chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Woke up around midnight with chills and fever.  Took my temperature and it was 102.2.  My legs and arms were also tingling and my body was very achy.  I also felt weak and tired.  I took 2 500 MG Acetaminophen and went back to bed.  Woke up a few hours later and took my temperature and it was down to 100.  Woke up in the morning and took my temperature and it was back to normal.  I felt better and the reactions to the Zoster vaccine had subsided.
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Peripheral swelling, Swelling face, Urticaria
Clinical narrative: Patient reported hives all over her body and swelling in her face and arms beginning approximately 5 PM on 06/05/2020, and lasting until the morning  of 06/06/2020. She reports taking two Claritin pills of unknown dosage the morning of 06/06/2020.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Fall, Gait disturbance, Nausea
Clinical narrative: Patient was walking out and started feel dizzy and lightheaded. She tripped and fell near the appointment desk. Denies hitting head. Initially felt nauseous and dizzy. Taken to a room. Initial vitals were: BP 75/50, pulse 53, 02 96%. Patient received some water. After five minutes vitals were: BP 92/62, pulse 63, 02 100%. She stated she was feeling better. Walked in the hallway and then took vitals 5 minutes later. BP 92/50, pulse 68, 02 96%. Discussed drinking and eating well prior to vaccination. She had not had much to eat or drink prior to vaccine. She admits to getting very anxious with shots.
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Feeling abnormal, Hypersomnia, Impaired work ability, Myalgia
Clinical narrative: feeling that bad; muscle soreness over injection site; fever; body aches; very tired; slept mostly; This case was reported by a consumer and described the occurrence of muscle soreness in a 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 months after receiving Shingrix, the patient experienced muscle soreness, fever, general body pain, tiredness, sleepiness and feeling bad. On an unknown date, the outcome of the muscle soreness, fever, general body pain, tiredness, sleepiness and feeling bad were unknown.   It was unknown if the reporter considered the muscle soreness, fever, general body pain, tiredness, sleepiness and feeling bad to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and had muscle soreness over injection site. The patient had fever, body aches, very tired and slept mostly 25hrs out of 48hrs. The patient could not afford to miss 2days of work after being out of work 2 months for the Covid virus. The patient was very hesitating to get 2nd dose. This case linked with US2020AMR091617, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR091617:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Pain, Pyrexia, Somnolence
Clinical narrative: feeling that bad; muscle soreness over injection site; fever; body aches; very tired; slept mostly; This case was reported by a consumer and described the occurrence of muscle soreness in a 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 months after receiving Shingrix, the patient experienced muscle soreness, fever, general body pain, tiredness, sleepiness and feeling bad. On an unknown date, the outcome of the muscle soreness, fever, general body pain, tiredness, sleepiness and feeling bad were unknown.   It was unknown if the reporter considered the muscle soreness, fever, general body pain, tiredness, sleepiness and feeling bad to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and had muscle soreness over injection site. The patient had fever, body aches, very tired and slept mostly 25hrs out of 48hrs. The patient could not afford to miss 2days of work after being out of work 2 months for the Covid virus. The patient was very hesitating to get 2nd dose. This case linked with US2020AMR091617, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR091617:Same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Feeling abnormal, Hypersomnia, Impaired work ability, Myalgia
Clinical narrative: muscle soreness over injection site; fever; body aches; very tired; slept mostly; feeling that bad; This case was reported by a consumer and described the occurrence of muscle soreness in a male 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 months after receiving Shingrix, the patient experienced muscle soreness, fever, general body pain, tiredness, sleepiness and feeling bad. On an unknown date, the outcome of the muscle soreness, fever, general body pain, tiredness, sleepiness and feeling bad were unknown.   It was unknown if the reporter considered the muscle soreness, fever, general body pain, tiredness, sleepiness and feeling bad to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and had muscle soreness over injection site. The patient had fever, body aches, very tired and slept mostly 25hrs out of 48hrs. The patient could not afford to miss 2days of work after being out of work 2 months for the Covid virus. The patient was very hesitating to get 2nd dose. This case linked with US2020AMR091587, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR091587:Same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Pyrexia, Somnolence
Clinical narrative: muscle soreness over injection site; fever; body aches; very tired; slept mostly; feeling that bad; This case was reported by a consumer and described the occurrence of muscle soreness in a male 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 months after receiving Shingrix, the patient experienced muscle soreness, fever, general body pain, tiredness, sleepiness and feeling bad. On an unknown date, the outcome of the muscle soreness, fever, general body pain, tiredness, sleepiness and feeling bad were unknown.   It was unknown if the reporter considered the muscle soreness, fever, general body pain, tiredness, sleepiness and feeling bad to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and had muscle soreness over injection site. The patient had fever, body aches, very tired and slept mostly 25hrs out of 48hrs. The patient could not afford to miss 2days of work after being out of work 2 months for the Covid virus. The patient was very hesitating to get 2nd dose. This case linked with US2020AMR091587, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR091587:Same reporter
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site swelling
Clinical narrative: injection site swelling; headache; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st June 2020, the patient received the 2nd dose of Shingrix. In June 2020, less than a day after receiving Shingrix, the patient experienced injection site swelling and headache. On an unknown date, the outcome of the injection site swelling and headache were not recovered/not resolved.   It was unknown if the reporter considered the injection site swelling and headache to be related to Shingrix.  Additional details were provided as follows On 1st June 2020 around 5.30 PM, the patient received the vaccine. On 2nd June 2020, the patient woke up in the morning with swelling at the injection site and a headache.  The reporter consented to follow up.
Age: 91.0
Sex: F
Vaccine: TD
Symptoms: Product storage error
Clinical narrative: Vaccine not viable, Out of  temperature range
Age: 35.0
Sex: F
Vaccine: VARZOS
Symptoms: Bone pain, Chills, Decreased appetite, Fatigue, Headache
Clinical narrative: Fever greater than 101.6 for 48 hours, muscle pain, bone pain, headache,  fatigue, chills, site redness, warmth and pain, skin painful to touch throughout body, loss of appetite
Age: 35.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Myalgia, Pain of skin
Clinical narrative: Fever greater than 101.6 for 48 hours, muscle pain, bone pain, headache,  fatigue, chills, site redness, warmth and pain, skin painful to touch throughout body, loss of appetite
Age: 35.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Fever greater than 101.6 for 48 hours, muscle pain, bone pain, headache,  fatigue, chills, site redness, warmth and pain, skin painful to touch throughout body, loss of appetite
Age: 25.0
Sex: M
Vaccine: HEP
Symptoms: Abdominal discomfort, Nausea, Pyrexia, Vomiting
Clinical narrative: Employee reported fever of 101.2. Nausea, Vomiting, and upset stomach. Employee stated that this happened the evening after Immunization.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Blood pressure decreased, Cold sweat, Posture abnormal
Clinical narrative: I gave the patient a TDAP (RD) and the Menveo (LD). I had patient laying down while I gave both shots. After the shots I had patient laying down with it tilted and had mom standing by his side. I asked the patient how he felt and he state he felt good. I was having them wait 15 minutes before leaving. About ten minutes later I hard mom yell help. By the time I got to the room he was slouched down on the bed. I had Dr come into the room and revalute the patient. The patient was clammy. We put and ice pack on his head, and checked his BP. We continued to have pt lay down. We checked his BP a few more times. Pt bp come up to normal and made sure he was able to stand and walk. PT state he felt fine, but the situation scared him. Once we knew he could walk/stand/and feel fine, we release his family. I gave mother the packed for vasovagal syncope packet, to go home with and to call for any other concers.
Age: 70.0
Sex: M
Vaccine: TD
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine not viable, Out of temperature range,  No adverse reaction,  Will revaccinate.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Fear, Middle insomnia, Mobility decreased, Pain, Pain in extremity
Clinical narrative: The patient woke up in the middle of the night and could not move her head or upper body, reporting that it was very frightening. She reported extreme achiness and soreness in her upper body and arm throughout the remainder of the next morning and afternoon.
Age: 76.0
Sex: M
Vaccine: TDAP
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccine not viable. out of temperature range. no adverse reaction. will revaccinate
Age: 59.0
Sex: M
Vaccine: TD
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine not viable,  Stored out of temperature range. No adverse reaction,  Will revaccinate.
Age: 8.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No known adverse effects; An 8 year old patient received a dose of GARDASIL 9.; This spontaneous report was received from a medical assistant referring to a 8-year-old patient on unknown gender. Information about patient's pertinent concurrent conditions, medical history, concomitant medications and previous drug reactions or allergies was not provided.  On 19-DEC-2019, the patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) as prophylaxis (concentration, number of administered dose, vaccination scheme frequency, route and anatomical location of vaccination were not reported; reported lot number 1621931 and expiration date 26-JAN-2022) (product administered to patient of inappropriate age). No known adverse effects. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1621931; expirationdate: 26-JAN-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: F
Vaccine: HPV4
Symptoms: Neoplasm malignant, Papilloma viral infection
Clinical narrative: on her 16th birthday she found out she had cancerous cells related to HPV; on her 16th birthday she found out she had cancerous cells related to HPV; This spontaneous report was received from a consumer (patient's mother) and refers to a 16-year-old (currently 28-year-old) female patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On unknown dates in 2006, when the patient was 12 or 13-year-old, she was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) shots (dose, route of administration, lot number and expiration date were not reported) for human papilloma virus (HPV) prophylaxis. On an unknown date in 2009, on her 16th birthday, the patient found out that she had cancerous cells related to HPV (captured as cancer and HPV infection). She sought medical attention and went to the doctor. She received several unspecified procedures as treatment for the events. The patient's last check for the cancerous cells, performed on an unknown date, was clear. However, the patient's mother stated that it did not mean that her daughter was totally cured. The patient's mother did not know which strain of HPV the patient developed. The outcome of the events was reported as recovering. The relatedness between the events and suspect therapy was not provided.  Upon internal review, the event of cancer was considered to be medically significant.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash, Rash vesicular
Clinical narrative: outbreak / on neck, chest, shoulders and back; Shingles on face/Shingles rash; Varicella-like; This case was reported by a consumer via call center representative and described the occurrence of rash in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included herpes virus infection.   On 2nd March 2020, the patient received the 1st dose of Shingrix. In March 2020, less than 2 weeks after receiving Shingrix and an unknown time after starting acyclovir and Valacyclovir, the patient experienced rash, shingles and varicella-like rash. The patient was treated with acyclovir and valaciclovir hydrochloride (Valacyclovir). On an unknown date, the outcome of the rash, shingles and varicella-like rash were unknown.   It was unknown if the reporter considered the rash, shingles and varicella-like rash to be related to Shingrix  Additional details were provided as follows The patient experienced an outbreak of Shingles then went to physician and the outbreak started on face then traveled down the neck.  On 13th March 2020, the patient experienced another breakout on neck, chest, shoulders and back. On 13th March 2020, the patient's physician started Acyclovir 1 gram three times a day which she took for about 2 weeks. On 5th May 2020, her 2nd outbreak was started. The patient used Valacyclovir 500mg that she had from the past. The blisters were no blisters, looks like chicken pox rash. The reporter did not consent to follow up.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Tenderness
Clinical narrative: arm is tender; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included cardiac pacemaker malfunction (Failed Electrode in Heart). Concomitant products included cyanocobalamin (B12 Injection).   On 1st June 2020, the patient received the 1st dose of Shingrix (intramuscular). On 1st June 2020, immediately after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: Approximately 10:30AM The patient received 1st dose of Shingrix  and experienced arm was tender since the injection.  The reporter did consent to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Adverse drug reaction, Influenza like illness
Clinical narrative: flu like symptoms; side effects; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a adult male 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 influenza-like symptoms and adverse drug reaction. On an unknown date, the outcome of the influenza-like symptoms and adverse drug reaction were unknown.   It was unknown if the reporter considered the influenza-like symptoms and adverse drug reaction to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported.  The patient after receiving the 1st dose of experienced flu like symptoms and other unspecified events listed in the side effect profile.  The patient had not elaborated beyond the flu like symptoms. the caller did not wish to participate in a safety report and would not elaborated on flu like symptoms, or other side effects. The reporter did not consent to follow up. For tolerance to 2nd dose refer linked case US2020AMR093099, reported by the same reporter. ; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR093099:
Age: 38.0
Sex: F
Vaccine: TD
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine not viable. Stored out of temperature range. No adverse reaction, Will revaccinate
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Cyanosis, Rash
Clinical narrative: rash and bluish feet the evening of  vaccines.  Rash gone in 15 minutes. No fever baby acting normally
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Urticaria
Clinical narrative: Mom, called with concerns about Patient who received one vaccination today in her left arm. She developed two small welts on the left arm about 2 hours after the vaccine was administered however, the welts were not near the injection site. She now has 5 or 6 large welts on other areas of her body. One large welt on her leg, one on the neck, another under her chin and one on her back. Mom wonders if the welts are a common reaction to Menactra vaccine. Patient had her first dose of Menactra in 2015 and she did not have this reaction. Patient is very allergic to peanuts and even the residue on surfaces has caused her to have hives up to two weeks after the surface was touched by a peanut consuming individual. Mom wonders if she came into contact while in the office with a surface contaminated with peanut residue. Patient told Mom that she saw another child entering the building as she was leaving and he was eating peanut butter pretzels. Patient took 25 mg Benadryl 3 hours ago. Advice given to give another 25 mg Benadryl now and continue with 50 mg Benadryl every 6 hours as needed for hives. Mom has EpiPen on hand and is aware of the need to use it for cough, wheezing, shortness of breath, swelling of the tongue or vomiting. Will ask Dr. if VAERS report is indicated and whether MenB vaccine would be recommended at age 17/18 years. Mom agrees to call back tomorrow morning with an update on Patient's hives, to the ER for concerns of anaphylaxis or worsening hives.
Age: 22.0
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional adverse event; I was administered the second dose ofGARDASIL 9 around 3/21/2020 after the first dose ofGARDASIL 9 was administered around four years ago; This spontaneous report has been received from a healthcare professional who was also a 26 years old patient of unknown gender, referring to her/himself. The patient's current condition, history condition and concomitant medication were not provided.  In 2016 (reported as around four years ago (unspecified date)), the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot# and expiration date; dose, strength and route were unknown) for prophylaxis. On 21-MAR-2020 (reported as around 21-MAR-2020), the patient was administered the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (intramuscular) (inappropriate schedule of product administration). No additional adverse event.
Age: 0.33
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: No additional adverse effects reported; The patient was administered the wrong vaccine; 4 month old patient was administered PROQUAD; This spontaneous report was received from a medical assistant who refers to a 4-month-old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies was provided.  On 22-MAY-2020, the patient was mistakenly administered the wrong vaccine which was measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), recombinant human albumin (rHA), lot # S031706, expiration date upon internal validation has been established as 06-APR-2021 (same as reported) (dose, strength, anatomical location were not provided), for prophylaxis (wrong product administered and product administered to patient of inappropriate age). No additional adverse effects were reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional adverse effects reported; patinet was administered a dose if improperly stored VARIVAX; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 27-MAY-2020, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX), lot # S035124 and expiration date 04-NOV-2021, (strength, dose, frequency and anatomical location not reported) via subcutaneous route for prophylaxis (product storage error). It was reported that the vaccine was reconstituted with properly stored sterile diluent. The storage temperature was reported as minus 14 degree Celsius to minus 10 degree Celsius (minus 13.42 degree Celsius) for timeframe of 1 hour. There was no previous temperature excursion. Data logger was involved. No additional adverse effect reported.  This is one of the two reports received from the same reporter.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse events; the patient was administered improperly stored dose of proquad on 04-06-2020; This spontaneous report was received from a nurse regarding a patient of unknown age and gender. The patient's medical history, historical drugs, drug allergies, concurrent conditions and concomitant medications were not reported.   On 04-JUN-2020, the nurse reported that the patient was administered an improperly stored dose of measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (PROQUAD) (product storage error) (lot# S021324 and expiry date was reported as 05-JAN-2021; dose, route of administration and product indication were not reported) with properly stored DILUENT MRK Injection (lot# T003594 and expiry date was reported as 07-JUL-2022). The vaccine was stored at 21.4 Fahrenheit (F) for 2 hours. There was no previous temperature excursion. No adverse effect was reported. The call was because of data logger. No product quality complaint (PQC) was present.
Sex: M
Vaccine: VARZOS
Symptoms: Cerebrovascular accident
Clinical narrative: stroke; Information has been received from a lawyer regarding a case in litigation and refers to a male patient (pt) of an unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 14-FEB-2014, the pt was inoculated with zoster vaccine live (ZOSTAVAX) as prescribed and/or administered by a pharmacist at a pharmacy (strength, dose, dose number, route, anatomical site of vaccination, lot number and expiration date were not provided) for the long-term prevention of shingles and/or zoster-related conditions. On an unknown date (reported as subsequent to the pt's zoster vaccine live (ZOSTAVAX) inoculation), the pt was hospitalized and treated by a healthcare provider for stroke (cerebrovascular accident). As a direct and proximate result of pt's use of the zoster vaccine live (ZOSTAVAX) vaccine, the pt had and would continued 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 would continue to suffer such losses, and damages in the future. At the time of this report, the outcome of cerebrovascular accident was unknown. The reporter assessed that the event was related to zoster vaccine live (ZOSTAVAX).  Upon internal review, cerebrovascular accident was determined to be a medically significant event.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Burning pain; This case was reported by a other health professional via interactive digital media and described the occurrence of pain burning in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain burning. On an unknown date, the outcome of the pain burning was unknown.   It was unknown if the reporter considered the pain burning 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 adult as per the vaccine indication. The patient received Shingrix and had burning pain.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Immunosuppressant drug therapy, Leukaemia, Vaccination failure
Clinical narrative: received 1st and 2nd dose of Shingrix / developed Shingles twice; Leukemia; Shingles; This case was reported by a physician via call center representative and described the occurrence of vaccination failure in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), leukemia (serious criteria GSK medically significant) and shingles. The patient was treated with immunosuppressants nos (Immunosuppressant Drug (Nos)). On an unknown date, the outcome of the vaccination failure, leukemia and shingles were unknown.   It was unknown if the reporter considered the vaccination failure, leukemia and shingles to be related to Shingrix and Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group of the patient was not reporteed but selected as an adult as per vaccine indicaion. The reporter stated that, the patient received 1st and 2nd dose of Shingrix 2 years before the date of reporting, and experienced shingles 2 times,1st in 2019 and 2nd time in 2020. The patient had leukemia and was under immunosupressive treatment. No further details were reported
Age: 97.0
Sex: F
Vaccine: TD
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine not viable, Stored out of temperature range. No adverse reactions
Age: 67.0
Sex: M
Vaccine: TD
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine not viable, Stored out of temperature range. No adverse reaction
Age: 22.0
Sex: F
Vaccine: TD
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine not viable, Stored out of temperature range. No adverse reaction.
Age: 18.0
Sex: F
Vaccine: TD
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine not viable. Stored out of temperature range. No adverse reaction
Age: 16.0
Sex: M
Vaccine: TD
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine not viable, Stored out of temperature range. No adverse reaction.
Age: 54.0
Sex: M
Vaccine: TD
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine not viable, Stored out of temperature range. No adverse reaction.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Vaccination complication
Clinical narrative: 05/15/20 family member called and said she felt like Patient was having an adverse reaction to a vaccine he received on 05/13/20. Stated child had swelling and redness to be around 3-4 inches in diameter at injection site on left arm and hot to touch. Child had no fever. Discussed vaccines can cause redness ans swelling at the injection site but to bring child by the clinic for us to look at arm and to take to PCP for evaluation. Family did not bring child to clinic. Tried to call unable to make contact by phone. 05/18 left message for child's grandmother, to give us a call. 5/21/20 grandmother called, she said her and her son are Patient's legal gaurdians, Child had telemediciane with APRN  child was started on benadryl and claritn  for possible reaction to vaccine. PCP does not want to make decision regarding future vaccine at this time. Redness and swelling went down 2 days after starting medication.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: Body temperature increased
Clinical narrative: elevated temp, high 102
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain, Blood test, Diarrhoea, Haematochezia, Hyperhidrosis
Clinical narrative: Injection Tuesday, June 2 Wednesday, June 3 redness & feverish where injection was given on right arm Friday, June 5, 3:00 a.m. severe abdominal cramps, body sweats and diarrhea for 3 hours All day Friday I felt achy and diarrhea continued as did cramps.  10 a.m. I had blood in my stool and called my Dr. to talk to a nurse.  She suggested I go to ER to be checked.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth, Pain, Rectal examination
Clinical narrative: Injection Tuesday, June 2 Wednesday, June 3 redness & feverish where injection was given on right arm Friday, June 5, 3:00 a.m. severe abdominal cramps, body sweats and diarrhea for 3 hours All day Friday I felt achy and diarrhea continued as did cramps.  10 a.m. I had blood in my stool and called my Dr. to talk to a nurse.  She suggested I go to ER to be checked.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: pain, swelling and redness extending down arm.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: Crying, Injection site induration, Injection site nodule
Clinical narrative: hardened knot at injection site and inconsolable crying
Age: 71.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Injection site pain, Pain
Clinical narrative: She said her right arm was still sore from the injection from 3-5-2020  and today is 6-9-2020.   She said the site or arm started getting sore a few days after the injection was given.  She is complaining that it hurts when she lifts anything and when she lifts it above her head like she is raising her hand.  She said it is a sharp pain at a certain point of her getting the hand at a certain height.   She thought it was due to the Boostrix but I indicated that the Pneumovax was given in that arm at her request.  I told her that  she needs to inform her Dr.  She said that she is going to see her Dr in a couple of weeks and will inform them then.
Age: 39.0
Sex: M
Vaccine: ANTH
Symptoms: Hypoaesthesia
Clinical narrative: Ring and Pinky finger numbness at the tip of fingers. Physician recommended to monitor. Seek EMS treatment for adverse reactions such as SOB, itching, hives, etc.
Age: 1.0
Sex: M
Vaccine: MMRV
Symptoms: Pyrexia, Rash
Clinical narrative: FEVER AND RASH
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Enlarged uvula
Clinical narrative: Patient reported a swollen Uvula and severe stomach cramps.
Age: 35.0
Sex: F
Vaccine: DTAP
Symptoms: Haemorrhagic stroke
Clinical narrative: Hemorrhagic Stroke, 8 hrs after the vaccine was administered.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Body temperature increased, Culture urine, Feeling abnormal, Hypoaesthesia
Clinical narrative: Pt called on 6/09  stating that she felt awful, and didn't get any sleep due to severe nerve pain on touch and numbness and tingling everywhere, even on the bottom of her feet , She stated that she felt so weak that she could not even "let the dog out" or climb the stairs, Patient ended up calling in sick to work . this started about 6pm on 06/08. Patient ended up going in to the clinic on 06/09 and saw a prescriber. She stated that she had a 100.6 temperature and that her Dr stated that she might have a urinary tract infection.. She was prescribed a sulfa antibiotic for 3 days. I contacted patient at 6pm 06/09 and pt stated that she still felt numbness and tingling all over and felt "awlful" yet .
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Impaired work ability, Insomnia, Neuralgia, Paraesthesia
Clinical narrative: Pt called on 6/09  stating that she felt awful, and didn't get any sleep due to severe nerve pain on touch and numbness and tingling everywhere, even on the bottom of her feet , She stated that she felt so weak that she could not even "let the dog out" or climb the stairs, Patient ended up calling in sick to work . this started about 6pm on 06/08. Patient ended up going in to the clinic on 06/09 and saw a prescriber. She stated that she had a 100.6 temperature and that her Dr stated that she might have a urinary tract infection.. She was prescribed a sulfa antibiotic for 3 days. I contacted patient at 6pm 06/09 and pt stated that she still felt numbness and tingling all over and felt "awlful" yet .
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Erythema, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: starting Saturday afternoon 6/6 arm itchy, red, swollen, warm to touch mid upper arm, saw Dr Monday 6/8 and got antibiotic doxycycline to treat cellulitis
Age: 56.0
Sex: F
Vaccine: UNK
Symptoms: Dizziness, Presyncope
Clinical narrative: Reported near syncope, dizziness x few minutes. Sat + drank some water & resolved
Age: 69.0
Sex: F
Vaccine: PNC
Symptoms: Erythema
Clinical narrative: Pt. has redness on her arm. She took Benadryl, It helped her to get down little
Age: 62.0
Sex: F
Vaccine: VARZOS, HEPAB, UNK, VARZOS
Symptoms: Arthralgia, Chills, Dizziness, Groin pain, Influenza like illness
Clinical narrative: Patient experienced dizziness, nausea, chills, felt feverish (however, no elevated temperature).  soreness and stiffness in her neck, sore throat and feeling as if throat was swollen.  Pain radiating in her back back between her shoulder blades and into her ribs (she felt like she had a broken rib). Her legs ached as well.  She did have soreness and tenderness at the injection site.  She described redness around the site that lasted a day, and re-appeared a few days later.  She felt the symptoms had resolved by 6-1-2020
Age: 62.0
Sex: F
Vaccine: VARZOS, HEPAB, UNK, VARZOS
Symptoms: Injection site erythema, Injection site pain, Lymphadenopathy, Musculoskeletal chest pain, Nausea
Clinical narrative: Patient experienced dizziness, nausea, chills, felt feverish (however, no elevated temperature).  soreness and stiffness in her neck, sore throat and feeling as if throat was swollen.  Pain radiating in her back back between her shoulder blades and into her ribs (she felt like she had a broken rib). Her legs ached as well.  She did have soreness and tenderness at the injection site.  She described redness around the site that lasted a day, and re-appeared a few days later.  She felt the symptoms had resolved by 6-1-2020
Age: 62.0
Sex: F
Vaccine: VARZOS, HEPAB, UNK, VARZOS
Symptoms: Neck pain, Oropharyngeal pain, Pain in extremity, Pyrexia, Tenderness
Clinical narrative: Patient experienced dizziness, nausea, chills, felt feverish (however, no elevated temperature).  soreness and stiffness in her neck, sore throat and feeling as if throat was swollen.  Pain radiating in her back back between her shoulder blades and into her ribs (she felt like she had a broken rib). Her legs ached as well.  She did have soreness and tenderness at the injection site.  She described redness around the site that lasted a day, and re-appeared a few days later.  She felt the symptoms had resolved by 6-1-2020
Age: 62.0
Sex: F
Vaccine: VARZOS, HEPAB, UNK, VARZOS
Symptoms: Back pain, Chills, Dizziness, Injection site erythema, Injection site pain
Clinical narrative: Patient experienced dizziness, nausea, chills, felt feverish (however, no elevated temperature).  soreness and stiffness in her neck, sore throat and feeling as if throat was swollen.  Pain radiating in her back back between her shoulder blades and into her ribs (she felt like she had a broken rib). Her legs ached as well.  She did have soreness and tenderness at the injection site.  She described redness around the site that lasted a day, and re-appeared a few days later.  She felt the symptoms had resolved by 6-1-2020
Age: 62.0
Sex: F
Vaccine: VARZOS, HEPAB, UNK, VARZOS
Symptoms: Musculoskeletal chest pain, Musculoskeletal stiffness, Nausea, Neck pain, Oropharyngeal pain
Clinical narrative: Patient experienced dizziness, nausea, chills, felt feverish (however, no elevated temperature).  soreness and stiffness in her neck, sore throat and feeling as if throat was swollen.  Pain radiating in her back back between her shoulder blades and into her ribs (she felt like she had a broken rib). Her legs ached as well.  She did have soreness and tenderness at the injection site.  She described redness around the site that lasted a day, and re-appeared a few days later.  She felt the symptoms had resolved by 6-1-2020
Age: 62.0
Sex: F
Vaccine: VARZOS, HEPAB, UNK, VARZOS
Symptoms: Pain, Pain in extremity, Pharyngeal swelling, Pyrexia
Clinical narrative: Patient experienced dizziness, nausea, chills, felt feverish (however, no elevated temperature).  soreness and stiffness in her neck, sore throat and feeling as if throat was swollen.  Pain radiating in her back back between her shoulder blades and into her ribs (she felt like she had a broken rib). Her legs ached as well.  She did have soreness and tenderness at the injection site.  She described redness around the site that lasted a day, and re-appeared a few days later.  She felt the symptoms had resolved by 6-1-2020
Age: 2.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Injection site pain, Injection site pustule, Injection site rash, Injection site swelling
Clinical narrative: Patient Mom reported 1 day post vaccine administration patient had a couple of raised red bumps that "look like chickenpox" around the immunization site, on the Rt leg, as well as some swelling.  Ibuprofen given which helped the swelling. Denied fever or other symptoms. Resolved per parent in 48 hours but remained faintly bruised looking.  On 6/5/2020 4 small blisters appeared on the right calf. Appear fluid filled.
Age: 2.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Blister, Injection site bruising, Injection site reaction, Injection site swelling, Rash vesicular
Clinical narrative: Patient Mom reported 1 day post vaccine administration patient had a couple of raised red bumps that "look like chickenpox" around the immunization site, on the Rt leg, as well as some swelling.  Ibuprofen given which helped the swelling. Denied fever or other symptoms. Resolved per parent in 48 hours but remained faintly bruised looking.  On 6/5/2020 4 small blisters appeared on the right calf. Appear fluid filled.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Acute haemorrhagic oedema of infancy, Contusion, Erythema, Gait inability, Injection site bruising
Clinical narrative: acute hemorrhagic edema of infancy. Swollen legs and feet. Severe bruised look of the legs and arms for several weeks. Could not walk for over a week. Low grade fever. Multiple erythematous papillose, merciless and patches on Upper and Lower extremities. There was not a treatment. It resolved on its own in a few weeks.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Papule, Peripheral swelling, Pyrexia
Clinical narrative: acute hemorrhagic edema of infancy. Swollen legs and feet. Severe bruised look of the legs and arms for several weeks. Could not walk for over a week. Low grade fever. Multiple erythematous papillose, merciless and patches on Upper and Lower extremities. There was not a treatment. It resolved on its own in a few weeks.
Age: 1.25
Sex: F
Vaccine: DTAPHEPBIP, MMR, VARCEL
Symptoms: Full blood count, Immune thrombocytopenia, Petechiae, Pruritus, Rash maculo-papular
Clinical narrative: Patient started with maculopapular rash on fact that then progressed to petechia on her face, scalp, ears and neck along with maculopapular rash on trunk and lower extremities 10 days after vaccination. No fevers, no nausea, vomiting or diarrhea, no altered mental status, no seizure, no mucous membrane involvement, rash spares palms and soles. Patient was otherwise well and acting appropriately despite rash.  Treatment- given petechia and reports of ITP after MMR CBC was ordered. Benadryl prn was started for itching, and follow up in 2 weeks. Return precautions discussed with parent Outcomes - unavailable yet
Age: 18.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse symptoms reported; improperly stored vaccines were administered to patients; This spontaneous report was received from a nurse referring to an unspecified patients of unknown age and gender. The patients pertinent medical history, concurrent conditions, drug reactions or allergies, and concomitant therapies were not provided.       On 03-DEC-2019, The nurse identified that on an unknown date, 8 unspecified patients were vaccinated with an improperly stored (product storage error) measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # R026719 has been verified to be a valid number; expiration date 17-MAR-2020), and 5 unspecified patients with varicella virus vaccine live (oka/merck) (VARIVAX) (lot # R018138 has been verified to be a valid number; expiration date 25-JUN-2020) both vaccines for prophylaxis (strength, dose, frequency, route of administration, anatomical location were not reported). The temperature excursion was at 6 degrees Fahrenheit (F) to 14 degrees F (-14 degrees centigrade (C) to -10 degrees C) (8.7 F), for a time frame of 50 minutes, and  the previous temperature excursion was at 6 degrees Fahrenheit (F) to 14 degrees F (-14 degrees centigrade (C) to -10 degrees C) (6.9 F) for a timeframe of 50 minutes. It was reported that the call was due to data logger. No adverse symptoms were reported.  This case was determined as non-valid due to lack of patient identifiers.  Upon receipt of follow-up information from nurse on 08-JUN-2020, it was determined that the case is now valid as the patient identifiers were reported.   The patient was 18 years-old. The suspect product of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was deleted. On 15-NOV-2019 (previously reported as 03-DEC-2019), the patient was vaccinated with improperly stored (product storage error) varicella virus vaccine live (oka/merck) (VARIVAX) and on 18-DEC-2019, the patient was vaccinated again with varicella virus vaccine live (oka/merck) (VARIVAX) (lot # R018138 has been verified to be a valid number; expiration date 25-JUN-2020) both for prophylaxis (strength, dose, frequency, route of administration, anatomical location were not reported).  This is one of the several reports received from the same reporter.; Sender's Comments:  US-009507513-2006USA003313:same reporter US-009507513-2006USA003314:same reporter
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: The patient experienced no symptoms; An improperly stored VARIVAX was used on 12-FEB-2020; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions, or allergies were not provided.  It was reported that on 10-JUL-2019, the vaccine varicella virus vaccine live (oka/merck) (VARIVAX) (lot number S005080, which has been verified to be valid, expiration date validated as 19-FEB-2021) had a temperature excursion, therefore, the reporter mentioned that "the expiration date was changed to 10-OCT-2019". However, on 12-FEB-2020, the patient was vaccinated with the improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (dose, vaccination scheme and site of administration were not reported), administered subcutaneously as prophylaxis (product storage error). The sterile diluent (MERCK STERILE DILUENT) used for administration was properly stored and was not expired. The patient experienced no symptoms.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No patients experienced symptoms; Improperly stored dose of PROQUAD was administered to the patient on 02-JUN-2020; This spontaneous report was received from a nurse referring to a patient of unknown age and gender.   The patient's concurrent conditions, medical history and concomitant medications were not reported.   On 02-JUN-2020, dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) subcutaneously, lot # S031705 and expiration date 06-APR-2021 (dose and frequency were not reported) as prophylaxis, which was improperly stored in a temperature of 17.2°F in a timeframe of 14 hours and 2 minutes and reconstituted with a properly stored sterile diluent (STERILE DILUENT MRK INJ HH) was administered to the patient.   It was reported that the call was made due to data logger and no previous temperature excursion occurred.  No adverse symptoms were reported for the patient.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2006USA001657: US-009507513-2006USA001645: US-009507513-2006USA001624: