chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 47.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Confusional state, Feeling abnormal, Flushing, Headache, Impaired work ability
Clinical narrative: facial flushing; neck pain; fuzziness; confusion; nausea; headache; hard time doing her job; patient received an expired dose of VARIVAX; varivax; route of administration: intramuscular; This spontaneous report as received from a nurse practitioner refers to a 47-year-old female patient. The patient's medical history was not reported, her concurrent conditions included: hypothyroidism, dyslipidaemia, sleep apnoea syndrome and seasonal allergies. Concomitant therapies included dexlansoprazole (DEXILANT) and levofloxacin(LEVAQUIN).   On 18-JAN-2019, the patient was vaccinated with expired dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot # M044347, expiration date: 04-NOV-2018, 0.5 milliliter (strength and dosing schedule were not reported) intramuscularly (considered as inappropriate route of administration) for prevention of varicella. On the same date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II)(recombinant Human albumin rHa), lot #R002049, expiration date 22-JAN-2020, 0.5 ml (strength, dosing schedule and route of administration were not reported) for prophylaxis. The patient reported she had side effects back when these doses of vaccines were given. She sought for medical help and had gone to the emergency room (ER) the next day- 19-JAN-2019, with symptoms of facial flushing, neck pain, fuzziness, confusion, reported having a hard time doing her job, nausea, and headache. The doctor had mentioned it could had been from the vaccines she had been given and advised her to check on them. The patient stated she felt fine on 20-JAN-2020, (reported as: on the next day) and was then back at baseline, the events were considered to be resolved. Action taken with vaccines was not applicable.   The causality assessment between varicella virus vaccine live (oka/merck)(VARIVAX) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was not reported.
Age: 47.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Nausea, Neck pain
Clinical narrative: facial flushing; neck pain; fuzziness; confusion; nausea; headache; hard time doing her job; patient received an expired dose of VARIVAX; varivax; route of administration: intramuscular; This spontaneous report as received from a nurse practitioner refers to a 47-year-old female patient. The patient's medical history was not reported, her concurrent conditions included: hypothyroidism, dyslipidaemia, sleep apnoea syndrome and seasonal allergies. Concomitant therapies included dexlansoprazole (DEXILANT) and levofloxacin(LEVAQUIN).   On 18-JAN-2019, the patient was vaccinated with expired dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot # M044347, expiration date: 04-NOV-2018, 0.5 milliliter (strength and dosing schedule were not reported) intramuscularly (considered as inappropriate route of administration) for prevention of varicella. On the same date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II)(recombinant Human albumin rHa), lot #R002049, expiration date 22-JAN-2020, 0.5 ml (strength, dosing schedule and route of administration were not reported) for prophylaxis. The patient reported she had side effects back when these doses of vaccines were given. She sought for medical help and had gone to the emergency room (ER) the next day- 19-JAN-2019, with symptoms of facial flushing, neck pain, fuzziness, confusion, reported having a hard time doing her job, nausea, and headache. The doctor had mentioned it could had been from the vaccines she had been given and advised her to check on them. The patient stated she felt fine on 20-JAN-2020, (reported as: on the next day) and was then back at baseline, the events were considered to be resolved. Action taken with vaccines was not applicable.   The causality assessment between varicella virus vaccine live (oka/merck)(VARIVAX) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was not reported.
Sex: U
Vaccine: VARZOS
Symptoms: Blindness
Clinical narrative: vision loss; Information has been received from a lawyer and a patient of unknown age and gender regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. In 2013, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot# and route unknown) for the long-term prevention of shingles and/or zoster-related conditions. Subsequent to the inoculation (date not reported), the patient was treated by a healthcare provider for vision loss. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the event vision loss was not recovered. The causality assessment was considered as related by the lawyer.  Upon internal review, vision loss was determined to be medically significant.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blood creatine phosphokinase, Blood lactic acid, Blood pressure measurement, Bradycardia, C-reactive protein
Clinical narrative: bradycardia (HR as low as 40's), variable BP, dizziness, fever, diffuse body aches, cough, extreme fatigue, chills
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Cough, Dizziness, Fatigue, Full blood count
Clinical narrative: bradycardia (HR as low as 40's), variable BP, dizziness, fever, diffuse body aches, cough, extreme fatigue, chills
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Metabolic function test, Pain, Pyrexia, Urine analysis
Clinical narrative: bradycardia (HR as low as 40's), variable BP, dizziness, fever, diffuse body aches, cough, extreme fatigue, chills
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Asthenia, Dizziness, Fatigue, Heart rate decreased, Hypertension
Clinical narrative: bradycardia (HR as low as 40's), variable BP, dizziness, fever, diffuse body aches, cough, extreme fatigue, chills
Age: 65.0
Sex: M
Vaccine: FLU4
Symptoms: Hypersensitivity, Injection site pain, Pain
Clinical narrative: Patient reports pain at area of injection initiating after vaccine was given on 10/23/2020. Patient is still reporting pain on 12/3/2020, stating it has radiated down arm to forearm as well as shoulder. Patient has seen his primary care provider who informed him it was some sort of allergic or adverse reaction at the sight of injection. Patient denies any other adverse effects including fever, shortness of breath, swelling or redness at sight of injection. Area does not appear to be infected. Pain is unrelieved with OTC analgesic use such as Aleve.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Dizziness, Loss of consciousness, Syncope
Clinical narrative: Patient had a syncopal episode approx. 10 minutes following immunizations. She was dizzy, attempted to walk to clinic room door, and pass out. She lost consciousness for 30-60 seconds.
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Headache, Influenza like illness, Injection site induration, Injection site nodule, Neck pain
Clinical narrative: Left arm pain / Pain which radiates from the neck to down her arm; Knot at the sight of the injection of the Shingrix vaccine / bubble due to the vaccine; headache; Feeling of having the flu; Pain which radiates from the neck to down her arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2020-2021 season) for prophylaxis.   The patient's past medical history included breast cancer. Previously administered products included Shingrix with an associated reaction of pain in extremity (received 1st dose on unknown date, refer case US2020AMR230419). Concurrent medical conditions included hashimoto's disease.   In October 2020, the patient received the 2nd dose of Shingrix. On an unknown date, the patient received Influenza vaccine Quadrivalent 2020-2021 season. On an unknown date, less than 2 months after receiving Shingrix, 10 days after receiving Influenza vaccine Quadrivalent 2020-2021 season and an unknown time after starting ibuprofen, the patient experienced pain in arm, injection site induration, headache, influenza-like symptoms and neck pain. The patient was treated with ibuprofen, muscle relaxants (Muscle Relaxant) and gabapentin (Neurotin). Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain in arm, injection site induration, headache, influenza-like symptoms and neck pain were unknown.   Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingric and few days later received a flu vaccine both vaccines were in the left arm and about days later she started to have left arm pain and she has a knot at the sight of the injection of the Shingrix vaccine.  The patient describes the left arm pain which radiates from the neck to down her arm.  The patient had headache and the feeling of having the flu, which resolved.  The HCP initially started her on an ibuprofen and then muscle relaxant for the arm pain, which did not help.  The customer had ultrasound done to check if there was a bubble due to the vaccine and no significant finding was noted.  The customer was asked to do physical therapy and the physcial therapy increased her left arm pain and was started on Neurotin.  The patient received the Shingrix vaccine at the pharmacy and received the flu vaccine from the HCP office. The reporter consented to follow up.  It was unknown if the reporter considered the pain in arm, injection site induration, headache, influenza-like symptoms and neck pain to be related to Shingrix and Influenza vaccine Quadrivalent 2020-2021 season.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020228597:same reporter US-GLAXOSMITHKLINE-US2020AMR230419:same reporter
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Pain, Pain in extremity, Ultrasound scan normal
Clinical narrative: Left arm pain / Pain which radiates from the neck to down her arm; Knot at the sight of the injection of the Shingrix vaccine / bubble due to the vaccine; headache; Feeling of having the flu; Pain which radiates from the neck to down her arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2020-2021 season) for prophylaxis.   The patient's past medical history included breast cancer. Previously administered products included Shingrix with an associated reaction of pain in extremity (received 1st dose on unknown date, refer case US2020AMR230419). Concurrent medical conditions included hashimoto's disease.   In October 2020, the patient received the 2nd dose of Shingrix. On an unknown date, the patient received Influenza vaccine Quadrivalent 2020-2021 season. On an unknown date, less than 2 months after receiving Shingrix, 10 days after receiving Influenza vaccine Quadrivalent 2020-2021 season and an unknown time after starting ibuprofen, the patient experienced pain in arm, injection site induration, headache, influenza-like symptoms and neck pain. The patient was treated with ibuprofen, muscle relaxants (Muscle Relaxant) and gabapentin (Neurotin). Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain in arm, injection site induration, headache, influenza-like symptoms and neck pain were unknown.   Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingric and few days later received a flu vaccine both vaccines were in the left arm and about days later she started to have left arm pain and she has a knot at the sight of the injection of the Shingrix vaccine.  The patient describes the left arm pain which radiates from the neck to down her arm.  The patient had headache and the feeling of having the flu, which resolved.  The HCP initially started her on an ibuprofen and then muscle relaxant for the arm pain, which did not help.  The customer had ultrasound done to check if there was a bubble due to the vaccine and no significant finding was noted.  The customer was asked to do physical therapy and the physcial therapy increased her left arm pain and was started on Neurotin.  The patient received the Shingrix vaccine at the pharmacy and received the flu vaccine from the HCP office. The reporter consented to follow up.  It was unknown if the reporter considered the pain in arm, injection site induration, headache, influenza-like symptoms and neck pain to be related to Shingrix and Influenza vaccine Quadrivalent 2020-2021 season.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020228597:same reporter US-GLAXOSMITHKLINE-US2020AMR230419:same reporter
Age: 31.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Erythema, Skin warm
Clinical narrative: patient has large red patch on right arm , warm to touch.  appeared same day as vaccines given.  Patient will monitor area of redness and will be seen in follow up virtual appointment tomorrow
Age: 57.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Anxiety, Arthralgia, Chills, Decreased appetite, Feeling abnormal
Clinical narrative: On 11/30/2020 @ 3:15 pm i received both vaccines One and Shingles. I had second thoughts about getting both at the same time.  Ans expressed this to the MA I was told It would be fine.  I still was anxious. I was trusting the doctor aa rhe MA said if there were any concerns he would go get the doctor.  The first side effect was  shivering, followed by headache and my right arm swelled and started to itch at 6:33 pm  The next day (11/1) around 8 pm. I couldn't stop shivering, my teeth were clattering headache was dibilitating. I felt nauseated and very off. My entire body muscles, joints ached horribly. I was immobilized and could hardly make it to the bathroom. Headache continued, no appetite. I used cold compress on right arm. It helped. I called the PCP  (11/2) office and was told to take tylenol by PCP I called immunologist office (ordering doctor) and still have not heard back from the office.  Later that evening the shivering and clattering of teeth was very bad. Could not get warm. I had a fever of 102 I did my best to stay hydrated. The headache wouldn't budge.  My right arm has calmed down. My left arm is VERY SORE.
Age: 57.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Feeling cold, Headache, Mobility decreased, Myalgia, Nausea
Clinical narrative: On 11/30/2020 @ 3:15 pm i received both vaccines One and Shingles. I had second thoughts about getting both at the same time.  Ans expressed this to the MA I was told It would be fine.  I still was anxious. I was trusting the doctor aa rhe MA said if there were any concerns he would go get the doctor.  The first side effect was  shivering, followed by headache and my right arm swelled and started to itch at 6:33 pm  The next day (11/1) around 8 pm. I couldn't stop shivering, my teeth were clattering headache was dibilitating. I felt nauseated and very off. My entire body muscles, joints ached horribly. I was immobilized and could hardly make it to the bathroom. Headache continued, no appetite. I used cold compress on right arm. It helped. I called the PCP  (11/2) office and was told to take tylenol by PCP I called immunologist office (ordering doctor) and still have not heard back from the office.  Later that evening the shivering and clattering of teeth was very bad. Could not get warm. I had a fever of 102 I did my best to stay hydrated. The headache wouldn't budge.  My right arm has calmed down. My left arm is VERY SORE.
Age: 57.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Pain in extremity, Peripheral swelling, Pruritus, Pyrexia
Clinical narrative: On 11/30/2020 @ 3:15 pm i received both vaccines One and Shingles. I had second thoughts about getting both at the same time.  Ans expressed this to the MA I was told It would be fine.  I still was anxious. I was trusting the doctor aa rhe MA said if there were any concerns he would go get the doctor.  The first side effect was  shivering, followed by headache and my right arm swelled and started to itch at 6:33 pm  The next day (11/1) around 8 pm. I couldn't stop shivering, my teeth were clattering headache was dibilitating. I felt nauseated and very off. My entire body muscles, joints ached horribly. I was immobilized and could hardly make it to the bathroom. Headache continued, no appetite. I used cold compress on right arm. It helped. I called the PCP  (11/2) office and was told to take tylenol by PCP I called immunologist office (ordering doctor) and still have not heard back from the office.  Later that evening the shivering and clattering of teeth was very bad. Could not get warm. I had a fever of 102 I did my best to stay hydrated. The headache wouldn't budge.  My right arm has calmed down. My left arm is VERY SORE.
Sex: F
Vaccine: VARZOS
Symptoms: Neck pain, Pain in extremity
Clinical narrative: Pain from the left elbow to the left side of her neck; Pain from the left elbow to the left side of her neck; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included breast cancer.   In October 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced pain in arm and neck pain. On an unknown date, the outcome of the pain in arm and neck pain were unknown.   It was unknown if the reporter considered the pain in arm and neck pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix in her left arm and had pain from the left elbow to the left side of her neck.  No additional information was available. The reporter did not consent to follow up. This case linked with US2020AMR230419 and US2020228595, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR230419:same reporter US-GLAXOSMITHKLINE-US2020228595:same reporter
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: flu from a flu shot; Initial information was received on 12-Oct-2020 regarding an unsolicited valid non-serious  case from the patient via social media.  This case is linked to cases 2020SA294135, 2020SA294140, 2020SA294160, 2020SA294161, 2020SA294162, 2020SA294163, 2020SA294142, 2020SA294143, 2020SA294164, 2020SA294165, , 2020SA294145, 2020SA294166, 2020SA294167, 2020SA294174, 2020SA294175, 2020SA294146, 2020SA294147, 2020SA294148, 2020SA294168, 2020SA294169, 2020SA294149, 2020SA294170, 2020SA294171, 2020SA294151, 2020SA294172, 2020SA294173, 2020SA294150, 2020SA294152, 2020SA294153, 2020SA294154, 2020SA294155, 2020SA294156, 2020SA294136, 2020SA294137, 2020SA294157, 2020SA294158, 2020SA294125, 2020SA294138, 2020SA294139, 2020SA294159 and 2020SA294231 (same reporter).  This case involves an unknown demographic patient who had flu from the shot (influenza) while the patient received INFLUENZA VACCINE.  The patient's medical history, past medical treatment(s), vaccination(s), family history and concomitant medications were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer, batch number and other dosing details were not reported) for prophylactic vaccination.  On an unknown date, the patient had flu from the shot (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data were not reported.  Corrective treatment was not reported.   The event outcome was unknown.  There will be no information available on the batch number for this case.
Age: 83.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site pain, Pain, Pain in extremity, Sleep disorder
Clinical narrative: Individual stated that during the time of vaccination, the vaccinator had difficulty getting the medication injected through the needle to the skin. Individual stated that the vaccine was cold which could have caused the pain and discomfort. Individual has not been able to really use her arm, has a lot of pain, throbbing, and discomfort, the pain is worse at night time and keeps her up because of it. Individual stated that it hurts worse at night. Individual did have physical therapist check it out but nothing was resolved. Flu Shot Coordinator suggested seeing PCP.
Age: 83.0
Sex: F
Vaccine: FLU4
Symptoms: Vaccination complication
Clinical narrative: Individual stated that during the time of vaccination, the vaccinator had difficulty getting the medication injected through the needle to the skin. Individual stated that the vaccine was cold which could have caused the pain and discomfort. Individual has not been able to really use her arm, has a lot of pain, throbbing, and discomfort, the pain is worse at night time and keeps her up because of it. Individual stated that it hurts worse at night. Individual did have physical therapist check it out but nothing was resolved. Flu Shot Coordinator suggested seeing PCP.
Sex: F
Vaccine: FLUR4
Symptoms: Erythema, Injection site erythema
Clinical narrative: the skin getting red in area the injection was given; Initial information received on 25-Nov-2020 regarding an unsolicited valid non-serious case from a consumer/other non-health professional.   This case involves elderly female patient (currently 74-year-old) who experienced the skin getting red in area the injection was given (vaccination site erythema), while she received INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  At the time of the event, the patient had ongoing Rubber sensitivity, allergic to mercury, Hypersensitivity with and that she is allergic to smells, perfumes and chemicals., Perfume sensitivity, Allergy to chemicals, Fibromyalgia, Drug hypersensitivity and Deafness and that she takes a steroid shot.  On an unknown date (in 2018- 2019 season), the patient received a dose (under 65 years old dose as opposed to the dose for her age group) of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot number, expiry date not reported) via unknown route at an unknown administration for prophylactic vaccination. On an unknown date, the patient developed non-serious the skin getting red in area the injection was given (vaccination site erythema) (unknown latency) following the administration of INFLUENZA QUADRIVAENT RECOMBINANT VACCINE.  It was reported that she has had the flu shot before but would sometimes skip taking it. It that year before last she took Flublok but that she took the under 65 years old dose as opposed to the dose for her age group. She has a high sensitivity to medicine and that she has to take a very low dose. she skipped the flu shot last year and is debating whether to take it this year or not. She told that pharmacist suggested her to take the small dose. She was also asking for if there would be any concern in taking Fluzone.  Relevant laboratory test results included: Blood pressure measurement - On an unknown date: [hit real high].  It was not reported if the patient received any corrective treatment.  Outcome was unknown at the time of reporting.  There will be no information available on the batch number for this case.
Age: 22.0
Sex: M
Vaccine: FLU4
Symptoms: Back pain, Dizziness, Flushing, Lacrimation increased, Rhinorrhoea
Clinical narrative: Member complained of severe back pain  w/ Pain scale of 5/10, ten minutes post injection of the Flu vaccine, excessive tearing of both eyes, congestion, flushed face/skin, lightheadedness, runny nose, hands were shaking and jittery.. Initial vital signs-BR:144/92, PR:80 bpm, RR:16. Flu vaccine info is as follows: Lot#: P100276658 Exp. Date: 30June2021  911 called at 11:14 am. Flu vaccination is at an off-site location.  FIRE arrived on scene after a few minutes and ambulance arrived in less than 10 minutes. Ambulance staff assessed patient and patient was taken to appropriate level of care Medical Centre.
Age: 22.0
Sex: M
Vaccine: FLU4
Symptoms: Tremor
Clinical narrative: Member complained of severe back pain  w/ Pain scale of 5/10, ten minutes post injection of the Flu vaccine, excessive tearing of both eyes, congestion, flushed face/skin, lightheadedness, runny nose, hands were shaking and jittery.. Initial vital signs-BR:144/92, PR:80 bpm, RR:16. Flu vaccine info is as follows: Lot#: P100276658 Exp. Date: 30June2021  911 called at 11:14 am. Flu vaccination is at an off-site location.  FIRE arrived on scene after a few minutes and ambulance arrived in less than 10 minutes. Ambulance staff assessed patient and patient was taken to appropriate level of care Medical Centre.
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Mass, Pain
Clinical narrative: subcutaneous mass about 1.5cm in size, initially painful, pain has now resolved
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling, Rash
Clinical narrative: Patient was fine after vaccination, only to next day report rash and swelling  on arm.  Not localized to injection site.  Swelling was up and down vaccinated arm.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Pain, Peripheral swelling, Pyrexia, Skin warm
Clinical narrative: Patients states at 2 am on 12/2/20 started experiencing a swollen arm, hot to the touch, fever/aches/ chills, temp of 103. Pt called 911 as she felt she was going to faint and paramedics checked vitals. Paramedics advised against going to ER considering all vitals were WNL despite fever. Pt had follow up with MD on 12/2 at 4:30 pm. MD advised pt to come in to be seen for swollen arm but pt refused. Pt was told to take Zyrtec and Benadryl OTC by MD. Fever has resolved. Pt temp is 98.7. Pt still complains of swollen arm due to vaccine.
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema
Clinical narrative: Patient had redness quarter size around the area of the injection, she stated she had no SOB, swelling, or pain in the injection site
Age: 3.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema
Clinical narrative: Large  area erythema 10cm by 7cm to right shoulder around site of injection.
Age: 50.0
Sex: F
Vaccine: RAB
Symptoms: Chest pain, Dyspnoea, Headache, Heart rate decreased, Laboratory test
Clinical narrative: Day 0 and 3 Rabies vaccine received, Day 7 Rabies Vaccine received; Day 14 Rabies Vaccine. Immunoglobulin injection given in left thigh in conjunction with Day 0 rabies r shoulder vaccine; Day 3, 11/14/2020, 10:30AM; Day 7 11/18/2020 10:30AM;  Day 14 11/25/2020 12:00PM.  Day 0 adverse events heart palpations, pain all over body, difficulty breathing with chest pain, headache, neck pain for a few days.  Day 3 same symptoms just not as severe; heart palpations, pain all over body, difficulty breathing with chest pain, headache, neck pain for few days. Day 7 very severe heart palpations, pain all over body, difficulty breathing with chest pain, headache, neck pain, tingling down head and neck and spine, stiff neck, left leg pain, nausea, low heart rate symptoms for over a week.  Day 14 very severe heart palpations, pain all over body, difficulty breathing with chest pain, headache, neck pain, tingling down head and neck and spine, stiff neck, left leg pain, nausea, low heart rate for over a week. Follow up care Cardiologist appointment - Cardiologist referred to follow up with General Practitioner. General Practitioner recommended advil for treatment and to follow up with Neurologist if needed.
Age: 50.0
Sex: F
Vaccine: RAB
Symptoms: Musculoskeletal stiffness, Nausea, Neck pain, Pain, Pain in extremity
Clinical narrative: Day 0 and 3 Rabies vaccine received, Day 7 Rabies Vaccine received; Day 14 Rabies Vaccine. Immunoglobulin injection given in left thigh in conjunction with Day 0 rabies r shoulder vaccine; Day 3, 11/14/2020, 10:30AM; Day 7 11/18/2020 10:30AM;  Day 14 11/25/2020 12:00PM.  Day 0 adverse events heart palpations, pain all over body, difficulty breathing with chest pain, headache, neck pain for a few days.  Day 3 same symptoms just not as severe; heart palpations, pain all over body, difficulty breathing with chest pain, headache, neck pain for few days. Day 7 very severe heart palpations, pain all over body, difficulty breathing with chest pain, headache, neck pain, tingling down head and neck and spine, stiff neck, left leg pain, nausea, low heart rate symptoms for over a week.  Day 14 very severe heart palpations, pain all over body, difficulty breathing with chest pain, headache, neck pain, tingling down head and neck and spine, stiff neck, left leg pain, nausea, low heart rate for over a week. Follow up care Cardiologist appointment - Cardiologist referred to follow up with General Practitioner. General Practitioner recommended advil for treatment and to follow up with Neurologist if needed.
Age: 50.0
Sex: F
Vaccine: RAB
Symptoms: Palpitations, Paraesthesia
Clinical narrative: Day 0 and 3 Rabies vaccine received, Day 7 Rabies Vaccine received; Day 14 Rabies Vaccine. Immunoglobulin injection given in left thigh in conjunction with Day 0 rabies r shoulder vaccine; Day 3, 11/14/2020, 10:30AM; Day 7 11/18/2020 10:30AM;  Day 14 11/25/2020 12:00PM.  Day 0 adverse events heart palpations, pain all over body, difficulty breathing with chest pain, headache, neck pain for a few days.  Day 3 same symptoms just not as severe; heart palpations, pain all over body, difficulty breathing with chest pain, headache, neck pain for few days. Day 7 very severe heart palpations, pain all over body, difficulty breathing with chest pain, headache, neck pain, tingling down head and neck and spine, stiff neck, left leg pain, nausea, low heart rate symptoms for over a week.  Day 14 very severe heart palpations, pain all over body, difficulty breathing with chest pain, headache, neck pain, tingling down head and neck and spine, stiff neck, left leg pain, nausea, low heart rate for over a week. Follow up care Cardiologist appointment - Cardiologist referred to follow up with General Practitioner. General Practitioner recommended advil for treatment and to follow up with Neurologist if needed.
Age: 63.0
Sex: F
Vaccine: FLUR4
Symptoms: Injected limb mobility decreased, Peripheral swelling
Clinical narrative: Patient reported that her left arm had swelling starting 2-3 days after the vaccine and continued until it required her to see her physician who started her on a steroid and antihistamine.  She states that she still does not have full function of her left arm and has trouble lifting it above her shoulder.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Anxiety, Decreased appetite, Mental disorder, Nervousness, Skin warm
Clinical narrative: Patient said that he felt like he was having a nervous breakdown, he had anxiety, nervousness, shaking hands.  He said his skin felt like it was on fire (feeling like sunburn), he was sensitive to temperature, loss of appetite (lost 5-10 pounds), He said that there was no rash, swelling, or shortness of breath.  He said he is normally a good sleeper but, for about a week and a half he could only sleep for about 3 hours and then was wide awake.  He tried taking melatonin.  He said he went to the immediate care who wouldn't treat him since they thought it sounded like he was having a nervous breakdown.  He said he called his primary physician who gave him Lexapro but, when I spoke to their office, they didn't realize he had an issue with a vaccine.  The patient said the Lexapro didn't work and he wasn't taking that anymore.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Sleep disorder, Tremor
Clinical narrative: Patient said that he felt like he was having a nervous breakdown, he had anxiety, nervousness, shaking hands.  He said his skin felt like it was on fire (feeling like sunburn), he was sensitive to temperature, loss of appetite (lost 5-10 pounds), He said that there was no rash, swelling, or shortness of breath.  He said he is normally a good sleeper but, for about a week and a half he could only sleep for about 3 hours and then was wide awake.  He tried taking melatonin.  He said he went to the immediate care who wouldn't treat him since they thought it sounded like he was having a nervous breakdown.  He said he called his primary physician who gave him Lexapro but, when I spoke to their office, they didn't realize he had an issue with a vaccine.  The patient said the Lexapro didn't work and he wasn't taking that anymore.
Age: 2.0
Sex: M
Vaccine: HIBV, HIBV
Symptoms: Computerised tomogram, Dyspnoea, Endotracheal intubation, Laboratory test, Pneumothorax
Clinical narrative: Collapsed lung, difficulty breathing that required oxygen and eventually intubation.
Age: 2.0
Sex: M
Vaccine: HIBV, HIBV
Symptoms: X-ray
Clinical narrative: Collapsed lung, difficulty breathing that required oxygen and eventually intubation.
Age: 2.0
Sex: M
Vaccine: HIBV, HIBV
Symptoms: Catatonia, Chest X-ray abnormal, Endotracheal intubation, Intensive care, Oxygen saturation decreased
Clinical narrative: Collapsed lung, difficulty breathing that required oxygen and eventually intubation.
Age: 2.0
Sex: M
Vaccine: HIBV, HIBV
Symptoms: Use of accessory respiratory muscles, Wheezing
Clinical narrative: Collapsed lung, difficulty breathing that required oxygen and eventually intubation.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Injection site pain, Pain
Clinical narrative: Very sore at point of injection. Next day following vaccination, achy, chills, low energy (all very unusual for me)
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site pruritus, Injection site rash, Nausea, Pain in extremity
Clinical narrative: 12 hours after shot, experienced nausea and headache and sore arm; next day, feverish with headache, along with sore arm; all symptoms resolved except for sore arm by three days except for new symptom, itchy rash at site of injection and continued soreness of arm.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: 12 hours after shot, experienced nausea and headache and sore arm; next day, feverish with headache, along with sore arm; all symptoms resolved except for sore arm by three days except for new symptom, itchy rash at site of injection and continued soreness of arm.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Pain, Pain in extremity
Clinical narrative: VERY SORE left arm, from the day after vaccination to now, five months later.  I cannot reach out to the left to reach the toilet paper, I cannot reach into the refrigerator or microwave with my left arm, it hurts to reach into my medicine cabinet to get my toothbrush, it hurts to reach for a hanger in a closet.  I cannot lift my left arm straight out to the side.  I can move it more when it is bent at the elbow.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Confusional state, Decreased appetite, Erythema, Fatigue, Feeling abnormal
Clinical narrative: Fever of 101.3 for 12 hours--second day, fever of 99.8; third day, no fever.  Soreness, redness (Red patch on arm 4"x6".  Still presenting on third day), swelling.  Flu-like symptoms with brain fog, body aches, fatigue, loss of appetite, nausea, strong headache, strong muscle pain--day one.  Second day--fatigue, low grade fever, nausea, and brain fog remained.  Third day--brain fog, fatigue, loss of appetite.  Experienced same with Shot 1.  Full recovery occurred after 7 days.  Brain fog presented as serious confusion--making wrong turns when driving, not recognizing surroundings, getting lost, not comprehending instructions and information.  No previous brain issues or reduced cognitive ability.  ER administered Vertigo medication to address brain fog after Shot 1.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Influenza like illness, Myalgia, Nausea, Pain
Clinical narrative: Fever of 101.3 for 12 hours--second day, fever of 99.8; third day, no fever.  Soreness, redness (Red patch on arm 4"x6".  Still presenting on third day), swelling.  Flu-like symptoms with brain fog, body aches, fatigue, loss of appetite, nausea, strong headache, strong muscle pain--day one.  Second day--fatigue, low grade fever, nausea, and brain fog remained.  Third day--brain fog, fatigue, loss of appetite.  Experienced same with Shot 1.  Full recovery occurred after 7 days.  Brain fog presented as serious confusion--making wrong turns when driving, not recognizing surroundings, getting lost, not comprehending instructions and information.  No previous brain issues or reduced cognitive ability.  ER administered Vertigo medication to address brain fog after Shot 1.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Swelling
Clinical narrative: Fever of 101.3 for 12 hours--second day, fever of 99.8; third day, no fever.  Soreness, redness (Red patch on arm 4"x6".  Still presenting on third day), swelling.  Flu-like symptoms with brain fog, body aches, fatigue, loss of appetite, nausea, strong headache, strong muscle pain--day one.  Second day--fatigue, low grade fever, nausea, and brain fog remained.  Third day--brain fog, fatigue, loss of appetite.  Experienced same with Shot 1.  Full recovery occurred after 7 days.  Brain fog presented as serious confusion--making wrong turns when driving, not recognizing surroundings, getting lost, not comprehending instructions and information.  No previous brain issues or reduced cognitive ability.  ER administered Vertigo medication to address brain fog after Shot 1.
Age: 63.0
Sex: M
Vaccine: UNK
Symptoms: Arthralgia, Chills, Erythema, Pyrexia
Clinical narrative: fever, chills, severe joint aches and red streaks around the entire arm
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected Vaccination failure; patients who have received both doses of Shingrix and had shingles; This case was reported by a pharmacist via call center representative and described the occurrence of suspected vaccination failure in a an unspecifed number of patients who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The pharmacist states that the patients received both doses of Shingrix and had shingles occurrences. The reporter consented to follow up. This case was considered as suspected vaccination failure, since the details regarding time to onset for event and laboratory confirmation for herpes zoster were not provided.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Decreased appetite, Diarrhoea, Fatigue, Headache
Clinical narrative: Side effects experienced are injection site redness and swelling, arm pain radiating across chest, nausea, diarrhea, severe headache, fever, loss of appetite, fatigue, shivering, and whole body aches. Headache has improved after day two.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Nausea, Pain, Pain in extremity
Clinical narrative: Side effects experienced are injection site redness and swelling, arm pain radiating across chest, nausea, diarrhea, severe headache, fever, loss of appetite, fatigue, shivering, and whole body aches. Headache has improved after day two.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Side effects experienced are injection site redness and swelling, arm pain radiating across chest, nausea, diarrhea, severe headache, fever, loss of appetite, fatigue, shivering, and whole body aches. Headache has improved after day two.
Age: 4.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site induration, Injection site pain
Clinical narrative: C/O stinging sensation at site of flu shot. Has hard lump at site. Not warm to touch, no fever. Able to move arm without difficulty.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Headache, Nausea, Pain
Clinical narrative: Body aches, progressing to headache this morning. This afternoon and currently having significant stomach pain, with some nausea. Symptoms, ( stomach ache ) ,seems to be lessening.. Have taken some ibuprofen, no other treatment sought at this time. Has now been about 24 hours post injection.
Age: 22.0
Sex: M
Vaccine: FLU4, IPV, MNQ, TDAP
Symptoms: Dizziness, Fear of injection, Head discomfort, Immediate post-injection reaction, Loss of consciousness
Clinical narrative: The patient experienced a Syncopal episode while he was receiving the listed immunizations. He was sitting in a chair prior to the event due to a severe fear of needles. He stated his head felt heavy and then he passed out, an Ammonia Inhalant was used and he regained consciousness. He did become "extremely" light headed after he regained consciousness but did not pass out again.  There was no physical injury during this episode.
Age: 22.0
Sex: M
Vaccine: FLU4, IPV, MNQ, TDAP
Symptoms: Syncope
Clinical narrative: The patient experienced a Syncopal episode while he was receiving the listed immunizations. He was sitting in a chair prior to the event due to a severe fear of needles. He stated his head felt heavy and then he passed out, an Ammonia Inhalant was used and he regained consciousness. He did become "extremely" light headed after he regained consciousness but did not pass out again.  There was no physical injury during this episode.
Age: 68.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Mobility decreased, Pain, Shoulder injury related to vaccine administration
Clinical narrative: Patient called in December to report the flu shot she received in September had caused an adverse reaction. She was sore for a few days and unable to raise her arm. Upon consulting with an orthopedic specialist she was informed the vaccine she received was most likely administered incorrectly. It was most likely administered too high causing shoulder damage/pain.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Arthritis, Mobility decreased, Pain, Pain in extremity, X-ray
Clinical narrative: Recieved inj. at my PCP office by an MA at approx. 2:30 PM. by 6:30 pm started having twingy shoulder pains.  By 7:00 excruciating pain and unable to move left arm without lifting with other hand.  I took 2 aleve's nothing, put a heating pad around shoulder. no relief.  could not get comfortable at all.  Husband arrived home from work @ 2:00 am and immediately to me to the ER.  Once admitted the Dr. stated that if a vaccine is injected incorrectly too high on the arm, (Which mine was very high).  The vaccine ends up entering the joint.  The antibodies in the vaccine have a reaction to your body that it's an infection.  They explained the IV meds they would be administering and doing shoulder xrays.  I was sent home with a sling, , anti-inflamatory ,medrol dose pak, cephalexin , oxycodone and Bactrim DS.  (for 7 Days) The first day, I did rest and sleep.  Taking the pain meds only the 1st day, but all others the entire 7 days, I was feeling much better and the pain was mild.  Now by 2 days after medication all gone.  I have consistent shoulder pain with arm movement.
Age: 79.0
Sex: F
Vaccine: FLU4
Symptoms: Incorrect route of product administration
Clinical narrative: Flu vaccine was not administered correctly.  The dose was not injected into the muscle of the arm as recommended.
Age: 72.0
Sex: M
Vaccine: FLUR4
Symptoms: Arthralgia, Joint range of motion decreased, Musculoskeletal stiffness, Neck pain, Pain in extremity
Clinical narrative: Patient reports a rash that started all over his body. Rash comes and goes away. He also reports stiffness in the shoulder and is hard to mobilize. He has pain up his left arm to his shoulder blade and neck. symptoms began the same day as his shot
Age: 72.0
Sex: M
Vaccine: FLUR4
Symptoms: Rash
Clinical narrative: Patient reports a rash that started all over his body. Rash comes and goes away. He also reports stiffness in the shoulder and is hard to mobilize. He has pain up his left arm to his shoulder blade and neck. symptoms began the same day as his shot
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Pain in extremity
Clinical narrative: Pt reports arm soreness developed after the injection as expected, but continued up to 4 weeks after. Pt reports taking Tylenol and moving arm for temporary relief. Reports pain has become an ache at the time of this report.
Age: 9.0
Sex: F
Vaccine: FLUC4
Symptoms: Abnormal behaviour, Cellulitis, Erythema, Hypersensitivity, Peripheral swelling
Clinical narrative: Parent said the child's arm was swollen, red, and hot to the touch.  She said the child also had some behavioral issues.  They took her to the ER on 12/02/2020 and the ER said she had an allergic reaction and cellulitis.
Age: 9.0
Sex: F
Vaccine: FLUC4
Symptoms: Skin warm
Clinical narrative: Parent said the child's arm was swollen, red, and hot to the touch.  She said the child also had some behavioral issues.  They took her to the ER on 12/02/2020 and the ER said she had an allergic reaction and cellulitis.
Age: 91.0
Sex: M
Vaccine: FLUA4
Symptoms: Chills, Death, Feeling cold
Clinical narrative: Patient relayed to daughter that he was cold and was having chills.  He stated he was going to take a shower.  He passed away sometime after this and was found 2 days later per his daughter.  Date of death was listed as 9/17/2020 on death certificate.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin exfoliation
Clinical narrative: Pt came in 12/1/20 and stated since the vaccine her hands have been peeling
Age: 82.0
Sex: F
Vaccine: FLUA4, FLU4
Symptoms: Injection site pain, Mobility decreased, Myalgia, Sleep disorder, Ultrasound scan
Clinical narrative: Pain in arm at injection site ever since shot was administered and  Severe muscle ache for 2 months also pain when sleeping and can?t lift anything.. I am icing it and trying not to use it.
Age: 82.0
Sex: F
Vaccine: FLUA4, FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pain in arm at injection site ever since shot was administered and  Severe muscle ache for 2 months also pain when sleeping and can?t lift anything.. I am icing it and trying not to use it.
Age: 61.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Back pain, Decreased appetite, Headache, Injection site erythema, Injection site swelling
Clinical narrative: Per patient report - patient developed a red, raised welt approx. 3 in x 3.5 in on L) upper arm the evening after receiving immunizations. Also reported low back pain, achy, no appetite and headache. Symptoms reported from 10/19/20-10/20/20.
Age: 61.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Pain, Urticaria
Clinical narrative: Per patient report - patient developed a red, raised welt approx. 3 in x 3.5 in on L) upper arm the evening after receiving immunizations. Also reported low back pain, achy, no appetite and headache. Symptoms reported from 10/19/20-10/20/20.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Erythema, Pruritus, Skin irritation, Urticaria
Clinical narrative: Hives on chest.  Very red irritated,  burning and itching.   Hives starting at armpit down side of body to the hip on both sides.  Very itchy