chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 13.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect reported; unknown doses of improperly stored GARDASIL 9 were administered; This spontaneous report as received from a nurse refers to a 13-year-old patient of unknown gender. No information regarding the patient's pertinent medical history, concomitant medication, drug reactions and allergies was provided.  On 01-JUL-2019, the patient was vaccinated with improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # R027577, expiration date 23-JUN-2021 (dose and route of administration were not provided) for prophylaxis. The vaccine was stored in the lowest registered temperature below 36 Fahrenheit degrees (30.60 F) for total 59 minutes and the highest registered temperature above 47 Fahrenheit degrees (49.10 F) for total 30 minutes. Previous temperature excursion was registered when the vaccine was stored in the temperature between 36 and 46 (45.5) Fahrenheit degrees for 1 hour. The digital data logger was involved.  No adverse effects were reported.; Sender's Comments:  US-009507513-1907USA012222: US-009507513-1907USA012231: US-009507513-1907USA012224: US-009507513-1907USA012225: US-009507513-1907USA012226: US-009507513-1907USA002267: US-009507513-1907USA012228: US-009507513-1907USA012229: US-009507513-1907USA012230: US-009507513-1907USA012221: US-009507513-1907USA012220: US-009507513-1907USA012219: US-009507513-1907USA012223:
Age: 11.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect reported; unknown doses of improperly stored GARDASIL 9 were administered; This spontaneous report as received from a nurse refers to a 11-year-old patient of unknown gender. No information regarding the patient's pertinent medical history, concomitant medication, drug reactions and allergies was provided.  On 01-JUL-2019, the patient was vaccinated with improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # R027577, expiration date 23-JUN-2021 (dose and route of administration were not provided) for prophylaxis. The vaccine was stored in the lowest registered temperature below 36 Fahrenheit degrees (30.60 F) for total 59 minutes and the highest registered temperature above 47 Fahrenheit degrees (49.10 F) for total 30 minutes. Previous temperature excursion was registered when the vaccine was stored in the temperature between 36 and 46 (45.5) Fahrenheit degrees for 1 hour. The digital data logger was involved.  No adverse effects were reported.; Sender's Comments:  US-009507513-1907USA012222: US-009507513-1907USA012231: US-009507513-1907USA012224: US-009507513-1907USA012225: US-009507513-1907USA012226: US-009507513-1907USA012227: US-009507513-1907USA002267: US-009507513-1907USA012229: US-009507513-1907USA012230: US-009507513-1907USA012221: US-009507513-1907USA012220: US-009507513-1907USA012219: US-009507513-1907USA012223:
Age: 15.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect reported; unknown doses of improperly stored GARDASIL 9 were administered; This spontaneous report as received from a nurse refers to a 15-year-old patient of unknown gender. No information regarding the patient's pertinent medical history, concomitant medication, drug reactions and allergies was provided.  On 01-JUL-2019, the patient was vaccinated with improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # R027577, expiration date 23-JUN-2021 (dose and route of administration were not provided) for prophylaxis. The vaccine was stored in the lowest registered temperature below 36 Fahrenheit degrees (30.60 F) for total 59 minutes and the highest registered temperature above 47 Fahrenheit degrees (49.10 F) for total 30 minutes. Previous temperature excursion was registered when the vaccine was stored in the temperature between 36 and 46 (45.5) Fahrenheit degrees for 1 hour. The digital data logger was involved.  No adverse effects were reported.; Sender's Comments:  US-009507513-1907USA012222: US-009507513-1907USA012231: US-009507513-1907USA012224: US-009507513-1907USA012225: US-009507513-1907USA012226: US-009507513-1907USA012227: US-009507513-1907USA012228: US-009507513-1907USA002267: US-009507513-1907USA012230: US-009507513-1907USA012221: US-009507513-1907USA012220: US-009507513-1907USA012219: US-009507513-1907USA012223:
Age: 12.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect reported; unknown doses of improperly stored GARDASIL 9 were administered; This spontaneous report as received from a nurse refers to a 12-year-old patient of unknown gender. No information regarding the patient's pertinent medical history, concomitant medication, drug reactions and allergies was provided.  On 01-JUL-2019, the patient was vaccinated with improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # R027577, expiration date 23-JUN-2021 (dose and route of administration were not provided) for prophylaxis. The vaccine was stored in the lowest registered temperature below 36 Fahrenheit degrees (30.60 F) for total 59 minutes and the highest registered temperature above 47 Fahrenheit degrees (49.10 F) for total 30 minutes. Previous temperature excursion was registered when the vaccine was stored in the temperature between 36 and 46 (45.5) Fahrenheit degrees for 1 hour. The digital data logger was involved.  No adverse effects were reported.; Sender's Comments:  US-009507513-1907USA012222: US-009507513-1907USA012231: US-009507513-1907USA012224: US-009507513-1907USA012225: US-009507513-1907USA012226: US-009507513-1907USA012227: US-009507513-1907USA012228: US-009507513-1907USA012229: US-009507513-1907USA002267: US-009507513-1907USA012221: US-009507513-1907USA012220: US-009507513-1907USA012219: US-009507513-1907USA012223:
Age: 12.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect reported; unknown doses of improperly stored GARDASIL 9 were administered; This spontaneous report as received from a nurse refers to a 12-year-old patient of unknown gender. No information regarding the patient's pertinent medical history, concomitant medication, drug reactions and allergies was provided.  On 29-JUN-2019, the patient was vaccinated with improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # R027577, expiration date 23-JUN-2021 (dose and route of administration were not provided) for prophylaxis. The vaccine was stored in the lowest registered temperature below 36 Fahrenheit degrees (30.60 F) for total 59 minutes and the highest registered temperature above 47 Fahrenheit degrees (49.10 F) for total 30 minutes. Previous temperature excursion was registered when the vaccine was stored in the temperature between 36 and 46 (45.5) Fahrenheit degrees for 1 hour. The digital data logger was involved.  No adverse effects were reported.; Sender's Comments:  US-009507513-1907USA012222: US-009507513-1907USA002267: US-009507513-1907USA012224: US-009507513-1907USA012225: US-009507513-1907USA012226: US-009507513-1907USA012227: US-009507513-1907USA012228: US-009507513-1907USA012229: US-009507513-1907USA012230: US-009507513-1907USA012221: US-009507513-1907USA012220: US-009507513-1907USA012219: US-009507513-1907USA012223:
Sex: F
Vaccine: MMR
Symptoms: Allergy to vaccine
Clinical narrative: Drug reaction/Allergy: MMR; This spontaneous report was received from a medical assistant and refers to a currently 6-year-old female patient. The patient's medical history, concurrent conditions and concomitant medication were unknown to the reporter. On an unknown date, the patient was vaccinated with measles, mumps, and rubella virus vaccine (reported as MMR) (manufacturer unknown) (captured as measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II)) for prophylaxis (dosing details, route, lot number, and expiry date were not reported). On an unknown date, the patient experienced unspecified drug reaction/allergy (allergy to vaccine). The outcome of the event was unknown. The causal relationship between the event and suspect therapy was considered related.  This is one of the two reports received from the same reporter.; Sender's Comments:  US-009507513-1907USA004447:
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Tinnitus
Clinical narrative: ringing in ears worsening; This case was reported by a pharmacist and described the occurrence of aggravated ringing in ears in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included ringing in ears.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced aggravated ringing in ears. On an unknown date, the outcome of the aggravated ringing in ears was unknown.   It was unknown if the reporter considered the aggravated ringing in ears to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not reported. The patient experienced worsening of the ringing in her ears. The reporter asked whether this was a common side effect and something to worry about.
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of product administration, Injection site reaction
Clinical narrative: injection site reaction; wrong route of administration; This case was reported by a pharmacist via call center representative and described the occurrence of injection site reaction in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix (subcutaneous). On an unknown date, unknown after receiving Shingrix, the patient experienced injection site reaction and intramuscular formulation administered by other route. On an unknown date, the outcome of the injection site reaction and intramuscular formulation administered by other route were unknown.   It was unknown if the reporter considered the injection site reaction to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced injection site reaction. The pharmacist stated that a nurse told him that the patient received a dose of Shingrix subcutaneously, which led to inappropriate route of vaccine administered. The reporter did not consent to follow up. The reporter declined follow up because he did not have additional information.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a elderly female patient who received Herpes zoster (Shingrix) (batch number 7457P, expiry date 20th June 2020) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 7 days 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 reporter stated that the patient developed Shingles 1 week after receiving first dose of Shingrix.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Hair disorder, Headache, Hypoaesthesia, Immediate post-injection reaction, Influenza like illness
Clinical narrative: body pain; Pain during injection; left arm numbness; myalgia; hair hurts; headache; flu-like symptoms; nausea; This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a 60-year-old female patient who received Herpes zoster (Shingrix) (batch number 4H9G2, expiry date 25th September 2021) for prophylaxis.   On 11th July 2019, the patient received the 1st dose of Shingrix (intramuscular). On 11th July 2019, immediately after receiving Shingrix, the patient experienced injection site pain, numbness of upper extremities, myalgia, hair disorder, headache, influenza-like symptoms and nausea. On an unknown date, the patient experienced general body pain. On an unknown date, the outcome of the injection site pain and general body pain were unknown and the outcome of the numbness of upper extremities, myalgia, hair disorder, headache, influenza-like symptoms and nausea were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, numbness of upper extremities, myalgia, hair disorder, headache, influenza-like symptoms, nausea and general body pain to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix in the left deltoid. The patient experienced pain during injection. By the night, on the day of vaccination, the patient experience whole left arm numbness which was currently milder. Less than a day, after vaccination with Shingrix, the patient experienced numbness of upper extremities, myalgia, hair disorder, headache, influenza like symptoms and nausea. At the time of reporting, whole body pain (myalgia), hair hurts, headache, flu like symptoms, and nausea were ongoing. The reporter consented to follow up.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Myalgia, Nausea, Pain
Clinical narrative: body pain; Pain during injection; left arm numbness; myalgia; hair hurts; headache; flu-like symptoms; nausea; This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a 60-year-old female patient who received Herpes zoster (Shingrix) (batch number 4H9G2, expiry date 25th September 2021) for prophylaxis.   On 11th July 2019, the patient received the 1st dose of Shingrix (intramuscular). On 11th July 2019, immediately after receiving Shingrix, the patient experienced injection site pain, numbness of upper extremities, myalgia, hair disorder, headache, influenza-like symptoms and nausea. On an unknown date, the patient experienced general body pain. On an unknown date, the outcome of the injection site pain and general body pain were unknown and the outcome of the numbness of upper extremities, myalgia, hair disorder, headache, influenza-like symptoms and nausea were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, numbness of upper extremities, myalgia, hair disorder, headache, influenza-like symptoms, nausea and general body pain to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix in the left deltoid. The patient experienced pain during injection. By the night, on the day of vaccination, the patient experience whole left arm numbness which was currently milder. Less than a day, after vaccination with Shingrix, the patient experienced numbness of upper extremities, myalgia, hair disorder, headache, influenza like symptoms and nausea. At the time of reporting, whole body pain (myalgia), hair hurts, headache, flu like symptoms, and nausea were ongoing. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Pain; This case was reported by a pharmacist via call center representative and described the occurrence of pain in an unspecified number of adult patients who received Herpes zoster (Shingrix) for prophylaxis.  On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not applicable for this report. The healthcare professional reported that the patients experienced a lot of pain. No patient specifics were available. This case has been linked with US2019127009, reported by the same reporter.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Seizure, Syncope
Clinical narrative: Seizure/Syncopal event after administration of trumenba
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Impaired work ability, Malaise, Pain, Pain in extremity, Productive cough
Clinical narrative: 101.2 fever going on 5 days, pain in arm, pain radiating from upper spine, aches all over, URI with minimal response to antihistamine, productive cough, malaise, unable to work, missed work so far 3 days.  On Z-pack antibiotic  three days.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Spinal pain, Upper respiratory tract infection
Clinical narrative: 101.2 fever going on 5 days, pain in arm, pain radiating from upper spine, aches all over, URI with minimal response to antihistamine, productive cough, malaise, unable to work, missed work so far 3 days.  On Z-pack antibiotic  three days.
Age: 13.0
Sex: M
Vaccine: MMRV
Symptoms: Oedema peripheral, Pyrexia, Skin warm, Wrong product administered
Clinical narrative: MMR was ordered, MMRV given.  Pt started with  fever 103.7  6 days later 7/17/19.  Swelling into armpit, parents report size of tennis ball.  Hot to touch. resolved 2 days later 7/19/19
Age: 1.08
Sex: F
Vaccine: HEPA, HIBV, MMRV, PNC13
Symptoms: Rash generalised
Clinical narrative: All over body rash 10 days after administration of vaccines, including MMRV.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Chills, Injection site erythema, Injection site pain, Injection site reaction, Injection site warmth
Clinical narrative: Approximately 5-7 hours after receiving vaccine injection site became very painful, red, hot to touch. Over 24 hours patient developed chills and area of injection site remained red, blotchy approximately 5 in by 5 in. Pain subsided within 72 hours but injection site remains red.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Rash macular
Clinical narrative: Approximately 5-7 hours after receiving vaccine injection site became very painful, red, hot to touch. Over 24 hours patient developed chills and area of injection site remained red, blotchy approximately 5 in by 5 in. Pain subsided within 72 hours but injection site remains red.
Age: 11.0
Sex: F
Vaccine: HIBV, HPV9, MNQ
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient observed for 15-20 minutes, and Did NOT have any adverse events or outcomes. no signs or symptoms
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV, MMR
Symptoms: Electroencephalogram normal, Metabolic function test normal, Myoclonus, Pyrexia, Respiratory viral panel
Clinical narrative: High fever associated with new onset myclonus activity
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV, MMR
Symptoms: White blood cell count increased
Clinical narrative: High fever associated with new onset myclonus activity
Sex: U
Vaccine: VARZOS
Symptoms: Headache
Clinical narrative: headache; 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 11th July 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced headache. On an unknown date, the outcome of the headache was unknown.   It was unknown if the reporter considered the headache to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. In 11th July 2019, the patient received shingles vaccine. The patient experienced headache after receiving the vaccine.
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: little bumps on back, shoulder, and hips; This case was reported by a nurse via call center representative and described the occurrence of rash in a 66-year-old female patient who received Herpes zoster (Shingrix) (batch number KR7G2, expiry date 2nd June 2021) for prophylaxis.   On 24th April 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported, but it could be 65 or 66 years. The patient developed little bumps on her back, shoulder, and hips.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: arm rash; This case was reported by a other health professional via call center representative and described the occurrence of rash in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 5th July 2019, the patient received the 1st dose of Shingrix .5 ml. In July 2019, less than a week after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were received as follows: The reporter stated that, the patient had the rash at the injection site on her left arm 4-5 days following the injection and had spread down the arm. The reporter consented to follow up.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: numbness in both hands/ numbness in both feet; tingling in both hands; This case was reported by a consumer via call center representative and described the occurrence of numbness in hand in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   In June 2019, the patient received the 2nd dose of Shingrix (intramuscular). In June 2019, 7 days after receiving Shingrix, the patient experienced numbness in hand and tingling of extremity. On an unknown date, the outcome of the numbness in hand and tingling of extremity were not recovered/not resolved.   It was unknown if the reporter considered the numbness in hand and tingling of extremity to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient's husband. The patient received dose of Shingrix in the left arm. The patient received 1st dose of Shingrix in the month of March 2019. Approximately 1week after vaccination with Shingrix, the patient experienced  numbness and tingling in both hands. The reporter reported that, the numbness and tingling was more noticeable in the left arm. The patient also experienced numbness in both feet, however numbness on the left foot extends up the leg to the knee. The Patient reported that, it was continuous throughout the day, but more noticeable when his first wakes in the morning. The reporter consented to follow up. The reporter gave permission the patient's physician to be contacted. The patient and his wife, both received two doses at the same time. This case is 1 of the 2 cases reported by the same reporter. There was discrepancy between the outcome reported in the structured field (not recovered) and the outcome reported in the source document (recovering).
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Myalgia
Clinical narrative: muscle aches; knee pain; This case was reported by a pharmacist via call center representative and described the occurrence of muscle pain in a 77-year-old male patient who received Herpes zoster (Shingrix) (batch number 7PS9E, expiry date 10th September 2021) for prophylaxis.   The patient's past medical history included knee operation.   On 31st May 2019, the patient received the 1st dose of Shingrix. On 25th June 2019, 25 days after receiving Shingrix, the patient experienced muscle pain and knee pain. On an unknown date, the outcome of the muscle pain and knee pain were unknown.   It was unknown if the reporter considered the muscle pain and knee pain to be related to Shingrix.  Additional details were received as follows: The reporter stated that, the patient had muscle aches and knee pain, in both knees. The patient had a history of both knees having a surgical procedure but the reporter did not know what the specific procedure was. The reporter consented to follow up.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Pain in extremity, Paraesthesia
Clinical narrative: numbness in both hands/ numbness in both feet; tingling in both hands; Pain in tip of pinky finger; This case was reported by a consumer via call center representative and described the occurrence of numbness in hand in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   In June 2019, the patient received the 2nd dose of Shingrix (intramuscular). In June 2019, 1 day after receiving Shingrix, the patient experienced numbness in hand, tingling of extremity and pain in fingers. On an unknown date, the outcome of the numbness in hand, tingling of extremity and pain in fingers were not recovered/not resolved.   It was unknown if the reporter considered the numbness in hand, tingling of extremity and pain in fingers to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient's husband. The patient received dose of Shingrix in the left arm. The patient received 1st dose of Shingrix in the month of March 2019. Approximately 1 to 2 days after vaccination with Shingrix, the patient experienced numbness and tingling in both hands, and the tip of pinky finger was painful to the touch. The reporter reported that, the numbness and tingling was more noticeable in the left arm. The patient also experienced numbness in both feet, however numbness on the left foot extends up the leg to the knee. The Patient reported that, it was continuous throughout the day. The reporter consented to follow up. The reporter gave permission the patient's physician to be contacted. The patient and her husband, both received two doses at the same time. This is 1 of the 2 cases reported by the same reporter. There was discrepancy between the outcome reported in the structured field (not recovered) and the outcome reported in the source document (recovering).
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, 7 days 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 patient demographic details were not provided. The patient called to report that, 1 week after vaccination with Shingrix, the patient experienced shingles. The all above information was received at the time of reporting.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Influenza like illness
Clinical narrative: flu like symptoms; severe stomach pain; This case was reported by a pharmacist via call center representative and described the occurrence of influenza-like symptoms in a 58-year-old male patient who received Herpes zoster (Shingrix) (batch number 2AH5M, expiry date 18th May 2021) for prophylaxis.   On 28th March 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced influenza-like symptoms and stomach pain. On an unknown date, the outcome of the influenza-like symptoms and stomach pain were unknown.   It was unknown if the reporter considered the influenza-like symptoms and stomach pain to be related to Shingrix.  Additional details were provided as follows: The pharmacist reported that, after vaccination with Shingrix, the patient experienced flu like symptoms and severe stomach pain.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site induration, Injection site reaction, Rash erythematous
Clinical narrative: large hard, red rash/reaction at site of injection appeared shortly after injection.
Age: 25.0
Sex: F
Vaccine: TDAP
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Two hours after receiving vaccine started having tingling and numbness in feet. On 7/18/19 started affecting calves, knees, and hands sporadically.
Age: 22.0
Sex: F
Vaccine: HPV9
Symptoms: Anxiety, Cold sweat, Eye movement disorder, Pallor, Presyncope
Clinical narrative: Client had a vasovagal reaction  with seizure like activity 5 minutes after receiving 2nd round dose of HPV9.  Reaction lasted 1-2 minutes, client was supported by staff in chair, eyes rolled up, and she was shaking and unresponsive, pulse was regular, and client was breathing,  making 1-2 snoring noises.  Clammy, pale skin. Client became responsive, and was lowered down to mat on floor. Apple juice and graham crackers given. Client reported issues with low blood sugar, and not having breakfast prior, also was feeling anxious about shot.  Vitals WNL RR 18,  BP 103/83 , HR 62 at 9:36. Client slowly returned to sitting then standing position, and walked out of the clinic  20- 30 min after adverse event.
Age: 22.0
Sex: F
Vaccine: HPV9
Symptoms: Seizure like phenomena, Snoring, Tremor, Unresponsive to stimuli
Clinical narrative: Client had a vasovagal reaction  with seizure like activity 5 minutes after receiving 2nd round dose of HPV9.  Reaction lasted 1-2 minutes, client was supported by staff in chair, eyes rolled up, and she was shaking and unresponsive, pulse was regular, and client was breathing,  making 1-2 snoring noises.  Clammy, pale skin. Client became responsive, and was lowered down to mat on floor. Apple juice and graham crackers given. Client reported issues with low blood sugar, and not having breakfast prior, also was feeling anxious about shot.  Vitals WNL RR 18,  BP 103/83 , HR 62 at 9:36. Client slowly returned to sitting then standing position, and walked out of the clinic  20- 30 min after adverse event.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site paraesthesia, Injection site reaction, Injection site warmth, Rash erythematous
Clinical narrative: 4 by 2 inch bright red rash on left upper arm, warm to touch, burning/tingling pain to the touch, no itching. started to resolve after about 4 days
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Full blood count, Neutrophil count decreased, Polymerase chain reaction, Pyrexia, Rash
Clinical narrative: Maculopapular Rash clustered on Right Cheek and diffuse over trunk with a few spots noted on arms and legs. No lesions noted. Patient's foster mom reported Fever onset on 7/17/19 up to 102.0 and rash onset 07/20/19. Reports rash onset 07/20/19, no fever reported on day of rash and at ER visit. Last Tylenol and Motrin given was on 07/19/19. 07/22/19 - Called to check on patient and foster mother reported patient a low grade temperature 99.0 on 07/21/19 and no fever today. She stated rash was a little worse "more blotchy" yesterday, but today the rash is looking better.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Rash macular, Rash maculo-papular, Respiratory viral panel, Streptococcus test negative, White blood cell count decreased
Clinical narrative: Maculopapular Rash clustered on Right Cheek and diffuse over trunk with a few spots noted on arms and legs. No lesions noted. Patient's foster mom reported Fever onset on 7/17/19 up to 102.0 and rash onset 07/20/19. Reports rash onset 07/20/19, no fever reported on day of rash and at ER visit. Last Tylenol and Motrin given was on 07/19/19. 07/22/19 - Called to check on patient and foster mother reported patient a low grade temperature 99.0 on 07/21/19 and no fever today. She stated rash was a little worse "more blotchy" yesterday, but today the rash is looking better.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Back pain, Eye pain, Headache, Herpes zoster, Ophthalmic herpes zoster
Clinical narrative: Shingles outbreak on right forehead, scalp and eye lid. Shooting pains at right eye, sore through . Back pain, headache
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Shingles outbreak on right forehead, scalp and eye lid. Shooting pains at right eye, sore through . Back pain, headache
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Loss of consciousness, Nausea, Pallor
Clinical narrative: passed out, nausea, pale
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema
Clinical narrative: Seen in office 7/22/19 for erythema to R arm  approx. 3x5 inches.  Provider recommended ice pack, Tylenol prn.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Local reaction
Clinical narrative: localized reaction, erythema, no swelling
Age: 11.0
Sex: M
Vaccine: UNK
Symptoms: Nausea, Pallor
Clinical narrative: nausea, pale
Age: 59.0
Sex: F
Vaccine: DTAP
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain, Pain, Product administered at inappropriate site
Clinical narrative: The injection was given by a student nurse. I received it very high in my left shoulder. The pain at the injection site was immediate and  became extremely  intense as the dose was administered. After she finished, I could barely lift my arm and couldn?t speak. I?m no wimp and have had previous tetanus vaccinations.... this one has been like no other I?re ever received. I had very limited use of my arm for a week following the injection. Now, almost three weeks later, I still have not regained full function of my arm; I have limited motion as I try to raise my arm shoulder height, resulting in a sharp pain in the muscle lower down my arm (sorry I don?t know my muscle groups...).
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Asthenia, Back pain, Body temperature increased, Chills
Clinical narrative: It started with chills...then a couple hours later I was so tired it was a chore to move any part of my body.  I layed down and didn't move.  I started running a temperature of 101, had headaches and joint pain in my knees and back.  My head felt strange.   I slept all day and alll night.  The next morning I felt a little weak but began coming out of it.  By noon I was ok again.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Feeling abnormal, Headache, Hypersomnia
Clinical narrative: It started with chills...then a couple hours later I was so tired it was a chore to move any part of my body.  I layed down and didn't move.  I started running a temperature of 101, had headaches and joint pain in my knees and back.  My head felt strange.   I slept all day and alll night.  The next morning I felt a little weak but began coming out of it.  By noon I was ok again.
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Injected limb mobility decreased, Injection site joint pain, Injection site pain, Product administered at inappropriate site
Clinical narrative: The vaccine was administered high on the shoulder.  The needle mark left in the skin was less than 1 inch from the top of the shoulder.  The morning following the injection I woke up in severe pain, unable to easily move my shoulder.  The main marginally improved over the course of the first day following naproxen 440mg bid and apap 1g q6h, however I was still experiencing pain (which felt like joint pain as opposed to muscle pain) and limited range of motion.  Given the placement of the injection and my symptoms I'm fairly confident the needle entered part of my shoulder joint rather than being placed in my deltoid.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: I felt like i had the flu; This case was reported by a consumer and described the occurrence of influenza like illness in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced influenza like illness. On an unknown date, the outcome of the influenza like illness was unknown.   It was unknown if the reporter considered the influenza like illness to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not reported but the patient could be 74 or 75  years old. The patient reported that how the shingrix would still be as effective if it had been a year since her first injection and had not received the second dose at the reporting date. The patient was willing to receive the 2nd dose of Shingrix. A year ago, the patient experienced all of the side effects felt like had the flu after receiving 1st dose of Shingrix. The patient would have conversation to one of Shingrix product specialist. They did like for us to gather a little bit of information.
Age: 92.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash erythematous, Rash pruritic
Clinical narrative: non raised red rash on joints; itchy joints; This case was reported by a nurse via sales rep and described the occurrence of red rash in a 92-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced red rash and pruritus. On an unknown date, the outcome of the red rash and pruritus were recovered/resolved.   It was unknown if the reporter considered the red rash and pruritus to be related to Shingrix.  Additional information received were as follows: The patient experienced non raised red rash on joints that were itchy after receiving 1st dose of Shingrix, which lasted for 5 days. The reporter did not know if the reaction experienced was due to the vaccine or a surgery. The patient did not want to receive the 2nd dose of Shingrix.
Sex: U
Vaccine: VARZOS
Symptoms: Ear pain, Hypoaesthesia, Oropharyngeal pain, Pyrexia
Clinical narrative: ear pain; facial numbness; sore throat; fever; This case was reported by a other health professional via sales rep and described the occurrence of ear pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   In July 2019, the patient received the 1st dose of Shingrix. In July 2019, less than a month after receiving Shingrix, the patient experienced ear pain, numbness facial, sore throat and fever. On an unknown date, the outcome of the ear pain, numbness facial, sore throat and fever were unknown.   It was unknown if the reporter considered the ear pain, numbness facial, sore throat and fever 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 reported that they received Shingrix and had experienced ear pain and numbness in the face as well as sore throat and fever. The reporter gave consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Swelling
Clinical narrative: erythema; pain; swelling; This case was reported by a nurse via call center representative and described the occurrence of erythema in a 66-year-old female patient who received Herpes zoster (Shingrix) (batch number KR7G2, expiry date 2nd June 2021) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced erythema, pain and swelling. On an unknown date, the outcome of the erythema, pain and swelling were unknown.   It was unknown if the reporter considered the erythema, pain and swelling to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The nurse reported that the patient experienced erythema, pain and swelling after getting a Shingrix vaccine.
Sex: F
Vaccine: VARZOS
Symptoms: Ophthalmic herpes zoster
Clinical narrative: ocular herpes zoster; This case was reported by a physician via call center representative and described the occurrence of ophthalmic herpes zoster in a 85-year-old female patient who received Herpes zoster (Shingrix) (batch number D9474, expiry date 10th September 2021) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 61 days after receiving Shingrix, the patient experienced ophthalmic herpes zoster (serious criteria GSK medically significant). On an unknown date, the outcome of the ophthalmic herpes zoster was unknown.   It was unknown if the reporter considered the ophthalmic herpes zoster to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported, but it could be 84 or 85 years. The patient developed ocular herpes zoster 2 months after getting Shingrix vaccination.
Sex: F
Vaccine: MENB
Symptoms: Headache, Malaise, Pain
Clinical narrative: General ill feelings; Severe headache like her head was splitting, very painful; This is a spontaneous report from a contactable nurse via Pfizer Sales Representative. A female patient of an unspecified age received second dose meningococcal group b rlp2086 (TRUMENBA), via an unspecified route of administration from an unspecified date at single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient previously took Trumenba for immunization.  It was reported that the patient came in for second dose of meningococcal group b rlp2086 and left the office to run errands with her mother. She came back to office shortly after because she was experiencing severe headache like her head was splitting, very painful. She also complained about general ill feelings. Her vitals were fine, but doctor who was attending to her suggested patient should go to the ER. Outcome of the events was unknown.  Information on the batch number has been requested.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Hypersensitivity, Injection site erythema, Injection site swelling, Pain
Clinical narrative: Swelling & Redness at injection site. Bad headache Dr visit, assumed Allergic Reaction ER gave ABX Dr visit thinks Allergic Reaction Soreness Ok Range of motion
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion
Clinical narrative: Big bruise below vaccine site
Age: 12.0
Sex: M
Vaccine: MMR
Symptoms: Headache, Pyrexia, Rash
Clinical narrative: Pt reports fever to 101, slight rash on arms and headache.  All resolved within 24 hours.  No further issues.
Age: 76.0
Sex: F
Vaccine: HEPA, VARZOS
Symptoms: Feeling abnormal, Laboratory test, Mobility decreased, Pyrexia
Clinical narrative: Client reports the night of her vaccine date she went to bed with a fever, and wasn't feeling good.  Woke up around 0400 and could not get out of bed or raise her neck up.  Called son and he took her to ER.  They ran a bunch of test started her on anti-inflammatories and after 45 mins. she was able to move her neck.   Reports going home and no further problem.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous, Skin warm
Clinical narrative: Two days after receiving her 2nd dose of Shingrix, patient developed a pinkish/red circular rash about 2 inches below the injection site.   It feels slightly warm to the touch but is not raised.  Patient is experiencing no other symptoms.  Appears that the patient is potentially having an allergic reaction exacerbated by hot weather.  Advised tylenol, cold compresses, and benadryl, and to seek medical attention if fever develops or the rash worsens.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Erythema, Pruritus
Clinical narrative: about 5 days after receiving vaccine developed local 4cm x 2cm area of redness and itching
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site pain, Injection site rash, Pyrexia
Clinical narrative: At 1230 am I awoke with a  fever of102 and chills which lasted for 3 hours.  Both times I got the vaccine I felt extreme pain at the injection site for several days and a rash below.
Age: 5.0
Sex: F
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered
Clinical narrative: There was an administration error and the patient was given 2 doses of Varicella at one time. She was given MMRV, live and Varicella, live.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects; the patient was inadvertently administered a dose of Rotateq; This spontaneous report has been received from a medical assistant referring to a patient 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 18-JUL-2019, the patient was inadvertently vaccinated with an expired dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ) lot # R012957 with expiration date of 11-JUN-2019, orally (strength, frequency, dose, lot # and expiration date were not provided) for prophylaxis.  No adverse effects were reported.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Dyspnoea, Throat tightness
Clinical narrative: Immunization was given at 11:45 am. Patient started to feel like her throat was closing up around 5:00 pm. She also had dizziness and shortness of breath.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Pyrexia
Clinical narrative: Patient had a fever all night after receiving Shingrix, also flu-like symptoms for the following 24 hours.
Age: 1.3
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Pallor, Rash, Rash erythematous, Rash maculo-papular
Clinical narrative: Fine pink, blanching macular and papular rash most prominent over collar area, cheeks and groin relatively sparing the extremities.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Rash
Clinical narrative: Rash/redness over most of body(arms, legs, torso). Started saturday on patients stomach by sunday it was on arms/legs/torso. Patient used an oatmeal bath and benadryl . Rash is clearing up 7/22/19. patient went to urgent care physician they said to continue 24 hours of benadryl and gave the patient a prescription for steroids to use if not cleared up tomorrow (7/23)
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Pt complianed of slight fever and was concerned
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Axillary pain, Headache, Injection site pain, Lymph node pain, Lymphadenitis
Clinical narrative: I developed a slight headache and soreness in arm after vaccine. Approx. around 7pm I had a throbbing pain in my right upper front and back shoulder as well as under my arm. This throbbing did not let up. My lymph node seemed to be inflamed. I called the clinic I received the shot the next  morning and they told me they had not rec'd any complaints of adverse effects like this. I was informed I might want to call my doctor. I got worked in at the doctors office on 7/12/19. My lymph node was slightly enlarged and very tender to palpation. The NP I saw, said that because it was in the localized area of the shot, she would say it was just my body's adverse reaction to the shot. I was told to take ibuprofen and ice it down and if better by Monday, it was probably the shot. If not better, come back to office for further testing.  By Monday morning, it was a lot better and not near as tender or painful. The lymph node was so inflamed I couldn't stand to wear a bra or put my arm down. Felt a lot better in cool water and with ice. No problems now. I was told that I might want to report this so if anyone else had a reaction this way, it would be logged.