chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative
Clinical narrative: had a "titer" test done and the test results showed that she was "no longer immune to chicken-pox"; This spontaneous report was received from a 40-years-old female consumer, referring to herself. It was reported that she did not have any pertinent medical history, drug reactions or allergies; concomitant medications were not reported.   On 12-JUN-1995 and 01-AUG-1995, the patient was vaccinated with 0.5 milliliters (ml) as the first and second doses, of varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot numbers reported as "040313" and "041613", which have been verified as invalid) respectively, in her left deltoid, as chicken-pox virus prevention (concentrations, vaccinations scheme frequency, routes of administration and expiration dates were not reported).  In April 2019 (reported as "recently, around April or May of this year") the patient had a titer test done by her physician, and the results showed that "she was no longer immune to chicken pox" (viral titre decreased). Therefore, her physician was recommending her to get a third shot of varicella virus vaccine live (Oka/Merck) (VARIVAX).   The relatedness between varicella virus vaccine live (Oka/Merck) (VARIVAX) and the reported event was not provided by the reporter.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; a patient received unspecified dose of PEDV AXHIB that was improperly stored/experienced excursion; This spontaneous report was received from a nurse, concerning a patient of an unknown age and gender. The patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications were not reported.   On 05-AUG-2019 the patient was vaccinated with an improperly stored (product storage error),dose of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) lot number N003536, expiration date 02-NOV-2019, (strength, dose, frequency, route of administration and anatomical location were not reported) for prophylaxis.    The vaccine was stored at the temperature of 8.72 degrees Celsius for the time frame of 1 hour and 35 minutes. Previous temperature excursions were reported as (more than 1), the call was because of a data logger. No adverse effects were reported.
Sex: U
Vaccine: MMRV, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; the patient was administered PROQUAD that may have been improperly stored; This spontaneous report was received from a registered nurse refers to a patient of unknown age. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 20-AUG-2019, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (lot # S003169, expiry date:30-JUL-2020, anatomical location, route was not reported) for prophylaxis that may have been improperly stored (product storage error). The vaccine was reconstituted with sterile diluent(STERILE DILUENT) (lot# R022412 and expiry date:14-NOV-2019) that may have been improperly stored. The temperature, time frame was unknown by reporter. There was no previous temperature excursion noted and no data logger was involved. No adverse effects reported.
Sex: M
Vaccine: MMR
Symptoms: Viral titre decreased
Clinical narrative: titers levels were less than 25; This spontaneous report was received from a 51 year old male patient regarding himself. The patient had no pertinent medical history, no concurrent conditions, no concomitant medications and no drug reactions or allergies.      On 07-MAY-2019, the patient was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, (lot # R029513 with an expiration date in 14-OCT-2020), therapy type (rHA) 1 dose, for prophylaxis (strength, dose, frequency and route were not provided).         On 02-JUL-2019 ,the patient underwent a blood drawn for titer levels and the result showed that his titers levels were less than 25" after receiving the  dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (viral titre decreased). Moreover, it was also reported that the patient sought for medical attention, but no treatment was prescribed for the experienced event.     At the time of reporting, the outcome of viral titre decreased was reported as not resolved.    Causality assessment was not provided.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Laboratory test, Meniscus injury, Meniscus operation
Clinical narrative: she was admitted to the hospital on an unespecified date for surgery on a torn meniscus; she had shingles in either on her back or near her pupic area/she developed shingles twice that month; This spontaneous report has been received from a female patient of currently 75 years old reporting on herself. The patient's has asthma as concurrent condition. There were no drug or allergy history, or concomitant medications to be reported. She stated that she had shingles as historical condition.  On an unspecified date in June 2015, the patient was vaccinated with 1 dose of zoster vaccine live(ZOSTAVAX) (strength, frequency, route of administration, lot# and expiration date were not provided) as prevention of shingles.  The reporter stated that after she received zoster vaccine live (ZOSTAVAX) she got shingle monthly since an unspecified date (herpes zoster), in either on her back or "near her pupic area". She stated that she did not have shingles that frequently prior zoster vaccine live (ZOSTAVAX).  Furthermore, she stated that she believed she was admitted to the hospital on an unknown date for surgery on a torn meniscus (meniscus operation). Moreover, on an unspecified date in August 2019, the patient developed shingles twice that month. The patient sought medical attention and she received Valacyclovir as treatment, and unspecified laboratory test were performed.  The outcome of meniscus operation and herpes zoster was reported as not recovered. At the reporting time, the casual relationship between the aforementioned events and zoster vaccine live (ZOSTAVAX) was not reported.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; Patient received unspecified doseof ROTATEQ that was improperly stored; This spontaneous report was received from a medical assistant, concerning a patient of an unknown age and gender. The patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications were not reported.   On 13-AUG-2019, and 14-AUG-2019, previous temperature excursion was at the temperature of 34.7 degrees Fahrenheit (F), for 3 hours and 2 minutes.   On 27-AUG-2019 the patient was vaccinated with an improperly stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) (product storage error), per oral route, lot number S009940, expiration date 04-OCT-2020, (strength, dose and frequency were not reported) for prophylaxis.    The vaccine was stored at the temperature of 34.1 F for the time frame of 4 hours and 33 minutes. The call was because of data logger. No adverse effects were reported.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; patient received unspecified dose of ROTATEQ that was improperly stored; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant and historical drugs, drug reactions and allergies was not provided.     On 21-AUG-2019, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally,  lot # S009940, expiration date 04-OCT-2020 (strength and dose were not provided) for prophylaxis. The vaccine was exposed to a temperature excursion of 34.1 degree fahrenheit during 4 hours and and 33 minutes on 13-AUG-2019 and 14-AUG-2019. There was a previous temperature excursion of 34.7 degree fahrenheit during 3 hours and 2 minutes.  It was reported that digital data logger was involved. No adverse effects were reported.
Sex: U
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 patient of unspecified age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 2012, the patient was inoculated with zoster vaccine live (ZOSTAVAX), as prescribed and/or administered by a healthcare provider at the office of a physician, for the long-term prevention of shingles and/or zoster-related conditions. Subsequent to patient's zoster vaccine live (ZOSTAVAX) inoculation, patient was treated by a physician for herpes zoster. As a direct and proximate result of patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient (pt) of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 2017, pt was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, and route of administration were not specified), as prescribed and/or administered by a healthcare provider at pharmacy for the long-term prevention of shingles and/or zoster-related conditions. Subsequent to pt's zoster vaccine live (ZOSTAVAX) inoculation, pt was treated by a physician for shingles. As a direct and proximate result of pt's use of the zoster vaccine live (ZOSTAVAX) vaccine, pt has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient (pt) of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 2017, pt was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, and route of administration were not specified), as prescribed and/or administered by a healthcare provider at pharmacy for the long-term prevention of shingles and/or zoster-related conditions. Subsequent to pt's zoster vaccine live (ZOSTAVAX) inoculation, pt was treated by a health care professional for shingles. As a direct and proximate result of pt's use of the zoster vaccine live (ZOSTAVAX) vaccine, pt has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported.; patient received unspecified dose of ROTATEQ that was improperly stored.; This spontaneous report was received from a medical assistant referring to a patient of unknown age and unknown gender. Information of concomitant medication, concurrent condition, pertinent medical history and drug reaction/allergy was not provided.  On 13-AUG-2019 and 14-AUG-2019, rotavirus vaccine, live, oral, pentavalent(ROTATEQ) was excursion. On 26-AUG-2019, the reporter stated the patient received unspecified dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ)(lot# S009940 with expiration date 04-OCT-2020; strength, dose detail and route were not reported) that was improperly stored (improper storage of product in use) for prophylaxis. The rotavirus vaccine, live, oral, pentavalent(ROTATEQ) were exposed to temperature of 34.1 fahrenheit degree for 4 hours and 33 minutes. The previous temperature excursion was 34.7 fahrenheit degree for 3 hours and 2 minutes. No adverse effects were reported. Data logger was involved. The outcome of the event was unknown.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; patient received improperly stored VARlVAX; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Information about concomitant medications, medical history and drug reactions was not provided.     The excursion started on an unknown date in April 2019. Temperature 7.7 Fahrenheit (F) with time frame 30 minutes and previous temperature excursion was in range of 6F to 14F for 188 minutes. Data logger involved. The sterile diluent was properly stored. On 01-AUG-2019, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) (second dose, lot number R020650, expiration date 18-JUL-2020; frequency and route were not provided) for prophylaxis (product storage error). No adverse effects were reported.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site urticaria
Clinical narrative: tenderness at injection site; flat hives rash; This case was reported by a consumer via call center representative and described the occurrence of injection site tenderness in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st August 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced injection site tenderness and hives. On an unknown date, the outcome of the injection site tenderness and hives were not recovered/not resolved.   It was unknown if the reporter considered the injection site tenderness and hives to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient's husband. The patient received dose of Shingrix in the right deltoid. After vaccination with Shingrix, the patient experienced tenderness at injection site and flat hives rash along bicept and tricept of right arm that has not resolved. The reporter consented to follow up This is 1 of the 2 cases reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Adverse reaction
Clinical narrative: adverse reaction; This case was reported by a pharmacist via call center representative and described the occurrence of adverse reaction in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown.   It was unknown if the reporter considered the adverse reaction to be related to Shingrix.  Additional details were provided as follows: The pharmacist stated that the patient received one dose of Shingrix and had adverse reactions, and she was inquiring about the efficacy of just one dose of Shingrix. The pharmacist stated that the patient called previously and reported the adverse reaction information and provided case number. Upon research, the case was not found. Follow up email would be sent. No additional information regarding specific adverse reactions was available as call was completed before filing report.
Sex: F
Vaccine: VARZOS
Symptoms: Hypersensitivity
Clinical narrative: allergic reaction; This case was reported by a physician via other manufacturer and described the occurrence of allergic reaction in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 5 days after receiving Shingrix, the patient experienced allergic reaction. On an unknown date, the outcome of the allergic reaction was unknown.   It was unknown if the reporter considered the allergic reaction to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not reported. The patient's full demographics were not provided. The patient declined to participate in the adverse event reporting. No additonal information was available.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Rash
Clinical narrative: Rash near injection site; rash then down her back; This case was reported by a pharmacist via call center representative and described the occurrence of injection site rash in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th March 2019, the patient received the 1st dose of Shingrix (intramuscular). On 20th March 2019, less than a day after receiving Shingrix, the patient experienced injection site rash and rash. On an unknown date, the outcome of the injection site rash and rash were unknown.   It was unknown if the reporter considered the injection site rash and rash to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix in the left deltoid. After vaccination, the patient experienced rash near the injection site then down her back. The patient did not consent to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Nasopharyngitis
Clinical narrative: Came down with a cold; FLU LIKE SYMPTOMS; This case was reported by a consumer via call center representative and described the occurrence of cold in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th August 2019, the patient received Shingrix. On 26th August 2019, less than a day after receiving Shingrix, the patient experienced cold and influenza-like symptoms. On an unknown date, the outcome of the cold was not recovered/not resolved and the outcome of the influenza-like symptoms was unknown.   It was unknown if the reporter considered the cold and influenza-like symptoms to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not reported. The patient reported that he came down with a cold after receiving Shingrix. The patient also experienced flu like symptoms. The patient did not consent to follow-up. The caller refused to answer any questions.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site warmth
Clinical narrative: warm to touch at injection site; soreness at injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site warmth in a 62-year-old female patient who received Herpes zoster (Shingrix) (batch number 52R7X, expiry date 10th October 2021) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 20th May 2019, in the left arm (batch number KC9C4, expiry date 30 March 2020), refer case US2019AMR161158).   On 31st July 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 31st July 2019, less than a day after receiving Shingrix, the patient experienced injection site warmth and injection site pain. On an unknown date, the outcome of the injection site warmth was recovering/resolving and the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site warmth and injection site pain to be related to Shingrix.  Additional details were provided as follows: The reporter reported that, the patient experienced injection site warmth and injection site pain, after vaccination with dose of Shingrix. This case was 1 of the 2 linked cases.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Rash
Clinical narrative: Itching; Bumps on arm.; This case was reported by a pharmacist via call center representative and described the occurrence of pruritus in a 63-year-old male patient who received Herpes zoster (Shingrix) (batch number unknown, expiry date 26th November 2019) for prophylaxis.   On 11th August 2019, the patient received the 1st dose of Shingrix. In August 2019, less than 3 weeks after receiving Shingrix, the patient experienced pruritus and rash. On an unknown date, the outcome of the pruritus and rash were unknown.   It was unknown if the reporter considered the pruritus and rash to be related to Shingrix.  Additional information received were as follows: The patient experienced itching and bumps on arm. The reporter consented to follow up. The reporter did not had lot number.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Headache, Injection site pain, Nausea
Clinical narrative: headache; fever; chills; weakness; nausea; pain at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th August 2019, the patient received the 1st dose of Shingrix (intramuscular). On 6th August 2019, less than a day after receiving Shingrix, the patient experienced injection site pain. On 7th August 2019, the patient experienced headache, fever, chills, weakness and nausea. On 10th August 2019, the outcome of the injection site pain was resolved with sequelae. On 11th August 2019, the outcome of the headache, fever, chills, weakness and nausea were resolved with sequelae.   It was unknown if the reporter considered the injection site pain, headache, fever, chills, weakness and nausea to be related to Shingrix.  Additional details were provided as follows: The patient experienced injection site pain, headache, fever, chills, weakness and nausea. The patient planned to follow up with the physician on an unknown date. The patient consented to follow up.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: headache; fever; chills; weakness; nausea; pain at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th August 2019, the patient received the 1st dose of Shingrix (intramuscular). On 6th August 2019, less than a day after receiving Shingrix, the patient experienced injection site pain. On 7th August 2019, the patient experienced headache, fever, chills, weakness and nausea. On 10th August 2019, the outcome of the injection site pain was resolved with sequelae. On 11th August 2019, the outcome of the headache, fever, chills, weakness and nausea were resolved with sequelae.   It was unknown if the reporter considered the injection site pain, headache, fever, chills, weakness and nausea to be related to Shingrix.  Additional details were provided as follows: The patient experienced injection site pain, headache, fever, chills, weakness and nausea. The patient planned to follow up with the physician on an unknown date. The patient consented to follow up.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Erythema, Fatigue, Pain in extremity, Peripheral swelling
Clinical narrative: light headed; fever; Very tired; sore arm; redness on arm; Puffy arm; This case was reported by a consumer via call center representative and described the occurrence of light headedness in a 69-year-old female patient who received Herpes zoster (Shingrix) (batch number P57AA, expiry date 31st July 2019) for prophylaxis.   On 19th March 2019, the patient received the 1st dose of Shingrix. On 19th March 2019, less than a day after receiving Shingrix, the patient experienced light headedness, fever, tiredness, pain in arm, erythema of extremities and swelling arm. On 22nd March 2019, the outcome of the light headedness, fever and tiredness were recovered/resolved. On 26th March 2019, the outcome of the pain in arm, erythema of extremities and swelling arm were recovered/resolved.   It was unknown if the reporter considered the light headedness, fever, tiredness, pain in arm, erythema of extremities and swelling arm to be related to Shingrix.  Additional information received were as follows: In the evening of day of vaccination, the patient experienced light headed and very tired. The patient also had a fever. The patient's arm was sore, red and puffy. The light headedness, fatigue and fever resolved after 3 days. The patient's arm was sore, red and puffy for about 1 week. The reporter did not consent to follow-up.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: light headed; fever; Very tired; sore arm; redness on arm; Puffy arm; This case was reported by a consumer via call center representative and described the occurrence of light headedness in a 69-year-old female patient who received Herpes zoster (Shingrix) (batch number P57AA, expiry date 31st July 2019) for prophylaxis.   On 19th March 2019, the patient received the 1st dose of Shingrix. On 19th March 2019, less than a day after receiving Shingrix, the patient experienced light headedness, fever, tiredness, pain in arm, erythema of extremities and swelling arm. On 22nd March 2019, the outcome of the light headedness, fever and tiredness were recovered/resolved. On 26th March 2019, the outcome of the pain in arm, erythema of extremities and swelling arm were recovered/resolved.   It was unknown if the reporter considered the light headedness, fever, tiredness, pain in arm, erythema of extremities and swelling arm to be related to Shingrix.  Additional information received were as follows: In the evening of day of vaccination, the patient experienced light headed and very tired. The patient also had a fever. The patient's arm was sore, red and puffy. The light headedness, fatigue and fever resolved after 3 days. The patient's arm was sore, red and puffy for about 1 week. The reporter did not consent to follow-up.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Abdominal pain upper, Dyspnoea, Lip swelling, Swollen tongue, Urticaria
Clinical narrative: Started with hives 2 hours after shot..then 1 hour later..tongue swelled, lips swelled, stomach started hurting,difficulty breathing
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Injection site pain, Nausea
Clinical narrative: THE DAY AFTER VACCINATION PATIENT STATED SHE HAD INJECTION SITE SORENESS AS WELL AS NAUSEA, FATIGUE, AND HEADACHE. SYMPTOMS RESOLVED WITHIN A DAY.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Headache, Injection site pain, Nausea
Clinical narrative: THE MORNING AFTER VACCINATION PT STATES SHE WOKE UP WITH A HEADACHE, NAUSEA, STOMACH ACHE, AND INJECTION SITE SORENESS. STATES SYMPTOMS RESOLVED BEFORE BEDTIME THAT EVENING.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Unevaluable event
Clinical narrative: Rph:   NDC: 58160-0823-11
Age: 72.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Myalgia
Clinical narrative: Myalgia & Erythema
Age: 85.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pruritus, Injection site swelling, Injection site warmth, Pruritus, Urticaria
Clinical narrative: UrticariaPruritus & swelling, warmth and itching at injection site
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Rash & Rash
Age: 72.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Erythema multiforme, Injection site pain, Swelling, Tenderness
Clinical narrative: ErythemaMultiform & tenderness at injection site, progressive sensation "moved down my arm", On 7/31/19 pt returned to clinic with marked swelling, tenderness, & redness
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Peripheral swelling, Rash pruritic
Clinical narrative: patient with history of childhood chickenpox received a Shingrix zoster vaccination. 3 days after vaccination patient reported itchy rash on both legs, buttocks, and left hand w/ some swelling. Patient denied SOB or difficulty breathing, denied fever. MD was notified. Patient will not complete the series
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Body temperature increased, Bone pain, Chills, Fatigue
Clinical narrative: 07/24/2019 - WED: 7:17 PM PHARMACIST. SHINGRIX VACCiNE IM LEFT ARM. PAiNFUL WHEAL APPEARED iMMEDIATELY. PHARMACIST ADVISED TO PUT iCE ON iT ONCE HOME WHICH I DiD. 07/25/2019-THURS AM WOKE UP EXTREME FATIGUE MUSCLE ACHES, BONE PAIN 7/25 NAUSEOUS, STOMACH UPSET, SHiVERiNG. COULDN'T EAT ALL DAY. TEMP: 101F. LEFT ARM RED, iNFLAMMED 2" DIAMETER AT INJECTION SiTE THAT EVENING A BRIGHT RED RASH APPEARED ON ENTIRE FRONT, BACK, SIDE TORSO. CHEST & UP iNTO NECK, THROAT AREA & DOWN BOTH iNSiDE ARMS. BODY FELT WARM TO TOUCH BUT NO iTCHING OR BREATHiNG DiFFiCULTiES. (TEMP: 100. 6. pm) 07/26/2019- FRiDAY AM: CONTACT DR OFFiCE (MY PHYSICIAN). DR ON VACATION. TOLD TO GO TO 'URGENT CARE CENTER'. 'URGENT CARE' DR. ViTALS: TEMP 97.9 F B/P 136/84 PULSE 94, RESPiR 17, OXYGEN SAT. 98% ADVISED TO TAKE ALLEGRA ANTiHiSTAMiNE: NOT TO HAVE THE 2ND DOSE VACCiNE BECAUSE OF THiS ADVERSE REACTION, QUOTING" WHY TAKE THE CHANCE." PM: ON WAY HOME, STOPPED AT PHARMACiST (DiFFERENT PHARMACIST FROM 24TH) HE SAW MY RASh etc & said I COULD WAiT UP TO 6 months to get 2nd dose  HOWEVER AFTER SEEiNG RASH & HEARD MY REACTIONS, he qUOTED, "I SHOULDN'T TAKE THE CHANCE WITH THE 2ND DOSE IN SERIES" 07/27/2019 - SAT. BODY RASH GONE. TEMP: NORMAL. HOWEVER INJECTION SITE STiLL PAiNFUL 1" diameter 07/28/2019-SUN: BACK TO NORMAL EXCEPT RESiDUAL SORENESS AT VACCiNE SiTE. 07/30/2019 I LEFT PHONE MESSAGE AT VAERS TO FILE 'ADVERSE REACTION REPORT' TO SEND TO MY EMAIL.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeding disorder, Immediate post-injection reaction, Injection site erythema, Injection site inflammation, Injection site pain
Clinical narrative: 07/24/2019 - WED: 7:17 PM PHARMACIST. SHINGRIX VACCiNE IM LEFT ARM. PAiNFUL WHEAL APPEARED iMMEDIATELY. PHARMACIST ADVISED TO PUT iCE ON iT ONCE HOME WHICH I DiD. 07/25/2019-THURS AM WOKE UP EXTREME FATIGUE MUSCLE ACHES, BONE PAIN 7/25 NAUSEOUS, STOMACH UPSET, SHiVERiNG. COULDN'T EAT ALL DAY. TEMP: 101F. LEFT ARM RED, iNFLAMMED 2" DIAMETER AT INJECTION SiTE THAT EVENING A BRIGHT RED RASH APPEARED ON ENTIRE FRONT, BACK, SIDE TORSO. CHEST & UP iNTO NECK, THROAT AREA & DOWN BOTH iNSiDE ARMS. BODY FELT WARM TO TOUCH BUT NO iTCHING OR BREATHiNG DiFFiCULTiES. (TEMP: 100. 6. pm) 07/26/2019- FRiDAY AM: CONTACT DR OFFiCE (MY PHYSICIAN). DR ON VACATION. TOLD TO GO TO 'URGENT CARE CENTER'. 'URGENT CARE' DR. ViTALS: TEMP 97.9 F B/P 136/84 PULSE 94, RESPiR 17, OXYGEN SAT. 98% ADVISED TO TAKE ALLEGRA ANTiHiSTAMiNE: NOT TO HAVE THE 2ND DOSE VACCiNE BECAUSE OF THiS ADVERSE REACTION, QUOTING" WHY TAKE THE CHANCE." PM: ON WAY HOME, STOPPED AT PHARMACiST (DiFFERENT PHARMACIST FROM 24TH) HE SAW MY RASh etc & said I COULD WAiT UP TO 6 months to get 2nd dose  HOWEVER AFTER SEEiNG RASH & HEARD MY REACTIONS, he qUOTED, "I SHOULDN'T TAKE THE CHANCE WITH THE 2ND DOSE IN SERIES" 07/27/2019 - SAT. BODY RASH GONE. TEMP: NORMAL. HOWEVER INJECTION SITE STiLL PAiNFUL 1" diameter 07/28/2019-SUN: BACK TO NORMAL EXCEPT RESiDUAL SORENESS AT VACCiNE SiTE. 07/30/2019 I LEFT PHONE MESSAGE AT VAERS TO FILE 'ADVERSE REACTION REPORT' TO SEND TO MY EMAIL.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Nausea, Pain, Rash, Rash erythematous
Clinical narrative: 07/24/2019 - WED: 7:17 PM PHARMACIST. SHINGRIX VACCiNE IM LEFT ARM. PAiNFUL WHEAL APPEARED iMMEDIATELY. PHARMACIST ADVISED TO PUT iCE ON iT ONCE HOME WHICH I DiD. 07/25/2019-THURS AM WOKE UP EXTREME FATIGUE MUSCLE ACHES, BONE PAIN 7/25 NAUSEOUS, STOMACH UPSET, SHiVERiNG. COULDN'T EAT ALL DAY. TEMP: 101F. LEFT ARM RED, iNFLAMMED 2" DIAMETER AT INJECTION SiTE THAT EVENING A BRIGHT RED RASH APPEARED ON ENTIRE FRONT, BACK, SIDE TORSO. CHEST & UP iNTO NECK, THROAT AREA & DOWN BOTH iNSiDE ARMS. BODY FELT WARM TO TOUCH BUT NO iTCHING OR BREATHiNG DiFFiCULTiES. (TEMP: 100. 6. pm) 07/26/2019- FRiDAY AM: CONTACT DR OFFiCE (MY PHYSICIAN). DR ON VACATION. TOLD TO GO TO 'URGENT CARE CENTER'. 'URGENT CARE' DR. ViTALS: TEMP 97.9 F B/P 136/84 PULSE 94, RESPiR 17, OXYGEN SAT. 98% ADVISED TO TAKE ALLEGRA ANTiHiSTAMiNE: NOT TO HAVE THE 2ND DOSE VACCiNE BECAUSE OF THiS ADVERSE REACTION, QUOTING" WHY TAKE THE CHANCE." PM: ON WAY HOME, STOPPED AT PHARMACiST (DiFFERENT PHARMACIST FROM 24TH) HE SAW MY RASh etc & said I COULD WAiT UP TO 6 months to get 2nd dose  HOWEVER AFTER SEEiNG RASH & HEARD MY REACTIONS, he qUOTED, "I SHOULDN'T TAKE THE CHANCE WITH THE 2ND DOSE IN SERIES" 07/27/2019 - SAT. BODY RASH GONE. TEMP: NORMAL. HOWEVER INJECTION SITE STiLL PAiNFUL 1" diameter 07/28/2019-SUN: BACK TO NORMAL EXCEPT RESiDUAL SORENESS AT VACCiNE SiTE. 07/30/2019 I LEFT PHONE MESSAGE AT VAERS TO FILE 'ADVERSE REACTION REPORT' TO SEND TO MY EMAIL.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin warm, Urticaria
Clinical narrative: 07/24/2019 - WED: 7:17 PM PHARMACIST. SHINGRIX VACCiNE IM LEFT ARM. PAiNFUL WHEAL APPEARED iMMEDIATELY. PHARMACIST ADVISED TO PUT iCE ON iT ONCE HOME WHICH I DiD. 07/25/2019-THURS AM WOKE UP EXTREME FATIGUE MUSCLE ACHES, BONE PAIN 7/25 NAUSEOUS, STOMACH UPSET, SHiVERiNG. COULDN'T EAT ALL DAY. TEMP: 101F. LEFT ARM RED, iNFLAMMED 2" DIAMETER AT INJECTION SiTE THAT EVENING A BRIGHT RED RASH APPEARED ON ENTIRE FRONT, BACK, SIDE TORSO. CHEST & UP iNTO NECK, THROAT AREA & DOWN BOTH iNSiDE ARMS. BODY FELT WARM TO TOUCH BUT NO iTCHING OR BREATHiNG DiFFiCULTiES. (TEMP: 100. 6. pm) 07/26/2019- FRiDAY AM: CONTACT DR OFFiCE (MY PHYSICIAN). DR ON VACATION. TOLD TO GO TO 'URGENT CARE CENTER'. 'URGENT CARE' DR. ViTALS: TEMP 97.9 F B/P 136/84 PULSE 94, RESPiR 17, OXYGEN SAT. 98% ADVISED TO TAKE ALLEGRA ANTiHiSTAMiNE: NOT TO HAVE THE 2ND DOSE VACCiNE BECAUSE OF THiS ADVERSE REACTION, QUOTING" WHY TAKE THE CHANCE." PM: ON WAY HOME, STOPPED AT PHARMACiST (DiFFERENT PHARMACIST FROM 24TH) HE SAW MY RASh etc & said I COULD WAiT UP TO 6 months to get 2nd dose  HOWEVER AFTER SEEiNG RASH & HEARD MY REACTIONS, he qUOTED, "I SHOULDN'T TAKE THE CHANCE WITH THE 2ND DOSE IN SERIES" 07/27/2019 - SAT. BODY RASH GONE. TEMP: NORMAL. HOWEVER INJECTION SITE STiLL PAiNFUL 1" diameter 07/28/2019-SUN: BACK TO NORMAL EXCEPT RESiDUAL SORENESS AT VACCiNE SiTE. 07/30/2019 I LEFT PHONE MESSAGE AT VAERS TO FILE 'ADVERSE REACTION REPORT' TO SEND TO MY EMAIL.
Age: 77.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Asthenia, Diarrhoea, Dysstasia, Fatigue, Flatulence
Clinical narrative: By about 10 p.m. day of vaccine began to feel very tired & arm tender but not red, no hives, swelling, etc. Went to bed 11:30 p.m.; had nightmares (unusual) & woke up at 2:30 a.m. Decided to go to bathroom. Could barely stand or walk; knees weak, legs felt like jello, and both arms shaking pretty violently from shoulders to fingertips on arms (this was the very frightening part). Made it to bathroom & back to bed by holding on to walls, door knobs, etc. Got up 10 minutes later to throw up - a lot. Other than 5 or 10 minutes at a time, never could get back to sleep. At some point needed to throw up again. Finally got out of bed about 5:30 a.m. Drank an half an Ensure Plus & threw it up soon after. Diarhea, total exhaustion and naps about every hour through rest of Sunday. Monday (17 June) totally exhausted, diarrhea continued though not as frequent, nausea improved, totally listless & sleepy. This continued until Saturday 22 June when I finally was able to leave the house (i.e. the bathroom) long enough to drive to pharmacy and ask if they had other complaints and might have gotten a bad batch of the vaccine.  Had a long talk with pharmacy manager who said she'd never heard of such a severe reaction & took info so she could submit a form to you. She suggested I take Imodium & Align (or similar) which helped by that evening. The next day had a lot of gas all day and a spell of diarrhea from 11 p.m. to 130 a.m. Still felt exhausted. Intermittent periods of diarrhea or very loose stool and being unusually tired (I may be "old", but have always remained active) have continued over 2 months BUT each time I think I need to find a new family physician (having discovered my current one has retired), I have a day or two with no problems. I am just now getting back to more of my normal activities.      I'm not only more than a little upset that I've lost 2 months out of my life, but that I paid $169.99 to do it. On top of that, I think I would have to be insane to risk taking shot #2, so I guess that means I'm not even protected from shingles. (I did have the "original" shingles vaccine about 12 years ago as soon after chemotherapy as my oncologist felt it was safe; no reaction from it.)
Age: 77.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Gait disturbance, Insomnia, Listless, Loss of personal independence in daily activities, Muscular weakness
Clinical narrative: By about 10 p.m. day of vaccine began to feel very tired & arm tender but not red, no hives, swelling, etc. Went to bed 11:30 p.m.; had nightmares (unusual) & woke up at 2:30 a.m. Decided to go to bathroom. Could barely stand or walk; knees weak, legs felt like jello, and both arms shaking pretty violently from shoulders to fingertips on arms (this was the very frightening part). Made it to bathroom & back to bed by holding on to walls, door knobs, etc. Got up 10 minutes later to throw up - a lot. Other than 5 or 10 minutes at a time, never could get back to sleep. At some point needed to throw up again. Finally got out of bed about 5:30 a.m. Drank an half an Ensure Plus & threw it up soon after. Diarhea, total exhaustion and naps about every hour through rest of Sunday. Monday (17 June) totally exhausted, diarrhea continued though not as frequent, nausea improved, totally listless & sleepy. This continued until Saturday 22 June when I finally was able to leave the house (i.e. the bathroom) long enough to drive to pharmacy and ask if they had other complaints and might have gotten a bad batch of the vaccine.  Had a long talk with pharmacy manager who said she'd never heard of such a severe reaction & took info so she could submit a form to you. She suggested I take Imodium & Align (or similar) which helped by that evening. The next day had a lot of gas all day and a spell of diarrhea from 11 p.m. to 130 a.m. Still felt exhausted. Intermittent periods of diarrhea or very loose stool and being unusually tired (I may be "old", but have always remained active) have continued over 2 months BUT each time I think I need to find a new family physician (having discovered my current one has retired), I have a day or two with no problems. I am just now getting back to more of my normal activities.      I'm not only more than a little upset that I've lost 2 months out of my life, but that I paid $169.99 to do it. On top of that, I think I would have to be insane to risk taking shot #2, so I guess that means I'm not even protected from shingles. (I did have the "original" shingles vaccine about 12 years ago as soon after chemotherapy as my oncologist felt it was safe; no reaction from it.)
Age: 77.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Nausea, Nightmare, Somnolence, Tenderness, Tremor
Clinical narrative: By about 10 p.m. day of vaccine began to feel very tired & arm tender but not red, no hives, swelling, etc. Went to bed 11:30 p.m.; had nightmares (unusual) & woke up at 2:30 a.m. Decided to go to bathroom. Could barely stand or walk; knees weak, legs felt like jello, and both arms shaking pretty violently from shoulders to fingertips on arms (this was the very frightening part). Made it to bathroom & back to bed by holding on to walls, door knobs, etc. Got up 10 minutes later to throw up - a lot. Other than 5 or 10 minutes at a time, never could get back to sleep. At some point needed to throw up again. Finally got out of bed about 5:30 a.m. Drank an half an Ensure Plus & threw it up soon after. Diarhea, total exhaustion and naps about every hour through rest of Sunday. Monday (17 June) totally exhausted, diarrhea continued though not as frequent, nausea improved, totally listless & sleepy. This continued until Saturday 22 June when I finally was able to leave the house (i.e. the bathroom) long enough to drive to pharmacy and ask if they had other complaints and might have gotten a bad batch of the vaccine.  Had a long talk with pharmacy manager who said she'd never heard of such a severe reaction & took info so she could submit a form to you. She suggested I take Imodium & Align (or similar) which helped by that evening. The next day had a lot of gas all day and a spell of diarrhea from 11 p.m. to 130 a.m. Still felt exhausted. Intermittent periods of diarrhea or very loose stool and being unusually tired (I may be "old", but have always remained active) have continued over 2 months BUT each time I think I need to find a new family physician (having discovered my current one has retired), I have a day or two with no problems. I am just now getting back to more of my normal activities.      I'm not only more than a little upset that I've lost 2 months out of my life, but that I paid $169.99 to do it. On top of that, I think I would have to be insane to risk taking shot #2, so I guess that means I'm not even protected from shingles. (I did have the "original" shingles vaccine about 12 years ago as soon after chemotherapy as my oncologist felt it was safe; no reaction from it.)
Age: 77.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Vomiting, Walking aid user
Clinical narrative: By about 10 p.m. day of vaccine began to feel very tired & arm tender but not red, no hives, swelling, etc. Went to bed 11:30 p.m.; had nightmares (unusual) & woke up at 2:30 a.m. Decided to go to bathroom. Could barely stand or walk; knees weak, legs felt like jello, and both arms shaking pretty violently from shoulders to fingertips on arms (this was the very frightening part). Made it to bathroom & back to bed by holding on to walls, door knobs, etc. Got up 10 minutes later to throw up - a lot. Other than 5 or 10 minutes at a time, never could get back to sleep. At some point needed to throw up again. Finally got out of bed about 5:30 a.m. Drank an half an Ensure Plus & threw it up soon after. Diarhea, total exhaustion and naps about every hour through rest of Sunday. Monday (17 June) totally exhausted, diarrhea continued though not as frequent, nausea improved, totally listless & sleepy. This continued until Saturday 22 June when I finally was able to leave the house (i.e. the bathroom) long enough to drive to pharmacy and ask if they had other complaints and might have gotten a bad batch of the vaccine.  Had a long talk with pharmacy manager who said she'd never heard of such a severe reaction & took info so she could submit a form to you. She suggested I take Imodium & Align (or similar) which helped by that evening. The next day had a lot of gas all day and a spell of diarrhea from 11 p.m. to 130 a.m. Still felt exhausted. Intermittent periods of diarrhea or very loose stool and being unusually tired (I may be "old", but have always remained active) have continued over 2 months BUT each time I think I need to find a new family physician (having discovered my current one has retired), I have a day or two with no problems. I am just now getting back to more of my normal activities.      I'm not only more than a little upset that I've lost 2 months out of my life, but that I paid $169.99 to do it. On top of that, I think I would have to be insane to risk taking shot #2, so I guess that means I'm not even protected from shingles. (I did have the "original" shingles vaccine about 12 years ago as soon after chemotherapy as my oncologist felt it was safe; no reaction from it.)
Age: 77.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Asthenia, Diarrhoea, Fatigue, Gait disturbance, Injection site pain
Clinical narrative: By about 10 p.m. day of vaccine began to feel very tired & arm tender but not red, no hives, swelling, etc. Went to bed 11:30 p.m.; had nightmares (unusual) & woke up at 2:30 a.m. Decided to go to bathroom. Could barely stand or walk; knees weak, legs felt like jello, and both arms shaking pretty violently from shoulders to fingertips on arms (this was the very frightening part). Made it to bathroom & back to bed by holding on to walls, door knobs, etc. Got up 10 minutes later to throw up - a lot. Other than 5 or 10 minutes at a time, never could get back to sleep. At some point needed to throw up again. Finally got out of bed about 5:30 a.m. Drank an half an Ensure Plus & threw it up soon after. Diarhea, total exhaustion and naps about every hour through rest of Sunday. Monday (17 June) totally exhausted, diarrhea continued though not as frequent, nausea improved, totally listless & sleepy. This continued until Saturday 22 June when I finally was able to leave the house (i.e. the bathroom) long enough to drive to pharmacy and ask if they had other complaints and might have gotten a bad batch of the vaccine.  Had a long talk with pharmacy manager who said she'd never heard of such a severe reaction & took info so she could submit a form to you. She suggested I take Imodium & Align (or similar) which helped by that evening. The next day had a lot of gas all day and a spell of diarrhea from 11 p.m. to 130 a.m. Still felt exhausted. Intermittent periods of diarrhea or very loose stool and being unusually tired (I may be "old", but have always remained active) have continued over 2 months BUT each time I think I need to find a new family physician (having discovered my current one has retired), I have a day or two with no problems. I am just now getting back to more of my normal activities.      I'm not only more than a little upset that I've lost 2 months out of my life, but that I paid $169.99 to do it. On top of that, I think I would have to be insane to risk taking shot #2, so I guess that means I'm not even protected from shingles. (I did have the "original" shingles vaccine about 12 years ago as soon after chemotherapy as my oncologist felt it was safe; no reaction from it.)