chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site reaction, Injection site swelling
Clinical narrative: Immediate malaise - Headache-Eyes aches-Joints-Very ill-Pain-Red-swelling-Injection site  Next day-Rash below injection site-Gradually moved almost-to elbow-Bone in site injection-very sore-aching & painful
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: Immediate malaise - Headache-Eyes aches-Joints-Very ill-Pain-Red-swelling-Injection site  Next day-Rash below injection site-Gradually moved almost-to elbow-Bone in site injection-very sore-aching & painful
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Myalgia
Clinical narrative: Headache, muscle ache, shivering, very tired
Age: 39.0
Sex: F
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: Client which is employee was given pediatric dose of Hep B and so an additional dose was needed to administer the complete dose.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site rash
Clinical narrative: injection site at the right arm turned red and painful with some raised bumps 6 hours after receiving the vaccine
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Injection site pain, Injection site pruritus
Clinical narrative: Soreness at injection site, ache in injected muscle, red blotchiness on skin with intense itching above muscle injected, neck ache...5 days. In addition, fatigue, headache, body and muscle aches, shivering, low grade fever....2 days.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Myalgia, Neck pain, Pain, Pyrexia
Clinical narrative: Soreness at injection site, ache in injected muscle, red blotchiness on skin with intense itching above muscle injected, neck ache...5 days. In addition, fatigue, headache, body and muscle aches, shivering, low grade fever....2 days.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash macular
Clinical narrative: Soreness at injection site, ache in injected muscle, red blotchiness on skin with intense itching above muscle injected, neck ache...5 days. In addition, fatigue, headache, body and muscle aches, shivering, low grade fever....2 days.
Sex: M
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: This spontaneous report was received from two physicians referring to sever unspecified male patients of unknown age. The patients' concurrent conditions, medical history and concomitant therapies were not reported. Approximately in October 2018, reported as within the last 6 months, the patients had finger sticks at their doctor visits in order to check their cholesterol levels. The same patients then were vaccinated with a dose of GARDASIL 9 (dose, frequency, route, lot# and expiration date were not reported) for prophylaxis at the same office visit. The same patients fainted (syncope) after receiving dose of GARDASIL 9. The patients sought medical attention in the doctor's office. The outcome of the event was unknown. The action taken with the suspect vaccine was not applicable. The causality between the event and the suspect vaccine was not reported by the reporter. Upon internal review, event of  fainted (syncope) was considered as medically significant. This is one of two reports received from the same reporter; Sender's Comments: US-009507513-1904USA013128.
Sex: M
Vaccine: MMR
Symptoms: Fatigue, Joint stiffness, Lymphadenopathy, Musculoskeletal stiffness, Ocular hyperaemia
Clinical narrative: low grade fever; sore throat; fatigue; swollen glands; stiffness in both wrists and finger; stiffness in both wrists; red eye; This spontaneous report was received from 63-year-old male patient referring to himself. The patient had no pertinent medical history. On 12-APR-2019, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (frequency, lot# and expiry unknown) 1x0.5mL dose, subcutaneous for prevention of rubella. Concomitant therapies included acetaminophen, diazepam (VALIUM) and paroxetine hydrochloride (PAXIL). On 21-APR-2019, the patient experienced low grade fever (pyrexia), sore throat (oropharyngeal pain), fatigue, swollen glands (lymphadenopathy), stiffness in both wrists and a finger (joint stiffness) (musculoskeletal stiffness), red eye (ocular hyperaemia). Outcome of events was reported as recovering. Causality assessment was not reported.
Sex: M
Vaccine: MMR
Symptoms: Oropharyngeal pain, Pyrexia
Clinical narrative: low grade fever; sore throat; fatigue; swollen glands; stiffness in both wrists and finger; stiffness in both wrists; red eye; This spontaneous report was received from 63-year-old male patient referring to himself. The patient had no pertinent medical history. On 12-APR-2019, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (frequency, lot# and expiry unknown) 1x0.5mL dose, subcutaneous for prevention of rubella. Concomitant therapies included acetaminophen, diazepam (VALIUM) and paroxetine hydrochloride (PAXIL). On 21-APR-2019, the patient experienced low grade fever (pyrexia), sore throat (oropharyngeal pain), fatigue, swollen glands (lymphadenopathy), stiffness in both wrists and a finger (joint stiffness) (musculoskeletal stiffness), red eye (ocular hyperaemia). Outcome of events was reported as recovering. Causality assessment was not reported.
Sex: F
Vaccine: UNK, VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse effect; VARIVAX administered intramuscularly with an expired sterile diluent; VARIVAX administered intramuscularly with an expired sterile diluent; This spontaneous report as received from a pharmacist regarding to a 29-year-old female patient.    There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.     On 24-MAR-2019 the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) lot # (Lot# R024023, Expiry date: 22-AUG-2020) via intramuscular route in the left arm for prophylaxis (incorrect route of product administration).  Other suspect therapies included sterile diluent(Lot # N015632 & Expiry date: 18-FEB-2019) via intramuscular route in the left arm. It was reported that the varicella virus vaccine live (oka/merck)(VARIVAX) was reconstituted with properly stored but expired sterile diluent (expired product administered). No adverse effect was reported. The outcome of incorrect route of product administration, no adverse event and expired product administered was unknown.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Itching; Pain; Swelling; Redness; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 85-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th April 2019, the patient received the 1st dose of Shingrix (intramuscular). On 15th April 2019, 1 days after receiving Shingrix, the patient experienced injection site pain, injection site swelling and injection site erythema. On 16th April 2019, the patient experienced injection site itching. On an unknown date, the outcome of the injection site pain, injection site swelling, injection site erythema and injection site itching were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, injection site swelling, injection site erythema and injection site itching to be related to Shingrix.  Additional details were reported as follows: The patient received Shingrix vaccine and about 24 hours later the patient experienced pain, swelling and redness at the injection site. A day before at the time of reporting, the patient started experiencing itching at the injection site. The patient was still experiencing all of these events. The reporter did not consent to follow-up.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Back pain, Chills, Dizziness, Feeling cold
Clinical narrative: feeling cold; feeling faint; shivering; fever; nausea; back pain; joint pain; myalgia; lethargy; headache; This case was reported by a consumer via call center representative and described the occurrence of feeling cold in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included spinal operation (1 year before the date of reporting) and neck surgery (4 years before the date of reporting). Concurrent medical conditions included back disorder (back problems). Concomitant products included thyroid medication {nos} (Thyroid Medication).   On 20th April 2019, the patient received the 1st dose of Shingrix. On 20th April 2019, 12 hrs after receiving Shingrix, the patient experienced feeling cold, felt faint, shivering, fever, nausea, back pain, joint pain, myalgia, lethargy and headache. On an unknown date, the outcome of the feeling cold, felt faint, shivering, fever, nausea, back pain, joint pain, myalgia, lethargy and headache were recovered/resolved.   It was unknown if the reporter considered the feeling cold, felt faint, shivering, fever, nausea, back pain, joint pain, myalgia, lethargy and headache to be related to Shingrix.  Additional details were provided as follows: The patient received the 1st dose of Shingrix in right arm and the patient developed a fever approximately 12 hours after receiving the vaccine.  The patient stated that the fever ranged between 101 degree F to 101.7 degree F. The reporter consented to follow up.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Lethargy, Myalgia, Nausea, Pyrexia
Clinical narrative: feeling cold; feeling faint; shivering; fever; nausea; back pain; joint pain; myalgia; lethargy; headache; This case was reported by a consumer via call center representative and described the occurrence of feeling cold in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included spinal operation (1 year before the date of reporting) and neck surgery (4 years before the date of reporting). Concurrent medical conditions included back disorder (back problems). Concomitant products included thyroid medication {nos} (Thyroid Medication).   On 20th April 2019, the patient received the 1st dose of Shingrix. On 20th April 2019, 12 hrs after receiving Shingrix, the patient experienced feeling cold, felt faint, shivering, fever, nausea, back pain, joint pain, myalgia, lethargy and headache. On an unknown date, the outcome of the feeling cold, felt faint, shivering, fever, nausea, back pain, joint pain, myalgia, lethargy and headache were recovered/resolved.   It was unknown if the reporter considered the feeling cold, felt faint, shivering, fever, nausea, back pain, joint pain, myalgia, lethargy and headache to be related to Shingrix.  Additional details were provided as follows: The patient received the 1st dose of Shingrix in right arm and the patient developed a fever approximately 12 hours after receiving the vaccine.  The patient stated that the fever ranged between 101 degree F to 101.7 degree F. The reporter consented to follow up.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash, Pain, Pain in extremity
Clinical narrative: Sore arm leading to all over body soreness. Red injection site that later became a rash.
Age: 1.0
Sex: M
Vaccine: HEPA, HIBV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site mass, Injection site pain
Clinical narrative: Post vaccination mother stated that patient developed redness about 3 inches in diameter to left thigh Hep AM IM site and tenderness.  Mother stated feels a ball.  Pt guarding site.  Pt was prescribed Cephalexin Monohydrate 125mg/5ml, Reconstituted suspension, Oral GIVE 5 ML BY MOUTH EVERY TWELVE HOURS FX 7 DAYS TILL ALL TAKEN
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: multiple unspecified patients were administered a dose of improperly stored PROQUAD and VARIVAX; No adverse effects were reported.; This non-valid spontaneous report was received from a medical assistant referring to unspecified patients of unknown age and gender. There was no information about the patient's concurrent conditions, allergies, concomitant therapies or medical history.   On multiple unspecified dates, multiple unspecified patients were administered a dose of improperly stored Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) rHA for prophylaxis (Lot number R015738 with expiration date on 12-FEB-2019, dose, route of administration were not reported) or varicella virus vaccine live (Oka/Merck) (VARIVAX) ) for prophylaxis (Lot number R018780 with expiration date on 01-JUL-2020, dose, route of administration were not reported).  The administered dose of the vaccines experienced a temperature excursion in the range of 15 F to 46 F of 15.1 F for 1 hour and 20 minutes, as recorded by a data logger. The vaccines had not had any previous temperature excursions. There were no adverse effects reported. Furthermore, no product quality complaint was involved.
Sex: M
Vaccine: MMR, UNK
Symptoms: Measles antibody negative
Clinical narrative: negative measles titers; This spontaneous report as received from a medical assistant regarding to a 61-year-old male patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.     On an unknown date, the patient was previously vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (lot# and expiry date was not reported) for prophylaxis. Other suspect therapies included sterile diluent (lot# and expiry date was not reported). On an unspecified date, the patient had negative measles titers (measles antibody negative). No further information was provided. Outcome of Measles antibody negative was unknown. Causality was not reported.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeding disorder, Feeling cold, Nasopharyngitis, Nausea
Clinical narrative: nausea; Cold; coldness; This case was reported by a consumer via call center representative and described the occurrence of coldness in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th April 2019, the patient received the 2nd dose of Shingrix. On 20th April 2019, less than a day after receiving Shingrix, the patient experienced coldness. On 21st April 2019, the patient experienced nausea and cold. On an unknown date, the outcome of the coldness, nausea and cold were recovered/resolved.   It was unknown if the reporter considered the coldness, nausea and cold to be related to Shingrix.  Additional details were reported as follows: This case was reported by the patient's husband. The patient received the Shingrix on Saturday in her left arm. The patient experienced coldness that night of vaccination and cold and nausea the next day of vaccination and she couldn't eat breakfast, but all had resolved at this point. This case has been linked with US2019AMR073878, reported by the reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site pain
Clinical narrative: Injection site pain; This case was reported by a nurse via sales rep and described the occurrence of injection site pain in a 59-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, immediately after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient had minor achiness in the injected arm, after 1st dose of Shingrix. The achiness in the injected arm went away quickly, with no othe issues. For tolerance to the 2nd dose of Shingrix refer case US2019AMR069899, reported by the same reporter.
Sex: M
Vaccine: UNK
Symptoms: Influenza, Vaccination failure
Clinical narrative: Suspected vaccination failure; flu; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a 59-year-old male patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2018-2019 season) for prophylaxis.   In February 2019, the patient received Influenza vaccine Quadrivalent 2018-2019 season. On an unknown date, less than a year after receiving Influenza vaccine Quadrivalent 2018-2019 season, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza. On an unknown date, the outcome of the vaccination failure and influenza were unknown.   It was unknown if the reporter considered the vaccination failure and influenza to be related to Influenza vaccine Quadrivalent 2018-2019 season.  Additional details were provided as follows: This case was reported by the reporter's father. The age at vaccination was not reported. The patient recently received a dose of an unknown flu vaccine. After vaccination, the patient had flu. The reporter probably contracted it from the patient. This case was considered as suspected vaccination failure case as the laboratory tests and time to event onset were unknown at the time of reporting. The reporter did not consent to follow-up.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Myalgia, Pain
Clinical narrative: muscles are sore; Injection site pain/ Injection site tender/ Injection site achy/ Hurts/ feel local soreness again; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st April 2019, the patient received the 2nd dose of Shingrix. On 9th April 2019, 8 days after receiving Shingrix, the patient experienced injection site pain. On 19th April 2019, the patient experienced muscle soreness. On an unknown date, the outcome of the injection site pain was not recovered/not resolved and the outcome of the muscle soreness was unknown.   It was unknown if the reporter considered the injection site pain and muscle soreness to be related to Shingrix.  Additional details were provided as follows: The reporter received the second dose of the Shingrix vaccine and reported that the injection site was sore for a couple of days and then resolved. Ten days later on 19th April 2019, she reports that she began to feel local soreness again, the site was achy and it hurts when she moves her arm forward or back. She cannot sleep on the arm because of the soreness at the site of the injection. She described that it hurts to the touch at the injection site and was tender in a 4 to 6 inch radius from the injection site.  When she extends arm straight out the muscles were sore.
Sex: F
Vaccine: VARZOS
Symptoms: Feeling hot, Injection site erythema, Thermal burn
Clinical narrative: Red in the area of injection; Arm was heated up; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included flu shot.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, several days after receiving Shingrix, the patient experienced injection site erythema and extremities hot feeling of. On an unknown date, the outcome of the injection site erythema and extremities hot feeling of were unknown.   The reporter considered the injection site erythema and extremities hot feeling of to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not provided. The patient mentioned that a few days after her first dose of Shingrix her arm was heated up and red in the area of injection. The patient is currently dealing with burn on her thorax because she dropped her curling iron, The reporter did not indicated that this was before or after vaccination.
Sex: F
Vaccine: MENB
Symptoms: Headache, Hypoaesthesia, Paraesthesia
Clinical narrative: Headache along with some numbness; Headache along with some numbness; Tingling in her arm; This is a spontaneous report from a contactable consumer. This consumer (patient's mother) reported for her (daughter). A 21-year-old female patient received meningococcal group b rlp2086 (TRUMENBA, lot number and expiration date were not reported), via an unspecified route of administration in the left arm on 03Apr2019 15:00 at single dose for immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient which was a nursing student was given the vaccine around 3:00 pm on 03Apr2019, 3-4 hours later she developed a headache along with some numbness and tingling in her arm. The parent took her to ER. They treated her for headache at ER and sent her home. Patient was feeling better approximately 1-2 days later. Outcome of the events was recovering.
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Musculoskeletal pain
Clinical narrative: Developed painin right shoudler and all joints
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Disturbance in attention, Fatigue, Headache, Influenza like illness
Clinical narrative: Sore arm as expected (similar to first dose), however, also pain down arm into left  hand. By 8pm, extremely tired and difficulty focusing/mentally alert, so went to bed. Could not sleep - chills all night, body ached all over - head to toe, headache. In a.m., also queasy and achiness continued throughout body, also chills continued - ironically left arm and hand feeling improved. I had the shingles a few years ago and it felt like the start of when I had the shingles - like bad flu symptoms. Forced down light breakfast and took Motrin, using heating pad  - helping alleviate some symptoms, no longer queasy but still achy, cloudy headed, headache.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Insomnia, Nausea, Pain, Pain in extremity
Clinical narrative: Sore arm as expected (similar to first dose), however, also pain down arm into left  hand. By 8pm, extremely tired and difficulty focusing/mentally alert, so went to bed. Could not sleep - chills all night, body ached all over - head to toe, headache. In a.m., also queasy and achiness continued throughout body, also chills continued - ironically left arm and hand feeling improved. I had the shingles a few years ago and it felt like the start of when I had the shingles - like bad flu symptoms. Forced down light breakfast and took Motrin, using heating pad  - helping alleviate some symptoms, no longer queasy but still achy, cloudy headed, headache.
Age: 4.0
Sex: F
Vaccine: FLU4
Symptoms: Rash generalised, Skin warm
Clinical narrative: Patient developed a rash all over her body and felt warm to the touch. Benadryl administered after.
Age: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: ARM BECAME RED, SWOLLEN AND CELLULITIS
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Contusion, Impaired work ability, Muscle spasms, Pain in extremity
Clinical narrative: rec'd Tdap 4/26/19    reported 5/2/19 that increased pain, bruising and spasm left arm,  was seen in the ED and place off work one day and light duty 2 - 3 days
Age: 53.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Erythema, Migraine, Pain, Swelling
Clinical narrative: PT reports red swollen approx. the size of a racket ball. Since receiving the vaccine she has had diffuse body aches/ no fever but has chills/ and migraine/ pt reports 1 instance of vomiting has taken Zofran and vomiting has stopped. Pt declined overbook appt here today.
Age: 53.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Vomiting
Clinical narrative: PT reports red swollen approx. the size of a racket ball. Since receiving the vaccine she has had diffuse body aches/ no fever but has chills/ and migraine/ pt reports 1 instance of vomiting has taken Zofran and vomiting has stopped. Pt declined overbook appt here today.
Age: 53.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Decreased appetite, Headache, Migraine, Nausea
Clinical narrative: PT reports red swollen approx. the size of a racket ball. Since receiving the vaccine she has had diffuse body aches/ no fever but has chills/ and migraine/ pt reports 1 instance of vomiting has taken Zofran and vomiting has stopped. Pt declined overbook appt here today.
Age: 53.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain, Pyrexia, Vomiting
Clinical narrative: PT reports red swollen approx. the size of a racket ball. Since receiving the vaccine she has had diffuse body aches/ no fever but has chills/ and migraine/ pt reports 1 instance of vomiting has taken Zofran and vomiting has stopped. Pt declined overbook appt here today.
Age: 21.0
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: swelling and redness to right deltoid
Age: 23.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site discomfort, Injection site rash, Injection site swelling
Clinical narrative: Had  previously received one dose vaccine  7-8-2000 but series not completed.  Second dose given 4-30-19.  EE noted soreness & rash 5/1/19, returned to Occupational Health  1140 5/2/19  with slight swelling  & central redness 2-3 cm at injection site, with penumbra rash of lighter redness extending to 12-15 cm circularly around  site.  No significant distress-referred to worker's comp nurse for eval at 1415 5/2/19.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Dehydration, Diarrhoea, Kidney infection, Laboratory test, Pyrexia
Clinical narrative: Patient received IMZ on 4/24/19 and said on 4/26/19  suffered from diarrhea, vomiting, and fever. Pt said went to hospital on 4/29/19 and they said she was dehydrated and had a kidney infection.  The patient said she did not have any swelling or problems with her arm that she received the IMZ in.  Pt also stated she did not know if the IMZ caused this problem.  The pt has a post follow up MD visit on 5/3/2019
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: Patient received IMZ on 4/24/19 and said on 4/26/19  suffered from diarrhea, vomiting, and fever. Pt said went to hospital on 4/29/19 and they said she was dehydrated and had a kidney infection.  The patient said she did not have any swelling or problems with her arm that she received the IMZ in.  Pt also stated she did not know if the IMZ caused this problem.  The pt has a post follow up MD visit on 5/3/2019
Age: 17.0
Sex: M
Vaccine: HPV9
Symptoms: Extra dose administered
Clinical narrative: incomplete vaccine record when patient transferred into practice, extra dose of HPV9 vaccine was given
Age: 54.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Arthralgia, Joint stiffness, Muscle spasms, Muscle tightness, Musculoskeletal stiffness
Clinical narrative: Right and then left hand stiffness and muscle cramping with tightness felt. Pain in finger joints of right then left hand. Joint and muscle stiffness of upper extremities then both feet.
Age: 54.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Arthralgia, Joint stiffness, Muscle spasms, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Right and then left hand stiffness and muscle cramping with tightness felt. Pain in finger joints of right then left hand. Joint and muscle stiffness of upper extremities then both feet.
Age: 23.0
Sex: M
Vaccine: ANTH
Symptoms: Headache, Hyperhidrosis, Paraesthesia, Syncope
Clinical narrative: Administered Anthrax vaccine at event and patient reported left arm tingling, sweating and then he fainted in chair. Upon arousing seconds later he reported a headache. He was treated by medical staff on the scene and recovered fully within 15-20 min.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: Expired vaccine administered / a patient received a dose of VAQTA (R010369 3/25/2019) beyond its expiration date; No adverse effects have been reported; This spontaneous report as received from a medical assistant refers to a patient of unknown gender and age. No information regarding the patient's pertinent medical history, concomitant medication, drug reactions and allergies was provided.   On 16-APR-2019, the patient received a dose of hepatitis a vaccine, inactivated (VAQTA) 25/0.5, injection, 1 dosage form, intramuscularly, lot number R010369, expiration date 25-MAR-2019, for prophylaxis, beyond its expiration date. No adverse effects had been reported.
Sex: M
Vaccine: VARZOS
Symptoms: Back pain, Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: low back pain; swollen arm; hurting arm; red arm; This case was reported by a consumer via call center representative and described the occurrence of low back pain in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Zostavax.   On 20th February 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced low back pain, swelling arm, pain in arm and erythema of extremities. On an unknown date, the outcome of the low back pain, swelling arm, pain in arm and erythema of extremities were unknown.   It was unknown if the reporter considered the low back pain, swelling arm, pain in arm and erythema of extremities to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter called back asking about best time to receive 2nd dose within the 2 to 6 months and if any adverse event worse with 2nd dose than 1st dose.  The patient continues to have lower back back pain since after his first dose.  The patient had not reported the events to his physician still.  The patient also noted he had received the  The patient plans to get his 2nd dose the day after reporting after his first dose  The reporter thought it would be nice, when somebody had an arm that's swollen, or hurting, or red, to tell them what to do about it, like put on heat, put on cold, as they know, try to exercise the arm, or keep the arm immobile, and not told the patient to go see their doctor, because you administered the vaccine, you know, there should be some basic guidelines that you could tell the patient if he was in pain with his arm. This case has been linked with US2019AMR073880, reported by same reporter.
Age: 45.0
Sex: F
Vaccine: HEP
Symptoms: Feeling hot, Injection site pain
Clinical narrative: soreness at injection site; feels hot; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 45-year-old female patient who received HBV (Engerix B adult) for prophylaxis.   Concurrent medical conditions included food allergy.   On 22nd April 2019, the patient received the 1st dose of Engerix B adult. On 22nd April 2019, less than a day after receiving Engerix B adult, the patient experienced injection site pain and feeling hot. On an unknown date, the outcome of the injection site pain and feeling hot were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain and feeling hot to be related to Engerix B adult.  Additional details were provided as follows:  The patient received Engerix B adult on the left arm. The patient reported that she experienced soreness at the injection site, and feels hot.  Also, the patient reported that she had a yeast allergy,  The patient did not know that there was yeast in the vaccine.  The patient planned to follow-up with her physician on an unknown date. The reporter gave consent to follow up.
Sex: F
Vaccine: PNC13
Symptoms: Pruritus
Clinical narrative: Itching; This is a spontaneous report based on the information received by Pfizer (Reference ID: LRN3610234) from a contactable healthcare professional.  A female patient of an unspecified age received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified at a single dose for immunization. Medical history included seasonal allergic rhinitis, asthma, cough, diabetes and hypertension. Concomitant medication included budesonide, formoterol fumarate (SYMBICORT), fluticasone furoate (ARNUITY ELLIPTA), tiotropium bromide (SPIRIVA), montelukast sodium (SINGULAIR), prednisone, omeprazole, montelukast, losartan, formoterol fumarate, mometasone furoate (DULERA) and azithromycin. On an unspecified date, it was reported that the patient experienced itching. The outcome of the event was unknown.  Information on the batch number has been requested.
Sex: F
Vaccine: PNC13
Symptoms: Rash erythematous, Tenderness
Clinical narrative: Tender angry looking red rash; This is a spontaneous report from a contactable pharmacist. A female patient (age: over 65, units: unknown) received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13, lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date at 0.5 ml, single for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced tender angry looking red rash on an unspecified date. The outcome of the event was unknown. Event took place after use of product.  The information on the batch/lot number and expiration date has been requested.
Sex: U
Vaccine: PNC13
Symptoms: Swelling
Clinical narrative: swelling post vaccination; This is a spontaneous report from a contactable pharmacist received via a sales representative. A patient of unspecified age and gender  received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13, lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced swelling post vaccination on an unspecified date. The outcome of the event was unknown.  Information about lot/batch number was requested.
Sex: U
Vaccine: MNQ
Symptoms: No adverse event, Product preparation error, Product preparation issue
Clinical narrative: the nurse diluted vial of Menactra with sterile water before administering/No AE; Based on the information received on 26-Apr-2019, the report previously considered as non-valid became valid: the patients initials and date of birth was reported.  Initial information received on 26-Mar-2019 regarding an unsolicited valid non-serious case received from other healthcare professional.  This case involves a patient (age at revaccination was 12 years), who received a dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot number, Exp. Date, route and administration site not reported) on an unspecified date. It was reported that It was reported that the nurse diluted vial of vaccine with sterile water before administering.   Information on the batch number was requested.  It was an actual medication error case due to inappropriate reconstitution technique.   It was reported that the patient did not have any reaction.  corrective action: the patient was revaccinated on 26-Apr-2019 (dosing details and lot number not reported).  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.  Additional information received on 26-Apr-2019 received from other healthcare professional.  The date of birth of the patient was reported.  Information regarding dose restart (corrective action) and adverse event (no reaction) was reported.  The corresponding fields and narrative were updated accordingly.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Pain in Left arm unable to move it as well as before
Age: 6.0
Sex: F
Vaccine: DTAP, MMR
Symptoms: Culture throat, Oropharyngeal pain, Pyrexia, Rash, Streptococcus test
Clinical narrative: 4/28 PM, 101.2 fever, vomiting. No runny nose or coughing. Fever 4/29, didn't temp. Fine 4/30, no fever. Fine 5/1 AM, no fever.  5/1 PM fever, 101.6, complaining of sore throat. 5/2 AM woke up with rash on body and neck, progressed to face, still sore throat. No coughing or runny nose/congestion.
Age: 6.0
Sex: F
Vaccine: DTAP, MMR
Symptoms: Vomiting
Clinical narrative: 4/28 PM, 101.2 fever, vomiting. No runny nose or coughing. Fever 4/29, didn't temp. Fine 4/30, no fever. Fine 5/1 AM, no fever.  5/1 PM fever, 101.6, complaining of sore throat. 5/2 AM woke up with rash on body and neck, progressed to face, still sore throat. No coughing or runny nose/congestion.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Axillary pain, Pain in extremity, Paraesthesia
Clinical narrative: Severe pain and paresthesia in arm and armpit, that continued to worsen on 5/2/19.  The patient was advised to seek medical treatment
Age: 71.0
Sex: F
Vaccine: TYP
Symptoms: Arthralgia, Joint swelling, Mobility decreased, Nightmare
Clinical narrative: Reactions appeared the morning following each dose and lasted 1-2 days.  After the first 3 doses, there was swelling and pain in joints, first knees, then hands and wrists, making it difficult to use those joints, but not severe enough to stop taking the vaccine.  The night after the 4th dose, I had vivid nightmares.
Age: 1.67
Sex: F
Vaccine: HIBV
Symptoms: Product preparation error
Clinical narrative: Used wrong diluent
Age: 53.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site swelling, Pyrexia
Clinical narrative: PATIENT CAME TO THE PHARMACY TODAY 04/30/2019 AND SAID HE EXPERIENCED FEVER THE NEXT DAY ALONG WITH SOME MILD SWELLING ON THE ARM WHERE THE SHOT WAS ADMINISTERED. PT WAS INSTRUCTED TO USE BENADRYL OR CORTISONE CREAM OVER THE COUNTER AND COLD ICE PACKS. TODAY 05/02/2019 PATIENT FEELS BETTER AND ALL SYMPTOMS HAVE RESOLVED.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Red, hard, swelling on L arm. Dr.  recommended ice / ibuprofen.
Age: 48.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site pain, Injection site swelling, Pain, Swelling
Clinical narrative: Felt shooting pain down left arm at moment of injection, but no redness or swelling at site initially.  Swelling at site began about 2-3 hours later, with no redness or pain, and resolved by the next morning.  No systemic Sx's.  Began to notice swelling and tenderness in her left axillary region by the evening following the injection, but no fever or erythema.  The swelling increased by the next day, and was seen in the clinic later that day (about 48 hours post injection).   Exam reveals mild diffuse swelling just anterior to left pectoral muscle in the left axilla, with no discernible node or mass.  Has been advised to apply icepack for 10-15 minutes every several hours, and take Aleve every 4-6 hours, and follow up early next week to report on response. Day 2:
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling and redness on L thigh at injection site
Age: 3.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Patient presented with chickenpox virus in our office, 1 previous dose of varicella containing vaccine on 2/9/2017.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: chills, followed by redness, pain, warmth, swelling of injection site. Self-treating w/ice, ibuprofen
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect reported; 2 doses of improperly stored pneumovax was administered to unknown patients; This spontaneous non-valid report was received from a registered nurse concerning a unspecified number of patients.  The patients concurrent conditions, medical history, drug reactions or allergies were not reported. Concomitant medications included sterile diluent.  On 17-APR-2019, the patients received 1 doses of improperly stored Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) administered intramuscularly (lot#: R031812, expiration date 26-SEP-2020) and on an unknown date, the patients received 1 dose of improperly stored Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) administered intramuscularly (lot #: S002639, expiration date: 26-SEP-2020). The time frame was 17 minutes and the temperature was 0.3 degrees Celsius. The call was due to a data logger. There was previous temperature excursions. No adverse effects were reported.  This report is considered to be non-valid due to a lack of patients identifiers.
Age: 78.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Neuropathy peripheral
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 85-year-old patient of unknown gender. No information regarding the patient's medical history and concomitant medications was reported. On or around 28-MAY-2013, at the age of 78 years, the patient was vaccinated by a pharmacist with ZOSTAVAX injection (route of administration, dose, vaccination site, lot # and expiry date were not reported) for long-term prevention of shingles and zoster-related conditions. On an unknown date, the patient experienced herpes zoster and herpes zoster neuropathy. On an unspecified date, the patient was treated by a physician for herpes zoster and herpes zoster neuropathy. The outcome of the events herpes zoster and herpes zoster neuropathy was not reported. The reporter considered the events to be related to ZOSTAVAX. Upon internal review, the event of herpes zoster neuropathy was determined to be medically significant. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Unevaluable event
Clinical narrative: Many elderly patients who had received the shingles shot at the physician's office had contracted the shingles; Information has been received regarding a case in litigation for zoster vaccine live (ZOSTAVAX) (# 1810USA013393) from a lawyer (via factsheet) and a letter from a female patient who on a visit to a physician on 02-NOV-2016 for care of her shingles reported that the physician related to her that many of his elderly patients who had received the shingles shot at his office had contracted the shingles.  She believed that he stated about 5 % of his elderly population and he was considering no longer dispensing the shot as he had serious concerns regarding it.  She reported the physician informed her many of his patients and others reported severe pain in a part of the body prior to the outbreak of the shingles. [The indication for the shingles shot was considered prophylaxis. No information was provided on the site of administration, route of administration, date of administration or Lot number.] Treatment and outcome of shingles was not reported.  No further information was provided.  Additional information was not expected.; Sender's Comments:  US-009507513-1810USA013393:
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Injection site pain, Insomnia, Myalgia
Clinical narrative: sleepless; soreness; muscular aches; shivering site; This case was reported by a consumer via call center representative and described the occurrence of sleeplessness in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th April 2019, the patient received the 1st dose of Shingrix. On 8th April 2019, less than a day after receiving Shingrix, the patient experienced sleeplessness, injection site pain, muscle pain and shivering. On an unknown date, the outcome of the sleeplessness was unknown and the outcome of the injection site pain, muscle pain and shivering were not recovered/not resolved.   It was unknown if the reporter considered the sleeplessness, injection site pain, muscle pain and shivering to be related to Shingrix.  Additional details were provided as follows: The patient got the a dose of Shingrix injection. The patient experienced sleepless night with shivering, site soreness and muscular aches. The reporter wanted what to do about the events.
Sex: F
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: patient received 2 doses of Typhim VI dose 7.5 weeks earlier; Initial information received on 25-Apr-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 47 years old female patient who experienced patient received vaccine TYPHOID VI POLYSACCHARIDE VACCINE [TYPHIM VI].  The patient's past vaccination(s) included Hepatitis A, Hepatitis B and MMR receiving vaccines over the last month. The patient's past medical history, medical treatment(s) and family history were not provided.  Concomitant medications included RABIES VACCINE (RABIES VACCINE) for Immunisation three doses in series on date 22-Mar-2019, 29-Mar-2019 and 12-Apr-2019.  On 01-Mar-2019, the patient received a dose first dose of suspect TYPHOID VI POLYSACCHARIDE VACCINE (Solution for injection) lot number not reported via unknown route in unknown administration site.   On 24-Apr-2019, the patient received a second 0.5 mL dose of the same vaccine TYPHOID VI POLYSACCHARIDE VACCINE (Solution for injection) lot PZA881M, expiry date- 22-SEP-2020 via unknown route in the left deltoid.  It was a case of actual medication error due to Inappropriate schedule of vaccine administered.  The patient received a prior Typhim VI dose 7.5 weeks earlier. Occupation Health Nurse reports a female worker who will be traveling received a second Typhim VI dose on 24APR2019 due to missing paperwork in her chart documenting that she had already received the vaccine on 01MAR2019.  It was unknown if any adverse event was occurred.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Documents held by sender: none.