chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Walking aid user
Clinical narrative: Pt reported that she started having adverse effects starting the morning after receiving the flu shot (10/28). She started having changes in her vision and needed to blink multiple times to focus. That day she went to pick up her meds from her regular pharmacy and then went to choir practice. She was still having vision issues and then developed a headache, for which she took Tylenol to help with the pain, and then went home. When she was home her eyes started to dart side to side. She notes that she slept well that night but the following day had felt worse. On the morning of 10/29 she still had trouble with focusing and then felt unsteady. On 10/30 she said that she was feeling a little worse. She still had trouble with her eyes darting and her balance was getting worse, however she also had vomited once in the day. On 10/31 she stated that she couldn?t focus completely, had bad balance and had to stagger to throw out her trash. When she came back inside her house her eyes were still darting and felt like she was going to fall so she sat down and called the EMTs. They came about 5 minutes after her call and took her vitals, which were fine, and then they took her to Hospital. While at the ER, a chest x-ray, EKG and MRI of her head and neck were done, however she was not told of the results. The hospital also ran a urinalysis on the patient, which she states had tested positive for bacteria. A Rhomberg test and Epley test were administered in which she had trouble balancing and was leaning to the right. Due to this she spent the night at the hospital for observation and was given Zofran, but this had no good response for her. On 11/1 the patient was discharged to rehabilitation where she stayed for 11 days to work on her balance. The patient states that the nystagmus had slowly started to resolve and her balance had slowly gotten better during this time, however it is not completely back to normal. On 11/13 she was discharged to her primary doctor, who she saw on the Monday following her discharge. Since then the patient had home visits with physical therapy, who helped her with exercises to help her balance and to help her walk with a walker and then a cane. The patient has recently been able to visit the site for these appointments and her last appointment will be next week. Pt has appointment with Dr. on 1/30/20.
Age: 12.0
Sex: M
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient did not have any reaction
Age: 11.0
Sex: F
Vaccine: FLUC4
Symptoms: Pallor, Slow response to stimuli, Somnolence, Visual impairment
Clinical narrative: I gave patient the flu vaccine. I finished all as normal, then turned to give her sister her vaccine. I administered her sister's vaccine and the mom said "there is something wrong with her" and motioned to her. I went back to her, She appeared pale and slow to respond. I asked her if she was ok. She did respond and say she was ok but couldn't see well, that her vision was spotty. I asked her if she was having any trouble breathing she said no. She did not seem out of breath or labored. Her arm was not red or swollen. I asked her sit in her seat for a bit until she felt better. So we waited for minutes and about 5-7min later she seemed to have more color in face to questions faster. She was restore to feeling much better by the time she left. I called her mom a few hours later to check on her. Her mom said that she was sleepy but was feeling ok.
Age: 78.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Erythema, Herpes simplex, Pain, Pruritus
Clinical narrative: Next morning after shingles vaccine  was given to me, I woke with 2 red  blisters on my right side of chest - pain  Felt itchy took 5-6 days to go away -  few weeks later I got another blister on  right side of chest - back & itch - happened a few  more times - went to dermatologist 11-14-20 Every week or so, I break out on a large red  blister that is painful & itchy - never had this  before - started morning after shingles vaccine.  Dermatologist said it was Herpes-Simplex  wanted to know if I was worried or under  stress (which I was not) I am worried that this will keep  happening - I keep breaking out with 1 or 2 of these every few weeks - never had anything like this, ever -  Do not know if the person who  treated me at medical clinic really knew if or what it really is.  Supposed to get the 2nd shot but I am leary and afraid - do not know what to do.
Age: 78.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash
Clinical narrative: Next morning after shingles vaccine  was given to me, I woke with 2 red  blisters on my right side of chest - pain  Felt itchy took 5-6 days to go away -  few weeks later I got another blister on  right side of chest - back & itch - happened a few  more times - went to dermatologist 11-14-20 Every week or so, I break out on a large red  blister that is painful & itchy - never had this  before - started morning after shingles vaccine.  Dermatologist said it was Herpes-Simplex  wanted to know if I was worried or under  stress (which I was not) I am worried that this will keep  happening - I keep breaking out with 1 or 2 of these every few weeks - never had anything like this, ever -  Do not know if the person who  treated me at medical clinic really knew if or what it really is.  Supposed to get the 2nd shot but I am leary and afraid - do not know what to do.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Feeling cold, Insomnia, Joint stiffness
Clinical narrative: For several hours (at least 4 or 5) I was chilled and shivering severely. I got up to get warm socks and extra blankets and realized my muscles and joints were stiff and sore also. I had trouble sleeping because of the shivering and not able to get warm enough. Eventually I fell asleep. When I awoke in the morning I was fine and back to normal. I did call pharmacy to notify them in case the product was compromised by the power outage our town had experienced the previous evening before my shot. Our house had no power a little over 3 hours. I also notified my primary care provider and called the FDA and left a message to report my experience. What happened to me was probably quite minor, but I have never had anything unusual happen to me after an immunization - and I've had many over the years considering my age.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Musculoskeletal stiffness, Myalgia
Clinical narrative: For several hours (at least 4 or 5) I was chilled and shivering severely. I got up to get warm socks and extra blankets and realized my muscles and joints were stiff and sore also. I had trouble sleeping because of the shivering and not able to get warm enough. Eventually I fell asleep. When I awoke in the morning I was fine and back to normal. I did call pharmacy to notify them in case the product was compromised by the power outage our town had experienced the previous evening before my shot. Our house had no power a little over 3 hours. I also notified my primary care provider and called the FDA and left a message to report my experience. What happened to me was probably quite minor, but I have never had anything unusual happen to me after an immunization - and I've had many over the years considering my age.
Age: 78.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Mobility decreased, Peripheral swelling
Clinical narrative: Patient reported that her arm became swollen, red, and hard to move. She had pictures that showed swelling in upper and forearm. Patient reported she saw her doctor and doctor told her it may have been due to improper immunization technique.
Age: 9.0
Sex: F
Vaccine: FLUR4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: PATIENT DID NOT HAVE ANY REACTION
Sex: U
Vaccine: PNC13
Symptoms: Wrong product administered
Clinical narrative: Patient received Prevnar 13 instead of Prevnar 23-report attached
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Feeling abnormal, Hypoaesthesia, Livedo reticularis, Malaise, Nausea
Clinical narrative: felt fuzzy; hands felt tingle: numb.; Pins and needles; mom checked fingers: mottled, gently warmed color returned; not feeling well; nausea; This spontaneous report was obtained on request by the Company from the FDA (Agency number: 807968) on 11-NOV-2019, concerning an 11-year-old female patient. Information about the patient's past drug and medical history, as well as concomitant therapies and allergies were not reported.  On 26-MAR-2019, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) injection, in the left arm, lot number R017134 has been verified to be a valid lot number, expiration date not reported but upon internal validation was established as 29-APR-2021 (dose, route of administration and expiration date were not provided). On the same date, the patient was also vaccinated with meningococcal vaccine (dip toxoid) (MENACTRA) lot number 061528A; and diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid (ADACEL) lot number C5566AA (doses, route of administrations, and expiration dates were not provided), both vaccines administrated as prophylaxis.  On 27-MAR-2019 (reported as "next morning"), the patient was not feeling well (malaise), started feeling fuzzy, experienced nausea without vomiting and remained a febrile. Subsequently, the patient played basketball outside at a temperature of 50 degrees and her hands felt tingle: numbness, pins and needles, the mom checked her fingers, mottled, gently warmed, and color returned.   On 28-MAR-2019, this reoccurred again at soccer practice, unwitnessed by parents. It was cold outside at that time, however, no further episodes since this day.   At the time of this report, the outcome of the aforementioned events was reported as recovered, the causality assessment between the events and the vaccines was not provided.  Follow-up has been received from a registered nurse on 21-JAN-2020. The reporter stated that she was unable to locate a chart without more demographic information, all demographic information has been redacted on the VAERS reviewed.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Paraesthesia
Clinical narrative: felt fuzzy; hands felt tingle: numb.; Pins and needles; mom checked fingers: mottled, gently warmed color returned; not feeling well; nausea; This spontaneous report was obtained on request by the Company from the FDA (Agency number: 807968) on 11-NOV-2019, concerning an 11-year-old female patient. Information about the patient's past drug and medical history, as well as concomitant therapies and allergies were not reported.  On 26-MAR-2019, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) injection, in the left arm, lot number R017134 has been verified to be a valid lot number, expiration date not reported but upon internal validation was established as 29-APR-2021 (dose, route of administration and expiration date were not provided). On the same date, the patient was also vaccinated with meningococcal vaccine (dip toxoid) (MENACTRA) lot number 061528A; and diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid (ADACEL) lot number C5566AA (doses, route of administrations, and expiration dates were not provided), both vaccines administrated as prophylaxis.  On 27-MAR-2019 (reported as "next morning"), the patient was not feeling well (malaise), started feeling fuzzy, experienced nausea without vomiting and remained a febrile. Subsequently, the patient played basketball outside at a temperature of 50 degrees and her hands felt tingle: numbness, pins and needles, the mom checked her fingers, mottled, gently warmed, and color returned.   On 28-MAR-2019, this reoccurred again at soccer practice, unwitnessed by parents. It was cold outside at that time, however, no further episodes since this day.   At the time of this report, the outcome of the aforementioned events was reported as recovered, the causality assessment between the events and the vaccines was not provided.  Follow-up has been received from a registered nurse on 21-JAN-2020. The reporter stated that she was unable to locate a chart without more demographic information, all demographic information has been redacted on the VAERS reviewed.
Age: 7.0
Sex: M
Vaccine: FLUR4
Symptoms: Peripheral swelling, Skin warm, Tenderness
Clinical narrative: Swelling on the arm with tenderness and warm to the touch.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Back pain, Fatigue, Headache
Clinical narrative: Joint aches back, hip, shoulders.  Fatigue. Headache
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Body temperature increased, Chills, Feeling hot
Clinical narrative: Approximately 12 hours after injection I developed sever chills. Approximately 3 hours later I became extremely hot. At 6:30 Am temperature was 100.4
Age: 8.0
Sex: F
Vaccine: HPV9
Symptoms: Incomplete course of vaccination
Clinical narrative: They had their first two doses of Gardasil 9 vaccine whilst in October and December 2015. he third dose was due in April 2016 but this has not yet been administered.; This spontaneous reporter was received from a consumer and refers to a currently 13-year-old female patient. The patient's medical history, concurrent conditions, previous drug reactions, allergies and concomitant medications were not reported.  On 19-OCT-2015, the patient was vaccinated with her first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis (strength, route of administration, anatomical location, lot number and expiration date were not reported).  On 22-DEC-2015, the patient received her second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis (strength, route of administration, anatomical location, lot number and expiration date were not reported). On April 2016, the patient was scheduled to receive her third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) however it was not administered at the time of this report (inappropriate schedule of product administration).  This is one of two reports from the same source.; Sender's Comments:  US-009507513-2001USA006201:GB20200100404/ GB20-00550
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: multiple doses of improperly stored GARDASIL 9 were administered to multiple unspecified patients on unspecified dates; No additional adverse event reported; This spontaneous report has been received from a nurse concerning an unspecified number of patients of unknown age and gender.  Their past medical history, concurrent conditions, concomitant medications and drug allergy/reactions were not reported.  On an unknown date, the patients were vaccinated with improperly stored with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (lot number 1602284 has been verified to be a valid lot number, expiration date reported and validated as 26-SEP-2021) as prophylaxis (product storage error) (concentration, dose, dose description, frequency of vaccination scheme and anatomical location of vaccination were not reported).   The HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) underwent a temperature excursion of 9.26 degrees Celsius for 42 minutes, as recorded by the data logger. There was a previous temperature excursion of 17.5 degrees Celsius for a time frame of 7 hours and 28 minutes from the same data logger.   No adverse effects were reported for the patients.    This is a non-valid case due to lack of patient's identifier.
Sex: F
Vaccine: MMRV
Symptoms: Exposure via eye contact, No adverse event
Clinical narrative: The physician did not experience any symptoms; Physician inadvertently had PROQUAD sprayed in her eye during and administration to the patient; Physician inadvertently had PROQUAD sprayed in her eye during and administration to the patient; This spontaneous report has been received from a registered nurse, concerning a female patient of unknown age, who was a physician. Her concurrent conditions, medical history and concomitant medications were not reported.   On 23-JAN-2020, the physician inadvertently had measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) sprayed in her eye during an administration to a patient (lot # S013711 and expiration date on 31-NOV-2020). The physician did not experience any symptoms. No product quality complaint was involved.  Since the patient did not get a full dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD), case # 2001USA008752 was also created.; Sender's Comments:  US-009507513-2001USA008752:
Sex: U
Vaccine: MMR, MMRV, RV5, VARCEL
Symptoms: Product storage error
Clinical narrative: multiple unspecified patients received improperly stored doses of vaccines; This spontaneous report has been received from a physician referring to an unspecified number of patients of unknown age and gender. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not provided.   On an unknown date, the patients were vaccinated with improperly stored doses of rotavirus vaccine, live, oral, pentavalent(ROTATEQ), oral (indication, strength, frequency, dose, lot # and expiration date were not provided) for prophylaxis. Other suspect therapies included measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (indication, strength, frequency, dose, route, lot # and expiration date were not provided) for prophylaxis., measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (indication, strength, frequency, dose, route, lot # and expiration date were not provided) for prophylaxis; and varicella virus vaccine live (oka/merck)(VARIVAX) (indication, strength, frequency, dose, route, lot # and expiration date were not provided) for prophylaxis.  The rotavirus vaccine, live, oral, pentavalent(ROTATEQ) vaccine was exposed to a temperature range of 47°F, during a time frame of 24 hours. measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) was exposed to a temperature of 47°F during a time frame of 33 hours; measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) was stored at above 47°F during 33 hours; and measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) was stored at a temperature above 46°F during 33 hours.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: The patient did not experience any symptoms; The patient was administered improperly stored VARIVAX; This spontaneous report was received from an office manager referring to a patient of unknown age and gender. The patient's pertinent medical history, concomitant therapies, as well as drug reactions or allergies were not provided.   On 09-JAN-2020, it was identified that on an unknown date, the patient was inadvertently administered with an improperly stored dose (product storage error) of varicella virus vaccine live (oka/Merck)(VARIVAX) 1 dose each for prophylaxis (strength, frequency, route of administration, and anatomical location were not reported) (lot number R034394 had been verified to be a valid number; expiration date 27-NOV-2020), who was administered with sterile diluent (DILUENT MRK) as concomitant. The temperature excursion was at 6 degrees Fahrenheit (F), for a time frame of 20 minutes, and not had the previous temperature excursion. It was reported that the call was due to data logger, and the patient did not experience any symptoms.
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Injection site pain
Clinical narrative: feeling sick on the stomach; pain during injection; This case was reported by a consumer via call center representative and described the occurrence of upset stomach in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd January 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 22nd January 2020, immediately after receiving Shingrix, the patient experienced injection site pain. On 23rd January 2020, the patient experienced upset stomach. On an unknown date, the outcome of the upset stomach was recovering/resolving and the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the upset stomach and injection site pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported but it could be 72 or 73 years. After received the dose of Shingrix the patient experienced feeling sick on the stomach and pain during the injection. The follow up consent was not granted. This case has been linked with case US2020013018, reported by same reporter.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Feeling cold, Pain
Clinical narrative: Had about two hours of nearly continuous chills and could not seem to warm up during that time in the middle of the night.  Chills eventually stopped.  Feeling ache (as if coming down with or getting over the flu).
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia oral, Paraesthesia oral
Clinical narrative: lips were tingly / numb for about 30 minutes and then that feeling gradually dissipated and everything was fine after that.
Age: 46.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site bruising, Joint manipulation, Musculoskeletal pain
Clinical narrative: Shoulder pain began within about 1 hour of vaccine administration and has remained unchanged since then (about 3 months), with the exception that the pain became worse in the week before 01/28/2020. Bruised feeling at the injection site itself dissipated within a few hours, but shoulder pain has not gone away. Visited Dr. on 01/28/2020; she prescribed naproxen and rotator cuff stretches/exercises for 2 weeks, then PT if necessary, with a follow-up visit in 6 weeks to determine whether imaging and further treatment is needed. Nurse practitioner recommended filing this report of adverse event.
Age: 8.0
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No ADR noted.  RN noticed after the administration that the High-dose Fluzone was given instead of the standard Fluzone vaccine.  Per phone conversation with parent after this was discovered "Patient's mother stated that the her son is doing well and has had no reaction to the flu shot. " on 1/24/2020
Age: 52.0
Sex: F
Vaccine: PNC13
Symptoms: Body temperature increased, Chills, Headache, Influenza like illness, Influenza virus test negative
Clinical narrative: An hour after my shot my arm started feeling very sore and was tender to touch or move.  At 3am the next day I woke up with terrible body chills and I was achy and my head started hurting. I felt like I was getting the flu except I didn?t have a sore throat, or swollen glands. Took my temperature at 7am and it was 101.  At 4:30 I went to Urgent Care and my temperature was at 102.  I tested negative for the flu.  A day later I am still a little achy, and my arm is still tender and swollen through the bicep.  No fever.
Age: 52.0
Sex: F
Vaccine: PNC13
Symptoms: Middle insomnia, Pain, Pain in extremity, Peripheral swelling, Tenderness
Clinical narrative: An hour after my shot my arm started feeling very sore and was tender to touch or move.  At 3am the next day I woke up with terrible body chills and I was achy and my head started hurting. I felt like I was getting the flu except I didn?t have a sore throat, or swollen glands. Took my temperature at 7am and it was 101.  At 4:30 I went to Urgent Care and my temperature was at 102.  I tested negative for the flu.  A day later I am still a little achy, and my arm is still tender and swollen through the bicep.  No fever.
Age: 7.0
Sex: M
Vaccine: FLU4
Symptoms: Swelling face, Syncope
Clinical narrative: Patient fainted 1 minute after receiving vaccination. pt was out for 2 second. had bump on head and responded fine after mom picked him up. mom will follow up with pcp Dr
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No Additional Adverse Events reported; improperly stored vaccines may have been administered to unspecified patients; This spontaneous report has been received from a nurse, referring to patient of unknown gender and age. Information about the patient's pertinent medical history, concurrent conditions, and previous drugs reactions or allergies were not provided.  On 16-DEC-2019, the patient was vaccinated with an improperly stored (product storage error) hepatitis a vaccine, inactivated (VAQTA), (Therapy type: Digital Data Logger), lot number S025258 and expiration date 05-NOV-2020 for prophylaxis (strength, dose, dose number, frequency, route of administration, and anatomical location, were not provided).   The vaccine was stored at a temperature above 47 degree Fahrenheit (47.1 Fahrenheit), for a timeframe of 8 to 16 minutes, with no previous temperature excursion. The call was due to a Digital Data Logger.  No additional adverse events were reported.  This case is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2001USA009216: US-009507513-2001USA009217: US-009507513-2001USA009218: US-009507513-2001USA009219: US-009507513-2001USA009220: US-009507513-2001USA009221: US-009507513-2001USA009222: US-009507513-2001USA009223: US-009507513-2001USA009224: US-009507513-2001USA009225: US-009507513-2001USA009226: US-009507513-2001USA009189: US-009507513-2001USA009227: US-009507513-2001USA009228: US-009507513-2001USA009229: US-009507513-2001USA009190: US-009507513-2001USA009191: US-009507513-2001USA009192: US-009507513-2001USA009230: US-009507513-2001USA009231: US-009507513-2001USA009232: US-009507513-2001USA009193: US-009507513-2001USA009194: US-009507513-2001USA009233: US-009507513-2001USA009234: US-009507513-2001USA009195: US-009507513-2001USA009195: US-009507513-2001USA009196: US-009507513-2001USA009235: US-009507513-2001USA009236: US-009507513-2001USA009237: US-009507513-2001USA009197: US-009507513-2001USA009198: US-009507513-2001USA009199: US-009507513-2001USA009238: US-009507513-2001USA009239: US-009507513-2001USA009240: US-009507513-2001USA009200: US-009507513-2001USA009201: US-009507513-2001USA009241: US-009507513-2001USA009242: US-009507513-2001USA009243: US-009507513-2001USA009202: US-009507513-2001USA009203: US-009507513-2001USA009204: US-009507513-2001USA009244: US-009507513-2001USA009245: US-009507513-2001USA009205: US-009507513-2001USA009206: US-009507513-2001USA009246: US-009507513-2001USA009247: US-009507513-2001USA009248: US-009507513-2001USA009207: US-009507513-2001USA009208: US-009507513-2001USA009249: US-009507513-2001USA009250: US-009507513-2001USA009251: US-009507513-2001USA009209: US-009507513-2001USA009210: US-009507513-2001USA009252: US-009507513-2001USA009253: US-009507513-2001USA009254: US-009507513-2001USA009211: US-009507513-2001USA009212: US-009507513-2001USA009213: US-009507513-2001USA009214: US-009507513-2001USA009215:
Sex: M
Vaccine: PPV
Symptoms: Renal transplant
Clinical narrative: kidney transplant; This spontaneous report was received from a pharmacist via company representative refers to a male patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported.   On an unknown date in 2009, the patient was vaccinated with first dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (strength, dose, route, lot/ batch number and expiry date were not reported) for prophylaxis. On an unknown date in 2011, the patient had a kidney transplant (renal transplant) at unspecified location. The patient told to the pharmacist that he would need a second dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23). No product quality complaint was reported. The outcome of renal transplant was unknown. Causality assessment was not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Muscle spasms, Pain
Clinical narrative: outlier symptom that felt like a muscle spasm below my shoulder and wrapping around my upper waist; excruciating pain; This case was reported by a consumer and described the occurrence of muscle spasm in a patient who received Herpes zoster (Shingrix) for prophylaxis.   In October 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced muscle spasm and pain. On an unknown date, the outcome of the muscle spasm was unknown and the outcome of the pain was recovered/resolved.   It was unknown if the reporter considered the muscle spasm and pain to be related to Shingrix.  Additional information was received as follows: The age at vaccination was not reported. The patient felt like a muscle spasm below the shoulder and wrapping around my upper waist. The pain was excruciating and similar in placement to the PHN diagram for people with shingles.  The excruciating pain went away within 72 hours. The patient wanted to know if anyone else had the same response or reaction. For tolerance to 2nd dose, refer case US2020AMR011191.
Sex: U
Vaccine: VARZOS
Symptoms: Dyspnoea, Muscle spasms, Myalgia, Post herpetic neuralgia
Clinical narrative: think it was PHN / knew it was nerve related; could barely breath; pain was excruciating and similar in placement to the PHN diagram for people with shingles.; excruciating pain; This case was reported by a consumer and described the occurrence of post herpetic neuralgia in a patient who received Herpes zoster (Shingrix) for prophylaxis.   In January 2020, the patient received Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced post herpetic neuralgia, difficulty breathing, muscle spasm and pain. On an unknown date, the outcome of the post herpetic neuralgia, difficulty breathing and muscle spasm were unknown and the outcome of the pain was recovered/resolved.   It was unknown if the reporter considered the post herpetic neuralgia, difficulty breathing, muscle spasm and pain to be related to Shingrix.  Additional information was received as follows: The age at vaccination was not reported. The patient received Shingrix by the evening and experienced felt like a muscle spasm below the shoulder and wrapping around my upper waist. The pain was excruciating and similar in placement to the PHN diagram for people with shingles by the next morning. The patient stated it was so painful that patient wanted to go to the hospital. The patient stated that the pain tonight was less and at time of reporting quite manageable but for two days, patient could barely breath. The excruciating pain went away within 72 hours. The patient wanted to know if anyone else had the same response or reaction.
Age: 86.0
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Blood test normal, Computerised tomogram normal, Diarrhoea, Flatulence, Laboratory test
Clinical narrative: pancreatic insufficiency; diarrhea; gas; This case was reported by a consumer via call center representative and described the occurrence of pancreatic insufficiency in a 86-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included carica papaya (Papaya Tablets) tablet for product used for unknown indication.   Concurrent medical conditions included pre-diabetes.   On 23rd October 2019, the patient received the 1st dose of Shingrix. In October 2019, the patient started Papaya Tablets at an unknown dose and frequency. In October 2019, less than a week after receiving Shingrix, the patient experienced pancreatic insufficiency (serious criteria GSK medically significant), diarrhea and gas. The patient was treated with pancreatin (Creon). The action taken with Papaya Tablets was unknown. On an unknown date, the outcome of the pancreatic insufficiency and gas were unknown and the outcome of the diarrhea was recovering/resolving.   It was unknown if the reporter considered the pancreatic insufficiency, diarrhea and gas to be related to Shingrix.  Additional details were reported as follows: The patient was pre diabetic before getting the Shingrix shot and she was taking papaya pills at night before getting the shingrix shot.      The patient developed diarrhea within a week after receiving shingrix vaccine. She tried eating eggs and cheese to resolve the issue. The patient went to the doctor who ran blood tests and did stool sample and nothing was found. She was referred to a Gastroenterologist who determined she had pancreatic insufficiency.  She was prescribed to take creon enzyme tablets and those tablets helped with the diarrhea but patient stated that she was being told her pancreas may not improve. The patient had a computerised tomogram scan and there was no growth on pancreas and no cancer was detected. The reporter consented to follow up.      Lab Comments: On an unknown dates, the lab tests were performed
Age: 86.0
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Pancreatic failure, Stool analysis normal, X-ray
Clinical narrative: pancreatic insufficiency; diarrhea; gas; This case was reported by a consumer via call center representative and described the occurrence of pancreatic insufficiency in a 86-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included carica papaya (Papaya Tablets) tablet for product used for unknown indication.   Concurrent medical conditions included pre-diabetes.   On 23rd October 2019, the patient received the 1st dose of Shingrix. In October 2019, the patient started Papaya Tablets at an unknown dose and frequency. In October 2019, less than a week after receiving Shingrix, the patient experienced pancreatic insufficiency (serious criteria GSK medically significant), diarrhea and gas. The patient was treated with pancreatin (Creon). The action taken with Papaya Tablets was unknown. On an unknown date, the outcome of the pancreatic insufficiency and gas were unknown and the outcome of the diarrhea was recovering/resolving.   It was unknown if the reporter considered the pancreatic insufficiency, diarrhea and gas to be related to Shingrix.  Additional details were reported as follows: The patient was pre diabetic before getting the Shingrix shot and she was taking papaya pills at night before getting the shingrix shot.      The patient developed diarrhea within a week after receiving shingrix vaccine. She tried eating eggs and cheese to resolve the issue. The patient went to the doctor who ran blood tests and did stool sample and nothing was found. She was referred to a Gastroenterologist who determined she had pancreatic insufficiency.  She was prescribed to take creon enzyme tablets and those tablets helped with the diarrhea but patient stated that she was being told her pancreas may not improve. The patient had a computerised tomogram scan and there was no growth on pancreas and no cancer was detected. The reporter consented to follow up.      Lab Comments: On an unknown dates, the lab tests were performed
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Anaphylactic reaction, Dairy intolerance, Ear pruritus, Rash, Urticaria
Clinical narrative: Pt given whole milk and cheese for first time between 10-10:30 Pt developed "ear scratching" and hives around 1pm; call to office and advised to bring pt back to be evaluated Pt arrived at 1345 to office with full body rash and vomited Epi 0.15mL given IM; O2 via mask given; 911 called Pt transported to Hospital  ED Impression: Anaphylactic Reaction to Food, probably dairy-milk/cheese Epi Pen prescribed to pt
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Vomiting
Clinical narrative: Pt given whole milk and cheese for first time between 10-10:30 Pt developed "ear scratching" and hives around 1pm; call to office and advised to bring pt back to be evaluated Pt arrived at 1345 to office with full body rash and vomited Epi 0.15mL given IM; O2 via mask given; 911 called Pt transported to Hospital  ED Impression: Anaphylactic Reaction to Food, probably dairy-milk/cheese Epi Pen prescribed to pt
Age: 22.0
Sex: M
Vaccine: FLUR4
Symptoms: Syncope
Clinical narrative: @1725Pt c/o needing to sit down post flu vaccine. Offered water, but pt declined. Pt remained in room for 15 min while other family member received their flu vaccine. @1738 pt walking away from Clinic, but still in store and slid to the floor (unwitnessed by staff, but reported to staff by family members who was w/ him). Pt escorted to waiting room and dad grabbed sugary drink. Pt reports to only eating small amount today.  @1755 - pt tolerated 3/4s of snapple and states he is feeling better. Pulse steady w/ RRR @1815 - pt left clinic w/ family.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Fatigue, Injection site erythema, Myalgia
Clinical narrative: Fatigue, muscle and joint pain, chills, redness around injection site. On second day the redness covers bicep muscle in a ring the size of a blood pressure cuff, however  the other adverse effects are much better.
Age: 15.0
Sex: M
Vaccine: FLU4, HEP, HEPA, HPV9, IPV, MMRV, MNQ, TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: MMRV was given to a 15 yr old child and should not have been used. There was no adverse reaction that occured.
Age: 26.0
Sex: M
Vaccine: TDAP
Symptoms: Hypotension, Loss of consciousness
Clinical narrative: Donor had completed a plasma donation and then received a tetanus immunization. After the immunization, the donor experienced hypotensive LOC.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Immunisation, No adverse event, Product preparation issue
Clinical narrative: RN inadvertently reconstituted the ActHIB vial of vaccine with sterile diluent instead of reconstituting with DTaP-IPV Component. RN was new to clinic and had forgotten there were 2 vials for the Pentacel vaccine.  No adverse outcomes. Contacted RN line and spoke with staff and was told to have patient come back for full dose of Pentacel; the ActHIB portion child received was not valid. Patient came back on 1/28/20 for full Pentacel vaccine reconstituted as instructed.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Muscular weakness, Pain, Pain in extremity, Product administered at inappropriate site
Clinical narrative: My arm has been hurting since receiving the vaccination in October. I am experiencing weakness and pain upon movement that seems to be consistently getting worse. The shot was given where I do not have  much muscle. It was not given in the muscle up by my shoulder, but rather nearer to my elbow.  I am quite thin and tall and wore a short sleeved shirt under a thick sweater that day. When I arrived to the nurse, I pushed up my sweater and asked if that was high enough. She said yes. But now that I have had endless pain, I am thinking she gave me the shot too low and missed my muscle.  I am afraid it will continue to worsen.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: right arm swollen and appearance of redness after one day of vaccine injection
Age: 0.42
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: No adverse event, Product preparation issue
Clinical narrative: Pentacel series given in error.  The DTaP-IPV component was given alone, rather than reconstituted with the ActHib component. There was no adverse reaction, no medical treatment needed for this event.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Alopecia, Condition aggravated, Feeling abnormal, Pain in extremity
Clinical narrative: little soreness in her arm; was not feeling as well; Alopecia; condition aggrvated; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site swelling (1st dose received in July 2019). Concurrent medical conditions included alopecia.   In October 2019, the patient received the 2nd dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced pain in arm, feeling abnormal, alopecia and condition aggravated. On an unknown date, the outcome of the pain in arm and feeling abnormal were recovered/resolved and the outcome of the alopecia and condition aggravated were unknown.   It was unknown if the reporter considered the pain in arm, feeling abnormal, alopecia and condition aggravated to be related to Shingrix.  Additional details were provided as follows: The patient received 2nd dose of Shingrix and experienced little soreness in the arm, and was not feeling as well. The  reporter stated that, the patient recovered in few days from  symptoms. This case has been linked with case US2020003252 and US2020AMR003766, reported by same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: outbreak of shingles; This case was reported by a physician via sales rep and described the occurrence of shingles in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported.  The age group was not reported but it was selected as an adult as per the vaccine indication. After receiving 1st dose Shingrix, the patient had a new outbreak of shingles. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: itchy skin on several parts of my body; This case was reported by a consumer via call center representative and described the occurrence of itchy skin in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced itchy skin. On an unknown date, the outcome of the itchy skin was unknown.   It was unknown if the reporter considered the itchy skin to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported.  The age group was not reported but was selected as adult as per vaccine indication.  The patient received Shingrix vaccine and had itchy skin on several parts of the body (not hives) and asked that this was a common side effect.
Sex: U
Vaccine: VARZOS
Symptoms: Chills
Clinical narrative: intense chills; This case was reported by a other health professional via interactive digital media and described the occurrence of chills in a adult 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 a day after receiving Shingrix, the patient experienced chills. On an unknown date, the outcome of the chills was unknown.   It was unknown if the reporter considered the chills to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication.  After receiving the dose of Shingrix the patient experienced intense chills later that evening while in bed. The patient inquired that does this suggest that patient should not receive second shot.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness
Clinical narrative: chills; flu like symptoms; This case was reported by a consumer via call center representative and described the occurrence of chills in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced chills and influenza-like symptoms. On an unknown date, the outcome of the chills and influenza-like symptoms were not recovered/not resolved.   It was unknown if the reporter considered the chills and influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as an adult as per vaccine indication.  After receiving Shingrix vaccine the patient experienced chills and flu-like symptoms. The reporter wanted to know how long do side effects last from  the first shot.
Sex: U
Vaccine: VARZOS
Symptoms: Headache, Pyrexia
Clinical narrative: headache; fever; This case was reported by a consumer via call center representative and described the occurrence of headache in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd January 2020, the patient received the 2nd dose of Shingrix. In January 2020, less than a week after receiving Shingrix, the patient experienced headache and fever. On an unknown date, the outcome of the headache and fever were unknown.   It was unknown if the reporter considered the headache and fever to be related to Shingrix.  Additional details were provided as follows: The age at vaccination not provided. The age group was not reported but was selected as adult as per vaccine indication.  The patient received dose of Shingrix  and experienced headache and fever.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site induration, Injection site pain
Clinical narrative: induration at the injection site; left arm sore; tiredness; This case was reported by a consumer via call center representative and described the occurrence of injection site induration in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th January 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 21st January 2020, 1 days after receiving Shingrix, the patient experienced injection site induration, injection site pain and tiredness. On an unknown date, the outcome of the injection site induration, injection site pain and tiredness were not recovered/not resolved.   It was unknown if the reporter considered the injection site induration, injection site pain and tiredness to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix dose on left arm and next day, developed tiredness, induration at the injection site and soreness in the left arm. The reporter gave consent for follow up.