chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Constipation, Pyrexia
Clinical narrative: Fever and became constipated. Previously had BM 6-8 times a day now no BM since vaccinations.
Age: 39.0
Sex: F
Vaccine: FLU4, HEPAB, TBE
Symptoms: Dizziness, Immediate post-injection reaction, Paraesthesia
Clinical narrative: Immediately after getting the TWINRIX vaccination, (2nd dose of accelerated schedule 1st dose on 2/7/19 at a travel clinic) patient said they felt lightheaded. Pharmacist waited a few minutes and also administered FLUARIX QUAD. Pt was offered water which she drank. Pt mentioned she hadn't had anything to eat and was offered a lollipop which she took. Pt then said her fingers were tingling. Pharmacist asked if she felt any itching, patient said no. Pharmacist inspected injection sites of both arms and there was no swelling or redness. Pharmacist asked patient to continue to remain seated for a few minutes. After pt finished lollipop she said she was feeling much better. Pharmacist asked if she could take her blood pressure. Patient consented. At 12:24P BP was 79/61 with a pulse of 60. She stated that that was about normal for her and that her blood pressure usually runs low. Pharmacist was reluctant to let patient leave but patient assured her she promised she was fine. Pharmacist asked for PCP name and said she would call them to let them know she had this reaction. Pharmacist called patient later about 2:24P and she stated she had "no issues whatsoever" but that she had never had this happen to her after a vaccination. Pharmacist called PCP and told nurse of event and she said she would place a note in the chart.
Age: 48.0
Sex: F
Vaccine: HEPA, TD
Symptoms: Contraindication to vaccination, Rubber sensitivity
Clinical narrative: Hepatitis A vaccine from a single dose pre-filled syringe was administered to the patient who has an allergy to latex.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, HEP, HEPA, MMRV
Symptoms: Blister, Injection site erythema, Injection site pruritus, Injection site swelling, Type III immune complex mediated reaction
Clinical narrative: 2/12/19 Saw Dr., right arm swelled, itchy and red up to the collarbone area, unsure if cellulitis or vaccine reaction so started on cephalexin. 2/14/19 Went to Hospital because now had blisters along with continued swelling, diagnosed with an Arthus reaction and antibiotics were stopped.
Age: 3.0
Sex: M
Vaccine: MMR
Symptoms: Aggression, Diarrhoea, Epistaxis, Pyrexia
Clinical narrative: Diarrhea 7 times on 02/12/2019, three nosebleeds from 02/12/2019-02/13/2019, extreme aggression on 2/13/2019, and fever of 101.2 on 2/14/2019.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Patient complained about redness and itching on injection site. Patient went to the doctor and got antibiotics for 5 days. Doctor advised patient to seek medical attention if symptoms worsen.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Patient experienced hives on stomach and back approx. 5 pm the next day. At 10 pm she spoke to pharmacist who advised to seek medical attn. and proceeded to ER. Placed on prednisone and sent home.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Pain in extremity, Pyrexia
Clinical narrative: Fever, chills, sore arm, headache.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: Patient got new SHINGRIX vaccine and within 4 hrs had injection site reaction with redness/soreness/swelling that grew in size with time over several weeks to months into a large (approx 4-5) red rash then bruise on arm where injection was given. Pt came into office 4 months later and still has bruising that is now resolving.
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous
Clinical narrative: Patient got new SHINGRIX vaccine and within 4 hrs had injection site reaction with redness/soreness/swelling that grew in size with time over several weeks to months into a large (approx 4-5) red rash then bruise on arm where injection was given. Pt came into office 4 months later and still has bruising that is now resolving.
Age: 14.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Eye movement disorder, Immediate post-injection reaction, Musculoskeletal stiffness, Nightmare
Clinical narrative: Immediately after receiving vaccine patient got up and walked to mom, fell into her arms. His arm around her neck, stiffened, eyes rolled back, loc x 5 seconds and then woke up and said "I had a bad dream". Vitals stable. Patient laid down for 15-20 minutes. Episode lasted 5 seconds and patient had normal mentation after monitored in office x 1/2 hour and d/c'd home w/ mom.
Age: 14.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Eye movement disorder, Fall, Immediate post-injection reaction, Loss of consciousness, Musculoskeletal stiffness
Clinical narrative: Immediately after receiving vaccine patient got up and walked to mom, fell into her arms. His arm around her neck, stiffened, eyes rolled back, loc x 5 seconds and then woke up and said "I had a bad dream". Vitals stable. Patient laid down for 15-20 minutes. Episode lasted 5 seconds and patient had normal mentation after monitored in office x 1/2 hour and d/c'd home w/ mom.
Age: 14.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Seizure like phenomena, Syncope
Clinical narrative: Immediately after receiving vaccine patient got up and walked to mom, fell into her arms. His arm around her neck, stiffened, eyes rolled back, loc x 5 seconds and then woke up and said "I had a bad dream". Vitals stable. Patient laid down for 15-20 minutes. Episode lasted 5 seconds and patient had normal mentation after monitored in office x 1/2 hour and d/c'd home w/ mom.
Age: 59.0
Sex: M
Vaccine: FLUX
Symptoms: Chest pain, Nasopharyngitis, Pain
Clinical narrative: Patient reported getting a flu shot and had side effects of chest pain, cold, body aches, he will postpone dosing by a week. No add'l information noted. Patient does not consent to be contacted.
Age: 18.0
Sex: M
Vaccine: HPV9
Symptoms: Dizziness, Dysstasia, Nausea, Presyncope, Vomiting
Clinical narrative: Patient was instructed to call the clinic if he became ill after the vaccine, he stated that he started "throwing up a few times and felt nauseated" several hours after he was vaccinated. I explained that this was normal. With additional probing he explained that he felt faint and had to hold onto something to stand up. Because this was vasovagal, I am completing this form. I am on the advisory committee for the immunization coalition. I feel it is important for the safe provision of vaccines that all staff need to be aware of the reporting requirements.
Age: 61.0
Sex: F
Vaccine: FLUX
Symptoms: Guillain-Barre syndrome, Immunoglobulin therapy
Clinical narrative: Initial information received on 08-Feb-2019 regarding an unsolicited valid serious case received from a consumer/non-HCP. This case involves a 61 years old female patient developed Guillain-Barre syndrome, while she received vaccine INFLUENZA VACCINE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were reported as none. On an unknown date, (reported as on either 08-Nov-2011 or 11-Nov-2011) the patient received a dose of suspect INFLUENZA VACCINE lot number not reported via unknown route in the arm nos. On an unknown date, the patient developed a serious Guillain-Barre syndrome (about 10 or 11 days later around 8:00pm at night) following the administration of INFLUENZA VACCINE. The patient was hospitalized for this event approximately on 20-Nov-2011. The patient was discharged on 15-Dec-2011 (hospitalization during 25 days). Other relevant tests not reported. Final diagnosis was Guillain-Barre syndrome. The patient was treated with IMMUNOGLOBULINS NOS (IMMUNOGLOBULIN I.V). The patient outcome was reported as unknown for Guillain-Barre syndrome. List of documents held by sender- none.; Sender's Comments: This case concerns a 61 years old female patient who developed Guillain-Barre syndrome after vaccination with INFLUENZA VACCINE. The time to onset was compatible. There are multiple possible etiologies of Guillain-Barre Syndrome and the causal relationship with the vaccine cannot be ascertained without ruling out the other causes of this event. Based upon the reported information, the role of the vaccine cannot be assessed.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular, Varicella zoster pneumonia
Clinical narrative: Information has been received on 05-FEB-2019 from a lawyer and a female patient regarding a case in litigation. The patient was inoculated with ZOSTAVAX (lot number and expiration not reported) in 2016 at a medical center, as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster, also known as shingles,  and other complication.s The patient was treated at a medical center for a blistering vesicular outbreak which was diagnosed as severe varicella pneumonia.  As a direct and proximate result of the vaccine ZOSTAVAX and/or despite receiving ZOSTAVAX for long term prevention of shingles,  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. Upon internal review, severe varicella pneumonia was considered to be a medically significant event. Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Bedridden, Chills, Influenza like illness, Malaise, Nausea
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of feeling unwell in a 55-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included Lyme disease (diagnosed 20 years ago). On 4th September 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 4th September 2018, 3 hrs after receiving SHINGRIX, the patient experienced feeling unwell, general body pain, influenza like illness, chills, bedridden and nausea. On an unknown date, the outcome of the feeling unwell, general body pain, influenza like illness, chills, bedridden and nausea were recovered/resolved. It was unknown if the reporter considered the feeling unwell, general body pain, influenza like illness, chills, bedridden and nausea to be related to SHINGRIX. Additional details were provided as follows: The patient got SHINGRIX and felt very sick afterwards. The patient was very painful all over, felt like she had the flu and could not get out of bed the next day. The patient got the vaccine on a Tuesday. Wednesday was the worst and the patient did not feel better until Sunday. The reporter gave consent to follow up.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of feeling unwell in a 55-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included Lyme disease (diagnosed 20 years ago). On 4th September 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 4th September 2018, 3 hrs after receiving SHINGRIX, the patient experienced feeling unwell, general body pain, influenza like illness, chills, bedridden and nausea. On an unknown date, the outcome of the feeling unwell, general body pain, influenza like illness, chills, bedridden and nausea were recovered/resolved. It was unknown if the reporter considered the feeling unwell, general body pain, influenza like illness, chills, bedridden and nausea to be related to SHINGRIX. Additional details were provided as follows: The patient got SHINGRIX and felt very sick afterwards. The patient was very painful all over, felt like she had the flu and could not get out of bed the next day. The patient got the vaccine on a Tuesday. Wednesday was the worst and the patient did not feel better until Sunday. The reporter gave consent to follow up.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Blood culture negative, Blood urea increased, Blood urea nitrogen/creatinine ratio increased, Cellulitis, Injection site erythema
Clinical narrative: This spontaneous report was received from a physician concerning a 69 year old female patient who was a nonsmoker. The patient was allergic to metronidazole benzoate (FLAGYL) I.V. (moderate), levofloxacin (LEVAQUIN) (moderate) and sulfamethoxazole (mild). On 06-DEC-2018, the patient was vaccinated with PNEUMOVAX 23 in the left anterior medial lateral arm for prophylaxis (dose number, dosing details, lot# and expiry date not reported). On the same day, the patient presented with pain and soreness in the arm but thought it was routine for vaccination. The pain was getting worse during the day and on 07-DEC-2018 morning. On 07-DEC-2018, at night, the patient looked at the arm after she took off the shirt because the pain was getting worse and noted redness ad some swelling from the injection site nearly down to the elbow. On the same day, the patient visited the emergency room for evaluation. The patient was diagnosed with cellulitis of left arm. X-ray of the patient's left humerus was done which were normal. The patient was prescribed amoxicillin, clavulanate potassium (AUGMENTIN) for cellulitis. The following test were also performed: Blood urea which was 25 mg/dL (blood urea increased), blood urea nitrogen/creatinine ratio which was 30.1 (blood urea nitrogen/creatinine ratio increased) and blood culture revealed no growth at 5 days. Outcome of cellulitis was recovering. Outcome of blood urea nitrogen/creatinine ratio increased, and blood urea increased was unknown. The reporter's causality assessment was not provided. Upon internal review, cellulitis was determined to be medically significant.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Pain in extremity, X-ray limb normal
Clinical narrative: This spontaneous report was received from a physician concerning a 69 year old female patient who was a nonsmoker. The patient was allergic to metronidazole benzoate (FLAGYL) I.V. (moderate), levofloxacin (LEVAQUIN) (moderate) and sulfamethoxazole (mild). On 06-DEC-2018, the patient was vaccinated with PNEUMOVAX 23 in the left anterior medial lateral arm for prophylaxis (dose number, dosing details, lot# and expiry date not reported). On the same day, the patient presented with pain and soreness in the arm but thought it was routine for vaccination. The pain was getting worse during the day and on 07-DEC-2018 morning. On 07-DEC-2018, at night, the patient looked at the arm after she took off the shirt because the pain was getting worse and noted redness ad some swelling from the injection site nearly down to the elbow. On the same day, the patient visited the emergency room for evaluation. The patient was diagnosed with cellulitis of left arm. X-ray of the patient's left humerus was done which were normal. The patient was prescribed amoxicillin, clavulanate potassium (AUGMENTIN) for cellulitis. The following test were also performed: Blood urea which was 25 mg/dL (blood urea increased), blood urea nitrogen/creatinine ratio which was 30.1 (blood urea nitrogen/creatinine ratio increased) and blood culture revealed no growth at 5 days. Outcome of cellulitis was recovering. Outcome of blood urea nitrogen/creatinine ratio increased, and blood urea increased was unknown. The reporter's causality assessment was not provided. Upon internal review, cellulitis was determined to be medically significant.
Age: 53.0
Sex: M
Vaccine: FLUC4, VARZOS, FLUC4, VARZOS
Symptoms: Chills, Injected limb mobility decreased, Injection site pain, Insomnia, Pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 53-year-old male patient who received SHINGRIX (batch number 5544H, expiry date 15th May 2021) for prophylaxis. Co-suspect products included FLUCELVAX (batch number 252684, expiry date 30th June 2019) for prophylaxis. Previously administered products included FLUCELVAX (received on an unknown date with no problems). On 26th December 2018, the patient received SHINGRIX (intramuscular) and FLUCELVAX (intramuscular). On 26th December 2018, less than a day after receiving SHINGRIX, the patient experienced fever, chills, injection site pain and labeled drug-drug interaction medication error. On an unknown date, the patient experienced muscle discomfort, injected limb mobility decreased and radiating pain. On an unknown date, the outcome of the fever and chills were recovered/resolved and the outcome of the injection site pain was not recovered/not resolved and the outcome of the muscle discomfort, injected limb mobility decreased, radiating pain and labeled drug-drug interaction medication error were unknown. It was unknown if the reporter considered the fever, chills, injection site pain, muscle discomfort, injected limb mobility decreased and radiating pain to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX and FLUCELVAX on the same arm on the same day, which led to labelled drug-drug interaction medication error. The patient had chills and fever the night of receiving SHINGRIX. He also had soreness at the injection site. The patient thought the soreness would go away, but it had only increased. The patient thought the pain locked up his muscle, he could not lift his arm as high as the other and the pain radiated down to his palm like he had carpal tunnel. It was unknown if the reporter considered the fever, chills, injection site pain, muscle discomfort, injected limb mobility decreased and radiating pain to be related to FLUCELVAX as well.
Age: 53.0
Sex: M
Vaccine: FLUC4, VARZOS, FLUC4, VARZOS
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 53-year-old male patient who received SHINGRIX (batch number 5544H, expiry date 15th May 2021) for prophylaxis. Co-suspect products included FLUCELVAX (batch number 252684, expiry date 30th June 2019) for prophylaxis. Previously administered products included FLUCELVAX (received on an unknown date with no problems). On 26th December 2018, the patient received SHINGRIX (intramuscular) and FLUCELVAX (intramuscular). On 26th December 2018, less than a day after receiving SHINGRIX, the patient experienced fever, chills, injection site pain and labeled drug-drug interaction medication error. On an unknown date, the patient experienced muscle discomfort, injected limb mobility decreased and radiating pain. On an unknown date, the outcome of the fever and chills were recovered/resolved and the outcome of the injection site pain was not recovered/not resolved and the outcome of the muscle discomfort, injected limb mobility decreased, radiating pain and labeled drug-drug interaction medication error were unknown. It was unknown if the reporter considered the fever, chills, injection site pain, muscle discomfort, injected limb mobility decreased and radiating pain to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX and FLUCELVAX on the same arm on the same day, which led to labelled drug-drug interaction medication error. The patient had chills and fever the night of receiving SHINGRIX. He also had soreness at the injection site. The patient thought the soreness would go away, but it had only increased. The patient thought the pain locked up his muscle, he could not lift his arm as high as the other and the pain radiated down to his palm like he had carpal tunnel. It was unknown if the reporter considered the fever, chills, injection site pain, muscle discomfort, injected limb mobility decreased and radiating pain to be related to FLUCELVAX as well.
Age: 53.0
Sex: M
Vaccine: FLUC4, VARZOS, FLUC4, VARZOS
Symptoms: Carpal tunnel syndrome, Chills, Injected limb mobility decreased, Injection site pain, Labelled drug-drug interaction medication error
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 53-year-old male patient who received SHINGRIX (batch number 5544H, expiry date 15th May 2021) for prophylaxis. Co-suspect products included FLUCELVAX (batch number 252684, expiry date 30th June 2019) for prophylaxis. Previously administered products included FLUCELVAX (received on an unknown date with no problems). On 26th December 2018, the patient received SHINGRIX (intramuscular) and FLUCELVAX (intramuscular). On 26th December 2018, less than a day after receiving SHINGRIX, the patient experienced fever, chills, injection site pain and labeled drug-drug interaction medication error. On an unknown date, the patient experienced muscle discomfort, injected limb mobility decreased and radiating pain. On an unknown date, the outcome of the fever and chills were recovered/resolved and the outcome of the injection site pain was not recovered/not resolved and the outcome of the muscle discomfort, injected limb mobility decreased, radiating pain and labeled drug-drug interaction medication error were unknown. It was unknown if the reporter considered the fever, chills, injection site pain, muscle discomfort, injected limb mobility decreased and radiating pain to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX and FLUCELVAX on the same arm on the same day, which led to labelled drug-drug interaction medication error. The patient had chills and fever the night of receiving SHINGRIX. He also had soreness at the injection site. The patient thought the soreness would go away, but it had only increased. The patient thought the pain locked up his muscle, he could not lift his arm as high as the other and the pain radiated down to his palm like he had carpal tunnel. It was unknown if the reporter considered the fever, chills, injection site pain, muscle discomfort, injected limb mobility decreased and radiating pain to be related to FLUCELVAX as well.
Age: 53.0
Sex: M
Vaccine: FLUC4, VARZOS, FLUC4, VARZOS
Symptoms: Musculoskeletal discomfort, Pain, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 53-year-old male patient who received SHINGRIX (batch number 5544H, expiry date 15th May 2021) for prophylaxis. Co-suspect products included FLUCELVAX (batch number 252684, expiry date 30th June 2019) for prophylaxis. Previously administered products included FLUCELVAX (received on an unknown date with no problems). On 26th December 2018, the patient received SHINGRIX (intramuscular) and FLUCELVAX (intramuscular). On 26th December 2018, less than a day after receiving SHINGRIX, the patient experienced fever, chills, injection site pain and labeled drug-drug interaction medication error. On an unknown date, the patient experienced muscle discomfort, injected limb mobility decreased and radiating pain. On an unknown date, the outcome of the fever and chills were recovered/resolved and the outcome of the injection site pain was not recovered/not resolved and the outcome of the muscle discomfort, injected limb mobility decreased, radiating pain and labeled drug-drug interaction medication error were unknown. It was unknown if the reporter considered the fever, chills, injection site pain, muscle discomfort, injected limb mobility decreased and radiating pain to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX and FLUCELVAX on the same arm on the same day, which led to labelled drug-drug interaction medication error. The patient had chills and fever the night of receiving SHINGRIX. He also had soreness at the injection site. The patient thought the soreness would go away, but it had only increased. The patient thought the pain locked up his muscle, he could not lift his arm as high as the other and the pain radiated down to his palm like he had carpal tunnel. It was unknown if the reporter considered the fever, chills, injection site pain, muscle discomfort, injected limb mobility decreased and radiating pain to be related to FLUCELVAX as well.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site discolouration, Injection site inflammation, Injection site pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 70-year-old female patient who received SHINGRIX (batch number G45LN, expiry date 13th March 2021) and (batch number 5S34K, expiry date 13th March 2021) for prophylaxis.  On 28th November 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, the dose was an unknown dose. On 28th November 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain and injection site inflammation. On an unknown date, the patient experienced injection site discoloration. On an unknown date, the outcome of the injection site pain and injection site inflammation were recovered/resolved and the outcome of the injection site discoloration was not recovered/not resolved. It was unknown if the reporter considered the injection site pain, injection site inflammation and injection site discoloration to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on left arm. The batch number of SHINGRIX adjuvant was reported as 5534K, which was changed to 5S34K as per sales data sheet. Less than a year after receiving SHINGRIX, the patient experienced long term discoloration at the injection site. The pharmacist reported that the appearance was similar to an age spot but lighter. The reporter did not consent to follow-up.
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Asthenia, Fatigue, Gait inability, Immediate post-injection reaction
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of joint pain in a 55-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included ligament injury. Previously administered products included SHINGRIX with an associated reaction of chills (1st dose received on an unknown date). On 3rd February 2019, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. In February 2019, less than a week after receiving SHINGRIX, the patient experienced joint pain, chills, fever, general body pain, injection site pain, injection site erythema, injection site induration, injection site warmth, injection site swelling, influenza-like symptoms and exhaustion. The patient was treated with diclofenac sodium (Voltaren (Diclofenac Sodium)) and arnica tincture (Arnica). Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the joint pain, chills, fever, general body pain, influenza-like symptoms and exhaustion were recovered/resolved and the outcome of the injection site pain, injection site erythema, injection site induration, injection site warmth and injection site swelling were not recovered/not resolved. It was unknown if the reporter considered the joint pain, chills, fever, general body pain, injection site pain, injection site erythema, injection site induration, injection site warmth, injection site swelling, influenza-like symptoms and exhaustion to be related to SHINGRIX. Additional details were provided as follows: The batch number for SHINGRIX was not reported. The patient experienced bad chills, slight fever and body aches similarly which she experienced after receiving 1st dose of SHINGRIX. Additionally the patient experienced strong pain in joints and an old ligament injury and told that the side effects were worse with 2nd dose of SHINGRIX than the last time and was curious how long would they last. The patient experienced pain at the injection site, red at the injection site, the injection site was raised, hard at the injection site, hot to the touch at the injection site and burning at the injection site. The injection site was raised 90 mm wide. The patient also said that she had to stay in bed for two days because she was exhausted, had flu like symptoms, chills, fever and body aches.  On the day of reporting, the patient felt better and was able to leave her home, however, the reaction that she experienced at the injection site were pretty much intact after 3 days of having the injection and it was extremely painful at the injection site. The patient received treatment with Voltaren cream, arnica, topical pain products but nothing helped. The patient said that she did not have any physician.
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site warmth, Ligament pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of joint pain in a 55-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included ligament injury. Previously administered products included SHINGRIX with an associated reaction of chills (1st dose received on an unknown date). On 3rd February 2019, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. In February 2019, less than a week after receiving SHINGRIX, the patient experienced joint pain, chills, fever, general body pain, injection site pain, injection site erythema, injection site induration, injection site warmth, injection site swelling, influenza-like symptoms and exhaustion. The patient was treated with diclofenac sodium (Voltaren (Diclofenac Sodium)) and arnica tincture (Arnica). Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the joint pain, chills, fever, general body pain, influenza-like symptoms and exhaustion were recovered/resolved and the outcome of the injection site pain, injection site erythema, injection site induration, injection site warmth and injection site swelling were not recovered/not resolved. It was unknown if the reporter considered the joint pain, chills, fever, general body pain, injection site pain, injection site erythema, injection site induration, injection site warmth, injection site swelling, influenza-like symptoms and exhaustion to be related to SHINGRIX. Additional details were provided as follows: The batch number for SHINGRIX was not reported. The patient experienced bad chills, slight fever and body aches similarly which she experienced after receiving 1st dose of SHINGRIX. Additionally the patient experienced strong pain in joints and an old ligament injury and told that the side effects were worse with 2nd dose of SHINGRIX than the last time and was curious how long would they last. The patient experienced pain at the injection site, red at the injection site, the injection site was raised, hard at the injection site, hot to the touch at the injection site and burning at the injection site. The injection site was raised 90 mm wide. The patient also said that she had to stay in bed for two days because she was exhausted, had flu like symptoms, chills, fever and body aches.  On the day of reporting, the patient felt better and was able to leave her home, however, the reaction that she experienced at the injection site were pretty much intact after 3 days of having the injection and it was extremely painful at the injection site. The patient received treatment with Voltaren cream, arnica, topical pain products but nothing helped. The patient said that she did not have any physician.
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Loss of personal independence in daily activities, Muscular weakness, Myalgia, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of joint pain in a 55-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included ligament injury. Previously administered products included SHINGRIX with an associated reaction of chills (1st dose received on an unknown date). On 3rd February 2019, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. In February 2019, less than a week after receiving SHINGRIX, the patient experienced joint pain, chills, fever, general body pain, injection site pain, injection site erythema, injection site induration, injection site warmth, injection site swelling, influenza-like symptoms and exhaustion. The patient was treated with diclofenac sodium (Voltaren (Diclofenac Sodium)) and arnica tincture (Arnica). Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the joint pain, chills, fever, general body pain, influenza-like symptoms and exhaustion were recovered/resolved and the outcome of the injection site pain, injection site erythema, injection site induration, injection site warmth and injection site swelling were not recovered/not resolved. It was unknown if the reporter considered the joint pain, chills, fever, general body pain, injection site pain, injection site erythema, injection site induration, injection site warmth, injection site swelling, influenza-like symptoms and exhaustion to be related to SHINGRIX. Additional details were provided as follows: The batch number for SHINGRIX was not reported. The patient experienced bad chills, slight fever and body aches similarly which she experienced after receiving 1st dose of SHINGRIX. Additionally the patient experienced strong pain in joints and an old ligament injury and told that the side effects were worse with 2nd dose of SHINGRIX than the last time and was curious how long would they last. The patient experienced pain at the injection site, red at the injection site, the injection site was raised, hard at the injection site, hot to the touch at the injection site and burning at the injection site. The injection site was raised 90 mm wide. The patient also said that she had to stay in bed for two days because she was exhausted, had flu like symptoms, chills, fever and body aches.  On the day of reporting, the patient felt better and was able to leave her home, however, the reaction that she experienced at the injection site were pretty much intact after 3 days of having the injection and it was extremely painful at the injection site. The patient received treatment with Voltaren cream, arnica, topical pain products but nothing helped. The patient said that she did not have any physician.
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Chills, Fatigue, Influenza like illness, Injection site erythema
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of joint pain in a 55-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included ligament injury. Previously administered products included SHINGRIX with an associated reaction of chills (1st dose received on an unknown date). On 3rd February 2019, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. In February 2019, less than a week after receiving SHINGRIX, the patient experienced joint pain, chills, fever, general body pain, injection site pain, injection site erythema, injection site induration, injection site warmth, injection site swelling, influenza-like symptoms and exhaustion. The patient was treated with diclofenac sodium (Voltaren (Diclofenac Sodium)) and arnica tincture (Arnica). Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the joint pain, chills, fever, general body pain, influenza-like symptoms and exhaustion were recovered/resolved and the outcome of the injection site pain, injection site erythema, injection site induration, injection site warmth and injection site swelling were not recovered/not resolved. It was unknown if the reporter considered the joint pain, chills, fever, general body pain, injection site pain, injection site erythema, injection site induration, injection site warmth, injection site swelling, influenza-like symptoms and exhaustion to be related to SHINGRIX. Additional details were provided as follows: The batch number for SHINGRIX was not reported. The patient experienced bad chills, slight fever and body aches similarly which she experienced after receiving 1st dose of SHINGRIX. Additionally the patient experienced strong pain in joints and an old ligament injury and told that the side effects were worse with 2nd dose of SHINGRIX than the last time and was curious how long would they last. The patient experienced pain at the injection site, red at the injection site, the injection site was raised, hard at the injection site, hot to the touch at the injection site and burning at the injection site. The injection site was raised 90 mm wide. The patient also said that she had to stay in bed for two days because she was exhausted, had flu like symptoms, chills, fever and body aches.  On the day of reporting, the patient felt better and was able to leave her home, however, the reaction that she experienced at the injection site were pretty much intact after 3 days of having the injection and it was extremely painful at the injection site. The patient received treatment with Voltaren cream, arnica, topical pain products but nothing helped. The patient said that she did not have any physician.
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site induration, Injection site pain, Injection site swelling, Injection site warmth, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of joint pain in a 55-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included ligament injury. Previously administered products included SHINGRIX with an associated reaction of chills (1st dose received on an unknown date). On 3rd February 2019, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. In February 2019, less than a week after receiving SHINGRIX, the patient experienced joint pain, chills, fever, general body pain, injection site pain, injection site erythema, injection site induration, injection site warmth, injection site swelling, influenza-like symptoms and exhaustion. The patient was treated with diclofenac sodium (Voltaren (Diclofenac Sodium)) and arnica tincture (Arnica). Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the joint pain, chills, fever, general body pain, influenza-like symptoms and exhaustion were recovered/resolved and the outcome of the injection site pain, injection site erythema, injection site induration, injection site warmth and injection site swelling were not recovered/not resolved. It was unknown if the reporter considered the joint pain, chills, fever, general body pain, injection site pain, injection site erythema, injection site induration, injection site warmth, injection site swelling, influenza-like symptoms and exhaustion to be related to SHINGRIX. Additional details were provided as follows: The batch number for SHINGRIX was not reported. The patient experienced bad chills, slight fever and body aches similarly which she experienced after receiving 1st dose of SHINGRIX. Additionally the patient experienced strong pain in joints and an old ligament injury and told that the side effects were worse with 2nd dose of SHINGRIX than the last time and was curious how long would they last. The patient experienced pain at the injection site, red at the injection site, the injection site was raised, hard at the injection site, hot to the touch at the injection site and burning at the injection site. The injection site was raised 90 mm wide. The patient also said that she had to stay in bed for two days because she was exhausted, had flu like symptoms, chills, fever and body aches.  On the day of reporting, the patient felt better and was able to leave her home, however, the reaction that she experienced at the injection site were pretty much intact after 3 days of having the injection and it was extremely painful at the injection site. The patient received treatment with Voltaren cream, arnica, topical pain products but nothing helped. The patient said that she did not have any physician.
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia, Vaccine positive rechallenge
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of joint pain in a 55-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included ligament injury. Previously administered products included SHINGRIX with an associated reaction of chills (1st dose received on an unknown date). On 3rd February 2019, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. In February 2019, less than a week after receiving SHINGRIX, the patient experienced joint pain, chills, fever, general body pain, injection site pain, injection site erythema, injection site induration, injection site warmth, injection site swelling, influenza-like symptoms and exhaustion. The patient was treated with diclofenac sodium (Voltaren (Diclofenac Sodium)) and arnica tincture (Arnica). Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the joint pain, chills, fever, general body pain, influenza-like symptoms and exhaustion were recovered/resolved and the outcome of the injection site pain, injection site erythema, injection site induration, injection site warmth and injection site swelling were not recovered/not resolved. It was unknown if the reporter considered the joint pain, chills, fever, general body pain, injection site pain, injection site erythema, injection site induration, injection site warmth, injection site swelling, influenza-like symptoms and exhaustion to be related to SHINGRIX. Additional details were provided as follows: The batch number for SHINGRIX was not reported. The patient experienced bad chills, slight fever and body aches similarly which she experienced after receiving 1st dose of SHINGRIX. Additionally the patient experienced strong pain in joints and an old ligament injury and told that the side effects were worse with 2nd dose of SHINGRIX than the last time and was curious how long would they last. The patient experienced pain at the injection site, red at the injection site, the injection site was raised, hard at the injection site, hot to the touch at the injection site and burning at the injection site. The injection site was raised 90 mm wide. The patient also said that she had to stay in bed for two days because she was exhausted, had flu like symptoms, chills, fever and body aches.  On the day of reporting, the patient felt better and was able to leave her home, however, the reaction that she experienced at the injection site were pretty much intact after 3 days of having the injection and it was extremely painful at the injection site. The patient received treatment with Voltaren cream, arnica, topical pain products but nothing helped. The patient said that she did not have any physician.
Age: 15.0
Sex: M
Vaccine: HPV9
Symptoms: Injection site mass, Pain in extremity
Clinical narrative: Arm very sore, hurts. Lump at injection site.
Age: 66.0
Sex: M
Vaccine: PNC13
Symptoms: Axillary pain, Injection site cellulitis, Injection site erythema, Injection site swelling, Malaise
Clinical narrative: Redness and swelling at injection site with line of cellulitis near injection site. Pain in arm and under arm. Overall feeling of malaise.
Age: 66.0
Sex: M
Vaccine: PNC13
Symptoms: Pain in extremity
Clinical narrative: Redness and swelling at injection site with line of cellulitis near injection site. Pain in arm and under arm. Overall feeling of malaise.
Age: 4.0
Sex: F
Vaccine: UNK
Symptoms: Rash
Clinical narrative: Daughter has rash on leg following vaccine.
Age: 79.0
Sex: M
Vaccine: FLUC4
Symptoms: Gait disturbance, Mobility decreased, Muscular weakness, Myalgia
Clinical narrative: Patient reported severe muscle pain and weakness in his legs making it difficult to walk. He reported to a local ER with his spouse who said he wouldn't get out of the car due to his inability to move his legs.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to two patients of unknown age and gender. Information regarding the patients' pertinent medical history, concurrent conditions, concomitant and historical drugs was not provided. On an unknown date, the patients were vaccinated with improperly stored doses of ROTATEQ orally, lot # R002521, expiration date 18-SEP-2019 (dose was not provided) for prophylaxis. The vaccines were exposed to a temperature from 9°C to 25°C for 1 hour and 20 minutes. It was reported that digital data logger was involved. No adverse effects were reported. Follow-up information was received from a nurse on 08-FEB-2019. The two patients received the improperly stored doses of ROTATEQ on an unspecified date in December 2018. The vaccines were exposed to a total and highest previous temperature excursion above 9 °C for 2 hours and 20 minutes. On an unspecified date in November and December 2018, vaccines were exposed to temperatures excursion of 10.8 °C for 1 hour and 20 minutes and 11.5 °C for 1 hour, respectively. This is a non-valid case due to the lack of patient's identifiers.