chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a consumer via Clinic refers to a currently 69 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 13-APR-2017, the patient was vaccinated with improperly stored dose of PNEUMOVAX 23 1 dose unit (lot # M036728, Expiry date was not reported) for prophylaxis. There were no previous temperature excursions recorded. It was unknown if data logger was involved. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1801USA000166.
Sex: F
Vaccine: PNC13
Symptoms: Discomfort, Erythema, Inflammation, Peripheral swelling
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient of an unspecified ethnicity received PREVNAR 13, via an unspecified route of administration on an unspecified date at a single dose as pneumonia vaccination. The patient's medical history and concomitant medications were not reported. It was reported that consumer was not sure if the product was PREVNAR 13 or other Pneumonia vaccine from other manufacturers. It was also reported that she had her second pneumonia shot on an unspecified date reported as last Tuesday and 2 hours after, her arms swelled and inflamed. On an unspecified date reported as today, she had a big red mark on her triceps area and it's uncomfortable. She tried applying ice packs and it's still there. She tried calling her health care provided but cannot be reached or the doctor was away and so now she called Pfizer to asked for the possible side effects after having a shot of our Pneumonia vaccine. The outcome of the events "big red mark on her triceps area and it's uncomfortable" was not recovered while unknown for the other events. Information regarding the batch number has been requested.
Age: 78.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Cough, Injected limb mobility decreased, Injection site pain, Loss of personal independence in daily activities, Pain
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program, received from a contactable consumer (reporting for herself). A 78-year-old female patient started to receive PREVNAR 13 (NDC number: 00005-1971-05), via an unspecified route of administration at a single dose in the right arm as she was 78 and told needed a pneumonia shot and FLUZONE HD; (NDC number: 49281-0401-65), via an unspecified route of administration at unknown dose and frequency in the left arm to prevent colds and flu both given on 21Nov2017. Medical history included bronchitis and ongoing glaucoma. The patient commented that she keeps shrinking. Concomitant medication included ongoing latanoprost, patient was taking for 4-5 years for glaucoma slow down. On 22Nov2017 (reported as next day after receiving the vaccine), the patient reported that she was not able to move her arm, not able to lift anything, pain in arm and in a lot of pain. The patient tried a heating pad and nothing is working. It was further reported that the patient got her flu shot in her left arm in the normal spot and her PREVNAR 13 was in the right arm. The patient feels the bandage is higher on the right arm and commented that she feels like maybe with PREVNAR 13 hit the bone as the bandage was not normally where she had been given a shot. Both vaccine was given on the same day however her left arm was fine. The patient reported that pain was excruciating during the shot. The soreness and not able to move her right arm started next day after receiving the vaccine which the patient reported most painful at night. The patient also reported that her range of motion is about 45 degrees, it still hurts to put on a coat and can't put on her sweater. The pain is a dull when her arm is hanging down by her side and sharper if she lifts or moves it. The patient also reported that she got possible bronchitis, but not diagnosed, and coughing. The patient has had bronchitis before and that is what it felt like as the patient reported. The outcome of the events was unknown. The symptoms from the cough and what felt like bronchitis had resolved on unspecified date. Information on the batch number/ expiry date has been requested.
Age: 78.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Pain in extremity
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program, received from a contactable consumer (reporting for herself). A 78-year-old female patient started to receive PREVNAR 13 (NDC number: 00005-1971-05), via an unspecified route of administration at a single dose in the right arm as she was 78 and told needed a pneumonia shot and FLUZONE HD; (NDC number: 49281-0401-65), via an unspecified route of administration at unknown dose and frequency in the left arm to prevent colds and flu both given on 21Nov2017. Medical history included bronchitis and ongoing glaucoma. The patient commented that she keeps shrinking. Concomitant medication included ongoing latanoprost, patient was taking for 4-5 years for glaucoma slow down. On 22Nov2017 (reported as next day after receiving the vaccine), the patient reported that she was not able to move her arm, not able to lift anything, pain in arm and in a lot of pain. The patient tried a heating pad and nothing is working. It was further reported that the patient got her flu shot in her left arm in the normal spot and her PREVNAR 13 was in the right arm. The patient feels the bandage is higher on the right arm and commented that she feels like maybe with PREVNAR 13 hit the bone as the bandage was not normally where she had been given a shot. Both vaccine was given on the same day however her left arm was fine. The patient reported that pain was excruciating during the shot. The soreness and not able to move her right arm started next day after receiving the vaccine which the patient reported most painful at night. The patient also reported that her range of motion is about 45 degrees, it still hurts to put on a coat and can't put on her sweater. The pain is a dull when her arm is hanging down by her side and sharper if she lifts or moves it. The patient also reported that she got possible bronchitis, but not diagnosed, and coughing. The patient has had bronchitis before and that is what it felt like as the patient reported. The outcome of the events was unknown. The symptoms from the cough and what felt like bronchitis had resolved on unspecified date. Information on the batch number/ expiry date has been requested.
Age: 76.0
Sex: F
Vaccine: PNC13
Symptoms: Mobility decreased, Musculoskeletal stiffness, Nasopharyngitis, Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for herself. This 76-year-old female consumer received PREVNAR 13 on an unspecified date in fall 2017, at single dose, in right arm, for immunisation. Medical history included ongoing high blood pressure and swollen feet. Ongoing concomitant medications included insulin (had been taking it for 10 years) and 3 different types of high blood pressure products that she has been on for years and had no side effects other than swollen feet. On an unspecified date in 2017 the consumer right arm was sore, stiff. The consumer explained the side effects as a delayed reaction that started in fall 2017, a month later after the injection. At the time of report it was dissipating slowly, getting better. Since an unspecified date the consumer had also a cold which had not yet resolved at the time of report.  Then on an unspecified date in 2017 the consumer developed a similar reaction also in left arm (left arm sore, stiff, could not raise left arm above eye level) after receiving influenza vaccine in left arm, on an unspecified date in Nov2017 or early Dec2017 for immunisation. It was worse than the right arm. Information on the batch number has been requested.
Age: 6.0
Sex: M
Vaccine: MMR
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling at site. No systemic issues.
Age: 49.0
Sex: F
Vaccine: UNK
Symptoms: Adverse event following immunisation
Clinical narrative: Oth complications following immunization, NEC, init on 2018-01-01.
Age: 1.25
Sex: M
Vaccine: DTAP, FLU4, HIBV, PNC13
Symptoms: Blood test normal, Depressed level of consciousness, Fatigue, Pyrexia, Seizure
Clinical narrative: 8 hours after receiving the vaccine listed pt developed seizures and a low grade fever was noted. Duration of episode was reported by parent as being 2-3 minutes followed by 20 min of unarousability followed by normal but somewhat tired behavior.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown age. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 04-DEC-2017, the patient was vaccinated with an expired dose of ZOSTAVAX 65 ml, subcutaneously for prophylaxis (lot number M037015, expiration date 22-NOV-2017). The dose of ZOSTAVAX was reconstituted with sterile diluent (MERCK). No adverse effects were reported.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 15 year old patient of unknown gender. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported. On an unknown date, the patient was inadvertently vaccinated with ZOSTAVAX instead of VARIVAX (dose, route, lot number and expiration date were not reported) for prophylaxis. No adverse effects were reported.
Sex: F
Vaccine: VARZOS
Symptoms: Chest discomfort, Dysgeusia, Dysphagia, Pain
Clinical narrative: This spontaneous report was received from a physician and refers to a non-pregnant female patient of unknown age. The patient did not have any concomitant medications, pertinent medical history, drug reactions or allergies. On 15-DEC-2017, the patient was vaccinated with ZOSTAVAX (dose, route of administration, lot# and expiry date were not provided) for prevention of shingles. On 15-DEC-2017 (reported as "later in the day, after receiving the injection"), the patient experienced body aches, hard time swallowing, chest feeling heavy, and taste buds changing. No lab diagnostic was performed. On 18-DEC-2017, the patient came to the physician's office. No specific treatment was given, as the patient stated feeling better by the time they saw the physician. The outcome of the events was reported as recovering. The causality assessment was not provided.
Age: 68.0
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a consumer via Clinic refers to a currently 68 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 08-NOV-2017, the patient was vaccinated with improperly stored dose of PNEUMOVAX 23 1 dose unit (lot # M036728, Expiry date was not reported) for prophylaxis (product storage error). There were no previous temperature excursions recorded. It was unknown if data logger was involved. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1801USA000166:
Age: 69.0
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a consumer via Clinic refers to a currently 69 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 06-NOV-2017, the patient was vaccinated with improperly stored dose of PNEUMOVAX 23 1 dose unit (lot # M036728, Expiry date was not reported) for prophylaxis. There were no previous temperature excursions recorded. It was unknown if data logger was involved. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1801USA000166.
Age: 82.0
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a consumer via Clinic refers to a currently 83 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 24-APR-2017, the patient was vaccinated with improperly stored dose of PNEUMOVAX 23 1 dose unit (lot # M036728, Expiry date was not reported) for prophylaxis (product storage error). There were no previous temperature excursions recorded. It was unknown if data logger was involved. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1801USA000166.
Age: 72.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Asthenia, Cough, Fatigue, Influenza like illness, Myalgia
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of influenza-like symptoms in a 72-year-old female patient who received Influenza vaccine Quadrivalent unspecified season. Co-suspect products included ZOSTAVAX. The patient's past medical history included fibromyalgia, esophageal hernia, reflux esophagitis, esophageal dysphagia and esophageal stricture. On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season and ZOSTAVAX at an unknown dose. On an unknown date, less than a year after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced influenza-like symptoms, weakness, cough, fatigability generalized, polymyalgia and general body pain. On an unknown date, the outcome of the influenza-like symptoms, weakness, cough, fatigability generalized, polymyalgia and general body pain were unknown. It was unknown if the reporter considered the influenza-like symptoms, weakness, cough, fatigability generalized, polymyalgia and general body pain to be related to Influenza vaccine Quadrivalent unspecified season. Additional details were provided as follows: The reporter reported for a family member and had limited information as the patient was not under their care. The patient received flu vaccine a month ago and experienced flu like symptoms, severe general fatigue, generalized myalgia (aches all over, feels like flu), cough, weakness but no fever. All the events started several days after ZOSTAVAX (which was previously considered as shingles vaccine). HCP had a limited information as the patient was a family member and not a patient under their care. HCP was unsure of which flu vaccine the patient received and later clarified that the patient received ZOSTAVAX and not SHINGRIX at local pharmacy.
Age: 72.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Pain
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of influenza-like symptoms in a 72-year-old female patient who received Influenza vaccine Quadrivalent unspecified season. Co-suspect products included ZOSTAVAX. The patient's past medical history included fibromyalgia, esophageal hernia, reflux esophagitis, esophageal dysphagia and esophageal stricture. On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season and ZOSTAVAX at an unknown dose. On an unknown date, less than a year after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced influenza-like symptoms, weakness, cough, fatigability generalized, polymyalgia and general body pain. On an unknown date, the outcome of the influenza-like symptoms, weakness, cough, fatigability generalized, polymyalgia and general body pain were unknown. It was unknown if the reporter considered the influenza-like symptoms, weakness, cough, fatigability generalized, polymyalgia and general body pain to be related to Influenza vaccine Quadrivalent unspecified season. Additional details were provided as follows: The reporter reported for a family member and had limited information as the patient was not under their care. The patient received flu vaccine a month ago and experienced flu like symptoms, severe general fatigue, generalized myalgia (aches all over, feels like flu), cough, weakness but no fever. All the events started several days after ZOSTAVAX (which was previously considered as shingles vaccine). HCP had a limited information as the patient was a family member and not a patient under their care. HCP was unsure of which flu vaccine the patient received and later clarified that the patient received ZOSTAVAX and not SHINGRIX at local pharmacy.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Headache, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of stomach pain in a adult female patient who received SHINGRIX. Concurrent medical conditions included allergy. On 11th December 2017, the patient received SHINGRIX. In December 2017, several hours after receiving SHINGRIX, the patient experienced stomach pain, headache, fever and chills. In December 2017, the outcome of the stomach pain, fever and chills were recovered/resolved. On an unknown date, the outcome of the headache was recovering/resolving. The reporter considered the stomach pain, headache, fever and chills to be possibly related to SHINGRIX. Additional details were reported as follows: Concomitant products included vitamins. At 10:00 hours (in morning), the patient received SHINGRIX. The patient experienced stomach ache, headache, fever and chills in night. All events were resolved, however she still had slight headache at the time of reporting. It was reported that this case was reported previously, however, no duplicate case was found.
Age: 49.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Cough, Injection site pain, Lymphadenitis
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 49-year-old female patient who received SHINGRIX (batch number 5Z5LX, expiry date 30th October 2020). Concomitant products included CENTRUM MVI and Vitamin B Supplements. On 13th December 2017, the patient received the 1st dose of SHINGRIX (intramuscular). On 14th December 2017, 1 days after receiving SHINGRIX, the patient experienced injection site pain, shivering, weakness generalized, cough nonproductive, lymphadenitis cervical, nausea and malaise. On an unknown date, the outcome of the injection site pain, shivering, weakness generalized, cough nonproductive, lymphadenitis cervical, nausea and malaise were not recovered/not resolved. The reporter considered the injection site pain, shivering, weakness generalized, cough nonproductive, lymphadenitis cervical, nausea and malaise to be probably related to SHINGRIX. Additional details were provided as follows: The patient reported for herself. The patient received CENTRUM and Vitamin B supplements. The patient felt like she had been 'run over by a truck' and was 'sick as a dog'. When the patient woke up to go to work, she experienced uncontrollable shivering, malaise, general weakness, soreness at injection site, inflamed cervical lymph nodes on the left side, nausea and non-productive cough. The patient described that the shivering 'comes and goes'. The patient had denied permission to contact their physician.
Age: 49.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Nausea
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 49-year-old female patient who received SHINGRIX (batch number 5Z5LX, expiry date 30th October 2020). Concomitant products included CENTRUM MVI and Vitamin B Supplements. On 13th December 2017, the patient received the 1st dose of SHINGRIX (intramuscular). On 14th December 2017, 1 days after receiving SHINGRIX, the patient experienced injection site pain, shivering, weakness generalized, cough nonproductive, lymphadenitis cervical, nausea and malaise. On an unknown date, the outcome of the injection site pain, shivering, weakness generalized, cough nonproductive, lymphadenitis cervical, nausea and malaise were not recovered/not resolved. The reporter considered the injection site pain, shivering, weakness generalized, cough nonproductive, lymphadenitis cervical, nausea and malaise to be probably related to SHINGRIX. Additional details were provided as follows: The patient reported for herself. The patient received CENTRUM and Vitamin B supplements. The patient felt like she had been 'run over by a truck' and was 'sick as a dog'. When the patient woke up to go to work, she experienced uncontrollable shivering, malaise, general weakness, soreness at injection site, inflamed cervical lymph nodes on the left side, nausea and non-productive cough. The patient described that the shivering 'comes and goes'. The patient had denied permission to contact their physician.
Sex: F
Vaccine: UNK
Symptoms: Influenza B virus test positive
Clinical narrative: Patient tested positive for Influenza type B. She had not received the influenza vaccine for 2017-18.
Age: 53.0
Sex: F
Vaccine: HEPA
Symptoms: Abdominal pain upper, Diarrhoea, Headache, Nausea, Vertigo
Clinical narrative: About 3:30 pm on 12/28/2017 began to have loose, watery stools with stomach cramps. This continued to occur every 1-2 hours with episodes of intense vertigo, nausea and headache.
Sex: M
Vaccine: VARCEL
Symptoms: Expired product administered, Wrong drug administered
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 66 year old male patient. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On an unknown date in 2017, the patient was inadvertently administered an expired dose of VARIVAX lot # L013068 with expiration date of 14-APR-2017, subcutaneouslly, for prophylaxis (strength, dose and frequency were not reported) instead of the intended dose of ZOSTAVAX (strength, frequency, lot/batch # and expiration date were not reported). The VARIVAX was diluted in sterile diluent (DILUENT MRK). There was not a temperature excursion. No adverse effects were reported.
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from and refers to a 4 months patient of unknown gender. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions, allergies or concomitant medications. On 30-NOV-2017, the patient was vaccinated with an improper stored dose of ROTATEQ orally for prophylaxis, lot number N003984, expiration date 19-NOV-2018 or lot number M044397, expiration date 20-JUN-2018 (the specific lot number and dose administered were unknown by the reporter). The temperature excursion was above 32 degrees Fahrenheit (°F) up to 35.4 °F for a time frame of 45 minutes, without previous temperature excursion and was called because of a digital data logger. There was not product quality complain or adverse effect involved.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. There was no information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant medication. On 07-DEC-2017, the patient was inadvertently vaccinated with PNEUMOVAX 23 lot # M006922, expiration date 21-JUN-2017 (formulation, strength, dose, frequency, route of administration were not reported) for prophylaxis. No adverse event was reported. No additional information was provided.
Age: 56.0
Sex: F
Vaccine: PPV, TD
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 56 year old female patient. The patient's concomitant therapies included aspirin (manufacturer unknown), vitamin B-Complex, calcium plus vitamin D, FLEXERIL, gabapentin, SYNTHROID, meloxicam, PAXIL and CRESTOR. The patient had no pertinent medical history, drug reactions and allergies. On 13-DEC-2017, the patient was vaccinated with PNEUMOVAX 23, lot # N023650, expiration date: 20-MAY-2019, in the left deltoid for prophylaxis (dose and exact route of administration were not reported). On the same day, the patient was also vaccinated with TETANUS AND DIPHTHERIA TOXOIDS ADSORBED. On 14-DEC-2017, the patient called physician's office and reported skin reactions on the injection site, as there was redness and swelling at the injection site which was "size of the golf ball". There was no fever, dyspnea, rash or facial swelling. The patient was advised to put an ice on the injection site. Also, the patient was prescribed with tramadol to use per needed. There was no laboratory diagnostic studies performed. On 18-DEC-2017, the patient was seen by the physician and the injection site was still swollen, however the event resolved in a few more days on an unknown date in December 2017. The relatedness between the events and PNEUMOVAX 23 was not reported.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Blood gases, Chest X-ray, Chest pain, Drug screen, Dysphagia
Clinical narrative: Rash at injection sites. Pt took 1 Benadryl at 2300 and 1 at 2330. Pt had trouble swallowing, chest pain, and itching. Was taken to the ER at Medical Center.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Fibrin D dimer, Injection site rash, Pregnancy test, Pruritus
Clinical narrative: Rash at injection sites. Pt took 1 Benadryl at 2300 and 1 at 2330. Pt had trouble swallowing, chest pain, and itching. Was taken to the ER at Medical Center.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Pain, Pain in extremity
Clinical narrative: Patient noted that almost immediately after receiving vaccine his opposite arm became sore as well, within a few hours his entire body was sore also - basically full body aches and pain in all joints by the end of the day.
Age: 1.5
Sex: F
Vaccine: FLU4, HEPA
Symptoms: Influenza virus test negative, Respiratory arrest, Resuscitation, Unresponsive to stimuli
Clinical narrative: ? febrile seizure vs BRUE in afternoon after event. Was unresponsive approx 30s not breathing required layperson CPR. EMS was called and transported child and stayed in ER several hours for observation. Child was d/c that evening.
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Confusional state, Fatigue, Vaccination complication, Vision blurred
Clinical narrative: Email received 12/29/17 from patient: Sent: Friday, December 29, 2017 1:25 PM Subject: flu vaccine reaction I heard you may be the person to talk to? I had a fairly severe reaction to my flu shot I received this year. I filled out an EMS report and left a message for employee health to call me but never heard back from them. Within an hour of my flu shot I developed significant blurred vision and confusion and went on to develop some intense joint pain with fatigue later that day and into the night. I normally do not have neurological problems and I have perfect vision at baseline. My questions are as follows: 1. What is the lot number of the flu vaccination I received and what are the specific additives? 2. Are there other people who received the flu vaccination this year that had adverse side effects similar to myself? 3. Who is responsible for reporting this adverse reaction to the CDC or other pertinent agencies? 4. What are the recommendations for future flu shots based on my reaction to this one? Thank you for your time and attention to this matter. Follow up email received 1/3/18: I never had any tests or ER visits done.  I did fill out an SAS report and also contacted my primary care providers office to report event in case they wanted to see me.  The best I can tell, I am recovered with the exception that I've been experiencing more joint pain than I can recall in the past but I'm not sure if that is related or just coincidence.
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. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 30-NOV-2017, the patient was vaccinated with an improperly stored dose of PROQUAD lot number N015624 and expiration date of 15-NOV-2018 for prophylaxis (dose, route of administration, lot number and expiration date were not reported) reconstituted with sterile water diluent lot number N007932 and expiration date of 06-MAY-2018. No adverse effects were reported. The vaccine was exposed to a temperature excursion of 15°F to 46°F with a time frame of 15 hours and 50 minutes, while the sterile water diluent did not undergo a temperature excursion. There was no previous temperature excursion. A "data logger" was involved. There was not product quality complaint involved. This is one of the two reports received from the same reporter.; Sender's Comments: US-009507513-1801USA001046:
Age: 26.0
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 26 year old patient of unknown gender. The patient's pertinent medical history and concurrent conditions were not reported. Concomitant therapies included sterile diluent (MERCK STERILE DILUENT). On 28-NOV-2017, the patient was vaccinated with an expired VARIVAX lot # L042265 with expiration date 26-OCT-2017 (dosage and route were not reported). No adverse effects reported.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker and refers to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history, drug reactions and allergies were not provided. On 13-DEC-2017, the patient was vaccinated with an expired dose of ZOSTAVAX lot # M036296; expiry date 14-NOV-2017 (dose and route of administration were not reported). Sterile diluent (MERCK STERILE DILUENT) used to reconstitute the vaccine was not expired. 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. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 29-NOV-2017, the patient was vaccinated with an improperly stored dose of PROQUAD lot number N010115 and expiration date of 24-SEP-2018 for prohylaxis (dose, route of administration, lot number and expiration date were not reported) reconstituted with sterile water diluent lot number (lot number and expiration date were not reported). No adverse effects were reported. The vaccine was exposed to a temperature excursion of 15°F to 46°F with a time frame of 15 hours and 50 minutes, while the sterile water diluent did not undergo a temperature excursion. There was no previous temperature excursion. A "data logger" was involved. There was not product quality complaint involved. This is one of the two reports received from the same reporter.; Sender's Comments: US-009507513-1712USA002600:
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, Therapy non-responder
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of therapy non-responder in a 54-year-old female patient who received Hepatitis B vaccine. Co-suspect products included Hepatitis B vaccine. On an unknown date, the patient received the 1st dose of Hepatitis B vaccine and the 2nd dose of Hepatitis B vaccine. In November 2017, 20 years after receiving Hepatitis B vaccine and Hepatitis B vaccine, the patient experienced therapy non-responder. On an unknown date, the outcome of the the therapy non-responder was unknown. It was unknown if the reporter considered the therapy non-responder to be related to Hepatitis B vaccine and Hepatitis B vaccine. Additional details were provided as follows: The age at vaccination was not reported but could be 33 or 34 years. Approximately 20 years ago, in 1997, the patient received 2 doses in a series of Hepatitis B vaccination. In November 2017, the patient had a blood test performed and the results of the test showed the previous vaccination did not stay in her blood, which led to the patient to be therapy non-responder. The patient's physician recommended the patient to be vaccinated against Hepatitis B again. The patient received 1st dose of ENGERIX B at the end of November 2017 and expected to get the 2nd dose at the end of December 2017. The dental assistant called to find out how quickly after the second of the three-dose series for ENGERIX-B could expect to have the titer test show positive for this vaccination. A clarification request was raised for vaccination schedule, as the information could not be obtained, the case was kept valid. This case was associated with medical information inquiry and the package insert was mailed to the dental assistant.
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Fever, red hot swollen firm spot on buttock where she was given injection. Was seen on day 5.
Age: 30.0
Sex: M
Vaccine: TYP
Symptoms: Dizziness, Syncope
Clinical narrative: Lightheadedness leading to brief syncopal episode. Patient could not tolerate any other position than supine for 2 hours. Received 25mg BENADRYL PO and symptoms resolved.
Age: 75.0
Sex: M
Vaccine: FLU3
Symptoms: Burning sensation, Erythema, Peripheral swelling, Pyrexia, Skin warm
Clinical narrative: Patient noticed that arm got red and got bigger over time that evening. Patient said redness was close to 12 inches in length. Patient got feverish. The second day patient put on a cold pack for 20 minutes at a time, that alleviated the burning and redness slightly. Patient did not take any TYLENOL. Patient said the redness on day 3 progressed to pinkness, but still is hot. Patient is no longer feverish.
Age: 28.0
Sex: F
Vaccine: FLUC4
Symptoms: Abortion missed, Exposure during pregnancy, Ultrasound antenatal screen abnormal
Clinical narrative: Was 9 weeks and 1 day pregnant when I received this vaccination. At 10 weeks and 1 day pregnant, a routine ultrasound showed the baby stopped growing at 9 weeks and 1 day (I had experienced a missed miscarriage). Due date was July 11 2018. Baby measured 2.5 cm to determine 9w1d death.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Acne, Rash erythematous, Rash pruritic
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of itchy rash in a 57-year-old female patient who received SHINGRIX (batch number 9XC39, expiry date 30th January 2020). On 9th December 2017, the patient received SHINGRIX (intramuscular) .5 ml. On 17th December 2017, 8 days after receiving SHINGRIX, the patient experienced itchy rash, erythematous rash and pimples. On an unknown date, the outcome of the itchy rash, erythematous rash and pimples were not recovered/not resolved. It was unknown if the reporter considered the itchy rash, erythematous rash and pimples to be related to SHINGRIX. Additional details were provided as follows: The pharmacist reported that one of their employees received the SHINGRIX vaccine. The patient broke out in a rash. Rash was all over torso and was bothersome but not life-threatening. Rash was described as being itchy, red and pimply.
Age: 57.0
Sex: M
Vaccine: FLUX
Symptoms: Swelling face
Clinical narrative: Pt managed by non-PCP. States previously received the influenza vaccine outside the clinic and developed facial swelling as a result. Denies any future influenza vaccines.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of pain in arm in a 75-year-old female patient who received SHINGRIX (batch number 9XC39, expiry date 30th January 2020). Concomitant products included BREO, PRILOSEC, trazodone, ARMOUR THYROID, azithromycin, ethambutol, Metoprolol, Rifampin, rosuvastatin, TRAVATAN Z and triamcinolone. On 13th December 2017, the patient received the 1st dose of SHINGRIX. In December 2017, less than a week after receiving SHINGRIX, the patient experienced pain in arm, swelling arm and erythema of extremities. On an unknown date, the outcome of the pain in arm, swelling arm and erythema of extremities were unknown. The reporter considered the pain in arm, swelling arm and erythema of extremities to be almost certainly related to SHINGRIX. Additional details were provided as follows: This case was not previously reported to anyone. Concomitant products also included CLODERM and hormone replacement therapy. The patient received SHINGRIX on the left arm and experienced pain in her left arm, redness on her left arm, and swelling on her left arm. This case has been linked with US2017GSK200906, reported by same reporter.
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from an administrator referring to a 10 week-old patient of unknown gender. The patient's relevant medical history, drug reactions/allergies and concomitant medication were not reported. On 28-NOV-2017, the patient was vaccinated with an improperly stored dose of ROTATEQ lot number: N003984 (expiration date: 19-NOV-2018) or lot number: M044397 (expiration date: 20-JUN-2018), orally, for prophylaxis (strength and dosage schedule were not provided). The specific lot number of ROTATEQ administered to the patient was unknown by the reporter. There was digital data logger involved. The storage characteristics were the following: Temperature: at or above 32 F up to 35 F (35.4F) for 45 minutes. - Previous temperature excursion: No No adverse effects were reported.
Age: 29.0
Sex: U
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to a 29 year old patient of unknown gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. In approximately October 2017, reported as 2 months ago the patient was vaccinated with PROQUAD for prophylaxis (dose, route of administration, lot number and expiration date were not reported). No adverse effects were reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concurrent conditions were not reported. On 04-DEC-2017, the patient was vaccinated with an improperly stored dose of VARIVAX lot # N015477 with expiration date 18-MAY-2019, for prophylaxis (dose and route of administration were not reported). Concomitant therapies included sterile diluent (STERILE DILUENT) which was properly stored. No adverse effects were reported. It was stated that the vaccine was exposed to a temperature between 15 to 46 Fahrenheit degrees with a time frame of 63 hours. No previous temperature excursion was reported. This is one of several reports from the same reporter.; Sender's Comments: US-009507513-1801USA001109: US-009507513-1801USA001110:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concurrent conditions were not reported. On 04-DEC-2017, the patient was vaccinated with an improperly stored dose of VARIVAX lot # N015477 with expiration date 18-MAY-2019, for prophylaxis (dose and route of administration were not reported). Concomitant therapies included sterile diluent which was properly stored. No adverse effects were reported. It was stated that the vaccine was exposed to a temperature between 15 to 46 Fahrenheit degrees with a time frame of 63 hours. No previous temperature excursion was reported. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1712USA002726: US-009507513-1801USA001110.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concurrent conditions were not reported. On 04-DEC-2017, the patient was vaccinated with an improperly stored dose of VARIVAX lot # N015477 with expiration date 18-MAY-2019, for prophylaxis (dose and route of administration were not reported). Concomitant therapies included sterile diluent(STERILE DILUENT) which was properly stored. No adverse effects were reported. It was stated that the vaccine was exposed to a temperature between 15 to 46 Fahrenheit degrees with a time frame of 63 hours. No previous temperature excursion was reported. This is one of several reports from the same reporter.; Sender's Comments: US-009507513-1712USA002726: US-009507513-1801USA001109:
Sex: U
Vaccine: FLU4
Symptoms: Wrong drug administered
Clinical narrative: In error pt was given a low dose pediatric flu vaccine, she was contacted and came back to the facility and received a regular dose of vaccine as recommended.
Age: 38.0
Sex: M
Vaccine: TDAP
Symptoms: Chills, Dizziness, Headache, Lethargy, Mobility decreased
Clinical narrative: The next 2 day 12-23 and 12-24 I experienced: Extreme lethargy (Had to go back to sleep after 6 hours). This was after a full 8 hours rest. Chills with uncontrolled shaking, Fever, Entire deltoid swollen and slightly painful when touched. Was hard to move arm. Slight muscle weakness. 12-25 and 12-26: Still abnormally lethargic, but had about 80 percent of my energy back. Arm still fully swollen. All other symptoms gone. 12-27: Returned to work after holiday and was still had some lethargy. Had a dizzy spell halfway through 8 hour shift. Drank water and took aspirin. Recovered to a dulling headache for the evening until I went to sleep at 9:00 PM. Arm less swollen and not as painful when touched. 12-30: Same amount of lethargy. Arm no longer swollen and painful. Bicep brachii and brachioradialis muscles have continuous non painful twitching. Never experienced this before. 1-3 (Today): Still same amount of lethargy. Same amount of muscle twitching.
Age: 38.0
Sex: M
Vaccine: TDAP
Symptoms: Muscle twitching, Muscular weakness, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: The next 2 day 12-23 and 12-24 I experienced: Extreme lethargy (Had to go back to sleep after 6 hours). This was after a full 8 hours rest. Chills with uncontrolled shaking, Fever, Entire deltoid swollen and slightly painful when touched. Was hard to move arm. Slight muscle weakness. 12-25 and 12-26: Still abnormally lethargic, but had about 80 percent of my energy back. Arm still fully swollen. All other symptoms gone. 12-27: Returned to work after holiday and was still had some lethargy. Had a dizzy spell halfway through 8 hour shift. Drank water and took aspirin. Recovered to a dulling headache for the evening until I went to sleep at 9:00 PM. Arm less swollen and not as painful when touched. 12-30: Same amount of lethargy. Arm no longer swollen and painful. Bicep brachii and brachioradialis muscles have continuous non painful twitching. Never experienced this before. 1-3 (Today): Still same amount of lethargy. Same amount of muscle twitching.
Age: 38.0
Sex: M
Vaccine: TDAP
Symptoms: Tremor
Clinical narrative: The next 2 day 12-23 and 12-24 I experienced: Extreme lethargy (Had to go back to sleep after 6 hours). This was after a full 8 hours rest. Chills with uncontrolled shaking, Fever, Entire deltoid swollen and slightly painful when touched. Was hard to move arm. Slight muscle weakness. 12-25 and 12-26: Still abnormally lethargic, but had about 80 percent of my energy back. Arm still fully swollen. All other symptoms gone. 12-27: Returned to work after holiday and was still had some lethargy. Had a dizzy spell halfway through 8 hour shift. Drank water and took aspirin. Recovered to a dulling headache for the evening until I went to sleep at 9:00 PM. Arm less swollen and not as painful when touched. 12-30: Same amount of lethargy. Arm no longer swollen and painful. Bicep brachii and brachioradialis muscles have continuous non painful twitching. Never experienced this before. 1-3 (Today): Still same amount of lethargy. Same amount of muscle twitching.
Age: 58.0
Sex: M
Vaccine: FLUC4
Symptoms: Injected limb mobility decreased, Injection site pain, Muscle disorder
Clinical narrative: Extreme left upper arm and bicep pain, at times limited ROM and increased pain. Currently seeing an ART specialist on site Indicates the following issues: adhesion's in bicep and deltoid muscle tissues.
Age: 1.92
Sex: F
Vaccine: FLU4
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Patient was given the 0.5mL instead of the 0.25mL FLUZONE. CDC informed me there is no reaction to the patient.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Pyrexia, Vomiting projectile
Clinical narrative: Pt experienced projectile vomiting and fever, went to ER, given zofran. Symptoms better less then 24 hours after vaccine administration.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Erythema, Myalgia, Pain in extremity, Pruritus
Clinical narrative: Patient is exchange student. Her host mother texted me a photo of patient's arm about 48 hours after vaccination. The photo showed 2 quarter sized circular patches of skin on her anterior forearm just above her antecubital area. Patient told her host mother that these patches were "itchy" and that her arm was achy. The vaccine was given in her left deltoid muscle several inches away from reddened area. Patient told her host mother that this started about 8 hours after the vaccine was given and skin was itchy. The reddened patches had not changed in size in last 24 hours per client. She also described her arm as "achy." Reviewed routine side effects with her host mom which includes sore muscle and instructed that ibuprofen or acetaminophen could help with achiness. Also recommended cool compress to arm. Suggested marking edges of reddened area with waterproof marker to determine if reddened area was increasing in size. Instructed to seek medical attention if skin worsening or any additional reddened area appears.
Age: 23.0
Sex: F
Vaccine: HEPA
Symptoms: Underdose
Clinical narrative: Client was given a pediatric Hepatitis A vaccine and should have been given an adult Hepatitis A vaccine.
Age: 16.0
Sex: F
Vaccine: FLU4, HPV9, MENB, MNQ
Symptoms: Pallor, Vomiting
Clinical narrative: VOMITING 1 CUP BRIGHT ORANGE VOMIT; SUBSEQUENT VITALS: SPO2: 99% HR 85 BP 125/83 RA TEMP 98.4 F ORAL. COLOR RETURNED TO FACE AFTER CRACKERS AND WATER. PATIENT REPORTS SHE DID NOT LOSE CONSCIOUSNESS, HAD NOT EATEN TODAY AND STARTED HER MENSTRUAL PERIOD SAME DAY. TAKEN TO DOCTOR FOR PHYSICAL AFTER VACCINE ADMINISTRATION.
Age: 62.0
Sex: F
Vaccine: TYP
Symptoms: Abdominal pain, Alanine aminotransferase increased, Constipation, Dizziness, Escherichia test negative
Clinical narrative: VIVOTIF was taken on 10/14/17, 10/16/17, 10/18/17, and 10/20/17. Adverse reactions started on 10/28/17. They were an abrupt onset of lower abdominal cramps and constipation, and dizziness and shakiness right before, during and after defecation. Patient tried to alleviate constipation with laxatives. At present (1/3/18), the dizziness and shakiness have subsided, but the abdominal cramping and constipation persists.