chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 85.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Condition aggravated, Disturbance in attention
Clinical narrative: hip pain prior to the vaccine but it has become worse since getting the vaccine; CANNOT FOCUS; This case was reported by a pharmacist via call center representative and described the occurrence of arthralgia aggravated in a 85-year-old female patient who received Herpes zoster (Shingrix) (batch number EE924, expiry date 29th January 2022) and (batch number N4C23, expiry date 4th November 2019) for prophylaxis.   Concurrent medical conditions included pain in hip (had a very small amount of hip pain prior to the vaccine).   On 1st November 2019, the patient received the 2nd dose of Shingrix .5 ml. On 1st November 2019, the 2nd dose was .5 ml. In November 2019, less than a week after receiving Shingrix, the patient experienced arthralgia aggravated and concentration impaired. On an unknown date, the outcome of the arthralgia aggravated and concentration impaired were not recovered/not resolved.   It was unknown if the reporter considered the arthralgia aggravated and concentration impaired to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix in the left arm. The pharmacist stated that, after vaccination the patient had hip pain and was not able to focus. The patient had a very small amount of hip pain prior to the vaccine but it had become worse since getting the vaccine. The reporter stated that it was unknown, which hip had pain. The patient's arm felt good. There were two lot numbers listed because the pharmacist was not certain which one was correct. She strongly thought it was the EE924 but wanted to provide both just in case. The reporter consented to follow up.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Facial paralysis
Clinical narrative: Bell's palsy was on the right side of face; This case was reported by a consumer via call center representative and described the occurrence of bell's palsy in a 63-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included diabetes, hypertension, back pain and clubfoot (right club feet'). Concomitant products included lorazepam, diltiazem hydrochloride (Diltiazem), thyroxine sodium (Levothyroxine), lisinopril, glimepiride, metformin and hydrocodone bitartrate + paracetamol (Vicodin).   On 25th October 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 7th November 2019, 13 days after receiving Shingrix, the patient experienced bell's palsy (serious criteria GSK medically significant). On an unknown date, the outcome of the bell's palsy was not recovered/not resolved.   It was unknown if the reporter considered the bell's palsy to be related to Shingrix.  Additional details were provided as follows: The patient reported for himself. The patient received Shingrix in his left arm. The patient had Bell's palsy on the right side of his face. The patient planned to continue follow-up with his physician on an unknown date. Emergency room visit was required. The patient consented to follow up.
Age: 0.17
Sex: F
Vaccine: RV1
Symptoms: Haematochezia
Clinical narrative: bloody stools; This case was reported by a physician via call center representative and described the occurrence of blood in stool in a 2-month-old female patient who received Rota (Rotarix lyophilized formulation) for prophylaxis.   On 11th July 2019, the patient received the 1st dose of Rotarix lyophilized formulation (oral) 1 ml. On 11th July 2019, immediately after receiving Rotarix lyophilized formulation, the patient experienced blood in stool (serious criteria GSK medically significant). On an unknown date, the outcome of the blood in stool was recovered/resolved.   It was unknown if the reporter considered the blood in stool to be related to Rotarix lyophilized formulation.  Additional details were provided as follows: The patient experienced blood stools shortly after receiving Rotarix vaccine. The patient had a few episodes of bloody stools before the issue resolved.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Anal hypoaesthesia, Borrelia test, Chills, Dyschezia, Dysuria
Clinical narrative: Numbness in groin and rectal area / Numbness in feet; Dfficulty urinating; difficulty defecating; feel numbness in rectal area; Skin became sensitive to touch; Skin was painful to the touch; rash; Difficulty walking; Flu like symptoms; Chills; Achy all over; Headache; May have multiple sclerosis; This case was reported by a consumer via call center representative and described the occurrence of multiple sclerosis in a 51-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th October 2019, the patient received the 1st dose of Shingrix (intramuscular). In October 2019, 1 day after receiving Shingrix, the patient experienced multiple sclerosis (serious criteria GSK medically significant). On 20th October 2019, the patient experienced influenza-like symptoms, chills, pain and headache. On 24th October 2019, the patient experienced sensitive skin, skin pain, rash and walking difficulty. On 25th October 2019, the patient experienced numbness in feet, urination difficulty, defecation difficult and anal numbness. On an unknown date, the outcome of the multiple sclerosis, sensitive skin, skin pain, rash, walking difficulty, numbness in feet, urination difficulty and defecation difficult were not recovered/not resolved and the outcome of the influenza-like symptoms, chills, pain and headache were recovered/resolved and the outcome of the anal numbness was unknown.   It was unknown if the reporter considered the multiple sclerosis, influenza-like symptoms, chills, pain, headache, sensitive skin, skin pain, rash, walking difficulty, numbness in feet, urination difficulty, defecation difficult and anal numbness to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient's wife. The patient received Shingrix on left arm. The patient experienced flu like symptoms, described as achy all over and chills and headache.  The patient's skin became sensitive to touch, primarily on the left side above the waist but below the underarm. The skin was painful to the touch. The patient also experienced difficulty walking. The patient then began to feel numbness in his groin and rectal area. and had difficulty urinating and defecating due to not being able to have feeling. On 29th October 2019,the patient went to the emergency department. The patient did not remain overnight and was advised to see a neurologist the next morning.  On 31st October 2019, the patient was dianosed with multiple sclerosis. The neurologist said that the patient might have multiple sclerosis. The neurologist performed an MRI of the spine and brain, which were unremarkable.   The patient was also tested for Lyme disease but results are not known at the time of reporting. The reporter consented to follow up.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Gait disturbance, Headache, Hypoaesthesia, Influenza like illness, Magnetic resonance imaging brain normal
Clinical narrative: Numbness in groin and rectal area / Numbness in feet; Dfficulty urinating; difficulty defecating; feel numbness in rectal area; Skin became sensitive to touch; Skin was painful to the touch; rash; Difficulty walking; Flu like symptoms; Chills; Achy all over; Headache; May have multiple sclerosis; This case was reported by a consumer via call center representative and described the occurrence of multiple sclerosis in a 51-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th October 2019, the patient received the 1st dose of Shingrix (intramuscular). In October 2019, 1 day after receiving Shingrix, the patient experienced multiple sclerosis (serious criteria GSK medically significant). On 20th October 2019, the patient experienced influenza-like symptoms, chills, pain and headache. On 24th October 2019, the patient experienced sensitive skin, skin pain, rash and walking difficulty. On 25th October 2019, the patient experienced numbness in feet, urination difficulty, defecation difficult and anal numbness. On an unknown date, the outcome of the multiple sclerosis, sensitive skin, skin pain, rash, walking difficulty, numbness in feet, urination difficulty and defecation difficult were not recovered/not resolved and the outcome of the influenza-like symptoms, chills, pain and headache were recovered/resolved and the outcome of the anal numbness was unknown.   It was unknown if the reporter considered the multiple sclerosis, influenza-like symptoms, chills, pain, headache, sensitive skin, skin pain, rash, walking difficulty, numbness in feet, urination difficulty, defecation difficult and anal numbness to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient's wife. The patient received Shingrix on left arm. The patient experienced flu like symptoms, described as achy all over and chills and headache.  The patient's skin became sensitive to touch, primarily on the left side above the waist but below the underarm. The skin was painful to the touch. The patient also experienced difficulty walking. The patient then began to feel numbness in his groin and rectal area. and had difficulty urinating and defecating due to not being able to have feeling. On 29th October 2019,the patient went to the emergency department. The patient did not remain overnight and was advised to see a neurologist the next morning.  On 31st October 2019, the patient was dianosed with multiple sclerosis. The neurologist said that the patient might have multiple sclerosis. The neurologist performed an MRI of the spine and brain, which were unremarkable.   The patient was also tested for Lyme disease but results are not known at the time of reporting. The reporter consented to follow up.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Magnetic resonance imaging spinal normal, Multiple sclerosis, Pain, Pain of skin, Rash
Clinical narrative: Numbness in groin and rectal area / Numbness in feet; Dfficulty urinating; difficulty defecating; feel numbness in rectal area; Skin became sensitive to touch; Skin was painful to the touch; rash; Difficulty walking; Flu like symptoms; Chills; Achy all over; Headache; May have multiple sclerosis; This case was reported by a consumer via call center representative and described the occurrence of multiple sclerosis in a 51-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th October 2019, the patient received the 1st dose of Shingrix (intramuscular). In October 2019, 1 day after receiving Shingrix, the patient experienced multiple sclerosis (serious criteria GSK medically significant). On 20th October 2019, the patient experienced influenza-like symptoms, chills, pain and headache. On 24th October 2019, the patient experienced sensitive skin, skin pain, rash and walking difficulty. On 25th October 2019, the patient experienced numbness in feet, urination difficulty, defecation difficult and anal numbness. On an unknown date, the outcome of the multiple sclerosis, sensitive skin, skin pain, rash, walking difficulty, numbness in feet, urination difficulty and defecation difficult were not recovered/not resolved and the outcome of the influenza-like symptoms, chills, pain and headache were recovered/resolved and the outcome of the anal numbness was unknown.   It was unknown if the reporter considered the multiple sclerosis, influenza-like symptoms, chills, pain, headache, sensitive skin, skin pain, rash, walking difficulty, numbness in feet, urination difficulty, defecation difficult and anal numbness to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient's wife. The patient received Shingrix on left arm. The patient experienced flu like symptoms, described as achy all over and chills and headache.  The patient's skin became sensitive to touch, primarily on the left side above the waist but below the underarm. The skin was painful to the touch. The patient also experienced difficulty walking. The patient then began to feel numbness in his groin and rectal area. and had difficulty urinating and defecating due to not being able to have feeling. On 29th October 2019,the patient went to the emergency department. The patient did not remain overnight and was advised to see a neurologist the next morning.  On 31st October 2019, the patient was dianosed with multiple sclerosis. The neurologist said that the patient might have multiple sclerosis. The neurologist performed an MRI of the spine and brain, which were unremarkable.   The patient was also tested for Lyme disease but results are not known at the time of reporting. The reporter consented to follow up.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Sensitive skin
Clinical narrative: Numbness in groin and rectal area / Numbness in feet; Dfficulty urinating; difficulty defecating; feel numbness in rectal area; Skin became sensitive to touch; Skin was painful to the touch; rash; Difficulty walking; Flu like symptoms; Chills; Achy all over; Headache; May have multiple sclerosis; This case was reported by a consumer via call center representative and described the occurrence of multiple sclerosis in a 51-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th October 2019, the patient received the 1st dose of Shingrix (intramuscular). In October 2019, 1 day after receiving Shingrix, the patient experienced multiple sclerosis (serious criteria GSK medically significant). On 20th October 2019, the patient experienced influenza-like symptoms, chills, pain and headache. On 24th October 2019, the patient experienced sensitive skin, skin pain, rash and walking difficulty. On 25th October 2019, the patient experienced numbness in feet, urination difficulty, defecation difficult and anal numbness. On an unknown date, the outcome of the multiple sclerosis, sensitive skin, skin pain, rash, walking difficulty, numbness in feet, urination difficulty and defecation difficult were not recovered/not resolved and the outcome of the influenza-like symptoms, chills, pain and headache were recovered/resolved and the outcome of the anal numbness was unknown.   It was unknown if the reporter considered the multiple sclerosis, influenza-like symptoms, chills, pain, headache, sensitive skin, skin pain, rash, walking difficulty, numbness in feet, urination difficulty, defecation difficult and anal numbness to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient's wife. The patient received Shingrix on left arm. The patient experienced flu like symptoms, described as achy all over and chills and headache.  The patient's skin became sensitive to touch, primarily on the left side above the waist but below the underarm. The skin was painful to the touch. The patient also experienced difficulty walking. The patient then began to feel numbness in his groin and rectal area. and had difficulty urinating and defecating due to not being able to have feeling. On 29th October 2019,the patient went to the emergency department. The patient did not remain overnight and was advised to see a neurologist the next morning.  On 31st October 2019, the patient was dianosed with multiple sclerosis. The neurologist said that the patient might have multiple sclerosis. The neurologist performed an MRI of the spine and brain, which were unremarkable.   The patient was also tested for Lyme disease but results are not known at the time of reporting. The reporter consented to follow up.
Age: 0.17
Sex: F
Vaccine: DTAP
Symptoms: Haematochezia
Clinical narrative: excessive blood in her stool; Initial information received on 07-Nov-2019 regarding an unsolicited valid serious case received from a consumer/non-health care professional.  This case involves an 8 weeks (age at the time of report is 10 weeks) old female patient who experienced excessive blood in her stool (haematochezia), while she received vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  At the time of the event, the patient had ongoing Milk allergy (she was breast feeding).  On an unknown date, the patient received a dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot number not reported via unknown route in unknown administration site.  On an unknown date, (unknown latency) following the vaccination the patient experienced excessive blood in her stool (haematochezia). This event was assessed as medically significant.  (Other relevant tests included no lab data.)  Final diagnosis was blood in stool.  It was not reported if the patient received a corrective treatment.  The outcome of the event was unknown at the time of reporting.  Information on the batch number was requested.; Sender's Comments: This case involves an 8 weeks old female patient who presented with blood in stool after vaccination. Time to onset is compatible with the role of the vaccine. At the time of the event, the patient had ongoing Milk allergy (she was breast feeding). More details regarding patient's medical history, previous vaccination history, etiological workup and investigation reports to identify alternative etiology are needed for complete assessment of the case. Based on the available information, the role of the vaccine cannot be assessed.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Decreased appetite, Dizziness, Musculoskeletal stiffness, Myalgia
Clinical narrative: Began with stiffness in back of neck within first hour. Severe muscle aches, loss of appetite, lightheaded. Within 34 hours, felt a lot better.
Age: 45.0
Sex: M
Vaccine: FLU3
Symptoms: Peripheral swelling, Pruritus, Rash erythematous, Rash pruritic, Urticaria
Clinical narrative: hives, itching 3 hours after receiving the vaccine.  no egg allergy.  had in the past without issue.  red, itchy rash, swelling of hands.  no SOB, throat tightness.  no denies any other new contacts with any foods, products, etc.  no new meds.  tried benadryl with little relief.
Age: 57.0
Sex: F
Vaccine: FLU4, HEPA, TDAP
Symptoms: Breast engorgement, Breast reconstruction, Breast swelling, Cough, Dyspnoea
Clinical narrative: Began coughing about 6 hours after vaccines were given.  Thought throat was "a little tight" and was having a hard time breathing so took Benedryl 25 mg.  Left arm, left arm pit and the side of left breast swelled for 8 days.  Was  unable to lift left arm for over a week.  Both breasts felt engorged.  Patient applied ice under left arm and took 600 mg of Advil every 8  hours for 1 week.  Patient had double mastectomy and reconstruction surgery in 2014.  Symptoms are almost gone now.
Age: 57.0
Sex: F
Vaccine: FLU4, HEPA, TDAP
Symptoms: Injected limb mobility decreased, Peripheral swelling, Swelling, Throat tightness
Clinical narrative: Began coughing about 6 hours after vaccines were given.  Thought throat was "a little tight" and was having a hard time breathing so took Benedryl 25 mg.  Left arm, left arm pit and the side of left breast swelled for 8 days.  Was  unable to lift left arm for over a week.  Both breasts felt engorged.  Patient applied ice under left arm and took 600 mg of Advil every 8  hours for 1 week.  Patient had double mastectomy and reconstruction surgery in 2014.  Symptoms are almost gone now.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Joint range of motion decreased, Peripheral swelling, Rash erythematous
Clinical narrative: By middle afternoon on 11/8/19. Initially red rash near injection site. 11/9, 11/10- Had swelling to arm. 11-12-19- Pt. notified clinic of her reaction and by that time dull ache to arm & more ROM.
Age: 68.0
Sex: M
Vaccine: UNK
Symptoms: Asthenia, Myalgia, Pain in extremity, Pyrexia, Somnolence
Clinical narrative: I was given a flu vaccine on the 11th at 4:30 pm and by the next morning my arm was very sore and  I was weak very sleepy, muscle ache, slight fever. Stayed in bed all day and was better by 8:00 pm on the 12th.
Age: 12.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Abdominal discomfort, Dizziness, Immediate post-injection reaction, Vision blurred
Clinical narrative: Patient reported that immediately after receiving the second vaccine (Gardasil), he had blurry vision so bad that he could not see, felt dizzy,  and that he had an upset stomach. Pt guided to cot to lay down, but he asked to stay seated, resting his head on the wall behind him. Parent stated child had eaten breakfast, but staff offered an orange juice to see if it would help to calm upset stomach and monitored child for 10 minutes after injection. Child stated that his vision improved and his stomach felt better. Patient/child was alert through process and able to communicate his needs. Parent was comfortable and staff felt child had improved enough to leave after improvement of symptoms.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Pt contacted office 11/12/19 with reports that her Right arm was painful and unable to move extremity, pt came into office for evaluation, was prescribed Tramadol to help with pain and to be monitored. Pt was contacted 11/13/19 for follow up on how she was doing with report that her arm was 100 % better with no pain and range of motion was per her norm.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Ear discomfort, Injection site pruritus, Paranasal sinus discomfort, Pruritus
Clinical narrative: experienced: some localized itching at the site of the injection, but no hives, followed by more generalized itching (still no hives). Then I started to feel really congested and could feel quickly worsening sinus pressure, which put pressure in my ears, thus making me feel a little dizzy. But that was where things maxed out and it got better from there. I took a Zyrtec and Aleve and am mostly back to normal. Not sure if it was a reaction to the vaccine itself or something I was exposed to in the process. I do have some environmental allergies and sensitivities, so perhaps that was a factor.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Respiratory tract congestion
Clinical narrative: experienced: some localized itching at the site of the injection, but no hives, followed by more generalized itching (still no hives). Then I started to feel really congested and could feel quickly worsening sinus pressure, which put pressure in my ears, thus making me feel a little dizzy. But that was where things maxed out and it got better from there. I took a Zyrtec and Aleve and am mostly back to normal. Not sure if it was a reaction to the vaccine itself or something I was exposed to in the process. I do have some environmental allergies and sensitivities, so perhaps that was a factor.
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Electrocardiogram ambulatory, Headache, Nausea, Palpitations, Pruritus
Clinical narrative: With in 30 minutes experienced nausea, vomiting, extreme itching and headache
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Vomiting
Clinical narrative: With in 30 minutes experienced nausea, vomiting, extreme itching and headache
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Chills, Dehydration, Hypersomnia, Myalgia
Clinical narrative: Muscle soreness started around 11 pm on 11-12.  On 11-13 I was feeling a bit shaky, but went to work.  I was dehydrated and shivering around 11 am.  Once at home I collapsed, unable to get out of bed, was napping for several hours, feverish.  Had over 99 temp in evening, temperature probably higher earlier.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Nervousness, Pyrexia, Syncope
Clinical narrative: Muscle soreness started around 11 pm on 11-12.  On 11-13 I was feeling a bit shaky, but went to work.  I was dehydrated and shivering around 11 am.  Once at home I collapsed, unable to get out of bed, was napping for several hours, feverish.  Had over 99 temp in evening, temperature probably higher earlier.
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Lip swelling, Swelling face
Clinical narrative: patient reported lip/facial swelling approximately 45 minutes to 1 hour after receiving shot, patient took 50mg of Benadryl with resolution of symptoms
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Chills, Fatigue, Gastrointestinal pain, Headache
Clinical narrative: NOV 13 1430 mild nausea and HA. 1800: chills  2015: shivering, peripheral vasoconstriction, HA, nausea - temp 100.8 p.o. - 2 ibuprofen + 1 Zofran. 2045 chills stopped, veins in hand now visible, temp still 100.8 with HA and nausea. 2115: feeling nice and warm, HA, nausea - temp 101.4!!  NOV 14  0350: woke with worsening HA, gut ache, temp 100.0 p.o.  0400: 1000mg acetaminophen. 0500: HA resolving temp 99.6.  0745: HA resolved, still have gut ache, mild fatigue - temp 97.8 p.o. (my normal)
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Vasoconstriction
Clinical narrative: NOV 13 1430 mild nausea and HA. 1800: chills  2015: shivering, peripheral vasoconstriction, HA, nausea - temp 100.8 p.o. - 2 ibuprofen + 1 Zofran. 2045 chills stopped, veins in hand now visible, temp still 100.8 with HA and nausea. 2115: feeling nice and warm, HA, nausea - temp 101.4!!  NOV 14  0350: woke with worsening HA, gut ache, temp 100.0 p.o.  0400: 1000mg acetaminophen. 0500: HA resolving temp 99.6.  0745: HA resolved, still have gut ache, mild fatigue - temp 97.8 p.o. (my normal)
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Magnetic resonance imaging, Pain in extremity, Tendonitis
Clinical narrative: Client reported to the health clinic to report that her left arm still hurt 2 weeks following the vaccine. She claimed that it was the vaccine.  Unable to fully extend her arm upward. due to pain  of 6-7/10.  Had been taking  tylenol and ibuprofen for pain. No swelling, redness or hardened tissue at the time of examination on 11/1/19. Limited ability to raise arm above her head before her complaints of pain. Refused warm compress. - plan to follow up with that at home. Followed up with her physician and subsequently reported 'tendonitis'.
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Allergy test, Blood test, Injection site swelling, Pruritus, Urticaria
Clinical narrative: pt was fine the day of the vaccine administration. patient awoke the next day with localized swelling to the site of the vaccine and hives to his abdomen and back. Thigh was itchy. NO difficulty breathing or swallowing.
Age: 88.0
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased, Pain, Swelling
Clinical narrative: severe constant pain,  swelling,  can not move arm,
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Bone pain, Formication, Influenza like illness, Limb discomfort, Myalgia
Clinical narrative: Ran a fever the following night + sore muscles + bones (felt like a case of the flu) for 1 1/2 days. Still - after 2 1/2 months - having tingling on the left arm. Feels like "ants crawling" + the blood running up + down the veins in left arm. At night, the feeling of a "rolling pin" moving up + down the arm awoken me. The vein in the elbow is raised when the tingling occurs. The "sensation" happens multiple times each day, sometimes 2 or 3 times in an hour. From 8/21 to 11/6 Still feeling tingling sensation on the left arm
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Paraesthesia, Pyrexia
Clinical narrative: Ran a fever the following night + sore muscles + bones (felt like a case of the flu) for 1 1/2 days. Still - after 2 1/2 months - having tingling on the left arm. Feels like "ants crawling" + the blood running up + down the veins in left arm. At night, the feeling of a "rolling pin" moving up + down the arm awoken me. The vein in the elbow is raised when the tingling occurs. The "sensation" happens multiple times each day, sometimes 2 or 3 times in an hour. From 8/21 to 11/6 Still feeling tingling sensation on the left arm
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Headache, Myalgia
Clinical narrative: CHILLS/SHIVERING MUSCLE/JOINT ACHES HEADACHE - STARTED 2AM 9/27 FOR 24' - HEADACHE REMAINED 9/28
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, PNC, RV5
Symptoms: Cardiopulmonary failure, Death, Developmental delay, Failure to thrive, Lactic acidosis
Clinical narrative: metabolic acidosis; failure to thrive; developmental delay; feeding difficulties; lactic acidosis; acute cardiopulmonary failure; Information has been downloaded from regulatory authority(HQWYE953231AUG07)  This spontaneous report was received from an other healthcare professional, regarding a 2-month-old male patient. The patient's concurrent condition included congenital anomaly. The patient's historical conditions, past drugs and concomitant medications were not reported. On 23-AUG-2007, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ), diphtheria toxoid, hepatitis b virus vaccine rhbsag (yeast), pertussis acellular 3-component vaccine, poliovirus vaccine inactivated (vero), tetanus toxoid (PEDIARIX); the lot/batch number, expiration date and route were unknown for both the products, pneumococcal 4 6b 9v 14 18c 19f 23f conj vaccine (crm197) (PREVNAR) (batch/lot number B53981A; expiry date not reported) via intramuscular route and received all three vaccines received at a dose of one dosage form for immunization. On 25-AUG-2007, 3 days after onset of therapy the patient experienced metabolic acidosis, failure to thrive, developmental delay, feeding difficulties (poor feeding infant), lactic acidosis and acute cardiopulmonary failure (cardiopulmonary failure) and was hospitalized due to the events and on same day, the patient died. The cause of death was reported as lactic acidosis, cardiopulmonary failure and metabolic acidosis. The outcome of the events failure to thrive, poor feeding infant and developmental delay was reported as unknown. Autopsy was not performed. The relatedness between the events and the suspect therapy was not reported.; Reported Cause(s) of Death: Lactic acidosis; Metabolic acidosis; Cardiopulmonary failure
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, PNC, RV5
Symptoms: Metabolic acidosis, Poor feeding infant
Clinical narrative: metabolic acidosis; failure to thrive; developmental delay; feeding difficulties; lactic acidosis; acute cardiopulmonary failure; Information has been downloaded from regulatory authority(HQWYE953231AUG07)  This spontaneous report was received from an other healthcare professional, regarding a 2-month-old male patient. The patient's concurrent condition included congenital anomaly. The patient's historical conditions, past drugs and concomitant medications were not reported. On 23-AUG-2007, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ), diphtheria toxoid, hepatitis b virus vaccine rhbsag (yeast), pertussis acellular 3-component vaccine, poliovirus vaccine inactivated (vero), tetanus toxoid (PEDIARIX); the lot/batch number, expiration date and route were unknown for both the products, pneumococcal 4 6b 9v 14 18c 19f 23f conj vaccine (crm197) (PREVNAR) (batch/lot number B53981A; expiry date not reported) via intramuscular route and received all three vaccines received at a dose of one dosage form for immunization. On 25-AUG-2007, 3 days after onset of therapy the patient experienced metabolic acidosis, failure to thrive, developmental delay, feeding difficulties (poor feeding infant), lactic acidosis and acute cardiopulmonary failure (cardiopulmonary failure) and was hospitalized due to the events and on same day, the patient died. The cause of death was reported as lactic acidosis, cardiopulmonary failure and metabolic acidosis. The outcome of the events failure to thrive, poor feeding infant and developmental delay was reported as unknown. Autopsy was not performed. The relatedness between the events and the suspect therapy was not reported.; Reported Cause(s) of Death: Lactic acidosis; Metabolic acidosis; Cardiopulmonary failure
Sex: F
Vaccine: FLU3, MMR, TDAP, VARCEL
Symptoms: Exposure during pregnancy
Clinical narrative: the patient was administered a dose of VARIVAX, MMRII, Flusone and ADACEL while the patient was pregnant; the patient was administered a dose of VARIVAX, MMRII, Flusone and ADACEL while the patient was pregnant; This spontaneous prospective pregnancy report was received from a nurse and refers to a female patient of unknown age. No information regarding patient's concurrent conditions, past medical history, concomitant medications, drug reactions or allergies was provided.  On an unspecified date, the patient became pregnant. The dates of last menstrual period (LMP), approximate date of conception, and estimated date of delivery (EDD) were not provided and were unable to calculate. Pregnancy outcome was pending. On an unknown date in 2019, while the patient was pregnant, she was vaccinated with a dose of varicella virus vaccine live (oka/merck) (VARIVAX) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (contraindicated products in pregnancy) for prophylaxis (doses, route of administration, lot numbers and expiration dates were not provided). Other suspect therapies included influenza virus split virion 3v vaccine inactivated (FLUZONE) and diphtheria toxoid, pertussis acellular 5-component vaccine, tetanus toxoid (ADACEL) (doses, route of administration, indication, lot numbers and expiration dates were not provided). The outcome of the events was unknown.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: bump; swelling and redness at the injection site; swelling and redness at the injection site; the muscle felt hot/ warmth at injection site; syringes that came in this package of PNEUMOVAX "all have about 30 little black or blue dots" / PQC Packaging: Foreign matter or Extraneous Marks or Matter Seen on the; syringes that came in this package of PNEUMOVAX "all have about 30 little black or blue dots"; This spontaneous report was received from a pharmacist and refers to a 66-year-old female patient. The patient did not have pertinent medical history, concomitant medications, drug reactions or allergies.  On 26-SEP-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), 0.5 milliliter, 1 dose syringe, intramuscular in the left arm, lot #R017900, expiration date 26-MAR-2020 (exact dose and frequency were not reported), for prevention of pneumonia.  On 26-SEP-2019 (also reported as that same day), the patient started to complain about swelling and redness at the injection site in the left arm. The patient also had a bump and the muscle felt hot. She sought medical attention (also reported as she went to the doctor). Laboratory tests were not performed. As a treatment for the events, the patient received antibiotics (unspecified), prednisone and anti-inflammatory (unspecified). On 26-SEP-2019, the pharmacist reported that all 10 syringes that came in the package of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) had about 30 little black or blue dots circling around the syringe where the label was. The pharmacist reported that it was hard to tell whether black and blue dots were on the inside or the outside of the syringe and they did not rub off from the glass. There was no damage noted to the packaging or the products and the vaccines were not exposed to moisture. Prior to use the vaccines were kept in refrigerator. The products were never exposed to storage temperatures outside of recommendation. One other pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) syringe from this package was administered to another patient. On an unknown date in 2019, the patient recovered from injection site mass, injection site warmth, injection site erythema and injection site swelling. The outcome of 30 little black or blue dots circling around the syringe where the label was was not provided.  The causality between the events and suspect therapy with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not reported.  This is one of two cases received from the same reporter.; Sender's Comments:  US-009507513-1910USA011769:
Sex: U
Vaccine: MNQ
Symptoms: Immunisation, Product preparation error
Clinical narrative: Inappropriate reconstitution technique; Wrong solution used in drug reconstitution; This case was reported by a other health professional via sales rep and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo at an unknown dose. On 1st November 2019, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and wrong solution used in drug reconstitution. On an unknown date, the outcome of the inappropriate preparation of medication and wrong solution used in drug reconstitution were unknown.  Additional details were received as follows: The age at vaccination was not reported. On 2nd October 2019, clinic nursing staff noticed a box with a single vial of diluent only left.  The vaccines was vaccinated the day before the reporting date and there was no way to discern which patient received Menveo reconstituted incorrectly men A reconstituted with sterile water as diluent, which led to inappropriate preparation of medication and wrong solution used in drug reconstitution. These patients were then re-vaccinated with Menveo. This case 1 of 22 cases reported by the same reporter.
Sex: U
Vaccine: MNQ
Symptoms: Immunisation, Product preparation error
Clinical narrative: Inappropriate reconstitution technique; Wrong solution used in drug reconstitution; This case was reported by a other health professional via sales rep and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo at an unknown dose. On an unknown date, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and wrong solution used in drug reconstitution. On an unknown date, the outcome of the inappropriate preparation of medication and wrong solution used in drug reconstitution were unknown.  Additional details were received as follows: The age at vaccination was not reported. In a separate clinic on another day, it was noted that an HCP had given a patient Menveo with menA reconstituted with sterile water, not the menCWY diluent provided. Through researching this HCP's previous vaccine administrations, it was determined that between 8th August 2019 and 28th October 2019, the Health care professional had vaccinated with Menveo prepared incorrectly men A reconstituted with sterile water, which led to inappropriate preparation of medication and wrong solution used in drug reconstitution. These patients were then re-vaccinated with Menveo. This case 1 of 22 cases reported by the same reporter.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: swollen lymph note; fever; chills; site of the injection was hot; swelling; hard; usual pain associated with a shot/njection was burning; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included autoimmune disorder. Concomitant products included allergens (nos) (Allergy Injection).   On 1st November 2019, the patient received the 1st dose of Shingrix (intramuscular). On 1st November 2019, less than a day after receiving Shingrix, the patient experienced injection site pain. On 2nd November 2019, the patient experienced fever, chills, injection site warmth, injection site swelling and injection site induration. On 4th November 2019, the patient experienced enlargement of lymph nodes. On 3rd November 2019, the outcome of the fever and chills were resolved with sequelae. On 4th November 2019, the outcome of the injection site pain was resolved with sequelae. On an unknown date, the outcome of the injection site warmth, injection site swelling, injection site induration and enlargement of lymph nodes were recovering/resolving.   It was unknown if the reporter considered the injection site pain, fever, chills, injection site warmth, injection site swelling, injection site induration and enlargement of lymph nodes to be related to Shingrix.  Additional details were provided as follows: The patient after vaccination had pain, chills and fever. The patient had injection site was hot and burning and became swollen, hard and hot to the touch. The patient also noticed that her lymph node on the side in which the injection was given was swollen. The patient received her weekly allergy shot on the same day but does not think this had anything to do with her side effects. The patient consented to follow up.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Lymphadenopathy, Pyrexia
Clinical narrative: swollen lymph note; fever; chills; site of the injection was hot; swelling; hard; usual pain associated with a shot/njection was burning; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included autoimmune disorder. Concomitant products included allergens (nos) (Allergy Injection).   On 1st November 2019, the patient received the 1st dose of Shingrix (intramuscular). On 1st November 2019, less than a day after receiving Shingrix, the patient experienced injection site pain. On 2nd November 2019, the patient experienced fever, chills, injection site warmth, injection site swelling and injection site induration. On 4th November 2019, the patient experienced enlargement of lymph nodes. On 3rd November 2019, the outcome of the fever and chills were resolved with sequelae. On 4th November 2019, the outcome of the injection site pain was resolved with sequelae. On an unknown date, the outcome of the injection site warmth, injection site swelling, injection site induration and enlargement of lymph nodes were recovering/resolving.   It was unknown if the reporter considered the injection site pain, fever, chills, injection site warmth, injection site swelling, injection site induration and enlargement of lymph nodes to be related to Shingrix.  Additional details were provided as follows: The patient after vaccination had pain, chills and fever. The patient had injection site was hot and burning and became swollen, hard and hot to the touch. The patient also noticed that her lymph node on the side in which the injection was given was swollen. The patient received her weekly allergy shot on the same day but does not think this had anything to do with her side effects. The patient consented to follow up.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth, Myalgia
Clinical narrative: Inection site redness; Injection site feverish; muscle soreness; This case was reported by a pharmacist via call center representative and described the occurrence of muscle soreness in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th October 2019, the patient received the 1st dose of Shingrix (intramuscular). On 30th October 2019, less than a day after receiving Shingrix, the patient experienced muscle soreness. On 1st November 2019, the patient experienced injection site erythema and injection site warmth. On an unknown date, the outcome of the muscle soreness was resolved with sequelae and the outcome of the injection site erythema and injection site warmth were recovering/resolving.   It was unknown if the reporter considered the muscle soreness, injection site erythema and injection site warmth to be related to Shingrix.  Additional details were provided as follows: The patient experienced muscle soreness on the day of the injection. The patient had the site became red and feverish to the touch in an area about the size of a fist. The reporter stated that it was growing and down to his elbow.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Fatigue, Impaired work ability, Influenza like illness
Clinical narrative: Soreness at the injection site; Can hardly hold her head up; Nerve pain; Feeling Weak; Flu-like symptoms; Chills; Feeling Achy; Fatigue; Cannot sleep on the side of her body where she received the vaccination because the injection site is "super sore; Missed work; This case was reported by a consumer via call center representative and described the occurrence of nerve pain in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd November 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 3rd November 2019, less than a day after receiving Shingrix, the patient experienced injection site pain and neck discomfort. In November 2019, the patient experienced nerve pain, feelings of weakness, influenza-like symptoms, chills, pain, fatigue, sleeplessness and activities of daily living impaired. On an unknown date, the outcome of the nerve pain, feelings of weakness, influenza-like symptoms, chills, pain, fatigue, sleeplessness, activities of daily living impaired, injection site pain and neck discomfort were not recovered/not resolved.   It was unknown if the reporter considered the nerve pain, feelings of weakness, influenza-like symptoms, chills, pain, fatigue, sleeplessness, activities of daily living impaired, injection site pain and neck discomfort to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient, The patient received dose of Shingrix in the left arm. The patient stated that, around 3:30 pm or 4:00 pm on Sunday 3rd November 2019 received dose of Shingrix. Around midnight, the patient experienced nerve pain, feelings of weakness, influenza-like symptoms, chills, pain, fatigue, sleeplessness, inability to work, injection site pain and neck discomfort. The patient experienced nerve pain down the side of the body that would alternate from  the left side to the right side. The patient also stated that, could not sleep on the side of the body where received the vaccination because the injection site was super sore. On 4th November 2019, the patient could not go to work because of symptoms. No additional details were provided.