chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Decreased appetite, Headache, Injection site pain, Injection site swelling, Nausea
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a female patient who received SHINGRIX for prophylaxis. On 30th August 2018, the patient received the 1st dose of SHINGRIX. On 30th August 2018, several hours after receiving SHINGRIX, the patient experienced fever, general body pain, headache, nausea and appetite lost. On an unknown date, the outcome of the fever, general body pain, headache, nausea and appetite lost were unknown.  It was unknown if the reporter considered the fever, general body pain, headache, nausea and appetite lost to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient's body temperature was recorded as 100 degree F. The patient developed fever, body ache, headache, mild nausea, loss appetite, and not to mention swollen tender arm at the injection site. The patient was asking whether the 2nd injection was recomended in 2 to 6 months, should the patient expect to have less adverse reaction with the second injection or more, and how long should the patient expect the reactions to be lasted.
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a female patient who received SHINGRIX for prophylaxis. On 30th August 2018, the patient received the 1st dose of SHINGRIX. On 30th August 2018, several hours after receiving SHINGRIX, the patient experienced fever, general body pain, headache, nausea and appetite lost. On an unknown date, the outcome of the fever, general body pain, headache, nausea and appetite lost were unknown.  It was unknown if the reporter considered the fever, general body pain, headache, nausea and appetite lost to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient's body temperature was recorded as 100 degree F. The patient developed fever, body ache, headache, mild nausea, loss appetite, and not to mention swollen tender arm at the injection site. The patient was asking whether the 2nd injection was recomended in 2 to 6 months, should the patient expect to have less adverse reaction with the second injection or more, and how long should the patient expect the reactions to be lasted.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Asthenia, Chills, Decreased appetite, Feeling abnormal
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache in a 59-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included rheumatoid arthritis. Concomitant products included methotrexate. In April 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, 1 days after receiving SHINGRIX, the patient experienced headache, shivers, skin discoloration, weakness, upset stomach and appetite absent. On an unknown date, the outcome of the headache, shivers, skin discoloration, upset stomach and appetite absent were recovered/resolved and the outcome of the weakness was recovering/resolving. It was unknown if the reporter considered the headache, shivers, skin discoloration, weakness, upset stomach and appetite absent to be related to SHINGRIX. Additional details were provided as follows: The day after receiving SHINGRIX, the patient she the worst headache she has ever had in her life. She also had shivering, weakness and felt sick to her stomach such that she could not eat. She could not get off her sofa for 2 days she felt so bad. A few weeks after the first dose, the patient went to get her hair done and her hairdresser noticed what looked like a burn on the side of her forehead by her hairline. She had not burned herself and it was not painful at all. It resolved after about 3 weeks. This case has been linked with case US2018158113 (for 2nd dose), reported for same patient and case US2018158115 and US2018158117, reported by same reporter.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Skin discolouration
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache in a 59-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included rheumatoid arthritis. Concomitant products included methotrexate. In April 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, 1 days after receiving SHINGRIX, the patient experienced headache, shivers, skin discoloration, weakness, upset stomach and appetite absent. On an unknown date, the outcome of the headache, shivers, skin discoloration, upset stomach and appetite absent were recovered/resolved and the outcome of the weakness was recovering/resolving. It was unknown if the reporter considered the headache, shivers, skin discoloration, weakness, upset stomach and appetite absent to be related to SHINGRIX. Additional details were provided as follows: The day after receiving SHINGRIX, the patient she the worst headache she has ever had in her life. She also had shivering, weakness and felt sick to her stomach such that she could not eat. She could not get off her sofa for 2 days she felt so bad. A few weeks after the first dose, the patient went to get her hair done and her hairdresser noticed what looked like a burn on the side of her forehead by her hairline. She had not burned herself and it was not painful at all. It resolved after about 3 weeks. This case has been linked with case US2018158113 (for 2nd dose), reported for same patient and case US2018158115 and US2018158117, reported by same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site swelling, Injection site urticaria
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of injection site wheal in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site wheal, influenza-like symptoms and injection site swelling. On an unknown date, the outcome of the injection site wheal, influenza-like symptoms and injection site swelling were unknown. It was unknown if the reporter considered the injection site wheal, influenza-like symptoms and injection site swelling to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not applicable for this report. The age group was not reported but was selected as adult as per vaccine indication. The patient experienced flu-like symptoms and had an injection site welt the size of a baseball. The purpose of the healthcare professional's call was not to report the adverse events, she mentioned these, as an information, the reporter was asked if she wanted to report any case specifically and she declined, said the patient had flu like symptoms and larger swelling around the site. This case has been linked with case US2018158133, reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site muscle pain in a adult female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (1st dose received and experienced slight injection site pain refer linked case US2018158689). In June 2018, the patient received the 2nd dose of SHINGRIX. In June 2018, less than a month after receiving SHINGRIX, the patient experienced injection site muscle pain. On an unknown date, the outcome of the injection site muscle pain was unknown. It was unknown if the reporter considered the injection site muscle pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The pharmacist reported that the patient received 2 doses of SHINGRIX. Approximately in June 2018, the patient received 2nd dose of SHINGRIX. The patient experienced deep muscle pain and soreness that although somewhat improved, was still present 2 months after the injection at the date of reporting.
Sex: F
Vaccine: FLUX
Symptoms: Tenderness
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of tenderness in a adult female patient who received unspecified Influenza vaccine for prophylaxis. The patient's past medical history included breast cancer (didn't get any vaccine or bloodwork done in right arm.). Previously administered products included herpes zoster live-attenuated vaccine (received ZVL vaccine 5 years before the reporting date). On an unknown date, the patient received Influenza vaccine. On an unknown date, less than a year after receiving Influenza vaccine, the patient experienced tenderness. On an unknown date, the outcome of the tenderness was unknown. It was unknown if the reporter considered the tenderness to be related to Influenza vaccine. Additional details were reported as follows: The patient received influenza vaccine in left arm. The age at vaccination was not reported. Every year, the patient received flu vaccine, but did not always experience tenderness. The patient was unaware of the name brand of flu vaccine. HCP was not asked. The health care professional (HCP) not asked. This case linked with case US2018156128, reported by the same reporter for the same patient.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Malaise, Myalgia
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of myalgia in a 57-year-old male patient who received SHINGRIX for prophylaxis. On 3rd April 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced myalgia and feeling unwell. On an unknown date, the outcome of the myalgia and feeling unwell were unknown. It was unknown if the reporter considered the myalgia and feeling unwell to be related to SHINGRIX. Additional details were provided as follows: The patient had a dose of SHINGRIX and experienced what he thought to be regular side effects, that is myalgia and not feeling. This case has been linked with case US2018GSK157614 (same patient) reported by the same reporter. The reporter agreed to be contacted for follow up.
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a female patient who received Influenza vaccine Quadrivalent unspecified season for prophylaxis. On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced injection site swelling, injection site pain and injection site erythema. On an unknown date, the outcome of the injection site swelling, injection site pain and injection site erythema were recovered/resolved. It was unknown if the reporter considered the injection site swelling, injection site pain and injection site erythema to be related to Influenza vaccine Quadrivalent unspecified season. Additional details were provided as follows: The age at vaccination was not reported. The patient did not have the name of the flu vaccine or manufacturer and had limited information regarding the events related to the flu vaccine.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Extensive swelling of vaccinated limb, Headache, Injection site erythema, Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 72-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of injection site erythema (1st dose received on 21st June 2018, refer case ID US2018158177). Concomitant products included clindamycin and methotrexate. On 27th August 2018, the patient received the 2nd dose of SHINGRIX. On 28th August 2018, 1 days after receiving SHINGRIX, the patient experienced extensive swelling of vaccinated limb, injection site warmth, injection site erythema, injection site pain, headache, sleepiness, fever and chills. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the extensive swelling of vaccinated limb, injection site warmth, injection site erythema, injection site pain, headache, sleepiness, fever and chills were not recovered/not resolved. It was unknown if the reporter considered the extensive swelling of vaccinated limb, injection site warmth, injection site erythema, injection site pain, headache, sleepiness, fever and chills to be related to SHINGRIX. Additional details were provided as follows: The patient started taking clindamycin the same day he received SHINGRIX. About 24 hours later, the patient started going between chills and fever. He has had headaches and was sleeping 12 hours a day. The patient's arm was red, swollen, painful and warm at the injection site. The swelling was about 4 to 5 inches in diameter and had been getting worse as the days go by. At the date of reporting, the nurse at the fitness center drew a circle around the swelling so he could see if it continues to get worse or was getting better. The patient denied permission to contact their physician.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site warmth, Pyrexia, Somnolence, Vaccine positive rechallenge
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 72-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of injection site erythema (1st dose received on 21st June 2018, refer case ID US2018158177). Concomitant products included clindamycin and methotrexate. On 27th August 2018, the patient received the 2nd dose of SHINGRIX. On 28th August 2018, 1 days after receiving SHINGRIX, the patient experienced extensive swelling of vaccinated limb, injection site warmth, injection site erythema, injection site pain, headache, sleepiness, fever and chills. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the extensive swelling of vaccinated limb, injection site warmth, injection site erythema, injection site pain, headache, sleepiness, fever and chills were not recovered/not resolved. It was unknown if the reporter considered the extensive swelling of vaccinated limb, injection site warmth, injection site erythema, injection site pain, headache, sleepiness, fever and chills to be related to SHINGRIX. Additional details were provided as follows: The patient started taking clindamycin the same day he received SHINGRIX. About 24 hours later, the patient started going between chills and fever. He has had headaches and was sleeping 12 hours a day. The patient's arm was red, swollen, painful and warm at the injection site. The swelling was about 4 to 5 inches in diameter and had been getting worse as the days go by. At the date of reporting, the nurse at the fitness center drew a circle around the swelling so he could see if it continues to get worse or was getting better. The patient denied permission to contact their physician.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased appetite, Dizziness, Headache, Musculoskeletal pain, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of light headedness in a 76-year-old female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced light headedness, headache, shoulder pain, runny nose, appetite lost and pain in arm. On an unknown date, the outcome of the light headedness, headache, shoulder pain, runny nose, appetite lost and pain in arm were unknown. It was unknown if the reporter considered the light headedness, headache, shoulder pain, runny nose, appetite lost and pain in arm to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient reported that, on an unknown date the patient experienced light headedness, pain in arm, shoulder pain, runny nose, loss of appetite and head hurt. This case was linked with case US2018157965, reported by same reporter for the same patient.
Sex: F
Vaccine: VARZOS
Symptoms: Rhinorrhoea
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of light headedness in a 76-year-old female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced light headedness, headache, shoulder pain, runny nose, appetite lost and pain in arm. On an unknown date, the outcome of the light headedness, headache, shoulder pain, runny nose, appetite lost and pain in arm were unknown. It was unknown if the reporter considered the light headedness, headache, shoulder pain, runny nose, appetite lost and pain in arm to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient reported that, on an unknown date the patient experienced light headedness, pain in arm, shoulder pain, runny nose, loss of appetite and head hurt. This case was linked with case US2018157965, reported by same reporter for the same patient.
Sex: F
Vaccine: MENB
Symptoms: Erythema
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of erythema in a 18-year-old female patient who received BEXSERO for prophylaxis. Previously administered products included BEXSERO with an associated reaction of induration (received 1st dose on 18th July 2018 and experienced induration, refer case US2018GSK158625). On 24th August 2018, the patient received the 2nd dose of BEXSERO .5 ml. In August 2018, less than a week after receiving BEXSERO, the patient experienced erythema. On an unknown date, the outcome of the erythema was unknown. It was unknown if the reporter considered the erythema to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was nor reported but it could be 17 or 18 years. The patient received the BEXSERO in an unknown arm. The patient experienced redness of 3 inches and 1 and half inches in height. The reporter believed this to be related to the product. The reporter agreed to follow up. This case has linked to case US2018GSK158625, reported by the same reporter for same patient.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling hot, Tremor
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of feeling hot in a 81-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pain in extremity (1st dose received on 23rd May 2018, for tolerance refer case US2018158669). On 1st August 2018, the patient received the 2nd dose of SHINGRIX. On 1st August 2018, less than a day after receiving SHINGRIX, the patient experienced feeling hot and tremor of hands. On an unknown date, the outcome of the feeling hot and tremor of hands were recovered/resolved. It was unknown if the reporter considered the feeling hot and tremor of hands to be related to SHINGRIX. Additional details were provided as follows: The patient experienced shaking hands and feeling feverish which resolved within a half hour after the injection.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 79-year-old female patient who received SHINGRIX for prophylaxis. On 11th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional information was reported as follows: The batch number for SHINGRIX was not reported. The patient was vaccinated on the left arm. This case was linked with case US2018158732 (2nd dose), reported by the same reporter for the same patient.
Age: 61.0
Sex: F
Vaccine: TDAP
Symptoms: Paraesthesia, Weight decreased
Clinical narrative: Initial information received on 28-Aug-2018 regarding an unsolicited valid serious case received from a consumer. This case involves a 61 years old female patient who experienced one episode of loss of consciousness, lymph nodes in her neck are 'pulsing", burning sensation to her entire body, numbness in her ankles and toes, chest heaviness and pressure, difficulty breathing, sweating, drop in blood glucose, pressure in her head, confusion, feeling "foggy", painful joints, loss of appetite, four pound weight loss, feels pressure in her neck on the right side from mid-throat to collar bone, "jabs of pain" in her feet and hands and calves and looser than normal stool, worsening headache, tingling and nausea while she received vaccine ADACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient did not receive any other vaccine concomitantly. On 15-Aug-2018, the patient received a 0.5 ml dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot number U5898AA and Expiration Date 31-May-2020) in the left deltoid. On 25-Aug-2018, the patient developed a serious one episode of loss of consciousness, 10 days following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. This event was assessed as medically significant. On unknown date, the patient developed a non-serious lymph nodes in her neck are 'pulsing", burning sensation to her entire body, numbness in her ankles and toes, chest heaviness and pressure, difficulty breathing, sweating, drop in blood glucose, pressure in her head, confusion, feeling "foggy", painful joints, loss of appetite, four pound weight loss, feels pressure in her neck on the right side from mid-throat to collar bone, "jabs of pain" in her feet and hands and calves, looser than normal stool, worsening headache, tingling and nausea following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. Relevant tests were not reported. Final diagnosis was one episode of loss of consciousness, looser than normal stool, "jabs of pain" in her feet and hands and calves, feels pressure in her neck on the right side from mid-throat to collar bone, four pound weight loss, loss of appetite, nausea, painful joints, feeling "foggy", confusion, pressure in her head, drop in blood glucose, sweating, difficulty breathing, chest heaviness and pressure, numbness in her ankles and toes, burning sensation to her entire body, tingling, worsening headache and lymph nodes in her neck are 'pulsing". It was not reported if the patient received a corrective treatment. The outcome of the events was not reported. List of documents held by sender: None. Sender's Comments: This case involves a 61 years old female patient who presented with loss of consciousness post vaccination with ADACEL. Time to onset is compatible. However, patient's medical history, medical condition at the time of vaccination and lab tests ruling out alternate etiologies were not provided. Based upon the reported information, the role of the vaccine cannot be assessed.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Headache, Myalgia, Pain, Pruritus, Pyrexia
Clinical narrative: Fever 102 F,  headache (predicted), muscle ache (expected) but 2 days post-injection started to develop small red spots on hands and feet. Some filled with water and burst, turning into larger red , flat spots. Itchy and somewhat painful. Several on fingertips. Nurse at urgent care said it was not shingles since appearance was bilateral. She said she had never seen similar response. I am not allergic to eggs. Had first dose of SHINGRIX about 2 weeks prior to flu vac. I have photos if desired. I still have remaniants of the bumps but they appear to be healing. Treated them with corticosteroids cream OTC, Bender il and liquid bandaid to protect site.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Rash erythematous, Rash vesicular
Clinical narrative: Fever 102 F,  headache (predicted), muscle ache (expected) but 2 days post-injection started to develop small red spots on hands and feet. Some filled with water and burst, turning into larger red , flat spots. Itchy and somewhat painful. Several on fingertips. Nurse at urgent care said it was not shingles since appearance was bilateral. She said she had never seen similar response. I am not allergic to eggs. Had first dose of SHINGRIX about 2 weeks prior to flu vac. I have photos if desired. I still have remaniants of the bumps but they appear to be healing. Treated them with corticosteroids cream OTC, Bender il and liquid bandaid to protect site.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pain in extremity, Peripheral swelling, Pyrexia, Somnolence
Clinical narrative: She had pain and swelling in arm for 1 week. Fever on the first night. She was nauseated and drowsy.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Feeling hot, Pain
Clinical narrative: (1) Body aches, head-to-toe, (2) body shivers and teeth chattering, (3) Feeling hot after taking 2 ADVIL 19 hours after injection.
Age: 6.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Redness with swelling on the injection site. At first itchy but painful for patient.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Pain in extremity, Rash, Rash erythematous, Skin warm
Clinical narrative: Left arm is extremely sore and patient is having difficulty moving arm. She also has a red warm rash on left arm.
Age: 17.0
Sex: F
Vaccine: HPV9, MENB, MNQ
Symptoms: Cold sweat, Loss of consciousness, Pallor, Syncope
Clinical narrative: Approx. 2 minutes after vaccines were completed- syncope event, ammonia placed in front of nose and patient regained consciousness. Became clammy, pale. Within 5 minutes patient was back to baseline.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood pressure increased, Dizziness, Gait disturbance, Headache, Heart rate increased
Clinical narrative: Severe headache started immediately after shot. When I got home headache was worse, nausea, hurting all over body, fever, as night went on could not walk to bathroom without holding on to something, very dizzy. Blood pressure on bottom was 94. Pulse rate stayed at 95 and only dropped to 94 through night and all day Sunday until 3:00pm went back to normal pulse and blood pressure. Still had headache until Monday morning. I was very sick could not sit or stand up all night after shot. I went to Dr. on Monday morning he said I should not take the next shot at all.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Malaise, Nausea, Pain, Pyrexia
Clinical narrative: Severe headache started immediately after shot. When I got home headache was worse, nausea, hurting all over body, fever, as night went on could not walk to bathroom without holding on to something, very dizzy. Blood pressure on bottom was 94. Pulse rate stayed at 95 and only dropped to 94 through night and all day Sunday until 3:00pm went back to normal pulse and blood pressure. Still had headache until Monday morning. I was very sick could not sit or stand up all night after shot. I went to Dr. on Monday morning he said I should not take the next shot at all.
Age: 60.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Dizziness, Fatigue, Headache, Injection site pain
Clinical narrative: Soreness at injection site. Muscle pain. Nausea. Chilling. Fever. Headache. Dizziness. Fatigue .
Age: 60.0
Sex: F
Vaccine: PNC13
Symptoms: Myalgia, Nausea, Pyrexia
Clinical narrative: Soreness at injection site. Muscle pain. Nausea. Chilling. Fever. Headache. Dizziness. Fatigue .
Age: 36.0
Sex: F
Vaccine: TYP
Symptoms: Abdominal discomfort, Abdominal pain upper, Erythema, Flushing, Nausea
Clinical narrative: First pill was taken on the evening of 9/2/2018 at which point there was minor nausea and upset stomach for the remainder of that night and into 9/3/2018. I was also flush to the point where people would ask why my cheeks were red. Due to this nausea, I did not eat breakfast and proceeded to return to the clinic on 9/4/2018 for my Hep A and B and 2nd does of Rabies vaccine. After which point, I got lunch and had stomach cramping. At this point the cramping intensified as did the nausea to the point where even drinking some water became painful. The pain would come in waves (with or without eating food or drinking liquid) and last for about an hour. I would turn flush and feel achy. I returned to the clinic on 9/6/18 at which point I was told to stop taking the vaccine. That day, I was still not hungry so ate very little. I did not have severe cramping on this day. By 9/7/18 I was totally normal.
Age: 36.0
Sex: F
Vaccine: TYP
Symptoms: Pain
Clinical narrative: First pill was taken on the evening of 9/2/2018 at which point there was minor nausea and upset stomach for the remainder of that night and into 9/3/2018. I was also flush to the point where people would ask why my cheeks were red. Due to this nausea, I did not eat breakfast and proceeded to return to the clinic on 9/4/2018 for my Hep A and B and 2nd does of Rabies vaccine. After which point, I got lunch and had stomach cramping. At this point the cramping intensified as did the nausea to the point where even drinking some water became painful. The pain would come in waves (with or without eating food or drinking liquid) and last for about an hour. I would turn flush and feel achy. I returned to the clinic on 9/6/18 at which point I was told to stop taking the vaccine. That day, I was still not hungry so ate very little. I did not have severe cramping on this day. By 9/7/18 I was totally normal.
Age: 28.0
Sex: M
Vaccine: HEPA, TDAP, TYP
Symptoms: Wrong product administered
Clinical narrative: He and his wife were getting vaccines. The TDAP was for her but given to him instead.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. Information regarding the patient's concurrent conditions, medical history and concomitant medications was not provided. On 14-AUG-2018, the patient was vaccinated with one improperly stored dose of ROTATEQ orally, lot # N029669, expiration date: 02-SEP-2019 for prophylaxis. The administered dose of ROTATEQ was exposed to the temperature between 9 degree Celsius to 25 degree Celsius (9.3 degree Celsius) for 15 minutes. Previous temperature excursion was between 2 degree Celsius to 8 degree Celsius (1.8 degree Celsius) for 10 minutes. Digital data logger was involved. No adverse effects were reported.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Hypersensitivity, Pain in extremity, Peripheral swelling, Tenderness
Clinical narrative: Patient received her 2nd SHINGRIX dose on 9/8/18 at around 10:15AM. She called on 9/10/18 at about 12:30PM to report that in the morning during her shower she realized her arm was very sore, red, slightly swollen, and tender to touch. I (pharmacist) asked if the allergic reaction was localized or if any other signs and symptoms (e.g. trouble breathing, fever, etc.). Patient verbalized it was just her arm and I recommended her to take 2 tablets of BENADRYL when she gets home from work as it can cause drowsiness. I told her I would call her primary care physician to have the office also document this in her records. I called the office at 12:45pm and at 1:03pm was able to talk to a nurse who said Dr. is not in office but she will relay the message to the covering doctor. Called patient at ~6pm and left her a voicemail for follow-up. On 9/11/18 (9:26am) was able to speak to staff at the doctor's office and stated that the incident is already documented and patient was told by the nurse practitioner to take BENADRYL and ice it as well. They told her if redness persists or spread to go in for an office visit. I called patient at 9:32am to relay the information and patient verbalized understanding and stated she is feeling a lot better after the BENADRYL and the arm does not look as red.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Erythema, Pruritus
Clinical narrative: On 9/1/18 I developed what looks like poison ivy on my right hand. Blisters, redness, itching occurred. This spread to my abdomen and to my left hand developing blisters, redness and itching. It lasted 10 days before I contacted Dr. to get a Rx for Steroid treatment. I don't know if it is poison ivy OR related to the SHINGRIX vaccination. I am worried about getting the second dose. Please advise.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Headache, Injection site pain, Injection site paraesthesia, Pain in extremity, Paraesthesia
Clinical narrative: Pt received flu vaccine on 10/17/17. About 8 hours later, she started getting tingling in her upper arm (arm that flu shot was given in) which extended up into her neck. The patient visited the ER to address this tingling. The tingling feeling would come and go and last anywhere from 10 minutes to 1 hour. She stated that she developed a headache associated with the tingling. She mentioned that she got the flu shot at the Clinic, and the shot hurt "really bad" when she got it, and thought the person giving it to her might have hit a nerve. She gets the flu shot every year, and this has never happened before; usually, she will get a circle of redness on her arm (about 3-4 inches in diameter), but she did not get that this year. ER doctor told patient to use TYLENOL/MOTRIN as needed for discomfort and instructed the patient to return if she had any increased symptoms, fever, worsening headache, or weakness in the left upper extremity. Patient was also instructed to f/u with the Clinic in the morning for a recheck. As of today (9/11/18), Pt still has pain in the arm.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Neck pain
Clinical narrative: Patient stated that the second day after receiving the vaccination that he had soreness on the left side of his neck and redness and pain at the injection site. The redness was about 3-4 inches in diameter around the area of the vaccination. No bruising however. Pharmacist spoke with patient about taking TYLENOL to help with pain or to use ice or heat whichever felt better on the neck and injection site area.
Age: 30.0
Sex: M
Vaccine: TD, TYP
Symptoms: Back pain, Musculoskeletal stiffness
Clinical narrative: 30-year-old AD male with a past medical history significant for known NSAID allergies (ibuprofen, and aspirin cause angioedema). Patient received typhoid and Td on 5 September 2018.  Within one hour patient began to develop upper back pain and neck stiffness. Symptoms progressed in severity enough to prompt an evaluation by the emergency department on the same day, where he was prescribed ULTRAM and NORFLEX. However, he has been somewhat noncompliant with these medications due to the sedative effects of these medications and the requirement to continue to work. Patient specifically denies any red flags such as paresthesias, muscle weakness, generalized rash, lip swelling, tongue swelling, throat tightness, or any airway or vascular compromise associated with these or any previous immunizations.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: The arm is red and swollen from the injection site of the PNEUMOVAX 23 all the way to the elbow.  The greatest swelling is close to the elbow. It is warm to the touch. Patient has used ice last night and taken a single dose of BENADRYL last night. She is going to repeat the BENADRYL this morning and a dose of MOTRIN.
Age: 74.0
Sex: M
Vaccine: PNC13
Symptoms: Pain in extremity
Clinical narrative: Patient received PREVNAR 13 on 8/14/18. He called into the pharmacy on 09/11/2018. Patient states that the immunization was painless, but his arm was hurting afterwards (starting next day) for a "long time". Patient was advised to take a tablet of TYLENOL at the time of immunization in case of possible pain at the injection site. When asked if he took the TYLENOL, patient said that "TYLENOL is poison" and he would never take it. Patient was asked if there anything that we could do for him at the moment, and he said "no".
Age: 1.58
Sex: F
Vaccine: FLU4
Symptoms: Extra dose administered
Clinical narrative: Patient received a flu vaccine on 2/22/18 and 3/22/18 because she had only received one dose in the previous season. She returned to clinic on 4/25/18 and received a 3rd flu vaccine in the same season that was not necessary.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Injection site discolouration, Injection site erythema, Injection site swelling, Pain in extremity
Clinical narrative: Localized irritation. Erythema radiating out 2-3 inches from injection site. Raised white area radiating out 1/4 inch from injection site. Still evident 5 days after injection. Pain in arm greater than 4 days, most intense the first 2 days. Unable to raise arm above chest level for 2 days. Treated with ibuprofen and acetaminophen.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin irritation
Clinical narrative: Localized irritation. Erythema radiating out 2-3 inches from injection site. Raised white area radiating out 1/4 inch from injection site. Still evident 5 days after injection. Pain in arm greater than 4 days, most intense the first 2 days. Unable to raise arm above chest level for 2 days. Treated with ibuprofen and acetaminophen.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Headache, Nausea, Pain, Vomiting
Clinical narrative: Vaccine not in list - SHINGRIX vial. Nausea vomiting headache diarrhea achiness.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Patient came in with a warm red patch on her left arm 3 inches below the injection site. She said that it did not cause her pain and did not itch. Per our treatment protocol, patient was advised to use ice and ibuprofen to control any pain/swelling.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Blood culture negative, Erythema, Full blood count, Injection site erythema, Injection site swelling
Clinical narrative: 66-year-old female presenting to ED on 9/1/18 for evaluation left upper extremity redness and swelling. Symptoms began that morning. She indicates area of redness, swelling of medial left upper arm extending into left forearm. States the swelling was worse this morning and has improved throughout the day. Denies any other symptoms.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Metabolic function test, Peripheral swelling, Procalcitonin, Ultrasound Doppler
Clinical narrative: 66-year-old female presenting to ED on 9/1/18 for evaluation left upper extremity redness and swelling. Symptoms began that morning. She indicates area of redness, swelling of medial left upper arm extending into left forearm. States the swelling was worse this morning and has improved throughout the day. Denies any other symptoms.
Age: 4.0
Sex: M
Vaccine: FLU4
Symptoms: Vomiting
Clinical narrative: Vomiting.
Age: 3.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site rash, Injection site swelling, Rash
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 3-year-old male patient. The patient's pertinent medical history included an unspecified reaction to PREVNAR 13. On 09-AUG-2018, the patient was vaccinated with (Oka/Merck) VARIVAX injection, into left arm (lot # R002506, expiration date: 25-JAN-2020, indication was reported as vaccination, dose and route of administration were not provided). On 10-AUG-2018, the patient experienced swelling and a rash in left arm with small little bumps around the injection site. The physician sent the patient to an unspecified emergency room on 10-AUG-2018, where patient received unspecified BENADRYL. The patient was treated and released from emergency room the same night. No laboratory diagnostics or studies were performed. The outcome of the events was reported as recovering. The relatedness between the events and (Oka/Merck) VARIVAX was not reported.
Age: 1.0
Sex: F
Vaccine: MMRV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner who was reporting on a 1 year old female patient. The patient's concurrent conditions, medical history and concomitant medicines were unspecified. On an unknown, date approximately in 2013 (reported as at her 1 year visit), the patient the was vaccinated with measles-mumps-rubella and varicella virus vaccine (manufacturer unknown) with first dose at her first year visit. It was not known if the patient had received Oka/Merck VARIVAX (dose, unit, route of administration, #lot and expiration date were not reported) and (wistar ra 27-3) M-M-R II (dose, unit, route of administration, #lot and expiration date were not reported) or Oka-Merck PROQUAD (dose, unit, route of administration, #lot and expiration date were not reported) at this visits for prophylaxis. On an unknown date, approximately in 2016, the patient the was vaccinated with measles-mumps-rubella and varicella vaccinations (manufacturer unknown) with second dose at her fourth year visit. It was not known if the patient had received Oka/Merck VARIVAX (dose, unit, route of administration, #lot and expiration date were not reported) and (wistar ra 27-3) M-M-R II (dose, unit, route of administration, #lot and expiration date were not reported) or Oka-Merck PROQUAD (dose, unit, route of administration, #lot and expiration date were not reported) at these visits for prophylaxis. On 17-AUG-2018, at her 6 years check up, the patient was vaccinated with a dose of Oka-Merck PROQUAD third dose (dose, unit, route of administration, lot# and expiration date were not reported) reconstituted in sterile diluent (manufacture unknown) for prophylaxis. No adverse effects were noted.
Age: 72.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Injected limb mobility decreased
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injected limb mobility decreased in a 72-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included Herpes Zoster Vaccine (received a few years before the reporting date). Concurrent medical conditions included back disorder, spinal disorder (two times spine fracture.), sciatic neuralgia and mobility decreased. Concomitant products included PNEUMONIA VACCINE. On 25th April 2018, the patient received the 1st dose of SHINGRIX. On 25th April 2018, less than a day after receiving SHINGRIX, the patient experienced injected limb mobility decreased. On 30th April 2018, the outcome of the injected limb mobility decreased was recovered/resolved. It was unknown if the reporter considered the injected limb mobility decreased to be related to SHINGRIX. Additional information was received as follows: The reporter stated that she received SHINGRIX on the left arm and Pneumonia vaccine on the right arm. At night, the patient's left arm having difficulty of moving it and went on for 5 days then resolved.  She noted that she could not move both legs or arms due to the sciatic nerves in her legs and she had a history of back and spine issues long before SHINGRIX. The patient stated that surgery was planned in the future because she had nerve on bone areas that are causing her pain.  She would like to get the second dose of SHINGRIX in her backside but stated no pharmacy would gave it to her there.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of rash in a 52-year-old female patient who received SHINGRIX (batch number TP5E5, expiry date 15th November 2020) for prophylaxis. On 3rd July 2018, the patient received the 1st dose of SHINGRIX .5 ml. In July 2018, 2 days after receiving SHINGRIX, the patient experienced rash. On an unknown date, the outcome of the rash was recovered/resolved. The reporter considered the rash to be unrelated to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on the left arm. The healthcare professional reported that,  the patient experienced a rash under the arm (left arm pit area). It was stated that, the reaction started a few days after the vaccination date which lasted for 3 to 4 weeks. The patient also shaved after receiving the vaccine. The healthcare professional would like to know if this was a common reaction and if the patient should receive the 2nd dose. This was escalated to an MED for recommendations.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, 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 71-year-old male patient who received SHINGRIX for prophylaxis. On 18th August 2018 13:15, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a month after receiving SHINGRIX, the patient experienced injection site pain, injection site swelling and injection site erythema. On an unknown date, the outcome of the injection site pain and injection site erythema were recovered/resolved and the outcome of the injection site swelling was not recovered/not resolved. It was unknown if the reporter considered the injection site pain, injection site swelling and injection site erythema to be related to SHINGRIX. Additional information was received as follows: The patient received SHINGRIX on the right deltoid. The pain and redness have subsided, but the swelling persisted.
Sex: F
Vaccine: MENB
Symptoms: Adverse event, Pain in extremity
Clinical narrative: This case was reported by an other health professional via sales rep and described the occurrence of pain in arm in an adolescent female patient who received BEXSERO for prophylaxis. On an unknown date, the patient received BEXSERO at an unknown dose. On an unknown date, unknown after receiving BEXSERO, the patient experienced pain in arm and adverse event. On an unknown date, the outcome of the pain in arm was recovered/resolved and the outcome of the adverse event was unknown. It was unknown if the reporter considered the pain in arm and adverse event to be related to BEXSERO. Additional details were provided as follows: This case was reported by Certified Medical Assistant (CMA). The age at vaccination was not reported. The patient experienced arm soreness 5 days out and other reactions. The reporter agreed for follow up contact.