chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: C-reactive protein increased, Immediate post-injection reaction, Injection site pain, White blood cell count increased
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of injection site pain in a 73-year-old male patient who received SHINGRIX. Concomitant products included Aspirin, LIPITOR, NORVASC and hydrochlorothiazide. On 16th April 2018, the patient received the 1st dose of SHINGRIX .5 ml. In April 2018, 20 hrs after receiving SHINGRIX, the patient experienced white blood cell count increased and C-reactive protein increased. On 16th April 2018, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovering/resolving and the outcome of the white blood cell count increased and C-reactive protein increased were unknown. The reporter considered the injection site pain to be related to SHINGRIX. The reporter considered the white blood cell count increased and C-reactive protein increased to be possibly related to SHINGRIX. Additional details were provided as follows: The reporting physician was himself the patient. It was reported that immediately after vaccination the patient experienced pain at injection site (right arm) that he described as mild to moderate local pain. The pain had gotten better and arm was still sore now 3 days later. The patient had blood labs drawn approximately 20 hours after the injection for his annual physical and noted C-reactive protein elevated and slightly elevated white blood cell count. The patient was responsible prescriber for his own SHINGRIX prescription.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Injection site erythema, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 68-year-old male patient who received SHINGRIX (batch number B5EK2, expiry date 28th April 2020). On 14th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 15th April 2018, 1 days after receiving SHINGRIX, the patient experienced fever, injection site erythema and chills. On 17th April 2018, the outcome of the fever and chills were recovered/resolved. On an unknown date, the outcome of the injection site erythema was recovering/resolving. The reporter considered the fever, injection site erythema and chills to be probably related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX vaccine on left deltoid on 14th April 2018 at 11:27. The health care professional reported that patient received their first dose of SHINGRIX and the next day experienced fever and chills that lasted for 2 days then resolved. Additionally, he developed a red spot (size is about the size of a half dollar) about an inch below the injection site the day after he was administered SHINGRIX. It was getting better but has not yet resolved.
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Injection site hyperaesthesia, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of tiredness in a adult male patient who received SHINGRIX. Concomitant products included allopurinol. On 13th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 13th April 2018, less than a day after receiving SHINGRIX, the patient experienced tiredness, injection site hyperesthesia and pain in arm. On an unknown date, the outcome of the tiredness, injection site hyperesthesia and pain in arm were recovered/resolved. It was unknown if the reporter considered the tiredness, injection site hyperesthesia and pain in arm to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on left arm. The patient reported that he felt little tired within hours of receiving the SHINGRIX vaccine. The patient's arm was sore (less than a day after vaccination) and it resolved within two days. The patient also experienced some sensitivity at the injection site (less than a day after vaccination). The patient had denied permission to contact their physician.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Arthralgia, Chills, Hyperhidrosis, Insomnia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of sleeplessness in a 71-year-old male patient who received SHINGRIX. Concomitant products included venlafaxine, hydrochlorothiazide and Lisinopril. On 18th April 2018 10:00, the patient received the 1st dose of SHINGRIX (intramuscular). On 18th April 2018, less than a day after receiving SHINGRIX, the patient experienced sleeplessness, sweating, joint pain, shivering, upset stomach and muscle pain. The patient was treated with ibuprofen. On an unknown date, the outcome of the sleeplessness, sweating, joint pain, shivering, upset stomach and muscle pain were recovering/resolving. The reporter considered the sleeplessness, sweating, joint pain, shivering, upset stomach and muscle pain to be probably related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX vaccine on the right arm. The patient was unable to sleep after vaccination.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of sleeplessness in a 71-year-old male patient who received SHINGRIX. Concomitant products included venlafaxine, hydrochlorothiazide and Lisinopril. On 18th April 2018 10:00, the patient received the 1st dose of SHINGRIX (intramuscular). On 18th April 2018, less than a day after receiving SHINGRIX, the patient experienced sleeplessness, sweating, joint pain, shivering, upset stomach and muscle pain. The patient was treated with ibuprofen. On an unknown date, the outcome of the sleeplessness, sweating, joint pain, shivering, upset stomach and muscle pain were recovering/resolving. The reporter considered the sleeplessness, sweating, joint pain, shivering, upset stomach and muscle pain to be probably related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX vaccine on the right arm. The patient was unable to sleep after vaccination.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 74-year-old female patient who received SHINGRIX (batch number 3Z4KL, expiry date 31st January 2020). Concomitant products included carvedilol, Furosemide, omeprazole, latanoprost, Oxybutynin Chloride and SYNTHROID. On 6th April 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 6th April 2018, immediately after receiving SHINGRIX, the patient experienced injection site pain, injection site swelling and injection site itching. In April 2018, the outcome of the injection site pain, injection site swelling and injection site itching were recovered/resolved. The reporter considered the injection site pain, injection site swelling and injection site itching to be related to SHINGRIX. Additional details were provided as follows: Concomitant medication included Latanoprost eye drops. At 2:30 pm, the patient received SHINGRIX on the right arm. Less than a day after vaccination, the patient experienced swelling and itching at the injection site. The events lasted for 10 days.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash macular
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of erythromacular rash in a 67-year-old male patient who received SHINGRIX (batch number C523T, expiry date 30th April 2019). On 14th April 2018, the patient received SHINGRIX .5 ml. On an unknown date, the dose was an unknown dose. On 14th April 2018, 5 hrs after receiving SHINGRIX, the patient experienced erythromacular rash. On an unknown date, the outcome of the erythromacular rash was not recovered/not resolved. It was unknown if the reporter considered the erythromacular rash to be related to SHINGRIX. Additional details reported as follows: The patient experienced a few red spots on his lower abdomen and a few on one leg. The reporter did not know which leg. The reporter did not know the site of injection. The reporter neglected to ask for patient initials.
Sex: M
Vaccine: VARZOS
Symptoms: Blood creatine phosphokinase increased, Erythema, White blood cell count increased
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of creatine phosphokinase increased in a male patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced creatine phosphokinase increased, erythema of extremities and increased white cell count. On an unknown date, the outcome of the creatine phosphokinase increased, erythema of extremities and increased white cell count were unknown. It was unknown if the reporter considered the creatine phosphokinase increased, erythema of extremities and increased white cell count to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the healthcare professional who himself was the patient. The health care professional reported that he experienced an increase in creatine phosphokinase (CPK) and white cell count as well as redness on his arm after receiving SHINGRIX. No additional information could be obtained because the health care professional had patients he had to see and appeared frustrated that he was on hold for so long in attempt to reach someone in medical information. The health care professional hung up abruptly.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site bruising in a 78-year-old female patient who received SHINGRIX (batch number 9XC39, expiry date 30th January 2020). On 16th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In April 2018, less than a week after receiving SHINGRIX, the patient experienced injection site bruising. On an unknown date, the outcome of the injection site bruising was not recovered/not resolved. It was unknown if the reporter considered the injection site bruising to be related to SHINGRIX. Additional details were provided as follows: The patient had the vaccine on Monday and she came into the pharmacy that morning with a large bruise at the site of injection. It was not prescribed by a doctor but her doctor expressed his wishes for her to be vaccinated. When asked about causality, there was no answer but he began to ask other questions and seemed confused by the question so I left it unanswered but clearly he thought it was caused by the vaccination.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a 61-year-old female patient who received SHINGRIX. On 14th March 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 16th March 2018, 2 days after receiving SHINGRIX, the patient experienced injection site swelling, injection site warmth, pain and injection site erythema. In March 2018, the outcome of the injection site swelling, injection site warmth and injection site erythema were recovered/resolved. On an unknown date, the outcome of the pain was unknown. The reporter considered the injection site swelling, injection site warmth, pain and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The reporter had a consumer that received the SHINGRIX vaccine approximately one month before the date of reporting. The patient was achy and the injection site was swollen, red, and warm. The next day the patient reported that the injection reaction had enlarged and was two inches in diameter. It resolved the next day. The reporter was unable to provide additional information at the time of the call. This case has been linked with US2018068916, reported by the same reporter.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Product quality issue
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 76-year-old male patient who received SHINGRIX (batch number HG4P3, expiry date 13th July 2020). On 31st January 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, 61 days after receiving SHINGRIX, the patient experienced shingles and pharmaceutical product complaint. On an unknown date, the outcome of the shingles and pharmaceutical product complaint were unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional information was received as follows: The patient's doctor reached out to the pharmacy to report patient's adverse event. This case was associated with product complaint, as the patient felt that the lot was defective. The patient received SHINGRIX on left deltoid. The patient got a full blown case of shingles.
Age: 86.0
Sex: M
Vaccine: VARZOS
Symptoms: Diarrhoea, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 86-year-old male patient who received SHINGRIX. Concomitant products included Metformin, Rosuvastatin, amiodarone, CENTRUM Vitamins, ELIQUIS, JANUVIA, Insulin (Long Acting), Insulin Short Acting and metoprolol. On 10th April 2018, the patient received the 1st dose of SHINGRIX. On 13th April 2018, 3 days after receiving SHINGRIX, the patient experienced diarrhea. In April 2018, the patient experienced pain in arm. In April 2018, the outcome of the pain in arm and diarrhea were recovered/resolved. It was unknown if the reporter considered the pain in arm and diarrhea to be related to SHINGRIX. Additional details were provided as follows: The daughter reported that her father (patient) received the SHINGRIX vaccine and experienced a sore arm. The patient received SHINGRIX in the unknown arm.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse drug reaction
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of adverse drug reaction in a adult patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced adverse drug reaction. On an unknown date, the outcome of the adverse drug reaction was unknown. Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that they had a patient at their store who experienced a severe reaction, but did not provide further details while on the phone.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope, Urinary incontinence
Clinical narrative: Syncope w/urinary incontinence approximately 5 minutes after HPV vaccine.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse drug reaction
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of adverse drug reaction in a adult patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced adverse drug reaction. On an unknown date, the outcome of the adverse drug reaction was unknown. It was unknown if the reporter considered the adverse drug reaction to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The reporter reported that the patient experienced more adverse reactions to SHINGRIX than expected.
Sex: U
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Abdominal pain, Herpes zoster, Pruritus, Rash
Clinical narrative: This case was reported by a consumer and described the occurrence of shingles in a patient who received SHINGRIX. On 9th April 2018, the patient received the 1st dose of SHINGRIX. On 9th April 2018, less than a day after receiving SHIGRIX, the patient experienced abdominal pain. In April 2018, the patient experienced shingles. On 17th April 2018, the patient experienced rash. On an unknown date, the outcome of the shingles, rash and abdominal pain were unknown . It was unknown if the reporter considered the shingles, rash and abdominal pain to be related to SHINGRIX. Additional information was received as follows: The age at vaccination was not reported. The patient experienced abdominal pain near the surface of skin within a day or two. On 17th April 2018, the rashes began to appear. The patient's physician diagnosed it as Shingles and prescribed steroids. The patient had passed this information to FDA (Food Drug and Administration) and CDC (Center for Disease Control and Prevention) as well.
Sex: U
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Abdominal pain, Herpes zoster, Rash
Clinical narrative: This case was reported by a consumer and described the occurrence of shingles in a patient who received SHINGRIX. On 9th April 2018, the patient received the 1st dose of SHINGRIX. On 9th April 2018, less than a day after receiving SHIGRIX, the patient experienced abdominal pain. In April 2018, the patient experienced shingles. On 17th April 2018, the patient experienced rash. On an unknown date, the outcome of the shingles, rash and abdominal pain were unknown . It was unknown if the reporter considered the shingles, rash and abdominal pain to be related to SHINGRIX. Additional information was received as follows: The age at vaccination was not reported. The patient experienced abdominal pain near the surface of skin within a day or two. On 17th April 2018, the rashes began to appear. The patient's physician diagnosed it as Shingles and prescribed steroids. The patient had passed this information to FDA (Food Drug and Administration) and CDC (Center for Disease Control and Prevention) as well.
Sex: U
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a consumer and described the occurrence of shingles in a patient who received SHINGRIX. On 9th April 2018, the patient received the 1st dose of SHINGRIX. On 9th April 2018, less than a day after receiving SHIGRIX, the patient experienced abdominal pain. In April 2018, the patient experienced shingles. On 17th April 2018, the patient experienced rash. On an unknown date, the outcome of the shingles, rash and abdominal pain were unknown . It was unknown if the reporter considered the shingles, rash and abdominal pain to be related to SHINGRIX. Additional information was received as follows: The age at vaccination was not reported. The patient experienced abdominal pain near the surface of skin within a day or two. On 17th April 2018, the rashes began to appear. The patient's physician diagnosed it as Shingles and prescribed steroids. The patient had passed this information to FDA (Food Drug and Administration) and CDC (Center for Disease Control and Prevention) as well.
Age: 70.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Feeling abnormal, Myalgia, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of muscle pain in a 70-year-old male patient who received SHINGRIX (batch number B5EK2, expiry date 28th April 2020). On 12th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In April 2018, less than a month after receiving SHINGRIX, the patient experienced muscle pain, hallucination and chills. On an unknown date, the outcome of the muscle pain, hallucination and chills were recovered/resolved. The reporter considered the muscle pain, hallucination and chills to be probably related to SHINGRIX. Additional information was received as follows: The patient spent a lot of time on the couch due to adverse event.
Age: 70.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Hallucination, Myalgia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of muscle pain in a 70-year-old male patient who received SHINGRIX (batch number B5EK2, expiry date 28th April 2020). On 12th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In April 2018, less than a month after receiving SHINGRIX, the patient experienced muscle pain, hallucination and chills. On an unknown date, the outcome of the muscle pain, hallucination and chills were recovered/resolved. The reporter considered the muscle pain, hallucination and chills to be probably related to SHINGRIX. Additional information was received as follows: The patient spent a lot of time on the couch due to adverse event.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Myalgia, Pain in extremity, Pyrexia
Clinical narrative: Severe pain in arm that was injected. Fever. Muscle aches. Headache. General feeling of fatigue.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Muscular weakness, Pain in extremity, Protein urine present
Clinical narrative: Arm weakness ache that started right away after receiving flu vaccine. Lasted for a few months and then affected right arm. Had PE and protein in urine a few months later. I believe this set off a response due to flu vaccine.
Sex: M
Vaccine: MMR
Symptoms: Antibody test negative
Clinical narrative: This spontaneous report was received from an administrator, who was also a medical assistant and refers to a male patient of unknown age, starting medical school. No information about the patient's pertinent medical history, concomitant medications, drug reactions and allergies was provided. On an unknown date, when the patient was a child, he was vaccinated with 2 doses of M-M-R II (exact dose, route of administration, lot# and expiration date were not reported). On an unknown date, the patient had an unspecified test and the results showed low titre levels. The patient sought medical attention. The outcome of the event was reported as not recovered/not resolved. The causality assessment was not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 06-APR-2018, the patient was vaccinated with a dose of expired ZOSTAVAX subcutaneous injection, lot # M038350, expiration date 06-DEC-2017 (exact dose and route of administration were not reported). The vaccine was reconstituted with sterile diluent. It was reported that both ZOSTAVAX and sterile diluent were properly stored. No adverse effects were reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. Information on pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 16-APR-2018, the patient was vaccinated with improperly stored PROQUAD (therapy type: rHA) (strength, dose and route of administration were not reported) (lot # N025926, expiry date: 18-MAR-2019) for prophylaxis. The vaccines were reconstituted with properly stored sterile diluent (manufacturer unknown) (lot # and expiry date were not reported). The vaccines were exposed to a temperature of 47 degree Fahrenheit (F) to 77 F for 53 minutes. The prior temperature excursion was from 47 F to 77 F for 45 minutes. The digital data logger was involved in recording the temperature excursion. No adverse effects were reported. No further details were provided. No product quality complaint (PQC) was involved.
Age: 65.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Diarrhoea, Injection site erythema, Injection site swelling, Injection site warmth, Malaise
Clinical narrative: This spontaneous report was received from a consumer (patient's wife) referring to a 65 year old male patient. The patient's had triple heart bypass surgery, in the 1980s he had a staph infection in the same arm and had shingles 10-15 years ago. On an unknown date in 2005 (13 years ago), the patient had PREVNAR. Concomitant therapies includes VYTORIN, JARDIANCE, metformin, TOPROL, lisinopril and gabapentin. Information on drug reactions/allergies was reported as none. On 11-APR-2018, the patient was vaccinated with PNEUMOVAX 23 1 injection (strength, dose, lot # and expiry were not reported) and ZOSTAVAX 1 injection (strength, dose, lot # and expiry were not reported), at the same time in the same arm for prophylaxis. On 12-APR-2018 (reported as the next day), the patient did not feel well, was nauseous and complained of pain in the arm where the vaccines were administered. On 12-APR-2018 (that same day), the patient developed diarrhoea and the injection site arm became "bright red and boiling hot" to the touch. On 13-APR-2018 (reported as by Friday), the nausea and diarrhoea had stopped but the swelling in his arm extended from the injection sight to his elbow. On 13-APR-2018 (reported as that day), the patient contacted the clinic where the vaccines were administered and asked for help. An unspecified physician recommended to take BENADRYL. The patient took unspecified dose/intervals of BENADRYL and also loratadine. On 14-APR-2018 (reported as by Saturday afternoon), the swelling in the patient's arm began to decrease. At the time of the call, the reporter said that the patient's arm was pink at the injection site and still "painful but not as bad" as it was. Lab diagnostics/studies was not performed. The patient sought medical attention for the events. The outcome of malaise, vaccination site swelling, vaccination site warmth, vaccination site erythema and vaccination site pain were reported as recovering/resolving. On 13-APR-2018, the outcome of nausea and diarrhoea were recovered/resolved. Causality assessment was not reported. No further adverse event information was provided. There was no product quality complaint (PQC) reported.
Age: 65.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Nausea, Vaccination site pain
Clinical narrative: This spontaneous report was received from a consumer (patient's wife) referring to a 65 year old male patient. The patient's had triple heart bypass surgery, in the 1980s he had a staph infection in the same arm and had shingles 10-15 years ago. On an unknown date in 2005 (13 years ago), the patient had PREVNAR. Concomitant therapies includes VYTORIN, JARDIANCE, metformin, TOPROL, lisinopril and gabapentin. Information on drug reactions/allergies was reported as none. On 11-APR-2018, the patient was vaccinated with PNEUMOVAX 23 1 injection (strength, dose, lot # and expiry were not reported) and ZOSTAVAX 1 injection (strength, dose, lot # and expiry were not reported), at the same time in the same arm for prophylaxis. On 12-APR-2018 (reported as the next day), the patient did not feel well, was nauseous and complained of pain in the arm where the vaccines were administered. On 12-APR-2018 (that same day), the patient developed diarrhoea and the injection site arm became "bright red and boiling hot" to the touch. On 13-APR-2018 (reported as by Friday), the nausea and diarrhoea had stopped but the swelling in his arm extended from the injection sight to his elbow. On 13-APR-2018 (reported as that day), the patient contacted the clinic where the vaccines were administered and asked for help. An unspecified physician recommended to take BENADRYL. The patient took unspecified dose/intervals of BENADRYL and also loratadine. On 14-APR-2018 (reported as by Saturday afternoon), the swelling in the patient's arm began to decrease. At the time of the call, the reporter said that the patient's arm was pink at the injection site and still "painful but not as bad" as it was. Lab diagnostics/studies was not performed. The patient sought medical attention for the events. The outcome of malaise, vaccination site swelling, vaccination site warmth, vaccination site erythema and vaccination site pain were reported as recovering/resolving. On 13-APR-2018, the outcome of nausea and diarrhoea were recovered/resolved. Causality assessment was not reported. No further adverse event information was provided. There was no product quality complaint (PQC) reported.
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to a 13 year old male patient. On 14-JUL-2016, the patient received first dose in vaccination series of GARDASIL 9 (lot #: L037554, expiration date: 25-DEC-2017), second dose in vaccination series of GARDASIL 9 (lot #: N020353, expiration date: 28-APR-2020) on 22-MAR-2018, and third dose in vaccination series of GARDASIL 9 (lot #: N022727 expiration date: 12-JUN-2020) on 12-APR-2018 (dose, unit and route not specified) as prophylaxis. No adverse effects reported. Product quality complaint was not involved.
Sex: F
Vaccine: PPV
Symptoms: Antibody test negative, Blood immunoglobulin A decreased, Blood immunoglobulin G decreased, Blood immunoglobulin M normal, Immunodeficiency common variable
Clinical narrative: This literature marketed report was received from the authors of a published literature article, refers to a 50-year-old female patient whose immune evaluation was consistent with Common variable immunodeficiency (CVID). On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacture unknown) (strength, dose and route were unspecified). The patient had poor antibody responses to polysaccharide antigens after both a pneumococcal vaccine and its conjugated version (No therapeutic response) and was diagnosed with CVID in 2014. The patient had the following lab tests: Serum IgA was 54 mg/dL, Serum IgG was 551 mg/dL, Serum IgM was 113 mg/dL; S. pneumo Serotype 1 (1) Pre-Titers was 1.1, Post-Titers was 1.2;S. pneumo Serotype 3 (3) Pre-Titers was 0.9, Post-Titers was 0.6; S. pneumo Serotype 4 (4) Pre-Titers was 0.4, Post-Titers was less than 0.3;S. pneumo Serotype 5 (5) Pre-Titers was 10.9, Post-Titers was 6.1; S. pneumo Serotype 8 (8) Pre-Titers was 7.4, Post-Titers was 7.2;S. pneumo Serotype 9 (9N) Pre-Titers was 2.2, Post-Titers was 1.8; S. pneumo Serotype 12 (12F) Pre-Titers was 0.4, Post-Titers was 0.4; S. pneumo Serotype 14 (14) Pre-Titers was 0.6, Post-Titers was 0.6;S. pneumo Serotype 19 (19F) Pre-Titers was 2.8, Post-Titers was 2.6;S. pneumo Serotype 23 (23F) Pre-Titers was 3.3, Post-Titers was 3.2; S. pneumo Serotype 26 (6B) Pre-Titers was 2.1, Post-Titers was 1.8;S. pneumo Serotype 51 (7F) Pre-Titers was 17.9, Post-Titers was 11.3;S. pneumo Serotype 56 (18C)  Pre-Titers was 10.5, Post-Titers was 5.3;S. pneumo Serotype 68 (9V)  Pre-Titers was 35.7, Post-Titers was 35.2. She was started on intravenous immunoglobulin at 400 mg/kg monthly. The outcome of the event was unknown.
Sex: F
Vaccine: PPV
Symptoms: Immunoglobulin therapy, Therapy non-responder
Clinical narrative: This literature marketed report was received from the authors of a published literature article, refers to a 50-year-old female patient whose immune evaluation was consistent with Common variable immunodeficiency (CVID). On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacture unknown) (strength, dose and route were unspecified). The patient had poor antibody responses to polysaccharide antigens after both a pneumococcal vaccine and its conjugated version (No therapeutic response) and was diagnosed with CVID in 2014. The patient had the following lab tests: Serum IgA was 54 mg/dL, Serum IgG was 551 mg/dL, Serum IgM was 113 mg/dL; S. pneumo Serotype 1 (1) Pre-Titers was 1.1, Post-Titers was 1.2;S. pneumo Serotype 3 (3) Pre-Titers was 0.9, Post-Titers was 0.6; S. pneumo Serotype 4 (4) Pre-Titers was 0.4, Post-Titers was less than 0.3;S. pneumo Serotype 5 (5) Pre-Titers was 10.9, Post-Titers was 6.1; S. pneumo Serotype 8 (8) Pre-Titers was 7.4, Post-Titers was 7.2;S. pneumo Serotype 9 (9N) Pre-Titers was 2.2, Post-Titers was 1.8; S. pneumo Serotype 12 (12F) Pre-Titers was 0.4, Post-Titers was 0.4; S. pneumo Serotype 14 (14) Pre-Titers was 0.6, Post-Titers was 0.6;S. pneumo Serotype 19 (19F) Pre-Titers was 2.8, Post-Titers was 2.6;S. pneumo Serotype 23 (23F) Pre-Titers was 3.3, Post-Titers was 3.2; S. pneumo Serotype 26 (6B) Pre-Titers was 2.1, Post-Titers was 1.8;S. pneumo Serotype 51 (7F) Pre-Titers was 17.9, Post-Titers was 11.3;S. pneumo Serotype 56 (18C)  Pre-Titers was 10.5, Post-Titers was 5.3;S. pneumo Serotype 68 (9V)  Pre-Titers was 35.7, Post-Titers was 35.2. She was started on intravenous immunoglobulin at 400 mg/kg monthly. The outcome of the event was unknown.
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Musculoskeletal pain, Neck pain, Pain in extremity
Clinical narrative: This spontaneous report as received from a consumer refers to a 72 year old female patient with osteoporosis. The patient's medical history included an episode of shingles. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX, subcutaneous for prophylaxis. It was reconstituted with sterile diluent. On an unknown date, the patient experienced pain in her neck, shoulders, back and arm. The outcome of events was reported as not recovered/not resolved. Causality assessment was not provided.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a nurse practitioner referring to an adult patient of unknown age and gender. The patient's medical history, concurrent conditions and drug or allergy reactions were not provided. On an unspecified date in April 2018, the patient was inadvertently vaccinated with a dose PROQUAD, subcutaneously (strength, dose, dose number, lot number and expiration date were not reported), for prophylaxis; instead of an intended unspecified vaccination. Concomitant therapies included a sterile diluent (lot number and expiration date were not reported). No adverse events were reported.
Age: 23.0
Sex: M
Vaccine: ANTH
Symptoms: Headache, Injection site pain
Clinical narrative: Received a spontaneous report on 23JAN2018, 24JAN2018 and 25JAN2018 from personnel. The physician reported that on 23JAN2018, a patient who was overseas, received 5 ml of BIOTHRAX vaccine injected into the deltoid rather than the prescribed 0.5 ml amount. The subject experienced soreness at the site, and then developed mild headaches approximately 8 hours after the injection. No other complications were reported after 24 hours observation. The subject was restricted from caffeine and working out for the first 72 hours. It was also noted that he received a flu shot on 19DEC2017 and was on doxycycline for malaria prophylaxis. FOLLOW UP Information was received on 16FEB2018 from the physician. The physician reported that the patient was evaluated by medical personnel and no evidence of lingering side effects was found. It was also noted that the patient felt excellent, had no signs of complications at the sight, and no signs or symptoms that would lead one to believe he is not in perfect/usual health. No additional information is expected.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Extra dose administered, No adverse event, Wrong drug administered
Clinical narrative: Patient was given a 2nd dose of PVC13 instead of receiving PPSV23. Patient tolerated this well, no reaction.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site rash, Injection site swelling
Clinical narrative: SWELLING AT INJECTION SITE ALONG WITH RASH. WENT TO SEE FAMILY DOCTOR AND WAS GIVEN A STERIOD SHOT TO HELP WITH THE REACTION.
Age: 12.0
Sex: U
Vaccine: MENB
Symptoms: Malaise, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable physician via Pfizer sales representative. A 12-years-old patient of an unspecified ethnicity and gender received the first dose of TRUMENBA, via an unspecified route of administration on an unspecified date at single dose for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced malaise and fever on an unspecified date with outcome of unknown. Events took place after use of product. No follow-up attempts are possible. No further information is expected.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Fatigue, Headache, Listless, Pain
Clinical narrative: Initial unsolicited report received from a consumer on 24-Apr-2018. This case involves a 16-year-old female patient who was vaccinated with a 0.5 mL dose of MENACTRA (one dosage, batch number: U5841AA, expiry date, dose in series and site of administration were not reported) intramuscularly on 10-Apr-2018. The patient's medical history included allergy to Amoxicillin. Concomitant medication was not reported. On 10-Apr-2018, in the evening on the same day post vaccination, the patient developed headache, body aches, feeling extremely tired and listless. No other vaccinations given on that day. Relevant lab investigations and corrective treatment were not reported. On an unknown date, the patient was recovered from the events. List of documents held by sender: none.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Chest discomfort, Feeling abnormal, Oral mucosal exfoliation, Tinnitus, Urticaria
Clinical narrative: Peeling in the mouth. Welps on legs, chest, face. Felt bad. Ears ringing. Chest pressure.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Myalgia
Clinical narrative: Shivering, headache, myalgia and general fatigue, Relieved by NSAID. Shivering lasted about 24 hours, myalgia, general fatigue about 48 hours.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site reaction, Rash erythematous, Rash pruritic
Clinical narrative: Some normal pain at injection site. (Time was incorrect on previous question - according to pharmacy receipt, I received the SHINGRIX immunization at 5:16 PM - I'm not sure if I can go back and change it on this form). Primary reason for report is red flat rash that developed approximately 48 hours later just below the injection site. Spread towards shoulder and became itchy the next morning, remained flat and disappeared in 4 days. I never developed any blisters and the rash remained flat and mildly itchy, relieved by hydrocortisone cream. I did not see my doctor or report it to the pharmacy.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Haematology test normal, Headache, Hypoaesthesia, Immunology test normal, Laboratory test normal
Clinical narrative: Fever, body aches all over including arm pits and groin area, headache, numbness in fingers and toes, neck pain.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Neck pain, Pain, Pyrexia, Urine analysis normal
Clinical narrative: Fever, body aches all over including arm pits and groin area, headache, numbness in fingers and toes, neck pain.
Age: 31.0
Sex: F
Vaccine: VARCEL
Symptoms: Chest discomfort, Dyspnoea, Pyrexia
Clinical narrative: Employee came today to receive her second dose and asked me if she would have the same side effects as the first dose. When questioned she said she had a fever, which of course is a possibility, but she also said she had shortness of breath and it felt like someone was sitting on her chest for several days afterwards. She did not report this at the time, nor did she seek any medical treatment.
Age: 37.0
Sex: F
Vaccine: FLU4, MMR
Symptoms: Arthralgia, Asthenia, Blood count normal, Fatigue, Full blood count
Clinical narrative: Administered vaccines on Tuesday, 4/17/18. On Monday, 4/23/18, patient notified us that she has not been feeling well since "Friday 4/20/18." She reported to be experiencing fatigue, joint pain, and swelling to her upper and lower extremities. States that she is unable to put on her watch due to the excessive swelling. Sent patient to Occupational medicine on 4/23/18.
Age: 37.0
Sex: F
Vaccine: FLU4, MMR
Symptoms: Malaise, Metabolic function test normal, Peripheral swelling, Vaccination complication, Viral infection
Clinical narrative: Administered vaccines on Tuesday, 4/17/18. On Monday, 4/23/18, patient notified us that she has not been feeling well since "Friday 4/20/18." She reported to be experiencing fatigue, joint pain, and swelling to her upper and lower extremities. States that she is unable to put on her watch due to the excessive swelling. Sent patient to Occupational medicine on 4/23/18.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Dermatitis allergic, Feeling cold, Headache, Incomplete course of vaccination
Clinical narrative: First night had horrible chills. Could not warm up. Nasty headache in morning. Lasted 2 days. Arm swelled...Hot to touch. Returned to doctor on April 18th and was put on Doxycycline. 5 days later broke out in horrible rash. Went to Dermatologist 2x first visit Dermatologist thought it was yeast infection. Put me on appropriate meds. Rash spread...Second visit Dermatologist determined it was not a yeast infection but some type of reaction, perhaps to Doxycycline?? New medication for rash. Will not be taking second dose of SHINGRIX!
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Peripheral swelling, Rash, Skin warm
Clinical narrative: First night had horrible chills. Could not warm up. Nasty headache in morning. Lasted 2 days. Arm swelled...Hot to touch. Returned to doctor on April 18th and was put on Doxycycline. 5 days later broke out in horrible rash. Went to Dermatologist 2x first visit Dermatologist thought it was yeast infection. Put me on appropriate meds. Rash spread...Second visit Dermatologist determined it was not a yeast infection but some type of reaction, perhaps to Doxycycline?? New medication for rash. Will not be taking second dose of SHINGRIX!
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Cellulitis, Chills, Headache, Peripheral swelling, Skin warm
Clinical narrative: First night had horrible chills. Could not warm up. Nasty headache in morning. Lasted 2 days. Arm swelled...Hot to touch. Returned to doctor on April 18th and was put on Doxycycline. 5 days later broke out in horrible rash. Went to Dermatologist 2x first visit Dermatologist thought it was yeast infection. Put me on appropriate meds. Rash spread...Second visit Dermatologist determined it was not a yeast infection but some type of reaction, perhaps to Doxycycline?? New medication for rash. Will not be taking second dose of SHINGRIX!
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Dermatitis allergic, Feeling cold, Headache, Incomplete course of vaccination
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of cellulitis in a 70-year-old female patient who received SHINGRIX. Concomitant products included LIPITOR and SINGULAIR. On 10th April 2018, the patient received the 1st dose of SHINGRIX. In April 2018, 7 days after receiving SHINGRIX and an unknown time after starting Doxycycline Hydrochloride, the patient experienced cellulitis (serious criteria GSK medically significant), chills, skin warm, swelling arm and headache. The patient was treated with Doxycycline Hydrochloride. On an unknown date, the outcome of the cellulitis, feeling hot and swelling arm were recovering/resolving and the outcome of the chills was recovered/resolved and the outcome of the headache was unknown. The reporter considered the cellulitis, chills, feeling hot, swelling arm and headache to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX vaccine. The patient went to sleep about 4 to 5 hours after having the vaccine. Several hours after receiving the vaccination, the patient woke up with terrible chills. She put another cover up at night but was still experiencing chills. The patient also woke up the next day with a very annoying headache on the top of the headache, she stayed home the next day. A few days later (several days) after receiving vaccination, her arm where she received the vaccine started to swell and it got really hot to the touch. Then the next day, the patient did not have it and then it came back in full force. A week after receiving the vaccine, one of her coworkers said that she had cellulitis on her arm. She visited her physician and was prescribed doxycycline for one week to treat cellulitis. The patient required Emergency visit. The patient wanted to know should she take another dose.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Peripheral swelling, Rash, Skin warm
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of cellulitis in a 70-year-old female patient who received SHINGRIX. Concomitant products included LIPITOR and SINGULAIR. On 10th April 2018, the patient received the 1st dose of SHINGRIX. In April 2018, 7 days after receiving SHINGRIX and an unknown time after starting Doxycycline Hydrochloride, the patient experienced cellulitis (serious criteria GSK medically significant), chills, skin warm, swelling arm and headache. The patient was treated with Doxycycline Hydrochloride. On an unknown date, the outcome of the cellulitis, feeling hot and swelling arm were recovering/resolving and the outcome of the chills was recovered/resolved and the outcome of the headache was unknown. The reporter considered the cellulitis, chills, feeling hot, swelling arm and headache to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX vaccine. The patient went to sleep about 4 to 5 hours after having the vaccine. Several hours after receiving the vaccination, the patient woke up with terrible chills. She put another cover up at night but was still experiencing chills. The patient also woke up the next day with a very annoying headache on the top of the headache, she stayed home the next day. A few days later (several days) after receiving vaccination, her arm where she received the vaccine started to swell and it got really hot to the touch. Then the next day, the patient did not have it and then it came back in full force. A week after receiving the vaccine, one of her coworkers said that she had cellulitis on her arm. She visited her physician and was prescribed doxycycline for one week to treat cellulitis. The patient required Emergency visit. The patient wanted to know should she take another dose.