic, assessed to be at risk for Dehydration and was admitted to hospital for IV fluids, work up and monitoring.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Injection site swelling, Pain, Pyrexia
Clinical narrative: "Received the shingles vaccine on Wednesday, 7-17-19, and have  been suffering from all the symptoms associated with the vaccine every day  since then.  I have had swelling at injection site, body aches, chills, and  fever.  The highest fever (101.5) was this afternoon (7/22/2019).
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Aphasia, Arthralgia, Chills, Malaise, Myalgia
Clinical narrative: Patient states that she had a severe malaise following her second dose. She had joints and muscles aching, a fever of 100.8, chills and intense shivering to the point of not being able to talk. She says she's never felt this ill before. She has had slight improvement as of 12 noon the following day after injection.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Patient states that she had a severe malaise following her second dose. She had joints and muscles aching, a fever of 100.8, chills and intense shivering to the point of not being able to talk. She says she's never felt this ill before. She has had slight improvement as of 12 noon the following day after injection.
Age: 18.0
Sex: M
Vaccine: HPV9
Symptoms: Dizziness, Immediate post-injection reaction, Loss of consciousness, Posture abnormal, Snoring
Clinical narrative: Immediately after vaccine was administered and a band aid placed on the site, patient loss consciousness, fell to side and began snoring. About 20-30 seconds later he awakened and stated "Sorry I fell asleep". Patient aware of his location. Patient remained laying down for 30 minutes. Vitals stable. We attempted several times to sit him up, but he became dizzy each time. Vitals remained stable. Patient states he has no history of syncope with vaccines or medical procedures. This was the third vaccine in this series and has had no previous adverse events with vaccine #1 and #2. Patient's father was called to drive him home since he was still feeling a bit dizzy and off upon discharge.
Age: 80.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pruritus, Injection site rash, Injection site vesicles
Clinical narrative: Per patient's description of the adverse event; over the 5 days following IM administration of Shingrix, patient gradually developed itching, rash, blisters around the injection site, which eventually spread beyond the injection area
Age: 80.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pruritus, Injection site urticaria, Injection site vesicles
Clinical narrative: Per patient's description of the adverse event; over the 5 days following IM administration of Shingrix, patient gradually developed itching, rash, blisters around the injection site, which eventually spread beyond the injection area
Age: 71.0
Sex: M
Vaccine: TDAP
Symptoms: Erythema, Induration
Clinical narrative: Localized erythema and induration, without pain and without any signs of cellulitis or abscess . Developed within 24 hours of injection and patient sought attention 4 days post-injection. No systemic symptoms or side effects.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Eye irritation, Headache, Pain, Pyrexia
Clinical narrative: Achy, 100 degree fever, eyes burning, headache.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Blood creatine phosphokinase normal, Fatigue, Local reaction, Myalgia, Swelling
Clinical narrative: 1w 1 day severe local reaction; swelling day 2-4 severe fatigue and muscle pain ended up in ER
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Injection site pruritus, Injection site rash
Clinical narrative: starting at around 22 hours after injection---Fever (101.7 and climbed after I was too tired to check); chills; muscle aches; mild headache; fatigue; rash on arm around injection (4" x 4 " approximately)  Continued at peak intensity for about 10 hours; fever moderated and other symptoms lessened through next 36 hours.  Site of  rash started to itch but no blisters after 24 hours from injection  3 days after injection still minor head ache and mild itching; some body aches
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia, Pain, Pyrexia
Clinical narrative: starting at around 22 hours after injection---Fever (101.7 and climbed after I was too tired to check); chills; muscle aches; mild headache; fatigue; rash on arm around injection (4" x 4 " approximately)  Continued at peak intensity for about 10 hours; fever moderated and other symptoms lessened through next 36 hours.  Site of  rash started to itch but no blisters after 24 hours from injection  3 days after injection still minor head ache and mild itching; some body aches
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness, Injection site pain, Injection site warmth, Insomnia
Clinical narrative: This shot was given in the uppermost part of my arm near the joint. I had intense pain and heat at the injection site and throughout the arm muscle. I did not feel well. Like I had a mild flu with chills and body aches. The arm pain continued. I took 2 Advil and went to bed when I got home.  the next day I got up and the flu like feeling went away but the pain did not.  The pain persists to this day and it is almost 6 months since I had the shot. It keeps me awake at night and makes it difficult to do things with my right arm.  When I went in for my second Zoster injection in the series, I told the pharmacist about the pain. She acted surprised. I had the second shot in my left arm. It was fine and I had no issues with it.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Musculoskeletal disorder, Pain
Clinical narrative: This shot was given in the uppermost part of my arm near the joint. I had intense pain and heat at the injection site and throughout the arm muscle. I did not feel well. Like I had a mild flu with chills and body aches. The arm pain continued. I took 2 Advil and went to bed when I got home.  the next day I got up and the flu like feeling went away but the pain did not.  The pain persists to this day and it is almost 6 months since I had the shot. It keeps me awake at night and makes it difficult to do things with my right arm.  When I went in for my second Zoster injection in the series, I told the pharmacist about the pain. She acted surprised. I had the second shot in my left arm. It was fine and I had no issues with it.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster
Clinical narrative: About 1 week later, I had ths shingles. iI first went to walk-in clinic and got antiviral. took that. Still had blisters so then went to my dr's PA. She gave me another run o the antiviral.  However, I was not happy to pay out about $280.00 to go through shingles. (The shot was almost $200.00 and the meds were about $40.00 each run). Having shingles is not fun. I don't know whether I want to pay so much again (in 6 months) to give myself shingles again. I asked the pharmacy to report this but I don't think they did. two other people there told me that it is common to get a mild case of shingles from the shot.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Chest pain, Oral discomfort, Swelling face
Clinical narrative: Patient was administered the vaccines noted above at about 5:42PM and left the office immediately after administration. Parents returned with patient at about 5:58PM complaining of facial swelling and a burning sensation of the lips and chest. CPNP evaluated the patient, initiated 911 and ordered IM epinephrine, which was administered in the patient's right thigh. A pulse ox was placed on the patient and vitals were stable. EMS arrived at this 6:06PM and transported patient to Medical Center for further evaluation and monitoring.  No further medications were given in the hospital. Patient was discharged after about 4 hours of monitoring with no further reaction and improvement of symptoms. Patient given EpiPen Jr. and referral to allergy/immunology specialist.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pain in extremity, Skin warm
Clinical narrative: On 07/18/19, 67 yo F presented to clinic for annual wellness visit. During this visit, pt was ordered and administered Pneumococcal Conjugate 13-Valent (Prevnar 13) vaccine in right deltoid (NDC: 0005-1971-02, Lot #Y03623, exp: 3/31/2021). RN reported "Patient developed warmth, redness and pain to upper extremity post immunization. Symptoms persist 5 days after injection." No documentation of this reaction within the pt's chart. No report of any treatment interventions. RN indicated that "Appointment scheduled for examination". Unknown when this appoint is scheduled.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Feeling abnormal, Injection site pain, Injection site swelling, Nausea
Clinical narrative: Soreness and swelling at site, achy all over, diarrhea the following day, nausea, feel generally awful.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Soreness and swelling at site, achy all over, diarrhea the following day, nausea, feel generally awful.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Injection site erythema, Injection site induration, Pyrexia
Clinical narrative: given 7/20/2019 @ pharmacy had fever that evening, red hard arm @ injection site. sunday 7/21/2019 developed a blister on arm today blisters on hands
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Erythema, Herpes zoster, Pain, Peripheral swelling
Clinical narrative: arm swelling and red, shingles outbreak on nose, blisters, pain, red ,
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Discomfort, Pain, Pain in extremity
Clinical narrative: Patient reported that her right arm after injection was sore, which said was least of her symptom.  About 9 pm  after she received her vaccine(at 3:22 PM ) on 7/22/2019 she began to experience total body aches and chills.  She did not check for a temperature.   She was uncomfortable enough that she did take Naprosyn 220 mg 1 tablet andit did help.  On 7/23/2019 she reports that her arm is sore but the other symptoms have gone away
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 66 years old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 2013, the  patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a physician for shingles. The outcome of the events shingles was not reported. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).   Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 85 years old male patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.  On 14-OCT-2009, the  patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a physician for shingles. The outcome of the events shingles was not reported. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).   Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effects reported; patient was vaccinated with improperly stored MMR II; This spontaneous report has been received from a medical assistant, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided.  On 30-MAY-2019, the patient was vaccinated with improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (albumin status rHA) one dose, lot # R024906 with expiration date 30-AUG-2020 (frequency, route and anatomical location were not provided) which was reconstituted with sterile diluent (dose, frequency, route, lot number and expiration date were not provided) for prophylaxis. No adverse effects reported.  The temperature and time frame were unknown by reporter. There was previously temperature excursions and digital data logger was involved.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA011469: US-009507513-1907USA010301: US-009507513-1907USA010302: US-009507513-1907USA010303: US-009507513-1907USA010304: US-009507513-1907USA010305: US-009507513-1907USA010306: US-009507513-1907USA010307: US-009507513-1907USA010308: US-009507513-1907USA010309: US-009507513-1907USA010310: US-009507513-1907USA010311: US-009507513-1907USA010312: US-009507513-1907USA010313: US-009507513-1907USA010314: US-009507513-1907USA010315: US-009507513-1907USA010316: US-009507513-1907USA010317: US-009507513-1907USA010318: US-009507513-1907USA010319: US-009507513-1907USA010320: US-009507513-1907USA010321: US-009507513-1907USA010322: US-009507513-1907USA010323: US-009507513-1907USA010324: US-009507513-1907USA010325: US-009507513-1907USA010326: US-009507513-1907USA010327: US-009507513-1907USA010328: US-009507513-1907USA010329: US-009507513-1907USA010330: US-009507513-1907USA010331: US-009507513-1907USA010332: US-009507513-1907USA010333: US-009507513-1907USA010334: US-009507513-1907USA010335: US-009507513-1907USA010336: US-009507513-1907USA010337: US-009507513-1907USA010338: US-009507513-1907USA010339: US-009507513-1907USA010340: US-009507513-1907USA010341: US-009507513-1907USA010342: US-009507513-1907USA010343: US-009507513-1907USA010344: US-009507513-1907USA010345: US-009507513-1907USA010346: US-009507513-1907USA010347: US-009507513-1907USA010348: US-009507513-1907USA010349: US-009507513-1907USA010350: US-009507513-1907USA010351: US-009507513-1907USA010352: US-009507513-1907USA010353: US-009507513-1907USA010354: US-009507513-1907USA010355: US-009507513-1907USA010356: US-009507513-1907USA010357: US-009507513-1907USA010358: US-009507513-1907USA010359: US-009507513-1907USA010360: US-009507513-1907USA010361: US-009507513-1907USA010362: US-009507513-1907USA010363: US-009507513-1907USA010364: US-009507513-1907USA010365: US-009507513-1907USA010366: US-009507513-1907USA010367: US-009507513-1907USA010368: US-009507513-1907USA010369: US-009507513-1907USA010371: US-009507513-1907USA010372: US-009507513-1907USA010373:
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effects reported; patient was vaccinated with improperly stored MMR II; This spontaneous report has been received from a medical assistant, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided.  On 05-JUN-2019, the patient was vaccinated with improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (albumin status rHA) one dose, lot # R024906 with expiration date 30-AUG-2020 (frequency, route and anatomical location were not provided) which was reconstituted with sterile diluent (dose, frequency, route, lot number and expiration date were not provided) for prophylaxis. No adverse effects reported.  The temperature and time frame were unknown by reporter. There was previously temperature excursions and digital data logger was involved.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA011469: US-009507513-1907USA010301: US-009507513-1907USA010302: US-009507513-1907USA010303: US-009507513-1907USA010304: US-009507513-1907USA010305: US-009507513-1907USA010306: US-009507513-1907USA010307: US-009507513-1907USA010308: US-009507513-1907USA010309: US-009507513-1907USA010310: US-009507513-1907USA010311: US-009507513-1907USA010312: US-009507513-1907USA010313: US-009507513-1907USA010314: US-009507513-1907USA010315: US-009507513-1907USA010316: US-009507513-1907USA010317: US-009507513-1907USA010318: US-009507513-1907USA010319: US-009507513-1907USA010320: US-009507513-1907USA010321: US-009507513-1907USA010322: US-009507513-1907USA010323: US-009507513-1907USA010324: US-009507513-1907USA010325: US-009507513-1907USA010326: US-009507513-1907USA010327: US-009507513-1907USA010328: US-009507513-1907USA010329: US-009507513-1907USA010330: US-009507513-1907USA010331: US-009507513-1907USA010332: US-009507513-1907USA010333: US-009507513-1907USA010334: US-009507513-1907USA010335: US-009507513-1907USA010336: US-009507513-1907USA010337: US-009507513-1907USA010338: US-009507513-1907USA010339: US-009507513-1907USA010340: US-009507513-1907USA010341: US-009507513-1907USA010342: US-009507513-1907USA010343: US-009507513-1907USA010344: US-009507513-1907USA010345: US-009507513-1907USA010346: US-009507513-1907USA010347: US-009507513-1907USA010348: US-009507513-1907USA010349: US-009507513-1907USA010350: US-009507513-1907USA010351: US-009507513-1907USA010352: US-009507513-1907USA010353: US-009507513-1907USA010354: US-009507513-1907USA010355: US-009507513-1907USA010356: US-009507513-1907USA010357: US-009507513-1907USA010358: US-009507513-1907USA010359: US-009507513-1907USA010360: US-009507513-1907USA010361: US-009507513-1907USA010362: US-009507513-1907USA010363: US-009507513-1907USA010364: US-009507513-1907USA010365: US-009507513-1907USA010366: US-009507513-1907USA010367: US-009507513-1907USA010368: US-009507513-1907USA010369: US-009507513-1907USA010370: US-009507513-1907USA010372: US-009507513-1907USA010373:
Sex: U
Vaccine: MMR, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effects reported; patient was vaccinated with improperly stored MMR II; This spontaneous report has been received from a medical assistant, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided.  On 19-JUN-2019, the patient was vaccinated with improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (albumin status rHA) one dose, lot # R024906 with expiration date 30-AUG-2020 (frequency, route and anatomical location were not provided) which was reconstituted with sterile diluent (dose, frequency, route, lot number and expiration date were not provided) for prophylaxis. No adverse effects reported.  The temperature and time frame were unknown by reporter. There was previously temperature excursions and digital data logger was involved.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA011469: US-009507513-1907USA010301: US-009507513-1907USA010302: US-009507513-1907USA010303: US-009507513-1907USA010304: US-009507513-1907USA010305: US-009507513-1907USA010306: US-009507513-1907USA010307: US-009507513-1907USA010308: US-009507513-1907USA010309: US-009507513-1907USA010310: US-009507513-1907USA010311: US-009507513-1907USA010312: US-009507513-1907USA010313: US-009507513-1907USA010314: US-009507513-1907USA010315: US-009507513-1907USA010316: US-009507513-1907USA010317: US-009507513-1907USA010318: US-009507513-1907USA010319: US-009507513-1907USA010320: US-009507513-1907USA010321: US-009507513-1907USA010322: US-009507513-1907USA010323: US-009507513-1907USA010324: US-009507513-1907USA010325: US-009507513-1907USA010326: US-009507513-1907USA010327: US-009507513-1907USA010328: US-009507513-1907USA010329: US-009507513-1907USA010330: US-009507513-1907USA010331: US-009507513-1907USA010332: US-009507513-1907USA010333: US-009507513-1907USA010334: US-009507513-1907USA010335: US-009507513-1907USA010336: US-009507513-1907USA010337: US-009507513-1907USA010338: US-009507513-1907USA010339: US-009507513-1907USA010340: US-009507513-1907USA010341: US-009507513-1907USA010342: US-009507513-1907USA010343: US-009507513-1907USA010344: US-009507513-1907USA010345: US-009507513-1907USA010346: US-009507513-1907USA010347: US-009507513-1907USA010348: US-009507513-1907USA010349: US-009507513-1907USA010350: US-009507513-1907USA010351: US-009507513-1907USA010352: US-009507513-1907USA010353: US-009507513-1907USA010354: US-009507513-1907USA010355: US-009507513-1907USA010356: US-009507513-1907USA010357: US-009507513-1907USA010358: US-009507513-1907USA010359: US-009507513-1907USA010360: US-009507513-1907USA010361: US-009507513-1907USA010362: US-009507513-1907USA010363: US-009507513-1907USA010364: US-009507513-1907USA010365: US-009507513-1907USA010366: US-009507513-1907USA010367: US-009507513-1907USA010368: US-009507513-1907USA010369: US-009507513-1907USA010370: US-009507513-1907USA010371: US-009507513-1907USA010373:
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 79 year old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 18-FEB-2013, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced herpes zoster. On an unspecified date, the patient was treated by a physician for herpes zoster. The outcome of the event was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).   Additional information has been requested.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Nerve injury
Clinical narrative: shingles; nerve damage; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 70 year old male patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 29-AUG-2016, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions. On unspecified dates, the patient experienced shingles and nerve damage. On unspecified dates, the patient was treated by a healthcare provider for shingles and nerve damage. The outcome of the events was not reported. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).   Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; improperly stored; This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. The patient's relevant medical history, concurrent conditions, historical drugs and drug reactions/ allergies were not reported.   On 15-JUL-2019, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # S000132 and expiry date 02-JAN-2021 (dose number, route of administration and anatomical location were not reported) for prophylaxis. Concomitant therapies included sterile diluent which was used to reconstitute the varicella virus vaccine live (oka/merck) (VARIVAX) was stored properly.   The storage temperature and time frame was reported as 15 degree Fahrenheit to 46 degree Fahrenheit (29.1 degree Fahrenheit) for 3 hours. There was no previous temperature excursion. No adverse effect was reported. Digital data logger was not involved. No Product Quality Complaint (PQC) was present.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Rash & Urticaria Pruritus PREDNISONE 30 MG EVERY DAY for 4 days, HYDROXYZINE 25 MG HS PRN, TRIAMCINOLONE UNITS BID PRN
Age: 17.0
Sex: M
Vaccine: HPV9
Symptoms: Nervousness, Pallor
Clinical narrative: Patient layed on table (was nervous) injection given mom was in the room. He layed For 15 minutes after & stated he was fine when told to sit - but don't stand yet. He was OK till got back to waiting room then turned white & layed on bench. Kept him laying and gave him ice for head & neck. Took BP was 107/64 pulse 70. Layed for 10 min. then took him to car in wheelchair. He stated he was OK. Gave info sheet on vasovagel to mom.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: - Patient got rash on torso a few days after getting shingrix vaccine
Age: 1.0
Sex: M
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Pt.'s mom noticed redness on 7/10/19 @ night. The next morning on 7/11/19 the left thigh with increased redness. Warm to touch. Pt. did not have fever. pt. came into office on 7/12/19. No fever but warm to touch. Redness measured 8.0cm from left to right and 5.5cm down left thigh. Mom applied Benadryl cream and will cont to monitor.
Age: 69.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Blood creatinine increased, Blood glucose increased, Chest discomfort, Chest pain, Dyspnoea
Clinical narrative: Patient went to ER and presented with "  substernal chest pain, intermittent, pressure-like, radiating into the neck and left arm,5/10, no aggravating and relieving factors, associated with a lot of nausea, sometimes vomiting.  Vomiting does not contain any coffee ground or blood.  No melena.  Also having shortness of breath, associated chest pain, no orthopnea, no leg swelling.  No cough/fever." Admitted 07/13 and d/c 07/18 from Hospital.
Age: 69.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Glycosylated haemoglobin increased, Nausea, Neck pain, Pain, Pain in extremity
Clinical narrative: Patient went to ER and presented with "  substernal chest pain, intermittent, pressure-like, radiating into the neck and left arm,5/10, no aggravating and relieving factors, associated with a lot of nausea, sometimes vomiting.  Vomiting does not contain any coffee ground or blood.  No melena.  Also having shortness of breath, associated chest pain, no orthopnea, no leg swelling.  No cough/fever." Admitted 07/13 and d/c 07/18 from Hospital.
Age: 69.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Troponin normal, Vomiting
Clinical narrative: Patient went to ER and presented with "  substernal chest pain, intermittent, pressure-like, radiating into the neck and left arm,5/10, no aggravating and relieving factors, associated with a lot of nausea, sometimes vomiting.  Vomiting does not contain any coffee ground or blood.  No melena.  Also having shortness of breath, associated chest pain, no orthopnea, no leg swelling.  No cough/fever." Admitted 07/13 and d/c 07/18 from Hospital.
Age: 35.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Erythema, Pain, Tenderness
Clinical narrative: Large erythema with tenderness and pain
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Asthenia, Back pain, Chills, Fatigue
Clinical narrative: 7/19/19 - woke up with very sore Left arm, muscles across the back were very sore and stiff as will as back of neck 7/19/19 - mid day suddenly was very tired  and starting getting achey joints 7/19/19 - evening  still achey and very tired took some tylenol and went to bed 7/20/19 - middle of night 3AM woke up to go to bathroom and got a bad case of the chills, later on ran a fever  7/20/19 - Saturday felt weak and out of sorts all day and evening  - no energy 7/21/19 - Sunday 12:30AM woke up with a pounding headache.  took tylenol and put a ice pack on my head and 2 hours later it went away Sunday 7/21/19 - `10AM - woke up with no symptoms anymore and none since
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Feeling abnormal, Headache, Musculoskeletal stiffness, Neck pain, Pain in extremity
Clinical narrative: 7/19/19 - woke up with very sore Left arm, muscles across the back were very sore and stiff as will as back of neck 7/19/19 - mid day suddenly was very tired  and starting getting achey joints 7/19/19 - evening  still achey and very tired took some tylenol and went to bed 7/20/19 - middle of night 3AM woke up to go to bathroom and got a bad case of the chills, later on ran a fever  7/20/19 - Saturday felt weak and out of sorts all day and evening  - no energy 7/21/19 - Sunday 12:30AM woke up with a pounding headache.  took tylenol and put a ice pack on my head and 2 hours later it went away Sunday 7/21/19 - `10AM - woke up with no symptoms anymore and none since
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: 7/19/19 - woke up with very sore Left arm, muscles across the back were very sore and stiff as will as back of neck 7/19/19 - mid day suddenly was very tired  and starting getting achey joints 7/19/19 - evening  still achey and very tired took some tylenol and went to bed 7/20/19 - middle of night 3AM woke up to go to bathroom and got a bad case of the chills, later on ran a fever  7/20/19 - Saturday felt weak and out of sorts all day and evening  - no energy 7/21/19 - Sunday 12:30AM woke up with a pounding headache.  took tylenol and put a ice pack on my head and 2 hours later it went away Sunday 7/21/19 - `10AM - woke up with no symptoms anymore and none since
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: DTAP was expired 07/07/19 and was given 07/19/19.
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Electrocardiogram normal, Insomnia, Pruritus, Rash, Syncope
Clinical narrative: initially complained of itching the evening of the vaccine being administered 7-15-19.  The next morning had  a rash with itching that was severe and interfered with sleep.  rash and itching improving by 7-19-19, then on 7-21-19 had syncopal episode at church unprovoked while kneeling.  had eaten and denied dehydration.  area was air conditioned and was not overcrowded.  was not in the act of standing up.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Nausea, Pain in extremity
Clinical narrative: Patient reported she had soreness on her left arm after receiving the 1st & 2nd doses.  With the 2nd dose, she also had diarrhea x 17 and nausea for a few days.  She denied fever, headache, and vomiting.  She took Imodium for diarrhea.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Cough, Peripheral swelling, Pyrexia
Clinical narrative: Swollen arm and coughing. Fever of 102.5. Patient went to urgent care and got treated with docycyline, tylenol, and motrin
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site rash, Pain, Pyrexia
Clinical narrative: Patient reported 2 inch diameter rash and soreness around injection site as well as fever and general aches
Age: 54.0
Sex: F
Vaccine: PPV, TDAP, VARZOS
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Patient developed redness/swelling in LEFT ARM.  She visited the beach over the weekend and stated that she had take Aleve to help ease swelling and also applied sunscreen frequently in the area.  The redness seemed to be spreading when she came by the pharmacy on 7/22/2019, Monday.  I suggested for her to see her physician and get checked out.   I followed up with her today, Tuesday (7/23/2019).  She went to go see her physician and was prescribed a Medrol Dose Pak.  She stated that according to her doctor,  it was a little difficult to determine which vaccine actually caused the bad reaction.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Headache, Laboratory test normal, Neck pain, Pain in extremity, Pyrexia
Clinical narrative: Reports fever of 104. headache, Leg aches, and back of neck. Went to ER. Wa given IV fluids and Toradol.  Labs were normal.  Was discharged and now feels better.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Hypersensitivity, Pain, Pruritus, Skin warm
Clinical narrative: Localized hypersensitivity with erythema, warmth, pain and itching. Gradual improvement with cool compresses, no additional treatment required
Age: 56.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Axillary mass, Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: Soreness, itching, redness and heat at injection site began within minutes. On Monday July 22, 2019 3:00 pm noticed I had developed large tender lump in armpit area on the left side.
Age: 56.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Tenderness
Clinical narrative: Soreness, itching, redness and heat at injection site began within minutes. On Monday July 22, 2019 3:00 pm noticed I had developed large tender lump in armpit area on the left side.
Age: 56.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Axillary mass, Injection site reaction, Tenderness
Clinical narrative: Soreness, itching, redness and heat at injection site began within minutes. On Monday July 22, 2019 3:00 pm noticed I had developed large tender lump in armpit area on the left side.
Age: 16.0
Sex: M
Vaccine: HPV9
Symptoms: Anogenital warts
Clinical narrative: Patient was administered all three doses of GARDASIL 9 and then presented to the clinic with genital warts; Information has been received from a physician via company representative, concerning a 16-years old male patient. The patient's medical history, concurrent conditions, previously drug reactions, allergies and concomitant medications were unknown by the reporter.    On unknown dates, the patient was vaccinated with all three doses of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (strength, route of administration, anatomical location, lot number and expiration date were unknown) for prophylaxis.  On approximately 12-JUL-2019, the patient experienced genital warts. The patient went to the physician's office and an unspecified treatment was given to the patient. The outcome of the genital warts was unknown at the time of this report.   The causal relationship between the genital warts and the therapy with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) was not provided.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Pyrexia
Clinical narrative: Chills, fever, headache. General feeling of being tired
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Swelling face, Swollen tongue
Clinical narrative: The following morning patient presented with tongue swelling, left sided head ache, and swollen face. Roughly 24 hours post administration symptoms have slightly improved. Pharmacist recommended Benadryl to treat swelling and to report to ER if symptoms persist or worsen.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Fatigue, Headache, Myalgia, Pyrexia
Clinical narrative: muscle pain, tiredness, weakness, headache, fever
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue
Clinical narrative: Per Patient, started feeling very fatigue 1 to 2 days following the 2nd dose of the Shingrix shot.  Still feeling very fatigue even up to current date of 7-23-19.  Told patient will notify md and for her to follow-up with md as well.  Spoke to employee from Dr.'s office at 1:30pm on 7-23-19