chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 35.0
Sex: M
Vaccine: FLUC4, HEPAB, TDAP
Symptoms: Syncope
Clinical narrative: Patient has a history of syncope after blood donations and vaccines. Patient was told to sit down for 15 minutes after vaccines were given. Patient fainted for about 60 seconds before being aware again. EMT showed up and patient refused to go to the hospital. The patient stayed at the pharmacy for 30 minutes until he is comfortable leaving.
Age: 26.0
Sex: F
Vaccine: VARCEL
Symptoms: Cellulitis
Clinical narrative: Cellulitis infection, given bactrim SD
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Disturbance in attention, Fatigue, Headache
Clinical narrative: Flu like, headache, muscle ache, joint ache, surface of skin sore, chills, shivering, hard to concentrate, tiredness, pain at site area of injection. These symptoms are similar to shot 1 but more severe so I am reporting them.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site pain, Myalgia, Pain of skin
Clinical narrative: Flu like, headache, muscle ache, joint ache, surface of skin sore, chills, shivering, hard to concentrate, tiredness, pain at site area of injection. These symptoms are similar to shot 1 but more severe so I am reporting them.
Age: 13.0
Sex: F
Vaccine: HEP
Symptoms: Syncope
Clinical narrative: Syncope post vaccination while still in doctors office
Age: 1.0
Sex: F
Vaccine: FLU4, HEPA
Symptoms: Balance disorder, C-reactive protein, Fall, Feeling abnormal, Full blood count
Clinical narrative: Patient had rashes and fevers on and off since the vaccination.  I did not at the time realize that timeline.  On March 6, patient began falling to her right side and her right side of her body seemed week.  She would space out and not respond for up to 15 seconds at a time.  The symptoms were transient, coming and going with a low grade fever 100.8. We took her to the Emergency room and at that time her symptoms had stopped and neurological exam was normal.  We were told it was vestibular ataxia and told to follow up with pediatrician Her ears were totally clear in the that visit and every other visit after. Then she started walking on her toes and was unable to walk without assistance.  She then would go in and out of having balance issues,
Age: 1.0
Sex: F
Vaccine: FLU4, HEPA
Symptoms: Hemiparesis, Neurological examination normal, Pyrexia, Rash, Red blood cell sedimentation rate
Clinical narrative: Patient had rashes and fevers on and off since the vaccination.  I did not at the time realize that timeline.  On March 6, patient began falling to her right side and her right side of her body seemed week.  She would space out and not respond for up to 15 seconds at a time.  The symptoms were transient, coming and going with a low grade fever 100.8. We took her to the Emergency room and at that time her symptoms had stopped and neurological exam was normal.  We were told it was vestibular ataxia and told to follow up with pediatrician Her ears were totally clear in the that visit and every other visit after. Then she started walking on her toes and was unable to walk without assistance.  She then would go in and out of having balance issues,
Age: 1.0
Sex: F
Vaccine: FLU4, HEPA
Symptoms: Toe walking, Unresponsive to stimuli, Vestibular disorder, Walking aid user
Clinical narrative: Patient had rashes and fevers on and off since the vaccination.  I did not at the time realize that timeline.  On March 6, patient began falling to her right side and her right side of her body seemed week.  She would space out and not respond for up to 15 seconds at a time.  The symptoms were transient, coming and going with a low grade fever 100.8. We took her to the Emergency room and at that time her symptoms had stopped and neurological exam was normal.  We were told it was vestibular ataxia and told to follow up with pediatrician Her ears were totally clear in the that visit and every other visit after. Then she started walking on her toes and was unable to walk without assistance.  She then would go in and out of having balance issues,
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site bruising, Injection site pain, Injection site pruritus, Pain
Clinical narrative: On 2/17-The pharmacy received a phone call from patient. She spoke to me, the pharmacist, who administered the vaccine earlier that day. Patient said that the sight looked like a bruise and was tender. The patient was asked if there was any other adverse affects and, at the time, she said no. She stated that she watch to see if the redness would grow and call us if there was change. On 2/19 Patient came to the pharmacy in the morning and said she had a fever on 2/18 but she no longer had a fever. She had body aches as well. She stated that the sight was "slightly itchy" the previous day. I told her that she could take an analgesic (acetaminophen) for the fever and pain. She indicated that she didn't take anything since receiving the vaccine. I told her she could take Benadryl or any antihistamine for the itch. She told me that it didn't itch anymore. She thought the redness and bruise wasn't growing but it wasn't diminishing either. I told her that we could contact her physician, she said she would contact us if there is any further change. She stated that she no longer had a fever. I told her I would report the incident and I would research to see if she should receive the 2nd Shingrix dose since she had this adverse reaction that could be an allergic reaction.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: On 2/17-The pharmacy received a phone call from patient. She spoke to me, the pharmacist, who administered the vaccine earlier that day. Patient said that the sight looked like a bruise and was tender. The patient was asked if there was any other adverse affects and, at the time, she said no. She stated that she watch to see if the redness would grow and call us if there was change. On 2/19 Patient came to the pharmacy in the morning and said she had a fever on 2/18 but she no longer had a fever. She had body aches as well. She stated that the sight was "slightly itchy" the previous day. I told her that she could take an analgesic (acetaminophen) for the fever and pain. She indicated that she didn't take anything since receiving the vaccine. I told her she could take Benadryl or any antihistamine for the itch. She told me that it didn't itch anymore. She thought the redness and bruise wasn't growing but it wasn't diminishing either. I told her that we could contact her physician, she said she would contact us if there is any further change. She stated that she no longer had a fever. I told her I would report the incident and I would research to see if she should receive the 2nd Shingrix dose since she had this adverse reaction that could be an allergic reaction.
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site pain, Peripheral swelling
Clinical narrative: Patient complaints of pain at injection site. Her arm is ared ans swollen
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Blood culture negative, CSF test normal, Electroencephalogram normal, Febrile convulsion, Influenza virus test
Clinical narrative: Pt presented with new onset seizures Pt transported to hospital by EMS admitted for full evaluation. Inpatient course uneventful with normal video EEG and CSF studies. Pt diagnosed with atypical febrile seizure. Pt also was diagnosed with RSV in hospital. Pt was treated with acyclovir and ceftriaxone until cultures negative.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Respiratory syncytial virus infection, Respiratory syncytial virus test positive, Seizure
Clinical narrative: Pt presented with new onset seizures Pt transported to hospital by EMS admitted for full evaluation. Inpatient course uneventful with normal video EEG and CSF studies. Pt diagnosed with atypical febrile seizure. Pt also was diagnosed with RSV in hospital. Pt was treated with acyclovir and ceftriaxone until cultures negative.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Pyrexia
Clinical narrative: Fever up to 103.5 per mom and dad
Age: 8.0
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Erythema, Pain, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: Right arm swollen, red hot to touch noted the eve after vaccine administered. Patient complained of pain and puritis. Patient tp clinic for assessment. Advised hot compresses and return if fever develops or no improvement.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Axillary pain, Hypoaesthesia, Lymph node pain, Musculoskeletal pain
Clinical narrative: Patient received first shingles vaccine dose on 9/27/19; patient had expected pain and tenderness at site of injection.    Patient not sure if received vaccine on day listed or day prior.    Per patient, arm felt like someone had punched it, felt off like tired and not feeling great.  As time went on, pain in arm disappeared, left shoulder started to hurt.   At night, patient wakes up from pain when Ibuprofen wears off. Sometimes patient has problems driving so has to put arm on the side.  The shoulder and lymph nodes underneath hurt; patient is not sure why lymph nodes are painful.  Patient reports that on 2 occasions arm went completely numb for about 3 minutes when reached for somethingcertain positions. Because of numbness in arm, patient thought she was having a heart attack.  On 1/6, patient went to doctor for a physical and blood work was normal. Patient mentioned the shoulder problems during appointment and doctor mentioned possible pinched nerve. Patient did not provide any guidance/treatment for arm.  Shoulder issues have gotten worse as time goes on; patient not sure if incident caused arthritis or if symptom will continue.    Patient went to pharmacy on 2/15 and she mentioned that she reported it. Patient is not sure if there were some issues with the vaccine administration.  Patient has not been to the doctor since.  Patient is taking Advil every day and has to elevate arm with pillow to sleep.  Patient has not been sick for about 3 years prior to this incident.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blood test normal, Fatigue, Feeling abnormal, Hypoaesthesia, Impaired driving ability
Clinical narrative: Patient received first shingles vaccine dose on 9/27/19; patient had expected pain and tenderness at site of injection.    Patient not sure if received vaccine on day listed or day prior.    Per patient, arm felt like someone had punched it, felt off like tired and not feeling great.  As time went on, pain in arm disappeared, left shoulder started to hurt.   At night, patient wakes up from pain when Ibuprofen wears off. Sometimes patient has problems driving so has to put arm on the side.  The shoulder and lymph nodes underneath hurt; patient is not sure why lymph nodes are painful.  Patient reports that on 2 occasions arm went completely numb for about 3 minutes when reached for somethingcertain positions. Because of numbness in arm, patient thought she was having a heart attack.  On 1/6, patient went to doctor for a physical and blood work was normal. Patient mentioned the shoulder problems during appointment and doctor mentioned possible pinched nerve. Patient did not provide any guidance/treatment for arm.  Shoulder issues have gotten worse as time goes on; patient not sure if incident caused arthritis or if symptom will continue.    Patient went to pharmacy on 2/15 and she mentioned that she reported it. Patient is not sure if there were some issues with the vaccine administration.  Patient has not been to the doctor since.  Patient is taking Advil every day and has to elevate arm with pillow to sleep.  Patient has not been sick for about 3 years prior to this incident.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Lymph node pain, Sleep disorder
Clinical narrative: Patient received first shingles vaccine dose on 9/27/19; patient had expected pain and tenderness at site of injection.    Patient not sure if received vaccine on day listed or day prior.    Per patient, arm felt like someone had punched it, felt off like tired and not feeling great.  As time went on, pain in arm disappeared, left shoulder started to hurt.   At night, patient wakes up from pain when Ibuprofen wears off. Sometimes patient has problems driving so has to put arm on the side.  The shoulder and lymph nodes underneath hurt; patient is not sure why lymph nodes are painful.  Patient reports that on 2 occasions arm went completely numb for about 3 minutes when reached for somethingcertain positions. Because of numbness in arm, patient thought she was having a heart attack.  On 1/6, patient went to doctor for a physical and blood work was normal. Patient mentioned the shoulder problems during appointment and doctor mentioned possible pinched nerve. Patient did not provide any guidance/treatment for arm.  Shoulder issues have gotten worse as time goes on; patient not sure if incident caused arthritis or if symptom will continue.    Patient went to pharmacy on 2/15 and she mentioned that she reported it. Patient is not sure if there were some issues with the vaccine administration.  Patient has not been to the doctor since.  Patient is taking Advil every day and has to elevate arm with pillow to sleep.  Patient has not been sick for about 3 years prior to this incident.
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Cough, Feeling abnormal, Injection site erythema, Injection site swelling
Clinical narrative: facial swelling located under her eyes/the sinus area is puffy and tender; the sinus area is puffy and tender; injection site is still swollen; injection site is still warm to touch; joint pain; body aches; headache was slight; nausea was slight; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th February 2020, the patient received the 1st dose of Shingrix. On 7th February 2020, less than a day after receiving Shingrix, the patient experienced injection site swelling, injection site warmth, joint pain, general body pain, headache and nausea. On 8th February 2020, the patient experienced facial swelling and tenderness. On an unknown date, the outcome of the injection site swelling, injection site warmth, joint pain, general body pain and facial swelling were recovering/resolving and the outcome of the headache and nausea were recovered/resolved and the outcome of the tenderness was unknown.   It was unknown if the reporter considered the injection site swelling, injection site warmth, joint pain, general body pain, headache, nausea, facial swelling and tenderness to be related to Shingrix.  Additional details were provided as follows: At 1: 00 PM, the patient receicved a dose of Shingrix on the left arm. On the same day of vaccination at evening, the patient experienced all the symptoms except for the facial swelling which she noticed when she woke up the following day. The headache and nausea was slight.  The injection site was still swollen and warm to the touch. The facial swelling was located under her eyes.  She described it as the sinus area. The area was puffy and tender. The reporter consented to follow up.
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site warmth, Loss of personal independence in daily activities, Myalgia, Nausea, Pain
Clinical narrative: facial swelling located under her eyes/the sinus area is puffy and tender; the sinus area is puffy and tender; injection site is still swollen; injection site is still warm to touch; joint pain; body aches; headache was slight; nausea was slight; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th February 2020, the patient received the 1st dose of Shingrix. On 7th February 2020, less than a day after receiving Shingrix, the patient experienced injection site swelling, injection site warmth, joint pain, general body pain, headache and nausea. On 8th February 2020, the patient experienced facial swelling and tenderness. On an unknown date, the outcome of the injection site swelling, injection site warmth, joint pain, general body pain and facial swelling were recovering/resolving and the outcome of the headache and nausea were recovered/resolved and the outcome of the tenderness was unknown.   It was unknown if the reporter considered the injection site swelling, injection site warmth, joint pain, general body pain, headache, nausea, facial swelling and tenderness to be related to Shingrix.  Additional details were provided as follows: At 1: 00 PM, the patient receicved a dose of Shingrix on the left arm. On the same day of vaccination at evening, the patient experienced all the symptoms except for the facial swelling which she noticed when she woke up the following day. The headache and nausea was slight.  The injection site was still swollen and warm to the touch. The facial swelling was located under her eyes.  She described it as the sinus area. The area was puffy and tender. The reporter consented to follow up.
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Periorbital swelling, Pyrexia, Swelling face
Clinical narrative: facial swelling located under her eyes/the sinus area is puffy and tender; the sinus area is puffy and tender; injection site is still swollen; injection site is still warm to touch; joint pain; body aches; headache was slight; nausea was slight; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th February 2020, the patient received the 1st dose of Shingrix. On 7th February 2020, less than a day after receiving Shingrix, the patient experienced injection site swelling, injection site warmth, joint pain, general body pain, headache and nausea. On 8th February 2020, the patient experienced facial swelling and tenderness. On an unknown date, the outcome of the injection site swelling, injection site warmth, joint pain, general body pain and facial swelling were recovering/resolving and the outcome of the headache and nausea were recovered/resolved and the outcome of the tenderness was unknown.   It was unknown if the reporter considered the injection site swelling, injection site warmth, joint pain, general body pain, headache, nausea, facial swelling and tenderness to be related to Shingrix.  Additional details were provided as follows: At 1: 00 PM, the patient receicved a dose of Shingrix on the left arm. On the same day of vaccination at evening, the patient experienced all the symptoms except for the facial swelling which she noticed when she woke up the following day. The headache and nausea was slight.  The injection site was still swollen and warm to the touch. The facial swelling was located under her eyes.  She described it as the sinus area. The area was puffy and tender. The reporter consented to follow up.
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Headache, Injection site swelling, Injection site warmth, Nausea
Clinical narrative: facial swelling located under her eyes/the sinus area is puffy and tender; the sinus area is puffy and tender; injection site is still swollen; injection site is still warm to touch; joint pain; body aches; headache was slight; nausea was slight; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th February 2020, the patient received the 1st dose of Shingrix. On 7th February 2020, less than a day after receiving Shingrix, the patient experienced injection site swelling, injection site warmth, joint pain, general body pain, headache and nausea. On 8th February 2020, the patient experienced facial swelling and tenderness. On an unknown date, the outcome of the injection site swelling, injection site warmth, joint pain, general body pain and facial swelling were recovering/resolving and the outcome of the headache and nausea were recovered/resolved and the outcome of the tenderness was unknown.   It was unknown if the reporter considered the injection site swelling, injection site warmth, joint pain, general body pain, headache, nausea, facial swelling and tenderness to be related to Shingrix.  Additional details were provided as follows: At 1: 00 PM, the patient receicved a dose of Shingrix on the left arm. On the same day of vaccination at evening, the patient experienced all the symptoms except for the facial swelling which she noticed when she woke up the following day. The headache and nausea was slight.  The injection site was still swollen and warm to the touch. The facial swelling was located under her eyes.  She described it as the sinus area. The area was puffy and tender. The reporter consented to follow up.
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain, Swelling face, Tenderness
Clinical narrative: facial swelling located under her eyes/the sinus area is puffy and tender; the sinus area is puffy and tender; injection site is still swollen; injection site is still warm to touch; joint pain; body aches; headache was slight; nausea was slight; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th February 2020, the patient received the 1st dose of Shingrix. On 7th February 2020, less than a day after receiving Shingrix, the patient experienced injection site swelling, injection site warmth, joint pain, general body pain, headache and nausea. On 8th February 2020, the patient experienced facial swelling and tenderness. On an unknown date, the outcome of the injection site swelling, injection site warmth, joint pain, general body pain and facial swelling were recovering/resolving and the outcome of the headache and nausea were recovered/resolved and the outcome of the tenderness was unknown.   It was unknown if the reporter considered the injection site swelling, injection site warmth, joint pain, general body pain, headache, nausea, facial swelling and tenderness to be related to Shingrix.  Additional details were provided as follows: At 1: 00 PM, the patient receicved a dose of Shingrix on the left arm. On the same day of vaccination at evening, the patient experienced all the symptoms except for the facial swelling which she noticed when she woke up the following day. The headache and nausea was slight.  The injection site was still swollen and warm to the touch. The facial swelling was located under her eyes.  She described it as the sinus area. The area was puffy and tender. The reporter consented to follow up.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: An unspecified number of patients were administered with improperly stored Pneumovax23 above 47 degrees F; No additional adverse events; This spontaneous report was received from a registered nurse reporting about an unspecified number of patients of unknown age. Information about the patients' medical history, concurrent conditions or concomitant medications was not provided.     On an unknown date, the patients were vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), with lot # S033516 and expiration date of 29-JUN-2012, that was administered for prophylaxis; that was improperly stored at a temperature too high, over 47 degrees F. No additional adverse events were reported. On 09-DEC-2019, the vaccine's temperature was 50.9 degrees F for 18 minutes. On 14-JAN-2020, the vaccine's temperature was 47.1 degrees F for 15 minutes. On 31-JAN-2020, the vaccine's temperature was 62.5 degrees F for 15 minutes.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: The patient did not experience any symptom; One patient was vaccinated with improperly stored PROQUAD; Information has been received from a physician concerning a patient of unknown age and gender. There was no information about patient's concurrent conditions, medical history or concomitant medications.  On 25-JAN-2020, the patient was vaccinated with a dose of improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (rha) lot # S002496 and expiration date of 23-JUL-2020, (route of administration and anatomical location were not reported) for prophylaxis, which was stored in the range of -9 to 8 Celsius degrees to (-7 Celsius degrees) for 50 minutes. The vaccine was reconstituted with sterile diluent(STERILE DILUENT).  No previous temperature excursion was reported.  The patient did not experience any symptom.   Digital data logger was involved.
Sex: M
Vaccine: VARZOS
Symptoms: Cough, Herpes zoster, Pneumonia, Post herpetic neuralgia, Rash
Clinical narrative: multiple reoccurrences of pneumonia; shingles; postherpetic neuralgia; Information has been received from a lawyer referring to a male patient of unknown age. Information about concurrent condition and concomitant medication was not reported. The pt's historical condition included pneumonia. On or around 14-FEB-2013, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX), the pt suffered a severe painful rash on the left side of the buttocks wrapping around to the left anterior thigh and on to the left side of the penis. The pt also experienced a severe, persistent cough. The pt was diagnosed with shingles, postherpetic neuralgia and multiple reoccurrences of pneumonia. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms have resulted in physical limitations not present prior to using the vaccine. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events shingles, postherpetic neuralgia and multiple reoccurrences of pneumonia was considered to be not recovered and causal relationship was assessed as related.     The lawyer considered the events shingles, postherpetic neuralgia and multiple reoccurrences of pneumonia to be disability.  Upon internal review, multiple reoccurrences of pneumonia was determined to be medically significant.
Sex: U
Vaccine: MMRV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: No known adverse effects.; A 53 year old patient received a dose of PROQUAD; This spontaneous report has been received from a medical assistant concerning a 53-year-old patient of unknown gender. The patient's current conditions, pertinent medical history, drug reactions or allergies, and concomitant therapies were not reported.   On 18-FEB-2020, the 53-year-old patient was vaccinated with a dose of  Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live, recombinant Human albumin (rHA) (PROQUAD) (product administered to patient of inappropriate age), 1 dosage form for prophylaxis  (lot number S0172393, has been verified to be a valid, expiration date reported as 01-DEC-2020,  but upon internal validation, it was established as 01-DEC-2021) (concentration, frequency of vaccination scheme, route and anatomical location of vaccination were not reported).  No known adverse effects were reported.
Sex: U
Vaccine: MMR
Symptoms: Product storage error
Clinical narrative: No additional adverse events reported; the patient was administered an improperly stored dose of MMR II that was reconstituted with a properly stored dose of diluent.; This spontaneous report has been received from a pharmacist, referring to a patient of unknown age and gender. The patient's concomitant medication included sterile diluent. The patient's pertinent medical history and drug reactions/allergies were not provided.    On 16-JAN-2020, the patient was vaccinated with an improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (1 dose, lot # R030813, expiration date 24-OCT-2020; strength and route were unknown) for prophylaxis that was reconstituted with a properly stored dose of diluent.   The measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was stored above 47 degrees Fahrenheit (74 degrees Fahrenheit) for 13 hours (product storage error). There was no previous temperature excursion. There was data logger involved. There was no additional adverse events reported (no adverse event).
Sex: M
Vaccine: VARZOS
Symptoms: Feeling abnormal, Musculoskeletal pain, Pain, Pain in extremity
Clinical narrative: arm was sore and it felt like someone had punched him in the arm; sharp pain in the shoulder/nail stuck in his shoulder; Throbbing pain/pounding; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In December 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 2 months after receiving Shingrix and an unknown time after starting ibuprofen, the patient experienced pain in arm, shoulder pain and throbbing pain. The patient was treated with ibuprofen. On an unknown date, the outcome of the pain in arm and shoulder pain were not recovered/not resolved and the outcome of the throbbing pain was recovering/resolving.   It was unknown if the reporter considered the pain in arm, shoulder pain and throbbing pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix around the second week of Christmas. He stated that after the injection his arm was sore and it felt like someone had punched him in the arm.  The caller described the pain as throbbing and pounding. The caller stated that the initial soreness and pain went away but he has a sharp pain in the shoulder. He stated that the sharp pain starts at the end of the day and goes on through the middle of the night. He stated that he feels as if there was a nail stuck in his shoulder. He stated he can still move the arm around and that he takes Ibuprofen for the sharp pain.  The caller stated that he has had injections throughout his life and has never had this happen before.  The caller had name of health care professional clinic but not the address.  The reporter consented to follow up.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Discomfort, Injection site pain, Insomnia, Lethargy
Clinical narrative: aching in her joints of both her wrist and hands /Aching both hand joints /pain in hips; both shoulders ached; had to work extra hard to move around,like lethargy/trying to walk through molasses; lethargy; arm injection site became excruciating painful; did not sleep at all that Friday night; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th February 2020, the patient received the 2nd dose of Shingrix .5 ml. On 7th February 2020, less than a day after receiving Shingrix, the patient experienced injection site pain and sleeplessness. On 8th February 2020, the patient experienced arthralgia, shoulder pain, mobility decreased and lethargy. On 9th February 2020, the outcome of the injection site pain, sleeplessness, arthralgia, shoulder pain, mobility decreased and lethargy were recovered/resolved.   It was unknown if the reporter considered the injection site pain, sleeplessness, arthralgia, shoulder pain, mobility decreased and lethargy to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in left arm and injection site became excruciating painful, she could not find a comfortable position even when she propped her left arm on a pillow.  She did not sleep at all night and her large joints and some of her small joints were aching, her hips and both shoulders ached the worse. She also experienced aching in her joints of both her wrist and hands but the left wrist and left hand were worse. She also had to work extra hard to move around, she compared it to like lethargy or trying to walk through molasses. She went to bed early on and when she got up all her symptoms had resolved.  The reporter did not consent to follow up. The NDC number reported as 58160082311.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Mobility decreased, Musculoskeletal pain
Clinical narrative: aching in her joints of both her wrist and hands /Aching both hand joints /pain in hips; both shoulders ached; had to work extra hard to move around,like lethargy/trying to walk through molasses; lethargy; arm injection site became excruciating painful; did not sleep at all that Friday night; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th February 2020, the patient received the 2nd dose of Shingrix .5 ml. On 7th February 2020, less than a day after receiving Shingrix, the patient experienced injection site pain and sleeplessness. On 8th February 2020, the patient experienced arthralgia, shoulder pain, mobility decreased and lethargy. On 9th February 2020, the outcome of the injection site pain, sleeplessness, arthralgia, shoulder pain, mobility decreased and lethargy were recovered/resolved.   It was unknown if the reporter considered the injection site pain, sleeplessness, arthralgia, shoulder pain, mobility decreased and lethargy to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in left arm and injection site became excruciating painful, she could not find a comfortable position even when she propped her left arm on a pillow.  She did not sleep at all night and her large joints and some of her small joints were aching, her hips and both shoulders ached the worse. She also experienced aching in her joints of both her wrist and hands but the left wrist and left hand were worse. She also had to work extra hard to move around, she compared it to like lethargy or trying to walk through molasses. She went to bed early on and when she got up all her symptoms had resolved.  The reporter did not consent to follow up. The NDC number reported as 58160082311.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site bruising, Injection site erythema, Injection site pain
Clinical narrative: Rash on both of her legs; The rash turned into flaky skin; Red spots; Pain at the injection site; Swelling on her right deltoid region of the arm; Redness on her right deltoid region of the arm; Bruising on her right deltoid region of the arm; Fever; Chills; Headache; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   In October 2019, the patient received the 2nd dose of Shingrix. In October 2019, less than a day after receiving Shingrix, the patient experienced injection site pain, injection site swelling, injection site erythema, injection site bruising, fever, chills and headache. In February 2020, the patient experienced red spotty rash. On an unknown date, the patient experienced rash and flaking skin. On an unknown date, the outcome of the injection site pain, injection site swelling, injection site erythema, injection site bruising, fever, chills and headache were recovered/resolved and the outcome of the rash, flaking skin and red spotty rash were unknown.   It was unknown if the reporter considered the injection site pain, injection site swelling, injection site erythema, injection site bruising, fever, chills, headache, rash, flaking skin and red spotty rash to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and experienced pain at injection site, fever, chills, and headache.  This adverse event lasted for total of three days.  After the day of vaccination, she experienced swelling, redness and bruising on her right deltoid region of the arm. This lasted for total of one week.  About 3 months post vaccination she experienced a rash on both of her legs primarily between the knee and ankle. The rash turned into flaky skin and at the time of reporting red spots for 2 weeks.  The reporter consented to follow up. No further details were provided.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Pyrexia, Rash, Rash erythematous, Skin exfoliation
Clinical narrative: Rash on both of her legs; The rash turned into flaky skin; Red spots; Pain at the injection site; Swelling on her right deltoid region of the arm; Redness on her right deltoid region of the arm; Bruising on her right deltoid region of the arm; Fever; Chills; Headache; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   In October 2019, the patient received the 2nd dose of Shingrix. In October 2019, less than a day after receiving Shingrix, the patient experienced injection site pain, injection site swelling, injection site erythema, injection site bruising, fever, chills and headache. In February 2020, the patient experienced red spotty rash. On an unknown date, the patient experienced rash and flaking skin. On an unknown date, the outcome of the injection site pain, injection site swelling, injection site erythema, injection site bruising, fever, chills and headache were recovered/resolved and the outcome of the rash, flaking skin and red spotty rash were unknown.   It was unknown if the reporter considered the injection site pain, injection site swelling, injection site erythema, injection site bruising, fever, chills, headache, rash, flaking skin and red spotty rash to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and experienced pain at injection site, fever, chills, and headache.  This adverse event lasted for total of three days.  After the day of vaccination, she experienced swelling, redness and bruising on her right deltoid region of the arm. This lasted for total of one week.  About 3 months post vaccination she experienced a rash on both of her legs primarily between the knee and ankle. The rash turned into flaky skin and at the time of reporting red spots for 2 weeks.  The reporter consented to follow up. No further details were provided.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Rash
Clinical narrative: rash at the injection site and down her arm/rash at the injection site; This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 70-year-old female patient who received Herpes zoster (Shingrix) (batch number M9P52, expiry date 18th December 2021) for prophylaxis.   On 8th October 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 5 months 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 patient experienced a rash at the injection site and down her arm. The rash resolved after about 1.5 weeks.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Injection site pain, Musculoskeletal pain
Clinical narrative: Injection site pain that went from the patient´s shoulder to the elbow; Injection site pain that went from the patient´s shoulder to the elbow; Injection site pain that went from the patient´s shoulder to the elbow; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 56-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16th January 2020, the patient received the 1st dose of Shingrix. On 16th January 2020, immediately after receiving Shingrix, the patient experienced injection site pain, shoulder pain and pain in elbow. On an unknown date, the outcome of the injection site pain, shoulder pain and pain in elbow were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, shoulder pain and pain in elbow to be related to Shingrix.  Additional details were provided as follows: Some time after vaccination, the patient felt pain at the site of injection that went from the patient´s shoulder to the elbow. The reporter consented to follow up.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Pain, Pain in extremity
Clinical narrative: Arm pain / cannot raise her arm without pain; she still cannot raise her arm without pain; pain upon movement; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th December 2019, the patient received the 1st dose of Shingrix. On an unknown date, couple of days after receiving Shingrix, the patient experienced pain in arm, injected limb mobility decreased and pain upon movement. On an unknown date, the outcome of the pain in arm was not recovered/not resolved and the outcome of the injected limb mobility decreased and pain upon movement were unknown.   It was unknown if the reporter considered the pain in arm, injected limb mobility decreased and pain upon movement to be related to Shingrix.  Additional details were reported as follows: The patient received Shingrix and few days after experienced arm pain.  The pain has persisted and she still cannot raise her arm without pain.  It was worst at night when she was immobile than it was when she was moving during the day. Reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: rash on legs and back; This case was reported by a pharmacist 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 an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, unknown 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 administration was not reported. The patient received Shingrix and experienced rash on legs and back.
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Expired dose of Adacel was inadvertently administered / No AE; Initial information was received on 11-Feb-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 47 years old female patient who on 11-Feb-2020 was vaccinated with 0.5 ml DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot U5872AA and expiry 06-Feb-2020) via intramuscular route in the left deltoid for prophylactic vaccination (expired product administered).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included RABIES VACCINE (RABIES VACCINE) for an unknown indication.  It was an actual medication error case due to expired vaccine used.  At a time of reporting no adverse event reported.  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 and Module VI of the 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.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired dose of Daptacel was inadvertently administered to a 4 year old patient, NO AE.; Initial information received on 11-Feb-2020 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a four years old male patient who was vaccinated with an expired 0.5 ml dose of vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (fifth dose in series, lot number: C5366BA and expiry date: 07-Feb-2020) via intramuscular route in the left thigh on 10-Feb-2020.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included POLIO VACCINE INACT (IPV); MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR); and VARICELLA ZOSTER VACCINE (VARICELLA VACCINE).  It was actual medication error due to expired vaccine used.  At the time of report no adverse event was 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.
Age: 2.0
Sex: M
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: nurse administerd expired Daptacel to 30 months old maile patient, no AE; Initial information was received on 11-Feb-2020 regarding an unsolicited valid non-serious case from a physician.  This case involves a 30 months old male patient who was administered with an expired dose of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (lot C5366AA, expiry date: 07-Feb-2020) via unknown route in unknown administration site for prophylactic vaccination.  Medical history, medical treatments, vaccinations and family history were not provided.  It was a case of actual medication error due to expired vaccine used.  At the time of report no adverse event was reported.  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 and Module VI of the 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.