chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 23.0
Sex: M
Vaccine: FLU4
Symptoms: Dizziness, Hyperhidrosis
Clinical narrative: Pt felt dizzy and got diaphoretic after getting the vaccine. Was found in the grocery isle about 10 minutes after receiving vaccine.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Headache and severe muscle pain beginning at 11:30 pm on 11/3. Treated with naproxen. These symptoms lasted approx 24 hours. Redness at injection sight continued to get larger for next 72 hours. After 72 hours it was still swollen and painful and began itching. Several blisters appeared at this time.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site vesicles, Myalgia
Clinical narrative: Headache and severe muscle pain beginning at 11:30 pm on 11/3. Treated with naproxen. These symptoms lasted approx 24 hours. Redness at injection sight continued to get larger for next 72 hours. After 72 hours it was still swollen and painful and began itching. Several blisters appeared at this time.
Age: 62.0
Sex: M
Vaccine: FLUC4
Symptoms: Injection site pain
Clinical narrative: Patient came in pharmacy stated he had received a flu shot  a couple of weeks ago and his arm was still sore. He stated the pain is not in one specific area, it comes and goes and that in certain positions he doesn't feel it as much. He says sometimes it hurts more at the shoulder and then sometimes its more at the elbow. He had no pain until he received the flu shot. He has taken some otc naproxen it has helped. He has not seen a doctor yet, but may if the pain does not subside.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient came into pharmacy on 11/6 and told pharmacist that she had the worst reaction to the flu shot. A large portion of her upper arm was swollen and red/bruised. A week later the skin was still very observably bruised but the area had gotten smaller according to the patient. She was in pain for a few days but now she is better. Patient just wanted us to know what had happened to her. She's fine now.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site pruritus
Clinical narrative: Patient reported pain and tenderness at site of injection for 3 days, and then intense itchiness after the pain went away lasting for a few days. Rph spoke to the patient 7 days after receiving vaccine and there was still intense itchiness. Rph advised patient to take BENADRYL and consult with her primary care doctor.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Patient got a pattern of redness on her upper arm and some swelling.
Age: 40.0
Sex: F
Vaccine: FLUC4
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Patient came to pharmacy on 10/25/18 complaining of a very sore arm and limited mobility. I suggested that she may want to see a doctor if needed if the pain continued. On Friday, 10/26/18 I called the patient and she stated she had spent 2 hours at urgent care on Thursday 10/25/18 after speaking with me at the pharmacy. The outcome of her urgent care visit was to take ibuprofen and put ice/heat on her arm. She stated she was feeling much better after finding pressure points that helped relieve the pain. Then, on 11/06/18, patient called and stated her arm was still hurting and that she was going to urgent care to have an xray. I asked her to let me know the outcome. In the afternoon of 11/06/18 patient presented a prescription to the pharmacy to be filled for Diclofenac gel 1% from urgent care, along with a referral for physical therapy. She stated the doctor suggested she was possibly having a reaction to the flu vaccine she had received.
Age: 48.0
Sex: F
Vaccine: UNK
Symptoms: Blood test, Lymphadenopathy, Mobility decreased, Musculoskeletal stiffness, Neck pain
Clinical narrative: About 7-10 days after the shot I got the most painful stiff neck and upper spine. I could hardly lift my neck off of my pillow. It felt like my vertebrae were being crushed and that my neck was not strong enough to hold up my head. The most intense neck pain I have ever felt. This lasted from about Oct. 11 until Oct. 31. Then, on November 1 I noticed the lymph nodes in my neck, just above my collar bone were huge. They were very squishy to touch. They are still extremely enlarged today, Nov. 6.
Age: 48.0
Sex: F
Vaccine: UNK
Symptoms: Nuclear magnetic resonance imaging, Spinal pain
Clinical narrative: About 7-10 days after the shot I got the most painful stiff neck and upper spine. I could hardly lift my neck off of my pillow. It felt like my vertebrae were being crushed and that my neck was not strong enough to hold up my head. The most intense neck pain I have ever felt. This lasted from about Oct. 11 until Oct. 31. Then, on November 1 I noticed the lymph nodes in my neck, just above my collar bone were huge. They were very squishy to touch. They are still extremely enlarged today, Nov. 6.
Age: 54.0
Sex: F
Vaccine: MMR
Symptoms: Rash
Clinical narrative: Rash.
Age: 27.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Hypoaesthesia, Immediate post-injection reaction, Injection site discomfort, Injection site pain
Clinical narrative: Patient states immediately after shot, she felt itchy and tenderness at the site. Later in evening the discomfort worsened and area became swollen. Also reports weakness and numbness felt on her neck through fingertips.
Age: 27.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pruritus, Injection site swelling
Clinical narrative: Patient states immediately after shot, she felt itchy and tenderness at the site. Later in evening the discomfort worsened and area became swollen. Also reports weakness and numbness felt on her neck through fingertips.
Age: 64.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site pain, Pain in extremity, Vaccination site streaking
Clinical narrative: Patient had red streak under armpit about 3 inches long and pain under arm and at injection site. BENADRYL 25 mg every 4-6 hours and ibuprofen.
Age: 83.0
Sex: F
Vaccine: FLUA3, PNC13
Symptoms: Injected limb mobility decreased, Injection site bruising, Injection site pain, Injection site swelling
Clinical narrative: Left arm site of injection swelling, pain and bruise for 1.5-2 inches mark. Pt said she couldn't move arm for 3 days. Getting better slowly
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Axillary pain, Chills, Contusion, Lymphadenitis, Pyrexia
Clinical narrative: I received the SHINGRIX vaccine at my pharmacy. The injection was in my left upper arm. Within 3 hours I developed a very painful area under that arm, between my armpit and chest. I also developed chills and a fever of 101.5 F, which lasted for 24 hours. The day following the injection, the area near my armpit/chest was very swollen and painful. Two days later it had not improved. I went to my primary care doctor. He was perplexed but decided it must have been related to my lymphatic system and a response to the vaccine. The swelling went away after a week. The area was then bruised for another week. I want to emphasize that this was not the injection site.
Age: 20.0
Sex: F
Vaccine: HEP, MMR, VARCEL
Symptoms: Axillary pain, Radicular pain, Tenderness
Clinical narrative: Tender area of axillary nerve. Painful, same area with mild radicular pain along distribution of radial nerve. Slowly improving over the last month.
Age: 57.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Back pain, Headache, Injection site pain, Pyrexia
Clinical narrative: Pt calls with C/O fever 104, and 9:10 back pain that started 3:30am. Pt received flu and 1st shingles vaccine yesterday in clinic. Pt took two TYLENOL and one hydrocodone at 8:30 (1.5 hours ago). Temp is now 100.3, but back pain has not improved. Pt stated that he normally sleeps on his side, but slept on his back last night (due to both arms sore from vaccines). Pt also has a headache. Pt denies dyspnea, rash, difficulty swallowing, slurred speech, confusion, decreased/painful urination, NV, neck pain/light sensitivity, altered vision. Temperature has responded to TYLENOL. Advised patient alternate ice/heat to help with back pain.
Age: 79.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Blood test, Chest X-ray, Electrocardiogram, Injection site pain, Memory impairment
Clinical narrative: Pain at site (bad). Collapsed; did not know people or year; was taken to ER. Admitted to hospital on Thurs.; released on Sat. 10-13-18. Blood tests; X-rays (chest); EKG; Brain scan; were performed.
Age: 79.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Scan brain, Syncope
Clinical narrative: Pain at site (bad). Collapsed; did not know people or year; was taken to ER. Admitted to hospital on Thurs.; released on Sat. 10-13-18. Blood tests; X-rays (chest); EKG; Brain scan; were performed.
Age: 8.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Lt arm swollen and red-11-2-18 9:00AM started PRELONE 10x10cm area of redness, swelling-not tender, moves arm well.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: Pain and soreness in vaccinated arm 6 days after vaccination. Felt tingling in fingers which stopped 3 days after vaccination.
Age: 74.0
Sex: M
Vaccine: FLU4
Symptoms: Blood test normal, Rash, Skin discolouration
Clinical narrative: Patient had rash on back and side. The rash then spread to hips/legs and arms. The rash on legs slightly clearing up. Discoloration on part of arms as well.
Age: 66.0
Sex: M
Vaccine: FLUA3
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Customer came into pharmacy today said the site of injection hurts still and feels like swelling. No swelling noticed but feels tenderness.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Dyspnoea, Influenza like illness, Injection site swelling
Clinical narrative: 5 inch swelling area around site. 101 temp, difficulty breathing, flu like symptoms.
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Syncope
Clinical narrative: Fainting (Syncope) Patient received influenza vaccine and became dizzy then fainted while sitting in chair. I was able to wake her after 4 minutes. Her color returned to normal. Paramedics checked her vitals and released her.
Age: 85.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: Duplicate dose of flu vaccine given. 1st dose-10/1/18. 2nd dose-11-5-18.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Skin warm
Clinical narrative: Pt had swelling and redness measuring several inches around injection site. Pt came in Thursday to show arm and said that it was also warm. The swelling had subsided since Tuesday. It was still a little red. Pt instructed to apply ice and can take ibuprofen or BENADRYL at night. If it were to get worse, Pt would be calling Dr.
Age: 5.0
Sex: M
Vaccine: MMR
Symptoms: Abdominal pain upper, Diarrhoea, Headache, Henoch-Schonlein purpura, Oropharyngeal pain
Clinical narrative: 12/7/16-Received MMR #1 at 5 year old check up. C/O stomach pain in the car on the way to the office, but normal exam and would not say if stomach still hurt. 1/20/17-Diagnosed with strep throat. Put on amoxicillin. 1/23/17-rash and vomiting for 1-2 days, headache, stomach ache, sore throat, diarrhea. Diagnosed with HSP. - Purpura on legs, buttock, lower back. 1/27/17-changed to KEFLEX to finish strep treatment. 1/20/17-(+) rapid strep test. 1/23/17-UA - 50 ketones, trace protein.
Age: 5.0
Sex: M
Vaccine: MMR
Symptoms: Pharyngitis streptococcal, Protein urine present, Purpura, Rash, Streptococcus test positive
Clinical narrative: 12/7/16-Received MMR #1 at 5 year old check up. C/O stomach pain in the car on the way to the office, but normal exam and would not say if stomach still hurt. 1/20/17-Diagnosed with strep throat. Put on amoxicillin. 1/23/17-rash and vomiting for 1-2 days, headache, stomach ache, sore throat, diarrhea. Diagnosed with HSP. - Purpura on legs, buttock, lower back. 1/27/17-changed to KEFLEX to finish strep treatment. 1/20/17-(+) rapid strep test. 1/23/17-UA - 50 ketones, trace protein.
Age: 5.0
Sex: M
Vaccine: MMR
Symptoms: Urine ketone body present, Vomiting
Clinical narrative: 12/7/16-Received MMR #1 at 5 year old check up. C/O stomach pain in the car on the way to the office, but normal exam and would not say if stomach still hurt. 1/20/17-Diagnosed with strep throat. Put on amoxicillin. 1/23/17-rash and vomiting for 1-2 days, headache, stomach ache, sore throat, diarrhea. Diagnosed with HSP. - Purpura on legs, buttock, lower back. 1/27/17-changed to KEFLEX to finish strep treatment. 1/20/17-(+) rapid strep test. 1/23/17-UA - 50 ketones, trace protein.
Age: 12.0
Sex: M
Vaccine: FLU4, MNQ, TDAP
Symptoms: Asthenia, Blood glucose normal, Blood pressure decreased, Cold sweat, Immediate post-injection reaction
Clinical narrative: Immediately following receipt of MENACTRA, TdaP and flu patient became weak. Decreased BP noted, pale, clammy, glucose was normal. Responded to lying down giving juice. Likely vasovagal reaction.
Age: 12.0
Sex: M
Vaccine: FLU4, MNQ, TDAP
Symptoms: Pallor, Presyncope
Clinical narrative: Immediately following receipt of MENACTRA, TdaP and flu patient became weak. Decreased BP noted, pale, clammy, glucose was normal. Responded to lying down giving juice. Likely vasovagal reaction.
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Impaired work ability, Mobility decreased, Pain, Product administered at inappropriate site
Clinical narrative: Vaccine administered (witnessed) to be given above deltoid muscle- Had typical soreness first 1-3 days then developed sharp pains and mobility issues commencing on day 4. Requires rest, time out of work and P.T.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Hot, red and swollen site. Applied ice and gave TYLENOL.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Site swollen, hot and red. Gave BENADRYL.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Exposure during pregnancy
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of vaccine exposure during pregnancy in a 16-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline), GARDASIL (non-gsk) and MENACTRA (non-gsk) for prophylaxis. Concurrent medications included Iron. On 16 September 2009 at 11:30, the subject received 1st dose of BOOSTRIX (.5 cc, unknown, right arm), 1st dose of GARDASIL (unknown) and 1st dose of MENACTRA (unknown) and experienced vaccine exposure during pregnancy. The subject's baby is due on 26 May 2010. The subject was referred to an obstetrics physician for continued follow-up. Follow-up received from reporting healthcare professional on 4 January 2010: The subject's last menstrual period occurred on 19 August 2009. The pregnancy was reportedly a normal conception. All vaccinations were given intramuscularly on 16 September 2009 at gestation week 4 of pregnancy. The reporter stated that they had seen and confirmed the pregnancy through a school-community based mobile unit program and according to the last attempt, the subject had not connected to an obstetrician, but stated that she was in the process of doing so. The subject had gone to a one-time clinic for an ultrasound and reported feeling well and was taking prenatal vitamins. Follow-up information received via the reporting nurse practitioner on 23 August 2010 indicated that there were no additional details to provide at this site regarding this case. It was again reported that the subject had been referred to an obstetrician for further assistance. No additional information expected. [Pregnancy Notes] On 06 November 2018, this case was considered as lost to follow-up.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Injection site erythema, Injection site pain, Myalgia, Nausea
Clinical narrative: Ache all over, low-grade fever, headache, and nausea.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia
Clinical narrative: Ache all over, low-grade fever, headache, and nausea.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Nausea, Pain, Pyrexia
Clinical narrative: Ache all over, low-grade fever, headache, and nausea.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Pain, Pain in extremity
Clinical narrative: This case was reported by a consumer and described the occurrence of nerve damage in a adult patient who received SHINGRIX for prophylaxis. On 25th June 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced nerve damage, muscle damage, pain in arm, activities of daily living impaired, arm discomfort, limbs stiffness, mobility decreased and wakefulness. On an unknown date, the outcome of the nerve damage, muscle damage, pain in arm, activities of daily living impaired, arm discomfort, limbs stiffness, mobility decreased and wakefulness were unknown. It was unknown if the reporter considered the nerve damage, muscle damage, pain in arm, activities of daily living impaired, arm discomfort, limbs stiffness, mobility decreased and wakefulness to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient received SHINGRIX vaccine in left arm. The patient was convinced that he/she was crippled for life and sustained permanent nerve and muscle damage in left arm and shoulder. The pain was deep and constant. It was not excruciating pain, but always there making routine movements and activities uncomfortable, difficult and troublesome. The pain was severe enough to keep the patient awake at nights. The patient was presented with loss of flexibility and movement in the arm. At the time of reporting, the patient went to the gym and work through the discomfort, but was constantly aware of what I believed to be the lasting effects of the SHINGRIX injection. The patient thought that, if it keeps him/her from getting shingles (again) it would be worth it. As per patient shingles only lasts for few weeks, and this pain and discomfort and loss of flexibility that patient had experienced seems to be permanent. The patient was still trying to decide.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Insomnia, Limb discomfort, Loss of personal independence in daily activities, Mobility decreased, Muscle injury
Clinical narrative: This case was reported by a consumer and described the occurrence of nerve damage in a adult patient who received SHINGRIX for prophylaxis. On 25th June 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced nerve damage, muscle damage, pain in arm, activities of daily living impaired, arm discomfort, limbs stiffness, mobility decreased and wakefulness. On an unknown date, the outcome of the nerve damage, muscle damage, pain in arm, activities of daily living impaired, arm discomfort, limbs stiffness, mobility decreased and wakefulness were unknown. It was unknown if the reporter considered the nerve damage, muscle damage, pain in arm, activities of daily living impaired, arm discomfort, limbs stiffness, mobility decreased and wakefulness to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient received SHINGRIX vaccine in left arm. The patient was convinced that he/she was crippled for life and sustained permanent nerve and muscle damage in left arm and shoulder. The pain was deep and constant. It was not excruciating pain, but always there making routine movements and activities uncomfortable, difficult and troublesome. The pain was severe enough to keep the patient awake at nights. The patient was presented with loss of flexibility and movement in the arm. At the time of reporting, the patient went to the gym and work through the discomfort, but was constantly aware of what I believed to be the lasting effects of the SHINGRIX injection. The patient thought that, if it keeps him/her from getting shingles (again) it would be worth it. As per patient shingles only lasts for few weeks, and this pain and discomfort and loss of flexibility that patient had experienced seems to be permanent. The patient was still trying to decide.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Musculoskeletal stiffness, Nerve injury, Pain in extremity, Poor quality sleep
Clinical narrative: This case was reported by a consumer and described the occurrence of nerve damage in a adult patient who received SHINGRIX for prophylaxis. On 25th June 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced nerve damage, muscle damage, pain in arm, activities of daily living impaired, arm discomfort, limbs stiffness, mobility decreased and wakefulness. On an unknown date, the outcome of the nerve damage, muscle damage, pain in arm, activities of daily living impaired, arm discomfort, limbs stiffness, mobility decreased and wakefulness were unknown. It was unknown if the reporter considered the nerve damage, muscle damage, pain in arm, activities of daily living impaired, arm discomfort, limbs stiffness, mobility decreased and wakefulness to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient received SHINGRIX vaccine in left arm. The patient was convinced that he/she was crippled for life and sustained permanent nerve and muscle damage in left arm and shoulder. The pain was deep and constant. It was not excruciating pain, but always there making routine movements and activities uncomfortable, difficult and troublesome. The pain was severe enough to keep the patient awake at nights. The patient was presented with loss of flexibility and movement in the arm. At the time of reporting, the patient went to the gym and work through the discomfort, but was constantly aware of what I believed to be the lasting effects of the SHINGRIX injection. The patient thought that, if it keeps him/her from getting shingles (again) it would be worth it. As per patient shingles only lasts for few weeks, and this pain and discomfort and loss of flexibility that patient had experienced seems to be permanent. The patient was still trying to decide.
Sex: F
Vaccine: PPV, PPV, PPV
Symptoms: Back pain, Headache, Muscle spasms, Pain in extremity
Clinical narrative: This spontaneous report was received from a consumer via a company representative referring to a 68 year old female patient. The patient did not have medical history. The patient's concurrent conditions included allergy to unspecified antibiotics. On 26-OCT-2018, the patient was vaccinated with a dose of PNEUMOVAX 23 (strength, dose number, route, frequency and lot number were not provided) for prophylaxis. On 26-OCT-2018, after 5 minutes of vaccination, the patient experienced a sharp searing pain in her back along her spine. It was reported that she went to unspecified Urgent Care and a unspecified "pulmonary test" was completed that was negative in it's response. Additionally, on the same date, the patient experienced soreness at the injection site. It was reported that no treatment was given. Cancer and overdose was not involved. On 26-OCT- 2018, the patient recovered from back pain, injection site pain and spinal pain. The reporter did not assess the relatedness between back pain, injection site pain and spinal pain and PNEUMOVAX 23.
Sex: F
Vaccine: PPV, PPV, PPV
Symptoms: Back pain, Muscle spasms, Pain
Clinical narrative: This spontaneous report was received from a consumer via a company representative referring to a 68 year old female patient. The patient did not have medical history. The patient's concurrent conditions included allergy to unspecified antibiotics. On 26-OCT-2018, the patient was vaccinated with a dose of PNEUMOVAX 23 (strength, dose number, route, frequency and lot number were not provided) for prophylaxis. On 26-OCT-2018, after 5 minutes of vaccination, the patient experienced a sharp searing pain in her back along her spine. It was reported that she went to unspecified Urgent Care and a unspecified "pulmonary test" was completed that was negative in it's response. Additionally, on the same date, the patient experienced soreness at the injection site. It was reported that no treatment was given. Cancer and overdose was not involved. On 26-OCT- 2018, the patient recovered from back pain, injection site pain and spinal pain. The reporter did not assess the relatedness between back pain, injection site pain and spinal pain and PNEUMOVAX 23.
Sex: F
Vaccine: PPV, PPV, PPV
Symptoms: Back pain, Injection site pain, Spinal pain
Clinical narrative: This spontaneous report was received from a consumer via a company representative referring to a 68 year old female patient. The patient did not have medical history. The patient's concurrent conditions included allergy to unspecified antibiotics. On 26-OCT-2018, the patient was vaccinated with a dose of PNEUMOVAX 23 (strength, dose number, route, frequency and lot number were not provided) for prophylaxis. On 26-OCT-2018, after 5 minutes of vaccination, the patient experienced a sharp searing pain in her back along her spine. It was reported that she went to unspecified Urgent Care and a unspecified "pulmonary test" was completed that was negative in it's response. Additionally, on the same date, the patient experienced soreness at the injection site. It was reported that no treatment was given. Cancer and overdose was not involved. On 26-OCT- 2018, the patient recovered from back pain, injection site pain and spinal pain. The reporter did not assess the relatedness between back pain, injection site pain and spinal pain and PNEUMOVAX 23.
Age: 53.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Cough, Eye pruritus, Immediate post-injection reaction, Injection site pain, Oropharyngeal pain
Clinical narrative: States she pain at the site and surrounding area and that she had a bruise. She got tingling (feels like bugs crawling) of L arm, L side of face, L side of tongue, top of head, back of neck including ear on Left and down left leg. That was on Friday and these symptoms lasted through the weekend and then she email Employee Health on Monday I sent her to the ER for evaluation. During the previous 4 days she did not seek treatment even though these are not normal side effects.
Age: 53.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Pain in extremity, Paraesthesia, Paraesthesia oral, Sensory disturbance
Clinical narrative: States she pain at the site and surrounding area and that she had a bruise. She got tingling (feels like bugs crawling) of L arm, L side of face, L side of tongue, top of head, back of neck including ear on Left and down left leg. That was on Friday and these symptoms lasted through the weekend and then she email Employee Health on Monday I sent her to the ER for evaluation. During the previous 4 days she did not seek treatment even though these are not normal side effects.
Age: 53.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Injection site bruising, Injection site pain, Injection site paraesthesia, Paraesthesia
Clinical narrative: States she pain at the site and surrounding area and that she had a bruise. She got tingling (feels like bugs crawling) of L arm, L side of face, L side of tongue, top of head, back of neck including ear on Left and down left leg. That was on Friday and these symptoms lasted through the weekend and then she email Employee Health on Monday I sent her to the ER for evaluation. During the previous 4 days she did not seek treatment even though these are not normal side effects.
Age: 67.0
Sex: M
Vaccine: FLU3, FLU4
Symptoms: Guillain-Barre syndrome, Muscular weakness
Clinical narrative: Dr office called and reported to us that patient was diagnosed with Guillain-Barre syndrome. No other info was shared. Dr office also said they reported in VAERS.
Age: 67.0
Sex: M
Vaccine: FLU3, FLU4
Symptoms: Guillain-Barre syndrome, Respiratory tract infection
Clinical narrative: Dr office called and reported to us that patient was diagnosed with Guillain-Barre syndrome. No other info was shared. Dr office also said they reported in VAERS.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Balanoposthitis, Blood test normal, Choking, Dyspnoea, Erythema
Clinical narrative: My son had a 12-15 min. convulsive episode (seizure) 6.5 days after his shots. He was non-responsive / staring, limp for about 5 min. When I picked him up he could not use his legs and collapsed, his neck lolled to the side, his eyes crossed, tongue came out, he made a choking gasp, then turned red and convulsed. I called 911. He foamed at the mouth and I tried to clear his airway. He was not breathing for several minutes and I was told by operator how to perform CPR. Rolled him on his side, I attempted CPR, he started breathing and fell asleep. Convulsions and lack of oxygen lasted between 7-10 minutes and ended 2-3 minutes before paramedics arrived. Paramedics checked oxygen level / temp. (both normal). He was taken to the ER where they ran blood work for meningitis, high white blood cell count, infection, and/or a vitamin deficiency. All blood work came back normal. He had no fever. No EEG was given. We were told that sometimes seizures in young children "just happen" and to watch him closely for the next 48 hours. He has not had another seizure since his immunizations. Note: There is a family history of adverse reaction to the DTP shot. My sister had a febrile seizure with her DTP shot. Was told that it wouldn't be a problem with my son because this was Dtap with the acellular pertussis. Clearly that is NOT the case and the Dtap can still lead to seizures.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Foaming at mouth, Hypotonia, Hypovitaminosis, Musculoskeletal disorder, Posture abnormal
Clinical narrative: My son had a 12-15 min. convulsive episode (seizure) 6.5 days after his shots. He was non-responsive / staring, limp for about 5 min. When I picked him up he could not use his legs and collapsed, his neck lolled to the side, his eyes crossed, tongue came out, he made a choking gasp, then turned red and convulsed. I called 911. He foamed at the mouth and I tried to clear his airway. He was not breathing for several minutes and I was told by operator how to perform CPR. Rolled him on his side, I attempted CPR, he started breathing and fell asleep. Convulsions and lack of oxygen lasted between 7-10 minutes and ended 2-3 minutes before paramedics arrived. Paramedics checked oxygen level / temp. (both normal). He was taken to the ER where they ran blood work for meningitis, high white blood cell count, infection, and/or a vitamin deficiency. All blood work came back normal. He had no fever. No EEG was given. We were told that sometimes seizures in young children "just happen" and to watch him closely for the next 48 hours. He has not had another seizure since his immunizations. Note: There is a family history of adverse reaction to the DTP shot. My sister had a febrile seizure with her DTP shot. Was told that it wouldn't be a problem with my son because this was Dtap with the acellular pertussis. Clearly that is NOT the case and the Dtap can still lead to seizures.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Protrusion tongue, Respiratory arrest, Resuscitation, Seizure, Staring
Clinical narrative: My son had a 12-15 min. convulsive episode (seizure) 6.5 days after his shots. He was non-responsive / staring, limp for about 5 min. When I picked him up he could not use his legs and collapsed, his neck lolled to the side, his eyes crossed, tongue came out, he made a choking gasp, then turned red and convulsed. I called 911. He foamed at the mouth and I tried to clear his airway. He was not breathing for several minutes and I was told by operator how to perform CPR. Rolled him on his side, I attempted CPR, he started breathing and fell asleep. Convulsions and lack of oxygen lasted between 7-10 minutes and ended 2-3 minutes before paramedics arrived. Paramedics checked oxygen level / temp. (both normal). He was taken to the ER where they ran blood work for meningitis, high white blood cell count, infection, and/or a vitamin deficiency. All blood work came back normal. He had no fever. No EEG was given. We were told that sometimes seizures in young children "just happen" and to watch him closely for the next 48 hours. He has not had another seizure since his immunizations. Note: There is a family history of adverse reaction to the DTP shot. My sister had a febrile seizure with her DTP shot. Was told that it wouldn't be a problem with my son because this was Dtap with the acellular pertussis. Clearly that is NOT the case and the Dtap can still lead to seizures.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Strabismus, Syncope, Unresponsive to stimuli, White blood cell count normal
Clinical narrative: My son had a 12-15 min. convulsive episode (seizure) 6.5 days after his shots. He was non-responsive / staring, limp for about 5 min. When I picked him up he could not use his legs and collapsed, his neck lolled to the side, his eyes crossed, tongue came out, he made a choking gasp, then turned red and convulsed. I called 911. He foamed at the mouth and I tried to clear his airway. He was not breathing for several minutes and I was told by operator how to perform CPR. Rolled him on his side, I attempted CPR, he started breathing and fell asleep. Convulsions and lack of oxygen lasted between 7-10 minutes and ended 2-3 minutes before paramedics arrived. Paramedics checked oxygen level / temp. (both normal). He was taken to the ER where they ran blood work for meningitis, high white blood cell count, infection, and/or a vitamin deficiency. All blood work came back normal. He had no fever. No EEG was given. We were told that sometimes seizures in young children "just happen" and to watch him closely for the next 48 hours. He has not had another seizure since his immunizations. Note: There is a family history of adverse reaction to the DTP shot. My sister had a febrile seizure with her DTP shot. Was told that it wouldn't be a problem with my son because this was Dtap with the acellular pertussis. Clearly that is NOT the case and the Dtap can still lead to seizures.
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Hypersensitivity, Immediate post-injection reaction, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Arm immediately swelled and turned red, the Band Aid left an impression in her arm from the swelling, that was on Friday when she came to Employee Health on Monday the arm redness was about 4 inches wide darker red in color and still very warm with slight swelling. Because we concerned she may be developing cellulitis she was sent to the ER. They said it was allergic local reaction and that in time it should get better.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This spontaneous report was received from an administrator and refers to an adult patient of unknown age and gender. No information regarding the patient's concurrent condition, medical history, concomitant medications and drug reactions or allergies was provided. On an unknown date, the patient was vaccinated with pediatric dose of VAQTA lot # N023953, expiration date 05-NOV-2018 (route of administration was not reported) for prophylaxis. No adverse effects were reported.
Age: 63.0
Sex: M
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a nurse practitioner, referring to a 63 year old male patient. Information about medical history, concurrent condition and concomitant therapy was unknown. On an unknown date, the patient was vaccinated with improperly stored PNEUMOVAX 23 (dose, strength and frequency were unknown; lot# N014946, expiration date: 01-FEB-2019) intramuscular injection for prophylaxis. No adverse effects were reported. Temperature excursion was reported as 21 Fahrenheit (F) degrees for 1 hour and 30 minutes (1 cycle). There was no previous temperature excursion. A digital data logger was involved.
Sex: F
Vaccine: HPV9
Symptoms: Vaccination failure
Clinical narrative: This spontaneous report was received from the patient's father concerning a 17 year old female patient. The patient's medical history concurrent conditions, drug reactions, allergies and concomitant medications were not reported. On an unknown date, the patient was vaccinated with GARDASIL 9 for prophylaxis (strength, dose, frequency, dose number, anatomical location, route of administration, lot number and expiration date were not reported). The reporter informed that since an unspecified date (reported as for 2 years), GARDASIL 9 did nothing, and that it would have been better if the patient did not get vaccinated at all. At the time of reporting, the outcome of GARDASIL 9 doing nothing (vaccination failure) for 2 years was unknown. The causal relationship between the vaccination with GARDASIL 9 and the event was not provided by the reporter. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1810USA014045.
Sex: F
Vaccine: HPV9
Symptoms: Vaccination failure
Clinical narrative: This spontaneous report was received from the patient's father concerning a 20 year old female patient. The patient's medical history concurrent conditions, drug reactions, allergies and concomitant medications were not reported. On an unknown date, the patient was vaccinated with GARDASIL 9 for prophylaxis (strength, dose, frequency, dose number, anatomical location, route of administration, lot number and expiration date were not reported). The reporter informed that since an unspecified date (reported as for 2 years), GARDASIL 9 did nothing, and that it would have been better if the patient did not get vaccinated at all. At the time of reporting, the outcome of GARDASIL 9 doing nothing for 2 years was unknown. The causal relationship between the vaccination with GARDASIL 9 and the event was not provided by the reporter. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1810USA013314.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider/physician recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 25-JAN-2016, a physician administered the ZOSTAVAX (lot number, dosage and route of administration not provided) to the patient. On or about 02-NOV-2016, the patient was treated by a physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive 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; a diminished quality of life; increased risk of premature death; aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Back pain, Injection site pain, Injection site swelling, Swelling
Clinical narrative: This spontaneous report as received from a pharmacist via company representative refers to a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 30-OCT-2018, the patient was vaccinated with PNEUMOVAX 23 (dose, dose number, route of administration, lot # and expiry date was not reported) for prophylaxis. On October 2018 (reported as 12 hours later), the patient had intense pain and swelling from injection site which radiated to back of patient. The patient went to the emergency room and received arm sling to wear. At the time of report, the patient did not recover from the events. The reporter's causality assessment between the events and the suspect therapy was not reported.
Age: 18.0
Sex: F
Vaccine: HPV9
Symptoms: Back pain, Blood culture positive, Facial pain, Gastrointestinal tube insertion, Headache
Clinical narrative: This spontaneous report was received from a physician refers to an 18 year old female patient. Information on patient's pertinent medical history, drug reactions/allergies and concomitant medications were unknown. On an unknown date in early October 2018, the patient was vaccinated with GARDASIL 9 (strength, dose, lot# and expiry were not reported) via intramuscular route for prevention of Human papillomavirus (HPV). On 18-OCT-2018, the patient came to physician's office and reported "with illness, puffy eyes, headache, back and neck and facial pain, sore throat and cervical adenopathy. The physician also reported that the patient received a work out for mononucleosis and pharyngitis. He was prescribed with oral steroids (unspecified). On 21-OCT-2018, the patient went to the emergency room and was admitted in the hospital. The reporter informed that the patient was given treatment with morphine for pain, intravenous steroids (unspecified) and nasogastric tube intubation was also placed. The patient had blood cultures and the result revealed as positive. The reporter reported that the patient was still hospitalized. The outcome of ill-defined disorder, pharyngitis, infectious mononucleosis, lymphadenopathy, oropharyngeal pain, facial pain, neck pain, back pain, headache and eye swelling was not recovered. The causality assessment was not reported. There was no product quality complaint (PQC) reported.
Age: 18.0
Sex: F
Vaccine: HPV9
Symptoms: Ill-defined disorder, Infectious mononucleosis, Lymphadenopathy, Neck pain, Oropharyngeal pain
Clinical narrative: This spontaneous report was received from a physician refers to an 18 year old female patient. Information on patient's pertinent medical history, drug reactions/allergies and concomitant medications were unknown. On an unknown date in early October 2018, the patient was vaccinated with GARDASIL 9 (strength, dose, lot# and expiry were not reported) via intramuscular route for prevention of Human papillomavirus (HPV). On 18-OCT-2018, the patient came to physician's office and reported "with illness, puffy eyes, headache, back and neck and facial pain, sore throat and cervical adenopathy. The physician also reported that the patient received a work out for mononucleosis and pharyngitis. He was prescribed with oral steroids (unspecified). On 21-OCT-2018, the patient went to the emergency room and was admitted in the hospital. The reporter informed that the patient was given treatment with morphine for pain, intravenous steroids (unspecified) and nasogastric tube intubation was also placed. The patient had blood cultures and the result revealed as positive. The reporter reported that the patient was still hospitalized. The outcome of ill-defined disorder, pharyngitis, infectious mononucleosis, lymphadenopathy, oropharyngeal pain, facial pain, neck pain, back pain, headache and eye swelling was not recovered. The causality assessment was not reported. There was no product quality complaint (PQC) reported.
Age: 18.0
Sex: F
Vaccine: HPV9
Symptoms: Pharyngitis, Swelling of eyelid
Clinical narrative: This spontaneous report was received from a physician refers to an 18 year old female patient. Information on patient's pertinent medical history, drug reactions/allergies and concomitant medications were unknown. On an unknown date in early October 2018, the patient was vaccinated with GARDASIL 9 (strength, dose, lot# and expiry were not reported) via intramuscular route for prevention of Human papillomavirus (HPV). On 18-OCT-2018, the patient came to physician's office and reported "with illness, puffy eyes, headache, back and neck and facial pain, sore throat and cervical adenopathy. The physician also reported that the patient received a work out for mononucleosis and pharyngitis. He was prescribed with oral steroids (unspecified). On 21-OCT-2018, the patient went to the emergency room and was admitted in the hospital. The reporter informed that the patient was given treatment with morphine for pain, intravenous steroids (unspecified) and nasogastric tube intubation was also placed. The patient had blood cultures and the result revealed as positive. The reporter reported that the patient was still hospitalized. The outcome of ill-defined disorder, pharyngitis, infectious mononucleosis, lymphadenopathy, oropharyngeal pain, facial pain, neck pain, back pain, headache and eye swelling was not recovered. The causality assessment was not reported. There was no product quality complaint (PQC) reported.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received on 05-NOV-2018 from a lawyer regarding a case in litigation concerning a male patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not provided. On or about 06-AUG-2013, the patient was inoculated with the ZOSTAVAX (lot number, expiration, dose and route unknown), as recommended for routine adult health maintenance and the intended purpose of long-term prevention of shingles and zoster related injuries. Upon information and belief, on or about August 2013, health care providers recommended, prescribed, and/or administered the ZOSTAVAX to the patient for the intended purpose of long-term prevention of shingles and zoster-related injuries. The vaccine did not prevent shingles or zoster-related injuries as intended. In 2015, the patient was treated at a hospital for shingles or herpes zoster and other zoster-related injuries. As a direct and proximate result of the ZOSTAVAX and/or despite receiving ZOSTAVAX for long-term prevention of shingles and zoster related injuries, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received on 05-NOV-2018 from a lawyer regarding a case in litigation concerning a male patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not provided. In or about May 2014, the patient was inoculated with the ZOSTAVAX (lot number, expiration, dose and route unknown), as recommended prescribed, and/or administered by a physician for routine adult health maintenance and the intended purpose of long-term prevention of shingles and zoster related injuries. The vaccine did not prevent shingles or zoster-related injuries as intended. Later in approximately September 2014, the patient was treated by a physician for shingles. The patient was prescribed Gabapentin to treat pain related to his shingles and zoster-related injuries. As a direct and proximate result of the ZOSTAVAX and/or despite receiving ZOSTAVAX for long-term prevention of shingles and zoster related injuries, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.