chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Musculoskeletal stiffness, Neck pain, Pain
Clinical narrative: barely move her arm / lot of difficulty moving normally; reaction that was hot and red; reaction that was hot and red; got shoulder pain; right thumb is clicking and moving out of its position; is painful; neck pain; neck pain and its stiff; This case was reported by a consumer via patient support programs and described the occurrence of mobility decreased in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Shingrix and Influenza vaccine Quadrivalent unspecified season. On an unknown date, less than a year after receiving Shingrix and Influenza vaccine Quadrivalent unspecified season, the patient experienced mobility decreased, erythema, feeling hot, shoulder pain, dislocated thumb, pain, neck pain and stiff neck. On an unknown date, the outcome of the mobility decreased, erythema, feeling hot, shoulder pain, dislocated thumb, pain, neck pain and stiff neck were unknown.   It was unknown if the reporter considered the mobility decreased, erythema, feeling hot, shoulder pain, dislocated thumb, pain, neck pain and stiff neck to be related to Shingrix and Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The age at vaccination was not reported. The patient received flu shot a month after the Shingrix shot. The patient experienced hot and red. Then she got shoulder pain and she can barely move her arm.  The patient had been treating with heat and creams. Her right thumb was clicking and moving out of position and she has to put it back in place and is painful and not feeling right. She was having neck pain and it is stiff. The patient was having a lot of difficulty moving normally.
Sex: U
Vaccine: VARZOS
Symptoms: Illness, Pyrexia
Clinical narrative: Fever; Very sick; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fever and sickness. On an unknown date, the outcome of the fever and sickness were unknown.   It was unknown if the reporter considered the fever and sickness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication.  The patient received 1st dose of shingrix and was very sick and experienced fever.
Sex: U
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: Sick; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced sickness. On an unknown date, the outcome of the sickness was recovered/resolved.   It was unknown if the reporter considered the sickness to be related to Influenza vaccine Quadrivalent unspecified season.  Additional information was provided as follows: The age at vaccination was not reported. The patient was feeling sick after receiving the 1st flu shot. The patient's doctor was trying to convince the patient for further doses but, the patient had made it clear that it won't happen. For the tolerance of 2nd flu shot, refer the case- US2020AMR227335.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR227335:2nd time
Sex: U
Vaccine: FLUX
Symptoms: Illness, Vaccine positive rechallenge
Clinical narrative: Sick; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   Previously administered products included Influenza vaccine with an associated reaction of illness (received 1st time on an unknown date, for tolerance refer case- US2020AMR227331).   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced sickness. Rechallenge with Influenza vaccine Quadrivalent unspecified season was positive. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Influenza vaccine Quadrivalent unspecified season.  Additional information was provided as follows: The age at vaccination was not reported. The patient reported that Flu shot made him/her sick. The patient's doctor was trying to convince the patient for further doses but, the patient had made it clear that it won't happen. No further information was provided.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR227331:1st time
Sex: U
Vaccine: FLUX
Symptoms: Influenza, Vaccination failure
Clinical narrative: I caught the flu really bad/suspected vaccination failure; I caught the flu really bad/suspected vaccination failure; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, less than a year after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the influenza was recovered/resolved.   It was unknown if the reporter considered the vaccination failure and influenza to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The patient reported the case for himself/herself. The age at vaccination was not reported. The patient reported that the only time the patient took the flu shot caught the flu really bad and commented never again for him/her and never caught it again and to each their own. This case was considered as suspected vaccination failure as laboratory test confirmation and time to onset for the event was unknown at the time of reporting.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Nausea, Pain
Clinical narrative: All over body aches; Queasiness; This case was reported by a consumer via call center representative and described the occurrence of general body pain in a 63-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th November 2020, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 13th November 2020, 1 days after receiving Shingrix, the patient experienced general body pain and queasy. On an unknown date, the outcome of the general body pain and queasy were not recovered/not resolved.   The reporter considered the general body pain and queasy to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in the left arm. vaccine on 12th November 2020 and on 13th November 2020, patient experienced all over body aches and queasiness.      The patient was asking if he was contagious to others. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: first dose provoked adverse reactions / (left in bed for 3 days),; This case was reported by a physician via call center representative and described the occurrence of malaise in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included paracetamol (Tylenol).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced malaise. On an unknown date, the outcome of the malaise was recovered/resolved.   It was unknown if the reporter considered the malaise to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient had received the Tylenol pre vaccination of shingrix. It was reported that patient received the 1st dose of shingrix vaccine and after that patient was left in bed for 3 days. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020225587:same patient, Shingrix vaccine
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Immediate post-injection reaction, Injection site haemorrhage
Clinical narrative: arm has been sore; The cotton patch had 10 drops of blood, more than he saw after his flu shot in the same (left) arm 1 month ago; it feels like a knot in the muscle; chills; slight headache; fatigue; body aches; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 60-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Flu vaccine with an associated reaction of pain in extremity (received 1 month before the date of reporting, refer case US2020AMR226308).   On 12th November 2020, the patient received the 1st dose of Shingrix (intramuscular). On 12th November 2020, immediately after receiving Shingrix, the patient experienced pain in arm and injection site hemorrhage. In November 2020, the patient experienced muscle mass, chills, headache, fatigue and general body pain. On an unknown date, the outcome of the pain in arm, muscle mass, chills, headache, fatigue, general body pain and injection site hemorrhage were unknown.   It was unknown if the reporter considered the pain in arm, muscle mass, chills, headache, fatigue, general body pain and injection site hemorrhage to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in the left arm and arm had been sore ever since, there was no redness and the patient stated it felt like a knot in the muscle.  The cotton patch had 10 drops of blood. Blood and arm soreness were more than the flu shot received in the same arm (1 month ago). The patient also had chills, slight headache, fatigue and body aches. The reporter did not consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR226308:same patient
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Muscle mass, Pain, Pain in extremity
Clinical narrative: arm has been sore; The cotton patch had 10 drops of blood, more than he saw after his flu shot in the same (left) arm 1 month ago; it feels like a knot in the muscle; chills; slight headache; fatigue; body aches; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 60-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Flu vaccine with an associated reaction of pain in extremity (received 1 month before the date of reporting, refer case US2020AMR226308).   On 12th November 2020, the patient received the 1st dose of Shingrix (intramuscular). On 12th November 2020, immediately after receiving Shingrix, the patient experienced pain in arm and injection site hemorrhage. In November 2020, the patient experienced muscle mass, chills, headache, fatigue and general body pain. On an unknown date, the outcome of the pain in arm, muscle mass, chills, headache, fatigue, general body pain and injection site hemorrhage were unknown.   It was unknown if the reporter considered the pain in arm, muscle mass, chills, headache, fatigue, general body pain and injection site hemorrhage to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in the left arm and arm had been sore ever since, there was no redness and the patient stated it felt like a knot in the muscle.  The cotton patch had 10 drops of blood. Blood and arm soreness were more than the flu shot received in the same arm (1 month ago). The patient also had chills, slight headache, fatigue and body aches. The reporter did not consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR226308:same patient
Sex: F
Vaccine: TDAP
Symptoms: COVID-19, Pyrexia, Vaccination site erythema, Vaccination site inflammation, Vaccination site swelling
Clinical narrative: the patient right deltoid became very swollen, with a red round area about 2 and a half inches, it is warm to touch, not necessarily painful but she running a low grade fever at 99.4 F; the patient right deltoid became very swollen, with a red round area about 2 and a half inches, it is warm to touch, not necessarily painful but she running a low grade fever at 99.4 F; the patient right deltoid became very swollen, with a red round area about 2 and a half inches, it is warm to touch, not necessarily painful but she running a low grade fever at 99.4 F; the patient right deltoid became very swollen, with a red round area about 2 and a half inches, it is warm to touch, not necessarily painful but she running a low grade fever at 99.4 F; the patient right deltoid became very swollen, with a red round area about 2 and a half inches, it is warm to touch, not necessarily painful but she running a low grade fever at 99.4 F; Initial information regarding an unsolicited valid non-serious case received from a nurse and transmitted to Sanofi on 15-Oct-2020.  This case involved a 80 years old female patient right deltoid became very swollen, with a red round area about 2 and a half inches, it is warm to touch, not necessarily painful (vaccination site inflammation associated with vaccination site erythema and vaccination site swelling and vaccination site warmth) but she running a low grade fever at 99.4 F (pyrexia), while she received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  Relevant medical history, past medical treatment, vaccination and family history were not provided.  At the time of the event, the patient had ongoing COVID-19.  Concomitant medications included INFLUENZA VACCINE INACT SPLIT 3V (FLUZONE HIGH DOSE) and PARACETAMOL (TYLENOL).  On 08-Oct-2020, the patient received a 0.5 mL dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot U6706AA, expiry date: 30-Jul-2022) via intramuscular route in the right deltoid for prophylactic vaccination.  On an unknown date, deltoid became very swollen, with a red round area about 2 and a half inches, it is warm to touch, not necessarily painful (vaccination site inflammation associated with vaccination site erythema and vaccination site swelling and vaccination site warmth) but she running a low grade fever at 99.4 F (pyrexia), 3 days (as reported) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  Final diagnosis was the patient right deltoid became very swollen, with a red round area about 2 and a half inches, it is warm to touch, not necessarily painful but she running a low grade fever at 99.4 f and the patient right deltoid became very swollen, with a red round area about 2 and a half inches, it is warm to touch, not necessarily painful but she running a low grade fever at 99.4 f.   It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome was unknown for the reported events.
Sex: F
Vaccine: TDAP
Symptoms: Vaccination site warmth
Clinical narrative: the patient right deltoid became very swollen, with a red round area about 2 and a half inches, it is warm to touch, not necessarily painful but she running a low grade fever at 99.4 F; the patient right deltoid became very swollen, with a red round area about 2 and a half inches, it is warm to touch, not necessarily painful but she running a low grade fever at 99.4 F; the patient right deltoid became very swollen, with a red round area about 2 and a half inches, it is warm to touch, not necessarily painful but she running a low grade fever at 99.4 F; the patient right deltoid became very swollen, with a red round area about 2 and a half inches, it is warm to touch, not necessarily painful but she running a low grade fever at 99.4 F; the patient right deltoid became very swollen, with a red round area about 2 and a half inches, it is warm to touch, not necessarily painful but she running a low grade fever at 99.4 F; Initial information regarding an unsolicited valid non-serious case received from a nurse and transmitted to Sanofi on 15-Oct-2020.  This case involved a 80 years old female patient right deltoid became very swollen, with a red round area about 2 and a half inches, it is warm to touch, not necessarily painful (vaccination site inflammation associated with vaccination site erythema and vaccination site swelling and vaccination site warmth) but she running a low grade fever at 99.4 F (pyrexia), while she received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  Relevant medical history, past medical treatment, vaccination and family history were not provided.  At the time of the event, the patient had ongoing COVID-19.  Concomitant medications included INFLUENZA VACCINE INACT SPLIT 3V (FLUZONE HIGH DOSE) and PARACETAMOL (TYLENOL).  On 08-Oct-2020, the patient received a 0.5 mL dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot U6706AA, expiry date: 30-Jul-2022) via intramuscular route in the right deltoid for prophylactic vaccination.  On an unknown date, deltoid became very swollen, with a red round area about 2 and a half inches, it is warm to touch, not necessarily painful (vaccination site inflammation associated with vaccination site erythema and vaccination site swelling and vaccination site warmth) but she running a low grade fever at 99.4 F (pyrexia), 3 days (as reported) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  Final diagnosis was the patient right deltoid became very swollen, with a red round area about 2 and a half inches, it is warm to touch, not necessarily painful but she running a low grade fever at 99.4 f and the patient right deltoid became very swollen, with a red round area about 2 and a half inches, it is warm to touch, not necessarily painful but she running a low grade fever at 99.4 f.   It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome was unknown for the reported events.
Age: 61.0
Sex: F
Vaccine: FLU4, TDAP, VARZOS
Symptoms: Erythema, Peripheral swelling, Rash
Clinical narrative: Left arm red & swollen. Red area about 4 inches long, 2-3 wide. Rash all chest and breasts to top of belly
Age: 71.0
Sex: F
Vaccine: FLUA4
Symptoms: Blood thyroid stimulating hormone, Diarrhoea, Metabolic function test, Muscle spasms, Muscle tightness
Clinical narrative: Runny nose, muscle cramps in legs, muscle tightness, vomiting, diarrhea 4-5, symptoms lasted 4-5 hours, achy
Age: 71.0
Sex: F
Vaccine: FLUA4
Symptoms: Pain, Rhinorrhoea, Vomiting
Clinical narrative: Runny nose, muscle cramps in legs, muscle tightness, vomiting, diarrhea 4-5, symptoms lasted 4-5 hours, achy
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal distension, Ecchymosis, Erythema, Injury, Rash papular
Clinical narrative: On the right forearm there is a red purple patches consistent with ecchymoses or recent trauma. Diffuse papular erythematous eruption on the bilateral flanks from the spine to the midline of the abdomen. Hyperpigmentation in a photo distribution consistent with sun damage and solar lentigo as well as hyperpigmention and erythema consistent with recent sun damage and solar lentigo on the face, V of the chest and bilateral upper/lower extremities. Traimcinolone cream was prescribes at OV.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Skin hyperpigmentation, Solar lentigo
Clinical narrative: On the right forearm there is a red purple patches consistent with ecchymoses or recent trauma. Diffuse papular erythematous eruption on the bilateral flanks from the spine to the midline of the abdomen. Hyperpigmentation in a photo distribution consistent with sun damage and solar lentigo as well as hyperpigmention and erythema consistent with recent sun damage and solar lentigo on the face, V of the chest and bilateral upper/lower extremities. Traimcinolone cream was prescribes at OV.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Peripheral coldness
Clinical narrative: Severe chills and uncomfortably cold hands and feet from 9:00 p.m. evening of injection (11/20/2020) through about 4:00 a.m. 11/21/2020. Followed by severe headache through now (11/23/2020), currently almost 11:00 a.m.  Ketorolac 10 mg plus Sumatriptan 25 mg has finally given me some relief.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Patient reports arm pain and decreased ROM
Age: 56.0
Sex: F
Vaccine: FLUA3
Symptoms: Arthralgia, Mobility decreased
Clinical narrative: Shoulder pain and impaired mobility. SIRVA
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: patient called almost 2 weeks after getting her vaccination saying that she has a sharp pain radiating all the way to her wrist
Age: 63.0
Sex: F
Vaccine: FLUR4
Symptoms: Alcohol test positive, Cellulitis
Clinical narrative: Patient claims she got cellulitis from injection Confirmed alcohol swab was used and admitted as accuracy to Pharmacy
Age: 65.0
Sex: M
Vaccine: FLU4, FLU4, PPV, PPV
Symptoms: Chills, Dizziness, Feeling cold, Injection site bruising, Injection site erythema
Clinical narrative: That evening 11/20/2020 at about 8pm patient started to experience  hands and arms cold to the touch, shivering uncontrollably almost like 'parkinsons'. Heated up water bottles and applied to arteries.  Patient experienced wooziness, vertigo and severe coldness, malaise for 48 hours.  Patient unknown to what injection was administered  to which arm. Right arm shows bruising from injections site, redness, and tender.  Both vaccines administered the same day, same time.  Anitbody test done on 11/20/20 to see if have had COVID Patient stated about 80% recovered
Age: 65.0
Sex: M
Vaccine: FLU4, FLU4, PPV, PPV
Symptoms: Injection site pain, Malaise, Peripheral coldness, SARS-CoV-2 antibody test, Vertigo
Clinical narrative: That evening 11/20/2020 at about 8pm patient started to experience  hands and arms cold to the touch, shivering uncontrollably almost like 'parkinsons'. Heated up water bottles and applied to arteries.  Patient experienced wooziness, vertigo and severe coldness, malaise for 48 hours.  Patient unknown to what injection was administered  to which arm. Right arm shows bruising from injections site, redness, and tender.  Both vaccines administered the same day, same time.  Anitbody test done on 11/20/20 to see if have had COVID Patient stated about 80% recovered
Age: 73.0
Sex: F
Vaccine: FLU4, PNC13, VARZOS
Symptoms: Constipation, Feeling abnormal, Pyrexia
Clinical narrative: Pt reports new constipation unrelieved by OTC medications starting the same day she received her vaccinations. I told her we would report this as a possible adverse event. I encouraged her to reach out to a doctor office for help in getting some relief, but I also encouraged her to continue to drink plenty of water and to try Miralax. I also told her she could try magnesium citrate, but that it would cause a bit of abdominal cramping  and advised her to try other products first. She also reports generally feeling badly with occasional fevers. I assured her this is a normal response and that she can continue to take OTC medications for the fever.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash, Sensitive skin, Swelling
Clinical narrative: PT CALLED SAYING HE HAS A MILD RASH ON HIS CHEECK/NECK AREA, LITTLE SWOLLEN AND SESITIVE TO TOUCH. HE DID NOT HAVE ANY DIFFICULY BREATHING OR ANY OTHER SYMPTOMS. ADVISED PATIENT TO SPEAK WITH MD AND SEEK EMERGENCY HELP ANY TIME SYMPTOMS WORSEN. FOLLOWED UP WITH PT AGAIN TODAY, HE SPOKE WITH MD AND MD ADVISED TO JUST WAIT, PT THINKS RASH IS GOING DOWN AND NOT SO MUCH SENSITIVE TO TOUCHING ANYMORE.
Age: 73.0
Sex: F
Vaccine: FLU4, VARZOS, FLUX, VARZOS
Symptoms: Axillary pain, Feeling abnormal, Injection site erythema, Injection site swelling, Mass
Clinical narrative: left arm had swelling pain [7] on 0-10 scale pain into arm pit unable to move my arm site was red swelling larger than my hand cupped over it ,I used warm cloth soft massage and Aleve small mass still remains in the arm. fever and just not feeling well for 3 days. I also has a flu shot in the right arm the same day not reaction to it
Age: 73.0
Sex: F
Vaccine: FLU4, VARZOS, FLUX, VARZOS
Symptoms: Mobility decreased, Peripheral swelling, Pyrexia
Clinical narrative: left arm had swelling pain [7] on 0-10 scale pain into arm pit unable to move my arm site was red swelling larger than my hand cupped over it ,I used warm cloth soft massage and Aleve small mass still remains in the arm. fever and just not feeling well for 3 days. I also has a flu shot in the right arm the same day not reaction to it
Age: 73.0
Sex: F
Vaccine: FLU4, VARZOS, FLUX, VARZOS
Symptoms: Axillary pain, Hypokinesia, Injected limb mobility decreased, Injection site erythema, Injection site mass
Clinical narrative: left arm had swelling pain [7] on 0-10 scale pain into arm pit unable to move my arm site was red swelling larger than my hand cupped over it ,I used warm cloth soft massage and Aleve small mass still remains in the arm. fever and just not feeling well for 3 days. I also has a flu shot in the right arm the same day not reaction to it
Age: 73.0
Sex: F
Vaccine: FLU4, VARZOS, FLUX, VARZOS
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Nausea, Pyrexia
Clinical narrative: left arm had swelling pain [7] on 0-10 scale pain into arm pit unable to move my arm site was red swelling larger than my hand cupped over it ,I used warm cloth soft massage and Aleve small mass still remains in the arm. fever and just not feeling well for 3 days. I also has a flu shot in the right arm the same day not reaction to it
Age: 73.0
Sex: F
Vaccine: FLU4, VARZOS, FLUX, VARZOS
Symptoms: Axillary pain, Feeling abnormal, Injection site erythema, Injection site swelling, Mass
Clinical narrative: The arm was immobile for a week; pain went into the arm pit area; nausea; feverish for 36 hours; severe pain at the injection site; area turned red; area / was swollen; area/ hot to touch; a mass formed at the injection site; This case was reported by a consumer via call center representative and described the occurrence of movements reduced in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On 13th September 2020, the patient received the 1st dose of Shingrix and Influenza vaccine Quadrivalent unspecified season. On 13th September 2020, less than a day after receiving Shingrix and Influenza vaccine Quadrivalent unspecified season, the patient experienced injection site pain, injection site erythema, injection site swelling, injection site warmth and injection site mass. On an unknown date, the patient experienced movements reduced (serious criteria GSK medically significant), axillary pain, nausea and fever. The patient was treated with naproxen (Aleve) and non-drug therapy (Warm Compress). On an unknown date, the outcome of the movements reduced, injection site swelling, axillary pain, nausea and fever were unknown and the outcome of the injection site pain and injection site mass were recovering/resolving and the outcome of the injection site erythema and injection site warmth were recovered/resolved.   It was unknown if the reporter considered the movements reduced, injection site pain, injection site erythema, injection site swelling, injection site warmth, injection site mass, axillary pain, nausea and fever to be related to Shingrix and Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The age at vaccination was not reported It was reported that patient received the 1st dose of Shingrix and also flu shot on 13th September 2020 and after that patient experienced pain at the injection site also the injection site area turned red and was swollen and hot to touch. It was also reported that the pain went into the arm pit area and a mass formed at the injection site on the left arm and the arm was immobile for a week.,also She felt nausea and feverish for 36 hours. Patient took Aleve and applied warm compresses. The reporter consented to follow up.
Age: 73.0
Sex: F
Vaccine: FLU4, VARZOS, FLUX, VARZOS
Symptoms: Mobility decreased, Peripheral swelling, Pyrexia
Clinical narrative: The arm was immobile for a week; pain went into the arm pit area; nausea; feverish for 36 hours; severe pain at the injection site; area turned red; area / was swollen; area/ hot to touch; a mass formed at the injection site; This case was reported by a consumer via call center representative and described the occurrence of movements reduced in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On 13th September 2020, the patient received the 1st dose of Shingrix and Influenza vaccine Quadrivalent unspecified season. On 13th September 2020, less than a day after receiving Shingrix and Influenza vaccine Quadrivalent unspecified season, the patient experienced injection site pain, injection site erythema, injection site swelling, injection site warmth and injection site mass. On an unknown date, the patient experienced movements reduced (serious criteria GSK medically significant), axillary pain, nausea and fever. The patient was treated with naproxen (Aleve) and non-drug therapy (Warm Compress). On an unknown date, the outcome of the movements reduced, injection site swelling, axillary pain, nausea and fever were unknown and the outcome of the injection site pain and injection site mass were recovering/resolving and the outcome of the injection site erythema and injection site warmth were recovered/resolved.   It was unknown if the reporter considered the movements reduced, injection site pain, injection site erythema, injection site swelling, injection site warmth, injection site mass, axillary pain, nausea and fever to be related to Shingrix and Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The age at vaccination was not reported It was reported that patient received the 1st dose of Shingrix and also flu shot on 13th September 2020 and after that patient experienced pain at the injection site also the injection site area turned red and was swollen and hot to touch. It was also reported that the pain went into the arm pit area and a mass formed at the injection site on the left arm and the arm was immobile for a week.,also She felt nausea and feverish for 36 hours. Patient took Aleve and applied warm compresses. The reporter consented to follow up.
Age: 73.0
Sex: F
Vaccine: FLU4, VARZOS, FLUX, VARZOS
Symptoms: Axillary pain, Hypokinesia, Injected limb mobility decreased, Injection site erythema, Injection site mass
Clinical narrative: The arm was immobile for a week; pain went into the arm pit area; nausea; feverish for 36 hours; severe pain at the injection site; area turned red; area / was swollen; area/ hot to touch; a mass formed at the injection site; This case was reported by a consumer via call center representative and described the occurrence of movements reduced in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On 13th September 2020, the patient received the 1st dose of Shingrix and Influenza vaccine Quadrivalent unspecified season. On 13th September 2020, less than a day after receiving Shingrix and Influenza vaccine Quadrivalent unspecified season, the patient experienced injection site pain, injection site erythema, injection site swelling, injection site warmth and injection site mass. On an unknown date, the patient experienced movements reduced (serious criteria GSK medically significant), axillary pain, nausea and fever. The patient was treated with naproxen (Aleve) and non-drug therapy (Warm Compress). On an unknown date, the outcome of the movements reduced, injection site swelling, axillary pain, nausea and fever were unknown and the outcome of the injection site pain and injection site mass were recovering/resolving and the outcome of the injection site erythema and injection site warmth were recovered/resolved.   It was unknown if the reporter considered the movements reduced, injection site pain, injection site erythema, injection site swelling, injection site warmth, injection site mass, axillary pain, nausea and fever to be related to Shingrix and Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The age at vaccination was not reported It was reported that patient received the 1st dose of Shingrix and also flu shot on 13th September 2020 and after that patient experienced pain at the injection site also the injection site area turned red and was swollen and hot to touch. It was also reported that the pain went into the arm pit area and a mass formed at the injection site on the left arm and the arm was immobile for a week.,also She felt nausea and feverish for 36 hours. Patient took Aleve and applied warm compresses. The reporter consented to follow up.
Age: 73.0
Sex: F
Vaccine: FLU4, VARZOS, FLUX, VARZOS
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Nausea, Pyrexia
Clinical narrative: The arm was immobile for a week; pain went into the arm pit area; nausea; feverish for 36 hours; severe pain at the injection site; area turned red; area / was swollen; area/ hot to touch; a mass formed at the injection site; This case was reported by a consumer via call center representative and described the occurrence of movements reduced in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On 13th September 2020, the patient received the 1st dose of Shingrix and Influenza vaccine Quadrivalent unspecified season. On 13th September 2020, less than a day after receiving Shingrix and Influenza vaccine Quadrivalent unspecified season, the patient experienced injection site pain, injection site erythema, injection site swelling, injection site warmth and injection site mass. On an unknown date, the patient experienced movements reduced (serious criteria GSK medically significant), axillary pain, nausea and fever. The patient was treated with naproxen (Aleve) and non-drug therapy (Warm Compress). On an unknown date, the outcome of the movements reduced, injection site swelling, axillary pain, nausea and fever were unknown and the outcome of the injection site pain and injection site mass were recovering/resolving and the outcome of the injection site erythema and injection site warmth were recovered/resolved.   It was unknown if the reporter considered the movements reduced, injection site pain, injection site erythema, injection site swelling, injection site warmth, injection site mass, axillary pain, nausea and fever to be related to Shingrix and Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The age at vaccination was not reported It was reported that patient received the 1st dose of Shingrix and also flu shot on 13th September 2020 and after that patient experienced pain at the injection site also the injection site area turned red and was swollen and hot to touch. It was also reported that the pain went into the arm pit area and a mass formed at the injection site on the left arm and the arm was immobile for a week.,also She felt nausea and feverish for 36 hours. Patient took Aleve and applied warm compresses. The reporter consented to follow up.
Age: 66.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Cellulitis, Malaise, Peripheral swelling
Clinical narrative: The Patient received 2 vaccines on 11/03/20. Based on the information given to the Pharmacy by the patients Spouse the patient was feeling unwell that evening and there was evidence of swelling in the Arm. The patient was taken to the Drs office  and was prescribed antibiotics  for cellulitis. The patient is also being treated for Atrial fibrillation per information given by the spouse.
Age: 41.0
Sex: F
Vaccine: UNK
Symptoms: Burning sensation, Contusion, Injected limb mobility decreased
Clinical narrative: I cannot lift up my arm for 2 weeks and when I call to the farmacy they told me to apply some ice packs and I did .  One day after the ice pack apply I have bruises under my skin and it feel like burning when I touch it.  Until today (11-23-2020) the bruises still  stay on my left arm.  I still can?t lift up my arm high.
Sex: M
Vaccine: VARZOS
Symptoms: Blister
Clinical narrative: Patient came in a month ago wanting to let us know that he had an adverse reaction to the shot. Few days after shot patient stated that he started developing blisters on his nose. Fluid started to accumulate. Patient stated went to PCP and they prescribed him sulfatrim, valtrex. All symptoms disappeared within a week of taking the treatment
Age: 43.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Discomfort, Dyspnoea, Dysstasia, Emotional distress, Muscle spasms
Clinical narrative: Approximately 4-6 minutes post vaccination patient started complaining of spasms radiating up and down spine, spasms created pain in spine, pt stated he felt that when his blood pumped he would feel the spinal spasm/pain.  Patient was in distress, discomfort, and had to sit down.  Breathing was accelerated.  Patient was given epipen 0.3mg for breathing issues (stated had a little trouble breathing and later stated breath felt warm).  Patient was then given oxygen by clinic next door to us.  02 was 93 right after epinephrine given, rose to 96-97 10-15 minutes later.  BP was 160/103 post epinephrine, lowered to 140/88 10-15 minutes later.  EMS arrived and evaluated patient approximately 18 minutes after reaction.  Patient felt normal and wanted to return home with his wife.  He was counseled by myself, EMS, and clinic's nurse.  He signed off with EMT approximately 35 minutes post event and then wife drove him home.  I checked on him at 12:46pm, approximately 2 hours after event and he feels normal, but is seeing doctor today.
Age: 43.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Respiratory rate increased, Spinal pain
Clinical narrative: Approximately 4-6 minutes post vaccination patient started complaining of spasms radiating up and down spine, spasms created pain in spine, pt stated he felt that when his blood pumped he would feel the spinal spasm/pain.  Patient was in distress, discomfort, and had to sit down.  Breathing was accelerated.  Patient was given epipen 0.3mg for breathing issues (stated had a little trouble breathing and later stated breath felt warm).  Patient was then given oxygen by clinic next door to us.  02 was 93 right after epinephrine given, rose to 96-97 10-15 minutes later.  BP was 160/103 post epinephrine, lowered to 140/88 10-15 minutes later.  EMS arrived and evaluated patient approximately 18 minutes after reaction.  Patient felt normal and wanted to return home with his wife.  He was counseled by myself, EMS, and clinic's nurse.  He signed off with EMT approximately 35 minutes post event and then wife drove him home.  I checked on him at 12:46pm, approximately 2 hours after event and he feels normal, but is seeing doctor today.
Age: 45.0
Sex: M
Vaccine: HEP, HEPA, MMR
Symptoms: Injection site rash, Peripheral swelling, Rash, Somnolence, Tenderness
Clinical narrative: Client left the clinic after staying for 15 minutes and returned c/o rash.  Client stated that rash appeared at about 5-10 minutes after he left the clinic.  Rash was noted on his left temporal area, left upper arm around the injection site and a 0.6 diameter "mosquito bite-like" bump on his left forearm.  Diphenhydramine 2 capsule of 25mg PO given to client.  Vitals taken; BP- 136/92, Pulse- 71, Temp- 94.8; O2 Sat 97%.  No other symptom. Medical director of the clinic stated that client could take another dose of Diphenhydramine 50 mg in 30 to 60 minutes and repeat every 6 hours prn. Instructions given to client and he stated understand.  Called client at 4:45 pm, client stated that the rash was gone but tender at the sites of the rash. Sleepy, no other complaint.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: Caller is a nurse reporting a temperature excursion, requesting stability data; This spontaneous report as received from a registered nurse referring to a patient of unknown age and gender. The pertinent medical history, concomitant therapies and drug allergy or reactions were unknown.  On 20-OCT-2020, the patient was vaccinated with 1 dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot number S038700, which has been verified to be valid, expiration date reported and validated as 01-DEC-2021) for prophylaxis (formulation, strength, vaccination scheme, route of administration and anatomical site of vaccination were not reported). The vaccine administered experienced a temperature excursion of -6.6 degrees Celsius for a time frame of 1 hour and 45 minutes, as recorded by a data logger. There was no previous temperature excursion reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2010USA010348: US-009507513-2010USA010299: US-009507513-2010USA010735: US-009507513-2010USA010384: US-009507513-2010USA010598: US-009507513-2010USA010518: US-009507513-2010USA010577: US-009507513-2010USA010526: US-009507513-2010USA010709:
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: 17 people were given vaccines during improperly stored; This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided.  On 02-NOV-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # S035125, expiration date: 04-NOV-2022, 0.5 milliliter (dosing schedule and route of administration were not reported) for prophylaxis. Administered dose of vaccine underwent temperature excursions: -13.9 Celsius (C) degrees to -14.7 Celsius (C) degrees in the following time frames: -14 C to -10 C (-13.9 C): for 30 minutes, -14 C to -10 C (-14.2 C) for 15 minutes; -14 C to -10 C (-14.7 C) for 20 minutes and -14 C to -10 C (14.6 C) for 5 minutes, as recorded by digital data logger.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered
Clinical narrative: No additional adverse events reported; an expired dose of ROTATEQ was administered; This spontaneous report was received from a registered nurse and refers to a 2 month old patient of unknown gender.    The patient's concurrent conditions, medical history, drug reactions, allergies and concomitant therapies were not provided.   On 11-NOV-2020 (also reported as yesterday), the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally (dose and frequency not reported) lot # S000954 has been verified to be a valid lot number, expiration date 17-OCT-2020 (expired product administered). It was reported that the vaccine was stored at the appropriate storage condition specified in the product label. No adverse event reported.
Age: 77.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: PNEUMOVAX-23 vaccine gave him a low grade fever, chills, and body aches.; PNEUMOVAX-23 vaccine gave him a low grade fever, chills, and body aches.; PNEUMOVAX-23 vaccine gave him a low grade fever, chills, and body aches.; This spontaneous report was received from a consumer referring to his father - a 77-year-old male patient. There was no information regarding the patient's pertinent medical history or concomitant medications provided. He had no drug reactions and allergies.  On 12-NOV-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), one time injection (strength, dose, route of administration, lot # and expiration date were not provided), for prophylaxis.  On 14-NOV-2020, the vaccine gave the patient a low grade fever, chills, and body aches. The outcome of pain, pyrexia and chills was reported as recovered/resolved on 16-NOV-2020. The reporter considered the events to be related to Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23).
Age: 42.0
Sex: M
Vaccine: UNK
Symptoms: Arthralgia, Dizziness, Fatigue, Feeling abnormal, Headache
Clinical narrative: Heart racing; Super dizzy; Fever; Joints were killing me; Head was pounding; felt like I was being tortured; Super drained; Spontaneous report received on 25SEP2020.  A patient reported that he experienced "heart racing" (PT: Palpitations), "super-dizzy" (PT: Dizziness), "fever" (PT: Pyrexia), "joints were killing me" (PT: Arthralgia), "head was pounding; felt like I was being tortured" (PT: Headache), and "super-drained" (PT: Fatigue), following the administration of BioThrax (anthrax vaccine adsorbed) for post exposure prophylaxis (PEP). On 24SEP2020 at 09:00, the patient received second dose of BioThrax in his left arm. He reported that there was no illness prior to the injection and no issues on day of injection. He woke up at approximately 00:30 and reported that "heart racing, joints were killing me, head was pounding, felt like I was being tortured, super-drained and super dizzy".   It was reported that he woke up around 04:00 and checked his temperature and it was 101 so he took Motrin (ibuprofen) 800mg and his fever was reduced to around 99. He was told to "take lots of fluids, rest and continue Motrin all day and if it did not take his temperature down to call his doctor". He also stated that he took more Motrin around 11:30 or 12:00 on 25SEP2020 and the temperature was staying down. At the time of report, most of his symptoms were resolved but his head was still pounding   A follow up information was received on 29SEP2020, from the consumer. He reported that by Sunday evening (27SEP2020), 95 percent of his symptoms was resolved. He further stated that by Monday morning (28SEP2020), all of the symptoms were resolved, and he was ready to go back to work and currently not experiencing any adverse events. The patient was recovered from the reported events, at the time of report.  Concomitant medication included oral Ciprofloxacin (500mg twice daily) started for PEP on 10SEP2020.  He denied medical history and stated that he had no reaction after the first injection.  Company Comment: A consumer had palpitations, pyrexia, headache, arthralgia, dizziness, and fatigue after receiving BioThrax. In response to the events, consumer took Motrin, lots of fluids, rest and all events recovered with in a few days. Considering the case information, and the potential of BioThrax to cause these events, the causality of palpitations, pyrexia, headache, arthralgia, dizziness, and fatigue is assessed as possible.; Sender's Comments: A consumer had palpitations, pyrexia, headache, arthralgia, dizziness, and fatigue after receiving BioThrax. In response to the events, consumer took Motrin, lots of fluids, rest and all events recovered with in a few days. Considering the case information, and the potential of BioThrax to cause these events, the causality of palpitations, pyrexia, headache, arthralgia, dizziness, and fatigue is assessed as possible.